Summary:
Summary Statement of Deficiencies D0000 A complaint survey was performed at Sabine Medical Center - CLIA # 19D0465060 on March 12, 2018 through March 15, 2018. Sabine Medical Center was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to document each step in testing and reporting of proficiency testing (PT). Findings: 1. Review of the laboratory's PT records for 2017 revealed the laboratory did not have documentation of the following: a) 2017 Immunology/Immunohematology 3rd Event: Laboratory Director signature on the attestation and performance review statements. b) 2017 Immunology/Immunohematology 1st Event: Attestation not signed by Laboratory Director c) 2017 Hematology/Coagulation 2nd Event: Laboratory Director Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- signature on the attestation statement, Performance Review and Laboratory