SOW-NEURACEQ.pdf

STATEMENT OF WORK

NEURACEQ-F18 FLORBETABEN UNIT DOSE RADIOPHARMACEUTICAL

DELIVERY TO

THE LEXINGTON, KY VA HEALTH CARE SYSTEM, NUCLEAR MEDICINE /PET

DEPT.

Delivery/Scope: Quantities expressed in the schedule are estimates based on usage for one year. Quantities may vary based on patient demand. The initial term of this agreement will be for base plus 4 years.

• All Radiopharmaceuticals 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.

• Contractor/Supplier shall abide by (CFR 10) Title Code of Federal Regulations, which states: A licensee may use for medical use only:

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

• All routine orders for F18 Neuraceq shall be placed as needed by the Nuclear Medicine Staff at least 24 hours prior to the patient study date and delivered for the specified dates and times. It is understood that orders for the next day must be placed with the Pharmacy by 5:00pm.

• The Contractor will ensure that all Neuraceq doses are delivered at least 15-30 minutes prior to the dose calibration time.

• Patients last name only will be entered in the Contractors Web site to reserve a dose.

• C&A requirements do not apply, and a Security Accreditation Package is not required.

• If the ordered Radiopharmaceutical is not available and cannot be delivered to the VA when needed, the contractor will notify the VA Nuclear Medicine Department within 2 hours before the scheduled delivery time.

• The first delivery shall be made to Nuclear Medicine (Room A-152a) depending on product availability within 15- 30 minutes before the calibration time unless prior authorization arrangements have been made. Product must be available for calibration times as early as 11:00. Delivery shall be made directly to a Nuclear Medicine Technologists on duty. Deliveries before 6:00am shall be made by contacting the VA Police Department located on the first floor to unlock the Nuclear Medicine Department Night Entry (Room A-152A) for placement of the packages.

• The Contractor shall deliver all radiopharmaceuticals with NO added fuel surcharge.

• Delivery personnel shall be bonded by the Contractor.

• Contractor shall provide evidence of special driver’s licenses required for transporting hazardous materials, and the couriers must be wearing identification tags upon enter the VA.

• Contractor shall meet all Nuclear Regulatory Commission, Department of

Transportation, FDA, OSHA, and all other State and Federal rules and regulations.

• All radiopharmaceuticals shall be delivered in proper shielded containers with disposal impenetrable biohazard liners. Shipping containers and their labeling must comply with all federal and state regulations.

• Contractor will provide a packing list which provides a Description product code, activity amount, Calibration date/time, Expiration date/time, volume, Qty, Rx # with each delivery.

• All unit dose radiopharmaceuticals delivered must have a bar code for scanning into a dose tracking system.

• Any recalled / incorrectly delivered dose for any reason shall be credited for the full amount.

• If the ordered Radiopharmaceutical is not available and cannot be delivered to the VA when needed, the Contractor will notify the VA Nuclear Medicine Department 859- 381-5927 by 8:00am local time and will not bill the customer.

• Customer must notify Pharmalogic by 8:00am local standard time on the day of the patient’s study to cancel an order or the customer shall be responsible for the payment.

• Incorrectly delivered doses shall not exceed one per month.

• Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed two per year.

• Federal Holidays will be observed, and the Nuclear Medicine Department will be closed on the days listed below:

- New Year’s Day

- Martin Luther King’s Birthday

- Presidents Day

- Memorial Day Juneteenth

- Independence Day Labor Day

- Columbus Day

- Veterans Day

- Thanksgiving

- Christmas Day

- Any other day declared a Federal Holiday by the US President.

• Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians.

• Radiopharmaceuticals shall be calibrated and labeled with concentration, calibration time, total volume, total activity and expiration time and date.

• The Radiopharmacy shall be USP <825> compliant for sterile compounding and shall provide a statement to this effect.

• Product information including suppliers’ source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier’s license and procedures shall be provided upon request at no additional charge.

• Consultation services regarding radiopharmaceutical applications, problems, controls, etc., shall be provided upon request at no charge.

• Personnel authorized to place orders: The following personnel are authorized to telephone and or fax radiopharmaceutical orders:

• Supervisory Nuclear Medicine Technologist

• Nuclear Medicine / PET Technologist

• Other Lexington VA Medical Staff as designated

Invoicing

• Contracting Officer Representative (COR) shall be provided with a copy of the invoice at the end of each month for approval before submission to the Contract Radiopharmacy’s Business Center for processing. Invoices shall be submitted electronically to: Jennifer.Coffey@va.gov.

• Said invoices will be reviewed by the COR for accuracy and any discrepancies corrected and a new invoice sent before invoice is finalized. All invoices will include the following

a) Name and address of the Contractor

Invoice date and purchase order number Contact number or PO# An itemized listing of charges.

• Invoices are to be submitted by the contractor to the Invoice Processing Payment System for payment.

• Contractor shall be paid monthly, in arrears, upon a submission of a properly prepared invoice for services / supplies during the period.

Performance/Quality

• Incorrectly delivered doses shall not exceed one per month.

• Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one per quarter, i.e. 4 per year.

• It is the offerors 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 Representative via the most expedient method.

• Contractor shall provide complete documentation of quality control results upon request.

Product information including suppliers’ 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.

• Offeror will perform quality control on each agent dispensed. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Only those products that pass quality control may be sent to the VA Nuclear Medicine Service. The supplier will demonstrate documentation of quality control performance of any item upon request of the VA Nuclear Medicine Service.

• All products are purchased subject to acceptance by the VA Nuclear Medicine Service.

Products that fail to meet quality control criteria of Nuclear Medicine will not be accepted.

Products will be rejected and may be discarded if found unsatisfactory by the Nuclear Medicines quality control 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.

Qualifications: Personnel assigned by the contractor to perform the services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by VA Facility Director.

Personnel Policy: The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for those personnel: workers compensation professional liability insurance, health examinations, income tax withholding and Social Security payments. Such personnel shall not be considered VA employees for any purpose and shall be considered employees of the contractor.

Evaluation Methodology: The Government intends to award this contract based on the lowest price technically acceptable.

• The Government intends to award one Firm Fixed Price requirement contract if applicable to the responsible Offeror summiting proposals that are determined to be lowest price technically acceptable. Lowest Price, Technically Acceptable (LPTA) means that the award will be made to the Offeror whose price is lowest among all proposals that were deemed to be technically acceptable.

• Technically acceptable will be measured minimally by:

The Offerors ability to meet desired turnaround times as stated in the Statement of

Work.

Past performance references.

• The solicitation specifies the technical requirements that the VA Health Care System has established above in the detailed Statement of Work (SOW) the award will be made based on the lowest “aggregate” price of proposals meeting or exceeding the acceptable standards for non-cost factors in accordance with FAR 15.101-2(b)(1).

• The Government intends to award this contract on a base period of 12 months and four

(4) consecutive twelve-month option years.