RFP_2025-556-CDII.docx

California Health and Human Services Agency RFP # 2025-556-CDII Committee for the Protection of Human Services Institution Review Board Consulting Services Page 27

REQUEST FOR PROPOSAL # 2025-556-CDII

California Health and Human Services Committee for the Protection of Human Subjects Institutional Review Board Consulting Services

The State of California Health and Human Services Agency (CalHHS), Committee for the Protection of Human Subjects (CPHS) invites you to review and respond to this Request for Proposal (RFP) # 2025-556-CDII for Institutional Review Board (IRB) consulting services.

In submitting a proposal, bidders shall comply with the instructions found herein. In addition to those programs and preferences that are specified in this solicitation, bidders are encouraged to consider programs and preferences that are available, such as those for the use of small businesses, disadvantaged businesses, disabled veteran businesses, and other businesses covered by programs and preferences.

The CalHHS is committed to meeting the State’s twenty five percent (25%) Small Business participation goal and wants to encourage Certified Small Businesses (SB), Microbusinesses (MB), and any bidders willing to commit to subcontracting a minimum of twenty five percent (25%) of their net bid price to certified SB or MB to submit proposals. This RFP includes an incentive of 5% for SB/MB or Non-SB/MB willing to commit to subcontracting at least 25% to a certified SB/MB. This RFP also includes an incentive of at least three percent (3%) for Disabled Veteran Business Enterprise (DVBE).

All agreements entered with the State of California will include, by reference, the Department of General Services (DGS), General Terms and Conditions (GTC 02/2025) and Contractor Certification Clauses (CCC 04/2017) that may be viewed and downloaded at the following internet site:

https://www.dgs.ca.gov/OLS/Resources/Page-Content/Office-of-Legal-Services-Resources-List-Folder/Standard-Contract-Language

The Agreement resulting from this procurement shall not exceed $150,000 for the initial term of 12 months, with a State option to extend the Agreement for an additional 12 months and additional funds of $150,000.

This RFP is being conducted using the Secondary Method. This method requires evaluation of proposals by an evaluation team with the award made to the responsible and responsive bidder earning the highest score.

INTRODUCTION

The CPHS seeks to procure the services of a qualified consultant or consultant team to assist the CPHS in reviewing, evaluating, and enhancing the policies and procedures associated with the CPHS Institutional Review Board (IRB) to align and comply with the regulatory requirements of the U.S. Food and Drug Administration (FDA) and the U.S. Health and Human Services (HHS) Office of Human Research Protections (OHRP) and other applicable Federal and State rules and regulations.

For more information, please visit the websites below:

OHRP

https://www.hhs.gov/ohrp/regulations-and-policy/index.html

FDA IRBs https://www.fda.gov/about-fda/cder-offices-and-divisions/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials

For a detailed description of the required services, please see Section II – Sample Agreement, Exhibit A - Statement of Work starting on page 34. The specific tasks can be found in Section 5, Scope of Services / Specific Tasks starting on page 35.

The designated contact person for this RFP is:

Procurement Official's Name: Miguel Jauregui

In the opinion of the CalHHS, this RFP is complete and without need of explanation. However, if you have questions, or should you need any clarification, please submit your questions in writing to the Procurement Official in accordance with the Questions and Answers portion of this RFP. Please note that no verbal information given will be binding upon the CalHHS unless such information is issued in writing as an official addendum.

Americans with Disabilities Act To comply with the nondiscrimination requirements of the Americans with Disabilities Act of 1990 (ADA), it is the policy of the State of California to make every effort to ensure that its programs, activities, and services are available to all persons, including persons with disabilities.

For persons with a disability needing a reasonable accommodation to participate in the procurement process or for persons having questions regarding reasonable accommodations of the procurement process, you may contact the Procurement Official. To ensure that we can meet your need, it is best that we receive your request for reasonable accommodations at least 10 working days before the scheduled event, e.g., meeting, conference, or procurement deadline.

California Health and Human Services Agency RFP # 2025-556-CDII

Institution Review Board Consulting Services Page 2

California Health and Human Services Agency RFP # 2025-556-CDII

Institution Review Board Consulting Services Page 73

1. KEY ACTION DATES

It is recognized that time is of the essence. All bidders are hereby advised of the following schedule and will be expected to adhere to the required dates and times.

All dates after Final Date for Proposal Submission are approximate and may be adjusted as conditions indicate without addendum to this RFP.

