PAP Devices and Associated Items Positive Air Pressure CPAP APAP ASV
1
DEPARTMENT OF VETERANS AFFAIRS (VA)
DENVER ACQUISITION & LOGISTICS CENTER (DALC)
REQUEST FOR INFORMATION (RFI) VA791-17-N-0071
SOURCES SOUGHT SYNOPSIS
1. PROJECT: PAP DEVICES AND ASSOCIATED ITEMS
2. BACKGROUND:
The VA DALC, hereinafter called "the Agency", is conducting market research and seeking information and comment through this Request for Information (RFI) from all interested vendors regarding the availability of commercial Positive Air Pressure (PAP) DEVICES AND ASSOCIATED ITEMS (NAICS 334510) described in this document as well as commercial business practices.
One benefit for the vendor community is that the VA DALC has a warehouse operation and is capable of receiving large, manufacture direct purchases. The VA DALC is a national distribution center which procures through large contracts various medical equipment and supplies. The DALC contracts can include a single ordering entity and billing point and a single warehouse delivery point.
Vendors should note that responses to this RFI may in part be utilized by the Agency in a determination whether or not to set aside particularly listed Agency items or item exclusively for participation by various small business socio-economic concerns.
This is a Request for Information only. It is not an invitation to submit any offers or bids. This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. Do not submit any offers or bids in response to this (RFI). Responses to this RFI are not offers and cannot be accepted by the Agency to form a binding contract. The Agency will not award a contract on the basis of this RFI nor will it pay for information or comments submitted to the Agency in response to this RFI.B
3. INFORMATION REQUESTED AND QUESTIONS TO BE ADDRESSED:
The procurement is for commercially available items. There is a set of questions and information requests for each item. Some questions ask about industry commercial practices. Regarding the draft items, a vendor may choose to provide a RFI response to one or more of the listed items. The term vendor refers to those members of industry providing a response to this RFI.
Vendors are encouraged to provide any information or comments that they believe would be useful to the Agency in its descriptions of the item and minimum technical requirements.
Please note that the Agency may utilize RFI response information and comments that it receives to help develop a possible later Agency Request for Proposals (RFP) that may later be posted publically on FedBizOpps.gov. Therefore, vendors shall not submit any proprietary or confidential information. The use of information submitted to the Agency as a result of this RFI will be at the discretion of the Agency.
The Agency is not obligated to provide comments to vendor submissions. The Government will not pay for any RFI response information, including but not limited to, information or comments requested or questions answered, nor will it recognize or reimburse any costs associated with any RFI submission. Responders are solely responsible for all expenses associated with responding to this RFI. Therefore, the Government recommends that vendors submit electronic versions of, or web links to, previously prepared presentations, documentation, white papers, and other relevant information.
4. RESPONSES
Responses must be submitted to the Department of Veterans Affairs, Denver Acquisition and Logistics Center, on or before 4:00 PM Mountain Time on Friday, February 10, 2017. Please e-mail responses. Note, however, that our e-mail function is very limited as to the size of file that it can receive, approximately 5mb per e-mail. Multiple e-mails are allowed. Please e-mail RFI responses to: Michael.Johnson67e81@va.gov with a copy to kip.sheppard@va.gov In the e-mail subject line please identify as an RFI response. Any questions must be e-mailed to Mr. Michael W. Johnson (see e-mail above) by 12:00 PM (noon) Mountain Time on Wednesday, January 25, 2017. E-mail communication must include the company name, address, point of contact name and title, e-mail address, and telephone number.
DRAFT ITEM LIST - QUESTIONS and INFORMATION REQUESTS FOLLOWS
5A. Draft Description: Draft Minimal Technical Requirements: Auto-Titrating Continuous Positive Airway Pressure (APAP) Machines; 5-AA Questions / Information Requests for: Auto-Titrating Continuous Positive Airway Pressure (APAP) Machines
5B. Draft Description: Draft Minimal Technical Requirements: Minimal Technical Requirements:
Bilevel Positive Airway Pressure (BPAP) Machines; 5-BB Questions / Information Requests for: Bilevel Positive Airway Pressure (BPAP) Machines
5C. Draft Description: Draft Minimal Technical Requirements: Minimal Technical Requirements:
Adaptive Servo-Ventilation (ASV) Machines; 5-CC Questions / Information Requests for: Adaptive Servo-Ventilation (ASV) Machines
5D. Draft Description: Draft Minimal Technical Requirements: Minimal Technical Requirements:
Positive Airway Pressure (PAP) Interfaces (Full Face Masks); 5-DD Questions / Information Requests for: Positive Airway Pressure (PAP) Interfaces (Full Face Masks)
5E. Draft Description: Draft Minimal Technical Requirements: Minimal Technical Requirements:
Positive Airway Pressure (PAP) Interfaces (Nasal Masks); 5-EE Questions / Information Requests for: Positive Airway Pressure (PAP) Interfaces (Nasal Masks)
5F. Draft Description: Draft Minimal Technical Requirements: Minimal Technical Requirements:
Positive Airway Pressure (PAP) Interfaces (Nasal Pillows); 5-FF Questions / Information Requests for: Positive Airway Pressure (PAP) Interfaces (Nasal Pillows)
5G. Draft Description: Draft Minimal Technical Requirements: Minimal Technical Requirements:
