Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 review of the American Proficiency Institute (API) instructions and proficiency test (PT) records and confirmed by interview, the laboratory failed to obtain at least 100% for D(Rho) typing for 1 of 3 testing events in 2017 as evidence by: 1. Review of API proficiency testing records for 2017 for D(Rho) typing, revealed 1 of 3 testing events when the laboratory received an 80% (100% satisfactory). 2nd event 2017 = 80% Rh-06, lab result Rh negative (expected result Rh positive) 2. In an interview with the primary testing person on 12/14/18 at 1000 hours in the office, she confirmed that the laboratory received the above scores. D2160 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(e) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- unacceptable analyte or unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute proficiency testing records from 2017 and 2018 and confirmed in interview, the laboratory failed to document remedial action for all unacceptable analyte testing event scores. Findings include: 1. Review of the API performance evaluation records revealed "laboratories are responsible for documenting and performing