This first edition of the National Standards for Ambulatory Care Centers was developed through

a consensus process which entailed the participation of all the relevant stakeholders.
From the beginning, the aim was to have a set of standards that are detailed and descriptive,
assembled around the key services of Ambulatory Care Centers, based on the current best
healthcare practices.

NATIONAL STANDARDS FOR AMBULATORY CARE CENTERS

The goal of this manual is to be used as a reference for achieving the optimal care for patients
and their families, given the national challenges that we are facing today. All standards included
in this manual are effective from 1st January 2020.

The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) is a non-profit
organization emerging from the Saudi Health Council and is responsible for setting and
implementing the quality and patient safety standards in Saudi Arabia.
CBAHI began a few years ago with only a few hospitals enrolled in the accreditation process and
a limited number of surveyors and staff.
Today, CBAHI is proud to have a comprehensive set of evidence-based standards that are utilized
for the assessment of thousands of healthcare facilities across the country.

‫المعايـيـــر الوطنـيــة للمراكـــز والمجمـعــات الطبــــيـــة الخــارجيــة‬

‫المعاييــر الوطنـيــة‬
‫للمراكـــز والمجمعات الطبية الخارجية‬

‫ المملكة العربية السعودية‬،‫ الرياض‬،‫ حي المروج‬،12264 ‫ الرياض‬،2415 :‫ب‬.‫ص‬

NATIONAL
P.O. Box 2415, Riyadh 12264 Al-Muruj Dist., Riyadh, Saudi Arabia

920012512
STANDARDS FOR
cbahi@cbahi.gov.sa AMBULATORY FIRST EDITION 2019
CARE CENTERS EFFECTIVE FROM 1st January 2020
NATIONAL STANDARDS FOR
AMBULATORY CARE CENTERS

Saudi Central Board for

Accreditation of Healthcare
Institutions

First Edition
2019

Effective
1st January 2020
 The mission of the Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) is
to continuously improve the safety and quality of healthcare services in the Kingdom of Saudi
Arabia, by supporting healthcare facilities to continuously comply with the accreditation standards.
CBAHI does this through the provision of preparation, on-site assessment, monitoring, education,
publications and consultation services.

CBAHI is making every possible effort to separate its consultative and educational programs as
well as all publications it produces from its accreditation activities. This manual is produced for the
sole use of the individual healthcare facilities and healthcare professionals in Saudi Arabia. CBAHI
provides supplementary educational sessions to explain the intent of this manual and its contents
and therefore, attendance at these activities is helpful in achieving compliance with the quality
and safety standards followed by accreditation. Attendees at CBAHI training, orientation and
educational programs and purchasers of its publications will not have a distinctive treatment by
any CBAHI associates including CBAHI surveyors, nor receive any privilege regarding assessment
scoring results or outcome.

The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI), a not-for-profit
governmental organization, has been required by its formation order to support all healthcare
organizations in Saudi Arabia through different mechanisms, including the production of scientific
peer reviewed standards, materials and publications.

This is a copyright material. No part of this publication may be reproduced or stored in a retrieval
system for usage outside the concerned organization, or transmitted for public use in any form
or by any means such as, electronic mechanical, photocopying, recording or otherwise - without
prior permission of CBAHI which can be accessed on the following address: cbahi@cbahi.gov.sa

Requests for copies or permission to make copies of any part of this work should be sent to the
above email address or otherwise to the following mailing address below:

Department of Public Relations

The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI)
P.O. Box 9264, Riyadh, 12264, Kingdom of Saudi Arabia
ISBN: 978-603-90504-5-2
Printed in the Kingdom of Saudi Arabia, Riyadh

For more information about CBAHI publications, please visit: http://www.cbahi.gov.sa

4
‫المركــز الســعودي العتمــاد المنشــآت الصحيــة ( ســباهي) هــو الجهــة الرســمية المخولــة منــح شــهادات اعتمــاد الجــودة‬
‫لكافــة المرافــق الصحيــة الحكوميــة والخاصــة التــي تعمــل فــي المملكــة العربيــة الســعودية‪ .‬ينبثــق المركــز أساســً عــن‬
‫المجلــس الصحــي الســعودي ‪ ،‬ويعتبــر جهــة غيــر هادفــة للربــح ‪ ،‬يتولــى بشــكل ٍ أساســي تقييــم المنشــآت الصحيــة‬
‫بغــرض تحديــد مــدى التزامهــا بتطبيــق معاييــر الجــودة وســامة المرضــى التــي صممهــا المركــز لهــذا الغــرض‪ .‬بــدأ‬
‫المركــز عملــه تحــت مســمى المجلــس المركــزي العتمــاد المنشــآت الصحيــة بقــرار معالــي وزيــر الصحــة رئيــس مجلــس‬
‫الخدمــات الصحيــة رقــم (‪ )144187‬وتاريــخ ‪1426-9-1‬هـــ ‪ ،‬واســتمر فــي تأديــة المهــام المناطــة بــه حتــى صــدور قــرار مجلــس‬
‫الــوزراء الموقــر رقــم (‪ )371‬وتاريــخ ‪1434-11-24‬هـــ ‪ ،‬القاضــي بتحويلــه إلــى المركــز الســعودي العتمــاد المنشــآت الصحيــة‬
‫‪ ،‬واســتمراره فــي وضــع وتطبيــق المعاييــر الوطنيــة للجــودة وســامة المرضــى فــي كافــة المرافــق الصحيــة ومنــح‬
‫شــهادات االعتمــاد المتعلقــة بذلــك‪ .‬يعتبــر الحصــول علــى االعتمــاد الوطنــي مــن قبــل المركــز الســعودي إلزاميــً علــى‬
‫كافــة المرافــق الصحيــة الحكوميــة والخاصــة بموجــب القــرار ســالف الذكــر وبموجــب قــرار المجلــس الصحــي الســعودي‬
‫رقــم ( ‪ ) 58/ 8‬وتاريــخ ‪1433-1-9‬هـــ ‪ ،‬كمــا تشــترط وزارة الصحــة الســعودية تطبيــق معاييــر االعتمــاد الوطنــي الموضوعة‬
‫مــن قبــل المركــز وإثبــات ذلــك بالحصــول علــى شــهادة االعتمــاد كمتطلــب مســتقبلي مــن متطلبــات االســتمرار فــي‬
‫الترخيــص للمنشــآت الصحيــة الخاصــة الخاضعــة إلشــرافها‪.‬‬

‫‪The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) is the official agency‬‬
‫‪authorized to grant accreditation certificates to all governmental and private healthcare facilities‬‬
‫‪operating today in Saudi Arabia. CBAHI has emerged from the Saudi Health Council as a non-‬‬
‫‪profit organization. The principal mission of CBAHI is to set the healthcare quality and patient‬‬
‫‪safety standards against which all healthcare facilities are evaluated for evidence of compliance.‬‬
‫‪The foundation of CBAHI dates back to October 2005 as the Central Board for Accreditation of‬‬
‫‪Healthcare Institutions, formed then by the Ministerial Order Number (144187). Since then, it‬‬
‫‪continued pursuing its mission until 30-9-2013 when the Cabinet of Ministers Decree Number‬‬
‫‪(371) called for changing of the name to become the Saudi Central Board for Accreditation of‬‬
‫‪Healthcare Institutions, and also mandated the national accreditation by CBAHI on all healthcare‬‬
‫‪facilities. The Ministry of Health is planning to mandate CBAHI accreditation as a future prerequisite‬‬
‫‪for renewal of operating licenses, and a step towards encouraging more participation in this‬‬
‫‪ambitious national initiative.‬‬

‫‪5‬‬
 Table of Contents

Foreword 7

Standards Development Committee/ Advisory Committees & Experts Panel 8

Preface 9

Part I- Introduction & Explanatory Notes 11

• CBAHI at a Glance 12
• Healthcare Accreditation: Definition and Importance 12-13
• Standards Development Process 14-15
• Accreditation Survey 15-16
• Structure of the National Ambulatory Healthcare Standards Manual 16
• List of Standards 17-23
• Effective Date of the National Ambulatory Healthcare Standards Manual 23

Part II- Accreditation Policies 25

• Eligibility for Accreditation 26

• Registration with CBAHI 26
• Accreditation Pathway 26-28
• Survey Visit/ Survey Team 28
• Rescheduling of Surveys 28-29
• Accreditation Decision Rules 29-30
• Appeal against Accreditation Decision 31
• Accreditation Maintenance (Post Survey Requirements) 31-33
• Sentinel Events 33-34
• Accreditation Suspension and Revocation 34-35
• Random Surveys 36
• Accreditation Certificate and Seal 36
• Release of Accreditation- Related Confidential Information 36-37
• Complaints against an Accredited Facility 37-38
• Conflict of Interest 38
• Truthfulness and Ethics Clause 39
37
Part III- Accreditation Standards 41
94-12
• 1) Leadership of the Organization (LD) 42-59
• 2) Provision of Care (PC) 60-67
• 3) Laboratory Services (LB) 68-74
• 4) Radiology Services (RD) 75-76
• 5) Dental Services (DN) 77-78
• 6) Medication Management (MM) 79-85
• 7) Management of Information (MOI) 86-89
• 8) Infection Prevention and Control (IPC)‎ 90-96
• 9) Facility Management and Safety (FMS) 97-103
• 10) Day Procedure Unit (DPU) 104-109
• 11) Dermatology & Aesthetics Medicine (DA) 110-113

Glossary and Acronyms 115-133

 Foreword

Healthcare system in Saudi Arabia is currently witnessing a major shift at all levels. Under the
new vision 2030, the government is determined to bridge the long-standing gap between the
healthcare we have and the healthcare we should have. It is evident we need to change the way
in which we deliver the care and to re-design the health care system to become more efficient and
more productive. The main goal however, remains the same under all conditions. That is to focus
on improving the community health, while increasing the capacity and capability of healthcare
services for meeting one of the fastest growing population rates.

The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) has a pivotal role
to play now and in the future. It represents an independent entity, that is responsible for setting
the standards of healthcare provision and assessment of healthcare organizations against those
standards. The aim is to ensure better quality and a more reliable environment of care. This manual
is directed towards thousands of ambulatory healthcare centers, mainly polyclinics scattered
all over the country. They represent an important partner with the public sector in providing
healthcare to more than thirty-two million people. Ensuring that the healthcare provided in these
centers is compatible with the desired standards is of a prime importance. Benefits are numerous,
but most notably is the reduction of variations in the quality of care among different providers,
minimization of waste and increasing patients and staff satisfaction.

Healthcare accreditation in Saudi Arabia is an example to follow for different countries in the
region. Being accredited by the International Society for Quality in Healthcare (ISQua), CBAHI
is adding more to its credibility as a trusted accreditation body that is in compliance with the
international standards.

We are all thankful to the country’s sincere and committed leadership for its endless support
towards a better and safer healthcare.

H.E. Dr.
H.E. Dr. Tawfiq
Tawfig AlRabiah
AlRabiah
Minister of Health & Chairman of Saudi Health Council

7
 Standards Development Committee/ Advisory Committees
and Experts Panel
Experts including physicians, nurses, pharmacists, laboratory specialists, infection control
practitioners, biomedical engineers, administrators and public policy makers representing all
health sectors in Saudi Arabia, have actively guided the development of the National Ambulatory
Healthcare Standards. Several professional bodies have assisted as well with the development and
refinement of the standards. CBAHI would like to extend thanks and appreciation to all health
authorities, organizations and individuals who participated in or provided external commentaries
to this important national initiative. The following is a list of participants in alphabetical order.
Dr. Abdulkarim Taha Krimly Eng. Abdullah Al Dalan
Ambulatory Healthcare Services – Private King Faisal Specialist Hospital & Research
Sector Center

Dr. Abdullah Ali Al Qahtani Eng. Abdullah Al Maddah

Ambulatory Healthcare Services – Private CBAHI
Sector

Mr. Abdullah Al Khashan Dr. Abdulrahman Hawsawi

CBAHI - MOH Saudi Commission for Health Specialties

Mr. Ahmad Al Dabet Dr. Ahmed Al Otaibi

Medical services – Ministry of Defense CBAHI

Dr. Ahmed Yahia Bahloul Dr. Ali Al Raddadi

CBAHI CBAHI

Mrs. Amal Saleh Dr. Bisher Alshanawani

CBAHI Ambulatory Healthcare Services – Private
Sector

Dr. Desouky Fayed Dr. Hamad Al Salhi

CBAHI CBAHI

Dr. Hossam Ghoneim Dr. Jamal Abu Shamalah

CBAHI CBAHI

Dr. Khalid AbdElGaffar Dr. Khalid Al Harbi

Al Imam University MOI/SSF

Ms. Lisa Michelle Ryder Dr. Maher AlSakkak

CBAHI CBAHI - Ministry of Defense

Dr. Majdah Shugdar Dr. Majed Al Maghrabi

CBAHI CBAHI

Dr. Malik Dhaher AlShammari Mrs. MA. Lourdes Saldo

CBAHI CBAHI

Dr. Mohammad Garout Dr. Mohammad Zaki Al Baik

CBAHI Prince Sultan Military Medical City

Mr. Mohammed Al Khairi Mr. Mohammed Al Qahtani

CBAHI Ministry of Health

Dr. Mohammed Al Toukhi Dr. Nora Al Nuwaiser

Council of Cooperative Health Insurance Medical services – Ministry of Defense

Dr. Omar Al Ajaji Dr. Salem Al Wahabi

Ambulatory Healthcare Services – Private CBAHI
Sector

Dr. Samir Bahrawi Dr. Wafaie El Sakkary

Ambulatory Healthcare Services – Private CBAHI
Sector

Mr. Zyad Al Daham

Security Forces Hospital Program

8
 Preface

The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) is proud to introduce
this first edition of the National Standards for Ambulatory Healthcare Centers. Over the past
decade or so, the health sector in Saudi Arabia has witnessed a major advancement at all levels.
One remarkable area was the great expansion in the number of ambulatory healthcare centers
and clinics, and the complexity of healthcare services they provide to more than thirty-two million
population scattered over more than two million square kilometers area. This comes along with a
great advancement in the medical field globally, with more focus on the need for environments of
care that support performance measurement and continuous quality improvement. Here comes
the rationale for a national, evidence-based standard that would support ambulatory healthcare
centers in Saudi Arabia in improving the quality and safety of patient care and treatment.

Since its official inception in late 2005, accreditation by the “Central Board” was a voluntary
program that showed a remarkable success over the years. Lately, this has transformed into a
national mandatory program that is intended to be linked with licensure to enhance its mission
and encourage additional participation of more than three thousand ambulatory centers operating
today across the country.

During the development of this manual, one of the most important challenges we faced was
to develop standards that would apply to all ambulatory care centers, considering the variation
in the quality levels across the continuum of care, as we move from smaller centers in towns
and peripheries, to the larger medical centers in major cities. Being comprehensive, detailed and
sometimes prescriptive in design and nature, this edition of the National Standards for Ambulatory
Healthcare Centers was built to be as relevant and applicable as possible, once implemented in
the relevant centers licensed to practice in the Kingdom of Saudi Arabia.

Upon pursual of this manual, it provides important information about CBAHI, the eligibility
for accreditation, the scheduling of accreditation surveys, the survey preparation, the on-site
survey and the accreditation decision rules. In the remaining part, one can find all the standards
distributed over the relevant chapters.

Our sincere appreciation and gratitude are extended to the Committees Teams and Task Forces
who contributed to the development, compilation, design, review, revision and production of
this manual. We would like to convey our appreciation to the healthcare professionals who have
been obliging and generous with their professional feedback, time, constructive comments and
suggestions. We wish to also mention, our heartfelt gratitude to H.E Dr. Mohammed H. Khosheim,
an inspiring leader in the sphere of Healthcare Quality and the founder of CBAHI.

For further information on other accreditation programs of CBAHI, including all comments and
suggestions for improvement, please contact us on cbahi@cbahi.gov.sa

Dr. Salem Al Wahabi

Director General - CBAHI

9
PART I
INTRODUCTION &
EXPLANATORY NOTES
 CBAHI at a Glance

The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) is the official agency
authorized to grant healthcare accreditation to all governmental and private healthcare facilities
operating today in the Kingdom of Saudi Arabia.

Having originally emerged from the Saudi Health Council as a non-profit organization, CBAHI is
primarily responsible for setting quality and safety standards to ensure a better and safer healthcare
system. Its first official inauguration was after the Ministerial Decree number 144187/11 in
October 2005, which called for the formation of the Central Board for Accreditation of Healthcare
Institutions, tasked with the initiation of a national voluntary healthcare accreditation program.
In 1434/2013, the Council of Ministers mandated accreditation by CBAHI and gave the board its
current name.

The mission of the Saudi Central Board is to support all healthcare facilities, through accreditation
to continuously comply with quality and patient safety standards.

The vision of the Saudi Central Board is to be the leading healthcare accreditation agency in the
region.

In addition to the Ambulatory Healthcare Accreditation program, CBAHI currently has three other
accreditation programs (Primary Healthcare, Hospital Healthcare and Clinical Laboratories and
Blood Banks). Other accreditation programs are under process.

CBAHI’s goal is to achieve two conjoined initiatives, in congruence with (the 2030) vision. The
first initiative is to expand the range of efficient and effective accreditation programs to cover
healthcare services. The second initiative is to work with several partners to support the health
system in Saudi Arabia and the region by increasing the depth of quality improvement and patient
safety, as well as by disseminating knowledge through training and education. Driven by its core
values, a dedicated team of surveyors and staff, CBAHI is determined to be a major driving force
and a recognized standard for the provision of safe and high-quality healthcare.

CBAHI is proud to be one of the few healthcare accreditation agencies globally, accredited by the
International Society for Quality in Healthcare (ISQua), for hospital standards, surveyor training
programs and for organization.

Healthcare Accreditation: Definition and Importance

Healthcare accreditation is an assessment process that involves a rigorous, transparent and

comprehensive evaluation by an external independent accreditation body. The Healthcare Facility
(HCF) undergoes an appraisal of its systems, processes and performance by peer reviewers or
surveyors, to ensure that all tasks are conducted in a manner that meets applicable predetermined
and published national standards. Before the external evaluation, i.e., the survey visit, the HCF is
expected to conduct a comprehensive self-assessment to determine its level of preparedness, and
how close it is to achieving full compliance with the standards. Therefore, accreditation represents
the healthcare accreditation body’s public recognition of the achievement of accreditation
standards by an HCF. Standards set out a common framework to support HCFs in providing
effective, timely and quality services. They are designed to deliver improved levels of care and
treatment to the citizens and residents of Saudi Arabia. Evidence from scientific research shows
that engagement in a robust healthcare accreditation program improves the structure, process
and outcome of care that healthcare facilities provide. Accreditation is not merely a certificate to
obtain and hang on the wall. If utilized properly, accreditation can provide the following benefits:

12
• Accreditation provides a framework for organizational structure and management.
Accreditation standards focus on the governance and leadership structures and
functions within a HCF and the appropriate management of its business and day-to-
day activities.

• Accreditation helps improve patient safety and minimizes the risk of near misses, adverse
outcomes and medical errors. Ensuring patient safety through risk management and
risk reduction is at the center of all accreditation standards and is the ultimate goal of
the self-assessment and survey activities.

• Accreditation enhances community confidence in the quality and safety of care provided.
When a HCF achieves accreditation, the message is clear – its leaders are committed to
providing a nationally accepted standard of care in health services delivery.

• Surveyed HCFs have found that seeing their operation through the eyes of experienced
surveyors gave them a useful, more objective assessment of their internal administrative
and clinical processes, as well as effective proposals for improving their processes and
services delivered to the community.

• Accreditation in the long term, increases efficiency and enhances lean practices, which
in turn leads to decreasing waste and achieving optimal results with less consumption
of resources.

• Accreditation helps improve a healthcare facility’s competitiveness.

• Boosting public confidence in an accredited facility will encourage more patients to

seek care and treatments in that facility. This will positively impact its competitiveness in
the healthcare sector and increase its market share.

• Achieving accreditation will fulfill the regulations required by the Ministry of Health,
which is now considering linking the national accreditation by CBAHI to the licensing
of healthcare facilities.

• Registration with CBAHI and enrollment in its national accreditation program are
accepted by the Ministry of Health (at this stage) as satisfactory evidence for the purpose
of license renewal. Eventually all HCFs operating in Saudi Arabia must achieve CBAHI
accreditation.

• Accreditation has a link to reimbursement from insurers and other third parties. There
is a growing tendency, nationally and internationally, to link accreditation with eligibility
for insurance reimbursement.

• Accreditation provides a robust tool for continuous quality improvement efforts in the
HCFs and helps facility leadership to ensure the sustainability of quality improvement
projects and initiatives.

• Accreditation offers great learning and educational opportunity. This is achieved

through staff education on best practices and by emphasizing the importance of patient
education and patient rights.

13
 Scope of Accreditation Surveys

The scope of the CBAHI survey includes all standard related functions of the surveyed HCF. Each
assessment survey is tailored to the type, size and range of services the facility offers. Applicable
standards from this manual are determined by CBAHI, based on the scope of ‎the services provided
by the HCF undergoing a survey. Additionally, the onsite survey team will ‎consider the specific
applicability of individual standards. ‎

Standards Development Process

A standard is a statement of excellence or an explicit predetermined expectation that defines the

key functions, activities, processes and structures required for HCFs to ensure the provision of
safe, quality care and services.

Standards are developed by peer experts in their specific field and it is against these standards
to which conformity of the healthcare facility is evaluated. Simply stated, a standard describes a
HCF’s acceptable performance level. Within this context, there should be no confusion between
accreditation standards and licensure standards. When applied to licensure of an individual
practitioner or organization, the standard is usually set at a minimal level designed to protect
public health and safety. Accreditation standards, on the other hand, are designed as optimal and
achievable. When met, they will establish a high-quality level in a system.

Broadly speaking, CBAHI standards, as well as those of all other relevant accrediting agencies,
focus on three major aspects depending on which area they are addressing.
Structure; standards address the system’s inputs, such as manpower, design of the HCF building,
the availability of personal protective equipment for health workers, such as gloves and masks and
the availability of equipment and supplies, such as microscopes and laboratory reagents.
Process; standards address the clinical and administrative activities or interventions carried out
within the HCF in the care of patients or the management of the facility or its staff. Examples
include patient assessment, patient education and medication administration.
Outcome; standards involve the assessment of an intervention’s benefits and whether the
activity’s expected purpose was achieved. They provide information regarding predicted outcomes
which are being realized. Examples include patient satisfaction, health-care-associated infections,
medication errors, sentinel events and adverse events such as falls and injuries.

CBAHI standards set expectations for HCF performance which are reasonable, attainable,
measurable and therefore, conducive to a survey. Standards were built to serve as the basis of
an objective evaluation process that can help HCFs measure, assess and improve performance.
CBAHI is striving to be a nationally recognized symbol of excellence, respected throughout the
industry and by other relevant authorities, as an assurance that accredited HCFs meet rigorous
standards of quality and operational integrity that emphasize consumer protection and patient
engagement. Therefore, the process of standards development at CBAHI follows a long and
robust methodology to ensure our standards are correct, evidence-based, relevant and clear. As
with previous accreditation books, this book contains standards of quality and patient safety that
are descriptive in nature and department-oriented. Specialized task forces develop the first draft
of CBAHI standards, including focus groups and standards development committees that utilize
input from a variety of sources, including:

• The standards set by professional scientific societies, both locally and internationally.
• Scientific literature review and research studies.
• Relevant laws, rules, and regulations.
• National (or international) emerging issues related to healthcare quality and patient
safety.
• Input from healthcare professionals, providers, and patients.
• Panels of experts and consensus on best practices, given the current state of knowledge
and technology.

14
The process of standard development can last up to18 months before an initial draft is produced.
The draft standards are then distributed nationally for review and made available for comment on
the standards Field Review page of the CBAHI website. Based on the feedback received during
the field review, the draft standards may be revised and again reviewed by the relevant experts
and technical committees. The draft standards are finally approved by the Steering Standards
Development Committee and provided to the CBAHI Board for comments and remarks before
submission to the Saudi Health Council for approval. Thereafter, standards are provided in both
paper and electronic formats and distributed to HCFs.

An e-version is also made available on the CBAHI website. To comply with the guidelines of
the International Society for Quality in Healthcare (ISQua), a period of six months is allowed for
publishing of the standards before they are effective. Once the standards are in effect, ongoing
feedback is sought for continuous improvement. The survey process is then tailored to address the
new standards, and surveyors are taught how to assess compliance with the standards.

Accreditation Survey

CBAHI surveyors typically employ a variety of evaluation techniques and strategies to objectively
decide whether the facility meets standards related to key systems and functions, such as
governance and leadership, patient care processes, medication management, infection control,
management and safety of the facility environment and quality assurance. For example, the
survey team may review written documents (e.g., strategic and operational plans and budgets,
and clinical policies and procedures). In addition to reviewing documents, surveyors will interview
facility leaders, physicians, nurses, employees and patients to determine the facility’s performance
and compliance with standards. For example, the surveyor might interview a staff member to
check on the process he or she would complete to report a medical error, that caused harm to one
of the patients receiving care in that facility. Similarly, a surveyor might interview a patient about
his or her level of satisfaction with the care the HCF provides.

HCF leaders, including members of the governing body, may be interviewed regarding facility
processes and how they are designed to meet standards related to planning, budgeting, quality
assurance activities and human resources management. Surveyors tour the facility’s buildings and
patient care areas to evaluate standards related to overall cleanliness, building safety, fire safety,
waste management, equipment and supply management, infection control and emergency
preparedness. Other diagnostic and support services such as the laboratory, radiology, pharmacy,
central sterile services and day procedure unit are also assessed for safety, effectiveness, quality
control and equipment management.

In summary, during an on-site survey, surveyors use a variety of evaluation approaches to determine
the facility’s compliance or performance regarding applicable structure, process and outcome
standards. These methods might include any combination of the following:

In summary, during an on-site survey, surveyors use a variety of evaluation approaches to determine
the facility’s compliance or performance regarding applicable structure, process and outcome
standards. These methods might include any combination of the following:

• Interviews with facility leadership, clinical and support staff, patients and family.
• Observation of patient care and services.
• Facility tour and observation of patient care areas, building facilities, equipment
management and diagnostic testing services.
• Review of written documents such as policies and procedures, orientation and training
plans, budgets and quality improvement plans.

15
 • Review of personnel files.
• Review of patients’ medical records.
• Evaluation of the facility’s achievement of specific outcome measures (e.g., acquired
infection rates, patient satisfaction) through review and discussion of monitoring and
improvement activities.

The CBAHI team surveys a HCF depending on the volume and complexity of the services that the
facility provides, the number of locations or care settings included in the survey and the type of
survey such as focused or full. The scope of the survey visit includes all standards-related functions
in the HCF. This implies that any service/function/area not covered by CBAHI standards will not be
assessed during the survey visit. CBAHI determines applicable standards from this book based on
the scope of services and the onsite survey team’s decision regarding the applicability of individual
standards.

Structure of the National Standards for Ambulatory Care Centers

The National Standards for Ambulatory Care Centers are assembled into eleven chapters consisting
of key services and functions that ambulatory healthcare centers provide in Saudi Arabia. The
standards within these chapters are arranged according to the workflow within the services.

The chapters are:

• Leadership of the Organization (LD)

• Provision of Care (PC)
• Laboratory Services (LB)
• Radiology Services (RD)
• Dental Services (DN)
• Medication Management (MM)
• Management of Information (MOI)
• Infection Prevention and Control (IPC)‎
• Facility Management and Safety (FMS)
• Day Procedure Unit (DPU)
• Dermatology & Aesthetics Medicine (DA)

Each chapter includes a brief introduction that explains the chapter’s relevance and contribution
to safety and quality patient care. Each standard consists of a stem represented by a concise
statement. This is followed by one or more sub standards to further illustrate the standard’s
requirements. Each substandard is constructed in a way to serve by itself as the evidence of
compliance that is going to be measured and scored during the on-site survey. Each standard is
accompanied by an explanation to help the ambulatory HCFs understand the intent behind it.

No matter how robust the methodologies used in building the standards, room for improvement
will always exist. Therefore, all comments and remarks on standards can be made and viewed
on the CBAHI website, which includes an electronic form that allows HCFs, experts and other
interested parties to comment on current standards. The form allows for continual stakeholder
feedback on the standards. This is one of several CBAHI initiatives for improving the efficiency and
effectiveness of internal processes, including standards development to better meet the needs
and expectations of our partners.

16
Survey Process

The goal of the survey process is to ensure that the CBAHI standards are integrated into the HCF’s
daily practices. In addition to conferences, interviews and a review of documents, the major part
of the survey visit will involve an evaluation of standards implementation and the performance of
different processes within the HCF.

Preventable adverse events commonly occur in HCFs all over the world. Thus, CBAHI realizes that
compliance with the standards does not guarantee a safe patient environment. The ambulatory
healthcare facilities undergoing CBAHI accreditation must fully comply with these standards.

The central principle behind CBAHI standards selection is to ensure that the center has well-
qualified and competent staff working in a well-organized setting to deliver effective and reliable
services.

If you cannot imagine the importance of the presence, of the following standards, try to imagine
the adverse effect and impact of their absence. However, accreditation itself is not the end.
Rather, it should be viewed as the first step in an endless journey towards quality improvement
and excellence.

There are (133) Standards distributed throughout the chapters.

* (C) denotes core standard, i.e. full compliance is mandatory for all.

List of Standards
Number Standard
The governing body defines its structure and operational responsibilities in a
LD.1
written ‎document.
The governing body approves and evaluates the center’s quality and patient safety
LD.2
program and risk management program.
LD.3 The center has a current organizational chart.
LD.4 The center is managed effectively by a qualified director.
The leaders together with governance develop the center’s scope of services based
LD.5
on community needs.
LD.6 The leaders work collaboratively to develop the center’s strategic plan.
LD.7 The leaders transform the approved strategic plan into an operational plan.
LD.8 The leaders work collaboratively to develop the operational budget.
LD.9 The leaders work collaboratively to fulfill the mission and provide quality care.
LD.10 The leaders develop a staffing plan for the center.
LD.11 The leaders develop a policy and procedure for staff recruitment.
LD.12 All categories of staff have clearly written job descriptions.
The leaders develop an effective process for credentialing and re-credentialing all
LD.13 (C)
healthcare providers.
LD.14 (C) All medical staff members have current delineated clinical privileges.
LD.15 All new employees attend a mandatory orientation program.

17
 List of Standards
Number Standard
The leaders develop and implement a policy that ensures nurses and other allied
LD.16
healthcare staff are competent in specific procedures.
The leaders ensure staff are trained and test competent in the safe operation of
LD.17
equipment including medical devices.
LD.18 The leaders support continuing education and training for all categories of staff.
LD.19 Staff are trained and kept up to date with cardiopulmonary resuscitation.
The leaders develop an effective process to evaluate staff performance at least
LD.20
annually.
The leaders implement a comprehensive program to protect the health and safety
LD.21
of staff.
LD.22 The leaders support and protect the patient and family rights.
The leaders ensure that patients/families have the right to be involved in their own
LD.23
care and treatment.
The leaders develop and implement a policy and procedure to describe the
LD.24
patients’ right to voice their complaints and concerns.
The leaders ensure that patients/families have the right to accurate billing for
LD.25
provided services.
The leaders develop ethical standards to guide patients’ care and employees’ code
LD.26
of conduct.
LD.27 The center provides assistance to patients with special needs.
The center has an implemented policy for controlling the development and
LD.28
maintenance of key documents.
The center develops a comprehensive quality improvement and patient safety
LD.29
program.
The leaders prioritize and select a set of indicators that focus on the structure,
LD.30
process, and outcome of the services provided within the center.
LD.31 The leaders develop and implement a comprehensive risk management program.
LD.32 The leaders develop and implement an incident reporting policy.
LD.33 The leaders oversee any contracts for clinical or operational services.
The leaders ensure the integrity and security of telemedicine, teleradiology and
LD.34
interpretation of other diagnostic remote contracted services.
The leaders implement policies and procedures to guide the efficient procurement
LD.35 of equipment either purchased or donated, medications and essential medical
consumables in accordance with national laws and regulations.
LD.36 The leaders ensure an aesthetic appeal for the center.
Patients have access to services based on their health needs and available services
PC.1
and are registered with the center for providing such services.
PC.2 (C) The center has a process to ensure the correct identification of patients.

