proficiency test assessment of clinical laboratory capability in the United States

final report
  • 101 Pages
  • 4.44 MB
  • 1561 Downloads
  • English
by
National Bureau of Standards , [Washington]
Medical laborato
Statement[by] Peter W. Finkel [and] Ted R. Miller.
SeriesNBSIR -- 73-163., NBSIR -- 163.
ContributionsMiller, Ted R. joint author., United States. Dept. of Health, Education, and Welfare. Division of Health Evaluation.
The Physical Object
Paginationxii, 101 p.
ID Numbers
Open LibraryOL17718010M

Get this from a library. A proficiency test assessment of clinical laboratory capability in the United States: final report.

[Peter W Finkel; Ted R Miller; United States. Department of Health, Education, and Welfare. Division of Health Evaluation.]. proficiency test for each major sub-area of major disciplines of a laboratory’s scope of accreditation at least every four years.

The following paragraphs summarize the proficiency testing requirements of some of the major accreditation bodies in the United States.

This is not a complete listing of all accreditation bodies. Laboratory results play a major role in guiding clinical decisions. It has been reported 1 that fewer errors occur in clinical diagnostic laboratories compared with other hospital settings and that the clinical laboratory has made greater efforts than other health care sectors to decrease the occurrence of medical errors.

2 Many strategies have been adopted to reduce lab errors, including Cited by: 3. Each English Language Proficiency Test problem is tagged down to the core, underlying concept that is being tested. The English Language Proficiency Test diagnostic test results highlight how you performed on each area of the proficiency test assessment of clinical laboratory capability in the United States book.

You can then utilize the results to create a personalized study plan that is based on your particular area of need. The laboratory animal science (LAS) field has a long-standing tradition of high standards in animal care. Training for personnel working with animals is required by various national and international guidelines and laws.

Description proficiency test assessment of clinical laboratory capability in the United States PDF

1, 2, 21, 30, 32 In addition, proficient personnel minimize variables in experiments and improve animal welfare by reducing mistakes while working with animals 4, 38 and limit Cited by: 2.

Proficiency testing (PT) is a valuable tool for assessing laboratory performance and verifying the accuracy and reliability of test results. Participation is required by the Clinical Laboratory Improvement Amendments (CLIA) of for each of the microbiology subspecialties (bacteriology, mycobacteriology, mycology, parasitology, and virology), and the regulations include specific PT.

Traditional Proficiency Surveys in the U.S. Originally designed as a voluntary exercise, proficiency testing (PT) was created to help ensure comparability of clinical test measurements among laboratories. Laboratories received samples from a central agency and were asked to report results on several measurands.

Clinical Laboratory Performance on Proficiency Testing Samples -- United States, Regulation of laboratory testing for human health is mandated by law in the United States; the most recently enacted regulatory law is the Clinical Laboratory Improvement Amendments of (CLIA) *.

Proficiency Testing in the Clinical Laboratory 5 and its use as a quality indicator for stakeholders at various levels. The value of PT for staff competencies, peer group comparisons and educational opportunities followed close behind in importance.

Many laboratories extend the value of PT over time by using materials such. The reference laboratories are chosen for each measurand by the technical advisor for the proficiency test in question based on his or her knowledge of the laboratory and the uncertainty the laboratory is able to quote for the measurand.

The reference laboratories are generally A2LA accredited laboratories (accredited for the measurand in. Welcome to HN Proficiency Testing, Inc.

You can get an overview of the tests we offer on our availability page. Through this site you can access your test history, book tests and enter test results. To use these features, you have to create a login ID. When you create your login ID you have to. which a laboratory’s accreditation is partly dependent.

Based on the results of the test, the laboratory will evaluate its performance, which may include any necessary implementation and corrective actions.

A regular assessment of the technical performance of a laboratory is an. assessment and management are used in the clinical laboratory in a similar way when developing a robust quality plan for the testing process. Risk assessment helps clinical laboratories recognize potential adverse events, be proactive and forward thinking, and establish appropriate measures to prevent or minimize negative outcomes to patient care.

The assessment of competency and proficiency is a vital component of a laboratory animal training program, because this process confirms that the trainees have met the learning objectives for a. Eurofins Central Laboratory is dedicated to providing all analytical laboratory testing required in clinical trials.

With over 20 years of experience, our laboratory testing portfolio has become one of the broadest available in the industry. Role of Proficiency Testing in Building Laboratory Capacity in United States Submitted by: United States Food Safety Cooperation Forum Partnership Training Institute Network Proficiency Testing Workshop Beijing, China September Centers for Disease Control and Prevention.

