Summary:
Summary Statement of Deficiencies D0000 An offsite revisit survey was conducted on October 10, 2019, for all previous deficiencies cited on August 29, 2019. All deficiencies have been corrected. The facility is in compliance with with all regulations surveyed. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory director (LD) failed to ensure the laboratory was enrolled in an HHS approved PT program for the testing performed. Findings include: 1. PT document review revealed the laboratory was not enrolled in PT for the specialty of Endocrinology -- Serum hCG (human chorionic gonadotropin) for 2018 and 2019 thus far. 2. A phone interview with the executive director on 9/13/2019 at approximately 1:15 p.m. confirmed the lack of PT for serum hCG for the aforementioned time periods. 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 --