Egyptian Ministry of Health and Population

Damietta Health Directorate

Laboratories Management

(ISO 15189:2022 & GAHAR Integrated )

Issued by: Dr. Marwa Anwar

Consultant Clinical Pathologist
The Quality Manager of Damietta laboratories Management
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 Contents
1. Preface 3
2. Introduction: 3
2.1 Purpose of the Manual
2.2 Scope of Laboratory Services
2.3 Mission, Vision, Values
2.4 Quality Policy
3. Overview of Laboratory Quality Management System(LQMS) 5
4.1 Definition
4.2 Purpose of LQMS
4.3 key components
4.4 Standards and Accreditation
4.5 Benefits of LQMS
4. Organizational & Management Structure 7
3.1 Organizational Chart
3.2 Roles and Responsibilities
3.3 Impartiality, Ethics & Confidentiality
5. Appropriate planning and management of clinical laboratories 10
5.1 Compliance with Laws, Regulations, and Guidelines in Laboratory 10
Services
5.2 Laboratory Staff Competency Assessment. 12
5.3 Management of Laboratory Reagents and Supplies 14
5.4 Equipment management 17

6. Effective operational processes in the laboratory 20

6.1 Pre analytical process 20
6.2 Specimen tracking and handling 22
6.3 Analytical method and verification 23
6.4 Laboratory procedure manual and technical procedure 25
6.5 Internal quality control 27
6.6 External quality control 29
6.7 Post analytical process 31
6.8 Turn Around Time (TAT) 33
6.9 Urgent laboratory results (STAT) 35
7. Safe laboratory services 37

8. Effective point of care testing. 40

9. Information Management (LIS) 42

10. Process Improvement 45

11. References 48

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 1. Preface
This Laboratory Quality Manual has been developed by the Quality manager of
Damietta governorate Laboratory Sector to serve as a unified reference for all
governorate laboratories. It provides a comprehensive framework that aligns with the
requirements of ISO 15189:2022 and the GAHAR Accreditation Standards, ensuring
that all laboratories operate with a consistent approach to quality, safety, and patient-
centered service.

The manual outlines the essential policies, processes, and responsibilities required to
maintain accurate, reliable, and timely laboratory services. It supports laboratory teams
in fulfilling their roles, meeting national and international standards, and continuously
improving performance across all government laboratory facilities.

By following this manual, laboratories will strengthen the quality of diagnostic services,
enhance biosafety practices, promote environmental responsibility, and improve
outcomes for patients and healthcare providers. It reflects the government’s
commitment to advancing laboratory excellence, supporting public health, and
achieving sustained accreditation readiness.

2. Introduction

2.1 Purpose of the Manual

Its purpose is to ensure that every laboratory delivers consistent, accurate, reliable,
and safe diagnostic services in alignment with ISO 15189:2022 and the GAHAR
Accreditation Standards.
The manual provides guidance for implementing standardized processes, maintaining
competence, and supporting continuous quality improvement in all laboratory
departments.
2.2 Scope of the Manual
The manual applies to all clinical laboratories, It covers all aspects of laboratory
operations: from sample collection to reporting of results and includes administrative,
technical, safety, and environmental requirements.
2.3 Scope of Laboratory Services
Each laboratory provides diagnostic services to inpatients, outpatients, emergency units,
and public health programs. This manual supports the full testing cycle, including pre-

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examination, examination, and post-examination activities, and it ensures coordination
with clinicians and healthcare teams.
2.4 Mission, Vision, and Values
Mission
To provide accurate, timely, safe, and patient-centered diagnostic services that support
clinical decision-making and public health priorities.
Vision
To establish a unified, high-quality governorate laboratory network that consistently
meets international standards and achieves excellence in diagnostic care and
accreditation.
Values
 Accuracy
 Integrity
 Reliability
 Patient safety
 Professional competence
 Environmental responsibility
 Continuous improvement
2.5 Quality Policy
The governorate laboratory network is committed to delivering high-quality laboratory
services, maintaining technical competence, adhering to ISO 15189 and GAHAR
requirements, ensuring biosafety and biosecurity, protecting patient confidentiality,
and promoting a culture of safety and sustainability.
This policy is communicated to all laboratory staff and is reviewed periodically for
effectiveness and alignment with national goals.

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[Link] of Laboratory Quality Management (LQM)

3.1 Definition

Laboratory Quality Management (LQM) is a systematic framework

designed to ensure that laboratory services are accurate, reliable, timely,
safe, and consistent. It encompasses all processes from pre-analytical,
analytical, to post-analytical phases, as well as staff competency,
safety, equipment, and continuous improvement.

3.2 Purpose of LQM

The primary goals of a laboratory quality management system are:

 Deliver accurate and reliable test results that support patient care
and clinical decisions.
 Ensure patient and staff safety.
 Maintain regulatory and accreditation compliance.
 Promote efficient laboratory operations and optimal resource
utilization.
 Facilitate continuous improvement in all laboratory processes.

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3.3 Key Components of LQM

When all of the laboratory procedures and processes are organized into an
understandable and
workable structure, the
opportunity to ensure that
all are appropriately
managed is increased. The
quality model used here
organizes all of the
laboratory activities into
12 quality system
essentials. These quality
system essentials are a set
of coordinated activities
that serve as building
blocks for quality
management. Each must
be addressed if overall
laboratory quality

improvement is to be
achieved. This quality
management system model was developed by CLSI,1 and is fully
compatible with ISO standards.

Component Description
Organization & Management Clear roles, responsibilities, and leadership for
implementing quality policies.
Personnel Competence Staff training, competency assessment, and ongoing
professional development.
Equipment & Instrumentation Proper selection, calibration, maintenance, and verification
of laboratory instruments.
Reagents & Consumables Quality control of reagents, proper storage, labeling, and
traceability.
Pre-Examination Processes Patient identification, specimen collection, handling,
transport, and preparation.
Analytical Processes Use of validated methods, adherence to SOPs, and
monitoring through internal QC.
Post-Examination Processes Result verification, interpretation, reporting, and archiving
of specimens and data.
Internal & External Quality IQC for day-to-day monitoring; EQA for benchmarking
Control performance against peers.
Information Management Accurate documentation, data integrity, confidentiality, and
accessibility.
Turnaround Time (TAT) Measurement and improvement of TAT to ensure timely
Monitoring reporting of results.

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 Safety & Risk Management Laboratory safety, risk assessment, incident reporting, spill
management, PPE use.
Continuous Improvement Audits, corrective and preventive actions (CAPA),
management review, and process optimization.

3.4 Standards and Accreditation

Laboratory quality management is guided by international and national

standards, such as:

 ISO 15189:2022 – Medical Laboratories

 GAHAR Laboratory Accreditation Standards
 JCIA Laboratory Management Standards
 CAP (College of American Pathologists) Guidelines
 Local regulations and hospital policies

These standards ensure laboratories maintain competence, reliability,

and compliance.

3.5 Benefits of a Laboratory Quality Management System

 Ensures patient safety and confidence in test results.

 Reduces errors and inefficiencies across laboratory processes.
 Supports continuous staff development and competency.
 Facilitates regulatory compliance and accreditation readiness.
 Enhances overall operational efficiency and cost-effectiveness.

4. Organizational & Management Structure

4.1 Organizational Structure of Laboratories

The laboratory operates under a defined organizational framework that

ensures clear leadership, proper delegation of responsibilities, and effective
management of resources.
The structure includes administrative, technical, quality, and safety
functions, supporting compliance with ISO 15189 and GAHAR
requirements.

