GAHAR Handbook for

CLINICAL
LABORATORIES
ACCREDITATION STANDARDS
General Authority for Healthcare Accreditation and Regulation

Table of Contents
Foreword .................................................................................................................................... 3
Introduction ................................................................................................................................ 4
Scope of this Handbook ............................................................................................................ 6
Purpose ...................................................................................................................................... 7
Reading and Interpretation of the book .................................................................................... 8
Used Language and Themes ................................................................................................. 10
Accreditation Overview ............................................................................................................ 11
How to apply for a GAHAR survey? ....................................................................................... 13
Look back period ..................................................................................................................... 14
Scoring Guide .......................................................................................................................... 15
Accreditation Decision Rules ................................................................................................... 16
List of Acronyms ....................................................................................................................... 20
Section 1: Accreditation Prerequisites and Conditions .......................................................... 22
Transparent and ethical relationships .......................................................................................... 24
Sustaining compliance with accreditation standards ................................................................... 26
Section 2: Patient-Centered Standards .................................................................................. 27
GAHAR Safety Requirements ............................................................................................. 28
GAHAR Safety Requirements ............................................................................................. 29
Patient-Centeredness Culture ............................................................................................. 30
Planning and protecting the patient-centeredness culture .......................................................... 33
Outlining the fundamental rights and responsibilities of clients .................................................. 34
Empowerment and involvement of clients and their families ...................................................... 36
Responsiveness to clients' and families' voices .......................................................................... 38
Section 3: Total Testing Process Standards .......................................................................... 41
Laboratory Pre- Examination process ................................................................................ 42
Safe and proper testing process ................................................................................................... 46
Proper Specimens requesting, collection, handling, and transportation..................................... 47
Laboratory Examination process ......................................................................................... 53
Ensure accurate reagent labelling ................................................................................................ 55
laboratory method selection ......................................................................................................... 56
Laboratory test verification I validation ......................................................................................... 57
properly Implement the examination procedures ........................................................................ 59
Laboratory Quality Control of Examination Procedures ..................................................... 61
Laboratory internal quality control system ................................................................................... 64
Identify Quality control result violations and implement appropriate corrective I preventive
actions ........................................................................................................................................... 66
External quality programs and proficiency testing in ensuring quality standards ....................... 67
Alternative assessment procedure(s)/Methods and instruments comparison ............................ 70
Laboratory Post-Examination process ................................................................................ 72
Ensuring Safe, accurate client results reporting .......................................................................... 76
Proper specimen's storage, retention and disposal ..................................................................... 78
Ensuring appropriate turnaround time for each laboratory test................................................... 79
Accurate identification of critical test results ................................................................................ 80
Process of amended laboratory reports ....................................................................................... 82
Section 4: Organization-Centered Standards ........................................................................ 84

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General Authority for Healthcare Accreditation and Regulation
Environmental and Facility Safety ........................................................................................85
Effective leadership and planning of environment and facility safety. ......................................... 91
Safe fire planning ........................................................................................................................... 93
Safe hazardous materials and waste management plan ............................................................ 95
Safety and security planning ......................................................................................................... 96
Safe utility plan .............................................................................................................................. 98
Safe emergency preparedness plan .......................................................................................... 100
Equipment Management System .......................................................................................102
Effective equipment management plan....................................................................................... 105
Safe laboratory equipment use ................................................................................................... 107
Infection Prevention and Control. .......................................................................................112
Efficient structure of the infection prevention and control program............................................ 116
Safe standard precautions ........................................................................................................... 117
Biosafety-Biosecurity plan ........................................................................................................... 126
Organization Governance and Management .....................................................................128
Effective governing body ............................................................................................................. 133
Effective organization direction ................................................................................................... 134
Effective organization head of department.................................................................................. 137
Effective financial management................................................................................................... 139
Safe, ethical, and positive organization culture .......................................................................... 140
Community initiatives ................................................................................................................... 144
Supply Chain Management. ................................................................................................146
Efficient Supply chain management ............................................................................................ 149
Effective Inventory management system.................................................................................... 151
Service agreement and Referral laboratory service................................................................... 153
Workforce Management ......................................................................................................156
Efficient workforce planning ........................................................................................................ 161
Efficient staff filing process .......................................................................................................... 166
Effective orientation program ...................................................................................................... 167
Effective training and education .................................................................................................. 168
Equitable staff performance evaluation ....................................................................................... 169
Efficient medical workforce structure .......................................................................................... 172
Information Management and Technology .........................................................................173
Document and Record Management .......................................................................................... 177
Effective Laboratory Information management system.............................................................. 179
Maintain Information Confidentiality and Security ...................................................................... 180
Laboratory Information System (LIS) ......................................................................................... 182
Data transfer and interfaces ........................................................................................................ 185
Auto- verification .......................................................................................................................... 185
Data retrieval and preservation ................................................................................................... 186
Quality and Performance Improvement. ............................................................................ 188
Effective Leadership Support for Sustaining Improvement ........................................................ 192
Efficient Data Management ......................................................................................................... 193
Efficient Risk Management Program .......................................................................................... 198
Sustaining improvement .............................................................................................................. 200
Annex (A) ................................................................................................................................202
Survey Activities and Readiness ............................................................................................204
Glossary ...................................................................................................................................214
References...............................................................................................................................222

