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Protocols for bedside testing.

Clinical testing in ward sideroom laboratories once produced much of the test data used in patient care decisions. For the last three decades, however, central laboratories have provided clinically important test information that could not be produced reliably or economically in ward labs. As a result, these central labs became the dominant testing site for acutely ill patients.

Now the pendulum is starting to swing back. Development of small, inexpensive, easy-to-operate laboratory systems has dramatically expanded clinical testing at the patient's bedside. Virtually all hospitals perform bedside glucoses, and many ward labs perform tests for scalp pH, blood gases, electrolytes, bilirubin, creatinine, urea, and some therapeutic drug monitoring.

These tests are run by physicians, nurses, and other ward personnel, most of whom have little or no formal training in clinical lab procedures. Bedside testing is generally a small part of their professional responsibilities and usually accorded less value than activities more directly related to patient care.

The staff responsible for bedside testing tends to be mobile, moving frequently to different locations in the hospital or in the community. Bedside test methods may vary at each location and require different procedures for systems that superficially appear to operate similarly. There is evidence that bedside test data produced by such staff members may be less reliable than data produced by the technically trained staff in the hospital's central laboratory.'

Nevertheless, locations outside the central lab can produce acceptable test results. Although bedside test data have shown excessive variability or inaccuracy at some institutions,(1), that is not always the case.(2) It is up to each institution to validate that all results used in patient care decisions are indeed reliable. Laboratorians should play an active role in this effort.

* Identifying test sites. The first step in assessing bedside testing reliability is to identify all test sites and staff members performing tests. This initial inventory should cover every section of the hospital, including general medicine and surgical units, operating rooms, intensive care units, infant care units, and the clinics. A check with the pharmacy and central supply on their distribution of bedside test supplies may unearth test sites that did not turn up on direct inquiry to patient care units.

* Recognizing problems, validating reliability. After the inventory of current bedside testing is completed, the institution can proceed to determine whether reliability is a problem at any of the test sites. At this point, it is essential to involve hospital administration because of the risk management (malpractice) issues, and nursing administration because its professional and support staffs usually perform the tests.

It may be useful, because of the division of administrative responsibilities at a particular hospital, to involve representatives of other units at this early stage. Later strategies to correct problems have a better chance of succeeding if all parties concerned with bedside testing take part in the problem recognition phase.

The study group needs to determine which bedside tests pose the greatest risk for the hospital, either because of widespread use or because of likely adverse outcomes if patient management decisions are based on erroneous or inaccurate test results. The central laboratory is in a good position to assess the different degrees of risk. This would enable the study group to develop a prioritized list of bedside tests to be evaluated (the review should cover all tests eventually).

Bedside glucose testing, for example, may be a primary concern since it is generally performed by a large number of nurses on all shifts, throughout the hospital. Alternatively, scalp pHs performed in the delivery suite or serum potassiums performed in the operating room could take higher priority because of the possible adverse consequences of using an erroneous result in such critical settings.

The study group then must develop a way to evaluate the reliability of results that could jeopardize patients if inaccurate. Such a study should examine all the usual steps in the testing process-patient preparation, specimen collection, functioning of the analytic system, the staff's ability to produce accurate and precise results, and entering of results in the patient's medical record.

One relatively simple way to evaluate the precision and accuracy of bedside testing is to compare the results with those from parallel testing of the same specimens analyzed in the hospital's central lab. In a study we performed in an intermediate-care nursery, the ward nurses agreed to perform a capillary blood glucose test whenever any specimen was to be sent on to the main lab. The laboratory glucose results, reported without charge to the patient, were compared with the results obtained by the nurses.(1)

Sometimes, it may be necessary to develop "pseudospecimens" to monitor the analyses being performed. In our capillary glucose study in the nursery, it became apparent that the high hematocrit in newborns might contribute significantly to result inaccuracy. So umbilical vein blood from normal deliveries was collected after the cord had been tied off and cut. The laboratory then prepared pseudospecimens with different hematocrits and glucose concentrations. After the glucose levels were measured, the pseudospecimens were delivered, on ice, for testing by the nurses.

Follow-up retesting in the lab demonstrated that the glucose levels had not changed significantly during the study period. This study showed that the high hematocrit in many of the infants' specimens was an important factor contributing to inaccurate capillary glucose determinations in the nursery.

A small pilot study of this kind, comparing the results of split specimens processed at bedside and in the central laboratory, can become a basis for initial evaluation of testing reliability. It may be necessary to employ other approaches for some tests, however, in view of specimen requirements (whole blood versus serum or plasma), the test modality (hematology , coagulation, or microbiology tests), or other aspects of the testing process, such as specimen collection, result recording, or reporting.

For example, documentation of the transcription error rate is as important an issue in quality management as demonstrating a system's precision and accuracy. If an analytic system can store test results on patients and quality control specimens, it may be useful to check the stored values against those entered in the patients' medical records. Obviously, the group members should agree that such studies are necessary and that they deal with real problems.

* Compliance with regulatory requirements. A decision to develop a quality management program for bedside testing can only result if the hospital leadership recognizes that a problem exists and that it could jeopardize patient care. Hospitals are required to identify potential problem areas and take corrective action.

For several years, the Joint Commission on Accreditation of Healthcare Organizations has clearly indicated its concerns about the reliability of all testing done in hospitals, regardless of the test site.(1) According to Joint Commission guidelines, health care facilities that offer laboratory testing without laboratory supervision must insure that:

+ Persons responsible for test performance and those responsible for overseeing testing activity are identified.

+ Persons performing tests have adequate, specific training and orientation on the tests offered.

+ Current, readily available policies and procedures are provided, including guidelines on specimen collection and preservation, instrument calibration, test performance, quality control, and the remedial action when QC results fall outside preset limits.

+ Quality control checks using suitable positive and negative reference specimens are done on all tests performed each day.

+ Appropriate test and quality control records are being maintained.

The Veterans Administration requires that all laboratory testing, regardless of location, comply with the standards and quality assurance requirements that apply to the clinical laboratory.(1) Although Medicare does not currently have specific guidelines addressing quality management standards for bedside testing, it does expect hospital respiratory care services performing tests used in patient care to meet the same quality management requirements as the hospital's clinical laboratory.

Identifying and documenting potential problems with bedside testing helps convince hospital administration, nursing services, and the medical staff that a quality management program is necessary to insure the reliability of test results used in patient care decisions. It is also an essential step in convincing these groups to allocate the resources that are needed to support the develop an operation of such a program.

Next month's article will discuss possible remedial strategies, including staff training, periodic maintenance, staff competency assessment, and routine monitoring of system functionality and accuracy.

1. Betsey, R.; Morrison, J.I.; Whitlow, K.J.; Baer, D.M.; Nelson. S.; and Hardwick, D.F. Managing bedside glucose testing in the hospital. JAMA 258: 1634-1638, 1987.

2. Godine, J.E.; Hurxthal, K.; and Nathan, D.M. Bedside capillary glucose measurements by staff nurses in a general hospital. Am. J. Med. 80: 803-806, 1986.
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Title Annotation:part 1
Author:Belsey, Richard; Baer, Daniel M.
Publication:Medical Laboratory Observer
Date:Feb 1, 1988
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