P09 SOW Radioisotopes.docx

?.## STATEMENT OF WORK (SOW)

RADIOPHARMACEUTICAL ISOTOPES FOR THE FARGO AND SIOUX FALLS VA HEALTH CARE SYSTEMS

1. General

a. The Contractor shall provide Radiopharmaceutical products and deliveries as listed herein, as requested by authorized VA Staff, in accordance with all applicable laws, regulations, directives, and policies for the following locations:

(1) Department of Veteran Affairs Sioux Falls VA Health Care System 2501 W. 22nd Street Sioux Falls, SD 57105

(2) Department of Veteran Affairs Fargo VA Health Care System Nuclear Medicine 2101 North Elm Street Fargo, ND 58102

b. Radiopharmaceutical products will be used at the Sioux Falls VAHCS & Fargo VAHCS, Nuclear Medicine Diagnostic Imaging Service. The Sioux Falls VAHCS & Fargo VAHCS is not USP Chapter 797 certified for Radiopharmaceutical products and as such, cannot make kits. All orders shall be delivered in Unit Dose (UD) amounts only. Required products may be in inhalable, ingestible or injectable as indicated in the Price/Cost Schedule.

c. The listed quantity in the Price/Cost Schedule is an estimate only. Actual quantities are contingent upon patient volume and required procedures.

d. The Sioux Falls VAHCS & Fargo VAHCS will not require access to any contractor/vendor-owned software.

e. Contractor may provide appropriate signs and posters alerting patients, employees, and the public, of safety precautions in handling of radioactive materials.

f. The COR assigned to this IDIQ will periodically review the TOs issued off the IDIQ to verify compliance with the designated terms. Instances of non-compliance will be noted and referred to the administering CO for consideration for action and in performing the annual IDIQ review. VA employees ordering off the IDIQ will also be evaluated for their compliance with IDIQ terms. Instances of non-compliance will be noted and referred to the administering CO and the relevant supervisor for consideration. The administering CO will perform annual reviews and as required by circumstances. Instances of excellent contractor service will be noted for the same purposes.

2. Qualifications

a. The contractor shall be licensed in the proper state (North Dakota, South Dakota). Additionally, contractor must the licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Offeror must provide copies of these licenses and certifications.

b. Contractor/supplier shall abide by (CFR 10) Title 10 Code of Federal Regulations, which states: Title 10 Code of Federal Regulations is available at: http://www.nrc.gov/reading-rm/doc-collections/cfr/. A licensee may use for medical use only:

i. Byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issue pursuant to the regulations in Title 10, Code of Federal Regulations, part 30 and SS32.72, or 32.74 of this chapter or the equivalent regulations of an Agreement State:

ii. Reagent kits that have been manufactured, labeled, packed, and distributed in accordance with the approval by the Commission pursuant to S32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

c. Hazardous Waste/Waste Regulation. The Contractor will comply with all applicable requirements of Federal, State and local hazardous waste regulations.

d. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA COS or designee show documented problems or continual unprofessional behavior/actions with any Contractor employee(s), she/he may request, without cause, immediate replacement of said Contractor employee(s). The CO and COR shall deal with issues raised concerning Contractor employee(s) conduct. The final arbiter on questions of acceptability is the CO.

3. Contractor Responsibility

a. The contractor shall guarantee the quality of all radiopharmaceuticals. Quality control shall include percent tag and MO99 breakthrough as appropriate. The Contractor shall conduct Quality Control on each agent dispensed. The Contractor shall guarantee the quality of all radiopharmaceuticals. The Contractor shall provide complete documentation on Quality Control results upon request.

b. All products provided under this contract shall meet all requirements of the Nuclear Regulatory Commission (NRC). All products provided under this contract shall be packaged and shipped in accordance with the requirements of the NRC and Department of Transportation (DOT). All products returned will also be packaged in accordance with the requirements of the NRC and DOT. The products under this contract shall meet all requirements under the FDA and United States Pharmacopeia and the National Formulary (USP-NF). Compliance with all OSHA manufacturing, packaging, and shipping regulations is required.

c. The contractor shall provide a quarterly linearity source as listed in the CLIN schedule. The activity requested can range from 25 to 250 mCi. All labeled products shall be LEU-derived radiopharmaceuticals where applicable and available.

d. In the event the product fails due to half-life or any other issue at the fault of the contractor because of transportation issues or delays, the contractor shall replace the product at no cost.

e. The Contractor shall provide 24 hours on call service for emergency procedures.

f. The Contractor shall provide documentation of inventory, disposal, and patient dose records, which documents compliance with Nuclear Regulatory Commission (NRC) requirements and Fargo VA HCS NHPP permit/NRC License.

g. The Contractor shall provide complete documentation on inventory, disposal, and patient dose records upon request.

h. The Contractor shall provide the radiopharmaceuticals and estimated quantities listed on the price schedule. Types and quantities of product may change throughout the course of the contract. The contractor will provide a mutually agreeable solution during product shortages. Contractor shall provide notification within 2 days of product change. In the event of a shortage the VA will receive first shipment of all products. Additionally, availability of sealed source and flood phantom purchases as requested.

i. Contractor must test all products for Quality Control periodically 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.

