Radiopharmaceutical SOW_DRAFT.docx

Department of Defense Defense Health Agency Statement of Work

Radiopharmaceutical Supplies

01October 2026

Naval Medical Center Portsmouth (NMCP)- Radiology Naval Hospital Jacksonville (Jacksonville)- Radiology Naval Medical Center Camp Lejeune (NMMCL)- Radiology

1.0 GENERAL INFORMATION

1.1 This is a non-personal supply contract to provide Pharmaceutical Solutions for cancer patients.

1.1.1 Description of supply: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform. The vendor will provide Pharmaceutical Solutions for cancer patients as defined in this Statement of Work (SOW).

1.1.2 Background: The Naval Medical Center Portsmouth (NMCP), Naval Hospital Jacksonville (Jacksonville, FL), and Naval Medical Center Camp Lejeune (NMMCL) Radiology Department have a current contract for radiopharmaceuticals and supplies that are expiring on 01 October 2026 and requires a new contract. The radiopharmaceuticals and supplies need to be delivered on an as needed basis to each Military Treatment Facilities (MTF) Radiology Department.

1.1.3 Scope:

1.1.3.1. NMCP - DELIVERY INSTRUCTIONS

1. The contractor shall provide all unit dose Radiopharmaceuticals used by the Radiology Department at NMCP.

1. The contractor shall provide delivery items at NMCP Receiving Dock, Monday through Friday from 0700 to 1600 (7:00 a.m. to 4:00 p.m.), excluding federal holidays. Receiving personnel may be reached at 757-953-5770.

1. The contractor will be contacted by the staff of the Radiology Department.

3.1. Contractor shall provide delivery and transportation of radioactive materials to the Naval Medical Center Portsmouth (NMCP) compound, conforming to all policies of the NMCP Radiation Safety Committee and all applicable National Regulatory Commission (NRC) and Department of Transportation (DOT) regulations governing transportation and handling of radioactive materials. Point of Contact: Radiation Safety Officer, Naval Medical Center Portsmouth, Phone: 757-953-1192 or pager 757-314-0745. Contractor’s pricing shall include costs of supplies (medical doses per patient), preparation and delivery of radioactive pharmaceuticals directly to the Radiology Department, Nuclear Medicine Division, Building 2, first floor, Room 121102.

3.2. All aspects of implementing and maintaining this contract relating to the use of radioactive materials will conform to the requirements of the Naval Medical Center Portsmouth Navy Radioactive Materials Permit 45-00183-11NP and all applicable federal regulations.

1. Routine Delivery Requirements:

4.1. Contractor Responsibilities

a) Delivery of all pharmaceuticals shall occur no later than 7:00 A.M. on the day of use (Monday – Friday), unless a second day delivery at 10:00 A.M. is required to accommodate the ordered dose calibration time. Except, delivery of NAI-131 orders shall occur no later than 1100 on the day of use (Monday – Friday). DEL MED or FEDEX delivery is acceptable.

b) Emergent orders (those placed on the same day of need) shall be delivered no later than 2 hours after the order is received by the pharmacy to meet the dose administration for patient care.

c) Tagged studies (In111 or 99mTc Ceretec) shall be returned to NMCP within 5 hours after radio pharmacy takes custody of the patient sample.

d) Contractor shall maintain 95% on-time rate for deliveries.

4.2. Government Responsibilities

a) Scheduled orders will be made via fax no later than 4:00 P.M. in the evening prior to calibration. After 4:00 P.M. orders will be made by phone.

1. Emergent Delivery Requirements:

5.1. Contractor Responsibilities

a) Orders made on an emergent basis (outside of normal hours) shall be delivered within 2 hours of being ordered via phone by authorized personnel.

