Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Watson Clinic LLP on 6 /19-6/20/25. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 have a written policy and procedure to assess one of one Testing Person who performed Histology Hematoxylin & Eosin (H&E) for two of two years (2023-2025). Findings included: 1. The laboratory manual reviewed and approved by the Lab Director on 3/5/24, included a policy titled Dermatopathology Quality Assurance approved by the Lab Director on 3/5/24, which stated for Competency Monitor that each Dermatologist /Dermatopathologist performing slide reading must perform annual competency to be completed by performing 5 slide reviews. There was no indication the procedure included the six required procedures in their competency assessment (direct observation, monitoring recording and reporting of test, review of worksheets, quality control, performance of function check (as needed), assessment of blind samples, and assessment of problem-solving skills). 2. The CMS-209 signed by the Lab Director on 6/10/25, listed one Testing Personnel (TP A) for H & E testing. TP A personnel record did not include a competency assessment for H & E testing for 2023-2025 other than peer reviews. 3. The Clinical Service Coordinator on 6/19/25 at 11:30 a.m., confirmed the written procedure for assessing testing personnel performing H & E did not include all the six required procedures for assessment. 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 --