Basics of Healthcare Quality and Patient Safety in the Book

Basics of Healthcare Quality and

Patient Safety
(Bylaw 2021)
2nd Year Technical Nursing Students

Prepared by:
Nursing Administration department
Faculty of Nursing
Suez Canal University

Second Term
2023-2024

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Basics of Healthcare Quality and Patient Safety in the Book

Prepared by Members of Nursing Administration Department:

1 Prof. Wafaa Abdel Azeem Elhosany Professor of Nursing

Administration, Suez Canal
University
2 Dr: Fathya Abdelrazik Afifi Associate Professor of Nursing
Administration - Suez Canal
University

3 Dr: Nadia Mohammed El-Sayed Associate Professor of Nursing

Administration - Suez Canal
University
4 Dr: Mahitab Mohammed Ahmed Lecturer of Nursing
Administration - Suez Canal
University
5 Dr: Sally Shabban Mallek Lecturer of Nursing
Administration - Suez Canal
University
6 Dr: Alaa Mohamed Salah Lecturer of Nursing
Administration - Suez Canal
University
7 Dr: Esraa Mohammed Soltan Lecturer of Nursing
Administration - Suez Canal
University

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Basics of Healthcare Quality and Patient Safety in the Book

Contents
No. Topics Page No.
1 Historical evolution of quality. 4
2 Introduction to Quality management . 15
3 Model and concept of TQM. 23
4 Quality / environment system standards in health care 49
5 Quality tools 60
6 Six sigma 73
7 Accreditation 83
8 Patient safety concept 97
9 Medication error 107
10 Patient falls 117

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Basics of Healthcare Quality and Patient Safety in the Book

Historical Evolution of Quality

Learning Objectives:
By the end of the lecture the student will be able to:
 Define quality terminology
 Identify Benefits of quality
 Discuss steps of quality concept development

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Basics of Healthcare Quality and Patient Safety in the Book

Introduction
A quality management system in health care is similar to quality management in
other businesses. quality movement can trace its roots back to medieval Europe,
where craftsmen begin organizing into unions called guilds in the late 13th
century. A Guild was a group of skilled craftsmen in the same trade in the same
town. Membership was a sign that; you were a skilled worker; anything you made
was up to standard and was sold for a fair price. In the early 20th century
manufacturers began to include quality process in quality practices. After the
United States entered World War 2 quality become a critical component of the
war effort.
Terminology:
Quality
According to Lange:
 Process which seek to attain the highest degree of excellence in the delivery
of patient care.

According to George:
 The ability of a product or service to meet consumer needs.

According to wild:
 The quality of a product of service is the degree to which it satisfies customer
requirements.

The U.S. Department of Defense (DOD)

 Defines quality as “doing the right thing right the first time, always striving for
improvement, and always satisfying the customer.”

According to (JCAHO) (Quality of care):

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Basics of Healthcare Quality and Patient Safety in the Book

 The degree to which patient care services increase the probability of desired
patient outcomes and reduce the probability of undesired outcome given the current
state of knowledge.
 Fred Smith, CEO of Federal Express, defines quality as “performance to the
standard expected by the customer.”
 The General Services Administration (GSA) defines quality as “meeting the
customer’s needs the first time and every time.”
 Boeing defines quality as “providing our customers with products and services
that consistently meet their needs and expectations.”
 Quality pioneer W. Edwards Deming has this to say about quality: Quality is a
dynamic state associated with products, services, people, processes, and
environments that meets or exceeds expectations and helps produce superior
value.
Another definition that is widely accepted is:
 Quality is the degree to which performance meets expectations.

Quality in the Health-Care System

The IOM defines quality as “the degree to which health services for individuals and
populations increase the likelihood of desired health outcomes and are consistent
with current and professional knowledge”.
Standard:
 Standard is a written value statement of rules, conditions and actions in a patient,
staff member, or the system that are approval by an appropriate authority.
 Standard statement are professionally agreed levels of performance, appropriate
to the population addressed , which reflect what is acceptable, observable,
achievable and measurable .

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Basics of Healthcare Quality and Patient Safety in the Book

A criteria
 Is a variable, or item, that is selected as a relevant indicator of the quality of
care. Criteria make the standards work because they are detailed indicators of
the standards and must be specified to the area or type of patient .

Threshold
 A threshold for quality means setting certain norms and criteria. Any program,
department, or institution, which reaches these norms and criteria, is deemed
to be of quality.
 Quality Assurance Agency for Higher Education(QAA ) 2011 refers to:
Threshold academic standard: The minimum standard that a student should
reach in order to gain a particular qualification or award, as set out in the
subject benchmark statements and national qualifications frameworks.

Benchmarking
 A process of comparison between the performance characteristics of separate,
often competing, organizations intended to enable each participant to improve
its own performance in the market place.

Six Sigma
 Six Sigma refers to a disciplined, data-driven approach and methodology for
eliminating defects in any process-from manufacturing to transactional and
from product to service.

Accreditation
 is a voluntary process by which the performance of an organization is
measured against nationally accepted standards of performance. Accreditation
standards are based on government regulations and input from individuals and
groups in the healthcare industry.

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Basics of Healthcare Quality and Patient Safety in the Book

Quality tools
 Tools are used to identify and solve quality problems that will ultimately lead
to better customer value and operational performance.

Patient safety
 It is an activity that reduces and eliminates the possibility of errors
and patient damage. It includes a fundamental desire to protect the
patient's right to safety as well as the rules and obligations
established by law for healthcare team.

Occupational and health safety

 According to the World Health Organization, Occupational safety and health

(OSH) embraces all the parameters involved in health and safety and focuses
in the prevention of risks at work. OSH comprises laws and guidelines for
protecting employees in their work environment.

Benefits of quality:
1) for organization:
-Acknowledges the organization commitment to quality and safety.
-Markets the organization and prospective staff as employer of choice.
-Promote cost containment.
-Identifies weak areas in the structure, process, and outcome of the staff that must be
changed. (19)
2) for patients:
Improve patient outcome.
Shorter length of stay.
Higher patient satisfaction.
3) for staff:
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Basics of Healthcare Quality and Patient Safety in the Book

Higher job satisfaction.

Reduce turnover and vacancy rate.
opportunities for staff training and development.
Quality management concept development (figure, 1)
1. Inspection
2. Quality Control
3. Quality Assurance
4. Quality Management
5. Total quality management improvement
6. Quality improvement
7. Continuous Quality Improvement
Inspection

Quality Control

Quality Assurance

Quality Management

Total quality management

Quality improvement

Continuous Quality Improvement

(figure, 1) Quality management concept development based on literature review .

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Basics of Healthcare Quality and Patient Safety in the Book

1- Inspection
 Variation meant potential waste. If a product varied too far from a target, it
had to be redone or discarded.
 Conformance to specifications became the central focus of quality, and
inspection (comparing final results to targets) became the primary method of
achieving conformance.
 Inspection It is the measurement testing, evaluation, &any other activity
necessary to verify that a product, process or a service conforms to specified
requirement

2) Quality Control
Inspection of the products alone, have proven to be unsatisfactory for
the producers. Failing batches have to be destroyed, repaired or sorted
out. All expensive mechanism to retain the confidence of the customers.
The inspection techniques themselves are not cheap either.
The control of the production processes focuses on eliminating all
causes of variation. Thus by controlling the variations of all inputs and
the production processes through standardization
It Is the process which involves determining the extent to which a service
matches some specified quality standards.
3) Quality Assurance
It is all systematic and planned actions which are necessary to provide
adequate confidence that a product or service will satisfy the given requirement for
quality.
The American nurses association defines QA as:
The sum of all the activities ensures that patients receive the best possible
nursing care.

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 Basics of Healthcare Quality and Patient Safety in the Book

A systematic testing and evaluation of nursing practice, it focuses on solving

problems and measuring achievement of standards
Quality Assurance involves setting standards, determining Criteria to meet those
standards, data collection, Evaluating how well the criteria have been met, making
Plans for change based on the evaluation, and following Up on implementation for
change
4) Quality management
 Preventive approach designed to treat problem before they become crisis.
 Quality management moved health care from a mode of identifying failed
standards, problem people to proactive organization in which problems are
prevented and ways to improve care and quality of care are sought.
 A comprehensive management approach that focuses on systematic, ongoing
and continuous awareness, monitoring and improvement of quality in clinical,
professional and administrative practice. a management philosophy the
emphasizes a commitment to excellence throughout the organization.
 Over the past several decades, the American healthcare system has moved from a
quality assurance (QA) model to one focused on quality improvement (QI). The
difference between the two concepts is that QA models target currently existing
quality; QI models target ongoing and continually improving quality. Two models
that emphasize the ongoing nature of QI include total quality management (TQM)
5) Total Quality Management
TQM, also referred to as continuous quality improvement (CQI), is a
philosophy developed by Dr. W. Edward Deming. TQM is one of the hallmarks of
Japanese management systems. It assumes that production and service focus on the
individual and that quality can always be better. Thus, identifying and doing the right
things, the right way, the first time and problem-prevention planning—not inspection
and reactive problem solving—lead to quality outcome.
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Basics of Healthcare Quality and Patient Safety in the Book

6) Quality improvement
An ongoing process of innovation, prevention of error and staff development that is
used by corporation and institutions that adopt the quality management philosophy.
QI activities have been part of nursing care since Florence Nightingale evaluated
the care of soldiers during the Crimean War (Nightingale & Barnum,1992) to
achieve quality health care, QI activities use evidence-based methods for gathering
data and achieving desired results.
QI is called by many names: quality assurance, FADE, PDSA, total quality
management (TQM), Six Sigma, and CQI. Regardless of the term used, QI is a
structured organizational process for involving personnel in planning and executing a
continuous flow of improvements to provide quality health care that meets or
exceeds expectations.

7) Continuous quality improvement (CQI)

Is a Process of identifying areas of concern (indicators), continuously collecting
data on these indicators, analyzing and evaluating the data, and implementing needed
changes. When one indicator is no longer a concern, another indicator is selected.
Common indicators include, for example, number of falls, medication errors, and
infection rates. Indicators can be identified by the accrediting agency or by the
facility itself. The purpose of CQI is to improve the capability continuously of
everyone involved in providing care, including the organization itself. CQI aims to
avoid a blaming environment and attempts to provide a means to improve the entire
system.
CQI relies on collecting information and analyzing it. The time frame used in a
CQI program can be retrospective (evaluating past performance, often called quality
assurance), concurrent (evaluating current performance), or prospective (future-
oriented, collecting data as they come in). The procedures used to collect data
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Basics of Healthcare Quality and Patient Safety in the Book

depend on the purpose of the program. Data may be obtained by observation,

performance appraisals, patient satisfaction surveys, statistical analyses of length-of-
stay and costs, surveys, peer reviews, and chart audits (Huber, 2000).

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Basics of Healthcare Quality and Patient Safety in the Book

REFRENCES :
 Deming’s Seven Deadly Diseases From David, L. &Davis, S. (2016):
Quality Management for Organizational Excellence: Introduction to Total
Quality. Eight Edition.
 Levin, G. (2014). Project Quality Management: Why, What and How. second
Edition
 Joint Commission International Accreditation Standards for Hospitals
(2014). Joint Commission on Accreditation of Healthcare Organization.
 Quality Assurance Agency for Higher Education (QAA), 2011,
Glossary,available at
http://www.qaa.ac.uk/AboutUs/glossary/Pages/default.aspx, accessed 9
September 2012, page not available 11 January 2017.

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Basics of Healthcare Quality and Patient Safety in the Book

Introduction to Quality management

Learning Objectives:
By the end of the lecture the student will be able to:
1. Define quality
1. Define quality in the health care system
2. Identify six dimensions for improving quality in healthcare
3. Describe approaches for assessing quality of care
4. Explain dimensions of quality
5. Define quality chains
6. Compare between the two views of total quality
7. Identify quality management framework

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 Basics of Healthcare Quality and Patient Safety in the Book

Introduction

Quality, Competitiveness and Customers

Whatever type of organization you work in these days – a bank, a hospital, a
university, an airline, an insurance company, local government, a factory –competition is
rife: competition for customers, for students, for patients, for resources, for funds.
Any organization basically competes on its reputation – for quality, reliability, price and
deliver – and most people now recognize that quality is the key to achieving sustained
competitive advantage.
Quality starts with understanding customer needs and ends when those needs are
satisfied.
Is this a quality watch?:
• ‘No, it’s made in Japan.’
• ‘No, it’s cheap.’
• ‘No, the face is scratched.’
• ‘How reliable is it?’
Clearly, the quality of a watch depends on what the wearer requires from a watch –
perhaps a piece of jewelry to give an impression of wealth; a timepiece that gives the
required data, including the date, in digital form; or one with the ability to perform at 50
meters under the sea? These requirements determine the quality.

Zero Defects
Implies that there is no tolerance for errors within the system. The goal of all
processes is to avoid defects in the product or service. Similar to six sigma: almost
zero defects
Quality in the Health-Care System

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Basics of Healthcare Quality and Patient Safety in the Book

The IOM defines quality as “the degree to which health services for individuals
and populations increase the likelihood of desired health outcomes and are consistent
with current and professional knowledge”.
Six dimensions for Improving Quality in Healthcare
Health care should be:
1. Safe: Avoiding injuries to patients from the care that is intended to help them
2. Effective: Providing services based on scientific knowledge to all who could
benefit and refraining from providing services to those not likely to benefit (avoiding
underuse and overuse)
3. Patient-centered: Providing care that is respectful of and responsive to individual
patient preferences, needs, and values and ensuring that patient values guide all
clinical decisions
4. Timely: Reducing waits and sometimes harmful delays for those who receive and
those who give care
5. Efficient: Avoiding waste, in particular that of equipment, supplies, ideas, and
energy
6. Equitable: Providing care that does not vary in quality because of characteristics
such as gender, ethnicity, geographic location, and socioeconomic status.

Three approaches to assessing quality of care

Structure:
 The factors that constitute the conditions under which care is provided.
They include:-
 Material resources, Such as Facilities and equipment.
 Human resources, such as the number, variety and qualifications of
professional personnel.

