DOCUMENT: Point of Care
CLASSIFICATION: Position Paper
STATUS: Final

As hospitals deal with rising health care costs, strategies have emerged that shorten patient stays or move care to the outpatient setting. In addition, the emergence of new technology and patient care models are driving laboratory testing to the patient’s side. These trends raise the following issues:

* What role should clinical laboratory professionals take in the performance of this testing?

* What role should clinical laboratory professionals take in the management of this testing?

* How can clinical laboratory professionals ensure the public that the testing is clinically relevant and accurate?

Point of care testing is not the panacea for all the ills of our current health care system, and the laboratory must be part of validating which tests should be appropriately performed at the bedside.

BACKGROUND

New trends in health care support the provision of laboratory testing at the point where patient care is rendered or to what is commonly called point of care testing. Rising health costs have created new expectations in hospitals: shortened patient stays, and a movement from an inpatient to an outpatient or ambulatory setting. As hospitals become treatment centers for the acutely ill, and no longer serve primarily as diagnostic centers, the subsequent change in the patient’s hospital stay and patient acuity have placed demands on the laboratory to deliver information in a manner which will facilitate rapid diagnosis and treatment. Because these demands have compressed the time frame for performing testing, shorter turn around times and an increase in the volume of stat testing have become a necessity.

Concurrent with these changes, rapid advances in automated technology have been made which have produced instrumentation which is easy to operate and can rapidly perform high quality tests results through the use of whole blood methodologies. This new arena of laboratory testing expands our scope of practice and leads to an important new consultative role for clinical laboratory scientists.

The need to maintain quality test results, while achieving shorter turn around times, lowering costs through faster discharges and countering personnel shortages, has resulted in hospitals developing a primary focus on point of care testing as a mechanism to accomplish these goals.

RATIONALE

Point of care testing should embrace the concepts that testing can be performed at or near the patients’ locations and is supplement to, not a replacement for, the central laboratory services. Technological advances have made it feasible for non-laboratory staff to perform the testing, but clinical laboratory scientists are essential to direct or oversee the overall programs. Although institutions may vary their approach in staffing these ancillary sites of testing, the responsibility for the overall approval and direction of these testing areas still should remain the responsibility of the central laboratory.

Clinical laboratory scientists are the single group of health care professionals who are trained in the areas of quality control and therefore can guarantee quality testing regardless of the site of that testing. Clinical laboratory scientists must focus on maintaining the quality of laboratory testing throughout the hospital and take a leading role in the management of quality control and quality assurance programs. The laboratory must maintain responsibility for the development of appropriate training programs for the non-laboratory personnel in the use of ancillary testing equipment, test procedures, documentation, review of test results, performance and monitoring of quality control, corrective action, proficiency testing, and equipment management. A review of personnel competency must be built into these programs. The laboratory, in collaboration with the appropriate medical staff, must also take responsibility for defining appropriate parameters and establishing guidelines for repeat testing or result rejection.

Point of care testing should not be viewed as a threat to the practice of laboratory science, but rather an opportunity to show our capabilities. A new challenging role has emerged for clinical laboratory scientists. The role has changed from doing to managing tasks; from producing to monitoring test results; from receiving test requests to making decisions regarding the appropriate testing for point of care programs. Clinical laboratory scientists must be members of the multidisciplinary groups given the task of defining roles and responsibility for each department involved in providing point of care testing. It may be advisable for hospitals to establish a point of care testing task force to determine the type of testing needed, the format for the provision of such testing and the establishment of roles and responsibilities for the involved hospital departments.

Institutions must be realistic in evaluating the cost of point of care testing, and mechanisms must be developed to prevent over utilization. Thorough cost accounting is needed to weigh the value of service versus cost, by factoring in the potential savings in potentially reduced lengths of stay. Those analyses that reveal additional expenses for this activity should be reviewed critically in light of rising health care costs.

THEREFORE IT IS THE POSITION OF ASCLS THAT:

1. Qualified, trained personnel should perform point of care laboratory testing. Whenever possible, laboratory personnel should perform testing.

2. Since clinical laboratory scientists have the expertise and training, clinical laboratory scientists should direct all point of care testing programs.

3. A needs assessment for the test menu should be developed through the joint efforts of the laboratory and the appropriate medical staff. The menu should include only these tests that are clinically relevant for point of care and those tests should be performed only when action is taken immediately as a result of the data obtained.

4. The laboratory should devise a complete quality assurance program. Continued competency in the performance of the tests should be part of such a program and should be monitored (evaluated) periodically by the clinical laboratory through the use of blind proficiency testing.

5. Laboratories have experience in training clinical laboratory scientists and should expand this curriculum to non-laboratory personnel. Training of non-laboratory personnel must be done through a structured curriculum under the auspices of trained laboratory personnel.

6. Clinical laboratory scientists and the central laboratory should retain the responsibility and authority for the selection and approval of instrumentation, since guidelines from NCCLS are well understood and practiced by this group. Instrument selection should consider ease of operation, cost effectiveness, and quality resulting.

7. Procedures should be clearly written by the laboratory to ensure that proper protocols are followed by all testing personnel.

8. Maintenance procedures, as established by the clinical laboratory, will be followed and documented.

9. Laboratories must ensure that testing at the point of care meeting the same accreditation/regulatory requirements as the central laboratory.

10. Careful consideration must be given to evaluation of the relative benefit and cost of point of care testing.

Updated 10/96