Justification-and-Approval-for-Sole-Source (CIU Contract).docx

Attachment C Justification and Approval for Sole Source (J&A)

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS/NIH.

b. Sponsoring organization. OD

c. Project Officer Information.

· Project Officer Name. Megan Brose

· Mailing address. 903 South 4th Street, Hamilton, MT, 59840

· E-mail address. Megan.brose@nih.gov

· Telephone number. 406-375-9642

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

a. Acquisition purpose and objectives. The Division of Safety manages the emergency response protocols for potential high-risk pathogen exposures of personnel working in high and/or maximum containment laboratories at the NIH Rocky Mountain Laboratories in Hamilton, Montana. These emergency response protocols are required to have patient isolation services at a licensed medical facility by a federal lawsuit settlement agreement and to remain in compliance with the incident response requirements of the federal select agent regulations. Having these mission critical safety services in place allows RML to continue emerging disease research in support of the mission of NIH and HHS.

b. Project background. In 2006, the NIH awarded a contract to Providence St. Patrick Hospital in Missoula, Montana to construct a Care and Isolation Unit to provide patient isolation services for personal potentially exposed to high-risk pathogens from the RML high and/or maximum containment labs. This was required by a federal lawsuit settlement agreement to provide patient isolation services at a licensed medical facility within 75 miles of RML [Coalition for a Safe Lab v. National Institutes of Health, CV-04-158-M-DWM (D. Mont. 2004)]. These services are also required to remain in compliance with the incident response requirements of the federal select agent regulations [42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331]. The NIH has continued to renew this contract to continue providing these critical safety services for the past 20 years to remain in compliance with both the lawsuit settlement agreement and the federal select agent regulations. Providence St. Patrick Hospital is the only medical facility within the required 75 mile radius that can provide these specialized services. This project will allow the NIH and RML to continue to provide these mandatory safety services to the RML and local Montana communities.

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

a. Project title. RML Regional Referral Hospital Care and Isolation Unit Services

b. Project description.

The purpose of this requirement is to provide care and isolation services for RML personnel who may experience potential high-risk exposures to pathogens from working in the high and/or maximum containment laboratories.

The contractor shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and non-personnel services necessary to perform the required support as defined in the Statement of Work (SOW) except for those items specified as government property, information and services furnished. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

The Care and Isolation Unit shall be located at a Regional Referral Hospital (RRH) within a 75-mile radius of RML in Hamilton, Montana.

The RRH shall have an infectious disease specialist available for consultation 24 hours a day, 7 days a week, and 365 days a year. The infectious disease specialist will work with NIH personnel to determine an appropriate course of action and potential treatments.

If clinical evaluation in the RRH is warranted, the infectious disease specialist will activate a plan to have the Care and Isolation Unit available for use by RML staff as soon as possible but not more than six (6) hours from the request.

The RRH shall be prepared to evaluate injured or ill RML staff in a negative pressure room for clinical or laboratory evidence of infection. The evaluation may involve obtaining and processing clinical specimens.

If in-patient care is clinically warranted, the RRH shall be able to safely provide the full range of standard intensive care clinical services for RML staff in the Care and Isolation Unit for a minimum of 3 days (72 hours).

The RRH shall have the capacity to decontaminate materials from the Care and Isolation Unit promptly. The RRH and Care and Isolation Unit must comply with Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and Clinical Laboratory Improvement Amendments (CLIA) standards.

c.

· Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

· Type of action.

New requirement Follow-on Other (specify): ______________________

· Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, Definite quantity or requirements): ___________ Other (specify): ___________ Completion Form Term form

· Acquisition identification number. Sources Sought Number : NIHOD00000XX

d. Total estimated dollar value and performance/delivery period. The estimated dollar value of this contract is $1,094,085.52. The period of performance for the base year is September 29, 2026 – September 28, 2027 (with a base year cost of $253,991.00), with four option year periods.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c) (1) as set forth in Federal Acquisition Regulation (FAR) 6.302-(X).

