Summary:
Summary Statement of Deficiencies D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the CMS Casper report 096 and the lack of documentation related to proficiency testing (PT) program and an interview with the laboratory personnel (LP) , it was determined that the laboratory failed to submit proficiency testing (PT) over several cycles for Chemistry during 2020 and 2021. The laboratory inspection occurred on 1/18/22 between 1 p.m. and 2:30 p.m. Findings include: 1. The Casper 096 report for the 2020-2021 was reviewed, and there was a score of 0 (zero) for several submissions. 2. The LP indicated that CAP (College of American Pathology) was used for 2020 and 2021 for PT. 3. The failure to submit metrics are below: 2020 Cycle 2 Analyte CMS PT value Routine Chemistry 0 Ph Blood Gas 0 PO2 Blood Gas 0 PCO2 Blood Gas 0 Chloride (CL) 0 Potassium (K) 0 Sodium (NA) 0 2020 Cycle 3 Analyte CMS PT value Routine Chemistry 0 Chloride (CL) 0 Potassium (K) 0 Sodium (NA) 0 2020 Cycles 1, 2 and 3 Analyte CMS PT value Routine Chemistry 0 Chloride (CL) 0 Potassium (K) 0 Sodium (NA) 0 4. At approximately 2:00 p.m. on 1/18/22, the LP and LD affirmed that there were no CAP proficiency report values for the timeframes mentioned above. 5. Hematology proficiency testing for 2020 and 2021 was acceptable. 6. There were no patients 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 -- testing during the 2020 and 2021 timeframes. 7. Reagent controls were run during the above periods and were deemed acceptable. 8. Testing is moderate complexity. -- 2 of 2 --