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 document review, lack of documentation, and interview with the Technical Supervisor (TS), the laboratory failed to include the 5 (specimen, test system, reagent, environment, and testing personnel) of 5 required components, the 3 (pre-analytic, analytic, and post-analytic) of 3 phases of testing which includes potential failures, the risk criteria, and the quality assessment (QA) plan for the Mycoplasma genitalium (M gen) when implementing the Individualized Quality Control Plan (IQCP). Findings include: 1. On 3/15/2021 at 12:36 pm, review of the IQCP documentation for the Hologic Panther instrument revealed the IQCP plan for the Mycoplasma genitalium (M gen) testing lacked documentation for the 5 (specimen, test system, reagent, environment, and testing personnel) of 5 required components, the 3 (pre-analytic, analytic, and post-analytic) of 3 phases of testing which includes potential failures, the risk criteria, and the quality assessment (QA) plan. 2. The IQCP was put into place and reviewed by the Laboratory Director on 7/30/2019. 3. A interview on 3/15/2021 at 12:36 pm with the TS confirmed the above findings. D5781