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 Technical Consultant (TC), controls procedures were not performed each day of patient testing for Potassium Hydroxide (KOH) prep slides. The laboratory performs approximately 4 KOH tests per year. Findings include: 1. Record review revealed that patient testing was performed on 11 /29/21 and no quality control procedures were performed. 2. In an interview on 10/20 /2022 at 12:30, the TC confirmed that KOH controls procedures are not performed with each day of patient 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 --