MAM Final Version 10 June 2021
MAM Final Version 10 June 2021
2021
Foreword
This Medical Audit Manual for Ethiopia guides users through the claim and clinical audit functions
of the country’s health insurance system. It revises and expands the first (2016) version of the manual.
The update was developed by the Ethiopian Health Insurance Agency with the assistance of the
Federal Ministry of Health, the USAID Health Financing Improvement Program (HFIP), and the
Clinton Health Access Initiative (CHAI).
As the Ethiopia’s health insurance system strives to attain its goal of financial risk protection for all
Ethiopians under the Universal Health Care (UHC) framework, health insurance membership is rising,
and more insurance schemes are being developed to address the health needs of citizens. Because of
these, the number and level of contracted facilities is increasing, as is the volume and complexity of
claims. These increases, while moving Ethiopia toward its UHC goal, challenges the claims
processing and payment mechanisms of the existing operational systems and workforce. As
community-based health insurance has expanded from pilot to nationwide scale-up, assessments have
documented issues such as beneficiaries’ complaints about sub-optimal care and intentions of misuse
by both providers and beneficiaries. The findings highlighted the need for business transaction reforms
– such as fraud and abuse prevention systems, and detection and deterrent interventions – between the
health insurance system and its client health care providers to ensure the efficiency and effectiveness
of health insurance services as well as the required health service quality.
The manual contains comprehensive frameworks and structures for medical audit services including
audit procedures and the roles and responsibilities of medical auditors and managers. The frameworks
and structures are based on international standards, the Ethiopian Auditors General Audit Manual,
Federal Ministry of Health Clinical Audit Guideline, and best practices of health insurance audit
functions. The medical audit practices laid out here will help greatly in eliminating the challenges
faced by the health Insurance system and enhance the professional capacity of auditors. The manual
is designed to be flexible and unrestrictive and shall be revised as and when necessary.
The Ethiopian Health Insurance Agency, therefore, urges all the users of this manual to carefully adopt
it as a practical guidebook.
Firehiwot Abebe
Director General,
Ethiopian Health Insurance Agency
ii
Acknowledgments
The EHIA is grateful to, and would like to sincerely thank, all those who, in one way or another,
helped with the realization of this manual.
Many thanks for the unreserved management and technical support rendered throughout the process
of the development of the manual by the senior management of EHIA.
The manual benefited well from the knowledge and rich experiences of the technical working group
members from EHIA, MoH, HFIP and CHAI. Thus, the EHIA would like to thank
Special thanks also go to Health Financing Improvement Program/USAIDS and Clinton Heath
Access Initiative for the financial and technical support and to all the institutions and professionals
who participated and provided input during the initial assessment and piloting of the manual.
Finally, thanks to all other internal and external reviewers for their invaluable inputs during the
preparation and review of the manual.
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Acronym
CBHI Community Based Health Insurance
EHIA Ethiopian Health Insurance Agency
HF Health Facility
HIS Health Insurance system
IT Information Technology
MRN Medical Record Number
STG: Standard Treatment Guideline
SUR: Service Utilization Report
UHC Universal Health Coverage
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Table of Contents
Foreword ............................................................................................................................................................ ii
Acknowledgments ............................................................................................................................................. iii
Acronym .............................................................................................................................................................iv
1. Introduction .................................................................................................................................................1
1.1. Background .........................................................................................................................................1
1.2. Purpose, Scope, and Organization of the Manual ...............................................................................2
1.2.1. Purpose ........................................................................................................................................2
1.2.2. Scope ...........................................................................................................................................2
1.2.3. Organization ................................................................................................................................2
1.3. Definition of Terms .............................................................................................................................3
1.4. Principles of a Medical Audit ..............................................................................................................3
1.5. The Benefits of a Medical Audit .........................................................................................................4
2. Claim Audit .................................................................................................................................................6
2.1. Overview .............................................................................................................................................6
2.2. Objectives ............................................................................................................................................6
2.3. Scope ...................................................................................................................................................7
2.4. Prepayment claim audit .......................................................................................................................7
2.4.1. Claim Audit Process ....................................................................................................................7
2.4.2. Trigger Thresholds and Responses............................................................................................13
2.4.3. On-site Claim Verification ........................................................................................................13
2.5. Beneficiary Audit ..............................................................................................................................14
2.6. Post-Payment Claim Audit ................................................................................................................15
2.7. Claim Audit Report Template ...........................................................................................................15
3. Clinical Audit ............................................................................................................................................17
3.1. Introduction .......................................................................................................................................17
3.2. Objectives ..........................................................................................................................................17
3.3. Scope .................................................................................................................................................17
3.4. Types of Clinical Audit .....................................................................................................................17
3.4.1. Comprehensive clinical audit ....................................................................................................17
3.4.2. Periodic Clinical Audit ..............................................................................................................18
3.4.3. Special Audit .............................................................................................................................19
3.5. Clinical Audit Process .......................................................................................................................20
4. Institutional Arrangements for Medical Audit ..........................................................................................24
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4.1. Human Resources and Capacity Building .........................................................................................24
4.1.1. Human resources recruitment and arrangement ........................................................................24
4.1.2. The medical audit structures ......................................................................................................26
4.1.3. Role and responsibility of actors ...............................................................................................26
4.1.4. Code of ethics ............................................................................................................................27
4.2. Monitoring and Evaluation................................................................................................................28
4.3. IT and Medical Audit system ............................................................................................................28
4.3.1. IT infrastructure for detecting fraud ..........................................................................................28
4.3.2. Data mining and analytics .........................................................................................................29
4.4. Handling Medical Audit Grievance ..................................................................................................29
ANNEXES ........................................................................................................................................................30
Annex 1: Similarities and Differences of Clinical Audit by Different Entities .............................................30
Annex 2. Sampling System ...........................................................................................................................30
Annex 3. The Five-Stage Approach to the Clinical Audit ............................................................................31
Annex 4. Clinical Audit Report Writing .......................................................................................................35
Annex 5. Special Clinical Audit Planning and Summary Form ....................................................................36
Annex 6. Medical Audit Teams’ Professional Mix .......................................................................................36
Annex 7. Checklist to Monitor a Clinical Audit Program .............................................................................40
1. Clinical care audit......................................................................................................................................42
2. Pharmacy audit checklist ...........................................................................................................................44
3. Referral audit tool......................................................................................................................................46
4. Quality improvement audit checklist ........................................................................................................48
Table of Figures
Figure 1: Claim audit process ....................................................................................................................... 16
Figure 2: Clinical audit Stage cycle ............................................................................................................. 28
Figure 3: Clinical audit process flow chart .................................................................................................. 33
Figure 4: Medical auditor’s recruitment process ......................................................................................... 36
Figure 5: Medical audit indicators components. ......................................................................................... 44
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Section 1: Introduction to Medical
Audit Manual
vii
1. Introduction
1.1. Background
The Ethiopian government has put in place short-, medium-, and long-term strategies to reform the health
sector so it can mobilize and efficiently use domestic and donor resources to ensure the delivery of health
care services of acceptable quality to the entire population, in a sustainable and equitable manner.
