FINAL PG_Part808.405-6_Atch2_Limiting_Sources_Justification_OVER_SAT.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C255-24-AP-3526

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C255-24-AP-3526

(1) Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 15, located at 3450 S 4th St Trafficway, Leavenworth, KS, in support of VISN 15 VA Health Care System; Kansas City VA Medical Center, 4801 Linwood Blvd, Kansas City, MO 64128.

2237 589-23-2-1618-0015.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

Order against: FSS Contract Number: 36F79720D0182.

Name of Proposed Contractor: Medi-Physics, Inc. dba GE Healthcare

Street Address: 251 Locke Drive

City, State, Zip: Marlborough, MA 01752

Phone: 800-292-8514

(3) Description of Supplies or Services:

The estimated value of the proposed action is $1,394,370.00.

1. Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to Kansas City VA Medical Center, Kansas City, MO located at 4801 E. Linwood Blvd, Kansas City, MO 64128 on a daily and/or as needed basis per this Statement of Work. Because of the critical need for these supplies in a timely manner, only vendors within a 50-mile radius of the VA Kansas City, MO need to respond to this RFQ.

2. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include DOT, DOE, UNNRC, and ICC regulations and standards.

3. Supplier shall hold a current unrevoked USNRC and/or FDA license to produce and distribute radiopharmaceuticals for human administration, and a license to receive, and dispose of radioactive waste. Supplier shall provide a copy of their radioactive https://www.acquisition.gov/far/part-8#FAR_8_405_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

VHAPG Part 808.405-6 Limiting Sources Page 2 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C255-24-AP-3526 material license to the Nuclear Medicine Service at Kansas City VA Medical Center (KCVA) upon commencement of this contract. Supplier shall immediately notify KCVA, upon any action be the USNRC agreement state and/or FDA to suspend or modify suppliers. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts.

4. DaTscan (Ioflupane I 123) Injection product radiopharmaceuticals not used will be returned for credit the next workday, using the DOT regulations.

5. 5. Upon notification of contract award, Contractor will provide, in writing, within ten

(10) days, the following information to the VA Medical Center:

a. Contractor’s regular work hours

b. Contractor’s telephone number for call-in orders during regular work hours.

c. Contractor’s telephone number and instructions for placing “Emergency” orders after contractor’s regular work hours, including weekends.

d. Contractor’s telephone number for expert advice concerning awarded products.

e. Contractor will furnish a statement that any radiopharmaceuticals delivered as “ready-to-use” (individual doses in syringes or vials for single or multiple uses) will have quality control performed by the Contractor, so that the delivered product will comply with the requirements of The Joint Commission (TJC) and/or with the United States Pharmacopeia.

f. Should any changes occur in above information during contract performance period, contractor will provide updates in writing.

6. Current package inserts of all radiopharmaceuticals supplied under this contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new and/or updated additions to the package inserts are made available, these will be sent to the Nuclear Medicine Service at Kansas City VA Medical Center.

7. Contractor shall make quality control records available to the VA Medical Center upon written request from the Contracting Officer.

8. Calibration time for each requested radiopharmaceutical is given in the Schedule of item, or if not so indicated, then it will be spelled out in the requirements provided by the Nuclear Medicine Service, otherwise it will correspond to the actual time of delivery.

9. If dosage is given to Contractor, then the quantity of radioactivity must be within the dose provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±20%.

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10. The expiration date and time shall be indicated and affixed to each product as noted below; in general:

a. Ready-to-use doses: not shorter than two (2) hours.

b. FDG-18: Not shorter than two (2) hours.

c. Kits intended for reconstitution by user: Not shorter than three (3) months from date of delivery.

d. Unused kits having expiration time not less than two (2) weeks will be exchanged by the Contractor at no additional charge for a comparable kit having the three (3) months life span.

11. In the event that a quality control or material defect is suspected and/or detected by any Veterans Affairs COTR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

a. Provide technical expertise in calibration.

b. Provide professional examination of product; submit results and recommendations to the Contacting Officer.

c. Make expedient replacement of any product suspected of being deficient.

12. Contractor shall produce radiopharmaceuticals as described in the Bid/Price Schedule.

Deliverables and Acceptance Criteria

1. Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the performance of work, as set forth below:

a. Provide up to four deliveries per day during regular operating hours to KCVA.

b. Deliver directly to the Nuclear Medicine Service at KCVA daily quantity of radiopharmaceuticals by 7:15 am, as requested from the previous day.

c. Deliver directly to the Nuclear Medicine Service at KCVA quantity of radiopharmaceutical requested on an as needed/emergent basis to arrive within two (2) hours of notification.

d. Deliveries occurring outside of working hours are directed to KCVA Police.

Contractor will not have access Nuclear Medicine outside of working hours.

e. other delivery times may be outlined by the KCVA under this contract.