1. Radiopharmaceutical requirements:

a) All radiopharmaceuticals shall be prepared in accordance with manufacturer’s specifications.

b) All applicable manufacturer recommendations pertaining to 99mTc eluate shall be observed including but not limited to 99Mo concentration <0.15 uCi/mCi Tc99m, AI+++ concentration <10ug/ml and expiration shelf life.

c) Radiochemical purity testing shall be performed on all radiopharmaceuticals in accordance with manufacturer recommendations.

d) Product substitutions (or equivalent) shall not be allowed without prior approval of appropriate NMCP Authorized User and Radiation Safety Officer (for radioisotope charges).

e) 99mTc MAA shall not exceed the product insert maximum suggested number of particles per dose and shall be adjusted at the request of NMCP in cases of patients with right to left shunts and pulmonary hypertension.

f) All diagnostic radiopharmaceutical doses shall be within +/- 10% of the requested activity at calibration time.

g) All therapeutic doses must be within +/-5% of requested activity at calibration time.

h) All “pigs” containing unit doses shall be appropriately labeled in accordance with regulations to include but not be limited to RP name, calibrated activity, Cal time, date, expiration, Pt. Name, Authorized username.

i) All unit dose syringes/vials shall display RP name, calibrated activity, cal time, date, expiration, Pt. name, authorized username.

j) All bulk radiopharmaceutical vials shall display RP name, calibrated activity, cal time, date, expiration, and authorized username.

1. Back-up delivery (Monday – Friday): Delivery of 1 vial of 99mTc04; 150mCi calibrated @ 2000.

1. Packing Slips: Two (2) copies of the packing slip shall be left with the delivery. Under no circumstances shall any price be changed due to problems with the product being delivered to and/or received by the Naval Medical Center Portsmouth. Should the quantities received, and our delivery be changed for any reason, a corrected packing slip should be mailed within two (2) working days with the proper number of items received.

1.1.3.2. NH JACKSONVILLE, FL - DELIVERY INSTRUCTIONS

1. The contractor shall provide all unit dose Radiopharmaceuticals used by the Radiology Department at Jacksonville.

2. The contractor shall provide Radiopharmaceuticals to Room 1274 during standard hours of care Monday through Friday from 0700 to 1630 (7:00 a.m. to 4:30 p.m.), including Federal holidays. After hours coverage will be available Saturday and Sunday from 0700 to 1630 (7:00 a.m. to 4:30 p.m.) and Monday through Sunday from 1630 to 0730 (4:30 p.m. to 7:30 a.m.), including Federal holidays.

3. The contractor will be contacted by the staff of the Radiology Department.

3.1. Contractor shall provide delivery and transportation of radioactive materials to the Naval Medical Center Portsmouth (NMCP) compound, conforming to all policies of the NMCP Radiation Safety Committee and all applicable National Regulatory Commission (NRC) and Department of Transportation (DOT) regulations governing transportation and handling of radioactive materials. Point of Contact: Radiation Safety Officer, Naval Medical Center Portsmouth, Phone: 757-953-1192 or pager 757-314-0745. Contractor’s pricing shall include costs of supplies (medical doses per patient), preparation and delivery of radioactive pharmaceuticals directly to the Radiology Department, Nuclear Medicine Clinic, Room 1270.

3.2. All aspects of implementing and maintaining this contract relating to the use of radioactive materials will conform to the requirements of Naval Hospital Jacksonville Navy Radioactive Materials Permit 45-00183-11NP and all applicable federal regulations.

4. Routine Delivery Requirements:

4.1. Contractor Responsibilities:

a) Delivery of all pharmaceuticals shall occur no later than 7:00 A.M. on the day of use (Monday – Friday), unless a second day delivery at 10:00 A.M. is required to accommodate the ordered dose calibration time. Except, delivery of NAI-131 orders shall occur no later than 1100 on the day of use (Monday – Friday). DEL MED or FEDEX delivery is acceptable.

b) Emergent orders (those placed on the same day of need) shall be delivered no later than 2 hours after the order is received by the pharmacy to meet the dose administration for patient care.

c) Tagged studies (In111 or 99mTc Ceretec) shall be returned to NMCP within 5 hours after radio pharmacy takes custody of the patient sample.

d) Contractor shall maintain 95% on-time rate for deliveries.

4.2. Government Responsibilities

a) Scheduled orders will be made via fax no later than 4:00 P.M. the evening prior to calibration. After 4:00 P.M. orders will be made by phone.

5. Emergent Delivery Requirements:

5.1. Contractor Responsibilities

a) Orders made on an emergent basis (outside of normal hours) shall be delivered within 2 hours of being ordered via phone by authorized personnel.

