Attachment 1 - Statement of Work.pdf

Reload of High Dose Irradiators Statement of Work (SOW)

August 21, 2023

Department of Health and Human Services

National Institutes of Health National Institute of Allergy and Infectious Diseases

Solicitation ID: RFQ-NIAID-23-2170668 for the

Division of Intramural Research

1. Introduction

The mission of the National Institute of Allergy and Infectious Diseases (NIAID) is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The NIAID has a requirement to contract the services of a Nuclear Regulatory Commission (NRC) designated manufacturing and distribution (M&D) licensee to perform source exchange on two J.L.

Shepherd & Associates (JLS) irradiators located at its Rocky Mountain Laboratories facility in Hamilton, Montana, and the National Institutes of Health (NIH) main campus in Bethesda, Maryland. The selected vendor will provide all labor, equipment, rigging and material to install new source capsules as well as take possession and remove, decommission, transport, and recycle the source capsules being replaced.

2. Background

The Office of the Director, Division of Intramural Research (DIR) is responsible for coordinating the maintenance and operations of NIAID’s scientific infrastructure. This acquisition is necessary for NIAID’s ability to effectively perform and maintain control of its mission and operations. Source reload is critical to maintain efficient operation of the irradiators at these NIAID facilities that are utilized for inactivation of the various pathogens investigated at these locations. Inactivation is necessary to allow downstream studies to be conducted in less restrictive environments without concerns for contamination. To this end, the irradiators must be maintained to deliver the required doses efficiently to ensure experimental timelines are met.

3. Scope

The scope of this effort includes all services and supplies necessary for a complete turn-key source reload operation for two Model 484-C irradiators. The work and services to be performed shall be subject to the requirements and standards contained in this Statement of Work.

4. Performance Requirements

4.1. The Contractor shall as of the Contract Award Date and for the duration of this contract be appropriately licensed by the NRC to perform manufacturing and distribution (M&D) activities on a J.L. Shepherd & Associates Model 484-C irradiator.

4.2. NRC Sealed Source and Device Registration (SSDR) Certificate No. CA598D113S lists a J.L. Shepherd Model 7810 sealed source capsule as the only model that can be loaded into the Model 484-C irradiator. Alternative, equivalent models of sealed sources will necessitate an amendment of NIAID’s NRC License. The NRC License amendment application shall be submitted by the designated NIAID Radiation Safety Officer (RSO) at each facility location within 30 days of the Contract Award Date and will require up to 90 days at NRC for processing.

4.3. The Contractor is responsible for shipping and transportation of the new and exchanged old sources and is responsible for the proper packaging and security of the radioactive materials in compliance with the NRC and Department of Transportation (DOT) regulations. The Contractor shall, as of the Contract Award Date or within a reasonable, defined schedule, possess a current, NRC-approved DOT Transportation Quality Assurance Program to package and transport Type B quantities of Co-60.

4.4. The Contractor shall provide a certification of FBI fingerprinting, background investigation, and criminal history records check in accordance with 10 CFR Part 37 for any individuals who will receive NIAID’s sensitive information, and education and experience histories for any personnel who will visit NIAID. Contractor employees who receive, generate, or acquire sensitive information shall protect the sensitive information from unauthorized disclosure.

4.5. The Contractor shall complete a turn-key source reload operation of the Model 484-C irradiators.

4.6. The Contractor shall provide a 1-year (or longer) warranty to ensure source rods function properly after installation.

5. Specific Tasks

5.1. For each location, the Contractor is responsible for supply of three Co-60 sources suitable for a gamma irradiator as described in the “Registry of the radioactive sealed sources and devices, safety evaluation of sealed source” No. CA 598D113S dated 25 May, 2006. Additional information regarding the radioactive materials (e.g., source size/activity, physical dimensions) will be provided by NIAID once the potential Contractor has successfully provided NIAID with a copy of their NRC license, documentation of compliance with above item 4.4, and a completed Non-Disclosure Agreement form.

