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How Idaho met the challenge of regulating POLs.

In just one year, this state's new regulations have improved

testing performed in office laboratories. Input from medical technologists helped make it possible.

The clinical laboratory community has been concerned for years about the quality of test results produced in physicians' offices by personnel without formal lab training. Such training for physicians themselves, in their medical-school days, usually has run from two weeks to one semester within a busy curriculum. Moreover, it has focused on interpretation and use of results rather than on methods and techniques.

Generally speaking, potential sources of error and necessary quality assurance practices are not understood in physicians' offices that lack trained laboratory specialists.

Idaho took its first step toward clinical laboratory regulation in 1976. Implementing recommendations by a governor's advisory council on health planning, the new rules made quality control, proficiency testing, and continuing education mandatory for all labs except those in which physicians personally performed the tests and those that were accredited by state-approved agencies.

The number of registered labs in the state was relatively small at that time. The Laboratory Improvement Section of the Bureau of Laboratories was able to establish a collaborative relationship with labs in the proficiency testing program , providing consultation and advice when necessary.

By 1985, however, the number of registered laboratories had more than doubled. There were 144 approved physicians' office labs (POLs), 47 licensed hospital labs, and 16 certified independent labs in Idaho. With no increase in its staffing, the state's Laboratory Improvement Section could no longer provide the kind of personal consultation it had in the past.

That was one pressure for regulatory overhaul. Another came in September 1985 when an Idaho Hospital Association resolution asked state authorities to establish regulatory equity between hospital and physicians' office labs. POLs, which did not have to meet formal personnel standards, enjoyed an unfair competitive advantage over hospital and independent labs, according to the resolution's backers.

The request for equity went to the Bureau of Laboratories, which had begun considering changes in the 1976 regulations. The bureau formed an advisory committee to gather input from many quarters. Besides officials from state agencies, there were committee members from the state hospital association; the Idaho Medical Association; the Idaho Society for Medical Technology (ISMT), which I represented; and a hospital and an independent laboratory.

The first meeting of the advisory committee was fruitful, yielding an extensive proposal for regulatory change patterned on Pennsylvania laboratory regulations and the POL certification system proposed by the American Board of Bioanalysis. (See box on page 32 for background on the Pennsylvania system.) These two sources categorized laboratories in three-tier systems based on test difficulty.

The advisory committee drew elements from both and proposed its own three-tier system for classifying physicians' office laboratories in Idaho. High school graduates with six months' experience and training were called for in level 1, laboratory technicians in level 11, and technologists in level III.

POLs in levels I and 11 would have had to retain the consultation services of a pathologist or a technologist with a minimum of five years' laboratory experience, including monthly on-site visits. Under the plan, all labs were still required to register with the state, establish a quality control program, and perform satisfactorily in a proficiency testing program.

Continuation of the quality control and proficiency testing exemption for physicians who performed tests on their own patients was opposed by the advisory committee.

The original proposal passed through three drafts, with the ISMT getting input from as many practicing laboratorians as possible. Seventy-nine out of 200 laboratory employees answered questionnaires about the proposal. They generally accepted the three-tier classification system as a means of insuring quality results.

Major concern arose over personnel qualifications, however. The second draft required only a high school diploma and 12 months' training for POLs performing level II tests, but survey respondents felt that more formal education and training would be necessary to adequately prepare POL personnel to do the types of tests included in level 11.

The views of ISMT members were incorporated into the final draft of the regulatory proposal. This draft included a requirement that POL personnel pass competency exams after completing the training specified for levels I and 11. Level I labs would have someone trained as a laboratory assistant or with six months' experience; level 11, an employee with medical laboratory technician training or one year of experience.

The Idaho Department of Health and Welfare next held public hearings on the proposal. The hearing officer found the planned personnel requirements unworkable based on oral and written comments from interested parties. He said they might jeopardize staffing of POLs for the foreseeable future since training programs and competency exams suggested for levels I and II were not in place in the state. He instead recommended training and competency requirements for laboratory supervisors, who would then be responsible for the other personnel in their labs.

These and other recommendations from the hearing officer were weighed by the chief of the Bureau of Laboratories as he prepared the revised version of the regulations. He also considered written comments from several physicians, who among other things doubted the need for a consultant in an office performing very simple tests.

Physicians were most outspoken about proposed elimination of the rule that fully exempted doctors who perform tests only on specimens from their own patients. Some perceived this as an encroachment on their right to practice medicine. One physician suggested that the proposed rules were biased in order to protect medical technologists and the state hospital association, which stood to gain (in his opinion) if physicians' office laboratories ceased to exist.

The final version of the rules and regulations was approved in December 1986 and took effect in February 1987. It included the three-tier testing classification of laboratories (see Figure 1).

Standards for personnel in level I and 11 laboratories were not stated, but these labs were required to secure consultation services. Level Ill procedures could only be performed by clinical laboratory technologists or technicians.

