36C24419Q1119-001.docx

STATEMENT OF WORK

SCOPE

The Wilmington VA Medical Center in Wilmington, Delaware, located at 1601 Kirkwood Highway Wilmington, DE 19805 has a requirement for a United States Nuclear Regulatory Commission (US NRC) and Food and Drug Administration (FDA) Licensed Contractor to provide radiopharmaceuticals for the Nuclear Medicine Department for patient care. The Wilmington VA Medical Center in Wilmington, Delaware intends to award a base year plus four option years, firm fixed price. Requirements Contract to a licensed Radio-pharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in Delaware with a period of performance of October 1, 2019 through September 30, 2024. The successful awardee agrees in accordance with the terms and conditions stated herein, to furnish Radiopharmaceuticals in accordance with Local, State, and Federal Regulations. The successful awardee shall be able to provide all of the items listed in the Schedule of Supplies with deliveries when required.

BACKGROUND

The Wilmington VA Medical Center in Wilmington, Delaware is responsible for providing high quality and timely commodities and services for our Veterans. The Department of Veterans Affairs (VA) has been directed to preferentially procure medical radioisotopes from non-High Enriched Uranium (HEU) sources. The Department of Veterans Affairs (VA) is also directed to ensure that the best possible medical supplies are procured timely and in accordance with proper regulations with vendors that are licensed and monitored according to Local, State, and Federal Regulations. Under the Atomic Energy Act, the United States Nuclear Regulatory Commission (NRC) is responsible for regulating uses of radioactive material including radio pharmaceuticals. The NRC requires all nuclear medicine facilities to be licensed. The license assures that the facility has a radiation protection program to protect both the patients and the staff. In addition, the staff must meet certain standards of training and experience before they are allowed to administer radioactive material to patients. Each state has one or more radiation programs that ensure safe use of radioactive materials. The NRC has transferred regulatory authority over the use of this material to 35 NRC Agreement States. In these states, the regulatory authority inspects the facility to ensure the staff is trained properly and the equipment is operating safely. FDA’s Center for Drug Evaluation and Research regulates the radio pharmaceuticals, ensuring effectiveness and patient safety. The mission of the National Institute of Standards and Technology (NIST) is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life.

A. STATEMENT OF WORK

1. Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to the Wilmington VA Medical Center in Wilmington, Delaware on a daily and or as needed basis in accordance with this Statement of Work. Because of the critical need for these supplies in a timely manner, only contractors that can deliver in less than two hours to the Wilmington VA Medical Center in Wilmington, Delaware need to respond to this Solicitation. Contractor shall be licensed by the State of Delaware. Additionally, the Contractor shall be licensed by the Nuclear Regulatory Commission or another agreement state besides Delaware and be regularly established in the business of providing radionuclides. Contractor shall provide copies of these licenses and certifications to the Contracting Officer with their proposal. Contractor shall provide evidence of delivery in less than 2 hours with this Solicitation. Please identify the location of the point of shipment to the address listed on this Solicitation. Verification will be completed via www.mapquest.com.

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 FDA, DOT, DOE, USNRC, and ICC regulations and standards. Documentation of US DOT package integrity testing shall also be provided.

3. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all Federal and State regulations. All packaging of radioactive material must be clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped.

4. Contractor shall label all products delivered as to the Wilmington VA Medical Center in Wilmington, Delaware with the radiopharmaceutical, activity, time of preparation, and expiration time and date.

5. Contractor shall hold a current unrevoked NRC and or agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material and an FDA license to produce and distribute radiopharmaceuticals for human administration. Contractor shall provide a copy of their radioactive material license with their proposal. Contractor shall immediately notify the Contracting Officer (CO) and Contracting Officer Representative (COR), upon any action by the NRC or an agreement state and or FDA to suspend or modify the radioactive materials license. Contractor shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts and applicable FDA requirements. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

6. Contractor will provide with their proposal, the following information:

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 to include 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 (JC) and or with the United States Pharmacopeia.

