Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on February 5, 2019. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of proficiency testing records for laboratory testing years 2017 and 2018 and an interview with the laboratory owner, the laboratory failed to enroll in a Health and Human Services (HHS) approved proficiency testing program for all testing specialties and subspecialties for testing year 2018. Findings include: 1. The laboratory failed to enroll in a HHS approved proficiency testing program for testing year 2018 for the moderate complexity test PT and INR laboratory testing. 2. The laboratory continued to perform patient PT and INR testing through April 2, 2018. This was confirmed by the laboratory owner on February 5, 2019 at approximately 10: 00 AM. The laboratory performed approximately 160 Hematology laboratory tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D2123 HEMATOLOGY CFR(s): 493.851(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 a review of the American Proficiency Institute (API) proficiency testing records for testing year 2017 and 2018 and an interview with the laboratory owner, the laboratory failed to participate in the API third event 2017 for Hematology and Coagulation. Findings include: 1. The laboratory failed to participate in the API 2017 third event for Hematology and Coagulation. 2. The laboratory was performing non- waived patient PT and INR Hematology testing through April 2, 2018. This was confirmed by the laboratory owner on February 5, 2019 at approximately 10:00 AM. The laboratory performed approximately 160 Hematology laboratory tests annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing records for testing year 2017 and 2018 and an interview with the laboratory owner, the laboratory failed to evaluate the results obtained from proficiency testing performed and to determine