Pathology Laboratories

Summary Statement of Deficiencies D0000 A recertification survey was conducted on April 18, 2022. Pathology Laboratories clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 D0000 A recertification survey was conducted on March 4, 2020. Pathology Laboratories was found not in compliance with 42 CFR 493, requirements for clinical laboratories. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform competency assessment for 2 (B, C) out of 3 (A, B, C) Testing Personnel in 2019. Findings: Review of the Laboratory Personnel Report (CMS 209), signed and dated by the Laboratory Director on 3/2/2020, showed that there are three testing personnel. Review of competency assessments showed that there were no competency assessment performed in 2019 for Testing Person B and C . During an interview on 3/4 /2020 at 10:42 AM, the Laboratory Director stated that no competency assessments were performed on the testing personnel in 2019. 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 --