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2019 ANNUALMEETING

NOVEMBER • 29 • 2019

MEETING BOOKLET

ONTARIO TRANSFUSION

TRANSMITTED INJURIES

SURVEILLANCE SYSTEM

(TTISS-ON)

1

Kayla Lucier

2

Table of Contents Agenda ............................................................................................................................. 3

List Of Attendees .............................................................................................................. 4

About TTISS Ontario ........................................................................................................ 6

Speaker Biographies ........................................................................................................ 8

Case 1 ............................................................................................................................ 11

Case 2 ............................................................................................................................ 13

Case 3 ............................................................................................................................ 15

Journal Articles ............................................................................................................... 18

Evaluation Form ............................................................................................................. 20

Expenses ....................................................................................................................... 21

Blank Paper .................................................................................................................... 24

Supplementary Materials

Canadian Adverse Transfusion Event (CATER) form

Transfusion Reaction Chart

Ontario Guide to Reporting Transfusion Reactions

Ontario Guide to Reporting Transfusion Reactions Online example

Download our TTISS-ON app today!

Prof. Emeritus Nancy Heddle, MSc. FCSMLS (D) Ontario TTISS Director [email protected]

Joanne Duncan, MSc. CCRP Ontario TTISS Coordinator

[email protected]

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2019 ONTARIO TRANSFUSION TRANSMITTED INJURIES

SURVEILLANCE SYSTEM ANNUAL MEETING

Friday, November 29, 2019

Downtown Toronto Hilton Doubletree Hotel Toronto Room

108 Chestnut Street, Toronto ON

AGENDA

8:30 to 9:00 Breakfast

9:00 to 9:15 Welcome and Introductions - TTISS Ontario - Nancy Heddle

9:15 to 9:45 Definition Working Group - Joanne Duncan/Natasha Rickards

9:45 to 10:45 TACO versus TRALI - Dr. Christine Cserti-Gazdewich

10:45 to 11:00 Refreshment Break

11:00 to 11:15 Hospital Interactive Feedback - Allahna Elahie/Donna Berta

11:15 to 11:30 Hospital Interactive Feedback for CBS - Dr. Bob Skeate

11:30 to 12:00 Health Canada Cases Submitted - Dr. Tonja Stothart

12:00 to 12:30 IVIg Gammagard Reactions Reported - Takeda Drug Specialist

12:30 to 13:15 Lunch

13:15 to 13:45 Table Review of Transfusion Reaction Cases

13:45 to 14:00 Transfusion Reaction Case 1 - Dr. Akash Gupta

14:00 to 14:15 Transfusion Reaction Case 2 - Dr. Aggrey Dhabangi

14:15 to 14:30 Transfusion Reaction Case 3 - Dr. Aditi Khandelwal

14:30 to 15:00 Discussion and Closing Comments

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LIST OF ATTENDEES

LAST FIRST HOSPITAL CITY Abdulwahab Widad Sunnybrook Health Science Toronto Bakker Sandra Guelph General Hospital Guelph Bas Shelley Chatham-Kent Alliance Chatham Bergeron Roxanne Canadian Blood Services Ottawa Berta Donna London Health Science London Bhatt Archana Southlake Regional Health Centre New Market Biemans Jennifer Canadian Blood Services Ottawa Biscocho Marietta Mount Sinai Hospital Toronto Blouin Darlene Cambridge Memorial Hospital Cambridge Callum Jeannie Sunnybrook Health Sciences Toronto Carroll Paula Hospital for Sick Children Toronto Chan Jennifer Mackenzie Health Richmond Hill Coimbra Peter Grifols Canada Mississauga Cober Nancy Ottawa Region Hospitals Ottawa Creighton Jerry Takeda Toronto Cserti-Gazdewich Christine University Health Network Toronto De Oliveira Maria William Osler Health System Brampton Dhabangi Aggrey McMaster University Hamilton Di Stefano Lanis Canadian Blood Services Hamilton Duncan Joanne McMaster University Hamilton Elahie Allahna Hamilton Health Sciences Hamilton Foster Terrie Canadian Blood Services London Gabe Caroline McMaster University Hamilton Gaskin Lynda Joseph Brant Hospital Burlington Gosein Varin Grifols Canada Mississauga Goyette Deanna TDMH & AHI Tillsonburg Gupta Akash McMaster University Hamilton Hall Sarah Lakeridge Health Ajax Heddle Nancy McMaster University Hamilton Herrington Christine Quinte Healthcare Belleville Huang Mary Canadian Blood Services Toronto Hughes Hertha Quinte Healthcare Belleville

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LIST OF ATTENDEES

LAST FIRST HOSPITAL CITY Ilagan Cesario Mount Sinai Toronto Irwin Tina Scarborough Health Network Scarborough Jones Marvin Health Sciences North Sudbury Khandelwal Aditi Canadian Blood Services Toronto Kichinko Tracy Brant Community Healthcare Brantford Krok Elizabeth St. Michaels Hospital Toronto Lafond Goretti Mackenzie Health Richmond Hill Lau Wendy The Hospital for Sick Children Toronto Leong Vivian Ministry of Health North York Li Na McMaster University Hamilton Luyckx Heather Trillium Health Partners Mississauga Moore Karen Middlesex Hospital Alliance Strathroy Newton Donna Northumberland Hills Cobourg Pye Tammy Campbellford Memorial Hospital Campbellford Qi Xiaodong(Claire) Humber River Hospital Toronto Rickards Natasha Canadian Blood Services Ottawa Sahni Neeru PRHC Peterborough Samani Amir Humber River Hospital Toronto Scheuermann Sheena ORBCoN Hamilton Skeate Robert Canadian Blood Services Toronto Sleep Pam Ross Memorial Hospital Lindsay Slomer Samantha St. Michael’s Hospital Toronto Soucie Sandra Woodstock General Woodstock St. John Melanie McMaster University Hamilton Stothart Tonja Health Canada Ottawa Tasmin Farzana University Health Network Toronto Terry Krysta Strathroy Middlesex General Strathroy Vansteelandt Pam IHLP Stratford Villeneuve Lorraine PRHC Peterborough Walters Krista Niagara Health System Niagara Watson Danielle Grey Bruce Health Services Owen Sound White Susan Canadian Blood Services Brampton White Terri PRHC Peterborough Yang Sophie Ministry of Health North York Ye Charles Southlake Regional Health Newmarket

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ABOUT TTISS ONTARIO

The Transfusion Transmitted Injuries Surveillance System (TTISS) is a national surveillance and monitoring system for the reporting of adverse reactions to blood products (blood components and plasma derivatives) run by the Public Health Agency of Canada (PHAC). Each province is responsible for collecting and reporting aggregate data, submitted voluntarily, by hospital Transfusion Medicine Laboratories (TML) or those responsible for reporting transfusion reactions in each hospital. Ontario is the largest user of blood components, in all of Canada (based on the percentage of units of blood components transfused). Currently TTISS-ON participating hospitals capture 100% of the transfusion activity in Ontario, representing all 159 hospitals. For the past 15 years, McMaster University has been the home of TTISS-ON, continuing to coordinate and develop the program. TTISS-ON is an integral part of the Canadian national hemovigilance system, as it is the only reporting agency that collects ALL transfusion reactions, whether or not they are related to the blood quality.

From 2014 to 2018 the number of red blood cells and fresh frozen plasma transfused has been declining in Ontario while the number of pooled platelets and cryoprecipitate transfused has increased. During this time, 1,234 PHAC reportable reactions were reported to TTISS-ON with TACO being the most reported reaction at 31% (Figure 1).

