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 Surveyor review of laboratory policy and procedure, personnel training & competency evaluation records, and interview with the laboratory staff, the laboratory failed to evaluate competency of its testing personnel. The findings include: a. The laboratory has 2 testing personnel who performs testing in hematology. However, the laboratory did not have any training and competency evaluation records for any of the testing person. b. On March 15, 2019 at 11:40 am laboratory testing personnel affirmed that the laboratory did not have any training & competency evaluation records. c. The laboratory's testing declaration form, signed by the laboratory Director on March 2, 2019, stated that the laboratory performs 2,000 tests annually in hematology. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on Surveyor review of proficiency testing and patient test records, lack of documentation of evaluation of proficiency testing performance, and interview with the laboratory testing personnel, the laboratory failed to evaluate proficiency testing 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 -- performance of the 3rd event in 2018 for lymphocyte %. The findings include: a. The laboratory obtained a 60% score for the lymphocyte % at the 3rd event of 2018 AAB proficiency testing. b. The laboratory failed to provide any documentation showing that it had evaluated the proficiency testing performance and made any