Summary:
Summary Statement of Deficiencies D2110 TOXICOLOGY CFR(s): 493.845(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) documentation and interview with the Technical Consultant (TC), the laboratory failed to attain an overall testing event score of at least 80 percent which constitutes unsatisfactory performance. This deficient practice had the potential to affect 139 patients tested in the subspecialty of Toxicology from 05/01/2023 through 05/31 /2023. Findings Include: 1. Review of the 2023 API PT documentation found the laboratory received the following unsatisfactory PT scores: 1st testing event of 2023: Chemistry Miscellaneous 0% 2. The TC stated the 0% (percent) score for the 1st testing event of 2023 was due to a staffing shortage and missed deadline. The TC further stated they contacted API and performed a remedial testing event, which was completed during the month of May 2023. The interview occurred at 10:53 AM on 03 /19/2024. 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 --