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General Authority for Healthcare Accreditation and Regulation

Foreword
Quality healthcare has become a global priority, particularly in the context of the Sustainable
Development Goals (SDGs), which emphasize the need for universal health coverage,
financial protection, and access to safe and effective healthcare services. The World Health
Organization (WHO) highlighted these critical needs in its 2018 reports, reinforcing the
importance of strong healthcare systems worldwide.

we are deeply committed to driving excellence in healthcare reform by fostering a strong

culture of safety and quality. We are proud to introduce the 2025 edition of the GAHAR
Handbook for Clinical Laboratories Accreditation Standards, an updated version that reflects
the latest advancements in patient safety practices and quality improvement concepts. This
edition is designed to help both accredited and non-accredited laboratories identify key
safety risks and continuously enhance their services.

This handbook integrates the latest best practices in quality improvement and patient safety,
ensuring laboratories are equipped to meet emerging challenges in healthcare. Our mission
remains clear: to uphold the highest standards of safety, quality, and patient-centered care
while supporting healthcare professionals in delivering safer, more effective services.

We hope this revised edition serves as both a practical guide and a source of inspiration for
laboratories across Egypt, the Middle East, and Africa, helping them advance their quality
journey and improve patient outcomes. Together, we can build a healthier future .

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Introduction
Welcome to the Second Edition of the GAHAR Handbook for Clinical Laboratories
Accreditation Standards, 2025.

Clinical laboratories play a vital role in modern healthcare, providing essential diagnostic
services that support patient care, disease prevention, and clinical decision-making. To
ensure the highest standards of safety, accuracy, and efficiency, laboratories must follow
structured processes that cover every stage of testing-from examination requests and
patient preparation to specimen collection, analysis, reporting, and ongoing quality
assurance.

This updated guide reflects our continued commitment to raising the bar in healthcare. It
provides clear, practical standards to help clinical laboratories achieve excellence in quality,
safety, and patient-centered care.

Building on the success and lessons from the 2021 edition, we've enhanced this handbook
with valuable feedback from our users and experts across various sectors. This
collaborative effort involved key stakeholders, including the Ministry of Health and
Population, private sector professionals, university faculty, and professional syndicates.
Their insights have helped us refine each chapter to keep pace with the ever-evolving
healthcare landscape.

The 2025 edition of the GAHAR Handbook for Clinical Laboratories Accreditation Standards
builds on the foundation of previous version, incorporating the latest advancements in
clinical laboratories, patient safety, and quality improvement science. This edition is
designed to align with international best practices while addressing Egypt's unique
healthcare landscape and regulatory requirements.

The content is organized into four key sections:

1. Accreditation Prerequisites and Conditions

2. Patient-Centered Standards
3. Testing process standards
4. Organization-Centered Standards

These sections are further divided into 14 chapters, each addressing critical aspects of
Laboratory's operations. This structured approach helps laboratories meet patient
expectations while ensuring a safe and supportive environment for healthcare professionals.