No state inspection program has been scheduled because the Bureau of Laboratories is shortstaffed. The new rules specify, however, that office lab consultants must make four on-site visits per year and submit an annual checklist to the bureau.

The checklist helps in the enforcement of previously existing requirements for quality control and proficiency testing. After a year of satisfactory performance, level I labs may apply for a reduction in the number of consultants' visits from four to two per year (this had been recommended by the hearing officer).

Physicians who perform tests on their own patients continue to be exempted from quality control and proficiency testing requirements and also do not have to retain a consultant.

Once the regulations came into being, the complex process of implementing them began. To begin with, the task of educating laboratories about the new requirements was and still is difficult because of the limited resources of the Bureau of Laboratories.

Another early problem the Bureau of Laboratories faced was how to identify potential consultants. The ISMT recognized the problem and published an article in its newsletter encouraging medical technologists to participate in the program. The society also arranged a workshop at its spring 1987 meeting for technologists who wished to serve as consultants.

By June 1987, the Bureau of Laboratories had approved 43 technologists and 12 pathologists as consultants. A list of their names was mailed to physicians' offices with a letter explaining the regulations. All laboratories were asked to re-register with the bureau by July 1, specify their level of testing, and name their consultant, if one was required.

As of July 1988, the state had 210 registered physicians' office labs. Ninety-four of the POLs had consultants, Ill were not required to have consultants, and five were not yet in compliance.

Consultants have to be trained to use the bureau's annual checklist. They also must become familiar with the bureau's quality

control guidelines.

While no statewide training programs have been established for level I and II lab employees, a few consultants have taken 'it upon themselves to set up programs in the office labs they serve. A large reference laboratory in eastern Idaho has established a fairly extensive training program for POL personnel.

One-on-one interaction between POLs and their consultants is the most ambitious educational effort yet undertaken by the Idaho Department of Health and Welfare. The use of the consultant network expands the personal contacts the department is able to make with all laboratories in the state, without increasing its operating staff or consuming additional public funds.

A few consultants are worried about liability for any recommendations they make to physicians. This issue needs to be investigated further with legal counsel so that, if necessary, consultants can get malpractice insurance.

The controversy about exempted physicians' office labs continues. In March 1988, the advisory committee met and learned that Idaho chiropractors also want an exemption for offices where they personally perform lab tests on their patients. They claim that an exemption for physicians only is discriminatory. The advisory committee again called for an end to the physician exemptions, but at press time the Bureau of Laboratories had not ruled on the matter.

One of the biggest benefits of the program so far has been the opened window between personnel in the physicians' office labs and medical technologists working in accredited labs. Office laboratory personnel with no prior training have been very receptive to information and guidance from their consultants.

Physicians have expressed concern over increased costs because of the consultation requirement, but many are receiving their consultation services without charge. Several large hospital and independent laboratories consult for free as an incentive to gain referral laboratory work from POLs.

A year after the initial checksist inspection by consultants, a second inspection showed significant improvement in laboratory procedures, especially in the area of quality control. The Bureau of Laboratories is also examining proficiency test results for signs of improvement in office laboratory testing, but not enough data exist at this time to draw conclusions. The bureau will have to monitor proficiency testing results from laboratories in levels I and II for a few more years to document the effectiveness of the consultation program.

These regulations have challenged all of Idaho's labs to work together and obtain high-quality results under all conditions.

Idaho's three-tier system for classifying physcian

Level I procedures Level II procedures

Urine specific gravity Manual white blood cell, red blood All other laboratory tests

Chemical examination of urine by cell, and platelet counts not included in levels I

dipstick Scotch tape test (microscopic) for andll

Chemical examination of blood by pinworm

dipstick Wet mount (microscopic) for Tri

Slide agglutination tests chomonas or yeast

Solid-phase qualitative immunoas- Automated instrumentation for

says with visual color develop- chemistry, hematology, or coagu

ment lation Spun hematocrit White blood cell differential count

Erythrocyte sedimentation rate with red blood cell morphology

Test for occult blood Microscopic examination of urine

Primary culturing for transmittal to sediments

an approved laboratory, including Direct Gram stain (microscopic)

preincubation if required Manual spectrophotometric tests

Other tests like those listed above, Throat culture screen for beta-he

mechanically simple to perform molytic streptococci

and requiring no interpretation Screens and colony counts for

urine infections

Other tests like those above, me

chanically not as simple to per

form as level I procedures and re

quiring a degree of interpretation
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No portion of this article can be reproduced without the express written permission from the copyright holder.
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Title Annotation:physicians' office laboratories
Author:Stanley, Susan E.
Publication:Medical Laboratory Observer
Date:Sep 1, 1988
Words:1893
Previous Article:Regulation of physicians' office laboratories.
Next Article:A case-study approach for teaching supervision.
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