Umdc Dermatology Mohs Chemosurgery

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at UMDC Dermatology MOHS Chemotherapy on 03/18/2020. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 Testing Person #D, the laboratory failed to perform competency evaluations on 2 (#B and #C) out of 3 Clinical Consultants and 3 (#B, #C, and #D) out of 4 Testing Personnel for 2 (2018-2020) out of 2 years reviewed. Findings Included: Review of the CMS 209 signed by the Laboratory Director on 03/12/20 revealed 3 Clinical Consultants and 4 Testing Personnel. The Laboratory Director was 1 of 3 Clinical Consultants and 1 of 4 Testing Personnel. Review of employee files revealed no competency evaluations on all 2 of the Clinical Consultants and all 3 of the Testing Personnel. Interview on 03/18/2020 at 11:00 AM the Testing Person #D confirmed that there were no competency assessments for the aforementioned staff. 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 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain from 8/29/17 to 7/19/18 for 1 out of 2 testing personnel who perform the reading and interpretation of the H&E slides. Findings: Review of the laboratory's records failed to show documentation of the peer review for testing personnel B from 8/29/17 to 7/19 /18. The laboratory uses peer review to evaluate the accuracy of the reading and interpretation of the H&E stain. During an interview on 7/19/18 at 9:50 AM, Testing Personnel C stated she did not know they needed to do peer review on all personnel who read and interpret the H&E stains. 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)