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Needed: consultants to physicians' office labs.

Laboratorians have a new outlet for promoting high-quality health care: They can help private practice physicians produce reliable test results in office labs. The same is true in distributed hospital laboratories in the ward, OR, and other locations.

Changing technical, economic, and political trends have third-party payers and regulators talking earnestly about the quality of testing performed in physicians' offices and hospital wards. Meanwhile, private practice testing is booming. By one estimate, some 190,000 physicians analyze lab tests in their offices--half of all outpatient tests.

Studies indicate that from 71 to 97 per cent of primary-care practices perform tests on the premises. Health insurance carriers offer no reliable figures, but data from providers in Germany show that lab testing constitutes 17 per cent of reimbursement for ambulatory services there.

Across the United States, blood glucose is the most common in-office chemistry analyte, while approximately 90 per cent of offices perform urinalyses. In North Carolina and Ohio, 70 per cent of all internists and family practitioners reportedly analyze throat cultures, and 61 per cent examine urine cultures. In Idaho, 52 per cent of physicians do their own WBC counts, 71 per cent measure hematocrit, 90 per cent perform microscopic urinalysis, and 58 per cent use slide assays to test for infectious mononucleosis.

This activity represents a substantial opportunity for clinical laboratory professionals to serve as consultants to physicians with office labs. The extent and distribution of hospital testing outside the clinical lab is not as well defined, but decentralized lab work--on wards and in the OR and ER--is definitely rising too.

What is causing this growth? Changing technology is one factor. Dry reagent systems for analyzing chemical composition of urine are established clinical tools. Similar methods for monitoring blood glucose levels at home, in the office, and at bedside have become important in diabetes management. This technology also provides an easy, rapid, and fairly reliable way to identify bacteriuria in the office.

Recently, several manufacturers have introduced inexpensive chemistry analyzers that encourage office testing. Some systems use conventional wet reagent systems; others, newer dry reagent technology. The latter gives physicians broad test capability on blood specimens: glucose, BUN, uric acid, LDH, CK, creatinine, hemoglobin, total bilirubin, AST, ALT, triglycerides, cholesterol, sodium, potassium, and theophylline. As many as 25 common analytes--including phenytoin and phenobarbital--will soon be available using dry reagent technology.

Of course, changes wrought by DRGs are also drawing lab work into private practice offices. Reimbursement formulas encourage preadmission testing. They also discourage physicians from using referral laboratories for outpatient testing by eliminating markups for send-outs and reducing payment for blood drawing.

The shifting distribution of physicians to rural communities has also added to the appeal of in-office testing. A practitioner in an isolated area can obtain data while a patient is still in the office, avoiding days' delay between the first visit and results. This is a great advantage when adjusting drug therapy or monitoring potassium levels, for example.

Who exactly carries out testing in physician's offices? Doctors perform about one-third of the test load; staff with some formal technician training account for another third.

Office assistants typically receive about 80 hours of lab training during a one-year, full-time course of study. They are usually taught to collect specimens (including some microbiology specimens for plating and isolation) and to perform chemical urinalysis with dry reagent dipsticks, simple hematology analysis, Gram stains, urine pregnancy tests, and mononucleosis slide tests.

Slightly more than one-third of private practice lab testing, however, is performed by employees who have no formal laboratory training. That's one reason for the widespread concern over the growth of testing in offices and on hospital wards.

Data on this issue are fragmentary, but a few relevant observations have been made. In Idaho, all labs, including those within physicians' offices, subscribe to a mandatory proficiency testing program. When the program first took wing, proficiency surveys from office labs revealed excessively high numbers of significant test errors. Inspections and questionnaires showed that quality assurance practices were scarce in most of the state's private practice laboratories. Standardization was uncommon, controls were seldom run with tests, and lab records were frequently nonexistent!

After quality assurance practices became mandatory, proficiency improved and errors fell to an acceptable level. A California study supported the findings: State-licensed office labs, which must conform to standardized QC practices, perform significantly better in proficiency testing surveys than their unlicensed counterparts.

Given this background, what are the needs of the physician with an office lab or the hospital with a distributed lab? What opportunities spring up for pathologists, technologists, and other lab professionals?

The practicing physician is responsible for correct interpretation of laboratory data and for consequent management. The clinician has always depended on the laboratorian for reliable data essential to sound clinical decision-making.

