Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on June 21, 2021. Condition and Standard level Citations were found. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 the review of American Proficiency Institure (API) Proficiency Testing (PT) documents for the analyte Prostatic Specific Antigen (PSA), for the year 2021 1st event, showed that the laboratory failed to participate by not submitting results. This is a condition level citation. REFERENCE:. D2094, D6017 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Testing (API), Proficiency Testing (PT) documents for the year 2021, 1st event for the analyte Prostatic Specific Antigen (PSA) showed that the laboratory failed with a score of 0%, for non-participation by not submitting results. Findings: 1. Review of the API PT documents for 2021, for the analyte PSA, showed that the laboratory failed to submit results for the 1st event. 2. Interview with the practice manager, Staff #2 (CMS 209 form), and representatives from HCA Healthcare, on June 21, 2021, in the conference room, confirmed that the results were not submitted, and stated that the samples were not received at the office, and no followup was done, until after the evaluation report was returned. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Testing (API), Proficiency Testing (PT) documentation and staff interview, the laboratory failed to provide Correction Action in 2020, for event 2, for the analyte Prostatic Specific Antigen (PSA). Findings: 1. Review of the PSA documents from API for the year 2020, event 2, the laboratory failed to provide