2. QUESTIONS AND ANSWERS

2.1. Questions regarding this RFP must be submitted via email to:

Miguel.Jauregui@chhs.ca.gov by the Deadline for Written Questions date and time specified in the Section 1, Key Action Dates.

2.2. Written questions must include the individual's name, firm name, and must reference RFP No. 2025-556-CDII.

2.3. Written responses to all questions will be collectively compiled and posted to the Cal eProcure website (https://caleprocure.com/pages/index.aspx). It is the responsibility of the Bidder to access the website for any changes or addenda that may be posted. It is the responsibility of the bidder to check Cal eProcure for all addenda.

2.4. CalHHS reserves the right to not provide a response to written questions submitted after the date and time for Deadline for Written Questions specified in Section 1, Key Action Dates.

3. SERVICES NEEDED

For a detailed description of the required services, please see Section II – Sample Agreement, Exhibit A - Statement of Work starting on page 34. The specific tasks can be found in Section 5, Scope of Services / Specific Tasks starting on page 35.

4. EVALUATION AND SELECTION

4.1 A State Evaluation Team will be established to evaluate and score each proposal on a consensus basis.

4.2 Proposals that contain false or misleading statements, or which provide references, which do not support an attribute or condition claimed by the Bidder, may be rejected.

4.3 The following Evaluation Criteria summarizes the items and the maximum number of points to be awarded for each stage of the evaluation by the State Evaluation team. Proposals that receive a “fail” on any Evaluation Item will be disqualified from receiving the contract award.

Table 4-1: Evaluation Criteria

4.4 During the evaluation of the proposals, the evaluation team may request that the bidder clarify any area of the proposal that the evaluation team determined to be unclear. For example, if there are clerical or mathematical errors in the proposal.

4.5 Administrative Evaluation of proposals will be evaluated and scored on a pass/fail basis. The Procurement Official and the Evaluation Team will review the Proposals to ensure the submission and completion of the required forms, documents, and certifications. Only those Proposals that receive a passing score will proceed to the other evaluation phases.

4.6 Bidders must provide a brief narrative describing their Firm’s Strengths and Experience pertinent to accomplishing the tasks in Exhibit A - Statement of Work. The State Evaluation Team will score the narrative.

4.7 Bidders must provide a brief narrative describing the experience of their proposed staff resources and how their experience meets the needs of accomplishing the tasks in Exhibit A - Statement of Work. The State Evaluation Team will score the narrative along with information provided in the proposed staffs’ résumé.

4.8 Bidders must describe the firm’s understanding and approach to accomplish the tasks in Exhibit A - Statement of Work. The State Evaluation Team will score the narrative.

4.9 Bidders must provide their costs for the required services as shown in Attachment 14, Cost Worksheet. The cost evaluation is based on the Bidder’s total cost for Years 1-3. The responsive Bidder with the lowest costs will be awarded 300 points. All other Bidders will receive a score calculated on a percentage basis of the lowest cost.

Table 4-2: Scoring Example Example

(Lowest Price ÷ Bidder’s Price) Cost Score (B x 300 = C)

Note: Decimals are rounded to the nearest hundredths.

4.10 Once scores are final, proposals will have applicable preferences and incentives applied as detailed in Section 12, Preference Programs.

4.11 Interview Evaluation (optional): The State, at its own discretion, may hold interviews as part of this evaluation. The State will determine, later, which bidders will be invited to participate in the interview evaluation.

4.12 The award, if made, will be to the Bidder who submitted the highest-scored responsive and responsible proposal. A responsive proposal is one which meets or exceeds the requirements stated in this RFP.

5. PROPOSAL REQUIREMENTS

5.1 Administrative Proposal Requirements

The following attachments are mandatory for bidders to complete and submit in their proposal (except if not applicable as indicated):

· Attachment #1 Proposal Checklist

· Attachment #2 Bidder/Proposal Certification Sheet

· Attachment #3 Contractor Certification Clauses (CCC-04/2017)

· Attachment #4 Bidder Declaration (GSPD-05-105)

· Attachment #5 DVBE Declarations (Std. 843)

· Attachment #6 Commercially Useful Function Documentation form

· Attachment #7 Darfur Contracting Act Compliance Certification

· Attachment #8 Iran Contracting Act Compliance Certification

· Attachment #9 Payee Data Record (Std. 204)

· Attachment #10 Civil Rights Form

· Attachment #11 Bidder Preferences and Incentives

· Attachment #12 Target Area Contract Preference Act (Std. 830) and Bidder’s Summary of Contract Activities and Labor Hours (GSPD-526) (if applicable)

· Attachment #13 General Artificial Intelligence (AI) Disclosure and Factsheet

5.2 Technical Proposal Requirements

· Attachment #14 Bidders Experience and Approach

· Attachment #16 Consultant Résumés

5.3 Cost Proposal Requirements

· Attachment #15 Cost Worksheet

6. SUBMISSION OF PROPOSAL

6.1 Proposals should provide straightforward and concise descriptions of the Bidder’s ability to satisfy the requirements of this RFP. The proposal must be complete and accurate. Omissions, inaccuracies, or misstatements may be cause for rejection of a proposal.

