Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of 2016-2018 proficiency testing (PT) records and an interview with the lead lab nurse, the laboratory director failed to attest/sign three of seven attestation statements for hematology PT Events 2016-2018. Findings include: 1. There were no signed attestation statements by the lab director available for review for hematology with complete blood count (CBC) 2016 PT Events A & B and 2018 PT event B. 2. In an interview, on October 3, 2018, at approximately 11:00 AM, the lead lab nurse confirmed no signed attestation statements by the lab director were available for review for hematology (CBC) 2016 PT Events A & B and 2018 PT event B. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of patient test records for 2016-2018 and an interview with the lead lab nurse, the laboratory failed to retain hematology complete blood count (CBC) instrument quality control (QC) printouts for two (2) years. Findings include: 1. 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 four of five patient CBC test records disclosed that insturment QC printouts were not retained from 2016-2018. 2. In an interview, on October 3, 2018, at 12:30 PM, the lead lab nurse confirmed that hematology (CBC) instrument quality control (QC) printouts were not retained for 2 years as required. -- 2 of 2 --