Lakewood Health System-Eagle Valley Clinic

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory director failed to approve two of two moderate complexity testing procedures in use by the laboratory in 2022, 2023, and 2024. Findings are as follows: 1. The laboratory performed moderate complexity Toxicology and Hematology testing as confirmed by Technical Consultant 2 (TC2) during a tour of the laboratory at 1:05 p.m. on 01/30/24. 2. The following moderate complexity testing equipment was observed as present and available for use during the tour: Toxicology - MEDTOXScan reader ( Drugs of Abuse testing) Hematology -Sysmex XP-300 analyzer (Complete Blood Count testing) 3. The laboratory maintained electronic procedures in the LakeNet SharePoint site. 4. Laboratory Director approval for the following testing procedures was not found during LakeNet SharePoint review on date of survey: MedTox Urine Drug Screen Procedure Sysmex XP-300 5. In an interview at 2:30 p.m. on 01/30/24, TC2 confirmed the above finding. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure hematology proficiency testing samples were tested consistent with the number of times the laboratory routinely tested patient samples. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Technical Consultant 1 (TC1) during a tour of the laboratory on 04/10/18 at 11:05 a.m. 2. The laboratory performed proficiency testing (PT) for Hematology using the American Proficiency Institute (API) proficiency testing provider. 3. Hematology PT samples HEM-11 through HEM-15 from the API 2016 3rd event were tested on multiple days as indicated on test result documents generated by the hematology analyzer. See below for date and time of day testing was performed. 11/10/16 11/11/16 Sample HEM-11 13:21 13:19 HEM-12 13:22 13:21 HEM-13 13:24 13:22 HEM-14 13:25 13: 24 HEM-15 13:27 13:25 4. In an interview on 04/10/18 at 12:05 p.m., TC1 confirmed the PT samples had been tested on multiple days and patient specimens would not routinely be handled in this manner. 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 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 -- 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)