Lakewood Health System

Summary Statement of Deficiencies D0000 The Lakewood Health System 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 June 18, 2025. The following standard-level deficiencies were cited: 493.1451 Technical supervisor responsibilities . D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) (b)(8)(vi) Assessment of problem-solving skills; and This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Supervisor failed to ensure a documented evaluation of problem solving skills was completed during 2024 annual competency assessments for 1 of 16 hospital laboratory testing personnel. Findings are as follows: 1. The laboratory performed Microbiology, General Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by the Technical Supervisor (TS) during a tour of the laboratory at 8:05 a.m. on 04/25/19. The following analyzers and equipment were observed as present and available for use during the tour of the laboratory: Cepheid GeneXpert Molecular Test System Gram stain kit Versa Trek Automated Microbial Detection System Sysmex XN 100 Automated Hematology Analyzer Nikon e400 microscope Ortho Workstation Immunohematology Analyzer 2. The laboratory's electronic Personnel Competency Assessment with Staff Ready procedure, located in the internal SharePoint folder, included a requirement to evaluate problem solving skills annually for each test system. 3. The 2024 Staff Ready Report for General Supervisor 3 (GS3) did not include assessment of problem solving skills for 10 of 24 test system areas. The problem solving assessment areas that were not included in GS3's report are listed below. Cepheid GeneXpert MVP Gram Stain Versa Trek blood cultures Vitros chemistry analyzer Urinalysis Sysmex XN 100 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 -- hematology analyzer Manual differential Manual cell counts Semen analysis/Post Vasectomy Gel Blood Banking The laboratory was unable to provide documentation of GS3's 2024 problem solving assessments for the above test systems upon request. 4. In an interview at 9:55 a.m. on 06/18/25, the TS confirmed the above finding. . -- 2 of 2 --

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)

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of non-regulated Immunology and Hematology analytes at least twice annually in 2017 and 2018. Findings are as follows: 1. The laboratory performed Immunology and Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 02/07/19 at 8:20 a.m. 2. The CRP* test and Semen Analysis microscopic examination were included on the Tests Performed at Lakewood Health System policy provided by the laboratory. 3. Twice annual verification of accuracy documents for CRP and Semen Analysis (motility and grade) were not found during review of laboratory records from 2017 and 2018. The laboratory was unable to provide the documents upon request. 4. In an interview on 02 /07/19 at 4:35 p.m. and 11:40 a.m. respectively, the GS confirmed the accuracy of the CRP test and Semen Analysis (motility and grade) had not been verified twice annually in 2017 and 2018. *C-Reactive Protein 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. 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 -- (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)