Summary:
Summary Statement of Deficiencies D2159 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review the the laboratory's records, proficiency testing (PT) reports, and an interview with the laboratory manager, the laboratory failed to return proficiency testing (PT) results within the time frame specified by the PT program for testing in the specialty of Immunohematology, during the year of 2018. Findings: 1. The PT program reported an unsatisfactory performance score of '0' for Rhesus [D (Rho)] testing during Event #3 of 2018 due to the late submission of the PT sample results from the laboratory. 2. The laboratory's PT documents revealed the following: a). The deadline to test and report the D (Rho) results to the PT program was 12/14 /2018 11:59 PM; b). The PT signature sheet attests that the PT samples were tested on 01/04/2019; and c). The D (Rho) test cards used to test the PT samples were dated 01 /04/2019. No documentation was provided to reveal why the PT samples were tested past the deadline and what