36C26122P0260_1.pdf

Justification and Approval Notice

*= Required Field Justification and Approval Notice

SUBJEC

T*

Blood and Blood Products, 593-C24005, 12/3/21 -09/30/22

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 95652-1012

SOLICITATION NUMBER* 36C26122Q0076

DELIVERY/TASK ORDER NUMBER 36C26122P0260

BASE NOTICE TYPE

ARCHIVE 60 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

PRODUCT SERVICE CODE* 6505

NAICS CODE* 621991

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

VA Sierra Pacific Network (VISN 21)

Network Contracting Office 21

5342 Dudley Blvd., Bldg. 209

McClellan CA 95652-1012

POINT OF CONTACT* Contract Specialist

Mohammed F Hussain mohammed.hussain2@va.gov

916-923-4534

AWARD INFORMATION

STATUTORY AUTHORITY* FAR5

AWARD NUMBER* 36C26122P0260

MODIFICATION NUMBER

AWARD AMOUNT* $462,654.00

LINE ITEM NUMBER

AWARD DATE (MM-DD-YYYY)* 12-03-2021

AWARDEE NAME* VITALANT

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 3* 6210 E OAK ST

AWARDEE ADDRESS LINE 4*

AWARDEE CITY SCOTTSDALE

AWARDEE STATE AZ

AWARDEE ZIP CODE 85257

ADDITIONAL INFORMATION

AGENCY’S URL www.va.gov

URL DESCRIPTION website

AGENCY CONTACT’S EMAIL ADDRESS mohammed.hussain2@va.gov

EMAIL DESCRIPTION e-mail

DESCRIPTION

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS

IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:36C261-21-AP-4138

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional Procurement Office West, Network Contracting Office 21, McClellan, CA 95652-1012 on behalf of VA Sierra Pacific Network (VISN 21), VA Las Vegas Medical Center.

2237: 593-22-1-967-0001

2. Nature and/or Description of the Action Being Processed: This procurement is for a sole source to a blood bank as authorized by statute for blood and blood products to include but not limited to packed red cells, fresh frozen plasma, transfusion services, platelets, and laboratory work related to blood work. The requirement for blood is on an “as needed” basis. The estimated value of the sole source is $2,415,720.00 for a one (1) year base period of performance, and four (4) one (1) year option periods.

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.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This contract will be a five year contract, one (1) year base period of performance, and four (4) one (1) year option periods for blood and blood products and services. The blood bank vendor must possess an unrevoked US license which is issued by the Director, Bureau of Biologics, FDA under Section 351 of the Public Health Service Act, as amended, 42 USC Section 262. All blood and blood products shall be collected, processed, labeled, tested, packaged and shipped in accordance with all regulations of the FDA, Center for Biological Evaluation and review, as described in CFR Title 21, Parts 600, 601, 606, 607, 610, 640, and 660, and the Department of Health and Human Services (DHHS). Blood shall be typed for ABO & Rh antigens and labeled in accordance with the methods recommended in the current editions of “Standard for Blood Banks and Transfusion Services and Technical methods and Procedures,” published by the American Association of Blood Banks. The blood bank is responsible for screening voluntary donors, collecting, screening for infectious disease, separating, storing, and delivery of blood products.

The blood bank must be able to deliver blood and blood products to the VA Las Vegas Medical Center for stock delivery, routine delivery, STAT delivery, and ASAP delivery.

Blood is critical to the VA Las Vegas Medical Center operations for tranfusions and other medical procedures.

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

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 4 Original Date: 08/30/17 Revision 03 Date:

02/11/2021 by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( ) 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 ( X ) 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):