This edition aligns with the Institute of Medicine's STEEEP principles, emphasizing:

Safety, Timeliness, Effectiveness, Efficiency, Equity, Patient-Centeredness.

By upholding these standards, we are dedicated to fostering a healthcare system that

consistently delivers outstanding care.

At the heart of this handbook are the 9 GAHAR Safety Requirements (GSRs); a
fundamental roadmap to creating a safer healthcare environment and ensuring compliance
with accreditation standards.

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We've refined and streamlined the content for better clarity and ease of use. While all
essential details remain, the improved structure makes it easier to navigate and implement
in real-world settings.

With this guide, we aim to empower laboratories with the tools and knowledge to achieve
and maintain the highest standards of patient care and operational excellence.

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Scope of this Handbook

These standards apply to the laboratories seeking to be accredited by the General Authority
for Healthcare Accreditation and Regulation (GAHAR):

Inclusions
These standards are applicable to:
Standalone laboratories.
Specialized clinical laboratories e.g.; genetics, molecular biology, bacteriology
Reference laboratories which receive samples from other healthcare facilities.

Exclusions
These standards are not applicable to:
Non-clinical laboratories (Research /calibration).
Hospital laboratories (Not fulfilling the above criteria).

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Purpose
GAHAR Handbook for Clinical Laboratories Accreditation Standards 2025 Edition is
designed to establish a clear framework for ensuring safe, high-quality, and patient-centered
laboratory services. These standards define the competency levels required across all
phases of laboratory testing, providing a benchmark for performance assessment and
continuous improvement.

The primary goal of this handbook is to enhance patient safety and service reliability by
guiding laboratories in implementing best practices in quality management, operational
efficiency, and risk mitigation. By adhering to these standards, laboratories can improve
diagnostic accuracy, streamline workflows, and ensure compliance with national and
international regulatory requirements.

This edition also emphasizes strong governance and workforce development, ensuring that
laboratory personnel are well-trained, competent, and supported in delivering exceptional
care. It provides guidance on staffing structures, documentation processes, and new
technologies, helping laboratories adopt innovative solutions while maintaining ethical and
professional integrity.

Compliance with GAHAR accreditation standards reinforces accountability and promotes a

culture of excellence, encouraging laboratories to continuously assess and enhance their
practices. This handbook serves as a valuable tool for laboratory leaders, healthcare
providers, and quality management teams, helping them drive sustained improvements in
patient care and workplace safety.

By following the GAHAR 2025 Clinical Laboratories Standards, laboratories will be better
equipped to meet evolving healthcare challenges, support universal health coverage goals,
and contribute to a stronger, more resilient healthcare system.

Ultimately, the handbook seeks to elevate the overall standard of healthcare delivery by
providing a structured approach to accreditation, ensuring patient-centered care, and
promoting accountability among healthcare providers.

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General Authority for Healthcare Accreditation and Regulation

Reading and Interpretation of the book

The General Authority for Healthcare Accreditation and Regulation evaluates the
organization's structure, process, and/or outcome by setting standards that
address these concepts.
This book is divided into Four sections, in addition to the foreword, introduction,
Scope of this handbook, Purpose, Use, Accreditation overview, Acknowledgments,
Acronyms, Survey activities and readiness, Glossary and References.
Each section is divided into chapters when applicable.
Each chapter has:
- An introduction that contains an overall intent.
- purpose that details follow the introduction, and each one has a standard or
more.
- Summary of changes to the chapter.
A standard is a level of quality or achievement, especially a level that is thought to
be acceptable; it is composed of a standard statement, keywords, intent, survey
process guide, evidence of compliance, and relevant standards.

