Summary:
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 Lab Manager, the laboratory failed to perform 6 month competency evaluations for two (#A, #B) of three lab personnel for one of one year reviewed (2017-2018). Findings Included: A review of the Form CMS 209, titled Laboratory Personnel Report, and signed by the lab director on 8/6/18 revealed Staff Member A was the Clinical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel, and Staff Member B was a Clinical Consultant and Testing Personnel. A review of Staff A and Staff B's personnel records revealed no evidence of 6 month competency evaluations for each position for 1 out 1 year (2017- 2018) reviewed. During an interview on 08/08/2018 at 11:30 AM the Histology Supervisor confirmed that there were no 6 month competency evaluations for Staff A or Staff B. 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 interview, the laboratory failed to verify the accuracy of the test for the subspecialty of Histopathology in patient specimen slides at least twice 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 -- annually for 1 out of 1 year reviewed (2017-2018) for 1 out of 2 Testing Personnel (Testing Personnel #B). Findings included: Review of Histopathology test peer review records for 2017 -2018 showed that no peer reviews were completed for Histopathology stained specimen slide interpretation for Testing Personnel #B. Interview on 08/08/18 at 11:50 AM, the Histology Supervisor confirmed that the laboratory failed to verify the accuracy of slide interpretations for Histopathology testing through peer review for 1 out 1 yea(2017-2018) for Testing Personnel #B. -- 2 of 2 --