Summary:
Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 8/7/18 through 8/8/18. The Bennett County Hospital laboratory was found not in compliance with the following requirement: D5217. 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 proficiency testing (PT) documentation and laboratory director interview, the laboratory failed to verify and document the accuracy of the test methods used for patient Clostridium difficile testing twice a year for 12 of 12 months reviewed (July 2017 through July 2018). Findings include: 1. Review of the laboratory's PT documentation revealed there had been no documentation the accuracy of the Clostridium difficile test had been verified twice a year for the time frame above. Interview on 8/7/18 at 4:00 p.m. with the laboratory's director revealed: *Clostridium difficile testing had been started approximately 1 year ago. *She was not aware that the laboratory needed to do twice a year accuracy or proficiency testing as Clostridium difficile testing was not a regulated analyte. 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 --