Medical Ultrasound Remote Control Graphic User Interface Testing and Validation - ACAN

PURPOSE
The purpose of this Advance Contract Award Notice (ACAN) is to signal the Canadian Space Agency’s (CSA) intention to enter into a sole source contract with:

Andrew W Kirkpatrick Professional Corporation
15 Coach Gate Way SW
Calgary, Alberta
T3H 1L7


To supply the services described below.


An Advance Contract Award Notice (ACAN) allows departments and agencies to post a notice, for no less than fifteen (15) calendar days, indicating to the supplier community that it intends to award a good, service or construction contract to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award. However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process.

You are hereby notified that the government intends to negotiate with one firm only as identified above. Should you have any questions concerning this requirement, contact the contracting officer identified herein.


DESCRIPTION OF THE WORK
Background :
Ultrasound is currently the only diagnostic medical imaging technology for imaging internal tissues and organs with mass, volume and power requirements conducive to space missions.  One of the drawbacks of medical ultrasound is the amount of training and practice required for an operator to be able to consistently acquire diagnostic quality ultrasound images, with ultrasound technicians typically requiring two years of training and clinical oversight prior to being considered proficient.  This is problematic for space flights as crew medical officers (CMO) on space flights may only be allocated a few days training.  The same problem exists in the provision of medical care in remote northern communities. Health care providers (nurses and general practitioners) in these communities rarely have the training required to make reliable diagnostic quality images, and as such, patients must wait for the assigned ultrasound technician to rotate through the community (if such a service is available) or must be transported to a medical care facility that has ultrasound equipment and trained staff.

In the space environment, NASA has overcome this training barrier to medical ultrasonography by developing tele-mentoring protocols with which a trained and certified ultrasonographer located on the ground can mentor a relatively untrained crewmember in both the operation of the ultrasound machine, and in the guiding of the operator through the required probe placement positions.  Recently, Ultrasonix Medical Corporation, based out of Richmond, British Columbia, has developed machines with a unique capability to allow technicians to remotely control some operations of the ultrasound machine.  This remote control capability, has the potential of providing the mission control-based (or hospital-based in terrestrial medicine) specialists the ability to remotely control the ultrasound machine in order to obtain diagnostic quality images and thus limiting mentoring of the untrained operator to probe placement only.  Ultrasonix was recently contracted by the CSA to further develop their remote control interface (Graphic User Interface), as per CSA requirements, into a potential clinical tool for space missions.

The purpose of this activity is to contract the testing of this newly developed remote control interface in a clinical setting in order to assess if such a tool could improve the efficacy and reliability of medical ultrasound imaging using minimally trained operators, as well, this contract will provide recommendations from qualified space-medicine specialists modifications to the technology to improve its functionality for eventual use in the space environment.


Definition of the Requirement:
The CSA requires comprehensive evaluation of the medical ultrasound remote control interface in its ability to improve tele-mentored ultrasonography using relatively un-trained ultrasound operators, as well as subject-matter expert recommendations on future improvements and applicability for use in the space environment.  Specifically, the contractor is required to perform the following:

1)	Receipt and verification of CSA-provided ultrasound machines as well as the remote control interface.  A computer running the remote control interface is to be networked to communicate with two ultrasound machines, running in tandem with video-conferencing systems to allow for audio communications as well as video.
2)	Benchtop testing to evaluate functionality and usability of the system and interface.
3)	Develop and implement a randomized trial of remotely guided imaging using the ultrasound remote control graphic user interface.  The trial must involve the following;
a.	Evaluation of the remote control interface in the remote tele-mentoring of relatively untrained operators by assessing in the acquisition of diagnostic quality ultrasound images with and without the use of the remote control interface.
b.	Testing will include, at a minimum, assessment of speed of image acquisition, image quality, the accuracy of diagnosis, as well as user satisfaction with the mentored examination and the technology.
c.	Practical evaluation of the remote control interface functionality from the perspective of;
i.	Ultrasound mentors
ii.	Naïve (untrained) ultrasound operators

d.	Use of space-relevant diagnostic imaging protocols (eg. FAST exam)
e.	The use of realistic ultrasound simulation platforms (phantom models) and/or live subjects
4)	Identification of issues related to;
a.	Using the remote control graphic user interface over a distributed network,
b.	Operation of the remote control user interface for diagnostic ultrasonography in the spaceflight (ISS) environment.
5)	Recommendations on changes/improvements to the remote control graphic user interface for future use in;
a.	Spaceflight, 
b.	Remote terrestrial settings.

6)	Produce a final report outlining testing procedures issues and recommendations for future development.


MANDATORY REQUIREMENTS 
To fulfill the requirements of the contract the supplier must be able provide the following conditions in terms of personnel and test environment:

1.	The team must have access to IT specialists for the installation and networking of the ultrasound machines as well as the computer-based remote control interface.
2.	Evaluation of the medical ultrasound remote control interface must be performed by physicians with experience in the tele-mentoring of untrained ultrasound operators in acquiring diagnostic quality ultrasound images.
3.	Provider must be able to solicit a motivated volunteer population that is available to perform the comparison and validation testing according to the contract schedule.  Volunteer population must be operational personnel with medical training comparable to the astronaut population. Population sample size must be based on statistical power analysis to allow the drawing of meaningful conclusions.
4.	Provider must be able to simulate space-relevant medical conditions using ultrasound simulation platforms (phantom models), or have access to a willing patient base.
5.	Evaluation of the medical ultrasound remote control interface for issues and recommendations pertaining to future use on ISS must be performed by a space medicine expert with knowledge and experience in the tele-mentoring and acquisition of medical ultrasound images during space missions.
6.	Provider has to have access to Ethics Review Board that can evaluate the test methods used.


