Summary:
Summary Statement of Deficiencies D0000 Federal Complaint Survey The Federal Complaint Survey was unsubstantiated with standard level deficiencies cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's package insert, patient test charts, and interview, the laboratories failed to adhere to the Coaguchek XS manufacturer's instructions by testing patients that were not on Coumadin therapy as evidenced by: 1. In review of the manufacturer's instructions for the Coaguchek XS PT states, "The Coaguchek XS system is intended for use by professional healthcare providers for quantitative prothrombin time testing for monitoring warfarin therapy." 2. In review of the patient charts on May 9th @1352, the following patients were not on Coumadin: a. patient #131801 tested 1/6/17 INR results 1.0, patient was not on Coumadin after chart review with the Laboratory Director b patient #18349 tested 1/9/18 INR results 1.0, patient was not on Coumadin after chart review with the Laboratory Director 3. In interview with the Laboratory manager on May 9th @1348 she stated that if any of the doctors in the facility order a prothombrin time they will just run it. She stated that they do not check to see if the patient are already on Coumadin. 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 --