5.2. The new source capsules shall be a J.L. Shepherd Model 7810 or equivalent and shall be suitable for use in the JL Shepherd Model 484-C irradiator as recognized by the NRC.

Contractor must provide certifications as well as proof of size, activity, and serial number for each source prior to delivery to the designated location. Leak test certificates shall also be provided to NIAID.

5.3. Contractor is responsible for the delivery of the sources to and from the designated locations using methods in accordance with requirements enforced by the NRC, DOT, and/or any applicable Agreement State regulations. Shipping will not be initiated by the Contractor until NIAID has provided written approval that above Item 4.3 has been met.

FOB Destination.

5.4. Contractor is responsible for providing all security, safeguards, and required notifications to state authorities while the sources are being transported to and from the designated location, and certification of FBI fingerprinting, background investigation, and criminal history records check for all individuals involved in the transportation as required under 10 CFR Part 37. The Government is responsible for all security measures and safeguards on the NIAID campuses in accordance with NIAID’s licenses and applicable NRC orders. If a shipment does not arrive according to schedule, the government will immediately notify the Contractor and assist in any investigations.

5.5. Contractor is responsible for arrangements of any material handling equipment such as rigging to move irradiators to/from preferred onsite relocations, forklifts and/or crane during the reload operation. Contractor must provide all appropriate radiation exposure monitoring instruments and tools to the site.

5.6. Contractor is responsible for the proper removal and disposal of NIAID’s currently existing sources in accordance with NRC or Agreement State regulations. The contractor shall provide source transfer documentation to NIAID upon taking possession of the current Co-60 sources.

5.7. The contractor shall clean source tubes and change or clean source rods in the irradiator.

All existing sources must be removed from the irradiator before cleaning of the source tubes is carried out. Designated NIAID personnel must witness and visually verify cleanliness of all source tubes before sources are reinstalled.

5.8. Contractor shall be responsible for centering all sources in Model 484-C irradiation chamber after source reloading. After reload, a complete preventative maintenance service shall be performed by the Contractor.

5.9. After reload, Contractor shall conduct an external radiation level survey and demonstrate that the limits are not exceeded for Model 484-C irradiators specified in “Registry of Radioactive Sealed Sources and Devices Safety Evaluation of Sealed Source” No. CA

598D113S dated 25 May 2006, Contractor shall be responsible for providing/installing any additional shielding necessary to meet these specified levels at no extra cost to the government. Contractor shall provide the designated NIAID RSO at each facility location with a report demonstrating the external survey results within 2 days of work completion.

5.10. Contractor shall perform a National Institutes of Standards and Technology (NIST) traceable calibration of dose rates in the irradiator chamber after loading the new sources. New isodose curves for each position of the irradiator turntable and each source configuration shall be provided to designated NIAID RSO at each facility location.

5.11. The contractor shall provide a detailed written plan to NIAID’s designated RSO at each facility location describing the process to safely reload the irradiator including how the contractor will safely clean the source tubes and change or clean the source rods, and how the source transfer will take place. The plan must include emergency procedures specific to the reload location that would be followed in the event of an unplanned incident. The contractor shall provide a copy of the written plan no later than three weeks after award of contract. Source reload work must be completed no later than 365 days after contract award date. Prior to the commencement of work, the contractor must first obtain the NIAID’s designated RSO concurrence on the work plan.

5.12. Contractor is responsible for the repair of any damage to the irradiator or the facility during the reload operation.

5.13. Contractor shall provide new user and refresher training to at least ten (10) NIH personnel on general operation and preventive maintenance, as well as safe handling of equipment.

6. Period of Performance

The total period of performance for this requirement is one year from date of award.

7. Places of Performance

NIH Main Campus – C.W. Bill Young Center 33 North Drive Building 33 Bethesda, MD 20892

Rocky Mountain Laboratories 903 South 4th Street

Hamilton, MT 59840

8. Security Requirements

8.1. Rocky Mountain Laboratories (RML)

Contractors will be required to show one (1) form of identification (a valid government-issued photo ID-driver's license, passport, green card, etc.) and to state the purpose of their visit. Campus access and security requirements, and vehicle inspections similar to those described in 8.2 A and D must be completed prior to gaining entry onto Campus.

