Stepwise Laboratory (Quality)

Improvement Process Towards

Accreditation (SLIPTA) Checklist
For Clinical and Public Health Laboratories
1.0 INTRODUCTION

Laboratory services are an essential component in the diagnosis and treatment of patients infected with
the human immunodeficiency virus (HIV), malaria, Mycobacterium tuberculosis (TB), sexually
transmitted diseases (STDs), and other infectious diseases. Presently, the laboratory infrastructure and
test quality for all types of clinical laboratories remain in its nascent stages in most countries in
Africa. Consequently, there is an urgent need to strengthen laboratory systems and services. The
establishment of a process by which laboratories can achieve accreditation at international standards is
an invaluable tool for countries to improve the quality of laboratory services.

In accordance with WHO’s core functions of setting standards and building institutional capacity, WHO-
AFRO has established the Stepwise Laboratory (Quality) Improvement Process Towards
Accreditation (SLIPTA) to strengthen laboratory systems of its Member States. The Stepwise
Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) is a framework for
improving quality of public health laboratories in developing countries to achieve ISO 15189 standards.
It is a process that enables laboratories to develop and document their ability to detect, identify, and
promptly report all diseases of public health significance that may be present in clinical specimens. This
initiative was spearheaded by a number of critical resolutions, including Resolution AFR/RC58/R2 on
Public Health Laboratory Strengthening, adopted by the Member States during the 58th session of the
Regional Committee in September 2008 in Yaoundé, Cameroon, and the Maputo Declaration to
strengthen laboratory systems. This quality improvement process towards accreditation further provides
a learning opportunity and pathway for continuous improvement, a mechanism for identifying resource
and training needs, a measure of progress, and a link to the WHO-AFRO National Health Laboratory
Service Networks.

Clinical, public health, and reference laboratories participating in the Stepwise Laboratory (Quality)
Improvement Process Towards Accreditation (SLIPTA) are reviewed bi-annually. Recognition is
given for the upcoming calendar year based on progress towards meeting requirements set by
international standards and on laboratory performance during the 12 months preceding the SLIPTA
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 audit, relying on complete and accurate data, usually from the past 1-13 months to 1 month prior to
evaluation.

2.0 Scope

This checklist specifies requirements for quality and competency aimed to develop and improve
laboratory services to raise quality to established national standards. The elements of this checklist are
based on ISO standard 15189:2007(E) and, to a lesser extent, CLSI guideline GP26-A4; Quality
Management System: A model for Laboratory Services; Approved Guideline – Fourth Edition.

Recognition is provided using a five star tiered approach, based on a bi-annual on-site audit of
laboratory operating procedures, practices, and performance.

The inspection checklist score will correspond to the number of stars awarded to a laboratory in the
following manner:

No Stars 1 Star 2 Stars 3 Stars 4 Stars 5 Stars

(0 – 141 pts) (142 – 166 pts) (167 – 192 pts) (193 – 218 pts) (219 – 243 pts) (244 – 258 pts)
< 55% 55 – 64% 65 – 74% 75 – 84% 85 – 94% ≥95%


A laboratory that achieves less than a passing score on any one of the applicable standards will work
with the Regional Office Laboratory Coordinator to:

• Identify areas where improvement is needed.

• Develop and implement a work plan.
• Monitor laboratory progress.
• Conduct re-testing where required.
• Continue steps to achieve full accreditation.

3.0 Parts of the Audit

This laboratory audit consists of three parts:

Part I: Profile of Laboratory

Part II: Audit Checklist

Evaluation of laboratory operating procedures, practices, and tables for reporting performance

Part III: Summary of Findings

Summary of findings of the SLIPTA audit and action planning worksheet

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PART I: LABORATORY PROFILE
Date of Audit Date of Last Audit

Prior Audit Status

Not Audited 0 Stars 1 Star 2 Stars 3 Stars 4 Stars 5 Stars
Name(s) and Affiliation(s) of Auditor(s)

Laboratory Name Laboratory Number

Laboratory Address

:
Laboratory Telephone Fax Email

Head of Laboratory Telephone (Head of Laboratory) Personal

Work
Laboratory Level (check only one) Type of Laboratory/Laboratory Affiliation (check only one)

National Reference Regional / Provincial Public Hospital Private

District Zonal Field Research Non-hospital Other – Please specify:

Outpatient Clinic ______________________
Laboratory Staffing Summary

Profession Number of Full Time Adequate for facility operations?

Employees
Degree-holding Professional Staff Yes No Insufficient Data

Diploma-holding Professional Staff Yes No Insufficient Data

Certificate-holding Professional Staff Yes No Insufficient Data

Microscopist Yes No Insufficient Data

Data Clerk Yes No Insufficient Data

Phlebotomist Yes No Insufficient Data

Cleaner Yes No Insufficient Data

Is the cleaner(s) dedicated to the laboratory only? Has the cleaner(s) been trained in safe waste handling?
Yes No Yes No
Driver Yes No Insufficient Data

Is the driver(s) dedicated to the laboratory only? Has the driver(s) been trained in biosafety?
Yes No Yes No
Other Yes No Insufficient Data

If the laboratory has IT specialists, accountants or non-laboratory-trained management staff, this should be indicated in the description of the
organizational structure on the following page.

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Does the laboratory have sufficient space, equipment, supplies, personnel, infrastructure, etc. to
execute the correct and timely performance of each test and maintain the quality management
system? If no, please elaborate in the summary and recommendations section at the end of the checklist.
Sufficient space YES NO

Equipment YES NO

Supplies YES NO

Personnel YES NO

Infrastructure YES NO

Other - Please specify: YES NO

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PART II: LABORATORY AUDITS

Laboratory audits are an effective means to 1) determine if a laboratory is providing accurate and reliable results; 2)
determine if the laboratory is well-managed and is adhering to good laboratory practices; and 3) identify areas for
improvement.

Auditors complete this audit using the methods below to evaluate laboratory operations per checklist items and to
document findings in detail.

 Review laboratory records to verify that the laboratory quality manual, policies, personnel files, equipment
maintenance records; audit trails, incident reports, logs, Standard Operating Procedures (SOPs) and other
manuals (e.g., safety manual) are complete, current, accurate, and annually reviewed.

 Observe laboratory operations to ensure:

o laboratory testing follows written policies and procedures in pre-analytic, analytic and post-analytic
phases of laboratory testing;
o laboratory procedures are appropriate for the testing performed;
o Deficiencies and nonconformities identified are adequately investigated and resolved within the
established timeframe.

 Ask open-ended questions to clarify documentation seen and observations made. Ask questions like,
“show me how…” or “tell me about…” It is often not necessary to ask all the checklist questions verbatim.
An experienced auditor can often learn to answer multiple checklist questions through open-ended
questions with the laboratory staff.

 Follow a specimen through the laboratory from collection through registration, preparation, aliquoting,
analyzing, result verification, reporting, printing, and post-analytic handling and storing samples to
determine the strength of laboratory systems and operations.

 Confirm that each result or batch can be traced back to a corresponding internal quality control
(IQC) run and that the IQC was passed. Confirm that IQC results are recorded for all IQC runs and
reviewed for validation.

 Confirm PT results and the results are reviewed and corrective action taken as required.

 Evaluate the quality and efficiency of supporting work areas (e.g., phlebotomy, data registration and
reception, messengers, drivers, cleaners, IT, etc).

 Talk to clinicians to learn the users’ perspective on the laboratory’s performance. Clinicians often are a
good source of information regarding the quality and efficiency of the laboratory. Notable findings can be
documented in the Summary and Recommendations section at the end of the checklist.

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AUDIT SCORING
This Stepwise Laboratory Improvement Process Towards Accreditation Checklist contains 111 main sections (a total of 334
questions) for a total of 258 points. Each item has been awarded a point value of 2, 3, 4 or 5 points—based upon relative
importance and/or complexity. Responses to all questions must be, “yes”, “partial”, or “no”.

 Items marked “yes” receive the corresponding point value (2, 3, 4 or 5 points). All elements of a question must be
present in order to indicate “yes” for a given item and thus award the corresponding points.
NOTE: items that include “tick lists” must receive all “yes” and/or “n/a” responses to be marked “yes” for the
overarching item.

 Items marked “partial” receive 1 point.

 Items marked “no” receive 0 points.

When marking “partial” or “no”, notes should be written in the comments field to explain why the laboratory did not fulfill this item
to assist the laboratory with addressing these areas of identified need following the audit.

Audit Score Sheet

Section Total Points
Section 1: Documents & Records
25
Section 2: Management Reviews
17
Section 3: Organization & Personnel
20
Section 4: Client Management & Customer Service
8
Section 5: Equipment
30
Section 6: Internal Audit
10
Section 7: Purchasing & Inventory
30
Section 8: Process Control and Internal & External Quality Audit
33
Section 9: Information Management
18
Section 10: Corrective Action
12
Section 11: Occurrence/Incident Management & Process Improvement
12
Section 12: Facilities and Safety
43

TOTAL SCORE 258

No Stars 1 Star 2 Stars 3 Stars 4 Stars 5 Stars

(0 – 141 pts) (142 – 166 pts) (167 – 192 pts) (193 – 218 pts) (219 – 243 pts) (244 – 258 pts)
< 55% 55 – 64% 65 – 74% 75 – 84% 85 – 94% ≥95%


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For each item, please circle either Yes (Y), Partial (P), or No (N). All elements of the item must be satisfactorily present to indicate
“yes”. Provide explanation or further comments for each “partial” or “no” response.
Y P N Comments Score
1.0 DOCUMENTS & RECORDS
1.1 Laboratory Quality Manual 4
Is there a current laboratory quality
manual, composed of the quality
management system’s policies and
procedures, and has the manual content
been communicated to and understood
and implemented by all staff?
ISO 15189: 4.2.3 , 4.2.4
Tick for each item
The quality manual includes the following
elements:
Y N
Structure defined per ISO15189, Section 4.2.4

Quality policy statement that includes scope of

service, standard of service, objectives of the
quality management system, and management
commitment to compliance
Description of the quality management system
and the structure of its documentation
Reference to supporting procedures, including
technical procedures
Description of the roles and responsibilities of
the laboratory manager, quality manager, and
other personnel responsible for ensuring
compliance
Documentation of at least annual management
review and approval
Standard: A quality manual should be available that summarizes the laboratory’s quality program, includes policies that address all areas of the laboratory service, and identifies the
goals and objectives of the quality program. The quality manual should include policies (processes and procedures) for all areas of the laboratory service and should address all of
the quality system essentials (QSE).
ISO 15189: 4.2.3, 4.2.4
1.2 Document and Information Control 2
System
Does the laboratory have a system in
place to control all documents and Y P N
information (internal and external
sources)?
Standard: A document control system should be in place to ensure that records and all copies of policies/procedures are current, read by personnel, authorized by proper
authorities, reviewed annually, and immediately prior versions filed separately as per national policy. There must be a procedure/policy on document control. Documents must be
uniquely identified to include title, page numbers, and authority of issue, document number, versions, effective date, and author.
There must be a procedure/policy on document control. Documents must be uniquely identified to include tile, page numbers, and authority of issue, document number, versions,
effective date, and author.
ISO 15189: 4.3.1, 4.3.2 ,d 4.3.3
1.3 Document and Records 2
Are documents and records properly
maintained, easily accessible and fully
Y P N
detailed in an up-to-date Master List?

