p 10 Qman 1 a Laboratory Quality Manual 25mar22 Draft

National Department of Health Central Public Health Laboratory in
conjunction with the Fleming Fund Country Grant (2020-22)
Title: Laboratory Quality Manual

ID: P_10_QMAN_1_A Draft
Developed by: E Velemu, J Ferguson, K Nathaniel Date: 9/9/21
Reviewed by: J Joseph, G Ak, S Mabone Issue date:
Review Period: Annual
Authorized by:
Location: For use across all Public Medical Diagnostic Laboratories in PNG
Changes to the last authorized version (amendment record:
Version Date of issue Changes

P_10_QMAN_1_A New document
Laboratory Quality Manual (PNG DRAFT 24Mar22) Page 2 of 45
In memorandum Professor Evelyn Lavu, 1963 - 2021, Director of

CPHL, a passionate leader who initiated the laboratory
improvement and quality journey in Papua New Guinea.
Notes from John Ferguson
Blue highlight indicates a generic text suitable for all labs

Yellow highlight indicates local content from PMGH or where local modification required
7/9/21 – Sections 1, 2 , 3 review as per LQMC meeting this week
https://extranet.who.int/lqsi/activities/3/47 (Lay the foundation for the management cycle) may
assist as well.
28/9/21 - Sections 4, 5 and 9 were also ready for your review
9/11/21 – PMGH version remains the single draft until we finalise content for Sections 1, 2 and
3- please send me your edits directly
24/11/21- Section 7 (process management) edited ready for review

29/11/21 Selected content from K Nathaniel’s PMGH draft version incorporated and annotated
27/1/22 Working copy updated with further annotations ready for working group
25/2/22 Further amendment to the working copy
7/3/22 Now designed to have Sections 1,2 and 3 as hospital specific sections; Section 4-14 are
suggested to be generic. Test list, opening hours and urgent tests – put on website.
10/3/22 This version with input from P Welehin, CPHL. Lab specific details removed
March 2022 review by pathologists, managers and scientists at PMGH, CPHL and Goroka sites
See minutes
17/3/22 post further review with Dr Mabone
24/3/22 further streamlining
Distribution and Document Control
The online version of this manual is the controlled document.
All sites are responsible to ensure that any printed copy is certified by local management as
reflecting the current online version.
Reprinting of a new version must lead to removal and destruction of old version copies by the
Quality /Document Control Officer.
Certification statement to be recorded on printed title page:
Version
Authorised by (name)
Signed
Date
Abbreviations and acronyms
BSL Biosafety Level

CDC Centers for Disease Control and Prevention, USA
EQA External Quality Assessment
EUCAST European Union Committee on Antimicrobial Susceptibility Testing
ISO International Organization for Standardization
LIMS Laboratory Information Management System
LQMS Laboratory Quality Management System
QC Quality Control
QM Quality Manual
QSE Quality System Essential
OIC Officer in charge
SOP(s) Standard Operating Procedure(s)
WHO World Health Organization
Table of Contents
Abbreviations and acronyms............................................................................................................................ 4
1. Introduction to the Quality Manual ..................................................................................................... 7
1.1 Mission statement .................................................................................................................................................................................... 7
1.2 Vision statement ........................................................................................................................................................................................ 7
1.3 Scope ................................................................................................................................................................................................................. 7
1.4 Information about individual public medical laboratories ........................................................................................... 7
2. Quality Policy ................................................................................................................................................. 8
3. QSE: Organization ........................................................................................................................................ 9
3.1 Organization policy ........................................................................................................................................................................................... 9
3.2 Conflict of interest and code of ethics .................................................................................................................................................... 9
3.3 Organization chart ............................................................................................................................................................................................. 9
3.4 Internal communication ................................................................................................................................................................................ 9
3.5 Personnel responsibilities ..........................................................................................................................................................................10
3.6 Supporting documents ..................................................................................................................................................................................12
4. QSE: Facilities and Safety ...................................................................................................................... 13
4.1 Policy ........................................................................................................................................................................................................................13
4.2 Facilities .................................................................................................................................................................................................................13
4.3 Security ...................................................................................................................................................................................................................14
4.4 Working environment ...................................................................................................................................................................................14
4.5 Staff biosafety educational resources .................................................................................................................................................14
4.6 Waste disposal ....................................................................................................................................................................................................14
5. QSE: Equipment ......................................................................................................................................... 16
5.1 Policy...............................................................................................................................................................................................................16
5.2 Selection of equipment ........................................................................................................................................................................16
5.3 Installation and acceptance criteria ...........................................................................................................................................16
5.4 Equipment inventory, records and master file ....................................................................................................................16
5.5 Validation and equipment calibration ......................................................................................................................................17
5.6 Preventive equipment maintenance and repair .................................................................................................................18
5.7 Decommissioning....................................................................................................................................................................................18
5.8 Supporting documents ........................................................................................................................................................................19
6. QSE: Purchasing and Inventory ..................................................................................................... 20
6.1 Policy ........................................................................................................................................................................................................................20
6.2 Reagents and consumables management .........................................................................................................................................20
6.3 Selection and evaluation of providers.................................................................................................................................................20
6.4 Procurement ........................................................................................................................................................................................................21
6.4.1 Equipment procurement................................................................................................................................................................... 21
6.4.2 Reagents, consumables and materials .....................................................................................................................................21
6.5 Stock management and inventory .........................................................................................................................................................21
6.6 Referral laboratories / subcontracting ..............................................................................................................................................21
6.7 Supporting documents (largely undefined) ....................................................................................................................................22
7. QSE: Process Management.................................................................................................................... 23
7.1 Policy ........................................................................................................................................................................................................................23
7.2 Sample management ......................................................................................................................................................................................23
7.2.1 Specimen collection and transport ............................................................................................................................................23
7.2.2 Specimen/sample receiving ...........................................................................................................................................................24
7.2.3. Specimen/sample handling, preparation and storage ................................................................................................. 24
7.3 Method validation ............................................................................................................................................................................................24
7.4 Quality Control ................................................................................................................................................................................................... 24
7.5 Result validation and reporting ..............................................................................................................................................................25
7.6 Records, Sample retention and disposal............................................................................................................................................25
7.9 Supporting documents (undefined) .....................................................................................................................................................27
8. QSE: Assessments .................................................................................................................................... 28
8.1 Policy ........................................................................................................................................................................................................................28
8.2 Internal assessments ......................................................................................................................................................................................28
8.2.1 Internal Audits.........................................................................................................................................................................................28
8.2.2 Review and follow up of corrective actions ..........................................................................................................................29
8.2.3 Staff suggestions .....................................................................................................................................................................................29
8.2.4 Review of requests, methods and sampling requirements .........................................................................................29

