National Veterinary Services Laboratories

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including 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 lack of viral transport media records and confirmed by laboratory personnel identifier #6 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 10/14/2022, the laboratory failed to retain records for viral transport media prepared in the laboratory, including lot numbers, expiration dates, quality control, and sterility checks for all media prepared from 04/30/2021- 10/14/2022. At the time of the survey, personnel identifier #6 confirmed that the laboratory did not have records for the viral transport media produced and used from 04/30/2021- 10/14/2022. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of performance specification records for the Taqpath COVID-19 Combo Kit and confirmed by personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 9:00 am on 10/10/2022, the laboratory director failed to ensure that the procedures for verification of performance specifications are adequate to determine the accuracy and precision for the Taqpath COVID-19 Combo Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Kit from 05/01/2022- 10/14/2022. The findings include: 1. The laboratory verified performance specifications for the Taqpath COVID-19 Combo Kit in May 2022. 2. Review of performance specification data indicated that an analysis of the raw data for accuracy determination had not been performed. In addition, the laboratory did not verify the performance specification of precision. 3. At the time of the survey, personnel identifier #2 confirmed that the laboratory director failed to ensure that the procedures for the verification of the performance specifications, accuracy and precision, are adequate. Personnel identifier #2 also confirmed that the records had not been reviewed by the laboratory director. -- 2 of 2 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of centrifuge function check records and the Qiagen QIAamp manufacturer's instructions and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:30 am on 4/30/2021, the laboratory failed to define the frequency for performing centrifuge speed and timer function checks. Additionally, the laboratory failed to perform centrifuge speed and timer function checks on one out of one centrifuge from 5/6/2020 - 4/30/2021. The findings include: 1. The laboratory used centrifuge 5674 to perform SARS-CoV-2 testing. 2. The Qiagen QIAamp manufacturer's instructions for the extraction step of the SARS-CoV-2 testing did not state the frequency of performing centrifuge speed and timer checks. 2. At the time of the survey, the laboratory had not performed speed and timer checks on centrifuge 5674 since 3/4/2016. 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 --