September 2023—A proficiency testing accreditation requirement in the new checklist edition was revised to add clarification, and a new requirement on viscoelastic testing will close an existing gap.
Read More »What’s required in ’23 for predictive marker tests
September 2022—Beginning next year, two additional predictive marker tests will require enrollment in proficiency testing (PT), but for any predictive marker using immunohistochemistry or in situ hybridization, only laboratories that perform both staining and interpretation must participate in CAP-accepted PT.
Read More »Gastric HER2, hsALK to join monitored PT list
September 2021—Beginning next year, CAP-accredited laboratories that perform HER2 immunohistochemistry in gastroesophageal adenocarcinoma or highly sensitive (hs) ALK in non-small cell lung cancer will be required to enroll in proficiency testing for those analytes.
Read More »At POC and in lab, 2 new checks on SARS-CoV-2 testing
November 2020—The CAP released in September its proficiency testing program for SARS-CoV-2 antigen testing, with the first shipment to laboratories set for Nov. 30. It also introduced recently a Quality Cross Check program that makes it possible for labs performing nucleic acid amplification testing for SARS-CoV-2 to monitor performance across multiple instruments, in compliance with the CMS directive prohibiting proficiency testing on multiple instruments.
Read More »Cytopathology in focus: Gynecologic cytology PT appeals: where they started,where they stand
May 2020—The CAP implemented proficiency testing for cervical cytology in 2006 as mandated by federal legislation. The performance of participants and granting of appeals on glass slides in the first year of the CAP Pap PT program was reported in detail by Crothers, et al. Once a participant initiates an appeal, the slide in question is pulled from the program for a blinded review by three board-certified anatomic pathologists who are members of the CAP Cytopathology Committee. In the first year, 155 participants failed the PT examination and appealed their testing results on 86 individual slides. After review, appeals were granted for 21 slides, resulting in 45 exam failure reversals. The overall appeal rate was 13/1,000 slides in the program.
Read More »DIY or Survey? Identifying interfering substances
October 2017—The interfering substance: Whether it’s in-laws on your doorstep or lipemia in your specimen, it has to be addressed. Ask Michelle K. Zimmerman, MD. These days, Dr. Zimmerman uses the CAP Interfering Substance Survey to detect the presence of hemolysis, lipemia, and icterus in clinical chemistry samples at Indiana University School of Medicine, where she is an assistant professor of pathology and laboratory medicine. But before her laboratory started using the Survey, how did it handle those interferences?
Read More »For NIPT laboratories, a new proficiency test in 2018
September 2017—The CAP Surveys program is offering for 2018 a novel external proficiency test for laboratories that perform screening of cell-free (cf) DNA in maternal plasma for common aneuploidies.
Read More »Glucose PT criteria reset stirs standards debate
June 2016—It may not be an exact science, but resetting standards is a long-established means of improving quality of testing, and it can also be a way of adapting to improvements in quality that have already been realized. In the case of the CAP’s recent tightening of proficiency testing criteria for hospital glucose testing, both purposes are at work.
Read More »Proficiency tests on multiple instruments: CMS clarifies regs
March 2016—If a laboratory does not perform its proficiency testing in accordance with a recently reiterated CMS directive regarding PT on multiple instruments, its standing with the Centers for Medicare and Medicaid Services could be at stake. In fact, “You could be sanctioned directly by the CMS,” says Thomas Long, MPH, CAP director of biostatistics.
Read More »3 new NGS Surveys on CAP 2016 PT launchpad
November 2015—More than two years ago, when the CAP decided to move forward with proficiency testing for next-generation sequencing, the decision point was modest. “We estimated that about 35 labs would subscribe, based on survey information, and that was sufficient for us to move forward,” says Karl V. Voelkerding, MD, chair of the CAP Next-Generation Sequencing project team.
Read More »NY cuts labs loose from requirement to use state’s PT
October 2015—With the New Year approaching, many laboratories that test New York state specimens can look forward to breathing a sigh of relief. Regulatory relief, that is. Thanks to a policy change by the state’s Clinical Laboratory Evaluation Program (CLEP), beginning Jan. 1, 2016, laboratories will still have to be inspected by the state, but can fill New York’s proficiency requirement with the proficiency tests of any organization to which the CMS has granted deemed status under CLIA.
Read More »Make no mistake — PT referral not allowed
October 2015—No one plans to screw up.Take the worker carrying out maintenance duties at a Damascus, Ark., U.S. Air Force base one evening in 1980. Surely the only thing on his mind was doing a decent job and going home. Unfortunately, his good intentions didn’t prevent him from accidentally dropping a socket from a socket wrench.
Read More »PT failures: steps to preventing a cease testing
September 2015—When the Clinical Laboratory Improvement Amendments of 1988 were implemented in the early 1990s, a number of significant changes to proficiency testing, or PT, were required. For the 83 tests or analytes (and microbiology subspecialties) defined as CLIA regulated, the law imposed requirements on both PT providers and laboratories.
Read More »Upper-echelon QA through Accuracy-Based Programs
June 2015—HbA1c, creatinine, testosterone, vitamin D, lipids, and maybe albumin. If you know what the common thread is among these analytes, then you may be familiar with the CAP’s Accuracy-Based Programs and their evolution over the past couple of decades.
Read More »PT referral rules bring regulatory relief for labs
July 2014—Laboratories now may be saved from draconian penalties, such as loss of a CLIA license and probation periods, for mistakenly sending proficiency test specimens to another facility. Under new rules published by the Centers for Medicare and Medicaid Services, laboratories have the regulatory relief the CAP advocated during the past decade. The CMS will still severely punish those attempting to cheat on proficiency testing, but laboratories that unknowingly or unintentionally refer PT specimens will face alternative sanctions, according to the regulations.
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