Limitations of Proficiency Testing Under CLIA '67

Abstract Proficiency testing (PT), recognized as a quality-assurance (QA) and quality-improvement tool, also has become the cornerstone of the Health Care Financing Administration's (HCFA) regulatory strategy under the revised Clinical Laboratory Improvement Act of 1967 (CLIA '67) and the proposed Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). Use of PT as a regulatory tool corrupts it for things it can do better. PT as a primary regulatory strategy has severe limitations. We explore the nature of these limitations and their implications for clinical laboratories as they impact on the long-term success of HCFA's approved regulatory PT programs in 1991 and beyond, and CLIA '88 PT, which is to be implemented in 1994.

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Review of Actual Proficiency-Testing Performance Under CLIA '67 (March 14, 1990) Rules: Perspective from the First Year's Data

Clinical Chemistry ◽

10.1093/clinchem/38.7.1254 ◽

1992 ◽

Vol 38 (7) ◽

pp. 1254-1259

Author(s):

B J Lanphear ◽

B J Burmeister ◽

S S Ehrmeyer ◽

R H Laessig ◽

D J Hassemer

Keyword(s):

Health Care ◽

Proficiency Testing ◽

Clinical Laboratory ◽

Health Care Financing ◽

Evaluation Criteria ◽

The United States ◽

Testing Performance ◽

Specialized Service ◽

One Year ◽

Mandated Evaluation

Abstract Under the Clinical Laboratory Improvement Act of 1967 the Health Care Financing Administration's proficiency-testing requirement applies to approximately 12,000 hospital, reference, and large-clinic laboratories in the United States. The Wisconsin State Laboratory of Hygiene is approved by the Health Care Financing Administration to provide proficiency testing in all specialties and subspecialties. The focus of the program is to provide highly specialized service and support to a limited number of participants in order to assess intralaboratory performance correctly. We report the findings over the four proficiency-testing events in 1991 for the subspecialty of routine chemistry, which serves approximately 470 participants. Failure rates for individual analytes on single proficiency testing events ranged from 0% to 13%. After four events or one year, if the mandated evaluation criteria and failure rules were strictly applied, as many as 11% of the laboratories could have found themselves involuntarily suspended from offering all routine chemistry testing.

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Health Care Financing Administration/Clinical Laboratory Improvement Amendments of 1988

Archives of Pathology & Laboratory Medicine ◽

10.5858/1999-123-0478-hcfacl ◽

1999 ◽

Vol 123 (6) ◽

pp. 478-481

Author(s):

Virginia Wanamaker

Keyword(s):

Health Care ◽

Drug Administration ◽

Clinical Laboratory ◽

Food And Drug Administration ◽

Health Care Financing ◽

Health Care Financing Administration ◽

Self Assessment ◽

Regulatory Requirement ◽

New Concepts ◽

Clinical Laboratory Improvement Amendments

Abstract The Health Care Financing Administration has introduced new concepts for the Clinical Laboratory Improvement Amendments of 1988 survey program. Surveyors now look at the laboratory as a whole as opposed to each regulatory requirement independently. This quality assurance approach allows the surveyor to assess the laboratory's ability to provide quality test results as well as identify and correct its own problems. Significant problems in laboratories are more easily identified using this method. Another new concept allows good performing laboratories to go longer between on-site surveys by completing a self-assessment questionnaire on alternate cycles. The Health Care Financing Administration is asking both surveyors and laboratories to evaluate these new approaches. The Health Care Financing Administration continues to work with the Food and Drug Administration through our Memorandum of Understanding to assess Food and Drug Administration requirements in hospitals and laboratories that provide transfusion services. Transfusion-related fatalities must be reported to the Food and Drug Administration and may be investigated by either the Health Care Financing Administration or the Food and Drug Administration. For fatalities needing investigation by both agencies, every effort will be made to conduct these jointly.

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Laboratory Sanctions for Proficiency Testing Sample Referral and Result Communication: A Review of Actions From 1993–2006

Archives of Pathology & Laboratory Medicine ◽

10.5858/133.6.979 ◽

2009 ◽

Vol 133 (6) ◽

pp. 979-982

Author(s):

Anthony A. Killeen

Keyword(s):

