Summary:
Summary Statement of Deficiencies D0000 An off site, proficiency testing (PT) desk review was conducted for Tug River Health Association Gary on January 2, 2024, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations with WSLH Proficiency Testing were reviewed for successful participation and compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. 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 the proficiency testing (PT) records from Wisconsin State Laboratory of Hygiene Proficiency Testing (WSLH PT) and the CMS CASPER 155D 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 -- Report, the laboratory failed to successfully participate in PT for the analyte #0335 PCO2 Blood Gas for two of three consecutive testing events. Findings: 1. CMS CASPER 155D revealed the following unsatisfactory scores for #0335 PCO2 Blood Gas: 60% 2023 Event 1 60% 2023 Event 3 2. WSLH PT evaluation reports confirmed the unsatisfactory scores of 60% in two of three consecutive testing events and the unsuccessful participation of the laboratory for the analyte PCO2 Blood Gas (#0335). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 the proficiency testing (PT) records from Wisconsin State Laboratory of Hygiene Proficiency Testing (WSLH PT) and the CMS CASPER 155D Report, the laboratory failed to perform successfully in PT for the analyte #0335 PCO2 Blood Gas for two of three consecutive testing events. Findings: 1. CMS CASPER 155D revealed the following scores for #0335 PCO2 Blood Gas: 60% 2023 Event 1 60% 2023 Event 3 2. WSLH PT evaluation reports confirmed the unsatisfactory scores of 60% in two of three consecutive testing events and the unsuccessful performance by the laboratory for the analyte PCO2 Blood Gas (#0335). -- 2 of 2 --