P03 LSJ 36C260-23-AP-5045 Ref Lab PVAMC.docx

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C260-23-AP-5045

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: 648-24-2-066-0013

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 interpretation) with the Oregon Health and Science University in support of the PVAMCs Oncology program, coagulation needs other critical referral testing needs . This award will allow services to continue as a follow-on award to VA260-17D-0027. VA Portland Health Care System is proposing a three-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 through competition. This bridge contract is required to maintain access to critical patient services while the long-term acquisition is being conducted.

Order against: |_| FSS Contract Number: _________________________________

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

The estimated value of the proposed action is $ 451,095.56 This requirement is to procure Reference Laboratory Services on an as-needed basis for the Laboratory Department at the VA Hospital in Portland Oregon. 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 3-month bridge, with an option to extend, to ensure continuation of services with OHSU and avoid any delays in veterans receiving critical/urgent medical diagnosis. Portland VA either does not have the ability to perform testing ourselves or the test is considered backup to our ability to provide critical testing that is needed to operate a 24/7 healthcare facility.

The proposed POP for the three-month bridge will be 1/1/2023 – 3/31/24. Services are required for referral laboratory services within the realm of cancer diagnosis and treatment, surgical pathology consultations, and back up testing to in-house critical life and limb testing.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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, for the Portland VA Medical Center.

Cancer and Coagulation Testing:

Because of the criticality and seriousness of cancer in the Veteran population, testing needs to be available shortly after specimen collection. The nature of the type of specimens received for these tests are considered fragile. Delays in processing these specimens beyond 1 hour can result in specimen degradation and result in unsatisfactory cell recovery or responses which could lead to inconclusive or inadequate diagnoses resulting in delayed treatment with potentially serious consequences. Every minute and hour delay in beginning treatment for Veterans with cancer, reduces the chance for remission or cure. Many specimens are fresh tissue requiring test processing to be initiated within 1 hour of collection to prevent specimen degradation which leads to unsatisfactory cell recovery or responses giving inconclusive or inadequate diagnoses resulting in delayed treatment with serious consequences for cancer patients.

All of the tests and studies listed in the category of Cancer Testing involve testing and/or culturing living cells from surgical or invasive procedures and include specialized stains to aid in the diagnosis and staging of malignancies. The specimens are considered unique and irretrievable and must be handled with extreme care. Delays in transporting or processing could cause specimen degradation, such as the proteins in the specimen will start breaking down, compromising the integrity of the specimen, and resulting in an inaccurate diagnosis. The specimen cell deterioration will result in an inconclusive diagnosis. Specimens are unique and irretrievable and aid in the diagnosis and staging of malignancies. STAT initial diagnosis and treatment initiation for leukemia and aggressive lymphoma are required.

Portland is not the only VISN20 Health Care System (HCS) with the requirement to begin processing within 1 hour of collection. VA Seattle HCS has this same requirement and satisfies it by sending specimens to their university affiliate, University of Washington.

Backup to in-house testing:

Tests found in this category of testing are considered backup up options to in-house testing. These tests are considered critical for life and limb and are required at a minimum for the operation for a 24/7 facility. The turn-around requirement for these tests mirrors the Portland VA in-house turnaround times for STAT and Routine Testing. The ability to continue to obtain critical tests results in a 24/7 facility would be necessary if the Portland VA had an issue that prevented us using our own testing platforms. This could look like; an instrument malfunction and tech support doesn’t have the ability to travel immediately; or an unplanned shortage on a required consumable or reagent.

OHSU is the only referral laboratory currently capable of providing the services described above, 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:

Sources sought solicitation: # 36C26024Q0080.

Sources sought solicitation was posted on 11/8/23 and responses were due on 11/22/23.

3 responses were received from SDVOB vendors, identified under 10. below.

Capability statements were received from these vendors. Each vendors capability statement was reviewed in its entirety. As each of these vendors testing facility is not located in Oregon, and logistical issues would limit the ability to transport specimens across state lines within the required time to ensure specimen processing is started within 1 hour – initial determination was that none of the interested SDVOB could meet the PVAMC requirements.

It should be noted that one of these SDVOB business has partnered with large referral laboratories such as Labcorp or Quest. Despite their partnership, the logistics of getting specimens to the referral testing site within 1 hour of collection would limit their ability to meet the PVAMC requirements.

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

Leave Blank for CO

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research was conducted to assess the availability of SDVOSB/VOSB’s and small businesses ability to fulfill this requirement. Market research was also conducted to assess the availability of commercial (larger) reference laboratory’s ability to fulfill this requirement. The market research findings indicate this requirement can only be met by the incumbent provider, OHSU due to their geographic location with respect to the VA location and the logistics of specimen transportation. Considering their connection to the VA with a sky bridge and interconnection with a pneumatic tube system – this allows OHSU to begin the testing and processing of certain specimens within 1 hour of collection. OHSU also is able to provide STAT lab capabilities, therefore also meeting the government need for reporting of certain tests results within 1 hour for STAT needs. OHSU close proximity to the VAPORHCS eliminates any delay in transportation/risk with regard to irretrievable or unique surgical specimens.

Lastly, market research identified that there was no other possible vendor with the ability to perform 100% of all required testing. This applies to all SDVOSB/VOSB/small businesses as well as larger commercial reference laboratories.

Therefore, the recommendations of the market research was that OHSU was the only capable vendor to meet the government needs.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition, and soliciting inquiries from interested parties.

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

This is a proposed 3-month award, with a six-month option to extend, to allow the time required to procure the reference lab services through competition. The Portland VAMC P&LMS has submitted a complete procurement package to NCO 20 to allow the needed time to ensure adequate competition is sought and the necessary time procure a multi-year award and a seamless transition to any potential change in awardee for these critical reference lab testing services.

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

Central Tox/Semper Fi Labs NEO Services MCI Diagnostic Center

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:

Future acquisitions shall require more extensive engagement with vendors to ensure they have a complete understanding of the requirements of the supplies or services they are submitting offers for. During the evaluation process, clear and precise communications shall be utilized to ensure that all parties involved are actively engaged in the process. In situations where some SDVOB / VOSB’s who may be frustrated that they were not chosen, will be encouraged to engage with contracting personnel to develop plans to become more competitive in the acquisition process.

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 Laboratory Manager Portland VA Medical Center

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

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

Jose Ronstadt Contract Officer Network Contracting Office 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.

Wendy Duval Contracting Officer Branch Chief – APC Network Contracting Office 20