Standard: An up-to-date Master List that comprehensively details all laboratory documents, policies, and procedures should be readily accessible in either hard copy or electronic
form. These should be retrievable within a timely manner. If documents and records are maintained in electronic form they should be backed up on CD or other media.
ISO 15189: 4.3.2 (b,c): “Procedures shall be adopted to ensure that… b) a list, also referred to as a document control log, identifying the current valid revisions and their
distribution is maintained; c) only currently authorized versions of appropriate documents are available for active use at relevant locations.”

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 1.4 Laboratory Policies and Standard 5
Operating Procedures
Are policies and standard operating
procedures (SOPs) for laboratory Y P N
functions current, available and
approved by authorized personnel?
ISO 15189 4.3.2
Tick for each item
Policies and/or SOPs that:
Yes No
Document & Record Control
Defines the writing, checking, authorization, review,
identification, amendments, control and
communication of revisions to -
and retention and safe disposal of -
all documents and records

Standard ISO15189: 4.3.1, 4.13.1-3

Conflict of Interest
Defines the systems in place to identify and avoid
potential conflicts of interest and commercial,
financial, political or other pressures that may affect
the quality and integrity of operations
.
Standard: ISO15189: 4.1
Communication
Defines the systems in place to ensure
effectiveness of the quality management systems

ISO15189: 4.1.6
Review of Contracts (Supplier and Customer)
Defines the maintenance of all records, original
requests, inquiries, verbal discussions and
requests for additional examinations, meetings,
and meeting minutes

Standard: ISO 15189: 4.4

Examination by Referral Laboratories
Defines the 1) evaluation, selection, and
performance monitoring of referral laboratories, 2)
packaging and tracking of referred samples, 3)
reporting of results from referral labs

Standard: ISO 15189: 4.5.1

Purchasing and Inventory Control
Defines the processes for 1) requesting, ordering
and receipt of supplies, 2) the selection of
approved suppliers, 3) acceptance/rejection criteria
for purchased items, 4) safe handling, 5) storage,
inventory control system, 6) monitoring and
handling of expired consumables

Standard: ISO 15189: 4.6

Advisory Services
Defines the required qualifications and
responsibility for providing advice on: 1) choice of
examinations, 2) the use of the services, 3) repeat
frequency, 4) required type of sample, 5)
interpretation of results, 6) maintenance of records
of communication with lab users

ISO 15189: 4.7

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Resolution of Complaints and Feedback
Defines how 1) complaints and feedback shall be
recorded, 2) steps to determine whether patient’s
results have been compromised, 3) investigative
and corrective actions taken as required, 4)
timeframe for closure and feedback to the
complainant

Standard: ISO 15189: 4.8

Identification and Control of Nonconformities
Defines the 1) types of nonconformities that could
be identified, 2) how/where to record, 3) who is
responsible for problem resolution, 4) when
examinations are to be halted, 5) the recall of
released results, 6) person responsible for
authorizing release of results after corrective action
has been taken

Standard: ISO 15189: 4.9

Corrective Action
Defines 1) where to record, 2) how to perform root
cause analysis, 3) who will be responsible for
implementing action plans within the stipulated
timeframes, 4) monitoring the effectiveness of
these actions in overcoming the identified
problems
Standard: ISO 15189: 4.10
Preventive Action
Defines what tools will be used, where the action
plan will be recorded, who will be responsible for
ensuring the implementation within an agreed time
frame and the monitoring of its effectiveness

Standard: ISO 15189: 4.11

Continual Improvement
Defines what quality indicators will be used and
how action plans for these areas will be recorded,
evaluated, and reviewed for effectiveness of
improvement

Standard: ISO 15189: 4.12

Quality and Technical Records
Defines what are quality and technical records,
how amendments would be done, traceability,
storage, retention and accessibility of all hard and
electronic records

Standard: ISO 15189: 4.13

Internal Audits
Defines the internal audit process, including roles
and responsibilities, types of audits, frequency of
audits, auditing forms to be used, what will be
covered, and identification of personnel responsible
for ensuring closure of any nonconformances
raised within the agreed timeframe and
effectiveness of corrective actions implemented

Standard: ISO 15189: 4.14

Management Review
Defines frequency, agenda (in line with 4.15.2 a-
m), key attendees required, and plan that will
include goals, objectives, action plans,
responsibilities, due dates and how
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decisions/actions taken will be communicated to
the relevant persons

Standard: ISO 15189: 4.15

Personnel Records/Files
Defines organizational plan, personnel policies,
what is required in a personnel file (minimum in line
with ISO 15189 Section 5.1.2) and location of
personnel files

Standard: ISO 15189: 5.1

Personnel Training
Defines staff appraisals, staff orientation, initial
training, refresher training, continuous education
program, recommended and required trainings,
and record-keeping of training

Standard: ISO 15189: 5.1.4, 5.1.6, 5.1.9

Competency Assessment
Defines the methods, ongoing competency testing
and training, and criteria used to assess
competency of personnel

Standard: ISO 15189: 5.1.11

Authorization
Defines the level of authorization for all tasks, roles
and deputies for all staff

Standard: ISO 15189: 5.1.7

Accommodation and Environmental Conditions
Defines any specific environmental and
accommodation requirements, and the
responsibility, monitoring, controlling, and recording
of these requirements

Standard: ISO 15189: 5.2.5

Equipment
Defines what records are to be maintained in
equipment file, the minimum information required
on equipment label; action to be taken for defective
equipment and maintenance frequency; and
access control

Standard: ISO 15189: 5.3

Calibration of Equipment
Defines frequency, the use of reference standards
where applicable, what is required on the
calibration label or calibration record and what
action to be taken if calibration fails

ISO 15189: 5.3

Pre-examination Procedures (Handbook)
Defines Specimen Collection, sample and volume
requirements; unique identification, special
handling; minimum requirements for completion of
a requisition form, transportation and receipt of
samples

ISO 15189: 5.4.2 ,5.4.3

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Specimen Storage and Retention
Defines pre- and post-sampling storage conditions,
stability and retention times

ISO 15189: 5.7.2

Examination SOPs
Defines all sub-clauses of ISO15189 Section 5.5.3
(a-q)

ISO 15189: 5.5.3

Equipment Validation/Verification
Defines methods to be used, how the lab ensures
that equipment taken out of the control from the lab
is checked and shown to be functioning
satisfactorily before being returned to laboratory
use, validation/verification acceptance criteria and
person responsible for final authorization for
intended use

ISO 15189: 5.5.2

Interrupted Services
Defines backup procedures for equipment failure,
power failure, unavailability of consumables and
other resources
Examination Validation/Verification
Defines methods to be used, acceptance criteria,
and person responsible for final authorization for
intended use

ISO 15189: 5.5.2

Quality Assurance
Defines the use of IQC and EQC, setting up of
ranges, monitoring performance and
troubleshooting guidelines

ISO 15189 5.6

Reporting of Results
Defines the standardized format of a report (in line
with ISO15189: Section 5.8.3), methods of
communication, release of results to authorized
persons, alteration of reports and reissuance of
amended reports

ISO 15189: 5.8

Patient Confidentiality
Defines the tools used to ensure patient
confidentiality and access control to laboratory
facilities and records (electronic and paper records)

ISO 15189: 5.8.13

Laboratory Safety or Safety Manual
Defines the contents to be included

ISO 15190: 7.5

Standard: Standard Operating Procedures (SOPs) should be established and maintained up-to-date for all tasks performed within the laboratory, safety and waste disposal,
document control, specimen collection and processing, inventory control, procurement, and quality assurance. SOPs should be reviewed for accuracy and relevance on an annual
basis. All policies and procedures should be approved by an authorized person.

11
 1.5 Policy and SOPs Accessibility 2
Are policies and SOPs easily accessible/
available to all staff and written in a
Y P N
language commonly understood by
respective staff?
Standard: All procedures shall be documented and be available at the workstation for relevant staff. Documented procedures and necessary instructions shall be available in a
language commonly understood by the staff in the laboratory.
ISO 15189: 5.5.3, 4.3.2 Part C
1.6 Policies and SOPs Communication 2
Is there documented evidence that all
relevant policies and SOPs have been
communicated to and are understood and Y P N
implemented by all staff as related to
their responsibilities?
Standard: Policies, processes, programs, procedures and instructions shall be documented and communicated to all relevant staff and management must ensure that these
documents are understood by staff and implemented.
ISO 15189: 4.2.1
1.7 Document Control Log 2
Are policies and procedures dated to
reflect when it was put into effect and Y P N
when it was discontinued?

Standard: The document control log or other documentation should capture the date the policy/procedure went into service, schedule of review, the identity of the reviewers, and
the date of discontinuation.
ISO 15189: 4.3.1, 4.3.2 Part (e) and (f): 4.3.2 - “Procedures shall be adopted to ensure that e) invalid or obsolete documents are promptly removed from all points of use, or
otherwise assured against inadvertent use; and f) retained or archived superseded documents are appropriately identified to prevent their inadvertent use.
1.8 Discontinued Policies and SOPs 2
Are invalid or discontinued policies and
procedures removed from use and
Y P N
retained or archived for the time period
required by lab and/or national policy?
Standard: Discontinued policies/procedures should be retained or archived in a separate file or place clearly marked to avoid use for the period of time required by laboratory
and/or national policy.
ISO 15189: 4.3.1, 4.3.2 Part (e) and (f) – see above
1.9 Data Files 2
Are test results and technical and
quality records archived in accordance Y P N
with national/international guidelines?

