Summary:
Summary Statement of Deficiencies D0000 A CLIA validation survey was completed on 01/23/2025, the laboratory was found out of compliance with the CLIA regulations. The conditions not met: D2016 - 42 C.F. R. 493.803 Condition: Successful Participation D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER 0155D) proficiency testing (PT) and American Proficiency Institute (API) proficiency testing (PT) records and interview with the general supervisor, the laboratory failed to successfully obtain an overall 100% satisfactory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- testing event score in PT for compatibility testing in the specialty of immunohematology for two out of two consecutive events for 2022-3 and 2023-1, resulting in unsuccessful PT performance. See D2181 D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) Failure to achieve an overall testing event score of satisfactory 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER 0155D) proficiency testing (PT) and American Proficiency Institute (API) proficiency testing (PT) records and interview with the general supervisor, the laboratory failed to successfully obtain an overall 100% satisfactory testing event score in PT for compatibility testing in the specialty of immunohematology for two out of two consecutive events for 2022-3 and 2023-1, resulting in unsuccessful PT performance. Findings include: 1. Review of PT records in the federal CASPER reporting system on January 3, 2025, showed the laboratory had an unsuccessful performance for compatibility testing for PT events 2022-3 and 2023-1. Event 2022-3, score 60% Event 2023-1, score 80% 2. Review of API PT evaluation reports showed the laboratory had an unsuccessful performance for compatibility testing in the specialty of immunohematology for two consecutive events. Event 2022-3, score 60%, sample numbers: SER-12 and SER-14. Event 2023- 1, score 80%, sample numbers: SER-03. 3. Interview with the general supervisor on January 23, 2024, at 8:50 AM confirmed the laboratory failed to successfully obtain satisfactory PT event scores for two consecutive events for compatibility testing resulting in unsuccessful PT performance. 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 surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the technical consultant, the laboratory failed to document