Near Patient Testing

RECOMMENDED GUIDELINES FOR HOSPITALS AND GENERAL PRACTICE

Adopted August 1993

Introduction

The supervision of health professionals involved in medical laboratory science/technology, which includes procedures involved in Near Patient Testing, is the responsibility of medical scientists/technologists and medical practitioners as set out in the Medical Laboratory Technologists Board's Regulations. The MLTB interpretation of supervision is currently under review.

The New Zealand Institute of Medical Laboratory Science has developed a set of protocols, to use as guidelines, for both medical technologists and medical practitioners involved in the supervision of Near Patient Testing being carried out either within a hospital or general practitioners office.

Within a hospital, the responsibility of the supervising medical practitioner needs to be clearly established by the hospital management. Equally, general practitioners in private practice need to be aware of their responsibilities.

Near Patient Testing can range from dry chemistries such as the "test strips" used for urinalysis and blood glucose assays, to solid state electronic equipment for measuring blood gases, electrolytes, glucose and haemoglobin. When laboratory testing is performed in wards or clinics (near patient testing) it is important that:

1.   Analyses are performed to a standard that benefits patient care by having in place:

• appropriate quality control procedures
• staff training programmes
• equipment maintenance programmes

2.   The results obtained are clinically comparable to those obtained for the same test in the laboratory.

3.   Unnecessary duplication of laboratory tests and services is avoided.

4.   Experienced individuals are responsible for the purchase of equipment for near patient testing.

The laboratory is best placed to ensure that these standards are met, and hence it is important that a close liaison is maintained between appropriate senior laboratory staff in wards or clinics involved in near patient testing. The following guidelines are therefore recommended when performing Near Patient Testing.

POLICY

Duplication of equipment and services should be avoided by providing an effective laboratory service at all times.

Near patient testing requires the close liaison of appropriate laboratory staff regarding the provision of the assay, purchase of equipment, operation, training, quality control and maintenance.

GUIDELINES FOR HOSPITALS

1. Consultation

Consult the appropriate senior laboratory staff when any near patient laboratory testing is planned.  Avoid duplication of services and justify near patient testing on a cost effective basis or by the demands of patient care.

2. Purchase and Selection of Equipment

Collaborate with laboratory staff on the selection and purchase of laboratory testing equipment and materials for use outside the laboratory.  Use the guidelines for selection and evaluation of laboratory equipment normally used by the laboratory.  The analytical results of near patient testing equipment should be as similar as possible to those of the equipment used in the laboratory.  The laboratory may involve other units (eg scientific and information centres) in the evaluation of equipment.  Involve other appropriate units for the provision of suitable facilities (eg electricity, benches, waste disposal) for near patient testing.  The laboratory carries out the preliminary setting up and evaluation of the equipment.

3. Operation of Equipment

Laboratory staff organise and implement a training programme for all staff involved in the operation of near patient testing equipment in the ward or clinic. This includes provision for retraining and training new personnel.  The laboratory maintains a list of trained operators.  Laboratory staff provide a method sheet detailing:

• patient preparation
• sample collection/preservation/stability
• equipment operation
• quality control procedures
• result reporting
• means of obtaining assistance from the laboratory

Maintain safety procedures as practised in the laboratory. Maintain correct disposal of blood and biological waste, reagents and good housekeeping practices. Instruments as a source of infection may be a more important issue than in the laboratory.

4. Recording and Reporting Results

The laboratory prepares worksheets for result recording at the near patient testing site. These include space for:

• the result
• patient identification
• time of analysis
• entry of QC and calibration results
• name of analyst

A copy of the results be recorded in the patient notes on an appropriate form.

5. Quality Assurance

The laboratory be responsible for organising a quality control programme.  Criteria for QC decision making be decided by consultation between laboratory staff, operators and appropriate other medical personnel.  The laboratory maintains an overview of the quality control results.  Participation in an external QC programme may be appropriate.  Where appropriate, eg Intensive Care Units, Near Patient Testing procedures should be TELARC registered.

