Point of Care Testing
POINT OF CARE TESTING
The New Brunswick Society of Medical Laboratory Technologists (NBSMLT) has a mandate provided by the Medical Laboratory Technology Act (1991). The purpose of this mandate is to advance and to maintain the standard of medical laboratory technology in New Brunswick, to govern and regulate medical laboratory technology services provided to the public and provide for the welfare of members of the public and the NBSMLT.
Point of care testing (POC) refers to laboratory tests performed outside the traditional laboratory setting. With improved technology and the development of sophisticated testing procedures, portability of some tests is feasible; however, the simplicity of operating the equipment and performing the test may be deceptive. In order to recognize the proper functioning of equipment and to provide reliable results, the operator must have training in the quality control procedures and knowledge of the analytical concept.
The NBSMLT endorses the use of point of care testing when it enhances patient care and when it is under the direct control and jurisdiction of the laboratory and qualified medical laboratory technologists.
The NBSMLT endorses standards which require :
1. There are written policies detailing Laboratory Services responsibility for:
- evaluation, selection and purchase of instruments and test materials
- the training and periodic recertification of all staff who are involved in testing and/or instructing patients in self-testing
- regular quality checks on all instruments, reagents and strips
- selection and provision of standards and quality control material to operators and for the operation of a quality control program involving periodic simultaneous determinations by the laboratory
- a quality assurance program
2. There are written policies requiring:
- a written order for the tests from a physician
- a written record of the test results in the clinical record, signed by the operator and showing the date and time of the test.
3. There are clear instructions on the procedure to be followed when abnormal results are obtained.
A point of care service has the potential of providing improved patient care; however, there is the risk of harm if it is not introduced properly. The laboratory must be responsible for the service by recommending, evaluating, supervising and controlling the testing. Non-laboratory personnel performing the analysis should be responsible to the laboratory for analytical competence.
GUIDELINES FOR A POINT OF CARE (POC) LABORATORY SERVICE
Communication through the hospital's Quality Improvement Committee to involve the appropriate senior administrative, laboratory, nursing and medical staff is necessary to plan and evaluate the need for a point-of-care test.
Factors to be considered:
- Duplication of service.
- Justification of the POC test on a cost effective basis or on the demand for continuous quality improvement of patient care.
- Demonstration of the existence of reliable technology.
- Critical nature of the test result.
II. PURCHASE AND SELECTION OF EQUIPMENT
Collaboration with laboratory staff is necessary with regard to the selection, evaluation and purchase of an instrument or device for use outside the laboratory.
The analytical results of the POC testing equipment should be as similar as possible to that of the laboratory.
The laboratory carries out the preliminary set-up and evaluation of the equipment.
III. OPERATION OF EQUIPMENT
The laboratory staff organize and implement a training program to certify personnel in a procedure or in the use of an instrument. This program provides for the training and certification of new personnel as well as recertification. A list of these personnel is maintained by the laboratory.
The laboratory is responsible for developing and updating the procedure to include:
- patient preparation
- sample collection and handling
- equipment operation
- quality control
- reporting test results
- confirmatory and/or repeat testing
- sources of error
- communication line for laboratory assistance
- safety procedures
- infection control
IV. MAINTENANCE AND SUPPLIES
Routine maintenance procedures and calibration may be performed by the laboratory.
The laboratory provides both a back-up and confirmation service as necessary.
Equipment repair and service should be requested through the laboratory.
The laboratory develops a policy regarding the inventory dating and storage of supplies.
V. RECORD KEEPING AND REPORTING RESULTS
The laboratory keeps a record for documenting maintenance procedures, service, troubleshooting and quality control.
The laboratory requires a written policy for reporting POC tests. The POC test result is part of the patient's permanent record and is distinguished from results obtained through laboratory testing.
VI. QUALITY ASSURANCE
The laboratory organizes and monitors a proficiency testing program.
Criteria for quality control decision-making is decided between laboratory staff, operators and medical staff.
A liaison committee consisting of the laboratory staff, operators and medical staff administers the specific POC service as part of continuous quality improvement for patient care.
(Approved March 18, 1995)