Standard: Copies or files of results should be archived. The length of time that reported data are retained may vary; however, the reported results shall be retrievable for as long
as medically relevant or as required by national, regional or local requirements.
ISO 15189: 5.8.6, 4.13.2, 4.13.3
1.10 Archived Results Accessibility 2
Are archived records and results easily
Y P N
retrievable in a timely manner?
Standard: Archived patient results must be easily, readily, and completely retrievable within a timeframe consistent with patient care needs.
ISO 15189: 5.8.6, 4.13.2
25

SECTION 1: DOCUMENTS & RECORDS Subtotal

12
For each item, please circle either Yes (Y), Partial (P), or No (N). All elements of the question must be satisfactorily present to
indicate “yes”. Provide explanation or further comments for each “partial” or “no” response.
Y P N Comments Score
2.0 MANAGEMENT REVIEWS
2.1 Workplan and Budget Y P N 2
Does management develop and
implement a workplan and develop a
budget that supports the laboratory’s
testing operations and maintenance of
the quality system?
Standard: Laboratories should be involved in the development of the work plan and budget for their activities. The workplan should reflect the findings of management reviews in
its goals, objectives, and actions. Not all labs will have budgetary authority as higher levels of management may have direct control for budget-making. If the laboratory does not
develop these guiding documents itself, it must communicate with upper management effectively about these areas, including providing a forecast of needs.
ISO 15189: 4.1.5 Part (a) and (h) “Laboratory management shall have responsibility for the design, implementation, maintenance and improvement of the quality management
system.”
2.2 Review of Quality and Technical Records 5
Does the laboratory supervisor routinely
perform a documented review of all Y P N
quality and technical records?

Tick for each item

Does the supervisor’s review include the

Yes No
following?
Follow-up of action items from previous reviews

Status of corrective actions taken and required

preventive actions
Reports from personnel

Changes in volume and type of work the

laboratory undertakes
Changes in the suitability of biological reference
ranges
Changes in the client handbook

Environmental monitoring log sheets

Specimen rejection logbook

Equipment calibration and maintenance records

IQC records across all test areas

Outcomes of PTs and other forms of Inter-

laboratory comparisons
Monitoring of turnaround time

Quality indicators

Outcomes from recent internal audit records

Results of assessment(s) or audits by external

bodies

13
 Customer complaints and feedback

Occurrence/incidence logs, nonconformities and

corrective action reports

Results of improvement projects

Operational procedures (for potential sources of

non-conformance and opportunities for
improvement)
Evaluation of performance of referral laboratories

Evaluation of supplier performance

Document Review

Documentation of review and action planning with

staff for resolution and follow-up review
Standard: There must be documentation that the laboratory manager/supervisor or a designee reviews the quality program regularly. The review must ensure that recurrent
problems have been addressed, and that new or redesigned activities have been evaluated.
ISO 15189: 4.15.2 (a) - (m). Management review shall include 4.15.2. (a) through (m).
2.3 Annual Review of Quality Management 5
Systems
Does the laboratory management
annually perform a review of all quality
Y P N
systems at a management review
meeting?
Does the management review meeting include the Tick for each item
following? Yes No
Follow-up of action items from previous
management reviews
Status of corrective actions taken and required
preventive actions

Reports from managerial and supervisory personnel

Changes in volume and type of work the laboratory

undertakes

Changes in the suitability of biological reference

ranges
Changes in the client handbook

Environmental monitoring log sheets

Specimen rejection logbook

Equipment calibration and maintenance records

IQC records across all test areas

Outcomes of PTS and other forms of Interlaboratory

comparisons
Turnaround time

Quality indicators

Outcomes from recent internal audit records

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Results of assessment(s) or audits by external
bodies
Customer Complaints and Feedback

Reports from managerial and supervisory personnel

Occurrence/incidence logs, nonconformities and

corrective action reports

Results from improvement projects

Operational procedures (for potential sources of

non-conformance and opportunities for
improvement)
Evaluation of performance of referral laboratories

Evaluation of supplier performance

Documentation of review and action planning with

staff for resolution and follow-up review
Standard: There must be documentation that the head of laboratory or a designee reviews the quality program at least once every 12 months. The review must ensure that
recurrent problems have been addressed, and that new or redesigned activities have been evaluated.
ISO 15189: 4.15
2.4 Quality Management System 3
Improvement Measures
Does the laboratory identify and Y P N
undertake quality improvement projects?
Standard: The monthly and annual reviews of the quality management system must be used as opportunities for identifying nonconformities and areas for improvement. Action
plans for improvement shall be developed, documented and implemented, as appropriate.
ISO 15189: 4.12.1
2.5 Communications System on Laboratory 2
Operations
Does the laboratory communicate with
upper management regularly regarding Y P N
personnel, facility, and operational
needs?
Standard: The laboratory must have a system in place for communicating with management regarding laboratory operations and effectiveness of the quality management system.
The communication and follow-up must be documented
ISO 15189: 4.1.6
17
SECTION 2: MANAGEMENT REVIEW Subtotal

15
For each item, please circle either Yes (Y), Partial (P), or No (N). All elements of the question must be satisfactorily present to
indicate “yes”. Provide explanation or further comments for each “partial” or “no” response.
Comments Score
Y P N
3.0 ORGANIZATION & PERSONNEL
3.1 Workload, Schedule and Coverage 2
Do work schedules show task Y P N
assignments & coordination of work for
adequate lab staff coverage?
Standard: Work schedules show who is in the laboratory and when they should be available. Work schedules are normally provided to hospital management showing laboratory
coverage. There shall be enough staff resources adequate to cover the work as required and tasks should be prioritized, organized, and coordinated based upon personnel skill
level, workloads, and the task completion timeframe
ISO 15189: 5.1.5 “There shall be staff resources adequate to the undertaking of the work required and the carrying out of other functions of the quality management system.”
3.2 Duty Roster And Daily Routine Y P N 2
Are daily routine work tasks established,
assigned (duty roster and workstation
assignments/tasks), monitored and
supervised by qualified professional
staff, and which indicates that only
authorized personnel perform specific
tasks?
Standard: A duty roster designates specific laboratory personnel to specific workstations and workstation tasks list the tasks associated with a specific workstation. E.g. personnel
X assigned to hematology (duty roster) expected to perform specific tasks (workstation tasks). Daily routines should be prioritized, organized and coordinated to achieve optimal
service delivery for patients.
ISO 15189: 5.1.7 “Laboratory management shall authorize personnel to perform particular tasks such as sampling, examination and operation of particular types of equipment,
including use of computers in the laboratory information system.”
3.3 Organizational Chart and Y P N 2
External/Internal Reporting Systems
Are lines of authority and responsibility
clearly defined for all lab staff, including
the designation of a supervisor and
deputies for all key functions?
Standard: An up-to-date organizational chart and/or narrative description should be available detailing the external and internal reporting relationships for laboratory personnel.
The organizational chart or narrative should clearly show how the laboratory is linked to the rest of the hospital and laboratory services where applicable
ISO 15189: 5.1.1, 4.1.5 Part (e & j)
3.4 Quality Management System Oversight Y P N 3
Is there a quality officer/manager with
delegated responsibility to oversee
compliance with the quality management
system?
Standard: There should be a quality manager (however named) with delegated authority to oversee compliance with the requirements of the quality management system. This
quality manager should report directly to the level of laboratory management at which decisions are made on laboratory policy and resources.
ISO 15189: 4.1.5 Part ( i)
3.5 Personnel Filing System 3
Are Personnel Files present? Y P N

If files are present, do they document or contain Tick for each item
the following: Yes No N/A
Employee Orientation

Education & Training (e.g., degrees/certificates)

Previous experience and work history (e.g. CV)

Written job description with documentation that

staff member received and signed a copy of
their job description

Letter of employment or appointment

16
 Review of job-relevant SOPs

Documented review of safety manual, evidence

of safety training
Review of procedure for employees to
communicate concerns about test quality and
laboratory safety
Registration with professional board

Training record documenting trainings received,

vendor training received on-site

Periodic Performance Review – including

Observation, Competency Assessment,
Coaching / Feedback, on-the-job training
Documentation of employee recognition (i.e.,
employee of the month, letter of commendation,
etc.)
Human Resource (HR) Data – (vaccination
status, accidental exposure during work injuries,
accident history, leave days taken, etc.)

Standard: Personnel files should be maintained for all current staff. Documentation should include job description, qualifications, training, experience, competency assessment
records, periodic performance review records, and records of vaccination, injuries, or workplace accidents.
ISO 15189: 5.1.2
3.6 Staff Competency Assessment and Y P N 3
Training
Is there a system for competency
assessment of personnel (both new hires
and existing staff) and does it include
planning and documentation of retraining
and reassessment, when indicated?

