CHHS15/128

Canberra Hospital and Health ServicesClinical ProcedurePathology Point-of-Care Testing (POCT) ProcedureContents

Contents....................................................................................................................................1

Purpose.....................................................................................................................................2

Alerts.........................................................................................................................................2

Scope........................................................................................................................................ 2

Section 1 – Introduction of POCT.............................................................................................2

Section 2 – Compliance with Quality Requirements.................................................................3

Section 3 – Patient Testing Requirements................................................................................4

Section 4 – Equipment Maintenance and Troubleshooting......................................................4

Section 5 – Clinical Staff Training and Competencies................................................................5

Section 6 – Nonconformities.....................................................................................................6

Section 7 – Risks........................................................................................................................6

Section 8 – Test Result Reporting.............................................................................................6

Section 9 – Records...................................................................................................................7

Section 10 – Work Safety Issues................................................................................................7

Implementation........................................................................................................................ 7

Related Policies, Procedures, Guidelines and Legislation.........................................................7

References................................................................................................................................ 8

Definition of Terms...................................................................................................................9

Search Terms............................................................................................................................ 9

Attachments............................................................................................................................10

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Purpose

This procedure is to ensure: Compliance with the Pathology Point-of-care Testing (POCT) Policy. POCT equipment is managed and maintained in a safe condition to minimise risk to

patients, staff and the directorate. POCT results are accurate, reproducible, reliable and comparable to ACT Pathology

laboratory results. POCT is performed in compliance with the quality requirements of the relevant NATA

and NPAAC accreditation standards, TGA Regulations, ISO 15189, ISO 22870 and the ACT Pathology Quality Management System.

Scope

Alerts

It is a mandatory requirement that the Pathology Executive Director be contacted before procuring and implementing a Point-of-Care Testing device.

Scope

This procedure applies to all ACT Health staff members trained in using POCT equipment for performing Pathology tests and all ACT Health staff members contemplating the introduction of POCT equipment. ACT Health staff not trained in using POCT equipment must not perform POCT.

This procedure does not apply to POCT equipment personally owned and operated by patients, nor does it apply to POCT equipment that is used only for research purposes.

This procedure is applicable to all patients cared for by ACT Health, for whom POCT is performed, irrespective of age. However, procedures for specific equipment and tests state their applicability and restrictions relating to patient age.

Section 1 – Introduction of POCT

Clinical staff wishing to introduce POCT must lodge a request with their Divisional Director, who is required to forward the request in writing to the ACT Pathology Executive Director for approval.

If the request is for a type of POCT already approved (as per the POCT Policy) and used by ACT Health, the ACT Pathology Executive Director will either approve or reject the Division’s request. If approved, the Executive Director will notify the POCT Coordinator of the decision so that implementation can proceed.

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If the request is for POCT involving a new test, technology or instrumentation not previously approved and used by ACT Health, the ACT Pathology Executive Director shall appoint a POCT Management Group composed of representatives from relevant ACT Pathology departments, and by invitation, a medical and nursing representative from the CHHS division making the request.

The POCT Management group will assess the request and then report to and advise the ACT Pathology Executive Director regarding provision of the new POCT, and shall assist in the evaluation and selection of POCT devices and systems, but will not make any final approval or rejection decision regarding its introduction and implementation.

The POCT Management Group assessment report to the ACT Pathology Executive Director should include, but not be limited to, the following:- An evaluation of the clinical need, effectiveness, benefit and cost efficiency of the

POCT activity- Market research of available technologies- An assessment of different methodologies- Information regarding completed accuracy, precision and validation studies,

including correlation studies with laboratory equipment and methods- An assessment of computer network and Laboratory Information System

connectivity- Assessment of calibration and quality control requirement- Assessment of Maintenance and servicing requirements- Availability of continuing manufacturer’s support- A determination of user access- An assessment of testing traceability- A determination of staff training requirements- A work safety risk assessment

When the ACT Pathology Executive Director receives the POCT Management Group’s report, this officer shall make the final approval or rejection decision as to whether the new POCT test, methodology or instrumentation shall be introduced and implemented by ACT Health.

Once the ACT Pathology Executive Director has approved the introduction of POCT, the POCT Coordinator installs new POCT equipment, completes the Equipment Checklist and verifies the performance of new POCT devices.

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Section 2 – Compliance with Quality Requirements

Certified competent clinical staff shall perform QC testing when scheduled in the procedure for the relevant POCT test, and immediately after commencing a new lot number of reagent, and record the results for review.

