Thedacare Medical Center-Orthopedic Spine And Pain

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 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and interview with a technical supervisor, staff A, the laboratory director, or a qualified designee, did not attest to the routine integration of the immunohematology PT samples into the patient workload using the laboratory's routine methods for two of two immunohematology events in 2022 and 2023. Findings include: 1. Review of the API immunohematology PT records showed staff A signed the immunohematology attestation statements as the designee. Further review showed the laboratory director, who is the immunohematology technical supervisor, did not sign two of two immunohematology attestation statements in 2022 and 2023. 2. Interview with staff A on May 23, 2023, at 9:20 AM confirmed the laboratory director, or a qualified designee, did not attest to the routine integration of the immunohematology PT samples into the patient workload using the laboratory's routine methods in 2022 and 2023. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the technical supervisor, staff A, the laboratory did not retain the lot and expiration date for the hematology reagent stains used for manual differentials on the Hematek 3000 slide stainer for ten of ten months reviewed in 2022 and 2023. Findings include: 1. Review of the hematology maintenance log showed no documentation of hematology stain lot or expiration date information from July 22, 2023, through May 24, 2023. 2. Interview with the staff A on May 24, 2023, at 11:36 AM confirmed the laboratory did not retain the lot and expiration dates from the hematology stain used for manual differentials. -- 2 of 2 --