Authorized or Required by Statute – Per VAAR 806.302-5(a)(2), Authorized or Required by Statute, full and open competition need not be provided for when awarding contracts for heatlhcare resources negotiated under the authority of 38 U.S.C. 8153. Blood banks fall under the statutory authority of 38 U.S.C. 8153. Vitalant Blood Bank is an FDA approved blood bank and the only blood bank capable of providing the supplies and services described in Section 3 above without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements. Vitalant Blood Bank is the only FDA approved active blood center in the city of Las Vegas, NV. The VA Las Vegas Medical Center cannot expand the geographic reach of available blood centers due to the two hour STAT delivery time frame, and because of the risks involved with long distance transport of blood products. During long distance transports, blood products can be exposed to extreme environmental conditions or improper handling, which compromise the quality of the blood. Because there are no other blood banks that can fulfill this requirement, a sole source contract is required for award to Vitalant Blood Bank.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A thorough search of the Las Vegas area for any additional blood bank was conducted, as well as a search of the FDA registered blood centers. FDA Blood Establishment Registration Database showed six blood centers within the city of Las Vegas, NV and two facilities including VA Southern Nevada Healthcare System with the status of “Active”. The six entities are Vitalant Blood Bank, Biomat USA, Inc, American National Red Cross, BioLife Plasma Services LP, CSL Plasma, Inc, Octapharma Plasma, Inc and two facilities are Sunrise Hospital LLC and University Medical Center of Southern Nevada.

Biomat USA, Inc is a Plasma Center not a blood bank, American Red Cross is a distribution center and mobile staging facility, BioLife Plasma Services is a plasma center, CSL Plasma Inc is also a plasma center, Octapharma Plasma, Inc is a plasma center, and two facilities are hospitals and does not sell and provide blood products.

BioLife Plasma Services, CSL Plasma Inc, Octapharma Plasma, Inc, Biomat USA Inc are plasma centers and not a blood bank so could not fulfil the entire need of the Government. Vitalant Blood Bank is the only FDA Active blood center capable of fulfilling the entire need of the VA Las Vegas Medical Center’s requirement.

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 4 Original Date: 08/30/17 Revision 03 Date:

02/11/2021 Within fourteen days of award, an award notice with the Justification and Approval will be posted to betaSAM.

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

The anticipated unit rates can be found fair and reasonable based on comparison to previous contracts awarded for blood products within similar geographic locales in the State of Nevada and in comparison, to published market rates found online.

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

As described in Section 5 above, market research conducted pursuant to FAR Part 10, VA Acquisition Regulation (VAAR) 810.001-70 Market Research Policy. Findings include information that Vitalant Blood Bank is the only blood bank facility in the Las Vegas, NV area that can offer full service for this requirement on the “AS NEEDED” basis.

VIP was queried under NAICS code 621991 (Blood and Organ Banks) and keyword “Blood banks”. The search did not yield any results. Searched Small Business Dynamic Search with NAICS code 621991 and profile location as Nevada, found only one company, “You Need It I Got It”, their primary business is electronic shopping and mail-order houses. Searched GSA eBuy. Searched FDA Blood Establishment Registration Database with the status of “Active”, State: Nevada and City: Las Vegas.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: IAW 21-CFR-607

(607.7(a)), all owners or operators of establishments that engage in the manufacturing of blood products are required to register, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act. Vitalant Blood Bank is the only FDA active facility in Las Vegas, NV.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Vitalant Blood Bank, 6210 E Oak St, Scottsdale, AZ 85257-1101.

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:

No other facilities are able to service the VA Southern Nevada Healthcare System (VASNHCS) Las Vegas for urgent requests for blood products. Vitalant Blood Bank has maintained that they handle all blood product delivery/courier services exclusively internal and do not use external sources. There is no opportunity for subcontracting for the delivery of blood products. The VASNHCS Las Vegas will continue to monitor the Las Vegas, NV area for additional FDA certified blood centers.

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.

PM Part 813.5 SAP for Certain Commercial Items Page 4 of 4 Original Date: 08/30/17 Revision 03 Date:

02/11/2021 Date Administrative Officer VHA VA Las Vegas 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.

_____ Date Contracting Officer Network Contracting Office (NCO) 21

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.

Date Director of Contracting Network Contracting Office (NCO) 21

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 belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Date Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)

A.1 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 CALENDAR DAYS.

(End of Clause)

A.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 CALENDAR DAYS; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

A.3 52.232-18 AVAILABILITY OF FUNDS (APR 1984)

Funds are not presently available for this contract. The Government's obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

(End of Clause)