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Pathologists make strides towards nontraditional testing standards.

Pathologists make strides toward nontraditional testing standards A conference last month in Atlanta signaled Washington that pathologists accept the proliferation of testing at nontraditional sites and are ready to contribute with quality assurance standards and/or guidelines.

A resulting series of conclusions and recommendations is seen by many as a valuable first-strike deterrent to Government regulation. The conference, sponsored by the College of American Pathologists, drew its findings from approximately 200 leading pathologists and other lab-related experts.

Conferees spent two days in working groups polishing findings on tests performed in physicians' offices, the home, and at patient bedside. Five groups explored definition of terms, analytical performance criteria, legal and regulatory issues, performance assessment, and procedural selection. A select faculty for each area presented papers and moderated discussions with other participants.

Statements from each group will be finalized and put into a complete CAP report by mid-August. At the close of the meeting, conference chairman Peter J. Howanitz, M.D., said, "We feel very close. I think after some minor editing we will have a major product available."

CAP's report could significantly influence the direction of testing regulation in Washington. A provision of the just-passed Consolidated Omnibus Budget Reconciliation Act (COBRA) instructs the Department of Health and Human Services to study standards that may apply to lab testing in physician offices. But at the Atlanta conference, a Health Care Financing Administration spokesman said the agency would rather leave the legwork to the private sector.

The following is a summary of the five work groups' findings:

* Definition of terms. Charged with presenting commonalities, this group defined a physician office lab as "any facility outside the walls of a dedicated conventional laboratory where clinical pathology studies are performed in direct support of personally delivered patient care and offered by a single or small group of MDs."

Bedside testing was described as "analytical testing performed by health care providers under direction of a physician in a health care institution or in the home." Home testing in itself was termed "an activity in which an analytical test is made by a lay person who has neither the resources of a lab nor the technical, medical, or scientific expertise."

In defining physician office testing, pathologists commented that the practice "should be organized to provide timeliness in response to diagnosis monitoring or changes in treatment, and facilitate the promotiuon of improved physician-patient relationships within the precepts of providing adequate quality assurance and economies of operation."

In presenting the findings, group chairman Keith Walker, M.D., noted the importance of improved doctor-patient relations as an element of office testing.

* Legal and regulatory. This group, led by Robert Strauss, M.D., concluded that acceptacle physician office lab performance criteria should be voluntary, involve proficiency testing, but without costly on-site inspections, and should rely on pathologists as consultants.

Should a doctor's office be subject to the same standards as clinical labs? Participants cast a "yes" vote for tests that are outcome-oriented, for identical tests, and for reference ranges.

Among the more controversial topics: home testing and monitoring. Several panel members expressed concern that consumers may misuse or misinterpret the growing number of home devices and diagnostic kits, although there was some agreement that responsibilities fall on Federal regulators and manufacturers for clear package labeling and instructions.

* Performance assessment. While noting that testing in new sites carries new responsibilities, this work group reported: "Principles and technologies currently applied for assessing and monitoring the quality of tests performed in hospital laboratories are directly applicable to home testing and physician office lab testing.

"Provisions for achieving operational simplicity for home and office testing must include the ability to monitor and maintain test reliability."

It was noted that physicians, pathologists, and lab practitioners have a responsibility "to make certain that standards are not compromised by geography."

Pathologists stated that quality assurance in the physician lab "should be maintained by continuing education programs, internal and external proficiency testing, and assistance from laboratory professionals. Quality assurance objectives for home testing are achieved by careful attention to procedural and interpretative instructions."

Work group members also called on manufacturers to play an active role in insuring that tests are reliably performed.

* Procedural selection. Participants reached a series of recommendations based on some 12 conclusions, the most significant of which were:

1. The clinical utility and validity of a test can be quantified for a specific population.

2. A decisional matrix for procedural selection can be defined. The group will present such a matrix in its contribution to the final report.

3. Rate of growth in testing is technology driven and/or limited.

The work group's recommendations, which generated only limited debate at a conference wrap-up session, were as follows:

1. Site-dependent validation of a procedure or technology should be generally available prior to selection.

2. Selection of procedures for distributive laboratories requires specific analysis of each setting.

3. Clinical utility and not market forces should determine procedural selection for laboratories.

4. Implementation of a procedure or technology for distributive labs should include a defined program for quality assurance.

* Analytical performance criteria. Michael Kafka, M.D., who led this group, presented preliminary recommendations that will be expanded in the August report. Most notably, panel members agreed that goals for analytical accuracy should be the same in all testing sites.

The group further advised that "goal specification is dependent on the intended clinical application of the tests. Goals may vary in stringency for a given analyte. Labs should select methods and instrumentation that best meet the analytical demands of intended clinical use."

A third recommendation stated: "Goals should be specified for the accuracy of an individual analytical result and the accuracy of method. Where appropriate and feasible, goals may be specified for comparability of methods."

The fourth recommendation presented by this work group was that standards and claims of analytic performance should be based on field experience.

Conference leaders said they are optimistic that efforts such as this by laboratorians will help discourage the Government from establishing mandatory standards.

Those hopes got a boost in Atlanta from Charles R. Booth, director of HCFA's Bureau of Eligibility, Reimbursement, and Coverage. Speaking at the final general session, Booth termed Federal intervention the "least desirable" alternative for quality assurance.

"I believe proficiency standards and testing can best be handled by the private sector," Booth stated. "I don't think this is something we [in Government] are capable of doing well. I will be encouraging my colleagues [within HCFA] to back away from it."

While Health Care Financing Administration officials appear impressed by current private initiatives, Washington observers note the agency still has a mandate from Congress to report on testing standards. Lawmakers are traditionally quick to call investigative hearings if they receive reports of adverse experiences from Medicare beneficiaries and constituents.

An overall theme at the CAP conference was that pathologists are ready to lend a hand in promoting quality assurance at different test sites. In informal discussions, attendees said the meeting shows that pathologists accept (even if they don't always approve of) new testing practices and will accept new measures for protecting patient care.

Attendees also took pride at the general level of consensus achieved among various participants. Summary presentations from all five working groups were generally well received at the final plenary session, and it appeared that changes to be made for the collective report would be mostly semantic.

Commenting on the conference results, Howanitz, chairman of the CAP's quality assurance service committee, noted: "We all feel that quality of care is important, and that was the driving mechanism. Once we established that outcome was the deciding factor in comparing results, it was easy to get consensus in all the groups."
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Publication:Medical Laboratory Observer
Date:May 1, 1986
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