Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was performed at The Pathology Laboratory, LLC- Alexandria, CLIA ID 19D2294114, on February 23, 2026. 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, personnel competencies, and interview with personnel, the laboratory failed to ensure personnel competency assessments for two (2) of seven (7) personnel reviewed were complete for 2025. Findings: 1. Review of the laboratory's personnel competency policies revealed "Competency for Clinical Consultants and Technical Supervisors will be performed initially and annually. Competency assessments for Testing Personnel will be performed and documented by a Technical Supervisor." 2. In interview on February 23, 2026 at 1:00 pm, the General Supervisor stated annual competency assessments are performed for her duties as General Supervisor. 3. Review of the laboratory's 2025 personnel competency forms revealed the following: a) General Supervisor Competency Evaluation form included a statement "Competency has been satisfactorily demonstrated: yes or no" b) Personnel Competency Form for testing personnel included a blank space to write the outcome of the "evaluation of competency" 4. Review of the 2025 annual competency assessments for the General Supervisor and Testing Personnel 6 revealed the outcome indicating if the personnel were deemed competent was not included. 5. In interview on February 23, 2026 at 1:30 pm, the General Supervisor confirmed the outcome of the 2025 competency assessments for the identified personnel were not completed. 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 -- D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) 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; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Refer to D5209. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Supervisors failed to ensure policies and procedures for assessing testing personnel competency were maintained. Refer to D5209. -- 2 of 2 --