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 surveyor review of laboratory records, observation of laboratory supplies, and interview with testing personnel, the laboratory has not verified the accuracy of urine microalbumin testing since July 2017. Findings include: 1. Review of laboratory records show verification of performance characteristics for urine microalbumin in July 2017. No proficiency testing records for microalbumin are available. 2. Observation of refrigerated storage on February 8, 2018 at 1:00 PM revealed reagents for microalbumin testing and controls are available for use. 3. Review of patient records from July 2017 through the present show six patient microalbumin results have been reported. 4. Interview with testing personnel, staff A, on February 8, 2018 at 1:15 PM confirm urine microalbumin testing has been performed and twice annual accuracy verification has not been performed. Further interview confirms the laboratory has not enrolled in a proficiency testing program for urine microalbumin for 2018. 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 --