6.2 The proposal package should be prepared in the least expensive method.

6.3 Proposals must be submitted electronically to Miguel.Jauregui@chhs.ca.gov by the date and times shown in Section 1 Key Action Dates. Proposals received after the date and time may not be considered. It is the responsibility of all bidders to request and receive a message from the State Procurement Official indicating that their proposal was received by the required due date and time.

6.4 Proposals must be e-mailed to Miguel.Jauregui@chhs.ca.gov. Proposals submitted to any other e-mail address shall not be accepted.

6.9 An individual, who is authorized to bind the proposing firm contractually, shall sign the Attachment 2, Proposal/Bidder Certification Sheet. The signature must indicate the title or position that the individual holds in the firm. An unsigned proposal may be rejected. Digital Signatures will be accepted.

6.10 A Bidder may modify a proposal after its submission by withdrawing its original proposal and resubmitting a new proposal prior to the proposal submission deadline as set forth in Section 1 Key Action Dates. Proposal modifications in any other manner, oral or written, will not be considered.

6.11 A Bidder may withdraw its proposal by submitting a written withdrawal request to the CalHHS, signed by the Bidder or an authorized agent. A Bidder may thereafter submit a new proposal prior to the proposal submission deadline. Proposals may not be withdrawn without cause subsequent to proposal submission deadline.

6.18 No oral understanding or agreement shall be binding on either party.

7. AWARD AND PROTEST

7.1 Notice of the proposed award shall be posted in a public place at the following location for five (5) working days prior to awarding the agreement:

California Health and Human Services Agency 1215 O Street Lobby Sacramento, CA 95814

AND

Department of General Services Office of Legal Services Attention: Bid Protest Coordinator 707 Third Street, 7th Floor, Suite 7-330 West Sacramento, CA 95605 Bid Protest Coordinator Email address: OLSProtests@dgs.ca.gov

AND

California Health and Human Services Agency Attn: Miguel Jauregui 1215 O Street, 11th Floor Sacramento, CA 95814 Email: Miguel.Jauregui@chhs.ca.gov

7.4 Within five (5) days after filing the initial protest, the protesting Bidder shall file with the Department of General Services, Office of Legal Services and the CalHHS a detailed statement specifying the grounds for the protest.

8. DISPOSITION OF PROPOSALS

8.1 Upon proposal opening, all documents submitted in response to this RFP will become the property of the State of California and will be regarded as public records under the California Public Records Act (Government Code Section 6250 et seq.) and subject to review by the public at the conclusion of the evaluation scoring process.

8.2 Proposal packages may be returned only at the Bidder’s expense unless such expense is waived by the awarding agency.

9. TIE BIDS

In the event of a tie score, the award will be determined by a coin toss, by the Procurement Official, to break the tie. The affected bidders will be invited. In the event of a precise tie between the responsible proposal of a certified small business and the responsible proposal of a certified disabled veteran owned business that is also a small business, the contract will be awarded to the disabled veteran owned small business. (GC § 14838 (f); 2 CCR 1896.8(f)).

10. AGREEMENT EXECUTION AND PERFORMANCE

Performance shall start not later than five (5) days, or on the express date set by the awarding agency and the Contractor, after all approvals have been obtained and the agreement is fully executed. Should the Contractor fail to commence work at the agreed upon time, the CalHHS, upon five (5) days written notice to the Contractor, reserves the right to terminate the agreement. In addition, the Contractor shall be liable to the CalHHS for the difference between Contractor’s proposal price and the actual cost of performing work by another contractor.

All performance under the agreement shall be completed on or before the termination date of the agreement.

11. PREFERENCE PROGRAMS

Qualified bidders may earn preference and incentive points by claiming any of the following preferences. These preferences are not mandatory and are optional for the Bidder to claim:

1. DVBE

2. Small Business (SB) Preference

3. SB Subcontractor Preference

4. Target Area Contract Preference Act

Bidders claiming these preferences will be awarded preferential points as a percentage of the overall evaluation score.

