Jurisdiction |
Assessment & selection of appropriate device/s for specified clinical task & setting |
Training & competency of operators (& ongoing skill maintenance) |
Patient/sample ID & secure recording of results |
Quality Control (QC) of the device (including records & corrective actions) |
Assessment (EQA) of testing regime (including operator and comparative assessment) |
AUSTRALIA |
Interim standards for POCT in
general practice trial |
Assessment of intended clinical
& diagnostic purpose, taking into account benefits and
disadvantages to patient,
analytical performance, space requirement, testing costs & IT to meet trial & practice requirements. |
Mandatory
Before introduction of POCT
with on-going competency assessment. Formal training, competency assessment & certification.
Use of “Quality Manual” & SOPs. |
Mandatory
Labelling of samples with 2
unique identifiers, if specimen not immediately and wholly consumed by the testing process (eg. finger-stick specimen). Disposal of unlabelled samples before testing of next sample.
Recording of result(s) in patient history. |
Mandatory
Appropriate use of internal QC
(minimum of 2 levels) plus electronic check where available. Standard pre- determined rules to reject or accept results. Record all results, non-conformities & corrective actions. |
Mandatory
Participation in an EQA for comparative assessment & peer
review.
Frequency as specified by particular EQA program, test dependent.
(NPAAC EQA requirements). |
Services which claim Medicare
benefit
(Category M and S laboratories) |
No recommendations. |
Mandatory
NPAAC standards, NATA
assessment and accreditation. |
Mandatory
NPAAC standards, NATA
assessment and accreditation. |
Mandatory
NPAAC standards, NATA
assessment and accreditation. Controls as appropriate for test, low/normal/high.
QC material independent of
POCT manufacturer, (NATA FAD 5.6.1). |
Mandatory
NPAAC standards, NATA
assessment and accreditation. Frequency as specified by particular EQA program, test dependent. |
QAAMS
Indigenous health – HbA1c, ACR testing |
Evaluation of testing device as
‘fit for purpose’. |
Mandatory / Policy
Formal training with on-going competency assessment of
device operators. Telephone support service. |
Not specified. |
Mandatory
Internal QC, 2 levels per month with onsite recording &
interpretation of QC results. QC
‘action sheet’ to determine acceptability for the continued
testing of patients.
Telephone support service. POCT Network review of QC results by supervisor. |
Mandatory
Enrolment in the relevant
RCPA QAP EQA program. Frequency as specified by
particular EQA program, test
dependent. 2 samples per month with 2 six monthly cycles per year. QA ‘action sheet’ for review. Telephone support service.
POCT Network review of EQA
results by supervisor. |
iCCnet, SA |
Evaluate diagnostic accuracy,
efficacy, clinical effectiveness
& cost effectiveness (‘fitness for purpose’). |
Mandatory
Formal training with on-going
competency assessment of device operators. Telephone support service |
Mandatory
Labelling of samples with 2
unique identifiers, if specimen is not immediately and wholly consumed by the testing process (eg. finger-stick
specimen). Disposal of unlabelled samples before
testing of next sample.
Recording of result(s) in patient history. |
Mandatory
Internal QC, minimum of one
per month or after changes which may affect device performance.
Set limits for QC acceptance. |
Mandatory
Enrolment in the relevant RCPA QAP EQA program.
Frequency as specified by particular EQA program, test
dependent. Generally, 2 samples
per month with 2 six monthly cycles per year (INR, 4 samples
per year).
|
CANADA |
Alberta (Physicians) |
‘Fitness for purpose’ &
assessment of why POCT
testing required.
Device to be appropriate for intended purpose. |
Guideline / Policy
Training of personnel to be documented. |
Guideline
Defined safety requirements. Sample collection procedures,
handling & storage according to manufacturer’s instructions.
Protocol required for patient preparation (fasting etc) and ID
with name and client number. |
Guideline
Calibration and QC as per manufacturer’s instructions. |
Guideline
Participation in EQA program strongly recommended.
Frequency determined by EQA
provider for the particular test. |
Ontario Ministry of Health
(for hospitals & long-term-care homes).