Clinical laboratory performance on proficiency testing samples – United States, MMWR ;45(9) Referenced in the PT Report. Leeber JC. Role of external quality assurance schemes in assessing and improving quality in medical laboratories. Clin Chim Acta. ;(2) Bureau of Clinical Laboratories Quality Assessment Plan 4 • Sensitivity: capability of a method or instrument to discriminate between measurement responses representing different levels (e.g., concentrations) of a variable of interest.

VII. Personnel Assessment A. Job descriptions are reviewed annually and revised as needed. External quality assessment (EQA) is a system for objectively checking laboratory performance using an external agency or facility Proficiency testing (PT) is one method for achieving this PT is educational and promotes continuous learning; it supports laboratories in implementing new biomarkers into clinical testing as well as maintaining.

Evaluation of An Alternate Proficiency Testing Program in a Tertiary Care Laboratory C. Shalapay, G. Cembrowski, C. Zimmer, T. Hofer U of A Hospital, Edmonton, AB, Canada Objective and Relevance: To meet laboratory accreditation requirements we developed an alternate proficiency testing (PT) program and have been using it for one year (2.

Clinical Laboratory Improvement Amendments of (CLIA, ) regulations states that technical supervisors are responsible for ensuring that staff maintain competency to perform test procedures and report results promptly, accurately, and proficiently.

CLIA () requires that the skills of technical personnel be assessed annually. A proficiency test assessment of clinical laboratory capability in the United States: final report /, by Peter W.

Finkel, Ted R. Miller, and Education United States. Department of Health (page images at. CLIA Exempt States Washington () Office of Laboratory Quality Assurance. Department of Health. NE th Street. Shoreline, Washington New York () Clinical Laboratory Evaluation Program.

State of New York Department of Health. The Nelson A. Rockefeller Empire State Plaza. Box Albany, New York. American Proficiency Institute – 2nd Test Event EDUCATIONAL COMMENTARY – COMPETENCY ASSESSMENT IN THE CLINICAL LABORATORY: DEVELOPING A COMPETENCY ASSESSMENT PROGRAM (cont.) 3.

“Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;” 2 A method to document. Established inCMPT provides external assessment challenges (EQA) for Clinical Microbiology and Water Testing Laboratories.

CMPT adheres to the philosophy that as a university based program, in addition to providing support for accreditation and regulatory specifications, there exists a mandate for CMPT to support continual improvement and continuing education and to provide a platform.

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Proficiency Testing (PT), as it is introduced in ISO/IECis the best method for evaluation of the laboratories performance by using interlaboratory comparisons. It provides independent evidence that the laboratory produces technically valid and reliable results.

For over 40 years, MLE, a service of the American College of Physicians, has provided reliable, user-friendly laboratory proficiency testing (PT) services at a substantial cost savings for those labs that perform diagnostic testing where blood and bodily fluids are drawn.

Clinical Laboratory Improvement Amendments (CLIA) PROFICIENCY TESTING. and. PT REFERRAL. DOs and DON’Ts. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) inestablishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results, regardless of where the test.

The Clinical Laboratory Improvement Amendments of (CLIA 88) applies to all facilities that perform tests on human specimens. To ensure the quality of these tests, the law requires that most facilities participate in proficiency testing (PT) procedures as an external quality control. On Decemthe Center for Clinical Standard and Quality/Survey & Certification group (part of the United States Centers for Medicare and Medicaid Services) published S&CCLIA.

This letter outlines competency assessment requirements for compliance with federal regulation 42 CFR, PartSubpart M.

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The Clinical Laboratory Improvement Amendments (CLIA). CLIA 88 requires that laboratories successfully participate in an approved proficiency testing program.

Proficiency testing is the external component of quality control since it involves peer review. It primarily measures accuracy because each laboratory’s results are compared to the interlaboratory mean, which is assumed to be the true value.laboratory registration, collection of fees, self- and on-site laboratory inspections, training guidelines, approving proficiency testing (PT), and accrediting professional organizations and exempting states.

CMS has regulatory power for enforcing sanctions when necessary.Revised Draft Report: Quality, Regulation and Clinical Utility of Laboratory-developed Tests CONFIDENTIAL NOT FOR DISTRIBUTION OR CITATION Quality, Regulation and Clinical Utility of Laboratory-developed Tests Technology Assessment Report Project ID: LABC J ECRI Institute Evidence-based Practice Center Fang Sun, M.D., Ph.D.