Figure 1: 2014-2018 Reportable Transfusion Reactions in Ontario, N = 1,234

AcuteHemolyticTransfusionReaction,

62,5%

DelayedHemolyticTransfusionReaction,

122,10%

AnaphylacticShock,7,0%

SevereAllergic/Anaphylactic/

Anaphylactoid,176,14%

AsepticMeningitis,13,1%

BacterialInfection,32,3%

TRALI,12,1%

PossibleTRALI,32,3%TAD,45,4%

TACO,380,31%

HypotensiveReaction,58,5%

IVIGHeadache,101,8%

PTPComponent,2,0%

Other/UnknownPain,192,15%

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Non-reportable reactions that are not captured by the national system include febrile non-hemolytic, delayed serologic, and minor allergic reactions. In Ontario, these more minor types of reactions are captured by a sentinel site model. Sentinel sites are a core of 28 Ontario hospitals that report all reactions and comprise approximately a third of all transfusion reactions and transfusions that occur in the province. These sites capture all reactions (reportable and non-reportable), enabling TTISS-ON to understand the complete burden of reactions from minor to severe. For the period 2014 to 2018, the sentinel sites reported a total of 2,520 reactions to transfused blood components and plasma derivatives: 538 (21%) fell into the moderate to severe category and were reported to PHAC; and 1,982 (79%) were classified as minor non-reportable category being captured through the sentinel site model (Table 1).

Table 1: 2014-2018 Sentinel Site Reporting of All Reactions, N = 2,520

Reportable? Blood Components

Plasma Derivatives

Both Total

Non-Reportable 1,757 221 4 1,982 Reportable 392 144 2 538 Total 2,149 365 6 2,520

By knowing the number of blood components transfused during this period (units), and number of reactions that occurred to blood components, we can calculate the frequency of these transfusion reactions by type in Ontario.

Table 2: 2014-2018 Sentinel Site Transfusion Reactions from Blood Components and Risk, N=2,149

Transfusion Reaction Blood Components N=823,500

Risk

Reportable (Moderate to Severe) n=392 (18%) Acute Hemolytic Reaction 17 1:48,441 Delayed Hemolytic Reaction 35 1:23,529 Anaphylactic Shock 4 1:205,875 Severe Allergic 73 1:11,281 Bacterial Infection 9 1:91,500 TRALI 2 1:411,750 Possible TRALI 10 1:82,350 TAD 10 1:82,350 TACO 160 1:5,147 Hypotensive Reaction 26 1:31,673 PTP 1 1:823,500 Other/Unknown Pain 46 1:17,902

Non-Reportable (Minor) n=1,757 (82%) Delayed Serological Reaction 366 1:2,250 Febrile Non Hemolytic Reaction 823 1:1,001 Minor Allergic Reaction 567 1:1,452 Total 2,149 1:383

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SPEAKER BIOGRAPHIES

Nancy Heddle Trained as a medical laboratory technologist, Nancy Heddle completed an ART in Transfusion Medicine and Master of Science degree in Health Research Methodology. She joined McMaster University in 2001 as the Director of the McMaster Centre for Transfusion Research, became a Professor in 2010, and currently is Professor Emeritus. Nancy continues to be involved in research and was recognized by AABB for her many contributions to clinical research with a prestigious award - Emily Cooley Memorial Award and Lectureship. This award “recognizes an individual who has demonstrated teaching ability and has made a major contribution to the field of transfusion medicine or cellular therapies”. More recently, in September 2019, Nancy gave the 21st Annual Graham a. Jamieson Lectureship in Blood Research at the American Red Cross in Rockville, MD.

Joanne Duncan Joanne Duncan earned a Bachelor of Science in Molecular Biology and received a Master of Health Research and Methodology before transitioning to work on clinical studies for the Department of Medicine at McMaster University. She started by project managing a national children’s health study before coming to work with the McMaster Centre for Transfusion Research, managing the TTISS program for Ontario. She enjoys playing golf, baseball and volleyball and enjoying time with her grandson.

Natasha Rickards Natasha Rickards has been a nurse for 29 years. Natasha joined Canadian Blood Services in 2002 and has been working for the Medical Services and Hospital Relations department since 2007. Natasha is currently working as the Transfusion Medicine Nurse specialist for the department. Natasha is the HLA/HPA Nursing Lead, Medical Services Projects lead as the key items in her portfolio. Natasha and Dr. Matthew Yan have been working with Jenny Beimans and her team within Canadian Blood Service Quality Assurance and Regulatory Affairs for over a year to standardize the definitions, labeling and data gathering of Adverse Transfusion Reactions within Canadian Blood Services. It was this work that identify the need to update the Transfusion Transmitted Injuries Surveillance System Users Manual version 3.0 that was implemented in 2007.

Dr. Christine Cserti-Gazdewich Dr. Christine Cserti-Gazdewich is a transfusion medicine specialist and consultant hematologist, originally trained in internal medicine and clinical hematology in Toronto, with fellowship training in transfusion medicine at Harvard. Based at the University Health Network for over 13 years now, she co-directs a large blood transfusion service through a number of teaching hospitals of the University of Toronto, with oversight responsibilities to a number of community/rural client sites across the province. Her chief interests in practice, leadership, and research are in immunohematology, hemovigilance, and complex/constrained hemotherapy scenarios.

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Allahna Elahie Allahna Elahie has been working within the Hamilton Regional Laboratory Medicine Program since 2014 as a Technical Specialist in Transfusion Medicine. In 2000, she graduated from the Michener Institute from the Medical Laboratory Sciences program, and has practiced in all disciplines at community hospitals and academic centres. She has held various roles including Resource Technologist for Urinalysis, Charge Technologist for Transfusion Medicine and Professional Practice Leader for Laboratory Services. She is also currently an Adjunct Lecturer within the Department of Medicine, Hematology and Thrombosis at McMaster University. Outside of work, Allahna spends her time with her husband, running around her 2 young kids to competitive gymnastics and junior band practice

Dr. Robert (Bob) Skeate Dr. Bob Skeate attended the University of Minnesota in Minneapolis for his medical degree, his Master degree in Health Informatics, and his training in Clinical Pathology and Transfusion Medicine. He then became a staff physician in the blood bank at the University of Minnesota Medical Center, an assistant medical director at the American Red Cross blood center in St. Paul, and an assistant professor at the University of Minnesota. He came to Canada in 2009 to work with Canadian Blood Services and is the associate medical director for the Eastern Region, focusing on Transfusion Medicine Training in Canada.

Dr. Tonja Stothart Dr. Tonja Stothart has worked as a Medical Evaluator for Health Canada in the Marketed Biologicals, Biotechnology and Natural Health Products Bureau of the Marketed Health Products Directorate (MHPD) for over 6 years. She has been practicing Emergency medicine for over 15 years and continues to conduct death investigations as a Coroner in Ottawa. Dr. Stothart has been involved in the post market surveillance of adverse reaction reports for blood, blood components as well as blood products and currently manages the Medical Section in the Bureau. For fun and excitement as well as relaxation, Tonja enjoys traveling and spending time (often in rinks/gymnasiums) with her 2 kids and husband.

Dr. Akash Gupta Dr. Akash Gupta is a first-year fellow in the Canadian Blood Services Transfusion Medicine Fellowship Program. He previously completed his residency in General Pathology at McMaster University.

Dr. Aggrey Dhabangi Dr. Aggrey Dhabangi is currently in his first year of the Transfusion Medicine Physician Training Program at McMaster University. He obtained both his medical degree and residency in Clinical Pediatrics and Child Health from Makerere University College of Health Sciences, Kampala, Uganda. He is a lecturer at Makerere University. Aggrey recently completed his PhD at the University of Amsterdam, Netherlands. His doctoral research focused on strategies for improving access to Transfusion in sub-Saharan Africa; in particular, the blood products, clinical care and community perceptions.

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Dr. Aditi Khandelwal Dr. Aditi Khandelwal completed her BSc in Biology at McMaster University, MD at McGill University, Internal Medicine and Adult Haematology at University of Toronto. She is now pursuing fellowship in Transfusion Medicine with CBS, based at University of Toronto, as well as an MSc in Systems Leadership and Innovation.