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Basics of Healthcare Quality and Patient Safety in the Book

 Organizational characteristics , such as the organization the medical and

nursing staff ,presence of teaching and research Functions, kind of
supervision and performance review ,the methods of paying for care
Process:
 The activities that constitute health care, including diagnosis, treatment,
rehabilitation and patient education. Usually as carried out by professional
personnel, but also including other contributions to care, particularly those of
the patients and Family.
Outcomes:
 Changes in health status.
 Changes in knowledge acquired by patients or family that may influence
health.
 Changes in the behavior of patients or family that may influence future health.
 Changes (desirable or undesirable) in individuals or populations
 Satisfaction with the care and its outcomes by patients and family members.
Dimensions of Quality: product
1. Performance: Basic operating characteristics
2. Features: Extra items added to basic features
3. Reliability: Probability product will operate over time
4. Conformance: Meeting pre-established standards
5. Durability: Life span before replacement
6. Aesthetics: Look, feel, sound, smell or taste
7. Safety: Freedom from injury or harm
Dimensions of Quality: Service
1. Time & Timeliness: Customer waiting time, completed on time
2. Completeness: Customer gets all they asked for
3. Courtesy: Treatment by employees
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Basics of Healthcare Quality and Patient Safety in the Book

4. Consistency: Same level of service for all customers

5. Accessibility & Convenience: Ease of obtaining service
6. Accuracy: Performed right every time
7. Responsiveness: Reactions to unusual situations
Understanding and Building the Quality Chains
At every supplier-customer interface then there resides a transformation process
right Suppliers + correct Inputs = correct Outputs + satisfied Customers (SIPOC).

Quality management (1980-now)

 Preventive approach designed to treat problem before they become crisis.
 Quality management moved health care from a mode of identifying failed
standards, problem to proactive organization in which problems are prevented and
ways to improve care and quality of care are sought.
 A comprehensive management approach that focuses on systematic, ongoing and
continuous awareness, monitoring and improvement of quality in clinical,
professional and administrative practice. a management philosophy the
emphasizes a commitment to excellence throughout the organization
Two views of quality

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Basics of Healthcare Quality and Patient Safety in the Book

 The traditional view of quality measured process performance in defective parts

per hundred produced. With total quality, the same measurement is thought of in
terms of defective parts per million produced.
 The traditional view focused on after-the-fact inspections of products. With total
quality, the emphasis is on continual improvement of products, processes, and
people in order to prevent problems before they occur.
 The traditional view of quality saw employees as passive workers who followed
orders given by supervisors and managers. It was their labor, not their brains, that
was wanted. With total quality, employees are empowered to think and make
recommendations for continual improvement. They are also shown the control
boundaries within which they must work and are given freedom to make decisions
within those boundaries.
 The traditional view of quality expected one improvement per employee per year.
Total quality organizations expect to make at least ten or more improvements per
employee per year.
 Organizations that think traditionally focus on short-term profits. The total quality
approach focuses on long-term profits and continual improvement.
Quality management principles:
1-Customer Focus: Hospital depends on their customers and therefore should
understand current and future customer needs, should meet customer requirements
and strive to exceed customer expectations

2-Leadership: Leaders establish unity of purpose and direction of the hospital they
should create and maintain the internal environment in which people can become
fully involved in achieving the hospital's objectives.

3-Involvement People: at all levels their full involvement enable their abilities to be
used for the hospital's benefit.

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 Basics of Healthcare Quality and Patient Safety in the Book

4-Process Approach: a desired result is achieved more efficiently when activities are
managed as a process.

5-System Approach to Management: Identifying, understanding and managing

interrelated process as a system contributes to the hospital's effectiveness and
efficiency in achieving its objective

6-Continual Improvement: the hospital's overall performance should be permanent

objective of the hospital.

7-Factual Approach to Decision Making: effective decision is based on the analysis

of data and information.

8-Mutually Beneficial Supplier Relationships: a hospital and its suppliers are

interdependent and mutually beneficial relationship enhances the ability of both to
create value.
 Over the past several decades, the American healthcare system has moved from a
quality assurance (QA) model to one focused on quality improvement (QI). The
difference between the two concepts is that QA models target currently existing
quality; QI models target ongoing and continually improving quality. Two models
that emphasize the ongoing nature of QI include total quality management (TQM).

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Basics of Healthcare Quality and Patient Safety in the Book

References:

 Gremyr, I., Bergquist, B., & Elg, M. (2020). Quality management: an

introduction.
 Goetsch, D. L., & Davis, S. B.(2016): Quality Management for organizational
excellence introduction to total Quality. Eighth Edition by Pearson Education,
n, Inc., Permissions Department, 221 River Street, Hoboken, New Jersey
07030 ISBN 10: 0-13-379185-8 ISBN 13: 978-0-13-379185-3

 David, L. &Davis, S. (2014): Quality Management for Organizational

Excellence: Introduction to Total Quality. Seventh Edition© Pearson
Education Limited 2014. Pp 1-19

 Diane K.Whitehead, Sally A.Weiss, Ruth M.Tappen:. (2010): Essentials of

nursing leadership and management /. -- 5th ed. Copyright © 2010 by F. A.
Davis Company. Pp.131-144.

 Mukhopadhyay, M. (2020). Total quality management in education. SAGE

Publications Pvt. Limited.

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Basics of Healthcare Quality and Patient Safety in the Book

Model and concept of Total quality management

Learning Objectives:
By the end of the lecture the student will be able to:
 Identify different concepts of total quality management.
 Explain benefits of total quality management.
 Explain categories of total quality management.
 Discuss principles of total quality management.
 Discuss key elements of total quality management.
 Discuss different total quality management models.

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Basics of Healthcare Quality and Patient Safety in the Book

Introduction

Total Quality Management is a combined effort of both top-level management as

well as employees of an organization to formulate effective strategies and policies to
deliver high quality products which not only meet but also exceed customer
satisfaction. Total Quality management enables employees to focus on quality than
quantity and strive hard to excel in whatever they do. According to total quality
management, customer feedbacks and expectations are most essential when it comes
to formulating and implementing new strategies to deliver superior products than
competitors and eventually yield higher revenues and profits for the organization.

Concepts of total quality management:

The concept of Total Quality Management (TQM) has been proposed by Dr.
Edwards Deming in 1940 but its use started in 1985 with the takeover by American
principles of working in Japanese:

 Focus on process improvement permanent, so that processes are visible,

repeatable and measurable
 Focus on analyzing and eliminating undesirable effects of production
processes
 Consideration of how the users use products in order to improve product
 Expanding beyond concerns of product management.

Total quality management is a set of management practices throughout the

organization geared to ensure the organization consistently meets or exceed customer
requirements. It is the integration of all functions and processes within an
organization in order to achieve continuous improvement of the quality of goods and
services. The goal is customer satisfaction.

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Basics of Healthcare Quality and Patient Safety in the Book

Quality—is to continuously satisfy customers’ expectations.

Total quality—is to achieve quality at low cost.
Total Quality Management—is to achieve total quality through everybody’s
participation.

Total Quality Pioneers

Total quality is not just one individual concept. It is a number of related concepts
pulled together to create a comprehensive approach to doing business. Many people
contributed in meaningful ways to the development of the various concepts that are
known collectively as total quality. The three major contributors are W. Edwards
Deming, Joseph M.Juran, and Philip B. Crosby. To these three, many would add
Armand V. Feigenbaum and a number of Japanese experts, such as Shigeo Shingo.

Deming’s and other scientific Contributions

Of the various quality pioneers in the United States, the best known is W. Edwards
Deming. According to Deming biographer Andrea Gabor:

 Deming also has become by far the most influential proponent of quality
management in the United States.

 Working as a janitor and at other odd jobs, Deming worked his way through
the University of Wyoming, where he earned a bachelor’s degree in
engineering. He went on to receive a master’s degree in mathematics and
physics from the University of Colorado and a doctorate in physics from Yale.
His only full-time employment for a corporation was with Western Electric.
Many feel that what he witnessed during his employment there had a major
impact on the direction the rest of his life would take.

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Basics of Healthcare Quality and Patient Safety in the Book

 Deming was disturbed by the amount of waste he saw at Western Electric’s

Hawthorne plant. It was there that he pioneered the use of statistics in quality.

 Although Deming was asked in 1940 to help the U.S. Bureau of the Census
adopt statistical sampling techniques, his reception in the United States during
these early years was not positive. With little real competition in the
international marketplace, major U.S. corporations felt little need for his help.
Corporations from other countries were equally uninterested. However, World
War II changed all this and put Deming on the road to becoming, in Andrea
Gabor’s words, “the man who discovered quality.”

 By the late 1940s Japanese leaders invited Deming to visit Japan and share his
views on quality. Unlike their counterparts in the United States, the Japanese
industrialists accepted Deming’s views, learned his techniques, and adopted
his philosophy. So powerful was Deming’s impact on industry in Japan that
the most coveted award a company there can win is the Deming Prize. In fact,
the standards that must be met to win this prize are so difficult and so
strenuously applied that it is now being questioned by some Japanese
companies.

 By the 1980s, Deming’s services began to be requested in his own country. By

this time, Deming was over 80 years old. He had not been received as openly
and warmly in the United States as he was in Japan. Deming’s attitude toward
corporate executives in the United States can be described as cantankerous at
best.

 The things for which he is most widely known are the Deming Cycle, his
Fourteen Points, and his Seven Deadly Diseases.

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Basics of Healthcare Quality and Patient Safety in the Book

The Deming Cycle was developed to link the production of a product with
consumer needs and focus the resources of all departments (research, design,
production, and marketing) in a cooperative effort to meet those needs. The Deming
Cycle proceeds as follows:

1. Conduct consumer research and use it in planning the product (plan).

2. Produce the product (do).

3. Check the product to make sure it was produced in accordance with the plan
(check).

4. Market the product (act).

5. Analyze how the product is received in the market place in terms of quality, cost,
and other criteria (analyze).

Deming’s Fourteen Points see figure (2), Deming modified the specific wording
of various points over the years, which accounts for the minor differences among the
Fourteen Points as described in various publications. Deming stated repeatedly in his
later years that if he had it all to do over again, he would leave off the numbers.

Deming’s Seven Deadly Diseases see figure (3), the Fourteen Points summarize
Deming’s views on what a company must do to effect a positive transition from
business as usual to world-class quality. The Seven Deadly Diseases summarize the
factors that he believed can inhibit such a transformation.

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Basics of Healthcare Quality and Patient Safety in the Book

figure (2) Deming’s Fourteen Points From Deming, W.E., Out of the Crisis, The
MIT Press, Cambridge, MA, 2000, pp. 24–86.

figure (3) Deming’s Deming’s Seven Deadly Diseases From David, L. &Davis, S.
(2016): Quality Management for Organizational Excellence: Introduction to Total
Quality. Eight Edition

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Basics of Healthcare Quality and Patient Safety in the Book

According to John Gilbert, TQM is a process designed to focus on customer

expectations, preventing problems, building commitment to quality in the workforce
and promoting open decision making.

According to International Organization for Standardization ISO, TQM is

defined as a management approach of an organization centered on quality, based on
the participation of all its members and aiming at long term success through
customer satisfaction and benefits to all members of the organization and society.

According to Crosby, a number of important principles and practices necessary

for successful quality improvement program, which include, for example,
management participation, management responsibility for quality, employee
recognition, education, reduction of the cost of quality (prevention costs, appraisal
costs, and failure costs), emphasis on prevention rather than after-the-event
inspection, doing things right the first time, and zero defects. Crosby claimed that
mistakes are caused by two reasons: Lack of knowledge and lack of attention.
Education and training can eliminate the first cause and a personal commitment to
excellence (zero defects) and attention to detail will cure the second. His philosophy
about quality can be best described in his four absolutes of quality management.
They are: the definition of quality is conformance to requirements, the system of
quality is prevention, the performance standard is zero defects, the measurement of
quality is the price of nonconformance.

According to price and chell, TQM is a management system, not a series of

programs, it is a system that puts customer satisfaction before profit. It is a system
that comprises a set of integrated philosophies , tools and processes used to
accomplish business objectives by creating delighted customers and employees.

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Basics of Healthcare Quality and Patient Safety in the Book

TQM is not a one-time process; instead, it is a continuous long-term process that

involves constant managerial efforts to be recognized and reinforced through
continuous data collection, evaluation, feedback and improvement programs.

For TQM to be effective, an organization has to be a learning managerial and non-

managerial entity that has to endeavor for continuous training and education,
measurement, accountability, recognition and rewards, communication, teamwork
and application of various tools and techniques.
Benefits of Total quality management
TQM can have an important and beneficial effect on employee and organizational
development. By having all employees focus on quality management and continuous
improvement, companies can establish and uphold cultural values that create long-
term success to both customers and the organization itself.

Cost reduction: Total Quality Management can reduce costs throughout an

organization when implemented consistently over time, especially in the areas of
scrap, rework, field service, and warranty cost reduction. Since these cost reductions
flow straight through to the bottom-line profits with no added costs being incurred,
there can be a startling rise in profitability.

Customer satisfaction: High-quality products that meet customers’ needs results in

higher customer satisfaction. High customer satisfaction, in turn, can lead to
increased marketing.

Productivity improvement: Productivity rises significantly, since employees are

giving much less of their time chasing down and correcting errors. Increased
productivity produces more output per employee, which often results in increased
profits.

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Basics of Healthcare Quality and Patient Safety in the Book

Well-defined cultural values.: Organizations that practice TQM develop and

nurture core values around quality management and continuous improvement. The
TQM mindset pervades across all aspects of an organization, from hiring to internal
processes to product development.

Defect reduction: Total Quality Management has a strong significance in improving

quality within a process, rather than checking out quality into a process. This not
only reduces the time required to fix errors, but makes it less significant to employ a
team of quality assurance personnel.

Principles of Total Quality Management:

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Basics of Healthcare Quality and Patient Safety in the Book

1- customer focus:

The first and prime principle of total quality management (TQM) is to focus on the
customers who are buying the products and services as well as potential customers.
Customers are the people who justify the quality of the products and services. So, the
company needs to ensure that the customers will feel that they have spent their
money on a quality product if it can last long to fulfill demands.

2- Leadership:

Leaders establish unity of purpose and direction. They should create and maintain
the internal environment in which people can become fully involved in achieving the
organization's objectives. Applying leadership principle will provide the following
advantages:
- Employees understand the needs and objectives of the organization and become
more enthusiastic to perform the work, which is reflected on the quality of product
and service.
-The events are verified and motivate the employees in the Society and its main
objectives.
-Reducing the misunderstanding and strengthen communication links between the
employees
-Considering the needs of all parties, including customers and business owners,
employees and suppliers.
-Develop a clear vision for the future of the organization.

3- Involvement of People

People from every level give their all-out efforts and dedication to the organization’s
profits. The total employee commitment leads to develop products and raise sales

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Basics of Healthcare Quality and Patient Safety in the Book

growth. So, all the employees in the organization have to be well-trained, committed,
and dedicated to achieving an interdependent goal on time.