Standard Components
Standard Statement:
In this handbook, each standard is written as a standard statement preceded with
a code.
Each standard is followed by a non-black-scripted statement that describes the
essential quality dimension(s) addressed by the standard.
• Keywords
-To help organizations understand the most important element of standard
statements, as these are words or concepts of great significance. It answers the
question of WHAT the standard is intended to measure.
Intent:
Standard intent is meant to help organizations understand the full meaning of the
standard.
The intent is usually divided into two parts:
o Normative: that describes the purpose and rationale of the standard
provides an explanation of how the standard fits into the overall
program. It answers the question of WHY the standard is required to be
met.
o Informative: is meant to help organizations identify the strategy to
interpret and execute the standard. It answers the question of HOW the
standard is going to be met.
Some standards require the implementation of minimum components of
processes to be documented, implemented, recorded, and/or monitored. These
components are usually preceded with the phrase "at least the following",
followed by a numbered/lettered list of requirements. Hence, these elements are
considered essential, indivisible parts of compliance with the minimum
acceptable standard.
Evidence of compliance (EOCs):
Evidence of compliance of a standard indicates what is reviewed and assigned a
score during the on-site survey process.
The EOCs for each standard identify the requirements for full compliance with
the standard as scoring is done in relation to "Met EOCs".
Survey process guide:
facilitates and assists the surveyors in the standard's rating for the required
EOCs.
• Related standards:

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As healthcare is a complex service, each standard measures a small part of it. To

understand what each standard means in the overall context of healthcare standards,
other standards need to be considered as well.

• Standards are categorized and grouped into three sets of groups:

Chapters, where standards are grouped as per uniform objective.
Quality dimensions, where each standard addresses a particular quality
dimension, and strategic categorization of standards to analyze their quality
characteristics.
Documentation requirements, where some standards require certain types of
documents.

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Used Language and Themes

This handbook used certain themes and vocabulary to ensure uniformity and clarity; These are the most
important ones that will help laboratories to interpret the standards: Process, Policy, Procedure, Program,
Plan, Guideline, Protocol
Whenever 'Process' is used in a standard, it indicates a requirement that is necessary to follow.
• 'Process':
A series of actions or steps taken in order to achieve a particular end.
• 'Documented Process':
A document that describes the process and can be in the form of policy, procedure, program,
plan, guideline, or protocol.
• Policy:
A principle of action adopted by an organization.
It usually answers the question of what the process is.
It is stricter than guidelines or protocols.
It does not include objectives that need to be met in a certain timeframe.
• Procedure:
An established or official way of doing something.
It usually answers the question of how the process happens.
It is stricter than guidelines or protocols.
It does not include objectives that need to be met in a certain timeframe.
• Plan:
A detailed proposal for doing or achieving something.
It usually answers the question of what the goal is, why, how it is going to be achieved, and
when.
It includes objectives that need to be met in a certain timeframe.
• Guideline:
A general rule, principle, or piece of advice.
It usually answers the question of what the process is and how it should happen.
Usually, it is more narrative than protocol.
• Protocol:
A best practice protocol for managing a particular condition, which includes a treatment plan
founded on evidence-based strategies and consensus statements.
Usually, it has graphs, flow charts, mind maps, and thinking trees.
1) Document versus Record:
• Document:
Created by planning what needs to be done.
• Record:
Created when something is done.
2) Physician Versus Medical staff member:
• Physician:
A professional who practices medicine
• Medical Staff member:
A professional who practices medicine, dentistry, and other independent practitioners.

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Accreditation Overview

This chapter aims to set the rules and requirements to obtain GAHAR accreditation for the laboratory
which includes, but not limited to, the following:

1. Compliance with licensure requirements for licensing the laboratory as mandated by laws and
regulations.
2. The laboratory must be operational for at least six months before it can apply for accreditation.
3. Compliance with the GAHAR Safety Requirements for laboratories(herein included), to ensure
the safety of the patients/ patients' families, visitors, and staff.
4. Compliance with the requirements of the standards according to Accreditation Decision Rules
in this handbook.

