Digestive Diseases Center

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted on October 28, 2021. Digestive Diseases Center clinical laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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 with the Histotechnologist, the laboratory failed to perform competency evaluations on 3 out of 3 Testing Personnel and Clinical Consultants (#2, 6,and 7) for 1 of 2 years ( June 2018- June 2019) reviewed. Findings Included: Review of Personnel Competency evaluations found no competencies for Staffs # 2, 6, and 7 for being the Testing Persons and Clinical Consultants. During an interview on 06/19/19 at 11:00 AM, the Histotechnologist confirmed that competency evaluations were not performed on Staffs # 2, 6, and 7. 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 --