11.1 DVBE Participation Program Requirement

The California Disabled Veteran Business Enterprise Program requires that agencies take all practical actions necessary to meet or exceed a Disabled Veteran Business Enterprise (DVBE) participation goal of three percent (3%) of the agency’s overall contract dollars.

Public Contract Code Section 10115 et seq. establishes a contract participation goal of at least three percent (3%) for Disabled Veteran Business Enterprise (DVBE). This goal applies to a state agency’s overall contracting program.

THE DEPARTMENT ELECTS TO WAIVE DVBE PROGRAM REQUIREMENTS FOR THIS SOLICITATION BUT OPTS TO INCLUDE THE DVBE INCENTIVE.

In accordance with §999.5 et seq. of the Military and Veterans Code, an incentive will be given to bidders who propose DVBE participation. For evaluation purposes only, the CALHHS shall apply an incentive amount based on the confirmed amount of DVBE participation.

The following incentive points shall apply to this solicitation:

(% of total points available) DVBE Incentive Points

11.2 Small Business Preference

A. As an incentive, a small business prime contractor who is a certified small business and is responsible for performing work that is at least 25% of its net bid price is eligible for a bid preference of five percent (5%) of the highest scored responsible proposal that is not eligible for the small business preference.

B. If you are in the process of obtaining your SB or DVBE certification, completed certification applications and required support documents must be submitted to the DGS’ Office of Small Business and DVBE Services (OSDS) no later than 5:00 p.m. on the final proposal submission date, and the OSDS must be able to approve the application as submitted.

11.3 SB Subcontractor Preference

As an incentive, a non-small business prime contractor who uses certified small business subcontractors for at least 25% of its net bid price is eligible for a bid preference of five percent (5%) of the lowest responsible proposal when competing against another non-small business.

11.4 Target Area Contract Preference Act (TACPA)

Score preference will be granted to California-based bidders in accordance with California Government Code section 4530 whenever contracts for goods or services are in excess of $100,000 and the bidders meet certain requirements as defined in the California Administrative Code (Title 2, Section 1896 et seq.) regarding labor needed to provide the services being procured. Bidders can earn a score preference of between one percent (1%) and nine percent (9%) depending on what parts of the preference they claim. Full details can be found on the STD 830 form itself. Bidders desiring to claim this preference must submit a full executed copy of Attachment 12 (STD 830 form).

The application of TACPA preference points may not displace an award to a Department of General Services (DGS) certified Small Business. However, a firm that receives a 5% non-small business subcontractor preference is not a certified Small Business and may be displaced by the application of the TACPA preferences.

The maximum preference allowed for TACPA is 9% and may not exceed $50,000.00 for any bid. In combination with any other preferences (TACPA, SB, non-SB subcontracting participation, recycled, etc.), the maximum limit of the combined preferences is 15% of the bid amount and, in no case, shall be more than $100,000.00 per bid.

Bidders’ questions regarding this preference are to be directed to:

Department of General Services Procurement Division – Dispute Resolution Unit 707 Third Street, Second Floor West Sacramento, CA 95605 Business Hours: 8:00 am – 4:00 pm

Email: TACPA@dgs.ca.gov

12. EXECUTIVE ORDER N-6-22 – RUSSIA SANCTIONS

On March 4, 2022, Governor Gavin Newsom issued Executive Order N-6-22 (the EO) regarding Economic Sanctions against Russia and Russian entities and individuals. “Economic Sanctions” refers to sanctions imposed by the U.S. government in response to Russia’s actions in Ukraine, as well as any sanctions imposed under state law. By submitting a bid or proposal, Contractor represents that it is not a target of Economic Sanctions. Should the State determine Contractor is a target of Economic Sanctions or is conducting prohibited transactions with sanctioned individuals or entities, that shall be grounds for rejection of the Contractor’s bid/proposal any time prior to contract execution, or, if determined after contract execution, shall be grounds for termination by the State.

13. LOSS LEADER

Pursuant to PCC Section 12104.5(b)(1), “It is unlawful for any person engaged in business within this state to sell or use any article or product as a “loss leader” as defined in Section 17030 of the Business and Professions Code.”

14. TAX DELINQUENCIES CONTRACT BAN

Public Contract Code section 10295.4 provides that a state agency shall not enter into any contract for goods or services with a contractor whose name appears on either list of the 500 largest tax delinquencies pursuant to Section 7063 or 19195 of the Revenue and Taxation Code. This prohibition applies to contracts executed on or after July 1, 2012. FTB and BOE will post and periodically update lists of the 500 largest tax delinquencies on their websites as required by law. Starting July 1, 2012, prior to executing contracts, state agencies must check the FTB and BOE lists to ensure the proposed awardee/vendor is not on either list.

