6.0 Terms of Reference for National POCT Committee (NPC) during Emergency &
Disaster
a) To assist in preparedness of POCT management during emergency and disaster.
b) To provide related consultation and technical input on POCT devices utilised
during emergency and disaster.
c) To offer guidance on standardisation of POCT devices.
d) To ensure that the masterlist of POCT devices / supplier registry is available and
updated.
e) To assist in the procurement of relevant POCT devices.
f) To advise on the appropriate use of POCT tests and device utilisation.
nd
National Policy & Guidelines For Point of Care Testing (2 Edition) 49
7.0 REFERENCES
1. Australasian Association of Clinical Biochemists (AACB) (2010), Guidelines for
Conducting Quality Control and External Quality Assurance for POCT; New South
Wales.
2. Australasian Association of Clinical Biochemists Point of Care Testing Committee
(2019), Point of Care Testing (Position Statement); New South Wales.
3. Center for Excellence in Disaster Management and Humanitarian Assistance (2019),
Malaysia: Disaster Management Reference Handbook; Hawaii.
4. Center For Hazards and Risk Research at Columbia University (2005), Malaysian
Natural Disaster Profile. Available from:
https://www.Ideo.columbia.edu/chrr/research/profiles/pdfs/malaysia_profile1.pdf
5. College of Pathologists, Academy of Medicine of Malaysia (2005), Guidelines on
Retention of Pathology Records and Materials, Part 1 (Version 1/2005), Malaysian J.
Pathol 2005; 27(1): 51-56.
6. Holt H & Freedman DB (2016), Internal quality control in point-of-care testing:
where's the evidence? Ann Clin Biochem. 2016 Mar; 53(Pt 2):233-9.
doi: 10.1177/0004563215615148.
7. Howerton D, Hearn TL, Onorato IM, Branson BM, Bock N et al (2020), Quality
Assurance Guideline for Testing using the OraQuick® Rapid HIV-1 Antibody
Testing; Centers for Disease Control and Prevention (CDC).
8. Ibrahim MS & Fakhru’l-Razi A (2006), Disaster Types in Malaysia: An Overview,
Disaster Prevention and Management, 15(2):286-298. doi:
10.1108/09653560610659838.
9. International Organization for Standard (2016), ISO 22870:2016: Point-of-Care
Testing (POCT) - Requirements for Quality and Competence (ISO/TC 212).
10. Irish Medicines Board, Clinical Governance of Point-of-Care Testing: The Role of the
Point-of-Care Testing Committee. Medical Devices Newsletter, Vol. 1, No. 15, 2006.
11. Medicines and Healthcare Products Regulatory Agency (MHRA) (2021),
Management and Use of Point of Care Test Devices; London.
12. Ministry of Health Malaysia (2010), Departmental Policy of Pathology Services,
Medical Development Division (MOH); Putrajaya.
13. Mooney C, Byrne M, Kapuya P, Pentony L, la Salle B, Cambridge T et al (2019),
Point of care testing in general haematology. Br J Haematol. 2019; 187(3):296–306.
14. National Academy of Chemical Biochemistry (NACB) (2006), Laboratory Medicine
Practice Guidelines: Evidence-Based Practice for Point of Care Testing; Washington
DC.
15. NHS England and NHS Improvement (2022), Point of care testing in community
pharmacies: Guidance for commissioners and community pharmacies delivering NHS
services, Version 1; London.
nd
National Policy & Guidelines For Point of Care Testing (2 Edition) 50
16. Nichols JH, Alter D, Chen Y, Isbell TS, Jacobs E, Moore N, Shajani-Yia Z (2020),
AACC guidance document on management of point-of-care testing. [Epub] J Appl
Lab Med June 4, 2020, doi:10.1093/jalm/jfaa059.
17. Stürenburg E & Junker R (2009), Point-of-care testing in microbiology: the
advantages and disadvantages of immunochromatographic test strips. Dtsch Arztebl
Int. 2009 Jan; 106(4):48-54. doi: 10.3238/arztebl.2009.0048.
18. Venner AA, Beach LA, Shea JL, Knauer MJ, Huang Y, Fung AWS, Dalton J,
Provencal M, Shaw JLV (2020), Quality assurance practices for point of care testing
programs: Recommendations by the Canadian society of clinical chemists point of
care testing interest group. Clin Biochem. 2021 Feb; 88:11-17.
doi: 10.1016/j.clinbiochem.2020.11.008
19. World Health Organization (WHO) (2005), Guidelines for assuring the accuracy and
reliability of HIV rapid testing: applying a quality system approach. World Health
Organization. https://apps.who.int/iris/handle/10665/43315.