8.3 External assessments .....................................................................................................................................................................................29
8.3.1 External Quality Assessment/ Proficiency testing ...........................................................................................................29
8.3.3 External audits ........................................................................................................................................................................................29
9. QSE: Personnel ........................................................................................................................................... 31
9.1 Policy ........................................................................................................................................................................................................................31
9.2 Recruitment and orientation ....................................................................................................................................................................32
9.3 Staff member personnel files ....................................................................................................................................................................33
9.4 Training and competency assessment ................................................................................................................................................33
9.5 Continuing education and professional development ..............................................................................................................34
9.6 Personnel performance appraisal .........................................................................................................................................................34
9.7 Non-permanent personnel .........................................................................................................................................................................34
10. QSE: Customer Service .............................................................................................................................. 36
10.1 Policy .....................................................................................................................................................................................................................36
10.2 Customers satisfaction measurement ..............................................................................................................................................36
10.3 Complaints management ..........................................................................................................................................................................36
10.4 Complaints from staff .................................................................................................................................................................................36
10.5 Supporting documents ...............................................................................................................................................................................36
11. QSE: Nonconforming Event Management – in need of further review ............................. 37
11.1 Policy .....................................................................................................................................................................................................................37
11.2 Corrective Actions .........................................................................................................................................................................................37
11.4 Assay Validation and Non- conforming Work..............................................................................................................................38
11.5 Corrective and Non-conforming Actions.........................................................................................................................................39
11.6 Supporting documents ..............................................................................................................................................................................39
12. QSE: Continual Improvement– in need of further review ....................................................... 40
12.1 Policy .....................................................................................................................................................................................................................40
12.2 Quality indicators ..........................................................................................................................................................................................40
12.3 Management review.....................................................................................................................................................................................40
12.4 Preventive action ...........................................................................................................................................................................................41
12.5 Example quality indicators.....................................................................................................................................................................41
12.5 Supporting documents (undefined) ..................................................................................................................................................41
13. QSE: Documents and Records ............................................................................................................... 42
13.1 Policy .....................................................................................................................................................................................................................42
13.2 Documentation management................................................................................................................................................................. 42
13.3 Documents and records control ...........................................................................................................................................................42
13.4 Archiving .............................................................................................................................................................................................................42
13.5 Supporting documents ...............................................................................................................................................................................43
14. QSE: Information Management............................................................................................................. 44
14.1 Policy .....................................................................................................................................................................................................................44
14.2 Information system – Security...............................................................................................................................................................44
14.3 Confidentiality ................................................................................................................................................................................................. 44
14.4 Supporting documents (undefined) ..................................................................................................................................................44
15. Appendices ..................................................................................................................................................... 45
1. Introduction to the Quality Manual

This quality manual provides a roadmap of the management system in place for public
laboratories in PNG including all the necessary policies and procedures that support a quality
management system as specified by the ISO15189 Standard for Medical Laboratories. The
manual is organized following the framework developed by the WHO.
The quality management system aims primarily at achieving customer satisfaction by

performing accurate and reliable analytical work of high quality that meets customer
requirements. The laboratory aims for continuous improvement of the system, and prevention
of the occurrence of nonconformities (unexpected wrong results or significant deficiencies of
practice).
1.1 Mission statement

Delivery of high quality laboratory services essential both for providing clinical diagnosis
for clinical decisions for patient care and as objective means to measure and monitor
treatment of diseases.
1.2 Vision statement

An affordable, accessible, equitable quality medical laboratory service for the residents of
the Papua New Guinea.
To provide continuous professional development as appropriate for staff and students who
work in the medical laboratories.
To improve the quality of work performed in medical laboratories by participating in

External Quality Assurance Programmes for improvement processes towards
Accreditation.
1.3 Scope
This quality manual describes the quality management system applicable to all PNG
laboratories. The QMS is essentially a complete operational policy and procedures for
management and staff. Its scope is for:
 Internal use - to communicate to staff the laboratory’s quality policy and objectives, to
make the staff familiar with the management structure and processes used to achieve
compliance with quality requirements. This should facilitate the implementation of the
quality management system as well as ensure its maintenance and required updates
during altering circumstances. This should also allow effective communication and
control of quality related activities and a documented base for quality system audits.
 External use - to inform the laboratory’s external partners and customers about its
scope of work, its quality policy as well as its implemented quality management system
and measures of compliance with quality.
1.4 Information about individual public medical laboratories

Refer to https://www.health.gov.pg for location-specific information on available diagnostic
services, pathology specialist consultation, laboratory organization, contact numbers, opening
hours and specimen collection guide.
2. Quality Policy
This laboratory is committed to the following principles:
Excellence Service
 Compliance with ISO15189  Timely, accurate and appropriate

requirements for laboratory diagnostic services without
management and quality, as interruption
demonstrated by internal audit  Quality , accurate and reliable lab
and external quality assurance results
 Compliance with the National  Laboratory staff who adhere to the
Health Service Standards vision and key objectives of the
Pathology Laboratory
 Good customer service
Teamwork and competence Integrity
 A strong collaborative approach  Management that avoids conflicts

with clinicians of interest and maintains
 Provision of continuing education transparency in all contracts and
and support for staff professional dealings
development of all cadres  Management that follows proper
 Provision of effective training and staff recruitment processes
competency assessment for staff  Staff who comply with the
laboratory’s Code of Ethics Staff
who respect patient, client and
staff confidentiality
Printed date:
Authorised by:
Signed: Date:
The printed authorised copy should be placed on the laboratory staff noticeboard.
3. QSE: Organization
3.1 Organization policy
The pathologist, coordinator of pathology services or laboratory manager has the authority,
competence and responsibility for the services provided.
Laboratory management ensures the following:

 there are no activities that could compromise laboratory performance;
 there are appropriate procedures to ensure ethical respect of patient samples and
confidentiality of patient information;
 duties and responsibilities of laboratory personnel are defined;
 appropriate communication is established within the laboratory;
 staff are empowered to implement the quality management system
 quality and biosafety officers are designated
3.2 Conflict of interest and code of ethics
Medical laboratories do not engage in any activity that might influence its technical judgment.
The laboratories are not committed to any commercial, financial or other pressure provided by
any particular organization that could influence its technical judgment or affect its
competencies and trust.
Every new staff member is to read and endorse the laboratory code of ethics statement.
3.3 Organization chart
Each laboratory should specify its organizational structure and review this annually. It is to be
made available on the Laboratory’s website location.
The management structure also requires specification – i.e. what management teams are in
place and how often they meet.
3.4 Internal communication
The management ensures appropriate communication takes place to keep staff members
informed.
Each laboratory defines its own internal communication strategy and section and management
meetings schedule. This is placed into a location-specific SOP for communication.
All staff and management meetings require an agenda and minutes that contain ‘SMART’ action
points in the minutes.
Meeting actions:
Meetings are only valuable if they lead to efficient action to deal with issues arising.
When an agenda has an agreed action that is necessary to resolve an issue, then this action
should be translated into ‘SMART’ action points in the minutes.
Example - A Clinician complaint regarding missing test results -

S—Specific Describe exactly the action that needs to be done eg Contact Clinician for
complaint details
M—Measurable Formulate the action in a way that it can be checked (measured)
whether it has been carried out eg record number of occasions Dr notifies laboratory
of missing results over a defined time.
A—Agreed Mention the person(s) who will carry out the action eg name of staff
member to contact the clinician, record the details, investigate the complaint,
determine possible causes and liaise with the Lab Manager to discuss the investigation
results.
R—Realistic Formulate a realistic action. An action which is not realistic will never be
carried out eg achieve reduction of complaints from clinician within 4 weeks.
T—Time-bound Deadline of the action eg Contact Clinician by Friday this week with a
view to Resolution within 4 weeks.
An example of an action plan to record in the meeting minutes for an item could be:
01.01.2020- Lab Technician, Joe Kangapu to contact Dr at PNG Clinic to obtain details, investigate
complaint, notify Lab Manager of findings and suggest possible solutions before the next meeting
date in 4 weeks.
3.5 Personnel responsibilities
The following roles are defined generically for all medical laboratories in this sequence of
accountability:
1. Laboratory Coordinator (PMGH only) or Laboratory Director (CPHL), Pathologist
(Provincial Specialist Hospital Lab)
2. Laboratory Manager
3. Scientific Officer in charge of section
4. Scientist/technologist /technician
5. Medical laboratory assistants
All laboratories maintain current job descriptions for these cadres. These are subject to review
at the annual staff performance appraisal meetings.
PMGH Pathologists and Pathologists under NDOH, attached to PMGH, report clinically to the
PMGH Lab Coordinator. They also report administratively to the Chief Pathologist
The CPHL Manager is responsible to Public Health Deputy Secretary, NDOH.
The PMGH Lab Coordinator reports to the PMGH Senior Executive Management who are
answerable to the PMGH Board, itself answerable to Minister of Health.
Overview of tasks by role
Laboratory Manager
 ensures that the necessary human and material resources, as well as the necessary
information, are available to enable effective operation and control of the processes of
the quality management system
 ensures adequate training
 manages contracts
 delegates tasks to qualified personnel
 ensures internal and external communication
Scientific Officer in Charge of section

