Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at WOODRUFF INSTITUTE, THE from 06/24/2025 to 06/30/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 laboratory records review and staff interview, the laboratory failed to have a personnel policy in the Procedure Manual and failed to do Initial competency evaluation for one out of six Testing Personnel (TP) Findings included: 1-Review of FORM CMS 209 signed by the Laboratory Director (LD) on 06/12/2025 revealed that the LD was Clinical Consultant (CC), Technical Supervisor (TS) for Histopathology and TP#1, the laboratory had also 5 more TP (TP#2, TP#3, TP#4, TP#5 and TP#6). 2- Review of Procedure Manual signed by the LD on 06/12/2025, revealed that the Procedure Manual failed to have a policy that described all the personnel, the job descriptions and the frequency of the competencies. 2- Review of personnel records revealed that TP#3 that is a pathologist who started testing since 03/25/2025 failed to have a Job description and the Initial Competency Evaluation. 3-During an interview on 06/24/2025 at 12:30 PM, with General Supervisor, he confirmed that TP#6 failed to have the Initial Competency evaluation. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)