HCA SIgned NCO 4 SSJ VAPHS Blood Products_Redacted.pdf

AP # 36C244-26-AP-0462 | VAPHS | Blood Products

Acquisition ID#: 36C244-26-AP-0462

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER FAR PART 12 ACQUISITION OF COMERCIAL PRODUCTS

AND COMMERCIAL SERVICES IAW FAR 12.102(b)

Acquisition Plan Action ID: 36C244-26-AP-0462 2237/Purchase Request #: 646-26-3-081-0001

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Network Contracting Office 04 in support of VISN 4, VA Pittsburgh Healthcare System (VAPHS), University Drive, Pittsburgh, PA 15240

2. Nature and/or Description of the Action Being Processed: This proposed action is a Fixed-Price ID/IQ Contract for blood supplier and reference testing for blood bank samples using sole source procurement procedures.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The VAPHS is requesting the purchase of blood products and reference testing for blood bank samples for transfusion needs and treatment for patients. The contract will be a three-year IDIQ contract.

The following elements are required:

Item # Description/Part Number* Estimated Yearly Qty

Red Blood Cells 2000

Apheresis platelets Leukocytes reduced 40 pathogen reduction technology platelet (PRT)

Frozen Plasma 525

Cryoprecipitate AHF Pooled 70

Irradiation 1000 LS005 ABO grouping 20 LS010 ABO discrepancy 10 LS015 Rh(D) Typing 20 LS025 Antigen typing, patient, per antigen 200 LS030 Antigen typing, patient, rare, per antigen 10 LS040 Direct Antiglobulin Test 50 LS050 ABO/Rh 20 LS105 Antibody Screen/each 20 LS110 4C Antibody Screen 10 LS115 Antibody Identification panel 40 LS120 Antibody Identification panel, rare 10