The on-site contractor personnel will be escorted by RML employees and will be issued a visitor badge each day while on site and shall return their badge to RML security personnel at the end of the day. Any contractor personnel showing up and requiring access without a prearranged badge request shall not be allowed to access the RML facility. In addition, RML reserves the right to refuse access to any individual(s) whose credentials, behavior, past performance, etc. are deemed inappropriate. The contractor is required to provide advance notification prior to conducting any on-site inspection, installation or maintenance. A twenty-four (24) hour minimum notice during normal business hours shall be given. All work shall be performed by US Citizens.

In addition to providing background investigation and criminal history check certifications as required under 10 CFR Part 37, all Contractor personnel will be required to complete a brief biosafety training prior to gaining access to the irradiator room.

8.2. Bethesda Campus – Building 33

A. Campus Access and Security

All visitors must enter through the NIH Gateway Center. You will be asked to submit to a vehicle or personal inspection. Visitors over 15 years of age must provide a form of government-issued ID such as a driver's license or passport.

Visitors under 16 years of age must be accompanied by an adult.

Please be aware: Federal law prohibits the following items on Federal property:

firearms, explosives, archery equipment, dangerous weapons, knives with blades over 2½ inches, alcoholic beverages, open containers of alcohol and marijuana (cannabis).

B. NIH Gateway Center

Visitors will be required to show one (1) form of identification (a government-issued photo ID-driver's license, passport, green card, etc.) and to state the purpose of their visit. The NIH Gateway Center is located adjacent to the Medical Center Metro Station at the South Drive entrance to campus from Rockville Pike / Wisconsin Avenue (Route 355). It combines visitor parking, non-commercial vehicle inspection and visitor ID processing, all in one location. The NIH will process all visitors in vehicles or as pedestrians.

Patients and patient visitors should continue to enter campus at the West Drive/Cedar Lane entrance during the hours of 6am–10pm, 7 days a week.

C. REAL ID

***REAL ID Enforcement Delayed Until May 7, 2025 – Extension Does Not Apply to Commercial Vehicle Operators***

As of May 7, 2025, the National Institutes of Health (NIH) will no longer accept identification credentials that fail to meet the minimum requirements and issuance standards for federal recognition per the REAL ID Act of 2005. The Act establishes minimum security standards for state-issued driver’s licenses and identification cards and prohibits federal agencies, such as NIH, from accepting for official purposes licenses and identification cards that do not meet these standards.

Under the REAL ID ACT, NIH may only accept state-issued driver’s licenses and identification cards that meet the standards required by the ACT to access our facilities. Enhanced Driver’s Licenses (EDL) issued by Michigan, Minnesota, New York, Vermont, and Washington are considered acceptable alternatives to REAL ID-compliant cards and will also be accepted for official REAL ID purposes. Most EDLs do not contain the star marking and this is acceptable. The EDLs do however state they are enhanced driver’s licenses and have an American flag either overlapping the picture or at the bottom right hand corner.

Individuals who come to the NIH’s Clinical Center for inpatient or outpatient services are not subject to the REAL ID Act of 2005.

Approved Forms of ID Required to Enter NIH Facilities as of May 7, 2025:

REAL ID Driver’s License or State Identification Card or Enhanced Driver’s License

Passport or Passport Card HSPD-12 PIV or CAC Card Permanent Resident Card Federally Recognized, Tribal-Issued Photo ID Canadian Provincial Driver's License or Indian and Northern Affairs Canada

Card USCIS Employment Authorization Card (I-766) Other Less Common Documents (e.g. Merchant Mariner Credential)

D. Vehicles

For visitors arriving in personal vehicles, on motorcycles or bicycles, the Gateway Vehicle Inspection Station (Building 66A), provides multiple inspection lanes and allows visitors to go through inspection and get a visitor badge in one centralized, efficient process. Vehicles enter the Gateway Center complex through a new roadway, "NIH Gateway Drive," just south of the intersection of the previous visitor entrance at South Drive and Rockville Pike. Vehicles that choose to bypass parking in MLP-11 will go through inspection and enter campus at Center Drive near the National Library of Medicine.