Requirements based on ISO
22870. |
Mandatory
Determine ‘fitness for purpose’, clinical need, fiscal justification
and resource requirements. Performance goals should be
the same as a licensed laboratory. |
Mandatory
Training, certification and recertification of POCT
operators. Ensure that only certified operators perform
POCT. |
Mandatory
Definition, documentation and implementation of processes &
necessary procedures. Ensure that POCT results are recorded
in the patient record in appropriate detail & that the
person performing the test is known. |
Mandatory
Establish procedures which identify non-conformities.
QC as recommended by manufacturer with regular
review by experienced person. Frequency determined by
device used & test performed. |
Mandatory
Participation in an EQA for comparative assessment & peer
review or regular comparison of results with a licensed
laboratory.
Frequency determined by EQA
provider for the particular test. |
Ontario, INR POCT
(physicians & patients) |
Guideline
Device must be thoroughly evaluated prior to clinical
implementation and provide results comparable to an
established laboratory method. |
Guideline / Policy
Operators must receive adequate training of key
competencies with an annual review. |
Guideline
Unique patient identifiers associated with each result,
patient record to include name, result, intended INR range,
device & test strip information. |
Guideline
QC external from POCT
manufacturer is preferred. Recommendations regarding
when to perform QC given. |
Guideline
EQA, minimum of twice per year (patients & doctors).
Operators with >10 patients per day should participate in a
formal EQA program. |
Quebec (private sector)
AETMIS |
Recommended for regulation
Should only be performed when
justified by the need for a rapid response and must remain a
complementary adjunct to
central laboratory services. |
Recommended for regulation
Testing must be performed:
- in a secure setting
- with strict quality standards
- by trained operators
- with periodic audits
- with QC & EQA
|
Recommended for regulation
Each step in the testing
procedure must be accurately recorded in the patient’s
medical file & any testing
error(s) identified. Patient confidentiality must be
maintained. |
Recommended for regulation
Minimum requirement, manufacturers’
instructions.
Actual frequency still to be defined. |
Recommended for regulation
Participation in an appropriate
EQA, details still to be defined. |
All ‘laboratories’, hospitals, &
tests performed outside of the medical laboratory (specific legal definition). |
Mandatory by 2016
‘Fitness for purpose’ and limited to medically justified
emergency situations or by genuine improvement in patient
care based on clinical requirements. Device suitability
based on analytical performance
& ergonomics. |
Mandatory by 2016
Staff
to be ‘properly trained’ with on- going competency evaluation based on ISO 22870. |
Mandatory by 2016
French requirements for patient identification & data
management based on ISO
22870. |
Mandatory by 2016
QC materials, incident management & biological
validation of results as determined by “local”
laboratory based on ISO 22870. |
Mandatory by 2016
Participation in an appropriate
EQA. |
Primary care ‘doctor’ & patient
self-testing.
Private doctor testing & patient self-testing are not considered “medical biology tests”. |
Unregulated |
Unregulated |
Unregulated |
Unregulated |
Unregulated |
GERMANY |
Hospitals, public & private
facilities. |
Private practice may offer
POCT as an adjunct to laboratory services. |
Mandatory
Operators must receive
adequate training of key competencies. Quality manual describing all aspects of test procedure required. |
POCT largely related to “unit
use procedures”. Correct procedure for sample collection
of high importance. Results to
be appropriately recorded. |
Mandatory
Minimum requirement,
manufacturers’ instructions but if these differ from the 2008
Directive of the German
Medical Association, the stricter criteria apply. Daily or weekly
depending on device. |
(1) Mandatory
(2) Recommended
(1) “Conventional laboratory procedures”; EQA or inter-
laboratory comparisons mandatory.
(2) “Unit use procedures”, no
obligation for private practice to participate in EQA but recommended. |
Primary care. |
Used for self monitoring; INR,
glucose. |
Operator training required |
POCT largely related to “unit
use procedures”. Correct procedure for sample collection
of high importance. Results to
be appropriately recorded. |
Minimum requirement,
manufacturers’ instructions but if these differ from the 2008
Directive of the German
Medical Association, the stricter criteria apply. Daily or weekly depending on device. |
(1) Mandatory
(2) Recommended
(1) “Conventional laboratory procedures”; EQA or inter-
laboratory comparisons mandatory.
