ATTACH_Attachment_1___Vendor_Submission_Form.xls
XLS spreadsheet 19 KB Posted
- Attached to
- Negative Pressure Wound Therapy Systems Federal contract opportunity
- Solicitation number
- SPE2D1-23-R-0001
About this file
This document contains a vendor submission form and details of a federal solicitation for negative pressure wound therapy systems. The solicitation seeks proposals for negative pressure wound therapy devices and related consumables, accessories, training and maintenance to support wound treatment. Evaluation criteria include the ability of devices to function in austere environments, achieve airworthiness certification for medical evacuation aircraft, and sustain system operations for the expected lifespan. Vendors must demonstrate their offerings meet or exceed requirements for pressure ranges, power sources, portability, infection control and other key characteristics. The selected vendor will receive a single-award indefinite delivery indefinite quantity contract to standardize these wound therapy systems across the procuring agency.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| ATTACH_Attachment_1___Vendor_Submission_Form_Amendment 2.xlsx | XLSX spreadsheet | |
| SF30_SPE2D123R0001_0002.PDF | ||
| NPWT_RFP SPE2D123R0001_Final_Amendment 0001.pdf | ||
| SF30_SPE2D123R0001_Amendment 0001.PDF | ||
| ATTACH_Solicitation_SPE2D123R0001.pdf | ||
| SF1449_SPE2D123R0001.PDF | ||
| ATTACH_Attachment_4___ECAT_Item_Price_Import_Template.xls | XLS spreadsheet | |
| ATTACH_Attachment_2___Pricing_Submission_Form.xls | XLS spreadsheet | |
| ATTACH_Attachment_3__AFI 44-108 InfectionControlProgram.pdf |
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Text version
Vendor Submission Form
| VENDOR SUBMISSION FORM (Completed by Vendors) | ||||||||
| VERSION 2 - 1/16/18 | ||||||||
| GOVERNMENT MINIMUM REQUIREMENTS AND OBJECTIVES | VENDOR SUBMISSION FOR RFP FACTOR | |||||||
| Customer should copy description, minimum requirements and objectives from RFP - Rest of form is to be completed by vendors | VENDOR MUST COMPLETE ALL INFORMATION IN COLUMN E, F, G AND H | |||||||
| RFP SOW SRD# | DESCRIPTION OF MINIMUM REQUIREMENT AND/OR OBJECTIVE | MINIMUM REQUIREMENT | OBJECTIVE | VENDOR MEETS MINIMUM REQUIREMENT (YES, NO, EXCEEDS MINIMUM, OR NA) (NA only used if there is no minimum requirement) | VENDOR MEETS OBJECTIVE (YES, NO, EXCEEDS OBJECTIVE, OR NA) (NA only used if there is no objective) | JUSTIFICATION FOR MEETING AND EXCEEDING REQUIREMENTS: Narrative on how vendor meets or exceeds minimum requirement meets and meets or exceeds Objective (Vendor must provide narrative to get credit - can attach narrative) | SUPPORTING INFORMATION LOCATION: Indicate where in the vendors offer the minimum requirement or objective is supported | COMMENTS AND/OR EXPLANATION OF WHY MINIMUM CANNOT BE MET. ALSO ANY ALTERNATE OFFER OR APPROACH |
| 1 | FDA Clearance | YES | N/A | |||||
| 2 | Aircraft Use | Vendor agrees to pass Joint Enroute Care Equipment Test Standard (JECETS) prior to delivery of any additional systems outside the ones required for testing. | Vendor shall provide any successful results, documentation or certification of other aircraft testing completed. For instance, documentation of usage by foreign militaries aircraft, FAA, or commercial flight certification showing passing results. | |||||
| 3 | Modes | The device controls shall consist, at a minimum, of: |
Modes (off/continuous/intermittent), Intermittent On Time Intermittent Off Time Vacuum Adjust Control
| Safety Lockout | N/A | |||
| 4 | Pressure Range | The negative pressure shall be adjustable and include at least -50 to -150 mm Hg pressure range | The negative pressure shall be adjustable, and the range shall be at least -25 to -200 mm Hg. |
The interval between pressures adjustments shall be no greater than 25 mm Hg.
