FBO_Post_JA_Exception_Attachment.pdf

OAGS Template and Instruction for a General Services Administration Federal Supply Schedule Limited Source Justification

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

HHS / Office of Commissioner / Office of Operations / Office of Finance, Budget, and Acquisitions

b. Sponsoring organization.

FDA Office of Operations (OO)/Office of Enterprise Management Services (OEMS)/ Program Effectiveness Office (PEO)

FDA Office of Operations (OO)/Office of Finance, Budget, and Acquisitions (OFBA)/ Immediate Office of the CFO – Enterprise Risk Management (ERM) Program

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Vanita Hill

ii. Mailing address: 8455 Colesville Rd, Silver Spring, MD 20910

iii. E-mail address: Vanita.Hill@fda.hhs.gov

iv. Telephone number: 240-402-8547

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The objectives of BPA order HHSF223201510010B/HHSF22317001 are to support, enhance and expand OMES’s ongoing operational efforts while being more responsive and effective in its support of mission-based services:

BPA order Management. Will facilitate the management of time, resources and skills necessary to successfully accomplish interrelated tasks.

• Strategic Communications Management. Develop and implement communication strategies to facilitate effective organizational communications and accomplish OO priority communication initiatives. Additionally, develop core communication plans and tools implementing industry best practices.

• Performance Management Analysis. Improve and maintain a set of analytic processes and metrics that enable OMES to assess strategic goals and then measure and manage performance against those goals. Core performance management processes include:

operational planning and assessment; consolidation and reporting; and monitoring of key projects linked to the strategic plan.

• Project Management Support. Support project management of special initiatives related to core OO priorities. Improve and implement standard operating procedures (SOPs) to effectively manage the special projects portfolio.

• Organizational Governance Support (Optional Task). Support operational governance management efforts, providing oversight, resources and skills necessary to successfully support the Councils within the governance structure, to include strategic communications and records management.

• Administrative Management and Program Support. Program development and management.

Refine policies, internal operating procedures, and job aides, as needed. Define quality control and assurance processes for ongoing operations. Facilitate implementation of recommendations for automation to further enhance operations. Provide administrative management expertise to assist in strategic planning and management of information requests, monitoring status and requesting trends as they become known.

• Combined FMFIA and Enterprise Risk Management Process. Facilitate the ongoing implementation of FDA’s Enterprise Risk Management program for OC in response to OMB Circular No. A-123, Management’s Responsibility for Enterprise Risk management and Internal Control, and supporting guidance from the Health and Human Services (HHS) Department. Support the maturity of the FDA’s integrated risk management program with Centers and Offices, identify recommendations for future growth, and assist FDA in maintaining risk assessment communication, training and facilitation, and working in conjunction with the Office of Policy Planning Legislation and Analysis and Office of Financial Management, and FDA’s governance structure.

• OO SharePoint Workflow and Site Design (Optional Task). Support the continued improvement of the OMES SharePoint site through expanding the existing site, reorganizing content in a more efficient manner, and creating applications and workflows that will facilitate better business practices and increase productivity of the OMES staff.

The ERM Program mandated by OMB A-123 and A-11 is required under the authority of the CFO Act and is in alignment with Internal Controls and HHS Enterprise Risk Management. The purpose of the acquisition is to provide Contractor support for the ERM vital functions: ERM executive Council; ERM CoP, FMFIA data collection and risk evaluation, and overall FDA enterprise risk mitigation processes and methodology. The ERM Program is in need of a mechanism for support as there is not sufficient time for possible contractor transition out and/or transition in due to stop work orders issued on the planned BTT BPA acquisition due to a protest, which was dismissed due to the FDA agreeing to voluntary corrective action.

b. Project background.

The Food and Drug Administration (FDA), Office of the Commissioner (OC), Office of Operations (OO), Office of Enterprise Management Services (OMES) (formally Office of Management), was established to systematically monitor and guide the planning and implementation of FDA administrative operations through proactive strategic assessment and analysis, information dissemination, decision support and the application of technical expertise. Specifically, OEMS is responsible for developing partnerships with OO and OC Super Offices to build evaluation capacity, improving decision making and risk management through systematic inquiry, strategic alignment to ensure mission effectiveness, offering administrative support across OC, aggressively advocating for process efficiency and achievement of superior results and facilitating change while standardizing OC crosscutting operations and promoting a culture of innovation.

