Summary:
Summary Statement of Deficiencies D2099 ENDOCRINOLOGY CFR(s): 493.843(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 the review of the American Proficiency Institute (API) proficiency testing reports, review of five (5) randomly selected patient result records from 06/16/2021 to 10/21/2021, and interview with the laboratory testing person (TP), the laboratory failed to attain a score of at least 80 percent for Endocrinology C-peptide analyte. The findings included: 1. The API third event for 2021 (Q3-2021) reported a proficiency testing score of 50% for the C-peptide analyte giving the subspecialty of Endocrinology a 50% overall score. 2. The TP confirmed on 12/6/2021 at approximately 11:00 a.m. that the laboratory had failed to attain a proficiency score of at least 80 percent for the C-peptide analyte. 3. Based on the laboratory's annual test volume declaration signed by the laboratory director on 12/6/2021 the laboratory analyzed and reported approximately 2,202 Endocrinology tests which include C- peptide. D2105 ENDOCRINOLOGY CFR(s): 493.843(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review on the proficiency testing (PT) performance records,