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CASE 1

History: 79 – Female

• Breast cancer, treated with surgery, radiation, and anastrozole• Asthma• Dyslipidemia• GERD• Hypothyroidism• Chronic back pain• Urinary incontinence• Carotid stenosis

Home Medications: • Ceftriaxone 2 grams IV q24h• Epinephrine infusion• Propofol infusion• ASA 80 mg PO daily• Levothyroxine 100 mcg po daily• Dalteparin 5000 units daily subcutaneous• Pantoprazole 40 mg IV daily• Insulin Humalog sliding scale

Current Medical History Patient was admitted to hospital after she had had a syncopal event at home. These was preceded by a week of malaise and fatigue. A few days prior to her admission, she had become more acutely unwell and had subjective fevers. Upon admission, she was found to have group G streptococcus endocarditis, with a vegetation on her mitral annulus. She was also found to have multifocal stroke with hemorrhage, which was likely secondary to septic emboli. She was stabilized on ceftriaxone. She was then transferred to a tertiary care center for surgical management.

Transfusion and Reaction 10 days after transfer, patient underwent mitral valve repair for infective endocarditis.

• Patient received one packed red cell during the surgical procedure (at 1033).• Post-operatively, patient received 2 units of frozen plasma in the ICU.

Patient was assessed by the ICU doctor at ~1530. The doctor was called back at ~1630 to assess because the patient had developed a rash on her chest and was becoming hypotensive (blood pressure dropped to 56/36 mmHg).

Investigations and Management: • Patient was treated with norepinephrine and then epinephrine.

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• Blood work acquired after the reaction showed:• WBC 28.5 x 109/L (ANC 24.1; pre transfusion 29.1 x 109/L)• Hb 85 g/L• Platelets 315 x 109/L.• Urinalysis showed no anomalies.• Bilirubin was normal, other hemolytic markers (LDH and reticulocytes) were not

drawn.• Investigations revealed no IgA deficiency.• Due to ongoing bleeding, patient received 7 additional red cell units over the next

two days

CONCLUSION:

RELATIONSHIP:

SEVERITY:

OUTCOME:

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CASE 2

History: 55 – Female

• Multifocal Motor Neuropathy (MMN)o Patient’s neuromuscular symptoms started about 5 years ago; with

weakness in the lower limbs. 3 years ago, the upper limbs becameinvolved –initially the digits. She had no bulbar symptoms. Nerveconduction studies performed were suggestive of axonal motorneuropathy, involving mainly the median nerve and tibial nerve; whileintramuscular recordings showed widespread chronic denervation of lowerand upper limb muscles. Anti-nerve serology panel and GM1– antibodywere negative [50% of MMN patients may have normal results].

Current Medical History • Most recent motor exam: Upper limbs strength; extensors – 3.5/5, Adductors –

4/5; Lower limbs strength; right side – 4/5, rest normal.• After discussing with the patient the benefits and adverse effects of IVIg in the

treatment of MMN, the patient consented for a trial of IVIg.

Transfusion: • Ordered:

o Induction dose: IVIg, 65g x 2 (130g, given over 2 days); and,o Maintenance: IVIg, 65g x 1– q 3weeks.

• Induction dose was given on Oct 21 & 22 respectively at the medical daycare. Monitoring of vitals was uneventful: i.e normal changes in vital signs or symptoms during IVIg

• Temp: ~36.9, BP: 108-132/76-88, Pulse; 67-80, RR: 18.

Blood Product Information: • On day 1 (Oct21): IVIg 65g (Gammagard® Liquid); weight 67 kg, Ht - 173• On day 2 (Oct22, morning): IVIg 65g (Gammagard® Liquid); weight 67 kg, Ht

-173

Reaction • On day 2; Oct22 evening; patient presented to the ER with fever, chills, nausea,

headache, and dark/amber urine. Temp was 39.5.• Lab Work: Blood type AB negative, Antibodies screen: negative

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Hb MCV WBC Platelet Bili Creat APPT INR PCO2 HCO3 Lactate

Pre 135 90.7 4.6 183 5 53 - - - - -

Post 129 87 6.0 199 - 48 27 1.1 47 27 1.1

• All other serum electrolytes were normal. Blood cultures (both anaerobic andaerobic) showed no growth.

• Total bilirubin, LDH, Rectic, Haptoglobin, DAT, and Eluates not done.

Management • Received IV Saline, IV Morphine 2mg and IV Gravol 25mg• After observation x 4hrs, patient was discharged home at 2230

Clinical Course • Patient seemed to have returned to normal function (was seen on Oct30 at

another clinic for unrelated medical review). Next neuromuscular clinical review ispending next q3 week dose.

CONCLUSION:

RELATIONSHIP:

SEVERITY:

OUTCOME:

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CASE 3

History: 74 - Female

• Therapy associated AML diagnosed March 2018, refused azacitadine, onpalliative management with tranexamic acid and supportive transfusions.

• Breast cancer grade I diagnosed in 1997 treated with surgery, adjuvant radiation,tamoxifen. Subsequent recurrence in 2011 and progression with mets to bone,lung, pleura on Anastrazole.

• Hypertension• Diabetes Type 2• ESBL Bacteremia in March 2018• Hospitalized in April 2018 with UGIB treated with endoscopic ligation of visible

vessel and pantoprazole

Home Medications: • Irbesartan-HCTZ 150/12.5mg daily• pantoprazole 40mg daily• metformin 500mg BID• anastrozole 1mg daily• atenolol 25mg daily• gabapentin 600mg TID

Blood Bank History: • ABO Blood group: A RhD POS• IAT: Antibody screen first positive on Jul 19, 2018 for Anti-E and Anti-K. Last

positive on Nov 3, 2018. Most recent antibody screen was negative• DAT IgG POS, C3d NEG since July 19, 2018• Receiving outpatient RBC transfusion with ABO compatible -E neg and -K neg

units.• Previous transfusion reactions:

o Aug 3, 2018 minor allergic reaction post- platelet transfusiono Nov 9, 2018 febrile non-hemolytic reaction post- 2u RBC, and 1u Plt

transfusiono Between Aug 2018 and Nov 2018, patient received several platelet and

RBC transfusions without any adverse events.

Transfusion: Indication - Plt 5 x 109/L secondary to bone marrow failure from AML During transfusion, patient feeling well, new lower extremity rash consistent with petechiae and purpura.

• Cetirizine (Reactine) 5 mg PO X 1 for previous allergic reaction to platelets

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• Platelets 1 pooled unit was given via PICC line.

After transfusion, patient received a PICC line flush (saline). Immediately after the flush, patient experienced chills/rigors.

Time Temp. HR BP Resp. Rate O2 Sat Notes

08:45 (pre) 35.8 77 93/52 18 95%

10:15 36.6 94 140/78 18 -

10:50 38.7 88 137/75 18 92%

11:30 37.3 97 66/37 - 97% On 2L NP.

Felt lightheaded.

Patient received 1L NS and Acetaminophen 1g PO

14:05 37.2 88 104/62 - 96% On 2L NP.

15:05 - 82 109/78 - 96% Blood

glucose 6.4mmol/L.

• Patient described tingling and numbness over chin and pain over right upperface. No lesions in the area.

Physical Exam: At 15:05:

• Pt appeared comfortable - alert, oriented, pale.• Extremities warm to touch and appeared flushed. There was angioedema of the

lips and peri-orbital area.• No tongue swelling and no stridor and no changes in voice.• Lungs had bibasilar crackles and vesicular breath sounds at apex.• Heart sounds S1 and S2 were regular, with a systolic murmur over aortic area

and LLSB, bounding peripheral pulses, legs symmetric with no edema.• Abdomen was soft, non-tender, normal bowel sounds.• Skin exam showed no urticaria, 1 purpuric lesions on left side of chin, 1 on left

arm and 1 on left thigh. Petechiae on lower legs, no lesions in the mouth.

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Investigations and Management: • Patient was immediately resuscitated with crystalloids.

o Since she responded to fluids rapidly, epinephrine was not administered.o Epinephrine was strongly considered, and patient was opposed to it

before trial of fluids.• She was admitted to the hospital in a monitored setting for further management.

Within 2 hours, she was afebrile and had a normal blood pressure with noevidence of compromised perfusion of critical organs.

