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 Medical Laboratory Evaluation (MLE-M2) proficiency testing reports, review of five (5) randomly selected patient result records from 10/11/2019 to 02/09 /2021, and interview with the laboratory technical supervisor (TS), the laboratory failed to attain a score of at least 80 percent for Endocrinology free thyroxine (TY) . The findings included: 1. MLE-M2 second event 2019 (Q2-2019) reported a proficiency testing score of 40% for the Free Thyroxine (TY) analyte giving the subspecialty of Endocrinology a 70% overall score. Sample Reported Result Expected Result CH-06 6.6 5.0-7.8 CH-07 5.6 4.0-6.5 CH-08 *12.0 5.0-7.7 CH-09 *9.1 3.4-5.8 CH-10 *5.5 1.4-2.7 2. The technical supervisor confirmed on 03/15/2021 that the laboratory had failed to attain a proficiency score of at least 80 percent for Free Thyroxine (TY). 3. Based on the laboratory's annual test volume declaration (03/15 /2021) the laboratory analyzed and reported 3,298 Endocrinology tests. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on laboratory technical supervisor and testing personnel interviews, proficiency 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 -- test reports documents for Endocrinology, and policies and procedures record review on March 15, 2021; the laboratory director failed to ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. See D2099. -- 2 of 2 --