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 A typical organizational hierarchy includes:
 Laboratory Director
 Quality Officer / Quality Manager
 Safety and Biosafety Officer
 Section Heads (Hematology, Biochemistry, Microbiology, etc.)
 Technical Staff and Technologists
 Support and Administrative Staff

‫مسؤول المستلزمات و الشراء الموحد‬ Quality officer

Biosafety officer ‫الموظف االداري‬

‫قسم‬ ‫قسم‬ ‫قسم‬ ‫قسم‬

‫قسم‬

‫قسم‬

4.2 Roles and Responsibilities

Laboratory Director

 Provides overall leadership and ensures compliance with ISO 15189,

GAHAR standards, and national regulations.
 Approves the Quality Manual and major policies.

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 Ensures adequate resources, staffing, and training.
 Reviews quality and safety performance regularly.

Quality Officer / Quality Manager

 Oversees the implementation, maintenance, and monitoring of the Quality

Management System (QMS).
 Coordinates internal audits, external quality assessments, and corrective
actions.
 Ensures document control, record management, and staff awareness of
quality procedures.
 Reports quality performance indicators.

Safety & Biosafety Officer

 Ensures implementation of biosafety, biosecurity, and infection control

measures.
 Conducts risk assessments for biological and chemical hazards.
 Provides training on PPE, waste management, spill response, and
emergency procedures.
 Ensures compliance with national biosafety regulations and GAHAR
safety standards.

Section Heads

 Supervise day-to-day activities within their specialty area.

 Ensure staff competency and proper implementation of SOPs and QC
procedures.
 Manage equipment, reagents, and workflow.
 Support audit processes and improvement initiatives.

Technical Staff / Technologists

 Perform laboratory procedures in accordance with SOPs.

 Maintain proficiency and participate in training and competency
assessments.
 Handle samples safely and ensure accurate reporting.
 Report deviations, incidents, and nonconformities.

Administrative & Support Staff

 Support clerical, inventory, maintenance, and communication functions.

 Ensure proper documentation and coordination with clinical departments.

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 4.3 Impartiality, Ethics, and Confidentiality

All laboratory personnel must:

 Perform duties objectively and without bias.

 Maintain patient confidentiality in accordance with GAHAR Patient
Rights Standards.
 Avoid conflicts of interest.
 Uphold professionalism, honesty, and accountability.
 Handle clinical information responsibly and securely.

5. Appropriate planning and management of clinical

laboratories

5.1 Compliance with Laws, Regulations, and Guidelines in

Laboratory Services
5.1.1 Purpose
To ensure that all laboratory services are planned, delivered, and operated
in full compliance with applicable laws, regulations, accreditation
requirements, and recognized professional guidelines governing medical
laboratory practice.

5.1.2 Scope
This SOP applies to all laboratory sections and personnel involved in pre-
analytical, analytical, and post-analytical activities.

5.1.3Responsibility

Role Responsibility
Laboratory Ensures the laboratory complies with all relevant laws,
Director/Manager regulations, and accreditation requirements; approves internal
policies.
Quality Manager Maintains updated copies of regulatory and accreditation
standards; conducts compliance audits.
Section Supervisors Implement procedures according to regulatory requirements;
report non-compliance issues.
Laboratory Staff Follow all laws, regulations, and guidelines related to
laboratory activities.

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5.1.4 Definitions

Term Definition
Regulations Mandatory national or local governmental requirements
governing laboratory operations.
Guidelines Professional or scientific recommendations for best practice.
Accreditation Standards issued by bodies such as GAHAR, ISO 15189, or
Requirements JCIA.

5.1.5 Policy

Policy Statement Description

5.1 Compliance Laboratory services shall be planned, provided, and operated
Requirement according to all applicable laws, regulations, accreditation
standards, and professional guidelines.
5.2 Policy Updates All policies and procedures are reviewed regularly and updated to
reflect new legal and regulatory requirements.
5.3 Staff Awareness All staff are informed of and trained in updated regulations and
standards relevant to their duties.
5.4 Documentation Regulatory documents, licenses, and accreditation certificates are
maintained, accessible, and up-to-date.
5.5 Monitoring Compliance is monitored through internal audits and corrective
actions.

5.1.6 Procedure

 Identification of Applicable Laws and Regulations

Step Action
1 Quality Manager identifies all laws, regulations, and accreditation standards
relevant to laboratory operations.
2 A master list of applicable requirements is maintained and reviewed annually.
3 New or updated regulations are incorporated into laboratory policies promptly.

 Implementation of Requirements
Step Action
1 Laboratory Director ensures alignment of all services with applicable requirements.
2 Section supervisors implement procedures accordingly in their units.
3 Staff receive training on new or updated regulations.

 Monitoring and Verification of Compliance

Monitoring Activity Description
Internal Audits Regular audits verify compliance with laws, regulations, and
accreditation standards.
Documentation Ensure licenses, permits, and accreditation documents are current.
Review
Corrective Actions Action plans are implemented for any non-compliance identified.

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  Communication
Requirement Method
Sharing updates Emails, meetings, training sessions, or bulletin boards
Staff acknowledgment Signature sheets or digital confirmation
External Regulatory bodies, accreditation agencies, and hospital
communication administration

5.1.7 Records
Record Type Description
Updated regulations Master list of applicable requirements
list
Audit reports Findings, non-conformities, and corrective actions
Staff training records Attendance and competency verification
Licenses and Accreditation certificates, facility permits, equipment regulatory
certificates approvals

5.2 Laboratory Staff Competency Assessment:

5.2.1 Purpose
To ensure all laboratory personnel perform assigned duties safely,
accurately, and in accordance with accreditation standards.

5.2.2 Scope
Applies to all laboratory staff involved in pre-analytical, analytical, and
post-analytical processes.

5.2.3 Responsibility
Role Responsibility
Laboratory Approves competency tools; ensures compliance; reviews
Director/Manager results.
Section Supervisors Perform assessments; document results; provide feedback
and corrective action.
Laboratory Staff Participate in assessments; follow improvement plans.

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5.2.4 Definitions
Term Definition
Competency Demonstrated ability to apply knowledge, skills, and judgment to perform
tasks correctly and safely.

5.2.5 Policy
Policy Requirement Description
Policy Approval The hospital maintains an approved policy covering
competency elements (a–e).
Annual Assessment Competency assessments are conducted at least annually
and as needed.
Documentation Results are recorded and maintained in personnel files.
Assignment Based on Staff duties are assigned based on demonstrated
Competency competency.
Restrictions Staff may perform only tasks for which they are competent.

5.2.6 Procedure
 Competency Elements
Element Description
a) Direct Observation Assess specimen collection, labeling, testing, equipment use,
and safety practices.
b)Performance Evaluate QC participation, daily work accuracy, and
Monitoring compliance with procedures.
c)Problem-Solving Evaluate troubleshooting ability and response to errors.
Assessment
d) Test or Case Review Use blind samples, proficiency tests, re-testing, or report
review.

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 e)Knowledge Assessment Written/verbal tests to evaluate understanding of SOPs and
safety standards.

 Steps of Competency Assessment

Step Action
1. Prepare Schedule Supervisors create an annual competency plan.
2. Conduct Assessment Use approved forms and tools to assess each competency
element.
3. Document Findings Record results and attach supporting evidence.
4. Identify Gaps Determine deficiencies or training needs.
5. Implement Corrective Provide retraining, supervision, or mentoring.
Actions
6. Re-Evaluate Reassess competency after corrective actions.

