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Stat testing in the new CLIA era.

The decade of the '80s was unique to health care providers in its intense and unrelenting focus on cost containment for medical services. Laboratories were plagued by the mutually exclusive requirements of providing high-quality laboratory testing on demand while maintaining tight fiscal accountability. When the demand rose for more personalized services, specifically Stat testing, solutions became increasingly complex.

The more Stat testing a laboratory was performing, the less efficient and the more costly that service became. Strategies to reduce Stat testing regularly appeared in the clinical laboratory literature. That these recommendations were not entirely heeded is evident from the number of such articles continuing to be published in the 1990s.

The longstanding issues of lengthening turnaround time (TAT) and increasing demands for Stat results remain. These issues originated in the 1960s and persisted through the two decades that followed, to the extent that their resolution was occasionally suggested as a measure of the quality of laboratory performance. The response for the '90s requires innovation and radical redirection of resources that centers on patients' needs. What must happen is a transformation, probably to a decentralized system of a smaller number of carefully targeted laboratory tests. These assays, appropriate for each patient's diagnosis and condition, are likely to be provided by fewer laboratorians than in the past or at present.

* Explosion of technology. Problems related to TAT and excessive Stat requests surfaced following the explosion of laboratory technologies during the 1960s and '70s. Instrumentation with new capabilities expanded the menu of laboratory data available to clinicians for diagnosis and monitoring of patients to a degree that many in the laboratory and elsewhere found excessive.

Previously, the laboratories of the 1940s and '50s had excelled in manual performance of single requests for selected analytes that were generally of precise clinical utility. With the rapid transition to the automated multiparameter screening mode of the '60s and '70s--the pre-DRG era--an ethical dilemma presented itself, posed by the creation of far more data for each patient than any clinician needed or wanted.

Despite an eloquent plea by George D. Lundberg, M.D., editor-in-chief of scientific publications at the American Medical Association, that laboratory services retain the proper patient-oriented focus, [1] follow-on testing (the additional testing performed when abnormal results are found during screening) expanded geometrically. The market had been created by the instruments themselves, based on the greater statistical probability of abnormal results when large numbers of analytes are screened. Laboratorians encouraged this screening mentality, which seemed to offer opportunities to accumulate data and as a valid justification of the expense of the highly sophisticated instruments that were streamlining and revolutionizing laboratory operations. Continuing concern for the ignored wisdom of customizing services for needs of individual patients surfaced in the form of demands for more timely data--translated as increased numbers of Stat requests.

From 1981 to 1986, people participating in an ASCP-sponsored workshop series we co-directed about the laboratory's role in controlling Stats addressed the scope of the Stat problem and the laboratory's responsibility to the patient as most important user of the health care system. By then, the focus of many laboratories had shifted away from the patient, frequently as interpreted by the patient's private physician, to the needs or wishes of the laboratory.

In some laboratories, for example, routine instrument maintenance was performed ar the beginning was performed at the beginning of the day shift. This practice irretrievably delayed the delivery of test results to physicians, who typically make early morning hospital patient rounds between 6:00 and 8:30 a.m. before embarking on a full day of scheduled office visits. Missing their rounds might mean losing a day of treatment.

To suit the convenience of the laboratory staff and to make more efficient use of complex analytical instruments, the lab provided patient data at ever-lengthening intervals from the time ordered. The longer the delay, the larger the number of Stat orders--to the dismay and consternation of laboratorians whose carefully planned schedules were disrupted by the nuisance of physician orders requesting test results on a different schedule. Ironically, while understanding the importance defined by each medical staff, even today some laboratories continue to resist accommodating their primary client, the patient.

* TAT vs. routine testing. Stat requests predictably increase when routine testing takes longer than is satisfactory to clinicians. A repeat survey of laboratories in 1988 comparing TAT post-DRG with comparable information obtained in 1980 showed that for the majority (56%) of reporting laboratories, TAT either had not changed or had lengthened. [2] In addition, complaints about inadequate TAT were received by more labs in 1988 than in 1980. Most involved delays in the receipt of results of chemistry tests (64%) and hematology tests (29%) by personnel in emergency rooms, critical care areas, and the surgical suite.

This persistent delay in laboratory reporting probably accounts for the recent emphasis on the development and subsequent rapid acceptance of simplified instrumentation based on whole blood testing that accomplishes the majority of testing required Stat by critical care areas. The portable instruments are designed for use in or immediately adjacent to the patient areas in which the information is required. The clear move to decentralization, supported by the JCAHO and other accrediting agencies, should provide new opportunities for laboratorians to solve creatively quality assurance issues such as selection, training, and competency testing of personnel; evaluation and follow-up of proficiency testing errors; quality control of equipment and reagents, including trend or drift analysis; preventive maintenance programs for instruments; and validation of new instrumentation prior to on-line use.

Many respondents to the survey cited above believed they could improve their TAT by purchasing new equipment (30%), trying to change ordering habits (that is, reducing the number of Stats being requested (28%), adding staff (23%), and/or computerization (16%), [3] Laboratorians will face severe restrictions on purchasing new instruments in the future as capital equipment is gradually folded into hospital DRG reimbursement and cost becomes even more a factor in future Medicare payment decisions. Nevertheless, computerization and the purchase of instruments are too important to improvement to be delayed.

Today we find guidelines for instrumentation decisions for Stat testing readily available, unlike the situation fo the early 1980s. The prospect of adding staff has become unrealistic and impractical as the number of persons who are practicing laboratory technology or training to do so decreases. The institutions themselves surveyed in the MLO study cited above [3] documented that efforts to reduce unnecessary Stats were unsuccessful in 15% of respondents' labs, as were efforts to change physicians' test-ordering patterns (15%). Laboratorians should welcome the challenge of the '90s to develop new solutions to the "Stat problems."

* Innovation. The foundation of the current strategy for timely availability (rapid TAT) of necessary (true Stat) laboratory results must be concern for the patient. The strategy will begin with appropriate and detailed cost analysis of the alternatives. The physical arrangements of laboratory services must be taken into account. The next decision, purchase of appropriate instrumentation, will depend on the results of cost analysis. The most difficult factor entails innovative approaches to staffing, considering that having a sufficient number of medical technologists on staff is rapidly becoming a pleasant memory. The role of technologists in the new patient-based Stat testing system will be redefined to conserve this precious human resource.

The CLIA '88 regulations that demand proficiency testing of technical performance (except for waivered analytes) would reduce the need for credentialing. One reason for CLIA's intensified PT requirements may well have been the forecasted shortage of medical technologists.

Finally, new emphasis on patient outcome will drive quality management of laboratory services. The problem of Stat requests will disappear during the current decade as the total character of delivery of such services is transformed from centralized laboratories to decentralized specialized services located physically closer to the patient.

[1] Lundberg, G.D. "Managing the Patient-Focused Laboratory." Oradell, N.J., Medical Economics Books, 1975.

[2] Hallam, K. Turnaround time: Speeding up, but is it fast enough? (Special Report, Part 1). MLO 20(8):28-34, August 1988.

[3] Hallam, K. Turnaround time: How labs improve their performance (Special Report, Part II). MLO 20(8):39-46, August 1988.
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Title Annotation:Clinical Laboratories Improvement Act
Author:Sazama, Kathleen
Publication:Medical Laboratory Observer
Article Type:Cover Story
Date:Dec 1, 1991
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