Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the Laboratory Test List & Annual Volume form, proficiency testing (PT) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:45 am on 01/07/2021, the laboratory failed to verify the accuracy of serum human chorionic gonadotropin (HCG) qualitative testing at least twice annually for four out of four time periods from January 2019- December 2020. The findings include: 1. The Laboratory Test List & Annual Volume form listed Cardinal Health qualitative HCG Combo testing. 2. Personnel identifier #2 confirmed that the laboratory did not enroll in PT for serum HCG qualitative testing. 3. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not have additional records indicating the verification of accuracy of serum HCG qualitative testing from January 2019- December 2020. 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 --