18
 List of Standards
Number Standard
Patients are clinically assessed through an established assessment policy and
PC.3
procedure.
Physicians are provided with the results of requested investigations according to a
PC.4
time frame.
The center develops and implements a process for reporting critical test results
PC.5
whether on-site or outsourced.
A care plan is developed by the attending physician to meet the patient’s needs
PC.6
considering patient and family’s cultural and spiritual matters.
Consultations are available to meet the healthcare provider's request and patient’s
PC.7
needs in a timely manner.
Staff members assist patients and, when appropriate, their families in fully
PC.8 participating in making informed decisions about their care, treatment and
procedures.
Patients and, when applicable, their families are educated about their healthcare
PC.9
needs.
PC.10 Informed consent is obtained from the patient or guardian.
Patients planned for a surgery/procedure give their informed consent to the
PC.11
surgery/procedure and the anesthesia/sedation.
The center has an effective process to safely provide care to patients who require
PC.12
Cardio Pulmonary Resuscitation (CPR).
Policies and procedures guide the transfer of patients in need of urgent admission
PC.13
to hospitals.
PC.14 Ambulance services are available and meet the patient’s needs.
PC.15 The center has an emergency services to deal with minor emergencies.
Laboratory services are available or outsourced to meet the needs of the patient
LB.1
population served.
LB.2 The laboratory has the right space and facilities relevant to the services provided.
LB.3 The laboratory develops and implements a comprehensive safety program.
The laboratory develops and implements a comprehensive infection control
LB.4
program.
The laboratory has a clearly defined and implemented process describing its role in
LB.5
selecting and evaluating providers of reference laboratory services.
The laboratory has a clearly defined and implemented process for laboratory
LB.6
instrument and equipment management.
The laboratory develops and implements a policy for the documentation of
LB.7
specimen receipt and inspection.
The laboratory develops a policy and procedure for the quality control of test
LB.8
methods.

19
 List of Standards
Number Standard
The laboratory develops a policy and procedure for Proficiency Testing (PT)
LB.9
sufficient for the extent, complexity and scope of services.
LB.10 The laboratory defines the format and contents of laboratory reports.
LB.11 The laboratory has a process for correcting or amending reported results.
The laboratory develops and implements a comprehensive process for Point-of-
LB.12
Care-Testing (POCT).
Radiology services are available or planned with other institutions to meet patient
RD.1
needs and in accordance with applicable national standards, laws and regulations.
RD.2 (C) The center has a radiation safety program.
There is implemented process to keep the radiology equipment in safe, functional
RD.3
condition.
DN.1 Dental staff have appropriate qualifications.
DN.2 A comprehensive assessment is performed and documented for each patient.
DN.3 The dentist documents the treatment plan in the patient’s medical record.
DN.4 Infection control guidelines are available and implemented by dental staff.
DN.5 Safety rules are applied in the dental laboratory.
Medication use processes are available to meet patient needs and in accordance
MM.1
with applicable laws and regulations.
MM.2 The center has an updated and well-structured formulary.
MM.3 The center has a process for the appropriate storage of medications.
The center has a process for ensuring the stability of medication available in multi-
MM.4
dose containers.
MM.5 The center has a process for identifying and handling expired medications.
The center develops a policy and procedure for the safe prescribing of
MM.6
medications.
The center develops and implements guidelines for the correct prescribing of
MM.7
antibiotics.
The center develops a process to manage narcotics, psychotropic medications, and
MM.8
other controlled medications according to laws and regulations.
The center safely manages high-alert and look-alike, sound-alike, LASA
MM.9
medications.
MM.10 The center evaluates the appropriateness of prescriptions before dispensing.
Medication preparation areas comply with infection control measures and safe
MM.11
practices.
The center develops and implements a policy and procedure on medication error
MM.12
reporting.
MM.13 The center monitors allergies to medications.

20
 List of Standards
Number Standard
The center develops and implements a policy and procedure for the reporting of
MM.14
adverse drug reactions ADR’s.
The leaders define in a plan the information that is shared among the staff and
MOI.1
with other governmental and non-governmental entities and its format.
The leaders develop standardized diagnosis codes, procedure codes and symbols,
MOI.2
and minimize abbreviations.
MOI.3 All patients seen in the center have unique medical records.
The leaders develop a policy on the rules and regulations for writing in patients’
MOI.4
medical records.
The leaders develop a process for completing and storing the patient medical
MOI.5
record.
The center has an implemented policy and procedure for the use of information
MOI.6
technology.
MOI.7 (C) The center has an effective clinical documentation improvement (CDI) program.
The center implements a coordinated program to reduce the risk of healthcare-
IPC.1
associated infections.
Infection prevention and control activities are integrated and coordinated by an
IPC.2
interdisciplinary team.
The leaders develop and ensure the implementation of infection control policies
IPC.3
and procedures targeting the most important infection risk processes.
Communicable diseases are tabulated and reported as required by laws and
IPC.4
regulations.
The leaders develop and implement a policy and procedure for healthcare
IPC.5
associated infection prevention.
The leaders design and ensure the implementation of an effective hand hygiene
IPC.6
program.
IPC.7 (C) Centers providing sterilization services strictly follow rigorous sterilization rules.
Patients with communicable diseases and those who are colonized or infected
IPC.8 with epidemiologically important organisms are separated from other patients,
staff and visitors.
Personal protective equipment is readily accessible and available and is used
IPC.9
correctly by staff in all patient care areas.
The leaders define in a policy the cleaning, decontamination and disinfection
IPC.10
processes in all patient care areas.
The leaders define in a policy the safe procedures for waste collection, storage and
IPC.11 (C)
disposal.
The leaders develop and ensure the implementation of a program for the
IPC.12
prevention and management of sharp injuries.
IPC.13 Sharps are discarded in appropriate containers.

21
 List of Standards
Number Standard
IPC.14 Housekeeping has policies and procedures describing its functions.
FMS.1 The leaders establish and support a facility management and safety program.
FMS.2 Interdisciplinary rounds are scheduled and conducted to ensure safety.
FMS.3 The center’s environment is safe for patients, visitors and staff.
The leaders develop and monitor the implementation of a fire prevention
FMS.4
program.
FMS.5 The center is secured and protects its users.
The leaders develop a plan for the inspection, testing and maintenance of medical
FMS.6
equipment.
FMS.7 The leaders develop an emergency plan, and staff are trained on it.
FMS.8 The leaders develop a hazardous materials (HAZMAT) and waste disposal plan.
The leaders develop a policy and procedure for the safe use of various types of
FMS.9
compressed gasses.
DPU.1 All day surgeries and procedures are performed in the day procedure unit.
Leaders develop and implement a policy and procedure to guide the care of
DPU.2
patients in the day procedure unit.
The patient is accepted into the unit by the nursing staff after a rigorous
DPU.3
verification procedure.
DPU.4 The procedure/surgery room is a functional operating room.
DPU.5 The day procedure unit is fully equipped for managing difficult intubations.
Patients booked for a surgery/procedure shall have a pre-sedation/anesthesia
DPU.6
assessment performed by the anesthesiologist prior to the surgery.
The center ensures the correct implementation of the policy on preventing wrong
DPU.7
patient, wrong site and wrong procedure.
The patient’s condition is continuously monitored during sedation or anesthesia,
DPU.8 including local anesthesia and the information is documented in the patient
medical record before the patient leaves the operating room.
DPU.9 The unit has a recovery room.
Each patient’s post-sedation/anesthesia physiological status is continuously
DPU.10
monitored and documented in the patient’s medical record.
An operative report is documented immediately after the surgery/procedure,
DPU.11
before the patient leaves the recovery room and is signed by the surgeon.
DPU.12 The patient is discharged home by an attending physician after the procedure.
DA.1 Dermatology and aesthetics services are managed by an experienced physician.
DA.2 Physicians’ privileges outline the exact procedures to be done by each physician.
The unit performs periodic education and competency testing for clinical staff
DA.3
assisting in procedures.

22
 List of Standards
Number Standard
The managing physician ensures the compliance of procedural rooms with all
DA.4
required safety rules.
DA.5 The unit maintains a dated and timed list of the procedures performed.
Implemented evidence based clinical practice guidelines are developed by the unit
DA.6 physicians and approved by the service manager for all procedures performed in
the unit.

Effective Date of the National Standards for Ambulatory Care Centers

The effective date is 1st January 2020. This applies to ambulatory healthcare centers seeking
accreditation by CBAHI.

23
PART II
ACCREDITATION
POLICIES
 Eligibility for Accreditation

All HCFs licensed to practice in the Kingdom of Saudi Arabia are eligible for CBAHI accreditation.
However, eligibility for a survey visit is contingent upon the following requirements:

• The HCF meets all licensing requirements to operate (and therefore, has a valid license,
when applicable) as indicated by the statutes and regulations of the Ministry of Health.

• The HCF meets any additional licensing requirements as indicated by other relevant
authorities (e.g., Civil Defense, Saudi Commission for Health Specialties, Saudi Food
and Drug Authority).

• The HCF meets the legal definition as per the regulations of the Ministry of Health and
the international guidelines in this regard:

- Licensed as a an ambulatory healthcare center under the law governing healthcare

institutions in Saudi Arabia.
- Has an organized medical staff and nursing services.
- Maintains permanent and full-/partial-time facilities.
- Provides diagnostic and therapeutic services for patients.

• The HCF provides healthcare services addressed by CBAHI’s National Standards.

• The HCF has been in operation for at least twelve (12) months before the on-site survey.

• The HCF completes and returns an application form.

Registration with CBAHI

Registration with CBAHI for accreditation is required for all eligible HCFs. This is the first step
towards accreditation.

HCFs are required to register by completing the Healthcare Facility Registration Form located on
CBAHI’s portal. Registration is a quick yet essential step, that provides the Healthcare Accreditation
Department at CBAHI with necessary information about the registering facility. Upon successful
registration, a system-generated auto-reply with a code number will be provided to the registering
facility. The code number will be used for all future communications with CBAHI.

Accreditation Pathway

To obtain CBAHI accreditation, a healthcare facility must complete several activities. Upon successful
registration, the following resources will be provided to HCFs seeking CBAHI accreditation:

• National Standards
• Healthcare Accreditation Guide

The Accreditation Guide provides all required information to help the HCF prepare for the survey
visits. It contains an abstract of each survey activity, including logistical needs, session objectives
and suggested participants.

Each year, CBAHI decides based on “first-come, first-served” scheduling and in accordance with its
yearly operational plan, which HCFs will be enrolled in its accreditation program for that particular
year. CBAHI will notify by a letter of enrollment those HCFs included in its yearly accreditation
program.

26
CBAHI provides ongoing HCF Orientation Programs in different locations throughout the year.
HCFs must to attend at least one of the HCF Orientation Programs that CBAHI offers. Although
any HCF can attend, preference is giving to facilities selected for the current year accreditation
program. During these orientation sessions, the standards, accreditation policies and survey
process are explained in detail. This is a good opportunity for HCF‎representatives to ask about
the intent of a standard and how it will be implemented. Dates and venues of the orientation
programs will be communicated to the HCFs in a timely manner.

All HCFs enrolled in accreditation are encouraged to conduct a comprehensive self-assessment

using the Self-Assessment Tool (SAT) that CBAHI provides. This tool is intended to help the facility
assess how close it is to satisfactory compliance with the standards and requirements. It also
provides an idea of how much preparation and time the HCF needs before it can be ready for a
survey visit. Usually, SAT is for the HCF’s internal use, but CBAHI might require it before conducting
a survey to help determine the facility’s preparedness.

Several other accreditation organizations use self-assessment. If objectively and adequately

conducted, self-assessment obtains better insight into the baseline situation of each facility
and provides a common communication tool between the facility seeking accreditation and the
accrediting body. When both parties reach a compromise about the level of preparedness for a
survey visit based on the self-assessment findings, a survey can be scheduled for a tentative date
suitable for both.

Some HCFs (especially those with no experience in accreditation) may choose a Mock Survey Visit.
This visit is offered by CBAHI (subject to the availability of resources) mainly as an educational tool
to clarify accreditation policies, standards and their explanation. In addition to the survey process,
the applicability of the different chapters of the standards manual, as well as to further assess the
position of the facility by verifying the self-assessment’s findings.

The Mock Survey is recommended, but not mandatory. Some HCFs may choose for an upfront
Real Survey.

Once a HCF has applied for a real survey visit and completed the pre-survey requirements as
mentioned below, the date of the visit will be determined depending on the scheduling availability
as decided by the Healthcare Accreditation Department at CBAHI. The date of the survey will be
shared with the facility. Generally, a minimum of seven days will be allowed for HCF notification
before the survey is conducted. When a short-notice survey is to be conducted, the facility
leadership is expected to receive the survey team and facilitate its work. Failure to do so will
subject the HCF to denial of accreditation, as explained later.

In all cases, the following requirements must be completed before CBAHI conducts a survey visit:

• The HCF must submit a completed Survey Application Form, located on CBAHI’s portal.
• The Service Agreement must be acknowledged and duly signed by the facility, and a
copy returned to CBAHI a minimum of 45 days before the actual survey date.
• The HCF must provide evidence of payment of the required accreditation fees.

It should be noted that the maximum number of mock surveys in which a HCF can participate
is subject to several variables (e.g., the available resources at CBAHI, the level of commitment
demonstrated by the HCF towards achieving compliance with the standards, the findings of
the self-assessment and so forth). A mock survey is a valuable opportunity for education and
learning from experienced peer surveyors who, through their work in healthcare organizations,
are exposed to a wide variety of best practices. There is no limit to the number of real surveys

27
 a facility can have before achieving accreditation, but six months is the minimum time interval
between two consecutive real surveys. However, this should not be misinterpreted as an “open-
ended” exercise. The time interval between registration and the achievement of accreditation
is 6 to 18 months, on average. Therefore, the facilities that will eventually prove incapable of
achieving accreditation as reasonably persuaded by CBAHI will be excluded, either temporarily or
permanently from the national accreditation program and referred to the relevant authorities for
further action.

Survey Visit/Survey Team

To earn and maintain accreditation, a HCF must undergo an on-site survey conducted by the
CBAHI survey team. CBAHI handles all scheduling arrangements for surveys in coordination with
the healthcare facility. The date of the survey visit will be determined based on the capacity of
CBAHI’s yearly operational plan and the satisfactory level of preparedness as evidenced by the
findings of the self-assessment.

HCFs enrolled in the accreditation program will be notified by CBAHI to complete and submit
the Survey Application Form (SAF) available on CBAHI’s portal, and to indicate the type of survey
requested (e.g., mock or real survey). A survey notification letter will be sent to the facility
indicating the date of the survey and other relevant information.

The size and specialties of facility survey team members are usually fixed, but this might change
according to the size of the HCF and its scope of services. As mentioned before, compliance
assessment is accomplished through various survey activities and methods, such as a review
of documents, a review of medical records and personnel files, staff or patient interviews and
the findings observed during the facility tour and unit visits. Whatever the methodology used,
the CBAHI survey is structured to be an intelligent search for areas of noncompliance with the
standards rather than as a checklist exercise. Generally, the survey team is composed of two
healthcare professionals.

The survey is conducted under the leadership that has been designated by CBAHI. The team leader
is responsible for assuring that all survey activities are completed within the specified timeframes
and according to CBAHI’s policies and survey protocols. The HCF under survey is required to
facilitate the work of the survey team members and to allow the survey team leader to practice
his/her role and responsibilities, which include:

• Preparing and communicating the survey plan to the HCF;

• Chairing the opening and closing meetings;
• Communicating with facility leadership regarding survey progress and initial findings;
• Evaluating team progress and adjusting survey plans as needed;
• Coordinating and preparing the survey report and submitting it to CBAHI.

Further details about the survey team and the dynamics of the survey visit can be found in the
Accreditation Guide provided to all HCFs upon successful registration.

Rescheduling of Surveys

HCFs scheduled for surveys are strongly encouraged to adhere to the survey date proposed by
CBAHI. However, rescheduling may be considered for review at CBAHI’s discretion on a case-by-
case basis, only upon:

• A rationale for rescheduling that is acceptable to CBAHI (e.g., events that will hinder
the flow of the survey process such as changes in the ownership of the facility, natural
or other disasters, or relocation of the facility to another building).
• At least thirty (30) days’ notice with an official letter from the HCF chief executive
officer indicating the reason(s) for the rescheduling request.

28
Occasionally, requests for rescheduling of the survey visit that meet the above conditions are
accepted with no penalties. Another more realistic date is selected and agreed upon with the
facility, provided this does not happen more than once during one accreditation cycle. However,
requests for rescheduling that do not meet the above conditions are subject to rejection (and the
survey will be conducted) or a “penalty charge” equal to (25%) of the required survey fee.

Accreditation Decision Rules

In general to become accredited, the HCF must meet all applicable standards at an acceptable
level. CBAHI utilizes a multilevel process for making accreditation and reaccreditation decisions.
This is to ensure fairness, consistency, objectivity, and accuracy. Therefore, CBAHI benefits from
any relevant report and/or significant findings or issues of concern related to the surveyed facility
that were brought to attention by relevant health authorities or past accreditation surveys.

Accreditation decisions are released and communicated to the HCF within thirty (30) days after
the conclusion of the survey visit. The accreditation decision-making process is based on:

• The findings of the survey team members as recorded in the survey report.
• Discussions regarding the survey findings between the surveyor and the specialty team
leader (STL).
• Review of the draft report by the participating HCF for feedback or correction of any
issues of fact before the accreditation decision is made.
• Review/discussion during the meeting of the Accreditation Decision Committee (ADC).
This committee may request additional evidence before making a final recommendation
for an accreditation decision. All accreditation decisions are then ratified by the CBAHI
Director General.

It is important to note that the decision to grant accreditation is based primarily on the findings
of the on-site survey as recorded by the surveyors in the survey report. However, the overall
numerical score the HCF obtains is one important factor, among others, upon which the ADC
members rely when making their recommendation. Other factors are:

• Criticality of the non-compliant standard(s), for example the degree of severity and
immediacy of risk to patients, visitors or staff safety.
• Any concerns regarding the non-compliant standard(s), for example the degree of
severity and immediacy of risk to patients, visitors or staff and the facility.

Criticality has several levels. The most serious is when the surveyor notices an immediate threat to
safety or quality of care. Examples include:

• Expired material is being used.

• A bare electrical wire is hanging down without any protection.
• A patient is not properly identified.

When a CBAHI surveyor notices an immediate threat, whether or not it is directly linked to the
standards, the survey team leader will notify the HCF director and include the findings in the
survey report.

Each standard is composed of a stem statement and sub-standard(s). The substandard is the
evidence of compliance to be scored by the surveyor during the on-site survey. Each substandard
has an equal weight and is scored on a three-point scale as follows:

0 = Insufficient Compliance (less than 50% compliance with the standard).

1 = Partial Compliance (from 50% to less than 85% compliance with the standard).
2 = Satisfactory Compliance (85% and more compliance with the standard).
N/A = Not Applicable
29
 The score of each standard is calculated using the sum of the scores of the sub standards divided
by the maximum score of all the sub-standards. Partial compliance is not acceptable for core
standards.

The overall score of the HCF is calculated using the sum of the scores of all the applicable sub-
standards divided by the maximum score.

When one or more chapters of this manual are not applicable to a particular HCF, they are
indicated by “N/A.” Non-applicable chapters are not scored and are not included in either the
numerator or denominator of the overall score.

The ADC shall recommend one of the following accreditation decisions:

Accredited

Accreditation will be awarded when the surveyed HCF demonstrates an overall acceptable
compliance with all applicable standards at the time of the initial (or re-accreditation) on-site
survey, and when there are no issues of concern related to the safety of patients, staff, visitors
or the facility itself. Accreditation will also be recommended when the HCF has successfully
addressed all post-survey requirements and does not meet any rules for denial.

Scoring Guidelines:

• Overall score 75% or above.

• All Core standards are fully met.
• All applicable standards score 50% and above.

Denial of Accreditation

Denial of accreditation results when an HCF shows significant noncompliance with the
accreditation standards at the time of the on-site survey. It also results if one or more of the other
reasons leading to the denial of accreditation have not been resolved. When the HCF is denied
accreditation, it is prohibited from participating in the accreditation program for a period of six
months unless the Director General of CBAHI, for good reason, waives all or a portion of the
waiting period.

• Overall score less than 75%, or one of the core standards is not in full compliance, or
an applicable standard scores less than 50%.
• Presence of an immediate threat to the safety of patients, visitors or staff that is observed
by CBAHI surveyors during the on-site survey.
• Significant noncompliance with the accreditation standards at the time of the on-site
survey.
• Failure to submit the post-survey requirements in a timely manner.
• The HCF was subjected to a focused survey but still could not meet the requirements
for accreditation.
• Reasonable evidence exists of fraud, plagiarism or falsified information related to the
accreditation process. Falsification is defined as the fabrication of any information (given
by verbal communication or paper/electronic document) provided to CBAHI by an
applicant or accredited HCF through redrafting, additions or deletions of a document’s

30
 content without proper attribution. CBAHI perceives plagiarism as the deliberate use
of other HCF original (not common knowledge) material without acknowledging its
source.
• Refusal by the HCF to conduct a survey.

Appeal against an Accreditation Decision

A surveyed HCF can appeal the following accreditation outcomes:

• Denial of Accreditation (provided this is not due to a failure to submit the post-survey
requirements in a timely manner after granting accreditation or a failure to meet
requirements after a follow-up focused survey).
• Suspension/Revocation of Accreditation.

All appeals shall be made within a maximum of fifteen (15) calendar days from receipt of the official
survey report, through a cover letter sent from the center director to the CBAHI Director General
via registered mail/fast courier. This should include documentation to support the argument for
the appeal and a completed Appeal Request Form (ARF), located on CBAHI’s portal. Letters sent
via electronic mail or facsimile will not be considered.

Grounds for Appeal

The HCF is entitled to an appeal if the appeal is based on one or more of the following grounds:

• Relevant and significant information which was available to the survey team was not
considered in the making of the accreditation decision.
• The report of the surveyors(s) was inconsistent with the information presented to the
survey team.
• The existence of perceived bias among the surveyor(s).
• Information provided by the survey team was not duly considered in the survey report.
• The outcome of the appeal, if in favor of the appealer, will result in a change in the
accreditation status. CBAHI will not consider appeals that will not result in a change of
accreditation status.

Upon the initial acceptance of the appeal request (only when clear and convincing evidence
indicates that the facility sustained one of the grounds for appeal), the prior status of the HCF,
if any, shall be restored pending disposition of the appeal. The appeal request shall set forth the
specific grounds for the request and shall include a statement of the reasons for each ground,
along with any other relevant statements or documents the HCF wishes to include. A HCF applying
for an appeal must identify the specific alleged procedural failures or the specific manner in which
the decision was arbitrary or unreasonable and not based on, or consistent with, CBAHI standards
and policies. After a study of all relevant reports and evidence, one of the following decisions shall
be made and communicated to the appealer in a timely manner:

• The adverse decision is upheld.

• The healthcare facility’s appeal is upheld, and the denial of accreditation is modified or
reversed. In this circumstance, a full or focused re-survey may be decided upon.

Accreditation Maintenance (Post-Survey Requirements)

CBAHI has redesigned its accreditation to represent a continuous process versus a once-every-
three-years evaluation. Accredited HCFs must maintain their accreditation status by showing their
continued compliance with the standards and requirements of CBAHI throughout the accreditation

31
 cycle and in accordance with the specified time frames. This translates into standing and ad hoc
requirements.

Standing Requirements for Accreditation Maintenance

1- Corrective Action Plan (CAP)

When accreditation is awarded to a HCF, a Corrective Action Plan (CAP) addressing

all standards that were not in satisfactory compliance during the on-site survey may
be requested by CBAHI for review and acceptance within one hundred and twenty
(120) days from the date of the accreditation decision. The CAP ideally focuses on
demonstrating what has been done rather than what will be done. The CAP should
identify all non-compliant standards, the requirements for improvement, the corrective
actions that have been or will be taken (with dates and responsible individuals) and,
as applicable, the monitoring measures to ensure sustainability of the actions taken.
A delay in the submission of the CAP that exceeds thirty (30) days beyond the due
date without justification might result in temporary suspension of the accreditation
certificate.

2- Midterm Self-Assessment

Accredited HCFs must participate in a mid-cycle self-evaluation of standards compliance

(Midterm Self-Assessment). Fifteen months from the date of accreditation, the HCF
should start utilizing the self-assessment tool to assist in the periodic review of its
performance against the standards. The HCF then has three (3) months to complete
the assessment.

Completion of the midterm assessment will allow the HCF to identify areas of non-
compliance with the standards and, therefore, create a plan for correction of deficient
areas and to ensure the HCF comes into compliance before the next on-site survey.

For those areas, self-identified as non-compliant with CBAHI standards, the HCF may be
required to submit a CAP to CBAHI that includes evidence to substantiate the fact that
the standard has been brought into compliance. The relevant department at CBAHI will
review each facility’s plan of action via a telephone interview and will indicate whether
the action plan and timetables are acceptable for bringing the standard into compliance.

During the next on-site visit following submission of the midterm assessment, the
surveyor will look for evidence of compliance/correction that the HCF provided as
part of the plan of action. When, at the time of the midterm assessment, a legitimate
concern exists about the safety and quality of services provided by an accredited HCF,
CBAHI may require the HCF to undergo a mid-cycle survey (a fee will be charged to
cover the costs) and to submit a plan of action for areas of non-compliance.

when required to do so, a delay in submitting the midterm assessment by more than
sixty (60) days from the due date without an acceptable justification to CBAHI may
result in temporary suspension of accreditation, followed by revocation of accreditation
if the total delay exceeds ninety (90) days.

Ad Hoc Requirements for Accreditation Maintenance

1- Reporting of a sentinel event (effective date for reporting will be announced

later )

32
 When a sentinel event occurs, it must be reported to CBAHI within five (5) working
days of the internal notification of the event. A Root Cause Analysis (RCA) with a risk
reduction action plan must then be submitted to CBAHI within thirty (30) working days.

2- Notification of significant changes

Accredited HCFs must notify CBAHI in writing about any significant structural/functional/regulatory
changes that took place after the accreditation survey, no more than thirty (30) days after the
initiation/occurrence of such changes. These changes include, but are not limited to the following:

• A national regulatory body has mandated closure for all or part of the HCF.
• HCF accreditation by other international accrediting organizations has been
suspended or revoked.
• A new service is initiated for which CBAHI has standards, and that was not included
in the last survey.
• Any of the services are being offered in a new location or branch.
• Major construction/destruction/renovation work (building, floor or unit) has been
undertaken.
• A significant (30% or above) increase (or decrease) in the volume of services has
been experienced.
• The HCF has merged with or acquired an unaccredited facility.
• A significant change has occurred in the governance or ownership.

CBAHI will evaluate the impact of these changes, and a decision for conducting a focused survey
may be warranted accordingly.

A delay in notifying CBAHI of such significant changes in an accredited facility by more than sixty
(60) days from the due date, without a justification acceptable to CBAHI, may result in temporary
suspension of accreditation, followed by revocation of accreditation if the total delay exceeds
ninety (90) days.

Sentinel Events

A sentinel event is defined as any event leading to serious patient harm or death and that is
caused by healthcare rather than the patient’s underlying illness. By investigating sentinel events,
we can identify deficiencies in healthcare systems and processes and put actions in place to
prevent recurrence.

CBAHI has adopted the following as must-report events:

• Unexpected death
• Wrong patient, wrong procedure or wrong site
• Retained instrument or sponge
• Medication error leading to death or major morbidity
• Infant or child abduction
• Unexpected loss of a limb or function

The policy of CBAHI on sentinel events calls for the following:

• Open disclosure/open communication: Patients and their families are entitled at all
times to truthful and transparent communication and explanation of any sentinel events
happening to them.

• When a reportable sentinel event occurs in an HCF accredited by CBAHI, it must be

reported to CBAHI as indicated in the relevant policy. Healthcare facilities that are not
accredited by CBAHI are encouraged, but not required to report. Outside reporting,

33
 CBAHI may become aware of the occurrence of a sentinel event through a communication
from one of CBAHI’s surveyors, from the media, from a patient or relative, from the
healthcare facility’s employees or through other means of communication.

• CBAHI is interested in knowing about reportable sentinel events when they occur
in accredited facilities for learning and disseminating lessons learned to the medical
community, thereby avoiding the recurrence of such events in the future. Medical errors
and adverse events are opportunities for education and quality improvements.

• Reporting must be safe. Patients, families, and staff are encouraged and should
be empowered by the HCF leadership to report any sentinel event without fear of
retribution. CBAHI has zero tolerance for accredited HCFs taking disciplinary actions
against a staff member who reports a sentinel event. If the disciplinary action proves
to be related to reporting, this might negatively impact the HCF’s accreditation status.

• The HCF must report to CBAHI all sentinel events by filling out and submitting the
Sentinel Event Reporting Form (SERF), which is available at the CBAHI portal, within five
(5) working days of the internal notification of the sentinel event (the date when the
relevant authority in the HCF was notified of the incident). This should be followed by
a Root Cause Analysis (RCA) and Risk Reduction Action Plan within thirty (30) working
days from the date of notification of the sentinel event. Root Cause Analysis is a formal
process of investigation designed to identify the root causes of adverse events.

• CBAHI will study the sentinel event report for further action as appropriate. This includes
the submission of a progress report to show the progress made in implementing the
risk reduction plan and eliminating the chance of recurrence. It might also include a
validating focused survey scheduled or unannounced at CBAHI’s discretion.

• The outcome of a reported sentinel event is dependent on the level of commitment

the HCF demonstrates towards studying the root cause(s) of the incident and re-
designing its processes and systems to prevent recurrence. When CBAHI is persuaded
of this constructive approach of the concerned HCF in dealing with sentinel events,
accreditation is usually maintained. When this is not the case, CBAHI will pursue this
further to decide on the HCF’s eligibility to maintain its accreditation until the required
corrections are made. In other situations, in which the accreditation certificate is less
than six (6) months, and CBAHI is not persuaded that the corrections have been made,
an early full re-accreditation survey may be warranted.

Accreditation Suspension and Revocation

CBAHI expects nothing but truth, honesty and sincere intentions in all dealings and propositions from
HCFs engaged in its accreditation program. This “good faith” engagement applies continuously
throughout the accreditation cycle, and the HCF must ensure that it is not violated. In addition,
accredited HCFs must maintain the same momentum both before and after accreditation. Some
might argue that it is a natural tendency to ease back after a survey visit, but compliance with
the standards must not drop simply because the survey is completed, and accreditation has been
awarded. If CBAHI becomes aware, by any means of an accredited HCF that is not in compliance
with the standards, CBAHI will verify the situation and take appropriate action.

CBAHI may receive information regarding possible violations from accredited HCFs through several
channels, most importantly reports of related government agencies, written or verbal complaints
and the media. Types of violations include, but are not limited to, the following:

• CBAHI becomes aware of the presence of an immediate threat to the safety of patients
or staff in an accredited HCF.

34
 • The HCF is not committed to the specified timeframes for accreditation, for example
maintenance of timely submission of a corrective action plan after accreditation or
timely submission of a midterm self-assessment.

• The HCF failed to report a sentinel event as per the relevant policy without an acceptable
justification.

• The HCF is committing an act of misuse (see the policy on accreditation certificate and
seal), deception or any deliberate misrepresentation of the truth (see the policy on
truthfulness and the ethics clause).

• The HCF is discouraging communication or taking disciplinary action/reprisal against

patients or staff members trying to communicate directly with CBAHI about concerns
regarding safety or quality of care.