LS125 Enzyme panel-manufactured 15

LS130 Prewarm Setup 3

LS135 Saline Replacement setup 5

LS205 Adsorption procedure 15

LS210 Red cell treatment 10

LS215 Red cell stroma-alloadsorption 10

LS220 Enzyme treatment 10

LS225 Elution procedure 10

LS230 Titration studies, per titration 10

LS235 Red cell separation method 10

LS240 Red cell separation -percoll 10

LS245 Serum neutralization/inhibition procedure 10

LS250 serum treatment with chemical agents 10

LS255 thermal amplitude test 10

LS260 polyagglutination screen 10

LS265 Donath-Landsteiner test 10

LS270 Drug dependent antibody studies 10

LS275 pathological cold agglutinin screen 10

LS280 cold agglutinin titer 10

LS285/41

M Hemoglobin S 10

LS287 Kleihauer-Betke, Quantitative 5

LS290 Rosette Test, qualitative 10

LS292 Monocyte Monolayer assay (MMA) 10

LS295 DAT Neg AIHA Evaluation 10

LS305 platelet crossmatch test 10

LS310 Platelet antibody screen test 10

LS410 compatibility screen 10

LS415 crossmatch: Immediate spin (IS) 60

LS420 crossmatch: Antiglobulin (AHG) 60

LS425 Crosssmatch: Electronic (EXM) 60

LS435/57

M plasma thawing 10

LS445 blood type recheck 10

LS505 molecular extended red cell genotype/phenotype 20

LS510 Molecular genotype-platelet (HPA) 10

LS 520 RHCE genotype test 10

LS525 Molecular sequencing test 10

LS605 Donor/Products search fee, per search 60

LS610/55

M Unconfirmed antigen request, per component 60

LS615 rare search fee, per search 10

LS620 ARDP fee, per unit 10

LS625 Import fee per unit 10

LS705 transfusion reaction investigation-clerical 10

LS710 transfusion reaction evaluation-physician 10

LS805/42

M HLA selected platelet fee, per component 20

LS810/23

M Antigen typing, donor -confirmed or historical 50

LS815/24

M Antigen typing, donor, rare-confirmed or historical 5

LS825/43

M Crossmatched platelet tagging, per component 10

LS830 Donor Antigen screening, 1-10 units screened 10

LS835/18

M Rare unit Fee, per component 10

LS855/62

M Less than 5 days fresh, per RBC 10

LS860/63

M Less than 10 days fresh, per RBC 10

LS865/17

M Additional wash, each 10

LS870 Aliquot preparation, each 10

LS875 Aliquot preparation and Syringe, each 10

LS905 on-call fee 10

LS910 STAT request 10

LS915 ASAP request 10

LS925 External TS/ESP initial set up fee 10

LS926 External TS/ESP service fee, monthly 10

LS930/50

M sample/material handling fee 10

LS940/64

M STAT delivery fee 10

LS955/54

M ASAP delivery fee 10

LS960 External TS/ESP stocking fee, monthly 10

4. Statutory Authority Permitting Restricted Competition:

FAR 12.201-1 Simplified Procedures. 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 12.102(b) for restricting competition on this procurement. Competition is restricted on this procurement for the reasons below:

(x ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): VAPHS is a transplant center and often performs liver and kidney transplants on high-risk patients that may require an emergency platelet transfusion. A code red at the VA Pittsburgh is called when we have a patient that has significant blood loss. VAPHS experienced thirteen code reds from January 1,2024 to June 30, 2025, where there have been thirteen platelet products that were issued during this time and had a total of eleven products that were transfused under these conditions. Issuing platelets under a code red is a standard operating procedure in our blood bank. We have tried to procure a separate contract in the past for just platelets and platelet products; the cost of this contract amounted to half a million dollars. Upper management did not approve this contract because of an existing contract with another vendor, and it would have resulted in duplicating costs to the government.

The current blood product waste consistently exceeds limits for most of the contracted products.

Options explored have included attempting a blood transfer system with the current vendor for blood products, but transportation could not be consistently relied on for pick up or delivery of products due to other hospitals being too far away. Using the vendor, Vitalant, may relieve the product wastage because other Vitalant supplied hospitals are within a short driving distance of the VAPHS facility. Pickups and deliveries to swap our short-dated products are a more reasonable distance.

The current situation of blood product waste is leading to excessive government spending and significant financial loss. It is imperative to address this issue to optimize resource utilization and reduce unnecessary expenses. By using Vitalant, VAPHS will be able to save money by transferring blood products to other hospitals that can use them before they outdate. It will additionally utilize government taxpayer funds more efficiently.

Vitalant is currently the only vendor who offers emergency issue platelets for critical patients. It is crucial that location is within a 10- mile radius of VAPHS to ensure faster access to blood products, directly supporting safer transplants and surgical procedures while improving patient outcomes and reducing delays in critical care. It currently takes at least 3 hours to deliver from the current contracted vendor located in Johnstown Pennsylvania.

It is in the best interest of the government to reduce the amount of time and funding available, avoiding substantial duplicate costs and financial loss to the government as well as supplying crucial lifesaving products to patients for the highest quality of care.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research and operational experience demonstrate that the identified blood bank is the only available source capable of meeting VA’s requirement. Market research performed as described in #8 confirms that Vitalant is the only source capable of providing the required blood products at the necessary scale and safety standards. Awarding to another source would result in substantial duplication of cost to the Government that could not be recovered through competition and unacceptable delays in fulfilling the agency’s requirement.

Acquisition ID#: 36C244-26-AP-0462

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: A determination of price reasonableness will be conducted IAW FAR 12.204 (a)

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. A review of online product catalogs did not identify another blood supplier that can issue emergency platelets and a vendor that is within a 10-mile radius of the VA Pittsburgh that supports a blood transfer program to local Pittsburgh area hospitals. The contract specialist posted a sources sought to sam.gov and received zero responses. A search of FPDS-NG and USASpending was completed with no positive results.

The VA will continue to monitor the commercial marketplace to determine if other sources become available. Should other sources enter the marketplace, future procurements may be more competitive. At this time, only Vitalant meets the limitations of this procurement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

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

Vitalant 875 Greentree Road Pittsburgh, PA 15220 Phone : 877-258-4825

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:

For future requirements, additional market research will be completed to determine if market conditions and/or agency needs have changed.

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.

Name: Cathy Noble Title: Lab Contracting Manager Facility: 646 Pittsburgh VA

13. Approvals in accordance with 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.

Mickeya Linzie, Contracting Officer, Services 5

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

William Schlobohm, Branch Chief, Services 5

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and believe and approve for other than full and open competition.

Gerald F. Jacobs Executive Director Regional Procurement Office East