Proficiency Testing ◽

Human Services ◽

Clinical Laboratory ◽

Testing Sample ◽

Health And Human Services ◽

Department Of Health ◽

Clinical Laboratories ◽

The Us ◽

Key Terms ◽

Clinical Laboratory Improvement Amendments

Abstract Context.—The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations for proficiency testing (PT) include prohibitions against intentional PT sample referral or result communication, and specify sanctions against laboratories that violate these regulations. There has been little published analysis of sanctions against clinical laboratories because of PT violations. Objective.—To examine the application of principal sanctions as reported by the Centers for Medicare and Medicaid Services annually in the Laboratory Registry and to examine relevant aspects of judicial hearings and appeals in these cases. Design.—The Laboratory Registry was examined for all available years (1993–2006) to determine the incidence of application of principal sanctions for PT violations. In addition, the decisions from the US Department of Health and Human Services hearings and appeals were reviewed to better understand the judicial disposition of these cases. Results.—During the 14-year period examined, 78 laboratories received a principal sanction for a PT violation involving sample referral or result communication. During the same period, the number of laboratories in nonexempt states that would be expected to have participated in PT averaged 45 983. The interpretive meaning of the key terms intentional and referral, and the implications for sanctioned laboratories and their owners and operators are discussed. Conclusions.—Applications of a principal sanction for a PT violation were rare during the period of this study. However, the consequences of the imposition of such a sanction are severe. Suggestions are offered on policies and practices to minimize the risk of a PT sample referral or result communication.

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Diagnostic Challenges on the Laboratory Detection of Lupus Anticoagulant

Biomedicines ◽

10.3390/biomedicines9070844 ◽

2021 ◽

Vol 9 (7) ◽

pp. 844

Author(s):

Armando Tripodi

Keyword(s):

Lupus Anticoagulant ◽

Clinical Laboratory ◽

External Quality Assessment ◽

State Of The Art ◽

Diagnostic Procedures ◽

External Quality ◽

Glycoprotein I ◽

Current State ◽

Clinical Laboratories

Lupus anticoagulant (LA) is one of the three laboratory parameters (the others being antibodies to either cardiolipin or β2-glycoprotein I) which defines the rare but potentially devastating condition known as antiphospholipid syndrome (APS). Testing for LA is a challenging task for the clinical laboratory because specific tests for its detection are not available. However, proper LA detection is paramount for patients’ management, as its persistent positivity in the presence of (previous or current) thrombotic events, candidate for long term anticoagulation. Guidelines for LA detection have been established and updated over the last two decades. Implementation of these guidelines across laboratories and participation to external quality assessment schemes are required to help standardize the diagnostic procedures and help clinicians for appropriate management of APS. This article aims to review the current state of the art and the challenges that clinical laboratories incur in the detection of LA.

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Point-of-care testing: inspection preparedness

Perfusion ◽

10.1177/026765910001500208 ◽

2000 ◽

Vol 15 (2) ◽

pp. 137-142 ◽

Cited By ~ 3

Author(s):

John Bennett ◽

Cindy Cervantes ◽

Scott Pacheco

Keyword(s):

Clinical Laboratory ◽

Point Of Care ◽

Health Care Financing ◽

Well Being ◽

Regulatory Agencies ◽

Human Beings ◽

Point Of Care Testing ◽

Human Specimen ◽

Testing Site ◽

Clinical Laboratory Improvement Amendments

Point-of-care testing (POCT) in the operating room has changed dramatically since the implementation of the Clinical Laboratory Improvement Amendments (CLIA ‘88), which became effective in September 1992. With the implementation of CLIA ‘88, the Health Care Financing Administration (HCFA) mandated that human specimen testing ‘for the purpose of diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings’, must be performed by a certified laboratory or testing site. To attain and maintain accreditation, the need for more stringent and comprehensive documentation has become imperative. The Joint Commission for the Accreditation of Hospitals (JCAHO), the College of American Pathologists (CAPS), HCFA, and state regulatory agencies require data such as staff credentialling, staff training/competency, procedure manuals, quality control logs, quality assurance/corrective action plans, correlation studies, proficiency testing results, and equipment maintenance logs to assure specimens are analyzed in a reliable manner by competent personnel so as not to jeopardize the safety and well being of the patient. Developing a comprehensive, ongoing survey readiness plan that includes a pre-survey checklist of all the documentation required and having this documentation in order and up to date well in advance of the survey will greatly enhance the probability of a successful survey conducted by the various regulatory agencies.

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The Cost of Implementation of the Clinical Laboratory Improvement Amendments of 1988—The Example of Pediatric Office-Based Cholesterol Screening

PEDIATRICS ◽

10.1542/peds.96.2.230 ◽

1995 ◽

Vol 96 (2) ◽

pp. 230-234

Author(s):

Andrew M. Tershakovec ◽

S. Diane Brannon ◽

Michael J. Bennett ◽

Barbara M. Shannon

Keyword(s):

