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 the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to include how assessment was performed and what records were reviewed on four of four TP from 2015 to 2018. The TP # 1 listed on CMS form 209 confirmed on 3/6/19 at 10:15 am that CA did not include details. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the technical supervisor failed to perform Direct observation of patient specimen handling and processing requirement on four of four TP from 2015 to 2018. The TP # 1 listed on CMS form 209 confirmed on 3/6/19 at 10: 15 am that above procedure was not included in CA. D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES 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 -- CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the technical supervisor failed to perform Review of worksheets, quality control records and preventive maintenance records requirement on four of four TP from 2015 to 2018. The TP # 1 listed on CMS form 209 confirmed on 3/6/19 at 10:15 am that above procedure was not included in CA. -- 2 of 2 --