6. Radiopharmaceutical requirements:

a) All radiopharmaceuticals shall be prepared in accordance with manufacturer’s specifications.

b) All applicable manufacturer recommendations pertaining to 99mTc eluate shall be observed including but not limited to 99Mo concentration <0.15 uCi/mCi Tc99m, AI+++ concentration <10ug/ml and expiration shelf life.

c) Radiochemical purity testing shall be performed on all radiopharmaceuticals in accordance with manufacturer recommendations.

d) Product substitutions (or equivalent) shall not be allowed without prior approval of appropriate NH Jacksonville Authorized User and Radiation Safety Officer (for radioisotope charges).

e) 99mTc MAA shall not exceed the product insert maximum suggested number of particles per dose and shall be adjusted at the request of NH Jacksonville in cases of patients with right to left shunts and pulmonary hypertension.

f) All diagnostic radiopharmaceutical doses shall be within +/- 10% of the requested activity at calibration time.

g) All therapeutic doses must be within +/-5% of requested activity at calibration time.

h) All “pigs” containing unit doses shall be appropriately labeled in accordance with regulations to include but not be limited to RP name, calibrated activity, Cal time, date, expiration, Pt. Name, Authorized username.

i) All unit dose syringes/vials shall display RP name, calibrated activity, cal time, date, expiration, Pt. name, authorized username.

j) All bulk radiopharmaceutical vials shall display RP name, calibrated activity, cal time, date, expiration, and authorized username.

7. Back-up delivery (Monday – Friday): Delivery of 1 vial of 99mTc04; 150mCi calibrated @ 2000.

8. Packing Slips: Two (2) copies of the packing slip shall be left with the delivery. Under no circumstances shall any price be changed due to problems with the product being delivered to and/or received by the Naval Medical Center Portsmouth. Should the quantities received, and our delivery be changed for any reason, a corrected packing slip should be mailed within two (2) working days with the proper number of items received.

1.1.3.3. NMCCL - DELIVERY INSTRUCTIONS

1. The contractor shall provide all unit dose Radiopharmaceuticals used by the Radiology Department at NMCCL.

2. The contractor shall provide delivery and transportation Delivery of radioactive pharmaceuticals directly to the NMCCL Radiology Department, Nuclear Medicine Division, Hot Lab. Monday – Friday between 0600 - 1430. (6:00am-2:30pm) excluding federal holidays. Receiving personnel can be reached at 910-453-6988.

3. The contractor will be contacted by the staff of the Radiology Department.

3.1. Contractor shall provide delivery and transportation of radioactive materials to the NMCCL compound, conforming to all policies of the NMCCL Radiation Safety Committee and all applicable National Regulatory Commission (NRC) and Department of Transportation (DOT) regulations governing transportation and handling of radioactive materials. Point of Contact: Radiation Safety Officer, Naval Medical Center Camp Lejeune, Phone: 910-450-3009. Contractor’s pricing shall include costs of supplies (medical dose per patient), preparation and delivery of radioactive pharmaceuticals directly to the Radiology Department, Nuclear Medicine Division, first floor.

3.2. All aspects of implementing and maintaining this contract relating to the use of radioactive materials will conform to the requirements of the Naval Medical Center Camp Lejeune Navy Radioactive Materials Permit 45-35423-01 and all applicable federal regulations.

4. Routine Delivery Requirements:

4.1. Contractor Responsibilities:

a) Delivery of all pharmaceuticals shall occur no later than 7:00 A.M. on the day of use (Monday – Friday), unless a second day delivery at 10:00 A.M. is required to accommodate the ordered dose calibration time.

b) Emergent orders (those placed on the same day of need) shall be delivered no later than 2 hours after the order is received by the pharmacy to meet the dose administration for patient care.

c) Tagged studies (In111 or 99mTc Ceretec) shall be returned to NMCCL within 5 hours after radio pharmacy takes custody of the patient sample.

d) Contractor shall maintain 95% on-time rate for deliveries.

4.2. Government Responsibilities

a) Scheduled orders will be made via contractor’s website or fax no later than 4:00 P.M. in the evening prior to calibration. After 4:00 P.M. orders will be made by phone.

5. Emergent Delivery Requirements:

5.1. Contractor Responsibilities

a) Orders made on an emergent basis (outside of normal hours) shall be delivered within 2 hours of being ordered via phone by authorized personnel.

