Sierra Hematology & Oncology Medical Center

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the lack of laboratory written test procedures reflecting the current laboratory practice, review of five (5) randomly chosen patients results, and interview with the laboratory's staff (LS), it was determined that the laboratory failed to have current written procedures for all tests performed in the laboratory reflecting the current practice. The findings included: 1. On the day of the survey on January 25, 2023, at approximately 11:45 a.m. the laboratory failed to provide current written procedures for all test procedures performed in the laboratory. 2. For five (5) out of five (5) random patient test results reviewed covering period from 9/27/2021 to 1/2 /2023 the patients had various Hematology test ordered, analyzed, and reported for which the laboratory had no current written tests procedures available reflecting the current practice. 3. The LS confirmed on January 25, 2025, at approximately 12:30 p. m. that the laboratory did not have current written procedures available for all test performed in the laboratory. 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 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 -- 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 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing (PT) result reports, and interview with the laboratory testing personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Leucocyte Count (WBC), WBC Differential, and Platelet Count (Plt), in each testing event were unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory used Abbott Cell-Dyn Emerald to perform complete blood cell count (CBC) including WBC and WBC Differential, Erythrocyte Count (RBC), Hemoglobin (Hgb), Hematocrit (Hct), and Platelet Counts (Plt). b. The laboratory enrolled its PT programs with Medical Laboratory Evaluation (MLE) PT provider to ensure the accuracy of the CBC testing performances annually. c. The laboratory attained scores of 60% for the following analyte, WBC and Plt in the 3rd 2016 PT event, which were unsatisfactory analyte performance for the testing event. d. The laboratory attained a score of 66% for the following analyte, WBC Differentials in the 3rd 2016 PT event, which was unsatisfactory analyte performance for the testing event. d. The laboratory performed CBC in approximately 300 patient samples each month. e. The laboratory personnel affirmed (9/20/2018 @ 1 PM) that the laboratory failed to attained at least 80% of acceptable responses for WBC, WBC Differential, and Plt in the 3rd 2016 Hematology PT event which were unsatisfactory analyte performance for the testing event. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing (PT) result reports, and interview with the laboratory testing personnel, it was determined that the laboratory director failed to ensure that the laboratory attained a score of at least 80 percent of acceptable responses for CBC testing in the 3rd 2016 Hematology PT event and failed to perform the tests as required under subpart H of 42 CFR part 493. The findings included: a The laboratory used Abbott Cell-Dyn Emerald to perform CBC and enrolled its PT with MLE PT provider. b. The laboratory failed to attain a score of at least 80 percent of acceptable responses for WBC, Cell Differential, and Plt in the 3rd 2016 Hematology PT event were unsatisfactory analyte performance for the PT testing event. c. See D-2121. -- 2 of 2 --