The success of universal health coverage (UHC) depends on all people having access to evidence-based
care that is safe, effective, and people-centered. In line with the global Sustainable Development Goals
movement, the Ethiopian Government aims to achieve UHC through delivery of quality services and
financial protection. To do this, the government has implemented several major health sector reforms,
including the Health Care Financing Strategy, and it established the Ethiopian Health Insurance Agency
(EHIA) to develop a sustainable and equitable financing mechanism for delivering health care services to
all segments of the population. The EHIA is steering the journey to UHC through its community-based
health insurance (CBHI) and social health insurance programs, each targeting the different social groups in
the country.
CBHI is designed for people in the informal sector, to improve their financial access to health care services
and to protect them from the financial risks associated with illness. For people who work in the formal
sector, EHIA is preparing to implement social health insurance. Both insurance programs are based on the
concepts of solidarity and mutual help. Their institutional arrangements are designed to maximize their key
functions: resource mobilization, pooling, and purchasing of health care services.
Good governance and administration are critically important to health insurance programs. The
effectiveness and longevity of these programs depend on compliance with policies, strategies, guidelines,
and processes put in place to guide their actions. Their compliance also helps their beneficiaries develop
trust in the programs.
One process that is essential to an effective, sustainable, and trustworthy insurance program is the medical
audit. Medical audits must be carefully planned in order to produce maximum benefit – that is, to ensure
through measurement that the services the program’s contracted facilities provide to insurance beneficiaries
are evidence-based and meet certain standards.
The Joint Learning Network’s Toolkit to Develop and Strengthen Medical Audit Systems1 defines a
medical audit system as “a quality improvement process with a step-by-step analysis against explicit criteria
of cost and quality of care that seeks to improve patient outcomes and financial risk protection for an
effective and efficient healthcare system, where indicated changes are implemented at an individual, team,
or service level and further monitoring is used to confirm improvements in healthcare delivery.”
According to the Joint Learning Network, medical audits in the insurance sector can be divided into clinical
and non-clinical audits. Clinical audits audit actual practice against evidenced-based clinical standards of
care. Non-clinical audits, also known as claims audits, validate medical bills to confirm that the submitted
claims reflect the services rendered by the health care provider.
1
https://www.jointlearningnetwork.org/wp-content/uploads/2019/11/Medical_Audit_Systems_Toolkit.pdf
1
The EHIA developed and implemented a first clinical audit manual in 2015 and revised it in 2016. The
manual covered only the auditing of CBHI schemes. The initial reaction to the manual by both insurance
staff and providers was encouraging. The manual improved health insurance system-provider
communication by providing objective and relevant information and by helping them discharge activities
as per their contractual agreement and standards of care. However, the manual was not flexible and
comprehensive enough for the full range of medical audit functions and processes. For example, it focused
only on primary care facilities and on overstretched scheme staff; it did not audit secondary and tertiary
care facilities or engage senior medical professionals. As the coverage and the number of claims managed
increased, the health insurance program needed a more robust medical audit system to ensure that its
contracted providers were delivering quality health services to beneficiaries and to effectively prevent,
detect, and deter fraud and abuse by providers and beneficiaries.
Cognizant of these changes and needs, the EHIA revised and updated its earlier Clinical Audit Manual for
the Community based Health Insurance Schemes and renamed it the Medical Audit Manual.
The revision includes examining the achievements and challenges of the previous clinical audit manual and
by reviewing the medical audit systems of six countries: Ghana, Kenya, Rwanda, South Africa, South
Korea, and Tanzania.
(i) Provide health insurance auditors with practical, systematic, and disciplined guidance, tools, and
information to handle the medical audit cycle from planning to reporting
(ii) Enhance the quality and effectiveness of the medical audit by providing guidance on methods for
collecting and documenting relevant audit evidence, and procedures and processes for maintaining
a quality medical audit service
1.2.2. Scope
This manual is a tool for EHIA staff involved in medical audits and for facilities interested in being
contracted by the EHIA, irrespective of facility ownership. It also covers the claim audit process, as well
as other quality assurance and improvement activities of the health insurance system.
1.2.3. Organization
Medical audits are of two broad types: claim audit and clinical audit. Sections 2 and 3 of this manual discuss
each type in detail. Institutional arrangements – human resources, monitoring and evaluation, use of
information technology (IT), and handling of complaints and grievances – that are common to both types
of audits are discussed in the fourth section. Standard operating procedures, checklists, and sample audits
are included as annexes.
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1.3. Definition of Terms
Claim: a request sent from a health care provider to a health insurance system for reimbursement based on
services that have been provided to a person who is eligible for the services covered by the health insurance
system.
Claim audit: a process of validating claims submitted by health service providers by systematically
examining the beneficiary, services, and costs.
Claim dataset: are manual or electronic records of several transactions that contain information related
to beneficiary identification, diagnoses, procedures, and costs.
Batch: is an aggregation of a multiple claim data set requested from health care providers in specific period.
Claim management: is the organization, filing, updating, processing, auditing and reimbursement of
medical claims related to health services to beneficiaries.
Health care provider: public, private, or nonprofit health facilities (e.g., health centers, hospitals,
hospitals, clinics, medicine retail outlets, imaging, and diagnostic centers) that enter into contractual
agreement with the health insurance system to provide health services to the insurance beneficiaries.
Health insurance system: formal arrangement in which insured persons (beneficiaries) are protected
from the costs of medical services that are covered by the health insurance plan (the benefits). In Ethiopia,
it includes the EHIA head office, and its branches and schemes.
