SOO_Germ Free.pdf

Statement of Objectives (SOO) Germfree Service Contract for

Global Field Medical Laboratories (GFML)

By: Raymond Cajigas Date: July 09, 2025

STATEMENT OF OBJECTIVES (SOO)

Award/Mod Effective Version Date Award

Contract Number:

Task Order Number:

Contractor Name:

Tracking Number:

1. Contracting Officer’s Representatives (CORs):

a. Primary COR:

MAJ Janay Gusme XO,1st Global Field Medical Laboratory

DSN: 278-3606

MS Teams Work number: 520-714-5771 Mobile: 917-805-6746 janay.gusme.mil@army.mil

b. Technical Point of Contact (TPOC): Mr.

William Wall, Director

USAMMA / MMOD-PA

Office: 570-615-7744

DSN: 312-795-7744

william.d.wall.civ@army.mil

2. Requirement Title:

Germfree Global Medical Field Laboratories

3. Background:

The 1st Global Field Medical Laboratory (GFML) operates as a critical, rapid-response asset for chemical, biological, radiological, nuclear, and explosives (CBRNE) threat assessment and health surveillance on a global scale. This highly specialized unit deploys worldwide, often to austere or high-risk environments, to provide timely and accurate threat identification and analysis. The GFML's mission-critical capabilities are essential when:

• Rapid Threat Assessment is Required: Samples cannot be transported to fixed laboratories within a 24-hour timeframe, necessitating on-site analysis.

• High-Risk Environments Pose Challenges: Immediate hazard identification is required in areas with potential chemical, biological, or industrial contamination.

• Force Protection and Counter-Weapons of Mass Destruction (WMD) Operations are

Underway: The GFML supports these missions by providing on-the-ground surveillance, confirmatory laboratory testing, and health hazard assessments.

The unit's ability to deploy as a cohesive team or in task-organized elements ensures flexibility and responsiveness across a wide range of operational scenarios, supporting both environmental and occupational health, as well as addressing endemic and CBRNE threats.

Until 2024, the GFML’s equipment was serviced under contract number 47QFNA23F0054 by Scitech Services, through the 20th CBRNE Command. Effective 2024, the responsibility for maintenance and repair has been transitioned to Soldier Medical Devices (SMD), which will oversee procurement and sustainment activities. procurement and sustainment activities

4. Objectives:

The objective of this contract is to acquire a service agreement for six (6) Fume hoods (Model FHM-2.5SS) , twelve (12) Biosafety Cabinets (Model BBF-2SSCH), six (6) Filtration Systems (model FS-150) , six (6) Filtration Systems (model FS-75) and six (6) Glove boxes (Model PGB-

36) to conduct sustainment support for the GFML for up to 5 years.

5. Scope:

The Contractor shall provide non-personal service(s). These services include sustainment calibration, maintenance, equipment repair and scheduling, inventory, shelf-life management, warranty management, equipment service-contract information, preventive maintenance and scheduling, shipping, and management of the following devices: six (6) Fume hoods (Model FHM- 2.5SS) , twelve (12) Biosafety Cabinets (Model BBF-2SSCH), six (6) Filtration Systems (model FS-

150) , six (6) Filtration Systems (model FS-75) and six (6) Glove boxes (Model PGB-36)

6. Performance Requirements:

6.1 Task 1 – Preventative Maintenance and Annual Services

Preventative Maintenance and Annual Services: Perform preventative maintenance and annual services to the manufacturer’s specification and institutional biosafety protocols. The allowable degree of deviation from the standard procedure is +/-5% in terms of time intervals.

Maintenance schedule: Provide a 12 month with +/- 72 allowance maintenance schedule for each device

Comply with Safety Regulatory Standards: Ensure all maintenance activities follow all critical safety checks, such as HEPA filter integrity, airflow velocity, and decontamination steps with no deviation.

Maintain Accurate Records: Document all compliance activities through a combination of maintenance logs and calibration validation. Maintenance events must be logged with a timestamp, technician signature, and checklist of performed tasks.

6.1.1 Subtask 1 - Inspection

Annual Inspection: Provide a detailed annual (12months, +/-72 days allowance) inspection schedule for the devices listed below ensuring identification of mechanical issues, filter failures or airflow disruption.

