P03 Justification for Sole Source 36C260-24-AP-2686.pdf

Request for Sole Source Justification >SAT

VHAPG Part 806.3 OFOC Page 1 of 5 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C260-24-AP-2686

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C260-24-AP-2686 RPOW JOFOC Tracker: FY24 – NCO 20 - 1498

1. Contracting Activity:

Department of Veterans Affairs, Network Contracting Office 20 (NCO 20), 5115 NE 82nd Ave., STE 102, Vancouver, WA 98682 Funding ID 2237: 648-24-3-066-0059

2. Nature and/or Description of the Action Being Processed:

This is a request for approval for Other Than Full and Open Competition to procure testing services (to include interpretational fees) with the Oregon Health and Science University (OHSU) Laboratory of Immunogenetics and Transplantation (LIT) in support of the Department of Veteran Affairs, Portland Health Care System (VAPHCS) Transplant program.

This award will allow services to continue as a follow-on award to 36C26019P0114. VAPHCS is proposing a six-month bridge, to include a six-month option to extend services. The long-term goal, while the bridge is in place, is to secure a base plus 4-year, long term BPA for these testing services with a sole source award, due to the unique nature of the testing requirements. This bridge contract is required to maintain access to critical patient services while the long-term acquisition is being conducted.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The estimated value of the proposed action is $ 749,944.45

Prior to a Veteran receiving a kidney or liver transplant, it is required for he/she to have several high complexity tests performed to ensure the organ donor matches the Veteran's tissue and blood types. The OHUS LIT primary purpose is to ascertain optimum donor and recipient combinations that will reduce the chances that the body will reject a new kidney and/or liver. The results of these tests a r e a n a l y z e d a n d interpreted by expert lab personnel that specialize in immunogenetics and organ transplantation. Pathology and Laboratory Medicine Service at the VA Portland Health Care System, VAPHCS, does not have the capability to perform these tests.

This requirement is to procure Reference Laboratory Services on an as-needed basis for the Laboratory Department at the VA Hospital in Portland Oregon. Services are required for referral laboratory services in support of our The VAPHCS Transplant Program. There is a critical need to continue these testing services in support of VAPHCS Transplant program. Without the associated testing, the Transplant program at the VAPHCS would have a risk to patient safety (veterans on the transplant wait list). These testing services provided by OHSU LIT are required to maintain a patient on the transplant wait list for life saving surgery.

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Acquisition ID#: 36C260-24-AP-2686

The Joint Commission, responsible for accreditation of HealthCare Organizations, requires that referral laboratories are certified to perform the testing they offer. The proposed action is a 6-month bridge, with an option to extend, to ensure continuation of services with OHSU LIT and avoid any delays in veterans transplant testing needs.

The proposed POP for the six-month bridge will be 5/1/2024 – 10/31/2024.

4. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority):

Reference Laboratory Testing services are currently being provided by OHSU LIT, for the Portland Health Care System. Therefore, for this short-term 6-month contract, they are in the best position and only position to provide the immediate need for services as there will be no need to put new processes, to include logistics of transportation, in place. If a new vendor is selected, it may take up to six months to change over.

Further, the market research findings indicate this requirement can only be met by the incumbent provider, OHSU LIT, due to multitude of reasonings. Their geographic location with respect to the VAPHCS and the logistics of specimen transportation is best met by the interconnection of OHSU and VA by a sky bridge and a pneumatic tube system. This allows OHSU to begin testing and processing of time sensitive specimens quickly to meet the immediate need for this service. When an organ is identified as available for transplant, testing needs to be initiated immediately to identify and confirm a compatible recipient prior to the organ expiring. OHSU’s close proximity and unique connection to the VAPORHCS greatly reduces delays in transportation and reduces the risk of losing specimens during transit. Other carriers would have to use a carrier services or other transportation option causing potential issues including transit delays and increased risk of losing lab specimens in transit as compared to being able to transport directly through the pneumatic tube system.

The combination of regulatory requirements needed for these type of services is unique. In accordance with the United Network for Organ Sharing (UNOS) and the Organ Procurement and Transplantation Network (OPTN) guidelines, OHSU LIT meets all accreditation and compliance regulations for American Society for Histocompatibility and Immunogenetics (ASHI), and Clinical Laboratory Improvement Amendments (CLIA). The OPTN is a unique public-private partnership that

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Acquisition ID#: 36C260-24-AP-2686 links all professionals involved in the United States donation and transplantation service. OPTN develops national organ allocation policies and develops standards for transplantation institutions while monitoring and supporting quality and safety. UNOS has a federal contract to operate the National OPTN. OHSU LIT is the only UNOS/OPTN accredited laboratory within the state of Oregon.