15. GENERATIVE ARTIFICIAL INTELLIGENCE TECHNOLOGY USE AND REPORTING

The State of California seeks to realize the potential benefits of GenAI, through the development and deployment of GenAI tools, while balancing the risks of these new technologies. Bidders must notify the State in writing if their solution or service includes, or makes available, any GenAI, including GenAI from third parties or subcontractors.

The State has developed a GenAI Reporting and Factsheet (STD 1000) to be completed by the Bidder. Failure to submit the GenAI Reporting and Factsheet (STD 1000) will result in disqualification of the Bidder.

Failure to report GenAI to the State may void any resulting contract. The State reserves its right to seek all relief it may be entitled to as a result of such non-disclosure.

Upon receipt of a Bidder / Offeror / Contractor GenAI Reporting and Factsheet (STD 1000), the state reserves the right to incorporate GenAI Special Provisions into the final contract or reject bids/offers that present an unacceptable level of risk to the state.

ATTACHMENT 1 - PROPOSAL CHECKLIST

A complete proposal or proposal package will consist of the items identified below.

Complete this checklist to confirm the items in your proposal. Place a check mark or “X” next to each item that you are submitting in your proposal to the CalHHS. For your proposal to be responsive, all required attachments must be returned, (except if not applicable as indicated). This checklist must be returned with your proposal package.

Bidders shall organize their proposal with the attachments in the following order shown below. Failure to submit the attachments in the following order may cause your proposal to be rejected.

NOTE: The State does not guarantee that this checklist is comprehensive. Use of this checklist does not absolve bidders from reading the entire RFP nor will it excuse bidders of any obligations set forth in this RFP.

ATTACHMENT 2 - PROPOSAL/BIDDER CERTIFICATION SHEET

This Proposal/Bidder Certification Sheet must be signed and returned along with all the required attachments in PDF format.

Firm Name:

Address:

Person Authorized to Bind Firm:

Email Address:

Phone Number

The signature affixed and dated hereon certifies compliance with all the requirements of this RFP. By signing this form, I (we) certify the following:

1. The information contained in this Response is accurate and all required Exhibits and information submitted as a part of this Response are certified to be true and binding upon the bidder.

2. This is a firm fixed cost and irrevocable proposal for one hundred and eighty (180) days following the RFP Response Due Date, as specified in the Key Action Dates and Times, and agree to execute an agreement, if awarded.

3. This firm’s ability and willingness to perform the services as described in the RFP.

4. The firm’s proposed staff resources are available to perform all services and providing all deliverables as described in this RFP.

5. The firm agrees to the State’s Terms and Conditions of this RFP and will comply with the requirements set forth in this RFP without change or modification.

ATTACHMENT 3 - CONTRACTOR CERTIFICATION CLAUSES (CCC-04/2017)

The CCC-04/2017 is located on the Internet at:

https://www.dgs.ca.gov/OLS/Resources/Page-Content/Office-of-Legal-Services-Resources-List-Folder/Standard-Contract-Language

ATTACHMENT 4 - BIDDER DECLARATION (GSPD-05-105)

The Bidder Declaration is located at:

https://www.documents.dgs.ca.gov/dgs/fmc/gs/pd/gspd05-105.pdf

ATTACHMENT 5 - DVBE DECLARATIONS (STD. 843)

The Std. 843 is located at https://www.documents.dgs.ca.gov/dgs/fmc/gs/pd/pd_843.pdf

ATTACHMENT 6 - COMMERCIALLY USEFUL FUNCTION DOCUMENTATION

All certified small business, micro business, or DVBE contractors, subcontractors or suppliers shall meet the commercially useful function requirements under GC Section 14837(d) (4)(A) (i-v) (for SB) and Military and Veterans Code Section 999(b)(5)(B) (i) (I-V) (for DVBE) as stated below.

VENDOR NAME:

SUBCONTRACTOR NAME:

Mark all that apply: DVBE |_| Small Business |_| Micro Business |_|

SECTION 1:

A person or entity is deemed to perform “a commercially useful function” if a person or entity does all of the following. (Please answer the following questions.)

NOTE: A response of “No” to any of the questions above may result in your response to be deemed non-responsive and disqualified.

SECTION 2:

The Vendor shall provide a written statement detailing the role, services and/or goods the subcontractor(s) will provide to meet the commercially useful function requirement.