• The HCF intentionally lacks commitment to continuous compliance with CBAHI

standards. This might represent an overweening behavior and is a strong violation of
the CBAHI accreditation process.

• The HCF is deliberately violating any of the other accreditation policies mentioned
in this manual or other supporting documents and manuals provided by CBAHI for
accreditation.

Once CBAHI is convinced that one or more of the aforementioned violations exists in an accredited
HCF, it responds by taking one of the following actions, in any order:

• Issuing a letter of “At Risk of Suspension of Accreditation”

• Suspension of Accreditation
• Revocation of Accreditation

CBAHI determines the level of response to a certain violation based on several factors, including
the severity of the violation, its frequency, previous accreditation history, the source of information
regarding the violation, and the findings and conclusion of CBAHI’s inquiry. When necessary,
a focused or full survey might be conducted for validation purposes before a response can be
given or an action taken. This kind of survey is always for one or more of the above causes (e.g.,
when concerns have been raised about an accredited facility’s continued compliance with CBAHI
standards). An accredited HCF may undergo a survey at any time, at the discretion of CBAHI,
and the survey is usually unscheduled (the HCF receives 48 hours’ notice before the survey) or
unannounced (without advance notice) depending on the seriousness and type of violation.
Surveys can include either all of HCF’s services or only those areas in which a serious concern may
exist. HCFs are usually charged for these surveys, regardless of the outcome, and results can affect
the HCF’s accreditation status. If the HCF does not allow CBAHI surveyors to conduct the survey,
CBAHI may change the facility’s status to Revocation of Accreditation.

It should be noted that when the facility’s accreditation is suspended, the facility can regain
accreditation once the causative violation has been rectified. However, suspension will not be
lifted before a prohibition period of twelve (12) months from the date of suspension.

Revocation of accreditation is a more serious consequence that prohibits participation in the CBAHI
accreditation program for a minimum of eighteen (18) months from the date of revocation. In
both suspension and revocation of accreditation, CBAHI will communicate the new accreditation
decision to the relevant authorities and display it on its website. The Director General of CBAHI,
for a good reason, can waive all or a portion of the prohibition period.

35
 Random Surveys

To support CBAHI’s ongoing quality assurance initiatives, an accredited facility may be selected
for a random survey from nine (9) to thirty (30) months after an accreditation survey. Random
surveys are unannounced. A five percent sample of all accredited HCFs is randomly selected each
year for this activity. These random, unannounced surveys are a means by which CBAHI evaluates
the consistency and quality of its program, while also demonstrating to the public and regulators
that accredited HCFs remain committed to CBAHI standards throughout the accreditation cycle.
Random surveys also provide CBAHI and its surveyors with opportunities to further consult with
accredited HCFs in the interval between regular surveys. No fee shall be charged to the HCF when
a random survey is conducted.

The HCF may be selected for a validation survey visit as part of an inter-rater reliability program for
CBAHI surveyors within one (1) month after receipt of the accreditation decision report. This visit
outcome has no impact on the accreditation status granted in the real accreditation survey visit.
The HCF will not bear any cost.

Accreditation Certificate and Seal

Once accreditation is granted, HCFs are encouraged to display the CBAHI logo, accreditation
certificate and seal on the facility’s bulletin boards, banners, website, newsletters, brochures and
headed stationery.

CBAHI requires all accredited healthcare facilities to follow the guidelines and conditions for the
appropriate use of the CBAHI logo, accreditation certificate, and seal. Specifically, CBAHI works
to ensure that no accreditation material is used in a way that may mislead the public or others or
provide false information related to a healthcare facility’s accreditation status.

Upon receiving the certificate package, accredited HCFs are required to sign and return a
disclaimer/guidelines form related to the conditions of display and publication of the CBAHI logo,
accreditation certificate, and seal. These include:

• The printing of the accreditation seal is accurate and legible, with no degradation or
distortion.
• The size of the CBAHI logo and its accreditation seal should remain in the same permitted
proportion as that provided.
• The CBAHI logo, certificate, and seal should be used in the same format, with no extra
graphics or words.
• The HCF employs the same colors used in the CBAHI logo, or black and white when
the logo is used for certain printed materials such as newspaper advertisements,
newsletters, brochures, flyers, and posters.
• The HCF is prohibited from using the CBAHI logo or accreditation seal on business
cards.
• Upon expiry of the certificate validity period, or suspension/revocation of the
accreditation, the HCF shall immediately take action within a maximum of thirty (30)
days to refrain from using the CBAHI logo, accreditation certificate, and seal. Failure to
comply with the specified timeframe might subject the HCF to the appropriate decision
according to the policy on accreditation suspension and revocation.

Release of Accreditation-Related Confidential Information

CBAHI acknowledges that HCFs undergoing its accreditation survey are expected to provide
access to information related to the evaluation of their compliance with CBAHI standards.

As a guiding policy, to HCFs engaged in its different accreditation programs, CBAHI commits
to keeping confidential all information obtained or received during the accreditation process,

36
including all survey data and information that surveyors come across during the survey process.

For an HCF that is a participating member of the CBAHI accreditation program, some information
is subject to public release. This includes:

• The healthcare facility accreditation status being posted on the CBAHI website.
• The areas of the HCF that were included in the accreditation survey.
• The standards under which the accreditation survey was conducted.

Other accreditation-related information is not subject to public release except to the HCF in
question. The exception to this rule is when the CBAHI receives an official request for clarification
from relevant health authorities or public health agencies. This information includes:

• The mock and final accreditation survey reports.

• Accreditation Committee minutes and agenda materials.
• The notification letter of the survey report to the healthcare facility’s director.
• The accreditation certificate.
• The post-survey requirements, including any CAPs.
• The results of investigations related to a sentinel event, including the root cause analysis
prepared in response to that event.
• The results of investigations involving any falsified information the healthcare facility
provided to CBAHI.
• Any other information related to compliance with CBAHI standards obtained from the
HCF before, during or after the accreditation survey.

Complaints against an Accredited Healthcare Facility

CBAHI is interested in collecting information from a variety of sources to improve the quality and
safety of all accredited HCFs. One of these sources is complaints from patients, their families, HCF
staff, government agencies, the media and the public. In particular, staff members at any given
HCF accredited by CBAHI must be informed that they may make complaints directly to CBAHI
without fear of retaliatory actions from their HCF.

CBAHI addresses all complaints that would help identify possible noncompliance with its
accreditation standards, thereby posing a possible threat to the safety of patients, staff or the
public. More precisely, CBAHI can evaluate complaint information only in terms of its relevance to
compliance with CBAHI’s standards. Issues of a personal nature or individual disputes should be
dealt with by the concerned facility or the regional health authority. CBAHI cannot follow up on
complaints about HCFs which are not accredited.

When CBAHI receives a complaint against an accredited HCF, CBAHI will conduct an initial
screening to determine its relationship to standards and its impact on patient safety. If the
complaint does not relate to compliance with CBAHI standards, a response of “non-relevance”
will be forwarded to the complainant, who will be advised to forward the complaint to the HCF
leadership or the regional health authority. If the complaint relates to compliance with one or
more CBAHI standards, a response shall be made accordingly. The response will depend on a risk
assessment matrix that determines the probability and severity of the complaint. CBAHI will check
for other complaints about the same HCF. Broadly speaking, CBAHI will give one or both of the
following responses:

• CBAHI may write to the HCF about the complaint. When requested, the HCF must
make available its records of complaints and subsequent actions taken.

37
 • CBAHI may decide to visit the healthcare facility to verify whether a problem exists
in terms of meeting the standards involved in the complaint. Such visits are usually
unannounced, and the outcome may change the accreditation decision.

It is CBAHI policy not to disclose any information related to patients or complainants unless it
is authorized to do so. In addition to information about the complaint’s relevance to CBAHI
standards, the complainant will receive the following information:

• The course of action CBAHI took regarding the complaint.

• Whether CBAHI has decided to take action regarding an HCF accreditation decision
following completion of the complaint’s investigation.

To file a complaint against a CBAHI-accredited healthcare facility, an individual can send his/her
concern via the contact form on the CBAHI website. The individual can also file the complaint
directly by calling the Universal Access Number 920012512. CBAHI requires that the complainer
reveal his or her identity. Therefore, CBAHI will not consider anonymous complaints.

Conflict of Interest

CBAHI works to ensure the integrity and fairness of all businesses conducted by employees
working in the central office as well as the surveyors.

In addition, all healthcare facilities engaged in the CBAHI accreditation process are required
to refrain from any actual or potential act or behavior that might create a conflict of interest,
including:

• Proposing any fee, remuneration, gift or gratuity of any value to CBAHI employees or
surveyors for performance of their duties or survey-related activities.

• Employing, contracting or having any financial relationship with CBAHI employees or

surveyors for the purpose of providing consulting or related services in any capacity,
either directly or through another party. This includes services provided in preparation
for the survey, assisting in preparation of the self-assessment, conducting mock surveys,
helping with the interpretation of the standards and the like. All requests for consulting
services utilizing CBAHI employees or surveyors shall be directed to CBAHI.

• Not declaring to CBAHI any business (including consulting) or recruiting relationship

with one or more CBAHI surveyors either directly or through another party with whom
he or she is affiliated at any time during the preceding three (3) years.

38
Truthfulness and Ethics Clause

CBAHI strives to maintain the highest ethical and legal standards in the conduct of its business.
This includes honesty, transparency, and truthfulness in all its dealings, with avoidance of all
situations that might appear unethical or illegal. The same is expected from the HCFs seeking
CBAHI accreditation. CBAHI employees are committed to politely declining any gifts or gratuities
offered to them or to members of their families, including spouses, children, and parents, when
the donor expects something in return. Such gifts or gratuities may be attempts to gain an unfair
advantage or influence the manner in which the employee or surveyor performs his/her job duties.
Gifts of nominal value may be accepted as tokens of appreciation or goodwill provided they are
given as gestures of a professional relationship and do not involve or create the appearance of any
commitment in terms of survey results or accreditation decisions.

Business lunches, tea, coffee and snacks during the survey are permitted. Other social gatherings
are prohibited, and HCFs are encouraged to not offer such to the survey team. Using the HCF
vehicle to transport the survey team to and from the survey site is acceptable.

CBAHI’s confidential and proprietary business information is safeguarded and is utilized only in
keeping with the best interests of CBAHI, its obligations to third parties, and the highest ethical
and legal standards. Such information must not be disclosed to a third party without prior
approval of a duly authorized member of CBAHI management for an acceptable reason.

CBAHI maintains the confidentiality of all data and information about both CBAHI and HCFs in
accordance with CBAHI’s core values and relevant policies.

CBAHI is also committed to resolving complaints and ethical issues raised by CBAHI employees
or client HCFs to ensure justice, confidentiality, impartiality, timeliness and feedback to the
complainants.

39
PART III
ACCREDITATION
STANDARDS
 Chapter I
Leadership of the Organization (LD)

Introduction

For any ambulatory care center, quality and patient safety depend on effective leadership. ‎
Ambulatory care centers may vary in size, type of ownership and complexity of services. The
owner of the center may be a single private owner, a group of private owners, or a governmental
entity. In all cases, the owner (private or governmental) constitutes the center’s governing body
or governance. The governance or governing body is responsible for providing safe and quality
patient care. The center’s director, whom the governing body selects, is accountable for ensuring
the provision of safe and quality patient care. The center may be directed by a single owner who
maintains the dual role of governance and leadership
Large centers may have several divisions, such as nursing, medical, administrative, and facilities,
among others. A director manages each division.

In such large centers, the center’s director and division directors constitute the leadership group.
In small centers, leadership may be presented only by the center’s director. It is crucial for all
ambulatory care centers to have a clearly stated mission. The leadership of the center is responsible
for developing the mission and providing adequate ‎resources, through the governing body, to
fulfill this mission. Ambulatory care centers are of a much smaller size and are much less complex
than hospitals. Therefore, it is expected that the leader(s) will carry out most of the administrative
work, as explained in the following standards.
‎
The leadership chapter addresses the following:

• Organizational structure
• Structure and function of the governing body
• Roles and responsibilities of the center’s leaders
o Mission and vision and values, scope of services and strategic planning
o Effective human resource management
- Staffing plan
- Job descriptions for all types of employees
- Staff recruitment
- Credentialing and privileging
- Staff orientation and education
- Staff performance evaluation
- Staff health and safety program
o Patient and family rights
o Quality improvement and patient safety
- Developing and maintaining center’s policies
- Developing and supporting a quality improvement and patient safety program
- Developing and supporting a risk management program
- Contract oversight
- Supplies oversight

42
Standards

LD.1. The governing body defines its structure and operational responsibilities in a
written ‎document. ‎

LD.1.1. The governing body approves and periodically reviews, the center’s
mission, vision and values and makes it public.
LD.1.2. The governing body approves the center’s scope of services, the center’s
plans, programs and all policies and procedures.
LD.1.3. The governing body approves the center’s operating and capital budgets,
as well as other resources required to manage the center efficiently.
LD.1.4. When the center is part of network, the governing body plans for services
and functional relationships among the network components.
LD.1.5. The governing body defines any approval authority delegation.
LD.1.6. The governing body appoints a qualified director responsible for
managing the center.

Explanation

The governing body (owner(s), board of directors) should highlight its structure, role, ‎ and
responsibilities in a written document. Roles and responsibilities include approval o ‎ f strategic
and operational plans and budget, mission and vision, scope of services, the risk m ‎ anagement
program, and policies and procedures. Roles and responsibilities of the ‎governing body also
include appointing the center’s director and defining any leadership ‎delegation authority that
highlights the person responsible for managing the center in the ‎absence of the center’s director. ‎

LD.2. The governing body approves and evaluates the center’s quality and patient
safety program and risk management program.

LD.2.1. The governing body annually approves the quality and patient safety
program, including risk management.
LD.2.2. The governing body receives and evaluates the quality and patient safety
reports, including the corrective actions and outcomes from the center,
including risk management, at least quarterly.
LD.2.3. Recommended corrective actions by the governance are documented
and received by the center director for implementation.

Explanation

The governing body should ensure patient, staff and visitor safety by approving the q ‎ uality and
patient safety and risk management programs and periodically evaluating their ‎effectiveness. At
least every three months the governance should receive reports on selected i‎ndicators, all safety
concerns that staff reported, all medical complications, and ‎all financial and other administrative
risk issues. Governance, together with leadership, s‎hould work to formulate an action plan to
prevent errors and mitigate risk. Governance should observe and document the ‎implementation
and outcomes of corrective actions.

LD.3. The center has a current organizational chart.

LD.3.1. An approved and updated organizational chart identifies the relationship

between the center’s governance, leadership, and other directors with
names and titles.
LD.3.2 The organizational chart is communicated to all staff.
LD.3.3. The staff are aware of the organizational chart and its intent and can
demonstrate their ‎relationship to it.

43
 Explanation

Efficient and effective healthcare organization management requires effective staff ‎communication
and clear reporting lines. The organizational chart should be ‎developed to present the relationship
between the governance (the owner or board of ‎directors) and the center’s managing director(s),
and between the managing director(s) ‎and the front-line staff. Managerial positions in the chart
should be reported by title and name. ‎All center staff should be aware of their position in relation
to the organizational chart ‎and their line of command and required reporting. The chart should
be updated regularly, s‎igned by the center’s director and communicated to staff and displayed
clearly in the center. ‎

LD.4. The center is managed effectively by a qualified director.

LD.4.1. The center director has a written job description and his/her qualifications
match the requirements in the job description.
LD.4.2. The center director, with other leaders, develops the mission, vision and
values statements.
LD.4.3. The center director ensures the center’s compliance with all relevant laws
and regulations.
LD.4.4. The center director recommends to the governing body required new
policies for approval and ensures compliance with approved policies.
LD.4.5. The center director ensures the availability of adequate and proper
resources for the planned services in accordance with the approved
operating budget.
LD.4.6. The center director ensures a safe and functional facility environment for
patients, visitors, and staff.

Explanation

The center must be managed daily by a director. The job description of the center’s ‎director clearly
highlights his/her roles and responsibilities as well as the required job q
‎ ualifications and experience.
The director is responsible for the center’s compliance with a‎ ll applicable governmental laws
and regulations, including, but not limited to, patient care ‎regulations, medication management,
MOH regulations for the opening licensure, staffing ‎licensure and certification, civil defense
requirements, municipality requirements, and MOH ‎reportable diseases. The director is responsible
for responding to all governmental ‎inspections, including clear action plans for compliance.
Accreditation of the center by the ‎CBAHI is the ultimate responsibility of the center’s director. The
director ensures the a‎ vailability of the adequate number and the right mix of staff required for
the day-to-day ‎activities. He/she also ensures the continuous availability of the required supplies,
‎medications, and resources to safely run the center. The director recommends all required ‎policies,
procedures, protocols, and clinical practice guidelines that are required for the clinical, ‎managerial
and financial integrity of the center. The director ensures the facility is designed ‎to deliver the
intended services in a safe and secure environment for patients, staff and v‎ isitors. ‎ ‎

LD.5. The leaders together with governance develop the center’s scope of services
based on community needs.

LD.5.1. The scope of services includes the range of coverage in relation to

preventive medicine, health promotion, curative and rehabilitative
medicine.
LD.5.2. The scope of services includes the specialty services that the center
provides, the number of clinics for each specialty, the level of professional
coverage.
LD.5.3. The scope of services includes the age group that can be served and the
working hours.
LD.5.4. Services are displayed in the center, and patients and, when needed,
families can obtain additional related information from the reception
staff.
44
Explanation

The center shall function according to a predefined scope of services document d ‎ eveloped
collaboratively between governance and the center’s leaders (the center’s d ‎irector, medical
director, nursing director, human resources director, finance director, and administration director,
as applicable). The scope of services includes the range of clinical s‎ ervices in each provided specialty
based on the center’s location and the community n ‎ eeds (i.e., preventive, health promotion,
curative, and rehabilitative). The scope of services includes t‎ he number of clinics for each specialty,
age group, and working hours. The average number of patients anticipated to be seen, as well
the maximum number who can be seen, should also be highlighted. The scope of services also
includes the level of professional coverage for example consultants versus specialist.

LD.6. The leaders work collaboratively to develop the center’s strategic plan.

LD.6.1. The strategic plan is guided by the mission, vision and inputs from
patients/service users, their families, staff and where possible the wider
community.
LD.6.2. The strategic plan is based on a comprehensive evaluation of the internal
and external environmental factors.
LD.6.3. The strategic plan addresses all clinical and non-clinical services and
programs.
LD.6.4. The strategic plan spans a period of three to five years and is reviewed on
a regular basis.
LD.6.5. The strategic plan includes the broad goals and objectives required to
fulfill the center’s mission.

Explanation

Ambulatory care centers require forward planning to continue their mission and achieve their
vision. The planning may include mastering current services (centers of excellence) or introducing
new services. This strategic planning should be based on a comprehensive evaluation and analysis
of the internal and external operational and environmental factors that may affect the center’s
mission and vision, such as SWOT analysis and PEST analysis. The plan should have clear goals and
objectives to achieve in a time frame.

LD.7. The leaders transform the approved strategic plan into an operational plan.

LD.7.1. Goals and objectives are translated into operational plans with defined
projects, clearly delineated responsibilities, required resources and time
frames.
LD.7.2. Governance approves the resources required for executing the operational
plans.
LD.7.3. Operational plans are implemented and closely monitored for progress
by structure and process indicators.
LD.7.4. The plans are communicated to department directors and other staff.
LD.7.5. Department directors develop annual departmental plans in alignment
with the center’s strategic plan.

45
 Explanation

Strategic plan should be converted into an operational plan that contains steps to follow and
staff to lead and execute. Plans and resources are all approved by governance and tabulated for
further timely implementation. Staff involved in and/or affected by the plan should be informed
accordingly.

LD.8. The leaders work collaboratively to develop the operational budget.

LD.8.1. The leaders plan and budget for the upgrade or replacement of buildings,
equipment, and other resources.
LD.8.2. The budget process allocates resources to all patient care units based
on the scope of care and complexity of patient must ensure a safe and
effective facility.

Explanation

The leaders should develop an annual budget. This budget should take into consideration
any additional cost for replacing or upgrading equipment, upgrading services, and periodic
maintenance and repair. The budget should be distributed between the different patient care
areas (e.g., space, equipment, supplies, staffing, and other resources) to ensure seamless and safe
patient care. ‎

LD.9. The leaders work collaboratively to fulfill the mission and provide quality care.

LD.9.1. The leaders communicate the mission, vision and values to all staff and
customers.
LD.9.2. The leaders ensure the use of evidence-based and best practice
information to develop and improve the center’s services.
LD.9.3. The leaders work collaboratively to develop and carry out plans, policies,
and procedures.
LD.9.4. The leaders meet regularly to review the key performance indicators
of services, survey, audits and feedback and use the collected data to
improve the center’s operations.

Explanation

All staff should know the center’s mission and vision, and any amendments or changes should
be communicated to staff. The services should be evidence-based, and all policy and practice
guidelines that he leaders develop should be based on referenced and updated practices. Regular
leadership meetings shall take place to ensure that all plans are carried out effectively, and that
policies and practice guidelines are followed. Plans, policies, and practice guidelines should have
process indicators to ensure staff compliance, and outcome indicators to ensure their effectiveness.

LD.10. The leaders develop a staffing plan for the center.

LD.10.1. The staffing plan ensures that services meet the needs of safe patient
care.
LD.10.2. The staffing plan defines the number, type, and credentials of required
staff, and their roles.
LD.10.3. The center recruits and assigns appropriately qualified staff in accordance
with the staffing plan.

46
Explanation

The center’s leaders (the HR director together with the center director, medical director, ‎nursing
director, and administrative director) should formulate a staffing plan for the c‎ enter based on
the scope of services the center provides and the center’s capacity and working ‎hours. The plan
should include the number, type, and qualifications of staff required in all the center’s ‎areas
(medical and non-medical) to ensure safe patient care, according to MOH rules and r‎egulations,
and the smooth operation of other administrative areas. ‎

LD.11. The leaders develop a policy and procedure for staff recruitment.

LD.11.1. The policy and procedure highlight the receiving authority(s) of staff
resumes, the shortlisting process, and the accepted method for interview.
LD.11.2. Applicants are informed of their acceptance or refusal within a set time
frame.

Explanation

For the center to recruit the right staff, it must have a policy and procedure for staff recruitment.
The policy highlights the shortlisting process whereby all applicants’ CVs are reviewed to ensure
that they match the description of the job for which the candidate applied. An objective process
must exist for assessing the interviewee or the applicants; this process must include an approved
interview form. The applicants should be informed of their acceptance or denial of appointment
within the time frame specified in the policy.

LD.12. All categories of staff have clearly written job descriptions.

LD.12.1. The job description outlines the knowledge, skills, and attitude necessary
to perform the job responsibilities.
LD.12.2. The job description clearly defines roles and responsibilities for the
position.
LD.12.3. Job responsibilities and clinical work assignments are based on evaluation
of staff credentials.
LD.12.4. The job description is discussed with and signed by the employee upon
his/her hiring and is located in his/her personnel file.

Explanation

For smooth operational performance and accountability, each staff member must have his/
her own job description that outlines daily responsibilities, necessary qualifications, skills, and
experience. This job description shall help in recruiting the right staff for vacant positions and shall
constitute the basis for the staff evaluation, whether it is probationary or carried out at the end of
the year. This job description must be discussed with each staff personally, and it must be signed
at the time of hiring to acknowledge that the staff are fully aware of the job, its requirements,
and responsibilities.

LD.13. The leaders develop an effective process for credentialing and

(C) recredentialing all healthcare providers.

LD.13.1. The credentialing process applies to all clinical staff members: medical
staff, nursing staff, and other clinical staff licensed to provide patient
care.
LD.13.2. The credentialing process includes gathering, verifying, and evaluating
credentials including license, education, training, experience and
competence.
LD.13.3. To the extent possible, the credentials are verified from the original

47
 source directly or through a third party with documented evidence.
LD.13.4. The center ensures the registration of healthcare professionals with the
Saudi Commission for Health Specialties and licensing by the Ministry of
Health in accordance with laws and regulations.
LD.13.5. The credentialing process guides the appointment of healthcare staff to
their appropriate job assignment and is repeated every two (2) years to
ensure that staff are still capable of performing their job functions.
LD.13.6. Information about staff credentials, privileges, competencies, orientation,
training, education, and evaluation are kept securely in an updated
personnel file.

Explanation

The center must make all efforts to ensure the placement of new staff in the right position initially,
and every two years thereafter. This process of credentialing applies to all clinical staff licensed to
provide patient care (physicians, nurses, physiotherapists, technicians).
The credentialing process involves collecting all the information related to the staff (education,
training, experience, competencies, and licensure), verifying it from the primary source, and
evaluating it to ensure the staff fits in his/her assigned position. The center ensures that all
healthcare professionals are registered with the Saudi Commission and licensed by the MOH
according to rules and regulations. All staff who are credentialed and approved to work in the
center should have a record of their credentials kept safely with the administration. The process
is repeated every two years to ensure that staff remain authorized and capable of providing the
same job functions.

LD.14. All medical staff members have current delineated clinical privileges.
(C)
LD.14.1. The center has a policy and procedure for granting privileges to medical
staff.
LD.14.2. Clinical privileges are determined based on the center’s documented
competency and available services.
LD.14.3. The medical staff’s clinical privileges are recommended by the medical
director and approved by the governing body, either directly or by
appropriate delegation.
LD.14.4. The clinical privileges are reviewed and updated every two (2) years, and
earlier if needed.

Explanation

The privileging of physicians is the most rewarding proactive risk management approach with
respect to patients’ safety. It allows physicians to perform procedures and surgeries for which
they have been made qualified by education, training, and certification. This prevents patients’
exposure to risk of morbidities. Each physician should have a list of the invasive procedures that
he/she is allowed or privileged to perform.
The center must have a policy and procedure for granting individual privileges. Clinical privileges
should be distributed in the areas where the physician is practicing. The privileging process should
be reviewed and updated every two (2) years, and earlier if a physician receives new training on a
certain procedure or is found to be potentially dangerous in performing other procedures.

48
LD.15. All new employees attend a mandatory orientation program.

LD.15.1. The new employees’ general orientation program includes information

about the center’s mission, vision, values, and organizational structure;
patient and family rights; safety and security; the basics of infection
control; and an introduction to the center’s quality and patient safety
and risk management programs.
LD.15.2. Each new employee attends a department-specific orientation program,
including specific infection prevention and safety issues, that helps in
executing the specific job responsibilities as outlined in the job description.
LD.15.3. The new employee orientation is documented in the employee’s
personnel file.

Explanation

All new employees (full-time, part-time, visiting, and volunteers) should be oriented to the center.
A general orientation should include information about the center:

• Mission, vision, and values

• Current organizational structure
• Code of conduct and ethical framework
• Patient and family rights
• Safety and security
• Infection control
• Quality and patient safety and risk management programs

The orientation also includes a specific job orientation, which teaches the staff the requirements
for patients’ assessment and documentation, and how to deal with patient transfers, among
other essential processes in the staff’s area of practice. Policies related to vacations, penalties,
grievances, and separation may be compiled into a manual that is provided or accessible to staff.

LD.16. The leaders develop and implement a policy that ensures nurses and other allied
healthcare staff are competent in specific procedures.

LD.16.1. The policy contains a list of procedures requiring competency assessment

in each and every staff category.
LD.16.2. All newly hired staff are initially tested for the required competencies.
LD.16.3. All staff are tested annually for the required competencies.
LD.16.4. All test results are available in staff personal files.

Explanation

To ensure patients’ safety, staff must be tested both and annually on their competency in certain
procedures, according to their scope of work, such as:

• Taking blood samples

• Inserting intravenous lines
• Inserting an indwelling urinary catheter or simple urinary catheterization
• Inserting nasogastric tubes
• Performing electrocardiograms and cardiotocography
• Infection control practices and precautions (isolation procedures, hand hygiene, the
use of personal protective equipment, preventing needle stick injuries)
• Positioning patients for common radiological procedures

Competency assessment results are documented in staff personal files for evidence and monitoring
of compliance with the policy.

49
 LD.17. The leaders ensure staff are trained and test competent in the safe operation of
equipment including medical devices.

LD.17.1. A policy is in place to ensure staff are trained on the safe operation of the
current and newly introduced equipment and medical devices.
LD.17.2. The policy addresses the required training and competency testing of
staff operating specialized equipment.
LD.17.3. Only trained and competent staff handle specialized equipment and
medical devices.

Explanation

To safely operate medical equipment, reducing risk to patients and staff and increasing operational
efficiency, staff must receive appropriate training on this medical equipment. Periodic competency
testing is required, and newly introduced equipment should not be used until staff are trained and
tested competent on its use.

LD.18. The leaders support continuing education and training for all categories of staff.

LD.18.1. The center has a scheduled educational and training program based on
the center’s needs and person-centred care including quality, patient
safety, risk management and infection control practices.
LD.18.2. The leaders grant financial support and/or time off for staff to attend
educational and training activities relevant to the center’s scope of
services and in line with labor law.
LD.18.3. Employees’ records show documented evidence of training and
education.

Explanation

Staff professional development is important for improving the center’s services. The center should
drive continuous medical and nursing education and other categories of staff. The simplest way
is to provide a scheduled educational program fulfilling person-center care and the center’s
scope of services and needs, including quality, patient safety, risk management and infection
control practices, patient/service user rights, complaint management, shared decision-making,
communication skills, informed consent, and the cultural beliefs, needs and activities of different
patient/service user groups. Also, the center can grant either financial support or time off so
that staff can attend conferences, symposia, training courses and other educational activities.
Employees’ personnel files should show documentation of training and education.

LD.19. Staff are trained and kept up to date with cardiopulmonary resuscitation.

LD.19.1. All staff members who provide direct patient care receive training on
basic life support (BCLS).
LD.19.2. The center identifies other staff members to be trained in advanced life
support as appropriate to the age groups they serve (ACLS, PALS, NRP).
LD.19.3. All staff maintain the validity of their life support certification.

50
Explanation

Although the scope of services of most of the centers does not include high-risk patients, sudden
cardiopulmonary arrest may occur and potentially be lethal. Therefore, all staff members providing
direct patient care must have at least basic life support skills and certification. The center should
also identify other staff members who will be required to receive training in advanced life support,
such as those serving in emergency rooms. Age group life support skills and certification may also
be warranted for advanced pediatric life support and neonatal life support.

LD.20. The leaders develop an effective process to evaluate staff performance at least
annually.

LD.20.1. The performance evaluation is based on objective criteria and is consistent

with the expected competencies such as knowledge, skills and attitude
required to perform the employee’s job responsibilities as outlined in his/
her job description.
LD.20.2. The evaluation is done at the end of the initial probationary period and
annually thereafter.
LD.20.3. Staff are involved in the evaluation of their performance by commenting
on the required corrective action.
LD.20.4. Evaluations include personal goals to achieve for the next year that the
employee will carry out.
LD.20.5. Both the employee and his/her supervisor sign the performance
evaluation, which is kept in the employee’s personnel file.

Explanation

To ensure satisfactory staff performance according to job descriptions and privileges, a

standardized objective process for gathering and assessing the staff’s performance, scope of
practice, professional development, and attitude must be developed for each staff category.
The evaluation is carried out at the end of the initial probationary period and at least yearly
thereafter. Staff should acknowledge their performance and comment on any required actions for
improving their performance as set forth by their supervisors.
The performance evaluation should always include goals to achieve for the next year (part of the
evaluation for the next year). Both the employee and his/her supervisor sign the performance
evaluation, which is kept in the employee’s personnel file.

LD.21. The leaders implement a comprehensive program to protect the health and
safety of staff.

LD.21.1. The program covers all employees and is consistent with laws and
regulations.
LD.21.2. The program is based on the protection of staff from occupational health
and safety hazards and violence in the workplace.
LD.21.3. The program is coordinated with the center’s quality, safety, risk
management, and infection control programs, including health screening,
immunization, and post exposure management.
LD.21.4. Staff have confidential and secure medical records that reflect their
health status.