BPA order HHSF223201510010B/HHSF22317001, which will expire on December 31, 2020, was competed among the three BTT BPAs and was awarded to Deloitte Consulting LLP in the amount of $2,373,689.68 with a period of performance of September 5, 2017 through September 4, 2018 plus two option years totaling $7,305,004.98. Optional Tasks Governance Management (3.5.2) and Governance Strategic Communications, Administration and Records Management (3.5.3) for option years I and II were not exercised in the total amount of $343,471.00. The expiring BPA order’s period of performance was extended until December 31, 2020 increasing the total amount to $12,169,708.60.

Five new BTT BPAs were awarded with a period of performance of October 21, 2020 through October 20, 2025. However, due to a protest, which was dismissed due to the FDA agreeing to voluntary corrective action, each BPA awardee has been issued stop work orders. In order to continue these essential services, the Government intends to issue a sole source modification to the current order to ensure there is not a lapse in service.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title.

Office of Enterprise Management Services (OEMS) (formally Office of Management) Operational support and Enterprise Risk Management (ERM) Program Support

b. Project Description.

The contractor shall be tasked to work collaboratively with OEMS, OC, OO, FDA staff, and other federal officials as needed to provide a variety of operational support.

Activities in the scope of this order include:

• Daily support and operational activities

• Project planning, development, implementation and coordination

• Identifying areas of improvement and specific suggestions to address those improvements

Requirement type.

Support services (non-R&D)

Supplies/equipment

Information Technology (IT)

Other:

Type of action.

New requirement

Follow-on

Other:

Proposed contract/order type.

Firm-fixed-price

Time and materials

Indefinite delivery:

Other:

Completion Form

Term Form

Acquisition identification number.

OEMS OO-21-C-0032

ERM OO-21-0039

Requisition #1237652

c. Total estimated dollar value and performance/delivery period.

POP: January 1, 2021 – December 31, 2021 Total dollar amount $3,792,779.39 (OEMS CLIN 1 - $2,522,379.39 + ERM CLIN 2 - $1,270,400.00)

4. The authority and supporting rationale (see FAR 8.405-6(a)(1)(i); (b)(1)) and, if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

a. Acquisition authority.

This acquisition is conducted under the authority of the Multiple Award Schedule Program. In accordance with Federal Acquisition Regulation (FAR) 8.405-6(a), consideration of schedule contractors will be restricted to fewer than the number required at FAR 8.405-1, FAR 8.405-2, FAR 8.405-3 (i.e., fewer than three FSS contractors). FAR 8.405-6 (a)(1)(i), for a proposed order or BPA with an estimated value exceeding the micro-purchase threshold not placed or established in accordance with the procedures in FAR 8.405-1, FAR 8.405-2, or FAR 8.405-3, the only circumstances that may justify the actions are-

(A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays;

(B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

(C) In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-sources procedures.

This acquisition is conducted under the authority of the Multiple Award Schedule Program. In accordance with FAR 8.405-6(b), consideration of schedule contractors will be restricted only to the item peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer.

b. Demonstration of the proposed contractor(s) unique qualifications to provide the required supply or service.

• Name and address of the proposed contractor(s).

The current Contractor on the expiring BPA is DELOITTE CONSULTING L. L. P. (with a UFMS vendor number of #116706). Deloitte’s address is: 1725 DUKE ST, Alexandria, VA 22314-3456.

• Nature of the acquisition and proposed contractor(s) unique qualifications.

The current Contractor has been with the Program from its inception in 2017. Because of the rapid response of specialized work and due to the lack of a possible Transition Out and Transition In period, Deloitte LLP can provide continuous program coverage, with no lapse in risk mitigation and FDA risk management support for the Community. The current contractor is best suited to carry out the duties of a follow-on extension.