Clinical staff shall record QC test results together with the identification and signature of the staff member performing the test, and the date the test was performed, if all this information is not stored by the POCT device itself.

Clinical staff shall review QC results before performing POCT on patients.

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When unacceptable QC test results occur, clinical staff shall take action to correct POCT performance and record such action.

Clinical staff key trainers for a POCT method are responsible for monitoring QC performance of users in their area.

All POCT shall be enrolled in an EQAP, or if unavailable; participate in a sample exchange inter-instrument comparison programme with ACT Pathology.

Clinical staff shall ensure that the current procedure for a particular POCT test shall be kept with the equipment used to do the test.

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Section 3 – Patient Testing Requirements

Clinical staff members that have not been certified as currently competent for a specific POCT test shall not use it to perform patient Pathology tests.

POCT of patient samples must be in strict compliance with this procedure, the procedure relating to the specific POCT instrument/test, directions made by the POCT Coordinator and the ACT Health Point-of-care Testing (POCT) policy.

POCT instruments and methods must not be used for patient testing if quality control test results have not been performed when scheduled, or if these results are unacceptable (i.e. out of range).

Samples tested using POCT must be uniquely identified and unequivocally traceable to the patient that was sampled.

Clinical staff shall not operate a POCT device using another staff member’s POCT password or login credentials. Similarly, clinical staff shall not divulge or share their POCT password and login credentials with any other person.

At all times, POCT shall be accurate, reproducible, reliable and comparable to ACT Pathology laboratory derived test results.

POCT shall have the same level of quality assurance as is provided for Pathology testing performed within the laboratories of ACT Pathology.

POCT shall be compliant with ISO 15189 and ISO 22870.

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Section 4 – Equipment Maintenance and Troubleshooting

Currently certified competent clinical staff shall perform preventive maintenance on POCT devices when scheduled in the procedure for the relevant POCT device/method.

Competent clinical staff shall record preventive maintenance that has been completed, together with the date it was performed and the signature of the officer performing the maintenance.

Clinical staff must immediately remove from service malfunctioning POCT equipment, label it with an “Out of Service, Do NOT Use or Operate” tag and notify the POCT Coordinator.

Clinical staff shall record faults and problems in a log for each POCT device.

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Only approved, appropriately qualified and competent persons may service POCT equipment.

POCT equipment must be cleaned and decontaminated before servicing is performed, or the equipment is removed from the location where it is normally used for servicing.

The POCT Coordinator records corrective actions and repairs that are performed on POCT devices that have faults or problems, and the date that these actions were completed.

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Section 5 – Clinical Staff Training and Competencies

Training must include, but not necessarily be limited to:- Sample collection- Method principles and limitations- Preparation of reagents and equipment- Reagent storage- Calibration requirements- Quality control and EQAP- The significance of actions taken to correct analytical performance- Analytical procedure- Correct procedure for recording QC, EQAP and patient results- Clinical relevance and significance of patient results- Response to patient results falling outside reference intervals- Common procedural errors- Equipment maintenance and trouble shooting- Correct disposal of consumables- Infection control practices- Work safety requirements

As part of training, clinical staff must sign an acknowledgement that they have read the procedure for the relevant POCT test and that they will comply with it.

All clinical staff must be trained and certified as currently competent in the use of a POCT method before they are permitted to perform patient testing using that POCT method.

All clinical staff must have regular competency appraisals performed for each type of POCT method they are required to perform and be certified as competent for that test.

The frequency that clinical staff competency appraisals must be performed is documented in the procedure for the relevant POCT device or method.

Different clinical staff must be required to perform EQAP testing, the results of which are used to monitor the competency and performance of the staff member.

Clinical staff who have been absent from the work place for extended periods of time, must not perform patient testing using a POCT device or method until a competency appraisal has been performed on them for the relevant POCT device or method and they have been recertified as competent.

Where underperformance of a clinical staff member is identified, retraining and a repeat competency appraisal must be completed.

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The POCT Coordinator must be notified of repeated poor performance and compliance.

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Section 6 – Nonconformities

Where POCT nonconformities occur, they must be documented together with actions taken to eliminate their root cause, in order to prevent recurrence.

Nonconformities affecting patient management or care must be recorded in Riskman, together with appropriate corrective action that has been taken.