• Blood cultures from peripheral and PICC, repeat group and screen, hemolyticparameters, NT-proBNP, troponin, electrolytes and creatinine were also sent.

o Blood culture negative, repeat blood group and screen consistent with pre-transfusion testing, NT-pro BNP and troponin was not elevated,electrolytes were normal, creatinine was normal.

o Chest XRay showed no pulmonary infiltrates. Normal cardiac silhouette• Platelet segment was sent for culture and did not grow any organisms.• IgA and haptoglobin deficiency testing were not sent. Patient had received

numerous products without anaphylactoid reactions previously. IgA andhaptoglobin deficiency were thought to be unlikely.

CONCLUSION:

RELATIONSHIP:

SEVERITY:

OUTCOME:

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JOURNAL ARTICLES

Below, we have curated a list of journal articles with abstracts (whenever possible) that you may find of interest. Complete articles can be found on the accompanying TTISS-ON Annual Meeting USB drive.

Wiersum-Osselton et al. Revised international surveillance case definition of transfusion-associated circulatory overload: a classification agreement validation study. Lancet Haematol. 2019 Jul;6(7):e350-e358. doi: 10.1016/S2352-3026(19)30080-8

Background: Transfusion-associated circulatory overload (TACO) is a major cause of transfusion-related morbidity and mortality in countries with well developed transfusion services. The International Society of Blood Transfusion, the International Haemovigilance Network, and AABB (formerly American Association of Blood Banks), have developed and validated a revised definition of TACO.

Methods: International Haemovigilance Network-member haemovigilance systems (Australia, Austria, Denmark, Finland, Greece, India, Ireland, Italy, Japan, Malta, Netherlands, New Zealand, Norway, Slovenia, United Kingdom and United States) provided cases of respiratory complications categorised by their systems, including clinical parameters listed in the 2017 draft definition (part 1). Individual transfusion professionals were then invited to assess 24 case descriptions according to the draft definition (part 2). Positive and negative agreement and inter-rater agreement (κ) were calculated. Based on validation results, cases were reanalysed and slight adjustments made to yield the final 2018 TACO definition.

Findings: In part 1, 16 (44%) of 36 haemovigilance systems provided 178 cases, including 126 TACO cases. By use of the 2018 definition, 96 (76%) of 126 cases of TACO were in positive agreement. 19 (37%) of 52 cases were recognized as non-TACO respiratory complications. In part 2 (47 experts from 20 countries), moderate all-case agreement (κ=0·43) and TACO-specific agreement (κ=0·54) were observed. Excluding cases missing some clinical information (eg, N terminal pro-brain natriuretic peptide, distinctive chest x-ray findings, and relationship with existing respiratory co-morbidities like pneumonia and chronic obstructive pulmonary disease) improved all-case agreement to κ=0·50 (moderate) and κ=0·65 (good) for TACO cases.

Interpretation: The two-part validation exercise showed that the revised 2018 TACO surveillance case definition captures 76% of cases endorsed as TACO by participating haemovigilance systems. This definition can become the basis for internationally consistent surveillance reporting and contribute towards increased awareness and mitigation of TACO. Further research will require reporting more complete clinical information to haemovigilance systems and should focus on improved distinction between TACO and other transfusion respiratory complications.

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Vlaar et al. A consensus redefinition of transfusion-related acute lung injury. Transfusion. 2019 Jul;59:2465-2476. doi: 10.1111/trf.15311 Background: Transfusion-related acute lung injury (TRALI) is a serious complication of blood transfusion and is among the leading causes of transfusion-related morbidity and mortality in most developed countries. In the past decade, the pathophysiology of this potentially lifethreatening syndrome has been increasingly elucidated, large cohort studies have identified associated patient conditions and transfusion risk factors, and preventive strategies have been successfully implemented. These new insights provide a rationale for updating the 2004 consensus definition of TRALI. Study Design and Methods: An international expert panel used the Delphi methodology to develop a redefinition of TRALI by modifying and updating the 2004 definition. Additionally, the panel reviewed issues related to TRALI nomenclature, patient conditions associated with acute respiratory distress syndrome (ARDS) and TRALI, TRALI pathophysiology, and standardization of reporting of TRALI cases. Results: In the redefinition, the term “possible TRALI” has been dropped. The terminology of TRALI Type I (without an ARDS risk factor) and TRALI Type II (with an ARDS risk factor or with mild existing ARDS) is proposed. Cases with an ARDS risk factor that meet ARDS diagnostic criteria and where respiratory deterioration over the 12 hours before transfusion implicates the risk factor as causative should be classified as ARDS. TRALI remains a clinical diagnosis and does not require detection of cognate white blood cell antibodies. Conclusions: Clinicians should report all cases of post-transfusion pulmonary edema to the transfusion service so that further investigation can allow for classification of such cases as TRALI (Type I or Type II), ARDS, transfusion-associated circulatory overload (TACO), or TRALI or TACO cannot distinguish or an alternate diagnosis. Panch et al. Hemolytic Transfusion Reactions. N Engl J Med. 2019 Jul;381(2):150-162. doi: 10.1056/NEJMra1802338 Blood transfusion is the most common therapeutic procedure performed in hospitalized patients; some 15% of inpatients receive blood components during their stay. Approximately 1% of transfused products result in serious adverse reactions, including hemolytic transfusion reactions, which account for up to 5% of these serious adverse reactions. Although technical and administrative controls to prevent transfusion of ABO-mismatched blood have reduced transfusion-related deaths, immune-mediated hemolysis remains an important, if underappreciated, risk. Deaths attributed to emergency transfusion in patients with an unknown antibody history and hemolysis related to non–red-cell components such as platelets, plasma, and intravenous immune globulin constitute a small but serious problem. Delayed hemolytic transfusion reactions and life-threatening “bystander hemolysis” (i.e., hemolysis of autologous red cells), particularly in patients with hemoglobinopathies who have received multiple transfusions, present unique diagnostic challenges with regard to the timing of presentation, predictability, symptom overlap with other complications, and antibody identification and management. Owing to increases in solid-organ and hematopoietic stem-cell transplantation, donor lymphocyte–mediated immune hemolysis is no longer a rare event. Roubinian et al. Building consensus: steps toward standardised haemovigilance reporting. Lancet Haematol. 2019 Jul;6(7):e339-e340. doi: 10.1016/S2352-3026(19)30081-X International Society of Blood Transfusion Working Party on Haemovigilance, The Internatioal Haemovigilance Network, and AABB. Transfusion-associated circulatory overload (TACO) Definition (2018). 2019 Mar. https://www.isbtweb.org/fileadmin/user_upload/TACO_2018_definition_March_2019.pdf

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EVALUATION FORM OntarioTTISSAnnualMeeting

Friday,November29,2019

DISLIKE/AGENDAITEM NOTUSEFUL EXCELLENT

1 2 3 4 5

DefinitionWorkingGroup–JoanneDuncan/NatashaRickards

TACOversusTRALI–Dr.ChristineCserti-Gazdewich

HospitalInteractiveFeedback–AllahnaElahie/DonnaBerta

HospitalInteractiveFeedbackforCBS–Dr.BobSkeate

HealthCanadaCasesSubmitted–Dr.TonjaStothart

IVIgReactionIncrease–TakedaDrugSpecialist

Workshop–Case1–Dr.AkashGupta

Workshop–Case2–Dr.AggreyDhabangi

Workshop–Case3–Dr.AditiKhandelwal

DiscussionandClosingComments

Whatdidyouenjoyleastatthemeeting?

Whatdidyouenjoymostatthemeeting?

Suggestion(s)forfuturemeetings?

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EXPENSES OntarioTTISSAnnualMeeting

Friday,November29,2019

* Reimbursement Declaration *

Declaration of Claimant: I confirm that I attended this meeting and incurred these submitted expenses in so doing. I have read the expense reimbursement instructions (see over) and confirm that I am in compliance.