4- process approach:

The company needs to improve the process consistently to yield sound output. A
good result from the processes approach can bring customer satisfaction

The main advantages of Process approach:

-Lowering the costs and save times through effective use of resources.
-Improve processes within the organization and the results are consistent and
predictable.
-Focus and priority to provide opportunities for continuous improvement.
-Systematic identification of the activities necessary to obtain the desired result.
-Establish responsibility and accountability to manage key activities.

5-System approach to management

Identifying and understanding and managing a system of interrelated processes as a

system contributes to the organization effectiveness and efficiency in achieving its
objectives.
Applying this principle will produce the following advantages:
-Integration and harmonization of processes that will achieve the best results.
-The ability to focus the efforts on the key processes.
-Provide confidence to interested parties in the effectiveness and coherence and
efficiency of the Society.
-Restructuring of the system to achieve the objectives of the Society in the most
effective and efficient.

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Basics of Healthcare Quality and Patient Safety in the Book

6- Continual improvement
Continual improvement of the process is an essential step for every organization to
make their customer satisfied. Therefore, TQM assists in keeping watching the
constant improvement of the system to improve the services and products. It is the
most critical principle among the eight principles of TQM.
7-Factual Approach to Decision-Making
A factual approach to decision-making is another crucial principle of TQM. It
eases making decisions based on the information collected from data. Making a
decision based on facts is an effective way to achieve customer satisfaction.

8. Mutual Beneficial Supplier Relationship

Mutual beneficial supplier relationship is another important principle of total

quality management for building rapport with suppliers. It is also called reciprocity.
Usually, a business is conducted by multiple combined departments, and each of the
departments is assigned individual tasks, although the function of these departments
is interconnected. The total quality management process helps all sections work
combined to achieve an interdependent objective.

Key elements for implement of TQM

To successfully implemented TQM organization should focus on 6 key elements:
Confidence, Training, Teamwork, Leadership, Recognition and Communication

1-Confidence: It is a result of integrity and ethics of the organization without trust

cannot be built within the work of TQM. The trust helps the full participation of all
employees. Allows every employee empowerment which leads to involvement and
engagement.

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Basics of Healthcare Quality and Patient Safety in the Book

2-Training: Training is very important for employees to be very productive.

Supervisors are responsible for implementing TQM in their departments and to
spread the philosophy of TQM among employees operate. Training programs are
important in creating and maintaining an environment for quality improvement to
understand the importance of customer satisfaction and the corporate laboratory
objectives and to be able to contribute effectively to the continuous improvement
program.

3-Teamwork :To be successful in business teamwork is an essential element of

TQM, with the team can find solutions faster and better to the problems that occur in
the organization. Teams can provide improvement of processes and activities. The
teams people feel more comfortable to highlight problems that may occur and may
receive help from colleagues to find and implement solutions.

There are mainly three types of teams that TQM organizations have:
A. Quality improvement teams. Temporary teams created in order to analyze the
problems that appear or reappear, often are established for periods of 3-12 months.
B. Teams to solve problems. Intended to solve certain problems and to identify the
true root causes. Usually they have a duration of life between one week and three
months.
C. Work Teams. These are small working groups comprised of skilled workers who
share the same tasks and responsibilities. These teams use concepts such as:
employee involvement, self-leadership, quality circles. These teams meet one or two
hours per week.

4-Leadership :Leadership Probably the most important element of TQM. Appears

everywhere in organization. Leadership in TQM means that the manager must have

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Basics of Healthcare Quality and Patient Safety in the Book

the vision to inspire, to trace the strategic directions that would be understood and
implemented by all employees that will lead subordinates. For TQM to be successful
in business supervisor must be dedicated leadership subordinates. A leader must
understand the TQM, believe in his principles and to demonstrate this fact by faith
every day.

5-Communication :Communication is one that unites all these concepts. This acts as
a vital link between all elements of TQM. Communication is there a common
understanding of the ideas so that it emits and the one who receives them. TQM
success is conditioned by the communication between all members of the
organization, suppliers and customers. Superiors should create and maintain channels
of communication through which to receive and transmit information about TQM
processes
.
6-Recognition : This is the last element of the system, it should be given both for
and suggestions for performance, both for teams and individuals. Employees shall
endeavor to obtain recognition for themselves and for their teams. Detection and
recognition of individual contribution is the most important duty that each supervisor
has. Then when people recognized the merits of producing major changes in terms of
self-respect, productivity, quality and quantity of effort for each task. Recognition is
the greatest impact when it is close can be a reward or just a message from top
management.

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Basics of Healthcare Quality and Patient Safety in the Book

Total Quality Management Models:

There are many models of total quality management, and it is not necessary that
every organization should select and implement the same model. Following are the
various models of total quality management:

 Deming Application Prize

 Malcolm Baldrige Criteria for Performance Excellence
 European Foundation for Quality Management, and
 ISO quality management standards

Deming Application Prize:

The Deming Prize was established by the Board of Directors of the Japanese Union
of Scientists and Engineers in 1951. Its main purpose is to spread the quality by
recognizing performance improvements flowing from the successful implementation
quality control based on statistical quality control techniques.
There are ten primary elements in the Deming Application Prize (1996). This
checklist emphasizes the importance of top management’s active participation in
quality management activities and understanding of the main requirements of quality
improvement programs. It is also providing senior executives with a list of what they
need to do. The primary elements in the Deming Application Prize are listed below:

(1) Policies

 Quality and quality control policies and their place in overall business
management.
 Clarity of policies (targets and priority measures).
 Methods and processes for establishing policies.

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Basics of Healthcare Quality and Patient Safety in the Book

 Relationship of policies to long- and short-term plans.

 Communication (deployment) of policies, and grasp and management.
of achieving policies.
 Executives’ and managers’ leadership.
(2) Organization

 Appropriateness of the organizational structure for quality control and

status of employee involvement.
 Clarity of authority and responsibility.
 Status of interdepartmental coordination.
 Status of committee and project team activities.
 Status of staff activities.
 Relationships with associated companies (group companies, vendors,
contractors, sales companies, etc.).
(3) Information

 Appropriateness of collecting and communicating external information.

 Appropriateness of collecting and communicating internal information.
 Status of applying statistical techniques to data analysis.
 Appropriateness of information retention.
 Status of utilizing information.
 Status of utilizing computers for data processing.
(4) Standardization

 Appropriateness of the system of standards.

 Procedures for establishing, revising, and abolishing standards.
 Actual performance in establishing, revising, and abolishing standards.
 Contents of standards.
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Basics of Healthcare Quality and Patient Safety in the Book

 Status of utilizing and adhering to standards.

 Status of systematically developing, accumulating, handing down and
utilizing technologies.
(5) Human resources

 Education and training plans and their development and results

utilization.
 Status of quality consciousness, consciousness of managing jobs, and
understanding of quality control.
 Status of supporting and motivating self-development and self-
realization.
 Status of understanding and utilizing statistical concepts and methods.
 Status of QC circle development and improvement suggestions.
 Status of supporting the development of human resources in associated
companies.
(6) Quality assurance

 Status of managing the quality assurance activities system.

 Status of quality control diagnosis.
 Status of new product and technology development (including quality
analysis, quality deployment and design review activities).
 Status of process control.
 Status of process analysis and process improvement (including process
capability studies).
 Status of inspection, quality evaluation and quality audit.
 Status of managing production equipment, measuring instruments and
vendors.

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Basics of Healthcare Quality and Patient Safety in the Book

 Status of packaging, storage, transportation, sales and service activities.

 Grasping and responding to product usage, disposal, recovery and
recycling.
 Status of quality assurance.
 Grasping of the status of customer satisfaction.
 Status of assuring reliability, safety, product liability and environmental
protection.
(7) Maintenance

 Rotation of management (PDCA) cycle control activities.

 Methods for determining control items and their levels.
 In-control situations (status of utilizing control charts and other tools).
 Status of taking temporary and permanent measures.
 Status of operating management systems for cost, quantity, delivery,
etc.;
 Relationship of quality assurance system to other operating
management systems.
(8) Improvement

 Methods of selecting themes (important activities, problems and priority

issues).
 Linkage of analytical methods and intrinsic technology.
 Status of utilizing statistical methods for analysis.
 Utilization of analysis results.
 Status of confirming improvement results and transferring them to
maintenance/control activities.
 Contribution of QC circle activities.

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Basics of Healthcare Quality and Patient Safety in the Book

(9) Effects

 Tangible effects (such as quality, delivery, cost, profit, safety and

environment).
 Intangible effects.
 Methods for measuring and grasping effects.
 Customer satisfaction and employee satisfaction.
 Influence on associated companies.
 Influence on local and international communities.
(l0) Future plans

 Status of grasping current situations.

 Future plans for improving problems.
 Projection of changes in social environment and customer requirements
and future plans based on these projected changes.
 Relationships among management philosophy, vision and long-term
plans.
 Continuity of quality control activities.
 Concreteness of future plans.

The European foundation Model for TQM:

The European Quality model was officially launched in 1991. The primary purpose
of it is to support, encourage, and recognize the development of effective TQM by
European firms. The model of the European Quality model is divided into two parts,
Enablers and Results. The enablers are leadership, people management, policy &
strategy, resources, and processes. These five aspects steer the business and facilitate
the transformation of inputs to outputs. The results are people satisfaction, customer

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Basics of Healthcare Quality and Patient Safety in the Book

satisfaction, impact on society, and business results (the measure of the level of
output attained by the firm). The European Quality model (1994) consists of nine
primary elements, which are further divided into a number of secondary elements.
The primary and secondary elements are listed below:
(1) Leadership

 Visible involvement in leading total quality.

 A consistent total quality culture.
 Timely recognition and appreciation of the effects and successes of
individuals and teams.
 Support of total quality by provision of appropriate resources and
assistance.
 Involvement with customers and suppliers.
 Active promotion of total quality outside the organization.
(2) Policy and strategy

 How policy and strategy are based on the concept of total quality.
 How policy and strategy are formed based on information that is
relevant to total quality.
 How policy and strategy are the basis of business plans.
 How policy and strategy are communicated.
 How policy and strategy are regularly reviewed and improved.
(3) People management

 How continuous improvement in people management is accomplished.

 How the skills and capabilities of the people are preserved and
developed through recruitment, training, and career progression.

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Basics of Healthcare Quality and Patient Safety in the Book

 How people and teams agree on targets and continuously review

performance.
 How the involvement of everyone in continuous improvement is
promoted and people are empowered to take appropriate action.
 How effective top-down and bottom-up communication is achieved.
(4) Resources

 Financial resources.
 Information resources.
 Material resources and fixed assets.
 The application of technology.
(5) Processes

 How processes critical to the success of the business are identified.

 How the organization systematically manages its processes.
 How process performance measurements, along with all relevant
feedback, are used to review processes and to set targets for
improvement.
 How the organization stimulates innovation and creativity in process
improvement.
 How the organization implements process changes and evaluates the
benefits.
(6) Customer satisfaction.
(7) People satisfaction.
(8) Impact on society.
(9) Business results.

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Basics of Healthcare Quality and Patient Safety in the Book

The Malcolm Baldrige National Quality model:

In 1987, the US Congress passed the Malcolm Baldrige National Quality

Improvement Act, and thus established an annual quality award in the US. The aim
of the model is to encourage American firms to improve quality, satisfy customers,
and improve overall firms’ performance and capabilities. The model framework can
be used to assess firms’ current quality management practices, benchmark
performance against key competitors and world- class standards and improve
relations with suppliers and customers. The Malcolm Baldrige National Quality
model framework (1999) is listed as follows:

(1) Leadership

 Organizational leadership.
 Public responsibility and citizenship.
(2) Strategic planning

 Strategy development.
 Strategy deployment.
(3) Customer and market focus

 Customer and market knowledge.

 Customer satisfaction and relationships.
(4) Information and analysis

 Measurement of organizational performance.

 Analysis of organizational performance.
(5) Human resource focus

 Work systems.
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Basics of Healthcare Quality and Patient Safety in the Book

 Employee education, training, and development.

 Employee well-being and satisfaction.
(6) Process management

 Product and service processes.

 Support processes.
 Supplier and partnering processes.
 Business results.
 Customer focused results.
 Financial and market results.
 Human resource results.
 Supplier and partner results.
 Organizational effectiveness results.

ISO quality management standards:

WHAT IS ISO 9001?

- It is a quality management model that can be adopted by any kind of

organization.
- The system is focused on the meeting of customer requirements
and enhancing of customer satisfaction.
WHAT IS ISO 9001:2008 QMS -
REQUIREMENTS?

- Quality: degree to which customer requirements have been met.

- Management: coordinated activities to direct and control an organization.
- System: set of interrelated or interacting elements.

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Basics of Healthcare Quality and Patient Safety in the Book

- Quality management system: a system to direct and control an organization

regarding quality.
- Requirements: a set of management parameters for your QMS.
The system and process approach:

- Quality must be managed by a system.

- The system must be managed using the process approach because the system
is made up of processes.
- These processes are linked to each other.
- A process has inputs, resources, activities, outputs and customers. Manage them
all.

Product = Any output- physical product or services

Output = product
Product = result of a process
Process = a set of inter-relating activities focused towards producing the output
Input = requirements
Process approach:

Every process require specific inputs, resources, activities, outputs and customers
What can do now is:
- Define and document the inputs
- Define and document the kinds of resources that your processes use
- Define and document the activities and their interactions
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Basics of Healthcare Quality and Patient Safety in the Book

- Define and document the responsibilities

- Define and document the outputs
- You can name this document as Department Control Plan
-Then execute this plan, and monitor, measure, analyze and improve its
performance using Key Performance Indicators (KPIs)
-Thus, Plan – Do - Check – Act (Dr. W. Edwards Deming).

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Basics of Healthcare Quality and Patient Safety in the Book

References:

Alauddin, N., & Yamada, S. (2019). Overview of Deming criteria for total quality
management conceptual framework design in education services. Journal of
Engineering and Science Research, 3(5), 12-20.

Besterfield, D. H., Besterfield-Michna, C., Besterfield, G. H., Besterfield-Sacre,

M., Urdhwareshe, H., & Urdhwareshe, R. (2014). Total Quality Management
Revised Edition: For Anna University, 3/e. Pearson Education India.