The POCT Coordinator reviews nonconformities and the actions taken to resolve them and prevent recurrence and also reviews the success of these actions.

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Section 7 – Risks

The POCT Coordinator must be notified when risks of potential nonconformities are identified, and these risks must be registered in the Riskman Risk Register so that all relevant parties have access to them.

The Pathology Management committee (PMC) will review all risks and evaluate, modify and endorse actions to prevent the relevant nonconformity from occurring.

Records of requested and completed preventive actions are kept in the Riskman Risk Register.

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Section 8 – Test Result Reporting

Clinical staff members are responsible for permanently recording all POCT results in the relevant patient’s medical records, together with the date and time it was performed and the signatures of the staff members performing and recording the test.

Where POCT devices are not interfaced with the Laboratory Information System, Clinical staff key trainers are responsible for confirming that all POCT results are recorded in the relevant patient medical records.

The record of POCT results must have two unique identifiers, the patient’s full name (first and last names), and date of birth. Pathology results for inpatients and outpatients receiving a significant procedure must also record the patient’s MRN as a third unique identifier.

Patient medical records of POCT results shall be clearly distinguished from test results from the Pathology Laboratory.

Patient test results that are unexpected or very abnormal shall be confirmed by clinical staff by sending a repeat sample to ACT Pathology for testing.

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Section 9 – Records

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QC testing results, patient test results, reports of reviews, nonconformities, complaints, risks, corrective actions and all other quality records must be kept for the retention time stipulated by the NPAAC “Requirements for the Retention of Laboratory Records and Diagnostic Material” standard.

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Section 10 – Roles and Responsibilities The POCT Coordinator is responsible for: Ensuring this procedure is implemented. Monitoring clinical staff compliance with this procedure Maintenance of a POCT equipment inventory, which includes a unique inventory

number and the serial number for each device, and its location and service history. Providing clinical staff with trouble shooting support for malfunctioning POCT devices. Establishing POCT equipment maintenance schedules for clinical staff to comply with. Procurement of reagents, calibrators, and quality control material. Establishing systems whereby there is a record of materials and reagents used for any

particular patient test performed. Registering POCT methods that have been varied from the manufacturer’s instructions

in the ACT Pathology IVD Register; and registering class 4 tests in the TGA ARTG, in compliance with federal government regulations and legislation.

Establishing appropriate QC programmes for all POCT methods Reviewing QC performance of POCT devices. Ensuring that each POCT instrument is enrolled in an EQAP, or if there is none available,

a specimen exchange programme with ACT Pathology.

Reviewing EQAP results and requesting corrective actions that need to be completed by users of the POCT instrument.

Coordinating the theoretical and practical training of all users of POCT equipment and methods.

Designing documents and methods for appraising the POCT competency of users, including knowledge of work safety issues.

Coordinating the performance of regular competency appraisals on all POCT users. Maintaining a register of certified users of each type of POCT equipment. Ensuring there are up to date records of clinical staff initial training and completed

competency appraisals, including staff performance deficiencies and completed retraining, and performance of EQAP testing.

Conducting training and competency appraisals of key trainers of POCT equipment. Maintaining a register of key trainers for each type of POCT equipment or method.

These key trainers are responsible for monitoring QC performance of users in their area and conducting training and competency appraisals on these users.

Auditing POCT user compliance with quality standards, this procedure, the ACT Health POCT policy and procedures for specific POCT methods.

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Ensuring that risk assessments are performed on all identified risks and providing the ACT Pathology Quality Manager with the completed risk assessment for recording in the Riskman Risk Register to enable all divisions involved to access the risk; and notifies the ACT Pathology Director of Operations of the risk.

Clinical staff performing POCT are responsible for the following: Ensure that they have current competency certification for all POCT methods/devices

they need to use. Compliance with this procedure, the ACT Health POCT policy and relevant procedures

for specific POCT methods and tests. Completion of actions required by the POCT Coordinator within the designated

timeframe.

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Section 11 – Work Safety Issues

Assessments of all new POCT technology must include a work safety risk assessment. All POCT must be undertaken in a safe and responsible manner that does not place the

patient or any staff member at risk. All Work Safety policies and legislation must be strictly complied with. Reagents must be disposed of in accordance with ACT Health’s Dangerous Substance

regulations. All consumables contaminated as part of the POCT procedure must be disposed in

accordance with required regulations. Work safety issues must be reported to the ACT Pathology Work Safety Committee as

well as that pertaining to the Division where the test was performed.