A) General rules:
The accredited laboratory has to inform GAHAR of any change in the field of services provided
(adding a new service, cancelling an existing service, or increasing the volume of an existing service
by more than 20%) in writing to the e-mail reg@gahar.gov.eg. at least one month prior to the actual
implementation of this change.
• The laboratory shall ensure the validity of the documents and data provided at all stages of the
accreditation process. If there is evidence that the submitted documents are proven to be
inaccurate, the laboratory is at risk for rejection of accreditation.
• The accreditation may be withdrawn or at risk of rejection, if there is evidence that the facility
has falsified or withheld or intentionally misleading the information submitted to GAHAR.
• The facility is not permitted to use GAHAR's certificate or logo in a misleading manner.
• GAHAR shall inform the facility about the accreditation decision within a period not exceeding
30 working days starting from the date of completion of the survey visit.
• GAHAR has the right to publish the end result of survey visit, accreditation suspension or
rejection, according to the requirements.
• The accredited laboratory has to communicate all sentinel events to GAHAR within 48 hours of
the event or becoming aware of the event via email notification using the following link:
Sentinel.Event@gahar.gov.eg. The root cause analysis shall be submitted no later than 45
days starting from the date of the occurrence or its notification with the appropriate corrective
plan to prevent/reduce its recurrence according to the nature of the event, (Refer to standard
no. QPl.06 for more information).

B) Compliance with current relevant laws, regulations, licensures requirements, and their
updates.

C) Accreditation may be suspended (for a period not exceeding 6 months) if:

■ The laboratory fails to pass unannounced survey,
■ The laboratory data in the application form does not match its status upon evaluation visit.
■ Sentinel events related to the safety of patients, healthcare providers or visitors that has been
reported to GAHAR while root cause analysis with the appropriate corrective plan not submitted
within 45 days starting from the date of the occurrence or its notification.
■ The GAHAR has not been notified of any changes in the scope of services provided (e.g.
adding a new service, cancelling an existing service, or increasing the volume of an existing

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service by more than 20%) within at least one month before the actual implementation of this
change.

D) Accreditation may be withdrawn or at risk of rejection if:

■ The facility fails to pass follow up surveys in case of conditioned accreditation.
■ GAHAR team discover any falsification, withhold or intentionally misleading the information
submitted during or after the survey visit, or it is proven that the attached and submitted
documents are inaccurate.
■ The facility prevents GAHAR regulatory team/inspectors from doing their duties, such as refusal
or preventing them from reviewing documents and data related to the scope of their duties.
■ The facility refuses to meet the auditors' team or GAHAR surveyors in the announced I
unannounced evaluation visits.
■ A legal document issued by an administrative agency or Supreme Court rules against the
facility either by permanent or temporary closure.
■ Moving the facility from its actual place mentioned in the application form, or when the facility is
demolished, reconstructed, or rebuilt without any pre notification to GAHAR.
■ Exceeding the period prescribed for suspension of accreditation without correcting the reasons
for this suspension.

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How to apply for a GAHAR survey?

A laboratory. seeking GAHAR accreditation begins by:

■ Log in to the online platform (Portal) of the General Authority for Health Accreditation and
Regulation to register the data of the laboratory, via the following
link https://eportal.gahar.gov.eg.
■ Create a new account.
■ Choose the type of service, type of facility, and user's data.
■ Complete the basic data of the application (the electronic registration application).
■ Complete the contact information; the applicant's data; and the Laboratory data and upload the
required documents.
■ Print the application request, fill in the declaration, and get it sealed with the laborator's seal, re­
upload, and click on "Issue application".
■ You can browse the system anytime to follow up the status of the request and implement the
required requests of GAHAR.
■ GAHAR will determine the survey financial fees, and bank account details will be shared.
■ The Laboratory will make the payment to the central bank of Egypt on the bank account, and it
will send to receipt back via email.
■ An appointment for the survey visit will be determined for the Laboratory.
■ GAHAR's Surveyors team will evaluate your Lab, according to the GAHAR handbook for
Laboratories accreditation standards.
■ The survey report is submitted to the accreditation committee to review and decide based on
decision rules.
■ The Laboratory is notified of the decision of the accreditation committee. The laboratory has 15
days to submit an appeal. If no appeal is submitted, the chairman of GAHAR approves the
decision, and a final certificate is issued.