Mailing Address of Claimant – * INCLUDE POSTAL CODE *

If a McMaster Employee, provide Employee Number: Send this Reimbursement Declaration + all original receipts to: Joanne Duncan McMaster Transfusion Research Program Attention: TTISS Working Group Meeting McMaster University, Health Sciences Department of Medicine, HSC-3H50 1280 Main St. W. Hamilton, ON L8S 4K1 E-mail: [email protected]

Signature of Claimant Printed Name of Claimant

Title of Claimant E-mail of Claimant

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OntarioTTISSAnnualMeetingFriday,November29,2019

* Expense Reimbursement Instructions *

1) Meals are not eligible

Ø Breakfast and Lunch (November 29, 2019) are provided

2) Kilometreage is reimbursed at $0.54/km. Ø INCLUDE A RETURN TRIP GOOGLE MAP showing total

kilometres travelled 3) For AIR TRAVEL, you must submit your TICKET AND BOTH

BOARDING PASSES in order to receive reimbursement. 4) Incidental expenses (i.e. fares for which receipts are not normally issued,

such as parking meters, subway fares, and bridge tolls) must be ITEMIZED on the signed note if original receipts are not submitted.

*ALL ORIGINAL RECEIPTS must be submitted*

(Only exception is incidentals when presented as above)

Remember: Please sign attached list of all of the expenses you are claiming (e.g., kilometreage, airfare, parking, taxis, etc.) Send all original receipts + Reimbursement Declaration (see over) to: Joanne Duncan McMaster Transfusion Research Program Attention: TTISS McMaster University, Health Sciences Department of Medicine, HSC-3H50 1280 Main St. W. Hamilton, ON L8S 4K1 E-mail: [email protected] Dates From:_______________________ To: ________________________ Location(s): ____________________________________________________________ Purpose: _____________________________________________________________

23

OntarioTTISSAnnualMeetingFriday,November29,2019

Expense Detail Receipt Requirement Please attach original receipts.

Foreign Exchange Amount Rate

Cdn $ Equivalent less Personal

Airfare Customer portion of Ticket (Requires receipt and Boarding Passes)

$

Railway/Bus Passenger Ticket Stub $

Auto Allowance ____ kms X $ 0. 54km (requires Google Map, including return trip) $

Vehicle Rental Customer’s copy of the rental charges.

$

Taxi Taxi Receipt $

Accommodation Detailed statement including charges $

Supplies Supply receipts $

Miscellaneous (please give details): $

$

$

Signature of Claimant for Expenses Listed and Submitted

24

BLANK PAPER ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

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CANADIAN TRANSFUSION ADVERSEEVENT REPORTING FORM

PAGE 1 OF 3

F100_V3.0E (November 2007)Disponible en français

Public HealthAgency of Canada

Agence de la santépublique du Canada

LAST NAME FIRST NAME

HEALTH CARD NUMBER HOSPITAL CARD NUMBER

1. RECIPIENT IDENTIFICATION

Sex: Male Other

Female Unknown

Date of Birth:

Day Month Year

Case ID:

FACILITY IDENTIFICATIONCITY PROVINCENAME OF FACILITY HOSPITAL CODE

Immune-Compromised

Patient Diagnosis/Category:Blood Group:

Pregnancies/Miscarriages Yes <3 mo. Yes >3 mo. UnknownNo

Transfusions Yes <3 mo. Yes >3 mo. UnknownNo

2. CLINICAL HISTORY

Please see reverse for categories.ABO: A B O AB Rh: Pos Neg

Other Clinical History Describe:

Yes Describe:

Transfused under anesthesia: General Local/regional None

Date and time occurred:

Day Month Year

3. DATE, TIME AND PLACE OF INCIDENT / ADVERSE REACTION

3a. Incident Information

3c. Report of Possible Transfusion Related Blood Borne Infection

Date and timereported:

Placeoccurred:

ICU ORER RECMSW CHROB OP

Time (hh:mm)Day Month Year

Please see reverse for definitions.

Viral Infection Other Infection

Specify:Patient Identification Incident

Specify:Product Related Incident

Specify:Equipment Related Incident

Specify:Other IncidentBacterial Infection

ADVERSE REACTION (Complete all sections)

INCIDENT (Complete sections 1,3,& 6 before & complete all sections during/after)PRODUCT TRANSFUSED YES NO

Chest X-ray Results: Bilateral Infiltrates Other Describe:

Clinical Information for TRALI:

Evidence of Circulatory Overload:Explain:

Positive Negative Elevated DecreasedResultsDate Specimen Taken

(ddmmmyyyy)Name of Laboratory Tests:

4b. Abnormal Tests/Laboratory Results

Blood Culture Results:

For culture performed on the product

For culture performed on recipient post transfusion

(hh:mm)# of

Positive# of

NegativeIf positive, specify organism(s)

identified (genus/species)Date/Time Specimen Taken

(ddmmmyyyy) Unit no. or Lot no.

4. CLINICAL SIGNS AND LABORATORY RESULTS4a. Clinical Signs and Symptoms

No Clinical Sign/Symptom

Temperature before: after:

Pulse before: after:

Respiration before: after:

Blood Pressure before: after:

Jaundice

Hemoglobinuria

Oliguria

Diffuse Hemorrhage

Shock

Pain Specify:

Other Specify:

Chills/rigors

Urticaria

Other skin rash

Shortness of breath

Hypoxemia

Nausea/vomiting

O sat:2

Yes

No

Hospital Sample Collection to be sent to blood supplier centre – please see reverse for instructions

Time (hh:mm)

3b. Premedication and Anesthesia

Premedication:

Specify drug/dose/route:

NoYes

Page 8


PAGE 2 OF 3

7. RESULTS OF INVESTIGATION & CONCLUSION

Delayed Serological Transfusion Reaction (new alloantibodies)

Febrile Non-Hemolytic Reaction

No Transfusion ReactionAllergic Reaction: Minor Severe Anaphylactic/Anaphylactoid Anaphylactic Shock

Donor:Viral Infection Infected Uninfected UnknownBacterial Infection Other Infection

Comments:

5. SUSPECT BLOOD, BLOOD COMPONENTS, OR BLOOD PRODUCTS (PLASMA DERIVATIVES)

*Please see reverse for definitions.




Sex: Male Other

Female Unknown

Date of Birth:

Day Month Year

Case ID:

6. MEASURES TAKEN

Transfusion Restarted

Transfusion Stopped

None

Antipyretics

Steroids

Antihistamines

Analgesics

DiureticsBlood Culture

Chest x-ray

ICU Required

Product Culture

Supplementary O2

Antibiotics

Vasopressors Other Measures TakenSpecify:

ABO System Specify:

Other System Specify:

Delayed

AcuteHemolytic Reaction:Cause:

Incompatible Transfusion: Unintentional Intentional

Specify:

Specify type of infection:

duration: _______

Mechanical Ventilation

Specify type of infection:

Effective




Expiry date(ddmmmyyyy)Unit no. or Lot no.

Transfused blood, blood components, or blood products (plasma derivatives)

Product code/name (hh:mm) (hh:mm)(ddmmmyyyy) (ddmmmyyyy)

Transfusion Started Transfusion Finished

Date DateHour HourGroup of unit

BloodSuppliercentrecode*RhABO

Amount administered

Unit of measureAmount Fraction

Product modification*

Hospital Supplier


PAGE 3 OF 3

9. COMMENTS – COMPLETED BY CANADIAN BLOOD SERVICES (CBS)

CBS Medical Director:

( )

Signature:

Telephone Number: Ext Date &Time:

Day Time (hh:mm)YearMonth

Last Name First Name

8. COMMENTS

Reporting Physician or Designate:

( )

Signature:

Telephone Number: Ext Date &Time:

Day Time (hh:mm)YearMonth

Last Name First Name

Relationship of Adverse Event to Transfusion:

Severity of Adverse Event:

Outcome of Adverse Event:

Hospital Procedure Involved:

Describe:

Equipment/SuppliesInvolved:

Describe: (include brand names/lot/model numbers)

Medical Follow-up: Treatment or Preventative Measures:

Blood Supplier Centre/Manufacturer Notified:

Date & Time: Time (hh:mm)

Status of Investigation:

Day Month Year

Action:

Action:

7. RESULTS OF INVESTIGATION & CONCLUSION (CONTINUED)

Definite Probable Possible Doubtful Ruled Out Not Determined

Grade 1 (Non-Severe)

Grade 2 (Severe)

Grade 3 (Life-threatening)

Grade 4 (Death)

Not Determined

Name of person contacted:No

In progress Concluded Cannot be conducted Reason:

TACO

Major or Long-Term Sequelae

Minor or No Sequelae

Not Determined

Describe the circumstances of death: Relationship of transfusionto recipient’s death:

Definite Doubtful

Probable Ruled Out

Possible Not Determined

Please see reverse for definitions. Please see

reverse for definitions.

