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's American Proficiency Institute (API) Chemistry proficiency testing records from 2018 and 2019, and confirmed in interview, the laboratory failed to attain a satisfactory score of at least 80% for the analyte pCO2, pH, and pO2 for 1 of 4 testing events. The findings were: 1. A review of the laboratory's API from 2018 and 2019 revealed the laboratory failed to attain a satisfactory score of at least 80% for the analytes pCO2, pH, and pO2 on 1 of 4 events: 2018 API Chemistry 2nd event pCO2 - 0% IB-06 - Lab result: 20; acceptable range: 21-32 IB-07 - Lab result: 127; acceptable range: 51-62 IB-08 - Lab result: 118; acceptable range: 60-71 IB-09 - Lab result: 133; acceptable range: 38-49 IB-10 - Lab result: 118; acceptable range: 28-39 pH - 0% IB-06 - Lab result: 7.74; acceptable range: 7.57 - 7.66 IB-07 - Lab result: 7.37; acceptable range: 7.1 - 7.18 IB-08 - Lab result: 7.20; acceptable range: 6.93 - 7.02 IB-09 - Lab result: 7.47; acceptable range: 7.21 - 7.30 IB-10 - Lab result: 7.68; acceptable range: 7.50 - 7.59 pO2 - 20% IB-06 - Lab result: 134; acceptable range: 101 - 132 IB-07 - Lab result: 127; acceptable range: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 51-93 IB-08 - Lab result: 118; acceptable range: 30 - 81 IB-09 - Lab result: 133; acceptable range: 62 - 99 2. An interview with the technical consultant on 7/11/19 at 1055 hours in the conference room confirmed the above findings. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(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 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 American Proficiency Institute (API) proficiency testing records, and confirmed in interview, the laboratory failed to document remedial action for PT failures for the analytes pCO2, pH, and pO2 for 1 of 4 testing events from 2018 and 2019. Findings were: 1. Review of the 2018 and 2019 API proficiency testing records revealed the laboratory failed to attain an 80% for the analyte pCO2, pH, and pO2 for 1 of 4 testing event for Chemistry. Cross refer to D2087 2. Review of the laboratory