Summary:
Summary Statement of Deficiencies D2056 VIROLOGY CFR(s): 493.831(a) (a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologist (CAP) proficiency testing records, and an interview with the Technical Supervisor (TS) on January 27, 2026, it was determined that the laboratory failed to attain a score of at least 80 percent acceptable responses for virology for Human Papillomavirus (CHPVM) during the second event of 2025. The findings included: 1. The laboratory enrolled in the CAP proficiency testing program for virology testing using the Roche 6800 analyzer. According to the CAP evaluation report, the laboratory attained an unsatisfactory score of %60 in virology during the second testing event of 2025. 2. On January 27, 2026, at approximately 10:00 am, the TS confirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on January 26, 2026, stated that the laboratory performed approximately 20,066 virology tests annually. 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 --