Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of 2021/2022 troponin verification of accuracy, and interview with the testing personnel (TP) #1, the laboratory failed to verify the accuracy of the analyte: troponin. Findings: 1. Review of troponin verification of accuracy revealed the laboratory failed to verify the accuracy of troponin testing two times a year since January 2021. 2. Interview with the TP #1 on April 11, 2023 at 9:00 AM confirmed the laboratory failed to verify twice annually the accuracy of troponin. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of chemistry individualized quality control plan (IQCP) and interview with testing personnel (TP) #1, the laboratory failed to follow the IQCP for 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 -- troponin quality control (QC) for 17 of 27 months. Findings: 1. Review of troponin IQCP stated troponin QC must be performed monthly. 2. Review of troponin QC showed no troponin QC documented from January 2021 to May 2022. 3. Interview with TP #1 on April 11, 2023 at 9:30 AM confirmed the laboratory failed to follow IQCP and perform troponin QC monthly. 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 the 2022/2023 performance evaluations and interview with testing personnel (TP) #1, the technical consultant (whom is also the laboratory director) failed to evaluate and document performance evaluations at least semiannually during the first year for two of two TP in 2022 and one of one TP in 2023. Findings: 1. Review of performance evaluations showed no semiannual performance evaluation was documented for testing personnel #13 and #16 in 2022. 2. Review of performance evaluations showed no semiannual performance evaluation was documented for testing personnel #3 in 2023. 3. Interview with TP #1 on April 11, 2023 at AM confirmed the technical consultant did not evaluate and document the semiannual performance evaluation for three TP. 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 2021/2022 performance evaluations and interview with testing personnel (TP) #1, the technical consultant (whom is also the laboratory director) failed to evaluate and document annual performance evaluations for eight of eight TP in 2021 and ten of ten TP in 2022. Findings: 1. Review of 2021 performance evaluations showed no annual performance evaluation for testing personnel #2, #7, #9, #11, #12, #14, #15 and #17 in 2021. 2. Review of 2022 performance evaluations showed no annual performance evaluation for testing personnel #2, #7, #9, #11, #12, #13, #14, #15, #16 and #17 in 2022. 2. Interview with testing personnel #1 on April 11, 2023 at 9:00 AM confirmed the technical consultant failed to evaluate and document annual performance evaluation for TP. -- 2 of 2 --