| 5 | Operations | Device must be operational while secured vertically and horizontally with accessibility of controls | N/A |
| 6 | Display | The Device shall have visual and audible alarms with the ability to silence active alarms and all-alarm suspension. Consider limitations due to aircraft ambient noise degrading effectiveness of audio alarms. | Shall provide audible and visual alarms in least 2 colors (Ex. high and routine priority) depending on the type of alarm. |
| 7 | Device display shall be digital and readable in low-light environments and Night Vision Goggle compatible | N/A | |
| 8 | Carrying Bag | The device shall have a carrying bag. | N/A |
| 9 | The carrying bag with the device inside shall be able to be carried with one hand using a handle or strap. | N/A | |
| 10 | The device and carrying bag together shall weigh equal to or less than 5lbs (2.3 Kg) | The device and carrying bag together shall weigh equal to or less than 3lbs (1.4 Kg) | |
| 11 | Portability and Mounting | Shall have a portable configuration, with the ability to be mounted onto an IV pole or rail. Shall have the ability to be secured to a standard NATO litter and Medical Equipment Rail Kit (MERK). | While contained in the carrying bag, the device shall be portable with the ability to be mounted onto an IV pole or rail. |
While contained in the carrying bag, the device shall have the ability to be secured to a standard NATO litter and Medical Equipment Rail Kit (MERK).
| 12 | Device must have some capability to secure if not mounted (i.e., handle or tie down point). | N/A | |
| 13 | Infection Control | Device must be able to be cleaned and disinfected in accordance with infection control guidance per AFI 44-108 Infection Control Program (Attachment 3) | N/A |
| 14 | Back Flow Prevention | Device must have back flow prevention | N/A |
| 15 | Collection canisters | Device shall have at least one canister of, at least 200ml in size, and all accessories required to connect the canister to the device itself. | Device shall have two or more canisters of, at least 200ml in size, and all accessories required to connect the canister to the device itself. |
| 16 | Canister shall be disposable, constructed from clear, non-breakable material and have an integral check valve to prevent leakage | Canister shall include a solidifying agent. | |
| 17 | Dressings | The system shall either be A) a single channel device with the ability to split the pressures into at least 2 wound locations simultaneously or B) shall be a multi-channel device with the capability to both treat a single wound site or pressurize at least 2 wound locations simultaneously. The vendor shall specify how this is accomplished (i.e., via two separate dressings or a single dressing with multiple pressure points). | N/A |
| 18 | Shall have the capability to use foam or gauze dressing. | Shall have the capability to use foam and gauze dressing. |
Shall have the capability for instillation.
The gauze or foam dressing shall not be proprietary
| 19 | Power Source | Shall operate from 110~240 VAC, 50/60 Hz, and a replaceable battery. | Shall operate from 110-240 VAC, 50/60/400 Hz and 12-28 VDC, and a replaceable battery. |
| 20 | Shall be capable of operating from any of the specified external AC or DC power sources while the internal battery is being recharged. Simultaneous operation and recharge shall not affect recharge time. Automatic switching between these power sources required | N/A | |
| 21 | Battery | Device must run continuously on battery power on a single charge on max suction for at least 6 hours. | Device must run continuously on battery power on a single charge on max suction for at least 12 hours. |
| 22 | Device must fully charge (> = 90 %) a depleted battery in 8 hours | Device must fully charge (> = 90 %) a depleted battery in 6 hours | |
| 23 | Device must display battery capacity | N/A | |
| 24 | Device must have battery shelf Life of at least 2 years | Device must have battery shelf life of at least 4 years | |
| 25 | Battery must be replaceable by a BMET | That battery shall be hot swappable by the user | |
| 26 | Device must include an extra battery | N/A | |
| 27 | Training | Vendor shall provide 1 initial training for the user and 1 refresher user training. | N/A |
| 28 | Vendor shall provide distance learning user training for the full system to include all components and accessories. | N/A | |
| 29 | Vendor shall provide training materials for users and maintenance on new functionality and enhancements. | N/A | |
| 30 | Manuals | Each device shall include 1 hard copy operator/user manual. Each delivery order will also include 1 digital equivalent manual. |
Each device shall include 1 hard copy service manual. 1 digital equivalent service manual will be sent to AFMRA.