Standard: Newly hired lab staff should be assessed for competency before performing independent duties and again within six months. All lab staff should be regularly assessed
for testing competency at least once a year. Staff assigned to a new section should be assessed before fully assuming independent duties. When deficiencies are noted, retraining
and reassessment should be planned and documented. If the employee’s competency remains below standard, further action might include supervisory review of work, re-
assignment of duties, or other appropriate actions. Records of competency assessments and resulting actions should be retained in personnel files and/or quality records. Records
should show which skills were assessed, how those skills were measured, and who performed the assessment.
ISO 15189: 5.1.11: “The competency of each person to perform assigned tasks shall be assessed following training and periodically thereafter. Retraining and reassessment shall
occur when necessary.”
3.7 Laboratory Staff Training Y P N 2
Does the laboratory have adequate
training policies, procedures, and/or
training plans, including cross-training
within the laboratory team, one-on-one
mentoring, and/or off-site external
training?
Standard: In line with national laboratory training plans, each laboratory should have functional training policies and procedures that meet the needs of laboratory personnel
through both internal and external training.
ISO 15189: 4.12.5, 5.1.6, 5.1.9
3.8 Staff Meetings 3
Are staff meetings held regularly? Y P N

Do meetings include the following items? Tick for each item

Yes No N/A
Follow-up of action items from previous staff
meetings
Discussion about problems and complaints
Review of documentation
Communication on reviewed/revised/redundant

17
 SOPs
Systemic and or recurrent problems and issues
addressed, including actions to prevent
recurrence
Review of results from prior corrective actions

Discussion and evaluation of improvement

topics/projects
Feedback given by staff that have attended
meetings, training, conferences etc.
Recognition of employees for exemplary
performance (i.e., employee of the month, letter
of commendation, etc.)
Relay of reports and updates from lab
attendance at meetings with clinicians (the use
of lab services and/or attendance at clinical
rounds)
Recording and monitoring of meeting notes for
progress on issues
Standard: “Laboratory management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding
the effectiveness of the quality management system. “The laboratory should hold regular staff meetings to ensure communication within the laboratory. Meetings should have
recorded notes to facilitate review of progress over time.
ISO 15189: 4.1.6
20

SECTION 3: ORGANIZATION & PERSONNEL Subtotal

18
For each item, please circle either Yes (Y), Partial (P), or No (N). All elements of the question must be satisfactorily present to
indicate “yes”. Provide explanation or further comments for each “partial” or “no” response.
Comments Score
Y P N
4.0 CLIENT MANAGEMENT & CUSTOMER SERVICE

4.1 Advice and Training by Qualified Staff 2

Do staff members with appropriate
professional qualifications provide
clients with advice and/or training Y P N
regarding required types of samples,
choice of examinations, repeat
frequency, and interpretation of results?
Standard: Professionally-qualified staff should provide advice on sample type, examination choice, frequency, and results interpretation.
ISO 15189:4.7; 4.12.5
4.2 Laboratory Handbook for Clients 2
Is there a laboratory handbook for
laboratory users that includes
information on services offered, quality
Y P N
assurance, laboratory operations, sample
collection, transport and agreed
turnaround times?
Standard: The laboratory should provide its clients with a handbook that outlines the laboratory’s hours of operation, available tests, specimen collection instructions, packaging
and shipping directions, and expected turnaround times.
ISO 15189: 4.7, 4.12.5, 5.5.6
4.3 Communication Policy on Delays in 2
Service
Is timely, documented notification
provided to customers when the
laboratory experiences delays or Y P N
interruptions in testing (due to equipment
failure, stock outs, staff levels, etc.) or
finds it necessary to change examination
procedures?
Standard: There shall be a policy for notifying the requester when an examination is delayed. Such notification shall be documented for both service interruption and resumption as
well as related feedback from clinicians. This does not mean that the clinical personnel are to be notified of all delays of examination, but only in those situations where the delay
could compromise patient care.
ISO 15189: 5.8.11
4.4 Evaluation Tool and Follow up 2
Is there a tool for regularly evaluating
client satisfaction and is the feedback
Y P N
received effectively utilized to improve
services?
Standard: The laboratory should measure the satisfaction of client clinicians and patients regarding its services, either on an ongoing basis or through episodic solicitations.
ISO 15189: 4.8, 4.15.2 Part (h)
8

SECTION 4: CLIENT MANAGEMENT & CUSTOMER SERVICE Subtotal

19
For each item, please circle either Yes (Y), Partial (P), or No (N). All elements of the question must be satisfactorily present to
indicate “yes”. Provide explanation or further comments for each “partial” or “no” response.
Comments Score
Y P N
5.0 EQUIPMENT
5.1 Adherence to Proper Equipment Protocol Y P N 2
Is equipment installed and placed as
specified in the operator’s manuals and
uniquely labeled or marked?
Standard: Equipments should be properly placed as specified in user manual away from the following but not limited to water, direct sunlight, vibrations, in traffic and with more
than 75% of the base of the equipment sitting on the bench top to avoid tip-over.
ISO 15189: 5.3.3 “Each item of equipment shall be uniquely labeled, marked, or otherwise identified.”
5.2 Equipment and Method Validation/ Y P N 2
Verification and Documentation
Are newly introduced equipment and
methods validated/verified on-site and
are records documenting validation
available?

Standard: Newly introduced methods or equipment should be validated onsite to ensure that their introduction yields performance equal to or better than the previous method or
equipment. Validation may be done versus the method or equipment being replaced or the prevailing gold-standard. An SOP should be in place to guide method validation.
ISO 15189: 5.5.2 “The laboratory shall use only validated procedures for confirming that the examination procedures are suitable for the intended use.”
5.3 Equipment Record Maintenance Y P N 2
Is current equipment inventory data
available on all equipment in the
laboratory?

Tick for each item

Yes No N/A
Name of equipment
Manufacturer’s contact details
Condition received (new, used, reconditioned)
Serial number
Date of purchase
Date when put “out of service”
Date of entry into service
Standard: Records shall be maintained for each item of equipment used in the performance of examinations. Such equipment list must include major analyzers as well as ancillary
equipment like centrifuges, water baths, rotators, fridges, pipettes, timers, printers, computers.
ISO 15189: 5.3.4
5.4 Equipment Maintenance Records 2
Is relevant equipment service information
Y P N
readily available in the laboratory?
Tick for each item
Yes No N/A
Service contract information
Contact details for service provider
Decontamination Records
Performance and maintenance records
Last date of service
Next date of service
Current location

20
Standard: Maintenance records must be maintained for each item of equipment used in the performance of examinations… These records shall be maintained and shall be readily
available for the lifespan of the equipment or for any time period required by national, regional and local regulations.
ISO 15189: 5.3.4
5.5 Obsolete Equipment Procedures Y P N 2
Is non-functioning equipment
appropriately labeled and removed from
the laboratory & storage areas?
Standard: The laboratory must have procedures for proper retirement of obsolete equipment and should be removed from the laboratory to free work and storage areas. The
equipment shall be properly decontaminated before being removed from the lab
ISO 15189: 5.3.7
5.6 Adherence to Equipment Calibration Y P N 2
Protocol
Is routine calibration of laboratory
equipment (including pipettes,
centrifuges, balances, and thermometers)
scheduled, as indicated on the
equipment, and verified?
Standard: All equipment in the laboratory that require calibration must be calibrated according to the schedule, which at minimum must meet the manufacturer’s recommendations.
This shall cover major analyzers as well as ancillary equipments like pipettes, thermometers, balances, centrifuges, timers, balances
ISO 15189: 4.2.5, 5.3.2

5.7 Equipment Preventive Maintenance Y P N 2

Is routine preventive maintenance
performed on all equipment and recorded
according to SOPs/log sheet?
Standard: Preventative maintenance by operators must be done on all equipment used in examinations including centrifuges, autoclaves, microscopes, safety cabinets
ISO 15189: 4.2.5, 5.3.2
5.8 Equipment Service Maintenance Y P N 2
Is equipment routinely serviced
according to schedule by qualified and
competent personnel and is this
information documented in appropriate
logs?
Standard: All equipments must be serviced at specified intervals by a qualified service engineer either through service contracts or otherwise. Service schedule must at minimum
meet manufactures requirements
ISO 15189: 4.2.5, 5.3.2
5.9 Equipment Parts for Repair Y P N 2
Are parts available to perform minor
repairs as per manufacturer’s
instructions?

Standard: “Equipment shall be shown (upon installation and in routine use) to be capable of achieving the performance required and shall comply with specifications relevant to
the examinations concerned.”
ISO 15189: 5.3.2
5.10 Equipment Malfunction - Response and Y P N 2
Documentation
Is equipment malfunction resolved by the
effectiveness of the corrective action
program and the associated root cause
analysis?
Standard: All equipment malfunctions must be investigated and documented on corrective action reports. Where user cannot resolve the problem, a repair order must be initiated
ISO 15189: 5.3.7, 4.9
5.11 Equipment Repair Monitoring and Y P N 2
Documentation
Are repair orders monitored to determine
if the service is completed? Does the
laboratory verify and document that it is
in proper working order before being put
it back into service?

Standard: All equipment should receive thorough documented checks to ensure proper functioning before being returned into service, following its absence from the laboratory.
ISO 15189: 5.3.10

21
 5.12 Equipment Failure - Contingency Plan Y P N 2
Are there back-up procedures for
equipment failure (including SOPs for
handling specimens during these times,
identification of a back-up lab for testing,
and referral procedures)?
Standard: Contingency plans must be in place, in the event of equipment failure, for the completion of testing. In the event of a testing disruption, planning may include the use of
a back-up instrument, the use of a different testing method, the referral of samples to another laboratory, or the freezing of samples until testing is reestablished.
ISO 15189: 5.3.1 “The laboratory shall be furnished with all items of equipment required for the provision of services (including primary sample collection, and sample preparation
and processing, examination and storage). In those cases where the laboratory needs to use equipment outside its permanent control, laboratory management shall ensure that
the requirements of this international Standard are met.”
5.13 Manufacturer’s Operator Manual Y P N 2
Are the equipment manufacturer’s
operator manuals readily available to
testing staff, and where possible,
available in the language understood by
staff?
Standard: Operator manuals must be readily available for reference by testing staff.
ISO 15189: 5.3.5
5.14 Communication on Effectiveness of Y P N 2
Quality Management System
Are equipment specifications and
maintenance needs routinely
communicated to upper management?
Standard: Laboratory management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the
effectiveness of the quality management system.
ISO 15189: 4.1.6
5.15 Laboratory Testing Services Y P N 2
Has the laboratory provided
uninterrupted testing services, with no
disruptions due to equipment failure in
the last year (or since the last audit)?

