The role of the laboratorian on the critical care team.
History has shown that once reliable, advanced technology is available--whether military weapons or laboratory equipment--it will be used. Although some turf-conscious laboratorians may continue to resist the diaspora of lab testing, its advance has become inevitable. The process by which tests are dispersed, while unique to each facility, will involve common considerations and problems to be solved.
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has scrutinized point-of-care testing within hospitals with an eye to firmer regulation. The 1990 standards require that laboratory testing include guidelines for quality control, quality assurance, test result reporting, and proficiency testing. The final CLIA '88 regulations will address these issues in excruciating detail. Whether test methodology, test complexity, or a mixture of both prevails, all are likely to be affected.
Laboratorians have the knowledge and ability to assure that point-of-care testing will be done correctly. It is our professional responsibility to the patient to become involved. Point-of-care testing is quickly moving forward in critical care settings such as intensive care units and open heart surgery to improve test turnaround time. This article will address some specific ways in which laboratorians can serve on the critical care team.
* Assessing need. The laboratory should become involved at the earliest possible stage when the need for point-of-care testing in the critical care setting is discussed. The usual impetus is to speed test result reporting. Each laboratory tends to be well aware of any deficiencies in that area.
Turnaround time studies can be done and the results compared with an established standard of care. Ideally, hospitals should establish a committee that will meet regularly to evaluate requests for decentralized testing.
Many issues must be examined, including cost, testing personnel, convenience, and revenue. The overriding questions to answer objectively are these: Will point-of-care testing lead to improved patient outcome? Will that outcome justify the cost? Finding the answers will require multidisciplinary discussion in which the laboratory team should play a highly vocal part.
* Forming the team. The laboratory team should include the medical director of the laboratory, the administrative director or equivalent, and any appropriate section supervisors or lead technologists. Some hospital laboratories have an alternate-site testing technologist or ancillary testing coordinator, who should be invited to participate as well.
In leading the team, the medical director and administrative director must bc able to work effectively with their counterparts from the critical care areas. In most hospitals, representatives will be selected from anesthesia, critical care medicine, cardiac surgery, and hospital administration. The decision to start point-of-care testing may take months or, if the need is great, a few days. Important issues to be decided include who will ultimately be responsible for testing, the testing method to be used, which personnel will perform the tests, how test results will be reported, and what procedure will be used for test charging.
* Supervisory control. Each institution must establish responsibility for point-of-care testing. Laboratory control is best. The laboratory that resists taking charge may find its resources progressively dwindling over the next several years as point-of-care testing increases, not only in critical care areas but also on the nursing units, clinics, and ancillary medical facilities. The laboratory should control the program; medical technologists, nurses, or ancillary health care personnel should perform the testing.
The laboratory is responsible for establishing written policies and procedures that include documentation of the entire testing process. The policies and procedures must follow all regulatory standards, including those of the JCAHO, CLIA, and state and local agencies. Education and training of testing personnel fall under the aegis of the laboratory as well. Close monitoring and periodic in-service training sessions are required. Proficiency testing must be performed according to regulatory guidelines.
* Testing methodology. The laboratory is expected to select the test method and instrumentation that will best serve the requirements of the critical care team. Tests most frequently desired are blood gas analysis, sodium, potassium, ionized calcium, hematocrit/hemoglobin, and glucose.
A number of analyzers combine blood gas analysis with other measurements. Currently, the major difference between instruments of this type is whether they analyze blood gas the conventional way or with new miniaturized disposable polymer electrode systems and tonometered disposable gas bags. The choice of instrumentation will depend primarily on required turnaround times and the expertise and number of personnel who will perform the tests. Conventional blood gas analysis with the additional tests may incur lower costs for reagents and disposables but can be performed only by highly trained medical technologists or respiratory technologists. Conventional blood gas instruments can be finicky to deal with at times and require extensive technical understanding and troubleshooting ability on the part of the operator. The new cartridge-based technology, however, is simple enough to operate and troubleshoot that it can be handled by certain other ancillary health care personnel.
