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 record review and interview, the laboratory failed to follow and document laboratory policy to assess competency for two (SP-4 and SP-5) of two employees performing potassium hydroxide (KOH) preparations for two (PT#3 and PT#4) of four patients reviewed for KOH. Finding(s) include: 1. Review of medical records indicted PT#3 and PT#4 had KOH preparations completed by SP#3. KOH preparations were performed on 7/6/2022 for PT#3 and 4/20/22 for PT#4. 2. In interview on 12/7/2023 at 12:20 pm, SP-1 (regional clinic manager) confirmed that there were two physicians' assistants, SP-4 and SP-5, that perform KOH preparations during their patient's visits as well as SP-2 (laboratory director). 3. Review of the "Policy & Procedure Manual PPM", reviewed by the laboratory director on 9/26/2023, revealed the policy," Personnel Competency Testing", Policy #: M-735-B-1, read, "All testing personnel must be reviewed for their ability to perform patient testing correctly and accurately ... Laboratory compliance requires training/competency to be completed initially, 6 months after the start date and annually thereafter. 4. Review of personnel files indicated the following: a) SP-4 was hired on 9/7/2021, there was no documentation of 6 month or annual competency since their hire date. b) SP-5 was hired on 11/1/2017, there was no documentation of 6 month or annual competency since their hire date. 5. On 12/7/2023 at 12:45 pm, SP-1 confirmed there is no documentation of six month or annual competency for SP-4 and SP-5. 6. Annual test volume for KOH is 50. 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 --