Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 01/29/2020 found that BSS International Inc clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory failed to get 100% for 1 out of 6 testing events reviewed during 2018-2019 for D(Rho) typing. Findings include: Review of the American Proficiency Institute (API) proficiency testing (PT) records revealed that the laboratory received 80 % for Rhesus (Rh) testing for the 3rd event of 2018. During an interview on 01/29/2020 at 2:30 pm, the testing personnel (TP) A confirmed that they received 80 % testing score for the event of above reference. 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 --