The cost per test is competitive with that of conventional technology or even lower because it requires less maintenance and troubleshooting and ultimately reflects less downtime. Each institution should do a cost analysis study before the tests and methods are selected. Instrumentation is available in sufficient variety to satisfy the requirements of virtually every critical care setting.
Method evaluation is extremely important. Instrumentation that works well in the centralized laboratory may be a disaster in the critical care setting. Ideally, each instrument under consideration should be evaluated separately, once within the centralized lab close to the reference method instrument and again in the critical care area.
The first evaluation will minimize variations in results between different operators and in alterations in specimens during transport, always a problem in evaluating two different blood gas instruments (such as the outgassing of p|O.sub.2~ during transport to the lab). The second evaluation will allow a realistic assessment of instrument performance by all members of the critical care team.
After adequate training and documentation, those who will actually operate the instruments should perform a trial run on all tests. Standard method validation studies, including linearity, precision, accuracy, and sensitivity, should be done and documented. Periodic correlation studies should be performed monthly or quarterly to assure that the point-of-care method is reliable, and in addition whenever a new operator begins to use the instrument.
* Who should test. Deciding who will perform the testing may be the most vexing issue facing the critical care team. Laboratory directors are usually loath to relinquish testing to nonlaboratory personnel, and with good reason, since the laboratory director is responsible for the quality of testing in the institution. Medical technologists are rarely enthusiastic about spending a day in a critical care unit experiencing long periods of boredom punctuated by intense, stressful activity. Nurses already have a tremendous number of tasks to accomplish and usually look upon performing laboratory testing as a fearful nuisance. Respiratory technologists may be comfortable with blood gas testing but not want to become involved with other kinds. Perfusionists are an exception; and with the proper technology and motivation, they can perform laboratory testing adequately in the cardiac surgery setting.
The key characteristic required is motivation. Without it, point-of-care testing will not be successful. Realistically, the decision concerning who will do the testing will depend on a variety of factors unique to each institution. Regulatory factors are of course predominant; in some states, only laboratory technologists or technicians are permitted to perform tests. Finally, no one yet knows what personnel standards the Health Care Financing Administration will place in the final version of CLIA '88.
The laboratory of each institution must consider its own potential loss of personnel and revenue. The number of nonlaboratory personnel doing point-of-care testing within an institution is an additional concern. It is much easier to monitor and supervise three perfusionists in cardiac surgery than 20 or more nurses in an intensive care unit. The Government's use of proficiency testing as a punitive tool bearing the threat of sanctions makes the decision of who will do the testing a potential cause of ulcers in many a laboratory manager. Unless the number of nonlaboratory individuals who perform testing is kept manageable, and all are well motivated with iron-clad supervision, it is safer to have laboratory personnel do point-of-care testing.
* Reporting results. Result entry must use a standard format. If the hospital has a laboratory computer, test results should be entered and verified quickly, optimally within a few hours. This is extremely important for adequate documentation. Any patient's chart may be examined in court years later. Without a retrievable report, it will be impossible to prove that a patient was adequately oxygenated when removed from the bypass pump. When evidence is needed, hand-written perfusion records are not considered as satisfactory as computer-generated reports.
The test result audit trail should be clear. Documentation should include the code number of the person performing the test as well as the date, time, and location at which it was performed. A computer format should delineate tests done at the point of care from those performed in the central laboratory. An ideal setup provides a computer interface between the point-of-care testing instrument and the laboratory computer. At least one point-of-care blood gas/electrolyte instrument now on the market can download patient results on a conventional floppy disk for subsequent entry into the laboratory computer.
* Test charging. The department that has the responsibility for point-of-care testing should handle its charges as well. Current procedural terminology codes should be used. Proper documentation of charging must be made available in insurance audits.
