Summary:
Summary Statement of Deficiencies D0000 A recertification survey was performed on April 18, 2024. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) document review and staff interview, the laboratory failed to perform and document QC on potassium hydroxide (KOH) slides. Findings include: 1. No QC documents were available to review on KOH slides at the time of survey. 2. Interview with the laboratory consultant, on 4/18/24, at 12 PM in the KOH lab area, confirmed controls were not performed on KOH slides . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) documents and an interview with the 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 -- laboratory consultant, the technical consultant (also serving as the lab director) failed to perform semiannual competency on all testing personnel. Findings: 1. Review of TP documents revealed the lack of semiannual competencies on TP #4 and #5 (CMS 209). 2. Interview with the laboratory consultant, in the document review office, on 4 /18/24 at 12:15 PM, confirmed the absence of the aforementioned competencies. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) documents and staff interview, the technical consultant failed to perform annual competency on all testing personnel. Findings: 1. 1. Review of TP documents revealed the lack of annual competencies on: TP #4 , #5, and #7 (CMS 209). 2. Interview with the laboratory consultant in the document review office on 4/18/24 at 12:15 PM confirmed the absence of the aforementioned competencies. -- 2 of 2 --