Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Biolife Plasma Services, LP on February 12, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 the review of proficiency testing (PT) records and interview with the center operations manager and technical consultant, the laboratory director failed to sign one (1) of six (6) attestation statements reviewed. PT record review included 2018 and 2019 testing events. Findings include: 1. Review of the American Association Bioanalysts (AAB) PT records for all three events in 2018 and 2019 (a total of 6 events) revealed that the laboratory director did not sign the 2019 3rd event attestation statement. 2. An interview center operations manager and technical consultant on 2/12 /20 at approximately 12:30 PM confirmed the findings. 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 --