P01 - SOW - NM and PET Radiopharmaceuticals.pdf

STATEMENT OF WORK

Lebanon VA Medical Center

Title of Project: Radiopharmaceuticals for Nuclear Medicine to include PET.

Scope of Work: The contractor shall provide all Radiopharmaceuticals and Inventory Management Services including equipment necessary to perform and supply any of the requests for the Lebanon VA Medical Center. The contractor shall perform to the standards in this contract.

Background: The VA Medical Center in Lebanon, PA, is establishing a contract to meet increased demand for receipt, storage, warehousing, inventory management, packaging and shipment preparation, distribution, and transportation for radiopharmaceutical products in support of the VA Medical Center Nuclear Medicine and PET needs. It is the intent of this contract to have a supply of Radiopharmaceuticals readily available for shipment/transportation and continuous Inventory Management Services and equipment during normal and other than normal working hours as described in this Statement of Work.

Offerors shall furnish and deliver F.O.B. Destination all items as listed in the “Schedule of Supplies and Services” and others that may be needed in the future. The Government prefers vendors who provide non-High Enriched Uranium sources (non-HEU). Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals.

Performance Period: The Government is requesting a one (1) year contract with a period of performance beginning August 1, 2023 through July 31, 2024.

Type of Contract: Firm Fixed Price

Contracting Officer Representative: Delivery shall be coordinated with the designated Contracting Officer Representative (COR) or Program POC:

a. Nominated COR: Yasir Nayati Phone: (717) 272-6621 x3621 Email: Yasir.Nayati@va.gov

Note: The COR or the Program POC has no authority to change the terms and conditions of the awarded contract.

GENERAL REQUIREMENTS

1. Contractor shall ensure that orders placed each day (Monday – Friday by 6:30PM) for delivery the next day.

2. A second order may be placed each business day (by 10 AM) for same day delivery.

3. If additional radiopharmaceuticals (M/F or holidays/weekends) then a delivery charge shall be added to the cost of the radiopharmaceuticals as specified.

4. Contractor shall provide an adequate supply of contract products to meet the requirements of Lebanon VA Medical Center as its distribution points.

mailto:Yasir.Nayati@va.gov

5. Contractor shall label all supplies as to the type and amount of radiopharmaceutical, lot number, preparation time, expiration time, date, etc., and provide a bar labeled insert to allow scanning data into a nuclear medicine information management system (NMIS).

Contractor product barcode system shall be compatible with Nuclear Medicine Information System (NMIS) in general.

6. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

7. Contractor shall meet all Nuclear Regulatory Commission (NRC), Department of Transportation, FDA, OSHA and all other agency rules and regulations (Federal and State). NRC must maintain all certifications throughout the performance of contract.

Contractor must have current license.

8. Contractor shall provide evidence of special driver’s licenses (competency) due to transporting hazardous materials. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, F.D.A., OSHA and all other agency rules and regulations (Federal and State).

9. Contractor shall test all products for Quality Control at an agreed upon frequency and only those products that pass quality control may be sent to the VA. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request.

10. Contractor shall pick up scheduled items, used and unused, for proper disposal.

11. Contractor shall perform quality control on each agent dispensed.

12. Contractor shall accept returns for credit under the following conditions:

a. Product(s) shipped in error.

b. Product(s) damaged in shipment

c. Concealed shipping damages

d. Recalled product(s)

e. Outdated products in unopened, original container (specifically authorized for return by manufacturer).

13. Contractor/supplier shall abide by (CFR 10) Title Code of Federal Regulations, which states: a Licensee may use for medical use only:

a. By-product material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35, and the equivalent regulations of an Agreement State.

b. Reagent kits that have been manufactured, labeled, packed, and distributed in accordance with the approval by the Commission pursuant to S32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

Product Substitutions: Any substitutions of product shall have the written approval of the VA Nuclear Medicine Service and the Contracting Officer or his/her designee.

No substitutions are currently requested to ensure consistency with follow-up imaging.

Product replacement: All defective or inferior products shall be replaced within the timeline specified at no costs to the VA.

