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Meeting the challenge of bedside testing; technology will continue to push patient testing beyond the bounds of the laboratory.

For many years now, simple patient tests have been analyzed outside the clinical laboratory.

Determinations of urine glucose and specific gravity are commonly performed in hospital wards, outpatient clinics, and physicians' offices. But recent advances in technology have made other, more sophisticated tests available at such locations, and increased the pressure to perform more and more tests beyond the laboratory's walls.

This new boom in out-of-laboratory testing has been fueled by changing reimbursement policies for private clinicians, independent labs, and hospitals. The dignostics industry is turning more and more attention to developing systems for physicians' offices and hospital wards.

Many of the new systems lend themselves to use outside the traditional lab setting. Reagent sticks with segments for detection of nitrite and leukocyte esterase, for example, can be used to detect bacteriuria and can sometimes replace standard urinalysis and culture. The specific gravity of urine may be estimated with a reagent stick that can substitute for other methods in certain situations. Capillary or venous blood glucose analysis can be performed with a strip containing all needed reagents. Nursing personnel or patients themselves can estimate the strip results visually or with an instrument.

Several manufacturers have introduced rather sophisticated dry reagent chemistry systems that offer a large menu of clincially important tests. Among them are the SeralyzerS, from the Ames Division of Miles Laboratories, and the Ektachem DT-60 from Eastman Kodak. Other systems will be available from several other major manufacturers soon.

Preliminary evaluations indicate these systems can produce highly accurate and precise chemistry results in the hands of relatively untrained personnel. The test menu they offer will be very useful in hospital clinics or critical care units. Availability of testing systems for electrolytes, glucose, and theophylline may prompt clinicians to request these instruments in clinical areas. Blood gas instruments asre already frequently reuested for coronary catheterization and pulmonary function laboratories and surgery.

Now we come to an important issue. Decentralized testing beyond the control of the clinical laboratory raises the disturbing threat of a decline in quality. For certain tests, it is imperative that the sample be drawn at the appropriate time. This is especially crucial for diabetic glucose levels; these samples must be drawn with knowledge of when the patient's last food intake and insulin administration occurred. In therapeutic drug monitoring, we must know when the drug was last given.

Even the seemingly simple dry reagent chemistry systems use reagent strips or films that may deteriorte if not stored or handled properly. Simple instruments, too, require proper maintenance to function correctly. Any system needs a periodic run of standards and controls to insure validity.

Tests must be performed according to recommended techniques, in the laboratory or outside it. Timing and incubation steps must be scrupulously adhered to, with no deviations allowed. Test s results should bge adequately documented, indicating who performed the test and when. Finally, records should be kept up to date, including a log of tests, quality control and standardization results, and instrument maintenance. All these steps, of course, are second natures to lab technologists familiar with accreditation requirements. Other medical personnel, however, may not even know about them, much less consider them important.

Legal questions also arise when tests are performed outside the laboratory. Case law has established that the person responsible for the testing is held to the same standards of practice and proficiency that apply in the laboratory. If malpractice is alleged, the defendant must show that the s same level of care and quality control was performed as if the test were done in a clinicla lab.

Several Federal and accrediting agencies have established policies relating to ancillary lab testing within hospitals. The College of American Pathologists will inspect and accredit limited-function labs within institutions that apply for this inspection. The Joint Commission on Accreditation of Hospitals has issued guidelines indicating that ancillary testing activities must conform to the same standardsa s clinical labs. The JCAH requires that an institution individually certify any laboratories staffed by nursing and non-laboratory personnel, and it establishes quality assurance and record-keeping requirements as well (Figure I).

The Veterans Administration also regulates testing not performed by the laboratory service. the special-function labs that perform this testing must be inspected and accredited, and they must also subscirbe to the CAP's proficiency testing program in order to maintain JCAH accreditation.

The pressures pushing testing outside the conventional lab setting will increase, and we must develop plans to meet the challenge of maintaining quality. Let's examine a number of alternative responses to the situation.

* Prohibition. We don't recommend this solution, for a number of reasons. If all out-of-lab testing is prohibited, it will be driven underground, but it won't go away. Some tests, like the reagent strip for blood glucose, are genuinely valuable in patient care. As we will discuss in a moment, it would be far better to help those who do perform these tests to do them well and accurately, wherever the testing process takes place.

* Permissiveness. Taking the opposite view, we could make no attempt to control testing performed away from the lab. This would probably lead to a proliferation of testing for blood gases, therapeutic drugs, electrolytes, glucose, and other analytes, without standardization or correlation with existing lab methods. Some of this testing would be performed well--and some would produce highly erroneous results. This, too, is obviously a poor solution.

* Lab supervision. We could require that all testing be done under the administrative control of the clinical laboratory. but it would be difficult for the lab to gain any control over the many nurses and other personnel performing dipstick testing. It is virtually impossible to effectively control employees who are not under the department's direct supervision. In all likelihood, they would often fail to perform or neglect to record imposed quality control procedures, and testing quality would be unlikely to improve.

* Lab participation and employee certification. We believe this approach to be the most workable. The laboratory should aprticipate in the decision to develop an ancillary lab. Once the decision is made, the lab should promote compatible results by providing advice on the scope of testing, methods, and equipment. This consultation should also cover record keeping, quality control, and staff education.

The hospital should require that personnel performing out-of-laboratory testing be certified by their respective departments. With the lab's cooperation, the nursing service and other services conducting testing could require proficiency surveys and periodic recertification of all employees performing tests. This program should include informal bedsie testing, such as blood glucose dipsticks, along with the activities of more formal satellite labs.

As part of the hospital's quality assurance program, these ancillary testing sites would need ongoing monitoring of quality control records, patient logs, and equipment maintenance logs. Designated special-function laboratories, such as a small blood-gas laboratory, would have to be inspected and accredited by the CAP or JCAH. This approach is already being explored: The Veterans Administration has recently developed a program in conjunction with the CAP to permit inspection and accreditation of distributed ancillary labs and to provide them with appropriate proficiency surveys.

We are convinced that the laboratory must play a role in the bedside and satellite testing boom. Our best opportunity for guaranteeing efficiency, accuracy, and consistency from out-of-lab testing lies in a program that demands a laboratory level of quality assurance, administered by the hospital department performing the testing.
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Author:Baer, Daniel M.; Belsey, Richard E.
Publication:Medical Laboratory Observer
Date:Aug 1, 1985
Previous Article:Laboratory careers: mixed signals for the future.
Next Article:Keeping the microbiology lab safe.

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