| The service manual will include theory of operation, trouble shooting, all maintenance and calibration requirements, illustrated parts breakdown with part numbers for each replaceable component, all applicable schematics [electronic, pneumatic, etc.]. Manuals will be the same as provided to OEM service engineers. | N/A | |||
| 31 | Warranty | Shall include a year of warranty. | The system has a warranty greater than one year | |
| 32 | Supportability | Shall support the device with parts, consumables, supplies, and software updates available and software updates for purchase to make repairs for 7 years from the date of the last system sold. | Shall support the device with parts, consumables, supplies, and software updates available and software updates for purchase to make repairs for 8 years from the date of the last system sold. | |
| 33 | Maintainability | Vendor shall only quote items that can be maintained by the AF biomedical equipment technicians. |
| All work shall be performed by BMETs with no training required. | N/A | |||
| 34 | The Device shall be maintainable by military Biomedical Equipment Technicians (BMET) using standard tools (as provided in standard BMET kit; no special tools required) without voiding warranty. Repair parts and/or telephone consultation before and after warranty period will be provided to DoD BMETs without need to attend manufacture specific training or incurring additional telephone consultation costs. Any service keys required shall be provided to the AF or with no expectation to have a maintenance contract or BMET training. | N/A | ||
| 35 | Device system software updates | Device system software that may require modification during system life shall be upgradable in the field by military Biomedical Engineering Technicians using a computer interface, the Internet, or a CD supplied by the manufacturer without changing hardware components of the device. Manufacturer notification of product software modification and/or updates sold to customers is required. Outdated software should not render the device unusable. | N/A | |
| 36 | Network Connectivity | Although no internet connectivity will be used while in deployed environment, if the device is capable of network connectivity. |
| Device must also be capable of disabling any networking ports or other communication ports, such as Wi-Fi or Bluetooth. | N/A | ||
| 37 | Operating System and Major Components | If the device has an Operating System, the OS shall be maintained and supported for the at least 3 years. |
All major component software applications (SQL, IIS, .Net, etc.) have current commercial support. N/A
Other features or value added offer beyond requirement and objectives above (vendor completes below) Explanation of value added offer
The Vendor Submission Form (Attachment #1) shall include a definitive statement addressing whether their offer meets all SOW Minimum Requirements set forth in the solicitation and included in Attachment 1
Sheet1
| SRD# | DESCRIPTION OF MINIMUM REQUIREMENT AND/OR OBJECTIVE | MINIMUM REQUIREMENT | OBJECTIVE |
| 1 | FDA Clearance | YES | N/A |
| 2 | Aircraft Use | Vendor agrees to pass Joint Enroute Care Equipment Test Standard (JECETS) prior to delivery of any additional units outside the ones required for testing. | Vendor shall provide any successful results, documentation or certification of other aircraft testing completed. For instance, documentation of usage by foreign militaries aircraft, FAA, or commercial flight certification |
| showing passing results. | |||
| 3 | Modes | The device controls shall consist, at a minimum, of: | N/A |
| Modes (off/continuous/intermittent), | |||
| Intermittent On Time | |||
| Intermittent Off Time | |||
| Vacuum Adjust Control | |||
| Safety Lockout | |||
| 4 | Pressure Range | The negative pressure shall be adjustable and include at least -50 to | The negative pressure shall be adjustable, and the range shall be at least -25 to -200 mm Hg. |
| -150 mm Hg pressure range | |||
| The interval between pressures adjustments shall be no greater than 25 mm Hg. | |||
| 5 | Operations | Device must be operational while secured vertically and horizontally with accessibility of controls | N/A |
| 6 | Display | The Device shall have visual and audible alarms with the ability to silence active alarms and all-alarm suspension. Consider limitations due to aircraft ambient noise degrading effectiveness of audio alarms. | Shall provide audible and visual alarms in least 2 colors (Ex. high and routine priority) depending on the type of alarm. |
| 7 | Device display shall be digital and readable in low-light environments and Night Vision Goggle compatible | N/A | |
| 8 | Carrying Bag | The device shall have a carrying bag. | N/A |
| 9 | The carrying bag with the device inside shall be able to be carried with one hand using a handle or strap. | N/A | |
| 10 | The device and carrying bag together shall weigh equal to or less than 5lbs (2.3 Kg) | The device and carrying bag together shall weigh equal to or less than 3lbs (1.4 Kg) | |
| 11 | Portability and Mounting | Shall have a portable configuration, with the ability to be mounted onto an IV pole or rail. Shall have the ability to be secured to a standard NATO litter and Medical Equipment Rail Kit (MERK). | While contained in the carrying bag, the device shall be portable with the ability to be mounted onto an IV pole or rail. |
| While contained in the carrying bag, the device shall have the ability to be secured to a standard NATO litter and Medical Equipment Rail Kit (MERK). | |||
| 12 | Device must have some capability to secure if not mounted (i.e., handle or tie down point). | N/A | |
| 13 | Infection Control | Device must be able to be cleaned and disinfected in accordance with infection control guidance per AFI 44-108 Infection Control Program (Attachment 3) | N/A |
| 14 | Back Flow Prevention | Device must have back flow prevention | N/A |