30

SECTION 5: EQUIPMENT Subtotal

22
For each item, please circle either Yes (Y), Partial (P), or No (N). All elements of the item must be satisfactorily present to
indicate “yes”. Provide explanation or further comments for each “partial” or “no” response.
Comments Score
Y P N
6.0 INTERNAL AUDIT
6.1 Internal Audits Y P N 5
Are internal audits conducted at
intervals as defined in the quality
manual and do these audits address
areas important to patient care?
Tick for each item
Yes No

Are audits being carried out by persons who are

not involved in lab activities in the section
being audited?
Are the personnel conducting the internal
audits trained and competent in auditing?
Is cause analysis performed for
nonconformities/noted deficiencies?
Are internal audit findings documented and
presented to the laboratory management and
relevant staff for review?
6.2 Audit Recommendations and Action Y P N 5
Plan & Follow up
Are recommendations for
corrective/preventive actions made
based on audit findings; is an action
plan developed with clear timelines
and documented follow-up?
Standard: Internal audits should be conducted at least annually. Investigation of individual problems may not reveal trends or patterns. Errors and incident reports should be
reviewed periodically to determine whether systemic problems are responsible for errors and/or incidents. Laboratory management shall monitor the results of any corrective
action taken, in order to ensure that they have been effective in overcoming the identified problems.
ISO 15189: 4.2.4, 4.10.3, 4.14
10

SECTION 6: INTERNAL AUDIT Subtotal

23
For each item, please circle either Yes (Y), Partial (P), or No (N). All elements of the question must be satisfactorily present to
indicate “yes”. Provide explanation or further comments for each “partial” or “no” response.
Comments Score
Y P N
7.0 PURCHASING & INVENTORY
7.1 Inventory and Budgeting System 2
Is there a system for accurately
forecasting needs for supplies and Y P N
reagents?
Standard: The Laboratory must have a systematic way of determining its supply and testing needs through inventory control and budgeting systems that take into consideration
past patterns, present trends, and future plans.
ISO 15189: 4.6.4 “The laboratory shall evaluate suppliers of critical reagents, supplies and services that affect the quality of examinations and shall maintain records of these
evaluations and list those approved.” ISO 15189: 5.1.4 (i) “Provide effective and efficient administration of the medical laboratory service, including budget planning and control
with responsible financial management.”
7.2 Service Supplier Performance Review 2
Are supply & reagent specifications
periodically reviewed and are approved Y P N
suppliers identified?
Standard: All suppliers of services used by the laboratory must be reviewed for their performance. Those that perform well must be identified and listed as approved suppliers.
Results of these reviews must be documented
ISO 15189: 4.6.4
7.3 Manufacturer/Supplier List 2
Is an up-to-date list of approved
manufacturers/suppliers available and
Y P N
includes their complete contact
information?
Standard: Each laboratory should keep a comprehensive and up-to-date list of approved manufacturers/suppliers that includes full contact details to expedite ordering, tracking,
and follow-up.
ISO 15189: 4.6.4
7.4 Budgetary Projections 2
Are budgetary projections based on
personnel, test, facility and equipment
Y P N
needs, and quality assurance procedures
and materials?
Standard: ISO 15189: 5.1.4 (i) “Provide effective and efficient administration of the medical laboratory service, including budget planning and control with responsible financial
management.”
7.5 Management Review of Supply Requests 2
Does management review the finalized
Y P N
supply requests?

7.6 Order Tracking, Inspection, and 2

Documentation
Are all orders tracked until delivery and
inspected, receipted, and labeled with Y P N
date of receipt when the orders are
checked in?

Standard: All incoming orders should be inspected for condition and completeness, receipted and documented appropriately and the date received in the laboratory and the expiry
date for the product should be clearly indicated.
ISO 15189: 4.6.1 and 4.6.3

24
 7.7 Inventory Control System 2
Is an inventory control system in place? Y P N
Tick for each item
Criteria and procedures for Yes No
Acceptance and rejection of consumables

Recording of lot number, date of receipt,

received by and date placed into service
Storage of consumables

Standard: There laboratory shall have an inventory control system for supplies that monitors receipt, storage and use of consumables
ISO 15189: 4.6.1, 4.6.3
7.8 Laboratory Inventory System 2
Are inventory records complete and
accurate, with minimum and maximum Y P N
stock levels denoted?
Standard: The Laboratory inventory system shall reliably inform the Laboratory of how much at minimum must be kept in the laboratory to avoid interruption of service due to stock
outs and how much at maximum must be kept by the lab to prevent expiry of reagents
ISO 15189: 4.6.3
7.9 Usage Rate Tracking of Consumables 2
Is the consumption rate monitored? Y P N
Standard: The inventory control system must allow the Laboratory to track rate of usage of consumables
ISO 15189: 4.6.3
7.10 Inventory Control System – Stock Counts 2
Are stock counts routinely performed? Y P N
Standard: The laboratory must routinely perform stock counts as part of its inventory control system
ISO 15189: 4.6.3
7.11 Storage Area 2
Are storage areas set up and monitored
Y P N
appropriately?
Tick for each item
Yes No N/A
Is the storage area well-organized and free of
clutter?
Are there designated places labeled for all
inventory items?
Are hazardous chemicals stored appropriately?

Is adequate cold storage available?

Are storage areas monitored as per prescribed
storage conditions?
Is the ambient temperature monitored
routinely?
Is storage in direct sunlight avoided?
Is the storage area adequately ventilated?

Is the storage area clean and free of dust and

pests?
Are storage areas access-controlled?
CAP Standard: Laboratory General Checklist, 2010
GEN 61300, 61400,61500,61600,61900,62000 and 62100
7.12 Inventory Organization and Wastage 2
Minimization
Is First-Expiration-First-Out (FEFO) Y P N
practiced?
USAIDStandard: To minimize wastage from product expiry, inventory should be organized in line with the First-Expiry-First-Out (FEFO) principle. Place products that will expire
first in front of products with a later expiry date and issue stock accordingly to ensure products in use are not past their expiry date. Remember that the order in which products are
received is not necessarily the order in which they will expire. USAID Deliver Project, the Logistics Handbook, Task Order 1, 2007

25
 7.13 Disposal of Expired Products 2
Are expired products labeled and
Y P N
disposed properly?
Standard: Expired products should be disposed of properly. If safe disposal is not available at the laboratory, the manufacturer/supplier should take back the expired stock at the
time of their next delivery.
7.14 Product Expiration Y P N 2
Are all reagents/test kits in use (and in
stock) currently within the manufacturer-
assigned expiration dates or within
stability?
CAP Standard: All reagent and test kits in use, as well as those in stock, should be within the manufacturer-assigned expiry dates. Expired stock should not be entered into use
and should be documented before disposal. Chemistry and Toxicology Checklist, CHM 12660, 2010
7.15 Laboratory Testing Services Y P N 2
Has the laboratory provided
uninterrupted testing services, with no
disruptions due to stock outs in the last
year or since last audit?

Standard: Testing services should not be subject to interruption due to stock outs. Laboratories should pursue all options for borrowing stock from another laboratory or referring
samples to another testing facility while the stock out is being addressed.
30

SECTION 7: PURCHASING & INVENTORY Subtotal

26
For each item, please circle either Yes (Y), Partial (P), or No (N). All elements of the question must be satisfactorily present to
indicate “yes”. Provide explanation or further comments for each “partial” or “no” response.
Comments Score
Y P N
8.0 PROCESS CONTROL and INTERNAL & EXTERNAL QUALITY AUDIT
8.1 Are guidelines for patient identification, Y P N 2
specimen collection (including client
safety), labeling, and transport readily
available to persons responsible for
primary sample collection?

Standard: “Specific instructions for the proper collection and handling of primary samples shall be documented and implemented by laboratory management and made available to
those responsible for primary sample collection.”
ISO 15189: 5.4.2
8.2 Are adequate sample receiving 3
procedures in place? Y P N
Tick for each item

Yes No N/A
Are specimens labeled with patient ID, test, and
date, time of collection, date of collection and
authorized requester?
Are all test requests accompanied by an acceptable
and approved test requisition form?
If not a 24 hour lab, is there a documented method
for handling of specimens received after hours?
Are all samples that are either received or referred
to a higher level laboratory accompanied by a
sample delivery checklist or transmittal sheet?
Are received specimens evaluated according to
acceptance/rejection criteria?
Are specimens logged appropriately upon receipt in
the laboratory (including date, time, and name of
receiving officer)?
When samples are split, can the portions be traced
back to the primary sample?
Is a two-identifier system in use and is each sample
assigned a unique identifying number?
Are procedures in place to process “urgent”
specimens and verbal requests?
Are specimens delivered to the correct workstations
in a timely manner?
Standard : ISO 15189: 5.4.1, 5.4.5, 5.4.7, 5.4.8, 5.4.10, 5.4.11, 5.4.13
8.3 Are specimens stored appropriately prior 2
to testing? Y P N

Are specimens disposed of in a safe manner?

Standard: “Relevant storage space and conditions shall be provided to ensure the continuing integrity of samples, slides, histology blocks, retained micro-organisms, documents,
files, manuals, equipment, reagents, laboratory supplies, records and results.” Specimens should be stored under the appropriate conditions to maintain the stability of the
specimen. Specimens no longer required should be disposed of in a safe manner, according to Biosafety regulations.
ISO 15189: 5.2.9, 5.7.3
8.4 Are specimens packaged appropriately 2
according to local and or international
regulations and transported to referral
Y P N
laboratories within acceptable
timeframes?
Standard: All samples shall be transported to the laboratory in such a manner as to prevent contamination of workers, patients, or the environment.
ISO Safety Standard 15190: Clause 26

