Statement of Work Unit Dose Radiopharmaceuticals.pdf

STATEMENT OF WORK

Supply and Delivery of Unit Dose Radiopharmaceuticals

Martin Army Community Hospital Department of Radiology, Nuclear Medicine Service

Fort Benning, GA 31905

1. GENERAL

1.1 The contractor shall provide supply and delivery of all radiopharmaceuticals in unit dose, shielded within a suitable container for transportation in accordance with all applicable Department of Transportation (DOT) laws and regulations, as well as local, state and Nuclear Regulatory Commission (NRC) regulations to the Nuclear Medicine Service, Martin Army Community Hospital (MACH), 6600 Van Aalst Boulevard, Fort Benning, GA 31905-5637.

1.2 BACKGROUND INFORMATION. The Nuclear Medicine Service provides services to active-duty military personnel, retirees, and their dependents. Services are provided 24 hours a day to inpatients and emergency patients, and 9.5 hours per day for outpatients. All individuals who provide diagnostic services shall be licensed and have the appropriate clinical privileges and training.

1.3 CONTRACTOR PERSONNEL. The contractor shall provide a copy of their Radioactive Material License specifying authorized nuclear pharmacist(s) named in their Radioactive Material License to prepare and dispense all radiopharmaceuticals.

1.4 DURATION OF CONTRACT.

Base Year 01 October 2025-30 September 2026

Option Year 1 01 October 2026 - 30 September 2027

Option Year 2 01 October 2027 - 30 September 2028

Option Year 3 01 October 2028 - 30 September 2029

Option Year 4 01 October 2029 - 30 September 2030

1.5 HOURS OF OPERATION

1.6.1 Martin Army Community Hospital Nuclear Medicine Service hours of operation are

5:00 am to 4:00 pm EST Monday through Friday. MACH observes all federal holidays.

1.7 PHYSICAL SECURITY. During normal duty hours, the contractor shall obtain entry into

Nuclear Medicine Clinic from the Nuclear Medicine Technologist. After hours the on-call

Nuclear Medicine Technologist will meet the contractor and escort him/her to the nuclear pharmacy. In an absolute emergency the contactor can contact the Administrative Officer of the Day (AOD) located at the information Desk in the Main Lobby of the Hospital. The contractor shall be escorted by the AOD who will unlock the cipher lock using the master key allowing the contractor to place the package inside the Nuclear Pharmacy (See SOP

Attachment 2).

1.7.1 AT Level I training. This standard language is for contractor employees with an area of performance within a DHA-controlled installation, facility, or area. All contractor employees, including subcontractor employees, requiring access to DHHQ, Direct

Reporting Markets (MTFs), Small Markets and Stand Alone (SSO) facilities and controlled access areas, shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable and annually thereafter. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the

COR or to the contracting officer, if a COR is not assigned, within 05 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: http://jko.jten.mil.

1.7.2. Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within a DHA controlled installation, facility, or area. Contractor and all associated sub-contractors’ employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of

Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity

Verification of Contractor Personnel) as directed by DOD, DHHQ and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

http://jko.jten.mil/

1.7.2a. For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center

Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

1.7.3. Controlled Unclassified Information (CUI). Include DFARS clause 252.204-7012, which requires the contractor to comply with NIST 800-171. Also include DFARS provision252.204-2019 into solicitations. Acquisition officials should follow procedures outlined in DFARS 204.73 and verify vendors have an adequate NIST SP 800-171 summary assessment score within the Supplier Performance Risk System (within PIEE). If the score doesn't show a medium- or high-level assessment with a score of 110 or better (as described in the "NIST SP 800-171 DoD Assessment Methodology"), include clause

252.204-7020 and obtain the vendor's "system security plan" and "plan of action" for NIST

SP 800-171 verification and assurance by Army security officials.

1.8 DELIVERABLES ACCEPTANCE

1.8.1 The Government will evaluate product deliverable acceptance from the contractor during this contract using the method of surveillance specified in Attachment 1. The

Government will record all receivables observed on delivery. When an observation indicates a defective deliverable item during the acceptance process, the Nuclear

Medicine supervisor will obtain the contractor’s representative’s initials on the record of the observation.

2. STANDARD DEFINITIONS

2.1 Administrative Officer of the Day (AOD). Military personnel duly appointed with authority to make decisions on behalf of the U.S. Government (USG) in the absence of the on-call nuclear medicine technologist.