SOLE SOURCE JUSTIFICATION
The CSA considers the team proposed by Andrew W Kirkpatrick Professional Corporation (consisting of Dr. Andrew Kirkpatrick and Dr. Douglas Hamilton) to be in a unique position to fulfill the requirements for the following reasons: 

1.	Andrew W Kirkpatrick Professional Corporation team (Dr. Andrew Kirkpatrick and Dr. Douglas Hamilton) has extensive experience and numerous publications in issues related to remote and tele-medicine (terrestrial and space).
2.	Andrew W Kirkpatrick Professional Corporation team (Dr. Andrew Kirkpatrick) has extensive experience and numerous publications in remote tele-mentoring of relatively untrained ultrasound operators in terrestrial environments.  This experience includes using a variety of ultrasound platforms, video streaming technologies as well a variety of image transmission and display devices (videoconferencing systems, computers, smartphones).  This experience also includes tele-mentoring and tele-ultrasonography in a variety of environments ranging from hospital to remote terrestrial settings.
3.	Andrew W Kirkpatrick Professional Corporation team (Dr. Andrew Kirkpatrick and Dr. Douglas Hamilton) has extensive experience and numerous publications in ultrasonography for a variety of medical conditions that are relevant to spaceflight (FAST, eFAST, ocular examination, pneumothorax, hemothorax, bone fractures).
4.	Andrew W Kirkpatrick Professional Corporation team (Dr. Douglas Hamilton) has extensive knowledge and experience in the provision of healthcare to astronauts during space missions to the International Space Station.  This involves extensive knowledge of space-relevant medical conditions, as well as in-flight medical equipment, procedures and consumables.  This also includes many years of experience in remote tele-mentoring and tele-ultrasonography of astronauts during space missions to the International Space Station as well as extensive knowledge of space-to-ground communications systems and procedures.
5.	Andrew W Kirkpatrick Professional Corporation team (Dr. Andrew Kirkpatrick and Dr. Douglas Hamilton) has worked with earlier versions of the Ultrasonix remote control interface in space analogue environments and is familiar with the functions of the interface.
6.	Andrew W Kirkpatrick Professional Corporation team (Dr. Andrew Kirkpatrick and Dr. Douglas Hamilton) has previously worked with and has access to a volunteer population of operational personnel (firefighters) that is similar to the astronaut community in terms of their medical training.
7.	Andrew W Kirkpatrick Professional Corporation team has access to Ethics Review Boards through the University of Calgary and Calgary Foothills Hospital that can evaluate the proposed research.  The team has extensive experience in obtaining ethics approvals from these boards for similar studies, which will be important for a successful and expedient ethics application process.
8.	Andrew W Kirkpatrick Professional Corporation team has access to both high fidelity ultrasound simulation platforms (phantom models), and a patient base.


The CSA considers this combined experience in terrestrial and space medicine, tele-medicine, tele-mentoring, and tele-utrasonography puts the team in a unique position to evaluate the ultrasound remote-control interface in the remote tele-mentoring of untrained operators, to identify issues related to the operation of the remote control user interface, and to make recommendations on changes/improvements for future use in terrestrial and spaceflight environments. To the best of our knowledge, there is no other provider in Canada with this unique combination of assets, knowledge and experience necessary for the successful completion of the specified tasks.

DURATION
The duration of the contract will be 1 year from contract award.

ESTIMATED COST
The estimated cost of the proposed contract is $40,000 plus applicable taxes. 

LIMITED TENDERING REASON:
The contract is proposed under the Government Contracting Regulations, Section 6 (d) that states “only one person or firm is capable of performing the contract”.

This requirement is not subject to the trade agreements.


INTELLECTUAL PROPERTY
The Canadian Space Agency has determined that any intellectual property rights arising from the performance of the Work under the resulting contract will belong to Canada, on the following grounds: 

•	where the main purpose of the Crown Procurement Contract, or of the deliverables contracted for, is to deliver a component or subsystem that will be incorporated into a complete system at a later date (not necessarily by the original Contractor), as a prerequisite to the planned transfer of the complete system to the private sector (not necessarily to the original Contractor), through licensing or assignment of ownership, for the purposes of Commercial Exploitation.

SUBMISSION OF STATEMENT OF CAPABILITIES
Suppliers who consider themselves fully qualified and available to provide the services/goods described herein, may submit a statement of capabilities in writing to the contact person identified in this Notice on or before the closing date of this Notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

The CSA file number, the contracting officer's name and the closing date of the ACAN must appear on the outside of the envelope in block letters or, in the case of a facsimile transmission, on the covering page, e-mail submission will not be considered.

Canada retains the right to negotiate with suppliers on any procurement.

Documents may be submitted in either official language of Canada.