To: Board of Supervisors
From: Anna Roth, Health Services Director
Report Title: Amendment to Purchase Order with TraceLink, Inc.
☒Recommendation of the County Administrator ☐ Recommendation of Board Committee
RECOMMENDATIONS:
APPROVE and AUTHORIZE the Purchasing Agent, or designee, to execute on behalf of the Health Services Director, (1) an amendment to purchase order #26349 with TraceLink, Inc., to increase the payment limit by $4,000 to a new payment limit of $8,500 and extend the term through March 6, 2026, and (2) Tracelink Enterprise Agreement for the license and configuration of pharmacy controlled substance software.
FISCAL IMPACT:
Approval of this amendment will result in an additional $4,000 in expenditures and will be funded by the Hospital Enterprise Fund I revenues.
BACKGROUND:
The Contra Costa Regional Medical Center (CCRMC) Inpatient Pharmacy Department started using Tracelink’s web-based platform in 2016 as required by Title II Drug Supply Chain Security Act (DSCSA) of the Drug Quality and Security Act (DQSA) enacted by Congress in November 2013. The purpose of the Act is to enhance FDA’s ability to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
The Drug Supply Chain Security Act (DSCSA) outlines requirements to develop and enhance drug supply chain security by 2023. This includes product tracing requirements that went into effect in 2015 for manufacturers, repackagers, wholesale distributors and “dispensers” (primarily pharmacies) to notify FDA within 24-hours after determining a product is illegitimate. Tracelink’s service provides a platform for electronic receipt and storage of the required product tracing information that pharmacies must maintain, as well as valuable supply chain information that may be requested from governing entities during investigation of counterfeit and illegitimate drugs, which may also include recalls on any drugs.
The final phase of the 10-year rollout of the Drug Supply Chain Security Act (DSCSA) charges the pharmacies with the implementation of an “enhanced system” for the interoperable, electronic tracing of drugs by November 27, 2023.
The agreement obligates the County to indemnify the contractor for claims arising out of the negligence or willful misconduct of County in performing the agreement. The contractor’s liability under the agreement is limited to the amount paid by County in the twelve months preceding the claim, provided that this limitation does not apply to contractor’s obligation to indemnify the County.
CONSEQUENCE OF NEGATIVE ACTION:
Failure to approve this amendment for subscription and configuration services will cause CCRMC to be non-compliant with the federal Drug Supply Chain Security Act.