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Maryland's experience: a case for regulating small POLs, too.

Many Maryland physicians' office laboratories exempted from state licensing requirements perform the same sophisticated tests that regulated labs do, a study has found. The unregulated POLs escape monitoring only because they serve practices with fewer than four physicians.

"Regulation based on the number of physicians in a group practice is simply arbitrary and provides neither equal protection to the State's citizens nor equal treatment of the State's POLs," declared the Maryland Department of Health and Mental Hygiene in a report on the study, which it conducted last year for the Maryland General Assembly.

The department is sponsoring a bill in the General Assembly to make regulation of POLs dependent on the types of tests performed rather than on group size. This enlightened view of state POL regulation reflects a trendof the 1980s. Some states, however, still cling to exemptions for small office practices, including those with labs that perform sophisticated tests. Federal certification of labs, including POLs, under the Clinical Laboratory Improvement Amendments of 1988 will limit waivers to facilities that perform only low-risk testing.

Maryland health department officials are pressing to bring their program in line with the Federal Government's in a bid for deemed status, so that the state can retain primacy over regulating its POLs.

All physicians' offices in Maryland-solo and group practices alike-must undergo proficiency testing if they perform sophisticated laboratory tests. Licensed POLs-those serving groups of four or more physicians-are also monitored for compliance with personnel and technical standards. Education and training are emphasized as means of meeting the standards.

The health department's Laboratories Administration offers assistance to POLs prior to their initial inspection. The regulations also require that a licensed POL employ or otherwise engage, full time or part time, at least one medical technologist who can provide the clinical laboratory expertise needed to meet and maintain the minimum standards.

Here are key findings from the study of unregulated labs:

Data from last year's survey and earlier surveys showed there are 1,491 single-physician POLs and 370 two- or three-physician unregulated POLs in Maryland. Of these, 1,148 (62 per cent) performed sophisticated test ing enrollment in an external proficiency testing program.

Fifty-four per cent of the single-physician POLs routinely performed sophisticated tests in microbiology , 38 per cent in hematology, and 29 per cent in chemistry. Among small group-practice POLs, 62 per cent performed sophisticated tests in microbiology, 54 per cent in hematology, and 44 percent in chemistry.

The unregulated POLs offered 88 different tests. In hematology, coagulation, and chemistry, they used 65 types of instruments, ranging from basic photometers to complex semiautomated and automated blood cell counters and chemistry analyzers.

Only 11.7 per cent of the single-physician POLs and 20.5 per cent of the two- and three-physician POLs employed testing personnel who had formal education and training in a laboratory science (medical technologists and medical laboratory technicians).

The report told of mistakes made by personnel who lacked such training. For example, a POL surveyor found last September that an employee recorded only those quality control results on an analyzer that fell within the established range of +/- 2 standard deviations from the mean. The most important QC results were omitted from the pool of data used to establish each month's new control means and ranges.

In October 1988, a physician told a POL surveyor that he had not had a positive culture for betahemolytic group A streptococci in some time. The surveyor observed that the throat culture incubator was not set at the optimal 35 C but rather at 42 C, a temperature at which group A streptococci do not grow well 'if at all.

Patients must be protected from such errors. POLs big and small should be regulated if their testing extends beyond the simplest procedures.
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Copyright 1989 Gale, Cengage Learning. All rights reserved.

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Title Annotation:physicians' office laboratories
Author:Fitzgibbon, Robert J.
Publication:Medical Laboratory Observer
Article Type:editorial
Date:Feb 1, 1989
Previous Article:Lab and individual information management.
Next Article:Strategies to achieve recognition and status.

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