As the incumbent contractor, OHSU meets all the above requirements, ensuring that they are able to immediately provide services given this short-term contract, without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A Request for Information (RFI) on solicitation # 36C26024Q0261 was posted on 1/29/24 through SAM with responses due on 2/9/24. The RFI included the Scope of Work and the requirements for the solicitation. The intent of this Sources Sought was to determine if there were any SDVOSB / VOSB’s capable of providing the services needed. Responses were reviewed from potential vendors as part of the market research.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

The anticipated cost for this acquisition is $749,944.45. Pricing for this bridge contract has increased when compared to the previous award, 36C26019P0114, which was been determined to be fair and reasonable in 2019. The increase in service cost mirrors similar increases to service cost from other vendors.

8. Description of the Market Research Conducted and the Results, or a Statement of the

Reasons Market Research Was Not Conducted:

Despite competitive procedures being exempt, in accordance with Title 38 USC 8153, market research was completed in accordance with FAR Part 10. As noted in Section 6 above, it included posting a Request for Information (RFI) with a synopsis of the proposed acquisition, advising industry of the pending acquisition, and soliciting inquiries from interested parties. The focus of the market research was to determine availability of SDVOSB/VOSB’s and small businesses ability to fulfill this requirement.

One response was received from a small business owner with a question that mas directed to the requirement of the laboratory being OPTN or UNOS accredited. There were no responses of interest received from SDVOSB vendors.

Market research was also performed to review other lab testing centers that could perform this type of service. The closest lab other than OHSU LIT lab capable of performing the required services, Blood Works, is approximately one-hundred and seventy-five miles away. With traffic this could take over 3 hours by car which could cause delays and includes a risk in getting specimens safely delivered and tested pre-transplant. Of all the laboratories with UNOS and OPTN affiliation, there are only 4 capable laboratories within region 6.

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Acquisition ID#: 36C260-24-AP-2686

Lastly, market research identified concludes that there is no other possible vendor with the ability to perform the required testing other than OHSU LIT, given the connection to VAPHCS and the regulatory and accreditation requirements. This applies to all SDVOSB/VOSB/small businesses as well as larger commercial reference laboratories. Being physically connected allows the distinct ability to transfer specimens and results without the logistics and complications of courier, and other pick-up options. This need is immediate for the short-term six-month contract while the longer one is being put in place. Therefore, the recommendation of the market research was that OHSU Lit was the only capable vendor to meet the government needs for this six-month sole sourced contract.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

This acquisition is proposed under statutory authority of Title 38 USC 8153.

Title 38 USC 8153 (a)(1)(3)(A) states:

If the health-care resource required is a commercial service, the use of medical equipment or space, or research, and is acquired from an institution affiliated with the Department in accordance with section 7302 of this title, including medical practice groups and other institution, blood banks, organ banks, or research centers, the Secretary may make arrangements for the acquisition of the resource without regard to any law or regulation (including any Executive order, circular, or other administrative policy) that would otherwise require the use of competitive procedures for acquiring the resource.

LIT testing on deceased donor kidneys is an element in the integrated actions that comprise an organ transplant. This is a unique qualification that falls within 38 USC 8153 (a)(1)(3)(A).

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Kashi Clinical Laboratories

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any

Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

Barriers to competition are not applicable - a sole-source acquisition is authorized by 38 USC 8153 and VA Directive 1663.

VHAPG Part 806.3 OFOC Page 5 of 5 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C260-24-AP-2686

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Kelsey Kiaha Date Chief Medical Technologist Portland VA

Date

Dean Fong MD Chief Pathology & Laboratory Medicine Service

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

SIGNATURE Date Jose Ronstadt Contracting Officer

Network Contracting Officer 20

b. One Level Above the Contracting Officer (Required over SAT but not exceeding

$750K): I certify the justification meets requirements for other than full and open competition.

SIGNATURE Date Jacob Jackson Contracting Officer Branch Chief – APC Network Contracting Officer 20 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx