Summary:
Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid Services) CASPER report and API (American Proficiency Institute) proficiency testing (PT) evaluations, the laboratory failed to successfully participate in Mycology testing for Dermatophyte Identification for two consecutive testing events, Event #3, 2022 and Event #1, 2023. The findings include: Refer to D2038. D2038 MYCOLOGY CFR(s): 493.827(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid Services) CASPER report and API (American Proficiency Institute) proficiency testing (PT) evaluations, the laboratory failed to satisfactorily perform in Mycology testing (Dermatophyte Identification) for two consecutive testing events, Event #3, 2022 and Event #1, 2023. The findings include: Refer to D2038. 1. A review of the CMS CASPER report revealed the laboratory scored 60 % for Dermatophyte Identification for Event #3, 2022 and Event #1, 2023. 2. A review of the API PT evaluations confirmed the above noted findings. -- 2 of 2 --