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 record review of CAP ( College of American Pathologists) proficiency testing records and interview with the laboratory manager, the laboratory failed 1 out of 3 events for ABO/RHO test during the year 2018. Findings included: Review of CAP proficiency records revealed that the laboratory failed the ABO/RHO second event of 2018 with a 0 % score due to late submit of results. During an interview on 6 /6/19 at 11:30 AM, the laboratory manager confirmed that the laboratory saved the results on file but failed to submit on time the event of reference. D2169 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(c) 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 record review of CAP ( College of American Pathologists) proficiency testing records and interview with the laboratory manager, the laboratory failed 1 out of 3 events for Unexpected Antibody Detection test during the year 2018. Findings included: Review of CAP proficiency records revealed that the laboratory failed the Unexpected Antibody Detection second event of 2018 with a 0 % score due to late 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 -- submit of results. During an interview on 6/6/19 at 11:30 AM, the laboratory manager confirmed that the laboratory saved the results on file but failed to submit on time the event of reference. D2178 COMPATIBILITY TESTING CFR(s): 493.863(c) 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 record review of CAP ( College of American Pathologists) proficiency testing records and interview with the laboratory manager, the laboratory failed 1 out of 3 events for Compatibility Testing during the year 2018. Findings included: Review of CAP proficiency records revealed that the laboratory failed the Compatibility Testing second event of 2018 with a 0 % score due to late submit of results. During an interview on 6/6/19 at 11:30 AM, the laboratory manager confirmed that the laboratory saved the results on file but failed to submit on time the event of reference. D2187 ANTIBODY IDENTIFICATION CFR(s): 493.865(c) 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 record review of CAP ( College of American Pathologists) proficiency testing records and interview with the laboratory manager, the laboratory failed 1 out of 3 events for Antibody Identification test during the year 2018. Findings included: Review of CAP proficiency records revealed that the laboratory failed the Antibody Identification test second event of 2018 with a 0 % score due to late submit of results. During an interview on 6/6/19 at 11:30 AM, the laboratory manager confirmed that the laboratory saved the results on file but failed to submit on time the event of reference. -- 2 of 2 --