(2) “Unit use procedures”, no obligation for private practice to
participate in EQA but recommended. |
REPUBLIC OF IRELAND |
Hospitals and clinics.
Guidelines based on ISO 22870 |
‘Fitness for purpose’ with
clinical needs and effectiveness defined. Should only
supplement laboratory testing.
Procedures based on ISO
22870. |
Guideline / Policy
Operators must receive
adequate training of key competencies with an annual review. Only certified operators to perform POCT. |
Guideline / Policy
Use of SOP’s which detail all
aspects of testing. Recording of results in patient record, audit trail and corrective action documentation using paper or electronic format using Data Protection Act procedures. |
Guideline / Policy
Minimum requirement,
manufacturers’ instructions. Possible mandated requirement for future accreditation. |
Guideline / Policy
Participation in EQA program
or inter-laboratory comparisons strongly recommended.
Possible mandated requirement for future accreditation. |
Primary and Community Care
(clinic, doctor, pharmacy). Guidelines based on ISO 22870 |
Must be performed in a well
structured & controlled manner. Device only to be used for the purpose intended. Operator
must ensure that the manufacturers’ performance is
achieved. |
Guideline / Policy
Operators must receive adequate training of key
competencies with on-going review.
|
Guideline / Policy
Use of SOPs which detail all aspects of patient preparation,
sample collection & testing. All result information to be
integrated into patient’s medical records. Clear specifications for
reporting & recording of results. |
Guideline / Policy
Device & test dependent. “Unit use procedure”, minimum 2
levels of QC per month. “Collective use procedure”, test
dependent, minimum of 2 levels of QC per day or per week.
|
Guideline / Policy
Participation in EQA program.
|
SPAIN |
Hospitals, clinics, doctors
(SEQC guidelines). |
Guideline
Justification & assessment of
need to conduct POCT testing. Selection of easy to use devices but with traceability of results to a recognised laboratory method. |
Guideline
Establishment of training
programs & controls for testing personnel.
|
Guideline
All information to be integrated
into patient’s medical records.
|
Guideline
Design of QC procedures by lab
professionals with corrective actions if necessary
|
Guideline
Participation in EQA programs
recommended. |
NEW ZEALAND |
Health Board contracts with
POCT included.
Accredited to ISO 22870. |
Mandatory
Compliance with ISO 22870. |
Mandatory
Compliance with ISO 22870. |
Mandatory
Compliance with ISO 22870. |
Mandatory
Compliance with ISO 22870.
QC program that ensures quality of testing & provides reliable MU data. |
Mandatory
Compliance with ISO 22870.
Participation in EQA program where available or inter- laboratory comparisons. |
UNITED KINGDOM |
Medicines & Healthcare Products Regulatory Agency
(MHRA/MDA)
Guidelines (for NHS trust policy). |
Guideline
‘Fitness for purpose’ with
clinical needs and effectiveness defined & justified. |
Guideline / Policy
Operators must receive
adequate training of key competencies with on-going review. Training record to be documented. |
Guideline / Policy
Use of SOP’s which detail all
aspects of patient preparation, sample collection & testing. All result information to be
integrated into patient’s medical records. Testing records to
include date & time, device
type, batch #, operator & patient
ID. |
Guideline / Policy
Minimum requirement,
manufacturers’ instructions. Recommended before analysis of a set of specimens. Detailed recommendations for recording non-conformities & corrective actions. |
Guideline / Policy
Participation in EQA program
or parallel testing, or inter- laboratory comparisons strongly recommended. |
England (NHS trust facilities,
hospitals, clinics) Generally required to be
accredited to CPA (UK)
standard. |
Mandatory
‘Fitness for purpose’ with
clinical needs and effectiveness defined & justified. |
Mandatory
Operators must receive training
of key competencies with on- going review. Only certified operators to perform POCT. |
Mandatory
Use of SOP’s which detail all
aspects of patient preparation, sample collection & testing. All result information to be integrated into patient’s medical records |
Mandatory
Device & test dependent.
