UNASSIGNED: To solicit quantifiable feedback from clinical laboratorians on the U.S. Food and Drug Administration (FDA) proposed rule to regulate laboratory-developed tests (LDTs) as medical devices.
UNASSIGNED: A ten-item questionnaire was developed and submitted to clinical laboratory customers of ARUP Laboratories, a national nonprofit clinical laboratory of the University of Utah Department of Pathology.
UNASSIGNED: Of 503 clinical laboratory respondents, only 41 (8 %) support the FDA\'s proposed rule. 67 % of respondents work in laboratories that perform LDTs and were therefore asked additional questions regarding the proposed rule. 84 % of these respondents believe that the proposed rule will negatively impact their laboratories, while only 3 % believe that they have the financial resources to pay for FDA user fees. 61 % of respondents anticipate removing tests from their laboratory menus if the proposed rule is enacted, while an additional 33 % indicated that they do not yet know. Only 11 % of respondents believe that they would pursue FDA submissions for all of their existing LDTs if the final rule is enacted. The vast majority of respondents (>80 %) were either \'extremely concerned\' or \'very concerned\' about the impact of the proposed rule on patient access to essential testing, financial and personnel resources to comply, innovation, the FDA\'s ability to implement the rule, and send-out costs and test prices.
UNASSIGNED: The majority of clinical laboratorians surveyed do not support the FDA\'s proposed rule on LDTs and report having insufficient resources to comply with the rule if it is enacted.

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Though testing for infectious diseases has long been performed in traditional clincial laboratory settings, more widespread availability of waived testing is expanding accessibility of patients to rapid test results. This is being further expanded to home testing. Nevertheless, with this greater democratization and availability of clinical testing there are important limitations that need to be balanced. In this article, we review the current test landscape for infectious diseases waived testing and opportunities for assuring optimal quality testing.

To determine the frequency of use of laboratory-developed tests (LDTs) in an academic medical center system.
Retrospective analysis of 2021 test order data from an academic medical center (hospital, outpatient clinics, and cancer center) was done. Measures included assay type, assay methodology, regulatory status, test order volume, inpatient vs outpatient setting, and provider medical specialty.
Of the 3,016,928 tests ordered in 2021, 2,831,489 (93.9%) were tests cleared, approved, and/or authorized by the US Food and Drug Administration (FDA); 116,583 (3.9%) were LDTs; and 68,856 (2.3%) were standard methods. These test orders were performed using a total of 1,954 distinct assays. Of these, 983 (50.3%) were FDA assays, 880 (45.0%) were LDTs, and 91 (4.7%) were standard methods. Laboratory-developed tests were more commonly ordered in the outpatient vs inpatient setting and represented a higher proportion of the test volume at the cancer center compared with the university hospital (5.6% vs 3.6%, respectively). The top 167 LDT assays accounted for 90% of the LDT volume (104,996 orders). Among the 20 most frequently ordered LDTs were mass spectrometry assays and tests used in the care of immunocompromised patients. Internal/family medicine placed the greatest number of orders (1,044,642) and ordered one of the lowest proportions of LDTs (3.2%).
Laboratory-developed tests made up a small percentage of the total laboratory tests ordered within the academic health system studied.

The Clinical Laboratory Improvement Amendments of 1988 were passed into law on October 31, 1988; regulations implementing this law have had a dramatic impact on the practice of cytology as well as the operations of the entire laboratory. Articles in the popular press followed by congressional hearings exposed faulty laboratory practices, with false-negative Pap tests being a major focus. The impact of this law on the cytology profession is reviewed in this paper. We discuss the response by professional organizations and laboratories to proposed regulations, including formation of consortium groups, development of interlaboratory comparison programs, and more stringent laboratory accreditation and inspection procedures. Public perceptions related to false-negative Pap tests and the litigation crisis are reviewed, as well as the development of new technologies that would improve test accuracy. Finally, the role of the Clinical Laboratory Improvement Advisory Committee in advising the government on laboratory regulations and cytology proficiency testing is discussed. Many of the regulations have promoted quality practices and cytology accuracy, but others have proven relatively inflexible and may have blocked innovation.

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.

Several independent research groups have shown that alterations in human sperm methylation profiles correlate with decreased fecundity and an increased risk of poor embryo development. Moving these initial findings from the lab into a clinical setting where they can be used to measure male infertility though requires a platform that is stable and robust against batch effects that can occur between sample runs. Operating parameters must be established, performance characteristics determined, and guidelines set to ensure repeatability and accuracy. The standard for technical validation of a lab developed test (LDT) in the USA comes from the Clinical Laboratory Improvement Amendments (CLIA). However, CLIA was introduced in 1988, before the advent of genome-wide profiling and associated computational analysis. This, coupled with its intentionally general nature, makes its interpretation for epigenetic assays non-trivial.
Here, we present an interpretation of the CLIA technical validation requirements for profiling DNA methylation and calling aberrant methylation using the Illumina Infinium platform (e.g., the 450HM and MethylationEPIC). We describe an experimental design to meet these requirements, the experimental results obtained, and the operating parameters established.
The CLIA guidelines, although not intended for high-throughput assays, can be interpreted in a way that is consistent with modern epigenetic assays. Based on such an interoperation, Illumina\'s Infinium platform is quite amenable to usage in a clinical setting for diagnostic work.

An explosion of knowledge and technology is revolutionizing medicine and patient care. Novel testing must be brought to the clinic with safety and accuracy, but also in a timely and cost-effective manner, so that patients can benefit and laboratories can offer testing consistent with current guidelines. Under the oversight provided by the Clinical Laboratory Improvement Amendments, laboratories have been able to develop and optimize laboratory procedures for use in-house. Quality improvement programs, interlaboratory comparisons, and the ability of laboratories to adjust assays as needed to improve results, utilize new sample types, or incorporate new mutations, information, or technologies are positive aspects of Clinical Laboratory Improvement Amendments oversight of laboratory-developed procedures. Laboratories have a long history of successful service to patients operating under Clinical Laboratory Improvement Amendments. A series of detailed clinical examples illustrating the quality and positive impact of laboratory-developed procedures on patient care is provided. These examples also demonstrate how Clinical Laboratory Improvement Amendments oversight ensures accurate, reliable, and reproducible testing in clinical laboratories.

Building collaborative working relationships (CWRs) with physicians or other prescribers is an important step for community pharmacists in establishing a collaborative practice agreement (CPA). This case study describes the individual, context, and exchange factors that drive pharmacist-physician CWR development for community pharmacy-based point-of-care (POC) testing. Two physicians who had entered in a CPA with community pharmacists to provide POC testing were surveyed and interviewed. High scores on the pharmacist-physician collaborative index indicated a high level of collaboration between the physicians and the pharmacist who initiated the relationship. Trust was established through the physicians\' personal relationships with the pharmacist or due to the community pharmacy organization\'s strong reputation. The physicians\' individual perceptions of community pharmacy-based POC testing affected their CWRs and willingness to establish a CPA. These findings suggest that exchange characteristics remain significant factors in CWR development. Individual factors may also contribute to physicians\' willingness to advance their CWR to include a CPA for POC testing.

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