 plans and co-ordinates the work schedule
 ensures stock management/material management
 ensures activities/processes included in the scope of the quality management system
are identified and performed in compliance with this manual;
 applies the necessary techniques and criteria in order to verify that established
processes/activities and their implemented controls are effective
 evaluates and identifies new products
Scientist/technologist
 manages, protects, and preserves stock
 reports to the senior scientific officer in charger any significant problems of which
he/she becomes aware in daily practice
 performs the tests
 controls and maintains equipment
 reports to Scientific Officer in Charge any significant problems of which he/she becomes
aware in daily practice
 checks performance of internal QC to validate the tests
Medical laboratory assistants (based level district hospitals, level 4 and below)
 manages, protects, and preserves stock
 reports to the senior scientific officer in charger any significant problems of which
he/she becomes aware in daily practice
 performs the tests
 controls and maintains equipment
 reports to Scientific Officer in Charge any significant problems of which he/she becomes
aware in daily practice
 checks performance of internal QC to validate the tests
Several additional roles are defined as below – sectional quality officer, biosafety officer,
Inventory officer and equipment officer. Existing staff are appointed to take on these additional
responsibilities as required by the size of the laboratory.
3.6 Supporting documents
Procedures Document number
Management structure, meetings & internal communication SOP Specific by lab site
Role descriptions
Sectional Quality Officer role description G_10_LQM_Ap_27_A
Biosafety Officer role description G_10_LQM_Ap_26_A
Equipment Officer role description G_10_LQM_Ap_28_A
Information sheets
Staff meetings G_10_Info_4_A

4. QSE: Facilities and Safety

4.1 Policy
Laboratory management are committed to appropriately address and manage the risks
associated with the biological agents being handled.
Each laboratory should identify a scientist to act as the biosafety officer and facilitate his/her
access to training (see below). This person is to monitor compliance, raise awareness of staff
and conduct monthly audits. He/she is to liaise closely with laboratory management who take
action as required to address issues as they arise.
Each laboratory requires a separate biosafety noticeboard in a prominent location.
Personnel are trained in the basics of safety and risk management issues. New staff are to
complete a biosafety training checklist. Annual fire safety training is recommended.
Fire extinguishers must be maintained and in-date.
The laboratory is provided with sufficient space and reliable infrastructure to perform its work,
to ensure the quality, safety and efficacy of the services provided, and to meet national safety
regulations.
The laboratory design provides an efficient and safe environment for the laboratory staff, other
health care personnel, patients, and the community.
A monthly risk assessment is conducted by the biosafety officer to identify housekeeping,

safety, waste and cleaning issues that require action.
Safety incidents/accidents are documented and actioned accordingly by management. Incident

records must be retained for at least 5 years.
A description of safety rules is available on this Laboratory Biosafety Information Sheet

G_10_Info_3_A.
4.2 Facilities
Safety shower and eye-wash station are accessible within the laboratory and are regularly
tested.
A separate clean staff area maintained for tea-room, bathroom facilities.
Sufficient clean laboratory gowns and PPE provided and the hospital undertakes to clean gowns
at least weekly.
The microbiology laboratory has a separate air handling unit that removes air to the outside
without recirculation to other parts of the laboratory. See G_10_Info_2_A, Physical Containment
2 (PC2) Standard Lab Requirements.
4.3 Security
The laboratory reception is clearly marked with the appropriate signage. Access to all facilities
other than reception is restricted to authorized personnel. Access is preferably regulated by a
numerical entry coded lock – the PIN number is made known to all laboratory personnel.
Access to the laboratory outside the opening hours is limited to laboratory management,
technical staff and to personnel on duty call.
4.4 Working environment
All manipulation presenting a risk of contamination (for the operator, environment and/or
sample) is isolated from other activities.
Working areas are kept clean, dust free and are well maintained.
4.5 Staff biosafety educational resources
Laboratory biosafety officers should complete these trainings.

Other staff are also encouraged to complete.
Evidence of completion of specific courses should provided to the laboratory manager.
CDC Lab Safety Courses 1. Fundamentals of Chemical Fume Hood Safety

2. Fundamentals of Centrifuge Safety
Create an account for yourself first by 3. Fundamentals of Working Safely in a Biological
following these instructions : Safety Cabinet
https://idmic.net/2019/08/24/cdc-lab- 4. Introduction to Laboratory Risk Management
training-videoclasses-easy-instructions-on- (LRM)
accessing/
WHO Good Microbiological Practices and 1. Autoclaves

Procedures (Safeguarding biosafety and 2. Transport
biosecurity in laboratories) 3. Sharps
2.5 hrs. of training total; no logon required4. Pipettes
5. Workflow
https://www.who.int/activities/safeguarding- 6. PPE
biosafety-and-biosecurity-in-laboratories 7. Surface decontamination
First aid (online course) – recommended First Aid Online with TCP (4-6 hour course)
for sectional biosafety officer role $40 AUD for each, todd@tcptraining.com
https://www.tcptraining.com/online-courses/first-aid-
online-courses
4.6 Waste disposal
Waste (chemical, biological and other) is segregated and disposed according to national
regulations on waste disposal. Refer to the laboratory waste management and disposal SOP.
People in charge of the waste disposal in the laboratory and hospital require training to handle
biohazardous waste.
Chemical wastes require disposal via an accredited waste management organisation in PNG.
Procedures (SOP) Document number
Safety manual (WHO Biosafety Manual 4th Edition 2020) G_10_EX_001_A

(all specific safety procedures including biosafety)
Monthly Laboratory Safety Audit checklist G_10_LQM_Ap_29_A
Use and Maintenance of Biological Safety Cabinets G_90_SOP_8_A
Waste decontamination and management G_10_SOP_22_A
Laboratory cleaning and disinfection G_10_SOP_16_A
Biosafety Officer - Role description G_10_LQM_Ap_26_A
Forms/Logs
Safety incident report form G_10_LQM_Ap_30_A
Visitors log G_10_LQM_Ap_31_A
JobAids and Information sheets
How to use a Zeomed Biohazard Spill Kit G_90_J_2_A
First aid kit G_90_J_3_A
Safe handling of chemicals Display this notice on the

https://www.safetypostershop.com/category/chemical- biosafety noticeboard
safety-posters/
Safety rules : Laboratory Biosafety Information sheet G_10_Info_3_A
Personal protective equipment G_10_Info_8_A
Physical Containment 2 (PC2) Standard Lab Requirements G_10_Info_2_A

5. QSE: Equipment
5.1 Policy
The management of the laboratory ensures that equipment is properly selected, installed,
validated, maintained and disposed of according to established procedures and
manufacturer's instructions to meet the needs of the laboratory to perform quality diagnostic
testing.
Consultation with the Facilities Standards Branch of the NDOH must be prioritized before
procurement of large items of equipment.
A laboratory/section equipment officer needs to be appointed, authorized and familiarized
with the role (see role description). The EO reports to the section/laboratory manager as
appropriate to the location.
This section will be reviewed when equipments are standardized per section. Commented [DSM1]: Standardizing large equipments to 2
or 3 for ease of procurement. I know John thinks otherwise.
New equipment purchased not yet captured must be included into the medical and dental Comments???
catalogue. Commented [DSM2]: NDOH at present having issues with
procurement of uncatalogued reagents of consumables unless
it is captured in the medical dental catalogue.
5.2 Selection of equipment

See Chapter 6, Purchasing and Inventory.
5.3 Installation and acceptance criteria

