Attachment B - SOW.docx

STATEMENT OF WORK

1. SCOPE

All Radiopharmaceutical Supplies shall be provided in accordance with the terms and conditions, provisions and clauses provided herein for the period of performance, which shall be dated from April 1, 2022 thru March 31, 2023 as the needs of VA Long Beach Nuclear Medicine continues for base year.

PARTICIPATING VA HEALTHCARE SYSTEMS:

VA Long Beach Healthcare System (VALBHCS) 5901 East 7th Street Long Beach, CA 90822

2. ROUTINE ORDERS

Routine orders require delivery the next business day, unless specified by authorized personnel.

3. EMERGENCY ORDERS

An emergency delivery requires same day delivery and with the time specified during the placement of order.

4. DELIVERY LOCATION, NORMAL WORK HOURS AND INSTRUCTIONS:

VA LONG BEACH HEALTHCARE SYSTEM:

Delivery Location – Radiology/Nuclear Medicine Imaging Service, Building 126, Room E119, 1st Floor Normal Work Hours – 8:00am to 4:00pm, Monday through Friday Instructions – 1) Isotopes arriving during normal work hours shall be delivered to the delivery location.

2) Isotopes arriving outside normal work hours, on weekends, or holidays, shall be delivered to the Ambulatory entrance of Bldg. 126 (main building facing 7th St) and must be signed for by the Medical Administrative Officer on duty. Isotopes are not to be left with the Telephone Operator or at the information desk at the lobby.

5. UNIT DOSE ITEMS

For unit-dose items, products shall be pre-drawn into a syringe, calibrated and delivered at time specified when ordered. The word “Dose” represents the maximum size potency per unit price; however, order may be less.

6. PACKAGING AND MARKING

a) The contractor shall package, mark and transfer all radioactive material in accordance with all applicable local, state, federal laws and regulations.

b) Items must be adequately packaged to prevent damage during shipping, handling, and storage.

c) All outer packages must contain the complete purchase number, obligation number and contract number in addition to the shipping address. The purchase number and obligation number will be provided by the individual at the time of ordering. The contract number will be provided upon notice of contract award.

d) Packaging List: A packing list/slip shall be enclosed with each shipment indicating the purchase/obligation and delivery order number, contract number, items/quantity ordered and items/quantity shipped.

7. RECALLED AND DEFECTIVE PRODUCTS

The Contractor will immediately notify the Contracting Officer Representative (COR) and Contracting Officer (CO) 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 is responsible for costs of processing recalls to replace recalled/defective products.

8. CERTIFICATION AND LICENSING REQUIREMENT

Pharmacists employed by the Contractor shall be an authorized user on the Contractor’s Radioactive Materials License. The Pharmacy of the Contractor shall be licensed by the State of Operation and by the Nuclear Regulatory Commission or Agreement State Agency.

9. SAFETY GUIDELINES AND REQUIREMENTS

Delivery personnel shall be trained in Radiation Safety Techniques, Nuclear Regulatory Commission, Joint Commission safety guidelines and Department of Transportation requirements.

10. NOTIFICATION

The contractor shall notify the Contracting Officer Representative (COR) or alternate point of contact (POC) at VALBHS of medication shortages and outages as soon possible.

The COR/alternate POC shall be contacted via phone or email:

Mobile: (562) 414-8030

11. NATIONAL HOLIDAYS OBSERVED BY THE GOVERNMENT

https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

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 referenced site 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.

12. CONTRACTOR DELIVERY PERSONNEL

All contractor personnel are required to wear clothing bearing the name of the Contractor and wear a badge that has the Contractor’s name. Contractor personnel must have a picture I.D. and must be able to speak English.

11.1 Contractor shall provide the COR with a list of contractor personnel expected to possibly enter the buildings. While on VALBHCS premises or off-site parking locations, all contractor personnel shall comply with the rules, regulations, and procedures governing the conduct of personnel and the operation of the facility.

11.2 Contractor personnel shall comply will all VALBHCS policies regarding health and security measures to enter VALBHCS facility. Measures may include but are not limited to answering health screening questions, having temperature taken, or any other measures VALBHCS may use to maintain health and safety of public entering facility.

11.3 Current policies shall be distributed and updated as needed by the COR.

11.4 It is the responsibility of the contractor’s personnel to park in the appropriate designated parking areas. Parking information shall be coordinated with facility COR.

11.5 VALBHCS shall not validate or make reimbursement for parking violations of the Contractor’s personnel under any circumstance.

11.6 Contractor shall comply with all security policies/requirements. All security policies/requirements must be met, and personnel cleared prior to the contractor performing work under this contract. Personnel that cannot meet the security and clearance requirements shall not be allowed to perform work under this contract.

13. Identification, Parking, Smoking, and VA Regulations:

12.1 Contractor personnel shall wear visible identification issued by VALBHCS Police Section at all times while on the premises of VALBHCS. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. VALBHCS will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at VALBHCS our outside of any designated smoking area on premises. Possession of weapons is prohibited. Enclosed containers, including tool kit shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

14. PLACEMENT OF VERBAL ORDERS

Contractors shall provide on a separate sheet of paper, the name, location, and telephone number of the office where the participating VA facility will call to place orders.

15. PERSONNEL POLICY

The parties agree that the contract personnel working this contract shall not be considered VA employees for any purpose and shall be considered employees of the contractor.

Delivery Requirements

· Contractor must be available 24hrs/day 365 day/year

· Pharmacy must be at a distance no more than one hour from facility to ensure timely delivery for emergency orders.

· The contractor shall have all applicable licenses and certifications issued by the NRC or Agreement state that allows shipping of radioactive materials to nuclear medicine providers in my state and must show proof all certifications and licenses are current.

· Contractor’s Radioactive Materials License

· Nuclear Regulatory Commission

· Department of Transportation requirements

· Joint Commission safety guidelines

· FDA approval

· All applicable certifications and licenses referenced in 49 CFR 172.

· Contractor must meet packaging requirements outlined in the statement of work (SOW), NRC and the 49 CFR 172.

· Company providing services must provide dose labels compatible with the Nuclear Medicine information System (NMIS) computerized radio-pharmacy database.

· All radiopharmaceutical compounding must meet the requirements of USP <795> and/or <797>

· The nuclear pharmacy shall not procure compounded preparations from another nuclear/compounding pharmacy for resale to VA Long Beach Healthcare System (VALBHS).

· Contractor shall maintain required vehicle insurance for the delivery of radiopharmaceuticals.

· Delivery personnel training shall have training in Hazmat and Security training that meets the requirements of 49 CFR 172 for transportation of radioactive materials.

· Prescription labels are compliant with Board of Pharmacy regulations and 49 CFR 172.

· The contractor’s physical facilities and equipment shall meet or exceed USP <797> requirements for compounding sterile preparations (buffer area, segregated compounding area, primary engineering controls, HEPA air filtration) including testing and certification.