2.2 Contracting Officer (KO). A person duly appointed with the authority to enter and administer contracts on behalf of the USG.

2.3 Government’s Representative (GR). An individual designated by the requiring activity to act as their representative to assist in administering a contract. The source and authority for a Government Representative is designated by the department or organization assigned.

2.4 Customer Complaint. A means of documenting certain kinds of contract service problems. A government program that is explained to every organization that receives service under this contract which is used to evaluate contractor’s performance.

2.5 Acceptable/ Unacceptable Outcome. A delivered product that does or does not meet the acceptable outcome standard for acceptance as outlined in the “Acceptance Outcome

Table (AOT) in “Attachment 1”.

2.6 Acceptance Requirement. The point that divides acceptable and unacceptable performance. When the method of surveillance is other than random sampling, the performance requirement is the number of defectives or maximum percent defective in the lot before the Government will consider affecting the price computation system in accordance with the Acceptance Outcome Table and the Inspection of Services Clause.

2.7 (Acceptance Outcome Table). Identifies the key service outputs of the contract that will be evaluated by the Government to ensure contract performance standards are met by the contractor. See Attachment 1.

2.8 Quality Assurance (QA). Those actions taken by the Government to ensure services meet the requirements of the Statement of Work (SOW) and all other service outputs.

2.9 Quality Control. Those actions taken by a contractor to control the performance of services so that they meet the requirements of the SOW.

2.10 Shielded. Those actions taken by a contractor to protect individuals from being exposed to radioactive material. This is done by putting a unit dose in a lead lined container.

3. TECHNICAL DEFINITIONS SPECIFIC TO THIS PWS

3.1 Hot Lab. A room within a Nuclear Medicine Clinic where radioactive material is stored and dispensed.

3.2 Material Safety Data Sheet Binder (MSDS). A document that contains information on the potential health effect of exposure to chemicals, and on safe working procedures when handling chemical products.

3.3 Nuclear Regulatory Commission (NRC). An agency that develops regulations governing nuclear reactors and nuclear material safety, issues orders to licensees, and adjudicates legal matters.

3.4 Radiopharmaceuticals. Radioactive Pharmaceuticals used in the field of Nuclear

Medicine as tracers in the diagnosis and treatment of diseases.

4. SPECIFIC TASKS

4.1 Contractor personnel shall make all deliveries directly to the Nuclear Medicine Hot Lab at the Martin Army Community Hospital, 6600 Van Aalst Boulevard, Fort Benning, GA

31905-5637. See Department of Radiology, Nuclear Medicine Services. See Standard

Operating Procedures (SOP) regarding deliveries at Attachment 2.

4.2 The quantities for daily deliveries will be coordinated with the Supervisor of the Nuclear

Medicine Service or his designee at (762) 408-2033. A list of NMS personnel will be updated as necessary and provided to the contractor.

4.3 All doses used for injections shall be delivered in plastic syringes.

4.4 Doses shall be individually shielded within a suitable container for transportation in accordance with all applicable Department of Transportation (DOT) laws and regulations.

4.5 The Government will transfer all unused doses and vials to radioactive waste within the

Nuclear Medicine Department. The Government and the contractor will jointly verify the doses not used by (1) reviewing the Nuclear Medicine logs and/or packing slips, or (2) by returning the packing slips to the contractor.

4.6 The contractor shall replace the incorrectly delivered item at no cost to Martin Army

Community Hospital.

4.7 The contractor shall label all supplies as to the amount of radiopharmaceutical, preparations time, expiration time, and date.

4.8 The contractor shall pick up prearranged patient’s blood sample no later than 8:00 A.M.

EST on the day scheduled. The contractor shall pick up blood, label the leukocytes, and return the Indium labeled white cells no later than 12:00 P.M. EST the same day.

4.9 All packaging of radioactive material shall be clearly labeled RADIOACTIVE on the outside of the shipping carton.

4.10 The contractor shall perform all quality control procedures as required by Federal and

State regulatory agencies. The pigs shall be checked with a Geiger-Muller survey meter for contamination and visually inspected for the presence of blood. The contractor will provide a process for cleaning radiopharmaceutical reusable pig externally and internally to detect the presence of radioactivity at a radiation level above background level, and if such radiation is detected storing the pig until the radiation has decayed to background level.

The pig should be disinfected, washed at a high enough temperature and for a long enough time to destroy microorganisms and remove blood contamination. Pigs contaminated with blood shall be treated in a 10% solution of bleach and water.