| 15 | Collection canisters | Device shall have at least one canister of, at least 200ml in size, and all accessories required to connect the canister to the device itself. | Device shall have two or more canisters of, at least 200ml in size, and all accessories required to connect the canister to the device itself. |
| 16 | Canister shall be disposable, constructed from clear, non-breakable material and have an integral check valve to prevent leakage | Canister shall include a solidifying agent. | |
| 17 | Dressings | The system shall either be A) a single channel device with the ability to split the pressures into at least 2 wound locations simultaneously or B) shall be a multi-channel device with the capability to both treat a single wound site or pressurize at least 2 wound locations simultaneously. The vendor shall specify how this is accomplished (i.e., via two separate dressings or a single dressing with multiple pressure points). | N/A |
| 18 | Shall have the capability to use foam or gauze dressing. | Shall have the capability to use foam and gauze dressing. | |
| Shall have the capability for instillation. | |||
| The gauze or foam dressing shall not be proprietary | |||
| 19 | Power Source | Shall operate from 110~240 VAC, 50/60 Hz, and a replaceable battery. | Shall operate from 110-240 VAC, 50/60/400 Hz and 12-28 VDC, and a replaceable battery. |
| 20 | Shall be capable of operating from any of the specified external AC or DC power sources while the internal battery is being recharged. Simultaneous operation and recharge shall not affect recharge time. Automatic switching between these power sources required | N/A | |
| 21 | Battery | Device must run continuously on battery power on a single charge on max suction for at least 6 hours. | Device must run continuously on battery power on a single charge on max suction for at least 12 hours. |
| 22 | Device must fully charge (> = 90 %) a depleted battery in 8 hours | Device must fully charge (> = 90 %) a depleted battery in 6 hours | |
| 23 | Device must display battery capacity | N/A | |
| 24 | Device must have battery shelf Life of at least 2 years | Device must have battery shelf life of at least 4 years | |
| 25 | Battery must be replaceable by a BMET | That battery shall be hot swappable by the user | |
| 26 | Device must include an extra battery | N/A | |
| 27 | Training | Vendor shall provide 1 initial training for the user and 1 refresher user training. | N/A |
| 28 | Vendor shall provide distance learning user training for the full system to include all components and accessories. | N/A | |
| 29 | Vendor shall provide training materials for users and maintenance on new functionality and enhancements. | N/A | |
| 30 | Manuals | Each device shall include 1 hard copy operator/user manual. Each delivery order will also include 1 digital equivalent manual. | N/A |
| Each device shall include 1 hard copy service manual. 1 digital equivalent service manual will be sent to AFMRA. | |||
| The service manual will include theory of operation, trouble shooting, all maintenance and calibration requirements, illustrated parts breakdown with part numbers for each replaceable component, all applicable schematics [electronic, pneumatic, etc.]. Manuals will be the same as provided to OEM service engineers. | |||
| 31 | Warranty | Shall include a year of warranty. | The system has a warranty greater than one year |
| 32 | Supportability | Shall support the device with parts, consumables, supplies, and software updates available and software updates for purchase to make repairs for 7 years from the date of the last unit sold. | Shall support the device with parts, consumables, supplies, and software updates available and software updates for purchase to make repairs for 8 years from the date of the last unit sold. |
| 33 | Maintainability | Vendor shall only quote items that can be maintained by the AF biomedical equipment technicians. | N/A |
| All work shall be performed by BMETs with no training required. | |||
| 34 | The Device shall be maintainable by military Biomedical Equipment Technicians (BMET) using standard tools (as provided in standard BMET kit; no special tools required) without voiding warranty. Repair parts and/or telephone consultation before and after warranty period will be provided to DoD BMETs without need to attend manufacture specific training or incurring additional telephone consultation costs. Any service keys required shall be provided to the AF or with no expectation to have a maintenance contract or BMET training. | N/A | |
| 35 | Vendors must establish an ECAT contract and agree to support the repair parts, accessories, consumables, optional items and components through ECAT for the life of the standardization. The Government reserves the right to specify which items shall be offered on ECAT and reserves the right to change this offering during the life of the standardization. | N/A | |
| 36 | Device system software updates | Device system software that may require modification during system life shall be upgradable in the field by military Biomedical Engineering Technicians using a computer interface, the Internet, or a CD supplied by the manufacturer without changing hardware components of the device. Manufacturer notification of product software modification and/or updates sold to customers is required. Outdated software should not render the device unusable. | N/A |
| 37 | Network Connectivity | Although no internet connectivity will be used while in deployed environment, if the device is capable of network connectivity. | N/A |
| Device must also be capable of disabling any networking ports or other communication ports, such as Wi-Fi or Bluetooth. | |||
| 38 | Operating System and Major Components | If the device has an Operating System, the OS shall be maintained and supported for the at least 3 years. | N/A |
| All major component software applications (SQL, IIS, .Net, etc.) have current commercial support. |
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