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

7. Current package inserts of all radiopharmaceuticals supplied under the awarded contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new or updated additions to the package inserts are made available, these will be sent to the COR Wilmington VA Medical Center in Wilmington, Delaware Nuclear Medicine Service.

8. Contractor shall make quality control records available to the COR upon written request from the CO or COR.

9. Contractor shall test all products for quality control. Periodically, this testing shall be performed at no cost to the Government. The contractor shall provide a detailed description of the test upon request.

10. Calibration time for each requested radiopharmaceutical is given in the Schedule of Supplies, 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.

11. If an ordered dosage of radioactive material is given to Contractor such that it is to fall within a specified range, then the quantity of radioactivity must be within the dose range provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±20%.

12. Technetium product radiopharmaceuticals not used will be returned for credit the next work day (including the bulk doses), using the DOT regulations. Credit will be reflected in the current month’s invoice.

13. Contractor shall replace any items delivered damaged or in error at no cost to the Government. COR shall define the replacement date and time. Replacements may be required immediately or within a specified time in accordance with the needs of the patient.

14. 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 six (6) hours.

b. Tc-99m Pertechnetate: Not shorter than twelve (12) 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.

15. In the event that a quality control or material defect is suspected or detected by the COR, the Contractor will be required to provide any consultation necessary to alleviate any said suspicion or defect by the following:

a. Provide technical expertise in calibration;

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

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

16. Procedure for labeling of patient's White Blood Cells (WBC) with Indium-111 Oxine or Tc- Ceretec for re-injecting to the same patient:

a. Telephone requests to the Contractor to arrange for the procedure will take place no later than 3:30 PM for the next workday procedure.

b. Furnishing of the syringe to the Nuclear Medicine Service and pick up of patient's blood specimen for labeling by the Contractor will be at 7:30 AM or later, if so specified by the COR.

c. The return by the Contractor, of the patient's Indium labeled White Blood Cells will take place not later than within 5 (five) hours from the time of specimen pick up time.

d. Pertinent documentation confirming that the identification of the labeled blood specimen matches with the blood specimen of the patient's blood specimen submitted for labeling procedure.

17. Contractor shall pick up Radiopharmaceuticals (used or unused) for proper disposal at no cost to the Government.

18. Contractor shall produce radiopharmaceuticals as described in the Schedule of Supplies.

B. Deliverables and Acceptance Criteria

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

a. Provide up to two deliveries per day during regular operating hours to the Wilmington VA Medical Center in Wilmington, Delaware at no additional charge. Delivery charges for STAT orders to be included on the Schedule of Supplies. STAT deliveries will average approximately three times a week.

b. Regular daily radiopharmaceutical doses ordered the previous day will be delivered in one morning delivery by 7:00 AM and not split into two separate deliveries with one delivered later in the day.

c. Deliver directly to the Nuclear Medicine Service , Wilmington VAMC the daily quantity of radiopharmaceuticals by 7:00 AM, as requested from the previous day. In addition to the morning delivery, one more delivery (During Normal Operating Hours) will be allowed daily at no cost per additional order or emergency.

d. Orders can be placed orally by telephone or fax transmission by ordering officers provided by the Contracting Officer Representative.

e. Deliver directly to the Nuclear Medicine Service Wilmington VA Medical Center in Wilmington, Delaware quantity of radiopharmaceutical requested on an as needed or emergent basis to arrive in less than two (2) hours after notification.

f. Radioactive dose boxes that are delivered outside of working hours can be placed in the locked box on floor 4C. The Contractor will have a key to the locked box for this purpose. The Contractor making the delivery shall not leave a radioactive materials package at Wilmington VA Medical Center in Wilmington, Delaware unless they have verbally communicated with a Nuclear medicine staff member.

g. Other delivery times may be outlined by the Wilmington VA Medical Center in Wilmington, Delaware in this Statement of Work.

