February 2020
Choosing Wisely at Georgian Bay General Hospital
Author: Jessie Clelland, MLT, CQM
Charge Technologist/Quality Leader, Georgian Bay General Hospital Laboratory
Georgian Bay General Hospital (GBGH) enrolled in the Choosing Wisely program to take a second look at overuse in testing, as 30% of tests and treatments have been deemed unnecessary (according to a 2017 report https://www.cihi.ca/en/unnecessary-care-in-canada). Choosing Wisely also provides our hospital with an opportunity to pause, question long-standing practices and take a leadership role in making the necessary changes for improving quality and safety, which in many cases, can also reduce costs.
We launched Phase 1 of the program on July 2, 2019 and it included “5 Quick Wins” which were successfully implemented:
- Uncoupling PT/INR and aPTT tests and revising the Emergency Department order sets
- Using troponin instead of CK, as it has greater specificity and sensitivity
- Removing “Daily lab” options from order sets
- Removing folate testing from our ordering systems
- Stop ordering of routine chest X-rays in the ICU, except to answer specific clinical questions
In October of 2019, only a short three months after the implementation of Phase 1, GBGH was deemed a Choosing Wisely Level 1 hospital. We have seen a reduction in CK testing by 84% and a reduction in aPTT testing by 87%.
It is anticipated our Phase 2 implementation will take place over the next 6-12 months. In preparation, we will be reviewing data throughout the hospital to determine where further improvements can be made. One opportunity on our radar is Transfusion Medicine and unnecessary transfusions. Over the next few months, we will be gathering data to look at our current transfusion state and determine areas where we can improve. Some of the data to be reviewed will include:
- Hemoglobin level prior to transfusion
- Diagnosis/ reason for transfusion
- Hemoglobin level after transfusion of one unit of packed RBC
- Hemoglobin level after transfusion of a second unit of packed RBC
- Platelet counts in patients prior to receiving a transfusion of platelets
- The number of Type and Screens performed unnecessarily due to panels used in the Emergency Department
From this data, GBGH will look to answer the following questions:
- Was the transfusion necessary?
- Was the patient transfused more than one unit of blood?
- If so, was the hemoglobin checked prior to the transfusion of each additional unit?
- Are platelets being transfused appropriately?
- Are we properly using our Emergency Department panels?
From the data gathered, we will also look at the percent of transfusions with a pre-transfusion hemoglobin less than 80 g/L and the percent of single unit red blood cell transfusions.
Once we fully understand our current state, we will explore if we should implement the following initiatives:
- Prospective MLT screening.
- Why give two when one will do?
- Education surrounding the proper use of panels in the Emergency Department.
In conclusion, Choosing Wisely has helped to improve the quality and safety for patients and employees at GBGH. After seeing the positive impact that Choosing Wisely has had with Phase 1, we will be moving towards Phase 2 with confidence knowing that more improvements are on their way.
Vanessa’s Law: New mandatory Health Canada reporting requirements for hospitals
Author: Amanda Pape, BHA, BSc, MLT
Charge Technologist | Team Leader Transfusion Medicine and Hematology
Halton Healthcare, Oakville, ON
Adverse drug reactions are one of Canada’s most serious and under-reported causes of health problems. The introduction of Vanessa’s Law, Bill C-17: Protecting Canadians from Unsafe Drugs Act, which came into effect on December 16, 2019, is the first amendment to the Food and Drugs Act in 50 years. Aimed at strengthening the safety of therapeutic products and its regulation, Vanessa’s Law will require hospitals to provide Health Canada with a report of a serious adverse drug reaction (ADR) or medical device incident (MDI) within 30 days of its documentation within their institution. Named after Vanessa Young, a 15-year-old girl from Oakville, Ontario, who died in March 2000 of a heart attack after taking cisapride as prescribed; a prescription drug known to have serious side effects causing death and later removed from the US and Canadian markets by May 2000.
The intent of Vanessa’s Law is to:
- increase the quantity of reporting of serious ADRs and MDIs;
- improve the quality of these reports;
- support Health Canada’s ability to take action when a serious risk to health is identified.
What does Vanessa’s Law mean for hospitals and healthcare professionals?
All hospitals are required to report serious ADRs and MDIs to Health Canada. Healthcare professionals play an important role in recognizing and documenting serious ADRs and MDIs, however, it is the hospital that is responsible for:
- determining clear roles and responsibilities for its employees;
- developing and maintaining policies and procedures for reporting;
- identifying reportable events;
- reporting ADRs and MDIs in a timely fashion;
- developing and complying with follow-up requests from Health Canada; and
- providing training to employees on compliance with mandatory reporting.
What does Vanessa’s Law mean for Transfusion and Diagnostic Laboratory Services?
Vanessa’s Law does impact the reporting of serious ADRs, or a cluster of minor ADRs, due to fractionated blood products (e.g. factor VIII concentrate) and plasma proteins (e.g. albumin) as stated under the Biologic Drugs section of the Act. In addition, hospitals are required to report MDIs due to medical laboratory diagnostic instruments, test kits for diagnosis, and tubing as stated under the Medical Devices section. It is the responsibility of the hospital to report these types of ADRs and MDIs to the manufacturer and Health Canada.
Vanessa’s Law does not change how hospitals currently report adverse recipient reactions (ARRs) due to blood and blood components. Mandatory reporting of ARRs related to the safety or quality of blood and blood components is mandated under Blood Regulations (pursuant to Section 30 of the Food and Drugs Act). The process for reporting remains the same and Transfusion Services should continue to report these ARRs as usual.
For a complete list of therapeutic products included and excluded from the mandatory reporting requirements under Vanessa’s Law, see Table 1 and 2. For a summary of required documentation and who to report to, see Table 3.
