Summary:
Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the c-reactive protein (CRP) procedure, quality controls records, the laboratory specimen log, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:30 am on 6/21/2022; the laboratory failed to perform two levels of CRP quality control materials each day of patient testing for one out of 12 days from 1/1/2022 - 3/4/2022. The findings include: 1. The CRP procedure stated that quality controls will be performed each day of patient testing. 2. On 1/12/2022, the laboratory performed CRP testing on one patient using reagent lot number KL18-5, expiration date 2022-02-05. 3. The laboratory did not perform two levels of CRP quality controls on 1/12/2022. 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 --