Advance Contract Award Notice (ACAN)
Title: Evaluation of Adverse Reaction Data Collected in National, Primary Care Electronic Medical Records for its use in Pharmacovigilance Activities
Solicitation Number: (Insert here)
1. The Purpose and Explanation of an ACAN
An Advance Contract Award Notice (ACAN) allows Health Canada to post a notice for no less than fifteen (15) calendar days, indicating to the supplier community that a goods, services or construction contract will be awarded to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the minimum requirements identified in the ACAN, the Contracting Authority may then proceed to award a contract to the pre-identified contractor.
2. Rights of Suppliers
Suppliers who consider themselves fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities demonstrating how they meet the advertised requirement. This Statement of Capabilities must be provided via e-mail only to the contact person identified in Section 12 of the Notice on or before the closing date and time of the Notice. If the Bidder can clearly demonstrate they possess the required capabilities, the requirement will be opened to electronic or traditional bidding processes.
3. Proposed Contractor
Centre for Studies in Primary Care
Queen's University
220 Bagot Street, P.O. Bag 8888
Kingston, Ontario
K7L 5E9
4. Definition of Requirements or Expected Results
One potential new source of Canadian adverse reaction data is the e-Health Infostructure. Electronic medical records are designed to facilitate depersonalized data sharing and could provide critical information on adverse reactions for enhanced post-market surveillance and improved product safety for Canadians. Across Canada, adoption of EMRs is now over 60 per cent, an increase from 37 per cent in 2009 and 23 per cent in 2006. However, the extent to which patient health information captured in digital health solutions can be leveraged depends on 1) its intended use, 2) the quantity and quality of the data for that use, and 3) whether it is entered in a way that supports extraction from the EMR.
The structure and completeness of relevant clinical information about ARs collected and stored in Canadian primary care EMRs is, for the most part, unknown. Given the varied implementations and local customizations of EMRs across Canada, it is not feasible to validate each existing system. These factors present challenges for the collection and use of post-approval adverse reaction data by Health Canada.
Tasks, Activities, and Deliverables
The Contractor shall carry out to the satisfaction of the Departmental Representative and/or Departmental Project Authority the tasks and deliverables listed below. This work will commence once Health Canada approval has been obtained. Tasks, activities and deliverables include:
a) A detailed EMR enhancement plan outlining the steps and approaches to be taken to leverage depersonalized EMR data repositories for the capture of ADRs (i.e., signal identification/generation), and the verification/confirmation of safety signals (i.e., pharmacoepidemiologic studies), will be the focus of the current project.
b) The EMR enhancement plan will include a prioritized data enhancement strategy for CPCSSN’s depersonalized EMR data repository, describing the key activities that will need to be undertaken to address the gaps and opportunities, and highlight the potential impact (positive and negative) of these data enhancement strategies on point-of-care documentation, CPCSSN and Health Canada resources for pharmacovigilance.
c) This strategy will include (but not be limited to) improving the completeness and standardization of depersonalized medication and allergy/intolerance data collected by primary care EMRs, implementing changes in data processing, providing feedback to Sentinels to encourage meaningful use of records, mapping to recognized pharmacosurveillance data models, developing a strategy to support stimulated reporting, and linking EMR data to administrative health databases. Since the data requirements for signal identification/generation and signal verification/confirmation differ to some extent, a separate EMR enhancement plan will be developed in parallel for each of these pharmacovigilance activities.
5. Minimum Requirements
Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements:
a) Have direct access to patient demographic and clinical information related to adverse reactions recorded in primary care electronic medical records:
- for at least 550,000 patients;
- from across no fewer than 8 Canadian provinces and territories
b) Have access and ability to extract patient demographic and clinical information related to adverse reactions from at least 10 different electronic medical record systems (e.g. Wolf, OSCAR, Nightingale, etc.) into The Canadian Primary Care Sentinel Surveillance Network database.
c) Have implemented a Privacy by Design process by which extracted data is immediately anonymised, coded and stored in data repositories that meet ISO 27001/2 standards for IS management and technological security requirements.
d) Have ability to analyse relevant patient demographic and clinical information related to adverse reactions for the purposes of pharmacosurveillance (e.g. beyond quality indicators).
e) Have a mechanism to provide timely feedback to primary care practitioners and which can be used to test and evaluate impacts of specific process changes to adverse reaction data collection at point-of-care within participating practices of The Canadian Primary Care Sentinel Surveillance Network.
f) Principal Investigator must have an advanced degree (PhD) with specialization in epidemiology or biostatistics, or equivalent professional experience as demonstrated by publication record. This senior epidemiologist must be able to provide expert epidemiologic, scientific, and technical leadership in designing and conducting epidemiologic investigations. The duties required in this position encompass advanced professional analytical work in the surveillance, detection, research, and prevention of diseases and injuries. Work involves overseeing and conducting advanced-level professional epidemiologic work by developing and designing methods of collecting, analyzing, and disseminating data and performing appropriate research.
6. Reason for Non-Competitive Award
For the proposed procurement, the following exception applies: (d) Only One Person or Firm is capable of performing the contract.
7. Applicable trade Agreements and Justification for Limited Tendering or the Procurement Strategy for Aboriginal Business
N/A
8. Ownership of Intellectual Property
The Contractor will own the Copyright.
9. Period of the Proposed Contract
The contract period shall be from date of contract award until July 31, 2015.
10. Estimated Value of the Proposed Contract
The total estimated value of the proposed contract should not exceed $49,856.00, including travel and living expenses, miscellaneous expenses and all applicable taxes.
11. Closing Date and Time
The closing date and time for accepting Statements of Capabilities is: June 24, 2015. 2:00 PM EDT.
12. Contact Person
All inquiries with regard to this Notice must be addressed by e-mail to:
Randy Brown
Senior Procurement and Contracting Officer
E-Mail: r••••••••@•••••.••.ca
