Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the hematology complete blood count(CBC) proficiency testing (PT) records, and interview with the Laboratory Technical Consultant determined the laboratory failed to retain all PT records in 2017. The fiindings include: 1. Review of he hematology CBC PT records for 2017 revealed the labortatory failed to retain the attestation sheet signed by the Laboratory Director for 2017 event 1 and the reviewed summary report for 2017 event 2. 2. Interview with the Technical Consultant on August 8, 2018, at approximately 10:45 AM confirmed the laboratory failed to retain all hematology CBC PT records for 2017. 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, Laboratory Personnel Competency files, and interview with the Technical Consultant determined the laboratory failed to establish and follow written policies and procedures to assess the Technical Consultant's competency in 2017 and 2018. The findings include: 1. Review of the Laboratory Procedure Manual failed to include a policy or procedure for the Laboratory Director assessing the competency of the Technical Consultant. 2. 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 -- Review of the Laboratory Personnel Competency files failed to include a competency assessment -- 2 of 2 --