Post Deployment Inspection: Following the unit’s return from deployment, a comprehensive post- deployment inspection shall be conducted with (x) days to ensure operational readiness, accountability of equipment, and adherence to maintenance standards.

The following describes the items to be inspected on each device.

• Fume hoods: FHM-2.5SS, QTY 6 o Hardware o EPDM tracks o Gaskets o Sash trim o LED lights o Exhaust duct connection o Control panel wiring connections o Viewing Panel

• Biosafety BBF-2SSCH, QTY 12 o Gaskets o View panel hinges and lift shocks/mechanisms o View panel gasket

• Filtration system: FS-150 and FS-75, QTY 6 o Valves o Clamps o Gaskets o Torque hardware to spec o VFD wiring connections

• Glove box: PGB-36, QTY 6 o Gaskets o Gloves o O-rings

6.1.2 Subtask 2 – Testing

Performance and Safety Standards: Validate all items listed below meet performance standards, safety standards, and comply with regulatory guidelines required for laboratory operations, to include critical components such as HEPA filters, air flow patterns, and containment systems are functioning effectively.

The following describes the items to be tested and replaced if needed on each device.

• Fume hoods: FHM-2.5SS, QTY 6 o Door motors/mechanisms as applicable o Electrical circuits o Interlocks o Proximity Sensors o Receptacles o Push Buttons o Hi/Lo pressure alarms

• Biosafety BBF-2SSCH, QTY 12 o Airflow performance smoke study

• Filtration system: FS-150 and FS-75, QTY 6 o Replacement of Carbon and Hepa filters if usage requires

• Glove box: PGB-36, QTY 6 o Electrical circuits o Interlocks o Valve assemblies o Replace Pass box door gasket o Standard rate of rise test o Inspect Glove Port O-rings o Torque hardware to spec

6.1.3 Subtask 3 – Replacements

Replacement Parts: Apply maintenance strategies that ensure faulty or worn-out parts are replaced in a timely manner. Components such as HEPA filters, gaskets, fans, and lighting must be in proper working condition to maintain effective containment and prevent contamination.

6.1.4 Subtask 4 – Certification

Annual and As- Needed Device Certification: Conduct annual certification by an accredited certifier to ensure compliance with National Sanitation Foundation (NSF)/ American National Safety Institute (ANSI) or National Sanitation Foundation and Controlled Environment Testing Association (NSF/CETA). Additional certifications shall be executed upon request by the GFML to include after relocation, repair, or incident that may compromise device function or integrity. The certification process must include, at a minimum, the following performance evaluations downflow and inflow velocity measurements, HEPA filter integrity testing (using a particle challenge test), smoke pattern test for airflow visualization, and verification of cabinet leak tightness

Certification details per device will be performed as per the following:

Class II BBF-2 Annual Certification

· Labor, Hepa filter replacements, gaskets,

· Equipment labels and digital testing reports

· NSF/CETA or NSF/ANSI accredited certifier

Class III PGB-36 Annual certification

· Labor, main chamber Hepa filter replacements, gaskets, gloves, and O-rings

· Factory trained field verified certifier with third party oversight

· Equipment labels and AGS guideline test reports

Fume Hood FHM 2.5 annual certification

· Airflow testing

· Smoke flow profile

· Equipment labels and digital testing reports

· NSF/CETA or NSF/ANSI accredited certifier

FS-75 Annual certification

· Replacement of (2) TEDA carbons and (1) HEPA filter and bag

· Filter integrity testing

· Pressure decay testing of housing and valves

· BIBO replacement

FS150 Annual certification

· Replacement of (2) TEDA carbons and (2) HEPA filter and bag

· Filter integrity testing

· Pressure decay testing of housing and valves

· BIBO replacement

6.2 Task 2 - Repairs

Repair Management: Ensure repairs are completed within a timely manner and by an accredited certifier to maintain optional performance and readiness and to avoid voiding the warranty and certification status. Create a repair response schedule that defines response times for initiating and completing repairs following notification of a malfunction or component failure. Distinct timelines should be provided for standard repairs and emergency repairs.

