Summary:
Summary Statement of Deficiencies 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 review of Proficiency Testing (PT) records from 2017 for testing performed in the specialty of Hematology and interview with the facility personnel, the laboratory failed to maintain a copy of the signed PT attestation statement from the 2nd testing event of 2017. Findings include: 1. No documentation was presented for review to indicate the laboratory maintained a copy of the PT attestation statement signed by the laboratory director for the 2nd testing event of 2017, for testing performed in the specialty of Hematology. 2. The facility personnel confirmed that the PT attestation statement indicated above could not be located during the survey. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on lack of verification documentation and interview with the laboratory director, the laboratory failed to verify the accuracy of Microbiology testing at least twice annually during 2015. Findings include: 1. The laboratory performs vaginal wet prep testing under the specialty of Microbiology, with an approximate annual test volume of 1. 2. No documentation was presented for review during the survey to indicate the laboratory verified the accuracy of the vaginal wet prep test, which is not included subpart I, at least twice annually during 2017. 3. The laboratory participates in proficiency testing (PT) as a means to verify accuracy for the vaginal wet prep testing, but scored 0% for the 1st and 3rd PT events of 2017, and no