New instruments and equipment are installed, calibrated and documented by the vendor who
assures satisfactory performance.
The laboratory ensures space, ventilation, humidity and electricity meet vendor’s
specifications for satisfactory performance.
The vendor provides documentation that each instrument meets all the required criteria for
its use in the laboratory.
The responsible laboratory staff member must verify that the equipment is capable of
achieving the necessary performance and that it complies with requirements relevant to the
examinations concerned. Document on the Equipment Qualification form.
When the new equipment has been properly installed and verified, designated staff will
receive appropriate training in the operation, safety and maintenance of the equipment. A
competency assessment needs to be completed.
5.4 Equipment inventory, records and master file

Each laboratory and section is responsible for maintaining a register of equipment. Updating
of this register is the responsibility of the Equipment Officer. See also below.
Uniquely identify equipment following this format: [lab initials]-[lab department]-[sequential

number] e.g. GO-90-001 – Goroka microbiology equipment item 1.
This identity needs to be entered against the hospital fixed assets register.
Example lab initials already in use:
C CPHL GO Goroka
P PMGH N Nonga
AN ANGAU M Mt Hagen
All equipment records, instructions and SOP are to be kept in a single master folder for each
instrument by the Equipment officer and located next to the equipment concerned1.
The staff responsible for particular equipment should also take responsibility for correct use
of the equipment and the keeping of relevant records.
The following information should be documented in the equipment inventory register:

 name of the equipment
 brand (manufacturer)
 laboratory inventory number (above)
 serial number
 model and year
 location
 date of purchase
 equipment validation (5.5) if relevant
 type of maintenance (contract with an external company, in house, etc.)
 regular preventive maintenance to be performed, and frequency to perform these
activities
 calibration activities
 record of preventive maintenance activities
 record of repairs - parts of the equipment that have been changed or repaired.
5.5 Validation and equipment calibration

The laboratory validates each new piece of equipment. The validation process depends on the
type of equipment and its use in the laboratory.
Where calibration requirements are applicable, the procedure for calibration and
measurement traceability should be followed as specified by the manufacturer’s guide and
documented in the master file.
Reproducibility and accuracy tests are performed, documented, reviewed and approved
before the instrument is used in the testing environment.
1The master file shall include all types of relevant records and maintenance throughout the in-service
period of the equipment. The performance records referred to in j) includes copies of
reports/certificates of all calibrations and/or verifications including dates, times and results,
adjustments, the acceptance criteria and due date of the next calibration and/or verification.
The EO conducts or delegates the required calibrations of the equipment and maintains
records of all interventions on the equipment in the equipment master file.
Use and maintenance of each equipment is based on the manufacturer's instructions.
A standard operating procedure (SOP) on the use, maintenance and safety risks of the
equipment is accessible at the bench in the master file.
The operating manual of each piece of the equipment is retained in the master file.
5.6 Preventive equipment maintenance and repair

The EO for each equipment should develop a documented program of preventive
maintenance, which, at a minimum, follows the manufacturer’s instructions.
Equipment shall be maintained in a safe working condition and in working order. This
includes examination of electrical safety; emergency stop devices where they exist and the
safe handling and disposal of chemical and biological materials by authorized persons. At a
minimum, manufacturer’s schedules or instructions, or both, shall be followed.
Whenever equipment is found to be defective, it shall be taken out of service and clearly
labelled ‘OUT OF ORDER’.
The EO should examine the effect of any equipment malfunction on previous diagnostic
examinations and notify the lab. manager to discuss whether corrective action is required.
Before service, repair or decommissioning of any equipment, the equipment should be
decontaminated.
When equipment is removed from the direct control of the laboratory, its performance must
be verified before it is returned for use.
5.7 Decommissioning
Obsolete or broken equipment is labelled “Out of Service”.
Disposal is to be approved by the Lab. Manager. Relevant disposal form to be completed (see
example in 5.8).
Laboratory staff are responsible for decontaminating the decommissioned equipment before
removal (see example checklist in 5.8).
All related document and records are retained for 3 years.

Procedures Document number
Selection, acquisition, installation and validation of equipment (see also Undefined

chapter 6 Purchasing and Inventory)
Equipment SOPs (calibration, operation and maintenance of significant Location specific SOPs
types equipment)
Forms/Logs
Daily temperature log (incubators, refrigerators, freezers) Location specific Commented [JF3]: P Welihin to draft based on PMGH
model
Equipment (asset) transfer and disposal form –local PHA process needs Location specific
to be followed.
Checklist for decontamination – example for adaptation
LABORATORY
DECOMMISSIONING CHECKLIST UOW.pdf
Role
Equipment Officer- Role description G_10_LQM_Ap_28_A

6. QSE: Purchasing and Inventory Commented [JF4]: This section awaits further review post
PNG trip and debrief with Wendy and Colleen
6.1 Policy
The laboratory management ensures an uninterrupted supply of consumables and/or services are
available to perform all quality laboratory functions.
The laboratory maintains a list of vendors that meet the requirements for the product or service to be
purchased and strives to purchase high quality reagents at a reasonable cost and without bias.
The laboratory has a documented procedure for ordering, receiving, documenting, evaluating and
storing all consumables supplies.
The laboratory has an inventory management system.
The laboratory selects its referral laboratories and is responsible for all tests performed by these
laboratories.
The larger laboratories should consider defining a role and appointment of a stock management officer.
6.2 Reagents and consumables management
The laboratory ensures that the procedures for the purchase, receipt and storage of all reagents
guarantee that the quality of testing is not compromised.
All new lots of reagents are crosschecked and documented with previous lots to ensure reproducibility.
Environmental conditions for the storage of all reagents and consumables are monitored and
documented.
The laboratory maintains a record of all laboratory supplies, including reagents and consumables. This
information includes:
 identity of the reagent or consumable
 manufacturer’s name and contact information for the supplier
 date of receiving and date of entering into service
 condition when received (e.g. acceptable or damaged)
 manufacturers’ instructions
 records that confirmed the reagent's or consumable’s initial acceptance for use
 performance records that confirm the reagents or consumables ongoing acceptance for use.
Reagents that are prepared within the laboratory, such as media, must contain all the above information
as well as the name of the person who prepared it and the date of preparation.
6.3 Selection and evaluation of providers

The laboratory evaluates the providers for the reagents, consumables and equipment. The evaluation
should be conducted against defined criteria which may include:
 value for money
 post-delivery support
 availability
 in-country distribution
 registration of the provider
All the evaluations are recorded and a list of retained providers is established.
6.4 Procurement
6.4.1 Equipment procurement

The laboratory ensures that when purchasing, leasing or acquiring new equipment, it conforms to the
established requirements (for example testing capacities). See chapter 5 Equipment.
6.4.2 Reagents, consumables and materials

Purchasing orders
The orders for purchase of supplies (reagents, consumables and materials) are requested using a
specific form and submitted for section 32 approval by divisional head at National Department of Health.
Receipt of orders
The laboratory confirms receipt of the supplies with the assistance of the Financial & Accounts
department.
The date of receipt is recorded.
The person in the laboratory taking receipt of the supplies crosschecks the information indicated on the
package and accompanying documents with the data of the order.
6.5 Stock management and inventory
The laboratory has a stock management system to ensure consumables are stored under correct
environmental conditions and are used prior to their expiration dates.
A regular inventory stocktake is performed (e.g. monthly).
6.6 Referral laboratories / subcontracting
The laboratory is responsible for all tests performed by another laboratory on patient samples that are
referred. The laboratory should select referral laboratories according to pre-defined criteria such as
competency to perform the requested tests.
It is the Laboratory Manager’s responsibility to designate the laboratories and/or companies with
whom they will subcontract tests or calibration. These will be listed and kept in a folder with all
documents referring to the subcontractors.
Subcontracting of samples may occur under any of the following circumstances:

 test not performed routinely by the laboratory
 instrument breakdown or reagents not available
 workload restrictions
 client requested turnaround time cannot be met.
Where a laboratory subcontracts any part of the calibration of equipment, this work is contracted with
a company complying with the requirements of this quality manual.
The laboratory ensures and can demonstrate that its subcontractor is competent to perform the
activities in question.
6.7 Supporting documents (largely undefined)
Processes ID Code
Selection and acquisition of equipment, reagents, consumables and

service providers
Receipt of supplies
Stock and inventory management
Purchasing
Forms/Logs
List of providers
Medical Supplies Stock Card