27
 8.5 Are referred specimens tracked properly 2
using a logbook or tracking form? Y P N
Standard: “The laboratory shall maintain a register of all referral laboratories that it uses. A register shall be kept of all samples that have been referred to another laboratory” The
referral log must be reviewed routinely for outstanding results and turnaround times
ISO 15189: 4.5.3
8.6 Is complete procedure manual available 3
at the workstation or in the work area? Y P N
Standard: “All procedures shall be documented and be available at the workstation for relevant staff. Documented procedures and necessary instructions shall be available in a
language commonly understood by the staff in the laboratory.”
ISO 15189: 5.5.3
8.7 Is there a reagent logbook for lot number 2
and dates of opening that reflects
Y P N
verification of new lots?
Standard: “Purchased equipment and consumable supplies that affect the quality of the service shall not be used until they have been verified as complying with standard
specifications or requirements defined for the procedures concerned. This may be accomplished by examining quality control samples and verifying that results are acceptable.”
ISO 15189: 4.6.2
8.8 Is each new lot number, new shipment of 2
reagents, or consumables verified before
Y P N
use?
Standard: “Purchased equipment and consumable supplies that affect the quality of the service shall not be used until they have been verified as complying with standard
specifications or requirements defined for the procedures concerned. This may be accomplished by examining quality control samples and verifying that results are acceptable.”
ISO 15189: 4.6.2
8.9 Is internal quality control performed, 3
documented, and verified before
Y P N
releasing patient results?
Standard: The laboratory shall design internal quality control systems that verify the attainment of the intended quality of results. It is important that the control system provide staff
members with clear and easily understood information on which to base technical and medical decisions
ISO 15189: 4.2.2, 5.6.1
8.10 Are QC results monitored and reviewed 3
(biases, shifts, trends, and Levy-
Jennings charts)? Is there
documentation of corrective action when
Y P N
quality control results exceed the
acceptable range in a timely manner?
Standard: “The laboratory shall design internal quality control systems that verify the attainment of the intended quality of results.”“ As part of the Laboratory internal quality control
systems L-J charts shall be used to monitor quantitative tests on a daily basis and reviewed routinely.
ISO 15189: 5.6.1
8.11 Are environmental conditions checked 2
and reviewed accurately? Y P N
Tick for each item
Are the following environmental conditions checked
Yes No N/A
daily?
Room temperature
Freezers
Refrigerator
Incubators
Water Bath
Standard: “The laboratory shall monitor, control and record environmental conditions, as required by relevant specifications or where they may influence the quality of the results.”
ISO 15189: 5.2.5
8.12 Have acceptable ranges been defined for 2
all temperature- dependent equipment
with procedures and documentation of Y P N
action taken in response to out of range
temperatures?
Standard: SMILE, Johns Hopkins University, Baltimore, MD, Pro 71-07, May 20, 2010. “Acceptable ranges or criteria must be defined, with documentation of action taken in
response to out of range temperatures.”

28
 8.13 Does the laboratory participate in 3
external Proficiency Testing (PT) or
exercise an alternative performance Y P N
assessment system when appropriate?

Tick for each item

Are the following criteria met? Yes No N/A
Are blinded characterized samples routinely
distributed for testing to determine accuracy?
Do PT samples come from providers who are
accredited or approved?
Are PT specimens handled and tested the same
way as patient specimens?
Is cause analysis performed for unacceptable PT
results?
Is corrective action documented for unacceptable
PT results?
Standard: The laboratory should handle, analyze, review, and report results for proficiency testing in manner similar to regular patient testing. Investigation and correction of
problems identified by unacceptable proficiency testing should be documented. Acceptable results that show bias or trends suggest a problem should also be investigated.
ISO 15189: 4.2.2, 5.6.4, 5.6.5, 5.6.7
8.14 Are test requests checked with test 2
results, thereby assuring the accuracy
Y P N
and completion of all tests?
Standard: “Authorized personnel shall systematically review he results of examinations, evaluate them in conformity with the clinical information available regarding the patient and
authorized the release the results.” A standard procedure should be followed for crosschecking all results. In instances where there is a LIS (laboratory information system) daily
printing of the pending reports list should be done routinely to cross-check the completion of all tests within the defined turnaround times.
ISO 15189: 5.7.1
33

SECTION 8: PROCESS CONTROL and INTERNAL & EXTERNAL QUALITY AUDIT Subtotal

29
For each item, please circle either Yes (Y), Partial (P), or No (N). All elements of the question must be satisfactorily present to
indicate “yes”. Provide explanation or further comments for each “partial” or “no” response.
Comments Score
Y P N
9.0 INFORMATION MANAGEMENT
9.1 Test Result Reporting System 2
Are test results legible, technically
verified by an authorized person, and Y P N
confirmed against patient identity?
Standard: Results must be written in ink, written clearly with no mistakes in transcription. Cancellation must follow Good Lab Practices. The persons performing the test must
indicate verification of the results. There must be signature or identification of person authorizing the release of the report.
ISO 15189: 5.8.3
9.2 Testing Personnel 2
Are testing personnel identified on the
Y P N
requisition and record?

Standard: The person who performed the procedure must be identified on the report for purposes of audit trail.
ISO 15189: 5.4.7 “All primary samples received shall be recorded in an accession book, worksheet, computer or other comparable system. The date and time of receipt of
samples, as well as the identity of the receiving officer, shall be recorded.”

9.3 Test Result Records 2

Are test results recorded in a logbook or
Y P N
electronic record in a timely manner?
Standard: In line with maintaining agreed turnaround times, the Laboratory shall perform and record test results in a timely manner and confidentiality of reported and stored result
reports shall be maintained.
9.4 Analytic System/Method Tracing 2
When more than one instrument is in use
for the same test, are test results
Y P N
traceable to the equipment used for
testing?
Standard: It is important that the laboratory has the ability to trace specimen results to a specific analytical system or method. Proficiency testing specimens would also fall under
specimen results.
9.5 Result Cross-check System 2
Is there a system for reviewing for
Y P N
transcription errors?
Standard: The laboratory must have a system for cross-checking of results before release to requesters in order to identify and correct errors
ISO 15189: 5.8.3 “Results shall be legible, without mistakes in transcription and reported to persons authorized to receive and use medical information.”

9.6 Archived Data Labeling and Storage 2

Are archived results (paper or data-
storage media) properly labeled and
Y P N
stored in a secure location accessible
only to authorized personnel?
Standard: All patient data, paper, tapes, disks should be properly labeled and stored securely in places accessible only to authorized personnel.
ISO 15189: 5.8.3 Annex B 6.4.

9.7 Information and Data Backup System 2

Are there documented procedures to
prevent the loss of test result data in the
Y P N
event of hardware/software failure, fire or
theft?
Standard: The laboratory should have a procedure to protect essential data in the event of equipment failure and/or an unexpected destructive event. These procedures could
include flood and fire safe storage of data, periodic backing up and storing of information, and off-site storage of backup data.
ISO 15189: 5.8.3 Annex B 3.3.

30
 9.8 Test Result Report 2
Is the laboratory result report(s) in a
standard form determined to be
Y P N
acceptable by its customers?
Tick for each item
Indicate for each item Yes No
Is the laboratory issuing the report clearly
identified?
Does the report contain the patient’s name,
address, and the hospital/destination of the
report?
Is the name of the person requesting the test
indicated on the report?
Is the type of sample received and the test
requested included in the report?
Are the date and time for specimen collection,
receipt of specimen, and release of report
indicated?
Does the report indicate biological reference
ranges for each test?
Is the result reported in SI units where
applicable?
Is there space for interpretation of results, when
applicable, and for indication of when
specimens are received and unsuitable for the
procedure requested for testing?
Does the result contain the name of the person
authorizing release of the report and the
signature of the person accepting responsibility
for its content?
9.9 Test Result 2
Are test results validated, interpreted and
released by appropriately-authorized
personnel?
18

SECTION 9: INFORMATION MANAGEMENT Subtotal

31
For each item, please circle either Yes (Y), Partial (P), or No (N). All elements of the item must be satisfactorily present to indicate
“yes”. Provide explanation or further comments for each “partial” or “no” response.
Comments Score
Y P N
10.0 CORRECTIVE ACTION
10.1 Are all laboratory-documented There must be at least a description of what 5
occurrence reports indicating the root happened and what was done to prevent it from
cause of the problem(s) and corrective &
Y P N happening again.
preventive actions taken to prevent
recurrence?
Standard: “Laboratory shall have a policy and procedures for the resolution of complaints or other feedback received from clinicians, patients or other parties. Records of
complaints and of investigations and corrective actions taken by the laboratory shall be maintained.”
ISO 15189: 4.8
10.2 Is non-conforming work reviewed and 2
submitted for troubleshooting and cause
Y P N
analysis?
Standard: “Procedures for corrective action shall include an investigative process to determine the underlying cause or causes of the problem. These shall, where appropriate,
lead to preventive actions. Corrective action shall be appropriate to the magnitude of the problem and commensurate with possible risks.” “The laboratory shall document, record
and, as appropriate, expeditiously act upon results from these comparisons. Problems or deficiencies identified shall be acted upon and records of actions retained.”
ISO 15189: 4.10.1; 5.6.7
10.3 Is corrective action performed on all non- 3
conforming aspects of the quality
Y P N
management system documented?
Indicate for each item Tick for each item
Yes No
Are results withheld, if indicated by the level of
control violated?
ISO 4.9.1 part d
Have these been recalled and corrected, if results
have been released?
ISO 4.9.1 part f
Is this approved by an authorized person, when
testing resumes?
ISO 4.9.1.part g
Standard: “Laboratory management shall have a policy and procedure to be implemented when it detects that any aspect of its examinations does not conform with its own
procedures or the agreed upon requirements of its quality management system or the requesting clinicians.”
ISO 15189:4.9
10.4 Are discordant results tracked and 2
appropriate corrective action taken? Y P N
Standard: “Procedures for corrective action shall include an investigative process to determine the underlying cause or causes of the problem.”
ISO 15189: 4.10.1
12
SECTION 10: CORRECTIVE ACTION Subtotal

32
For each item, please circle either Yes (Y), Partial (P), or No (N). All elements of the question must be satisfactorily present to
indicate “yes”. Provide explanation or further comments for each “partial” or “no” response.
Comments Score
Y P N
11.0 OCCURRENCE / INCIDENT MANAGEMENT & PROCESS IMPROVEMENT
11.1 Are graphical tools (charts and graphs) 2
used to communicate quality findings
Y P N
and identify trends?

Standard: “Apart from the review of the operational procedures, preventive action might involve analysis of data, including trend-and risk-analyses and external quality assurance.
“Use of graphical displays of quality data communicates more effectively than tables of numbers. Examples of graphical tools commonly used for this purpose include Pareto
charts, cause-and-effect diagrams, frequency histograms, trend graphs, and flow charts.
ISO 15189: 4.11.2 , Note 1
11.2 Are quality indicators (TAT, rejected 5
specimens, stock outs, etc.) selected,
tracked, and reviewed regularly to
monitor laboratory performance and Y P N
identify potential quality improvement
activities?