5.2.7 Records
Record Type Required Content
Competency assessment forms Completed and signed by supervisor and staff
Written tests Answer sheets, scoring, evaluator signature
Direct observation checklists Observation notes and outcomes
Corrective action records Training provided, follow-up plan
Annual competency report Summary for each staff member

5.3 Management of Laboratory Reagents and Supplies

5.3.1 Purpose
To ensure efficient
management of laboratory
reagents and supplies,
maintain high-quality
materials for accurate test
results, minimize costs, and
support safe and productive
laboratory operations.
5.3.2 Scope
This SOP applies to all laboratory staff involved in the procurement,
storage, handling, and use of reagents, consumables, and other laboratory
supplies.

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5.3.3 Responsibility
Role Responsibility
Laboratory Approves policies and procedures, ensures compliance,
Director/Manager monitors inventory management practices.
Section Supervisors Inspect, accept/reject reagents, supervise storage, and ensure
correct labeling and documentation.
Laboratory Staff Follow procedures for handling, labeling, storage, and
reporting of reagents and supplies.
Procurement/Stores Issue, dispatch, and document receipt of reagents and supplies;
Staff communicate with responsible laboratory personnel.

5.3.4 Policy
Policy Description
Requirement
Compliance Laboratory services comply with applicable laws, regulations,
accreditation requirements, and professional guidelines.
Efficiency Reagents and supplies are managed to reduce waste, control costs, and
maintain high-quality materials.
Documentation All actions related to reagent management are documented and records
maintained.
Responsibility Clear assignment of responsibilities for inspection, storage, reordering,
and usage.

5.3.5 Procedure
 Reagent Inspection and Acceptance
Step Description
a) Inspection Inspect received reagents for integrity, labeling, expiration dates, and
packaging conditions.
b) Acceptance / Accept only reagents that meet quality standards; reject damaged,
Rejection expired, or incorrect reagents and document the reason.

 Identification, Listing, and Labeling

Step Description
Identification Assign unique identifiers or codes to each reagent and supply.
Listing / Maintain an updated list of all reagents and supplies present in the
Inventory laboratory, including quantity and location.
Labeling Ensure clear labels with reagent name, concentration, lot number, and
expiry date.

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  Expiry and Quality Control
Step Description
Monitoring Regularly check expiration dates to prevent use of expired materials.
Expiry
Quality Follow guidelines for proper storage conditions and handling to
Assurance preserve reagent quality.

 Reordering and Stock Management

Step Description
Safety Stock Define minimum and maximum stock levels based on laboratory testing
Limits volume and usage patterns.
Reordering Initiate reorders when stock reaches safety limits, ensuring continuous
availability without overstocking.

 Requesting, Issuing, and Dispatching

Step Description
Requesting Laboratory staff submit requests for reagents and supplies to the
designated responsible person.
Issuing / Stores personnel issue reagents according to documented requests and
Dispatching record the transaction.
Responsibility Identify and document the person responsible for each stage: request,
issue, and receipt.

5.3.6 Records
Record Type Required Content
Reagent inspection forms Acceptance/rejection records, date, personnel signature

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Inventory lists Updated stock levels, locations, lot numbers, expiry dates
Reorder logs Date of request, supplier, quantities ordered
Issue/dispatch logs Date, recipient, quantity, personnel signature

5.4 Equipment Management

5.4.1 Purpose
To ensure all laboratory equipment is selected, installed, operated,
calibrated, and maintained in a way that guarantees accurate and reliable
results.
5.4.2 Scope
This section applies to all analytical instruments, support devices, and
measuring equipment used within the laboratory, including their
accessories, software, and reference materials.
5.4.3 Responsibilities
 Quality Officer: Ensures compliance with ISO 15189 & GAHAR
standards, reviews documentation.
 Section Supervisors: Maintain equipment logs, ensure calibration
and preventive maintenance.
 Technicians: Operate equipment according to SOPs and report
malfunctions.
5.4.4 Equipment Inventory
The laboratory maintains an updated Equipment Master List that
includes:
 Device name & model
 Serial number
 Manufacturer & supplier
 Location
 Date of installation
 Calibration/verification schedule
 Maintenance schedule
 Status (Active / Out of service)

5.4.5 Equipment Selection & Installation

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  Equipment must be suitable for the intended tests and meet technical
performance requirements.
 Installation must be performed by trained personnel or authorized
agents.
 Installation Qualification (IQ) and Operational Qualification (OQ)
records must be documented.

5.4.6 Calibration & Verification

 All measuring devices must be calibrated according to predefined
schedules.
 Calibration must be performed by accredited bodies (ISO 17025
when available).
 Verification is done after maintenance, power failures, or relocation.
 Records must include: method, results, acceptance criteria, and
corrective action if failed.

5.4.7 Preventive & Corrective Maintenance

 Preventive maintenance is performed as per manufacturer
recommendations.
 Maintenance logs must be updated with:
o Date
o Type of maintenance
o Performed by
o Parts replaced

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 o Next scheduled maintenance
 Equipment must be labeled “Out of Service” if unsafe or producing
unreliable results.

5.4.8 Equipment Operation

 Operation must follow approved Standard Operating Procedures
(SOPs).
 Only trained and authorized staff may operate equipment.
 Daily performance checks must be done (e.g., internal QC,
temperature checks).

5.4.9 Equipment Safety

 All equipment must meet electrical and biosafety standards.
 High-risk devices must have protective guards, emergency stop
buttons, and grounding.

5.4.10 Equipment Documents & Records

The following must be maintained:
 User manuals
 SOPs
 Calibration certificates
 Maintenance reports
 Error logs
 Service contracts
 Decontamination certificate before external servicing

5.4.11 Equipment Decommissioning

 Reasons: repeated malfunction, obsolete technology, or safety
issues.
 Documentation: decommission request, final performance
evaluation, safe disposal record.

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 [Link] operational processes in the laboratory

6.1 Pre-Analytical Processes

6.1.1 Purpose
To ensure the accuracy, safety, and quality of laboratory testing by
standardizing all activities from the time a test is ordered until the specimen
is processed and delivered to the testing location.
6.1.2 Scope
This SOP applies to all laboratory staff and personnel involved in test
ordering, specimen collection, transportation, and preparation prior to
analysis.
6.1.3 Responsibility
Role Responsibility
Laboratory Approves pre-examination policies, ensures compliance
Director/Manager with regulations, and monitors quality indicators.
Section Supervisors / Supervise specimen collection, labeling, handling, and
Coordinators transportation; monitor adherence to SOPs.
Laboratory Staff Collect, handle, label, and deliver specimens according to
standardized procedures; report deviations or errors.
Healthcare Providers / Provide complete and accurate test orders; inform patients
Ordering Clinicians as appropriate.
6.1.4 Policy
1. All pre-examination activities shall comply with applicable laws,
accreditation standards, and recognized guidelines.
2. Patients must be informed of available laboratory services, test
procedures, and any preparatory requirements prior to specimen
collection.
3. Laboratory staff must understand pre-analytical variation and
implement measures to reduce errors during the pre-examination
phase to ensure patient safety and reliable test results.

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6.1.5 Procedure
Step Description
1. Test Ordering Verify test requests for completeness, accuracy, and
appropriateness. Confirm patient identification and clinical
information.
2. Patient Preparation Inform patients about specimen collection procedures, fasting
& Education requirements, special handling instructions, and any potential
risks.
3. Specimen Collection Follow standardized procedures for specimen type, collection
technique, labeling, and identification. Ensure patient safety and
comfort.
4. Specimen Transport Use approved containers and transport conditions. Deliver
& Delivery specimens promptly to the laboratory testing location to maintain
integrity.
5. Pre-Analytical Check for hemolysis, clotting, contamination, or insufficient
Quality Control volume. Document and take corrective action if pre-analytical
errors are detected.
6. Documentation Record patient identification, test ordered, date and time of
collection, collector details, and any special instructions or
observations.