All therapeutic products have benefits and risks. Even though these products are carefully evaluated before they are licensed in Canada, ADRs and MDIs may become evident after a product is in use by consumers. Complying with the mandatory reporting requirements of Vanessa’s Law, shows a shared commitment to product safety among all healthcare professionals and manufacturers.
Submitting ADR and MDI Reports to Health Canada
There are three ways to submit a report of an ADR or MDI to Health Canada.
1. Fax or Mail
- Fillable PDF documents are available for download from Health Canada (see Resources below for direct links).
- Download the applicable PDF form.
- Complete all the required information and print the form.
- Fax or email the completed form to Health Canada. A fax number and mailing address are located on each form.
2. Online
- A fillable form is available at www.canada.ca/medeffect.
- Click on ‘Report an adverse reaction or side effect’ and follow the prompts.
- Complete all the required information and click ‘Submit’.
3. Electronic Secure File Transfer Protocol (sFTP)
- A system-to-system exchange of data from the hospital’s information system to Health Canada.
- To setup an account, contact the Canada Vigilance Program at hc.canada.vigilance.sc@canada.ca.
Appendices
Table 1: Therapeutic products subject to the mandatory reporting requirements for hospitals under Vanessa’s Law
Table 2: Therapeutic products not subject to the mandatory reporting requirements for hospitals under Vanessa’s Law
Table 3: Summary of applicable forms and where to report (CBS=Canadian Blood Services, CTAERF=Canadian Transfusion Adverse Event Reporting Form, TTISS-ON=Ontario Transfusion Transmitted Injuries Surveillance System)
Resources
Health Canada, 2019. Guidance Document – Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals
Serious Adverse Drug Reaction Reporting Form for Hospitals
Medical Device Problem Report Form for Health Care Professionals
Canadian Patient Safety Institute – Educational Support Materials
https://www.patientsafetyinstitute.ca/en/toolsResources/Vanessas-Law/Pages/default.aspx
For questions related to mandatory reporting for hospitals, contact the Canada Vigilance Program:
- Email: canada.vigilance.sc@canada.ca
- Phone: 1-866-234-2345
To enroll in the TTISS-ON database for reporting ARRs, complete the contact information form here:
Survey Results of Quality Improvement Initiatives in Transfusion Medicine
Author: Troy Thompson MLT, BAHSc (Hons)
Regional Manager, ORBCoN CE Region
The Ontario Transfusion Quality Improvement Plan (OTQIP) was developed in order to help hospitals reduce inappropriate red cell transfusions. In a recent audit in Ontario, approximately 25% of RBC units transfused were deemed inappropriate1. Similar findings have been demonstrated worldwide.
In order to improve appropriate red cell utilization, the OTQIP was developed in collaboration with the Choosing Wisely Canada campaign to support quality improvement initiatives at Ontario hospitals.
To assess uptake of various quality improvement initiatives in Transfusion Medicine, a recent survey was sent to Ontario hospitals. This article will highlight the results of the 2019 survey and the expansion of quality improvement initiatives in relation to blood product utilization in Ontario.
For the 2019 survey a total of 56 responses were received representing 76 hospital sites. The following results highlight the 2019 survey questions and the associated results.
Are you interested in adopting the OTQIP?
The OTQIP adoption rate was 91% for those hospitals that responded to the survey; 37% of respondents have already adopted the OTQIP and 54% of respondents are planning to adopt the OTQIP.
For those that have adopted or are planning to adopt the OTQIP, the results below highlight which aspects of the QIP have been or will be adopted.
Which part(s) of the OTQIP are being implemented?
Are you entering your data into the ORBCoN RBC eTracker tool? (Pre-transfusion hemoglobin <80 g/L and single unit transfusions)?
33% of respondents who have adopted the OTQIP are entering their data into the eTracker tool and 33% of respondents who will be adopting the OTQIP are planning to enter their data into the eTracker tool in the future.
Results of Audits entered into the ORBCoN eTracker tool (31 hospital sites)
Of the sites currently entering data into the eTracker tool, the average for all repeat audits for pre-transfusion Hb<80 g/L and single unit transfusions was 75% and 56% respectively.
Baseline audit results for pre-transfusion Hb levels <80 g/L were similar to repeat or subsequent audit results (74% vs 75%), highlighting the fact that clinicians at most sites have a good grasp of pretransfusion hemoglobin trigger levels. Baseline audits for single unit transfusions averaged 41% and on repeat 56% which represented a 37% increase in single unit transfusions over baseline.
Hospitals continue to promote quality improvement initiatives to increase appropriate blood utilization. However, some survey respondents have acknowledged that site specific barriers have limited the uptake of quality improvement initiatives for blood utilization. These include staffing levels and limited opportunities for physician education. Liberal blood transfusions have been associated with worse patient outcomes2-4 and blood products are in finite supply. Improving appropriate utilization will help to reduce adverse reactions and ensure that blood products are available to those patients who truly need them.
References
- Spradbrow J, Cohen R, Lin Y, et al. Evaluating appropriate red blood cell transfusions: a
quality audit at 10 Ontario hospitals to determine the optimal measure for assessing
appropriateness. Transfusion. 2016 Jul 27.
- Vincent JL, Baron JF, Reinhart K, et al. Anemia and blood transfusion in critically ill
patients. JAMA. 2002 Sept 25; 288(12):1499-507.
- Corwin HL, Gettinger A, Pearl RG, et al. The CRIT study: anemia and blood transfusion
in the critically ill-current clinical practice in the United States. Crit Care Med. 2004
Jan;32(1):39-52
- Goodnough LT, Maggio P, Hadhazy E, et al. Restrictive blood transfusion practices are
associated with improved patient outcomes. Transfusion. 2014 Oct;54(10 pt 2): 2753-9.
