C01 36C25722D0035_1.docx

SUBJECT*

STX Blood and Blood Products

GENERAL INFORMATION

Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

POINT OF CONTACT*

Contract Specialist Robyn J Nussbaum robyn.nussbaum@va.gov 806-354-7830

AWARD INFORMATION

MODIFICATION NUMBER

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

Justification and Approval Notice

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) JOFOC Tracker Number: 2021-12-22T14:22:43 Acquisition Plan Action ID: 36C257-21-AP-4489

1. Contracting Activity: Department of Veterans Affairs, VISN 17, South Texas VA Health Care System (STVAHCS), 2237 number 671-22-2-123-0001

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

NCO 17 intends to award a new firm-fixed price (FFP) IDIQ for five years for Blood and Blood Products. This is a follow-on to IDIQ number 36C25718D0068.

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

The Audie L. Murphy Veteran Affairs Health Care Center has a requirement for a local vendor in the San Antonio area of responsibility to provide all blood and blood products, and delivery services of those products and to provide Human and Human Blood Products for the STVHCS. These products must standards established by the AABB (American Association of Blood Banks), CAP (College of American Pathologists), FDA (Food and Drug Administration), TJC (The Joint Commission on Accreditation of Healthcare Organizations), and other accrediting agencies. The vendor shall be licensed by FDA for collection, processing and distribution of blood and blood products and services. The vendor shall use test methods and equipment approved for such testing and have trained persons performing the test(s). Upon request, the vendor shall provide evidence of their quality process, proficiency testing, and surveillance by accreditation agencies. The vendor must have a blood supply available 7 days a week/24 hour a day and be able to make deliveries for emergency within 60 minutes of notification. Contractor must present evidence of their technical capability to provide blood products which pass acceptable standards for Blood Banks. The total estimated value of the proposed action is $4,182,665.25. The period of performance is for five years beginning February 16, 2022 and ending February 15, 2027.

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;

VHAPM

Part

806.3 Other

Than

Full and

Open

Competition

(OFOC) SOP

Attachment

5:

Request for

Sole

Source

Justification

Format

>SAT

OFOC

SOP Revision

Original Date: 03/22/11

Revision

Date:

02/11/2021 Page of

( ) (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):

Market research conducted has not found any other capable businesses. The STVAHCS requires a local vendor who can provide emergent blood products in under 60 minutes to the facility for urgent cases, i/e, active bleeders, subdural hemorrhages, and any case where emergent blood products are necessary. These types of cases and life or death situations and not having a local vendor jeopardizes patient care. A vendor based outside the San Antonio, Texas area of responsibility would not be able to provide emergent products in under 60 minutes. On average, the STVAHCS has 12-15 crash blood situations per year where they can potentially request platelets and/or other blood products STAT (under 60 minutes). These are emergency situations where a patient has significant blood loss that warrants immediate transfusion of products. Additionally, the STVAHCS sees about 1-2 massive transfusions on average per year where multiple blood products are needed for transfusion. South Texas Blood and Tissue Center (STBTC) is a large business who is able to fulfill these orders STAT.

Additionally, STBTC is one of only a few blood centers in the country that meet the highest ISO 9000 standards and is the only blood center in and around the San Antonio area that has a blood supply available 7 days a week/24 hours a day and is able to make deliveries for emergency within 60 minutes of notification.

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

Sources Sought Notice number 36C25722Q0028 was published on Contract Opportunities from 10/19/2021 through 10/26/2021. There were no responses.

Notice of Intent to Sole Source number 36C25722Q0028_1 was published on Contract Opportunities from 11/30/2021 through 12/7/2021. There were no responses.

Due to the unique and very often emergency need for Human Blood and Blood Products, the market is very limited. The need for emergency delivery and proximity to meet this need is essential to Veteran patient care. Based on market research conducted, the need for a local vendor for Human Blood and Blood Products can be best met by STBTC. It has been determined to be in the Government’s best interest to proceed with a sole-source procurement to STBTC to avoid further delays that can impact patient care at the STVAHCS.

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

It is anticipated that price will be fair and reasonable based on STBTC offering the same items within the local market. The Contracting Officer will review contracts for similar items to ensure fair pricing.

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

· A search of the VIP database for SDVOSBs and VOSBs using the keyword “human blood” did not return any results.

· A search of SBA’s Dynamic Small Business Search (DSBS) page using NAICS code 325414, and the keyword “human blood” returned one result – Biocollections Worldwide, Inc. It is not expected this vendor would be able to fulfill the requirement as they are not located in the San Antonio, Texas area of responsibility.

· Sources Sought Notice number 36C25722Q0028 was published on Contract Opportunities from 10/19/2021 through 10/26/2021. There were no responses.

· Notice of Intent to Sole Source number 36C25722Q0028_1 was published from 11/30/2021 through 12/7/2021. There were no responses.

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

STBTC is one of only a few blood centers in the country that meets the highest ISO 9000 standards. They are the only blood center in and around the San Antonio area of responsibility that has a blood supply available 7 days a week/24 hours a day and is able to make emergency deliveries within 60 minutes of notification.

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

None.

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:

Market research will be conducted on future procurements to determine if there have been any changes in the marketplace for this requirement.

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.

Robert E.

Brown

528989 Digitally signed by Robert E.

Brown

528989 Date:

2022.01.04

08:29:23 -06'00' )1/4/2022 Laboratory Manager Date South Texas 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

ROBYN J. NUSSBAUM 393482

Robyn J. Nussbaum

Digitally signed by ROBYN J. NUSSBAUM 393482 Date: 2022.01.04 09:25:47 -06'00'

Page 1 of Contracting Officer, NCO 17 Date

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.

Page 1 of Michael J.

Digitally signed by Michael J. Tusinger 410059

Page 1 of -06'00' )Tusinger 410059 Date: 2022.01.04 09:49:27

Michael J. Tusinger Branch Chief, NCO 17 Date

c. Director of Contracting: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval for other than full and open competition.

MARK

LAYMAN

)Digitally signed by MARK LAYMAN Date: 2022.01.12 12:08:17 -06'00' Mark A. Layman Date Director of Contracting Network Contracting Office 17

d. 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 belief and recommend approval (if over $75 million) or approve ($750K to $75 million) for other than full and open competition.

CURTIS

JORDAN

JORDAN

Digitally signed by

CURTIS

Date:

2022.01.19

16:22:02

-07 00' Curtis M. Jordan Date Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)