51
 Explanation

The health and safety of staff are vital for the provision of best care. A staff health and safety
program should be available in all healthcare organizations. The program should cover working
areas to reduce occupational risks. There should be a vaccination program to protect staff liable
to infection from common viral illness (e.g., varicella zoster and hepatitis B).
Staff working in offices should receive random checks of their posture behavior and their furniture
to ensure its safety for their extended office hours. Manual workers should receive information
about the safe handling of goods and about avoiding strains and sprains and should be monitored
for the implementation of this information.
The program should have a policy for the prevention of needlestick injuries and other occupational
hazards, such as radiation and chemical exposures. The program should also focus on the use of
personal protective clothing and equipment when dealing with infectious diseases patients. The
program should focus on security issues to manage violence and aggression against staff. The
program should be well coordinated with the quality and patient safety and risk management
programs. Reports about staff health and safety should reach the governance as per requirements
for the quality and patient safety program. Staff files containing information about staff members’
vaccinations and illnesses should be available and kept safe and secure.

LD.22. The leaders support and protect the patient and family rights.

LD.22.1. The leaders develop and maintain a patient rights and responsibilities
statement and develop processes that support their implementation.
LD.22.2. The leaders ensure that patient rights and responsibilities are available to
patients and families and ensure patients are informed about their rights
and responsibilities in a manner they can understand.
LD.22.3. The leaders ensure that patients’ dignity, privacy and confidentiality are
respected.
LD.22.4. The leaders ensure that staff are provided training and education on
patient and family rights and responsibilities.

Explanation

Patient and family rights and responsibilities are paramount for ethical and safe patient care.
The leaders should develop all policies and procedures pertaining to patients and family rights,
including the bill of rights. Such policies and procedures should be available to patients and their
families in written documents that are close at hand or clearly displayed in the center. The leaders
ensure that staff are fully aware of – and trained on executing – the rights and responsibilities.
The leaders should exert all efforts to ensure that patients are treated with dignity and that
their privacy is always respected. Leaders should also ensure the safety and security of patients’
personal belongings. Patient and family rights respect their preferences and choices to the extent
possible within rules and regulations.

LD.23. The leaders ensure that patients/families have the right to be involved in their
own care and treatment.

LD.23.1. Patients/families have the right to be informed of their illness, the

proposed treatment and its prognosis.
LD.23.2. Patients/families have the right to be involved in the decision making of
their care plans.
LD.23.3. Patients/families have the right to professional assessment and
management of pain.
LD.23.4. Patients/families have the right to refuse or discontinue treatment or ask
for a second opinion.
LD.23.5. Patients/families have the right to request a detailed medical report and
sick leave notification.

52
Explanation

Patients and their families should be granted the right to be informed of their illness, the proposed
treatment, the cost incurred, and the prognosis of their treatment in a manner and language they
understand. Patients should agree to their care plans and should have the right to manage their
pain effectively. Patients are granted the right to ask for a second opinion if necessary, without
fearing that their care may be compromised. Patients have the right to request a detailed medical
report to be presented to other centers and sick leave notification for regulatory purposes.

LD.24. The leaders develop and implement a policy and procedure to describe the
patients’ right to voice their complaints and concerns.

LD.24.1. Patients’ complaints are resolved in a time frame described in the policy.
LD.24.2. The center assigns a staff member responsible for managing complaints.
LD.24.3. Patient satisfaction surveys are conducted at least quarterly.
LD.24.4. Data collected from surveys and complaints are analysed and trended,
and the information collected is used for improvement and integrated
into the quality and safety program.

Explanation

Patients’ satisfaction is a measure of their appreciation of the services that the center provides.
Patients’ complaints identify areas that require the immediate attention of leaders. The leaders
support the patients in their right to complain in a manner they prefer. The complaint system is
the responsibility of the patients’ relations officer or similar staff, who should have a policy and
procedure to follow. Every effort must be made to finalize patients’ complaints in a time frame
defined in the policy. All complaints are analyzed and trended, and information presented to
leaders for corrective actions is to be developed and implemented. Patients’ satisfaction surveys
should be conducted at least quarterly. Information and action plans from complaints and surveys
should be included in the quality and safety program and reported to governance.

LD.25. The leaders ensure that patients/families have the right to accurate billing for
provided services.

LD.25.1. The leaders ensure the availability of the price list for services provided to
patients and their sponsors.
LD.25.2 The patients and families have the right to receive an initial estimated
cost of required services.
LD.25.3. The patients and families have the right to obtain an invoice for services
rendered.

Explanation

The center’s price list should be accessible to patients and families and a receipt should be given
for services rendered, including insurance patients. It is the right of the patient and family to
receive an initial estimated cost for their treatment if requested. The request for an itemized bill
should be honored if requested by patients and families unless the service given is under the price
list of a “package deal”.

53
 LD.26. The leaders develop ethical standards to guide patients’ care and employees’
code of conduct.

LD.26.1. Marketing for staff and services, if performed, is carried out ethically as
per laws and regulations.
LD.26.2. The leaders develop a set of values and a professional code of conduct
for all employees.
LD.26.3. The leaders ensure that patients and their families are fully informed and
protected when they are involved in clinical research projects.
LD.26.4. The leaders develop a process to receive and resolve ethical dilemmas,
patient and non-patient related in a reasonable timeframe as determined
by the center.
Explanation

The leaders are responsible for developing the framework that governs how patient care is
conducted in an ethical manner across the center’s activities. The values and professional code of
conduct describe the center’s expectations of staff regarding their behavior and communication
with each other and with their patients. This includes the ethical portraying of services; reasonable
and accurate billing; the assuring that staff are engaging in ethical behavior with patients, visitors,
and staff; and the assuring that staff are wearing appropriate attire. Patient-related dilemmas
related to ethics may include decisions to not treat, to withdraw treatment, or to discontinue
treatment.

LD.27. The center provides assistance to patients with special needs.

LD.27.1. Dedicated street parking and drop-off points are available.

LD.27.2. Handrails for staircases are constructed.
LD.27.3. Ramps for elevated areas are available.
LD.27.4. The center’s entrance allows wheelchair access and elevators have
wheelchair access doors.
LD.27.5. Wheelchair-accessible toilets are available.

Explanation

Requirements critical for dealing with special needs patients should be considered in the planning
of all HCFs and services. Special needs patients should be looked after by providing them with
dedicated parking slots, wide entrances, accessible elevators, ramps for elevated areas, handrails
in corridors and stairs, and accessible toilets.

LD.28. The center has an implemented policy for controlling the development and
maintenance of key documents.

LD.28.1. The center has a unique identification for each key document, with title,
number, date of issue, and date of revision.
LD.28.2. Key documents are developed, approved, revised, and terminated by an
authorized individual.
LD.28.3. Key documents are dated and current.
LD.28.4. Key documents are revised according to a defined revision due date.
LD.28.5. Key documents are communicated to relevant staff and are always
accessible.
LD.28.6. A process is in place to ensure that key documents are always
implemented.
LD.28.7. A process is in place to ensure that only the last updated versions of key
documents are available for use in the center.

54
Explanation

For the proper execution of key function documents, policies, procedures, and processes,
they must be identical in their format for writing, and have tags that identify the originating
department, date of issue, date of revision, date of implementation, and date of expiry. Only
authorized individuals can change policies. Key function documents, policies, procedures, and
processes carry the name(s) of the author(s) and approving authority. A system must be in place to
ensure that only approved and non-expired policies are circulating and available to staff. All staff
should be familiar with the available key function documents, policies, procedures, and processes
relevant to their practice.

LD.29. The center develops a comprehensive quality improvement and patient safety
program.

LD.29.1. The leaders develop the program collaboratively.

LD.29.2. The program utilizes key performance indicators, and patient and staff
surveys to measure performance and improve clinical and managerial
areas.
LD.29.3. The information generated is readily accessible on a timely basis to those
responsible f‎or and/or involved in the delivery of the services, and is
utilized for making improvements and supporting the leaders’ decision
making.
LD.29.4. The program utilizes an evidence-based quality improvement method
such as “FOCUS – PDCA.”
LD.29.5. The center implements at least one improvement project per year.

Explanation

The center should ensure the quality of its services and its continuous improvement by developing
a quality management and patient safety program. Key performance indicators are utilized to
measure the performance of the services provided. Staff are notified of the performance findings,
and the information provided is utilized to further improve the clinical and managerial areas
(structure, process, and outcome). Improvements in quality utilize an evidence-based approach
such as FOCUS-PDCA.

LD.30. The leaders prioritize and select a set of indicators that focus on the structure,
process, and outcome of the services provided within the center.

LD.30.1. The selection process is based on the center’s important processes and
priorities.
LD.30.2. Each indicator has an operational definition, data collection method,
frequency for collection, analysis by qualified staff, mathematical
expression such as a ratio, with a defined numerator and denominator
or a percentage and a desirable target.
LD.30.3. Structure indicators may include, but not be limited to the following:
availability of essential supplies and equipment, availability of medical
records, availability of emergency medications, surgical volume, and staff
ratios.
LD.30.4. Process indicators may include, but not be limited to the following:
waiting time, documentation in medical records, site marking, and time
out processes.
LD.30.5. Outcome indicators may include, but not be limited to the following:
Patient and staff satisfaction, patient’s complaints, health-care-associated
infections, medication errors, sentinel events and various adverse events.

55
 LD.30.6. The performance monitoring results are discussed with staff, utilized in
their evaluation, and reported quarterly to the governance together with
action plans taken for improvement.
LD.30.7. The indicators are compared internally by historical trends and externally
by benchmarking to other similar centers when available.

Explanation

The collection of key performance indicators should follow an evidence-based approach as

outlined in LD.30.1 through LD.30.7. The indicators should cover a variety of issues based
on structure, process, and outcome. The indicators should regularly be presented to staff to
enhance their performance and also be utilized in their evaluation. Benchmarking of one’s own
performance should be carried out internally (comparing historical data) and externally, either
locally or internationally, to define the center’s position in terms of performance. A quarterly
report should be presented to the governance with improvement action plans if required.

LD.31. The leaders develop and implement a comprehensive risk management program.

LD.31.1. The program addresses clinical, managerial and financial risk.

LD.31.2. The reporting of incidents and variances, patients’ morbidities, and
clinical and financial claims constitute the program’s essential reactive
arm.
LD.31.3. The center develops and implements at least one proactive risk
management approach per year.
LD.31.4. The center develops and periodically updates a risk register for all
potential clinical, managerial, and financial processes in the center.
LD.31.5. The center utilizes an evidence-based process for grading risks based on
severity, frequency, and/or likelihood of occurrence.
LD.31.6. Information from the risk management program, including incidents,
analysis, and improvement projects, is communicated to staff and the
governing body at least quarterly.

Explanation

Healthcare organizations are risky places to visit and work in. The center should develop and
implement a risk management program that covers all aspects of its activities: clinical, managerial,
and financial. The program should be based on both reporting incidents and analyzing them to
prevent recurrences as well as a proactive approach such as failure mode and effects analysis
(FMEA) or any similar proactive risk management approach. The proactive approach should target
improving practices that are high risk, problem prone, or high volume, that have a substantial
financial impact, such as insurance rejections or that can markedly improve patients or staff
satisfaction. Risks should be graded according to an evidence-based unified score system, and
the center should maintain a list registering all its risky practices and procedures. Information
collected from the risk management program should be used to improve the system, and staff
should be informed of the findings and improvement projects at least quarterly.

LD.32. The leaders develop and implement an incident reporting policy.

LD.32.1. The policy outlines the types of incidents to be reported internally and
to relevant regulatory authorities and the time frame and mechanism for
reporting.
LD.32.2. The center utilizes a risk scoring matrix to categorize the severity of
incidences.
LD.32.3. Incidences, including near misses, involving patients are documented in
the medical record and patient and family are informed by the physician
of any investigation results.

56
 LD.32.4. The center compiles a report on incidences according to type and severity,
and an action plan to prevent its recurrence is distributed to staff and
governance at least quarterly.
LD.32.5. Sentinel events and severe near miss incidents are reported and
investigated and findings utilized to prevent recurrence.

Explanation

The center should develop an incident reporting policy with a unified reporting mechanism for
all occurrences, variances, or accidents. Reporting should include near misses as well (accidents
that were prevented or discovered before reaching the patient). To encourage staff to report, it is
preferable that the reporting be anonymous. Reporting any adverse event to the MOH or other
relevant authorities when required by rules and regulations is a must. All incidents are categorized
by type and severity. The center uses a risk scoring matrix to identify the severity of the incidence.
The center prepares a report on all incidences (including near misses) by its type and severity and
leaders develop an action plan to prevent its recurrence. The report is distributed to staff and to
the governing body at least quarterly.
Sentinel events are situations that lead to the death or serious incapacitation of a patient, and
may include the following:

a. Unexpected death
b. Unexpected loss of a limb or function
c. Retained instruments or sponge
d. Serious medication error leading to death or major morbidity
e. Infant or child abduction
f. Wrong site, wrong patient, or wrong procedure or surgery

Sentinel events are reported to CBAHI within 5 working days and a credible root cause analysis
is also reported to CBAHI within 30 working days. Sever near misses, that could lead to sentinel
events if reaches the patient, are a great opportunity to investigate and find a root cause that is
mitigated to prevent its recurrence.

LD.33. The leaders oversee any contracts for clinical or operational services.

LD.33.1. Contracted entities are selected based on evidence-based criteria that

the relevant department develops.
LD.33.2. The center director ensures relevant leaders’ recommendations and
approval on contracts.
LD.33.3. The leaders ensure that the contracted entity and services provided meet
applicable laws and regulations.
LD.33.4. The leaders ensure that the services provided are integrated into the
overall quality and patient safety program.
LD.33.5. The leaders regularly monitor and document the compliance of contracted
services with the appropriate standards and take documented corrective
actions for improvement when standards are not met.

Explanation

To ensure the best cost-effective outcomes from contracted services, the process owners
should closely monitor the implementation of contracts related to outsourced services, such as
housekeeping or laboratory services. To ensure that the monitoring process is translated into
agreed-upon process and outcome indicators, the process owners should approve contracts
before leaders give their final approval. Contract renewal should be based on the findings of the
indicators’ monitoring.

57
 LD.34. The leaders ensure the integrity and security of telemedicine, teleradiology and
interpretation of other diagnostic remote contracted services.

LD.34.1. Telemedicine, teleradiology and interpretation of other diagnostic remote

contracted services are registered with Ministry of Health.
LD.34.2. The leaders ensure the credentialing and privileging of the physicians
involved before starting the service.
LD.34.3. The leaders ensure the security and confidentiality of patient information
that may be exposed as a result of the telecommunication process.

Explanation

The provision of telemedicine and teleradiology among other remote diagnostic services such
as ECG interpretation has been recently introduced in the kingdom and has its own regulation.
The services provider should be approved and registered with the ministry of health. The center
should ensure the competency of the physicians providing the services by subjecting them to the
center’s credentialing and privileging process like other practicing physicians in the center. The
confidentiality and security of patient information should be secured by allowing access to the
relevant required information from the patient’s file only.

LD.35. The leaders implement policies and procedures to guide the efficient
procurement of equipment either purchased or donated, medications
and essential medical consumables in accordance with national laws and
regulations.

LD.35.1. Leaders ensure that all medical devices and supplies contractors and
suppliers have a Medical Device Establishment License (MDEL).
LD.35.2. Leaders ensure that all newly purchased medical devices have a Medical
Device Marketing Authorization (MDMA) certificate.
LD.35.3. Leaders approve newly introduced consumables based on a formal
testing and feedback process from end users.

Explanation

Non-approved medical equipment and supplies may not provide accurate investigation results,
accurate monitoring parameters, or safe patient care. Therefore, leaders should develop a
procurement policy to ensure the purchase of nationally approved medical equipment, medications,
and essential supplies. SFDA provides such information and performs visits to institutions to
ensure that only approved equipment, medications, and supplies are in use. Newly introduced
consumables require formal testing and approval by the end user before purchase.

LD.36. The leaders ensure an aesthetic appeal for the center.

LD.36.1. The center is clean and tidy at all times.

LD.36.2. The center is free of broken furniture, scratched and distorted walls.
LD.36.3. The ambient temperature is maintained between 20 - 24.4 Celsius.
LD.36.4. Nonirritant air freshener is used to control unwanted odor in the center.

Explanation

Confidence of patients’ in the center starts from the first impression. Patients’ experience is
also enhanced by feeling comfortable being treated in a clean and relaxing environment. The
center should always maintain cleanliness at all times with room temperatures ranging between
20 and 24.4 Celsius as per Occupational Safety and Health Administration “OSHA” standards.
Nonirritant air freshener is used to control odor of the different areas. Maintenance team should
always ensure the integrity of wall paint, floor tiles and furniture.

58
References

Agency for Healthcare Research and Quality (AHRQ). TeamSTEPPS®: Strategies and Tools to
Enhance Performance and Patient Safety. Rockville, MD: AHRQ, 2016.
https://www.ahrq.gov/teamstepps/index.html

Barends E, Rousseau DM, Briner RB. Evidence-Based Management: The Basic Principles.
Amsterdam: CEBMa, 2014.
https://www.cebma.org/wp-content/uploads/Evidence-Based-Practice-The-Basic-Principles-vs-
Dec-2015.pdf

Carroll RL, et al. Enterprise Risk Management: A framwork fos success. Chicago, IL: American
Society for Healthcare Risk Management, 2014.
http://www.ashrm.org/resources/patient-safety-portal/pdfs/ERM-White-Paper-8-29-14-FINAL.pdf

Centers for Disease Control and Prevention. Recommended vaccines for healthcare workers.
(Updated: Apr 15, 2014.)
http://www.cdc.gov/vaccines/adults/rec-vac/hcw.html

Centers for Disease Control and Prevention. Influenza Vaccination Information for Health Care
Workers. (Updated: Nov 1, 2016.)
http://www.cdc.gov/flu/healthcareworkers.htm

Chassin MR, Loeb JM. High-reliability healthcare: Getting there from here. Milbank Q. 2013
Sep;91(3):459–490
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3790522/

International Organization for Standardization. ISO 9001—What Does It Mean in the Supply
Chain? 2016.
https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/pub100304.pdf

iSixSigma. FEMA: Preventing a Failure Before Any Harm Is Done. Smith DL.
https://www.isixsigma.com/tools-templates/fmea/fmea-preventing-failure-any-harm-done/.

ISQua (www.isqua.org)

59
 Chapter II
Provision of Care (PC)

Introduction

Ambulatory care centers vary in the scope of services they provide and, thus, in the types of
patients they may effectively serve. The center should accept patients for services according to its
capability to provide the services that meet the identified patient’s needs.
Providing optimum care requires careful planning, coordination, and communication. The
ambulatory care center must provide an appropriate and thorough assessment of each patient,
and patient care must be planned and implemented to ensure the best possible outcome for the
patient. To support continuity of care, patient assessment and care must be documented in a
complete medical record for the patient. As the care process may need to occur between multiple
providers, a collaborative process should be in place to promote the continuity and coordination
of care when the patient is referred, transferred, or discharged.
Important processes and activities addressed in this chapter include the following:

• Access to care
• Scope and content of patient assessment
• Plan of care
• Consultations
• Patient’s and family’s education and participation in the treatment plan
• Cardiopulmonary resuscitation process
• Transfer and referral
• Emergency care

Standards

PC.1. Patients have access to services based on their health needs and available
services and are registered with the center for providing such services.

PC.1.1. A standardized process is in place for registering patients for services

based on their full name and ID number or passport number for visitors.
PC.1.2. Registration creates a medical record number that is unique to every
patient.
PC.1.3. Appointment staff are aware of the services that the center offers and to
direct patients to the appropriate services.
PC.1.4. An appointment system is in place to book patients in advance.
PC.1.5. Patients who present with emergencies beyond the capacity of the
center are stabilized before transfer to a higher center.

Explanation

A uniform process for registering patients ensures a strong link between the patient and the
unique medical record number generated. The use of a patient’s full name and medical record
number in identifying patients avoids miscorrelation with investigation results or the performing
of a procedure on the wrong patient. Appointments reduce congestion and ensure the availability
of services. Appointment staff should be made fully aware of the services provided and trained
to direct patients to the appropriate services. If the appointment staff are not fully aware of the
services, at a minimum, a nurse should be available at the appointment desk to book patients into
the appropriate clinics. Patients should be registered. Patients presenting with emergencies beyond
the center’s capacity should be stabilized before transfer to a higher center. The center provides
patients, families, and the wider community w ‎ ith information about accessing its s‎ ervices, using
an appropriate f‎ ormat and language (e.g., displayed posters, brochures, handouts, and w ‎ ebsites).

60
 PC.2. The center has a process to ensure the correct identification of patients.
(C)
PC.2.1. Patients are identified by at least two identifiers, full name as in
identification document and unique medical record number.
PC.2.2. Patients are identified prior to any blood withdrawal, investigation,
administration of medications and surgery or procedure.
PC.2.3. Patients are actively involved in the process of patient identification.

Explanation

Ensuring that the right patient receives the right care is an essential aspect of safe care. Patient
identification errors can occur in all types of clinical activities, w
‎ hether diagnostic or therapeutic. ‎
The intent is to precisely identify the individual as the person for whom the service or treatment
‎is intended and, additionally, to match the service or treatment to that individual. Acceptable
‎identifiers may be the patient’s name (at least three names)‎and m ‎ edical record number, the date
of birth, etc. At least two identifiers are used, and the patient’s name should be one of them.
Patients are identified at the point when they enter the healthcare facility.
Patient identification is reconfirmed during the:

• ‎ ollecting of blood samples and other specimens for clinical testing. ‎

C
• Administration of medications.
• Performing of a surgery or procedure.
• Performing of an X-ray or imaging procedure.

PC.3. Patients are clinically assessed through an established assessment policy and
procedure.

PC.3.1. The policy and procedure are developed collaboratively, highlighting the
scope and content of assessment by different specialties and in different
locations.
PC.3.2. The policy and procedure ensure the availability of a comprehensive
patient assessment in the first center’s visit.
PC.3.3. The policy and procedure highlight required screening for nutritional
needs, functional needs, the presence or absence of pain, the risk of fall,
and social needs.
PC.3.4. The policy and procedure explain the specific assessments when the
initial screening labels the patient “at risk” for the screening elements in
PC.3.3.

Explanation

Patient’s assessments are of paramount importance to reach the right diagnosis and establish the
appropriate plan of care. The center should have an assessment policy and procedure that the
various entities have developed collaboratively. This policy should clearly identify the scope and
content of the history and physical examination of the different specialties. During their first clinic
visit, all patients should undergo a comprehensive history and physical examination, regardless
of the nature of the disease. Patients should be screened for nutritional needs, functional needs,
the presence or absence of pain, the risk of fall, and any social needs. Those patients who screen
positive should be fully assessed and managed according to the findings.

61
 PC.4. Physicians are provided with the results of requested investigations according
to a time frame.

PC.4.1. The time frame for routine and stat or urgent investigations is developed
collaboratively with the laboratory, radiology and other services.
PC.4.2. The Turnaround Time document is available for routine and stat or urgent
radiology, laboratory and other services tests.

Explanation

For an effective treatment planning, physicians should receive the results of ordered investigations
in a time frame acceptable for the type of investigation carried out. The document should be
available for the turnaround time of routine and urgent investigations, whether carried out inside
or outside the center.

PC.5. The center develops and implements a process for reporting critical test results
whether on-site or outsourced.

PC.5.1. The process defines staff who receive the result.

PC.5.2. The process involves writing down the result by the receiver and reading
back the findings to the result provider.
PC.5.3. The read-back process and the physician’s intervention are documented
in the patient’s medical record.
PC.5.4. The center develops a process for contacting patients who left the center
when critical test results were reported.

Explanation

Critical test results are reported following a process developed cooperatively. The process clearly
defines the notified parties, means of communication, read-back sequence, and elements
required for documenting the event (date, time, patient identification, critical test result, read-
back documentation, and identification of both the notifying and notified persons).

PC.6. A care plan is developed by the attending physician to meet the patient’s needs
considering patient and family’s cultural and spiritual matters.

PC.6.1. The attending physician develops and documents the care plan by
utilizing the assessment information obtained by the nurse and other
disciplines participating in the care and the investigation results, as
applicable.
PC.6.2. The care plan is designed to achieve desired outcomes specified as
measurable goals.
PC.6.3. The care plan, is reviewed during every visit based on the outcome
measures and other significant changes in the patient’s condition.

Explanation

A documented care plan is vital to managing a patient’s condition. The care plan is developed
according to the assessment information that the healthcare team obtains. The plan should be
tailored to the patient and family’s spiritual and cultural needs as well.
The care plan should be in measurable goals, for example, maintain blood pressure between
120 over 80, maintain a pain score below 4, and maintain fasting blood sugar between 90 to
110 mg%. The attending physician should review this care plan during every visit and change it
according to the patient’s response, if necessary.

62
PC.7. Consultations are available to meet the healthcare provider’s request and
patient’s needs in a timely manner.

PC.7.1. The consultation clearly states the reason for and urgency of the request.
PC.7.2. Consultation requests provide appropriate answers to the issues that the
referring physician raised.
PC.7.3. Arrangements are made to ensure that consultations are immediately
available for emergency cases. Urgent consultations are referred to the
emergency room.

Explanation

Patients may need consultations to other specialties, and such consultations should be available
if the service sought is available. The consultation should clearly state the reason and its nature
(urgent or routine).
The consultation should be formulated in a manner that will help the consulted physician provide
the appropriate answers to the issues that the referring physician raised. All urgent consultations
are immediately referred to the emergency room if one is available in the center.

PC.8. Staff members assist patients and, when appropriate, their families in fully
participating in making informed decisions about their care, treatment
and procedures.

PC.8.1. Staff members provide patients/families with honest and accurate

information in a manner they can understand, about their illness,
options for treatment, proposed treatment, potential benefits, potential
complications, and the likelihood of success of treatment, respecting
their choices.
PC.8.2. Patients are supported in discussing their plan of care with the physician
and having all their questions answered.
PC.8.3. Patients are provided with all the information regarding the identity and
the professional status of his/her treating physician and how to contact
him/her.
PC.8.4. When a surgery or procedure is performed, the patient/family receive
from the surgeon information related to the surgery and from the
anesthesiologist information related to anesthesia or sedation.

Explanation

To help patients and families make the right decision in accepting a treatment or procedure, the
treating staff should strictly follow the elements in PC.8.1 through PC.8.4.

PC.9. Patients and, when applicable, their families are educated about their
healthcare needs.

PC.9.1. Patients’ and families’ education is based on their healthcare needs,

which include, but are not necessarily limited to: the nature of their
disease; necessary treatments; infection control practices; safe use
of medications, diet, and nutrition; medical equipment use; and
preoperative and postoperative care.
PC.9.2. Each patient and his/her family receive education to help them give
informed consent, participate in the care process, and understand any
financial implications of care choices.
PC.9.3. The clinical staff educate patients and families in easily understandable
language, and the provided education is evaluated for effectiveness.

63
 Explanation

Patient and family education is a cornerstone of the success of any treatment plan. A patient and
his/her family must be educated on the elements mentioned in PC.9.1 and PC.9.2. Staff should
make every effort to ensure the patient/family clearly understand the education provided. e.g.,
the patient/family member demonstrates learning or verbalizes understanding. This education is
documented in the patient’s medical record.

PC.10. Informed consent is obtained from the patient or guardian.

PC.10.1. Informed consent is obtained before surgery, invasive procedures,

anesthesia and sedation, the administration of blood and blood products,
and other high-risk treatments.
PC.10.2. Informed consent is obtained prior to taking photographs of body parts,
even if this is deemed critical for care.
PC.10.3. Informed consent is obtained before involving the patient in a research
project.
PC.10.4. The center develops and regularly updates a list of procedures and
conditions requiring informed consent.

Explanation

Patients have the right to be fully aware of the benefits, risks, complications, and consequences of
refusing treatments or investigations of an invasive nature, such as surgery, sedation, anesthesia,
contrast injections for radiology, chemotherapy, or blood administration. This consenting process
should also take place before the taking of any photographs for the patient or body parts and
before the patient’s involvement in any research project that may expose the patient’s identity or
jeopardize the patients’ safety.

PC.11. Patients planned for a surgery/procedure give their informed consent to the
surgery/procedure and the anesthesia/sedation.

PC.11.1. The leaders develop and monitor the implementation of a policy for
obtaining informed consent for a surgery or procedure, or for anesthesia
or sedation.
PC.11.2. The physician/dentist performing the procedure conducts the informed
consent process, which includes an explanation of the nature of the
procedure, the benefits of the procedure, the risks of the procedure,
alternative modalities, and the risks of not undergoing the procedure.
PC.11.3. A qualified physician/dentist conducts the informed consent process for
surgery/procedure.
PC.11.4. A qualified anesthesiologist conducts the informed consent process for
anesthesia/moderate and deep sedation.

64
Explanation

Patients and families have the right to fully understand the nature of the intended surgery
or procedure, including the expected benefits and risks, alternative methods for treatment
or investigation, the likelihood of success, and the risks of refusing the surgery or procedure.
The information must be given by the physician performing the surgery or procedure, and be
relayed in a manner understandable to the patient. It may include drawings or animations. The
anesthesiologist is responsible for providing information related to sedation or anesthesia. The
giving physician must sign the information. The patient (or substitute decision maker) must
acknowledge receipt of the information by signing against the information given. The consenting
process must be witnessed by another healthcare provider (for example, the nurse), who shall also
sign against the information as a witness. The center must have a policy outlining the consenting
process as in PC.11.1 through PC.11.4.

PC.12. The center has an effective process to safely provide care to patients who require
Cardio Pulmonary Resuscitation (CPR).

PC.12.1. The center develops and implements a policy and procedure outlining
the process.
PC.12.2. Standardized crash cart(s) are available in the patient care areas and are
age specific.
PC.12.3. The crash cart is checked every shift by a qualified staff.
PC.12.4. The role of staff involved in the CPR process is clearly defined in the
policy and monitored for implementation.

Explanation

To effectively resuscitate patients in cardiopulmonary arrest, policy and procedure must be

developed. The policy should emphasize the unification of all crash carts so that staff familiarize
themselves with crash carts in different locations. The crash cart should have a conversion table for
pediatric emergency medications and pediatric paddles for the defibrillator. The policy highlights
the frequency of checking the crash cart by the responsible nursing staff to ensure its readiness at
all times. The policy also highlights the team members responsible for the resuscitation, and the
role of each member.

PC.13. Policies and procedures guide the transfer of patients in need of urgent admission
to hospitals.

PC.13.1. Transfers are based on the patient’s need for continuing care and the
center’s capabilities.
PC.13.2. The receiving hospital clearly accepts responsibility for the patient’s care.
PC.13.3. The receiving hospital receives the necessary information to provide care
to the patient.
PC.13.4. The patient is monitored during the transfer process and the monitoring
data is kept in the patient’s medical record. The time of transfer is
documented.
PC.13.5. The receiving hospital acknowledges receiving the patient, the time of
arrival, and the patient’s condition, and the document is kept in the
patient’s medical record.

65
 Explanation

The safety of patients requiring transfer to a higher healthcare setting is important and is based
on patients’ acuity and the center’s clinical capability. The patient should be monitored closely
during the transfer process, and the monitoring findings recorded on a transfer monitoring sheet.
The receiving hospital receives a report on the patient’s condition. On the monitoring sheet, the
receiving hospital acknowledges having received the patient. The sheet should be kept in the
patient’s medical record back in the referring center.

PC.14. Ambulance services are available and meet the patient’s needs.

PC.14.1. The center owns or contracts with a fully equipped ambulance capable
of transferring sick patients of all age groups to higher centers when
needed.
PC.14.2. The required equipment is checked for proper functionality daily and
after each dispatch by the emergency services nurse or technician.
Findings are documented.
PC.14.3. Ambulance medications are checked for availability and expiry daily
and after each dispatch by the emergency services nurse or technician.
Findings are documented.
PC.14.4. During the transportation, the accompanying staff have the appropriate
life support certification.
PC.14.5. The ambulance is tested daily for proper operation and periodically
maintained. Findings are documented.
PC.14.6. The ambulance is included in the center’s infection prevention and
control program.