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Look back period

■ Surveyors are required to review standards requirements and evaluate organization compliance
with them over a lookback period.
■ Look back period: It is the period before the survey visit during which any laboratory, is obliged to
comply with the GAHAR accreditation standards. Failure to comply with this rule affects the
accreditation decision.
■ Look back period varies from one laboratory, to another, depending on the laboratory's
accreditation status.

■ A laboratory, seeking accreditation will:

o Comply with the GAHAR Handbook for laboratory Accreditation Standards as applicable for
at least four months before the actual accreditation survey visit.

■ A laboratory, seeking re-accreditation:

o For GAHAR-accredited laboratories, compliance with the GAHAR Handbook for laboratories
Accreditation Standards from receiving the approval of the previous accreditation till the next
accreditation survey visit.

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Scoring Guide
During the survey visit, each standard is scored for evidence of compliance (EOC).
These are mathematical rules that depend on the summation and percentage calculation of scores of
each applicable EOC as follows:
■ Met when the laboratory, shows 80% or more compliance with requirements during the required
lookback period with a total score of 2.
■ Partially met when the laboratory, shows less than 80% but more than or equal to 50%
compliance with requirements during the required look back period with a total score of 1.
■ Not met when the laboratory, shows less than 50% compliance with requirements during the
required look back period with a total score of 0.
■ Not applicable when the surveyor determines that, the standard requirements are out of the
organization's scope (the score is deleted from the numerator and denominator).
■ While most EOCs are independent, stand-alone units of measurement that represent the structure,
process, and/or outcome, few EOCs are dependent on each other. Dependence means that
compliance with one EOC cannot be achieved (or scored) without ensuring compliance with other
EOCs.

Scoring of each standard

■ Met: when the average score of the applicable EOCs of this standard is 80% or more.
■ Partially met when the average score of the applicable EOCs of this standard is less than 80% or
not less than 50%.
■ Not met when the average score of the applicable EOCs of this standard is less than 50%.

Scoring of each chapter

Each chapter is scored after calculating the average score of all applicable standards in this chapter.

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Accreditation Decision Rules

A laboratory can achieve accreditation by demonstrating compliance with certain accreditation decision
rules. These rules mandate achieving certain scores on a standard level, chapter level, and overall level
as the accreditation decision is composed of four decisions.

1st Decision: Status of Accreditation for a laboratory, (3 years).

■ Overall compliance of 80% and more, and
■ Each chapter should score not less than 70%, and
■ Only one whole standard is scored as not met, and
■ No single not met GSR standard.

ind Decision: Status of Conditioned Accreditation for a laboratory, (2 years).

■ Overall compliance of 70% to less than 80%, or
■ Each chapter should score not less than 60%, or
■ Up to one standard not met per chapter, and
■ No single not met GSR standard.

rd
Decision: Status of Conditioned Accreditation for a laboratory, (1 year).
■ Overall compliance of 60% to less than 70%, or
■ Each chapter should score not less than 50%, or
■ Up to two standards not met per chapter, and
■ No single not met GSR standard.

th
Decision: Rejection of Accreditation
■ Overall compliance of less than 60%, or
■ One chapter scored less than 50%, or
■ More than two standards not met per chapter, or
■ Not met GSR standard.

Laboratories having status of accreditation or conditioned accreditation with elements of noncompliance

are requested to:
■ Submit a corrective action plan for unmet or partially met EOCs and standards within 90 days for 1st
decision, 60 days for 2nd decision, and 30 days for 3rd decision to the email reg@gahar.gov.eg.
■ Apply and pass the accreditation survey in 2 years for 2nd Decision and 1 year for 3rd Decision.

Accreditation is valid for 3 years. Accreditation may be suspended or withdrawn if:

■ The laboratory fails to pass follow-up surveys in case of conditioned accreditation.
■ The laboratory fails to submit corrective action plans in case of the presence of not met EOC(s).
■ The laboratory fails to pass the unannounced survey.
■ The laboratory fails to comply with GAHAR circulars when applicable.