Acceptance: All products are purchased subject to acceptance by the Lebanon Medical Center. Products that fail to meet Quality Control criteria will not be accepted. Products will be rejected and may be discarded if found unsatisfactory when they are received, or later if deterioration of the product occurs before the expiration date. The VA will not be financially liable for unacceptable materials.

Recall Notices: It is the Contractor’s responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer and the Nuclear Medicine Contracting Officer Representative Amy Landis utilizing the most expedient method.

Contractor Consultation Service: Consultation service regarding radiopharmaceutical applications, problems, controls, etc., shall be provided upon request at no charge.

GENERAL ORDERING

Ordering: Normal orders shall be placed during the workday, and delivery shall be required by 6:30 am the following workday to the Lebanon VA Medical Center, Nuclear Medicine Department. Contractors shall ensure that orders placed each day (Monday – Friday by 4:30PM) shall be delivered by the next business day (Monday – Friday by 6:30 AM. A second order may be placed each business day by 10AM, for same day delivery. If there is need for an additional delivery of Isotopes (Monday – Friday or holidays/weekends) then a delivery charge can be added to the cost of the radiopharmaceuticals (See Schedule of Supplies and Services). Due to the demands of the Medical Center patient care requirements, contractor shall provide routine delivery and pick-up as many times as required by the Lebanon VA Medical Center. In the event that the requirements may be determined in advance, a longer delivery time may be scheduled accordingly. In accordance with the following:

a. The delivery order shall include the following information: contract item (s) and quantity, time (s) of delivery, and applicable VA order number.

b. Orders can be placed by the Lebanon VA Medical Center via telephone, fax, or e-mail.

c. Ordering Contact Information: Contractor shall provide contact information for the placement of orders for items listed in the “Schedule of Supplies and Services”

d. The Lebanon VA Medical Center CORs or POCs assigned to this contract will be the only individuals authorized to place orders under this contract:

i. Jasir Nayati CNMT (Primary COR)

ii. Amy Landis CNMT (Back-Up COR/POC)

iii. Imani Crumlin CNMT (POC)

Emergency Ordering Procedures: An added cost is provided IAW with specified line items of the schedule of items for the base for emergency preparation and delivery service of radiopharmaceuticals at other than normal working hours. Normal business hours are considered Monday through Friday: 6:30 am – 4:30 pm.

The Lebanon VA Medical Center considers the following Emergency duty hours:

• Weekdays (Monday – Friday) 4:30 pm – 6:30 am

• Weekends (Saturday/Sunday) All hours

• Federal Holidays: A list of the expected Federal Holidays is as follows: New Year’s

Day, Birthday of Martin Luther King, Jr., Washington’s Birthday, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day.

Deliveries: All orders will be agreed upon between the contractor and the Department Of Veterans Affairs prior to shipment. No delivery charge shall be made for additional deliveries during normal working hours, 7:00a.m.-4:00 Monday – Friday.

Emergency Deliveries: Requests for emergency doses shall be delivered within 90 minutes of placing the order. Emergency and priority studies consist of less than 20% of the daily schedule. Radioactive shipments prepared in advance to anticipate emergency or routine studies are not acceptable.

After Hours delivery: Weekend (Saturday/Sunday) and all Federal Holiday (or any other day specifically declared by the President of the United States to be a national holiday) deliveries shall be made by contacting the Veterans Medical Center Police to unlock Hot Lab for placement of the packages.

Contractor Early Deliveries: When the Contractor offers an earlier delivery date and time than specified, the Government reserves the right to award whether in accordance with the requested schedule or in accordance with the earlier schedule offered by the contractor. If a contractor offers a longer delivery than that requested, the Government may award based on that schedule. If the contract offers no other delivery schedule, the delivery requested shall apply.

Delivery proposed:

a. Delivery of supplies by the scheduled date will be complete except as otherwise authorized by the Ordering Personnel.

b. The Government may terminate this contract in whole or in part if the contractor fails to meet the required delivery schedule. The Contractor shall be liable for a fixed, occurring amount until the Government may reasonably obtain delivery of similar supplies. The contractor shall not be charged with damages when the delay in delivery arises out of causes beyond the control and without the fault or negligence of the contractor.

c. Delivery date and time specified may be adjusted by the Contracting Officer. The Contractor will be notified of this change at least seven (7) days prior to the original or adjusted delivery date.

