SOW FINAL 10-25-2020.docx

Statement of Work Radiopharmaceuticals

1.0 SCOPE

The Department of Veterans Affairs Central New York Healthcare System at Syracuse, located at 800 Irving Avenue Syracuse, NY 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 Syracuse VA Medical Center intends to award a base year plus two option year, firm fixed price, indefinite delivery indefinite quantity requirements contract to a licensed Radiopharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in New York State. The contractor agrees in accordance with the terms and conditions stated herein, to furnish Radiopharmaceuticals in accordance with local, state and Federal Regulations. The awardee shall be able to provide all items listed in price cost schedule with deliveries as required. Multiple awards WILL NOT be made.

1.1 BACKGROUND

The Syracuse VAMC is responsible for providing high quality and timely commodities and services for our Veterans. One area to serve our Veterans is to ensure that the best possible medical supplies are both 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 is responsible for regulating uses of radioactive material, including radio pharmaceuticals. 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. NRC has transferred regulatory authority over the use of this material to VACO National Health Physics Program (NHPP). 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 NIST is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life. Although a non-regulatory federal agency, NIST develops the standards for correct patient dosage of radio pharmaceuticals. * http://nrc-stp.ornl.gov/rulemaking.html#NY

2.0 STATEMENT OF WORK

1. Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to Syracuse VA Medical Center 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 that can deliver in less than two hours to the Syracuse VA Medical Center need to respond to this Request for Proposal. Contractor shall be licensed by the State of New York. Additionally, contractor shall be licensed by the Nuclear Regulatory Commission or another agreement state besides NY and be regularly established in the business of providing radionuclides. Contractor shall provide copies of these licenses and certifications to the Contracting Officer with the Request for Proposal. Contractor shall provide evidence of delivery in less than 2 hours with this Request for Proposal. Please identify the location of the point of shipment to the address listed on this Request for Proposal. 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 Syracuse VA Medical Center with the radiopharmaceutical, activity, time of preparation, expiration time and date.

5. Supplier shall hold a current unrevoked NRC and/or an 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. Supplier shall provide a copy of their radioactive material license with this proposal. Supplier shall immediately notify the CO and COR, upon any action by the NRC or an agreement state and/or FDA to suspend or modify the radioactive materials license. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts and applicable FDA requirements In addition all Tc99m generation must come from LEU (Low Enriched Uranium) - Mo-99 sources mandated by VACO NHPP. 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, 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 (JC) and/or with the United States Pharmacopeia.

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

7. 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 COR at the Syracuse VA Medical Center Imaging 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 VA. 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 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.

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 VA. COR shall define the replacement date and time. Replacements may be required immediately or within a specified time (as per patient needs).

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 and/or detected by the COR, 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 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, unused) for proper disposal at no cost to the Government.

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

3.0 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 two deliveries per day during regular operating hours to the Syracuse VA Medical Center free of charge. Delivery charge for STAT orders to be included on Schedule of Prices. STAT deliveries will occur, on average, three times a week.

b. Regular daily radiopharmaceutical doses ordered the previous day will be delivered in ONE morning delivery by 6:30 AM and not split into TWO separate deliveries ( with one delivered later in the day).

c. Deliver directly to the Nuclear Medicine department at the Syracuse VA Medical Center daily quantity of radiopharmaceuticals by 6:30 am, as requested from the previous day.

d. Orders can be placed orally by telephone and/or fax transmission by ordering officers provided by the contracting officer.

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

f. Radioactive dose boxes that are delivered outside of working hours must be placed in the Hot lab with VA police escort. The Contractor must notify the VA police at the Syracuse VA Medical Center at 315-425-4336. The contractor making the delivery shall not leave a radioactive materials package at the Syracuse VA Medical Center unless they have verbally communicated with a Nuclear medicine staff member or VA Police for the early morning delivery.

g. Other delivery times may be outlined by the Syracuse VA Medical Center under this contract.

2. If Monday is a federal holiday, no deliveries will be expected. 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 delivered within two (2) hours, or as specified.

b. Emergency, weekend, and holiday shipments are to be delivered to location(s) specified by the Syracuse VA Medical Center, unless otherwise specified when called for.

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

d. All Radiopharmaceuticals, Radio-assay 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 The Syracuse VA Medical Center under this contract, 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) the Syracuse VA Medical Center Purchase Order Number issued for the current fiscal quarter or month, and the Contractor’s invoice number. (Incorrect P.O. numbers may cause a substantial delay in payments.)

