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), 2022/2023 troponin quality control (QC), and interview with testing personnel (TP) #1, the laboratory failed to follow troponin IQCP for 6 of 17 months. Findings: 1. Review of troponin IQCP states quality control "completed on a monthly basis". 2. Review of 2022 troponin QC showed no monthly QC was performed in May, June, July, September, November and December. 3. Interview with TP #1 on May 31, 2023 at 10: 00 AM confirmed the laboratory failed to follow troponin IQCP. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --