To: Board of Supervisors
From: Anna Roth, Health Services Director
Report Title: Amendment #23-799-1 with Key Solutions, Inc.
☒Recommendation of the County Administrator ☐ Recommendation of Board Committee
RECOMMENDATIONS:
APPROVE and AUTHORIZE the Health Services Director, or designee, to execute on behalf of the County Amendment #23-799-1 with Key Solutions, Inc., a corporation, effective July 1, 2024, to increase the payment limit by $51,927 from $28,620 to a new payment limit of $80,547 for institutional review board (IRB) management software annual fees for Contra Costa Regional Medical Center (CCRMC) through June 30, 2027.
FISCAL IMPACT:
Approval of this amendment will result in additional expenditures of up to $51,927 for a three (3) year period and will be funded by 100% Hospital Enterprise Fund I.
BACKGROUND:
This contract meets the social needs of the County’s population by providing the IRB tool it needs to organize all files and documents that the Food and Drug Administration (FDA) requires for the organization to have. The Department contacted Key Solutions in Oct 2021 regarding its IRB SaaS solution as the leading vendor in the space. This software allows the IRB to organize all files and requirements for its cyclic FDA audits. Key Solutions, Inc., the current IRB service provider was given a sole-source contract for these services.
On May 9, 2023, the Board of Supervisors approved Contract #23-799 with Key Solutions, Inc., in an amount not to exceed $28,620, to provide IRB software services for CCRMC through June 30, 2024.
Under the terms of the contract the vendor’s liability is limited to the amount paid by County in the four months preceding the claim for damages. Under the contract the County is obligated to defend the vendor against third party claims relating to County’s data in the hosted system, and County’s use of the Service in violation of the contract.
Approval of Amendment Agreement #23-799-1 will allow County to pay for IRB annual fees through June 30, 2027, and allow term to match the Service Agreement which continues until terminated by either party.
CONSEQUENCE OF NEGATIVE ACTION:
If this contract is not approved, the IRB chair will continue to bear the burden of managing the record-keeping and audit requirements for the Institutional Review Board via spreadsheet and manually. A cumbersome and time-consuming task takes needed attention away from more critical needs and may negatively affect business practices and patient care.