Clinical Laboratory Improvement Amendments of 1988 (CLIA '88): A Review

2000 ◽  
pp. 340-371
Keyword(s):  
Clinical Laboratory ◽  
Clinical Laboratory Improvement Amendments

Point-of-care testing: inspection preparedness

Perfusion ◽  
2000 ◽  
Vol 15 (2) ◽  
pp. 137-142 ◽  
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.

scholarly journals Detection of Influenza A and B Viruses and Respiratory Syncytial Virus by Use of Clinical Laboratory Improvement Amendments of 1988 (CLIA)-Waived Point-of-Care Assays: a Paradigm Shift to Molecular Tests

2018 ◽  
Vol 56 (7) ◽  
Author(s):  
Marwan M. Azar ◽  
Marie L. Landry
Keyword(s):  
Respiratory Syncytial Virus ◽  
Antiviral Therapy ◽  
Influenza A ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
The United States ◽  
Nucleic Acid Amplification ◽  
Molecular Tests ◽  
Syncytial Virus ◽  
Clinical Laboratory Improvement Amendments

ABSTRACT An accurate laboratory diagnosis of influenza, respiratory syncytial virus (RSV), and other respiratory viruses can help to guide patient management, antiviral therapy, infection prevention strategies, and epidemiologic monitoring. Influenza has been the primary driver of rapid laboratory testing due to its morbidity and mortality across all ages, the availability of antiviral therapy, which must be given early to have an effect, and the constant threat of new pandemic strains. Over the past 30 years, there has been an evolution in viral diagnostic testing, from viral culture to rapid antigen detection, and more recently, to highly sensitive nucleic acid amplification tests (NAAT), as well as a trend to testing at the point of care (POC). Simple rapid antigen immunoassays have long been the mainstay for POC testing for influenza A and B viruses and respiratory syncytial virus (RSV) but have been faulted for low sensitivity. In 2015, the first POC NAAT for the detection of influenza was approved by the Food and Drug Administration (FDA), ushering in a new era. In 2017, the FDA reclassified rapid influenza diagnostic tests (RIDTs) from class I to class II devices with new minimum performance standards and a requirement for annual reactivity testing. Consequently, many previously available RIDTs can no longer be purchased in the United States. In this review, recent developments in Clinical Laboratory Improvement Amendments of 1988 (CLIA)-waived testing for respiratory virus infections will be presented, with the focus on currently available FDA-cleared rapid antigen and molecular tests primarily for influenza A and B viruses and RSV.

Letter to the Editor

PEDIATRICS ◽  
1994 ◽  
Vol 93 (1) ◽  
pp. 154-154
Author(s):  
Alejandro Hoberman ◽  
Ellen R. Wald
Keyword(s):  
Private Practice ◽  
Occupational Safety ◽  
Clinical Laboratory ◽  
Regulatory Agencies ◽  
Health Administration ◽  
Safety And Health ◽  
Effective Care ◽  
Laboratory Procedures ◽  
The One ◽  
Clinical Laboratory Improvement Amendments

Dr Murray correctly points out that the concerns of office-based pediatricians regarding regulations imposed by the Clinical Laboratory Improvement Amendments (CLIA) and Occupational Safety and Health Administration (OSHA) greatly affect the likely implementation of "new laboratory procedures" within the private practice sector. Although these regulatory agencies, on the one hand, intend to assure quality control when evaluating specimens and on the other hand, safety for patients and employees, they are often perceived as obstacles to effective care.

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

PEDIATRICS ◽  
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.