Explanation

A fully equipped ambulance should be available at all times to transport patients requiring a higher
level of care in a hospital setting. The ambulance should be equipped with life support measures
for all age groups for whom the center cares. The ambulance should be periodically maintained
with documented logs. The ambulance’s patient care compartment should be disinfected after
the transfer of patients, and should be included in the center’s infection control program.

PC.15. The center has an emergency services to deal with minor emergencies.

PC.15.1. Qualified staff manage the emergency services with a minimum of two
(2) years of experience.
PC.15.2. At a minimum, a physician and a nurse are ACLS certified per shift.
PC.15.3. The emergency service have the necessary equipment for the stabilization
and resuscitation of major emergencies.
PC.15.4. The center has a formal agreement with hospitals to transfer major
emergencies after stabilization.

Explanation

The center should be able to manage minor emergencies in a dedicated emergency area that is
easily accessible by the public. The staff managing the emergency area should be qualified and
trained in emergency care and in immediately identifying critical cases that require immediate
stabilization prior to transfer to a hospital. At a minimum, on each shift, a physician and a nurse
are ACLS certified to manage complicated cases and help with cardio-pulmonary resuscitation.
To expedite the transfer of emergency cases requiring a hospital, the center should have formal
agreements with several hospitals, and the staff should have the required contact information for
the referral centers.

66
References

Agency for Healthcare Research and Quality. Care Coordination. Jul 2016.
https://www.ahrq.gov/professionals/prevention-chronic-care/improve/coordination/index.html

ECRI Institute. ECRI Institute PSO Deep Dive. Patient identification: Executive summary. Aug 2016.
https://www.ecri.org/Pages/Patient-Identification-Deep-Dive.aspx

Roy CL, et al. An initiative to improve the management of clinically significant test results in a large
healthcare network. Jt Comm J Qual Patient Saf. 2013 Nov;39(11):517–527

World Health Organization (WHO) - Patient Safety Solutions | volume 1, solution 2 | May 2007.
https://www.who.int/patientsafety/solutions/patientsafety/PS-Solution2.pdf

ISQua (www.isqua.org)

67
 Chapter III
Laboratory Services (LB)

Introduction

The assessment/reassessment of patients to determine the proper diagnosis, the course of

treatment, and the evaluation of the treatment plan for future decisions may require laboratory
services. To meet the patient’s needs, the center should either provide basic laboratory services or
outsource them to a recognized laboratory through a formal contracting process.
This chapter addresses the following:

• Physical structure
• Staffing
• Safety program
• Specimen collection
• Equipment management program
• Labeling
• Quality management program
• Point of care testing

Standards

LB.1. Laboratory services are available or outsourced to meet the needs of the patient
population served.

LB.1.1. ‎ The laboratory develops a services and specimens’ manual that is

distributed to all patient care areas.
LB.1.2. ‎ The manual includes the available tests either in-house or send-out and
their Turn Around Times (TATs).
LB.1.3. ‎ The manual includes the prescribed process for requesting the
introduction of a new test. ‎
LB.1.4. The manual includes patient preparation for specimen collection. ‎
LB.1.5. ‎ The manual includes positive patient identification. ‎
LB.1.6. The manual includes quality and quantity of sample. ‎
LB.1.7. ‎ The manual includes phlebotomy, sample collection and labeling
procedures. ‎
LB.1.8. ‎ The manual includes requisition and required clinical data. ‎
LB.1.9. The manual includes specimen packing, handling and transportation.
LB.1.10.‎ The manual includes specimen rejection reasons.

Explanation

Developing and maintaining a current scope of services that meets the needs of the patient
population, clients, and customers is a sign of commitment to quality and professional practice.
The laboratory scope of services should be clearly defined, and easily accessible to all lab staff, as
well as internal and external customers. Equally important is the availability of a comprehensive
specimen collection manual to guide the clinical staff in the process of lab test requisition,
specimen collection, labeling, and handling.

LB.2. The laboratory has the right space and facilities relevant to the services provided.

LB.2.1. ‎ The laboratory’s design and location meet applicable local and
international ‎regulations. ‎
LB.2.2‎. The laboratory has adequate patient waiting areas and lavatories. ‎
LB.2.3. ‎ Adequate spaces are available for each laboratory activity/section. ‎

68
 LB.2.4. ‎ The laboratory has adequate storage space for reagents, supplies,
consumables, samples, waste holding, and records. ‎
LB.2.5. ‎ The laboratory has adequate space for administrative and clerical staff. ‎
LB.2.6. ‎ The laboratory has adequate water taps and sinks for handwashing and
for washing contaminated equipment. ‎
LB.2.7‎
. The laboratory is equipped with adequate electrical outlets and
emergency power. ‎
LB.2.8. ‎
The laboratory has adequate lighting, ventilation and adequate
temperature and humidity controls. ‎
LB.2.9. ‎ The laboratory corridors are not obstructed and maintain access control
and adequate emergency exits.
LB.2.10‎. Safety signs are adequately displayed and distributed in the laboratory.
LB.2.11. ‎ The laboratory workplace is free of h
‎ azards, clutter and distractions, with
clean and well-maintained floors, walls, ceilings, bench tops, and sinks.
LB.2.12‎. Means of communication and telephones are conveniently located in the
laboratory. ‎

Explanation

Deficiencies in space and/or facilities are regarded as minor unless they are so severe that they
interfere with the quality of work or quality control activities and safety. In this case, they become
a major issue.

LB.3. The laboratory develops and implements a comprehensive safety program.

LB.3.1. ‎ The laboratory safety program complies with the national and
‎international laboratory safety standard and is readily available to all
laboratory personnel.
LB.3.2. ‎ ‎ The safety program includes a chemical hygiene plan, control of
compressed and flammable gases, and the monitoring of fumes and
vapors, as well as their respective Safety Data Sheets.
LB.3.3.‎ The safety program includes biological safety procedures, the use of
standard precautions, and the use of eyewash stations and emergency
showers.
LB.3.4.‎ The safety program includes electrical safety as well as fire prevention
and control plans.
LB.3.5‎. The safety program mandates an annual safety training and competency
assessment.
LB.3.6‎. ‎The laboratory has a process for the monitoring of the safety program
through regular safety inspections and analysis of the findings. The
process is used to improve the laboratory’s safety, and its findings are
integrated with the center’s quality improvement and patient safety
program.

Explanation

The laboratory director is the person who is ultimately responsible for laboratory safety. He/
she will be responsible for providing laboratory personnel with a comprehensive safety manual
and assigning a safety officer to provide guidance and monitoring. The safety manual outlined
above addresses common laboratory risks and hazards. To meet specific risk factors, specialized
laboratories might need to develop additional safety requirements.
Regardless of how much experience they may have, laboratory personnel must be properly
trained on all applicable safety procedures and assessed for competence, both upon their hire
and periodically thereafter.
The director of the laboratory or a designee is responsible for conducting regular safety inspections/
audits to ensure the proper state of readiness and function of safety apparatuses, alarms, and
evacuation procedures. Appropriately trained personnel should conduct inspections/audits.

69
 LB.4. The laboratory develops and implements a comprehensive infection control
program.

LB.4.1. ‎ The laboratory infection control program complies with the national
and ‎international laboratory infection control standards and is readily
available to all laboratory personnel.
LB.4.2. ‎ ‎The infection control program includes the provision and use of Personal
Protective Equipment.
LB.4.3.‎ The infection control program includes biological safety procedures, the
use of standards precautions, and the use of fume hoods and biological
safety cabinets.
LB.4.4.‎ The infection control program includes an infectious diseases and viral
exposure plan.
LB.4.5.‎ The infection control program mandates an annual training and
competency assessment.
LB.4.6.‎ The laboratory maintains a process for monitoring the infection control
program through regular infection control inspections and analysis of the
findings, which are utilized to improve the laboratory infection control
and integrated with the center’s infection control program.

Explanation

Labs, because of their equipment and function, constitute a key area. All efforts should be made
to prevent infection. Therefore, the elements in LB.4.1 to LB.4.6 should be strictly followed.
Regardless of how much experience they have, laboratory personnel must be properly trained on
all applicable infection control procedures and assessed for competence, both upon their hire and
periodically thereafter.
The director of the laboratory or a designee is responsible for conducting regular infection control
inspections/audits to ensure the proper state of infection prevention and control practices.
Appropriately trained personnel should conduct inspections/audits.

LB.5. The laboratory has a clearly defined and implemented process describing its role
in selecting and evaluating providers of reference laboratory services.

LB.5.1. The process requires selection criteria, including accreditation status.

LB.5.2. The process outlines an inclusive list of send-out tests.
LB.5.3. The process describes specimen collection, labeling, handling,
transportation, and results reporting.
LB.5.4. A service contract specifies agreements’ conditions with the reference
laboratory.

Explanation

Laboratories may outsource advanced testing for better quality and/or cost-effectiveness. Reference
laboratory services are some of the critical services that should be adequately controlled. Proper
control of reference laboratory services includes:

• Selection: Selection of reference laboratories must be based primarily on the

quality of such laboratories’ performance. Referral specimens should be sent to
an accredited laboratory. The laboratory director should ensure that the reference
laboratories provide turnaround times that meet clinical needs.
• Scope of service: An inclusive list of outsourced services/tests must be kept current.
• Specimen requirements: The referring laboratory should follow all requisition,
collection, and handling instructions that the reference laboratory specifies.
• Result reporting: Testing records and patient reports must state the name of the
reference lab performing the test and the identification of the person authorizing
the release of the results.

70
 • Agreement/service contract: a signed document specifying the expectations of
the two parties involved should be readily available for quick reference. Essential
elements of such a document may include:

• Scope of service
• Agreement conditions (including accreditation status)
• Sample requirements
• Turn Around Time
• Result reporting
• Release of information to the third party
• Solving disputes
• Validity of the agreement and review schedule

LB.6. The laboratory has a clearly defined and implemented process for laboratory
instrument and equipment management.

LB.6.1. The process defines the selection, receipt, installation, and identification
of equipment.
LB.6.2. The process outlines the validation of laboratory equipment for its
intended use.
LB.6.3. Manufacturer instructions related to monitoring, maintenance,
calibration, and standardization are referenced.
LB.6.4. The process includes the required investigation and follow-up of
equipment malfunction or failure.

Explanation

The process of critical equipment selection should consider the criteria that the laboratory
established. In the selection of new equipment, it is important to consider not only the performance
of equipment as it will be used in the facility but also any supplier issues regarding ongoing service
and support. Also, a mechanism should be in place to uniquely identify and track all critical
equipment.

The unique identifier may be the manufacturer’s serial number or a unique identification applied
by the laboratory or organization-wide identification system.

Upon receipt of critical equipment, the laboratory should develop a written plan for installation
and operational and performance qualifications;

• Install according to the manufacturer’s specifications.

• Verify the equipment’s functionality by ensuring that the criteria the manufacturer
established for the equipment’s intended use are met.
• Assure that the equipment performs as expected in the facility’s processes.

After installation, activities designed to ensure that equipment functions as intended should be
scheduled and performed according to the manufacturer’s recommendations and regulatory
requirements. Such activities include calibration, maintenance, monitoring, functional and safety
checks, and preventive maintenance. Recalibration and requalification may be necessary if repairs
are made that affect the equipment’s critical operating functions. Recalibration and requalification
should also be considered when existing equipment is relocated. Evaluation and trending of
equipment calibration, maintenance, and repair data will help the facility identify equipment that
may need replacement. When equipment is found to be operating outside acceptable parameters,
the potential effects on the quality of products or test results must be evaluated and documented.
Good laboratory practices call for a defined process for dealing with reported results and delivered
services when the system is later found to be compromised.

71
 LB.7. The laboratory develops and implements a policy for the documentation of
specimen receipt and inspection.

LB.7.1. The policy includes the required checks for proper packaging.
LB.7.2. The policy includes the required checks for quality and quantity of the
specimen.
LB.7.3. The policy includes the required checks for the adequacy of specimen
labeling.
LB.7.4. The policy includes the required checks for request completion.
LB.7.5. The policy includes the required checks for label/request discrepancies.

Explanation

Because patient/specimen misidentification may cause morbidities or mortalities, the best hope
for prevention lies in preventing or detecting errors in every phase of the laboratory processes.
When a sample is received in the laboratory, documented checks must be made to confirm that
the information on the sample label and the information on the request are identical. If any doubt
exists about the identity of the patient or about the labeling of the sample, a new sample must
be obtained.
Requests for tests or services may be submitted in electronic or written format. Requests must
contain sufficient information for accurate patient identification. Other information necessary to
process a lab request includes gender, age, diagnosis, and the name of the authorized prescriber
ordering the test. Verbal requests are acceptable in urgent situations but should be documented
in accordance with facility policies.

LB.8. The laboratory develops a policy and procedure for the quality control of test
methods.

LB.8.1. Quality control follows the manufacturer’s instructions.

LB.8.2. The policy and procedure clearly identify the performance and review
responsibility. Control specimens are handled and tested in the same
manner and by the same laboratory personnel who are testing patient
samples.
LB.8.3. The policy and procedure highlight the number and frequency of running
controls.
LB.8.4. The policy and procedure mandate the acquisition of the correct reference
range when the reagents/methodology change.
LB.8.5. The policy and procedure mandate the establishment of tolerance limits
for results.
LB.8.6. The policy and procedure highlight the corrective action(s) to be taken in
the event of unacceptable results.

Explanation

Quality control (QC) testing is performed to ensure the proper functioning of materials, equipment,
and methods during operations. QC performance expectations and acceptable ranges should be
defined and readily available to staff so that they will recognize unacceptable results and trends to
respond appropriately. The facility determines the frequency of QC testing in accordance with the
applicable regulatory requirements, accreditation standards, and manufacturer instructions. QC
results should be documented concurrently with performance. Unacceptable QC results must be
investigated, and corrective action must be taken, if indicated, before continuing the operational
process. If products or services were provided since the last acceptable QC results were obtained,
it may be necessary to evaluate the conformance of these products or services. The review of
quality control data must be documented and include follow-up for outliers, trends, or omissions
not previously addressed.

72
LB.9. The laboratory develops a policy and procedure for Proficiency Testing (PT)
sufficient for the extent, complexity and scope of services.

LB.9.1. The policy and procedure ensure all analytes are covered with PT.
LB.9.2. The policy and procedure highlight alternative PT performed when
appropriate.
LB.9.3. The policy and procedure have clear instructions for the receipt,
processing, and reporting of PT results.
LB.9.4. PT samples are tested by the same personnel handling the patient
samples.
LB.9.5. PT samples are tested using the same method used for testing the patient
samples.
LB.9.6. PT samples are not referred to another external laboratory for testing.
LB.9.7. PT results are not shared with another external laboratory.
LB.9.8. PT results are evaluated and compared to the acceptable performance.
LB.9.9. Unacceptable performance is investigated, and appropriate corrective
actions are taken.
LB.9.10. Laboratory management review and approve PT records.
LB.9.11. Corrective actions are implemented and monitored.

Explanation

Assessments are systematic examinations to determine whether actual activities comply with
planned activities, are implemented effectively, and achieve objectives. Assessments can be
internal or external and can include quality assessments, peer reviews, self-assessments, and
proficiency testing.
The laboratory must establish and maintain a process for proficiency testing (External Quality
Assessment). The laboratory director must review the results of assessments to determine the
appropriateness and effectiveness of corrective/ preventive actions (if taken).

LB.10. The laboratory defines the format and contents of laboratory reports.

LB.10.1. The report identifies the testing laboratory.

LB.10.2. The report includes full patient identification.
LB.10.3. The ordering physician is identified.
LB.10.4. The date and time of specimen collection and the source of the specimen
are clearly written.
LB.10.5. The reporting date and time are identified.
LB.10.6. The test result(s) and reference intervals/range are highlighted.
LB.10.7. The condition of the specimen that may limit the test’s adequacy is
written down.
LB.10.8. Identification of the authorized person releasing the report is highlighted.

Explanation

As applicable, all the above elements of a laboratory report must be available in the laboratory
information system or in paper records.

LB.11. The laboratory has a process for correcting or amending reported results.

LB.11.1. ‎ The process highlights the definitions of report corrections and

amendments. ‎
LB.11.2. ‎ The process describes the format of the corrected report. ‎
LB.11.3‎. The process requires the inclusion of the previous result in the corrected
report. ‎
LB.11.4‎. The process requires the notification of the ordering physician. ‎

73
 Explanation

If a formal reference interval study is not possible or practical, the laboratory should carefully
evaluate the use of published data for its own reference ranges, and retain documentation of this
evaluation. The reference interval can be verified by testing samples from 20 healthy representative
individuals; if no more than two results fall outside the proposed reference interval, that interval
can be considered verified for the population studied.
For many analytes (e.g., therapeutic medications and CSF total protein), literature references or a
manufacturer’s package insert information may be appropriate.
Criteria for evaluating reference intervals include the introduction of a new analyte, a change in
analytic methodology, or a change in patient population.
If it is determined that the range is no longer appropriate for the patient population, corrective
action must be taken.

LB.12. The laboratory develops and implements a comprehensive process for Point-of-
Care-Testing (POCT).

LB.12.1. POCT is defined in writing.

LB.12.2. The responsibility of managing the POCT is assigned to the laboratory.
LB.12.3. Guidelines are available describing the process of acquiring POCT devices/
methods.
LB.12.4. The process defines the training and competency testing requirements.
LB.12.5. ‎ A list and location of all POCT devices is available around the center. ‎
LB.12.6. The process defines the maintenance and quality control of POCT
devices/methods.

Explanation

Point-of-Care Testing (POCT) is defined as tests that are designed to be used at or near the
site where the patient is located, that do not require permanent dedicated space, and that are
performed outside the physical facilities of the clinical laboratories. Other standards for quality
management, results reporting, and safety are applied. The POCT program should be centrally
coordinated in the laboratory, with designated qualified personnel who review testing and quality
control procedures, and conduct/oversee the training and competency assessment of testing
personnel. The surveyor will review all centrally maintained records and visit at least three testing
sites to evaluate compliance.

References

The Clinical & Laboratory Standards Institute (CLSI) guidelines

https://clsi.org/standards/

74
 Chapter IV
Radiology Services (RD)

Introduction

The assessment/reassessment of patients to determine the proper diagnosis, course of treatment,

and evaluation of the treatment plan for future decisions may require radiology services. To meet
patient needs, the center should offer radiology services or outsource them through a formal
agreement with a recognized radiology center. If the center provides radiology services, the
services are expected to meet the necessary national guidelines on radiation safety.

This chapter addresses the following:

• Staffing
• Radiation safety program
• Equipment maintenance program

Standards

RD.1. Radiology services are available or planned with other institutions to meet
patient needs and in accordance with applicable national standards, laws and
regulations.

RD.1.1. When radiology services are provided through a contract, the center is
responsible for providing oversight of the contracts.
RD.1.2. A licensed radiology technician carries out radiology services.
RD.1.3. Radiology services are supervised by, at a minimum, a radiology specialist
who reads, reviews, and authorizes all radiology reports.

Explanation

Basic radiological investigations should be available in the center, or the center should contract
with a licensed radiology unit to ensure timely performance of the investigations and receipt of
the written radiology report. The center’s radiology unit should be supervised by, at a minimum,
a radiology specialist who reads, reviews, and authorizes reports, and a licensed technician(s)
is responsible for performing the procedure. In the case of contracted radiological services, the
center should ensure the safety of its patients and the quality of its procedures by periodically
reviewing the radiation safety report and the maintenance reports of the radiology machine(s).

RD.2. The center has a radiation safety program.

(C)
RD.2.1. The program covers all areas that use ionizing radiation.
RD.2.2. All rooms where ionizing radiation is administered are tested and certified
radiation leak proof by the appropriate certifying local authority.
RD.2.3. Safety warnings are posted on the doors in clear and appropriate
locations.
RD.2.4. Prior to X-ray tests, women in the childbearing period with missed
menstruation are checked for the possibility of pregnancy.
RD.2.5. Personnel are monitored for radiation exposure by thermoluminescence
dosimeters (TLD) that are regularly checked.
RD.2.6. All types of radiation protection aprons are periodically inspected and
tested for integrity and effectiveness with documentation.

75
 Explanation

Patients, staff, and the environment should be protected from radiation by a well-constructed
radiation safety program. The program includes all areas utilizing ionizing radiation, such as the
dental panorama and mobile x-rays. Radiology rooms should be tested initially to ensure the
absence of a radiation leak. Equipment should be tested periodically to ensure the absence of a
leak. The same testing should be done for the dental panorama (if present). Warning signs should
be clearly posted. Women in childbearing periods should undergo a pregnancy test if they have
missed a period. Staff exposure to radiation should be monitored using thermoluminescence
dosimeters that are examined periodically, and staff should receive replacement cards during the
test time. Radiation protection aprons should also be tested periodically for their integrity.

RD.3. There is implemented process to keep the radiology equipment in safe,

functional condition.

RD.3.1. An operation and service manual is available for all equipment.

RD.3.2. Qualified personnel maintain the equipment.
RD.3.3. Maintenance and repair records are properly maintained, including corrective
actions.
RD.3.4. Equipment is periodically inspected and calibrated for proper functioning.

Explanation

To ensure the quality of films, avoid radiation leaks, and prevent overexposure, the radiology
equipment should follow a radiology maintenance program or system that must include, at a
minimum, the elements in RD.3.1 to RD.3.4.

References

MOH Publications - Guideline on the Assessment of Radiology

https://www.moh.gov.sa/en/Ministry/MediaCenter/Publications/Pages/default.aspx

Radiation Safety – FDA.

https://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/default.htm

The Joint Commission. Diagnostic Imaging Requirements Aug 10, 2015.

https://www.jointcommission.org/assets/1/18/AHC_DiagImagingRpt_MK_20150806.pdf

SFDA Role for Radiation Protection – SMPS

http://smps.org.sa/en/wp-content/uploads/2016/11/Al-Shareef-SFDA-Requirements.pdf

Safety and Health Topics | Radiation | Occupational Safety and Health

https://www.osha.gov/SLTC/radiation/

ISQua (www.isqua.org)

76
 Chapter V
Dental Services (DN)

Introduction

Dental clinics pose a risk to patients that is different from the risks posed in other clinics in the
center. This chapter addresses the peculiar dental standards that mitigate such risk, including:

• Staffing requirements
• Patients’ assessment and treatment planning
• Patients’ and families’ education
• Medical records documentation requirements
• Infection control requirements

Standards

DN.1. Dental staff have appropriate qualifications.

DN.1.1. The head of the dental services is a dentist qualified by education,

training and experience.
DN.1.2. Dentists perform dental treatments and procedures within their approved
privileges.
DN.1.3. During dental procedure the dentist is assisted by dental assistant.

Explanation

To avoid unwanted complications, dentists should work within their assigned privileges, assisted
by qualified dental assistants. To provide the best assistance to dentists, a minimum of one dental
assistant is required per chair.

DN.2. A comprehensive assessment is performed and documented for each patient.

DN.2.1. Chief complaint, chronic illnesses, medication history and allergies are
assessed and documented for each patient before dental procedures.

Explanation

Not knowing that a patient has a valvular lesion or is on anticoagulation medicines or suffer
from chronic illnesses (e.g., congenital heart disease), infectious diseases, hematological diseases
(e.g., hemophilia), can lead to serious morbidities if such patients undergo dental procedures
before following the appropriate precautions. Therefore, a comprehensive assessment must be
documented beforehand.

DN.3. The dentist documents the treatment plan in the patient’s medical record.

DN.3.1. The dentist documents the required radiological procedures.

DN.3.2. The dentist documents the type of antibiotic prophylaxis when needed.
DN.3.3. The dentist documents the procedure(s) to be performed and highlights
the teeth involved.
DN.3.4. The dentist documents the type and dose of local anesthesia or moderate
sedation if needed.
DN.3.5. The dentist documents the material used for filling.
DN.3.6. The need for informed consent is highlighted.

77
 Explanation

Based on assessment and dental examination findings, and to be both efficient and effective,
a treatment plan should be agreed upon by the patient and documented before the initiation of
any dental procedure. The plan includes elements in DN.3.1 to DN.3.6.

DN.4. Infection control guidelines are available and implemented by dental staff.

DN.4.1. A new pair of gloves and a new mask are used by the dentist and assistant
for every case.
DN.4.2. Protective eyewear is used by the dentists and assistant for every case.
DN.4.3. Patients receive eye protection by the assistant.
DN.4.4. Working area surfaces are cleaned by the assistant between patients.
DN.4.5. Evidence-based disinfection and sterilization practices are maintained
and updated by the assistant.

Explanation

Dental practice is a recognized source of infection for patients and staff. All efforts should be
made to prevent cross infection. The elements in DN.4.1 to DN.4.5 should be implemented and
monitored.

DN.5. Safety rules are applied in the dental laboratory.

DN.5.1. Fire detection and abatement equipment is available.

DN.5.2. Butane and other flammable gases are stored safely outside the
laboratory.
DN.5.3. A hooded exhaust is available in the casting area.
DN.5.4. Oxygen cylinders are safely stored.
DN.5.5. Fumes and dust are safely evacuated.
DN.5.6. An eyewash station is available and in good functioning condition.

Explanation

Dental labs, by nature of their equipment, pose serious safety risks. Therefore, staff safety is
crucial in dental labs. The safety rules in DN.5.1 to DN.5.6 must be strictly followed.

References

Infection prevention and control manual for dental settings, MOH, 2013
https://www.moh.gov.sa/Ministry/MediaCenter/Publications/Documents/2018-11-22-005.pdf

ISQua (www.isqua.org)

78
 Chapter VI
Medication Management (MM)

Introduction

The standards in this chapter focus on medication management as it applies to outpatient

prescriptions, and medication use in the day procedure unit, the emergency room, and owned
outpatient pharmacies. Therefore, some standards may not apply to a specific center. The
standards focus on the following:

• Scope of medication services

• Safe storage of medications
• Safe medication preparation
• Review of prescriptions for appropriateness
• Handling of expired medications
• Management of narcotics and psychotropic medications
• Management of medication errors and adverse drug reactions

Standards

MM.1. Medication use processes are available to meet patient needs and in accordance
with applicable laws and regulations.

MM.1.1. The medication use processes are managed by qualified staff who have
a valid registration with the Saudi Commission for Health Specialties.
MM.1.2. The center establishes an interdisciplinary mechanism for overseeing and
monitoring medication management processes.
MM.1.3. An updated list exists of the signatures of medical staff who are authorized
to prescribe medications, along with their prescribing privileges.

Explanation

Medications are an important resource and a cornerstone of patient care. As such, they must
be managed by qualified licensed staff as per the Saudi commission and MOH regulations. All
healthcare providers involved in purchasing, storing, prescribing, dispensing, and administering
medications are involved in overseeing medication management in the center. The appropriate
medication room space, in ED and DPU, and its hours of operation should allow for the optimal and
satisfactory delivery of medications to patients. To facilitate communication and safe prescribing
practices, the center maintains an updated list of current prescribers in the center, including their
signatures and prescribing privileges.

MM.2. The center has an updated and well-structured formulary.

MM.2.1. The formulary contains all the essential medications and is updated
annually.
MM.2.2. The formulary is adopted from a relevant source that is available for
Saudi Arabia and approved by the Saudi Food and Drug Authority.
MM.2.3. The medication formulary is available to the healthcare team.

79
 Explanation

The formulary process is the cornerstone of proper medication management and rational use.
It consists of preparing, using, and updating a formulary list of essential medications. The
formulary manual provides adequate information about all essential medications that should be
available in the center at all times. Formulary medications are selected based on the standard
treatment guidelines or protocols that the center has developed or adapted for use. Periodic
review is necessary because of changing costs and indications, new information about safety,
and the emergence of new medicines. The formulary supports clinical staff in choosing the most
appropriate therapies and selecting the most cost-effective, good-quality medication according
to the standard treatment guidelines. This ensures the provision of better-quality care and more
efficient, equitable use of resources.

MM.3. The center has a process for the appropriate storage of medications.

MM.3.1. The center has an appropriate storage area for non-refrigerated

medications and refrigerators for storing vaccines and commonly
refrigerated medications.
MM.3.2. Medications are stored as per manufacture guidelines.
MM.3.3. All medication and vaccine refrigerators are connected to alternate
power source and a temperature log is maintained at all times.
MM.3.4. The center develops and implements a process for the handling of
medications and vaccines when temperature monitoring indicates out of
range.

Explanation

Medications can lose its potency if not stored in the appropriate environment as recommended
by the manufacturer. Loss of potency during storage may influence pharmaceutical efficacy and
safety. Proper environmental control (i.e., proper temperature, light, and humidity; sanitation,
ventilation, and segregation conditions) must be maintained wherever drugs and supplies are
stored anywhere in the center. Vaccines are more susceptible to temperature fluctuations,
therefore it is best to be stored separately from other refrigerated medications that are in a more
demand for opening and closing the refrigerator. All medication refrigerators must be connected
to an electrical outlet that has an alternate power supply that starts immediately if there is an
interruption to the main power supply. The center must develop a process on what to do with
medications that are stored in an area that had out of range temperature.

MM.4. The center has a process for ensuring the stability of medication available in
multi-dose containers.

MM.4.1. The center develops and maintains a set of guidelines for ensuring
the stability of sterile multi-dose vials, vaccines, and other multi-dose
medications.
MM.4.2. The center ensures all open multi-dose containers are labeled with the
opening date and time, the expiry date and staff initials.

80
Explanation

Multiple-dose vials (MDVs) are widely used in all healthcare settings. By definition, an MDV
contains antibacterial preservatives and, according to manufacturer’s recommendations, may be
used more than once. It is important to recognize that although common preservatives used in
MDVs are effective against most bacteria, they are not antiviral agents. They do not protect against
contamination when healthcare personnel fail to follow safe injection practices. In addition,
contaminating pathogens are able to survive in MDVs for approximately two hours before the
preservative takes full effect. Endotoxins can survive even after the preservative inactivates the
organism. The contamination rate of MDVs in published studies has been as low as 0% and as
high as 27%.

Whenever possible, multi-dose vials should be dedicated to a single patient. If multi-dose vials
must be used for more than one patient, they should not be kept or accessed in the immediate
patient treatment area. If a multi-dose has been opened or accessed (e.g., needle-punctured), the
vial should be dated and discarded within 30 days unless the manufacturer specifies a different
(shorter or longer) date for that opened vial. If a multi-dose vial has not been opened or accessed
(e.g., needle-punctured), it should be discarded according to the manufacturer’s expiration date.
The manufacturer’s expiration date refers to the date after which an unopened multi-dose vial
should not be used. The beyond-use date refers to the date after which an opened multi-dose
vial should not be used. The beyond-use date should never exceed the manufacturer’s original
expiration date.

MM.5. The center has a process for identifying and handling expired medications.

MM.5.1. The center has a written and implemented process for detecting and
returning the nearly expired medications before the expiration date.
MM.5.2. Expired medications are not found in any patient care areas.
MM.5.3. The center maintains documents of return of expired medications to the
supplier or manufacturer, or evidence of its proper destruction.
MM.5.4. All expired and/or nearly expired medications are properly labeled and
stored separately from other medications.

Explanation

Multiple-dose vials (MDVs) are widely used in all healthcare settings. By definition, an MDV Expired
medications may lose all their potency over time and become ineffective for treatment. The center
should maintain a written policy for managing near-expiry and expired medications following the
requirements in MM.5.1 through MM.5.4

MM.6. The center develops a policy and procedure for the safe prescribing of medications.

MM.6.1. All prescriptions are identified by accurate patient demographics

including name, age and medical record number.
MM.6.2. Allergy status is clearly identified on the prescription.
MM.6.3. For all pediatric prescriptions, weight is identified.
MM.6.4. Abbreviations are not used in prescriptions.
MM.6.5. Prescribed medication is documented in the medical record.
MM.6.6. The prescribing of narcotics and controlled medications follows Ministry
of Health laws and regulations.