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

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

Providence St. Patrick Hospital, 500 West Broadway St, Missoula, MT, 59802

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

The Providence St. Patrick Hospital in Missoula, Montana provides critical services as the Regional Referral Hospital for the National Institute of Allergy and Infectious Diseases (NIAID) Rocky Mountain Laboratories (RML) Integrated Research Facility located in Hamilton, Montana. These services are required to staff and maintain the Care and Isolation Unit that is used in the event of any potential exposure(s) of RML personnel to dangerous pathogens in high and maximum containment research labs. Although the likelihood of such exposures is low due to multiple redundant safety practices, procedures and engineering controls, the impact can be catastrophic resulting in severe illness or even death. Therefore, special Care and Isolation Units are required to provide medical treatment for individuals with these types of exposures by dedicated health care providers and support teams within specialized containment hospital suites. This is a component of the incident response requirements of the federal select agent regulations [42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331]. In addition, the establishment and maintenance of this Care and Isolation Unit through the Providence St. Patrick Hospital is a requirement of a lawsuit settlement agreement [Coalition for a Safe Lab v. National Institutes of Health, CV-04-158-M-DWM (D. Mont. 2004)]. If this contract is not renewed it will immediately put NIH RML out of compliance with both the federal select agent regulations and Montana District Court lawsuit settlement agreement. This option year execution protects the health and safety of both NIH employees and the surrounding communities in Montana.

The hospital that provides these isolation services must meet the requirements of a Level 3 Assessment Center by the National Special Pathogens System (NSPS) and National Emerging Special Pathogens Training and Education Center (NETEC). The Care and Isolation Unit at Providence St. Patrick Hospital in Missoula, Montana is the only Level 3 Assessment Center in the State of Montana. There are no other centers within the 75-mile radius of RML that is required by the lawsuit settlement agreement mentioned above. There are specific facility, physical infrastructure, environment infection control, personal protective equipment, training, emergency management, treatment and care, personnel management, laboratory, waste management, and decedent management requirements that medical facilities must meet to qualify as a Level 3 Assessment Center, which the Providence St. Patrick Hospital does meet as indicated by the NSPS/NETEC directory.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Market research was conducted by the Contracting Officers’ Representative (COR) on August 13, 2026 to determine if any new Assessment Centers have been approved by the NSPS/NETEC. There are no additional Level 3 Assessment Centers within the 75-mile radius of RML nor in the entire state of Montana. Therefore, there are no other sources available that meet the criteria for these legally mandated services. Documentation of this information is included with the acquisition package for reference.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

An independent Government Cost Estimate has been developed (IGCE) based on the history of the previous contract, current market conditions and program expectations. However, to ensure that the price will be fair and reasonable, the data from the IGCE will be compared with the proposal received from the offeror. An award will be made only if during negotiations; it is shown that the anticipated cost to the government will be fair and reasonable. It is acknowledged that the price will be higher than in previous years due to the need to add preliminary diagnostic testing capability for post-exposure patient monitoring and care, which was an identified after-action improvement item from a post-exposure incident in 2025.

The offeror is expected to submit price proposal for the base year and four option periods of the contract. Offeror has been notified that their proposal will be evaluated in comparison with the IGCE, and negotiations will be conducted to make the contract price reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research was conducted by the Contracting Officers’ Representative (COR) on August 13, 2026 to determine if any new Assessment Centers have been approved by the NSPS/NETEC, which is a requirement for providing these critical services. There are no additional Level 3 Assessment Centers within the 75-mile radius of RML nor in the entire state of Montana. Therefore, there are no other sources available that meet the criteria for these legally mandated services. Documentation of this information is included below.

Based upon this market research, Providence St. Patrick Hospital is the only vendor to meet the Government’s needs.