Warranty Management: Establish a comprehensive 1-year warranty that covers all parts and labor associated with the repairs and services of the Germfree biosafety equipment in accordance with the manufacturer’s guidelines and accredited personnel. If a repaired component fails within the warranty period, the contractor shall perform the necessary repairs again at no additional cost to the unit, including any required recertification.

Task Order Management Plan

Monthly Status Report

Tasks apply to the table of devices below

# Part number Description 1 PGB-36 Glovebox, Portable, 36"

Glovebox, Portable, 36in, Class III BSC. Dims: 36x20x23.75, Includes 2 interior outlets.

2 FS75-PGB HEPA Carbon Filtration System

75 CFM CBR HC Exhaust Filtration System. Provides negative pressure to Glovebox, protection from Biological and Chemical hazards before exhausting back into the environment. Single HEPA, two Carbon filters.

Intelligent control panels. 120V-50-60 Hz, 20 Amp 1-phase power supply needed.

3 FHM-2.5SS GF 30" wide Portable Fume hood

The FHM-2.5SS Stainless Steel Fume Hood provides a safe environment for handling volatile chemicals. This hood provides an ergonomic, easily accessible work area, while maintaining complete operator safety.

Requires FS-150 for operation.

4 FS150-FHM 150 CFM HEPA Carbon Filtration

The FS-150 HEPA and ASZM-TEDA Carbon Filtration System is designed to provide the necessary exhaust airflow volume and negative pressure to maintain the Germfree FHM-2.5 Portable Fume Hood in a safe operational mode. The system consists of HEPA and ASZM-TEDA carbon filters in series, and an exhaust blower with speed control.

5 BBF-2SSCH Biological Safety Cabinet

This Class II, Type A biosafety cabinet is designed for the safe handling of low- to moderate-risk agents. It provides protection for the user, stored products, and the environment from particulate and aerosol hazards through a laminar-flow exhaust system and HEPA filters.

Deliverables: Technician’s Report

The contractor must include a comprehensive technician’s report detailing all findings from the inspection, testing, and any parts replaced or repaired during the preventive maintenance or repair of the devices. This report should document the condition of the cabinet, test results, identify any issues, corrective action taken, and verification of proper function after maintenance.

7. Performance Standards.

The devices outlined in the SOO shall be repaired, replaced, and tested in accordance with NSF/CETA or NSF/ANSI Standards and performed by an accredited certifier.

8. Place of Performance.

Mission Location: Services will be performed for the Global Field Medical Laboratory (GFML) located at Aberdeen Proving Grounds MD at the following address:

6597 Reconnaissance Street, Building 5116 Aberdeen Proving Ground, MD 21005-5001

Or at Tobyhanna Army Depot at

Tobyhanna Army Depot 11 Hap Arnold Blvd Bldg 7 Bay 1 Tobyhanna, PA 18466

Place of Performance: The work shall be performed on site at one of the two government facilities listed above. Most of the services will be performed at Aberdeen proving grounds. In the event their equipment breaks while the unit is deployed, and they decide to send it for repairs, the repairs will be performed at Tobyhanna. Local travel to and around the mission location may be required throughout the period of performance; this travel will not be reimbursed. Long-distance travel within CONUS may be required to meet the requirements of this SOO. Long distance travel within CONUS must be pre-approved in writing by the COR prior to the Contractor incurring the cost in support of this contract.

9. Period of Performance: One (1) year after contract award with four (4) optional years.

10. Delivery Schedule:

SOO

Task

Deliverable Title Format Number

Calendar Days After

Maintenance completed

1 Technician Report Contractor-Determined

Format

2 Copies to COR;

Letter Only to KO

Cost breakdown for services or repair parts outside of what’s agreed in the contract

Contractor-Determined Format

2 Copies to COR;

Letter Only to KO

3 Certification Report

Equipment labels and digital testing reports Per device 15

11. Security Requirements: This section supplements Block 13 of the Government provided DD Form 254, Contract Security Classification Specification. The following security requirements shall apply to this effort.

