scholarly journals Manufacturer's Guidelines for Performing Diagnostic Tests May Be Too Ambiguous to Satisfy Clinical Laboratory Improvement Amendments Prenalytical Standards

2012 ◽  
Vol 138 (suppl 1) ◽  
pp. A295-A295
Author(s):  
Cynthia Turner ◽  
Jennifer Scott ◽  
Sudha Pottumarthy ◽  
Vern Juchau
Keyword(s):  
Diagnostic Tests ◽  
Clinical Laboratory ◽  
Clinical Laboratory Improvement Amendments

scholarly journals Considerations from the College of American Pathologists for implementation of an assay for SARS-CoV-2 testing after a change in regulatory status

2021 ◽  
Author(s):  
David R. Peaper ◽  
Daniel D. Rhoads ◽  
Kaede V. Sullivan ◽  
Marc R. Couturier ◽  
Romney M. Humphries ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Clinical Laboratory ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Regulatory Status ◽  
Pass Through ◽  
Clinical Laboratory Improvement Amendments ◽  
Regulatory Landscape ◽  
The U.S

The U.S. Food & Drug Administration FDA regulates the marketing of manufacturers’ in vitro diagnostic tests IVDs including assays for the detection of SARS-CoV-2. The U.S. government’s Clinical Laboratory Improvement Amendments CLIA of 1988 regulate the studies that a clinical diagnostic laboratory needs to perform for an IVD before placing it into use. Until recently, the FDA has authorized the marketing of SARS-CoV-2 IVDs exclusively through the Emergency Use Authorization EUA pathway. The regulatory landscape continues to evolve, and IVDs will eventually be required to pass through conventional non-EUA FDA review pathways once the emergency declaration is terminated in order to continue to be marketed as an IVD in the U.S. When FDA regulatory status of an IVD changes or is anticipated to change, the laboratory should review manufacturer information and previously performed internal verification studies to determine what, if any, additional studies are needed before implementing the non-EUA version of the IVD in accordance with CLIA regulations. Herein, the College of American Pathologists’ Microbiology Committee provides guidance for how to approach regulatory considerations when an IVD is converted from EUA to non-EUA status.

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 ROC Curves in Clinical Chemistry: Uses, Misuses, and Possible Solutions

2004 ◽  
Vol 50 (7) ◽  
pp. 1118-1125 ◽  
Author(s):  
Nancy A Obuchowski ◽  
Michael L Lieber ◽  
Frank H Wians
Keyword(s):  
Phase I ◽  
Sample Size ◽  
Gold Standard ◽  
Diagnostic Tests ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Roc Curves ◽  
Sample Size Determination ◽  
Phase Iii ◽  
Test Accuracy

Abstract Background: ROC curves have become the standard for describing and comparing the accuracy of diagnostic tests. Not surprisingly, ROC curves are used often by clinical chemists. Our aims were to observe how the accuracy of clinical laboratory diagnostic tests is assessed, compared, and reported in the literature; to identify common problems with the use of ROC curves; and to offer some possible solutions. Methods: We reviewed every original work using ROC curves and published in Clinical Chemistry in 2001 or 2002. For each article we recorded phase of the research, prospective or retrospective design, sample size, presence/absence of confidence intervals (CIs), nature of the statistical analysis, and major analysis problems. Results: Of 58 articles, 31% were phase I (exploratory), 50% were phase II (challenge), and 19% were phase III (advanced) studies. The studies increased in sample size from phase I to III and showed a progression in the use of prospective designs. Most phase I studies were powered to assess diagnostic tests with ROC areas ≥0.70. Thirty-eight percent of studies failed to include CIs for diagnostic test accuracy or the CIs were constructed inappropriately. Thirty-three percent of studies provided insufficient analysis for comparing diagnostic tests. Other problems included dichotomization of the gold standard scale and inappropriate analysis of the equivalence of two diagnostic tests. Conclusion: We identify available software and make some suggestions for sample size determination, testing for equivalence in diagnostic accuracy, and alternatives to a dichotomous classification of a continuous-scale gold standard. More methodologic research is needed in areas specific to clinical chemistry.

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