Medical Supplies
Stock card.pdf
Stock log
Inventory log
Role
Stock management officer - Role description – draft

G_10_LQM_Ap_33_A
Stock (inventory) Officer role description 12Mar22 draft.docx
7. QSE: Process Management

7.1 Policy
The laboratory has processes for each phase of the sample processing: pre-examination,
examination and post-examination phases, to ensure accurate and reliable testing.
The laboratory has quality control measures to monitor the examination phase of testing.
Processes following the path of workflow
7.2 Sample management
7.2.1 Specimen collection and transport
The laboratory provides written instructions for specimen collection and transport.
The laboratory provides suitable specimen containers.
Specimen transport follows national and international transport regulations and staff
concerned require current IATA dangerous goods certification.
7.2.2 Specimen/sample receiving
The laboratory establishes written specimen/sample acceptance and rejection criteria for each
test offered and provides this information to its customers, as applicable. All
specimens/samples are inspected according to these acceptance/rejection criteria.
The laboratory rejects specimens/samples that are not suitable for processing as per the
relevant section SOP. The requestor is notified of the reason for rejection. If the
specimen/sample is critical and cannot be rejected, the examination is performed and a
notation is made on the report.
In the case of critical specimens/samples, such as one of limited volume, the laboratory
management consults with the requestor to agree which tests have highest priority.
A unique registration (laboratory) number is assigned to each specimen/sample to be analysed.
7.2.3. Specimen/sample handling, preparation and storage
If the specimen needs to be shared for different tests throughout the laboratory and/or storage
purposes, each aliquot (sample) is labelled individually with the unique registration (lab)
number.
Patient samples are stored at 2-6degC for 7 days in buckets that are labelled by day of week.
7.3 Method validation
The methods used in the laboratory, that have been published in scientific reviews or
transmitted by national or international reference centres, have been verified and documented
under the laboratory's conditions and adapted when needed.
7.4 Quality Control
Internal quality control provides assurance that the results of testing are valid.
Laboratory technical staff are trained to review and take appropriate action regarding quality
control data in accord with the relevant Section QC SOP.
Equipment calibration and servicing are monitored (responsibility Equipment Officer role).
The QC results are documented on relevant QC worksheets to create a permanent traceable

record (all technical staff).
If internal QC results are not satisfactory (i.e. nonconforming), patients’ examination results
may need to be withheld dependent on how serious the issue is – management review required.
When problems occur the laboratory investigates, corrects and repeats sample testing (see
chapter 11 Nonconforming Event Management).
7.5 Result validation and reporting
Examination results are reviewed by authorized personnel and agreed upon before validation
and issue. If discrepancies occur the authorized personnel initiates corrective actions prior to
issue.
Corrections following report issue need to be issued as an amended status report. The report
must indicate the prior incorrect result and how that was amended with date and authorisation
details.
The authorized personnel contact the clinician, ward or public health service for further clinical
details, if needed, or to transmit critical results (see list below).
Final reports are signed by the authorized personnel and released to the requestor.
Critical results that require immediate reporting are defined by the individual
laboratory and reflected on to the web entry for that location.
7.6 Records, Sample retention and disposal Commented [JF5]: Drs Joseph Seluia to advise PNG-
specific requirements
This section is referenced from the NPAAC guidelines for retention of Laboratory Records and
Diagnostic Material, 7th Edition, 2018.
Records/specimens/ Location of Record File Minimum Retention Time

diagnostic material
Test request form Laboratory Reception 1 to 3 years
Testing Records Technical Departments
 Work books,
Worksheets and 3 years
result edits
QC/QA Records Technical Departments 36 months
Equipment – Major Life of analyser +3years
Maintenance Records
Personnel Records Laboratory Manager / HR Period of employment

+3 years
Laboratory Methods Technical Departments While current +3years
Procedures
Anatomical Pathology
Copy of original report 10 years for adults
or ability to reprint the Laboratory Reception
information content of 7 years from the age of majority for
an original report minors
Slides
Sections of fixed tissues Anatomy Laboratory 10 years Commented [MOU6]: Will check for our lab
preserved in mounting Commented [JF7R6]: Thanks Dr Joseph
medium
Blocks
Tissue embedded in Anatomy Laboratory 10 years or over Commented [MOU8]: Will check for our lab,
paraffin wax
Unblocked wet tissue 1 month from date of issue of report

from specimen removed Anatomy Laboratory
at surgery
Test Results Computer data base Indefinite from 1990
Cytology / Histology 20 years
fine needle 20 years
aspiration/selected
Abnormals
Unblocked tissue from 3 months from date of issue of report
histological samples Laboratory unless a sumetation is imposed, such
retained at autopsy, or as the need to reunite retained
organs retained at specimen with the body before a
autopsy with consent funeral has been stipulated by NOK
Chemical Pathology
Serum, plasma, other
body fluids specimens Laboratory Section 7 days
Cytology
Copy of original report 10 years for adults
or ability to reprint the Laboratory Reception
information content of 7 years from the age of majority for
an original report minors
Exfoliative non-
gynaecological cytology Laboratory 10 years
& fine needle aspiration
(FNA) slides & cell
blocks.
Gynaecological (cervical)
cytology slides Laboratory filing cabinets 10 years Commented [MOU9]: Need to check as storage will be an
Residual specimens of issue for both cytology and histology
sputum, urine & other 7 days

body fluids following
cytology slides
Specimens received in
liquid based fixative 1 month
Haematology
Blood films
(1) Clinically significant 1 year
(2) Not clinically 1 month
significant
Blood specimens , other 7 days mainly for purpose of
than 1 and 2 identification and traceability, noting
that repeat testing may not be
technically reliable after 2 days
Bone marrow slides and 10 years for adults
reports 7 years from the age of majority for
minors
Immunohaematology
(Blood Transfusion)
Samples 7 days
Laboratory records of
blood products made 20 years
and issued
Laboratory records of all
immunohaematology 20 years
testing
Microbiology
Slides Slides
(1) Wet preparations (1) Wet preparations
(2) Gram stains (2) Gram stains
(3) Ziehl-Neelsen stains (3) Ziehl-Neelsen stains
(4) Other stained slides (4) Other stained slides
Isolates
(i) Clinically significant 5 days
(considered to be all
blood culture and sterile
site isolates including
any cultured isolate
which is reported by the
laboratory as a pathogen
in contrast to
contaminants and
commensal flora) Discard
(ii) Not clinically
significant
Urine specimen for 3 days from date of issue of report,
microbiological under refrigeration
examination
For disposal of samples, refer to Section 4, Facilities and Safety.
7.9 Supporting documents (undefined)
Procedures ID Code
Analytical, Quality Control, Equipment calibration SOPs Local laboratory documents
Forms/Logs
8. QSE: Assessments
8.1 Policy
The laboratory performs ongoing quality assessments such as:

 periodic review of examination requests, suitable methods and sampling requirements
 monitoring and evaluation of customer feedback, staff suggestions and impact of
potential failures on examination results and customer expectations
 monitoring of quality indicators, corrective actions undertaken, and follow-up
 participation in proficiency testing program (EQA) and management review of the
corresponding reports
 participation in internal and external audits
The laboratory strives to continuously improve the quality of laboratory performance, the
effectiveness of the quality management system and the reliability of test data.
The laboratory does its best to identify and resolve any nonconformity that may affect
laboratory performance and patient outcome.
8.2 Internal assessments
Note: until a laboratory has fully implemented standard operating procedures for
particular processes, it is not useful to conduct internal auditing of the same processes. The
initial LQM focus should be on developing the SOPs, training of staff and assessment of
competency.
8.2.1 Internal Audits

