Summary:
Summary Statement of Deficiencies 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 troponin individualized quality control plan (IQCP), troponin quality control (QC) from November 2022 to date September 6, 2023, and interview with technical consultant (TC) #1, the laboratory failed to follow troponin IQCP for 7 of 10 months for Level 1 and 8 of 10 months for Level 2. Findings: 1. Review of troponin IQCP states quality control "completed on a monthly basis". 2. Review of 2022/2023 troponin QC showed no monthly QC was performed in the followong months: 2022 Level 1 - November and December Level 2 - November and December 2023 Level 1 - January, February, March, May, June, Level 2 - January, February, March, May, June, July 3. Interview with TC #1 on September 6, 2023 at 10:00 AM confirmed the laboratory failed to follow troponin IQCP. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 -- This STANDARD is not met as evidenced by: Based on review of performance evaluations, and interview with the technical consultant (TC) #1, the TC failed to perform initial performance evaluations on 14 of 14 testing personnel (TP). Findings: 1. Review of performance evaluations showed no initial performance evaluations performed on TP #2, #3, #4, #5, #6, #7, #8, #11, #12, #13, #14, #15, #17 and #18. 2. Interview with TC #1 on September 6, 2023 at 10:30 AM confirmed the TC failed to perform initial performance evaluations. -- 2 of 2 --