6. Must provide radiopharmaceutical invoice with each delivery with each dose to the VA Medical Center

4.0 VA OPERATING HOURS

The delivery of products provided by this 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 (2) below.

The following terms have the following meanings:

Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:00 a.m. to 4:30 p.m.

Delivery shall be accomplished: 6:30 a.m. and on an as needed basis during normal operating hours.

Vendor 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, and Christmas, and any other day specifically declared by the President of the United States to be a national holiday

5.0 CONTRACT AWARD

Upon Contract Award (within 3 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 medical center and Contractor’s laboratory pharmacy

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

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

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

6.0 QUALITY REQUIREMENTS

Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control (QC) shall include pH testing, percent tag, alumina, and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of QC results will 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 will provide documentation demonstrating compliance with applicable agreement state or NRC license requirements to the Radiation Safety Officer or COR.

7.0 PERSONNEL POLICY

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

2. Qualifications - Personnel assigned by the contractor to prepare and provide the products covered by this contract shall be nuclear pharmacists, or licensed technologist working under the supervision of nuclear pharmacist licensed in a State, Territory or Commonwealth of the United States or the District of Columbia.

8.0 SPECIAL CONTRACT REQUIREMENTS: HHS/OIG

To ensure that the individuals providing services under the 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 and/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/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 this offer, 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 the offer was signed.

9.0 CONTRACTOR STAFF ROLES AND RESPONSIBILITIES

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

Vendor shall be in compliance with USP 797 guidelines.

10.0 CONTRACTOR PERFORMANCE ASSESSMENTS

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

Record. The Government will keep completed assessments and may serve as past performance data. Past performance data will be available to assist agencies in the selection radio-pharmacy providers for future projects. Past performance data may also be utilized in future procurement efforts.

11.0 DESIGNATION OF CONTRACT OFFICER REPRESENTATION

COR will be designated in writing. COR will be furnishing technical guidance and advice regarding the work being performed under this 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 contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer.

12.0 CONTRACTOR RECALL AND SAFETY PLAN AND PROCESS NOTIFICATION TO FACILITY

Contractor shall take immediate action to notify the Contracting Officers Representative (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.

13.0 HIPAA COMPLIANCE

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 (VA). In accordance with HIPAA, the Contractor will be required to enter into a Business Associate Agreement (BAA) with VA found at attachment #1.

14.0 AVAILABILITY OF FUNDS DURING A CONTINUING RESOLUTION

At the beginning of each new fiscal year (October 1st) the federal government or parts thereof may be operating under a Continuing Resolution 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 Continuing Resolution (CR), funds will only be available for performance under this contract up to and including the expiration date of the CR, and any extension thereof. The Government's obligation for performance of this 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 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.

15.0 REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS)

As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) 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 contract 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 VA 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 the solicitation. The contractor is responsible to notify the contracting officer of any change to the contractor’s representative during the contract performance period. Contractor’s representative contact information consists of a name 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 complete. 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 VA 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.

16.0 PROHIBITION (WORKING OUTSIDE OF US)

The entire performance of the contract shall be within the borders of the United States of America, the District of Columbia and/or Puerto Rico. The Contractor shall not access any VA data/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 VA data/information to locations outside the above-stated borders.

17.0 CONTRACT TERM

This IDIQ shall be for one (1) base year plus two (2) option years. Base year will run from 12/01/2020 through 11/30/2021. Option year 1 will run from 12/01/2021 through 11/30/2022. Option year 2 will run from 12/01/2022 through 11/30/2023.

18.0 Schedule of Items Needed

Prices quoted are all inclusive including all associated costs including shipping, handling, packaging, storage, licenses etc. excluding emergency delivery, Pharmacist After-Hour Emergency Call-Back and Weekend White Blood Cell labeling charge.

Base Year (December 1, 2020 through November 30, 2021)

(HIDA)

CONTRACT TOTAL:

Option Year 1 (December 1, 2021 through November 30, 2022)

(HIDA)

CONTRACT TOTAL:

Option Year 2 (December 1, 2022 through November 30, 2023)

(HIDA)

CONTRACT TOTAL:

After hour/Emergency charges – Syracuse VA Medical Center Deliveries during normal work hours (Monday - Friday) at no charge. Offeror (s) may list any additional charges below:

1Emergency Delivery: Charge for delivering unscheduled Emergency orders during normal business hours within two hours of receiving the order by phone from the VA.

2Pharmacist (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).

3Weekend WBC labeling charge: The charge for the pharmacy to attach a radionuclide to the patient’s white blood cells on a weekend.