2. If shipments are contracted to be delivered specifically on Mondays, but Monday is a holiday, then the shipment will take place the next regular workday. Holidays are listed herein.

3. Shipments “called when needed” may be requested during regular work hours, or after, as “emergency”, including weekends, holidays and nights.

4. Shipments requested as an “Emergency” will be delivered as follows:

a. Requests placed after regular work hours (weekend, holiday, and night) will be

VHAPG Part 808.405-6 Limiting Sources Page 4 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C255-24-AP-3526 delivered within three (3) hours, or as specified.

b. Emergency, weekend and holiday shipments are to be delivered to location(s) specified by each facility, unless otherwise specified when called for.

c. All shipments will be labeled as RADIOACTIVE MATERIAL in compliance with all pertinent regulations.

d. All Radiopharmaceuticals, Radioassay Kits and/or Analytic Kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the contract and all applicable Local, State and Federal Laws.

e. Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by KCVA under this contract, will be strictly adhered to.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

This is a highly specialized radiopharmaceutical which allows imaging of the brain to determine presence of amyloid plaque in the structures of the brain which may lead to dementia or other cognitive disorders. GE is currently the only vendor that provides this material. The vendor is within the 50-mile radius that requires the radiopharmaceutical to be handled and delivered.

They shall provide up to four deliveries per day during regular operating hours to KCVA. Deliver directly to the Nuclear Medicine Service at KCVA daily quantity of radiopharmaceuticals by 7:15 am, as requested from the previous day. Deliver directly to the Nuclear Medicine Service at KCVA quantity of radiopharmaceutical requested on an as needed/emergent basis to arrive within two (2) hours of notification.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

GSA has already determined the prices of supplies and fixed-price services, and rates for services offered at hourly rates, under schedule contracts to be fair and reasonable.

Therefore, ordering activities are not required to make a separate determination of fair and reasonable pricing, except for a price evaluation as required by 8.405-2(d). By placing an order against a schedule contract using the procedures in 8.405, the ordering activity has concluded that the order represents the best value (as defined in FAR 2.101) and results in the lowest overall cost alternative (considering price, special features, administrative costs, etc.) to meet the Government’s needs.

GE is providing the VA with a discount from their FSS contract of 43.47% of manufactured pricing. Manufacture list price is $2,468.00, discounted rate is $1,394.94 per dose.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Market research found that https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_2 https://www.acquisition.gov/far/part-8#FAR_8_405 https://www.acquisition.gov/far/part-2#FAR_2_101

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Medi-Physics, dba GE Healthcare details is the only entity that has an awarded contract listed in the National Acquisition Center Catalog that manufactures and supplies the I-123 Ioflupane DaTscan radiopharmaceuticals.

(7) Any Other Facts Supporting the Justification: The vendor is within the 50-mile radius that requires the radiopharmaceutical to be handled and delivered. They shall provide up to four deliveries per day during regular operating hours to KCVA. Deliver directly to the Nuclear Medicine Service at KCVA daily quantity of radiopharmaceuticals by 7:15 am, as requested from the previous day. Deliver directly to the Nuclear Medicine Service at KCVA quantity of radiopharmaceutical requested on an as needed/emergent basis to arrive within two (2) hours of notification.

Under the Federal Supply Schedule and National Contract Programs, the NAC awards multiple award schedule, national contracts, and blanket purchase agreements for the acquisition and direct delivery of pharmaceuticals; medical, surgical, dental and patient mobility equipment/supplies; high technology medical equipment; temporary allied healthcare staffing services; and just-in-time distribution programs.

VHA HCAs implemented VHAPM Part 808.004-70 Use of Other Priority Sources to identify VHA mandatory strategic sourcing contract vehicles for VHA COs and Ordering Officers. These contracts were put in place to streamline the procurement process when ordering or purchasing medical supplies and equipment in support of VHA medical facilities. The mandate is also a key instrument in implementing VHA’s Supply Chain Operation’s priority to leverage the resources of VHA to provide high quality medical supplies and equipment based on clinical input with prices that reflect VHA’s purchasing power.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: The I-123 Ioflupane DaTscan radiopharmaceutical is extremely specialized, but the facility will continue to keep abreast of the current marketplace to ascertain if competition can be sought for future procurements.

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

SIGNATURE

Darin Compton/COR DATE

Darin Compton 01/15/2025 https://www.va.gov/opal/about/nacFsss.asp https://www.va.gov/opal/about/nacNcs.asp https://dvagov.sharepoint.com/sites/vhapromanual/SitePages/VHAPM-Part-808.004-70.aspx

VHAPG Part 808.405-6 Limiting Sources Page 6 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C255-24-AP-3526

10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER SIGNATURE DATE

Janie Juszczak/NCO 15

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

NAME

NCO/PCO XX Duty Title

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

NAME DATE

VHA Head of Contracting Activity (HCA) https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx