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 record review and interview with the Lab Manager the laboratory failed to perform quality control (QC) daily for BNP (B-type natriuretic peptide) testing since 11/06/17. Findings Included: Review of QC for BNP testing found 2 levels of QC ran every month. During an interview on 04/30/18 at 3:15 PM the Lab Manager confirmed that QC was ran only monthly and no IQCP (Individualized Quality Control Plan) had been performed to deviate from running the controls every day of testing. 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 --