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C. 41
To: Board of Supervisors
From: Anna Roth, Health Services Director
Date: May  9, 2023
The Seal of Contra Costa County, CA
Contra
Costa
County
Subject: Contract #23-799 with Key Solutions, Inc.

APPROVE OTHER
RECOMMENDATION OF CNTY ADMINISTRATOR RECOMMENDATION OF BOARD COMMITTEE

Action of Board On:   05/09/2023
APPROVED AS RECOMMENDED OTHER
Clerks Notes:

VOTE OF SUPERVISORS

AYE:
John Gioia, District I Supervisor
Candace Andersen, District II Supervisor
Diane Burgis, District III Supervisor
Ken Carlson, District IV Supervisor
Federal D. Glover, District V Supervisor
Contact: Rajiv Pramanik (925) 765 - 8689
cc: F Carroll     M Wilhelm    
I hereby certify that this is a true and correct copy of an action taken and entered on the minutes of the Board of Supervisors on the date shown.
ATTESTED:     May  9, 2023
Monica Nino, County Administrator
 
BY: , Deputy

 

RECOMMENDATION(S):

APPROVE and AUTHORIZE the Health Services Director, or designee, to execute on behalf of the County Contract #23-799 with Key Solutions, Inc., a corporation, in an amount not to exceed $28,620, to provide institutional review board management software to Contra Costa Regional Medical Center (CCRMC) for the period from July 1, 2023, through June 30, 2024.

FISCAL IMPACT:

Approval of this contract will result in annual expenditures of up to $28,620 and will be funded as budgeted by the Department in FY 2023-24, by 100% Hospital Enterprise Fund I revenues.

BACKGROUND:

  








BACKGROUND: (CONT'D)
This contract meets the social needs of the County’s population by providing the IRB (Institutional Review Board) the tool it needs to organize all files and documents that the FDA (Food and Drug Administration) 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 institutional review board service provider is a sole-source contract for these services.   
  
Approval of new contract #23-799 allows the contractor to provide software as a service 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.

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.

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