11.3 Are the outcomes of internal and 3

external audits, PT, customer feedback
and all other information derived from the
tracking of quality indicators used to
improve lab performance? Y P N

11.4 Is the outcome of the action taken 2

checked and monitored to determine the
effectiveness of improved quality of lab
Y P N
performance?
Standard: “Laboratory management shall implement quality indicators for systematically monitoring and evaluating the laboratory’s contributing These indicators should be
compared against a benchmark from an acknowledged guideline.” “ Laboratory management, in consultation with the requesters, shall establishes turnaround times for each of
its examinations. A turnaround time shall reflect clinical needs.” Key indicators of quality must be monitored regularly and evaluated for opportunities to improve testing services.
Indicators should be drawn from pre-analytic, analytic, and post-analytic phases and reflect activities critical to patient outcomes, those that correspond to a large proportion of the
laboratory’s patients, or areas that have been problematic in the past. These indicators should be compared against a benchmark from an acknowledged guideline.
ISO 15189: 4.12.4, 5.8.11
12

SECTION 11: OCCURRENCE/INCIDENT MGT, & PROCESS IMPROVEMENT Subtotal

33
For each item, please circle either Yes (Y), Partial (P), or No (N). All elements of the question must be satisfactorily present to
indicate “yes”. Provide explanation or further comments for each “partial” or “no” response.
Comments Score
Y P N
12.0 FACILITIES & SAFETY
12.1 Is the size of the laboratory adequate and 2
the layout of the laboratory, as a whole,
organized so that workstations are Y P N
positioned for optimal workflow?
Standard: The laboratory floor plan should be configured to promote high quality work, personnel safety, and efficient operations.
ISO 15189: 5.2.2
12.2 Are the patient care and testing areas of 2
the laboratory distinctly separate from
Y P N
one another?
Standard: “There shall be effective separation between adjacent laboratory sections in which there are incompatible activities. Measures shall be taken to prevent cross-
contamination.” Client service areas (i.e., waiting room, phlebotomy room) should be distinctly separate from the testing areas of the laboratory. Client access should not
compromise ‘clean’ areas of the laboratory. For Biosafety reasons, microbiology and TB testing should be segregated in a separate room(s) from the general laboratory testing.
ISO 15189: 5.2.6
12.3 Is each individual workstation maintained 2
free of clutter and set up for efficient
Y P N
operation?
Are the following criteria met: Tick for each item
Yes No N/A
Does the equipment placement/layout facilitate
optimum workflow?
Are all needed supplies present and easily
accessible?
Are the chairs/stools at the workstations
appropriate for bench height and the testing
operations being performed?
ISO 15190: 6.3.5
Is reference material readily available ( critical
values and required action, population reference
ranges, frequently called numbers?
CAP Standard: Age-and sex-specific reference intervals (normal values) must be verified or established by laboratory. If a formal reference intervals study is not possible or
practical, then the laboratory should carefully evaluate the use of published data for its own reference ranges, and retain documentation of this evaluation.
General Checklist, GEN.42162, 2010
12.4 Is the physical work environment 2
appropriate for testing? Y P N
Tick for each item
Is the workplace:
Yes No N/A
Free of clutter?

ISO 15190: 13.0

Adequately ventilated?

ISO 15190: 6.3.3

Free of excess humidity?
ISO 15190: 6.3.3
Adequately lit?
ISO 15190: 6.3.1
Climate-controlled for optimum equipment
function?
ISO 15190: 6.3.2
Are filters checked, cleaned and/or replaced at
regular intervals, where air-conditioning is
installed?

34
 Are wires and cables properly located and
protected from traffic?
Is there a functioning back-up power supply
(generator)?
Is critical equipment supported by uninterrupted
power source (UPS) systems?
Is equipment placed appropriately (away from
water hazards, out of traffic areas)?
Is a contingency plan in place for continued
testing in the event of prolonged electricity
disruption?
Are appropriate provisions made for adequate
water supply, including deionized water (DI) or
distilled water, if needed?
Is clerical work completed outside the testing
area?
Is major safety signage posted and enforced
including NO EATING, SMOKING, DRINKING?

Standard: The laboratory space should be sufficient to ensure that the quality of work, the safety of personnel, and the ability of staff to carry out quality control procedures and
documentation. The laboratory should be clean and well organized, free of clutter, well ventilated, adequately lit, and within acceptable temperature ranges. “Emergency power
supply should be adequate for refrigerators, freezers, incubators, etc., to ensure preservation of patient specimens. Depending on the type of testing performed in the laboratory,
emergency power may also be required for the preservation of reagents, the operation of laboratory instruments, and the functioning of the data processing system.” ISO 15189:
5.2.5 and 5.2.10 and CAP GEN.66100, General Checklist, 2010
12.5 Is the laboratory properly secured from 2
unauthorized access with appropriate
signage? Y P N

Standard: The access of unauthorized persons to the laboratory should be strictly limited to avoid the unnecessary contact of individuals with contaminated areas, reagents, or
equipment. Unnecessary traffic also disturbs workflow and can distract staff members.
ISO 15189: 5.2.7
12.6 Is laboratory-dedicated cold and room 2
temperature storage free of staff food
items, and are patient samples stored
separately from reagents and blood Y P N
products in the laboratory refrigerators
and freezers?

Standard: Staff food items should be stored in separate locations dedicated to that purpose, not in laboratory storage areas, particularly cold storage. Laboratory reagents and blood
products should be stored separately when refrigerated or frozen.
ISO 15190: 11.1

12.7 Is the work area clean and free of leakage 2

& spills, and are disinfection procedures
conducted and documented? Y P N

Standard: The work area should be regularly inspected for cleanliness and leakage. An appropriate disinfectant should be used. At a minimum, all bench tops and working surfaces
should be disinfected at the beginning and end of every shift. All spills should be contained immediately and the work surfaces disinfected.
ISO 15189: 5.2.10; ISO 15190:13

12.8 Is a certified and appropriate Biosafety If required by testing activities. 2

cabinet (or an acceptable alternative
processing procedure) in use for all
specimens or organisms considered to
be highly contagious by airborne routes? Y P N
(Biosafety cabinet should be recertified
according to national protocol).

Standard: A Biosafety cabinet should be used for to prevent aerosol exposure to contagious specimens or organisms. For proper functioning and full protection, Biosafety cabinets
require periodic maintenance and should be serviced accordingly.
ISO 15190: 16

35
 12.9 Is a laboratory safety manual available, 3
accessible, and up-to-date? Y P N
Tick for each item
Does the safety manual include guidelines on the
Yes No N/A
following topics?
Blood and Body Fluid Precautions
Hazardous Waste Disposal
Hazardous Chemicals / Materials
MSDS Sheets
Personal protective equipment
Vaccination
Post-Exposure Prophylaxis
Fire Safety
Electrical safety
Standard: A safety manual shall be readily available in work areas as required reading for all employees. The manual shall be specific for the laboratory's needs. The Safety Manual
shall be reviewed and updated at least annually by laboratory management.
ISO 15190: 7.4
12.10 Is sufficient waste disposal available 2
and is waste separated into infectious
and non-infectious waste, with
Y P N
infectious waste autoclaved?
Standard: Waste should be separated according to biohazard risk, with infectious and non-infectious waste disposed of in separate containers. Infectious waste should be discarded
into containers that do not leak and are clearly marked with a biohazard symbol. Sharp instruments and needles should be discarded in puncture resistant containers. Both infectious
waste and sharps containers should be autoclaved before being discarded to decontaminate potentially infectious material. To prevent injury from exposed waste, infectious waste
should be incinerated, burnt in a pit, or buried.
ISO 15190:22
12.11 Are hazardous chemicals / materials 2
properly handled? Y P N
Tick for each item
Yes No N/A
Are hazardous chemicals properly labeled?
Are hazardous chemicals properly stored?
Are hazardous chemicals properly utilized?
Are hazardous chemicals properly disposed?
Standard: All hazardous chemicals must be labeled with the chemical’s name with hazard markings clearly indicated. Flammable chemicals must be stored out of sunlight and
below their flashpoint, preferably in a still cabinet in a well-ventilated area. Flammable and corrosive agents should be separated from one another. Distinct care should always be
taken to handle hazardous chemicals safety in the workplace.
ISO 15190: 17.1 and 17.3
12.12 Are ‘sharps’ handled and disposed of 2
properly in ‘sharps’ containers that are
Y P N
appropriately utilized?
Standard: All syringes, needles, lancets, or other bloodletting devices capable of transmitting infection must be used only once and discarded in puncture resistant containers that
are not overfilled. Sharps containers should be clearly marked to warn handlers of the potential hazard and should be located in areas where sharps are commonly used.
ISO 15189: 5.2.10;CAP GEN.773100, General Checklist, 2010
12.13 Is fire safety included as part of the 2
laboratory’s overall safety program? Y P N
Tick for each item
Yes No N/A
Are all electrical cords, plugs, and receptacles
used appropriately and in good repair?

Is an appropriate fire extinguisher available,

properly placed, in working condition, and
routinely inspected?
ISO 15190: 19.7

Is an operational fire warning system in place in

laboratory with periodic fire drills?

