Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's "Split Sample Record" for 2017, 2018 and 2019, used for documentation of proficiency testing of Uricults, a review of the policy and procedure, and an interview with the Registered Nurse, Office Administrator, the surveyor determined the laboratory failed to ensure the accuracy of Uricult testing (growth or no-growth) was verified at least twice annually. Additionally, the laboratory failed to implement their policy to perform the proficiency testing at least every six months. This affected the second opportunity to verify the accuracy of Uricult testing in 2018. The findings include: 1. A review of the Split Sample Record (2017 CLIA Manual) revealed four split samples of Uricults were performed in 2017 for proficiency testing. 2. At 10:50 AM on 5/30/19, the surveyor inquired if any proficiency testing had been performed in 2018, as no documentation was found in the 2018 CLIA manual. The office administrator looked through both manuals, and stated the records must be in another book. At 10:55 AM, the office administrator brought records for 5/21/18 and 1/14/19. There was only one record of proficiency testing for the Uricult in 2018. 3. A review of the policy and procedure included the following: "Proficiency testing will be completed at least every 6 months by obtaining one specimen; half the specimen will be sent to outside lab (LabCorp) and the other half will be completed at our office using the above procedure guidelines. Results will be compared by the Lab Director and recorded in our lab book. Proficiency testing maybe referred to as a split sample." 4. At 11:00 AM on 5/30/19, the surveyor reviewed the policy and procedure with the office administrator and asked if this was still the laboratory's policy. The office administrator confirmed the above noted policy and procedure, as well as the failure to perform a second proficiency check in 2018. 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 -- When asked who monitored to ensure proficiency testing was completed during the year, the office administrator stated the nurse, who was responsible, had been out-of- office. -- 2 of 2 --