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National Policy & Guidelines For Point of Care Testing (2 Edition) 51
8.0 ABBREVIATIONS
AMO Assistant Medical Officer
CE Conformité Européenne, meaning "European Conformity"
CPRC Crisis Preparedness and Response Centre
DCD Disease Control Division
DHO District Health Office
EQA External Quality Assurance
FBC Full Blood Count
FDA US Food and Drug Administration
FHDD Family Health Development Division
FMS Family Medicine Specialist
HOU Head of Unit
ICT Information & Communication Technology
IQC Internal Quality Control
LIS Laboratory Information System
MKA/K Makmal Kesihatan Awam/Kebangsaan (National Public Health Laboratory)
MLT Medical Laboratory Technologist
MO Medical Officer
MOH Ministry of Health
MSQH Malaysian Society for Quality in Hospitals
POCT Point-of-Care Testing
NPC National POCT Committee
PHPC Public Health POCT Committee
QAP Quality Assurance Programme
SHD State Health Department
SO Science Officer
SOP Standard Operating Procedure
TAT Turnaround Time
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National Policy & Guidelines For Point of Care Testing (2 Edition) 52
9.0 GLOSSARY
POCT Advisor A person who provides advisory support on POCT services
through regular contact with POCT Committees and Operators.
Concession company Company with the right to operate a specific business within the
government's jurisdiction subject to certain terms.
POCT Coordinator A person who is responsible in organising, managing and
planning POCT events or activities to ensure POCT services run
smoothly and effectively.
POCT Device Equipment used outside the laboratory to perform medical
diagnostic testing.
Person-in-Charge A person who is responsible in leading and managing POCT
activities to achieve the highest possible standards of excellence
in all its activities.
POCT Operator Any person who is trained and competent in handling a POCT
device whether it is used directly to produce results, for
maintenance or for quality control. This includes clinicians,
nursing staff, healthcare assistants and healthcare scientists.
Supplier A person or organisation that provides and delivers products /
services to the requester.
nd
National Policy & Guidelines For Point of Care Testing (2 Edition) 53
10.0 APPENDICES Appendix I
BPOCT001A/2022
REQUEST FOR APPROVAL OF NEW POCT TEST/CHANGE OF POCT DEVICE FORM
All point-of-care testing must be evaluated and approved by (NAME OF HOSPITAL) POCT Committee to
ensure that it meets institutional goals as well as state and national regulations. To expedite your request,
please complete all information below. Please attach all pertinent documents (brochure/pamphlet/journals etc)
and supplier/vendor profile to this form and submit to:
(NAME OF HOSPITAL) POCT Coordinator, Attn: ….……………………….....................................
Test and device requested (Please tick)
1)
Device (please specify): Quantity:
Test (please specify):
2) Justification
(To be filled if requesting for change of POCT device)
Name(s) of current device(s):
3) Method of procurement:
Reagent rental
Asset
4) POCT device/analyser/rapid test kit specifications*
Easy to use: YES / NO
Size (dimension):
Portability: YES / NO
Maintenance requirement: YES / NO
Storage temperature:
Internal Quality Control availability: YES / NO
*Where applicable
5) Reagent/strip/consumable specifications*
Ready to use: YES / NO
Shelf-life duration:
Onboard stability duration:
Storage temperature:
Internal Quality Control availability: YES / NO
*Where applicable
6) Location of POCT device
Space availability:
Electrical requirements:
Network requirement (if applicable):
Other requirements:
7) Estimated annual test volume:
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National Policy & Guidelines For Point of Care Testing (2 Edition) 54
8) Personnel
Estimated number of potential users:
Job categories of potential users:
9) Estimated cost (inclusive of verification study)
One-off
1 Device cost
2 Renovation (if any)
Total
Operational cost (Annually)*
1 Reagents
2 Calibrators
3 Internal Quality Control Material
External Quality Assurance
4
Programme
5 Consumables
6 Maintenance
7 Training
Total
*Where applicable
Requester:
Name: Signature and Stamp:
Designation:
Department:
Telephone No.:
E-mail:
Date:
For POCT Committee Use Only Reference
(To be completed in 2 weeks after receipt) Number
Date of receipt: Signature and stamp:
Name:
Designation:
Date of evaluation: Signature and stamp:
Name:
Designation:
Request Approved: YES / NO
Comments:
Name: Signature and stamp:
Designation:
Date:
nd
National Policy & Guidelines For Point of Care Testing (2 Edition) 55
Appendix I (Example)
BPOCT001A/2022
REQUEST FOR APPROVAL OF NEW POCT TEST / CHANGE OF POCT DEVICE FORM
All point-of-care testing must be evaluated and approved by (NAME OF HOSPITAL) POCT
Committee to ensure that it meets institutional goals as well as state and national regulations. To
expedite your request, please complete all information below. Please attach all pertinent documents
(brochure/pamphlet/journals etc.) and supplier/vendor profile to this form and submit to:
(NAME OF HOSPITAL) POCT Coordinator, Attn: Dr Ahmad Kamal
1) Test and device requested (Please tick)
√ Device (please specify): i STAT Quantity: 1
√ Test (please specify): Blood Gases & Electrolytes
2) Justification
To be used in participated international medical event i.e., Motor GP (yearly event) and
Critical Patient Escort and Retrieval (CPERT) ambulance service.
