Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed at Orion Laboratories, CLIA ID 19D2296523, on May 29, 2024. Orion Laboratories was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1415 CONDITION: Laboratories performing moderate complexity testing; Clinical Consultant 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 observation, review of laboratory polices and patient test records, as well as interview with personnel, the laboratory failed to follow their policy for hematology slide review for one (1) of ten (10) patients reviewed. Findings: 1. Observation by surveyor during the laboratory tour on May 29, 2024 at 10:25 a.m. revealed the laboratory utilized a Sysmex XN 550 hematology analyzer for hematology testing. 2. Review of the laboratory's "Manual Differential & Slide Review" policy section "Criteria for Slide Review" revealed the following: a) "Includes review of WBC's, RBC's, and PLTS" b) "The following are Instrument flags which will prompt tech to perform a Slide Review:...PLT ABN Dist" 3. Review of the instrument printout for patient ID E623501 revealed an "*" flag for the MPV result. 4. In interview on May 29, 2024 at 2:38 p.m., the Laboratory Director stated the "*" flag indicated platelet abnormal distribution and a slide review for morphology should be performed. 5. Review of the patient final report revealed the patient did not have a morphology review performed as required by laboratory policy. 6. In interview on May 29, 2024 at 2:38 p.m., the Laboratory Director confirmed a morphology review was not performed on the patient identified above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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)