Point of Care Testing - wsh.nhs.uk15)167PointofCareTesting.pdf · aspects of Point of Care Testing (POCT) throughout West Suffolk Hospital NHS Trust. Also, to ensure that these principles

Source: Pathology Status: Approved Page 1 of 13

Issue date: June 2017 Review date: June 2020 Document reference: PP(17)167

For use in (clinical areas): All clinical areas

For use by (staff groups): All users of Point of Care Testing equipment

For use for (patients/treatments): Patients

Document owner: Point of Care Testing, Pathology

Status: Approved

Contents

1. PURPOSE .....................................................................................................................2

2. SCOPE ..........................................................................................................................2

3. INTRODUCTION ...........................................................................................................2

4. BACKGROUND .............................................................................................................2

5. RESPONSIBILITIES ......................................................................................................3

6. NEW DEVICES ..............................................................................................................4

7. BUDGETARY ARRANGEMENTS FOR NEW DEVICES .............................................4

8. HEALTH AND SAFETY/INFECTION CONTROL OF DEVICES ..................................4

9. TRAINING ......................................................................................................................4

10. DEVICE OPERATION ...................................................................................................5

11. STANDARD OPERATING PROCEDURES (SOPS) ....................................................5

12. RECORDING RESULTS ...............................................................................................5

13. DEVICE MAINTENANCE ..............................................................................................5

14. SUPPORT ......................................................................................................................6

15. INTERNAL QUALITY CONTROL AND EXTERNAL QUALITY ASSESSMENT (IQC and EQA) .........................................................................................................................6

16. ADVICE TO GENERAL PRACTITIONERS & OTHER NON-HOSPITAL SITES .........6

17. REFERENCES ..............................................................................................................7

18. APPENDIX 1: Point of Care Testing (POCT) Application Form ...............................10

Trust Policy and Procedure Document ref. no: PP(17)167

POINT OF CARE TESTING POLICY

West Suffolk Hospitals NHS Trust

Source: POCT, Pathology Status: Approved Page 2 of 13

Issue Date : June 2017 Review date: June 2020

Document reference: PP(17)167

1. PURPOSE

Historically there has been a proliferation of point of care testing (POCT) without the necessary case

of need or quality assurance. This policy will address:

• The need for POCT

• Procurement and support of appropriate equipment • Quality assurance Furthermore, the purpose of this policy is to inform staff of the principles of best practice for all aspects of Point of Care Testing (POCT) throughout West Suffolk Hospital NHS Trust. Also, to ensure that these principles are followed to guarantee device suitability, safety, reliability, accuracy, efficiency and ultimately good clinical outcomes. All new and/or replacement POCT equipment requires a completed ‘Point of Care Testing (POCT) Application Form’- see Appendix 1.

2. SCOPE

This policy applies to all staff groups who use POCT devices, including locum, bank and agency staff working on behalf of West Suffolk NHS Foundation Trust (WSFT). Within this policy all staff groups using POCT will be referred to as ‘operators’.

3. INTRODUCTION

Point of Care Testing (POCT) as defined by the International Organization for Standardization (ISO) as ‘testing that is performed near or at the site of a patient with the result leading to possible change in the care of the patient’. It is also sometimes referred to as ‘near patient testing’. Typically POCT is performed by non-laboratory staff, mainly medical and nursing staff, outside of the main laboratory. POCT is widely used in the Trust and is likely to increase because of advancing technology and changing clinical practice. Equipment currently supported in the Trust includes: glucose meters, blood gas analysers (which measure electrolytes, metabolites and cooximetry in addition to pH and gases), haemoglobin devices, haemoglobin A1c analysers, coagulometers, urine meters and pregnancy testing.

4. BACKGROUND

The Department of Health, in 1989, hazard notices were issued following a number of patient fatalities linked to inappropriate use of POCT. These notices recommended a lead role for Pathology in managing POCT.

The Joint Working Group on Quality Assurance published guidelines, on which Pathology professional organisations are represented, for the implementation of POCT, covering procurement, internal quality control and external quality assessment (IQC and EQA), health & safety, risk management, user training, equipment maintenance and clinical liaison. These were updated in January 1999.

United Kingdom Accreditation Service (UKAS), the national quality standards body for Pathology, requires that POCT support is managed by Pathology and recommends a Trust wide committee to oversee this service.





The Commission for Health Improvement (CHI) has specified the essential elements of Clinical Governance: risk management and quality, audit, staff management and training, clinical effectiveness and outcomes.