6.1.6 Key Quality Considerations

Aspect Description
Patient Ensure patients understand laboratory services and any required
Communication preparation.
Error Prevention Identify sources of pre-analytical variation and implement corrective
measures.
Specimen Integrity Maintain proper labeling, handling, and transport to prevent
compromise of test results.
Safety Follow infection control, biohazard handling, and patient safety
protocols.
6.1.7 Records
Record Type Required Content
Test request forms Complete order, clinician signature, patient ID
Specimen collection logs Collector ID, date/time, special instructions
Transport records Specimen condition, time of delivery
Pre-analytical quality checks Documentation of errors and corrective actions

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6.2 Specimen Tracking and Handling
6.2.1 Purpose
To ensure accurate tracking, secure handling, and proper storage of patient
specimens, preventing deterioration, loss, or damage, and supporting
reliable laboratory testing and patient safety.
6.2.2 Scope
This SOP applies to all personnel involved in specimen registration,
collection, labeling, transportation, reception, analysis, and storage.
6.2.3 Responsibility
Role Responsibility
Laboratory Approves specimen handling policies, ensures compliance,
Director/Manager and monitors specimen integrity and tracking practices.
Authorized Laboratory Staff Evaluate specimens upon receipt, ensure compliance with
/ Supervisors acceptance criteria, and maintain tracking records.
Collection and Transport Collect, label, and transport specimens according to SOPs,
Personnel ensuring security and integrity.
Laboratory Staff Maintain specimen documentation, track location and status,
and report discrepancies or errors.

6.2.4 Policy
1. All specimens shall be tracked and handled in accordance with
applicable laws, accreditation standards, and laboratory guidelines.
2. Patient specimens must be secured, and measures taken to prevent
deterioration, loss, or damage at all stages from collection to storage.
3. Specimens failing acceptance criteria shall be rejected and
documented, and corrective actions implemented as required.
4. Only authorized personnel are permitted to evaluate and handle
specimens upon receipt.

6.2.5 Procedure
 Specimen Registration, Collection, and Labeling
Step Description
Registration Assign a unique identifier to each specimen; document patient
information, test requested, date/time, and collector ID.
Collection & Collect specimens according to SOPs; label with patient ID, specimen
Labeling type, date/time, and other required identifiers.

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  Specimen Reception and Evaluation
Step Description
Reception Specimens are received by authorized staff at the laboratory.
Evaluation Against Inspect for:
Acceptance Criteria •Correct patient identification
•Proper labeling
•Adequate volume
•Integrity of specimen (e.g., no hemolysis, clotting, or
contamination)
•Appropriate container and transport conditions |
| Acceptance / Rejection | Accept specimens that meet criteria;
reject non-conforming specimens, document reason, and notify
relevant staff. |

 Specimen Tracking and Storage

Step Description
Tracking Record specimen location, status, and history in the laboratory information
system or manual log.
Handling & Store specimens under appropriate conditions (temperature, light
Storage protection, etc.) according to test requirements until analysis.
Security Ensure restricted access to specimen storage areas to authorized personnel
only.

6.2.6 Records
Record Type Required Content
Specimen registration logs Unique identifier, patient details, test requested, collector ID,
date/time
Acceptance/rejection Criteria evaluated, authorized staff signature, corrective
records action if applicable
Tracking logs Specimen location, status updates, storage conditions
Storage logs Temperature monitoring, access records, duration of storage

6.3 Analytical Methods and Verification

6.3.1 Purpose
To ensure that laboratory testing is accurate, reliable, and reproducible by
using validated analytical methods and assigning competent staff to
perform and verify examination procedures before routine use.
6.3.2 Scope
This SOP applies to all analytical activities performed in the laboratory,
including the use of specialized instruments, validated examination
procedures, and verification of new or modified methods.

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6.3.3 Responsibility
Role Responsibility
Laboratory Approves analytical method policies, ensures validation and
Director/Manager verification practices, and reviews verification results.
Section Supervisors / Perform analysis using validated methods, verify examination
Technical Staff procedures, document results, and report deviations.
Competent Staff Members Operate specialized instruments, follow SOPs, and participate
in method verification according to assigned responsibilities.
Quality Assurance Review verification documentation, monitor method
Personnel performance, and ensure compliance with accreditation
standards.

6.3.4 Policy
1. All analytical methods shall be validated or verified according to
reliable guidelines and manufacturer instructions before routine use.
2. Only competent staff shall operate specialized instruments or
perform analytical procedures.
3. The laboratory shall assign staff responsibilities for each analytical
activity.
4. Verification of examination procedures shall be documented,
including the results obtained and the responsible staff member’s
review.
5. Verification activities must ensure that analytical methods meet the
intended use, accuracy, and reproducibility requirements.

6.3.5 Procedure
 Assignment of Competent Staff
Step Description
Staff Assignment Assign qualified and trained personnel to operate specific analytical
instruments or perform specific examination procedures.
Competency Maintain records of staff qualifications, training, and competency
Documentation assessments for assigned analytical tasks.

 Verification of Examination Procedures

Step Description
Validation / Use examination procedures as provided by the manufacturer
Manufacturer without modification unless method verification is performed.
Instructions
Verification Planning Develop a verification plan following reliable guidelines (e.g.,
CLSI, ISO 15189).
Performance Verify the analytical method by testing samples to ensure
Confirmation accuracy, precision, sensitivity, specificity, and reproducibility.

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Documentation Record procedures used for verification, results obtained, staff
involved, and any deviations observed.
Review and Authorized staff member reviews verification results, signs off,
Authorization and approves the method for routine use.

 Performance Characteristics (where applicable)

Characteristic Description
Accuracy Comparison of test results to reference methods or materials.
Precision / Reproducibility Repeatability of results under the same conditions and
between operators/instruments.
Analytical Sensitivity / Lowest measurable quantity accurately detected.
Detection Limit
Analytical Specificity / Ability to measure the analyte without interference from
Interference other substances.
Linearity / Reportable Range Range over which results are accurate and proportional to
concentration.
Reference Interval Confirmation that reference intervals are appropriate for the
Verification tested population.

6.3.6 Records
Record Type Required Content
Verification plans Method, procedure, performance characteristics to be verified
Verification results Data, calculations, observations, and deviations
Staff assignment records Competency documentation, qualifications, and authorization
Review and approval Signature of authorized personnel, date, and comments

6.4 Laboratory Procedure Manual and Technical

Procedures
6.4.1 Purpose
To provide documented, standardized instructions for all laboratory
activities supporting analytical testing, ensuring consistency, quality, and
compliance with accreditation requirements.
6.4.2 Scope
This SOP applies to all laboratory personnel involved in analytical testing,
quality assurance, and related laboratory processes.
6.4.3 Responsibility
Role Responsibility
Laboratory Approves the laboratory procedure manual and ensures all
Director/Manager technical procedures are current and accessible.
Section Supervisors / Ensure staff follow documented procedures, provide
Technical Staff guidance, and report deviations.

25
Laboratory Staff Adhere to technical procedures and provide feedback for
review and improvement.
Quality Assurance Review procedures periodically and update as needed to
Personnel maintain compliance and quality standards.

6.4.4 Policy
1. The laboratory shall maintain a comprehensive procedure
manual covering all activities supporting analytical testing.
2. Technical procedures shall be written in a language clearly
understood by all staff and made available in appropriate
locations, whether paper-based, electronic, or web-based.
3. Technical procedures must be consistently followed to ensure
accurate, reproducible results.
4. Procedures shall be regularly reviewed and updated to reflect
current practices, new technologies, and regulatory requirements.
5. The procedure manual supports training of new employees and
serves as a reference for experienced staff.

