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 review of the laboratory procedure manual, the form used for documenting testing personnel training and competency, and interview with the laboratory liaison, the laboratory failed to have a procedure that included all six criteria for assessing personnel competency in 2017, 2018, and 2019. The findings include: 1) Review of the laboratory procedure manual revealed no procedure for testing personnel competency assessment. The following six criteria were not included in the procedure manual: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills. 2) Review of the form used for documenting testing personnel training and competency revealed that direct observation of patient testing, monitoring the recording and reporting of test results, record review including intermediate test results, worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of maintenance and function checks, blind testing, and problem solving were not included on the form. 3) Interview with the laboratory liaison May 29, 2019 at 11:30 am confirmed the laboratory procedure manual did not include a policy for assessing testing personnel Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- competency. The checklist used for documenting training and competency did not include the six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS). 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 review of the laboratory proficiency testing records, the laboratory's proficiency testing program reports and interview with the laboratory liaison, the laboratory failed to verify the accuracy of urine microscopy twice a year in 2018. The findings include: 1) Review of the laboratory proficiency testing records revealed enrollment in proficiency for urine microscopy. Performance evaluation reports were not available for 2018 events one and three; and the laboratory scored a 50% for urine microscopy for 2018 event two. 2) Review of the laboratory's proficiency testing program performance summary report obtained from the laboratory's proficiency testing provider revealed a score of 50% for 2018 events two and three for urine microscopy. 3) Interview with the laboratory liaison on May 29, 2019 at 11:30 am confirmed the laboratory enrolls in proficiency testing for verification of accuracy of urine microscopy procedures. No records were available for 2018 events one and three, and the laboratory scored 50% for 2018 event two. The laboratory failed to verify the accuracy of urine microscopy twice a year in 2018. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The laboratory director failed to ensure compliance with regulations (Refer to D6004), failed to ensure proficiency testing reports were available and reviewed (Refer to D6018), failed to ensure the proficiency testing