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 record review and interview, the facility failed to verify the accuracy of creatinine (urine) testing twice annually in 2019. Findings include: 1. Review of 2019 challenges by the American Proficiency Institute (API) indicated challenges one and two for 2019 received failing scores of 67% for creatinine (urine) test. There was no documentation that the laboratory attained additional challenges for creatinine (urine) in 2019. 2. Four of four patients (#1 on 1/25/19, #2 on 4/18/19, #3 on 8/21/19, and #4 on 12/12/19) had been reported for urine creatinine without benefit of acceptable API challenge scores for 2019. 3. In interview on Monday, 1/27/20 at 9:40 a.m., SM#1 (Staff Member) confirmed the facility failed to obtain two passing API challenges for creatinine (urine) for 2019. 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 --