6.4.5 Procedure
 Development of Technical Procedures
Step Description
Identify Test List all analytical methods performed in the laboratory.
Methods
Write Technical Develop step-by-step instructions covering:
Procedures  Sample handling and preparation
 Equipment operation and calibration
 Analytical method steps
 Quality control and validation procedures
 Safety precautions |
| Language & Accessibility | Ensure procedures are clear,
understandable, and accessible at the point of use. |
| Approval | Laboratory Director/Manager reviews and
approves all procedures before implementation. |

 Implementation and Use

Step Description
Staff Training Train staff on technical procedures prior to performing analytical
tests independently.
Consistent Ensure procedures are followed during all testing activities to
Adherence maintain quality and reliability.
Documentation Record use of procedures in training logs and competency
assessments.

26
  Review and Update
Step Description
Periodic Technical procedures shall be reviewed at defined intervals or when:
Review  New equipment or methods are introduced
 Regulatory or accreditation requirements change
 Errors or deviations are identified |
| Update & Approval | Revised procedures must be approved by
the Laboratory Director/Manager and communicated to staff. |

6.4.6 Records
Record Type Required Content
Procedure List of all technical procedures, approval signatures, revision dates
manual
Training records Staff trained on specific procedures, date, trainer, competency
evaluation
Review logs Documentation of periodic reviews, updates, and staff notifications
Deviations Records of any deviations from procedures and corrective actions

6.5 Internal Quality Control (IQC)

6.5.1 Purpose
To ensure the reliability, accuracy, and consistency of laboratory test
results by implementing a structured internal quality control program.
6.5.2 Scope
This SOP applies to all laboratory personnel performing analytical testing
and responsible for monitoring and maintaining the quality of test results.
6.5.3 Responsibility
Role Responsibility
Laboratory Approves IQC policies, ensures compliance, monitors
Director/Manager performance, and reviews follow-up actions.
Section Supervisors / Implement IQC procedures, analyze control results, investigate
Technical Staff trends or outliers, and take corrective actions.
Laboratory Staff Perform IQC testing, document results, report deviations, and
adhere to established procedures.
Quality Assurance Review IQC data, identify systemic issues, and verify
Personnel corrective/preventive actions.

6.5.4 Policy
1. Internal quality control testing is performed regularly to monitor and
ensure the reliability of test results.

27
 2. Appropriate control materials are used to verify that the laboratory’s
analytical systems produce accurate and reliable patient results.
3. Outliers, trends, or deviations in control results are promptly
analyzed, documented, and corrective/preventive actions
implemented before major problems occur.
4. IQC results are documented, reviewed, and maintained in
accordance with accreditation requirements.
6.5.5 Procedure
 Control Material Use
Step Description
Selection Use stabilized control materials appropriate for the test system,
representing low, medium, and high concentrations as required.
Preparation Follow manufacturer instructions or laboratory SOPs for preparation,
storage, and handling of control materials.
Testing Perform IQC according to the laboratory’s established schedule (e.g.,
Frequency daily, per shift, per batch).

 Monitoring and Analysis

Step Description
Result Recording Document all IQC results in control charts or laboratory information
system.
Trend and Outlier Examine results for shifts, trends, or values outside predetermined
Analysis acceptable ranges.
Investigation Identify potential causes of deviation, including instrument
malfunction, reagent issues, or operator error.

 Corrective and Preventive Actions

Step Description
Immediate Action Stop patient testing if control results are out of range.
Root Cause Determine cause of deviation or trend.
Analysis
Corrective Action Adjust instruments, reagents, procedures, or retrain personnel as
required.
Preventive Action Implement measures to prevent recurrence of identified issues.
Documentation Record all analyses, actions, and follow-up in the IQC log or LIS.
6.5.6 Records
Record Type Required Content
Control material logs Control lot numbers, expiration dates, preparation details
IQC results Date, operator, instrument, control values, deviations
Corrective/preventive Investigation notes, corrective measures, verification of
actions effectiveness
Trend analysis charts Control charts, statistical analysis, review signatures

28
6. External Quality Control / External Quality Assessment
(EQA) or its alternatives is developed and implemented.

6.6.1 Purpose
To objectively assess the quality of laboratory results by participating in
external quality assessment programs, ensuring comparability with peer
laboratories, supplementing internal quality control, and promoting
continuous improvement.

6.6.2 Scope
This SOP applies to all laboratory personnel involved in proficiency
testing, external quality assessment, and reporting of results for all tests
performed within the laboratory’s scope.

6.6.3 Responsibility
Role Responsibility
Laboratory Approves participation in EQA programs, ensures compliance,
Director/Manager reviews results, and initiates corrective actions.
Section Supervisors / Receive, process, test, and report proficiency specimens
Technical Staff according to SOPs and established timelines.
Laboratory Staff Perform testing of proficiency specimens using routine
methods alongside regular patient samples.
Quality Assurance Monitor participation, review results, compare with peer
Personnel laboratories, and recommend improvements.

6.6.4 Policy
1. The laboratory shall participate in external quality assessment
programs covering the maximum number and complexity of tests
performed.
2. Participation supplements internal quality control and provides
objective performance assessment against peer laboratories.
3. Proficiency testing specimens shall be handled according to written
protocols, tested by routine staff, and reported to the EQA provider
within the required timeframe.
4. Results shall be reviewed and corrective or preventive actions
implemented for any deviations identified.

29
6.6.5 Procedure

 Enrollment and Planning

Step Description
Program Subscribe to EQA/proficiency testing schemes that cover laboratory’s
Selection scope of tests.
Scheduling Ensure receipt of EQA specimens aligns with testing schedules and
routine workflows.
Documentation Maintain records of enrollment, subscription, and EQA program details.

 Testing of Proficiency Specimens

Step Description
Receipt of Verify EQA specimens for integrity, labeling, and storage conditions
Specimens upon arrival.
Testing Test EQA specimens using routine laboratory methods and workflow,
along with regular patient testing.
Staff Assignment Assign routine, competent staff to perform testing to ensure accurate
representation of laboratory performance.

 Reporting and Follow-Up

Step Description
Result Submission Report test results to the EQA provider within the specified
timeframe, following written protocols.
Result Review Review EQA feedback and compare performance with peer
laboratories and expected consensus values.
Corrective / Preventive Investigate deviations, implement improvements, and document
Actions actions taken.

6.6.6 Records
Record Type Required Content
EQA subscription records Provider details, scope of tests, subscription dates
Proficiency testing logs Receipt date, test method, staff performing tests, results

30
Result submission Dates, submission method, personnel responsible
documentation
Review and corrective action Analysis of deviations, corrective measures,
records effectiveness verification

6.7 Post-Examination Processes is developed and

implemented to ensure accurate reporting and release of
verified laboratory tests.

6.7.1 Purpose
To ensure laboratory test results are reported accurately, clearly, and
timely, and that specimens and records are properly stored, retained, and
disposed of in accordance with regulations and hospital policies.
6.7.2 Scope
This SOP applies to all laboratory personnel involved in reviewing,
verifying, reporting, storing, and archiving laboratory results and
specimens.
6.7.3 Responsibility
Role Responsibility
Laboratory Approves post-examination policies, ensures compliance with
Director/Manager retention, storage, and disposal procedures.
Authorized Laboratory Review, verify, and release results; maintain proper
Staff documentation and implement storage and disposal procedures.
Laboratory Staff Follow SOPs for reporting, archiving, and specimen handling;
ensure accurate documentation.
Quality Assurance Monitor post-examination processes, verify compliance, and
Personnel identify areas for improvement.