Positive Airway Pressure (PAP) Interfaces (Total Face Masks); 5-GG Questions / Information Requests for: Positive Airway Pressure (PAP) Interfaces (Total Face Masks)
5H. Draft Description: Draft Minimal Technical Requirements: Minimal Technical Requirements:
Positive Airway Pressure (PAP) Tubing; 5-HH Questions / Information Requests for: Positive Airway Pressure (PAP) Tubing
5I. Draft Description: Draft Minimal Technical Requirements: Minimum Technical Requirements (MTRs) for PAP Facial Interface Chinstraps; 5-II Questions / Information Requests for: PAP Facial Interface Chinstraps
5J. Draft Description: Draft Minimal Technical Requirements: Minimum Technical Requirements (MTRs) for Positive Airway Pressure (PAP) Machine Filters; 5-JJ Questions / Information Requests for: Positive Airway Pressure (PAP) Machine Filters
5. DRAFT ITEM LIST - QUESTIONS and INFORMATION REQUESTS by item:
5A. Draft Description: Draft Minimal Technical Requirements: Auto-Titrating Continuous Positive Airway Pressure (APAP) Machines
All offerors shall submit the manufacturer's documentation that products meet International Organization for Standardization 80601-2-70: International Standard: International Standard: Particular Requirements for basic safety an essential performance of sleep apnoea breathing equipment therapy ( ISO PAP standard )
All offerors shall submit the manufacturer's documentation that products meet United States FDA 510K Standard.
General Device Specifications:
Devices must be supplied in individual, standard commercial packaging in standard commercial configuration.
A power cord and operating instructions brochure must be supplied with the device.
All APAP machines must have integrated humidifier.
APAP machine (with empty humidifier) must weigh 7lbs or less.
When operating and producing 10 cmH2O pressures, machine noise must be below 40 dB. Supportive documentation must be provided.
Machine must accept and work properly with facial interfaces from at least three different manufacturers.
Machines must have a carrying case that accommodates the machine, facial interface, and tubing.
Machine must be able to use standard size tubing: Length 6-12 feet, diameter 22 mm with a female connector.
Machine must accommodate tubing with heating coil.
Operating Instructions: Must be provided in the English language for both prescriber and user with diagrams, figures, and pictures. User instructions must be written at a 6th grade level.
Operational Modes: There must be two modes of operation:
Prescriber/Clinician Mode - enables settings to be made and adjusted by the prescriber and PAP technicians. Prescribers and PAP technicians must be able to lock the settings made so that the user cannot make adjustments to the parameters set.
User Mode - enables a limited range of comfort settings to be made and adjusted by the user.
Prescribed Parameter Set-Up: Must be possible through ALL of the following methods.
Directly from operation keys on the APAP device
Remotely using PC/Mac software via USB drive/data card application
Remotely using secure wireless, cloud-based technology
APAP Parameter Settings:
Machines must have selectable pressure between an inclusive lower pressure of 5 and an inclusive upper pressure of at least 20 cmH20 in increments of 1 cmH20 or less.
Airflow must keep the facial interface pressurized with a positive pressure needed to maintain airway patency.
Machines must have continuous PAP (CPAP) capability in addition to APAP capability.
Machine auto-adjustment must be based on airflow limitation.
The high and low pressure range boundaries must be settable independently by the prescriber and PAP technicians.
Machines must have ramp capability that allows positive pressure to gradually increase over time (maximum pressure increments 2 cm H2O, total ramp time must be adjustable between 0 and 15 minutes or more).
Data Parameters, Access, and Storage:
Machine must store a minimum of 90 days of "time-on-mask" usage data downloadable using a memory-chip AND secure wireless, cloud-based transmission.
Usage data must include time-on-mask, pressure(s) delivered, mask leak, and estimation of residual sleep disordered breathing events (AHI and residual event types including obstructive apneas, hypopneas, clear airway apneas).
All data must be made available in structured variable form with HL-7 capability.
Summarized data must be provided for 4 weeks or more, and full disclosure data must be provided for 3 nights or more.
Memory chip readers, associated software, and updates to that software must be made available to facilities.
Wireless data transmission must be available on every APAP machine.
Maintenance, Cleaning, and Infection Control:
APAP units must be able to be cleaned and disinfected with commercially available household cleaning agents.
It must be possible to completely dismantle the humidifier and disinfect all parts thermally (machine washable).
Machine must use either washable or disposable filters and accept optional pollen, ultra-fine, or HEPA filters.
The device must not require any user maintenance other than external cleansing, humidifier cleaning, and changing/cleaning of particulate filters throughout its lifetime.
Documentation must be provided with each machine and to the VA facility that specifies the manufacturer s recommendations for routine servicing (including recommended resources for maintenance/ servicing).
Power Supply Specifications:
The APAP device must have an automatic universal power supply that will allow 100 to 240 V AC operation at 50-60Hz with no need for changes to any settings.
Maximum power consumption without humidifier on 120 V AC power must be