Kiran, D. R. (2016). Total quality management: Key concepts and case studies.
Butterworth-Heinemann, 1st ed., 15-23.
Mehralizadeh, Y., & Safaeemoghaddam, M. (2010). The applicability of quality
management systems and models to higher education: A new perspective. The TQM
Journal.
Mohammed, A. S. A., Tibek, S. R. H., & Endot, I. (2013). The principles of total
quality management system in world Islamic call society. Procedia-Social and
Behavioral Sciences, 102, 325- 334.

Milosan, I. (2014). Studies about the key elements of total quality

management. European Scientific Journal, 1(3), 57-61.
Oakland, J. S. (2014). Total quality management and operational excellence: text
with cases. Routledge.

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Basics of Healthcare Quality and Patient Safety in the Book

Quality / environment system Standard in health care

Learning objectives
By the end of this lecture, the student should be able to;
 Define Quality.
 Define Health Care Quality.
 Define standard.
 Define standards of care.
 List Purposes of standards.
 List Characteristics of standards.
 Identify Importance of standards in health care .
 Identify types of standard.
 Identify the need for standards of care.
 Mention Prerequisites for successful, professional setting, and control of
standards of nursing care.
 Identify how we can use standards.
 Identify who writes the standards.
 Define criteria and criterion
 Mention standards approaches.
 Discuss steps of writing standards, checking standards.
 Identify methods of mentoring standards.

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Introduction
Standard must be evidence based and dynamic, always moving, always changing
to ensure or improve the quality of care rather than just a paper exercises, Once a
standard is easily achieved it should be replaced by another standard that will
improve patient care. The old standard may be review occasionally and monitored to
check that the outcomes are still being achieved. Every member of staff should be
involved in both the setting and the monitoring of the standards. Standards should
reflect the expertise of the caring teams and the specific care required for the patient
in the clinical area. Standard must be evidence based and dynamic –always moving,
always changing to ensure or improve the quality of care – rather than just a paper
exercises.

Standard:
Standard is a written value statement of rules, conditions and actions in a patient,
staff member, or the system that are approval by an appropriate authority. Standard
statement are professionally agreed levels of performance, appropriate to the
population addressed , which reflect what is acceptable, observable, achievable and
measurable .
-It is a tool to measure the quality of care as part of quality assurance.
-A standard is a document that provides requirements, specifications,
guidelines or characteristics that can be used consistently to ensure that materials,
products, processes and services are fit for their purpose .
What are standards of care?
Standards are valid, acceptable definitions of the quality of care. Standards cannot
be valid unless they contain criteria to enable care to be measured and evaluated in
terms of effectiveness and quality.

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Standards written without criteria can be likened to using a ruler without any
measurements marked on it and then attempting a scale drawing: the measurements'
would be an estimate and therefore inaccurate and variable.
The measurement of standards is not quality assured
Quality assurance is the level of excellence produced and documented in the process
of patient care. Care based on the best knowledge available and achievable at a
particular facility.
Quality assurance only occurs when the gaps have been identified following
measurement, and action has been taken to ensure standards are achieved.
A standard is an instrument with which to measure the quality of care as part of
quality assurance.
Purposes of standards
-To evaluate the quality of nursing practice in any nursing practice.
-To compare and improve the existing nursing practice
-To provide a common base for practitioners to coordinate and unify their efforts in
the improvement
-To identify the element of independent function of nursing practices.
-To provide a basis for planning and evaluating educational program for
practitioners.
-To inform society of our concern for the improvement of nursing practice.
-To assist the public in understanding what to expect of nursing practice.
-To identify areas for developing core curriculum for practicing nurses.
-To provide legal protection for nurses.

Characteristics of standards
acceptable, achievable and flexible.
*Must be framed by the members of the nursing profession.
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Basics of Healthcare Quality and Patient Safety in the Book

Should be phrased in positive terms like good, excellent, etc.

Must be understandable and unambiguous.
*Must be based on current knowledge and scientific practice.
Must be reviewed and revised periodically.
Importance of standards in health care
It describe in measurable terms the care provided for patients through: -

-Monitoring care .

-Assessing the level of service.

-Identify deficiencies.

-Communicate expectations.

-Introduce new knowledge.

-Make explicit what we do.

ensure that products and services are safe.

Standard classified into:

Output Standards: measures performance results in terms of quantity, quality, cost,
or time.
Input Standards: measures work efforts that go into a performance task.
Types of standard
1. Physical standards: patient acuity rating to establish nursing care hours per
patient day.
2. Cost standards: the cost per patient day.
3. Capital standards: the review of monetary investments or new programs.
4. Revenue standards: the revenue per patient day for nursing care.

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Basics of Healthcare Quality and Patient Safety in the Book

5. Program standards: which guide the development and implementation of

programs to meet client's needs
6. Intangible standards: include staff development or personnel orientation cost
7. Goal standards: which outline qualitative goals in shorthand long term planning.
8-Strategic plan standards: which outline checkpoints in developing and
implementing the organizations strategic plan.
Why do we need standards of care?
Well-written standards enable professionals to describe, in measurable terms, the
care they provide for patients, what is required to carry out that care and what the
expected outcome will be:
1. A philosophy of nursing: The document identified the need for that values and
philosophy to guide nursing practice before quality nursing care could be
assured .The philosophy had to be agreed and made explicit.
2. The relevant knowledge and skills: There must be a clear identification of the
skills and knowledge required by nurse in order to carry out care effectively.
3. The nurse's authority to act and clear accountability: Accountability is the key
of information to professional standards. Nurses must be clear about the extent
of their authority responsibility and accountability to carry out their job
effectively.
4. The management of change.
5. The control of resources.
6. The organizational structure and management style.
7. The doctor – nurse relationship.

How can we use standards?

Standards can be used to obtain information to:
 Monitor care.
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Basics of Healthcare Quality and Patient Safety in the Book

 Assess the level of service.

 Identify deficiencies.
 Communicate expectations.
 Introduce new knowledge.
 Make explicit what professionals do.
Who writes the standards?
 Standards are written by staff working in clinical areas. They are written on topics
that they select, and are relevant to the needs of both staff and patients.
 Standards are often written to solve a problem but they may also be written for
an area of concern or one of particular interest or good practice.
 Being involved in setting and monitoring standards of care means being
committed to looking at what you do and being prepared to take the appropriate
action to change things to improve the quality of patient care . All standards
should be research – base.
Criteria
Criteria defined as descriptive statements of performance, behaviors, circumstances
or clinical status that represent a satisfactory, positive or excellent state of affairs.
A criterion is a variable, or item, that is selected as a relevant indicator of the quality
of care. Criteria make the standards work because they are detailed indicators of the
standards and must be specified to the area or type of patient .

Threshold
A threshold for quality means setting certain norms and criteria. Any programme,
department, or institution, which reaches these norms and criteria, is deemed to be of
quality.
Criteria must be
 Measurable.

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Basics of Healthcare Quality and Patient Safety in the Book

 Specific.
 Relevant.
 Clearly understandable.
 Clearly and simply stated.
 Achievable.
 Clinically sound.
 Reviewed periodically.
 Reflective of all aspects of the patient or client status.
There are three types of criteria:
Structure criteria:
It involves all requirements, of what must be provided in order to achieve the
standard such as:
 Physical environment and building.
 Equipment.
 Staff: numbers, mix, training, experiences.
 The organization system.
 Support services.

Process criteria:
It describes what action must be take place in order to achieve the outcomes may be:
 The assessment techniques and procedures.
 Methods of delivery of care.
 Methods of giving information.
 Methods of documenting.
 How resources are used.

Outcome:
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Basics of Healthcare Quality and Patient Safety in the Book

It describe the effect of the care – the results expected in order to achieve the
standard in terms of behaviors, responses, level of knowledge, and health status.
These evaluate the patient's status and it measures the patient change in health
statues. This change may be due to nursing care, Medical care, or as a result of
services offered to the patient and it reflect effectiveness and results, rather than the
process of giving the care and evaluation of the competences of staff carrying out the
care.
There are seven steps can be used when writing any nursing standard
(structure, process or outcome),
1-Select the area of nursing for which the standard is to be written and identify the
type (structure, process, and outcome).
2-Identify the objectives for the standard stating explicitly what you intend to
achieve.
3-Specify the nursing action essential to achieve the objectives
4- Where possible specify a timeframe for each action.

5- Write up the standard in a logical order.

6- Review the work done to eliminate ambiguous or "irrelevant information that
cannot be evaluated.
7-Test the new will be achieved and to set and record a realistic date

Checking Standards
Once you have written the standard, check that the criteria:
 Describe the desired quality of performance.
 Have been agreed.
 Clearly written (not open to misinterpretation)
 Contain only one major thought.
 Measurable.

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Basics of Healthcare Quality and Patient Safety in the Book

 Concise.
 Specific.
 Achievable
 Clinically sound.
 Evidence – based.
Monitoring Standards
There are two approaches to monitoring standards, through:
 Retrospective evaluation involves all assessment methods that occur after patient
or client has been discharged.
 Concurrent evaluation involves assessment that takes place while the patient or
client is still receiving care.

As care is being giving Concurrent evaluation may be affected by: Assessment of

outcome, patient interview, conferences between patient, staff, and relative, direct
observation of care and measurements the competency of the nurse.
At the end of episode of care Retrospective evaluation of the quality of nursing
care may be affected by: Post- care patient interview, post –care patient
questionnaire, post –care staff conferences and audit the records.
Methods of monitoring Standards
There are various methods of monitoring standards, of which the most commonly
used are:
 Observation of care.
 Asking the patient, client or relative questions.
 Checking the records
 Questionnaires
1. Questions should be phrased

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2. Questions must be expressed simply and clearly, making sure not to use
words and phrases that have more than one meaning.
3. Ask questions one at a time.
4. Questions should be short
5. Give the respondent an opportunity to write his or her comments.
 The care plane
The patient's or client's care plan is very effective method of monitoring when
a standard that is writing for a group of patients or clients is monitored for an
individual.

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Basics of Healthcare Quality and Patient Safety in the Book

References :
 Joint Commission International Accreditation Standards for Hospitals
(2014). Joint Commission on Accreditation of Healthcare Organization.
 Joshi, M. S., & Berwick, D. (2014). Healthcare quality and the patient. The
healthcare quality book: Vision, strategy, and tools, 3-29.
 Marpuis , B.L., and Huston, C.J. (2012): Leadership roles snd management
functions in nursing 2 nd E., Lippincott , Philadelphia , P.P . (116-129).
 Ross, M. (2012). Health and health promotion in prisons. Routledge.
 Sjöström, H., Christensen, L., Nystrup, J., & Karle, H. (2019). Quality
assurance of medical education: lessons learned from use and analysis of the
WFME global standards. Medical Teacher, 41(6), 650-655.

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Basics of Healthcare Quality and Patient Safety in the Book

Quality Tools

Learning Objectives:
By the end of the lecture the student will be able to:
 Define quality tools.
 Discuss old seven quality tools
 Discuss New seven quality tools

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Basics of Healthcare Quality and Patient Safety in the Book

Introduction
Employees need to understand how to assess quality by using a variety of quality
control tools, how to interpret findings, how to correct problems and analyzing
quality problems. In this section we look at seven different quality tools. These are
often called the seven tools of quality control, Sometimes workers use only one tool
at a time, but often a combination of tools is most helpful.
Definition of quality tools:

Quality tools are the charts, check sheets, diagrams, graphs, techniques, and methods
that are used to create an idea, engender planning, analyze the cause and process,
foster evaluation, and create a wide variety of situations for continuous quality
improvement.

Types of quality tools:

Old seven quality tools are traditional:

1. Check sheets
2. A histogram

3. A scatter diagram

4. A Pareto diagram

5. A flowcharting

6. One form of a cause-and-effect (C&E) diagram

7. A control chart

New seven quality tools are modern:

1. An affinity diagram

2. A tree diagram

3. A process decision program chart

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Basics of Healthcare Quality and Patient Safety in the Book

4. A matrix diagram

5. An interrelationship digraph

6. Prioritization matrices

7. Activity network diagrams

Check sheet (data collection sheet):

 A check sheet, also known as a tally sheet, is a form for gathering systematic
data and registering to get a clear view of the facts.
 It is used to keep track of how often (facts) something occurs.
 The form of the check sheet is tailored for each situation/application.
 A checklist is used to indicate the frequency of a certain occurrence.

Histogram:

 A histogram is a bar/diagram showing a distribution of variable quantities or

characteristics.
 It is a graphical display of the frequency distribution of the numerical data.
 The data are displayed as a series of rectangles of equal width and varying
heights.
 A histogram is used to show clearly where the most frequently occurring values
are located and the data is distributed.
 It is also a tool for determining the maximum process results.
 It enables to analyze and quickly visualize the features of a complete set of data.

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Basics of Healthcare Quality and Patient Safety in the Book

Cause-And-Effect Diagram (or Fishbone Diagram) or (Ishikawa Diagram):

 I lie cause-and-effect (C and E) diagram is a graphical-tabular chart to list and

analyze the potential causes of a given problem.
 The cause-and-effect diagram is also called the fishbone diagram because of its
appearance and the Ishikawa diagram after the man who developed it in 1943.
 The C and E diagram consists of a central stem leading to the effect (the problem)
with multiple branches of the stem listing the various groups of possible causes of
the problem.
 The C and E diagram has unlimited applications in research, manufacturing,
marketing, office operations, services, and so forth.
 The C and E diagrams are used as:
o To analyze cause and effect relationships,
o To facilitate the search for solutions of related problems,
o To standardize existing and proposed operations and
o To educate and train personnel in decision-making and corrective-action
activities.

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Basics of Healthcare Quality and Patient Safety in the Book

When creating a fishbone" diagram, each "vertebrate" is a section of one of 6 basic

categories. Once a main "fishbone" with six "bones" is created, each individual -
bone" or section, can then be broken down further into another "fishbone" of
individual items for analysis. The 6 basic categories are easily remembered from the
anagram "5 M" and I E These basic categories are:
1. Man - Does the operator have the proper training. experience. and ability to
perform the function?
2. Method -Are the work instructions available and up to date? Do they reflect the
best method to perform the task? Are the proper tools available? Are the process
parameters specified clearly?
3. Machine - Does the machine have the capability to produce the product as
specified? Does the machine have the ability to produce the product on a consistent
basis? Are there regular routine maintenance and preventative maintenance tasks?
Are they performed according to schedule?
4. Material - Are the correct materials available for the process? What is the quality
of the material used in the process? Is there more than one supplier and does quality
vary with different suppliers? What types of material problems could exist?
5. Measurement - Are the measurement instruments adequate fur the process? Are
they maintained correctly and regularly calibrated? Are the measurement instruments
affected by environmental conditions such as temperature, vibration, dirt, etc.?