6.7.4 Policy
1. All post-examination activities shall comply with applicable laws,
accreditation standards, and hospital policies.
2. Laboratory results shall be reviewed and verified by authorized staff
before release.
3. Specimens and laboratory records shall be stored, retained, and
disposed of according to defined criteria and retention times.
4. The laboratory shall ensure easy retrieval of required results and
specimens when needed.

31
6.7.5 Procedure
 Final Report Data Requirements
Element Description
Laboratory Identity Name and address of the laboratory.
Patient Identification Full patient name, unique patient ID, date of birth, or medical
record number.
Tests Performed List of all tests performed on the specimen.
Ordering Clinician Name of the clinician who ordered the tests.
Specimen Collection Date, time, and source of specimen.
Reporting Date and time results are reported.
Test Results & Reference Results with applicable reference ranges.
Intervals
Verification Name/ID of authorized staff member who reviewed and
approved results.
Interpretation / Comments Explanatory, advisory, or interpretive comments where
necessary.

 Review, Verification, and Reporting

Step Description
Review Authorized staff verify results for accuracy, completeness, and consistency.
Approval Authorized staff sign or electronically approve the final report.
Reporting Results are delivered to the ordering clinician via approved methods (electronic,
paper, LIS).

 Specimen Storage and Retention

Step Description
Storage Store specimens under appropriate conditions according to type,
stability, and testing requirements.
Retention Time – Retain final laboratory reports for the defined period as per hospital
Results policy and accreditation requirements.
Retention Time – Retain specimens according to defined retention schedule for
Specimens potential repeat testing or verification.

 Specimen Disposal
Step Description
Disposal Dispose of specimens that have exceeded retention time or are no longer
Criteria needed.
Method Follow approved procedures for safe disposal (e.g., biohazard
containers, incineration, chemical inactivation).
Documentation Record disposal date, method, and personnel responsible.

32
  Evidence of Compliance
Evidence Description
Approved Policy Documented hospital SOP covering elements a–f.
Staff Awareness Laboratory staff trained and aware of post-examination
policy.
Authorized Reviewers Defined staff responsible for reviewing and releasing results.
Retention & Retrieval Implemented processes for easy retrieval of final reports.
Specimen Storage & Implemented storage, retention, and disposal procedures.
Disposal
Specimen Accessibility Required specimens are easily retrievable for testing or
verification.

6.7.6 Records
Record Type Required Content
Final report logs Patient ID, test performed, date/time, verifier, comments
Review and approval Signature/ID of authorized staff, date, and method of
records verification
Specimen storage logs Location, storage conditions, dates
Retention and disposal Specimen ID, retention period, disposal date, method,
records personnel responsible

6.8 Laboratory results are reported within the acceptable

turnaround time.
6.8.1 Purpose
To ensure timely delivery of laboratory test results by monitoring,
measuring, and improving turnaround times, thereby supporting effective
clinical decision-making and patient care.
6.8.2 Scope
This SOP applies to all laboratory personnel involved in specimen
processing, testing, result reporting, and monitoring of turnaround times.
6.8.3 Responsibility
Role Responsibility
Laboratory Approves TAT policy, monitors performance, evaluates
Director/Manager trends, and implements corrective actions.
Section Supervisors / TeamMeasure and monitor TAT, identify delays, and coordinate
Leaders corrective measures.
Laboratory Staff Perform tests according to workflow, document timestamps,
and report any delays or deviations.
Quality Assurance Review TAT data, verify compliance with established
Personnel benchmarks, and recommend process improvements.

33
6.8.4 Policy
1. Turnaround time (TAT) is defined as the total elapsed time from
specimen collection to reporting of test results to the requesting
healthcare provider.
2. The laboratory shall monitor TAT for all tests and maintain records
for quality assurance and process improvement.
3. Assigned personnel are responsible for measuring, documenting,
and evaluating TAT data.
4. When TAT exceeds acceptable limits, laboratory management shall
investigate causes and implement corrective or preventive actions.
5. Laboratory workflow and TAT benchmarks shall be reviewed
periodically and adjusted as necessary to ensure efficiency and
patient safety.

6.8.5 Procedure
 TAT Measurement
Step Description
Specimen Collection Record date and time when the specimen is collected from the
Timestamp patient.
Specimen Receipt Record date and time when the specimen arrives at the
Timestamp laboratory.
Test Completion Record date and time when testing is completed.
Timestamp
Result Reporting Record date and time when results are released to the requesting
Timestamp provider.
TAT Calculation Total TAT = Time from collection to result reporting.
Document in LIS or logbook.

 Monitoring and Evaluation

Step Description
Regular Review Assigned staff reviews TAT data daily, weekly, or monthly
depending on test volume.
Benchmark Compare TAT against predefined acceptable limits for each test.
Comparison
Investigation Identify causes of delays (workflow inefficiencies, equipment
downtime, staffing issues, etc.).
Corrective Action Implement changes to improve TAT or adjust benchmarks based on
realistic workflow capabilities.

 Documentation and Reporting

Step Description

34
 Record Keeping Maintain logs of TAT data for all tests, including timestamps, staff
involved, and corrective actions taken.
Reporting Summarize TAT performance periodically to laboratory management
and QA for review.
Continuous Use TAT data to optimize workflow, staffing, and resource allocation
Improvement to enhance patient care.

6.8.6 Records
Record Type Required Content
TAT logs Specimen ID, collection time, receipt time, test completion time,
result reporting time
TAT monitoring Summary of TAT data, identified delays, corrective actions
reports
Corrective action Documentation of workflow modifications, process improvements,
records or benchmark adjustments

6.9 STAT results are reported within the defined timeframe.

6.9.1 Purpose
To ensure timely processing and reporting of urgent laboratory tests (STAT
tests) where delays could be life-threatening, supporting rapid clinical
decision-making and patient care.
6.9.2 Scope
This SOP applies to all laboratory personnel involved in ordering,
collecting, processing, testing, and reporting of STAT samples.
6.9.3 Responsibility
Role Responsibility
Laboratory Approves STAT testing policy, monitors performance,
Director/Manager ensures compliance with TAT targets for urgent samples.
Section Supervisors / Prioritize STAT samples, oversee rapid processing, and
Technical Staff ensure timely reporting of results.
Laboratory Staff Collect, process, test, and report STAT samples according to
established procedures.
Ordering Clinicians Identify and request appropriate STAT tests, providing clear
clinical justification.
Quality Assurance Monitor STAT testing performance, review TAT, and
Personnel recommend process improvements.

6.9.4 Policy
1. STAT testing is reserved for urgent clinical situations where any
delay could adversely affect patient care.

35
 2. The laboratory shall define the tests eligible for STAT processing
and establish TAT goals for each.
3. STAT samples shall be prioritized throughout the workflow:
ordering, collection, testing, and reporting.
4. The laboratory shall monitor STAT TAT and implement corrective
actions when turnaround times exceed defined limits.

6.9.5 Procedure
 Ordering STAT Tests
Step Description
Test Eligibility Maintain a list of tests approved for STAT requests.
Request Clinician identifies urgent need and submits STAT test order, including
Process clinical justification and patient identification.
Documentation Record STAT request in the laboratory information system (LIS) or
manual log.

 Collection and Reception

Step Description
Specimen Collect sample according to SOPs, ensuring minimal delay.
Collection
Labeling Clearly mark specimens as STAT to ensure priority handling.
Transport Deliver specimens immediately to the laboratory testing area, using rapid
transport mechanisms if necessary.