Please see reverse for definitions.

Yes

Death

Case ID:




Sex: Male Other

Female Unknown

Date of Birth:

Day Month Year

TAD*

TRALI* Time to Recovery (hrs)

Hypotensive Reaction

ACE Inhibitors

PTP

TA-GVHD

Hemochromatosis

Aseptic Meningitis

IVIg headache

Unknown

Other Results of InvestigationSpecify:

Possible TRALI* Time to Recovery (hrs)

Risk Factors:

*Please see reverse for definitions.




Standardized List for the patient diagnosis/category:

ß Hematology/Bone Marrow Transplant

ß Oncology

ß Medical

ß Surgical

ß Obstetrics/Gyne/Perinatal

ß Trauma

ß Neonatal

2. CLINICAL HISTORY

Place of Incident/Adverse Reaction

ICU Intensive Care UnitAll intensive care units including i.e. neonatal, special care nursery, neuro, medical, burn unit

ER EmergencyEmergency and/or Trauma areas

MSW Medical/Surgical WardAll inpatient care areas within a facility i.e. medical ward, surgical, hematology

OB ObstetricsObstetrics including labour and delivery, case room and birth centre

OR Operating RoomOperating room including day surgery

REC Recovery RoomRecovery Room including post anesthesia recovery

CHR Chronic CareChronic Care refers to long term care facilities/units

OP Outpatient ClinicOutpatient refers to ambulatory care areas, medical day units, essentially where outpatients would come to receive a transfusion during daylight working hours

3. DATE, TIME AND PLACE OF INCIDENT / ADVERSE REACTION

Product Modification Codes

IRR Irradiated

CMV Negative for anti-CMV

D Deglycerolized

DV Divided

LV Low volume

PR Plasma reduced

W Washed

P Pooled

T Thawed

5. SUSPECT BLOOD, BLOOD COMPONENTS, OR BLOOD PRODUCTS (PLASMA DERIVATIVES)

Hospital Sample Collection to be sent to blood supplier centre:

For ß patient samplesß transfused unit(s) sample(s) when availableß crossmatch testing samples (time-sensitive samples)

your local blood supplier centre to obtain the most up-to-date shipping and sample requirements.

Call

4. CLINICAL SIGNS AND LABORATORY RESULTS

Blood Supplier Centre CodesPlease refer to your local Canadian Blood Services or HÉMA-QUÉBEC codes.




7. RESULTS OF INVESTIGATION & CONCLUSION

Definition of Transfusion Related Acute Lung Injury (TRALI)

ß In patients with no evidence of Acute Lung Injury (ALI) prior to transfusion, TRALI is diagnosed if:˙ New ALI is present:ß Acute onsetß Hypoxemiaw PaO / FiO £ 300 or2 2w Oxygen saturation is < 90% on room air orw Other clinical evidenceß Bilateral lung infiltrates on frontal chest x-rayß No evidence of circulatory overload˙ It occurs during, or within 6 hours of completion of transfusion˙ There are no other risk factors for ALI

Definition of Possible Transfusion Related Acute Lung Injury

ß In patients with no evidence of ALI prior to transfusion, possible TRALI is diagnosed if:˙ New ALI is present:ß Acute onsetß Hypoxemiaw PaO / FiO £ 300 or2 2w Oxygen saturation is < 90% on room air orw Other clinical evidenceß Bilateral lung infiltrates on frontal chest x-rayß No evidence of circulatory overload˙ It occurs during, or within 6 hours of completion of transfusion˙ There are one or more risk factors for ALI:

Predisposing factors for ALI include:ß Direct Lung Injuryw Aspirationw Pneumoniaw Toxic inhalationw Lung contusionw Near drowningß Indirect Lung Injuryw Severe sepsisw ShockwMultiple traumaw Burn injuryw Acute pancreatitisw Cardiopulmonary bypassw Drug overdose

Definition of Transfusion Associated Dyspnea (TAD)

TAD is characterized by respiratory distress within 24 hours of transfusion that does not meet the criteria of TRALI, TACO, or allergic reaction. Respiratory distress should not be explained by the patient’s underlying condition.




Relationship of Adverse Event to Transfusion

DefiniteSelect “Definite” if a clinical and/or laboratory event occurred within a time period consistent with the administration of the blood, blood component, or blood product (plasma derivative) and was proven by investigation to have been caused by transfusion.Bacterial contamination is considered “Definite” if it meets ALL of the following criteria:ß The same bacteria are found in the recipient and the blood, blood component, or

blood product (plasma derivative).ß Contamination of the blood sample or laboratory contamination is not suspected.

ProbableSelect “Probable” if a clinical and/or laboratory event occurred within a time period consistent with the administration of the blood, blood component, or blood product (plasma derivative) and did not seem to be explainable by any other cause.Bacterial contamination is considered “Probable” if it meets the following criteria:ß Positive blood, blood component, or blood product (plasma derivative) culture.ß Contamination of the blood sample or laboratory contamination is not suspected.ß The recipient presents signs and symptoms of sepsis (nothing else explains it).ß The recipient’s blood culture was not done.˙ No specimen was available.˙ A blood culture was not ordered.

ß The recipient’s blood culture is negative.˙ The recipient is already taking antibiotics.

PossibleSelect “Possible” if the clinical and/or laboratory event occurred within a time period consistent with the administration of the blood, blood component, or blood product (plasma derivative) but could also be explained by a concurrent disease or by the administration of a drug or other agent.Bacterial contamination is considered “Possible” if it meets the following criteria:ß The recipient’s blood culture is positive.ß Contamination of the blood sample or laboratory contamination is not suspected.ß The recipient presents signs and symptoms of sepsis (nothing else explains it).ß A blood, blood component, or blood product (plasma derivative) culture was not

done.˙ No specimen was available.˙ A blood culture was not ordered.

DoubtfulSelect “Doubtful” if the clinical or laboratory event occurred within a reasonable time period but the preponderance of data supports an alternative explanation.Bacterial contamination is considered “Doubtful” if:ß The blood, blood component, or blood product (plasma derivative) culture is positive

for one pathogen and the recipient’s blood culture is positive for a different pathogen, or the blood, blood component, or blood product (plasma derivative) culture is positive or the recipient’s blood culture is positive but contamination of the sample or laboratory specimen is suspected.

Ruled outSelect “Ruled Out” if the clinical and/or laboratory event occurred within a time period inconsistent with the administration of the blood, blood component, or blood product (plasma derivative) or, if it occurred within a consistent time period and it was proven to have no relationship to the transfusion.

Not DeterminedSelect “Not Determined” if it remains to be determined whether the event was related to the administration of the blood, blood component, or blood product (plasma derivative) and further information is forthcoming.

7. RESULTS OF INVESTIGATION & CONCLUSION (CONTINUED)

Severity of Adverse Event

Grade 1 (Non-Severe)Select “Grade 1 (Non-Severe)” if the recipient may require medical intervention (e.g. symptomatic treatment) but lack of such would not result in permanent damage or impairment of a body function.

Grade 2 (Severe)Select “Grade 2 (Severe)” ifß the recipient requires in-patient hospitalization or prolongation of hospitalization

directly attributable to the event;ß the adverse event results in persistent or significant disability or incapacity; orß the adverse event necessitates medical or surgical intervention to preclude

permanent damage or impairment of a body function.

