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 the throat cultures for the specialty bacteriology proficiency testing (PT) attestation records in 2016-17 and an interview with the primary testing person determined the laboratory director failed to ensure that all PT attestation statements are signed during 2016 and 2017. The findings include: 1. Review of the 2016 1st-3rd events and 2017 1st-3rd events PT records for throat cultures for the specialty bacteriology revealed the laboratory director did not sign the attestation statements for testing persons during the 2016 1st-2nd events and 2017 1st, 2nd, and 3rd events. 2. Interview with the primary testing person on February 27, 2018, at approximately 9:50 AM confirmed that the director failed to attest/sign attestation statements during the 1st-2nd events and 2017 1st, 2nd, and 3rd events.. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the May 17 through December 5, 2016 throat cultures for the specialty bacteriology quality control (QC) records and interview with lead testing person, the laboratory failed to maintain the bacteriology QC printouts for the throat cultures: media lot and expiration dates, Taxo A disc lot and expiration dates, positive control ATCC lot and expiration dates for 2016. The findings include: 1) Review of the May 17 through December 5, 2016 throat cultures for the quality control (QC) records the bacteriology QC for throat cultures: media lot and expiration dates, Taxo A disc lot and expiration dates, positive control ATCC lot and expiration dates for 2016. 2) Interview with primary testing person at approximately 2:30 p.m. on February 27, 2018 confirmed missing the May 17 through December 5, 2016 throat cultures for the quality control (QC) records the bacteriology QC for throat cultures: media lot and expiration dates, Taxo A disc lot and expiration dates, positive control ATCC lot and expiration dates for 2016. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require