Lakewood Health System - Motley Clinic

Summary Statement of Deficiencies D0000 . The Lakewood Health System - Motley Clinic laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on November 13, 2025. The following standard-level deficiency was cited: 493.1236 Evaluation of proficiency testing performance . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to investigate two unacceptable Hematology proficiency testing (PT) results out of thirty challenges completed in 2023. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 12:00 p.m. on 11/13/25. 2. The laboratory performed PT using the American Proficiency Institute (API) proficiency testing provider. 3. The laboratory received one unacceptable Lymphocyte (LYM) PT result of fifteen testing challenges completed in 2023 and one unacceptable Mean Corpuscular Hemoglobin (MCH) PT result of fifteen testing challenges completed in 2023 as indicated in the API 2023 2nd Hematology/Coagulation Comparative Evaluation report. See below. 2023 - 2nd Hematology/Coagulation event Test: LMY Sample: HSY-07 Laboratory result: 13.9 API expected result: 16.6 - 22.2 Test: MCH Sample: HSY-09 Laboratory result: 21.4 API expected result: 29.8 - 32.4 4. Unacceptable PT result investigation was required as established in the laboratory's Proficiency Testing Guidelines procedure found in the laboratory protocols internal Sharepoint site. 5. Investigation documentation for the unacceptable LYM and MCH scores was not found during review of laboratory PT records. The laboratory was unable to provide investigation 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 -- and

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)