Grade 3 (Life-threatening)Select “Grade 3 (Life-threatening)” if the recipient required major intervention following the transfusion (vasopressors, intubation, transfer to intensive care).

Grade 4 (Death)Select “Grade 4 (Death)” if the recipient’s death was suspected to be the consequence of a transfusion reaction.

Not determinedSelect “Not determined” if the consequences of the transfusion reaction are not certain.

Outcome of Adverse Event

DeathSelect “Death” if the recipient died.ß Relationship of Transfusion to Recipient’s Death

Document the relationship of the transfusion to the recipient’s death by selecting one of the following:ß Definite

Select “Definite” if the recipient’s death occurred within a time period consistent with the administration of the blood, blood component, or blood product (plasma derivative) and was proven by investigation to have been caused by transfusion.ß Probable

Select “Probable” if the recipient’s death occurred within a time frame consistent with the administration of the blood, blood component, or blood product (plasma derivative) and did not seem to be explainable by any other cause.ß Possible

Select “Possible” if the death occurred within a time period consistent with the administration of the blood, blood component, or blood product (plasma derivative) but could be explained by a concurrent disease or by the administration of a drug or other agent.ß Doubtful

Select “Doubtful” if the death occurred within a reasonable time period in relation to the transfusion but the preponderance of data supports an alternative explanation.ß Ruled Out

Select “Ruled Out” if the death occurred within a time period inconsistent with the administration of the blood, blood component, or blood product (plasma derivative) or, if it occurred within a consistent time period, but was proven to have no relationship to the transfusion.ß Not Determined

Select “Not Determined” if it cannot be determined if the recipient's death was related to the transfusion.

Major or Long-Term SequelaeSelect “major or long term sequelae” if the recipient developed either an infection with a persistent infectious agent (HIV, Hepatitis C, Hepatitis B), or a transfusion reaction with major or long-term sequelae or the anticipation of difficulties with future transfusions (e.g. development of antibodies to antigens present in more than 95% of donations).

Minor or No SequelaeSelect “Minor or No Sequelae” if the recipient had no sequelae or permanent disability from the reaction or developed antibodies to low or medium frequency antigens (<95%) or other minor reactions.

Not DeterminedSelect “Not Determined” if the outcome of the adverse event is not certain.




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DevelopedbytheTTISS-ONEducationCommittee–Version3:November2019Page1of4

The“CanadianTransfusionAdverseEventReportingForm”(CTAERF)canbeusedforreportingtotheOntarioTransfusionTransmittedInjuriesSurveillanceSystem(TTISS-ON),CanadianBloodServices(CBS),CanadaVigilanceProgram(HealthCanada)andManufacturersofPlasmaDerivatives.TodownloadtheCTAERFgoto:http://www.transfusionmedicine.ca/sites/transfusionmedicine/files/ctaer_form-eng.pdfNote:RemovepatientnameandOHIPnumberbeforefaxingoremailingtheCTAERF.1. ReportingtoOntarioTransfusionTransmittedInjuriesSurveillanceSystem(TTISS-ON)Allreactions(excludingminorallergic,febrilenon-hemolyticanddelayedserological)arereportabletoTTISS-ON,includingthosethatarenotrequiredtobereportedtotheCanadaVigilanceProgram,CBSortheManufacturerofPlasmaDerivative(e.g.AcuteHemolyticreactionduetoamislabelledspecimen).TTISS-ONreportsaggregatede-identifieddatatothePublicHealthAgencyofCanadaaspartoftheNationalTTISSprogram.

• EnterinformationcollectedusingtheCTAERFintotheREDCapTTISS-ONdatabaseathttps://ttiss.mcmaster.caorFAXtheCTAERFto905-524-2983(Attention:TTISS)

• ToobtainapasswordtoenterinformationintheTTISS-ONdatabase,filloutthecontactinformationformbyclickingthelink:https://ttiss.mcmaster.ca/surveys/?s=R7EEM83X7A

• FormoreinformationaboutTTISS-ONcontact:JoanneDuncan,TTISSOntarioCoordinator,McMasterUniversity,HamiltonTel:905-525-9140ext.22934 Email:[email protected]

2. ReportingtotheCanadaVigilanceProgram(asperHealthCanadaBloodRegulations)FAXorMailtheCTAERFto:

CanadaVigilanceProgramHealthProductsSurveillanceandEpidemiologyBureau(HPSEB)MarketedHealthProductsDirectorate/HealthProductsandFoodBranchTunney'sPastureAddressLocator:1908COttawa,Ontario,K1A0K9Fax:613-957-0335&Telephone:(613)957-0337E-mail:[email protected](Donotsendreportsviaemail,forinquiriesonly)

ForreportingtoHealthCanadaundertheMedicalDeviceRegulations:http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/frm-0317-faq-eng.php

3. ReportingtoCanadianBloodServices(CBS)

RefertoPage2andFAXormailtheCTAERFto:

YourlocalCanadianBloodServicesDistributionDepartmentNotethatifpatientbloodsamplesarebeingsenttoCBSfortesting,thepatient’snameisrequired

4. ReportingtoManufacturerofPlasmaDerivative

RefertoPage3andFAXorEmailtheCTAERFtotheappropriateManufactureroftheimplicatedderivative.Forcontactinformationgoto:https://www.blood.ca/en/hospitals/plasma-productsanddownloadtheManufacturerContactList.

OntarioGuideforReportingTransfusionReactions

DevelopedbytheTTISS-ONEducationCommittee-Version3:November2019Page2of4

YES

NO

YES

NO

NO

NOYES

YES

NoFurtherReportingRequired

IstheATE(ARR)attributabletoanactivityatthehospitalthataffectedthesafety/efficacyofthecomponent?Examples:-ATEs(ARRs)duetomislabelingofthecomponentbytheTML(e.g.unirradiatedbloodlabelledasirradiated)

-Bacterialcontaminationduetopoolingofcomponentatthehospitalorstoringofbloodinamalfunctioningfridge

-REPORTTOBOTHtheCanadianBloodServicesandtheCanadaVigilanceProgramifitisnotclearwhetheranATE(ARR)isduetoahospitalactivitythataffectedthecomponentorthecomponentitself(e.g.contamination)

ReportATE(ARR)toCanadianBloodServices(CBS)

FAXtheCTAERFtolocalMedicalOffice(seeInstructionsp.1)ReporttheATE(ARR)immediatelyiffatalityorifsuspectedtobeattributabletoqualityofcomponent(e.g.bacterialorviralcontamination).Otherreactionsaretobereportedaspromptly/immediatelyaspossibleNote:CBSreportsasrequiredtotheCanada

VigilanceProgram

IstheATE(ARR)oneofthefollowing?• MinorAllergic• FebrileNon-Hemolytic• DelayedSerological

ReportATE(ARR)toCanadaVigilanceProgramanddorequiredactions

Section110ofBloodRegulations

(HealthCanadaBloodRegulations)

FAXormailCTAERFwithin24hoursofafatality,otherwisewithin15days(seeInstructionsp.1)Finalreportisrequiredonceinvestigationiscomplete

ReportATE(ARR)toOntarioTransfusionTransmittedInjuriesSurveillanceSystem(TTISS-ON)EnterdatadirectlyintotheTTISS-ONwebdatabaseorsendCTAERFbyFAXwithin3months(seeInstructionsp.1)

ReportingTransfusionReactionstoBLOODCOMPONENTS*forHospitalTransfusionMedicineLaboratories(TMLs)

*RedBloodCells,Platelets,FrozenPlasma,CryosupernatantPlasma,Cryoprecipitate

IstheATE(ARR)oneofthefollowing?