SIGNATURE OF VENDOR (PRIME): DATE:

ATTACHMENT 7 - DARFUR CONTRACTING ACT COMPLIANCE CERTIFICATION

Public Contract Code §§10475 -10481 applies to any company that currently or within the previous three (3) years has had business activities or other operations outside of the United States. For such a company to bid on or submit a Proposal for a State of California contract, the company must certify that it is either: a) not a scrutinized company; or b) a scrutinized company that has been granted permission by the Department of General Services (DGS) to submit a Proposal. If your company has not, within the previous three (3) years, had any business activities or other operations outside of the United States, you do not need to complete this form.

OPTION #1 – CERTIFICATION

If your company, within the previous three (3) years, has had business activities or other operations outside of the United States, in order to be eligible to submit a bid or Proposal, please insert your company name and Federal ID Number and complete the certification below.

I, the official named below, CERTIFY UNDER PENALTY OF PERJURY that: a) the prospective Vendor/Bidder named below is not a scrutinized company per Public Contract Code §10476; and b) I am duly authorized to legally bind the prospective Vendor/Bidder named below. This certification is made under the laws of the State of California.

By (Authorized Signature)

Printed Name and Title of Person Signing

OPTION #2 – WRITTEN PERMISSION FROM DGS

Pursuant to Public Contract Code §10477(b), the Director of the DGS may permit a scrutinized company, on a case-by-case basis, to bid on or submit a Proposal for a contract with a state agency for goods or services, if it is in the best interests of the State. If you are a scrutinized company that has obtained written permission from the DGS to submit a bid or Proposal, complete the information below.

We are a scrutinized company as defined in Public Contract Code §10476, but we have received written permission from the DGS to submit a bid or Proposal pursuant to Public Contract Code §10477(b). A copy of the written permission from DGS is included with our bid or Proposal.

Initials of Submitter

Printed Name and Title of Person Initialing

ATTACHMENT 8 - IRAN CONTRACTING ACT COMPLIANCE CERTIFICATION

(Public Contract Code Sections 2202-2208)

Prior to bidding on, submitting an Proposal, or executing a contract or renewal for a State of California contract for goods or services of one million dollars ($1,000,000) or more, a Vendor must either: a) certify it is not on the current list of persons engaged in investment activities in Iran created by the California Department of General Services (DGS) pursuant to Public Contract Code Section 2203(b) and is not a financial institution extending twenty million dollars ($20,000,000) or more in credit to another person, for 45 days or more, if that other person will use the credit to provide goods or services in the energy sector in Iran and is identified on the current list of persons engaged in investment activities in Iran created by DGS, or b) demonstrate it has been exempted from the certification requirement for that solicitation or contract pursuant to Public Contract Code Section 2203(c) or (d). To comply with this requirement, the Vendor must insert its financial institution name and Federal Identification Number (if available) and complete one of the options below. Please note: California law established penalties for providing false certifications, including civil penalties equal to the greater of two hundred and fifty thousand dollars ($250,000) or twice the amount of the contract for which the false certification was made, contract termination, and three-year ineligibility to bid on contracts. (Public Contract Code Section 2205.)

OPTION #1 - CERTIFICATION

I, the official named below, certify I am duly authorized to execute this certification on behalf of the Vendor/financial institution identified below, and the Vendor/financial institution identified below is not on the current list of persons engaged in investment activities in Iran created by DGS and is not a financial institution extending twenty million dollars ($20,000,000) or more in credit to another person/Vendor, for 45 days or more, if that other person/Vendor will use the credit to provide goods or services in the energy sector in Iran and is identified on the current list of persons engaged in investment activities in Iran created by the DGS.

By (Authorized Signature)

Printed Name and Title of Person Signing

OPTION #2 – EXEMPTION

Pursuant to Public Contract Code Sections 2203(c) and (d), a public entity may permit a Vendor/financial institution engaged in investment activities in Iran, on a case-by-case basis, to be eligible for, or to bid on, submit a Proposal for, or enters or renews, a contract for goods and services. If a Vendor has obtained an exemption from the certification requirement under the Iran Contracting Act, fill out the information below, and attach documentation demonstrating the exemption approval.

By (Authorized Signature)

ATTACHMENT 9 - PAYEE DATA RECORD (STD. 204)

The Std. 204 is located at https://www.documents.dgs.ca.gov/dgs/fmc/pdf/std204.pdf

ATTACHMENT 10 - CALIFORNIA CIVIL RIGHTS LAWS ATTACHMENT

The California Civil Rights Laws form is located at https://www.dgs.ca.gov/OLS/Forms

ATTACHMENT 11 - BIDDER PREFERENCES AND INCENTIVES

All Bidders: Complete All Sections Below and Submit with Your Proposal.

