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CAP, physician groups push to develop office testing standards.

CAP, physician groups push to develop office testing standards

An alliance of physicians' professional organizations is advancing work on voluntary standards for in-office testing, in part as an effort to preempt a Government regulatory thrust.

At press time, Congress was still debating legislation ordering that Federal standards be drafted by the end of 1986. The House of Representatives approved the measure in October, but its fate had yet to be resolved by Senate and House budget conferees (see story on page 22).

Interest in Washington appears widespread, but Federal guidelines could be obviated if physician groups successfully prove they are policing themselves. Thus far, three groups have taken the initiative to form the intersociety Committee on Laboratory Assessment (COLA). They are the College of American Pathologists (CAP), the American Society for Internal Medicine (ASIM), and the American Academy of Family Physicians (AAFP).

Much work remains on the essential elements of the program before it can be marketed to physicians. But association leaders anticipate office lab assessments will be in full swing by this time next year. They indicate the program may include:

An "honor code' system of proficiency testing, in which physicians or their laboratory managers complete a questionnaire on office testing practices.

Certification indicating the office lab complies with the standards as approved by the boards of all three associations.

Ongoing educational support for physician office labs facing compliance problems.

The CAP has taken the lead in organizing COLA, based on its lengthy experience in laboratory assessment. Spokesperson Pamela Cramer comments that the groups "believe in common standards for medical care, wherever treatment is delivered.' But, she acknowledges, "it is anticipated the program may help fend off Federal regulation . . .. That may be one of the motivations for physicians to participate.'

Much of the pressure for Government involvement has come from laboratory associations seeking to level the regulatory playing field. Different quality control requirements, they contend, give doctors an unfair economic advantage while raising uncertainties over patient care.

In statements recently submitted to Congress, Dr. Mark Birenbaum of the American Association of Bionanalysts testified that, "Given the increasing volume of outpatient laboratory services in physician offices, the trend for physicians to practice in larger and larger groups, and the growing sophistication of this testing, it seems reasonable to apply Medicare laboratory quality standards [to these offices] as well.

"One step with minimal administrative burden would be to require all physician labs to participate successfully in a proficiency testing program that is either operated or approved by the state agency or the Secretary of Health and Human Services. Such a program should cover all clinical lab and anatomical pathology specialties and subspecialdes in which the lab is engaged. This is one of the conditions presently imposed on independent labs.'

Other lab spokespersons have framed the matter as both a quality of care and Medicare budget issue. According to Sherry Park, vice president of the American Clinical Laboratory Association, "Because of the absence of any quality assurance regulation, these physician office laboratories may perform at substandard levels, creating the potential that a disease will continue undetected. When illness remains undiagnosed, the cost of treatment when diagnosis finally occurs is usually higher than it would have been had the condition been diagnosed earlier.'

Responding to such concerns, COLA members are attempting to devise a standards program that would be both voluntary and non-punitive. The group, comprised of two physician members from each association, has devoted much of its time to date reconciling the interests of clinicians and pathologists. Issues include formats for on-site inspection, test accuracy and appropriate use, and personnel requirements.

One fruit of the effort is expected to be a questionnaire that offices can use to gauge the appropriateness of laboratory facilities, equipment, and procedures.

Stressing that it's early in the development stage, Dr. Steven Kroger, an internist on the committee, notes, "We're planning to give enrollees in the program a self-assessment checklist that will address many of the aspects that would be covered in an independent on-site inspection. We would be putting the physicians or the lab managers on their honor to fill out the questionnaire correctly. In that process, they will learn what kinds of things are expected in terms of quality control.'

Kroger anticipates the standards to be similar to CAP criteria for hospital labs, with perhaps some modifications. While there are currently no plans for independent on-site inspections, he reports that the possibility "hasn't been ruled out.'

Physician offices meeting the criteria on the first assessment would be eligible for certification, while labs that fail would have an opportunity to make the necessary adjustments and reapply.

Continuing educational support is expected to be an integral part of the standards program. Possible aspects include the distribution of printed material and a local or regional network of consulting pathologists.

Concern in Washington may be spurring the work on guidelines, but physicians assert there is also a strong private-sector demand. According to Dr. Kroger, "Our organizations have been interested in promoting quality lab work for a long time. ASIM, for example, has had a proficiency testing service for some 12 or 13 years. The spectre of Government regulation? Sure, it's there. But everyone would prefer voluntary certification. The problem is there hasn't been anything in place. There are many doctors who want standards for themselves, and to show patients and third-party payers that they comply.'

If all goes according to plan, COLA may begin testing its certification package in pilot projects this spring. Assuming the association boards approve, it will be marketed to physicians by 1987. Committee members note, however, that the group is not a closed council and may be receiving input from other individuals or organizations in the interim.

Regardless of the outcome in Congress, other arms of the Government will this year be reaching out to gather more data on physician in-office testing. Most notably, the Centers for Disease Control recently dispensed $100,000 to study physician lab practices and utilization in Georgia, North Dakota, Oregon, and West Virginia. Researchers will be using the money to improve testing, education, and training in about 30 smaller labs in each state.

The studies are expected to yield information on the type and frequency of tests doctors are performing, as well as findings on proficiency testing, performance deficiencies, personnel requirements, and the availability of remedial training. The primary focus will fall on personnel who actually do the tests, but lab directors who interpret the results will also come under scrutiny.

Data gathered in the one-year reviews will be made public in a final report. CDC officials say they hope to fund further studies in the near future. Although CDC is somewhat removed from the policy-making arena in Washington, its research might play a role in any debate over the imposition of mandatory standards.

Medicare debate draws to a close

At press time, House and Senate conferees were nearing a mid-December vote on 1986 Medicare reforms --including a proposal on physician testing standards.

The measure, approved by the House but not the Senate, instructs the Secretary of HHS to report this year with recommendations for standards that might be legislated. The review would address standards needed to protect the quality of in-office testing, taking into account the variation among physician practices.

The joint committee was also set to vote on a laboratory fee ceiling set at 115 per cent of the national median for tests now reimbursed by fee schedule. As approved by the House, that limit would drop to 110 per cent on Oct. 1, 1986. It appeared that Senate negotiators might back their House colleagues, in deference to overall budget targets.
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Title Annotation:College of American Pathologists
Publication:Medical Laboratory Observer
Article Type:editorial
Date:Jan 1, 1986
Previous Article:Making the best of laboratory inspections.
Next Article:How technology transfer is changing lab medicine.

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