4.11 The contractor shall meet all Nuclear Regulatory Commission, Department of

Transportation, Food and Drug Administration (FDA), and all other agency rules and regulations (Federal and State).

4.12 The contractor shall be responsible for any incidents/ accidents resulting in a spill, leak, or any other contamination and shall be responsible for spill cleanup or decontamination, if the incident occurred before entering or after leaving Martin Army

Community Hospital. Likewise, the contractor shall remedy any accident within Martin

Army Community Hospital caused by the contractor’s negligence.

4.13 All unit doses without specific delivery instructions will be ordered on an “as needed basis.” The Contractor shall deliver such radiopharmaceuticals during and after working hours, including Saturday, Sunday, and holidays, within one (1) hour of placing the order over the phone, unless otherwise specified.

4.14 Emergency deliveries shall be available 24 hours a day, every day to include Saturday, Sunday, and holidays, during the full duration period of the contract. Response time shall be no more than 30 minutes after receiving a page or call, and (11/2) hour after placing an order. The Government will pay for all items ordered on an emergency basis, including those not used.

4.15 Any cost to replace damaged or incorrect products will be borne by the contractor.

4.16 Invoices shall be submitted monthly (one invoice per month, 12 invoices per year), in arrears, via e-mail to the supervisor, Nuclear Medicine Service (NMS), who will review and certify the invoice. The certified invoice will be provided to the Government Representative

(GR) who will notify the contractor that their invoice is ready to be submitted in iRAPT/WAWF for processing for payment through the Defense Finance and Accounting

Service (DFAS). Contact information for the Supervisor, NMS, will be provided after the contract has been awarded.

4.17 The contractor shall take immediate action to notify the Supervisor or any staff technologist of the Nuclear Medicine Service, Martin Army Community Hospital, whenever a product, piece of equipment, or item is recalled or considered dangerous, hazardous, or unsafe to remove such products, equipment, or items from use.

4.18 The contractor shall submit proof of automobile insurance with their offer and maintain and provide proof of automobile insurance for the entire duration of the contract.

4.19 The contractor shall provide a copy of their laboratory’s current quality control manual to the Nuclear Medicine supervisor within ten (10) working days after contract is awarded.

The manual will be kept on hand for regulatory inspections.

4.20 The contractor shall provide material safety data sheet (MSDS) binders and updates on all delivered products at no charge to Martin Army Community Hospital within ten (10) working days after contract award.

4.21 The contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, patient education, i.e., white papers, journal information on procedures, and/or updated dose parameters.

5. APPLICABLE PUBLICATIONS AND FORMS

5.1 Copy of Government current Radioactive Material License

5.2 Copy of contractor’s current Radioactive Material License

5.3 U.S. Nuclear Regulatory Commission’s (NRC) 10 CFR Part 35, Medical Use of Byproduct

Material. NRC has regulatory authority over the possession and use of byproduct, source, or special nuclear material in medicine.

5.3.1 Part 19, Notices, Instructions, and Report to Workers: Inspection and Investigations

5.3.2 Part 20, Standards for Protection against Radiation

5.4 Local agreement state, (which Georgia is) has regulatory authority under the Atomic

Energy Act of 1954 to license and regulate byproduct materials

5.5 NUREG- 1556, Vol 9, Rev 2; Consolidated Guidance about Medical licenses, which provides guidance on the revised Part 35 rule

5.6 Department of Transportation (DOT) Title 49 of the Code of Federal Regulations:

oversees the safety and security of hazardous material during shipping. DOT works with the

Nuclear Regulatory Commission to keep shipments safe

5.7 CFR 10, Code of Federal Regulations, Title 10 of the NRC Regulation

Attachment 1:

Supply and delivery of unit Dose Radiopharmaceuticals

Acceptable Outcomes Table

The following minimum Performance Requirement Summary applies. The Government may modify inspection methods in accordance with site-specific requirements.

Performance Objective

Performance Standard Acceptable Quality Level

(AQL)

Method of Inspection Reference PWS Supply and delivery of Unit Doses

All doses used for injections shall be delivered in plastic syringes.

Doses in plastic syringes 100% of the time

Delivered In Accordance to standard 100% of the time

Checked by Technologist/or Supervisor doing login procedure. Monthly CPAR

Section 4.3

Doses shall be individually shielded within a suitable container for transportation in accordance with all applicable Department of Transportation (DOT) laws and regulations.

All doses must be in lead lined PIG containers 100% of the time.

