Summary:
Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to achieve a proficiency testing (PT) score of 80% (percent) for the analyte blood urea nitrogen (BUN) in the second PT event in 2020 and the third PT event in 2021 in the specialty of Chemistry. All patients tested for BUN during the respective testing events in 2020 and 2021 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "Proficiency Testing Policy", approved by the Laboratory Director via signature and date on 09/12 /2019 and provided on the date of the inspection found the statement "If unacceptable results occur, a proficiency testing deficiency corrective summary is completed...". 2. Review of the laboratory's 2020 College of American Pathologists (CAP) Chemistry PT documentation, provided on the date of the inspection, revealed the following unacceptable analyte testing scores: Second PT Event C-B 2020 BUN; 0% Third PT Event C-C 2021 BUN; 0% 3. Review of the submitted CAP forms, participant summary and documentation of the laboratory's proficiency testing deficiency corrective summary revealed clerical errors with 10 out of 10 of the unacceptable BUN results in the testing events indicated above. TP#1 confirmed the unacceptable BUN PT scores were submitted with incorrect units of measure. The interview occurred on 02/16/2022 9:15 A.M. 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 --