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 proficiency testing policy, review of proficiency testing results from the American Proficiency Institute (API) proficiency testing agency, and staff interview on 01/21/2020, the laboratory failed to ensure proficiency testing samples were tested by all testing personnel who routinely perform patient testing for API 2019 Hematology/Coagulation 1st, 2nd, and 3rd events. Findings include: 1. Review of the policy and procedure manual revealed the Proficiency Testing Procedure did not include any statement regarding rotation of proficiency testing specimens amongst the staff. 2. There was no evidence of Testing Personnel #1 or #3 listed on the CMS Form 209 testing proficiency samples for any event in 2019. 3. Testing personnel acknowledged in an interview at 1:20 PM on 01/22/2020, the laboratory failed to have a system to ensure proficiency testing samples were rotated among all testing personnel responsible for patient testing. 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 --