Clinical audit: a quality improvement process that seeks to improve patient care and outcomes through
systematic review of care against explicit criteria and the implementation of change.
Medical auditor: a certified health or health financing professional who has an in-depth knowledge of
quality, patient safety, and EHIA principles and standards; has effective communication, interviewing, and
teaching skills; and is considered a “peer” by those whose facility or program he/she is assessing.
Medical record: A compilation of data supporting and describing an individual’s health care encounter
including data on diagnoses, treatment, and outcomes Also known as the health record or clinical record.
• Confidentiality: The medical audit and auditors are bound by rules of confidentiality. The data
collected for a medical audit must be relevant to the audit objectives and not be used for any
purpose other than the audit. When possible, information should be made anonymous before it is
used in an audit. Both the data and the audit report should be kept secure.
• Data driven: A medical audit can be undertaken only if enough relevant and good-quality data
are available to ensure credible results are produced.
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• Structured: A medical audit should be part of a structured program to improve quality of care
and prevent improper payments within the health insurance system. Hence, the medical audit
should be aligned with national/regional principles, frameworks, tools, and approaches for quality
improvement.
• Participatory: A medical audit is participatory in nature. It involves multidisciplinary teams that
comprise health care workers and finance professionals at any level or tier of the health care system.
Working in teams ensures that appropriate skills are pooled throughout the process.
• Professionalism: A medical audit needs specific clinical and financial competencies,
confidentiality of the results, and adherence to tools and principles.
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Section 2: Claim Audit
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2. Claim Audit
2.1. Overview
Claim audit aims to prevent and detect fraud, abuse, and waste in the insurance system and execute timely
reimbursement. In addition, it encourages health service providers to foster compliance with standards,
clinical guidelines, and contracts. This section explains how to conduct prepayment, beneficiary audit and
post payment claim audit within the claim management practice of the insurance system.
A pre-payment claim audit determines if the claim dataset submitted for payment to a health insurance
system is as per the contract agreement and set standards. The health insurance system reviews the
submitted claims to identify anomalies and confirm that the claims reflect the correctness of services
provided to the named beneficiaries.
A claim audit depends primarily on the documentation submitted by the health service provider, such as
the claim form (paper or electronic), medical records, fee schedule, contracts, and costs incurred.
Beneficiary audits collect utilization information from selected beneficiaries through various means. Post
payment claim audit reanalyze sample of claim dataset at the insurance system.
2.2. Objectives
2.2.1. General Objective: To optimize operational efficiency by providing timely and accurate claim
reimbursement and institutionalize mechanisms prevent, detect, and mitigate the level of risk associated
with claims fraud; and to produce strategic evidence for decision making in the health insurance system.
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• Assure quality by validating submitted claims against standard of care and the contractual
agreement
• Synthesis of strategic information for decision making
2.3. Scope
The health insurance system’s claim auditor reviews claim to determine health care provider compliance
with benefit package, coding, and billing rules and takes appropriate action if needed. Hence, the scope of
the claim audit applies to all health care providers that have entered a contractual agreement with the health
insurance system and audit beneficiaries.
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Health Insurance System (Check if set criteria are met or not)
1. Claim submission
Reject if criteria 2. Claim reception
HEALTH
not met
FACILITY
4. Claim adjudications
• New claim data set prepared and submitted
Reject if criteria
not met ii. Diagnosis
Reject if criteria
vi. Medicine
not met
Rejected
Accepted
After checking and verifying the completeness of the above checklist, the claim dataset will be forwarded
for initial claim review.
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Step 3: Initial claim review
During initial claim review, the health insurance officer checks the claim form/s against the checklist in
Table 2 for any errors or omissions. The point is to verify that the profile information of the beneficiary on
the claim matches the details in the health insurance system beneficiary database. If the response to any of
these criteria is ‘No,’ the claim will be rejected and returned to the facility for correction and resubmission.
In the case of electronic submission, only the rejected ones will return to the facility. Upon correction and
resubmission, the corrected one will be part of the initial claim dataset and will be analyzed altogether.
Table 2. Checklist for Initial Claim Review
No Criteria Yes No Action
1 Is the general appearance of the claim neat, readable, and Advise on how to improve
complete?
2 Is the serial number consistent? Correct the consistency
3 Is the treatment date for each claim aligned with the requesting Reject if it is out of the claim
batch? batch
4 Is the request submitted for an eligible beneficiary? (Check Reject the claim if not active
eligibility of the beneficiary with the active members list). member
5 Is the total of all claims, correct? Insert a new column and label Reject, if there is a difference
it ‘new total’ and sum up all the charges. Compare the ‘new between the ‘total’ and ‘new
total’ with the ‘total’. total’
6 Is there duplication of claims? Reject the duplicate claim
7 Is there a CBHI ID-MRN mismatch? Reject if there is a mismatch
8 Is the service cost requested as per the contract? Reject if it is inconsistent
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• Procedure to provider: selective screening of services that need review for a given provider.
• Frequency to time: screen for a certain number of services provided within a given time.
• Diagnosis to procedure: screen for services submitted with a specific diagnosis.
• Procedure to place of Service: selective screening of claims where the service was provided in a
certain setting such as a major surgery at health center level.
• Comparison with standard (E.g., service cost, standard treatment guidelines (STGs))
The health insurance system might encompass a three-level hierarchy of review based on the complexity
of the claim submitted. The following triage hierarchy can be applicable: i) Staff review (by an officer of
the health insurance system), ii) Peer review (staff of the insurance system,), and iii) Committee review (at
zonal, regional, or national level).
i) Staff review: In staff review, one member of the health insurance team looks at the claim, focusing
on trends, and the appropriateness of claim specifications (e.g., a close review of claim areas with a
high probability of error, such as duplicate claim and arithmetic error). Usually, this level of review is
the continuation of the initial review. It runs a test of homogeneity and a pivot table for further analysis.
ii) Peer review: The health insurance officer who does the initial review of the claim can request a
second review by a peer (staff of the health insurance system) as per needed. For instance, peer review
is requested when a professional view on medicines, clinical care, diagnostics etc. is needed.
iii) Committee Review: It is advisable to have a review committee of experts with specialized skills
for fair and enhanced reviews of claims at zonal, regional, or national level. It can be a standing
committee that meets on a regular basis to review complicated claims, or it can be called in on an ad
hoc basis. Members can be representatives from the health system or insurance system at the zonal,
regional, or national level, or they can be outside experts employed on a contractual basis. In addition
to reviewing claims, the committee also can suggest changes to billing rules and insurance specific
processes.