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Implementation

This procedure will be advertised to all ACT Health staff on the ACT Health Intranet News Hub for four weeks, and via an all staff e-mail.

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Related Policies, Procedures, Guidelines and Legislation

Legislation Health Professionals Act 2004

http://www.legislation.act.gov.au/a/2004-38/default.aspe Public Sector Management Act 1994

http://www.legislation.act.gov.au/a/1994-37/current/pdf/1994-37.pdf Therapeutic Goods Act, 1989 Therapeutic Goods (Medical Devices) Regulations, 2002

http://www.comlaw.gov.au/Details/F2012C00424

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Work Health and Safety Act 2011http://www.legislation.act.gov.au/a/2011-35/default.asp

Work Health and Safety Regulation 2011http://www.legislation.act.gov.au/sl/2011-36/default.asp

Policies ACT Health Pathology Point-of-care Testing (POCT) Policy ACT Health Risk Management Policy, DGD12-011 ACT Health Work Health and Safety Policy, DGD12-036 ACT Health Dangerous Substance Management Policy, DGD13-008 CHHS Blood Glucose and Ketone Point-of-Care Testing, CHHS12/177 Women Youth & Children Community Health Programs Special schools: Measuring

Blood Glucose Levels using the Optium Xceed Monitor and an Accu-chek blood letting device in a School Setting, 11.1.8

Women’s Health Service (WHS) Pregnancy Test Urinary Human Chorionic Gonadotropin (UHCG) PROCEDURE, 10.1.10.

Canberra Sexual Health Centre (CSHC) Pregnancy Testing at CSHC PROCEDURE, CHHS 13/034

ACT Health Urine Specimen – Urinalysis PROCEDURE, CED11-59 ACT Health Urinalysis Assessment PROCEDURE, 3.2.18 Women’s Health Service (WHS) Urinalysis Procedure for Women’s Health Nurses, 10.1.3 Division of Women Youth & Children Maternity: Fetal Fibronectin PROCEDURE

Standards NPAAC ‘Requirements for the Retention of Laboratory Records and Diagnostic Material,’

Sixth Edition 2013. ISO 15189:2012 ‘Medical Laboratories – Requirements for Quality and Competence.’ ISO 22870:2006 ‘Point-of-care Testing (POCT) – Requirements for Quality and

Competence.’ NATA Interpretation of NPAAC Requirements and ISO 15189, Medical Testing Field

Application Document, Requirements for Accreditation, November 2013. The Regulatory Requirements for In-house IVDs in Australia, Version 1.0, January 2012,

Australian Government Department of Health and Ageing, Therapeutic Goods Administration.

Classification of IVD Medical Devices, Version 1.1, November 2011, Australian Government Department of Health and Ageing, Therapeutic Goods Administration.

National Safety and Quality Health Service Standards, September 2012, Australian Commission on Safety and Quality in Health Care.

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References

Australasian Association of Clinical Biochemists Point of Care Testing Implementation Guide, 2008.

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Definition of Terms

ARTGAustralian Register of Therapeutic Goods, held by the TGA.

Clinical StaffFor the purposes of this procedure, this is a generic term defining medical and nursing ACT staff other than ACT Pathology laboratory workers.

EQAPExternal Quality Assurance Programme, also known as proficiency testing. This involves enrolling in the programme. The organiser issues aliquots of samples to all participants for analysis and return of test results. The organiser then assesses the results from participants for comparability and returns a performance report to the participants.

IVDAny In-vitro Diagnostic device.

NATANational Association of Testing Authorities.

NPAACNational Pathology Accreditation Advisory Council, a division of the Australian Government department of Health and ageing.

Point-of-care Testing (POCT)Testing that is performed near or at the site of a patient (i.e. not in the Pathology Laboratory) by non Pathology staff, with the result leading to possible change in the care of the patient. Also known as Near-patient Testing.

Quality Control (QC)A set of procedures designed to monitor the performance of a test method and provide assurance that patient test results are accurate, reproducible and reliable. QC involves testing control materials of known concentration of the analyte being tested and taking action when the test results of these materials are unacceptable.

TGATherapeutic Goods Administration. An agency of the Australian Government Department of Health and ageing.

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Search Terms

Pathology

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Point of CarePoint-of-CareTestingTestsMeterAnalyserReaderPOCTPOC

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Attachments

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