1. Objective
2. Introduction
3. Management of NPT
4. Cost Benefit Analysis (Business Case)
5. Health & Safety
6. Training
7. Standard Operating Procedure (SOP)
8. Recording of Results
9. Log Book
10. Support
11. Internal Quality Control and Quality Assessment
12. Budgetary arrangements
13. Advice to GPs and other non-hospital sites
14. Advice to patients
15. NPT: Summary of actions and responsibilities

TABLE 1: Summary of main issues for NPT

REFERENCES

1. The objective of this policy is to minimise the risk to patient care by ensuring that Near Patient Testing (NPT) of patient samples is performed to acceptable analytical and clinical standards of quality.

1. There may be considerable benefits to patients by using the latest methodology to carry out tests in close proximity to patients. Non-pathology staff or the patients themselves may perform some of these tests.
2. There is a requirement to ensure that all NPT equipment used within the Trust:
   · Is suitable for its intended purpose
   · Meets safety and quality standards
   · Can be supported adequately
   · The results of the investigations performed are recorded
   · Is operated only by staff trained in its use
3. The appropriate use of these tests should be considered as a Clinical Governance issue and subject to examination of clinical effectiveness.
4. For the purposes of these guidelines, the word "device" includes the whole range of items from simple urine dipstick tests to sophisticated analysers.
5. To achieve the best possible results from such devices it is essential that there is close liaison with Pathology relating to all aspects of such tests.
6. The Joint Working Group on Quality Assurance has published updated Guidelines on NPT and this Policy reflects those guidelines in the context of what has already been set up in Basildon + Thurrock Trust.
7. NPT devices within the Trust currently includes:
   · Blood glucose testing
   · Blood gas analysis
   · Blood electrolyte analysis
   · Bilirubin testing in neonates
   · Coagulation testing
   · Urine dip-sticks
   · Urine pregnancy testing
   · Hba1c testing in Paediatric clinics
   · Alcohol testing in Accident & Emergency

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1. A Near Patient Testing Advisory Group (NPTAG) has been established to advise on current and future NPT within the Trust.
2. The NPTAG shall ensure that NPT Devices are implemented and used appropriately and that each NPT test is undertaken safely and reliably.
3. The NPTAG will co-ordinate NPT usage and development and ensure that methods introduced are appropriate, rationalised and cost effective.
4. No NPT Devices should be used within the Trust unless approval has been obtained from the NPTAG.
5. The NPTAG shall ensure that areas identified in this policy are addressed effectively.
6. A NPT operational sub-group will be developed to progress the procedures and operational issues reporting to NPTAG.
7. The procurement of any NPT equipment must be accompanied by a full Cost Benefit Analysis, which is approved by NPTAG.

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. Pathology must be involved in the production and evaluation of the cost benefit analysis.
3. Details of all the financial consequences of the purchase must be included. These will include the direct costs of running, maintenance, consumables quality control and service contract. The Cost Benefit Analysis must include full indirect costs for Pathology involvement, including support, training and QC/QA monitoring, as well as the inevitable cost of replacement.
4. The Cost Benefit Analysis 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 NPT Advisory Group must be consulted about the compatibility of all devices.
5. The NPT Advisory Group must approve all Cost Benefit Analysis applications, before funding is sought.

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1. Policies consistent with current legislation and Guidance must be enforced. 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. The Consultant Microbiologist/Infection Control Team must be involved in decisions on placement and maintenance of equipment.
3. Evidence of appropriate decontamination (e.g. a ‘permit-to-work’ certificate) must be given before servicing or repair of equipment, as advised in the Standard Operating Procedure (SOP).

1. Only staff and/or patients whose training and competence has been established and documented can use any device, including simple dipstick tests.
2. Following procurement and installation, relevant staff and/or patients must be trained in the safe and proper use of the device. The training course must be specified and supervised by the relevant Pathology department and provided by the manufacturer or local staff trained to the satisfaction of the relevant Pathology department, usually Pathology link nurses.
3. Once competence has been achieved and documented, the user (staff or patient) can be added to the "Named Operator List". Tests on the device in the designated area of use may only be carried out by those on the "Named Operator List". In exceptional circumstances users on a "Named Operator List" may carry out tests on the same device in another designated area.
4. For some devices update training is necessary to maintain a high standard of performance. This is particularly important for users 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.

1. A SOP must be produced. This must be available to and followed by all users of the device.
2. The SOP master copy must be held by Pathology and available to accreditation agency Inspectors.

1. All patient and Quality Control/Quality Assessment (QC/QA) results must be recorded. This record must include unequivocal patient identity, time of test, the result, relevant QC results and the identity of the user.
2. The mechanism for the transfer of results from the device to the patient's record must be unambiguous and stated in the SOP.
3. All patients’ results must be treated as confidential and kept in a secure place. The storage of results should be in line with the storage maintained by the laboratory and compatible with RCPath guidelines
4. Pathology staff and individuals identified by NPTAG must have free access to QC/QA results.

1. Each device must have a "log-book' in either paper or electronic form in which details are recorded of maintenance, faults, corrective actions and repairs by named individuals. Pathology staff and individuals identified by NPTAG must have free access to the logbooks.
2. Logbooks should be retained for the lifetime of the equipment or a minimum of 10 years.

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1. There must be a service level agreement between the users and the Pathology service defining the responsibilities for maintenance, troubleshooting, repairs, continuing training and QA monitoring.
2. A designated person (usually Pathology link nurse) must be responsible for ensuring 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. A device that fails to perform to specification must be withdrawn immediately from service until full remedial action has been completed. The procedure will be documented in the SOP.
4. The SOP must state who has the responsibility and the authority to withdraw the device from service.
5. Pathology 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.

1. The Pathology department is responsible for ensuring that the performance of the device is checked by appropriate internal QC and external QA assessments.
2. The Pathology department and specific personnel identified by the NPTAG should be involved in clinical governance issues and should carry out regular audits of the reliability and effectiveness of the tests being carried out.

1. In hospitals, prior to the procurement, there must be an agreement between the device's purchaser, its users, the Pathology service and the Pharmacy department 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, quality control and quality assessment.

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

1. When devices are issued to, or bought by patients for home monitoring, the consultant or General Practitioner responsible for care must ensure that the patient receives adequate training. This has to cover all aspects of performance including the interpretation of results.
2. The Health & Safety implications must also be explained to the patient. The Pathology link nurse would be an appropriate person to undertake this task.
3. The manufacturers of devices designed specifically for patient use should supply suitable training materials, which should have been developed in co-operation with experts in the relevant profession. Devices should not be purchased if such training materials are not available.

1. Table 1 is a summary of the main issues that need to be addressed in the provision of Near Patient Testing.
2. The table identifies who should perform the tasks and who should be responsible for ensuring that the issue has been properly addressed.

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TABLE 1: Summary of main issues for Near Patient Testing 

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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' Clin Biochem, 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 J Clin 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. Sie:st, 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.

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 Notice 1996.

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

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