36
 ISO 15190: 9.3
Standard: Electrical chords and plugs, power-strips, and receptacles should be maintained in good condition and utilized appropriately. Overcrowding should be avoided and chords
should be kept out of walkway areas. An approved fire extinguisher should be easily accessible within the laboratory and be routinely inspected and documented for readiness. Fire
extinguishers should be kept in their assigned place, not be hidden or blocked, the pin and seal should be intact, nozzles should be free of blockage, pressure gauges should show
adequate pressure, and there should be no visible signs of damage. A fire alarm should be installed in the laboratory and tested regularly for readiness and all staff should
participate in periodic fire drills.
12.14 Are safety inspections or audits 2
conducted regularly and documented? Y P N
Standard: Safety inspections or audits, using a safety checklist, should be conducted periodically to ensure the laboratory is a safe work environment and identify areas for redress
and correction.
ISO 15190 7.3.1 and 7.3.2
12.15 Is standard safety equipment available 2
and in use in the laboratory? Y P N
Tick for each item
Yes No N/A
Biosafety cabinet(s)
ISO 15190: 16
Covers on centrifuge(s)

Hand-washing station
ISO 15190: 12.7
Eyewash station/bottle(s) and showers where
applicable
ISO 15190: 12.10
Spill kit(s)

First aid kit(s)

ISO 15190: 12.9
Standard: It is the responsibility of laboratory management to ensure the laboratory is equipped with standard safety equipment. The list above is a partial list of necessary items.
Biosafety cabinets should be in place and in use and all centrifuges should have covers. Hand washing stations should be designated and equipped and eyewash stations (or an
acceptable alternative method of eye cleansing) should be available and operable. Spill kits and first aid kits should be kept in a designated place and checked regularly for
readiness. ISO 15190: 5.1
12.16 Is personal protective equipment (PPE) 2
easily accessible at the workstation and
Y P N
utilized appropriately and consistently?
Standard: Management is responsible to provide appropriate personal protective equipment—gloves, lab coats, eye protection, etc. — in useable condition. Laboratory staff must
utilize personal protective equipment in the laboratory at all times. Protective clothing should not be worn outside the laboratory. Gloves should be replaced immediately when torn or
contaminated and not washed for reuse.
ISO 15190: 12
12.17 Are laboratory personnel offered 2
appropriate vaccination//preventive
Y P N
measures?
Standard: Laboratory staff should be offered appropriate vaccinations--particularly Hepatitis B. Staff may decline to receive the vaccination, but should sign a declination form to be
held in the staff member’s personnel file.
ISO 15190: 11.3
12.18 Are post-exposure prophylaxis policies 2
and procedures posted and implemented
Y P N
after possible and known exposures?
Standard: The laboratory must have a procedure for follow-up of possible and known percutaneous, mucus membrane, or abraded skin exposure to HIV, HBV, or HCV. The
procedure should include clinical and serological evaluation and appropriate prophylaxis.
ISO 15190: 9
12.19 Are occupational injuries, medical 2
screening or illnesses documented in the
safety occurrence log? Y P N

Standard: All occupational injuries or illnesses should be thoroughly investigated and documented in the safety log or occurrence log, depending on the laboratory. Corrective
actions taken by the laboratory in response to an accident or injury must also be documented.
ISO 15190: 9

12.20 Are drivers/couriers and cleaners 2

working with the laboratory trained in Y P N

37
 Biosafety practices relevant to their job
tasks?
Standard: All occupational injuries or illnesses should be thoroughly investigated and documented in the safety log or occurrence log, depending on the laboratory. Corrective
actions taken by the laboratory in response to an accident or injury must also be documented.
ISO 15190: 10
12.21 Is a trained safety officer designated to 2
implement and monitor the safety
program in the laboratory, including the Y P N
training of other staff?
Standard: A safety officer should be designated to work with the laboratory manager to implement the safety program, monitor the ongoing safety conditions and needs of the
laboratory, coordinate safety training, and serve as a resource for other staff. This officer should receive safety training.
ISO 15190: 7,10
43

SECTION 12: FACILITIES & SAFETY Subtotal

ETHICAL PRINCIPLES IN LABORATORY MEDICINE

Laboratories shall uphold the principle that the welfare and interest of the patient are paramount and patients should be treated
fairly and without discrimination. (ISO 15189 Annex C.2.1)

Every medical laboratory shall provide its services to all users in a manner that respects their health rights and without discrimination. (ISO
15189 Annex C 2.2)

Every medical laboratory shall ensure that patient consent is obtained for all procedures carried out on the patient. In emergency situations, if
consent is not possible under these circumstances, necessary procedures may be carried out, provided they are in the best interest of the
patient. (ISO 15189 Annex C 4.1)

Medical laboratories should have in place policy guidelines that address conflicts of interest, undue internal or external pressure, and
confidentiality that could influence the credibility of the work conducted and information generated by the laboratory. (ISO 15189 Clause 4.1.4
and 4.1.5 b, c, d and 5.1.13)

Personnel employed within medical laboratories shall not compromise their organization by engaging in activities that could adversely affect
quality of work, competence, impartiality, judgment or operational integrity. (ISO 15189 Clause 4.1.5 b, d).

38
Criteria Are internal quality control procedures routinely FREQUENCY
1 conducted for all test methods? Daily Weekly w/
Every
Run
1.1 Monitoring of control values
Quantitative tests
Semi-quantitative tests
Qualitative tests
1.2 Monitoring with internal standards
Quantitative tests
Semi-quantitative tests
Qualitative tests
1.3 Monitoring quality of each new batch of kits
Quantitative tests
Semi-quantitative tests
Qualitative tests
1.4 Documentation of internal controls and kits validation
Quantitative tests
Semi-quantitative tests
Qualitative tests
COMMENTS and RECOMMENDATIONS

39
Criteria Has the laboratory achieved acceptable PT results Date of Were results Results &
of at least 80% on the two most recent PT panel reported % Correct
2 challenges? receipt within 15
days?
HIV Serology %
2.1 Most recent HIV panel Y N
2.2 Second most recent HIV panel Y N
HIV DNA PCR %
2.3 Most recent HIV DNA PCR panel Y N
2.4 Second most recent HIV panel Y N
HIV Viral Load %
2.5 Most recent HIV DNA PCR panel Y N
2.6 Second most recent HIV panel Y N
CD4 Count %
2.7 Most recent CD4 panel Y N
2.8 Second most recent CD4 panel Y N
Chemistry %
2.9 Most recent Chemistry panel Y N
2.10 Second most recent Chemistry panel Y N
Hematology
2.11 Most recent Hematology panel Y N
2.12 Second most recent Hematology panel Y N
Malaria %
2.13 Most recent Malaria panel Y N
2.14 Second most recent Malaria panel Y N
Mycobacterium tuberculosis %
2.15 Most recent TB smear panel Y N
2.16 Second most recent TB smear panel Y N
2.17 Most recent TB culture panel Y N
2.18 Second most recent TB culture panel Y N
2.19 Most recent drug susceptibility panel Y N
2.20 Second most recent drug susceptibility panel Y N
Other disease of public health significance (please specify) %

2.21 Most recent PT panel Y N

2.22 Second most recent PT panel Y N
Other disease of public health significance (please specify) %
2.23 Most recent PT panel Y N
2.24 Second most recent PT panel Y N
40
PART Ill: SUMMARY OF AUDIT FINDINGS
SUMMARY
Noted Commendations

Noted Challenges

RECOMMENDATIONS

41
ACTION PLAN (if applicable)
Follow-up Actions Responsible PersonsTimeline Signature

42
Criteria for (5 star certification and accreditation of international standards)

1. Test results are reported by the laboratory on at least 80% of specimens within the
turnaround time specified (and documented) by the laboratory in consultation with its
clients. Turnaround time to be interpreted as time from receipt of specimen in laboratory until
results reported. DATA NOT COLLECTED ON THIS ELEMENT

2. Internal quality control (IQC) procedures are practiced for all testing methods used by the
laboratory.
Ordinarily, each test kit has a set of positive and negative controls that are to be included in
each test run. These controls included with the test kit are considered internal controls, while
any other controls included in the run are referred to as external controls. QC data sheets and
summaries of corrective action are retained for documentation and discussion with auditor.

3. The scores on the two most recent WHO AFRO approved proficiency tests are 80% or
better.
Proficiency test (PT) results must be reported within 15 days of panel receipt. Laboratories that
receive less than 80% on two consecutive PT challenges will lose their certification until such
time that they are able to successfully demonstrate achievement of 80% or greater on two
consecutive PT challenges. Unacceptable PT results must be addressed and corrective action
taken.

NOTE: A laboratory that has failed to demonstrate achievement of 80% or greater on the two
most recent PT challenges will not be awarded any stars, regardless of the checklist score they
received upon audit.

Score
Score on annual on-site inspection is at least 55% (at least 142 pts):
Y N

No Stars 1 Star 2 Stars 3 Stars 4 Stars 5 Stars

(0 – 141 pts) (142 – 166 pts) (167 – 192 pts) (193 – 218 pts) (219 – 243 pts) (244 – 258 pts)
< 55% 55 – 64% 65 – 74% 75 – 84% 85 – 94% ≥95%

Lead Auditor Signature
Date

43
SOURCES CONSULTED

AS 4633 (ISO 15189) Field Application Document: 2009

Centers for Disease Control - Atlanta - Global AIDS Program. (2008). Laboratory Management Framework and
Guidelines. Atlanta, GA: Katy Yao, PhD.

CLSI/NCCLS. Application of a Quality Management System Model for Laboratory Services; Approved Guideline—Third
Edition. CLSI/NCCLS document GP26-A3. Wayne, PA: NCCLS; 2004. www.clsi.org.

CLSI/NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second Edition. CLSI/NCCLS
document HS01-A2. Wayne, PA: NCCLS; 2004. www.clsi.org.

College of American Pathologists, USA. (2010). Laboratory General and Chemistry and Toxicology Checklists.

Guidance for Laboratory Quality Management System in the Caribbean - A Stepwise Improvement Process. (2012).

International Standards Organization, Geneva (2007) Medical Laboratories – ISO 15189: Particular Requirements for
Quality and Competence, 2nd Edition.

Ministry of Public Health, Thailand. (2008). Thailand Medical Technology Council Quality System Checklist.

National Institutes of Health, (2007, Feb 05). DAIDS Laboratory Assessment Visit Report. Retrieved July 8, 2008, from
National Institutes of Health Web site: http://www3.niaid.nih.gov/research/resources/DAIDSClinRsrch/Laboratories.htm.

National Institutes of Health, (2007, Feb 05). Chemical, Laboratory: Quality Assurance and Quality Improvement Monitors.
CHECKLIST FOR SITE SOP REQUIRED ELEMENTS, Retrieved July 8, 2008, from
http://www3.niaid.nih.gov/research/resources/DAIDSClinRsrch/Laboratories.htm.

National Institutes of Health, (2007, Feb 05). Laboratory: Chemical, Biohazard and Occupational Safety, Containment and
Disposal. CHECKLIST FOR SITE SOP REQUIRED ELEMENTS, Retrieved July 8, 2008, from
http://www3.niaid.nih.gov/research/resources/DAIDSClinRsrch/Laboratories.htm.

PPD, Wilmington, North Carolina, (2007). Laboratory Report.

South African National Accreditation System (SANAS). (2005). Audit Checklist, SANAS 10378:2005.

USAID Deliver Project. The Logistics Handbook. (2007). Task Order 1.

44