The checklist for claim adjudication is divided into four categories: diagnosis-related, investigation-related,
medicine/supply-related, and cost and any other issues-related. As pre-payment claim audit covers 100%
of the claim, the adjudication process identifies claims with questionable services and costs for further
investigation.
Is the requested health service cost not as per the fee schedule If Yes, deny the claim
and agreement?
Outliers detected by central tendency If Yes, hold the claim
and plan to clarify
further
Does the service cost of procedure vary from the cost of similar If Yes, deny the claim
procedures?
Does the service utilization frequency seem unusual for the If Yes, deny the claim
period (E.g., request for card and consultation in less than 2
weeks, too many visits, etc)?
Has the claim been criticized on the service quality or any, at the If Yes, hold the claim
time of service (pre-informed or complained or reported and plan to clarify
service)? further
At any claim review process, health facilities can be requested to submit supplementary materials so that it
can support the decision process. The health facility may be requested by phone, fax, or email or any
convenient methods for the specific documents and explanation of why a variation happened.
Step 5. Decision
After reviewing the submitted claim data set, the health insurance system will execute the possible
decisions:
The last three decisions will enable the health insurance scheme to avoid or recoup overpayments and return
underpayments.
Step 6: Follow-up
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The health insurance scheme should continuously monitor to prevent errors in services and commodities
that pose the greatest financial risk to the scheme and greatest health risk to the beneficiary. It also should
monitor facility adherence to agreed standards and audit recommendations. Facilities with flagged claims
may be put on monitoring, be required to receive relevant training, be warned, be subject to close review,
or even be subject to on-site investigation. A reward or recognition system for facilities with clean audits
also helps maintain them as best-performing facilities.
As the above implies, triggers can easily be embedded and used in an automated claim audit system. It
is more challenging to embed triggers in a manual claim audit system.
On-site verification of suspicious claims can result from claims data triggers such as an insurance ID-MRN
mismatch; deviation from an STG; a request by the health care providers; and complaints by beneficiaries,
whistle-blowers, or the public. On-site verification involves scrutinizing a submitted claim against records
available at the health facility to determine authenticity. On-site audit findings may be used to initiate a
special clinical audit.
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The on-site audit process encompasses the following steps:
Preparatory stage: An auditor identifies areas for verification and relevant documents regarding the
exercise to be conducted. The auditors should prepare for the health facility a list of documents needed –
medical records, patient files, registers, prescriptions, order slips, laboratory investigations, etc. – and
communicate it for retrieval ahead of the visit.
Facility entry stage: The audit team meets with the health facility management team and briefs them on
the purpose of the verification exercise. The team should request a representative who is a clinician or
another person who is knowledgeable about the area to be verified. This person will ensure that all
documents are available and ready for review, and an appropriate workspace is available.
Excursion stage: The audit team will sit down and check each item to be verified against existing medical
records and standards.
Exit stage: After the verification exercise is completed, the audit team will call an exit meeting at which
it will present a verification report to the facility management team. The team will write an official letter to
the facility management within two weeks, informing them of anomalies, deductions, and suggestions on
how to rectify those anomalies.
The communications with beneficiaries after or during patient care should observe the following rules:
• All beneficiaries’ contacts are handled with the utmost care and sensitivity.
• Patients are contacted at reasonable hours, in agreement with the patients.
• The audit or investigation is not to be discussed with the patient except to explain the process in
general terms.
• When a patient is approached, auditors show their identification and explain their role.
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• The patient is asked if he/she minds answering questions regarding their enrollment or the service
which was claimed. If the patient does not wish to cooperate, auditors will not take any further
action at that time.
If the questionable claim issue cannot be resolved directly with the beneficiary, the health insurance
program should take the following actions:
1. Where there is strong evidence that a beneficiary has abused the insurance program, the
beneficiary is reported to police authorities for investigation.
2. Where there is strong evidence of over-servicing by a provider, the health facility may be
subjected to a further audit/investigation.
This entails purposeful selection of a random sample of claims to check accuracy of the health insurance
system’s claim audit process. Hence, previously submitted claims are randomly selected and scrutinized
using the audit process. These claims are checked through the routine claim audit process to determine the
overall claim audit accuracy for a year or the agreed time.
Post-payment claim audits should be conducted by both the contracting health insurance system for self-
evaluation and by the next level of the health insurance system for verification (e.g., schemes by branches
and branches by the agency). Based on the post-payment audit, schemes will be identified for capacity
building or recognition.
• Objective
• Audit period
• Major findings and recommendations
Introduction
Objectives and scope
Audit methods
Key findings
Claim adjustments and decisions
Recommendations
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Section 3: Clinical Audit
16
3. Clinical Audit
3.1. Introduction
A clinical audit is a quality improvement process with a stepwise analysis of health care services against
explicit criteria of quality of care. An effective clinical audit system ensures an effective, efficient, and
financially sustainable health care system. The goal is to improve patient outcomes, patient satisfaction,
and financial sustainability.
In our health insurance system, clinical audits are performed mainly to verify that health care providers are
delivering services to health insurance beneficiaries in compliance with what is stipulated in the contract,
national clinical standards, and the National Referral Guideline.
3.2. Objectives
The objectives of the health insurance clinical audit are:
• To verify, using available methods and tools, that the services provided to beneficiaries are as per the
terms of agreement, are of optimal quality, and meet local and national standards.
• To enhance continuous quality improvement practices in health facilities
• To prevent and detect intentional and unintentional malpractice or errors in service provisions
• To improve beneficiary satisfaction in the health insurance system
3.3. Scope
A clinical audit is applicable to all health facilities contracted or to be contracted with the health insurance
system. It will be conducted by trained medical auditors at different levels of the health insurance system.
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• Facilities that meet the minimum requirements of the self-assessment become eligible for a
comprehensive audit by the health insurance system; those that do not meet the minimum
requirements are advised to improve.
