Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manuals, lack of documentation, and interview with testing personnel (TP) #2; the laboratory failed to follow the established competency procedure in place to assess employee competency for 3 of 3 TP who perform potassium hydroxide (KOH) testing. Findings include: 1. Review of the laboratory's policy and procedure manual identified the procedure titled "Testing Procedure for KOH" that stated "Initial training will occur when a new clinician joins the practice. Training will occur again at the 6-month mark and then annually thereafter." 2. Review of laboratory records revealed laboratory failed to have documented competency assessments for TP #3, TP #4, and TP #5 who perform KOH testing. 3. Interview with TP #2 on 11/04/2025, at 12:05 pm, confirmed that the laboratory failed to have a competency reviews completed for three of three TP in place for microscopic KOH testing. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, record review, review of patient log, and interview with testing personnel (TP) #2; the laboratory failed to perform control procedures specified by the laboratory for potassium hydroxide (KOH) testing from 01/02/2023 though the survey date of 11/04/2025. Findings include: 1.Review of the laboratory's policy and procedure manual identified the procedure titled "KOH QC policy" that stated "Procedure: Each morning a quality control slide will be read under the microscope. A KOH control for Mycology is a suspension of inactivated fungal spores and mycelia that can be used to verify the quality of a potassium hydroxide (KOH) preparation. The preparation will include placing the mycology control on a clean glass slide, Adding one drop of the KOH preparation and then reviewing the slide. Expected Daily result: Fungal mycelia appear as reflected strands under bright field microscopy or phase contrast microscopy. Few if any epithelial cells should be present." 2. Review of records titled "QC form" revealed the laboratory had failed to document the use of QC slides from 01/02/2023 to the date of survey 11/04/25 3. An interview with TP #2 at 12:27 pm on 11/04/2025 confirmed the laboratory failed to follow the laboratories established quality control procedure for KOH testing. 4. Review of laboratory patient log titled "KOH Log" revealed that 238 patients had KOH testing performed from 1/5/2023 to 9 /12/25. D5781