The Medical Devices Agency after professional consultation, issued guidance on the management of POCT (DB2002(03)).

The NHS Purchasing and Supply Agency issued guidance on the procurement of POCT equipment.

This policy is designed to ensure that POCT at WSFT complies with all such advice and guidance.

5. RESPONSIBILITIES 5.1 Summary of Key Actions and Responsibilities

This table is a summary of the main issues which need to be addressed in the provision of POCT. The table identifies who should perform the tasks and who should be responsible for ensuring that the issue has been properly addressed.

Issue

Action by

Responsible for action

Evaluated by

Cost benefit analysis (business case)

Clinical Unit / POCT Team

Trust Management POCT Committee / Trust Management

Health & Safety


Trust Management POCT Team / H&S and Risk Office

Training (including record of trained staff)


Trust Management POCT Team / UKAS

SOP

POCT Team Trust Management POCT Team / UKAS

Routine Operation

Operators Line Manager POCT Team

Recording Results

Operators Trust Management Trust Management

Support

POCT Team POCT Team POCT Team

Maintenance Operators / POCT Team / EBME

POCT Team / EBME POCT Team / EBME

IQC & EQA

Operators / POCT Team

Trust Management POCT Team

Budgetary arrangements


Trust Management POCT Committee / Trust Management

5.2 POCT Committee The POCT committee oversee new equipment purchases including POCT team support, consumable costs, and operator training. This will enable the trust to provide:

high quality and cost-effective patient care

effective risk management, including control of infection

coherent and informed service planning, and Trust-wide equipment standardisation

optimum financial arrangements, including discount agreements with suppliers for equipment and consumables





fully trained users of POCT, resulting in efficient use of ward and laboratory staff time

networked IT support of POCT, for activity monitoring, faster trouble-shooting and patient data capture

record-keeping and audit

ability to continue and extend, as necessary, high quality support of expanding service needs

6. NEW DEVICES 1. There must be a clear definition of the problem that the device would solve so that a full

examination of all possible solutions can be made. 2. The POCT Team must be involved in the production and evaluation of the cost benefit analysis

based on whole life cost of the device. 3. A full business case must be produced detailing all the financial consequences of the purchase.

These will include the direct costs of running, maintenance, consumables quality control and service contract. The business case must include the full indirect costs for POCT Team involvement, including support, training and internal quality control and external quality assessment (IQC and EQA) monitoring, as well as the inevitable cost of replacement.

4. The business case must recognise the need for any device to be compatible with existing equipment, both in the laboratory and in other areas of the hospital. The POCT Team and relevant laboratory department must be consulted about the compatibility of all devices.

5. Any device being considered must be compliant with the Medical Devices Directive and relevant European safety standards.

7. BUDGETARY ARRANGEMENTS FOR NEW DEVICES Prior to procurement, there must be an agreement between the device purchaser and the POCT Committee for the budgetary consequences of the purchase. Definitions must be put in place for the responsibility for the ordering of reagents, consumables, servicing, training, support, internal quality control and external quality assessment.

8. HEALTH AND SAFETY/INFECTION CONTROL OF DEVICES 1. In hospitals and clinics, whether in the public or private sector, managers of the Clinical service

involved together with the Pathology service must jointly develop and enforce policies consistent with current legislation and Guidance. For example: the Health & Safety at Work Act 1974, Consumer Protection Act 1987, the Control of Substances Hazardous to Health Regulations 1988, Safe Working and the Prevention of Infection in Clinical Laboratories – Model Role for Staff and Visitors, HSC 1981, Protection against Blood-born infections in the workplace: HIV and hepatitis (ACDP) 1995.

2. There should be close liaison between the Safety Officers of the testing site and Pathology. 3. A “Permit-to-work” certificate, providing evidence of appropriate decontamination, must be issued

before servicing or repair of equipment in accordance with trust policy. 4. The Infection Control Team / Consultant Microbiologists must be involved in decisions on

placement and maintenance of equipment.

9. TRAINING 1. Only staff whose training and competence has been established and documented should use any

device, including simple dipstick tests.





2. Following procurement and installation, relevant staff must be trained in the safe and proper use of the device. The training course must be specified by the POCT Team and provided by the manufacturer or the POCT Team.