• The contracting body in the insurance system conducts a comprehensive audit of eligible
facilities as a prerequisite for contracting and provides recommendations for how to resolve
any gaps identified.
• For facilities that meet the minimum requirements of the comprehensive audit, the health
insurance system and the facility sign a contract to which are annexed the comprehensive audit
findings.
• The insurance system follows up on the gaps identified during future periodic audits (refer to
period audit part).
• The health insurance system conducts the audit using a checklist specifically designed for the
level of the facility.
• The contract is renewed for those facilities that meet the requirements. The health insurance
system and these facilities sign a contract to which the comprehensive audit findings are
annexed.
• For facilities that do not meet the requirements, the insurance system provides
recommendations for improving the identified gaps and gives the facilities time to make the
improvements (further discussion).
• The health insurance system follows up with the facilities on their progress making the
recommended improvements as part of the periodic audit (Section 3.4.2).
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monitor improvements. Although brief, the periodic audit is a critical aspect of the medical audit system
that focuses on four identified priority areas prone to poor quality or abuse:
Clinical care: Periodic checks of the relevance and adequacy of clinical care given to insurance
beneficiaries, assessed through a review of patient medical records.
Pharmacy service: Poor availability of drugs and supplies is a major challenge to the health
insurance system because it greatly affects beneficiary satisfaction. In addition, it is a costly service.
This audit assesses the availability of drugs and supplies and the appropriateness of the prescribed drugs
(the right drug for the right illness and availability of required information on prescription papers, etc.).
Quality improvement on identified gaps: will assess the implementation of sustainable health
service quality improvement initiatives/activities.
Referral system: The referral database and referral system are audited to assess the relevance,
efficiency, and effectiveness of the system and to ensure that insurance beneficiaries are getting optimal
health care.
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3.5. Clinical Audit Process
Logistics
prepara
Ready tion Commun
supporti icate
with
ve docs facility
Ready Entrance
checklist conferen
ce
Audit Perform
plan audit
Reinitiat Action
e the plan
audit
Final Exit
audit confere
report nce
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The audit team collects the supporting documents that the team will reference while conducting the audit.
These include:
• At the exit conference, the audit team shares their preliminary audit results and
observations with selected health facility department heads and management team.
Management can clarify issues identified, and it works with the audit team to plan how
the health facility will remediate the weakness in a way that can be verified during the
next audit.
9. Final audit report (see also Annex 4)
• The final audit report includes the date and location of the audit and identifies all
participants who took part in or contributed information to the audit. The report should
identify clearly which parts or activities of the organization were audited.
• The report also includes the audit findings, agreed gaps, and the proposed solutions to
the gaps. It proposes an improvement plan and sets deadlines by which corrective
actions or audit responses are to be completed. It also explains how corrective actions
can be verified.
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Section 4: Institutional Arrangements for
Medical Audit
23
4. Institutional Arrangements for Medical Audit
This section discusses human resource arrangements and capacity building, monitoring and evaluation, and
dispute management.
Therefore, pre-service, and in-service education and training on the medical audit should be strengthened;
frequent checks of the knowledge and skill of the auditors and capacity building in the form of refresher or
coaching should be provided; and a national registry of trained and certified auditors should be
institutionalized. Figure 3 illustrates the steps in selecting and training the medical auditors.
I. Attend a formal classroom course that uses the Medical Insurance Manual and covers
topics including standards, the audit process, and scoring.
II. Observe one (or more) “mock” or practice audits conducted by experienced certified
trainers. The number of observations required is based on the experienced certified
trainers’ evaluations.
III. Conduct one (or more) “mock” or practice audits under the observation of experienced
certified trainers. The number required is based on the experienced certified trainers’
evaluations.
IV. Demonstrate the ability to write an audit report that includes findings and
recommendations for remediation of each standard that was not fully met.
Certification management: The health insurance system will establish a database consisting of a medical
auditor candidate’s biographic data and contact details, and date of completion of certification requirements,
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before issuing the certificate. The database will be kept safe and the information it contains confidential
and will update the activity of the certified medical auditors (Active/Not Active for the year). This will be
used at the end of the fifth year to renew or revoke the certificate. To renew the certificate, the medical
auditors must participate in at least in one medical audit per year.
Audit facilitators: are designated health insurance system staff at woreda, zone, regional, and national
levels. Their primary role is to lead routine management of medical audit activities. The facilitator guides
the process from design and planning to documentation and dissemination of the final audit report. During
an audit, he/she facilitates audit implementation and helps the audit team reach a common understanding
of the audit methodology, assimilate the evidence, and work effectively.
Audit team leaders; are senior clinicians responsible for conducting the audit. They actively support the
facilitator in day-to-day activities and liaise with the facilitator to plan and to execute all audit activities,
coordinate and organize trainings, produce audit reports, and carry out other activities as needed.
Medical audit team members/auditors are certified/entitled to perform medical audits and serve on
an audit team. The health insurance system defines auditors as professionals with an in-depth knowledge
of quality, patient safety, key health system standards, finance standards, and the auditing tools. They have
effective communication, interviewing, and teaching skills and are considered a “peer” by those whose
facility/organization they are assessing. In addition to conducting actual audits, auditors may, when it serves
the health insurance system’s interests, also serve as consultants to help health facilities prepare for the
audit.
4.1.3.1. Role and responsibility of the health insurance system at all levels:
• Ensure robust processes are in place for the effective management of the medical audit.
• Ensure effective structures are in place to support the medical audit system and monitor the
structures to make sure they operate effectively.
• Approve the national annual and strategic plan for medical audit and align them with the respective
plans of EHIA.
• Ensure the medical audit function is adequately resourced and has appropriate human resource
selection, training, deployment, and retention mechanisms.
• Provide support, leadership, facilitation, and management of audits and quality improvement across
the health insurance system with a focus on increasing quality outcomes and value for money.
• Ensure availability of robust indicators for monitoring and evaluation of the medical audit system
and install a reporting and feedback loop.
• Promote action to improve the quality and safety of patient care through prioritization of outcomes
identified.
26
• Ensure effective dissemination of audit outcomes, recommendations and improvements to health
service providers and authorities.
• Safeguard completion of the audits to health insurance system standards and the implementation.
• Liaise with audit team leader in the planning, implementation, and evaluation of audit activities.