 Testing and Analysis

Step Description
Prioritization STAT samples are processed ahead of routine samples.
Testing Perform test using validated methods and instruments.
Documentation Record date and time of test start, completion, and any deviations from
standard workflow.

 Results Reporting
Step Description
Review and Authorized staff review results promptly for accuracy.
Verification
Reporting Communicate results immediately to the requesting clinician via
phone, electronic system, or other approved urgent reporting methods.
Documentation Log the reporting time and staff responsible for verification and
communication.

36
6.9.6 Monitoring and Quality Assurance
Step Description
TAT Monitoring Track time from sample collection to result reporting for STAT tests.
Performance Evaluate trends in STAT TAT and investigate any delays.
Review
Corrective Actions Adjust workflow, staffing, or resources to meet STAT TAT targets and
improve efficiency.

6.9.7 Records
Record Type Required Content
STAT test request logs Patient ID, test requested, ordering clinician, date/time of
request
Specimen collection and Collection time, receipt time, staff involved
receipt
Test performance and Date/time of testing, staff responsible, deviations
verification
Results reporting Time of result release, verification signature,
communication method

[Link] laboratory services

7.1 Laboratory Safety Program is implemented.

7.1.1 Purpose
To maintain a safe laboratory environment by identifying hazards,
implementing safety measures, and ensuring compliance with national
regulations and accreditation standards to protect staff, patients, and
visitors.
7.1.2 Scope
This SOP applies to all laboratory personnel, visitors, and contractors who
access laboratory facilities, and covers chemical, biological, physical,
radioactive, and ergonomic hazards.
7.1.3 Responsibility
Role Responsibility

Laboratory Develops, approves, and updates the safety program;

Director/Manager ensures compliance; monitors safety performance.

37
Safety Officer / QA Personnel Conducts risk assessments, safety audits, monitors
incidents, and reports to the hospital safety committee.

Laboratory Staff Follow all safety measures, use PPE appropriately, report
incidents, and participate in training.

Hospital Environment & Reviews laboratory safety reports, approves corrective

Safety Committee actions, and monitors program effectiveness.

7.1.4 Policy
1. A comprehensive laboratory safety program shall be documented,
communicated, implemented, reviewed, and updated annually.
2. The program shall cover staff, specimen, environmental, and
equipment safety, chemical hazards, incident handling, waste
disposal, PPE, and risk management.
3. Laboratory management shall provide necessary resources such as
spill kits, safety showers, eye washes, and ensure they are tested and
functional.
4. Safety incidents shall be reported, investigated, and corrective
actions implemented promptly.
5. All laboratory staff shall receive training on the safety program and
demonstrate understanding.

7.1.5 Procedure
 Safety Measures
Area Description

Healthcare Proper use of PPE, hand hygiene, vaccination, ergonomic

Professionals workstations, training on safe practices.

Specimen Safety Correct labeling, handling, transport, and storage of biological

specimens to prevent exposure or contamination.

Environment & Maintain clean workspaces, regular equipment maintenance,

Equipment hazard signage, fire safety, ventilation control.

Chemical & Hazardous Maintain a chemical inventory, labeling, and storage according
Materials to hazard class; use SDS for reference.

Incident Handling Immediate response to accidents, exposures, spills;

documentation and reporting; corrective and preventive actions.

Laboratory Waste Segregation and disposal of chemical, biological, sharps, and

Disposal radioactive waste according to regulations.

38
Safety Data Sheets Maintain up-to-date SDS for all chemicals; make them
(SDS) accessible to staff.

Chemical Spill & Procedures for safe containment and decontamination; use of
Clean-Up spill kits.

Personal Protective Guidelines for selection, use, cleaning, and disposal of gloves,
Equipment (PPE) lab coats, goggles, masks, and respirators.

Risk Management Conduct semiannual laboratory risk assessments, identify

hazards, implement mitigation strategies, and monitor
effectiveness.

 Training and Communication

Step Description

Staff Training Conduct initial and annual refresher training on laboratory safety
program, SOPs, and emergency procedures.

Communication Post safety guidelines, chemical inventories, SDS, and emergency

contacts in visible locations throughout the laboratory.

Documentation Maintain training logs with staff signatures, dates, and topics covered.

 Monitoring and Evaluation

Step Description

Risk Assessment Perform semiannual laboratory risk assessments; report findings to

hospital safety committee.

Safety Equipment Ensure spill kits, safety showers, and eye wash stations are functional
Checks and tested regularly.

Incident Reporting Log and investigate all safety incidents; implement corrective actions
and preventive measures.

Program Review Annually review and update safety program based on audit findings,
incident reports, and regulatory changes.

7.1.6 Evidence of Compliance

Evidence Description

Written Safety Program Includes all elements a–j, regularly updated and approved.

Staff Training Records Documentation that all staff received and understood
training.

Risk Assessment Reports Semiannual reports submitted to hospital safety committee.

39
 Safety Equipment Logs Records of testing and functionality of spill kits, safety
showers, and eye wash stations.

Incident & Corrective Documentation of incidents, investigations, and

Action Records implemented corrective actions.

Monitoring & Review Records showing hospital oversight, program effectiveness,

and improvements implemented.

7.1.7 Records
Record Type Required Content
Safety Program Document SOP, approval signature, revision dates
Training Logs Staff name, date, topic, trainer signature
Risk Assessment Reports Hazard identification, mitigation measures, review dates
Safety Equipment Check Logs Dates tested, condition, responsible personnel
Incident Reports Description, date/time, staff involved, corrective actions
Waste Disposal Records Type of waste, disposal date, method, staff responsible

[Link] Point of care testing

8.1 Purpose
To ensure that point-of-care testing (POCT) is performed safely,
accurately, and reliably at or near the patient site, in compliance with
hospital policy, accreditation standards, and manufacturer guidelines.
8.2 Scope
This SOP applies to all personnel performing POCT, overseeing POCT
devices, and managing associated reagents and supplies across the hospital.
8.3 Responsibility
Role Responsibility
Laboratory Approves POCT policy, assigns responsible staff, monitors
Director/Manager performance, and ensures compliance with standards.
POCT Coordinator / Oversees POCT operations, maintains device quality, ensures
Assigned Staff availability of reagents and supplies, and conducts audits.
POCT Operators / Staff Perform POCT according to SOPs, document results, maintain
quality, and report any issues.
Quality Assurance Monitor POCT quality metrics, perform inspections, and verify
Personnel corrective actions.

40
8.4 Policy
1. POCT shall be performed safely and correctly with accurate and
reliable results.
2. The laboratory shall assign a responsible staff member for oversight
of POCT devices and consumables.
3. All POCT sites and tests performed shall be identified, documented,
and regularly audited.
4. Any deficiencies identified during inspection shall be corrected
promptly.
5. Staff performing POCT shall be trained, competent, and aware of
device operation and quality assurance requirements.

8.5 Procedure
 Identification and Documentation of POCT Sites
Step Description
Site Identification Maintain a list of all hospital locations where POCT is performed.
Test Catalogue Document the tests performed at each site, including
manufacturer instructions and test limitations.
Responsible Staff Assign a POCT coordinator for oversight of operations, quality,
Assignment and supplies.

 Device and Reagent Management

Step Description
Device Ensure devices are regularly calibrated, maintained, and functioning
Maintenance properly.
Reagent Monitor stock levels of reagents and supplies; ensure continuous
Availability availability.
Quality Checks Perform internal quality control (IQC) according to manufacturer
guidelines and hospital policy.