Generally defined by the “local” laboratory or equivalent to that used by the “local” laboratory. |
Mandatory
Enrolment in the relevant EQA
program; device & test dependent. Frequency as specified by the particular program. Generally supervised by “local” laboratory. |
England (primary care doctors
with special funding program). |
Determined by individual
practice |
Mandatory
Each practice must ensure that
all staff involved in providing any aspect of care under the program has the necessary training and skills. |
Mandatory
Ensure that POCT results are
recorded in the patient record. Maintain adequate records of the performance of the service. |
Mandatory
The arrangements made for QC
to be provided for approval. |
Mandatory
Participation in EQA program,
frequency as specified by EQA
program. |
Scotland (NHS trust facilities,
hospitals, clinics, patient self- testing). |
Determined by individual trust
requirements, but taking into account benefits & disadvantages.
|
Mandatory
Operators must receive training of key competencies.
|
Mandatory
Manufacturers’ instructions as minimum requirement. Use of
SOP’s which detail all aspects of patient preparation, sample
collection & testing.
|
Mandatory
Minimum requirement, manufacturers’ instructions.
Record of non-conformities &
corrective actions to be kept. |
Mandatory
Participation in EQA program, frequency as specified by EQA
program. |
Wales (all facilities including
primary care) |
Mandatory
POCT defined as diagnostic test done by non-laboratory staff.
‘Fitness for purpose’ &
assessment of why POCT
testing required. |
Mandatory
Operators must receive training of key competencies. Only
certified operators to perform
POCT. |
Mandatory
Results of all patient, QC & QA
samples to be recorded with, date, time & operator details.
Full audit trails documentation.
|
Mandatory
Mandatory; at agreed intervals on samples of known values.
Generally determined by “local”
laboratory.
|
Mandatory
Participation in EQA program, frequency as specified by EQA
program.
|
Northern Ireland (trust
facilities, hospitals, clinics, primary care doctors).
Required to be accredited to
CPA (UK) standard. |
Mandatory
‘Fitness for purpose’ with clinical needs and effectiveness
defined & justified.
According to RCPath guidelines |
Mandatory
Operators must receive training of key competencies. Only
certified operators to perform
POCT.
Training record to be documented. |
Mandatory
Use of SOP’s which detail all aspects of patient preparation,
sample collection & testing. SOP must be written to CPA
(UK) standard. A formal reporting procedure must be
established.
|
Mandatory
Mandatory; at pre-determined intervals.
|
Mandatory
Participation in EQA program, frequency as specified by EQA
program.
|
UNITED STATES OF AMERICA |
Waived tests (less complex tests
as defined; including Na, K, Glucose, Hb, Lipids, Urea,
Creatinine, Influenza, INR,
HbA1c, FOB, Urine dipsticks). |
Appropriateness of waived
test(s) “with no risk to human health”, as approved by the
FDA. |
Mandatory
Qualifications of supervisor &
those performing tests must be documented. |
Mandatory
Manufacturers’ instructions,
with records available to the inspecting authority (HHS). |
Mandatory
Minimum requirement -
manufacturers’ instructions. |
Guideline
Announced & unannounced
inspections by HHS. EQA participation encouraged but not required for waived tests. |
Moderate complexity tests as
defined, including blood gas, hepatitis testing, FBE, etc. |
Specialised testing, requires full
accreditation |
Mandatory
Competency requirements as
defined by accreditation inspection agency. |
Mandatory
Instructions for collection,
labelling & processing with specimen rejection policy. Use of SOP’s which detail all
aspects of patient preparation, sample collection & testing. |
Mandatory
Requirements may differ
depending on inspection agency. Example, CAP; daily QC testing at 2 levels with corrective action reporting. Manufacturer’s instructions validated. |
Mandatory
Participation in EQA program,
frequency as specified by EQA
program.
Split sample testing if EQA
program not available. |