Summary:
Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of the Roanoke Medical Center for Women was conducted on 01/13/23 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies 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 proficiency testing (PT) records, the CASPER 0155D Individual Laboratory Profile Report, and email communication with lab director, the laboratory failed to participate in one of three ABO/RHO and D (RHO) events in 2022. Findings include: 1. Review of the CASPER 0155D Individual Laboratory Profile Report and the 2022 American Proficiency Institute (API) PT records (three events) revealed the laboratory received the following score of 0%: 2022 Event 3- 0% - for the ABO/RHO and D(RHO) module (Notation by API-failure to participate). 2. An email communication with the lab director on 01/13/23 at approximately 1330 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 --