Limitations of Proficiency Testing Under CLIA '67

1992 ◽  
Vol 38 (7) ◽  
pp. 1237-1244 ◽  
Author(s):  
R H Laessig ◽  
S S Ehrmeyer ◽  
B J Lanphear ◽  
B J Burmeister ◽  
D J Hassemer
Keyword(s):  
Health Care ◽  
Quality Assurance ◽  
Proficiency Testing ◽  
Clinical Laboratory ◽  
Health Care Financing ◽  
Clinical Laboratories ◽  
Regulatory Strategy ◽  
Clinical Laboratory Improvement Amendments ◽  
Quality Improvement Tool

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.

scholarly journals Laboratory-Developed Tests: A Legislative and Regulatory Review

2017 ◽  
Vol 63 (10) ◽  
pp. 1575-1584 ◽  
Author(s):  
Jonathan R Genzen ◽  
Jeffrey S Mohlman ◽  
Jerry L Lynch ◽  
Michael W Squires ◽  
Ronald L Weiss
Keyword(s):  
Clinical Laboratory ◽  
Draft Guidance ◽  
In Vitro Diagnostics ◽  
Regulatory Oversight ◽  
Regulatory Review ◽  
Policy Documents ◽  
Congressional Hearings ◽  
Clinical Laboratory Improvement Amendments ◽  
Intense Debate

Abstract BACKGROUND Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that “home brew” tests—now commonly referred to as laboratory-developed tests (LDTs)—are subject to the same regulatory oversight as other in vitro diagnostics (IVDs)4. In 2010, the FDA began work on developing a proposed framework for future LDT oversight. Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation. While the proposed guidance has not been implemented, many questions regarding LDT oversight remain unresolved. CONTENT This review provides an overview of federal statutes and regulations related to IVDs and clinical laboratory operations, with a focus on those potentially applicable to LDTs and proposed regulatory efforts. Sources reviewed include the Code of Federal Regulations, the Federal Register, congressional hearings, guidance and policy documents, position statements, published literature, and websites. SUMMARY Federal statutes regarding IVDs were passed without substantive evidence of congressional consideration toward the concept of LDTs. The FDA has clear oversight authority over IVD reagents introduced into interstate commerce. A 16-year delay in publicly asserting FDA authority over LDTs, the pursuit of a draft guidance approach toward oversight, and establishment of regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) applicable to LDTs contributed to community uncertainty toward LDT oversight. Future regulatory and/or legislative efforts may be required to resolve this uncertainty.

scholarly journals Validation of immunohistochemical tests performed on cytology cell block material: Practical application of the College of American Pathologists’ guidelines

CytoJournal ◽  
2019 ◽  
Vol 16 ◽  
pp. 6 ◽  
Author(s):  
Swati Satturwar ◽  
Renuka Malenie ◽  
Ann Sutton ◽  
Ding Dai ◽  
F. Zahra Aly
Keyword(s):  
Clinical Laboratory ◽  
The United States ◽  
Cell Block ◽  
Laboratory Staff ◽  
Academic Center ◽  
Formalin Fixed Paraffin ◽  
Formalin Fixed Paraffin Embedded ◽  
Validation Set ◽  
Clinical Laboratory Improvement Amendments

The advent of fiberoptic endoscopy with biopsy has revolutionized procurement of specimens from deep sites. This has translated into more cytologic specimens whereby the material is limited and best handled by cytology laboratory staff. While the diagnosis of the pathologic process is of utmost importance, there is increasing expectation that the diagnosis be specific and accurate as not to require additional biopsy for initiation of treatment. This expectation has driven demand in immunohistochemical (IHC) and molecular studies conducted specifically on material processed as cytology specimens. The Clinical Laboratory Improvement Amendments of 1988 requires laboratories in the United States of America to verify the performance of patient tests. Due to varying laboratory practices with respect to validation of IHC assays, the College of American Pathologists introduced guidelines for analytic validation of IHC tests. These guidelines address how to perform validation by recommending the number of cases in the validation set, comparator concordance, and when to revalidate. The main thrust of the guidelines is based on formalin-fixed paraffin-embedded tissue with only one expert consensus opinion referring to validation of IHC tests on cytology specimens which delegates to the medical director, the determination of number of positive and negative cases to be tested. This article will outline how an academic center approaches validation of IHC studies performed on cytology cell block specimens using the College of American Pathologists guidelines. A stepwise approach from selection of antibodies to validate followed by building the validation panel and evaluating the stain results for concordance against the gold standard of histology tissue specimen will be described. A rationale for dealing with discordant results and future innovations will conclude the report.

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