81
 Explanation

Inappropriate prescriptions account for 30% of medication errors; some of these errors can be
serious. Medication prescription in the center should follow the elements mentioned in MM.6.1
through MM.6.6.

MM.7. The center develops and implements guidelines for the correct prescribing of
antibiotics.

MM.7.1. A multidisciplinary team from the center adopts and updates the
antibiotics guidelines.
MM.7.2. The guidelines for antibiotics prophylaxis are properly implemented
before surgery and/or dental procedures and monitored.
MM.7.3. The guidelines for empiric and therapeutic use of antibiotics are properly
implemented and monitored.

Explanation

Antibiotics misuse is a global concern. Misuse of antibiotics has a negative impact on the safety
of patients and the community, increasing antibiotic-resistant micro-organisms and the overall
cost of healthcare. The development and implementation of antibiotic guidelines are scientifically
proven to prevent, control, and treat infections. Each center should develop and update its own
evidence-based guidelines, taking into consideration its own anti-bigram and pathogens identified
by the surveillance system. Guidelines should include surgical prophylaxis and the empiric and
therapeutic use of antibiotics. Appropriate antibiotic use can be challenging nowadays. To
prevent the development of resistance, centers are expected to define the prescribing privileges
of antibiotics.

MM.8. The center develops a process to manage narcotics, psychotropic medications,

and other controlled medications according to laws and regulations.

MM.8.1. The center has a process for receiving, storing and dispensing narcotics,
psychotropic medications, and other controlled medications.
MM.8.2. The center maintains an inventory of narcotics, psychotropic medications,
and other controlled medications.
MM.8.3. The center has a process for prescribing narcotics, psychotropic
medications, and other controlled medications.

Explanation

Narcotics and controlled medicines are those agents, either naturally or compounded, that have
been included in schedule #1 and schedule #2 in the SFDA regulations manual. The center must
implement the related rules and regulations of the SFDA and MOH as stated. Medications are
stored and secured behind locked steel doors or inside steel cabinets with double locks and/
or double doors all over the center. Limited quantities of essential controlled and narcotics
medications may be allowed in patient care units according to clinical needs. The documentation
process should be maintained for all related steps, such as requisition, procurement, ordering,
dispensing, distribution, endorsement, registration, and discarding of the unused portion and
empty containers.

MM.9. The center safely manages high-alert and look-alike, sound-alike (LASA)
medications.

MM.9.1. The center identifies, in writing, its high-alert and LASA medications.
MM.9.2. The center has a process for managing high-alert and LASA medications.

82
Explanation

Throughout the medication use process, medication errors related to look-alike and/or sound-
alike medications and/or packages are common in the healthcare setting. Look-alike, sound-
alike medications account for an estimated 25% to 30% of medication errors. With tens of
thousands of medications currently on the market, the potential for serious error due to confusing
medication names is significant. Contributing to this confusion are incomplete knowledge of
medication names; newly available products; similar packaging or labeling; similar clinical use;
illegible prescriptions; and misunderstandings during the issuing of verbal orders. Examples of
high-alert medications include concentrated electrolytes, controlled medications and narcotics,
antithrombotic medications (e.g., heparin, warfarin), and insulin. The full list is published by
the Institute of Safe Medication Practice and the World Health Organization. The process for
managing such medications may include separating the look-alike/sound-alike medications and
limiting access to high-alert medications.

MM.10. The center evaluates the appropriateness of prescriptions before dispensing.

MM.10.1. The appropriateness review includes allergies, indications, dosage,

frequency, route of administrations therapeutic duplication and possible
interactions.
MM.10.2. The center maintains an updated medication profile for each patient
treated in the emergency room or day procedure unit.
MM.10.3. The review process is done by a pharmacist or a physician.
MM.10.4. The reviewer discusses any concerns in the process with the prescriber
before medication dispensing.

Explanation

The following could harm patients or render treatment ineffective: dispensing unclear prescriptions;
dispensing prescriptions without ensuring the relevant diagnosis; dispensing prescriptions without
determining allergies or the presence of interactions, and dispensing the wrong dose. The center
should adopt a safety culture allowing the pharmacist to contact physicians for clarification of
prescriptions or receipt of additional information pertinent to the prescription, and to notify the
physician if the medication is not available so an alternative may be prescribed. Drug-drug and
drug-food interactions should be clearly documented in the medical records. Pharmacist should
dispense medications only for their approved indications.

MM.11. Medication preparation areas comply with infection control measures and safe
practices.

MM.11.1. Medication preparation areas are clean and tidy, with clean preparation
surfaces.
MM.11.2. The preparation area is equipped with a wash sink, antiseptic soap, and
a sharps container of appropriate size.
MM.11.3. Parenteral medications are prepared aseptically.
MM.11.4. Medications that are prepared and not immediately utilized are labeled
with the medication name, dose, route of administration, and patient’s
identifiers.

Explanation

Prepared medications can be a cause of patient morbidity if they were prepared aseptically or given
to the wrong patient. Therefore, medication preparation should follow the elements mentioned
in MM.11.1 through MM.11.4

83
 MM.12. The center develops and implements a policy and procedure on medication error
reporting.

MM.12.1. The pharmacy maintains a written policy and procedure for medication
error reporting.
MM.12.2. The policy defines significant medication error, the time frame for
reporting, and the reporting format.
MM.12.3. Medication error reporting is active and ongoing.
MM.12.4. The center performs an intensive root-cause analysis for all significant
medication errors.
MM.12.5. The center utilizes the reported information to improve the medication
use process and reduce the error rate.

Explanation

Reporting medication errors prevents recurrence and enables the immediate management of
the incident to reduce patient harm. The center should maintain a policy for the reporting of
medication errors, including classification, definition, reporting format, time frame for reporting,
and immediate intervention for patients to reduce harm. All significant medication errors should
undergo a root cause analysis. Data gathered from the reporting and the root cause analysis is
used to modify the medication management process to prevent recurrence of errors.

MM.13. The center monitors allergies to medications.

MM.13.1. The center has a process in place to ensure the reporting of medication
allergies.
MM.13.2. The newly discovered allergies are documented in patient medication
profile.

Explanation

Allergies can be a source of morbidity among patients if they are not highlighted to caregivers,
including pharmacy staff. All prescriptions should clearly highlight the patient’s allergy status.
As part of the prescription review process, relevant staff should discuss allergy status with the
prescriber to stop or change prescribed medication.

MM.14. The center develops and implements a policy and procedure for the reporting
of adverse drug reactions (ADR’s).

MM.14.1. The policy and procedure defines significant ADRs and the time frame
for reporting.
MM.14.2. An intensive analysis is performed for all significant ADRs.
MM.14.3. Treating physicians are notified of the analysis results.
MM.14.4. The medical record is flagged for significant ADRs and the patient
receives the appropriate medical care for the reaction.
MM.14.5. Significant ADRs are reported to the relevant authorities as per laws and
regulations.

Explanation

Adverse drug reaction (ADR) is a response to a drug which is noxious and unintended, and which
occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or
for the modification of physiological function. An unexpected adverse reaction refers to a reaction
whose nature or severity is not consistent with domestic labeling or market authorization or
expected based on the drug’s characteristics. A serious adverse reaction is any medical occurrence

84
that, at any dose normally used in humans, results in death, requires inpatient hospitalization
or prolongation of existing hospitalization, results in persistent or significant disability, or is life-
threatening.

The monitoring of medication effects includes observing and documenting any adverse effects.
The healthcare institution establishes a mechanism for reporting adverse events and the time frame
for reporting. Healthcare organizations are responsible for ensuring that patients are treated as
safely as possible. Prevention of ADRs is possible and, indeed, necessary. Studies have shown that
over 50% of adverse drug reactions may be preventable. Most ADRs are related to the prescribing
of an incorrect dose or the administration of a drug to a patient with a known allergy. Many ADRs
could be avoided if the relevant healthcare worker had asked specific questions before prescribing
and/or dispensing a drug. ADRs are to be reported to the SFDA.

References

Agency for Healthcare Research and Quality Patient Safety Network. Patient Safety Primer:
Medication Errors. (Updated: Mar 15, 2016.).
http://psnet.ahrq.gov/primer.aspx?primerID=23

Centers for Disease Control and Prevention. Core Elements of Hospital Antibiotic Stewardship
Programs. 2016.
http://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html

Ensuring good dispensing practices - World Health Organization

http://apps.who.int/medicinedocs/documents/s19607en/s19607en.pdf

Improving medication safety - World Health Organization

https://www.who.int/patientsafety/education/curriculum/PSP_mpc_topic-11.pdf?ua=1

Institute for Safe Medication Practices. Medication Safety Tools and Resources. 2016.
https://www.ismp.org/tools

The Joint Commission. Preventing infection from the misuse of vials. Sentinel Event Alert. 2014
Jun;52:1–6.
https://www.jointcommission.org/assets/1/6/SEA_52.pdf

US Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States,
2013. (Updated: Jul 17, 2015.)
http://www.cdc.gov/drugresistance/threat-report-2013/

ISQua (www.isqua.org)

85
 Chapter VII
Management of Information (MOI)

Introduction

Information management is a cornerstone of patient care and the decision support process by
center leaders. Center leaders are required to design and implement an information management
plan that defines the following:

• Managing the information required by governmental and external agents

• Managing internal information requirements
• Maintaining the security and confidentiality of information
• Retaining records
• Documenting and completing patients’ unique medical record

Standards

MOI.1. The leaders define in a plan the information that is shared among the staff and
with other governmental and non-governmental entities and its format.

MOI.1.1. The plan highlights how patient demographic and medical information
is shared among medical and administrative staff.
MOI.1.2. The plan identifies how the types of information are communicated by
leaders to staff and vice versa.
MOI.1.3. The plan includes the Ministry of Health required information and the
frequency of reporting.
MOI.1.4. The plan highlights the patient’s personal and medical information
required to refer the patient to a higher center.
MOI.1.5. The plan identifies the staff security levels for accessing the information.
MOI.1.6. The plan identifies how the various information is secured and safely
stored.
MOI.1.7. The plan highlights the different documents retention time consistent
with Ministry of Health rules and regulations.

Explanation

Communication failures are responsible for a third of the causes of morbidities and mortalities
in healthcare. Identifying and organizing the flow of information inside the organization and
with external customers helps streamline communication and eliminate communication errors.
All stakeholders should collaboratively develop a management of information plan that includes
the following:

• Managing the patients’ information (medical records and whether it is in paper

format, electronic or combined)
• Managing the internal communication between staff and the leaders such as
memoranda, management notifications and staff complaints.
• Managing externally required information by MOH and other regulatory bodies.
• The plan identifies how information is secured.
• The plan identifies the level of security for each type of document and how staff can
access only the information authorized to see.
• The plan identifies how the information is backed up and restored if needed.
• The plan identifies the retention time of the different documents and information
relevant to the rules and regulations of MOH and other regulatory bodies.

86
MOI.2. The leaders develop standardized diagnosis codes, procedure codes and symbols,
and minimize abbreviations.

MOI.2.1. The staff use diagnosis and procedure codes consistent with Ministry of
Health and other regulatory bodies’ requirements.
MOI.2.2. A list of approved abbreviations and symbols is distributed in all patient
care areas for reference.

Explanation

Abbreviations can be problematic and at times even dangerous, particularly in the context of the
‎‎
prescribing of medications. In addition, when one abbreviation is used for multiple medical terms,
‎‎confusion regarding the author’s intent may result in medical errors. ‎
Standardized diagnoses and procedure codes help centers track pathology and common
procedures, and complies with insurance companies’ requirements. Abbreviations and symbols
could be interpreted differently, thus inadvertently changing the intended care plans. Therefore, a
limited list should be circulated to all staff in all areas, and its correct use monitored.

MOI.3. All patients seen in the center have unique medical records.

MOI.3.1. Each patient has a unique medical record number.

MOI.3.2. Each patient has only one medical record or historical volumes of the
same.
MOI.3.3. The medical record’s contents are arranged according to a standardized
process.
MOI.3.4. Medical record contains the required patient demographics, including
national identification, contact information, emergency contacts and
insurance category.
MOI.3.5. Medical record contains updated medical information sufficient to safely
manage the patient and promote continuity of medical care.
MOI.3.6. Patient allergies, prior adverse reactions, and chronic infections are
confidentially documented and consistently displayed in a specified area
of the patient’s record.

Explanation

To ensure continuity of care, each patient cared for in the center should have his/her own medical
record that has a unique medical record number. The medical record shall contain, at a minimum
history and physical examination, plan of care, investigations, consultations, observations, allergies,
consents, procedure reports, and medications, all the elements in MOI.3.3 through MOI.3.6.

MOI.4. The leaders develop a policy on the rules and regulations for writing in patients’
medical records.

MOI.4.1. The policy identifies the category of staff allowed to write in the medical
record.
MOI.4.2. All entries are legible, dated, timed, and signed by the author.
MOI.4.3. Entries written in error are not deleted or erased. Instead, a line is passed
through the error text and dated, timed, and signed by the author.
MOI.4.4. Only standardized and approved abbreviations and symbols are used in
medical records.

87
 Explanation

Uniformity of writing in medical records ensures proper documentation and avoids misinterpretation
of written information. Therefore, a policy should be developed and implemented based on the
elements in MOI.4.1 through MOI.4.4

MOI.5. The leaders develop a process for completing and storing the patient medical
record.

MOI.5.1. The center has a dedicated and secure storage area for medical records.
MOI.5.2. Regular checks are made on returned medical records to ensure their
completion.
MOI.5.3. Non-completed medical records are clearly separated from completed
ones in the storage area and are completed within a timeframe that the
organization defines.
MOI.5.4. The center maintains a record of the percentage of incomplete records
over time and uses this information to improve staff compliance with
record completion.
Explanation

At the end of a patient’s visit, the medical record should be returned to the medical records store.
This keeps the medical records safe, secure, and in good order. Upon its receipt in the store, the
medical record should be checked for completeness according to a written process that includes
complete demographics, medical information, and authentication. Every effort should be made
to complete the incomplete records within a time frame that the organization has identified.
On a monthly basis, the center should check a percentage of its records for completion, and the
collected information should be conveyed to staff and used to improve staff compliance with
completion.

MOI.6. The center has an implemented policy and procedure for the use of information
technology.

MOI.6.1. The policy and procedure highlight how the generated information is
stored and regularly backed up.
MOI.6.2. The policy and procedure describe the manual procedures required to
execute the various activities in the event of system failure, maintenance
or repair.
MOI.6.3. Staff can demonstrate the manual procedure for the downtime
regulation.

Explanation

Despite advances in infrastructure robustness, many HCFs still face database, hardware, and
software downtime, lasting short periods or shutting down work for days. To maintain the
completeness and comprehensiveness of data, an adequate data capturing process during
downtimes is critical. Gaps in patient data may result in gaps in patient care. A complete manual
system must be prepared for use during the downtime period and include both managerial and
clinical activities to prevent the interruption of care processes. End users involved in providing
center services should be trained on the planned manual system and know how to shift once the
electronic system is down. The downtime system must be assessed for effectiveness regularly and
after actual downtime incidents.
Documented reports of this assessment should be available, and actions taken in response to any
deficiencies.
Even though organizations may treat their storage media with care, these media can be damaged
accidentally or on purpose, and medical records can be unconsciously changed or erased. The
creation of backup copies limits the amount of information lost. Backup media should be safely
stored.

88
As part of information and data integrity, organizations are expected to have a clear mechanism
for backing up data to ensure ease of retrieval. The backup process is regularly implemented to
avoid any data loss or gaps in information which may affect gaps in the care and service provided,
as well as to avoid misinformed decision-making by leaders.

MOI.7. The center has an effective clinical documentation improvement (CDI)

program.
(C)

MOI.7.1. There is a policy and procedure for clinical documentation improvement

in the center.
MOI.7.2. The center has at a minimum a physician and a nurse who are properly
trained on clinical documentation improvement.

Explanation

Clinical Documentation Improvement (CDI) is fundamental in any healthcare organization. CDI

ensures the accurate reporting of the diagnoses and procedures to the health authorities as per
local regulations. Moreover, health Insurance payments and reimbursement are directly linked to
the proper documentation of the clinical episode, so that over and under-payments are avoided.
Documentation also helps in the proper utilization of resources, including time, medications,
supplies, investigations, and usage of the operating theatre.
CDI ensures timely completion of the medical records which would support safer care for patients
as well as all research activities related to the prevalence of medical errors, utilization of resources,
areas for improvement and so forth. A proper documentation translates into proper coding which
makes it possible for healthcare leaders plan for better delivery of healthcare services.
The center leadership is responsible for ensuring that clinical staff are well trained on all aspects
of clinical documentation as per CBAHI guidelines in this regard. Auditing of the quality of clinical
documentation in the medical records will be part of the survey activities.

References

HIM Body of Knowledge – AHIMA

http://bok.ahima.org/

ISQua (www.isqua.org)

89
 Chapter VIII
Infection Prevention and Control (IPC)

Introduction

The ambulatory care center requires processes to support the prevention and control of infection
that might be acquired or transmitted by patients, staff, and visitors while in the center. These
processes reduce the risk or spread of infection and ensure that care is provided in a clean,
sterile environment. To ensure staff and patient safety, infection prevention and control requires
an effective center-wide infection prevention and control program that identifies, reduces, and
eliminates infection risks.
This chapter outlines the requirements for the following processes and activities related to infection
prevention and control:

• Infection control program

• Staff education
• Hand hygiene
• Communicable diseases
• Cleaning, decontamination, disinfection, and sterilization
• Healthcare-associated infection
• Personal protective equipment
• Sharps safety
• Waste management
• Housekeeping

90
Standards

IPC.1. The center implements a coordinated program to reduce the risk of healthcare-
associated infections.

IPC.1.1. A qualified individual, acting on a full-time or part-time basis, is

responsible for the infection control program.
IPC.1.2. The program involves patients, visitors, staff, and volunteers.
IPC.1.3. The program involves all patient care areas and support services.
IPC.1.4. The infection control program is based on current scientific knowledge,
accepted practice guidelines, and applicable laws and regulations.
IPC.1.5. The infection control program’s components are contained in a manual
that is available to all staff members.

Explanation

The center should establish an evidence-based infection control program according to its scope of
services. The program must cover all related IC prevention and control activities that could ensure
maximum safety for patients, visitors, staff, volunteers, contractors, etc. Infection prevention and
control activities should be overseen by a person qualified in infection prevention and control
practices through education, training, experience, or certification. This qualified staff member
should directly report to higher administrative authority to ensure the presence of an independent
administrative unit that oversees IC issues in the whole center. The person fulfills program oversight
responsibilities as per standard requirements that should be described in the job description.

IPC.2. Infection prevention and control activities are integrated and coordinated by an
interdisciplinary team.

IIPC.2.1. The interdisciplinary team reviews and approves the infection control
policies and procedures and the improvements plans.
IPC.2.2. The interdisciplinary team evaluates and revises, on a continuous basis,
the procedures and mechanisms that the center develops to serve
established standards and goals.
IPC.2.3. The interdisciplinary team brings to the center’s attention new infection
control issues arising in different departments and suggestions for
solutions.
IPC.2.4. The interdisciplinary team evaluates the infection control program
annually and suggests any necessary additions or changes.

Explanation

Infection control personnel, in collaboration with quality personnel and the medical director
(or representative), must regularly review, approve, monitor, and evaluate all infection control
program components and activities to maintain optimum IC activities, outcomes, and safety.

IPC.3. The leaders develop and ensure the implementation of infection control policies
and procedures targeting the most important infection risk processes.

IPC.3.1. Disinfection and sterilization.

IPC.3.2. Handling of sharps.
IPC.3.3. Infectious materials and waste disposal.
IPC.3.4. Prevention and management of patients’ and workers’ exposure to
healthcare-associated infections.
IPC.3.5. Laundry and linen management processes.
IPC.3.6. Renovation projects guidelines.
IPC.3.7. Practices for support services departments.

91
 Explanation

To ensure a safe workplace for all the center’s attendees, all activities at the center should be
regulated and controlled by scientifically based infection control policies and procedures.

IPC.4. Communicable diseases are tabulated and reported as required by laws and
regulations.

IPC.4.1. The center tabulates and reports communicable diseases to the Ministry
of Health.

Explanation

To ensure that the center complies with MOH health requirements with regards to the reporting of
notifiable communicable diseases, the center should maintain evidence of reporting communicable
diseases to MOH as per the center policy. The center should also maintain evidence of staff
awareness of the center reporting system.

IPC.5. The leaders develop and implement a policy and procedure for healthcare
associated infection prevention.

IPC.5.1. Evidence based bundles are used for the insertions of devices.
IPC.5.2. Staff regularly collect and analyze data on device related and surgical site
infections.

Explanation

To optimize urinary catheter and peripheral line insertion and other procedures in patient care
areas, the center should maintain a policy for device-related infection prevention and the care
bundle (when applicable). The staff must be fully educated about the elements of the adopted
care bundle (when applicable). The center should regularly collect and analyze the data and assess
the bundle compliance rate for performance improvement.

IPC.6. The leaders design and ensure the implementation of an effective hand hygiene
program.

IPC.6.1. Written policies and procedures for implementing and monitoring

appropriate hand hygiene are available.
IPC.6.2. The center provides hand washing facilities sufficient to meet its needs.

Explanation

Hand hygiene (HH) is the most effective method of preventing infectious disease transmission.
The center should develop HH policies and procedures. The center supports HH by providing sinks
and appropriate hand washing soap and sanitizers in appropriate locations in the facility. The
center should maintain a monitoring process to continuously evaluate HH compliance among
staff. In addition, data about HH compliance and monitoring should be analyzed and integrated
into improvement projects.

IPC.7. Centers providing sterilization services strictly follow rigorous

(C) sterilization rules.

IPC.7.1. Qualified staff conduct the sterilization processes.

IPC.7.2. Adequate space is available for sterilization services that support
sterilization processes, and no instrument or equipment sterilization

92
 takes place outside this area.
IPC.7.3. A policy and procedure on the safe reprocessing of single-use items have
been implemented.
IPC.7.4. Personal protective equipment is available and used during
decontamination: heavy-duty gloves, waterproof aprons, facemasks,
goggles, and face shields.
IPC.7.5. Sterilizers are in good working order, and instructions for their use are
available.
IPC.7.6. Proper sterilization parameters are recorded.
IPC.7.7. Sterilization records are retained for one year.
IPC.7.8. Chemical indicators are used in every package. Biological indicators are
used at least weekly. Records of results are kept for one year.

Explanation

Infection risk is minimized through proper cleaning, disinfection, and sterilization of surgical
supplies and other invasive or noninvasive patient care equipment. To ensure the proper method
of collection, decontamination, cleaning, and sterilization, these services must be centralized and
maintained. CSSD staff must set clearly written policies and procedures that guide collection
and transportation, decontamination and disinfection, cleaning and sterilization, the storage of
sterile items, and a mechanism for the recall of sterile items in the event that the sterilization
process fails. The policy must be scientifically sound, and reviewed and approved by the infection
prevention and control, quality, and administration. When this service is outsourced, the center
should ensure that the contractor complies with all required safety standards. Re-sterilization of
single-use items should be carried out according to an evidence-based policy that ensures safe
sterilization without affecting the integrity of the item’s use and that specifies the number of re-
sterilization cycles and the point at which the item cannot be further re-sterilized.

IPC.8. Patients with communicable diseases and those who are colonized or infected
with epidemiologically important organisms are separated from other patients,
staff and visitors.

IPC.8.1. Written and implemented policies and procedures address standard and
isolation precautions for cases of suspected or proven communicable
diseases.
IPC.8.2. Patients with suspected communicable diseases are dealt with in an
isolation room equipped with a sink and personal protective equipment.
IPC.8.3. The isolation room is a negative pressure ventilation that is exhausted
to the outside unless it is filtered through a High-Efficiency Particulate
Air (HEPA) filter, or, at a minimum, is equipped with a portable HEPA
filter that is regularly maintained according to the manufacturer’s
recommendation.
IPC.8.4. Staff are trained to triage suspected communicable disease cases and
isolate them before transfer to the appropriate healthcare setting.
IPC.8.5. During direct care of patients on airborne precautions, staff use high-
filtration respirator masks (N-95, N-99).

Explanation

This is to ensure proper implementation of the appropriate type of isolation precautions (contact,
droplet, and airborne isolation precautions). Center preparedness for isolation precautions
includes: the availability of a negative pressure airborne isolation room (or an isolation room with
a portable HEPA filter) and of required supplies, particularly a respirator (high-filtration mask, e.g.,
N95) in patient care areas.

93
 IPC.9. Personal protective equipment is readily accessible and available and is used
correctly by staff in all patient care areas.

IPC.9.1. Written policies and procedures are available for the appropriate use of
gloves, gowns, facemasks, and protective eyewear.
IPC.9.2. Gloves are worn when the potential exists for contact with blood/body
fluids.
IPC.9.3. Gowns, masks, eyewear, or face shields and other protective equipment
are worn during all procedures which are likely to generate splashes,
soiling, or droplets of blood or other body fluids.

Explanation

Personal protective equipment (PPE) is a fundamental tool for proper infection prevention and
control practices. The center identifies those situations in which masks, eye protection, gowns, or
gloves are required in written policy, and provides a sufficient supply of PPEs as well as training in
their proper use.

IPC.10. The leaders define in a policy the cleaning, decontamination and disinfection
processes in all patient care areas.

IPC.10.1. The policy has a list of appropriate detergents and disinfectants as

defined and approved by the infection control personnel.
IPC.10.2. Detergents and disinfectants are available in all patient care areas.
IPC.10.3. Patient care areas are clean, and equipment is properly disinfected.

Explanation

Disinfectants are frequently used to eliminate infectious organisms. The choice of disinfectant to
be used depends on many factors. Some disinfectants have a wide spectrum (kill many different
types of microorganisms), while others kill a narrower range of disease-causing organisms but are
preferred for other properties (they may be non-corrosive, non-toxic, or inexpensive). To ensure
the proper use of disinfection, the selections and indications for use must be based on scientific
references and national laws and regulations, reviewed and supervised by infection control
personnel.

IPC.11. The leaders define in a policy the safe procedures for waste collection,
(C) storage and disposal.

IPC.11.1. The policy differentiates between regular waste and infectious waste.
IPC.11.2. The infectious waste is treated and disposed of in accordance to laws
and regulations.

Explanation

To protect the public and the environment from infectious organisms and to provide a safe,
healthy environment for the patient, healthcare worker, and visitors, the center should implement
a Medical Waste Management Program that regulates the segregation, handling, storage, and
disposal of medical waste and provide oversight for its implementation as per center policy.
The program should be implemented under national laws and regulations. The center should
ensure the availability of required supplies (yellow bags, red bags, medical waste containers, etc).
Medical waste workers should be vaccinated and trained on the safe handling of medical waste
as reflected in their employee health records.

94
IPC.12. The leaders develop and ensure the implementation of a program for the
prevention and management of sharp injuries.

IPC.12.1. Needles are not bent, broken, or recapped except in special and approved
circumstances. If recapping is necessary, the “scoop method” is used.
IPC.12.2. Needle sticks or sharps injuries are reported in a timely manner
and investigated. Data are trended over time and used to develop
improvement interventions.

Explanation

To prevent sharps injuries with exposure to blood-borne infections, the center should have a
defined system to prevent sharps injuries and ensure the proper handling of sharps. The handling,
use, and disposal of sharps within the center should be practiced according to a written policy
and procedure. Center staff should have the knowledge and skills necessary to handle sharps (i.e.,
needles are not bent or broken, the scoop method is used for necessary recapping, etc.).

IPC.13. Sharps are discarded in appropriate containers.

IPC.13.1. At least one puncture-proof and leak-proof sharps container is available

in a convenient place in every patient care area
IPC.13.2. Sharp containers are not overfilled and are disposed of as medical waste
when their contents are three-quarters of their sizes. They are not opened
to facilitate the transfer of sharps into other containers.

Explanation

The center should provide the necessary resources to implement a comprehensive program for
preventing sharps injuries. The center should ensure that the type of sharps box used is puncture-
resistant and leak-proof and that it presents no risks to staff or patients. A sufficient number of
appropriate sharp containers should be made available. Sharps boxes are properly located and
used, and sharps box disposal is handled in accordance with national laws and regulations.

IPC.14. Housekeeping has policies and procedures describing its functions.

IPC.14.1. All units have a cleaning/disinfection schedule that lists all environmental
surfaces and items to be cleaned.
IPC.14.2. The infection control staff periodically review the cleaning procedures,
schedules, and agents.
IPC.14.3. A process is in place to safely handle blood/ body fluids spills and waste.

Explanation

Environmental cleaning is a fundamental principle of infection prevention and control in the

center. The policy ensures appropriate decontamination of surfaces that could play an important
role in the transmission of dangerous pathogens including Clostridium difficile, and antibiotic-
resistant organisms such as methicillin-resistant staphylococcus aureus (MRSA), vancomycin-
resistant enterococci (VRE), etc. The center must implement clearly written housekeeping policies
and procedures that are reviewed by infection control staff. The center must also maintain
detailed cleaning schedules listing the center environmental surfaces, prepared and implemented
by housekeeping staff and monitored by Infection Control staff.

95
 References

Asia Pacific Society of Infection Control. APSIC Guidelines for Environmental Cleaning and
Decontamination. Accessed Nov 11, 2016.
http://apsic.info/documents/Environmental-Cleaning APSIC-Guideline-14-Jan-2013.pdf

Carling PC, Huang SS. Improving healthcare environmental cleaning and disinfection: Current and
evolving issues. Infect Control Hosp Epidemiol. 2013 May;34(5):507–513.

Centers for Disease Control and Prevention. Hand Hygiene in Healthcare Settings. 2016. 2016.
https://www.cdc.gov/handhygiene/

Guideline for Disinfection and Sterilization in Healthcare Facilities - CDC

https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf

Infection prevention and control manual, 2nd edition, 2013, National Guard Health Affairs.
https://www.moh.gov.sa/CCC/Documents/GCC%20Infection%20control%20manual%20
2013%20revisedOPT.pdf

US Centers for Disease Control and Prevention. Infection Control in Health Care Facilities.
(Updated:Aug 4, 2016.), 2016.
http://www.cdc.gov/flu/professionals/infectioncontrol/

Weber DJ, Rutala WA. Understanding and preventing transmission of healthcare-associated

pathogens due to the contaminated hospital environment. Infect Control Hosp Epidemiol. 2013
May;34(5):449–452.

Wei R, et al. Evaluation of detergents and contact time on biofilm removal from flexible endoscopes.
Am J Infect Control. 2013 Sep;41(9)e89–92.

World Health Organization (WHO) - Global Infectious Disease Surveillance. Fact Sheet 200. 2016.
https://www.who.int/news-room/fact-sheets

World Health Organization (WHO) - Infection Prevention and Control in Health Care. Accessed
Nov 13, 2016.
http://www.who.int/csr/bioriskreduction/infection_control/en/index.html

World Health Organization (WHO) - Revised CSSD Manual and Guidelines - Infection Control
Africa. 2014
http://www.icanetwork.co.za/wp-content/uploads/2014/03/N.-Damani-CSSD-WHO-guidelines.
pdf

ISQua (www.isqua.org)

96
 Chapter IX
Facility Management and Safety (FMS)

Introduction

A safe, functional, and effective environment for patients, staff, and other individuals is crucial
to prevent or minimize risks in the environment of care. The center leadership must provide all
necessary support and resources to improve safety in the workplace in alignment with regulatory
requirements.
The center must maintain plans for managing the safety of the environment and must implement
these plans. The center must collect and analyze data to determine the effectiveness of the plans
and facilitate continuous quality improvement.
Staff members must also receive education about their responsibilities. Education must commence
at orientation and continue on a regular basis thereafter.
Important aspects of facility management and safety that this chapter addresses include the
following:

• Safety
• Security
• Fire safety
• Emergency
• Hazardous materials
• Medical equipment
• Utilities

Standards

FMS.1. The leaders establish and support a facility management and safety program.