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

(1) Provide technical expertise in calibration .

(2) Provide professional examination of product; submit results and recommendations to the applicable point of contact.

(3) Make expedient replacement of any product suspected of being deficient.

k. Contractor must provide current material safety data sheets in a in a binder and updates as necessary on all delivered products for each medical center or the contractor must provide their website link where MSDS and package inserts for all radiopharmaceuticals can be read and printed.

l. Contractor must assign to each medical center an individual sales representative to aide in facilitation in the smooth coordination between the medical center and laboratory pharmacy.

m. The contractor will be responsible for all reimbursement of the original and/or repeat items because of mishandling or loss. RECALLED AND DEFECTIVE PRODUCTS: the Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled / defective products.

n. BACK-UP DOSES: Allowable, but only if 100% refundable.

3. Product Delivery

a. 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.

b. Contractor personnel, drivers, and alternates, shall be able to read, write, speak, and understand English language fluently. Personnel shall present a neat appearance and be easily recognized as a contract employee by wearing an identification badge that includes the company’s recognized as a contract employee by wearing an identification badge that includes the company’s name/logo and employee name and photograph. Vehicles used during this service shall prominently display the company’s name/logo.

c. The Government will NOT issue a Government identification badge for contract personnel. Should this requirement change after contract award, the contractor will be given thirty (30) days to obtain a VA-issued identification badge for each contract employee physically entering the Sioux Falls VAHCS & Fargo VAHCS.

d. Contractor must ensure that courier service/drivers maintain their Motor Carrier Permit, hazardous material license number, certificate of training of couriers (employees), valid state-issued drivers’ licenses, vehicle insurance and registration. The contractor shall be required to maintain a record log of courier deliveries, indicating time and date, number and description of items for each location, along with signatures.

e. All vehicles are to be insured in accordance with the regulations of the State of Minnesota at the expense of the contractor.

f. Contractor must label all products as to the amount of radiopharmaceutical, preparation time, expiration time and date, etc.

g. Contractor must follow all USP 797 guidelines and provide verification of compliance upon Contracting Officer request.

h. Contractor must replace any items delivered in error at no cost to the medical center.

i. For routine orders placed and delivered Monday through Friday between the hours of 7:00 a.m. to 5:00 p.m., delivery shall be made within 24 hours after receipt of telephone order from a designated individual in the Radiology Service prescribed below.

j. Emergency weekday orders placed between the hours of 7:00 a.m. to 5:00 p.m. Monday through Friday shall be delivered within 60 minutes after the vendor's receipt of the telephone order. All orders must be confirmed within 30 mins of receipt of order.

k. Emergency orders placed weeknights, weekends and holidays shall be delivered within 2 ½ hours after the vendor's receipt of the telephone order. All orders must be confirmed within 30 mins of receipt of order.

l. Authorized Ordering Individuals: Orders may be placed by telephone by one of the following: Fargo VA functions:

a. Nuclear Medicine Technologist

b. Imaging Supervisor

c. Nuclear Medicine Physicians

m. The Federal Holidays observed by the Federal Government are:

The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

4. Billing / Invoices

a. Payments: invoices are to be submitted monthly, in arrears, for all products delivered during the previous month. Invoices shall be sent to the address as indicated on the purchase order.

b. Contractor shall 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 must be received within 48 hours of notification by the VA.

c. Contractor must submit a weekly invoice to the COR, in arrears, showing period covered, billing date, name of preparation, quantity, and amount. The invoices shall contain the following information at a minimum:

i. Purchase Order Number

ii. Name of Radiopharmaceutical agent and the unit/unit cost

iii. Total price

d. Billings rendered by the contractor for services furnished under the terms of this contract shall be billed in full. Neither beneficiary, his/her insurer, nor any other third party shall be billed.

e. Payments for services will be at the rates specified in the Schedule of Supplies/Services.

f. Payment shall only be made for actual services rendered.