6. Radiopharmaceutical requirements:

a) All radiopharmaceuticals shall be prepared in accordance with manufacturer’s specifications.

b) All applicable manufacturer recommendations pertaining to 99mTc eluate shall be observed including but not limited to 99Mo concentration <0.15 uCi/mCi Tc99m, AI+++ concentration <10ug/ml and expiration shelf life.

c) Radiochemical purity testing shall be performed on all radiopharmaceuticals in accordance with manufacturer recommendations.

d) Product substitutions (or equivalent) shall not be allowed without prior approval of appropriate NMCCL Authorized User and Radiation Safety Officer (for radioisotope charges).

e) 99mTc MAA shall not exceed the product insert maximum suggested number of particles per dose and shall be adjusted at the request of NMCCL in cases of patients with right to left shunts and pulmonary hypertension.

f) All diagnostic radiopharmaceutical doses shall be within +/- 10% of the requested activity at calibration time.

g) All therapeutic doses must be within +/-5% of requested activity at calibration time.

h) All “pigs” containing unit doses shall be appropriately labeled in accordance with regulations to include but not be limited to RP name, calibrated activity, Cal time, date, expiration, Pt. Name, Authorized username.

i) All unit dose syringes/vials shall display RP name, calibrated activity, cal time, date, expiration, Pt. name, authorized username.

j) All bulk radiopharmaceutical vials shall display RP name, calibrated activity, cal time, date, expiration, and authorized username.

7. Back-up delivery (Monday – Friday): Delivery of 1 vial of 99mTc04; 150mCi calibrated @ 2000.

8. Packing Slips: Two (2) copies of the packing slip shall be left with the delivery. Under no circumstances shall any price be changed due to problems with the product being delivered to and/or received by the Naval Medical Center Portsmouth. Should the quantities received, and our delivery be changed for any reason, a corrected packing slip should be mailed within two (2) working days with the proper number of items received.

2.0. LIST of REQUIRED SUPPLIES

Naval Medical Center Portsmouth

Nuclear Medicine Clinic, Naval Hospital Jacksonville

Naval Medical Center Camp Lejeune

3.0. GENERAL INFORMATION

3.1. Ordering Period: 01 October 2026 – 30 September 2031

3.2. Delivery Locations:

NMCP- Naval Medical Center Portsmouth, Radiology – Nuclear Medicine, 620 John Paul Johns Circle, Portsmouth, VA 23708.

Jacksonville- Naval Hospital Jacksonville, Radiology – 2080 Child Street, Nuclear Medicine Jacksonville, FL 32214.

NMCCL- Naval Medical Center Camp Lejeune, Radiology – Nuclear Medicine, 100 Brewster Blvd, Camp Lejeune NC 28547.

3.3. Recognized Federal holidays: Deliveries are not required.

Independence Day

3.4. Contractor Identification: Contractor personnel performing services in a contractor capacity in a government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the Government understand that the person is contractor support personnel.

3.5. Start-Up Period: It is intended to make award of the resultant contract in time to allow up to fifteen (15) day start-up period in advance of the actual commencement of the performance period. The contractor shall make all necessary preparations, during this start-up period, to assume full responsibility for contract performance as of the contract start date. It is noted that invoices from the contractor will begin as of the commencement of supplies delivered and no reimbursement will be paid by the Government for efforts expended during the start-up period.

3.6. Delivery Orders:

3.6.1. Task orders may be placed by any warranted contracting officer serving at the Defense Health Agency.

3.6.2. Task orders against this contract may be placed by mail, facsimile, or through electronic commerce, including email in accordance with the terms and conditions of the contract.

