Summary:
Summary Statement of Deficiencies D0000 An onsite initial certification survey was conducted on 07/21/2026. The laboratory was found to be in compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of laboratory policy, American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing(PT) records, and confirmed in interview, the laboratory failed to retain a copy of all andrology PT records for one of one event in 2025 (Event S2) and all endocrinology PT records for one of two events in 2025 (Event M3) and two of two events in 2026 (Event M1 and M2). Findings included: 1. Review of the laboratory's policy "Quality Management Plan" stated: "17. Proficiency Testing ... 17.2.15. Records of external PT must be reviewed and signed by the Laboratory Director or Technical Consultant and must be maintained for a minimum of two years" 2. Review of AAB PT records revealed the laboratory failed to retain a copy the PT test records/raw data for the following events: 2025 Andrology (semen analysis) Event S2 Endocrinology (fertility testing) Event M3 2026 Endocrinology (fertility testing) Events M1 and M2 The laboratory was asked on 07 /21/2026 at 10:37 AM for the proficiency test records/raw data and none was provided. 3. During an interview in the office on 07/21/2026 at 11:17 AM, the laboratory supervisor confirmed the laboratory failed to retain a copy of all andrology PT records for one of one event in 2025 (Event S2) and all endocrinology PT records for one of two events in 2025 (Event M3) and two of two events in 2026 (Event M1 and M2). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- 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 CMS (Center for Medicare and Medicaid Services) 209 form, laboratory policies, personnel records, and confirmed in staff interview, the laboratory failed to have a policy for performing competency assessments for laboratory consultants and failed to perform competency assessments for one of one clinical consultant/technical consultant/technical supervisor/general supervisor in 2025 and 2026. Findings included: 1. Review of the laboratory's submitted CMS 209 form identified one person who was delegated to the role as clinical consultant, technical consultant, technical supervisor and general supervisor. 2. Review of the laboratory policy titled "Quality Management Plan" stated: " 7. Personnel, Training, and Competency 7.1. The CLIA regulation requires that certain laboratory positions are defined and have specific personnel requirements based upon the testing complexity level. All personnel associated with laboratory activities must meet or exceed CLIA personnel requirements ... 7.4. Competency Evaluations of Personnel 7.4.1. A competency evaluation must be performed for each test a person performs. Evaluations will be performed at six months after initial training was completed, and annually thereafter." The policy failed to include competency assessment requirements for clinical consultants, technical consultants, technical supervisors and general supervisors. 3. A review of personnel records in 2025 and 2026 revealed competency assessments for the laboratory supervisor who was delegated on the CMS 209 form as the clinical consultant/technical consultant/technical supervisor/general supervisor. The competency assessments were performed by a person who was NOT the laboratory director. 4. During an interview on 07/21/2026 at 11:01 AM, the laboratory supervisor stated that the person who completed his competency assessments was another technical supervisor at a sister laboratory, confirming the above findings. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory policy, American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, and confirmed in interview, the laboratory failed to document