9. Any other facts supporting the use of other than full and open competition.

The Care and Isolation Unit at Providence St. Patrick Hospital is the only medical facility within a 75-mile radius of RML that meets the requirements and has been approved as a NSPS/NETEC Level 3 Assessment Center. This is a requirement of a lawsuit settlement agreement [Coalition for a Safe Lab v. National Institutes of Health, CV-04-158-M-DWM (D. Mont. 2004)] and is required to remain in compliance with the federal select agent regulations [42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331]. These services cannot legally be acquired from another source. Additionally, NIH paid for the construction of this Care and Isolation Unit in 2006 through a previous contract mechanism. It would be a gross waste of government funds to pay for such duplicative renovations at another medical facility to bring them up to the requirements of a Level 3 Assessment Center. This process would also take significant time which is not appropriate or efficient. Providence St. Patrick Hospital is therefore the only responsible source that will satisfy this requirement.

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

No other sources have expressed interest in the acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

It is anticipated that this requirement will exist after completion of the future contract. Market research will be conducted at that time by searching for any new or additional Level 3 Assessment Centers that may have become approved by NSPS/NETEC within the 75-mile radius of RML.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Project Officer

Project Officer’s Immediate Supervisor

Head of the Sponsoring Program Office

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Contracting Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s). The Chief of the Contracting Office (CCO), if applicable, and the HCA shall indicate review of, and concurrence with, any J&A over $700,000[footnoteRef:1] by providing the information required below and signing in the applicable block. [1: This review and concurrence requirement is applicable to the dollar ranges over $700,000 cited in the FAR, specifically: (i) over $700,000 but not exceeding $13.5 million; (ii) over $13.5 million but not exceeding $68 million; and (iii) over $68 million – see FAR 6.304(a)(2) through (4) and 13.501(a)(2)(ii) through (iv). See HHSAR 306.304 and 313.501(a)(1)(iii) for additional information regarding CCO/HCA review of and concurrence with a J&A in these dollar ranges. These dollar ranges are current as of the date of issuance of interim acquisition policy memorandum No. 2008-03, but are subject to change.

Chief of the Contracting Office

Head of the Contracting Activity

15. Competition Advocate signature. The designated OPDIV Competition Advocate (CA), upon acceptance of the rationale provided in the J&A, shall complete the information required below and sign in the block provided as the approving official for any J&A over $700,000 but not exceeding $68 million[footnoteRef:2]. However, if the CA does not meet the requirements of FAR 6.304(a)(3)(ii) for a J&A over $13.5 million, but not exceeding $68 million, an individual other than the CA shall exercise the approval authority. [2: This approval authority is applicable to the following dollar ranges cited in the FAR, specifically: (i) over $700,000, but not exceeding $13.5 million; and (ii) over $13.5 million, but not exceeding $68 million – see FAR 6.304(a)(2) and (3) and 13.501(a)(2)(ii) and (iii). See HHSAR 306.304(a)(2) and (3) and 313.501(a)(ii) and (iii) for additional information regarding this approval authority, including when the CA does not meet the requirements of FAR 6.304(a)(3)(ii). These dollar ranges are current as of the date of issuance of interim acquisition policy memorandum No. 2008-03, but are subject to change.]

The signature of the CA, or that of an individual meeting FAR 6.304(a)(3)(ii) requirements for a J&A over $13.5 million, but not exceeding $68 million, shall serve as concurrence on any J&A over $68 million that requires the approval of the HHS SPE.

Competition Advocate

16. HHS Senior Procurement Executive signature. The HHS SPE, upon acceptance of the rationale provided in the J&A, shall complete the information required below and sign in the block provided as the approving official for any J&A over $68 million[footnoteRef:3]. [3: This dollar range is current as of the date of issuance of interim acquisition policy memorandum No. 2008-03, but is subject to change – see FAR 6.304(a)(4) and 13.501(a)(2)(iv). See HHSAR 306.304(a)(4) and 313.501(a)(2)(iv) for additional information regarding SPE approval of a J&A in this dollar range.

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