Summary:
Summary Statement of Deficiencies D0000 An on-site validation survey was completed on September 03, 2026 with the following standard level deficiencies 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 submitted Form Centers for Medicare and Medicaid (CMS) 209, written policies and procedures, lack of competency assessment documentation, and interview with the Technical Consultant (TC), the laboratory failed to follow written policies and procedures assessing competency assessments for 1 of 1 TC. Findings Included: 1) Review of the laboratory's submitted Form CMS 209 revealed one individual delegated the consultant position of TC since 2024. 2) Review of the laboratory's written policy titled 'SSH-NENJ Job Description and Qualifications; Non-Waived Testing Laboratory Services, Policy Number LS-07' stated the following on page 1 of 10: "Procedure: Laboratory personnel will be fully qualified by education, training, and experience according to the minimum levels established by CMS ...Documentation verifying the credentials, education, and training for all laboratory personnel shall be maintained in the personnel files.." Page 4 of 10: "Technical Consultant ... 1. Prior to delegating responsibility as a Technical Consultant, the following information will be reviewed ... a. Education b. Proof of training or experience ... If the individual's education, training, and experience satisfies one of the above, the Laboratory Director shall document a written and signed delegation of authority to the individual to serve as the laboratory's Technical Consultant ..." 3) Review of the laboratory's written policy titled 'SSH-NENJ Competency Verification for Non-Waived Laboratory Personnel, Policy Number LS- Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 04' stated the following on page 3 of 4: "2. Competency Assessment for the Technical Consultant: The Laboratory Director shall conduct a formal competency review of any individual serving as the Laboratory's Technical Consultant to evaluate the individual's competency to perform all required responsibilities of the Technical Consultant, as outlined under 42 CFR 493.1413. For avoidance of doubt, this competency assessment is solely related to the Technical Consultant's fulfillment of responsibilities related to the Technical Consultant role and shall not authorize the Technical Consultant to act as Testing Personnel absent a separate competency assessment performed in accordance with the requirements outlined ... The Laboratory Director shall complete the Technical Consultant Competency Assessment at the following intervals: (i) within thirty (30) days of the Laboratory Director's delegation of authority to the individual to serve as Technical Consultant ..." 4) Review of the laboratory's competency records revealed no competency assessment for the TC in 2024 or 2025. 5) In an interview on 9/3/2026 at 9:48 AM, the TC confirmed the findings above and her delegation as TC in 2024, but no competency assessment completed until 2026. 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)