Summary:
Summary Statement of Deficiencies D5519 MYCOLOGY CFR(s): 493.1263(b)(c) (b)For antifungal susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antifungal agent(s) before, or concurrent with, initial use, using an appropriate control organism(s). (b)(1) The laboratory must establish limits for acceptable control results. (b)(2) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(3) The results for the control organism(s) must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of Laboratory Test Requisition, Report Log documentation, and staff confirmation, the laboratory failed to document KOH quality control for 2016, 2017 and 2018. Findings include: 1. Review of 18 of 18 patients for 2016 Laboratory Test Requisition and Report Log revealed no KOH quality control documentation was noted from 08/24/2016 to 12/31/2016. 2. Review of 57 of 57 patients for 2017 Laboratory Test Requisition and Report Log revealed no KOH quality control documentation was noted from 01/01/2017 to 12/31/2017. 3. Review of 40 of 40 patients for 2018 Laboratory Test Requisition and Report Log revealed no KOH quality control documentation was noted from 01/01/2018 to 9/20/2018. 4. In an interview conducted on 09/20/2018 at approximately 0835 AM, Denver Dermatology Consultants staff confirmed no quality control was documented for 2016, 2017 and 2018 KOH microscopic exam. 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 --