As testing moves to office or ward laboratory, the physician becomes increasingly responsible for that reliability. The particular types of potential error differ from those in the hospital lab, but the physician must nevertheless be able to validate that results are accurate, precise, and assigned to the correct patient.

Physicians must understand the principles of testing and potential processing problems, and must establish protocols and procedures to ensure a laboratory test's validity in a diagnostic or management decision. This is especially important because the results produced by office or ward laboratories are usually translated immediately into management decisions.

Most likely, however, the physician lacks two prerequisites for reliable results: the laboratorian's awareness of the complexities of testing, and a set of quality assurance protocols to minimize the chance of test error.

After large, automated instruments made their debut, a major advance in laboratory medicine was the development of procedures, protocols, and materials to standardize commonly ordered tests and ensure the quality of results. The result was our present high level of quality in testing.

Now, further technological leaps are returning testing to the office laboratory. But prepackaged reagents and "black box" technology fall prey to many of the same types of problems experienced by large clinical labs using automated equipment. Tests processed by compact, microprocessor-controlled instrumentation must therefore be subject to rigorous control procedures.

New systems being developed and sold to physicians and hospitals equip office and ward labs to perform hematology, coagulation, microbiology, pregnancy, allergy, and clinical chemistry assays. But even when a member of the office staff or a hospital nurse runs tests, the physician retains responsibility--and liability--for the quality of results.

With little or no background in laboratory medicine, physicians will need help from local consultative services to evaluate instrumentation and develop procedures and quality assurance protocols that guarantee accurate and precise data on a par with other labs in the community. The same level of expert advise will be necessary at ancillary testing sites within the hospital.

Some problems are unique to office and ward labs. The physician and nurse who supervise lab work seldom understand sources of test error and other intricacies. The supervisor generally has only a vague awareness of the need for a QC program and is even less clear on what the program should include.

Furthermore, technical staffs tend to be incompletely trained, and most perform testing only as a secondary duty. These relatively low-level positions often have a high rate of turnover. Staff members usually obtain information about methods and kits from journal and direct-mail advertising and from sales representatives.

When an office lab purchases a test system, the manufacturer's sales rep usually trains the staff. This training often omits quality assurance. Test volume is low except in large group practices, making standardization and quality assurance discouragingly costly in relation to test income.

Most quality assurance materials are produced for larger laboratories. Package sizes assume more frequent use than that seen in physicians' office labs, making outdating and wastage a significant problem. QA materials for some systems--such as the dry chemistry dipstick and film--have not been sufficiently refined. Finally, low test volume prevents the physician from ordering supplies and reagents economically.

The consultative support that a laboratorian can provide covers a range of services: quality assurance, test and kit information, instrumentation and test trouble-shooting, in-service and new employee education, advice on regulation and reimbursement, business management, and professional clinical problems. A full list appears in Figure I.

The laboratorian who wants to break into the consulting field should look for an entree through contacts with the clinical lab's local practitioner clients. The consulting business is most likely to succeed as an enterprise serving physicians in the immediate community. Even broader educational services, such as seminars and newsletters, should stay within local boundaries to be fruitful.

There are already indications that physicians want services of this kind from area laboratorians. A pathology group in Ohio, for example, developed a program to provide many of the services mentioned to local physicians with office labs. Changing rules at the community's hospital made it possible for physicians to place office-generated test results on patients' charts. Each office laboratory, however, must first be accredited by the state. The pathology group helps office lab personnel meet accreditation requirements. Afterward, a member of the group's staff regularly visits the office labs to assist with problems and provide in-services.

On other fronts, some large reference labs are helping physicians develop their own office labs and providing them with consultation afterward. And one group of entrepreneurs in the West formed a referral agency of medical technologists who offer consulting services to laboratories in private practice.

The skills that a laboratorian uses daily are the ones most needed by physicians in office and distributed laboratories. Those who can identify where they're needed, plan a program of consulting services, and market their abilities may find that their future in the lab profession looks considerably brighter than anticipated.
COPYRIGHT 1985 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1985 Gale, Cengage Learning. All rights reserved.

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Title Annotation:part 2
Author:Baer, Daniel M.; Belsey, Richard E.
Publication:Medical Laboratory Observer
Date:Sep 1, 1985
Previous Article:A cost accounting system targeted to DGRs.
Next Article:Planning for your new laboratory computer; laying the proper foundation for installation of a computer system can avert disaster.

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