During internal audits, information is gathered about:
 processes and operating procedures
 staff competence and training
 equipment
 environment
 handling of samples
 quality control and validation of results
 recording and reporting practices.
The findings are compared with the laboratory’s internal policies and to the chosen national or
international standard. Any breakdown in the system or departure from procedures should be
identified. Any gap or nonconformity in performance shows if the policies and procedures that
the laboratory has set require revision or are not being followed.
Each laboratory is to determine its internal audit schedule annually at management review and
document this on an Internal Audit Schedule form. In general, a monthly audit is required
examining the function of one section. Section OICs will perform the audits for sections other
than their own.
All audit reports MUST be documented and presented at the Section Laboratory Meeting by
presentation from the Auditor. The audit report must include an action plan and it is the
responsibility of the OIC of the section audited to follow up on changes required.
The Laboratory Manager is responsible for training of auditors.

8.2.2 Review and follow up of corrective actions
All corrective actions undertaken in the laboratory will be reviewed and their follow up
evaluated.
This is described in the chapter 11 Nonconforming Event Management.
8.2.3 Staff suggestions

All staff is encouraged to offer suggestions for improvement of any aspect of the laboratory.
These suggestions are recorded, evaluated and implemented if useful. Feedback on the
suggestions implemented is provided to the staff.
8.2.4 Review of requests, methods and sampling requirements

Requests are systematically reviewed to evaluate the appropriateness of the methods used for
the test required.
The required sample volume and general sampling requirements are also reviewed every year
to ensure that samples are collected properly and in the correct volume needed for the best
performance of the test.
8.3 External assessments
8.3.1 External Quality Assessment/ Proficiency testing

Proficiency testing serves as a tool for quality improvement in the laboratory. One of the major
benefits is identifying performance issues and correcting them.
EQA programmes are selected to assess all areas of laboratory testing.
Each laboratory is to maintain a List of EQA enrolled programmes that is updated annually.
Microbiology sections that perform bacterial culture and AST are to enrol in the PPTC EQA
program.
8.3.3 External audits
Note. At the time of this edition, regular external laboratory auditing has not been
implemented in PNG and pends a legislated national approach to laboratory accreditation
and laboratory standards.
When third party international organisations conduct external audits, then such audit reports
require local management review and sharing with staff. Necessary corrective actions should
be determined, implemented effectively and documented
Procedures ID code
Internal audit procedures Undefined
Forms/Logs
List of enrolled EQA programmes (annual uodate) Local

document
Internal audit schedule Local
document
EQA results and management review Commented [JF10]: JF to finalise
G_90_WS_10_A
External quality assurance assessment and management review 25Feb22 Draft.docx
9. QSE: Personnel
9.1 Policy
The laboratory recognizes that its most important resource is its staff (personnel).
The laboratory management defines staff educational requirements and competency

qualifications necessary for conducting laboratory procedures.
The laboratory ensures that all staff (temporary, permanent, students, etc.) respect the
confidentiality of personal laboratory data. A staff or student member who fails to do this
may risk termination of employment.
The laboratory ensures that all staff respect the laboratory rules concerning health, safety and
security.
The laboratory ensures that all staff have received COVID-19 and hepatitis B vaccinations and
are up-to-date with tetanus vaccination.
Figure: Essential personnel management components (WHO LQMS Training Module:

Personnel )2
9.2 Recruitment and orientation

Recruitment:
- laboratory management strives to ensure recruitment is
unbiased and closely follows the requirements of the
hospital/provincial health authority as relevant
- laboratory works with the Human Resources Department
to ensure education qualifications and references of job
applicants are checked and to ensure legal
contracts/agreements are signed by all parties prior to
employment or within a set period
- job description for each position should include the specific
authorised responsibilities for the person
Orientation is to be completed within first week of employment. Checklist completed and filed
in personnel file (responsibility Lab Section Manager).
Safety orientation occurs before an employee is assigned to duties. Checklist completed and
filed in personnel file. (responsibility Biosafety Officer).
New staff are trained comprehensively on all policies and procedures in the department that
apply to their job description and assignments (responsibility Lab Section Manager). Three
checklists must be completed – Orientation, Biosafety and Code of Ethics.
2Reference: WHO LQMS training modules – module 2, Personnel: includes personnel management,
competency and training – 30 minutes duration [Register as external partner for free access to 5
existing training modules] https://extranet.who.int/hslp/training/course/view.php?id=122
Role descriptions for Quality, Equipment, Stock control and Biosafety Officers include
additional authorised responsibilities.
Competency of each new staff member is assessed before permitting to perform unsupervised
testing or reporting. This initial competency assessment may reveal the need for specific
training of the employee.
9.3 Staff member personnel files
A separate folder (e.g. ring folder) is

maintained for each staff member
(temporary, permanent or trainee) for lab.
reference (photo example right).
The staff folders must be held in a controlled

access area of the laboratory – e.g. the lab
manager’s office.
The orientation checklist, training records,

competency assessments, continuing
education training record including certificates, job descriptions and annual performance
development review (PDR) records are stored in the folder. Records of staff qualifications can
also be included (diplomas, training certificates).
9.4 Training and competency assessment
The laboratory provides training for all personnel, which

includes the quality management system, assigned work
processes and procedures, the laboratory information system,
health and safety, ethics and confidentiality.
Staff competencies cover technical and practical skills and general knowledge necessary for
performing specific job tasks.
Competency assessments schedules or programs for each staff should be established by the
laboratory.
Training and competency records: the laboratory maintains an individual record for each
staff member in their file that documents training and competency against all significant
elements of laboratory practice (responsibility Lab Section Manager).
Qualitative assessments of competency

As an interim until more wide ranging objective assessments can be done, competency levels
of staff are assessed qualitatively by the manager annually and maintained on a register
similar to this example from PMGH Microbiology:
(https://drive.google.com/drive/folders/1xd298chqq6Jo0y7Dgz8OFYHfuo0LAP3E?usp=sharing).
The following competency levels are assigned:

C0- minimal experience, C1- requires supervision, C2- competent, C3- can assess others
Objective competency assessments

These measure staff competency against an SOP by a range of reading, observation,
demonstration and problem solving tasks. It aims to identify problems with staff performance
and to correct these issues before they affect patient care.
The staff member should be given advance warning of the assessment so that he/she can
prepare by reading the SOP(s) and reviewing other resources.
If the assessment highlights improvements required, then an action plan involving further
training should be agreed with timely follow-up.
9.5 Continuing education and professional development
A continuing education program is organised for the professional

development of staff by the lab manager, assisted where possible by external
educators. A program is displayed and updated weekly.
Where relevant, staff should participate in continuing education and regular professional
development.
Records are kept for all training events, listing the presenter, date, topic and the attendees
(see Continuing Education event attendance record).
9.6 Personnel performance appraisal
Each staff is given the opportunity for an annual appraisal conducted by the
laboratory manager.
Issues to discuss can include:

- actions arising out of the previous year’s appraisal
- review of the job description, education and support
- work achievements, what’s working well, individuals to be recognised
- work challenges and concerns,
- service, operation and individual professional improvement areas
- work goals and priorities & potential challenges
- Following discussion : agreed employee actions ; agreed manager actions
The completed signed appraisal is retained in the staff member’s personnel file.
9.7 Non-permanent personnel
Students, post graduate trainees and those on attachment must follow the general laboratory
and safety orientation procedures for induction into the laboratory (see checklists below).
A baseline assessment post orientation should be offered to establish their understanding of

basic laboratory safety.

