Middlesboro Arh

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 05/11/2026 and concluded on 05/12/2026. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) (a)(3)(i) Records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on laboratory policy review and confirmed in staff interviews, the laboratory failed to retain documentation of required twice annual calibration verification (linearity) for 2 arterial blood gas analyzers for 2 of 2 years reviewed (year 2024 and year 2025). Findings included: Review of the laboratory's policy titled, "GEM Premier 5000 Analyzer SOP [Standard Operating Procedure]," dated 02/01/2023, revealed no information related to performing twice annual calibration verification (linearity) for arterial blood gas analyzers. During interview on 05/12/2026 at 1:15 PM, Technical Supervisor (TS) #2 and General Supervisor (GS) #4 stated the twice annual calibration verification (linearity) studies for the arterial blood gas analyzers were believed to have been performed, but the records could not be located. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 desk review of chemistry proficiency testing results from the American Proficiency Institute (API) proficiency testing agency on 11/3/2021, the laboratory failed to successfully participate in the total bilirubin (t bili) certified analyte in two testing events. See D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 desk review of Chemistry proficiency testing results from the American Proficiency Institute testing agency on 11/03/2021, the laboratory failed to successfully achieve satisfactory performance for the total bilirubin (t bili) certified analyte in two (2) testing events. Findings include: 1. The laboratory failed to achieve a satisfactory performance for the total bilirubin (t bili) in the first (1st) testing event of 2021. 2. The laboratory failed to achieve a satisfactory performance for the total bilirubin (t bili) in the third (3rd) event of 2021. -- 2 of 2 --