Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Virginia League of Planned Parenthood- East End on 05/30/24 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: D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on the review of the CASPER 0096D CLIA Application and Survey Summary Report, proficiency testing (PT) records, and an interview, the laboratory failed to participate in one of four Rh Anti-D typing events reviewed. Record review included all three PT events in 2023 and the first event in 2024. Findings include: 1. Review of the CASPER 0096D CLIA Application and Survey Summary Report and the American Proficiency Institute (API) PT records for the all three events in 2023 and the first event in 2024 revealed the laboratory received a score of 0% for the following event: 2024 Event 1- 0%- for the Rh Anti-D typing module (Notation by API-failure to participate). 2. An exit interview with the facility's Compliance Manager on 05/30 /24 at 11:00 AM 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 --