(To be filled if requesting for change of POCT device)
Name (s) of current device (s): Not applicable (NA)
3) Method of procurement:
√ Reagent rental
Asset
4) POCT device/analyser/rapid test kit specifications*
Easy to use: YES / NO
Size (dimension): 7.68 (W) x 23.48 (L) x 7.24 (D) in cm
Portability: YES / NO
Maintenance requirement: YES / NO
Storage temperature: Room Temperature
Internal Quality Control availability: YES / NO
*Where applicable
5) Reagent/strip/consumable specifications*
Ready to use: YES / NO
Shelf-life duration: 3 to 5 months
On board stability duration: 2 weeks to 2 months
Storage temperature: Room Temperature
*Where applicable
6) Location of POCT device
Space availability: Minimal space is needed
Electrical requirements: Battery operated
Network requirements (if applicable): Not required
Other requirements: Nil
7) Estimated annual test volume: 1500
8) Personnel
Estimated number of potential users: 50 staffs
Job categories of potential users: CPERT ambulance service personnel,
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National Policy & Guidelines For Point of Care Testing (2 Edition) 56
Medical Assistant
9) Estimated cost (inclusive of verification study)
One-off
1 Device cost RM 41,000.00
2 Renovation (if any) N/A
Total
Operational cost (Annually)*
1 Reagents RM 60,000.00
2 Calibrators N/A
Blood gas & RP:
3 Internal Quality Control Material
RM7200 for 3 boxes (2 levels)
4 External Quality Assurance Programme N/A
Printer paper : RM67/pkt
5 Consumables
Ultralife Battery: RM546 for 2 boxes
6 Maintenance FOC
7 Training FOC
Total RM 65,013.00
*Where applicable
Requester:
Signature and
Name
Dr Alina Ahmad Stamp:
Designation Emergency Physician UD56
Department Emergency and Trauma
Telephone No. 03-33338890 ext 3452
E-mail [email protected]
Date: 20th March 2017
For POCT Committee Use Only Reference
(To be completed in 2 weeks after receipt) Number 2/2017
th
Date of receipt: 20 March 2017 Signature and stamp:
Name: Dr Alidah Hashim
Designation: Chemical Pathologist UD54
th
Date of evaluation: 30 March 2017 Signature and stamp:
Name: Pn Halimah Daud
Designation: Science Officer C48
Request Approved: YES / NO
Comments:
Requested test is justified. Running budget is borne by the Department. Technical evaluation
findings show good performance and user-friendly device.
Signature and
stamp:
Name: Dr Farid Kamil
POCT Coordinator, Head of
Designation: Department of Pathology, HTAR
th
Date: 20 April 2017
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National Policy & Guidelines For Point of Care Testing (2 Edition) 57
Appendix II
BPOCT001B/2022
EVALUATION CHECKLIST FOR NEW POCT TEST / CHANGE OF POCT DEVICE
(To be filled up by the POCT Committee)
Name of requester :
Location and name of facility :
Proposed POCT Device :
Proposed Test :
Date of Request :
Remark /
No Criteria Concerns Yes No
Comment
Turnaround time
Patient related - immediate
1 Reduction of length of stay
and improved patient care
Patient convenience
Method
Precision
Sensitivity
Specificity
Interference
Linearity
2 Technical specifications
Batch vs discrete technology
Reagent and control stability
Reagent and control storage
requirements
Quality control requirements
Correlation
Space availability (the amount of
space available for instruments,
consumables, storage and paperwork
should be considered, including
3 Location of device fridge / freezer space required)
Environmental
(temperature/humidity etc.)