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Basics of Healthcare Quality and Patient Safety in the Book

Pareto Diagram:

 A Pareto diagram is a diagnostic tool commonly used for separating the vital few
causes that account for a dominant share of quality loss.
 This tool is named after Wilfredo Pareto, the Italian economist, who devised this
tool first.
 The Pareto diagram is based on the Pareto principle, which states that a few of the
defects account for most of the effects.
 Pareto analysis is also called as 80/20 rule and as ABC analysis. It means only
20% of problems (defects) account for 80% of the effects.
 This analysis is a method of classifying items, events, or activities according to
their relative importance.
 Pareto analysis can be used in a wide range of situations where one needs to
prioritize problems based on its relative importance.
 It can be used at risk assessment technique from activity level to system level.

Stratification Analysis:

 Stratification is a method of analysis of data by grouping it in different ways.

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Basics of Healthcare Quality and Patient Safety in the Book

 Literally, stratification means segregating group measurements, observations, or

any other data into several subgroups on the basis of certain characteristics. These
stratified data are used for identifying the influencing factors.
 Machines, suppliers, operators, tools, gauges, or time-dependent sources like
shifts, pre-post lunch, start or end of shifts, etc., are strata with respect to which
the study of variations is conducted for diagnosis and possible control/prevention
of variations.
 Thus, stratification is a simple very effective tool for improving the quality.

Scatter Diagram:

 The scatter diagram is a simple graphical device to depict the relationship

between two variables.
 A scatter diagram is composed of a horizontal axis containing the measured
values of one variable (independent, i.e.. cause) and a vertical axis, representing
the measurements of the variable (dependent, i.e., effect).
 This diagram displays the paired data as a cloud of points. The density and
direction of the cloud indicate how the two variables influence each other.

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Basics of Healthcare Quality and Patient Safety in the Book

 Although this diagram cannot prove that one variable causes the other, they do
indicate the existence of a relationship as well as the strength of that relationship.

Control Chart:

 A control chart, invented by Walter A. Shewart, is the most widely used tool in
statistical process control (SPC).
 A control chart is a graph that displays data taken over time and the variations of
this data to monitor the process within the control or not we are using control
charts.
 A histogram gives a static picture of process variability, whereas a control chart
illustrates the dynamic performance (i.e.. performance over time) of the process.

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Basics of Healthcare Quality and Patient Safety in the Book

Affinity diagram:

An affinity diagram is a data reduction tool in that it organizes a large number of

qualitative inputs into a smaller number of major categories. These diagrams are
useful in analyzing detect data and other quality problems. and used in conjunction
wen cause-and-erect diagrams or interrelationship digraphs.

Tree diagram:

A tree diagram can be used to show the relationships of a production process by

breaking A down from a few larger steps into many smaller steps. The greater the
detail of steps, the barer simplified they are.

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Basics of Healthcare Quality and Patient Safety in the Book

Process decision program chart:

A process decision program chart is a preventive control tool in that it prevents

problems from occurring in the first place and mitigates the impact of the problems If
they do occur. From this aspect, it is a contingency planning tool. The objective of
the tool is to determine the impact of the 'failures' or problems on the project
schedule.

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Basics of Healthcare Quality and Patient Safety in the Book

Matrix diagram:

A matrix diagram is developed to analyze the correlations between two groups of

ideas with the use of a decision table. This diagram allows one to systematically
analyze correlations.

Interrelationship digraph:

An Interrelationship digraph is used to organize disparate ideas. Arrows are drawn

between related ideas. An idea that has arrows leaving it but none entering is a 'root
idea." More attention is then given to the root ideas for system improvement. The
digraph is often used in conjunction with affinity diagrams.

Prioritization matrices:

Prioritization matrices are used to help decision-makers determine the order of

importance of the activities being considered in a decision. Key Issues and choices
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Basics of Healthcare Quality and Patient Safety in the Book

are identified for further improvement. These matrices combine the use of a tree
diagram and a matrix diagram.

Activity network diagrams:

Activity network diagrams are project management tools to determine which

activities must be performed when they must be performed, and in what sequence.

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References:

 Charantimath, P. M. (2011). Total Quality Management/Poornima M.

Charantimath. Delhi: Dorling Kindersley.

 Rumane, A. R. (Ed.). (2016). Handbook of construction management: scope,

schedule, and cost control. CRC Press.

 Vallabhaneni, S. R. (2015). Wiley CIAexcel Exam Review 2015 Focus Notes,

Part 2: Internal Audit Practice. John Wiley & Sons.
 Vijayan V. & Ramakrishnan H. (2014). Total Quality Management (For Tamil
Nadu Universities) Kindle Edition. S Chand.

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Basics of Healthcare Quality and Patient Safety in the Book

Six Sigma

Learning Objectives:
By the end of the lecture the student will be able to:
 Define of Six Sigma.
 Identify Philosophy of underlying Six Sigma.
 Identify different people in Six Sigma and their roles and responsibilities
 Discuss Six Sigma Methodology
 List advantages of Six Sigma
 Identify Limitations of Six Sigma

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Basics of Healthcare Quality and Patient Safety in the Book

Introduction
In current competitive environment, many health care organizations are taking
steps to ensure that they are providing the "absolute best care at the lowest possible
costs". Six Sigma are performance improvement methodology that could be utilized
to improve the quality of healthcare.
Definition of Six Sigma:
Six Sigma is an approach to conquering variation that was developed by Motorola
in the early 1980s. There are two definitions of Six Sigma, both of which an
appropriate. a technical definition and a cultural definition, as follows:
1. Technical Definition. Six Sigma is a statistical term used to measure the
performance of products and processes against customer requirements. By
definition, a step in the process that is operating at a Six Sigma level produces
only 3.4 defects per million opportunities.
2. Cultural Definition. Six Sigma is a management philosophy and a cultural belief
system that drives the organization toward world-class business performance and
customer satisfaction. It is based on scientific principles. including a decision-
making process based on facts and data.
Six Sigma refers to a disciplined, data-driven approach and methodology for
eliminating defects in any process-from manufacturing to transactional and from
product to service. A defect is a component that does not fall within the customer's
specification limits. For example, in administrative processes, Six Sigma may mean
optimizing response time to inquiries maximizing the speed and accuracy with which
inventory and materials are supplied, and fool proofing such support processes from
errors, inaccuracies, and inefficiency.

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Philosophy underlying Six Sigma:

The philosophy underlying Six Sigma is to reduce process output variation. The
performance of a process in terms of its variability is compared with different
processes using a common metric. This metric is Defects Per Million Opportunities
(DPMO). This calculation requires three pieces of data:

1. Unit. The item produced or being serviced.

2. Defect. Any item or event that does not meet the customer's requirements.
3. Opportunity. A chance for a defect to occur.
A calculation is made using the following formula. DPMO - (Number of defects ×
1,000,000) / Number of opportunities for error per unit × Number of units

As we have already studied, the control limit of acceptable error of any stream of
numbers is 3 Is' ('s being the standard deviation). A product is considered acceptable
if the variation is 3 s on the normal specification. These limits in specifications
permit 66.738 defects per million. In Six Sigma on a long-term basis, no more than
3.4 defect parts per million or 3.4 defects per million opportunities (DPMO) are
permitted.

For a Six Sigma process with only one specification limit (upper or lower), there are
six process standard deviations between the mean of the process and the customer's
specification limit. This is the origin of the name 'Six Sigma'. For a process with two
specification limits (upper and lower), this translates to slightly more than six
process standard deviations between the mean and each specification limit such that
the total defect rate corresponds to the equivalent of six process standard deviations.

A process that is in Six Sigma control will produce no more than two defects out of
every billion units. Often, this is stated as four defects per million units which is true

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if the process is only running somewhere within one sigma of the target
specification.

The overall performance of a process, as the customer views it, might be 3.4 DPMO.
However, a process could indeed be capable of producing a near-perfect output. As
the process sigma value increases from zero to six, the variation of the process
around the man value decreases. With a high enough value of process sigma, the
process approaches zero variation and is known as 'zero defects'.

There are two aspects to Six Sigma programs: the people side and the methodology
side.

Different people in Six Sigma and their roles and responsibilities:

The Executive Champion is usually the person who is in charge of the company or
business unit. The role of the Executive Champion typically involves the following:

 setting company goals and objectives using Six Sigma

 defining the necessary infrastructure for Six Sigma
 identifying and providing resources needed for Six Sigma deployment
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Basics of Healthcare Quality and Patient Safety in the Book

 identifying Six Sigma training requirements

 promoting Six Sigma throughout the organization.
Champions (or project sponsors) play an important role within Six Sigma as they
are responsible for the implementation of Six Sigma in their divisions. Some of the
common duties of a Champion include:

 aligning project activities with company goals and objectives

 selecting Six Sigma projects
 assigning Black Belts to the projects
 providing consistent guidance and support to project teams
 knocking down barriers where needed
 monitoring the progress of the projects (project reviews)
 sharing best practices after the completion of projects
 recognizing project gains and rewarding project members.
Black Belts are typically selected from the middle management. Some of the
common tasks of this role include:

 managing and facilitating Six Sigma projects

 providing technical support to Champions
 identifying opportunities for improvement
 mentoring Green Belts
 providing guidance and training to team members.
Black Belt selection requires special attention. It is advisable to prepare a list of
selection criteria comprising both technical and non-technical skills required for this
role.

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Basics of Healthcare Quality and Patient Safety in the Book

Green Belts are usually chosen from the staff levels within a department. It is
recommended to use a list of selection criteria (similar to that used in the Black Belt
selection process) reflecting the relevant requirements of this role. Green Belts play
an important part within Six Sigma as they are directly involved in the execution of
the Six Sigma projects. Some of the typical tasks of this role include:

 collecting and analyzing process data

 identifying requirements for process changes
 implementing changes to processes
 monitoring changed or improved processes.
Master Black Belt is a role that not only builds a bridge between the other roles but
also coordinates and facilitates all Six Sigma activities within the organization or the
business unit. Typical activities and duties of this role include:

 coordinating Six Sigma activities within the organization or business unit

 providing consultancy to Champions and Black Belts
 providing support to project teams
 training Black Belts and Green Belts.

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Six Sigma Methodology:

While Six Sigma's methods include many of the statistical tools that are employed in
other quality movements, DMAIC and DMADV are both special tools developed for
Six Sigma applications:

• Six Sigma methodologies are used to drive defects to less than 3.4 per million
opportunities.

• Data-intensive solution approaches.

• Implemented by Green Belts, Black Belts, and Master Black Belts.

• Ways to help meet the business/financial bottom-line numbers.

• Implemented with the support of a champion and process owner.

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Basics of Healthcare Quality and Patient Safety in the Book

When to Use DMAIC: The DMAIC cycle is a more detailed version of the Deming
PCDA cycle, which consists of four steps — plan, do. check, and act — that underlie
continuous improvement. The DMAIC methodology instead of the DMADV
methodology should be used when a product or process is in existence at your
company but is not electing customer specifications or is not performing adequately.
The objective here is to modify the process to stay within an acceptable range.
Determine the control parameters and how to maintain the improvements. Put tools
in place to ensure that the key variables remain within the maximum acceptance
ranges under the modified process.

When to Use DMADV: The DMADV methodology instead of the DMAIC

methodology should be used when:

♦ A product or process is not in existence and the company one needs to be

developed.

♦ The existing product or process exists and has been optimized (using either
DMAIC or not) and still doesn't meet the level of customer specification or Six
Sigma level.

Advantages of Six Sigma:

Some of the advantages of Six Sigma implementation are:

 Reduction in cost
 Less defects
 Reduced cycle time
 Increased capacity
 Higher flexibility
 Better products

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 Better management decisions in less time and at a lower cost

 Optimized information system strategies would produce better organizational
wisdom and smarter management decision.
Limitations of Six Sigma:

There are a number of limitations in the implementation of Six Sigma programs,

such as:

 Six Sigma program is not justified for short duration projects with the product
life cycle of 4 to 6 months only as Is the case with some of the electronic
items.
 Six Sigma is suitable for high-value projects only.
 Cost of implementation of Six Sigma is very high.
 All projects do not call for such a high-quality standard
 Some of the critics of the Six Sigma methodology feel that it does not offer
new tools or techniques but is a combination of old optimization tools.

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References:

 Akpolat, H. (2017). Six sigma in transactional and service environments.

Routledge.
 Chopra, R. (2018). Software quality assurance: a self-teaching introduction.
Stylus Publishing, LLC.
 Janakiraman, B., & Gopal, R. K. (2006). Total quality management: Text
and cases. PHI Learning Pvt. Ltd.
 Kachru, U. (2009). Production & Operations Management. Excel Books
India.
 Nunnally, B. K., & McConnell, J. S. (2010). Six sigma in the pharmaceutical
industry: understanding, reducing, and controlling variation in pharmaceuticals
and biologics. CRC Press.
 Saxena, J. P. (2009). Production & Operations Management. Tata McGraw-
Hill Privated Ltd.

