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. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 laboratory American Proficiency Institute (API) proficiency testing records from 2019-2020 and confirmed in interview, the laboratory failed to attain a satisfactory score of at least 80% for the chemistry analyte Total Bilirubin for 1 of 3 events in 2020. Findings were: 1. Review of API proficiency testing records from 2019-2020 revealed documentation that the laboratory failed to attain a satisfactory score of 80% for Total Bilirubin for 1 of 3 testing events in 2020. API 3rd event 20% Total Bilirubin CH-11: lab result 1.9 (acceptable range 3.1 -4.8) CH-12: lab result 0.5 (acceptable range 0.7 - 1.6) CH-13: lab result 2.1 (acceptable range 3.3 - 5.1) CH-14: lab result 1.3 (acceptable range 2.2 - 3.4) 2. An interview with the laboratory director on 11/6/20 at 0950 hours in the conference room confirmed the above findings. 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 --