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 review of laboratory correlation records for 2017, 2018, 2019 and interview with the laboratory director, the laboratory failed to establish a means to verify the accuracy of AFB stain and gram stain testing twice a year. Findings: 1. Review of correlation records for 2017, 2018 and to date 2019 revealed a lack of documentation to prove accuracy 2 times a year for AFB stain testing. 2. Review of correlation records for 2017, 2018 and to date 2019 revealed a lack of documentation to prove accuracy 2 times a year for gram stain testing. 3. Interview with the laboratory director on October 22, 2019 at 11:00 AM confirmed the laboratory failed to verify the accuracy of AFB stain and gram stain testing twice annually for 2017, 2018 and to date 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 --