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Basics of Healthcare Quality and Patient Safety in the Book

Accreditation

Learning Objectives:
By the end of the lecture the student will be able to:
1. Identify external forces impacting healthcare quality management
2. Define Accreditation
3. List the importance of accreditation
4. The JCI standards and accreditation programs
5. Define The Strategic Improvement Plan (SIP)
6. Identify General Eligibility Requirements for Survey
7. Define accreditation award
8. Identify accreditation length
9. Identify the accreditation process
10.Identify accreditation types
11.Explain levels of accreditation
12.Prepare for accreditation

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Introduction
Accreditation recognizes the quality of an institution or program and assists in its
improvement, and it is a process independent agencies use to evaluate academic
institutions. These accrediting agencies assess colleges to ensure they provide their
students with quality education programs that prepare them to excel in their desired
career field. To determine whether an academic institution meets these education
requirements, accrediting agencies review the courses it offers, its faculty and the
success of its former students. To maintain their accredited status, colleges complete
regular reassessments.
External Forces Impacting Healthcare Quality Management
Healthcare organizations, like all businesses, do not operate in a vacuum. Many
external forces influence business activities, including quality management.
Government regulations, accreditation groups, and large purchasers of health
services are major influences on the operation of healthcare organizations.
Regulations are issued by governments at the local, state, and national levels to
protect the health and safety of the public. Regulation is often enforced through
licensing. For instance, to maintain its license, a restaurant must comply with state
health department rules and periodically undergo inspection
What is accreditation?
Accreditation is a process in which an entity, separate and distinct from the health
care organization, usually nongovernmental, assesses the health care organization to
determine if it meets a set of requirements (standards) designed to improve the safety
and quality of care. Accreditation is usually voluntary.
Accreditation is a voluntary process by which the performance of an organization is
measured against nationally accepted standards of performance. Accreditation
standards are based on government regulations and input from individuals and
groups in the healthcare industry.
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Accreditation A self-assessment and external assessment process used by healthcare

organizations to assess their level of performance in relation to established standards
and implement ways to continuously improve
Accreditation in higher education:
The process by which a (non)governmental or private body evaluates the quality of a
higher education institution as a whole or of a specific educational program in order
to formally recognize it as having met certain predetermined minimal criteria or
standards. The result of this process is usually the awarding of a status (a yes/no
decision), of recognition, and sometimes of a license to operate within a time limited
validity. The process can imply initial and periodic self-study and evaluation by
external peers.
Accreditation standards are usually regarded as optimal and achievable.
Accreditation provides a visible commitment by an organization to improve the
safety and quality of patient care, to ensure a safe care environment, and to
continually work to reduce risks to patients and staff. Accreditation has gained
worldwide attention as an effective quality evaluation and management tool.
Healthcare organizations seek accreditation because it
 enhances public confidence,
 an objective evaluation of the organization’s performance, and
 stimulates the organization’s quality improvement efforts
 Setting priorities for improvement
 Redesigning care delivery processes
 Supporting change in the care delivery system
 Creating a system that supports evidence-based practice
 Facilitating the use of information technology
 Empowering the workforce & developing their capabilities

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 Seeking for patient-centered healthcare services that fulfill the patient’s needs
& preferences
 Establishing a more equitable healthcare system for all, regardless of the
socioeconomic standard, race, or religion.
 Assuring that all patients access a safe & a high quality care
 Reducing morbidity & mortality through reducing errors  Supporting a
system of high quality, less waste, low cost, & more value
JCI has developed standards and accreditation programs for the following:
• Ambulatory Care
• Clinical Laboratories
• Primary Care Centers
• The Care Continuum (home care, assisted living, long term care, hospice
care)
• Medical Transport Organizations
JCI also offers certification of clinical care programs, such as programs for stroke
care, cardiac care, or joint replacement.
JCI accreditation programs are based on an international framework of
standards adaptable to local needs. All the JCI accreditation and certification
programs are characterized by the following:
• International consensus standards, developed and maintained by an international
task force, and approved by an international Board, are the basis of the accreditation
program.
• The underlying philosophy of the standards is based on principles of quality
management and continuous quality improvement.
• The accreditation process is designed to accommodate the legal, religious, and/or
cultural factors within a country. Although the standards set uniform, high
expectations for the safety and quality of patient care, country-specific
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Basics of Healthcare Quality and Patient Safety in the Book

considerations related to compliance with those expectations are part of the

accreditation process.
• The on-site survey team and agenda will vary depending on the organization’s size
and type of services provided. For example, a large multispecialty organization may
require a four- or five-day survey by a physician, a nurse, and an administrator, while
a 50-bed, single-specialty hospital may require a shorter survey by a smaller team.
• JCI accreditation is designed to be valid, reliable, and objective. Based on the
analysis of the survey findings, final accreditation decisions are made by an
international accreditation committee.
How are the standards organized?
The standards are organized around the important functions common to all health
care organizations. The functional organization of standards is now the most widely
used around the world and has been validated by scientific study, testing, and
application.
The standards are grouped by those functions related to providing patient care and
those related to providing a safe, effective, and well-managed organization. These
functions apply to the entire organization as well as to each department, unit, or
service within the organization. The survey process gathers standards compliance
information throughout the entire organization, and the accreditation decision is
based on the overall level of compliance found throughout the entire organization
The Strategic Improvement Plan (SIP)
A Strategic Improvement Plan (SIP) is a required written plan of action that the
organization develops in response to “not met” findings identified in the JCI Official
Survey Findings Report.
The written SIP is expected to
• establish the strategies/approach that the organization will implement to address
each “not met” finding;
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Basics of Healthcare Quality and Patient Safety in the Book

• describe specific actions the organization will use to achieve compliance with the
“not met” standards/measurable elements cited;
• describe methodology to prevent reoccurrence and to sustain improvement over
time; and
• identify the measures that will be used to evaluate the effectiveness of the
improvement plan (submission of data to occur over the subsequent three years).
The SIP must demonstrate that the organization’s actions lead to full compliance
with the standards and measurable elements. The SIP is reviewed and approved by
the JCI office staff after the Accreditation Certification Letter and Gold Seal have
been awarded.
Update the standards
Information and experience related to the standards will be gathered on an ongoing
basis. If a standard no longer reflects contemporary health care practice, commonly
available technology, quality management practices, and so forth, it will be revised
or deleted. It is currently anticipated that the standards will be revised and published
at least every three years
General Eligibility Requirements for Survey
Any health care organization may apply for JCI accreditation if it meets the
following requirements:
• The organization is currently in operation as a health care provider organization in
the country and licensed (if required).
• The organization assumes, or is willing to assume, responsibility for improving the
quality of its care and services.
• The organization provides services addressed by JCI standards
Purpose of Accreditation Surveys
An accreditation survey assesses an organization’s compliance with JCI standards
and their intent statements.
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The survey evaluates the organization’s compliance based on:

• interview with staff and patients and other verbal information;
• on-site observations of patient care processes by surveyors;
• policies, procedures, clinical practice guidelines, and other documents provided by
the organization; and
• results of self-assessments when part of the accreditation process.
The on-site survey process, as well as continued self-assessment, helps the
organizations identify and correct problems and improve the quality of care and
services.
In addition to evaluating compliance with standards, their intent statements and the
International Patient Safety Goals, surveyors spend time in providing education in
support of the organization’s quality improvement activities
Accreditation Awards
To gain accreditation, organizations must demonstrate acceptable compliance with
all standards and achieve a minimal numerical score on these standards as identified
in the decision rules. Accredited organizations receive an Official Survey Findings
Report and award certificate. The report indicates the level of compliance with JCI
standards achieved by the organization
Length of Accreditation
Awards An accreditation award is valid for three years unless revoked by JCI. The
award is retroactively effective on the first day after JCI completes the organization’s
survey or, when follow-up is required, completes any required focused surveys. At
the end of the organization’s three-year accreditation cycle, the organization must be
reevaluated to be eligible for renewal of its accreditation award. If, during the period
of accreditation, the organization undergoes changes in its structure, ownership, or
services, it must notify JCI. JCI will then determine the need to re-survey the
organization and/or render a new accreditation decision
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Basics of Healthcare Quality and Patient Safety in the Book

Accreditation process:

1-Presurvey :Apply for Accreditation

A health care organization that wishes to be accredited begins the accreditation
process by completing and submitting the application for survey.
This document provides the essential information about the health care organization,
including ownership, demographics, and types and volume of services provided
either directly, under contract, or some other arrangement.
The application for survey:
• describes the organization seeking accreditation;

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• requires the organization to provide JCI with all official records and reports of
relevant licensing, regulatory, or other governmental bodies;
• authorizes JCI to obtain any records and reports about the organization not
possessed by the organization; and
• when finalized and accepted by JCI and the applicant, establishes the terms of the
relationship between the organization and JCI.
2-On-Site Survey Process
The surveyors will visit the organization during the dates established and according
to the prepared agenda.
The surveyors may ask to interview any personnel during the survey to visit any
other unit or location of the organization not on the agenda, or request additional
information.
The organization must cooperate with the surveyors to provide accurate information
about the organization and its compliance with the standards.
Delays in providing the required information will be considered noncooperation,
which may result in premature termination of the accreditation process. The tracer
methodology is the foundation of the JCI on-site survey
The tracer methodology does the following:
• Incorporates the use of information provided in the accreditation survey application
• Follows the experience of care for a number of patients through the organization’s
entire health care process
• Allows the surveyors to identify performance issues in one or more steps of the
patient care process or in the interfaces between processes
3-Postsurvey
Revision of the Official Survey Findings Report :The organization has seven days
from the last day of the survey to request, in writing or by e-mail, revision of the
report related to survey findings.
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This revision request must be accompanied by appropriate data and information to

support the request.
The Accreditation Committee considers this request for revision and makes the final
decision.
The Accreditation Decision: The JCI Accreditation Committee makes accreditation
decisions based on the findings of the survey. An organization can receive one of the
following two accreditation decisions: Accredited or Accreditation Denied.
Maintaining Accreditation
JCI will continue to monitor accredited organizations and certified programs for
compliance with all the International Patient Safety Goals and relevant JCI standards
on an ongoing basis throughout the three-year accreditation cycle
Types of accrediting organizations
Institutional Accreditation: The terms refer to the accreditation of an entire
institution, including all its programs, sites, and methods of delivery, without any
implication to the quality of the study programs of the institution.
Regional Accreditation: Accreditation granted to a higher education institution by
a recognized accrediting association or commission that conducts accreditation
procedures in a particular geographic area (usually that of three or more states).
Specialized Accreditation: The accreditation of individual units or programs (e.g.
professional education), by “specialized” or “program” accrediting bodies applying
specific standards for curriculum and course content.
Levels of Accreditation.
 Accreditation with Commendation: The highest level of accreditation, it is
awarded to hospitals that demonstrated more than satisfactory compliance with
JCAHO standards in all performance areas.
 Accreditation Without Type I Recommendations: This distinction is awarded to
hospitals that meet the JCAHO standards in all performance areas.
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 Accreditation with Type I Recommendations: Awarded to hospitals that

demonstrate satisfactory compliance with JCAHO standards in most performance
areas. But, the hospital has deficiencies in one or more performance areas or there is a
JCAHO requirement that must be corrected within a specified period of time before
total accreditation will occur.
 Provisional Accreditation: The hospital has demonstrated satisfactory compliance
with a subset of standards during a preliminary on-site visit. This decision remains in
effect until one of the other accreditation categories in assigned by JCAHO, based on a
complete evaluation six months later.
 Conditional Accreditation: The hospital fails to demonstrate satisfactory
compliance with JCAHO standards in multiple areas, or the hospital is unwilling or
unable to demonstrate compliance with one or more JCAHO standards, or the hospital
has failed to comply with one or more requirements, but is believed capable of
achieving satisfactory compliance within a specified period of time.
 Preliminary Denial of Accreditation: The hospital failed to demonstrate satisfactory
compliance in multiple JCAHO performance areas or has failed to meet JCAHO
standards in accreditation policy requirements. This accreditation decision is subject to
a subsequent review.
 Accreditation Denied: Accreditation is denied because the hospital does not meet the
Joint Commission Standards.
How to prepare for accreditation
Preparation strategies
1- Leadership Involvement
 Decision to become accredited.
 Knowledge of the standards and survey process.
 Commitment to change and sustaining the change.
 Allocation of resources.
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2- Education
 Education workshop discussing each standard and the required measurable elements.
 Include as many management and staff members as possible at the workshop.
 Ask questions relating to what your present practice is compared to the standards.
3- Identifying champions and team leaders
 Assign oversight of each chapter of standards to a respected champion/leader who
will identify team members from throughout the hospital.
 Look for good people skills, time management skills and consensus building skills
 Be prepared to change as new champions emerge, and some leaders drop out.
4- Identify policies and procedures
 Based on the standards, identify what policies and what procedures need to be revised
and/or developed (list is in the survey guide).
 Based on the revised and developed policies, identify what changes in
practice/procedures will be required.
5- Implementation
 Develop detailed implementation plans for all practice changes including who needs
to be educated.
 Include a time frame for each change.
 Group similar changes into appropriate groups.
 Develop specific ongoing monitoring to determine sustainability of implemented
changes.
6- Develop required plans (Quality, information, safety)
 Identify plans that need to be developed.
 Assign responsibility for development.
 Include time frame for approval and implementation.
7- Establish target dates
 Review timelines and required change.
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 Set a time frame for a mock review (Dress rehearsal).

 Set a target data for actual accreditation survey.
8- Activities of Mock and Actual Surveys
 Document review session.
 Interviews with leaders.
 Visits to patient care settings.
 Interviews.
 Medical record review.
 Building tour.
9- Action planning using Mock Survey result
 Assign responsibilities and time frames for areas requiring continued improvement.
 Monitor for continued compliance.
 Reset dates for accreditation survey if necessary and submit application for survey.
10- Accreditation
 Successfully complete the survey.
 Celebrate, Celebrate, And Celebrate.
 Begin follow up the very next day or even soon thereafter.
 Develop a process to continue to maintain the standards (Continued Readiness).

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References:
 Alderman, H. (2021). Accreditation. In Encyclopedia of Sport Management
(pp. 3-6). Edward Elgar Publishing.
 Eaton, J. S. (2015). An Overview of US Accreditation. Revised November
2015. Council for Higher Education Accreditation.
 Joint commission international accreditation standards for hospitals, 4th
edition, 2011.
 Patrice, S. (2009): Introduction to healthcare quality management ISBN 978-
1-56793-323-9 (alk. paper)

 Suskie, L. (2014). Five dimensions of quality: A common sense guide to

accreditation and accountability. John Wiley & Sons.

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Patient safety concepts

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Learning Objectives:
By the end of the lecture the student will be able to:
 Define safety

 Define patient safety

 Define medical error
 Define adverse event
 List types of medical error
 Identify factors that increase the chance of patient errors
 Identify facilities for healthcare that might promote patient safety.
 Explain nurse’s role to promote patient safety

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Introduction:
Patient safety can be considered one of the most important aspects of
healthcare. It is a major concern to all healthcare providers. It seems
perverse that patients can be harmed when they are treated and cared for
the occurrence of undesirable and unexpected adverse events in the
provision of health care services was mostly associated with caregiver
incompetence or negligence resulting in a focus on the concept of patient
safety to prevent future errors and errors.
Definition of safety:-
It is the condition in which the risk of injury to
persons or property is reduced to an acceptable
level or less through an ongoing process of risk
identification and risk management.
Safety is
 S– sense the error.

 A– act to avoid it.

 F – follow safety precautions.

 E – inquire about accidents and fatalities.

 T – take the necessary corrective action.

 Y – you're accountable.

