Summary:
Summary Statement of Deficiencies D0000 A validation survey was performed on July 23, 2026. The laboratory was found to be in compliance with condition-level CLIA requirements. The following 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 training and competency assessment of employees policy, review of testing personnel competency assessment records and interview with the laboratory manager, the laboratory failed to establish a competency assessment procedure that ensures 7 of 7 testing personnel (TP) were assessed for each specific test procedure performed for 2 years (July 2024 to July 2026). Findings: 1. The CLIA Laboratory Personnel Report (Form CMS 209) listed 7 employees as TP. 2. Review of the Training and competency assessment of employees policy revealed the policy failed to ensure TP were assessed for each specific test procedure performed. 3. Review of TP competency assessment records from 2025 revealed 7 TP were assessed for each testing specialty rather than each specific test procedure performed. 4. By interview on July 23, 2026, at 9:00 am, the laboratory manager confirmed the above findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of the Post-Vasectomy Semen Examination (Sperm Count) policy, a lack of documented temperature for specimens received, and an interview with the Laboratory Manager, the laboratory failed to check and document the temperature of semen specimens delivered to the laboratory for 2 of 2 years ( July 2024 to July 2026). Findings: 1. The Post-Vasectomy Semen Examination (Sperm Count) policy, page 1, Specimen:, stated "specimen needs to be kept at an ambient temperature (20 degrees to 37 degrees Celsius)." 2. The laboratory could not provide documentation for temperatures recorded for semen specimens received by the laboratory. 3. From July 2024 to July 2026, the laboratory performed 29 sperm count examinations. 4. By interview on July 23, 3036, at 12:40 pm, the laboratory manager confirmed the above findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (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)