The contractor shall coordinate visits with site Point of Contract (POC)s providing at least a 72-hour notice (or according to each site security requirements) prior to any site access. Contractor personnel without security clearances performing any task under this SOO must be escorted by cleared personnel (civilian, military, or contractor).

References:

11.1 Facility Security Clearance: N/A

11.2 Security Clearance: N/A

11.3 Investigation Requirements: N/A

11.4 Visit Authorization Letters (VAL): Visit requests shall be processed…

11.4.1 Visit Authorization Requirement (VAR) Package. VARs must be received via email and require pre-approval from the assigned COR five business days in advance of the report date. The VAL/VAR/VTN should be sent via email to the appropriate COR. The VAL/VAR/VTN should be sent using in a locked “Zip” file in one e-mail and then followed up by another e-mail with the password to unlock the Zipped file, because it contains sensitive information covered by the Privacy Act.

Documents to include in the VAR Package:

1. Inter-office Memorandum (IOM)

2. DD Form 254 Prime and/or Sub (Good Standing approval emails for current option year)

3. Contractor VAL signed by the Contractor Facility Security Officer (FSO)

If DISS is not available, the VAL must contain the following information on the company letterhead

• Company name, address, telephone number, facility security clearance

• CAGE CODE

• Contract/Order Number

• Name, SSN, date and place of birth, and citizenship of the employee intending to visit

• Certification of personnel security clearance and any special access authorizations required for the visit (type of investigation & date and adjudication date & agency)

• Name of COR/Alt COR

• Dates or period the VAL is to be valid

11.4.2 VTN Package: The Contractor FSO will forward a VTN letter to the COR identified in the SOO/TO/Sub for all employees leaving the contract/task order/subcontract.

11.4.2.3 In addition, the CORs and security managers shall inform the Security Office when contractor personnel are removed for cause from a contract. This step is being added to prevent contractor personnel removed for security related issues from returning to PM SMD without appropriate vetting. This step will also provide security with pertinent information to make an informed decision regarding potential contractor employees’ access to secure facilities and sensitive information.

The VTN must contain the following information on company letterhead

• Company name, address, telephone number, facility security clearance

• CAGE CODE

• Contract/Order Number

• Name, SSN, date and place of birth, and citizenship of the employee

• Name of COR/Alt COR

• Termination Date

• Reason for Termination

*Any VAL/VAR submitted without the above information will be denied.*

11.5 Security Contacts. Security Personnel can be contacted for Industrial or Personnel Security related issues at (301) 225-1235 or via mail at:

Janay Gusme

MAJ, MS

XO,1st Global Field Medical Laboratory

DSN: 278-3606

MS Teams Work number: 520-714-5771 Mobile: 917-805-6746 janay.gusme.mil@army.mil

11.6 Information Security and other miscellaneous requirements.

11.6.1 Contractor personnel shall comply with all local security requirements including entry and exit control for personnel and property at the Government facility.

11.6.1.2 SMD retains the right to revoke contractor personnel access to government facilities and networks, who violates one or more of Security Personnel Adjudicative guidelines, harassment or violence in the workplace while assigned to a contract clearly conflict with the interest of the Government.

11.6.1.3 If contractor employee is accused of violating state or federal laws and/or Government professional conduct policies or regulations, then the Government may require that such contractor employee be removed from Government premises and/or that such contractor employee be removed from supporting this contract, pending the duration and outcome of a Government investigation if the Contracting Officer finds that the conduct or violation alleged has the potential to negatively interfere with contract performance or operations at a Government facility. Only the Contracting Officer can make such a request on behalf of the Government. Removal of contractor employee shall not negatively impact contract performance.

mailto:janay.gusme.mil@mail.smil.mil

12. Government Furnished Property (GFP)/Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI): N/A

13. Other Pertinent Information or Special Considerations: NA

13.1 Packaging, Packing and Shipping Instructions: The vendor will work with the COR to have items pertaining to device service and maintenance shipped to place of performance.

13.2 Inspection and Acceptance Criteria: N/A

13.3 Property Accountability: N/A

13.4 Transitioning: N/A

13.5. Supply Chain Risk Management (SCRM): N/A

13.6 Training: N/A

13.7 Section 508 Accessibility Standards: N/A