APPENDIX

Hospital-wide Patient Care
Policy
Clinical Innovation /
Issuing Department: / Medical & Academic Affairs / Category: / Clinical Affairs
Issuing Authority: / James Wright / Sub-Category: / Innovation
Section Name: / Medical Affairs / Publication Status: / Approved
Content Reviewer: / Denis Daneman / Last Modified: / 2013-10-07 10:45
Additional Editors: / Mario Ramirez / Additional Readers: / Janice Campbell, Bairbre Connolly, Daune MacGregor, James Wright
Written By: / Randi Zlotnik Shaul / Review Committee Name: / Medical Advisory Committee

1.0 Introduction
The Hospital for Sick Children (SickKids) recognizes that innovation is essential to ongoing improvements in quality care of children. The hospital also recognizes that special considerations exist when introducing new procedures, techniques, technology, devices and treatment/therapy.
For those clinical developments that do not fall under the umbrella of the Research Ethics Board (REB) there is a need for a reasonable and appropriate innovation approval process to protect the interests of patients, clinicians and the institution.
The introduction of innovations may have significant organizational impact and may draw resources away from other initiatives. This impact should be assessed, justified, and approved by the designated parties. In addition, the process for introduction of innovations must be transparent and publicly defensible.
The intent of this policy is to provide a process and increase accountability with respect to the introduction of innovative treatment procedures and devices that fall outside the responsibility of the REB.
2.0 Definitions
Device / Medical Device -Any article, instrument, apparatus, or contrivance manufactured and sold for use in: (1) the diagnosis, treatment, mitigation, or prevention of a disease, disorder, or abnormal physical state, or its symptoms; (2) restoring, correcting, or modifying a body function or a body structure.
Innovation -Significant changes in clinical procedures, techniques, technology, devices and treatment/therapy (more than gradual change) that have not yet been introduced at the hospital but have been validated elsewhere. For the purposes of this policy, innovation requiring approval prior to introduction are those that: (1) have incremental cost implications; and / or (2) pose sufficient risk that independent review would be of benefit to the patient, clinician or staff person and/or hospital particularly in the event of an adverse outcome.
Research- A systematic investigation using scientific methods and standardized protocols to establish facts, principles or generalizable knowledge. See4.01 Ethical Conduct of Research ==>.
3.0 Consent
All consent documents referring to innovations must specifically state that the procedure or device is an innovation.
4.0 Diagnostic Imaging
5.0 Pediatrics

6.0 Surgery, Anaesthesia, Critical Care
Health care professional staff in the department(s) who would like to introduce an innovative procedure, treatment/therapy or medical device in the clinical setting must comply with the following:
Step 1 Completethe "Surgical, Anesthesia and Pain Medicine, and Critical Care Innovation" proposal with Clinical Program Director's signature, to the appropriate Chief.
The letter or proposal (see attached Innovation Form) must address the following points (as applicable):

  1. Name of staff member proposing the innovation and date of application
  2. Anticipated date for proposed procedure, treatment or use of device;
  3. Description of the innovative procedure, treatment or device;
  4. Evidence of effectiveness / rationale for request;
  5. Evidence of collegial endorsement and suggestion of advisers (internal or external) with whom Chief may consult;
  6. Potential risks and benefits to patient;
  7. Special consent considerations;("Consent to Treatment Form" must indicate that "This is an innovative procedure / treatment / device"; indicate the most appropriate)
  8. Declaration of any conflict of interest
  9. Requested approval period;(maximum of one year from the Chief approval date)
  10. Proposed number of patients to be treated during the approval period.
  11. Expected impact (positive or negative) on resources (e.g. procedure time, device costs, post op care, workload implications for others etc)
  12. Assurance that this proposal has been discussed with the CHS Director and that the CHS Director has confirmed availability of appropriate resources. (Require printed name of Clinical Program Director, Signature of Clinical Program Director, date of signature)
  13. Assurance of device safety and approval (may include "special" approval) for use in Canada;
  14. Evidence of necessary skill or training on the part of the innovator and the interdisciplinary team; and
  15. Plans for collecting and reporting quality assurance and outcome data. (Please note that results must be presented at divisional/departmental M&M Rounds irrespective of the outcome)

In reviewing a given proposal the appropriate Chief may call upon one or more independent advisors to assist in evaluating the proposal.

Any requests deemed "research" by the Chief will not be approved as an innovation under this policy.
Appropriate Chief will:
1. Approve the innovative use with or without restrictions; or
2. Grant clinical evaluation status for six to twelve months; or
3. Request that the innovative use be continued only through a study protocol approved by the REB or
4. Deny request as submitted.
Upon Chief approval, the submitting staff member will receive an email PDF of the signed “Innovative Procedures, Treatments and Devices” (IPTD) proposal, a letter assigning an IPTD number with reporting timelines, and a “Report Tracking Template” to track recipients.
STEP 2: Communicateto patients and families to ensure that they understand they are receiving an innovative procedure, treatment or device and document this on the "Consent to Treatment Form" (see number 7 of the 'Innovative Procedures, Treatment and Devices" proposal form)
STEP 3: Track recipients.Upon Chief approval, the submitting staff member will receive an e-mail copy of the signed "Innovative Procedures, treatments and Devices" (IPTD) proposal, a letter assigning an IPTD number with reporting timelines and a "Report Tracking template" to track recipients. The completed template must be submitted as PART ONE of the Final Report to the Chief.
STEP 4: Presenta summary of ALL IPTD recipients at the appropriate divisional/departmental Morbidity and Mortality (M&M) Rounds. Submission of the divisional/departmental M&M discussion summary report for ALL cases, incluyding adverse event, is PART TWO of the Final Report.
NoteResponsible staff mustimmediatelyreport any adverse eventresulting from the introduction of an innovative procedure, treatment or device to the appropriate Chief, and to the appropriate divisional/departmental Mortality and Morbidity Committee.SeeMortality Morbidity Reviews ==>.
STEP 5: Submitthe Report Tracking Template" and M&M discussion summary report with all innovative procedure outcomes to the appropriate Chief within six months (or 12 months iuf approved by the Chief) of approval. A reminder will be e-mailed one month before the due date.
Based on outcome data and other considerations (i.e. resources) the appropriate Chief will deem the procedure:
(1) appropriate for continued use
(2) not appropriate for continued use
(3) requiring formal research study.
(4) Continued evaluation as Quality Improvement (QI) project.
7.0. Complementary and Alternative Therapy
SeeComplementary and Alternative Therapies ==>
8.0 Research
SeeResearch Ethics Boardwebsite
9.0 Innovative Use of Drugs
SeeNon-Formulary Drug Requests and Innovative Drug Use ==>
10.0 References
Agich GJ. Ethics and Innovation in Medicine, Journal of Medical Ethics 2001; 27:295-296
Brower V.The Ethics of Innovation, EMBO Reports 2003; 4(4); 338-340.
McKneally MF. Ethical Problems in Surgery: Innovation Leading to Unforeseen Complications. World J Surg. 1999 Aug;23(8):786-8
Wright JG, Zlotnik Shaul R. Risk and Innovation at SickKids. Qmentum Quarterly - Quality in Health Care April 2012: 4:1, 40-42.
Health Canada. Health Products and Food Branch Inspectorate

©The Hospital for Sick Children. All Rights Reserved. This document is specific to SickKids internal activities at the time of printing. SickKids does not accept responsibility for use of this material by any person or organization not associated with SickKids. No part of the document should be used for publication without appropriate acknowledgement.