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Cited by 37Healthcare RegulationClinical Laboratory Practices and Quality ControlHealthcare Quality and Management

The DOI matches its Crossref record, with a small difference in title or year; 5 of the 5 references it cites were found in a registry or an index.

A Review and Analysis of the Clinical Laboratory Improvement Amendment of 1988: Compliance Plans and Enforcement Policy

Rivers, Patrick A., Dobalian, Aram, Germinario, Francesco A.·2005·Health Care Management Review
DOI 10.1097/00004010-200504000-00003
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Abstract

In 1988, Congress passed the Clinical Laboratory Improvement Amendment (CLIA), thereby extending coverage of the Clinical Laboratory Improvement Act of 1967 to include quality standards for all laboratory-based testing. The CLIA was enacted to ensure the accuracy, reliability, and timeliness of patient test results, regardless of the location where the tests were performed. This article assessed trends in the enforcement policy of the CLIA through an examination of the Laboratory Registry, an annual publication of those individuals or entities that have had sanctions imposed on them by the Centers for Medicare and Medicaid Services. We reviewed the CLIA, including its oversight, regulations that were promulgated based on it, and its enforcement procedures. We obtained the Laboratory Registries for 1993-2001. Sanctions were categorized into groups per the enforcement regulations (42 C.F.R. section sign 493.2 2000). The data indicated an increasing use of more lenient sanctions from 1997 to 2001, and a gradual increase in fraudulent activity for that same period. One possible explanation for this finding is that implementation of compliance plans by participating clinical laboratories had a mitigating effect on enforcement policy. Compliance plan guidance from the OIG provides an opportunity for laboratory service providers to be proactive in their attempts to decrease errors, and thus improve accuracy and reliability by documenting laboratory policies, procedures, and objectiv…

Overview

Integrity signals

Registry

Crossref · 10.1097/00004010-200504000-00003

Cites

5 of 5 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

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Citations

Cites

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Research works printed but not linked: 2

  1. Higgins, 2000, Journal of Medical Practice Management, 16, 99
  2. Boone, 1992, Archives of Pathology and Laboratory Medicine, 116, 681

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Metadata

Authors
Rivers, P. A., Dobalian, A., & Germinario, F. A.
Affiliations
  • Southern Illinois University Carbondale (US)
  • University of California, Los Angeles (US)
  • Health Services Research & Development (US)
ORCID
Venue
Health Care Management Review
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2005-04
Volume
30
Issue
2
Pages
93-102
ISSN
0361-6274 (ISSN-L)
DOI
10.1097/00004010-200504000-00003
OpenAlex
W2159942798
Cited by
37
References
5
Citations by year
2026: 2 · 2025: 2 · 2023: 3 · 2022: 2 · 2019: 3 · 2018: 1 · 2017: 1 · 2016: 1 · 2015: 1 · 2014: 1 · 2013: 3 · 2012: 3
FWCI
4.19
Type
journal article
Language
en
Open access
closed
Locations
  • Health Care Management Review (publishedVersion)
  • PubMed (publishedVersion)
Funders
Health Services Research and Development
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Regulation
  • Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Quality and Management
Keywords
Centers for Medicare and Medicaid Services, compliance plan, Office of Inspector General, laboratory quality standards, fraud, regulatory oversight
MeSH terms
Accreditation, Facility Regulation and Control, Laboratories, Policy Making, Quality Assurance, Health Care, United States, Centers for Medicare and Medicaid Services, U.S., Guideline Adherence

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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

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