• Ensure that the audit data and reports are compiled and communicated as per the guide.
• Ensure gaps and significant risks identified through audit are addressed.
• Support the development of realistic improvement plans and their successful implementation.
Each audit team should have an appointed team leader whose responsibilities include the following:
• Lead and coordinate medical audit activities and the overall team.
• Develop and coordinate the audit agenda with the health care facility.
• Ensure logistics have been arranged.
• Assign specific activities to each team member.
• Coordinate report preparation and submission to the health insurance system.
Failure to adhere to this code of ethics may be grounds for dismissal as an auditor.
27
4.2. Monitoring and Evaluation
The medical audit coordinator in collaboration with the audit team will ensure the preparation and
submission of the audit report to the health insurance system within one month of audit completion
according to the guidance below. The audit facilitator will prepare and submit an audit report and action
plan to the higher level of the health insurance system on a quarterly base.
Objectives:
• Measure the compliance of medical audit implementation with guidance in this manual.
• Measure the effectiveness of the medical audit interventions on health outcomes and cost.
• Generate evidence for further improvement and action.
• Identify and disseminate best practices.
• Ensure accountability at all levels.
The health insurance system will monitor the progress of the implementation of planned activities and
actions plans.
28
• Claims processing module
• Grievance redressed module
• Hotline module.
Stage 1: Complainant expresses concern about any aspect of the medical audit; however, no specific action
or remedy is required as the health insurance system rules have been applied correctly.
Stage 2: Complainant expresses concern about any aspect of the medical audit and is not satisfied with the
explanation provided in Stage 1. This requires further action by a staff member or referral to the health
insurance system manager at that same level for determination. The manager resolves the issue and the
provider is advised of the outcome and accepts the explanation.
Stage 3: Complainant expresses concern about any aspect of the medical audit and is not satisfied with the
explanation provided in Stage 2. The matter is referred as per the contractual agreement and legal issues in
away other grievance of the health insurance system.
29
ANNEXES
Annex 1: Similarities and Differences of Clinical Audit by Different Entities
Ministry of Health Health Insurance System
Health Facilities
Focus External quality Internal quality External quality assurance
assurance assurance
By Ad hoc team Facility staff Ad hoc team from surrounding
whom facilities and health insurance
system
Tool National Local standards Mixed (national for
standards + national comprehensive audit and
standard periodic and local for special
audit)
Priority RMNCH, On identified Priority: financial risk (high
HIV/TB/NCD, gaps cost) and client engagement
surgical service (clinical care, pharmacy,
referral and quality
improvement)
Annex 2. Sampling System
30
Annex 3. The Five-Stage Approach to the Clinical Audit
Clinical audit is a cyclical process with five stages:
Involve users: An effective audit requires the commitment of the audit team members and
cooperation of health facility staff. Hence, it is important to involve all these stakeholders as early
as possible and give everyone a chance to contribute. All those involved in the audit should be
identified officially before the audit commences, and their approval for involvement sought and
agreed. Agreement on leadership and ownership of the audit should be reached at this stage as well
as responsibility for management of audit results and recommendations.
Selecting a topic: Clinical topics first need to be prioritized in order to select the ‘right’ topics for
the audit. Useful questions clinical teams can ask in this regard are:
31
• Is the topic of concern high cost, volume, or risk to staff or users?
• Is there evidence of a serious quality problem?
• Is there evidence to inform standards, e.g., national and/ or provincial clinical guidelines?
• Is the problem amenable to change?
• Is the topic pertinent to national/ regional policy initiatives?
• Is the topic a priority for the health facility?
These problems and/ or differences between current and desired performance should provide the
required topics for the clinical audit.
Define the purpose of the audit: It is important at the beginning of an audit to have a clear sense
of purpose so once a problem is identified, the audit team needs to agree on the objectives for the
audit. The team should ask:
• What do I want to know by undertaking this audit?
• What do I want to achieve by undertaking this audit?
Verbs such as, ‘to improve,’ ‘to enhance,’ ‘to ensure,’ and ‘to change’ are useful in stating clear
objectives. For example:
• “To improve the safety of our drug prescribing.”
• “To enhance the quality of care given to patients by improving medical record
documentation.”
• “To ensure that every beneficiary received safe, courteous, and respectful care.”
• “To change and improve the patient flow in the facility.”
Objectives must be measurable and achievable and in line with the strategy and objectives of the
audit program and the organization as a whole. The agreed audit objectives should be documented
in an audit proposal form.
Provide the necessary structure(s): The clinical audit becomes truly beneficial to the health
facility as a quality improvement tool, when:
• A structured audit program is in place, i.e., there is a committee structure, feedback
mechanisms exist, and regular audit meetings are held.
• Funds are provided for the audit and appropriately used when responding to the findings of
clinical audit.
• Protected time is allocated to all staff members who will be involved in investigating the
audit topic, in collecting and analyzing data, and in completing the audit cycle.
Identify the skills and people needed to conduct the audit, encourage them to participate, and
train them: Clinical audits require a wide range of skills. The specific project will determine the
specific skills that the team members need (see the human resources section of this manual).
However, all audit project team members should have:
• A basic understanding of a clinical audit
• An understanding of and commitment to the aims and plans of the audit project
• An understanding of what is expected of the audit team
Data collection: A data collection tool and protocol for collection are usually required unless you can run
audit reports from a database. Where to find the data: Are the data you want collected routinely in the
patient medical record or databases? Although data from clinical records are frequently used, they are often
incomplete. Collecting data from several sources can help overcome this problem. Potential sources to
consider are: patient medical records, laboratory reports, prescriptions, pharmacy registers, radiology
reports, inpatient registers, and operation notes.
Sampling: An audit often involves making a pragmatic choice of the audit sample size. A clinical audit
does not have to involve extensive data collection. It is not research and does not require large numbers of
cases. It is a balance between what is practical to collect and what will confirm the level of performance in
comparison with the standard.
Data analysis: The analysis of all the data collected should be performed and comparisons drawn with the
existing criteria and standards. The clinical audit team draws conclusions on how well the standards were
met or not, identifies the root causes of problems, and disseminates the findings. Data analysis tools, such
as bar charts, run charts, and Pareto diagrams, should be used to identify and display information. The
clinical audit team should present the data in as many ways possible to ensure the maximum knowledge
and understanding of the clinical audit project is achieved throughout the facility.
