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 Testing Person #A, the laboratory failed to perform Bacteriology controls daily or establish an IQCP (Individualized Quality Control Plan) for 2 out of 2 years (2016-2018) reviewed. Findings Included: Review of QC (Quality Control) records revealed that QC was performed per the manufacturers instruction instead of daily. No IQCP was in place. Remel BactiDrop Spot Indol and BD Oxidase test kit - QC was performed every 6 months and when the lot number changed and a new shipment was received. Catalase-QC was performed when a new shipment or lot number of reagent was received. Kirby-bauer susceptibility testing-QC was performed weekly or before a new lot of disc or media was used. During an interview on 05/30/18 at 3:00 PM Testing Person #A confirmed that QC was not performed daily and there was no 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 --