Delivered IAW DOT 100% of the time

Inspected by Technologist/or Supervisor doing the opening of containers

Section 4.4

Label all supplies with the amount of radiopharmaceutical activity, preparation time, expiration time, and date

This must accompany the doses/radiopharmaceuticals 100 % of the time

Delivered IAW NRC regulations, Pharmacy SOP 100% of the time

Inspected by Technologist during the opening procedures and reported on the CPARs report.

Section 4.8

All packaging of radioactive material shall be clearly labeled RADIOACTIVE on the outside of the shipping carton and with the appropriate Transport Index label

The Transport Index label is equivalent to the maximum radiation level in mR/hr and must attached to the outside of the container.

100% of the time

Delivered IAW DOT regulations and NRC guidelines 100% of the time

Inspected by Technologist during opening procedures and On-call Technologists.

Section 4.10

Emergency deliveries shall be 24 hours a day to include weekends and holidays.

Response time shall be no more than 30 minutes after receiving a page or call, and 1 ½ hour delivery time after order has been placed.

Response time to call is 30 minutes and delivery time after placing call is 1 ½ hours 95% of the time.

AQL response time is 95%. Technologist on call will monitor and report to the supervisor. Annotated on the CPARs report.

Section 4.15

A process for cleaning radiopharmaceutical reusable pig externally and internally to detect the presence of radioactivity and blood contamination. Pig contaminated with blood shall be treated with 10% bleach and water.

Disinfecting the pig by exposing it to a disinfectant chemical, washed at a high temperature, long enough to destroy microorganism and remove blood contamination.

Provide a daily QC sheet explaining the method and cleaning process. Must be delivered with each delivery.

Checked by Technologist/or Supervisor doing login procedures. Monthly CPAR

Section 4.11

Attachment 2

DEPARTMENT OF RADIOLOGY

NUCLEAR MEDICINE SERVICE

MARTIN ARMY COMMUNITY HOSPITAL

FORT BENNING, GEORGIA 31905

STANDARD OPERATING PROCEDURE

DELIVERY OF RADIOACTIVE MATERIAL TO MARTIN ARMY COMMUNITY HOSPITAL (MACH)

1. Purpose: To ensure that packages containing radiopharmaceuticals received either during or after normal working hours are handled in a timely, secure, and safe manner.

This SOP provides guidance to vendors on the MACH delivery procedures of packages containing radioactive material and list points of contact for the Nuclear Medicine Service.

2. Scope: This SOP applies to all personnel assigned to the Nuclear Medicine Service, Radiologists, Radiation Safety Officer, AOD and Security Force, Martin Army Community

Hospital (MACH)

3. Objective: To describe the intent, format, structure, review, and verification procedures for the delivery of radiopharmaceuticals.

4. General: Martin Army Community Hospital receives radioactive materials packages each weekday, and occasionally on weekends. Strict federal guidelines govern the receipt of radioactive materials.

It is the responsibility of the vendor to ensure that they are adhering to the following policies and procedures:

Daily Unit Doses:

a. All routine deliveries are made during normal business hours of 5:30 am until 4:00 pm

b. The delivery personnel of the contracted radiopharmaceutical services provider(s) will not be furnished with the combination/key/access card to the door of the nuclear medicine

Hot Lab, room 1L73.

c. All radiopharmacy personnel making deliveries to the nuclear medicine department will be identified by employer/or MACH issued photo identification and shall be trained in this procedure.

d. The delivery personnel will park in the vendor’s parking lot (ground garage).

e. The delivery personnel will travel the ground floor and gain access inside by swiping his

MACH issued ID. He will continue to the first set of elevators and exit on the first floor and follow the signs to Nuclear Medicine clinic.

f. A representative of the Nuclear Medicine Clinic will meet the driver and verify that the delivered packages are identical to what was ordered. In the event of an errant delivery, the shipment will be refused, and the driver/vendor will be directed to return the package to the sender or to the correct addresses as appropriate.

g. The representative will escort the delivery person to the nuclear medicine pharmacy for delivery.

h. Access to the hot lab will be secured after the delivery of packages containing radiopharmaceuticals.

i. If delivery is made after duty hours, the technologist will coordinate the time of delivery and will meet the delivery personnel to accept delivery.

j. It is the responsibility of the nuclear medicine technologist to notify the radiation safety officer of any incidents involving receipt of a package containing radiopharmaceuticals that has been damaged.

k. RSO on-call contact number and/or nuclear medicine technologist: (TBD after award).