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PubMed1993

Physician office laboratory regulation: proven strategies to meet the demands of the CLIA (Clinical Laboratory Improvement Amendments).

This article outlines the requirements of the Clinical Laboratory Improvement Amendments, as implemented by regulations that became effective in late 1992. Background information about the statute and a description of the laboratory director's role are provided, and proven strategies for meeting the regulations' quality assurance requirements are discussed in detail.

Clinical Laboratory Techniques↗
PubMed1995

CLIA program; categorization of tests and personnel modifications--HCFA. Final rule with comment period.

In this rule we are responding to some of the comments on categorization of tests and personnel requirements received in response to rules published on February 28, 1992 and January 19, 1993. (In a future rule, we will be responding to the remaining comments.) We are revising our regulations to: Allow dentists and midlevel practitioners to perform tests in the "physician-performed" microscopy (PPM) subcategory of moderate complexity procedures (we now call the subcategory "provider-performed"); include three additional tests in PPM; and expand provisions relating to general supervisor and high complexity testing personnel.

Centers for Medicare and Medicaid Services, U.S.↗
PubMedDate not supplied

Competency assessment--an exploratory study.

CLIA '88 regulations require that laboratories evaluate and assure the competency of all personnel who perform laboratory tests. The study objective was to determine the interpretation of, compliance with, and implementation of these regulations by laboratories. Interviews were conducted with a stratified nonrandom sample of 20 laboratories including hospital, blood bank, commercial reference, physician office, group practice, and independent laboratories from 12 selected states. Information was collected about the history and development of their competency assessment programs and activities, their definition of competent staff, the interrelationship of competency assessment with performance appraisals, cost, benefits, and the assessment methods and tools used. Competence of laboratory personnel is a complex issue reflecting the dynamics and environment of each unique laboratory setting. This research found no consistent method of competency assessment implementation. This report provides a summary of methods and approaches. Learning what other laboratories are doing will assist managers in developing meaningful and cost-effective competency assessment programs. Documenting all competency assessment activities is important; it serves as a personnel performance management tool and satisfies inspectors. Used in the spirit of continuous quality improvement, the competency assessment program may point to ways of improving processes, personnel, and performance.

Employee Performance Appraisal↗
PubMedDate not supplied

Key performance indicators to assess laboratory operations. Action-packed benchmarking with HBSI (HBS International Inc.).

The first article of this series highlighted the five most widely used performance measurement systems for comparing laboratory and clinical department operations. This column has since taken an in-depth tour of two of the systems, the MECON PEERx and the Laboratory Management Index Program. We also have taken a slight detour to discuss the ORYX initiative, which has been mandated for certain types of health-care organizations accredited by the Joint Commission. In this issue we return to a more detailed analysis of one of the five most commonly used benchmarking systems for clinical services, HBS International, Inc.

Benchmarking↗
PubMed1999

The association of opportunistic infections with the occurrence of trimethoprim/sulfamethoxazole hypersensitivity in patients infected with human immunodeficiency virus.

Hypersensitivity from trimethoprim/sulfamethoxazole (TMP/SMX) has been linked to a reactive nitroso intermediate from sulfamethoxazole metabolism, which may be altered in patients with human immunodeficiency virus (HIV) infection. The authors determined the clinical factors that are associated with TMP/SMX hypersensitivity in patients with HIV. In a case control study, 54 controls currently tolerating TMP/SMX prophylaxis were randomly matched by date of hypersensitivity reaction in case patients to 28 patients with a history of a rash consistent with erythema multiforme from TMP/SMX. Demographic data, coadministered medications, laboratory data, and histories of opportunistic infections were extracted on all patients. A highly significant association was observed between the number of opportunistic infections and the occurrence of TMP/SMX hypersensitivity (p < 0.001), despite comparability of CD4 counts between case patients and controls (p > 0.1). A tendency for protection from TMP/SMX hypersensitivity in blacks was also observed (p = 0.066). These observations suggest that the mechanisms by which HIV produces cellular immune dysfunction and alters drug detoxification may be linked.

AIDS-Related Opportunistic Infections↗
PubMed1980

Laboratory medicine in the People's Republic of China.

In August 1979, 12 U.S. laboratory scientists visited the People's Republic of China in an attempt to introduce Chinese physicians and laboratorians to developments in laboratory medicine not yet known or understood in China. The author of this article, one of the group of visiting scientists, recounts the experience, and thus draws an interesting comparison between laboratory medicine in the United States with that in China.

China↗