• Transfusion-RelatedAcuteLungInjury

(TRALIorPossibleTRALI)• Severeallergicreaction/anaphylaxis• Bacterialcontamination• Posttransfusioninfection(e.g.HIV,

Hepatitis,Chagas,Malaria,WestNile)• AdverseeventsduetosuspectedCBS

mislabelling• Unexplainednewacutesevere

neutropeniaorthrombocytopenia(transfusion-relatedalloimmuneneutropeniaorthrombocytopenia)

• Otherunusualreactionwherethehospitalisconcernedthebloodcomponentisthecause

COMPLETEtheCanadianTransfusionAdverseEventReportingForm(CTAERF)excludingpatientnameandOHIPNo.

Investigateandidentifytypeoftransfusionreaction****ReferredtointhisdocumentasAdverseTransfusionEvent(ATE)andintheBloodRegulationsasAdverseRecipientReaction(ARR)

IstheATEtheresultoftransfusionpracticeorduetoanerroratthebedside?

Examples:Transfusionassociatedcirculatoryoverload(TACO);Incompatibletransfusionduetomislabeledsample;TransfusingthewrongpatientNote:ATEsresultingfromdevicemalfunction(e.g.bloodwarmer,infusionpump)arealsoreportabletoHealthCanada-MedicalDevicesRegulations

DevelopedbytheTTISS-ONEducationCommittee–Version3:November2019 Page3of4

YES

NO

YES

NO

YES

NOYES

Investigateandidentifytypeoftransfusionreaction****ReferredtointhisdocumentasAdverseTransfusionEvent(ATE)

ReportATE(ARR)toManufacturerofPlasmaDerivative(BloodProduct)

FAXoremailtheCTAERFtotheappropriatemanufacturer

(seeInstructionsp.1)

ReporttheATEimmediatelyiffatalityorif

suspectedtobeattributabletoproduct

quality(e.g.bacterialorviralcontamination).

Otherwiseassoonaspossible.

z Manufacturersdonotdiscourageanyreactionsfrom

beingreported

Note:TheManufacturerisrequiredtoreport

IstheATE(ARR)aminorreactioncommontotheplasmaderivative(bloodproduct)?(ie.FNHTRorminorallergic)

NoFurther

Reporting

Required

Seez

ReportATEtoOntarioTransfusionTransmittedInjuriesSurveillanceSystem(TTISS-ON)EnterdatadirectlyintotheTTISS-ONwebdatabasetoOntarioTTISSeachmonth(seeInstructionsp.1) zTTIISencouragesallreactionstobereported

ReportingTransfusionReactionstoPLASMADERIVATIVES*forHospitalTransfusionMedicineLaboratories

• ReferredtoasPlasmaProteinProducts(PPPs)byCanadianBloodServicesandBloodProductsbyHealth

Canada.TheseincludeIVIg,ProthrombinComplexConcentrate,RhIg,Albumin,S/DPlasma,Coagulation

FactorConcentrates,etc.

COMPLETEtheCanadianTransfusionAdverseEventReportingForm(CTAERF)excludingpatientnameandOHIPNo.

IstheATE(ARR)seriousoracuteasdefinedbytheFoodandDrugRegulations?

Thatresultedin:

a. Death

b. Life-threatening

c. Causeddisability

d. Admittedtohospital

e. Lengthenedhospitalstay

f. Congenitalmalformation

g. Requiredmedicalinterventiontoavoidanyof(a)to(f)

Examples:

• Seriousacute/delayedhemolyticreactions

• SeriousTACO/TAD/hypotensivereactions

• Asepticmeningitis

• Transfusion-RelatedAcuteLungInjury

(TRALIorPossibleTRALI)

• Severeallergicreaction/anaphylaxis

• Bacterialcontamination

• Posttransfusioninfection(e.g.Hepatitis)

• Unexplainednewacutesevereneutropeniaor

thrombocytopenia(transfusion-relatedalloimmuneneutropenia

orthrombocytopenia)

• Otherunusualreactionwherethehospitalisconcernedthe

plasmaderivativeisthecauselikeacutekidneyinjury,

thromboembolicevent

OR

IstheATE(ARR)CLUSTERofminorallergicor

FNHTRs?

ReportATE(ARR)toCanadaVigilanceProgramasper

Vanessa’sLawandtheFoodandDrugRegulations(Appendix1)

(FoodandDrugAct)

FAXormailCTAERFwithin24hoursofafatality,otherwisewithin15days

(seeInstructionsp.1)

Finalreportisrequiredonceinvestigation

iscomplete

DidtheminorATE(ARR)appearin“clusters”(ieclustersofFNHTRs,orminorallergicreactions)

DevelopedbytheTTISS-ONEducationCommittee–Version3:November2019 Page4of4

Appendix1:ImpactofVanessa’sLaw(TheProtectingCanadiansfromUnsafeDrugsAct)

Vanessa’sLawwillnotimpacttheregulatoryrequirementswithrespecttoinvestigationandreportingofadverserecipienttransfusionreactionsaspertheBloodRegulations(sections110-116).WhatismeantbythatisthattransfusionARsoccurringwithbloodandbloodcomponents(labilebloodproductsNOTfurthermanufacturedintoplasmaproteinproducts[PPP]orfractionatedplasmaproductsorothermanufacturedplasmaproductswithaDINnumber)aretobereportedastheyarenow.Vanessa’sLawwillnotimpactthose.

Unlikebloodcomponents(labilebloodproducts),plasmaproteinproducts(suchasalbumin,immuneglobulins,plasma-derivedbloodclottingfactorslikefactorVIII,etc),aremanufacturedstablebloodproductsthatareregulatedbyHealthCanadaasdrugs(undertheFoodandDrugRegulations).Assuch,plasmaproteinproducts(PPP)aresubjecttothenewhospitalmandatoryreportingtoHealthCanada(Vanessa’sLaw).

Whattypeofinformationaboutseriousadversedrugreactions(ADRs)needstobereportedtoHealthCanadaunderVanessa’sLaw?

Basedontheproposedregulations,hospitalsarerequiredtoreportcertaininformationaboutseriousADRsiftheinformationisinthecontrolofthehospital.

ForseriousADRs(inthiscaseinvolvingPPP),thefollowinginformationisrequired:

(a) thenameofthehospitalandthecontactinformationofarepresentativeofthathospital;(b) thedrug’sbrandname,propernameorcommonname;(c) inthecaseofadrugimportedunderPartC,Division10oftheFoodandDrugRegulations(subsectionC.10.001(2)),theidentifyingnumberorcodeofthedrug;(d) thedrugidentificationnumber(DIN)assignedforthedrug,ifapplicable;(e) thepatient’sageandsex;(f) adescriptionoftheseriousadversedrugreaction;(g) thedateonwhichthepatientfirstusedthedrugand,ifapplicable,thedateonwhichthepatientstoppedusingthedrug;(h) thedateonwhichtheseriousadversedrugreactionfirstoccurredand,ifapplicable,thedateonwhichthepatient’shealthwasrestoredtoitsstatepriortotheadversedrugreaction;(i) anymedicalconditionofthepatientthatdirectlyrelatestotheseriousadversedrugreaction;(j) anyconcomitanttherapeuticproductsusedbythepatient;and(k) theresultoftheseriousadversedrugreactiononthepatient’shealth.

However,HealthCanadaareopentoconsideringsomeflexibilityintheforminwhichwearewillingtoacceptreportsofseriousadversedrugreactionsfordifferentproductlines.InordertoreducesomeoftheadministrativeburdenassociatedwithhavingtocompletetwodifferentformstoreportaseriousADRrelatedtoaPPP(i.e.reportingtoTTISSandhospitalmandatoryreportingtoHealthCanada),wemaybeabletoconsideracceptingacompletedTTISSformforaseriousadversereactionrelatedtoaPPP.Aslongastheregulatoryrequirementsforhospitalmandatoryreporting(notedabove)aremetwithintheTTISSformthiswouldbeacceptable.

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ON-LINE INTERACTIVE VERSION OF THE ONTARIO GUIDE FOR REPORTING REACTIONS

Can be used at https://ttiss.mcmaster.ca

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https://ttiss.mcmaster.ca/

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2019 annual meeting - mcmaster university€¦ · 2019 annual meeting november • 29 • 2019...

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