POINT OF CARE TESTING: A PRIMER

Government Regulation

The Clinical Laboratory Improvement Amendments of 1988, often referred to as CLIA '88, or simply CLIA, were passed to regulate all clinical laboratory testing (previously only testing in central laboratories had been regulated). The regulations implementing the law were published in 1992 and took full effect in 1994. There was considerable publicity about the regulations when they came out, particularly with regard to their impact on physician's office laboratories. The emphasis on office laboratories may have led some to fail to realize that the regulations applied to all testing at any site (including, for example, stool for occult blood or urine dipsticks).

According to these regulations, laboratory testing is any examination or testing of any specimen obtained from a patient for the purposes of medical diagnosis, prognosis or monitoring, whether or not it takes place in an actual laboratory. (When no specimen is involved, such as occurs when measuring the blood pressure or using a pulse oximeter, this is considered patient monitoring and is not regulated.) The only testing exempted from the regulations was forensic testing, drug abuse testing and pure research testing. (The Yale Human Investigation Committee has determined that the exemption does not apply to research testing where the results are reported into the medical record or used to make medical management decisions. Such tests must adhere to all applicable regulations.) The State of Connecticut has also passed state regulations that closely follow the Federal ones.

The extent of regulation depends on the complexity of the tests. A limited number of simple tests are referred to as "waived" tests, because they are free of extensive regulation (see Table 1). Tests done with commercial kits or devices that require limited operator training are usually classified as "moderately complex." To qualify as moderately complex, testing must adhere to all manufacturer's instructions. The regulations for moderately complex tests are substantial. All other tests are considered "highly complex" and are the most intensively regulated.

There is a special category of moderately complex testing known as provider-performed microscopy (PPM). These are microscopic examinations of certain patient specimens performed as part of a physical examination (see Table 2). When performed by a "laboratory" that does not perform any other moderately or highly complex testing, PPM is treated similarly to waived testing. In particular, it is exempt from the requirement for a biannual inspection.

One universal requirement, common to all categories of testing, is that the testing be carried out under the authority of an appropriate certificate issued by the Health Care Finance Administration. All persons who perform point of care testing should assure that their testing is covered by an appropriate certificate. (In general, nurses and other hospital employees will be covered by certificates held by the Department of Nursing or the Department of Laboratory Medicine; physicians who perform testing personally should be covered by certificates held individually or by their practice groups.)

The JCAHO requirements for waived testing are slightly more demanding than the Federal requirements and are shown in Table 3. Table 4 summarizes the major requirements for moderately complex testing. Highly complex testing is generally not appropriate for performance at the point of care.

New POCT Devices

The bedside blood glucose monitor is the prototype for many of the new POCT instruments. In the past few years, devices have been introduced for measuring blood gases, electrolytes, BUN, hematocrit, activated clotting times and a variety of other analytes. Instruments are available from several manufacturers for most of these tests. Another category of POCT devices is self-contained immunoassays giving a simple positive or negative result. Urine pregnancy tests are the prototypes for these assays. More recent entrants include devices for drug abuse testing. Many other instruments and devices are in the pipeline. Such devices are commonly marketed in a manner similar to "me-too" drugs with little in the way of meaningful performance evaluations or comparisons. Even less information is available on whether use of these devices leads to actual improvement in patient care, when compared with testing in a central laboratory.

The assumption is that faster is always better. While this will certainly be true in some cases, it may not be in others. The only careful, prospective studies of the impact of POCT devices have come from Washington University. In one study, the use of POC coagulation testing during cardiopulmonary bypass surgery resulted in substantial reductions in O.R. time and in blood product use. In another, however, introduction of a POCT device for measuring electrolytes, BUN and glucose in the Emergency Department actually resulted in a slight increase in the average length of stay.

The clever technology that makes these instruments possible must be paid for. The result is that most test cartridges are relatively expensive, often more than 10 times the cost of reagents used for centralized testing. Medical staff time is also required to perform the test and complete the required documentation. For moderately complex tests, several minutes per result may be needed. The reduction in the volume of testing in the central lab due to POCT is typically small and may be nonexistent. The volume of blood glucose testing in the YNHH Clinical Chemistry Laboratory actually grew throughout the entire period during which bedside blood glucose monitoring was introduced. Because there is no meaningful reduction in the need for laboratory staff or instrumentation, savings in the central lab due to avoided tests is limited to the cost of the reagents. The sometimes considerable increase in expenses associated with POCT should be justified by clearly demonstrable improvements in patient care.

Point of Care Testing Committee and Coordinator

Because of the increasing importance of POCT, Yale-New Haven Hospital recently established a Point of Care Testing Committee. The primary mission of the POCT Committee is to assure the quality of POCT carried out at YNHH. While this includes assuring that POCT is done in compliance with regulations, the more important responsibility is assuring the achievement of the objective of these regulations, the production of accurate and reliable results. A related responsibility is assuring that POCT is carried out in a consistent manner throughout the hospital and that there is a single standard of quality for all laboratory testing, regardless of location.

