Summary:
Summary Statement of Deficiencies D2100 ENDOCRINOLOGY CFR(s): 493.843(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of CMS(Centers for Medicare and Medicaid Services) Casper report 155D, review of 2020 API(American Proficiency Institute) PT (proficiency testing) records and review of laboratory records 4/16/21, electronic communication with TC (technical consultant) on 4/19/21 and 4/20/21, and phone interview with the TC on 5 /10/21, the laboratory failed to notify the inspecting agency and the PT program when testing was suspended for serum HCG(human chorionic gonadotropin) and failed to participate with PT when testing resumed in 2020. Findings: Review of the CMS Casper report 155D and 2020 API PT records on 4/16/21 revealed the laboratory failed to participate and received a 0% score for serum HCG and an overall score of 0% for the Specialty of Endocrinology on the 2020 API Chemistry Core 3rd event. Review of laboratory records 4/16/21 revealed on the API Chemistry Core 3rd event's