Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed at Delta Pathology Group, LLC ASC, CLIA ID 19D2313029, on July 25, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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's policies and interview with personnel, the laboratory failed to establish a complete written competency assessment policy for testing personnel. Findings: 1. Review of the laboratory's "Professional Competency" policy revealed the laboratory did not include the following: a) initial training for pathologists who serve as testing personnel b) frequency of competency assessments to include semi-annual for new testing personnel 2. In interview on July 25, 2025 at 10:05 am, the Compliance Personnel confirmed the laboratory's written competency assessment policy did not include the identified information. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; 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 -- This STANDARD is not met as evidenced by: Based on review of policies and interview with personnel, the Laboratory Director failed to ensure complete policies and procedures for assessing personnel competency were established. Refer to D5209. -- 2 of 2 --