Electrical requirements
Network requirements (if applicable)
Ease of use
Size
Throughput
Number of test menu
4 Device specifications Portability of POCT device
Barcode capability for patients,
operator and consumables
Minimal maintenance requirements
Results can be transferred
electronically to patient records
Reagent/strip/consumable Ready to use
5
specifications Expiry date
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National Policy & Guidelines For Point of Care Testing (2 Edition) 58
On board stability. Adequate
workload to ensure that consumables
/ reagents shall be used before expiry
Sample type: Serum/Plasma /Whole
blood /Urine/Body Fluid
6 Sample requirements Sample volume: Adult/Paediatric
patients
Sample stability
7 Workload per year Estimated annual test volume
Peer comparison (Related documents
i.e., journal, evaluation reports)
Availability of appropriate internal
8 Quality Assurance
quality control materials
Availability of appropriate external
quality assurance program
Access to ongoing services and
support
Training and training materials
9 Services contract provided by supplier
Maintenance
After sales service
Reliability of supplier
Availability of supplier helpline
10 Supplier evaluation
Training available post-procurement
e.g.: refresher course
Capital expenditure
Affordability
11 Budget Operational costs (including
maintenance, consumables, quality
control, quality assurance materials
and connectivity costs)
Device must be from a certified body
Certification and e.g., CE, FDA
12
registration Device shall be registered under
Medical Device Act 2012
COMMENT/ RECOMMENDATION
Evaluated by : Verified by : Approved by :
Name : Name : Name :
Designation : Designation : Designation :
Date : Date : Date :
nd
National Policy & Guidelines For Point of Care Testing (2 Edition) 59
Appendix III
III
BPOCT002/2022
LIST OF POINT-OF-CARE TESTING COMMITTEES
Location and name of facility:
Email
No Name Designation Contact Number
Address
Prepared by : Approved by :
Name : Name :
Designation : Designation :
Date : Date :
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National Policy & Guidelines For Point of Care Testing (2 Edition) 60
Appendix IV
CHECKLIST FOR POCT AUDIT BPOCT003/2022
Name & Location:
Name of Auditor*:
*Auditor for Health Facilities = Competent personnel assigned by Officer-in-Charge
Date:
Device Device Device Device
POCT Device:
1 2 3 4
N
Areas Details of Assessment **Findings & Comments
o
1 Environment
Suitable location
Adequate space
Suitable temperature for
analysis
Accessible by user
2 Device Management
Daily / weekly / monthly
maintenance performed
2.1 Maintenance Maintenance log updated
Planned Preventive
Maintenance
Records of breakdown /
downtime (note length of
time)
2.2 Breakdown
Record and documentation of
troubleshooting / corrective
action
3 Quality Activity
Frequency of IQC - following
recommendation in
guidelines
IQC review - dated and
IQC signed
3.1
Implementation Corrective action and
troubleshooting
Proper record and
documentation of QC lot,
acceptable range and mean
Participation in EQA
EQA review - dated and
EQA / Peer signed
3.2 group Corrective action and
comparison troubleshooting
Proper record and
documentation
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National Policy & Guidelines For Point of Care Testing (2 Edition) 61
4 Sample
Proper sample handling
Use of correct container /
preservative
Disposal of sample
5 Results Management
Reporting of results - at least
2 unique identifiers
Results traceability
Recording of results onto
patients record / file
6 Training and Competency
All users trained
Training records updated
Competency log updated
List of competent users
updated
7 Storage of Reagents / QC materials / Consumables
Appropriate storage
temperature
Monitoring and charting of
storage temperature
Updated Bin Card/KEW Card
Opened date - recorded
Expiry date - recorded
8 Health and Safety
Appropriate PPE
Biohazard waste bin
Name of Auditee :
Name of Auditor :
Designation :
Designation :
Date : Date :
nd
National Policy & Guidelines For Point of Care Testing (2 Edition) 62
BPOCT/004A/2022
(S) Remark
Appendix V (R) Name of Supplier
(Q)
Date of
Procurement rocurement P
(P) Method of
Concession Company Registration No.
(O) 63
(N)
Asset Registration No.
(M)
Serial No.