2. If Monday is a federal holiday, no deliveries will be expected. Holidays are listed under section E.

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 (weekends, holidays, and nights) will be delivered within two (2) hours, or as specified by the ordering officer.

b. Emergency, weekend, and holiday shipments are to be delivered to the location specified by Wilmington VA Medical Center in Wilmington, Delaware 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 or Analytic Kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the Statement of Work and all applicable Local, State, and Federal Laws.

e. Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by Wilmington VA Medical Center in Wilmington, Delaware contained within this Statement of Work will be strictly adhered to.

5. All shipments will have a Packing Slip enclosed, giving information about the product and its identification, plus (for billing purposes) Wilmington VA Medical Center in Wilmington, Delaware, Purchase Order Number issued for the current fiscal year, and the Contractor’s invoice number. Incorrect Purchase Order Numbers as well as invoicing errors will cause a substantial delay in payments to the Contractor.

6. Contractor must provide radiopharmaceutical invoice with each delivery with each dose bar- coded using the Pinestar system. If the ) Wilmington VA Medical Center’s Pinestar system is not compatible with the bar coding that is provided, then the Contractor must provide whatever software or hardware is necessary to make the Government’s system compatible with the Contractor’s barcoding technology.

C. VA OPERATING HOURS

The delivery of products provided by the respective awarded contract shall be furnished by the Contractor in accordance with section 3.0 Deliverables and Acceptance Criteria. The Contractor shall not be required, except in case of an emergency, to furnish such products on a national holiday or during non-working hours as described below with the exception of normal next day delivery as described in (1) above and below.

The following terms have the following meanings:

Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:00 AM to 4:30 PM. Deliveries shall be accomplished by 7:00 AM and on an as needed basis during normal operating hours.

Contractor to include up to two (2) deliveries per normal working day during normal working hours as needed at no charge.

National Holidays: The ten holidays observed by the Federal Government are:

New Year's Day, Martin Luther King's Birthday, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving, Christmas, and any other day specifically declared by the President of the United States to be a national holiday

D. CONTRACT AWARD

Upon Contract Award (within 5 (five) business days) Awarded Contractor shall provide:

1. A copy of their laboratory’s current quality control manual to the COR.

2. A dedicated inside sales representative to aide in facilitation in the smooth coordination between the Nuclear Medicine Department and the Contractor’s Laboratory Pharmacy.

3. Material safety data sheets and updates on all delivered products as per the awarded contract and any additions throughout the life of the awarded contract.

4. Patient orientation education video presentations and other appropriate material at no additional cost to the Government.

5. Contractor shall provide signs and posters alerting patients, employees and the public, of safety precautions in handling of radioactive materials

E. QUALITY REQUIREMENTS

Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control shall include pH testing, percent tag, alumina, and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of quality control results shall be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided upon request at no charge. On an annual basis, the Contractor shall provide documentation demonstrating compliance with applicable agreement state or NRC license requirements to the COR.

F. PERSONNEL POLICY

1. The Contractor is responsible for all costs, including personnel costs, associated with this respective awarded contract unless otherwise specified.

2. Qualifications - Personnel assigned by the Contractor to prepare and provide the products covered within this Statement of Work shall be Nuclear Pharmacists, or a Licensed Technologist working under the supervision of a Nuclear Pharmacist licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia.

G. SPECIAL CONTRACT REQUIREMENTS: HHS/OIG

To ensure that the individuals providing services under the respective awarded contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the Contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud or abuse of the Medicare and Medicaid programs. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals and Entities. Any healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing their proposal, the Contractor certifies that all persons or entities listed in the Contractor’s proposal have been compared against the OIG list and are NOT listed as of the date their proposal was signed.

H. CONTRACTOR STAFF ROLES AND RESPONSIBILITIES

Must be in compliance with all NRC, USP, US FDA, state, local and JC guidelines. The Contractor shall be in compliance with USP 797 guidelines.

I. CONTRACTOR PERFORMANCE ASSESSMENTS

Assessments: The Government will do assessments of the Contractor’s performance. The Contractor shall have an opportunity to respond to said assessments.

Record: The Government will keep completed assessments to serve as past performance data. Past performance data will be available to assist agencies in the selection of radio-pharmacy Contractors for future requirements.

