Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency testing records review, testing personnel records review, patient test records review and interview with staff, the laboratory failed to ensure personnel who routinely perform patient testing also tested proficiency samples for 6 of 6 complete blood count (CBC) proficiency testing events reviewed from August 2016 to August 2018. Findings include: 1. Proficiency testing records review included documentation the lead testing person performed complete blood counts for 6 of 6 proficiency testing events over 2 years of testing reviewed. 2. The laboratory testing personnel records and patient review included a list of 3 testing personnel (A,B, and C) who routinely performed CBC testing. 3. In an interview with staff on 08/28/2016 at approximately 11:30 A.M. the laboratory technical consultant confirmed only one person performed proficiency testing between August 2016 and August 2018 and the other two testing personnel performed routine patient 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 1 --