1. SMALL BUSINESS / NON-SMALL BUSINESS PREFERENCE:

Bidder must check the appropriate box from the choices below.

My DGS Small Business certification number is:

Bidder must complete and submit Attachment 4: GSPD-05-105 Bidder Declaration, indicating the percentage of the revenue that will be received by each DGS certified Small Business Subcontractor.

2. DVBE INCENTIVE:

Bidder must check the appropriate box from the choices below.

Bidder must submit a complete Attachment 4: GSPD-05-105, Bidder Declaration, indicating the percentage of the revenue that will be received by each DGS certified DVBE Subcontractor. Bidder must also submit an Attachment 5, Std. 843 DVBE Declarations, for each DVBE Subcontractor, signed by the DVBE owner/manager.

BIDDER/ORGANIZATION

Name of Signer

Signature and Date

ATTACHMENT 12 - TARGET AREA CONTRACT PREFERENCE ACT

The policies and procedures specific to TACPA can be found at the link below:

https://tacpa.dgs.ca.gov/Home/About?Length=4

If claiming TACPA please submit both required forms below:

The STD 830 Target Area Contract Preference Act form is located at https://www.documents.dgs.ca.gov/dgs/fmc/pdf/std830.pdf

The GSPD-526 Bidder’s Summary of Contract Activities and Labor Hours is located at:

https://www.documents.dgs.ca.gov/dgs/fmc/gs/pd/gspd0526.pdf

ATTACHMENT 13 – GENERATIVE ARTIFICAL INTELLIGENCE DISCLOSURE & FACTSHEET

https://www.documents.dgs.ca.gov/dgs/fmc/pdf/std1000.pdf

ATTACHMENT 14 - BIDDERS EXPERIENCE AND APPROACH

INSTRUCTIONS: Bidders must provide a narrative to address the following three (3) items.

1) Firm Strength and Experience (maximum 1 page in length). Please describe the strengths and experience of your firm, including historical accomplishments, unique services, and expertise. Describe in detail key contributions your firm would bring to CalHHS and why your agency should be considered for this consulting services contract.

Scoring Excellent = 100 Good = 75 Fair = 40 Poor = Fail/Disqualified

2) Staff Strengths and Experience (maximum 3 pages in length). Please describe your proposed consultant resources and how their experience meets the needs of the SOW described in Exhibit A - Statement of Work, Section 5, Scope of Services.

*Desirable Staff Qualifications include but are not limited to:

a) Experience reviewing and analyzing the policies, standard operating procedures, and processes of an IRB or similar organization.

b) Experience reviewing and applying the applicable FDA and HHS OHRP regulations.

c) Experience with research that is overseen by Federal or State government.

d) Experience working with government agencies or offices.

*These qualifications can be collectively met by the team and not necessarily for each resource.

Bidders must also separately provide Consultant Résumés and References as Attachment 16. The résumés do not count toward the 3-page narrative limit.

Scoring Excellent = 200 Good = 150 Fair = 80 Poor = Fail/Disqualified

3) Understanding and Approach to completing the SOW tasks (maximum 6 pages) Please describe your firm’s approach to completing the following tasks as described in Exhibit A - Statement of Work, Section 5, Scope of Services / Specific Tasks. In response to this item, Bidders must provide specific work experience and may provide work samples as part of this narrative as long as the narrative does not exceed the maximum 6-pages requirement.

As part of this section, Vendors must prepare a sample Workplan with target milestones, timelines, start and end dates for each task and deliverable and a sample Monthly Status Report.

Scoring Excellent = 300 Good = 225 Fair = 120 Poor = Fail/Disqualified

ATTACHMENT 15 - COST WORKSHEET

INSTRUCTIONS: Bidders must complete and submit Tables 14.1 and 14.2 with the proposal response. Bidders must complete the yellow highlighted cells in Columns D, E, F, G, and H.

Column D - Bidders may insert rows to include additional Consultants as needed.

Column E – Bidders must include the estimated hours need for each consultant by task group.

Column F - Bidders must include the contract Billing Rate which must be the same for all Consultant resources. The Billing Rate must be all-inclusive of direct and indirect costs.

Column G – Bidders must provide a sum calculation of columns E x F.

Column H – Bidders must specify if the Consultant resource is a subcontractor.