Proficiency Testing ◽

Laboratory Testing ◽

Clinical Laboratory ◽

High Volume ◽

Chemistry Laboratory ◽

Screening Process ◽

Cholesterol Screening ◽

Low Volume ◽

The Cost ◽

Clinical Laboratory Improvement Amendments

Objective. To measure the additional costs of office-based laboratory testing due to the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), using cholesterol screening for children as an example. Methods. Four-to ten-year-old children who received their well child care at one of seven participating pediatric practices were screened for hypercholesterolemia. The average number of analyses per day and days per month were derived from the volume of testing completed by the practices. Nurses and technicians time in the screening process were measured and personnel costs were calculated based on salary and fringe benefit rates. Costs of supplies, analyzing control samples, instrument calibration, and instrument depreciation were included. Costs estimates of screening were then completed. CLIA '88 implementation costs were derived from appropriate proficiency testing and laboratory inspection programs. Results. In six practices completing a low volume of testing, 2807 children (5 to 6 children per week) were screened during the observation period, while 414 (about 25 children per week) were screened in one high-volume practice implementing universal screening over a 4-month period. For the six low-volume practices, the cost of screening was $10.60 per child. This decreased to $5.47 for the high-volume practice. Estimated costs of CLIA '88 implementation, including additional proficiency testing and laboratory inspection, added $3.20 per test for the low-volume practices, and $0.71 per test for the high-volume testing. Conclusions. Implementation of CLIA adds significantly to the cost of office-based chemistry laboratory screening. Despite these additional expenses, the cost of testing is still within a reasonable charge for laboratory testing, and is highly sensitive to the volume of tests completed.

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Evaluation of Blood Lead Proficiency Testing: Comparison of Open and Blind Paradigms

Clinical Chemistry ◽

10.1093/clinchem/47.2.322 ◽

2001 ◽

Vol 47 (2) ◽

pp. 322-330 ◽

Cited By ~ 29

Author(s):

Patrick J Parsons ◽

Andrew A Reilly ◽

Debra Esernio-Jenssen ◽

Lloyd N Werk ◽

Howard C Mofenson ◽

...

Keyword(s):

New York ◽

Proficiency Testing ◽

Clinical Laboratory ◽

Phase 1 ◽

New York State ◽

Blood Lead ◽

York State Department ◽

Clinical Laboratories ◽

Significant Difference ◽

Double Blinded

Abstract Background: Most proficiency testing (PT) programs operate with an open design in which clearly identified performance samples are distributed directly to participating laboratories on a shipping schedule announced in advance. In this study, we examine the effectiveness of assessing clinical laboratory performance for blood lead with an open PT by comparing its results with a double-blinded testing protocol. Methods: Aliquots from up to 72 blood lead performance pools from the New York State Department of Health and the Wisconsin State Laboratory of Hygiene were disguised as routine patient specimens and submitted in two phases to up to 42 certified clinical laboratories for blood lead analysis. These 42 laboratories also received aliquots of the same performance samples for blood lead analysis directly from the “open” PT program provider. Results: Data reported under blind and open strategies were scored against acceptable target ranges using the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) criteria established for blood lead, i.e., ± 0.19 μmol/L (± 4 μg/dL) or ± 10%, whichever is greater. Performance differences between the strategies were also assessed. We found that 17.7% of all blind PT results were classified as unacceptable compared with only 4.5% of open PT results (P <0.001). In phase 1, 13 of 22 laboratories (60%) exhibited a statistically significant difference (P <0.05) between their blind and open PT performances, although for 6 laboratories the poorer blind performance may not necessarily have led to unsuccessful PT participation under CLIA ’88 criteria. Seven (32%) laboratories had unsuccessful aggregate performance (<80%) under blind testing while maintaining successful performance in open testing. Of these seven, two had gross discrepancies motivating further investigation. Conclusions: The data suggest that although ∼60% of clinical laboratories make special efforts to improve analytical performance on open PT samples relative to performance achieved for routine patient specimens, in most cases the differences are clinically insignificant and would not likely affect cumulative PT performance. Occasional use of blind PT may deter the inclination to treat performance samples more carefully.

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Proficiency Testing from a Total Quality Management Perspective

Clinical Chemistry ◽

10.1093/clinchem/38.5.615 ◽

1992 ◽

Vol 38 (5) ◽

pp. 615-618 ◽

Cited By ~ 2

Author(s):

K Castañeda-Méndez

Keyword(s):

Health Care ◽

Quality Management ◽

Total Quality Management ◽

Proficiency Testing ◽

Health Care Financing ◽

Proficiency Tests ◽

Total Quality ◽

Management Perspective ◽

Care Costs

Abstract Public concern over increasing health-care costs plus dramatized testing errors, has resulted in CLIA '88 with its more stringent rules governing laboratory performance. The purpose of the 1990 U.S. Health Care Financing Administration Final Rules for Proficiency Tests is to separate the quality laboratory from the poorly performing one. From the perspective of total quality management, the customer (patient) defines quality as virtually error-free test results. The current proficiency testing format defeats this. Its effective purpose is not to identify quality laboratories but to shut down the most prolific laboratories--regardless of their quality. There are two reasons for this. First, the proficiency testing format is incomplete: it is missing a minimum frequency criterion. Second, the data for determining the quality of a laboratory's performance (the degree of error-free results) are not being used. I propose a solution based on continuous improvement that promotes voluntarism, favors the quality laboratory, and reduces federal regulation.

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