Delivery Location: Radiopharmaceuticals shall be delivered to:

• (The Hot Lab) located within the Nuclear Medicine Department Lebanon VA Medical Center 1700 S. Lincoln Ave

Lebanon, PA 17042

Access to this room during non-business hours shall be obtained by contacting VA Police Service or a key to a pass-through shall be provided by the Contracting Officer’s Representative (COR).

Delivery Commitment: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. All charges incurred for delivery shall be included in the fee schedule to include fuel surcharges. Contractor shall provide on an as-needed basis miscellaneous supplies and/or services including but not limited to the following:

a. OSHA compliant monitoring devices.

b. Sealed sources for QA procedures.

c. Dose calibrator calibration.

d. Annual calibration of survey meters.

e. RSO safety audits for Federal compliance.

Damages In-transit: Under FOB Destination procedures, any in-transit damage is the responsibility of the provider. The contractor is responsible for notifying the Contracting Officer or Contracting Officer Representative within 24 hours after loss or damage of material is known by the contractor. The contractor shall be responsible for initiating action to replace all damaged or missing material to the Government.

Packaging and Shipment Preparation: All unit dose radiopharmaceuticals delivered must have a bar code with it so the dose can be scanned into the department’s dose tracking system that it owns. All radiopharmaceuticals shall be delivered in unit dose form in lead-shielded containers. Plastic shrink wrap fitted at union of container cap and base should be present to ensure an untampered seal.

Calibration/labels: All radiopharmaceuticals shall be calibrated and labeled with concentration, calibration, time, total volume, total activity, lot number and prescription number.

Supplier Source Information: Product information including supplier's source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier's license and procedures shall be provided at no additional charge.

Added charges: Contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the contractor. Replacements shall be received within two (2) hours of notification by the VA.

Estimated Quantities for NM Radiopharmaceuticals per year:

LINE

ITEM

DESCRIPTION OF

SUPPLIES/SERVICES

ESTIMATED

QUANTITIES PER

YEAR

00001

I-123 SODIUM

IODIDE CAPSULE

200uCI

00002 TC99m SODIUM

PERTECHNETATE

BULK (PER mCi)

00003 TC99m SODIUM

PERTECHNETATE UD

25 mCi (ud)

00004 TC99m SODIUM

PERTECHNETATE 26-

50 mCi

00005 TC99m MEDRONATE

(MDP) 300

00006 TC99m

MACROAGGREGATED

ALBUMIN

00007 TC99m

PYROPHOSPHATE

(PYP)

00008 TC99m SESTAMIBI 2000

00009 TC99m SODIUM

PERTECHNETATE,

FLOOD/COR

00010 TC99m PENTETATE

(DTPA) 20

00011 TC99m MEBROFENIN 80

00012 TC99m MERTIATIDE 30

00013 TC99m SULFUR

COLLOID 100

00014 ULTRATAG RBC 10

00015

IN-111

PENTETREOTIDE

(OCTREOSCAN)

00016

TC99M

EXAMETAZINE

(CERETEC) WBC

00017 BLOOD COLLECTION

KIT 10

00018

FLOOD SOURCES

FOR: DISCOVERY NM

530C & DISCOVERY

NM/CT 670 GAMMA

CAMERAS

00019 Tc99m HMPAO Brain Scan 2

00020 201 TlCl (PER MCI) 30

00021 I-123 MIBG 3

00022 Tc99mIn-111 DTPA CSF Studies 6

00023 Tc99m DMSA 2

00024 67Ga Citrate (PER

MCI) 10

00025 Tc99m SULFUR

COLLOID FILTERED 5

00026 Tc99m MYOVIEW 2 00027 In111 Oxine WBC 2 00028 Tc99m Neurolite 2

00029 HESPAN 10

00030 DaTscan 72 00031 I-131 (1st mCi) 10 00032 I-131 ea add 640

Estimated quantities for PET Radiopharmaceuticals per year:

Isotope Est Volume [F18] Flouro-2-deoxy-D-glucose (FDG) 625 [F18] Sodium Flouride (NaF) 2 [F18] Florbetapir (AV-45, Amyvid) 6 [F18] Fluciclovine (Axumin) 25