Information sheets ID Code
Human resources (personnel) requirements G_10_Info_9_A
Procedures
Recruitment – refer to local (PHA/Hospital) procedures Local documents
Forms/Logs
Orientation checklist– example for adaptation G_10_Info_9_A
Biosafety orientation checklist – example for adaptation G_10_Info_9_A
Code of ethics statement Commented [JF11]: P Welihin agreed to review these

three
Code of ethics
11Mar22.docx
Training and competency record (individual) undefined
Continuing education event attendance record

G_10_WS_1_A Staff
Continuing Education meeting attendence sheet.docx
Public Service Staff Appraisal form

Public Service Staff
Appraisal document.docx
Competency assessment checklists
Disc AST Testing and QC Competency assessment example

G_90_COMP_1_A
References
Cumitech 39 Competency Assessment

Cumitech 39
Competency assessment.pdf
AIMS Competency Standards for Laboratory Scientists

AIMS
Competency-based Standards for Medical Scientists uploaded 6.9.12.pdf
10. QSE: Customer Service

10.1 Policy
The laboratory management is dedicated to providing quality and timely service to all
customers, both internal and external. The laboratory management commits to providing
adequate resources to meet customers’ requirements and to provide an on-going program for
continual improvement.
10.2 Customers satisfaction measurement

Customer surveys are implemented. The objective is to assess the satisfaction of the main
customers: patients, clinicians and public health institutes. The analysis of survey results leads
to implementation of corrective actions where needed.
10.3 Complaints management

Complaints received from outside the laboratory (i.e.: doctors, pathologist, specialists, patients)
are managed in order to lead to corrective or preventive actions (also refer to chapter 11
Nonconforming Event Management, and chapter 12 Continual Improvement).
The objective is to ensure continuous improvement of the quality system by taking into account
the customers' concerns. The claim management will facilitate tracking and investigating
potential non-satisfaction of customers.
10.4 Complaints from staff

Written complaints received from staff will be reviewed by the laboratory management to
determine actions required.
These may include:
- Discussion of the complaint with the complainant to clarify or respond
- Notification of the complaint as a non-conformance report so that corrective actions if
required can be documented and signed off by management
- Feedback to the complainant once the non-conformance report is closed
Forms/Logs Document ID
Customer survey form/questionnaire Undefined
Customer complaint logbook Undefined
Customer complaint / feedback G_10_WS_1_A
G_10_WS_1_A
Complaint Feedback Report 25Feb22 Draft.docx
11. QSE: Nonconforming Event Management – draft content for future

review
11.1 Policy
The laboratory is committed to the identification, documentation, correction, and prevention

of nonconforming events in all aspects of the quality management system including pre-
examination, examination and post-examination processes.
Procedures are in place that:

 designate the individuals responsible and actions necessary for handling
nonconformities;
 ensures that each nonconforming event is documented, recorded, and reviewed at
identified intervals, a root cause analysis performed, and that corrective action is taken
and documented;
 define when testing procedures and data reporting will be withheld due to
nonconformities and when, and under what conditions, examination can resume;
 defines the steps taken when examination data resulting from a nonconforming event
has already been released.
11.2 Corrective Actions
All nonconforming events (from occurrence reports, claims, audit reports, patient/customer
complaints, failed proficiency testing, etc.) are recorded, tracked, trends identified, and root
cause analysis performed. The appropriate corrective actions are taken.
The results of an occurrence assessment are communicated to management and become part
of periodic management review.
The objective is to ensure continuous improvement of the quality system.
The Quality Manager will assign the Template with a unique number.
- Quality non-conformances are denoted with Q#-year, for eg: Q01-2012, for the first quality
related incident for2012.
- For Safety related incidences, they are denoted by S#-year, e.g.: S01-2012, for the first Safety
related incident for 2012.
The Quality manager will then give the staff member or OIC the template to fill in. All staff
members are authorized to fill in the Templates.
The Laboratory manager is responsible for maintaining a list of all incidences that occur
within the laboratory.
The OIC for that section will report incidences at the Section Laboratory meetings.
All incidences will be discussed with senior management and OICs of all sections at the
Management review meeting.
Some examples of quality non-conformances are:

 Anything that directly affects a patient report
 Wrong reporting
 If kits not available because not ordered in timely manner
 QA/QC – QAP outside of range
 SOP/worksheet/form not followed
 Incorrect SOP/worksheet/form followed
 QA/QC not within range
 Negative control contamination
 Positive control not within correct range
 Orders for consumables not placed in time
 Equipment/Machine breakdown (for example: Fridge/Freezer/cool room)
 Incorrect samples tested
 Samples lost in transit
 Samples not processed in the correct time frame
 Sample processed using old protocol
 Regular non-attendance to compulsory meeting
Some examples of Safety Incident reports are:
 Chemical splash
 Chemical spill
 Sample containment failed (spill, dropped etc…)
 Needle stick injury
 Sharps injury
 Failure to wear appropriate PPE
11.4 Assay Validation and Non- conforming Work
OICs must review all internal quality assurance measures (negative/positive controls,) and
authorized the release of patient results. Similarly to an incident report, a report must detail
what happened, how, and how to prevent future occurrences.
Each section has a designated folder for recording problems and corrective action taken.
These folders are accessible and labelled for all staff to identify as per section.
11.5 Corrective and Non-conforming Actions

OICs must review all non-conforming events (from occurrences, audit reports, failed
proficiency testing, patient/customer complaints, etc) are recorded and root cause analysis
performed.
Procedures ID code
Forms/Logs
To be defined
Non conformance
report form.docx
Non-conformance incident report
To be defined
Nonconformance
log sheet.docx
Non-conformance incident log
12. QSE: Continual Improvement– draft content for future review

12.1 Policy
The laboratory continuously improves the effectiveness of its quality management system and
its processes, as stated in its quality policy and quality objectives.
A management review is performed annually to evaluate the laboratory’s quality management

system, evaluation activities, corrective actions and preventive actions.
The laboratory develops an action plan according to improvement needs quarterly and
monitors the effectiveness of the actions undertaken.
12.2 Quality indicators
The laboratory establishes quality indicators to monitor and evaluate performance of its
processes quarterly.
List here the quality indicators.
For example:
 the traceability of the sample from the reception to the storage after testing;
 the turnaround time from reception of the sample to the hand-out of the report;
 the reliability of the competence of the technical staff (average of test competency
assessments for determined tests).
These indicators are regularly monitored as for their concordance with the defined objectives
and the activities established in the laboratory. These indicators are presented during the
annual management review.
12.3 Management review
The Laboratory Senior staff management and OICs will meet at least annually to conduct the
management review. This is to ensure that the organization and the activities of the laboratory
remain appropriate and efficient. Therefore, it allows the evaluation and continuous
improvement of the efficiency of the quality system of the laboratory. The elements reviewed
are related to the quality system management.
Elements of entry of the management review (by section as appropriate):

 quality objectives of the past year
 quality indicators
 activity by section – number of tests
 occurrences and nonconforming events recorded
 customer complaints report
 customer satisfaction survey reports
 internal audit reports
 proficiency testing reports
 corrective/preventive actions and follow up
 changes in work load or type of work
 all pertinent factors: resources, budgeting, future activities, etc.
Elements of output of the management review:

 actions for improvement
 definition of the quality objectives for the next year
 establishment of new quality indicators in concordance with the new quality objectives
 improvement of the quality management system.
12.4 Preventive action
The laboratory reviews the data and implements preventive actions allowing the laboratory to
anticipate eventual nonconforming events in its activities. A follow up of the actions
implemented for improvement is ensured in the same way as described in chapter 11
Nonconforming Event Management.
12.5 Example quality indicators
 Turnaround time -described as the time taken from the receipt of the specimen to the
issue of the report
 The traceability of the specimen from the reception to the storage after testing
 The reliability of the competence of the technical staff (average of test competency
assessments for determined tests
Procedures ID code
Quality indicators (including management and use)
Management review
Evaluation activities (see chapter 8 Assessments)
Forms/Logs
Review logs
Preventive actions
13. QSE: Documents and Records