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Acknowledgement
Clinical Laboratories Standards Development Committee

Professor of Clinical Pathology and Professor of Pathology, Faculty of Medicine,

Accreditation Consultant, Faculty of Medicine, Benha University
Ain Shams University

Technical Manager of Egyptian Proficiency

Quality Manager at Central Public Health Testing Center, Central Public Health
Laboratories, Ministry of Health and Population Laboratories, Ministry of Health

Professor of Clinical Pathology, Faculty of Alameda Healthcare Quality Director

Medicine, Ain Shams University GAHAR Lead Surveyor
Director of Reference Laboratory for Egyptian
University Hospitals, SCUH

Professor of Clinical and Chemical Pathology

Head of the Central Public Health Laboratories, MOH

Dr. Naira Salah El Din Dr. Reham Magdy

Standards Development Standards Development
Team Member Team Member

Dr. Samar Sabri Dr. Marwa Elkabany

Standards Development Standards Development
Team Member Team Member

Dr. Mariam Elgendy Dr. Hend Saied

Standards Development Standards Development
Team Member Team Member
Mr. Mahmoud Elghamrawy
Dr. Hosam Khater
Standards Development
Standards Development
Team Member
Team Member
Dr. Muhammad Lotfy
Editorial Review and Proofreading
Dr. Walaa Abo-Elela
Head of Department

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Dr. Az.za Sadek Eldanasoury

Professor of Clinical Pathology Professor of Occupational Health and
Faculty of Medicine, Ain Shams University Environment, Faculty of Medicine, Ain
Shams University, EFS Consultant

Prof. Dr. Walaa Abdel-Latif

Professor of Medical Microbiology and
Professor of Clinical Pathology and Immunology, Faculty of Medicine, Ain
Transfusion Medicine Shams University
MBA Healthcare Management IPC Consultant
AAST/Cardiff)

Dr. Doaa Mohamed Abdou Abass Dr. Hossam Ahmed Abdelshafy

Clinical Pathology Specialist Quality and Accreditation Advisor
Healthcare Quality Specialist GAHAR Surveyor
GAHAR External Auditor

We extend our sincere gratitude to the laboratories participated in field testing

Chief Executive Director

Dr. Nancy Abdelaziz

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List of Acronyms
acronym Explanation

AAP Alternative Assessment Procedure

ABHR Alcohol-Based Hand Rub
APC Accreditation Prerequisites and Conditions
APIC Association for Professionals in Infection Control and Epidemiology
ASCLS The American Society for Clinical Laboratory Science
Bsc Biosafety Cabinet
CCTV Closed-circuit television
CDC Centers for Disease Control and Prevention
EFQM The European Foundation for Quality Management
EFS Environmental and Facility Safety
EMS Equipment Management System
EOG evidence of compliance
FEFO First Expire First Out
FMEA Failure Mode and Effects Analysis
GSRs GAHAR Safety Requirements
HBV Hepatitis B Virus
HGV Hepatitis C Virus
HIV Human Immunodeficiency Virus
ICRA Infection Control Risk Assessment
/FIG International Federation of Infection Control
/MT Information Management and Technology
/PC Infection prevention and control
LEP Laboratory Examination Process
LIS Laboratory Information System
LPO Laboratory Post-examination
LPR Laboratory Pre- Examination Process
LQC Laboratory Quality Control
OGM Organization Governance and Management
PASS Pull, Aim, Squeeze, and Sweep
PCC Patient-Centeredness Culture
PCRA Pre-Construction Risk Assessment
POCA Plan-Do-Check-Act
PPE Personal Protective Equipment
PT Proficiency Testing
QC Quality Control
QPI Quality and Performance Improvement
RACE Rescue, Alarm, Confine, Extinguish/Evacuate
SCM Supply Chain Management
SD Standard Deviation
SDGs Sustainable Development Goals
sos Safety Data Sheets
SMART Specific, Measurable, Achievable, Relevant, and Time-Bound
SOP Standards of Procedure
STEEEP Safety, Timeliness, Effectiveness, Efficiency, Equity, Patient-Centeredness

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acronym Explanation
TAT Turnaround time
UPS Uninterrupted Power Supply
WHO World Health Organization

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