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. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 2017 - 2019 American Proficiency Institute (API) proficiency testing (PT) results and confirmed in interview, the laboratory failed to attain at least 80% for the analyte Monocytes for 1 of 6 Hematology events. Findings were: 1. Review of the 2017 - 2019 API Hematology PT results revealed the laboratory received the following scores for Monocytes. 2019 2nd event (40% Monocytes) Hem- 08: lab result 8.3 (acceptable range 4.4 - 8.0) Hem-09: lab result 8.8 (acceptable range 6.5 - 8.7) Hem-10: lab result 8.9 (acceptable range 6.3 - 8.7) 2. An interview with the technical consultant #1 on 9/25/19 at 1010 hours in the admin office confirmed the above findings. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- proficiency testing failure. (2) For any unacceptable analyte or 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 review of the laboratory policy, American Proficiency Institute (API) proficiency testing records, PT