FMS.1.1. A qualified individual is responsible for the facility management and

safety program as a full-time or part-time employee.
FMS.1.2. The leaders establish an interdisciplinary team for overseeing and
monitoring the facility management and safety program.
FMS.1.3. The safety management program includes plans for emergency
management, utility systems, hazardous materials, fire safety, medical
equipment, building safety and security.
FMS.1.4. The safety management program includes the regular inspection, testing,
and maintenance of all the program’s operating components.
FMS.1.5. Data related to safety concerns are reviewed and analyzed with proper
action to prevent reoccurrences.
FMS.1.6. The leaders maintain adequate and complete documentation for the
facility management and safety program.
FMS.1.7. All staff including new hires, locum and trainees receive education on
the program. This education is repeated annually as relevant to their
practice.

97
 Explanation

The center develops individual programs or one master program that includes the following: ‎
a) Safety and Security ‎
Safety—The degree to which the center’s buildings, grounds, and e‎ quipment do not
pose a hazard or risk to patients, staff, and visitors.
Security— Protection from loss, destruction, tampering, or unauthorized ‎
access or use .
b) Hazardous materials—Handling, storage, and use are controlled, and h ‎ azardous
waste is safely disposed of. ‎
c) Emergencies—Response to disasters and emergencies is planned and ‎effective. ‎
d) Fire safety—Property and occupants are protected from fire and smoke. ‎
e) Medical technology—Technology is selected, maintained, and used in a ‎manner that
reduces risks. ‎
f) Utility systems—Electrical, water, and other utility systems are ‎maintained to minimize
the risks of operating failures. A backup system is available in case of failure.

Such programs are written and up to date in that they reflect actual c‎ onditions within the center’s
environment. A process exists for their r‎eview and updating. When the center has other entities
within the facilities to b
‎ e surveyed (e.g., coffee shop or gift shop), the center has an obligation to
‎ensure that these independent entities comply with the facility ‎management and safety program. ‎
‎To ensure these plans are properly disseminated to the center’s newly hired s‎ taff, an orientation
program should be established, covering all aspects of t‎he program to ensure patient, staff and
visitor safety.‎

FMS.2. Interdisciplinary rounds are scheduled and conducted to ensure safety.

FMS.2.1. The interdisciplinary team conducts a facility inspection round at least

four times per year.
FMS.2.2. The resulting information is documented and used for corrective
actions, planning, and budgeting for long-term facility upgrading and
replacement.
Explanation

Safety rounds by the safety team and other disciplines should take place regularly in the center.
‫‏‬The rounds are d ‎ esigned to d
‎ iscover any inconsistencies and to identify existing safety or security
hazards related to settings and ‎environment.
The results of rounds are formally documented. Corrective actions are taken to ensure that safety
requirements are met. The c‎enter ‎should be able to establish a systematic approach for the
necessary safety ‎expenditures (allocated
‎‎ budget).

FMS.3. The center’s environment is safe for patients, visitors and staff.

FMS.3.1. The leaders ensure that the building and its services comply with national
standards, environmental protection standards, laws and regulations and
the recommendations of professional centers.
FMS.3.2. The building and its surroundings are hazard free.
FMS.3.3. Periodic preventive maintenance (PPM) and corrective maintenance are
performed and recorded for all electrical and mechanical systems.
FMS.3.4. Maintenance records are kept for all electrical and mechanical systems,
including periodic preventive maintenance.
FMS.3.5. The center has adequate parking space, waiting areas and toilets.

98
Explanation

To ensure occupants’ safety and manage the risks within the healthcare environment, all centers,
‎regardless of size and resources, must comply with national ‎standards, environmental ‎protection
standards, laws and ‎ regulations, and the ‎ recommendations of professional agencies. ‎ The
leadership is ‎responsible for:
‎The building and its surroundings should be free of hazards such as; potentially loose objects,
exposed outlets or wiring, slippery floors, sharp ends and holes in the ground.

• Knowing which national and local laws, regulations, and other ‎‎requirements apply to
the center’s f‎acilities; ‎
• Planning and budgeting for the necessary upgrading or replacement as ‎‎identified by
monitoring data o ‎ r to meet applicable requirements and providing
‎‎ evidence of progress
toward implementing the i‎mprovements. ‎

The center must develop and implement a plan for periodic preventive and c‎ orrective maintenance
for the center’s setting, including electrical and ‎mechanical systems. Maintenance records are kept
for all mechanical and electrical equipment, such as air conditioning, power and equipment to
help in decisions regarding replacement or upgrades.
When the center has been cited for not meeting requirements, center l‎ eadership takes ‎responsibility
for planning for and meeting the ‎requirements in the prescribed time frame. ‎

FMS.4. The leaders develop and monitor the implementation of a fire prevention
program.

FMS.4.1. At least annually, staff are trained on fire drills and evacuation plans.
FMS.4.2. Records of fire and evacuation training are kept in personal staff files.
FMS.4.3. Egress routes, corridors, and fire escapes are marked and free from
obstacles.
FMS.4.4. Fire systems, including the fire alarm and fire equipment, are in place and
functioning.
FMS.4.5. Fire extinguishers are tested and distributed in the center according to
the type of extinguisher required.
FMS.4.6. The fire alarm system is maintained and tested and all maintenance
records are maintained.
FMS.4.7. A no smoking policy is approved and enforced.
FMS.4.8. “No smoking signs” are posted at all entrances and waiting areas.

Explanation

The fire safety of the center and its occupants must be ensured through a number of f‎acility
control measures, in addition to staff training on fire drills including the use of acronyms such
as RACE/PASS and evacuation techniques. T‎ hese measures must include the procurement of
fire-rated materials such as ‎furniture and curtains (proven through the materials’ specifications)
and ‎the establishment of fire and smoke compartments, especially for high-risk areas like ‎the
laboratory. Fire rating should also include windows, glass, and doors ‎along the compartment. ‎
Also, a staff training schedule on fire extinguisher use should be provided and consider different
types of fire extinguishing systems. The fire alarm ‎system is to be maintained and tested, and all
maintenance records are to be kept and updated. ‎
The NFPA rates cigarette smoking as one of the three main causes of fire in healthcare f‎acilities.
‎Cigarette smoking also poses a health risk for others in the form of passive smoking. ‎”No smoking”
signs are posted and a no smoking policy is enforced.

99
 FMS.5. The center is secured and protects its users.

FMS.5.1. Trained security personnel are available in the center according to its size
and design complexity.
FMS.5.2. The center’s equipment and data are secured.
FMS.5.3. The patient’s privacy is respected.
FMS.5.4. Security personnel or security systems restrict access to sensitive and high
risk areas.
FMS.5.5. Patient and staff files are accessible only to authorized persons.
FMS.5.6. All staff wear properly displayed identification badges.

Explanation

The center’s security program must ensure that everyone in the center is ‎protected from harm, loss,
or damage to property. Staff, vendors and o ‎ thers that the center identifies, such as contractors,
wear b‎ adges (temporary or permanent) or other forms of identification. ‎
Restricted areas such as operating rooms, labs, and intensive care units , medical records and IT
server rooms must be secure and monitored by security ‎personnel and/or security access control
systems. ‎
Children, elderly people and other vulnerable patients unable to protect ‎themselves or signal
for help must be protected from harm. In addition, ‎remote or isolated areas of the facility and
grounds may require the use of s‎ecurity cameras or the presence of security staff.
Security program policies and procedures must be disseminated to center ‎staff to clarify their roles
and responsibilities in different situations. ‎
To ensure security coverage of facilities, a security risk-assessment must be conducted to
determine the number of security personnel ‎necessary to cover the center’s main gates, entrances,
and security-sensitive ‎areas, and to conduct security actives such as security rounds. P‎ atients,
employees, and others must be able to sense the security ‎presence in the center. This presence
must be available throughout the c‎ enter’s operational time. ‎
Security personnel must be oriented to and familiar with their job ‎ descriptions, roles, and
responsibilities during various security scenarios a‎nd emergency cases. ‎
Female security personnel must be available as required, and security ‎personnel must be able to
communicate properly with the center’s ‎employees and patients, without language barriers. ‎

FMS.6. The leaders develop a plan for the inspection, testing and maintenance of
medical equipment.

FMS.6.1. An updated inventory list is available of all medical equipment.

FMS.6.2. Medical equipment with special installation requirements, HVAC, or room
modifications is installed following the manufacturer’s recommendations
and safety requirements.
FMS.6.3. The periodic preventive maintenance (PPM) program is implemented
for all medical equipment, according to the supplied and available
manufacturer’s service manual, and records are maintained.
FMS.6.4. The medical equipment is tagged with a PPM label.
FMS.6.5. All defective medical equipment is labeled accordingly.
FMS.6.6. Medical equipment is discontinued according to a clear policy including
lifespan, beyond economic repair, and vendor or governmental recalls.
Equipment is disposed of as per governmental rules and regulations.

100
Explanation

The medical equipment management program must be supported by policies a‎ nd procedures

that mitigate the risks associated with the introduction of n
‎ ew medical equipment, the tagging of
medical equipment, t‎he removal of equipment from service, agent/sub-contractors’ repairs, and
the use of e‎ xtension cords and cellular phones. ‎
To ensure that medical equipment is safe to use through proper installation, regular ‎‎inspection,
maintenance, and testing, a medical equipment management ‎‎program must be implemented.
Such a program must include: ‎

1. An inventory of medical equipment that covers, at a minimum, the equipment

‎‎name, its manufacturer, its model, its serial number, its location, its ‎organization
‎number, and its maintenance history. ‎
2. Installation requirements including modification of HVAC requirements and safety
precautions (for some types of laser equipment in ophthalmology and dermatology
clinics).
3. The availability of a system for medical equipment alerts and recall monitoring
‎‎
through SFDA and manufacturer notifications and ‎reporting m ‎ edical equipment
failures in a serious injury or ‎illness to SFDA. ‎
4. ‎The availability of a necessary service and operation manual, whether ‎‎a hardcopy or
softcopy, for reference when needed. ‎
5. The availability of calibrated necessary test and calibration equipment. ‎

Because medical equipment failures are expected, the center must develop
‎‎ a risk-assessment-
based backup plan for failed medical ‎equipment ‎ through the provision of standby medical
equipment or by shifting t‎o an equal m
‎ edical intervention alternative.

FMS.7. The leaders develop an emergency plan, and staff are trained on it.

FMS.7.1. The center’s emergency plan details how to respond to different

emergencies and how to minimize risks in the center.
FMS.7.2. The emergency plan defines the staff roles.
FMS.7.3. Staff are trained on the emergency drills annually. Staff are certified in
completing the emergency drills.
FMS.7.4. The emergency plan includes contact persons and authorities.
FMS.7.5. The emergency plan identifies the nearest healthcare facilities and staff
know where to refer patients during emergencies if needed.
FMS.7.6. The center has alternative power and water sources as part of its
emergency preparedness.
FMS.7.7. The emergency plan is documented, evaluated annually, and updated as
needed.

Explanation

To ensure the life safety of all occupants within the center and provide the utmost protection for
‎the facility ‎and its ‎equipment, staff must participate positively in protecting the ‎environment ‎and
responding to e‎ mergencies.
The center has a documented, evaluated, and updated (as needed) emergency ‎plan.
The center must assess the types of emergencies ‎it is more likely ‎to encounter and determine the
types ‎of action needed t‎ o ensure that patients and staff remain s‎ afe. ‎
A clear plan must outline leader and staff duties and ‎responsibilities in such emergencies. ‎Staff
are well trained in emergency d ‎ rills and know where to refer patients during emergencies‫ ‏‬if
‫‏‬needed. ‎‎Ongoing training is required to help ensure that staff are aware of those d ‎ uties and
responsibilities. To test s‎ taff readiness, all department staff must p
‎ articipate in a mix of announced
and unannounced drills, which must be documented.
Contingency plans are available for water and power sources during an emergency to ensure the
availability of alternate sources if needed.

101
 \FMS.8. The leaders develop a hazardous materials (HAZMAT) and waste disposal plan.

FMS.8.1. The leaders keep an updated register of all hazardous materials in the
center, along with their “Safety Data Sheets”.
FMS.8.2. Staff are trained in dealing with available hazardous materials and waste
disposal.
FMS.8.3. Hazardous materials and waste are controlled. The center exerts a
continuous effort to reduce hazardous materials.
FMS.8.4. Hazardous materials are stored, handled, transported, used, and disposed
of as per the “Safety Data Sheets”.
FMS.8.5. Waste disposal is done in an effective manner within the facility or
through an authorized contractor.
FMS.8.6. Fire-rated cabinets are used for flammable hazardous materials.

Explanation

The center must protect its occupants from the effects of hazardous materials and waste. C ‎ enters
produce a considerable amount of potentially infectious waste every day. T‎hus, the proper
handling, segregation of and disposal of w
‎ aste contribute to the reduction of infection risk in the
center.‎

A hazardous materials plan is in place that includes identifying and safely c‎ ontrolling hazardous
materials and waste throughout the facility.‎A hazardous material is any solid, liquid, or gas that
can harm people, other l‎iving organisms, property or the environment. ‎

Hazardous materials may be radioactive, flammable, explosive, toxic, c‎orrosive, oxidizers,

asphyxiants, pathogens, or allergens, or may have ‎other characteristics that render them hazardous
in specific circumstances. ‎

The hazardous materials program includes processes for: ‎

• Inventory of hazardous materials.‎

• Handling, storage, and use of hazardous materials. ‎
• Proper protective equipment and procedures to use and follow during use, spill, or
‎exposure. ‎
• Proper labeling of hazardous materials and waste.‎
• Reporting and investigation of spills, exposures and other incidents. ‎
• Documentation, including any permits, licenses or other regulatory ‎requirements.‎
• Education and training on the signs and symptoms of exposure to h ‎azardous
materials and the appropriate treatment according to ‎Safety Data Sheets (SDSs).‎

Information regarding procedures for handling or working with hazardous ‎materials in a safe
manner must be immediately available at all times, and i‎nclude the physical data of the material
(such as its ‎boiling point, flash point, etc.), its toxicity, its health effects, identification of proper
storage ‎and disposal after its use, the type of protective equipment required during i‎ts use, and
spill-handling procedures, including the required first aid for a‎ ny type of exposure.‎
Waste (medical and non-medical) must be disposed of according to local rules and regulations.

102
FMS.9. The leaders develop a policy and procedure for the safe use of various types of
compressed gasses.

FMS.9.1. The document highlights the use of cylinder transporters.

FMS.9.2. The document emphasizes the cylinder storage in well-ventilated areas.
FMS.9.3. The document describes how to secure the cylinders by positioning
upright against the wall and securing it by a chain or inside special
containers.
FMS.9.4. The document ensures the timely replacement of empty cylinders and
the availability of a backup system.
FMS.9.5. Centers equipped with piped gas systems follow the regulatory body’s
testing and safety requirements.
Explanation

Compressed gas systems are a standard feature of most healthcare facilities, and they require
special monitoring and maintenance to ensure their proper operation. Unlike other medical
equipment and systems, the use of gas under pressure can lead to a unique set of potential
failures that may not be readily apparent. This makes medical gas preventative maintenance
critical to a problem-free working environment.
Medical gas source equipment will vary depending on the type of gas and the size of the
institution. For smaller needs, cylinder-only solutions are often adequate. Compressors are also
used to provide medical air, and vacuum pumps are needed for suction. Failing to properly monitor
these complex pressurized systems can be costly, in terms of both increased use of consumables
and damage to permanent equipment.
Due to the nature of gas cylinders, special storage and handling precautions are necessary. The
hazards associated with compressed gases include oxygen displacement, explosion, toxicity, and
the physical hazards of a ruptured cylinder. HCFs must develop and implement a policy for handling,
storing, transporting, and disposing of various types of compressed gasses. Centers equipped
with piped gas systems should follow the regulatory body’s testing and safety requirements.

References

Joint Commission Resources. Labeling the hazard: OSHA to institute “global harmonization” of
hazard communications. The Joint Commission EC News. 2013, Jul;16(7):1-111, 3–4
https://www.jointcommission.org/assets/1/6/ECNews_July_2013_Hazard_Labeling.pdf

Lorenzi N. Critical features of emergency power generators. Health Facil Manag. 2015 Sep 2.
http://www.hfmmagazine.com/articles/1712-critical-features-of-emergency-power-generators

McLaughlin SB, Dagenais DA. Medical Gas Cylinder and Bulk Tank Storage. Chicago: ASHE,
Jun 2012
http://www.ashe.org/compliance/ec_02_06_01/01/pdfs/mg2012mclaughlin.pdf

World Health Organization (WHO) - Safe Hospitals.

https://www.who.int/hac/events/safe_hospitals_info.pdf

World Health Organization (WHO) - Safe Management of Wastes from Health-Care Activities,
2nd ed. 2014
http://www.searo.who.int/srilanka/documents/safe_management_of_wastes_from_healthcare_
activities.pdf

ISQua (www.isqua.org)

103
 Chapter X
Day Procedure Unit (DPU)

Introduction

Ambulatory care centers may have a day procedure unit where all day procedures are performed
under local anesthesia, sedation analgesia, or general anesthesia. This chapter focuses on the
standards required to safely manage patients in the day procedure unit, utilizing evidence-based
criteria.

This chapter addresses the following:

• Staffing
• Required policies and procedures
• Patients’ acceptance criteria
• Space and equipment requirements
• Patients’ assessment requirements
• The prevention of wrong patient, wrong procedure, and wrong site
• Monitoring of the patient during and after the procedure
• Discharge from recovery

Standards

DPU.1. All day surgeries and procedures are performed in the day procedure unit.

DPU.1.1. A qualified physician or anesthesiologist directs the unit.

DPU.1.2. A Saudi board-certified or equivalent anesthesiologist performs
anesthesia and/or sedation as required and is in charge of monitoring
the patient until the patient is discharged home.
DPU.1.3. The unit has a patient receiving area, procedure room(s), and a recovery
area with an ICU setup.
DPU.1.4. The unit has its own staff changing area.
DPU.1.5. The unit design follows infection control standards for the segregation of
clean and potentially infectious areas and air-conditioning requirements.
DPU.1.6. Dental procedures requiring sedation are performed under the same
conditions developed for the day procedure unit, and patients recover
in either a dedicated recovery room or the same dental room where the
procedure was performed.
DPU.1.7. The center maintains a registry of all the day cases performed.

Explanation

For patients’ safety, all procedures done in the center as day cases should be performed in a special
day procedure unit. The unit design should enable a patient and instrument flow that prevents
the spread of infection to patients and should have special positive pressure ventilation to prevent
the influx of potentially contaminated air. Bed space for pre-procedure and post-recovery areas
should follow minimum requirements. The procedure room measurement and design should
follow MOH requirements. A qualified physician should oversee the unit. The administration of
sedation or anesthesia should be done by a board-certified anesthesiologist, who shall also be
responsible for monitoring patients during the procedure and in the recovery area. One or two
ICU beds should be available in the unit in case a patient requires a longer recovery time or must
be observed overnight. All cases performed in the unit should be registered in a log book for
statistical purposes and for possible tracking of cases. Dental cases requiring sedation should
follow the same rules.

104
DPU.2. Leaders develop and implement a policy and procedure to guide the care of
patients in the day procedure unit.

DPU.2.1. The policy highlights the types of operations and procedures that may be
performed in the unit.
DPU.2.2. The policy describes how patients are received in the operating room.
DPU.2.3. The policy clearly explains the timeout procedure.
DPU.2.4. The policy includes the daily checking of anesthesia equipment.
DPU.2.5. The policy describes the required pre-sedation/anesthesia assessment
and pre-induction assessment.
DPU.2.6. The policy describes the intra-procedural/operative monitoring of
patients with or without anesthesia or sedation.
DPU 2.7. The policy describes how patients are received and discharged from the
recovery room.
DPU.2.8. The policy highlights the special considerations for surgeries involving
implantable devices or lenses.
DPU.2.9. The policy includes the identification and storage of gametes in assisted
reproduction units.

Explanation

To streamline activities in the day procedure unit and prevent morbidities, the unit must have
implemented policies and procedures for the activities mentioned in DPU.2.1 through DPU.2.9..

DPU.3. The patient is accepted into the unit by the nursing staff after a rigorous
verification procedure.

DPU.3.1. The patient is properly identified.

DPU.3.2. Informed consent is available.
DPU.3.3. The attending physician documents patient assessment and the
operational plan.
DPU.3.4 Surgical/procedural site marking is done, if required.
DPU.3.5. Relevant laboratory and radiology results are available.
DPU.3.6. The pre-sedation/anesthesia assessment is documented.

Explanation

To ensure the patient readiness for the procedure, staff should ensure the availability of the
elements in DPU.3.1 to DPU.3.6 before accepting the patient in the procedure room.

DPU.4. The procedure/surgery room is a functional operating room.

DPU.4.1. The room has an anesthetic machine.

DPU.4.2. A scavenging system is connected to the room.
DPU.4.3. An ECG machine is available within the vicinity.
DPU.4.4. A cardiac defibrillator is available and regularly checked.
DPU.4.5. A ventilator is available and regularly checked.
DPU.4.6. Medical gases and suction are available with a backup system.

Explanation

The equipment mentioned in DPU.4.1 to DPU.4.6 constitute the minimum requirement in the
procedure room to safely operate on patients.

105
 DPU.5. The day procedure unit is fully equipped for managing difficult intubations.

DPU.5.1. Laryngeal mask.

DPU.5.2. Gum elastic bogie.
DPU.5.3. Lighted stylet.
DPU.5.4. Cricothyroidotomy kit.
DPU.5.5. Fiber optic intubations scope.

Explanation

The equipment mentioned in DPU.5.1 to DPU.5.5 has proven to be lifesaving in cases of difficult
intubation and should be present in the day procedure unit.

DPU.6. Patients booked for a surgery/procedure shall have a pre-sedation/anesthesia

assessment performed by the anesthesiologist prior to the surgery.

DPU.6.1. The pre-sedation/anesthesia assessment is performed no more than

thirty (30) days before the surgery date. If the pre-anesthesia assessment
is performed within thirty (30) days, the pre-anesthesia assessment is
updated with documentation in the medical record.
DPU.6.2. The pre-sedation/anesthesia assessment highlights anesthetic risk score
and the patient’s suitability for the type selected.
DPU.6.3. The assessment results in a sedation/anesthetic plan that is agreeable to
both the physician performing the procedure and the patient/family.
DPU.6.4. The anesthesiologist reassesses the patient immediately before sedation/
anesthesia induction to assess the patient’s immediate suitability for the
procedure.

Explanation

To decide on the most suitable type of sedation or anesthesia, patients must have a full pre-
anesthesia/sedation assessment performed before any procedure in the day procedure unit. A
sedation or anesthesia written plan is crucial for the patient’s safety. The pre-sedation/anesthesia
assessment is valid for up to thirty days before the procedure. The assessment should highlight
the anesthesia risk score, such as the “ASA.” The immediate pre-induction anesthesia assessment
focuses on the patient’s immediate readiness for the procedure and excludes findings that may
require changing the anesthetic technique or postponing the procedure.

DPU.7. The center ensures the correct implementation of the policy on preventing wrong
patient, wrong site and wrong procedure.

DPU.7.1. The procedure site is marked before surgery if required, as in multiple

organs, laterality, or different levels.
DPU.7.2. A preoperative verification process is used and documented in the day
procedure unit before the patient is placed in the procedure room to
ensure the availability of the appropriate assessments, plans, consents,
diagnostics, equipment, instruments and implants.
DPU.7.3. The team which comprises of the surgeon, anesthesiologist and circulating
nurse performs and documents a time-out process immediately before
the procedure.

Explanation

Unfortunately, wrong patient, wrong site, and wrong procedure are still reported worldwide. The
evidence-based approach to prevent it is mentioned in DPU.7.1 to DPU. 7.3 and must be followed
and documented.

106
DPU.8. The patient’s condition is continuously monitored during sedation or anesthesia,
including local anesthesia and the information is documented in the patient
medical record before the patient leaves the operating room.

DPU.8.1. The patient’s vital signs, oxygen saturation, and ECG findings are
recorded by the anesthesiologist.
DPU.8.2. The anesthetic technique is recorded by the anesthesiologist.
DPU.8.3. The anesthetic or sedation agent, IV medications and other medications,
including dosage and the timing of administration are recorded by the
team.
DPU.8.4. Any unusual events are recorded.
DPU.8.5. Any investigations carried out are recorded.
DPU.8.6. The status of the patient at the end of the procedure is recorded.

Explanation

Patients may bleed unnoticed during surgery, develop lowered or raised blood pressure, or
experience cardio-respiratory compromise. Therefore, the patient’s general status should be
continuously monitored, even if the procedure is performed under local anesthesia. Monitored
findings should be recorded regularly on a specific monitoring sheet. The sheet should also include
the time that anesthesia began, the anesthetic agent used and its amount, the starting time of the
surgery or procedure, the fluid used, any investigations done during the procedure, any unusual
events, and the patient’s general status at the end of the procedure.

DPU.9. The unit has a recovery room.

DPU.9.1. A qualified anesthesiologist covers the recovery room.

DPU.9.2. The recovery room is equipped with continuous vital signs monitoring,
ECG, and pulse oximetry.
DPU.9.3. The recovery room is equipped with oxygen and suction.
DPU.9.4. The recovery room is equipped with a crash cart and defibrillator.
DPU.9.5. The recovery room is equipped with facilities for mobile ventilation in the
event that transportation to a hospital is required.

Explanation

Following surgery or procedure, patients must be monitored for some time until their general
condition returns to the pre-anesthesia/sedation status and to ensure the absence of immediate
complications. Therefore, patients should be observed in a special unit equipped with the elements
mentioned in DPU 9.1 through DPU. 9.5. In the absence of a specified recovery room, patients
shall recover in the procedure room until they are fit enough and able to be escorted home.

DPU.10. Each patient’s post-sedation/anesthesia physiological status is continuously

monitored and documented in the patient’s medical record.

DPU.10.1. The date and time of admission to the day procedure and discharge to
recovery are recorded.
DPU.10.2. The patient’s vital signs, oxygen saturation, and level of consciousness
are recorded.
DPU 10.3. The pain score is recorded.
DPU.10.4. Fluid output including urine and drains is recorded.
DPU.10.5. Tolerance to oral fluid is recorded.

107
 Explanation

To follow the patient’s recovery status and anticipate possible delays in recovery or potential
procedure complications, the parameters in DPU.10.2 through DPU 10.5 should be recorded
at regular intervals and documented in the patient’s records. The date and time of the patient’s
receipt and discharge from recovery should be documented to assist in the overall evaluation of
the patient’s recovery period.

DPU.11. An operative report is documented immediately after the surgery/procedure,

before the patient leaves the recovery room and is signed by the surgeon.

DPU.11.1. The report highlights the pre- and post-operative diagnosis.

DPU.11.2. The operative report documents the name of the surgeon,
anesthesiologist, and assistants.
DPU.11.3. The operative report clearly documents the operation or procedure
performed.
DPU.11.4. The operative report includes a description of the surgery or procedure,
findings, and complications, if any.
DPU.11.5. The amount of blood loss is documented.
DPU.11.6. The operative report flags any drains or packs left, the type of wound
closure, and the type of dressing used, with instructions on how and
when to remove.
DPU.11.7. The operative report includes specimens removed and the need for
histopathological examination.

Explanation

A complete operative or procedure report is essential for the immediate post-procedure care and
for continuing the care of the patient as an outpatient. The elements mentioned in DPU.11.1 to
DPU.11.7 are the minimum required to be written down before the patient leaves the recovery
room.

DPU.12. The patient is discharged home by an attending physician after the procedure.

DPU.12.1. The physician examines the patient to ensure the patient’s suitability and
stability for home discharge.
DPU.12.2. Post-procedure instructions are written in the patient medical record and
the patient/family are given a copy and educated on it.
DPU.12.3. The patient is informed about how to obtain help. An emergency contact
number is available outside normal working hours.

Explanation

It is of utmost importance to ensure the safety of the patient who is going home straight from
recovery. Day procedure unit patients shall be looked after at home by their relatives and must be
fully recovered from sedation and anesthesia, with no potential for complications. Such patients
are not allowed to drive home and should be escorted. The discharging physician should give
clear instructions on diet, the activity of daily living, medications and wound care (if required). The
patient should also receive clear and written instructions on how to seek medical help in case of
emergency.

108
References

World Health Organization (WHO) - Performance of correct procedure at correct body site.
https://www.who.int/patientsafety/solutions/patientsafety/PS-Solution4.pdf

US Food and Drug Administration. Implants and Prosthetics. 2015 Jun.

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/
default.htm

World Health Organization (WHO) - Surgical Safety Checklist.2008.

https://www.who.int/patientsafety/safesurgery/tools_resources/SSSL_Checklist_finalJun08.pdf

ISQua (www.isqua.org)

109
 Chapter XI
Dermatology & Aesthetics Medicine (DA)

Introduction

Although dermatology and aesthetics medicine are recognized scopes of medical services that
can be covered by the other chapters in this standards’ manual, yet their wide spread practices in
the ambulatory arena and their specific risky procedures warrants a separate chapter. The chapter,
therefore, focuses on specific human resources and structural requirements as well as clinical risk
management requirements.

Standards

DA.1. Dermatology and aesthetics services are managed by an experienced physician.

DA.1.1. The managing physician is appointed by the center’s director.

DA.1.2. The managing physician is a board-certified dermatologist or plastic
surgeon.
DA.1.3. The managing physician has a job description that matches his / her
supervisory role and accountability for the provision of safe and effective
services.

Explanation

A reliable and safe dermatology and aesthetics services requires well experienced and
knowledgeable leaders with a background of the specialty. The center leaders must design a
job description that explicitly defines the roles, responsibilities and accountabilities of the service
manager in the provision of safe, effective and customer focused services. The job description
highlights the supervisory role of the manager. The job description highlights the involvement of
the manager in ensuring the safety of patients and staff.

DA.2. Physicians’ privileges outline the exact procedures to be done by each physician.

DA.2.1. Privileges approved by the managing physician based on the physicians’

competency and experience.
DA.2.2. New procedures are performed by a physician only after updating his /
her privilege.
DA.2.3. The managing physician ensures that copies of privileges are available at
the procedural areas.
DA.2.4. The managing physician empowers the nurses to stop and report
physicians performing outside the scope of their privileges.
DA.2.5. The managing physician ensures that only registered trained nurses
perform aesthetics procedures “under physician’s supervision”.

Explanation

As outlined in the leadership chapter, the privileging of physicians is the most proactive risk
reduction event in clinical practice. The center exerts all efforts to delineate the privileges of the
dermatology and aesthetics physicians based on their credentials and competency. The center
ensures that the physicians are performing enough number of procedures to maintain their
skills. Neither the physician nor the center can introduce a new procedure without ensuring the
competency of the physician performing the procedure and without updating his / her privileges.

110
All privileges must be available at the site, or where procedures are performed in order for nurses
to ensure that the physician is privileged to do the procedure before preparing the patient for
it. Nursing empowerment avoids unnecessary interactions between physicians and nurses and
ensures patients’ safety. All dermatology and aesthetic procedures are to be done by the physicians
due to the delicate nature of the procedures and the its narrow safety margin, however some
procedures could be done by trained nurses under the direct supervision of the physician.

DA.3. The unit performs periodic education and competency testing for clinical staff
assisting in procedures.

DA.3.1. Education and competency assessment takes place at the initial

appointment and for every newly introduced equipment.
DA.3.2. The education includes how to manage related procedure complications.
DA.3.3. The education and competency assessment is repeated yearly, and
whenever a change takes place in a procedure.

Explanation

The center ensures that staff assisting in the procedures are competent in doing so. The competency
assessment takes place at the initial appointment of the staff and whenever a new equipment or
procedure is introduced. The assessment includes observing the patient for possible complications
and how to deal with it. The competency assessment is repeated at least yearly and whenever the
procedure is done differently. Evidence of education and competency is kept in staff’s personnel
file.