Report writing: An audit report should report the actual practice compared with the standard. The report
should identify shortcomings and needed improvements. The structure and content of an audit report is
shown on in claim audit section Reports should not identify individual patients or health care professionals,
but they need to be sufficiently detailed to inform managers and those with whom they are making contracts
that proper quality assurance programs for clinical performance are in place. Furthermore, managers need
to know what recommendations come from audit committees that have cost consequences, to enable them
to make informed decisions about resource allocations.
It is also important to involve management in the change planning and implementation stage. They may
need to allocate resources to the quality improvement and they should be advised on what quality
improvement activities are underway in their areas of responsibility.
STAGE 5: Sustaining Improvement
As the primary objective of audit is to improve health care delivery, sustaining any such improvement is
important. Thus, any systematic approach to changing professional practice should include plans to
monitor and evaluate the change in practice and plans to maintain and reinforce the change.
Monitoring and evaluating changes: Collecting data for a second time, after changes have been
introduced, is central to both assessing and maintaining the improvements made during clinical
audit. The same procedures of sample selection, information collection, and analysis should be used
throughout the process, to ensure that the data are valid and comparable with each other. If
performance targets were not reached during implementation, modifications to the plan or additional
interventions will be needed.
Maintaining and reinforcing improvement: Audit improvement should be integrated into the
overall quality improvement strategy in the health facility. If improvements are sustained, it
becomes very important for the team to celebrate and share their success with other facility staff
members and with management. Clinical audits may be used as a means to document and
disseminate best practices between different facilities in a scheme and even among
schemes/branches.
34
Annex 4. Clinical Audit Report Writing
A clinical audit report template is available which highlights that audit reports should contain the following
headings and contents:
1. Title Page
This includes the title of the report, who wrote it, and the date it was written. .
2. Contents Page
This lists the section headings in the report together with the page numbers on which the
sections start.
3. Executive Summary
This is an overview of the message in the report, with a clear summary of the recommendations.
4. Introduction/Background
These can be two separate sections or combined. It should set the context of the report and
define the scope and any limitations of the study.
5. Aims and Objectives
This should clearly identify what the audit wanted to achieve.
6. Standards
This section documents any standards against which current practices were measured. It should
include the relevant evidence base from which the standards are taken.
7. Methodology
This section details how the study was undertaken. It should include how the information was
collected, when the project took place, how it was carried out,
8. Results
The findings are presented in a logical and progressive manner and are interspersed with
graphics to assist understanding. The information given should justify the conclusions and
recommendations which follow.
9. Conclusions
These are derived from the results section and should also link back to the aims and objectives.
No new information should be included. Bullet points are a recommended way for emphasizing
the key points.
10. Recommendations
This section highlights the actions which need to be taken to follow on from the project. As
with the conclusion section, recommendations should be derived from the main body of the
report and should not include new information.
11. Action Plan
All reports must include an action plan based on the recommendations. It should include the
action required, who is responsible for doing it, and the date by which it should be completed,
and, if necessary, a date and plan for a re-audit.
35
Annex 5. Special Clinical Audit Planning and Summary Form
Special Clinical Audit Ethiopian Health Insurance Agency
Planning & Summary Form
Special audit Title: Audit Ref No
Audit Team
1. Senior Clinician 2. Audit facilitator
Background: What? Why? What benefits for the health insurance system?
------------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------
Aims & Objectives
Standards Target Evide Data
nce source
Presentation------------------------Date----------------------------------
36
Type of Comprehensive Periodic Audit Special Audit
Facility Audit (professional
to be requirements should
Audited be revised based on
audit’s scope)
(QI)
▪ Certified laboratory QI)
▪ Certified laboratory
▪ Certified accountant ▪ Certified IPC
(QI)
auditor auditor
▪ Certified health
▪ Certified health ▪ Certified nurse
informatics auditor
informatics auditor auditor (QI)
(QI, MR)
▪ Certified laboratory
(QI)
▪ Certified health
informatics auditor
(QI, MR)
▪ Certified specialist ▪ Certified ▪ As per need,
physician auditor (2) physician/Health
▪ Certified specialist
Officer auditor (QI,
▪ Certified pharmacy physician auditor
MR, diagnostics,
auditor (QI, MR,
pharmacy)
diagnostics,
▪ Certified nurse
▪ Certified nurse auditor pharmacy)
auditor
(QI,
▪ Certified pharmacy
▪ Certified IPC auditor
▪ Certified IPC/QI auditor (pharmacy,
▪ Certified laboratory
General Hospital
auditor QI)
▪ Certified accountant ▪ Certified HIT auditor ▪ Certified IPC
auditor auditor
▪ Certified accountant
▪ Certified health auditor ▪ Certified nurse
informatics auditor auditor (QI)
▪ Certified laboratory
(QI)
▪ Certified health
informatics auditor
(QI, MR)
37
▪ Certified physician ▪ Certified health ▪ As per need,
auditor officer/nurse auditor
▪ Certified physician
▪ Certified pharmacy ▪ Certified HIT auditor auditor (QI, MR,
auditor URTI, Pharmacy)
Certified pharmacy
▪ Certified auditor ▪ Certified pharmacy
nurse/health officer auditor (pharmacy,
Primary Hospital
auditor QI)
▪ Certified IPC auditor ▪ Certified IPC
auditor
▪ Certified laboratory
▪ Certified nurse
▪ Certified accountant
auditor (QI)
auditor
▪ Certified laboratory
▪ Certified health
(QI)
informatics auditor
▪ Certified pharmacy ▪ Certified pharmacy ▪ As per need,
auditor auditor
▪ Certified pharmacy
▪ Certified health ▪ Certified health auditor
officer/nurse/physici officer/nurse auditor
▪ Certified health
an auditor
▪ Certified accountant officer/nurse/physic
Health Center
▪ Certified accountant
auditor auditor
auditor
▪ Certified HIT auditor ▪ Certified HIT
▪ Certified HIT auditor
auditor
▪ NB: Specialized
▪ NB: Specialized
clinics as per need ▪ NB: Specialized
clinics as per need
clinics as per need
▪ Health ▪ officer/nurse/physician ▪ As per need
officer/nurse/physici auditor officer/nurse/physic
an auditor ian auditor
▪ Certified accountant
Third
Party
38
auditor ▪ As per need auditor
(pharmacy,
▪ As per need ▪ As per need
diagnostics, imaging)
(pharmacy, (pharmacy,
diagnostics, imaging) diagnostics,
imaging)
Note: HIT= Health Information Technician; MR= Medical Record; QI=quality improvement; URTI = Upper
Respiratory Tract Infection
39
Annex 7. Checklist to Monitor a Clinical Audit Program
(to be used to audit the medical audit system at headquarters, branch, and scheme annually)
Input
No
Yes
The Health Insurance System has a clinical audit team that meets at least
quarterly.