* Evaluating results. An overlooked function of the laboratorian on the critical care team is to evaluate any effects of the testing on patient outcome. Such studies can range from simple to very complex. One example might be monitoring the time required to remove patients from the perfusion pump in cardiac surgery with and without point-of-care testing. These patients could then be studied over time for any neurologic sequelae. Similar outcome studies could be set up for patients in the intensive care and emergency departments. Documentation and even publication of studies would encourage interdepartmental cooperation and enhance the institution's program of continual quality improvement.
Patient outcome studies are the most important way to evaluate point-of-care testing. Others include workload and cost considerations. The laboratory's workload statistics must reflect the time spent on supervisory, training, and clerical functions involved with the testing. The cost of testing should be routinely monitored as with any workstation inside the central laboratory.
* Pitfalls. The personality of the laboratory director who learns to supervise point-of-care testing successfully must include an element of fearlessness balanced by a healthy dose of skepticism. No one likes unpleasant surprises. It is crucial to be aware of all applicable local, state, and Federal regulations governing such testing and to adhere to them.
Conflicts within and outside the laboratory may occur during the initial stages of deciding whether point-of-care testing should be done. Frank discussion among all members of the critical care team will help break down such barriers. Everyone must come to realize that quality patient care is the goal.
The out-of-sight, out-of-mind syndrome can be a significant problem for the laboratorian if nonlaboratory personnel perform the tests. It is natural to feel out of place in unfamiliar settings, a predictable response of laboratorians if asked to work in critical care areas. Routine point-of-care testing rounds are a component of adequate supervisory control. In this way, small problems can be fixed before they become big ones. Testing personnel feel they are part of a team; rapport between departments is enhanced.
The laboratory should watch for such potential snags as insufficient training of operators, inadequate maintenance or calibration of instruments, poor documentation of quality control measures, and poor reporting of test results. An especially serious problem is testing by untrained, unauthorized personnel. One point-of-care testing instrument has system controls and security codes revealed only to authorized operators. Conceivably, those operators might share the code with unauthorized individuals. To prevent this, it must be made clear to all operators that testing by unauthorized personnel is strictly forbidden.
* Success story. Our laboratory successfully began point-of-care testing in the cardiac surgery suite in early 1990. The lab already had a pneumatic tube system in place that connected directly with the suite. Even in the best of circumstances, however, turnaround time for blood gas results was 15 minutes. When workload was heavy, obtaining hematocrit and potassium results could take as long as 45 minutes.
We considered using a whole-blood analyzer in the central laboratory that assessed blood gas, sodium, potassium, and hematocrit. We found in evaluating the system that it failed to improve our turnaround time significantly.
We then intensively evaluated an instrument that could be used in the open heart surgery room. Supervised by the lab, perfusionists did the tests. It worked well and remains in operation. Turnaround time for blood gas, sodium, potassium, ionized calcium, and hematocrit determinations is now two minutes.
Initial evaluation studies and ongoing correlation studies have revealed no problems with the technology. All three perfusionists who do the testing are highly motivated.
* Advantages. Point-of-care testing presents medical technologists with a number of ways to expand their roles. First, those charged with supervising the testing find job enhancement within the laboratory. Second, they are recognized throughout the hospital not only for doing the testing but also for spending time and effort in providing training, in-service presentations, and supervisory visits to others. Third, the medical community at large grants additional professional respect and cooperation to laboratorians as they consult with employees of labs in clinics and physicians' offices.
By viewing point-of-care testing as an opportunity rather than as a threat, and by learning new skills and sharing them with others, the laboratorian becomes an increasingly effective and appreciated member of the health care team.
Jackson O. Pemberton, M.D. is laboratory medical director at St. Elizabeth Medical Center, Edgewood, Ky.
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|Title Annotation:||MLO Special Issue: Point-of-Care Testing|
|Author:||Pemberton, Jackson O.|
|Publication:||Medical Laboratory Observer|
|Date:||Sep 1, 1991|
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