National Policy & Guidelines For Point of Care Testing (2 nd Edition)
Asset/ Rental
(L)
Model
(K)
: : : : : :
Brand
(J)
Registry of POCT Devices / Kits in MOH Facilities (I) Name Of Test
Name of Facility Prepared by Checked by Verified by
Year Category (H) Location
(A) (B) (C) (D) (E) (F) (G) No
Appendix VI BPOCT005/2022 Total Workload
Dec
Nov
Oct
Sept
Aug
64
Workload
July : : :
June Approved by : Designation
May Name Date
Apr
Mar National Policy & Guidelines For Point of Care Testing (2 nd Edition)
Feb
Jan
POCT device Glucometer Cholesterol meter Haemoglobinometer Bilirubinometer Full Blood Count Blood Gases Urine Pregnancy Urine Biochemistry Coagulometer Dengue Combo Leptospirosis Cardiac Markers Prepared by : : : Designation :
WORKLOAD Dipstick HIV Test CD4/CD8 Malaria Others Name Date
No 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Appendix VII
BPOCT006/2022
POCT - TRAINING AND COMPETENCY RECORD
Name of Trainee : JM NOR SYAFIQAH BT ABDUL RAHMAN
Designation : JM U 19
--------------- DEVICE
Contact No. : STRIP URINE KETONE DAN ALBUMIN
Location : DEWAN BERSALIN
N.B: This record should be kept by the Supervisor / Training Officer
Date of Signature of
No. Scope **Score
Training Trainer
1.0 THEORY
1.1 Method/principle of test 5
1.2 Handling and preparation of reagent/test strips/cassette 5
1.3 Proper storage conditions for strips/cassette/reagents 5
1.4 Calibration -
1.5 Internal Quality Controls 5
1.6 External Quality Programme/Peer group comparison -
1.7 Maintenance -
1.8 Understanding error messages -
1.9 Basic troubleshooting -
1.10 Test limitation(s) and interference(s) -
1.11 Health and safety regulations & compliance -
1.12 Patient preparation requirements 5
1.13 Sample collection procedures 5
1.14 Result interpretation & clinical decision limits 5
1.15 Incident reporting and adverse events -
2.0 PRACTICAL SESSION
2.1 Maintenance -
2.2 Calibration -
2.3 IQC -
2.4 Sample collection procedures 5
2.5 Sample analysis 5
TOTAL SCORE (%)
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National Policy & Guidelines For Point of Care Testing (2 Edition) 65
**SCORE: TOTAL SCORE
1 = Poor >90 % = Competent, able to train and audit
2 = Below average 80 -90% = Competent and able to run test
3 = Average 60 - 79% = Require supervision and re-training
4 = Good <60% = Not competent and cannot perform test. Require re-training
5 = Excellent
SUMMARY / COMMENT
Assessed by : Verified by :
Name : Name :
Designation : Designation :
Date : Date :
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National Policy & Guidelines For Point of Care Testing (2 Edition) 66
Appendix VIII
BPOCT007/2022
LIST OF PERSONNEL COMPETENCY
Device:
Location and name of facility:
Contact Person:
No Name Designation Date
Prepared by : Approved by :
Name : Name :
Designation : Designation :
Date : Date :
nd
National Policy & Guidelines For Point of Care Testing (2 Edition) 67
Appendix IX BPOCT008/2022 31 30 29 28 27
26 25
24
23
22
21
20
19
MAINTENANCE LOG FOR POINT-OF-CARE TESTING DEVICE (Where applicable)
18
68
17
16
15
14
13
12
11
10
9
National Policy & Guidelines For Point of Care Testing (2 nd Edition)
8
7
6
5
: : : :
4 4
3 2 3 2
Asset / Serial number Location and name of facility 1 Operator initials 1 Operator initials Operator initials : : :
Analyser Month a) Daily Item \ Date b) Weekly Item \ Date c) Monthly Item \ Date Reviewed by: Name Designation Date
Appendix X
BPOCT009A/2022
INTERNAL QUALITY CONTROL DATA RECORD
(QUANTITATIVE)
Month: Year:
Location
Test
Device ID / Serial number
QC / Strip Range Range Range
Date Lot Level 1 Level 2 Level 3 Pass / Performed Remarks
Fail
by
Number
L1 :
L2 :
L3 :
L1 :
L2 :
L3 :
L1 :
L2 :
L3 :
L1 :
L2 :
L3 :
L1 :
L2 :
L3 :
L1 :
L2 :
L3 :
L1 :
L2 :
L3 :
L1 :
L2 :
L3 :
L1 :
L2 :
L3 :
L1 :
L2 :
L3 :
L1 :
L2 :
L3 :
nd
National Policy & Guidelines For Point of Care Testing (2 Edition) 69
Appendix XI
BPOCT009B/2022
INTERNAL QUALITY CONTROL DATA RECORD
(QUALITATIVE)
Month: Year:
Location
Test
Level Level
Box/Vial/Bottle Performed
Date 1 2 Pass / Fail Remarks *
Lot Number by
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
L1 :
L2 :
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National Policy & Guidelines For Point of Care Testing (2 Edition) 70