6. Maintenance

Laboratory staff carry out all maintenance of near patient testing laboratory equipment.  The laboratory organises any service of the equipment by an outside organisation.  The laboratory provides a procedure for obtaining support, both within and outside normal laboratory hours.  The laboratory provides backup service in case of breakdown.

Acknowledgement

The NZIMLS thanks the Biochemistry Department of Waikato Hospital for their assistance in the formation of this policy.

GUIDELINES FOR GENERAL PRACTICE

1. Purpose

It is important before accepting the need for near patient testing on a site to define its purpose and nature, and the benefits expected of it.

2. Equipment

Equipment and reagents used for near patient testing should be compatible with equipment and reagents used elsewhere in the area and yield similar analytical results to those produced by the main laboratory.  Uniformity of equipment brings with it advantages such as simplification of training, the storage and supply of disposable reagents, servicing and maintenance.

3. Placement

Care must be exercised in deciding upon the placement of near patient testing facilities. The environment should be clean, well lit, but not in direct sunlight, temperature controlled and have facilities for storing the reagents. Adequate bench space for writing up results and appropriate containers for the disposal of reagents and blood contaminated waste should be available.

4. Safety

Staff must know the detailed procedures for the collection and handling of specimens of blood, urine and other body fluids and for their safe disposal on the completion of the test.

A near patient testing site should have an action plan to cover:

• malicious damage
• accidental swallowing of potentially hazardous material
• accidental skin puncture or cut
• breakages and leakages

5. Maintenance and Storage

It is essential that all users of near patient testing equipment are made familiar with the routine preventative maintenance procedures necessary to keep their equipment operating optimally. Instruction in simple maintenance, including calibration if necessary, should be given to all users by the supplier. A record of regular maintenance should be made in a log book kept adjacent to the equipment. More complicated servicing should be carried out on a regular basis by the supplier's service engineer or representative.

Any service malfunction should be reported to the supplier immediately.

Disposable reagents do have expiry dates and can, if improperly handled, deteriorate more rapidly thus producing invalid results. Adequate and appropriate storage facilities must be available. Stocks of reagents for near patient testing should only be used if stored properly and still within their expiry dates. Any reagents that fail to meet these criteria should be withdrawn and replaced. Out of date reagents should be destroyed or returned to the suppliers.

6. Training

Training developed by manufacturers must be appropriate for non laboratory staff. Only trained staff should use the equipment, despite difficulties due to the large numbers of potential users and the frequent change of staff during the lifetime of the equipment. The supplier of the near patient testing equipment is responsible for the training which will be required on a regular basis and given to all staff authorised to use the equipment.

Training must be sufficient to enable the operator to achieve reliable results. It should include instruction on regular calibration (if indicated), reagent management and the collection and handling of samples.  Training should also be given in quality assurance (see later, safety of equipment (electrical and mechanical, etc) potential hazards of patient samples and the possible problems encountered with the measurement procedure.  The training session must include some practical experience with the instrument and a detailed procedures document.

7. Documentation

A written record, including the name of the operator, must be entered in a book kept adjacent to the instrument for all results whether for calibrant, quality control or patient samples. The record must be made at the same time of the analysis and entered into the patient's clinical notes as soon as possible. In addition to the test result any other useful identification information should be recorded by hand.

8. Quality Assurance

The aim of quality assurance is to check on operator performance as well as upon the reagents and equipment. Most users of near patient testing are unaware of the general concepts of quality assurance and should be acquainted with them during their training in the use of near patient testing equipment.

Suitable quality control material should be made available to near patient testing users by the supplier. The nearest TELARC registered laboratory may also be able to assist in this area. A protocol for the use of quality control material covering frequency and interpretation of quality control results should be drawn up. The protocol should include strict rules that require the instrument to be taken out of use when quality control results are unacceptable or out of range. When this happens the supplier or other appropriate persons should be contacted to ensure the problem is rapidly dealt with.

9. Authorisation

Only those individuals who have undergone appropriate training should be authorised to use the equipment. An up to date list of users should be kept.

Some authorised person should be responsible for overseeing the use of the near patient testing equipment checking maintenance, reagents, quality control and documentation.