DA.4. The managing physician ensures the compliance of procedural rooms with all
required safety rules.

DA.4.1. Safety signs are posted outside the room.

DA.4.2. Laser procedural rooms do not have reflecting surfaces and do not store
flammable material.
DA.4.3. Personal eye protective goggles are worn by patient and team performing
laser procedure.
DA.4.4. Laser generated airborne contaminants are controlled by local exhaust
ventilation.
DA.4.5. The center’s director and the managing physician perform weekly
documented safety visits to all procedural rooms.

Explanation

The unit manager takes the ultimate responsibility of ensuring the safety of patients, visitors
and staff during the use of laser therapy and other invasive equipment inside the dermatology
and aesthetic unit. Procedures described in DA.4.1. to DA.4.4. must be strictly followed. The
unit manager performs weekly safety rounds on areas where laser and other invasive procedures
are performed and documents findings for both immediate correction and follow up of other
requirements.

111
 DA.5. The unit maintains a dated and timed list of the procedures performed.

DA.5.1. The list highlights the medical equipment used and the name of the
physician who performed the procedure.
DA.5.2. The list highlights the outcomes and any complications of the procedures.
DA.5.3. The list highlights the specimens sent for pathological examination.

Explanation

Collecting data on procedures helps to recognize common system mistakes for the sake of
its correction. Biopsy and other pathology specimens must be also recorded in this register to
strengthen the process of histopathology processing and facilitate the follow up of the results.

DA.6. Implemented evidence based clinical practice guidelines are developed by

the unit physicians and approved by the service manager for all procedures
performed in the unit.

DA.6.1. The guidelines highlight the indications and contraindications of the

procedures.
DA.6.2. The guidelines outline the pre-procedural assessment and investigations
required and consent requirements.
DA.6.3. The guidelines highlight the safety precautions to be followed.
DA.6.4. The guidelines outline the post-procedural recovery and follow up and
any pathology specimen processing required.

Explanation

All procedures performed in the unit must be evidence based. Practice guidelines facilitate the
performance of procedures by highlighting the indications, contra-indications, pre-procedural
requirements, how to manage pain, safety precautions during the procedure, recovery from
procedure and further follow up requirements.

112
References

DermNet New zealand trust, Lazers in dermatology, Author Vanessa Ngan, 2004
https://www.dermnetnz.org/topics/lasers-in-dermatology/

Lasers in dermatology, four decades of progress, Elizabeth L. Tanzi, Jason R. Lupton and Tina S.
Alster, J Am Acad Dermatol, July 2003
https://www.skinlaser.com/wp-content/uploads/2011/07/LASERS%20IN%20DERMATOLOGY.pdf

OSHA / Joint commission resources alliance, laser beam safety scheme, The Joint Commission
Environment of Care News, February 2015, Volume 18, Issue 2
https://www.jcrinc.com/assets/1/7/ECN0215_LaserBeam.pdf

113
GLOSSARY AND
ACRONYMS
 Glossary

Access

A person’s ability to get necessary medical care and services when needed. The ease of access is
determined by components such as the availability of medical services and their acceptability to
the individual and community, the locale of healthcare facilities, transportation, and the hours of
operation.

Accountability

The ability of a system to track an individual’s actions, or the acknowledgment and assumption of
responsibility for actions, decisions and policies.

Accreditation

A formal process by which a recognized body (accrediting body) assesses and recognizes that a
healthcare organization meets applicable, pre-determined standards.

Accident

An event or circumstance that could have resulted, or that did r‎esult, in unnecessary harm‎as a
result of an unplanned deviation in system operation.

Action Plan

A list of actions that must be undertaken to implement a strategy. An action plan states what is
to be done, who is to do it and when it is to be completed.

Activity

The description of how the task is carried out in practice‎.

Admission

A patient who has been physically placed in a bed. There are three types. Emergent‎: When
there is an immediate threat to life or the function of a limb is endangered.‎Urgent: ‎A prolonged
delay might be injurious to the patient’s health. Elective: When a patient’s health will not be
endangered by a delay in ‎admission. ‎

Adverse Drug Reaction

A response to a medicinal product that is noxious and unintended and that occurs at doses
normally used in a human for the prophylaxis, diagnosis, or therapy of disease or for the restoration,
correction, or modification of a physiological function.

Ambulatory Care

Medical care provided on an outpatient basis, including diagnosis, observation, treatment, and
rehabilitation services. Describes medical care or treatment that does not require an overnight stay

Ambulatory Patients

Patients who are being treated in ambulatory care settings rather than as hospital inpatients. They
come and go in the care setting and do not spend the night.

116
Appraisal

Determines the suitability of continuing medical staff membership or ‎privileges.

‎
Appropriateness

The extent to which a particular procedure, treatment, test or service is effective, clearly indicated,
not excessive, adequate in quantity and provided in the setting best suited to the client needs. The
degree to which the provided care services are relevant to an i‎ndividual’s clinical needs, given the
current state of knowledge. D
‎ oing the right things in accordance with the purpose.‎

Attitude

A settled way of thinking or feeling about something reflected in a person’s behavior.

Auditing

An ongoing process of reviewing an organization, its processes, its projects, its products, its
services, or the subsystem’s performance and compliance with standards or expectations.

Authority

The power and right of a person to use and allocate resources efficiently, to make decisions, ‎and
to give orders to achieve the organizational objectives.

Availability

The degree to which appropriate care is available to meet the individual patient needs.

Backup

The saving of files on magnetic tape or other offline mass storage media for the purpose of
‎preventing the loss of data in the event of equipment failure or destruction. ‎

Benchmarking

A continuous process of measuring products, services, and/or practices against the competition to
find and implement the best practices.

Best Practice

A procedure that research and experience has been shown to produce optimal results and that is
established or proposed as a standard suitable for widespread adoption.

Budget

A plan that represents an estimate of future cost against the expected revenue or allocated funds
to spend.

Capability

Power that gives a person, an organization or equipment the ability to do something difficult –
fulfill the customer requirement.

117
 Capacity

Availability of resources to complete work.

Cause

An event or action that makes something else happen.

Clinical Pathway

A multidisciplinary tool that describes routine interventions for a group of patients with similar
needs. It focuses on the patient and includes the expected outcomes at each step.

Clinical Practice Guidelines

Systematically developed statements that help practitioners and patients choose appropriate
healthcare for specific clinical conditions.

Code of Conduct

A set of principles and expected behaviors that constitute the expectations of employee performance
within a healthcare setting or as defined by the leadership group. How an organization ensures
that all its decisions and actions conform to morals.

Competency

Possession of the required skills, attitudes, and knowledge to perform the job.

Committee

A multidisciplinary body of persons officially delegated to consider, investigate, act on or report

on some matter or perform a specified function

Complaint

A verbal/written statement by a patient/family/visitor explaining a problem and/or requesting a

solution.

Compliance

Conformity in fulfilling requirements.

Confidentiality

Access to data and information only among individuals who have a need, a reason, and permission
for such access. An individual’s right to personal and informational privacy, including his/her
healthcare records.

Consistency/Uniformity

Having control over a process, to repeat itself over time regardless of other factors that may
introduce variability into the s‎ystem.

118
Continuity of Care

The degree to which patient care is coordinated among practitioners and organizations and over
time, without interruption, cessation, or unnecessary repetition of diagnosis or treatment.

Continuous Quality Improvement (CQI)

The culture, strategies, and methods necessary for continual improvement in meeting and
exceeding customer expectations. Patients and their families, staff, contractors, and visitors are all
examples of an HCF’s internal and external customers.

Continuous Quality Improvement Tools

TTools focusing on the process rather than the individual and promoting the need to analyze and
improve that process.

Corrective Maintenance

The repair of equipment/machinery to return it to original operating condition.

Credentialing

The process of obtaining, verifying, and assessing a healthcare professional’s qualifications

to determine whether that individual can provide patient care services in or for a healthcare
organization.

Criteria

Expected level(s) of achievement or specifications against which performance can be assessed..

Critical Test

A stat test with critical values/results or other results that the laboratorian, radiologist, or other
diagnostician has determined to be critical to the patient’s subsequent treatment decisions.

Culture

The invisible, intrinsic, and informal consciousness of t‎ he organization that guides the behavior of
individuals and shapes itself from their ‎behavior.

Customer Focus

Points at the importance of finding out what customers want and need, ‎and then trying to fulfill
these needs.

Data

Raw facts and figures from which information can be generated.

Database

An organized, comprehensive collection of stored data.

119
 Day Case Surgery

Surgical procedures that can be performed in a single day, without the need to admit the patient
for an overnight stay. Patients are admitted according to selection criteria, operated on and
discharged from the center on the same day as the surgery.

Day Procedure Surgery

The patient is admitted for investigation or operation on a planned non-resident basis.

Defect

A product that deviates from specifications or fails to meet the customers’ ‎expectations, or a
nonconformance or departure from expected quality. ‎

Delegate

The act of empowering to act for another.

‎Delegation of Authority

The division of authority and powers downwards to ‎the subordinate.

Discharge Instructions

Instructions given to the patient to ensure continuity of patient care at home. They usually cover
use of medication, use of equipment, wound care, limitations to diet or mobility, how and when
to seek urgent care, and follow-up equipment.

Discipline

Making a habit of properly maintaining correct procedures.

Dosimeter

A device used to measure an individual’s exposure to a hazardous environment, particularly when

the hazard is cumulative over long intervals of time or one’s lifetime.

Education

Instruction in how to think. Focuses on i‎ntegrating abstract concepts ‎into one’s knowledge of the
world.

Effect

A result. It is what happens because, or as the result, of another event or action.

Effectiveness

The degree to which care is provided in the correct manner, given the current state of knowledge,
to achieve the desired or projected outcome for the patient.

Efficacy

The power to produce an effect, for example clinical trials in medicine provide evidence of efficacy.

120
Equity

Fairness in the distribution of care and its effect on health.

Evaluation

The process of examining a subject and rating it based on its i‎mportant features.

Elective Surgery

Surgery that is scheduled in advance because it does not involve a medical emergency.

Employee

A person working for another person or a business firm for pay.

Evidence-Based Medicine

The practice of medicine or the use of healthcare interventions guided by or based on supportive
scientific evidence.

Error

Any deviation from the intended process; errors can be made by machines or people.
‎
Experience

A particular knowledge, skill, or practice initiated from direct observation of or participation in a

particular activity.

Expertise

Skill in or knowledge of a particular event.

External disaster

Any event in which there is a much larger demand for services than the usual load required.

Facility

The physical plant.

Family or Responsible Person

The person(s) with a significant role in the patient’s life. This may include a person not legally
related to the patient. This person is often referred to as a surrogate decision maker if he or she
is authorized to make care decisions for a patient when the patient loses decision-making ability.

Failure Mood Effect Analysis (FMEA)

A systematic method of identifying and preventing process problems before ‎they occur‎through
mitigation risk by determining what is likely to go wrong, the probability of it going wrong and
the severity if it does go wrong and then acting against it.

121
 Flow

The uninterrupted movement of patients, information, and materials.

Formulary

An approved list of medications and associated information related to medication use. The list is
subject to periodic review and modification.

Function

Refers to the set of activities required to produce a certain o

‎ utcome. ‎

Functional Status

The ability of individuals to take care of themselves physically and psychologically.

General Anesthesia

A medication-induced loss of consciousness during which patients are not arousable, even by
painful stimulation. The ability to independently maintain ventilator function is often impaired.
Patients often require assistance in maintaining a patent airway, and positive pressure ventilation
may be required because of depressed spontaneous ventilation or medication-induced depression
of neuromuscular function. Cardiovascular function may be impaired.

Goal

A broadly stated or long-term outcome written as an overall statement relating to a philosophy,

purpose, or desired outcome.

Governance

The function of determining the organization’s direction, setting objectives and developing policy
to guide the organization in achieving its mission.

Governing Body

In healthcare, it represents the individual(s), group, or agency with ultimate authority, responsibility,
and accountability for the overall strategic direction, methods of operation (management and
planning), establishment of policies, and maintenance of the safety and quality of care that the
facility provides.

Guidelines

Principles guiding or directing actions.

Harm

An unexpected or normally avoidable outcome that negatively affects a patient’s health ‎and/or
quality of life and that occurs or has occurred during the course of receiving healthcare or ‎services.

Hazardous Materials

Substances, such as chemicals, that are dangerous to humans and other living organisms.

122
Hazardous Waste

Waste materials that are dangerous to humans and other living organisms. Such materials require
special precautions for disposal.

Hazards

Situations with the potential to cause harm.

Healthcare-Associated Infections (HAIs)

Infections that patients acquire during the course of receiving treatment for other conditions or
that healthcare workers acquire while performing their duties within a healthcare setting. Specific
criteria must be met to define an infection as healthcare-associated.

Healthcare Organization

A generic term used to describe many types of organizations that provide healthcare services.

Healthcare Professional

Any person who has completed a course of study and is skilled in a field of health. This includes
physicians, dentists, nurses, or other healthcare professionals. Healthcare professionals are often
licensed by a government agency or certified by a professional organization.

HEPA Filter

A type of air filter. “HEPA” is an acronym for “high-efficiency particulate air” filter.

High-Alert Medications

Medications that bear a heightened risk of causing significant patient harm when they are used
in error. Although mistakes may or may not be more common with these medications, the
consequences of an error with these medications are clearly more devastating to patients.

High Risk

High probability that a severe injury will occur.

Hospital

A healthcare institution that has organized medical and other proficient staff and inpatient
facilities and delivers services 24 hours per day, seven days per week. It offers a varying range of
acute, convalescence and terminal care using diagnostic and curative services.

Immunization

The process by which an individual’s immune system becomes fortified against an ‎agent (known
as the immunogen). ‎

Incidents

Events that are unusual, are unexpected, may have an element of risk or may have a negative
effect on patients, staff or the hospital.

123
 Indicator

An observation expected to measure a certain aspect of performance. It is a quantitative measure

that can be used to assess and improve t‎ he performance of important administration, clinical and
supportive functions ‎that affect patient outcomes.

Indicator of Performance

A measurement tool used as a guide to monitor, evaluate, and improve the quality of patient care
and service.

Information

An interpreted set of data; organized data that provides a basis for decision-making.

Information Management

A term used to designate the manual or computer-based conveying of information throughout the
department/organization, or the creation, use, sharing, and disposal of data or information across
an organization. This practice is critical to the effective and efficient operation of organization
activities.

Informed Consent

A person’s voluntary agreement of one who has sufficient mental capacity with full knowledge
of the risks involved, probable consequences, and alternatives to make an informed decision. It
allows a patient to balance the probable risks against the probable benefits of any potential care.

Input

Work/information fed to the beginning of a process.

Internal Disaster

Any event that may endanger normal operation or when the HCF becomes non-functioning
within a given area. It may jeopardize the safety or well-being of patients, staff, and visitors.

Job Description

A written statement that describes the list of rules, duties, responsibilities, and required
qualifications of candidates, and the reporting relationship and coworkers of a particular job.

Key Performance Indicators (KPIs)

Measures of performance that are central to success.

Kit

A collection of components used to support the task.

Knowledge

A capacity that enables a person to fulfill certain tasks by selecting, interpreting, assessing, and
making decisions. The understanding of facts and procedures.

124
Leaders

The identified and designated individuals who have the responsibility of overseeing the effective
functioning of processes within a defined scope of services and determining a correct path.

Licensure

A legal right granted or evidenced by documentation issued by SCFHS (such as a physician, nurses,
psychiatrist, or ‎clinical social worker, or the operation of a health facility)‎in the form of a license,
registration or certification.

Look-Alike Sound-Alike (LASA) Medications

Medications with generic or proprietary names that look or sound like other medications.

Manager

Someone who works with people and systems to produce predictable results and who does the
correct things to stay on the path.

Medical Device

Any instrument, apparatus, machine, appliance, implant, reagent for in vitro use, software,
material, or other similar or related articles that the manufacturer intends to be used, alone or
in combination for human beings for one or more of the specific medical purpose(s): diagnosis,
prevention, monitoring, treatment or alleviation of disease, alleviation of or compensation for an
injury, investigation, replacement, modification, support of the anatomy or a physiological process
and the support or sustaining of life.

Note: Products that may be considered medical devices in some jurisdictions but not in others
include: disinfection substances, aids for persons with disabilities, devices incorporating animal
and/or human tissues, devices for in-vitro fertilization, or assisted reproduction technologies.

Medical Equipment

Equipment used for the specific purposes of diagnosing and treating disease or for rehabilitation
following disease or injury. It can be used either alone or in combination with any accessory,
consumable, or other piece of medical equipment (e.g., EKG machines, diagnostic ultrasounds,
surgical lights, patient beds, surgical tables, anesthesia machines and defibrillators).

Medical Record

A record that contains patient health information generated by one or more encounters. Included
in this information are patient demographics, assessment findings, problems, medications,
immunizations, diagnostic reports, provided education and any other relevant patient-specific
information.

Medication Error

Any preventable event that may cause or lead to inappropriate medication use or patient harm
while the medication is under the control of the healthcare professional, patient, or consumer.
Such events may be related to professional practice, healthcare products, procedures, and
systems including prescribing, order communication, product labeling, packaging, nomenclature,
compounding, dispensing, distribution, administration, education, monitoring and use.

125
 Medication Management

The overall effort by facilities and manufacturers to reduce medication errors that can occur
throughout the various stages of the medication use cycle: selection, procurement, prescription,
transcription, dispensing, distribution, administration and monitoring.

Mission

The reason or purpose for the existence of an organization or one of its components.

Mission Statement

A written expression that states the purpose of an organization or one of its components.

Monitoring

A planned, systemic, ongoing process to gather, organize, and review data/information on a

regular basis with the purpose of identifying changes in a situation.

Near-Miss

An event or situation that could have resulted in an adverse event that ‎caused patient harm but
that did not, either by chance or through timely intervention. ‎

Objectives

Concrete measurable steps taken to achieve goals.

Organization Structure

The style in which resources are assigned to tasks.

Organizational Chart

A diagram representing the structure of the facility and reporting relationships. It shows employee
positions, reporting relationships and lines of authority.

Orientation

The introductory process by which staff become familiar with all aspects of the work environment
and their responsibilities.

Outcome

A broad term used to describe the end result of a service, practice, procedure or intervention.

Patient

A person for whom a healthcare organization accepts responsibility for treatment, care and/or
service. An individual who is a direct recipient of care.

Patient Assessment

The gathering of information to evaluate a person’s health and healthcare needs.

126
Patient Complaint Process

The defined process describing the roles/responsibilities and time frames for handling any patient
complaint regarding the provision of his/her care.

Patient Safety

Freedom from accidental during the course of medical care; activities to avoid, prevent, or correct
adverse outcomes that may result from the delivery of healthcare.

Patient Satisfaction

A measurement that obtains reports or ratings from patients about services received from an
organization, hospital, physician, or healthcare provider.

PDCA

A scientific method utilized to improve processes. Acronym components: Plan the improvement.
Do the improvement. Check the results. Act to improve the process and hold gains. Also known
as the Shewhart cycle or learning cycle of change.

Personnel File

Collection of information about a staff member, covering personnel issues such as licensure,
certifications, leaves, appraisal reviews and job description.

Plan

To formulate or describe the approach to achieving goals related to improving the organization’s
performance.

Plan of Care (Care Plan)

A treatment plan especially designed for each patient, based on individual strengths and needs.
The caregiver(s) develop(s) the plan with input from the family and communication with each
other. The plan establishes goals and details appropriate treatment and services to meet the
patient’s special needs. The planning is an interdisciplinary process.

Policy

A written document that outlines the law, rule, regulation, or set of guidelines that drives the
processes or procedures. Policies are dynamic and reflect current knowledge and practices and
must be reviewed on a regular basis.

Predictive Maintenance Management

Performing tasks based on a historical pattern of breakdown, or techniques that help determine
the condition of in-service equipment to predict when maintenance should be performed.
Completing routine tasks at set intervals to prolong the life of the equipment. The scheduling of
planned maintenance actions aimed at preventing breakdowns and failures.

127
 Privileging

The process of reviewing an individual’s credentials through a credentials body to determine the
authority and responsibility to be granted to a practitioner for making independent decisions to
diagnose, initiate, alter, or terminate a regimen of medical or dental care. Privileging determines
the physician’s scope of practice in the organization determined by his/her competencies.

Probationary Period

The time period that the organization identifies for determining whether the employee is
competent to perform his/her duties and continue employment with the organization. Generally,
the time period for probation is three months.

Procedure

A written set of instructions that describes the approved and recommended steps for a particular
act or sequence of acts, or a specific, detailed series of actions that staff members must take to
implement a process and comply with a policy.

Process

A high-level set of interrelated steps (procedure) that must be executed, outlining what must
happen to ensure compliance with a policy.

Process Improvement

Mechanisms utilized to make improvements to a process through the use of continuous quality
improvement methods.

Project

A temporary activity aimed at achieving specific/narrow organization objectives.

Program

Organizational activities aimed at achieving broader organization objectives by coordinating a

group of projects.

Protocols

A plan, or set of steps, to be followed in a study, an investigation, or an intervention.

Quality

The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) has adopted the
following definition of quality: “Quality refers to the extent to which processes, products, and
services are free from constraints, waste, variation and defects with stability around optimum
target, on a consistent basis even under stressful condition, to achieve customer’s trust and
loyalty.” (S.AlWahabi, CBAHI,2015)

Quality Control
A management process in which performance is measured against expectations and corrective
actions are taken.

128
Quality Improvement Team

Individuals (cross-department functions/services) knowledgeable about a particular aspect of care

or service and commissioned to improve a process that has been identified as requiring attention.

Reappraisal/Reevaluation

An appraisal is to be conducted at least every 24 months. The medical staff appraisal procedures
must evaluate each individual practitioner’s qualifications and demonstrated competencies to
perform task/privileges.

Recovery Room

A place to provide immediate close observation to a post-anesthesia patient.

Referral

The process by which a patient is sent (1) from one clinician to another clinician or specialist; or
(2) from one setting or service to another, either for consultation or care that the referring source
is not prepared or qualified to provide.

Relevance

The overall pattern and balance of services; the best that could be a‎ chieved, taking into account
the needs and wants of the population as a whole‎.

Reliability

An organization’s potential to perform the promised service dependably and accurately.

Re-Privileging

The process of granting privileges to a practitioner who currently holds privileges within the facility.

Resource

Something that is needed or consumed while a function is ‎carried out. ‎

Risk

The combination of the assessment of the magnitude of an injury or potential injury, with the
probability that certain actions/events will occur.

Root Cause

The ultimate reason for an event/condition.

Root Cause ‎Analysis

A collective term used to describe a wide range of a‎ pproaches, tools and techniques used to
uncover causes of problems.

129
 Safe Care

The degree to which the risk of an intervention and the risk in the care environment are reduced
for a patient and others, including the healthcare practitioners.

Safety Data Sheet (SDS)

A form containing data regarding a particular substance’s properties. An important component

of workplace safety, it is intended to provide workers and emergency personnel with procedures
for handling or working with that substance in a safe manner and includes information such
as physical data (melting point, boiling point, flash point, etc.), toxicity, health effects, first aid,
reactivity, storage, disposal, protective equipment and spill handling procedures. The exact format
of an SDS can vary from source to source.

Scope of Practice

The range of activities that practitioners perform. The scope is determined ‎by training, law or
regulations. ‎

Scope of Services

The range of activities provided to patients and/or other customers by the leadership, clinical, and
support personnel. This describes the full range of services, the demographics (age groups, types
of patients), the diagnostics provided, the therapeutic interventions provided, and the number of
patients who receive each service annually. All the resource and competency requirements flow
from the organization’s scope of services.

Screening

A system for examining and separating into different groups.

Sedation

Minimal sedation: A medication-induced state during which patients respond normally to

verbal commands. Moderate Sedation: A medication-induced depression of consciousness
during which patients respond purposefully to verbal commands, either alone or after light tactile
stimulation. Deep Sedation: A medication-induced depression of consciousness during which
patients respond purposefully following repeated or painful stimulation.

Sentinel Event

An event that, when noted, requires intensive assessment and prompt response. An unexpected
occurrence involving death, serious physical or psychological injury, or the risk thereof, and any
event that might cause embarrassment or risk to the healthcare organization, with potential
legal ramifications and/or media inquiries or coverage. The phrase “or the risk thereof” includes
any process variation for which a recurrence would carry a significant chance of a serious
adverse outcome. Such events are called “Sentinel “because they signal the need for immediate
investigation and response.

Serious Adverse Drug Reaction

An adverse drug reaction that results in death, is life-threatening, requires inpatient hospitalization
or prolongation of existing hospitalization, or results in persistent or significant disability or
incapacity.

130
Skill

The ability to perform specific actions.

Stability

The extent to which a process has a predictable range of output or results over time.

Staff

A group of persons, as employees, charged with carrying out the work of an establishment, or
executing some undertaking, e.g., independent practitioners (temporary, visiting, part-time) and
volunteer.

Staffing Plan

The database document listing all HCF employees and positions. This also includes all other details
pertaining to the HCF’s manpower resources.

Stakeholders

Individuals and groups of people who have the ability to influence direction a‎ nd success, either
positively or negatively. ‎

Standard

A statement of excellence, or an explicit predetermined expectation that defines the key functions,
activities, processes, and structures required for healthcare facilities to assure the provision of safe
and quality care services.

Standard work

Standardized tasks performed in a standardized sequence in a standardized amount of time and

with a standardized amount of medicines, supplies and equipment to support them.

Standardization

The system of documenting and updating procedures for ensuring that everyone knows exactly
what is expected of them with a predetermined set of expectations.

Strategic Planning

A management tool to help an organization do a better job. It is a disciplined effort to produce

fundamental decisions and actions that shape what an organization is, what it does, and why it
does it, with a focus on the future direction.

Strategy

The process that involves goal setting, the specific actions to achieve those goals, and the allocation
of the resources to execute the actions.

Structure

Environmental features that shape process and outcomes: resources, money, equipment, supplies,
staff, and policies.

131
 Surveys

Methods by which an organization can measure customer satisfaction and obtain feedback on
written materials and oral presentations.

System

The infrastructure that enables the processes to achieve targets. A dynamic, purposeful collection
of interrelated, interacting, and i‎nterdependent groups of components working together to
achieve the same goals.

Task

The formal description of any piecework as it is expected to be carried out.

Team

A group of five to eight people consisting of a leader, facilitator, and members who are addressing
an issue that affects the operations of a process.

Terms of Reference

A formal, leadership-approved document that outlines the roles/responsibilities of a committee.

This document describes the committee’s expected performance and how often the committee is
expected to meet and includes a list of the membership and alternates if needed.

Timely

The degree to which care is provided to the patient at the most beneficial or necessary time.

Training

Instructions and practices designed to teach staff how to perform a job’s tasks.

Transfer:

The formal shifting of responsibility for the care of a patient from one care unit to another, one
clinical service to another, one qualified practitioner to another or one organization to another.
Temporary Transfer: This shifting will be for a short period of time, usually for the duration of
the care to be provided by the entity receiving the temporary transfer.
Permanent Transfer: The permanent shifting of responsibility to another institution or unit
constitutes a discharge situation from either the unit or organization.

Transport

The movement of an individual from one place to another using a transport aid or vehicle, either
motorized or manual (wheelchair, trolley, bed).

Trending

The evaluation of data collected over a period of time for the purpose of identifying patterns or
changes.

132
Triage

A system of establishing the order in which acts are to be carried out in an emergency. Prioritizing
patients according to their problems and symptoms. Determining the order of being managed.

Turn Around Time

The initial time from the starting point to the end point (e.g., for a stat order, the time the doctor’s
order was written or stated to the time it was carried out).

Utilization

The use, patterns of use, or rates of use of a specified healthcare service.

Values

The beliefs and philosophy of an organization that establish the basis for the operation and
provide guidelines for daily behavior.

Variance

Any event or circumstance not consistent with the standard routine operations.

Variation

The difference between an observed event and a standard or norm‎.

Vision

A description of what the organization would like to be or reach in the future.

Visitor

A transient individual who temporarily appears at the HCF for the purpose of visiting.

Waste

Anything other than the minimum amount of e‎ quipment, materials, parts, space, and worker’s
time which are absolutely essential ‎for adding value to the product/service, or‎any activity that
does not contribute to operation.

Acronyms Frequently Encountered in the CBAHI Accreditations

ARF: Appeal Request Form.

CAP: Corrective Action Plan.
CBAHI: Saudi Central Board for Accreditation of Healthcare Institutions.
HCF: Health Care Facility.
(ISQua): International Society for Quality in Healthcare.
MOH: Ministry of Health.
PDA: Preliminary Denial of Accreditation.
RCA: Root Cause Analysis.
SAT: Self-Assessment Tool.
SERF: Sentinel Event Reporting Form.

133
134
This first edition of the National Standards for Ambulatory Care Centers was developed through
a consensus process which entailed the participation of all the relevant stakeholders.
From the beginning, the aim was to have a set of standards that are detailed and descriptive,
assembled around the key services of Ambulatory Care Centers, based on the current best
healthcare practices.

NATIONAL STANDARDS FOR AMBULATORY CARE CENTERS

The goal of this manual is to be used as a reference for achieving the optimal care for patients
and their families, given the national challenges that we are facing today. All standards included
in this manual are effective from 1st January 2020.

The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) is a non-profit
organization emerging from the Saudi Health Council and is responsible for setting and
implementing the quality and patient safety standards in Saudi Arabia.
CBAHI began a few years ago with only a few hospitals enrolled in the accreditation process and
a limited number of surveyors and staff.
Today, CBAHI is proud to have a comprehensive set of evidence-based standards that are utilized
for the assessment of thousands of healthcare facilities across the country.

‫المعايـيـــر الوطنـيــة للمراكـــز والمجمـعــات الطبــــيـــة الخــارجيــة‬

‫المعاييــر الوطنـيــة‬
‫للمراكـــز والمجمعات الطبية الخارجية‬

‫ المملكة العربية السعودية‬،‫ الرياض‬،‫ حي المروج‬،12264 ‫ الرياض‬،2415 :‫ب‬.‫ص‬

NATIONAL
P.O. Box 2415, Riyadh 12264 Al-Muruj Dist., Riyadh, Saudi Arabia

920012512
STANDARDS FOR
cbahi@cbahi.gov.sa AMBULATORY FIRST EDITION 2019
CARE CENTERS EFFECTIVE FROM 1st January 2020
This first edition of the National Standards for Ambulatory Care Centers was developed through
a consensus process which entailed the participation of all the relevant stakeholders.
From the beginning, the aim was to have a set of standards that are detailed and descriptive,
assembled around the key services of Ambulatory Care Centers, based on the current best
healthcare practices.

NATIONAL STANDARDS FOR AMBULATORY CARE CENTERS

The goal of this manual is to be used as a reference for achieving the optimal care for patients
and their families, given the national challenges that we are facing today. All standards included
in this manual are effective from 1st January 2020.

The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) is a non-profit
organization emerging from the Saudi Health Council and is responsible for setting and
implementing the quality and patient safety standards in Saudi Arabia.
CBAHI began a few years ago with only a few hospitals enrolled in the accreditation process and
a limited number of surveyors and staff.
Today, CBAHI is proud to have a comprehensive set of evidence-based standards that are utilized
for the assessment of thousands of healthcare facilities across the country.

‫المعايـيـــر الوطنـيــة للمراكـــز والمجمـعــات الطبــــيـــة الخــارجيــة‬

‫المعاييــر الوطنـيــة‬
‫للمراكـــز والمجمعات الطبية الخارجية‬

‫ المملكة العربية السعودية‬،‫ الرياض‬،‫ حي المروج‬،12264 ‫ الرياض‬،2415 :‫ب‬.‫ص‬

NATIONAL
P.O. Box 2415, Riyadh 12264 Al-Muruj Dist., Riyadh, Saudi Arabia

920012512
STANDARDS FOR
cbahi@cbahi.gov.sa AMBULATORY FIRST EDITION 2019
CARE CENTERS EFFECTIVE FROM 1st January 2020