80NSSC26920246Q-1 QA Template (FILLED OUT) (002) (002).pdf

Q&A Document

80NSSC26920246Q-1 – Chamber Services for decompression sickness testing of exercise countermeasures.

Question 1: When does the 1-year date data collection period start? Is it subject to equipment delivery or IRB delays?

Answer 1: Contract may start as soon as Feb. 2026 so please assume Feb. 2027.

It’s important to note that the SOW states: “Organizations conducting these chamber tests will have completed pilot chamber tests to demonstrate their capabilities to and have their test data reviewed by NASA. Chambers selected for the tests described in the current Statement of Work will have documented and verified resolution of any deficiencies identified in their execution of NASA-defined DCS pilot test protocols. “

Since pilot testing has traditionally taken over a year, if a vendor doesn’t have this experience already, completing in a year is not feasible.

Question 2: What materials/equipment can be on loan from NASA, and what is the timeline for delivery to the site for this equipment?

Answer 2: See Table 2 in Statement of Work that lists loaner equipment.

Item(s) Quantity Notes These items may be loaned by NASA pending availability

Gentex Phantom + (POM+) oxygen masks with drink port

6-10

• Number of masks required depends upon number of subjects and operator per run and schedule.

• Loan by NASA can be arranged.

• Training should be procured by the facility from manufacturer-approved experts Gentex Phantom Mask Toolkit

1 • Loan by NASA can be arranged.

• Training should be procured by the facility from manufacturer-approved experts GE Vivid iQ Ultrasound & 3Sc-RS probe (or NASA-

1 • Loan by NASA can be arranged.

• Protocol-specific imaging training was provided by

NASA during chamber pilot study. Chamber is responsible for additional training to maintain approved equivalent) proficiency and/or train new operators. NASA will provide additional training if data collection protocols are modified by NASA.

COSMED K5 Portable Metabolic Gas Analysis System (or NASA-approved equivalent)

1 • Includes mask, K5 parts, and laptop

• Loan by NASA can be arranged

• Protocol-specific imaging training was provided by

NASA during chamber pilot study. Chamber is responsible for additional training to maintain proficiency and/or train new operators. NASA will provide additional training if data collection protocols are modified by NASA.

Question 3: What equipment must be provided by us and cannot be loaned from

NASA?

Answer 3: See Table 2 in Statement of Work (below)

Chamber is responsible for providing these items Decompression Chamber and supporting hardware

As Required

• Facility responsible items. Includes chamber functional and monitoring hardware for safe and effective operations, communication system, audio/video system, medical, toilet, trash can, etc.

EVA Workstation 1 system • Hardware consistent with NASA requirement, includes step station, arm ergometer, patient cot, umbilical management system, batteries for metronome (AAA), and peripherals.

• Requirements, CAD diagram, and parts lists are provided by NASA as needed.

Ultrasound station

1 • Including ultrasound stand, HDMI cables or other video/audio recording methods, surgical markers, hardware drive, US gel, wipes

VO2 Peak Testing Station

1 • Facility responsible item. Includes ECG*, metabolic cart*, and cycle ergometer (e.g., Lode Bike that can connect to metabolic cart).

• NASA will provide protocol and acceptable data record template.

Subject supplies As Required

• Facility responsible items, including clothing, hydration fluids (including container), toiletry/hygiene, handheld mirrors, skin fold calipers (per NASA protocol and data record template).

Mask (POM+) Integration

As required

• Facility responsible item, including but not limited to hydration canteen/connector, O2 supply system, mask harness, mask sizing caliper, and communication system.

• NASA will provide protocol and recommendations.

Mask (POM+)

Cleaning Supplies As

Required

• Facility responsible items.

• NASA will provide standard operating procedure and list of approved supplies.

Heart rate sensor batteries

(or as required)

• Facility responsible items.

• CR2025 Coin Battery, 1 in use, 1 for back-up

• For use during workload calibration sessions.

Other testing supplies

As Required

• Other miscellaneous items required for the safe and effective execution of this work

COSMED calibration gas tank and cart

1 • Facility responsible items. (Classified as “dangerous goods”)

• Calibration gas mix CGA-973 (16% O2, 5%CO2, N2 balance)

• Includes gas tank cart-trolley

• Verify expiration date per use

• COSMED P/Ns: Cart, A-860-900-003; Gas, A-860-000-

004) COSMED Sensor Kit

1 • Facility responsible items. (Classified as “dangerous goods”)

• Expires quickly. Facility shall ensure an unexpired kit is available in their facility throughout the project.

• COSMED P/N: C04391-01-11

COSMED K5 battery 2 • Facility responsible items. (Classified as “dangerous goods”)

• 1 primary and 1 backup

• COSMED P/N: C04273-01-05.

Question 4: Do we have any selection criteria for the subjects?

Answer 4:

• age 30-60 years

• in good general health and able to pass a medical exam equivalent to an Air

Force Class III physical exam

• VO2max > 27.5 ml/min/kg as measured from a peak cycle ergometry exercise test

• The physical exam and medical screening will include height, weight, skin fold measurements, body fat %, vision test, hearing test, urine illegal drugs screen, HIV, and Hepatitis B, 12 lead resting electrocardiogram, chest x-ray or low dose chest CT, Pulmonary Function Test (spirometry only), echocardiogram to evaluate for atrial septal defect and echocardiogram with intravenous agitated saline to evaluate for patent foramen ovale.

Exclusion:

• Exclusion criteria include pregnancy, positive illicit drug screen, atrial septal defect, sleep apnea, HIV, Hepatitis B, respiratory illness, smoking, or difficulty clearing ears with pressure changes. Exclusion for medication use includes any medications used for a psychotropic disorder, chronic pain, or a sleep disorder.

• Exclusionary antihypertensive medications include clonidine, guanabenz, guanfacine, methyldopa, nitrates (such as nitroglycerin, isosorbide dinitrate, or isosorbide mononitrate), reserpine, beta blockers, diuretics or four or more simultaneous antihypertensive medications which matches the guidelines from the Federal Aviation Administration’s Guide for Aviation Medical Examiners (updated 9/24/25) and the Association of Dive Contractors International’s International Consensus Standards for Commercial Diving and Underwater Operations (6.5 Edition).

Question 5: Who has �inal authority on subject selection?

Answer 5: The vendor should pick subjects based on the criteria and ask NASA for any suggested exceptions.

Question 6: Who is responsible for PHI information and health records handling, including approval for inclusion by IRB?

Answer 6: NASA will submit to NASA IRB. Vendor may submit to another IRB as well.

Subject and experimental data will be managed locally by the facility and shared with NASA for inclusion in the larger dataset to address the primary hypothesis of the study and for future modeling activities.

Question 7: Is the payment for services broken up by stages of completion, milestones, or only upon completion?

Answer 7: Vendor can submit milestone payment plan.

Question 8: Is there any opportunity for defrayment of upfront costs associated with materials acquisition to carry out the SOW?

Answer 8: Vendor can submit milestone payment plan including upfront costs.

Question 9: Is Stennis Space Center providing a suitable hypobaric chamber to perform the tests?

Answer 9: The procurement is for chamber services so unless vendor is from Stennis, there is no plan for Stennis chamber. Treatment chamber is also responsibility of the vendor.