Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 23, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 review of laboratory records and an interview with the Clinic's Technical Consultant(TC) (PT # 2 CMS 209), the laboratory failed to enroll in a CMS approved Proficiency Testing(PT) Program for Hematology/ Coagulation as required by Clinical Laboratory Improvement Amendments. Findings include: 1.) A review of PT documents revealed that patient testing began May of 2017 and the laboratory should have enrolled in Proficiency Testing by the 3rd quarter of 2017 for Hematology/ Coagulation but failed to do so. 2.) An interview with the Clinic's Technical Consultant (TC) (PT # 2 CMS 209) at approximately 12:35 pm on July 23, 2018 in the review conference room confirmed the Clinic was not enrolled in Proficiency Testing by the 3rd Quarter of 2017.. 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 --