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 review of proficiency testing records, the laboratory unsuccessfully participated in proficiency testing (PT) for the subspecialty of Endocrinlogy, and the analytes Thyroid Stimulating Hormone (TSH) and Free Thyroxine (Free T4). D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the Thyroid Stimulating Hormone (TSH) and Free Thyroxine (Free T4) analytes.. Findings: 1. The laboratory is subscribed to the American Proficiency Institute Chemistry Core PT program. 2. The laboratory received the following scores: 2020 First Testing Event: TSH = 0%, Free T4 = 20% 2020 Third Testing Event: TSH = 60%, Free T4 = 60% D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the subspecialty of Endocrinology. Findings: 1. The laboratory is subscribed to the American Proficiency Institute Chemistry Core PT program. 2. The laboratory received the following scores: 2020 First Testing Event: 40% 2020 Third Testing Event: 73% -- 2 of 2 --