Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, the Centers for Medicare and Medicaid Services form 209 Laboratory Personnel Report (CLIA) (CMS-209) and interview with the lead testing person, the laboratory failed to test urine culture and throat culture proficiency testing samples by routine testing personnel in 2022. The finding include: 1. Review of the laboratory's bacteriology proficiency testing records revealed that testing personnel numbers three and six performed three of three urine culture and throat culture proficiency testing events (2022 events one, two, and three). 2. Review of the form CMS-209 revealed six personnel who perform patient testing for urine cultures and throat cultures. 3. Interview with the lead testing person on January 12, 2022 at 11:30 am confirmed that testing personnel numbers three and six performed three of three proficiency testing events for 2022. The laboratory failed to test proficiency testing samples by the same personnel who perform patient testing for urine cultures and throat cultures in 2022. 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 --