After contract award, the State may shift costs in these tables as needed to complete services in this Agreement.

14.1 Cost Worksheet Contract Year 1

TASK

GROUP

(must be at least 1,000 hours)

BILLING RATE

(same for all resources)

EXTENSION PRICE

(E x F)

SUBCONT

(Y/N)

Task Group 1 Engagement Planning, Project Management, and Reporting

Total for Column G must not exceed $150,000.

N/A

N/A

14.2 Cost Worksheet Contract Year 2

TASK

GROUP

(must be at least 1,000 hours)

BILLING RATE

(same for all resources)

EXTENSION PRICE

(E x F)

SUBCONT

(Y/N)

Task Group 1 Engagement Planning, Project Management, and Reporting

Total for Column G must not exceed $150,000.

N/A

N/A

ATTACHMENT 16 - CONSULTANT RÉSUMÉS

Bidders must provide a résumé for each key staff. Résumés must include all relevant experience and a Reference for each experience listed. Each résumé must not exceed 3 pages in length. See example below.

Resource Name: Jane Doe (XYZ, Inc.)

1/1/2020 – 12/31/2020

Managed project schedule.

John Smith

ATTACHMENT 17 - CONTACT INFORMATION FOR REFERENCES

Bidders must provide contact information for the named reference associated with the job experiences listed in Attachment 16 as a separate attachment. CalHHS reserves the right to check references to verify the information submitted in Attachment 16 – Consultant Resumes.

ATTACHMENT 18 - CRITERIA FOR EVALUATION OF PROPOSAL

Proposals must be submitted by email to Miguel.Jauregui@chhs.ca.gov by the dates and times shown in Section 1 Key Action Dates.

If the proposal is made under a fictitious name or business title, the actual legal name of bidder must be provided.

EVALUATION CRITERIA AND MAXIMUM POINTS

SCORING FOR NARRRATIVE (Attachment 13)

SCORING FOR COST WORKSHEET (Attachment 14) Example

(Lowest Price ÷ Bidder’s Price) Cost Score (B x 300 = C)

SECTION II- SAMPLE AGREEMENT

EXHIBIT A - STATEMENT OF WORK

1. PURPOSE

This Statement of Work (SOW) reflects the services to be provided by <Contractor>, hereinafter referred to as the “Contractor,” for the California Health and Human Services Agency, Office of the California Surgeon General (CPHS), hereinafter referred to as “State” or “CalHHS”. The purpose of this Agreement is for the Contractor to provide communications and public relations consulting services. A detailed description of the services can be found in the Section 5 Scope of Services.

This SOW is governed by and incorporates by reference General Terms and Conditions (GTC 04/2017) and Contractor Certification Clause (CCC 04/2017) which can be found at the link below:

https://www.dgs.ca.gov/OLS/Resources/Page-Content/Office-of-Legal-Services-resources-List-Folder/Standard-Contract-Language

2. TERM

2.1. The term of this Agreement shall commence on April 22, 2024, or the date the Agreement is approved by the Department of General Services (DGS), whichever is later (referred to herein as the “Effective Date”) and continue through April 21, 2026.

2.2. If the Contractor has not completed performance of the services set forth in this Agreement within the term, the State reserves the option to extend the term of this Agreement, as necessary to receive complete performance by the Contractor for a period of up to twelve (12) months and at the originally agreed-upon costs specified in the Exhibit B Budget and Payment Detail.

2.3. The Contractor shall not be authorized to deliver goods or commence performance of services described in this Agreement prior to the Effective Date. Any delivery of goods or performance of services by the Contractor that commences prior to the Effective Date shall be considered gratuitous on the part of the Contractor.

3. WORK LOCATION

The Contractor will be required to perform some of the services, under this Agreement, onsite at the California Health and Human Services Agency (CalHHS) office located at 1215 O Street, Sacramento, CA 95814. Upon approval by the State Engagement Manager, the Contractor may be allowed to perform some of the services at a remote location.

4. MAXIMUM AMOUNT PAYABLE

The Maximum Amount Payable for this Agreement is $150,000. Budget, cost and invoicing details can be found in Exhibit B, Budget and Payment Details.

5. SCOPE OF SERVICES / SPECIFIC TASKS

Under the direction from the CPHS Engagement Manager, the Contractor shall perform the following duties:

Task Group 1 – Engagement Planning, Project Management and Reporting

Deliverable: Kick-Off Meeting Notes due 3 business days after the work starts.

Deliverable: Workplan due 10 business days after work starts.

a) Work performed.

b) Work planned.

c) What is…