3. Training should include other issues such as patient preparation and interpretation of results. 4. Once competence has been achieved and documented, the operator can be added to the

"Named Operator List". 5. For some devices update training is necessary to maintain a high standard of performance. This

is particularly important for operators who operate a device infrequently, or have had a break in the use of the device. This should be included in the Standard Operating Procedure (SOP).

10. DEVICE OPERATION Tests on the device in the designated area of use may only be carried out by those on the "Named Operator List".

11. STANDARD OPERATING PROCEDURES (SOPS)

1. An SOP must be produced, written to the standard required by inspectors from UKAS, or equivalent accreditation agencies.

2. This must be available to and followed by all operators of the device. 3. The document will include instructions on safe working practice, the interpretation of error

messages, the recording of data and the relevant IQC procedures.

12. RECORDING RESULTS 1. All patient and IQC/EQA results must be recorded. This record must include unequivocal patient

identity, time of test, the result, relevant IQC results and the identity of the user. 2. The mechanism for the transfer of results from the device to the patient record must be

unambiguous and stated in the SOP and monitored by the local manager for compliance. 3. All patient results must be treated as confidential and kept in a secure place. 4. If patient results are stored in a computer system, local rules on access to the system, whether

stand-alone or networked, should be maintained. Users should have access to the system by password which must be regularly updated.

5. The storage of results should be in line with the storage maintained by the laboratory and compatible with RCP guidelines.

6. The POCT team must have free access and oversight to all IQC/EQA results.

13. DEVICE MAINTENANCE

1. Both the POCT Team and EBME Department will maintain a whole life service history of all medical devices including POCT equipment in accordance with PP (04) 024 Policy & Procedure for the Management of Medical Equipment, and its successors.

2. All original contractor work sheets must be supplied to the EBME Manager for inclusion in the Trust’s equipment management database in a timely manner to ensure the accuracy of this data.

3. EBME will ensure all devices are maintained (in agreement with the budget holder) to a service schedule to ensure the safe, accurate and reliable operation of all equipment.

4. Broken devices or those showing error messages must be highlighted to the POCT Team for investigation. The POCT Team will then troubleshoot the device.





5. If a device is deemed faulty by the POCT Team, they will inform the EBME Department who will ensure that it is repaired either in house or by service contract. The performance of both contractors and internal staff is regularly monitored

6. Each device must have a "log-book' in either paper or electronic form in which details are recorded of the daily maintenance, QC results, faults, corrective actions and repairs by named individuals. The POCT Team must have free access to the log books.

14. SUPPORT

1. There must be an agreement between the operators and the POCT Team defining the responsibilities for maintenance, troubleshooting, repairs, continuing training and IQC/EQA monitoring.

2. Designated persons must be responsible for the day to day care of the system and control of environment contamination and for the maintenance of stocks of consumables and reagents within their shelf-life.

3. If devices are not used or cared for appropriately the POCT Committee will have the responsibility of removing the device from service. This must be stated in the SOP.

4. A device that fails to perform to specification must be withdrawn immediately from service until full remedial action has been completed.

5. The POCT Team must be informed immediately of any failure. 6. In the event of device failure alternative sites for the analyses should have been agreed,

documented and made known to the users.

15. INTERNAL QUALITY CONTROL AND EXTERNAL QUALITY ASSESSMENT (IQC and EQA)

1. UKAS require that all pathology disciplines, including POCT, participate in recognised EQA

schemes relevant to the test repertoires. 2. The POCT Team are responsible for ensuring that the performance of the device is checked by

appropriate internal IQC and external EQA assessments such as would satisfy the UKAS inspection criteria.

3. The POCT Team should be involved in clinical governance issues and should carry out regular audits of the reliability and effectiveness of the tests being carried out.

4. Trust or Hospital management must satisfy themselves that there is a demonstrable link between the users of the device and the POCT Team to ensure the "quality" aspects and reliability of the results produced.

5. Management must be made aware of the legal exposure involved if there is no supervision of devices through EQA schemes.

16. ADVICE TO GENERAL PRACTITIONERS & OTHER NON-HOSPITAL SITES

General Practitioners, Pharmacists and other Primary sector users are recommended to adopt the practices outlined for hospitals, including close liaison with POCT services. This would help produce "quality" results and manage the associated risks. Oversight of EQA schemes would have resource implications.