A further responsibility is to advise the Hospital on the introduction of new POCT devices. In this capacity, the POCT Committee will function somewhat similarly to the Pharmacy and Therapeutics Committee, which reviews requests to add new drugs to the formulary. A major difference is that approval of a device by the POCT Committee does not guarantee its introduction. Approved POCT devices must also be successful in a competitive review with other proposed new programs. Persons wishing to propose a device for consideration should obtain an application form from the POCT Coordinator.

At the same time the POCT Committee was formed, the position of POCT Coordinator was also created. Medical technologist Peter Marone, MT(ASCP), MBA, currently holds the position. He can be reached by campus mail (CB 407), phone (5-5212), pager (128*2351) and e-mail (peter.marone@yale.edu). Responsibility for correct test performance and regulatory compliance lies with the personnel performing the tests and their supervisors. The POCT Coordinator can provide advice and limited assistance in meeting these responsibilities (There are several thousand medical staff who perform POCT and one coordinator.)

The first major task being undertaken by the Coordinator is to define the extent of POCT in the Hospital and its clinics. It is possible that not all POCT has yet been identified. If you are performing any form of patient testing and there have been no changes made recently to comply with the regulations, you should notify Mr. Marone. Any other questions regarding POCT raised by this article should also be addressed to Mr. Marone.

This brief overview is of necessity incomplete. The full regulations encompass several hundred pages in the Federal Register. Moreover, the regulations are continuing to evolve. For specific and up-to-date information, please contact the Laboratory Medicine Regulatory Compliance Specialist, John Chase, PhD (5-7154), or the POCT Coordinator, Peter Marone (5-5212).

References

1. Department of Health and Human Services. Clinical Laboratory Improvement Amendments of 1988; Final Rule (42 CFR Part 405, et al.). Federal Register, 1992; 57:7001-7288.
2. Despotis GJ, et al. The impact of heparin concentration and activated clotting time monitoring on blood conservation. A prospective, randomized evaluation in patients undergoing cardiac operation. J Thorac Cardiovasc Surg 1995;110:46-54.
3. Parvin CA, et al. Impact of point-of-care testing on patients' length of stay in a large emergency department. Clin Chem 1996;42:711-717.

Petrie M. Rainey, M.D., Ph.D. Peter Marone, MT(ASCP), MBA

Table 1

Table 1. WAIVED TESTS

(These are simple tests that are minimally regulated -- See Table 3) Urinalysis dipsticks* Whole blood glucose* Hemoccult* Gastroccult* Urine pregnancy test (visual color comparison only)* pH testing for body fluids other than blood (qualitative color comparisons only)* Ovulation test (visual color comparison only) Erythrocyte sedimentation rate (non-automated) Hemoglobin-copper sulfate (non-automated) Hemoglobin by single analyte instruments Spun microhematocrit Rapid screen for Group A Streptococcus. (Quidel Quick View only) Cholesterol (Cholestech LDX, Chemtrak Accu-Check and Advance Care only) HDL cholesterol (Cholestech LDX only) Triglycerides (Cholestech LDX only) Screening test for Helicobacter pylori (Pyloritek Test only) *Point-of-Care tests known to be performed at Yale-New Haven Hospital

Table 2

Table 2. PROVIDER PERFORMED MICROSCOPY

Moderately complex tests that are treated as waived tests if the CLIA certificate lists only these and waived tests. See text) All direct wet mount preparations for the presences or absence of bacteria, fungi, parasites, and human cellular elements. All potassium hydroxide (KOH) preparations Pinworm examinations Fern tests Post-coital direct, qualitative examinations of vaginal or cervical mucous Urine sediment examinations Fecal leukocyte examinations Qualitative semen analysis (limited to the presence or absence of sperm and the detection of motility).

Table 3

Table 3. JCAHO REQUIREMENTS FOR WAIVED TESTING

The organization has assessed the use of waived testing and determined the extent to which it will be used The individuals responsible for performing waived testing and for direction and supervision of the testing activities have been identified The staff performing waived testing have adequate, specific training and orientation to perform tests and demonstrate satisfactory levels of competence. For each waived test performed, there are specific policies and procedures available to the person performing the test. Quality control checks are conducted for each procedure on a regular basis as defined by the organization. Quality control records are properly documented and maintained.

Table 4

Table 4. MAJOR REQUIREMENTS FOR MODERATELY COMPLEX TESTING

Satisfactory participation in an accredited proficiency testing program with at least three sets of unknowns per year. A documented Quality Control program with supervisory review of QC results at least weekly Complete written procedures in compliance with National Committee for Clinical Laboratory Standards (NCCLS) GP2-A2 document and available to all testing personnel. An adequate system for reporting results, including establishing critical values and documenting who performed each test. Proper labeling of reagents as to strength, storage requirements, date prepared or reveived, date placed in service and expiration date. Documented criteria for determining the frequency of recalibration Use of two or more controls and evaluation of their results with each analytical run A system for preventive maintenance and the regular checking and documentation of operating characteristics for all instruments and equipment. Documented specific training in the test procedure and periodic certification of competence for all testing personnel.