13.1 Policy
The laboratory ensures that documents and records are managed from creation and receipt to
archival and destruction, according to national laws, local regulations and international
standards. For background review Document Control and Records Management Information sheet
G_10_Info_5_A
13.2 Documentation management
The Fleming Fund Program Document Control Officer and local laboratory quality officers are
responsible for document management procedures as specified in the Document Control
Procedures SOP G_10_LQM_Ap_20_A.
Staff is not permitted to make temporary amendments to documentation without the prior
consent of the Quality Officer.
When new or modified policies, processes and procedures are instituted, staff require
retraining.
The laboratory quality manual and other controlled documents are reviewed once every two
years. The responsibility for the annual review lies with the Quality Officer and the Laboratory
manager.
The document control officer or local quality officer is responsible for the distribution of new
printed documents, retrieval of old printed documents and maintenance of records of
amendments.
13.3 Documents and records control
All documents are uniquely identified. Date of issue, revision version, total number of pages and
authorizing signatories are included in the document.
A document control log is maintained on the secure master file (Google drive) document
registry, identifying the current valid versions and their distribution. This is currently used for
documents that are applicable across all laboratories.
Master document registry:

https://docs.google.com/spreadsheets/d/1k6XC4WO-Qj9NqOvOYd2nKLg0Py8-
NVDzNYJVMD5i_QQ/edit#gid=587599536
Google Drive document folder structure:
https://drive.google.com/drive/u/0/folders/1yPWQUonYwOMWFyXjd86f_CtvSH1dwRFp
Local laboratory documents are to be registered and approved locally using the same processes.
13.4 Archiving
The document control and quality officers are responsible for the proper archiving of
documents and records.
The laboratory respects the national regulations or legislations concerning the retention time
of all records.
A copy of an obsolete document is kept within the “Obsolete document” Google drive folder to
provide a means for review if the situation arises.

Procedures ID Code
Document Control Procedures G_10_LQM_Ap_20_A
Information sheet
Document Control and Records Management G_10_Info_5_A
Document templates (examples)
Test SOP template (CPHL FFCG) G_10_TEMP_2_B
Worksheet G_10_TEMP_3_A
Role description G_10_TEMP_4_A
Information sheet G_10_TEMP_5_A
Competency assessment G_10_TEMP_6_A
Job Aid G_10_TEMP_7_A
Quality Manual Appendix G_10_TEMP_8_A
Role description
FF Document Control Officer- Role description G_10_LQM_Ap_28_A

14. QSE: Information Management

14.1 Policy
The laboratory has access to the data and information needed to provide a service that meets
the needs and requirements of internal and external customers. The laboratory information
system (LIS) is both computerized and paper based and provides for the collection, processing,
recording, storage, and retrieval of data, and has documented procedures in place to ensure the
confidentiality of patient information and the security of the data during each step of the
process.
14.2 Information system – Security
The computer-based information system is managed locally under the authority of the
respective Scientific Officer in Charge.
The information system used in the laboratory is managed by the hospital IT Department and
are responsible for installing on each computer a backup and antivirus system, and has
procedures in place to meet national and international needs for data protection and to restrict
unauthorized access.
Hard cover registers are used for paper-based records. These records are restricted for within
laboratory use only. Accessibility of information by non-laboratory staff are by request
approved by management.
14.3 Confidentiality
The personnel (temporary, permanent, student, etc.), whatever the duration of their contract,
will sign a confidentiality agreement.
The laboratory has a secure process for archiving and/or data disposal; refer to chapter 13
Documents and Records.

Procedures ID Code
Transmission of results
Informatics system maintenance and backup
LIMS down-time procedures
Forms/Logs
LIMS down-time log
Backup log
Confidentiality agreement
15. Appendices
Standard microbiology request form PMGH Goroka G_10_LQM_Ap_8_B

Document Control Procedures G_10_LQM_Ap_20_A
Organisational Charts, Human health and Animal health G_10_LQM_Ap_25_C
Biosafety Officer - Role description G_10_LQM_Ap_26_A
Quality Officer- Role description G_10_LQM_Ap_27_A
FF Document Control Officer- Role description G_10_LQM_Ap_28_A
Monthly Laboratory Safety Audit checklist G_10_LQM_Ap_29_A
Laboratory incident report form G_10_LQM_Ap_30_A
Visitor log form G_10_LQM_Ap_31_A
Equipment Officer- Role description G_10_LQM_Ap_32_A

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National Department of Health Central Public Health Laboratory in

conjunction with the Fleming Fund Country Grant (2020-22)

Title: Laboratory Quality Manual

Reviewed by: J Joseph, G Ak, S Mabone Issue date:

Review Period: Annual

Changes to the last authorized version (amendment record:

Version Date of issue Changes

In memorandum Professor Evelyn Lavu, 1963 - 2021, Director of

Notes from John Ferguson

Blue highlight indicates a generic text suitable for all labs

24/11/21- Section 7 (process management) edited ready for review

25/2/22 Further amendment to the working copy

17/3/22 post further review with Dr Mabone

24/3/22 further streamlining

Distribution and Document Control

The online version of this manual is the controlled document.

Certification statement to be recorded on printed title page:

Abbreviations and acronyms

BSL Biosafety Level

8.2.4 Review of requests, methods and sampling requirements .........................................................................................29

1. Introduction to the Quality Manual

The quality management system aims primarily at achieving customer satisfaction by

1.1 Mission statement

1.2 Vision statement

To improve the quality of work performed in medical laboratories by participating in

1.4 Information about individual public medical laboratories

 Compliance with ISO15189  Timely, accurate and appropriate

Teamwork and competence Integrity

 A strong collaborative approach  Management that avoids conflicts

Laboratory management ensures the following:

3.2 Conflict of interest and code of ethics

3.3 Organization chart

3.4 Internal communication

Example - A Clinician complaint regarding missing test results -

3.5 Personnel responsibilities

The CPHL Manager is responsible to Public Health Deputy Secretary, NDOH.

Overview of tasks by role

Scientific Officer in Charge of section

3.6 Supporting documents

Procedures Document number

Sectional Quality Officer role description G_10_LQM_Ap_27_A

Biosafety Officer role description G_10_LQM_Ap_26_A

Equipment Officer role description G_10_LQM_Ap_28_A

Staff meetings G_10_Info_4_A

4. QSE: Facilities and Safety

Each laboratory requires a separate biosafety noticeboard in a prominent location.

Fire extinguishers must be maintained and in-date.

A monthly risk assessment is conducted by the biosafety officer to identify housekeeping,

Safety incidents/accidents are documented and actioned accordingly by management. Incident

A description of safety rules is available on this Laboratory Biosafety Information Sheet

A separate clean staff area maintained for tea-room, bathroom facilities.

4.4 Working environment

4.5 Staff biosafety educational resources

Laboratory biosafety officers should complete these trainings.

CDC Lab Safety Courses 1. Fundamentals of Chemical Fume Hood Safety

WHO Good Microbiological Practices and 1. Autoclaves

4.6 Waste disposal

4.6 Supporting documents

Procedures (SOP) Document number

Safety manual (WHO Biosafety Manual 4th Edition 2020) G_10_EX_001_A

Monthly Laboratory Safety Audit checklist G_10_LQM_Ap_29_A

Use and Maintenance of Biological Safety Cabinets G_90_SOP_8_A

Waste decontamination and management G_10_SOP_22_A

Laboratory cleaning and disinfection G_10_SOP_16_A