17. REFERENCES Burnett, D., Freedman, D. Near-patient testing: The management issues. Health Services Management, 1994: March: 10-13 England J M, Hyde K, Lewis S M, Mackie I J, Rowan R M. Guide-lines for near patient testing: haematology. Clin Lab Haem 1995; 17: 301-310 Freeman, G.K. 'Desktop laboratory technology in general practice. Br Med J, 1992; 42: 311-2. Gault, M.H., Harding, C.E. 'Evaluation of I-STAT portable clinical analyses in a haemodialysis unit' ClinBiochem, 1996; 29: 117-24 Goldie DJ, Kemp H. Near patient testing: The challenge for clinical pathology. J Clin Pathol, 1993;46:689-90 Guidelines for the Implementation of Near Patient Testing. The Association of Clinical Biochemists.September, 1993 ACB Administration Office, 2 Cariton House Terrace, London SW1Y 5AF, UK. Jacobs E. Total quality management and point-of-care testing. Med Lab Observ, 1993;23(9S);42-6. Keffer JH, Economic considerations of point of care testing. Am J Clin Pathol, 1995;104 (Suppi l):S107-10. Kwak, Y.S., Hartfield, J. Naito, H.K. et al. 'Does bedside glucose shorten patient length of stay ?' Am JClin Pathol, 1994;102: 553-4. Mock, T., Morrison, D. Yatscoff, R. 'Evaluation of the I-STAT system: A portable chemistry analyser for the measurement of sodium, potassium, chloride, urea, glucose and haematocrit. Clin Biochem, 1995;28:187-92. Parvin CA, Lo SF, Deuser SM, Weaver LG, Lewis LM, Scott MG. Impact of point-of-care testing on patient's length of stay in a large emergency department. Clin Chem 1996:42;11-7. Marks, V. 'Essential considerations in the provision of near-patient testing facilities' Ann Clin Biochem,1988: 25: 220-5. McOueen MJ. The ethics and economics of out-of-laboratory testing. Can Med Assoc J, 1993;149:1653-6 McQueen MJ. How best do we define the application technology, point-of-care or point-of-need? Biologie Prospective. Comptes rendus du ge Colloque de Pont-a-Mousson. Ed. M.M. Galteu, P. Delwaide, G. Siest, J. Henny. John Libbey Eurotext, Paris, pp 9-13,1997. Rainey, P.M., Jatiow, P. 'Monitoring blood glucose meters’, Am J Clin Pathol, 1995;103:125-6. Stott, N.C.H. 'Desktop laboratory technology in general practice' Br Med J, 1989: 229: 579-86. Thue G. The Office Laboratory. A study related to near patient testing in general practice and occupational health care. Department of Public Health and Primary Health Care, University of Bergen,Norway Thue G, Sandberg S. Survey of office laboratory tests in general practice. Scand J Prim Health Care,1994;12:77-83.6





Department of Health Publications A Review of NPT in Primary Care: Health Technology Assessment Programme 1997. Lancet Devices for Multi-Patient Capillary Blood Sampling: Avoidance of Cross Infection by Correct Selection and Use: DH Safety Action Bulletin 1990. Need For Decontamination Of Blood Gas Analysers Used In Near Patient Testing: MDA Safety Notice1996. Extra-Laboratory Use Of Blood Glucose Meters And Test Strips: Contra-Indications, Training And Advice To The Users. MDA Safety Notice 1996. Blood Gas Measurements: The Need For Reliability Of Results Produced In Extra Laboratory Areas.NHS Hazard Notice 1989. Blood Glucose Measurements: The Need For Reliability Of Results Produced In Extra Laboratory Areas NHS Hazard Notice 1989. Medical Device and Equipment Management for Hospital and Community-Based Organisations. Medical Devices Agency DB 9801 January 1998. Near Patient Testing; A Statement of Best Practice for Scotland: Scottish Office 1996. Near Patient Testing: Welsh Scientific Advisory Committee (Welsh Office) 1995 Pathology Modernisation Team, Pathology – The Essential Service, Department of Health 2002

www.dh.gov.uk

Pathology Modernisation Team, Pathology- Modernising Pathology Services, Department of Health 2004 www.dh.gov.uk

BS EN ISO 22870:2006- Point of Care Testing ( POCT ) – Requirements for Quality and Competence

BS EN ISO 15189:2007- Medical Laboratories – Particular requirements for Quality and Competence

MRHA Device Bulletin- Management and Use of IVD Point of Care Devices. DB10 Feb 2010

http://www.dh.gov.uk/

http://www.dh.gov.uk/





Author(s): D.Stuart-Thompson , R.D.Sinclair

Other contributors: EBME, Jacqui Macdonald, wide distribution to clinical managers and heads of departments. All comments and feedback reviewed and changes made to policy as necessary.