 Staff Training and Competency

Step Description
Initial Training All operators receive training on device use, safety, specimen
handling, and quality control procedures.
Competency Evaluate operator competency periodically (annually or per
Assessment accreditation requirements).
Documentation Maintain training and competency records for all POCT staff.

41
  Auditing and Inspections
Step Description
Audit Form Develop an inspection checklist covering devices, reagents, staff
Preparation competence, and workflow.
Site Inspection Conduct regular inspections to identify deficiencies or non-
compliance.
Corrective Action Document and implement corrective actions for any deficiencies
identified.
Follow-Up Verify effectiveness of corrective actions in subsequent inspections.

 Reporting and Quality Assurance

Step Description
Result Record POCT results in patient records or LIS as appropriate.
Documentation
Quality Monitoring Track quality metrics, including IQC results, device errors, and
operator compliance.
Management Include POCT performance in periodic laboratory quality reviews.
Review

8.6 Records
Record Type Required Content
POCT site list Location, tests performed, responsible staff
Device maintenance log Calibration, maintenance dates, responsible personnel
Reagent inventory Stock levels, lot numbers, expiry dates
Staff training & competency Training dates, evaluation results, signatures
Audit & inspection reports Findings, deficiencies, corrective actions, follow-up
Quality control logs IQC results, device errors, actions taken

9. Information Management (LIS)

9.1. Purpose
To ensure that all laboratory information, whether electronic or paper-
based, is accurate, secure, traceable, accessible only to authorized
personnel, and managed in a way that supports reliable patient results.

9.2. Scope
This section applies to:
 The Laboratory Information System (LIS)

42
  All hardware and software related to data entry, storage,
transmission, and reporting
 Backup and security systems
 Paper records interfacing with electronic data
 Communication between the laboratory and clinical departments

9.3. Responsibilities
 Laboratory Director: Ensures availability of a secure, validated,
and functional LIS.
 Quality Officer: Monitors system compliance with ISO 15189 &
GAHAR.
 IT Department / LIS Vendor: System maintenance, upgrades,
cybersecurity.
 Laboratory Staff: Accurate data entry, verification of results, safe
password use.

9.4. LIS Validation & Verification

Before implementing any LIS or software update:
 Perform LIS validation to confirm accurate data processing.
 Verify interfaces with analyzers (pre-analytical, analytical, post-
analytical).
 Document any discrepancies and corrective actions.
 Ensure compatibility with national electronic health systems when
relevant.

9.5. Data Entry & Result Reporting

 Patient data must be entered accurately and verified.
 Analyzer interfaces should minimize manual transcription errors.
 Critical values must follow the laboratory’s Critical Result Policy.
 Results released must be clearly traceable to the authorizing person.
 Amendments must be documented with date, reason, and authorized
personnel.

9.6. Data Integrity

The laboratory ensures:
 Unique patient identifiers
 Protection from accidental changes
 Accuracy of timestamps

43
  Use of audit trails (Logs) to track all activities
 Prevention of lost, duplicated, or altered data

9.7. Information Security & Confidentiality

 Access to LIS is role-based (Username + Password).
 Passwords must be confidential and changed periodically.
 Patient information must not be shared except for authorized clinical
purposes.
 Electronic systems must be protected via firewalls, antivirus, and
secure networks.
 Screen lock is required when computers are unattended.

9.8. Backup, Storage & Disaster Recovery

 Daily automated backups of all LIS data.
 Off-site or cloud backup maintained by IT.
 Disaster recovery plan defined and tested annually.
 Restore procedures documented and verified periodically.

9.9. Document & Record Management

The LIS should support:
 Control of laboratory documents (SOPs, manuals, QC charts).
 Storage of results, QC, calibration, and instrument logs.
 Version control to prevent use of outdated documents.
 Retention periods compliant with national guidelines and
ISO/GAHAR.

9.10. LIS Maintenance & Downtime Procedures

 Preventive maintenance performed by IT or vendor.
 During system downtime:
o Use manual worksheets
o Document all results
o Enter them into LIS once restored
 Staff must follow a Downtime SOP outlining steps and
responsibilities.

9.11. Communication & Connectivity

 LIS must integrate with hospital systems and analyzer interfaces.

44
  Ensure secure electronic transmission of results to clinicians.
 Validate all interfaces after any updates or instrument replacements.

9.12. Continual Improvement

 LIS performance reviewed during management review.
 Regular audits of data integrity and security.
 User feedback collected to improve the system.
 Training provided for all new features

10. Process Improvement

10.1. Purpose

To ensure that the laboratory continuously monitors, analyzes, and

improves all processes to enhance the quality of services, patient safety,
and operational efficiency.

10.2. Scope
This section applies to all laboratory processes including:
 Pre-analytical, Analytical, and Post-analytical phases
 Customer service and communication
 Equipment and inventory management
 Personnel performance
 Document control, LIS, biosafety, and quality management
activities

10.3. Responsibilities
 Laboratory Director: Provides leadership, resources, and
approval for improvement plans.
 Quality Officer: Identifies opportunities for improvement, follows
up on indicators, and manages corrective/preventive actions.
 Section Supervisors: Implement improvements within their areas.
 All Staff: Participate in reporting problems, suggestions, and
improvement ideas.

10.4. Principles of Process Improvement

 Evidence-based decision making
 Data analysis and trend monitoring
 Customer (patient/clinician) focus

45
  Staff involvement and empowerment
 Standardization and prevention of recurrence
 Documentation and transparency

10.5. Sources for Identifying Improvement Opportunities

Improvement ideas may originate from:
 Internal audits
 External audits (GAHAR, ISO, central labs)
 Quality indicators (TAT, rejection rate, QC performance,
complaints)
 Staff suggestions
 Risk assessments
 Nonconformities and corrective actions
 Customer feedback (patients, clinicians)
 New regulations or technologies

10.6. Process Improvement Cycle

The laboratory follows the PDCA Cycle:

P – Plan
 Identify problem or
opportunity
 Analyze root causes (using
tools such as Fishbone, 5
Whys, Pareto)
 Define objectives
 Develop an action plan
 Assign responsibilities and
deadlines

D – Do
 Implement actions
 Provide necessary training
 Document the implementation steps
 Ensure minimal disruption to patient care

C – Check
 Measure results using indicators
 Compare outcomes to expected goals
 Verify effectiveness of implemented changes

A – Act

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  Standardize successful improvements
 Update SOPs, forms, and training records
 Share the results with staff
 Identify opportunities for further improvement

Fishbone diagram
10.7. Improvement Tools

 Root Cause Analysis (RCA)

 Fishbone Diagram
 5 Whys
 Pareto Analysis
 Flowcharts
 Risk Assessment Matrix
 Control Charts and quality indicators
 Benchmarking with other laboratories

10.8. Documentation
All improvement projects must be documented including:
 Problem description
 Data collected
 Root cause analysis
 Action plan
 Implementation details
 Evaluation results
 Updated documents
 Impact on quality and patient safety

10.9. Continual Improvement Report

The Quality Officer prepares periodic improvement reports covering:
 Achievements
 Ongoing projects
 Trends of indicators
 Areas needing additional improvement
 Recommendations for management review

10.10. Management Review Integration

Results of process improvement activities are discussed in management
review to support strategic decisions, resource allocation, and overall
quality goals.

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 References

 GAHAR Standards – Egyptian General Authority for Healthcare

Accreditation and Regulation.
 WHO Laboratory Quality Management System (LQMS)
Handbook, 2011.
 CLSI (Clinical and Laboratory Standards Institute) guidelines,
including:
 ISO 15189:2022 – Medical laboratories — Requirements for
quality and competence.
 CDC Guidelines for Laboratory Biosafety, latest edition.

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