J. DESIGNATION OF CONTRACT OFFICER REPRESENTATION

The Contracting Officer Representative (COR) will be designated in writing. The COR will be furnishing technical guidance and advice regarding the radiopharmaceuticals being provided under the respective awarded contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the respective awarded contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer.

K. CONTRACTOR RECALL AND SAFETY PLAN AND PROCESS NOTIFICATION TO FACILITY

The Contractor shall take immediate action to notify the COR whenever a product, piece of equipment ,or item is recalled or considered dangerous, hazardous or unsafe in order to remove such products, equipment or items from use. This notification process also applies to safety alerts. The Contractor recall and safety notification plan and process is necessary so that proper notification to individuals who have received or individuals who may utilize such products, equipment, or items can be made in as expedient and efficient manner as possible. The Contractor shall provide to the COR their plan for this safety notification process and also maintain a record system in order to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the COR.

L. HIPAA COMPLIANCE

The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs.

M. AVAILABILITY OF FUNDS DURING A CONTINUING RESOLUTION

At the beginning of each new fiscal year (1 October) the Federal Government or parts thereof may be operating under a Continuing Resolution (CR) and only be funded for a limited period of time rather than for the entire fiscal year. If at any time funds for this contract are provided under a CR, funds will only be available for performance under this respective awarded contract up to and including the expiration date of the CR, and any extension thereof. The Government's obligation for performance of this respective awarded contract beyond that date 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 for performance under this respective awarded contract beyond the expiration date of the CR, and any extension thereof, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability.

N. REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS)

As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs evaluates Contractor past performance on all contracts that exceed the thresholds outlined in FAR Part 42.15, and shares those evaluations with other Federal Government Contracting Specialists and Procurement Officials through the Past Performance Information Retrieval System (PPIRS). The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to the posting of each report. To fulfill this requirement, the Department of Veterans Affairs uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is uploaded to the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. Each Contractor whose contract award is estimated to exceed the thresholds outlined in FAR Part 42.15 is required to provide to the Contracting Officer contact information for the contractor’s representative with their response to this solicitation. The Contractor is responsible to notify the Contracting Officer of any change to the Contractor’s representative during the contract performance period. The Contractor’s representative contact information consists of their name, telephone number, and email address.

The Government will register the contract within thirty days after contract award. For contracts with a period of one year or less, the Contracting Officer will perform a single evaluation when the contract is completed. For contracts exceeding one year, the Contracting Officer will evaluate the contractor’s performance annually. Intermediate reports will be filed each year until the last year of the contract, when the final report will be completed. Each report shall be forwarded in CPARS to the contractor’s designated representative for comment. The Contractor’s representative will have thirty days to submit any comments and return the report to the Department Of Veterans Affairs Contracting Officer. Failure by the Contractor to respond within those thirty days will result in the Government’s evaluation being placed on file in PPIRS without Contractor’s comments.

O. PROHIBITION (WORKING OUTSIDE OF US)

The entire performance of the respective awarded contract shall be within the borders of the United States of America. The Contractor shall not access any Department of Veterans Affairs data or information (for example, by remote computer access) from locations that are outside the above- stated borders. Furthermore, the Contractor shall not send, transfer, mail or otherwise transmit any Department Of Veterans Affairs data or information to locations outside the above-stated borders.

After hour/Emergency charges – Wilmington VA Medical Center in Wilmington, Delaware Two Deliveries during normal work hours Monday through Friday at no charge. Offeror may list any additional charges below:

Emergency Delivery: Charge for delivering unscheduled Emergency orders (over 2 daily) during normal business hours within two hours of receiving the order by phone from the VA.

Pharmacist (Emergency after hours): The charge for having a Pharmacist called back to the Pharmacy after hours, prepare the ordered dose and have it delivered to the VA within two hours. (Emergency orders only outside of normal business hours.) (Is this needed since this has never occurred?)

Weekend WBC labeling charge: The charge for the pharmacy to attach a radionuclide to the patient’s white blood cells on a weekend