3.6.3. The period of performance of any task order shall be one year or less in duration.

4.0 ADMINISTRATIVE SPECIFICATIONS

4.1. Base Access: Commander, Navy Installations Command (CNIC), has established the Department of Navy Local Population ID Card/Base Access Pass Registration (DBID), a standardized process for granting unescorted access privileges to vendors, contractors, suppliers and service providers not otherwise entitled to the issuance of a Common Access Card (CAC) who seek access to and can provide justification to enter Navy installations and facilities. Vendors visiting the MTF may obtain daily passes directly from Naval Pass and ID office, by submitting identification credentials for verification and undergoing a criminal screening/ background check. Alternatively, if the vendor so chooses, it may voluntarily elect to obtain long-term credentials through enrollment, registration, background vetting, screening, issuance of credentials, and electronic validation of credentials at its own cost through one of the designated independent contractors NCACS service providers. Credentials will be issued every five years, and access privileges will be reviewed / renewed on an annual basis. The costs incurred to obtain Navy installation access of any kind are not reimbursable, and the price(s) paid for obtaining long-term NCACS credentials will not be approved as a direct cost of this contract. Further information regarding DBID can be found at SECNAV 5512/1 (MAY 2021)

4.2. Invoicing and Shipping Instructions – The following invoicing instructions will appear on each delivery order:

a. The delivery order written from this IDIQ FFP contract can be paid via Wide Area Workflow (WAWF) or the GPC Contract Ordering Official Cardholder (COOC). See each delivery order for invoicing.

b. Important Payment Information: In accordance with FAR Clause 52.232-25, entitled “Prompt Payment”, the contractor shall provide evidence of shipment with their invoice in order for the invoice to be considered proper. The evidence of shipment must include the signature of a Government representative authorized to sign and accept the delivery. Invoices submitted without evidence of shipment shall be considered to be improper within the meaning of FAR 52.232-25 and will be returned for correction and resubmittal.

5.0 Points of Contact

5.1 IDIQ Points of Contact:

Contracting Officer:

Carol Uebelacker - carol.e.uebelacker.civ@health.mil

5.2. Delivery Order Point of Contacts: POCs shall be listed in delivery order. Each Medical Treatment Facility will have individual Contracting Officer Representatives (COR) assigned.

6.0 Special Contract Requirements

6.1. AUTHORIZED CHANGES ONLY BY THE CONTRACTING OFFICER

a. Except as specified in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the contractor’s facilities or in any other manner communicates with contractor personnel during the performance of this contract shall constitute a change under the “Changes” clause of this contract.

b. The contractor shall not comply with any order, direction, or request of Government personnel unless it is issued in writing and signed by the Contracting Officer or is pursuant to specific authority otherwise included as part of this contract.

c. The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer’s. In the event the contractor effects any changes at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority, and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

6.2. Ordering Terms:

6.2.1. Pursuant to FAR 16.5, the Contractor agrees to the following terms of the proposed Indefinite Delivery Indefinite Quantity (IDIQ) Firm Fixed Price (FFP) contract exclusively with the Defense Health Agency (DHA).

6.2.2. Exact item descriptions available through this IDIQ FFP contract are specified within the SOW, List of Required Items. Exact quantities and delivery requirements are not known in advance and may vary considerably per order.

6.2.3. All delivery orders placed against this IDIQ FFP contract are subject to the terms and conditions set forth within or as noted below:

6.2.3.1. In accordance with FAR 16.505(a)(6), orders placed under indefinite delivery contracts must contain the following information:

(iii)For supplies and services, contract item number and description, quantity, and unit price or estimated cost or fee (iv) Delivery or performance schedule

(v) Place of delivery or performance (including consignee)

(vi) Any packaging, packing, and shipping instructions

(vii) Accounting and appropriation data

(viii) Method of payment and payment office, if not specified in the contract (see FAR 32.1110 (e)).

6.2.3.2. Special clauses shall be included, when required, on a delivery order basis and agreed to with contractor.

6.2.4. Warranty Terms: All products shall be covered by the standard commercial warranty of the contractor.

6.3. Delivery and Mark For Terms: Delivery shall be F.O.B. Destination within the continental United States, or as stated in each order. The Mark For Instructions shall be included in each order.

6.4. This IDIQ FFP contract does not obligate any funds. The Government is obligated only to the extent that an authorized delivery order is issued, while also meeting the minimum quantity as state within this IDIQ FFP.

6.5. This IDIQ FFP contract expires 30 September 2031, unless terminated in accordance with FAR 52.212-4.

6.6. The following office is hereby authorized to place delivery orders under this IDIQ FFP contract:

Defense Health Agency Contracting Office 808 Schreider Street Fort Detrick, MD 21702

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