Approvals and endorsements: Point of Care Testing Committee Medical Staffing Committee Directorate Clinical Governance Steering Groups TMT (11th April 2005)

Consultation: Point of Care Testing Committee Medical Staffing Committee Directorate Clinical Governance Steering Groups

Issue no: 5

File name: CHARLIES:/S:/CHEMISTRY/SOPS

Supercedes: 4

Equality Assessed YES

Implementation INTRANET

Monitoring: (give brief details how this will be done)

See responsibilities above

Other relevant policies/documents & references:

See POCT SOPs

Additional Information:





18. APPENDIX 1: Point of Care Testing (POCT) Application Form SECTION 1: POCT DEVICE/PROCESS DETAILS 1. What new/replacement POCT process/device is proposed?

2. What is the proposed location(s) of the new POCT process/device?

3. Who will be named person responsible for the new POCT device/process?

4. Who will have responsibility for necessary training and how will this be carried out?

5. Who will actually perform the POCT?

6. What extra staff time is involved in performing the POCT device/process?

7. How will results be recorded, including access to results through ‘results reporting’?

8. Will the users be restricted to staff in the location of the POCT process? If not, please

explain….

9. Who will be responsible for producing the Standard Operating Procedure for the POCT

process/device?

10. What is the rationale for this POCT and reason for using POCT rather than laboratory analysis?





11. Has a discussion with POCT and/or the laboratory taken place regarding methodology? If so,

with whom?

12. Has POCT/the laboratory been consulted with regard to units, reference ranges, sample types

and, if necessary, correlation with laboratory results?

13. What maintenance requirements are necessary? Has support been discussed with the relevant

department? If so, who with?

14. What happens if the device/process breaks down?

15. Who will manage the ordering of consumables and arrange maintenance contracts and

emergency call outs?

16. Is the POCT device being used as a rule-in or rule-out test? If so, what is its performance (i.e.

sensitivity, specificity etc.) and how will risk of false positive or false negative results be

managed?

17. Have you read the hospital Point of Care Testing Policy? Yes No

18. If the new POCT process/device proposed is approved, will it comply with the above

policy?

Yes No If not, please explain why.

19. Does the device have a barcode scanner? Yes No

19a. If yes, is the scanner compliant with the GS1 NHS barcode standard?

Yes No If not, please explain why.





SECTION 2: COST-BENEFIT ANALYSIS a. Capital (One-Off) and Annual Revenue Costs

Description Cost Quantity Total Cost

Capital

Revenue

Non-staff costs Consumables:

Collection devices:

Maintenance

Quality Control

External Quality Assessment

Staff time Testing

Training (trainer and trainee)

Support/maintenance (laboratory/POCT)

Other

Total Revenue p.a. (A)

Total 1st year cost (capital + revenue) (B)

b. Annual Savings

Type Description Saving

Cash-releasing Drugs

Other:

Other:

Other:

Other:

Total Cash-releasing savings p.a. (C)

Number Est. Saving

Non cash-releasing Bed days

Earlier discharge

Staff time

Other:

Other:

Total Non-cash-releasing savings p.a. (D)





c. Cost-Benefit Summary

1st year expenditure (capital + revenue) B

Recurring annual expenditure (revenue) A

Recurring cash-releasing saving C

Total 1st year expenditure/saving (set-up costs/savings) B - C

Total recurring annual expenditure/saving (recurring costs/savings) A - C

Total recurring non-cash releasing saving D

If there are set-up and/or recurring costs has a source of funding been identified? Yes No N/A SECTION 3: APPLICANT DETAILS Please give details of person responsible for proposed new POCT device/process

Name: Tel/Bleep No:

Position: Email:

Signed: Dept./Ward

Date: Directorate

This application must be supported by the Directorate Associate Director of Operations (ADO) and Clinical Director

Associate Director of Operations Clinical Director

Name: Name:

Signed: Signed:

Date: Date:

If you require any help or advice on completing this form, please contact the POCT Coordinator on extension: 2822.

Documents

Point of Care Testing - wsh.nhs.uk15)167PointofCareTesting.pdf · aspects of Point of Care Testing (POCT) throughout West Suffolk Hospital NHS Trust. Also, to ensure that these principles