Because this order was planned to be competed among the five new BTT BPAs, which currently have stop work orders issued against them due to a protest, which was dismissed due to the FDA agreeing to voluntary corrective action, there is not enough time to transition this work currently being performed by Deloitte Consulting to a possible new vendor. By the time a new order is competed, the current order will have expired on December 31, 2020, which would create a lapse in service due to the time it would take to onboard possible new personnel. A new order would also potentially require a new contractor to duplicate ongoing work, which would provide for a significant increase in cost and loss of work that is already in the stages of being completed.

Without the execution of this sole source follow-on extension to the current order, a disruption (i.e. a lapse) in essential services would result in decreased operational efficiency of the Agency, which would be an unacceptable outcome, since it would adversely affect the FDA’s mission. Extending HHSF223201510010B/HHSF22317001 for an additional 12 months would mitigate the noted operational risks. The current contractor is best positioned to provide the required continued services and accomplish the immediate work activities in the most schedule and cost-efficient manner until the current BTT BPA stop work orders are lifted.

5. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

The current order, HHSF223201510010B/HHSF22317001, set to expire on December 31, 2020, was awarded under Deloitte Consulting’s GSA contract 47QRAA18D001P, the pricing for which has already been determined to be fair and reasonable. This logical follow-on sole source modification to extend the period of performance one year represents the best value and results in the lowest overall cost alternative to meet the Government’s needs.

6. Description of the market research conducted among schedule holders and the results, or a statement of the reasons market research was not conducted.

Given that the BTT BPA awards were already existing, no additional market research was conducted.

Program planned on competing this requirement to vendors under the five new BTT BPAs, awarded on October 21, 2020, but stop work orders were issued due to a protest, which was dismissed due to the FDA agreeing to voluntary corrective action. The current order will expire on December 31, 2020.

Moreover, given the immediate continued need of the BTT requirements, it is not in the best interests of the Government to solicit new vendors via formal market research actions (e.g. sources sought and requests for information). The resultant time lapse of any related market research efforts, would cause a disruption in the required services.

7. Any other facts supporting the justification.

OEMS and ERM are important stakeholders charged to promote compliance, building customer experience, and foster innovation in support of FDA’s mission to promote and protect public health.

OEMS carries out this mission through a combination of management functions carrying out strategic and tactical enterprise-wide management series through the development and implementation and administrative policies, programs and initiatives. The current BPA order HHSF223201510010B/HHSF22317001 with Deloitte Consulting expires on December 31, 2020. All extensions of the original order are now expiring, with no available options. Due to due a lack of time for any possible transition to a new vendor and because the current order needs to maintain its current service level, a sole source follow-on extension to the current order is being pursued. In the interest of economy and efficiency, the extension is a logical follow-on to the original Federal Supply Schedule order. The Program fully intends to place an acquisition plan against the new BTT BPAs (after the stop work orders have been lifted) after the expiration of this order. This will allow for a successful transition out and transition in to the competitive bidder awarded under the BTT BPAs. In this instance Federal Supply Schedule ordering procedures would result in unacceptable delays in schedule, loss of programmatic funding, negatively impact FDA’s mission to promote and protect the public health.

8. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

a) Removal of barriers to competition.

Program planned on competing this requirement to vendors under the five new BTT BPAs, awarded on October 21, 2020, but stop work orders were issued due to a protest, which was dismissed due to the FDA agreeing to voluntary corrective action. The current order will expire on December 31, 2020.

b) Listing of sources, if any, that expressed an interest, in writing, in the acquisition.

The current Contractor on the expiring BPA is DELOITTE CONSULTING L. L. P. (with a UFMS vendor number of #116706). Deloitte’s address is: 1725 DUKE ST, Alexandria, VA 22314-3456.

9. Program office certification.

Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for limited sources) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

Signature:

COR/Requiring Activity POC

Program Official

Signature

COR/POC Immediate Supervisor

Head of the Sponsoring Program Office

10. Contracting Officer Certification.

This is to certify that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

Contracting Officer

11. Division Director and Head of the Contracting Activity signature(s).

Division Director

Head of the Contracting Activity

12. Competition Advocate signature.

Competition Advocate