Every section has an identified leader for clinical audit.
All clinical audit teams are inter-disciplinary and include representation from the
health insurance system and surrounding health facilities.
An annual clinical audit plan is prepared.
There is a dedicated budget for all clinical audit activities
This Medical Audit Manual is available in all units and contracted facilities.
A database or an IT system is available to support all clinical audit activities.
Process
The clinical audit team provides regular feedback on the audit to the staff of the
health facilities and of the health insurance system.
Clinical audits involve appropriate professionals.
All audit team members are trained on the clinical audit.
The clinical audit leader selected is the most senior and respected health
professional in the health insurance system.
Evidence is available that clinical audits are based on available standards /
criteria.
Improvement plans based on clinical audit outcomes are in place and
implemented.
Records are maintained for the conducted clinical audit meetings / training
events.
Output
Input structures are available as required by the expected clinical care.
40
Periodic clinical Audit Checklist
41
1. Clinical care audit
For new facilities applying to contract with the health insurance system, identify data sources from services provided in the last quarter. In case of
comprehensive audit for renewal of contract, use the Claims submitted by the facility to select 19 medical records randomly. Simple Random sampling,
Random number generator of calculators or Table of Random numbers can be utilized. The 19 medical record number and patient full name will be
recorded and forwards to the health facility for retrieval on the date of the visit. Upon receiving the medical records, the table below will be utilized to
capture data on each audit element. (If Yes=1, if No=0, NA= when non applicable) (Mixed method- should be narrated or SOP should be prepared) -
Recent visit per sheet (last visit) – observation while clerking for validation
42
3. Investigations
43
9
8
7
6
5
4
3
2
1
10
number
Prescription
Standard Prescription
prescription form
Total score
Abbreviation,
Abbreviations
agreed glossary
Date
MRN no.
Full Name of
contained within an
or
5.4. No local/personal
are
Patient-related information
Address
OPD/ IPD
Diagnosis
Name of medicine
Dose
2. Pharmacy audit checklist
Frequency
(excluding supply)
Route of
administration
Duration
Name
Profession
information
Signature
Medicine-related information Prescriber-related
Name
related
Profession
Dispenser-
information
Signature
Drugs on
Responses on review of prescriptions
prescription are
similar to drugs
indicated on
medical record
with the same date
Drugs on
prescription copied
similarly on
1. Prescription audit: identify 19 prescriptions using the SOP and complete the form below. Write 1 if Yes and 0 if No
pharmacy
registration book
Prescription verification
Prescribed and
dispensed drugs
are similar
Cost of drugs in
the registration
book /prescription
Cost
is similar to the
44
verification
updated pricelist
for the batch
11
12
13
14
15
16
17
18
19
Total
Average
Product 2
Product 3
Product 4
Product 5
Product 6
Product 7
45
Product 8
Product 9
Product 10
Product 11
Product 12
Product 13
Product 14
Total
Average
1 Updated list of services for which the health facility refers clients is available at OPD and liaisons office.
2 Staff oriented/trained on the updated list of services for which the health facility refers clients
3 There is current /updated agreement with the health facility accepting referred clients
4 The liaison officer communicates with the accepting facility before sending referred patients
5 The health facility has a record-keeping system (referral registration) to track all referrals
6 The health facility updates the registration book by collecting feedback from receiving facilities
7 Referral to the receiving facility done in accordance with the Primary Care Clinical Guideline (at PHC facilities) and other relevant
guidelines
46
2. Referral Letter verification and audit: Randomly select 19 referrals from the claim submitted from the facility using table of random number. Capture the name of the
patient, MRN and referral date to identify and scrutinize copy of the referral letter at the facility.
Write 1 if yes and 0 if No
s.no check documentation of
the following on the 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 Total Average
referral letter
Pt & facility related information
1 Patient's name, age, &Medical
record number
2 Name of referring health
professional
3 Name of receiving health facility
Clinical information
4 Description of chief complaint &
associated symptoms
5 Relevant clinical findings
6 Provisional diagnosis or clinical
impression
7 Reason for referral
Standard and completeness of referral sheet
8 Seal of the referring facility
9 Use standard referral format
Total
Average
Referral letter verification
1 Referral status mentioned on the
same date on the medical record
2 Referral status documented on the
referral registration book of the
facility
3 Referral justified by the primary
care Clinical guideline or other
relevant guidelines
47
4. Quality improvement audit checklist
The clinical audit team will closely work with the quality unit of the facility to ascertain the following.
1 Is there evidence that the facility’s quality team identifies and evaluates safety and quality issues identified through
supervision, review meetings, clinical audit and client concerns? (Verifying the implementation of quality improvement cycle)
3 Agreed gap 2
Review process is in place to evaluate quality improvement plans and assess performance data; findings are generated for
follow up and used to plan ahead; summary of findings are documented.
4 Agreed gap 3
Review process is in place to evaluate quality improvement plans and assess performance data; findings are generated for
follow up and used to plan ahead; summary of findings are documented.
5 Agreed gap 4
Review process is in place to evaluate quality improvement plans and assess performance data; findings are generated for
follow up and used to plan ahead; summary of findings are documented.
6 Is there evidence that staff and management know of the types of improvement activities that have been undertaken, i.e.
have these been communicated and celebrated?
48
7 Is there evidence that the facility has processes in place to track and improve client satisfaction?
• Look for: Comment and complaint forms are available for patients to complete?
• Secure patient comment and complaint boxes are in publicly accessible places?
• There is a current complaint register which includes responses and actions to address identified issues?
• There is evidence of regular/urgent meetings about client comments and complaints?
8 Does the facility monitor client satisfaction?
Look for:
Look for:
49