Response to Suspicious or Positive Findings

Response Team

Taconic recognizes that health quality is critically important to our clients. Taconic has a standing cross functional global team, the Response Team (Team), to rapidly address health test results that may have direct and/or significant consequences to customers. This team is mobilized with any suspicious or concerning health result and when there are issues or concerns impacting physical plants/maintenance (biosecurity) for animal locations.

The Team is headed up by Quality Assurance, and standing members include: Quality Assurance, Veterinary Sciences, Animal Barrier Production Operations, Genetics, Gnotobiotics Operations, Molecular and Diagnostic Analysis, Production and Capacity Planning, Customer Service and Marketing Communications. Additional ad hoc members to the Team may be added at the discretion of the Team to address the customers and/or products and services potentially impacted.

The Molecular and Diagnostic Analysis laboratory routinely notifies Veterinary Sciences of all results. In instances of suspicious, unusual, or unanticipated test results, the testing laboratory staff immediately elevates the data/results to the Molecular and Diagnostic Analysis laboratory management. These parties interpret these data and identify whether the Team must be mobilized. When the significance/relevance of data requires Team mobilization, the Molecular and Diagnostic Analysis Laboratory management immediately contacts Quality Assurance and the Team is mobilized.

The Team convenes to minimally review the data and: 1) develop an action plan to isolate the suspicious colony with control of supply, animal and personnel movement and immediately cease animal distribution from the location(s); 2) develop a confirmatory testing plan, 3) initiate short term business analysis regarding potential customer impact, and 4) develop the internal and external communication plan. Generally the confirmatory testing plan is executed within 24 hours. The Team typically meets daily and/or at time points when more testing data is available and/or when modification to the existing action plan is required. Customers are not typically contacted at this point unless a) they have received a shipment of gnotobiotic animals from an isolator that subsequently had a suspect finding or b) In cases where distribution is halted from a particular location with a suspect finding and no alternative inventory is available to fulfill orders.. In instances where confirmatory testing refutes the original finding, any specifically impacted customers are notified regarding the false positive testing data. An investigation follows to identify the root cause of the original data.

Response to Positive Results and Notification of Clients

Should additional testing confirm the original result(s), the Team reconvenes and modifies the current action plan as required and executes the external communication plan. This plan includes contacting each customer that has received animals from the location within the last 6 weeks (2 weeks for Germ Free) from the original suspicious test result or since the last negative test, whichever is longer. The specifically impacted customers are contacted by Customer Service via phone and via email Customer contact occurs rapidly after receipt of confirmatory test results.