P03 Sole Source 36C260-24-AP-2937 For SAM.pdf

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

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C260-24-AP-2937 JOFOC Log Number: FY24 – NCO 20 – 2793

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 20 (NCO 20), 1601 1601 E. Fourth Plain Blvd., Suite B428, Vancouver, WA 98661, Funding ID: 648-25-1-066- 0002.

2. Nature and/or Description of the Action Being Processed: This procurement is for Reference Laboratory Services in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This is a new firm-fixed-price follow-on action to continue procuring testing services (to include professional interpretation fees) with the Oregon Health and Science University (OHSU) in support of the Department of Veteran Affairs, Portland Health Care System (VAPHCS) oncology, dermatology, organ transplant programs, and coagulation testing needs as well as other critical referral testing requirements.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: 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 within the realm of cancer diagnosis and treatment, organ transplantation, surgical pathology consultations, and back up testing to in-house critical life and limb testing. This requirement includes STAT lab testing and processing of particular specimens. The results shall be delivered within one hour, and short stability specimens to be processed within an hour of collection. This is necessary to avoid the risk to patient safety and or potential loss of unretrievable specimens. The specific type of testing (to include professional interpretation) required will vary based on the number of patients treated at the VAPHCS . The estimated amount is based on previous volumes of testing experienced by the VAPHCS laboratory.

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 five (5) month term, with an option to extend services for six months. An award is required to ensure continuation of critical services and avoid any delays in veterans receiving critical/urgent medical diagnosis. VAPHCS either does not have the ability to perform testing 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 period of performance (POP) for this award will be 10/1/24 to 2/28/25. The Option to Extend Services, 52.217-8, will be included in the award. The estimated value of the proposed action is $741,387.92.

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:

Effective Date: 02/01/2022 Page 2 of 4

(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. Therefore, they are the only entity positioned to providing the immediate need for services. .

OHSU’s connection to the VA with a sky bridge and interconnection with a pneumatic tube system allows them to begin the testing and processing of time sensitive specimens quickly to meet the processing requirement of some samples, to be received, tested and results returned within 1 hour of collection.

The criticality and seriousness of Veterans treatment and diagnosis with cancer and the type of specimens utilized for diagnosis and treatment are fragile requiring processing to start within 1 hour of specimen collection. Such specimens include: fresh specimens collected during surgical or other invasive procedures, such as muscle and nerve/nervous system biopsies, bone marrow aspiration, and lumbar puncture. Beyond 1 hour will 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. Reflex studies, when indicated, may not be possible if delays to the start of processing age the specimen out.

All testing surrounding cancer diagnosis and treatment requires testing and/or culturing of living cells from surgical or invasive procedures. This includes specialized stains to aid in the diagnosis and staging of malignancies and other disorders such as degenerating muscle or nerve diseases. These types of 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 and nucleic acids in the specimen will start breaking down, compromising the integrity of the specimen and may result 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.

STAT lab capabilities require results within 1 hour of collection. This need is critical to maintain operations at VAPHCS. These categories of tests are backup to inhouse testing capabilities. This is critical to ensure that despite any equipment or supply failures, VAPHCS, can maintain operations and ensure access to critical medical care. This also ensures patients receive the appropriate care as soon as possible. As the incumbent contractor, OHSU has already met the requirements of LG 0084

– Laboratory TAT Policy, ensuring that they are able to immediately provide services, without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements

Coagulation and platelet function testing are critical monitors of the condition of all patients with liver diseases. VAPHCS, as one of very few VA liver transplant medical centers, it is crucial that VAPHCS comprehensive coagulation testing is immediately available. VAPHCS, a 1a facility, also cares for Veterans with clotting and bleeding disorders. Coagulation status must be monitored before, Effective Date: 02/01/2022 Page 3 of 4 during, and after not only liver transplant surgery but other surgical cases as well. Testing results are required to establish immediate update to dosage and treatment plan for blood clotting disorders or blood products usage. The availability of immediate testing and resulting through a reference laboratory to meet STAT testing requirements with help to achieve the goal of timely patient care.

Delays in treatment and management of coagulation and blood clotting disorders can lead to undesirable outcomes, especially for patients with high risk factors (cancer, cardiovascular disease, and serious health conditions). Furthermore, delays in test results hours may result in canceled/delayed surgeries/treatments.

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 #36C26024Q0080 was posted on 11/8/23, through SAM, with responses due on 11/22/23. 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 proposed pricing has been determined fair and reasonable in comparison to pricing in the current contract, 36C26024P0174. A formal determination of fair and reasonable pricing will be included in the contract file.

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

Market Research Was Not Conducted: 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 solicited inquiries from interested parties. Three (3) responses and capability statements were received from SDVOSB vendors identified under paragraph 10. The statements included information such as, accreditation, vendor agreements, personnel expertise, technical equipment, and instrumentation.

Each vendor’s capability statement was reviewed in its entirety. Each of these vendor’s testing facility is not located in Oregon and are therefore incapable of meeting the one hour turnaround time required. Logistical issues limit the ability to transport specimens across state lines within the required time to ensure the specimen is delivered, received, tested, and the results are received in one hour.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: OHSU is the academic affiliate of VAPHCS. The providers and clinical teams recommending and providing care often have joint appointments. Patient care may occur at both facilities. Thus, it is essential to the continuity of care and case integrity that services continue to be provided by OHSU. For example, many Tumor Boards, which discuss and plan patient care, have a mix of faculty and care team members from both facilities. During the Tumor Board, they review the pathology and pertinent laboratory information, including OHSU as a second opinion consultant. Another example is the Kidney Transplant team. VAPHCS oversees the West region of VHA overseeing kidney transplants.

The nephrologists (kidney specialists) have joint appointments and rely on the interpretation of the kidney biopsies by OHSU as VAPHCS does not have a pathologists with subspeciality training. A consistent pathologic interpretation is imperative because of the precise care required for transplanted organs.

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

Central Tox/Semper Fi Labs NEO Services MCI Diagnostic Center

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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:

This action allows for the time needed to properly competed and award a long-term contract. The long-term contract will be subject to full and open competition will allow for capturing possible changes in the marketplace.

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 Health Care System

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 Date Contracting Officer

NCO 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.

Jacob Jackson Date Chief, Ancillary Patient Care Branch

NCO 20

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