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Definition of patient safety:-

It is an activity that reduces and eliminates the possibility of errors and
patient damage. It includes a fundamental desire to protect the patient's
right to safety as well as the rules and obligations established by law for
healthcare teams.
Medical errors:
It is the failure of a planned activity to be carried out as intended or the
execution of a defective plan to achieve a purpose, including problems
with practice, services, methods, and systems.
According to Whitehead et al (2010) are classified into:
 Adverse event
 Sentinel event
 Near miss
 Intentionally unsafe acts
 Adverse event
It is a damage brought on by medical care rather than
the patient's underlying illness or condition. Acts of
omission or commission may cause adverse events.
An example:
Omission errors include failing to administer the patient's medication as
directed or to carry out a procedure.
Giving the patient the incorrect dosage of a medication is an error in
commission.

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 Sentinel events

It is described as unanticipated events that include risk, major physically

or psychologically injury, or death.
An example:
Loss of a limb or function unrelated to the patient's illness, wrong-side
surgery, and hemolytic transfusion responses are all considered serious
injuries.
 Near miss :

A possible adverse event that was discovered before to harming the

patient. It is a circumstance or incident that may have led to negative
outcomes but didn't.
For example,
A surgical or other procedure that was almost given to the wrong person
due to errors in patient identification verification but was discovered at the
last minute by accident.
 Intentionally unsafe acts

Any incidents that are the result of criminal behavior, intentionally

dangerous behavior, or incidents involving possible patient abuse.
Factors that increase the chance of patient errors
A. Situational and organizational factors:
 Unfamiliarity with the task
 Inexperience

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 Shortage of time
 Inadequate checking
 Poor procedures
 Poor human equipment interface
 Poorly designed equipment
 Noisy working conditions
 Short staffing
 Lack of training.

B. Individual factors:
 Inattention
 Memory lapse
 Failure to communicate
 Exhaustion
 Ignorance
 fatigue
 stress
 hunger
 illness
 language or cultural factors

Facilities for healthcare that might promote patient safety

1. Providing leadership for patient safety initiatives
2. Creating a culture of safety
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3. Providing training and continuous education

4. Improving reporting systems
5. Continuous research

1. Providing leadership for patient safety initiatives

 Hospitals must launch patient safety initiatives and track their
effectiveness, perhaps by including safety into performance metrics.
 Hospital administrators must initiate change management programs
to build support for patient safety and get leaders across the
organization committed to a prevention program

B-Creating a Culture of Safety

 Hospitals should avoid blaming specific healthcare providers and
promote the idea that failures are an opportunity to learn and provide
better care.
 Hospitals should adopt procedures to enhance quality.
 Patient safety should become part of performance and accountability

A safety culture:- There is an atmosphere of mutual trust where all

employees feel free to talk about safety concerns and proposed solutions
without worrying about retaliation or punishment.
Creating culture of safety:-
1- Support teamwork and respect others.
2- Educate staff.
3- Engage physicians.

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4- Encourage use of communicating.

5- Assign 1 (one) or 2 (two) clinical staff members.
6-Take a proactive approach to error.
7-Study and learn from near misses.
8- Search for information about how to do things safely.
9-Provide team training to a culture of safety.
10- Encourage patient and family involvement in the care process.
11- Share information about safety with others.
C-Providing Training and Continuous Education
 By distributing knowledge of best practices and educating professionals in risk
management, professional groups, colleges, and hospital associations should
promote and improve patient safety.
 Hospital safety training and development programs must be funded by
provincial governments.

D-Improving Reporting Systems

 Hospitals should base their reporting systems on worldwide documentation
and reporting.
 Use standardized reporting methods and communicate details about negative
events in hospitals.

E-Continuous Research
 Continuous observation and the quest for novel tactics are necessary for
patient safety. It is necessary to conduct research on creating worldwide and
national benchmarks.

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 To determine how effectively to distribute hospital resources, patient safety

research should concentrate on methods, returns on investment, and cost-
effectiveness.

Role of nurses to promote patient safety:

 monitoring patients for clinical deterioration.
 detecting errors and near misses.
 understanding care processes and weaknesses inherent in some systems.
 identifying and communicating changes in patient condition.
 performing countless other tasks to ensure patients receive high-quality care.
 Increases satisfaction of patients by provide high quality of care .
 focus on nursing practice away from habits and tradition to evidence and
research.
 Use evidence Based Nursing/Practice to delivery of health care
that integrates the best evidence from studies and patient care data with
clinician expertise and patient preferences and values.

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References :
 Agrawal, A. (2014). Patient Safety. Springer New York.
 Farokhzadian, J., Dehghan Nayeri, N., & Borhani, F. (2018). The long way
ahead to achieve an effective patient safety culture: challenges perceived by
nurses. BMC health services research, 18(1), 1-13.
 Sherwood, G., & Barnsteiner, J. (Eds.). (2021). Quality and safety in
nursing: A competency approach to improving outcomes. John Wiley & Sons.
 Vaismoradi, M., Salsali, M. and Marck, P. (2011).Patient safety: nursing
students' perspectives and the role of nursing education to provide safe care.
International Nursing Review, 58: 434-442. https://doi.org/10.1111/j.1466-
7657.2011.00882.x
 Woodward, S. (2017). Rethinking patient safety. Productivity Press.

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Medication Errors

Learning objectives:

By that end of this lecture the students will be able to:

 Define medication errors.
 Identify categories of medication errors.
 List risk factors of medication errors.
 Identify causes of medication errors.
 Mention types of medication errors.
 Identify rights of medication administration.
 Explain potential solutions to reduce medication errors and
improving medication safety.
 Mention strategies to prevent medication error from occurring.

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Introduction

At least 1.5 million people are harmed annually by medication errors,

which are the most frequent cause of medical mistakes in both hospitals
and ambulatory care settings.

Definition of medication errors:

A medication error is described as “any preventable event that may cause or lead to
inappropriate medication use or patient harm while the medication is in the control of
the health care professional, patient, or consumer” by the United States National
Coordinating Council for Medication Error Reporting and Prevention.
This includes prescribing, order communication, product labelling, packaging, and
nomenclature, compounding, dispensing, distribution, administration, education,
monitoring, and use, among other activities. Such events may be connected to
professional practice, health care products, procedures, and systems.

Categories of medication errors (according to the level of patient harm):

Category A: Circumstances or events occur that have the capacity to cause error (no
error).
Category B: An error occurred, but the error did not reach the patient (error, no
harm).
Category C: An error occurred that reached the patient but did not cause patient
harm (error, no harm).
Category D: An error occurred that reached the patient and required monitoring to
confirm that it resulted in no harm to the patient and/or required intervention to
preclude harm (error, no harm).

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Category E: An error occurred that may have contributed to or resulted in temporary

harm to the patient and required intervention (error, harm).
Category F: An error occurred that may have contributed to or resulted in temporary
harm to the patient and required an initial or prolonged hospital stay (error, harm).
Category G: An error occurred that may have contributed to or resulted in
permanent patient harm (error, harm).
Category H: An error occurred that required intervention necessary to sustain life
(error, harm).
Category I: An error occurred that may have contributed to or resulted in patient
death (error, death).
Risk factors of medication errors:
Factors associated with health care professionals
 Lack of therapeutic training
 Inadequate drug knowledge and experience
 Inadequate knowledge of the patient
 Inadequate perception of risk
 Overworked or fatigued health care professionals
 Physical and emotional health issues
 Poor communication between health care professional and with patients
Factors associated with patients

 Patient characteristics (e.g., personality, literacy and language barriers)

 Complexity of clinical case, including multiple health conditions,
polypharmacy and high-risk medications
Factors associated with the work environment

 Workload and time pressures

 Distractions and interruptions (by both primary care staff and patients)
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 Lack of standardized protocols and procedures

 Insufficient resources
 Issues with the physical work environment (e.g., lighting, temperature and
ventilation)
Factors associated with medicines

 Naming of medicines
 Labelling and packaging
Factors associated with tasks

 Repetitive systems for ordering, processing, and authorization

 Patient monitoring (dependent on practice, patient, other health care settings,
prescriber)
Factors associated with computerized information systems

 Difficult processes for generating first prescriptions (e.g., drug pick lists,
default dose regimens and missed alerts)
 Difficult processes for generating correct repeat prescriptions
 Lack of accuracy of patient records
 Inadequate design that allows for human error
Primary-secondary care interface

 Limited quality of communication with secondary care

 Little justification of secondary care recommendations
Causes of medication errors:

 Expired product
Usually occurs due to improper storage or preparations resulting in deterioration
or use of expired product.

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 Incorrect duration
Duration errors occur when medication is received for a longer or shorter period
of time than prescribed.

 Incorrect preparation
 Incorrect rate (most often occur with medications that are given as IV push
or infusions. This is particularly dangerous with many drugs and may result
in significant adverse drug reactions. Example: tachycardia due to rapid IV
epinephrine)
 Incorrect timing
 Incorrect dose
 Incorrect Patient Action
This occurs when a patient takes a medication inappropriately. Patient
education is the only way to prevent this type of error.
 Known Allergen
 Known Contraindication
 Distortion
A prevalent cause of medication error is distortions. The majority of
distortions may originate from poor writing, misunderstood symbols, use of
abbreviations or improper translation.

Types of medication errors:

 Prescribing error
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This includes:
- Incorrect prescription
- Illegible handwriting
- Drug allergy not identified
- Out of list abbreviations
 Omission
 Wrong time
 Unauthorized drug
 Improper dose (This error includes overdose, underdose and an extra dose)
 Wrong dose prescription/wrong dose preparation
 Administration error including the incorrect route of administration, giving
the drug to the wrong patient, extra dose, or wrong rate
 Monitoring error such as failing to consider patient liver and renal function,
failing to document allergy or potential drug interaction.
 Compliance error such as not following protocol or rules established for
dispensing and prescribing medication.
Rights of medication administration:

1. Right Patient

Ask the name of the client and check his/her ID band before giving the
medication.

2. Right Drug

Check and verify if it’s the right name and form.

3. Right Dose

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Check the medication sheet and the doctor’s order. Be aware of the difference
between an adult and a pediatric dose.

4. Right Route

Check the order if it’s oral, IV, SQ, IM, etc..

5. Right Time and Frequency

Check the order for when it would be given and when was the last time it was
given.

6. Right reason

Verify that the drug prescribed is appropriate to treat the patient's condition.

7. Right Assessment

Secure a copy of the client’s history to drug interactions and allergies.

8. Right to Refuse

Give the client enough autonomy to refuse the medication after thoroughly
explaining the effects.

9. Right Education

Provide enough knowledge to the patient of what drug he/she would be taking
and what are the expected therapeutic and side effects.

After medication has been administered

10. Right Documentation

Make sure to write the time and any remarks on the chart correctly.

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11. Right Evaluation

Check also the expiry date of the medication being given.

12. Right effect or response

Monitor the patient's response to the drug administered.

Potential solutions to reduce medication errors and improving

medication safety:

1. Educating health care providers and patients

 Educating health care providers about common causes of medication errors

 Providing simple tools to assist health care providers in safe medication
prescribing and use process;
 Considering how patients can be actively involved in medicine management;
 Providing patient engagement tools to address non-adherence.
2. Implementing medication reviews and reconciliation

 Ensuring that pharmacists actively review prescriptions.

 Encouraging and supporting use of medication reconciliation by clinicians.
- Medication review is a process of patients` medicines evaluation in order to
improve the health outcomes and mitigate the drug-related problems.

- Medication reconciliation is the formal process of establishing and documenting a

consistent, definitive list of medicines across transitions of care and then rectifying
any discrepancies.

3. Using computerized systems

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 Strengthening electronic prescribing and alert systems. Computerized provider

order entry with decision support may be particularly effective when targeted
at a limited number of potentially inappropriate medications and when
designed to reduce the alert burden by focusing on clinically-relevant
warnings.
4. Focus on building a positive safety culture

Effective leadership and supportive culture are essential for improving safety.
This means creating an environment where professionals and patients feel able to
speak up about safety issues that they are concerned about, without fear of blame
or retribution. It means promoting an environment where people want to report
risks and safety incidents in order to learn from them and reduce their recurrence,
and where incidents are seen as caused largely by system failures rather than
individuals.

Strategies to prevent medication errors from occurring:

 Double check the dosing and frequency of all high alert medication
 If unsure about the drug or dose, speak to the pharmacist.
 If the writing is illegible, do not give the medication. Call healthcare provider
to confirm the drug or dose.
 Recheck the calculation to ensure that the patient will get the right therapeutic
dose.
 Ask another clinician to recheck your calculations.
 Consider using a name alert, some institution s use name alerts to prevent
similar sounding patient names from potential medication mix up
 Document everything
 Ensure proper storage of medication for proper efficacy.
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References
 Potter, P. A., Perry, A .G., Stockert, P. A., & Hall, A(2021). Potter &
Perry’s Essentials of Nursing Practice, Sae, E book. Elsevier Health Sciences.
 Van Ewijk, B.(2018). Medication Error Prevention: Improving Patient Health
Outcome.
 World Health Organization. (2016). Medication errors.

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Patient Fall

Learning objectives:

By that end of this lecture the students will be able to:

 Define Patient Fall

 Differentiate between fall and assisted fall
 Identify risk factors of fall
 Identify Fall assessment tools
 Explain Nursing Strategies in preventing fall
 Discuss Post fall interventions

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Definitions and Terms

A Patient Fall: Is defined as an unplanned descent to the floor with or without injury
to the patient. A fall may result in fractures, lacerations, or internal bleeding, leading
to increased health care utilization. Research shows that close to one-third of falls
can be prevented.

A Fall: is an event which results in the patient or a body part of the patient coming
to rest inadvertently on the ground or other surface lower than the patient, whether or
not an injury is sustained.

Assisted Fall: when a staff member minimizes the impact of the fall by easing the
patient’s descent, or in some manner attempts to break the patient’s fall.

Near Miss: a patient is in a situation at risk for fall, but fall did not occur, such as a
bed rail left down, patient without safety belt, anti-tipper bars left up, safe keeper bed
left unlocked. Patient transferring or ambulating without required assistance.

A Slip: is to slide accidentally causing the patient to lose their balance; this is either
corrected or causes a patient to fall.

A Trip: is to stumble accidentally often over an obstacle causing the patient to lose
their balance, this is either corrected or causes a patient to fall.

Anticipated falls - may occur when a patient whose score on a falls risk tool
indicates she or he is at risk of falls.

Unanticipated falls - occur when the cause of the fall is not reflected in the patient's
risk factor for falls, conditions exist which cause the fall, yet these are not predictable
(e.g., the patient faints suddenly).

Risk assessment tool - a conceptual framework involved a scale that organizes

knowledge on the etiology of predicting falls.
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OVR: Occurrence Variance Report is described as reporting incidents happens

related to falls

Risk factors for falls:

Intrinsic Risk Factors:

1. Advance Age: Age is one of the key factors for falls, older people of age more
than 65 years and younger children have the highest risk of serious injury arising
from a fall or death.

