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 staff interview, the Laboratory Director (LD) failed to ensure that the competency assessment of the General Supervisor (GS) was evaluated within six months of hire, as established in the laboratory policy for a high complexity testing laboratory. Findings include: 1. Record review on 03/11/2026 of the laboratory's "Competency Assessment_HHC_Cancer Institute ONC 10002" procedure revealed the following: a. "Competency assessment will be performed on biennial basis for the Clinical consultant, Technical Consultant, Technical Supervisor and General Supervisor- by the Lab Director for particular site". b. " For new hires for the above 1(a) roles, competency assessment will be performed within 6 months after the start date, then biennially thereafter." 2. Record review conducted on 03/11/2026 of the laboratory's "General Supervisor Performance Assessment Form (GSPA)" revealed the following: a. The form listed the "Name of GS" and included six criteria used to assess the responsibilities of the General Supervisor. All six criteria were marked "YES" under satisfactory. Each of the six criteria was dated 10/04/2024. b. The top right corner of the form contained the handwritten notation "sa 11-6-2025" and "6 mo." c. There was no documentation indicating that the Laboratory Director (LD) reviewed and assessed the competency of the General Supervisor within the required 6 months' timeframe. d. The Laboratory Director initialed the GSPA form with "sa" on 11/06/2025, approximately 13 months after the evaluation dated 10/04 /2024. 3. Staff interview on 3/11/2026 at 09:35 AM with the GS confirmed the above findings. 4. The laboratory performs 172,600 tests annually. 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 --