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CAP offers voluntary standards for nontraditional test sites.

CAP offers voluntary standards for nontraditional test sites After eight months of polishing and fine tuning, the College of American Pathologists has completed a report it will now submit to industry dialog on laboratory testing at nontraditional sites. The effort could ultimately sway Washington's decision as to whether the industry can regulate itself--or if it needs help.

By April, the Health Care Financing Administration is to report to Congress on possible standards for physicians' office laboratories. The agency is currently collecting data for that report, but sources indicate that enthusiasm for the project is minimal.

HCFA officials have stated that they prefer industry initiatives to the long arm of the law. An office within the agency is charged with collecting information on what tests are being performed in-office, which personnel run the tests, and how they generally perform. The queries are typical of Government investigations into perceived trouble spots.

Bureaucrats are closely monitoring efforts such as CAP's and the intersociety Committee on Office Laboratory Assessment (COLA). The latter group is getting off the ground with a pilot project featuring a self-inspection "checklist" that will allow doctors to compare their facilities and procedures with a common standard. Some 40 laboratories are said to be participating in the project to define elements in a quality assurance, education, and assessment program. COLA expects to emerge with some certification criteria for physician laboratories.

The CAP report, which becomes available publicly this month, draws on the findings of some 200 leading pathologists who gathered for a series of meetings in Atlanta last April. Attendees broke up into five working groups to explore issues in definition of terms, analytical performance criteria, legal and regulatory issues, performance assessment, and procedural selection.

The following is excerpted from the working groups' "inferences and recommendations." Complete findings are available in the report, which also includes manuscripts on the different topics, question and answer discussions, summaries, and bibliographies. For a copy ($49.95), call CAP at (312) 966-5700.

* Definition of terms. Essentially unchanged from earlier drafts, this group presents some basic definitions for testing in non-traditional sites. Specifically, physician office testing should ideally "be organized to provide timeliness in response to diagnosis, monitoring, or change in treatment and facilitate the promotion of improved physician-patient relationships within the precepts of providing adequate quality assurance and economics of operation."

Bedside testing is deemed to be lab testing provided in close proximity to the patient, and organized to give immediate, clinically reliable results that initiate, direct, or modify therapy. It should be performed by health care providers under direction of physician in an institution or the home.

One earlier version defined home testing as being performed by a lay person without "the resources of a laboratory nor the technical, medical, or scientific expertise." In the final report, the term "expertise" is dropped and replaced with "training ordinarily involved in the testing and use of information provided.

An added recommendation says home testing should only be performed if it has medical usefulness to a doctor in diagnosing, screening, or monitoring a health problem with no potential danger to public health, and if it doesn't subvert reporting requirements for dangerous communicable diseases.

* Legal and regulatory. Filing the lenthiest list of recommendations, this work group offers its acceptable regulatory criteria for physician office labs. It concludes that regulation should be voluntary, as through COLA, and should involve proficiency testing and pathologist consultation. Noting the difficulties with regulating the large number of office labs, thereport says on-site inspection and personnel requirements should not be necessary.

The role of consulting pathologists in the physician lab covers the selection of procedures and instrumentation, establishment of quality control, and ongoing personnel instruction/training.

Regarding licensure of clinical laboratories (hospital and independent), the panel notes: "Requirements vary from state to state and set a floor, not a ceiling." Rules may include criteria for personnel (education, experience, and responsibilities) and successful participation in external proficiency testing. On-site inspection may also be included.

In an added section on professional negligence, the report finds that malpractice "is the commission or omission of an act within a professional setting." Elements of negligence must be proved "preponderant," and include the duty of care owed, breach of care standards, nature of injury, proximate causation, and extent of damage. "Abandonment" can be construed if a pathologist is absent from an off-site lab and a problem ensues.

* Analytical performance criteria. In a new foreword to findings drafted at the conference, this group comments:

"Analytic performance within limited-function laboratories and the home can be expected to evolve and improve over time. Present performance needs to be assessed. Improvement toward desirable analytic goals must be promoted by ongoing educational efforts."

Among the panel's standing findings are that goals for analytic accuracy should be the same in all testing sites. It is advised that goal specification "is dependent on the intended clinical application of the test. Goals may vary in stringency for a given analyte. Laboratories should select methods and instruments that best meet the analytical demands of intended clinical use."

In a more recent recommendation, this work group concludes: "The goal-setting process for tests of identification differs from that for tests of quantitation. Both should be based on the intended clinical use."

Further, "Performance assessment methods for limited-function laboratories should be the same as for central laboratories. Performance assessment of home diagnostics will differ from the traditional methods of internal and external central laboratory quality control. However, the goals for accuracy of home diagnostics should be the same as for testing in other sites."

* Performance assessment. The lead finding here is: "Principles and techniques currently applied for assessing and monitoring the quality of tests performed in the hospital laboratory are directly applicable to home testing and physician office laboratory practice.

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

The panel also advises that clinicians have an "ethical and moral responsibility" to make sure that quality of care is not compromised by geographic location of the test. Further, industry must be active in protecting test reliability; ongoing education should be maintained in physician labs; and careful attention to procedural and interpretive instructions should accompany the growth in home testing.

*Procedural selection. Standing recommendations here are: 1) Clinical usefulness and not market forces or technology should guide procedural selection for distributive labs. 2) Site-dependent validation of test or technology should be generally available prior to procedural selection. 3) Selection of procedures for distributive labs requires a specific analysis of each individual setting. 4) Implementation of tests or technology for distributive labs should include a defined program for quality assurance.

Some recently added assumptions andconclusions are that the easier tests are to perform, the more quickly they will be used; procedural selection is ultimately judged by clinical usefulness; patient expectations and "need to know" are driving forces for change; and assessment of cost should not be limited to direct dollar costs alone.

This work group has also added a chart of requirements essential to quality assurance at various stages in the testing chain. Research: Quantify validity, reproducibility, and clinical usefulness. Industry: Quantify the degree to which it meets manufacturer claims and expand on clinical usefulness model. Clinical laboratory: Quantify the ability of office laboratory personnel to obtain acceptable test results. Distributive testing: Quantify the ability of the general public to obtain acceptable results the first time.

The will of Congress and the Administration will be directly influenced by such private-sector initiatives as the CAP's. Perceived problems affecting constituents traditionally draw knee-jerk resonses from politicians as Washington gears up--yes, already--for the 1988 elections.
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Title Annotation:College of American Pathologists
Publication:Medical Laboratory Observer
Date:Jan 1, 1987
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