E. Parking Please note: visitor parking is limited at NIH. Visitors are encouraged to use public transportation such as the Metrorail subway system, which has a convenient stop (Medical Center) on the NIH campus. Visit the "Metro" site for information on fares and schedules (link is external). The Gateway complex also includes MLP-11, a 342-space, multi-level underground parking garage. This visitor-only lot is the primary visitor parking for the NIH main campus. We strongly encourage all visitors to park in this garage, as there will be limited visitor parking on campus, other than for patients and visitors to the Clinical Center. Vehicles parking in MLP- 11 are outside of the perimeter security and will not go through vehicle inspection, reducing the amount of time it takes to get on campus.

The cost to park in MLP-11 is $2 per hour for the first three hours, $12 maximum for the entire day. This is the same rate currently charged for all visitors parking at the NIH. Visitors parking in MLP-11 should proceed to the Gateway Center to get a visitor badge and either walk or take a shuttle bus to their destination.

MLP-11 Hours of Operation:

Monday–Friday: 6am–9pm (entrance)

6am–11pm (exit)

Saturday–Sunday: Closed

When MLP-11 is closed, visitors can park in lots on the NIH main campus.

Vehicles left in the MLP-11 parking garage after 11pm on weekdays or during weekends are subject to ticketing and towing.

F. Commercial Vehicle Inspection Facility (CVIF) Commercial vehicle deliveries must undergo security screening at the Commercial Vehicle Inspection Facility (CVIF). It is located on Rockville Pike between North Drive and Wilson Drive and is open 24 hours a day, 7 days a week (inbound traffic only).

G. Building Security Due to the checking of IDs at the perimeter, employees and visitors will not be required to show their ID again to gain access to most of buildings on the NIH Bethesda campus during the normal business day. Employees and visitors should continue to wear their identification prominently at all times while on campus.

Guards will remain at certain buildings to address specific program requirements such as sensitive research and safety concerns. At building entrances where guards are posted: Visitors may be required to log in, wear a visitor’s pass and have an employee escort them through the building.

Visitors may be required to pass through a metal detector and have bags, backpacks or purses inspected or x-rayed as they enter buildings. Security staff will be looking for and confiscating any suspicious or potentially dangerous materials. U.S. Code prohibits bringing any dangerous weapons onto Federal property, including anything with a blade longer than 2 ½ inches.

H. Building 33 Specific Security

Additional security guards are posted at entrances to Building 33. Visitors will be required to log in, wear a visitor’s pass, and have an employee escort them throughout the building. Visitors will be required to pass through a metal detector and have bags, backpacks or purses inspected or x-rayed as they enter the building.

Delivery teams will be allowed to unload tools and equipment at the loading dock.

Parking for longer durations is granted on a temporary need basis and is subject to daily availability. Advance requests and arrangements should be made to ascertain this ability if desired.

Hours for visitation and delivery are 8:00 am – 5:00 pm, Monday - Friday.

Advance coordination should be arranged to ensure building escorts are available and ready as needed.

9. Deliverables

Deliverable SOW Reference

Recipient Due Date

Copy of NRC license, documentation of compliance with item 4.4, and a completed Non-Disclosure Agreement form

5.1 TBD 1 month of contract

award

Certifications, proof of size, activity, and 5.2 TBD 1 month prior to reload serial number for each source capsule Leak test certificates for each source capsule

5.2 TBD 1 month prior to reload

Source transfer documentation 5.6 TBD Within 12 hours after taking possession of Co-60

External Survey Report 5.9 TBD 2 days after completion Isodose curves for each position of the irradiator turntable and each source configuration

5.10 TBD 1 week after reload

Written plan describing process to safely reload the irradiator

5.11 TBD 1 month of contract

award