2. Gender: Across all age groups and regions, both genders are at risk of falls. It has
been noted that males are more likely to die from a fall, while females suffer more
non-fatal falls. Older women are especially prone to falls and increased injury
severity.

3. History of Falls: Patients that have had a recent fall, such as a fall in the past three
months, should be considered at a greater risk for possible falls. History of falls may
mask the influence of factors causing these earlier falls. It may be an indicator of an
underlying problem, e.g., impaired balance, which is the real causal agent.

4. Polypharmacy: which is known as the chronic co-prescribing of multiple

medications, has been reported as one of the main causes of falls among the elderly.
The risk of falls increased with the use of four or more drugs

5. High Risk Medications: that act on the brain or on the circulation leading to a fall
is causing these symptoms such as sedation, with slowing of reaction times and
impaired balance, hypotension, including paroxysmal hypotension, bradycardia,
tachycardia, or periods of asystole. Therefore, the risk of falls increases in patients
take medication that cause loss postural gait and balance control. Sedatives,

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anticonvulsants, benzodiazepines, ACE inhibitors, anti-infective agents,

antihistamine drugs, and chemotherapy drugs increases the rate of falling

6. Impaired Mobility: Impaired physical mobility is inability to move purposefully

within the physical environment that includes self-ambulation, bed mobility, moving
from chair to bed, limited range of motion, and inability to perform movements will
collectively cause muscle weakness, decrease muscle strength and power leading to
fall and injuries.

7. Postural Hypotension: or orthostatic hypotension is the sudden changes (drop) in

the blood due to change in the position or posture because it will decrease the blood
supply to vital organs causing dizziness and fainting resulting in falls.

8. Visual Acuity: Visual function changes and deteriorates with age, especially
elderly patients causing poorer eyesight, not able to see quite as clearly, or have
difficulty with sudden light changes or glare blurred vision, double vision, diplopia,
and myopia, and in turn consequently increases fall risk due to loss postural gait and
balance control resulting in falls.

9. Cognitive Dysfunction: People with confusion (memory or thinking problems)

have an increased risk of falling when in hospital due to cognitive impairment,
physical illness and being in unfamiliar surroundings.

Extrinsic Risk Factors

1. Poor Lighting: presents a number of serious risks to safety, that hazards in

hallways and walkways may not be visible.

2. Steep Steps: Stairs of all types are inherently hazardous because people have been
falling on them due to ill design or neglecting to use handrails, cause severe injury
and even death.

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3. Loose Carpets or Rugs: Fall injuries associated with rugs and carpets are
common and may cause potentially severe injuries.

4. Slippery Floors: are a leading cause of slips and falls. Floors may be slick due to
water, excessive or improperly applied wax or polish, or due to the constant
accumulation of moisture in the bathroom are a frequent ground for slip and falls.

5. Badly Fitting Footwear or Clothing: ill-fitting footwear, and specific design

features, such as elevated heels and backless styles, can impair balance control and
heighten the risk of falling.

6. Lack of Safety Equipment: Falls occurring on stairs or in bathrooms are

associated with a high risk of injuries among hospitalized patients, as many hospitals
lacks infrastructure and designed bathrooms well equipped with handles, grabs, side
rails, adequate supporting devices. Lacking this significantly associated with falls
and severe injuries and sometime death.

7. Inaccessible Lights or Windows: Inaccessible lights and windows are sometimes

commonly occurring reasons for falls and injuries as patient tries to access and open
the windows and doors using various surrounding tables and chairs resulting in slips
and loss of balance leading to severe injuries and falls.

8. New Environment: Patient administered in the hospital, which is a very new

environment and unknown surrounding to him/her. Lacks proper orientation and
patient education regarding the necessities and facilities significantly endangers the
patient for potential hospital acquired injuries and falls.

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Fall assessment tools:

Tool 1- Morse Fall Scale:

How to Use the Tool: The Morse Fall Scale uses six different patient risk factors
that gives an indication of the patient’s probability of falling by assigning a
numerical score. The total possible scoring on the scale is 125.

1. History of Falling: Scored as 25 if the patient has fallen during the present
hospital admission or if there was an immediate history of physiologic falls, such as
from seizures or an impaired gait prior to admission. If the patient has not fallen, this
is scored 0. If the patient falls for the first time inhouse, it is scored as 25.

2. Secondary Diagnosis: Scored as 15 if more than one medical diagnosis is listed

on the patient’s chart; if not, scored as 0.

3. Ambulatory Aid: Scored as 0 if patient walks without a walking aid even if

assisted by a nurse, uses a wheelchair, or is on bedrest and does not get out of bed. If
the patient uses crutches, a cane, or a walker, this item scores 15; if patient ambulates
clutching onto the furniture for support, score this item 30.

4. IV Therapy: Scored as 20 if the patient has an intravenous apparatus or a

heparin/saline lock inserted; if not, score 0.

5. Type of Gait: If the patient is in a wheelchair, the patient is scored according to

the gait he or she used when transferring from the wheelchair to the bed.

• Normal: Characterized by the patient walking with head erect, arms swinging
freely at the side, and striding unhesitantly. This gait scores 0.

• Weak: Characterized by the patient having a stooped gait but is able to lift the head
while walking without losing balance. If support from furniture is required, steps are
short, and patient may shuffle, this gait is scored as 10.
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• Impaired: Characterized by the patient having difficulty rising from the chair,
attempting to get up by pushing on the arms of the chair, and/or bouncing several
attempts to rise. Also, the patient’s head is down, they watch the ground while
grasping onto furniture for support, utilize a walking aid for support, or they cannot
walk without assistance. This gait is scored as 20.

6. Mental status: Measured by checking the patient’s own self-assessment of his

or her own ability to ambulate. Ask the patient, “are you able to go to the bathroom
alone or do you need assistance?” If the patient correctly judges his or her own
ability to ambulate and this is consistent with the ambulatory orders in the EHR, the
patient is rated as “normal” and scored 0. If the patient’s response is not consistent
with the mobility order or if the patient’s assessment is unrealistic, then the patient is
considered to overestimate his or her own ability and to be forgetful of limitations
and scored as 15.

Emergency Department Procedure

The Triage Nurse will assess fall risk for patients on admission. Any one of the
following three findings will result in the patient being deemed a high fall risk: a
Morse Score of 70 or greater, a history of a fall within the last 90 days, and the
patient demonstrating overestimation of abilities or forgetting limitations. All
patients assessed as high fall risk will have a yellow fall wrist band applied, and bed
alarm in place while being treated in the Emergency Department.

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Tool 2- Medication Fall Risk Score

Definition: A medication review fall-risk screening tool that is designed for use in
conjunction with nurse administered tools such as the Morse Fall Scale (MFS).

How to Use the Tool: The RN will evaluate medication-related fall risk on
admission and at regular intervals thereafter. The institutional electronic Medication
Fall risk Score website will add up the point value (risk level) for every medication
the patient is administered. If the patient is taking more than one medication in a

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particular risk category, the score should be calculated by: Risk Level Score ×
Number of Medications in that Risk Level Category.

Tool 3- Humpty Dumpty Falls Scale

Definition: The Humpty Dumpty Falls Scale (HDFS), a seven-item assessment scale
used to document age, gender, diagnosis, cognitive impairments, environmental
factors, response to surgery/sedation, and medication usage, is one of several
instruments developed to assess fall risk in pediatric patients.

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Low Risk Standard (Score 7-11) High Risk Standard (Score 12 or >)

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Nursing strategies in preventing fall:

1. Assessment: Assessing who are at risk for fall. All the patient in the hospital
shall be assess for risk of fall starting from the beginning journey at the
hospital. Then reassess frequently at regular intervals. Once the patients are
defined at risk for fall, they must be identified by a specific strategy using
colored Identification band or patient ID band for their level of risk for falls.
2. Patient Education and Awareness: Patients shall be provided with detailed
orientation regarding the room, windows, bed, light switch boards, call bells,
bathroom, outdoors, bedpans, bed exits, and equipment in the room and the
use of call bells in the beginning of the hospitalization itself, as this is the
period very much prone to have falls because patients are not aware about the
immediate surrounding and environment
3. Environmental Factors: Nurses and hospital staff shall always make sure
that the floor is dry, rooms, corridors have sufficient, and enough lighting that
makes things clearly visible. Effective parking of the unused and extra
furniture and equipment that makes unnecessary congestion and traffic in the
rooms. Nurses' calling bells have proven to be an effective strategy for
preventing falls because they alert nursing staff and health care providers that
a patient is in need of assistance
4. Nursing Assistance: It is the primary function of nurses to assist patients who
are in the hospital to provide routine care and assist in the performance of their
daily living activities. Ambulation to bathroom, chair and bedside movements
shall be assisted by the nurses.
5. Medication Management: Nurses must have a detail knowledge about the
medication action and side effects and shall be aware of the list if medications
causing risk of falls. Hence, implementing the interventions to prevent falls

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due to such medications is the nursing responsibility, which involves the

patient awareness and education, frequent assessment and monitoring, and
proving assistance with every ambulation to prevent falls.
6. Supporting Devices: Common fall prevention tools include canes and
walkers, which provide extra stability for patients who are unstable on their
feet. Patients may require help from caregivers for mobility, even with
assistive devices.

Post fall interventions:

Step 1: Assessment
1. The nurse must determine level consciousness patient if loss consciousness, the
nurse must immediately check circulation, airway and breathing and call rapid
response as needed.

2. If no loss, consciousness should determine serious injury, which defined as an

injury involving the neck or spine, or any other major trauma.

3. The attending nurse should not move the patient but should call for assistance
from another nurse and immediately notify a physician.

4. The nurse should perform head to toe assessment for obtain baseline information
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Step 2: Notification and communication

1. After comprehensive assessment, the nurse gathers physical examination findings
in addition to any other relevant information, such as past medical history,
medications, any recent laboratory results, and injury risk factors.

2. After that, the nurse notifies the physician about current situation and the nurse
should determine if any testing or medication holds are indicated.

3. The nurse is responsible for notify physiotherapy and occupational therapy

Step 3: Monitoring and Reassessment

1. After the patient returns to bed, perform frequent neurologic and vital sign checks,
including orthostatic vital signs.

2. Observe patient who have fallen and who are taking anticoagulants or antiplatelet
(blood thinning medications) carefully, because they have an increased risk of
bleeding and intracranial hemorrhage.

3. Ensure ongoing monitoring of patient, because some injuries may not be apparent
at the time of the fall. Frequency and duration of the observations that are required.

4. Contact with the physician and provide relevant details any change in patient
condition.

Step 4: Documentation

Post fall documentation consist of:

• Time of assessment by nurse.

• Potential cause or contributing factors of fall

• Location of fall

• Medications (especially contribute to fall, bleeding risk )

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• Review of recent laboratory results.

• Vital signs

• Pain assessment

• Physical examination completed

• Injury status

• Plan of care updated

• Family notification addressed.

1. Classification:

1.1 To measure the outcome of a fall, many facilities classify falls using a
standardized system.

1.2 Each organization should have injury tracking system, which consist of:

1.2.1 Define types of injuries (such as lacerations, fractures, and bleeds).

1.2.2 Severity of injury definition, which classified into:

• None: indicates that the patient did not sustain an injury secondary to the fall.

• Minor: indicates those injuries requiring a simple intervention.

• Moderate: indicates injuries requiring sutures or splints.

• Major: injuries are those that require surgery, casting, further examination (e.g.,
for a neurological injury).

• Deaths: refers to those that result from injuries sustained from the fall.

2. Reporting

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2.1 Most facilities also require that an incident report be completed for quality
improvement, risk management, and peer review.

2.2 Generate an incident report for every fall that occurs. The incident report will
need to contain, at a minimum:

2.2.1 The fact that the incident being reported was a fall.

2.2.2 The patient in whom the fall occurred.

2.2.3 The date the fall occurred.

2.2.4 The unit the patient was assigned to at the time of the fall.

2.2.5 The location of the fall.

2.2.6 A detailed report about the circumstances of the fall.

2.2.7 The level of injury, if any.

3. Analysis

3.1 Analyzing Fall Related Data:

3.1.1 Purpose of analysis fall related data is enable staff to identify causes or risk
factors also identify about circumstances occurrence of falls.

3.1.2 From analysis fall related data is identify about types of falls, severity of injury.

3.2 Standardizing Rates:

3.2.1 Fall rate:

 Fall Rate = Number of Patient Falls Number of Patient Bed Days × 1000
 The Joint Commission measures patient fall rates as the number of patient
falls, with or without injury to the patient, during the calendar month
multiplied by 1000 divided by patient days by Type of Unit.
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 Patient days are calculated using various methods, but the most accurate
method is to sum the actual hours of stay for all patients, whether in-patient or
short stay, and divide by 24.
3.2.3 Injury rates:

 Calculated the injury rate how many injuries occurred per 100 according to
the following formula:
 Injury Rate = (Number of injuries / Number of Injuries Number of Falls) ×
100
 The multiplier is changed to 100 to produce a meaningful rate for such a
rare outcome.
 We suggest measuring both major and minor injuries rates.
3.3 Root Cause Analysis : is a useful technique for understanding reasons for a
failure in the system. RCA is required if there has been a serious injury or if there has
been a death from fall.

3.4 Using Data Presentation Tools: Visual presentation of falls data is an effective
method for summarizing and presenting outcomes and trends over time among these
tools run chart and control chart.

• Run Charts: purpose from this tool in analyzing falls data is enhanced by ability to
comment on the chart with narrative on the graph when what actions were
implemented to reduce patient falls.

• Control Charts: are a specific kind of run chart which assess the amount variation
within a specified measure range referred to as upper and lower limits of
performance.

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References:

 Ambrose, A. F., Cruz, L., & Paul, G. (2015). Falls and fractures: a
systematic approach to screening and prevention. Maturitas, 82(1), 85-93
 Cox, J., Thomas-Hawkins, C., Pajarillo, E., DeGennaro, S., Cadmus, E.,
& Martinez, M. (2015). Factors associated with falls in hospitalized adult
patients. Applied Nursing Research, 28(2), 78-82.
 Huang, A. R., & Mallet, L. (Eds.). (2016). Medication-related falls in older
people: Causative factors and management strategies. Adis
 Law, M. W. (2013). Evidence-based guidelines of fall prevention programme
for hospitalized older patients. HKU Theses Online (HKUTO).

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