Plasma Protein and Related Products Redistribution Hospital User Guide
Training on how to report your near to expiring Plasma Protein and Related Products that need to be reditributed
In this Issue
- Whither convalescent plasma therapy?
- Major clinical trial finds convalescent plasma does not help patients with COVID-19
- Patient Engagement in the CONCOR-1 Trial: Formation and Involvement of the Community Advisory Committee
- Featured Resource: Transfusion Committee Handbook
Whither convalescent plasma therapy?
Dana V. Devine, PhD Chief Scientist, Canadian Blood Services and Director, UBC Centre for Blood Research
The concept of using the plasma from someone who has recovered from an illness to treat patients in the early stage of the same illness is not new. Our understanding of the immune system led to the development of this approach in the early 1900’s, and there was fairly widespread use of convalescent plasma to treat patients suffering in the 1918 influenza pandemic . Seeking to determine whether this approach could be used as a therapeutic for treating patients with COVID-19, many clinical trials were set up around the world, including in Canada. The CONCOR-1 trial examined the effectiveness of COVID convalescent plasma (CCP) compared to routine patient care . This trial was stopped early for futility as it became clear that the study would not achieve its statistical goal . Similarly, the international REMAP CAP study which focused on ICU patients was also stopped for futility . Studies that have shown success are characterized by very early use of CCP and use of a product that has a high titre of virus neutralizing antibodies . This should not be surprising as we know that a typical person mounts an antibody response to a pathogen (or vaccine) within 5 days or so. The use of CCP may actually be detrimental to some patients as it creates a strong immune response that may actually worsen disease . The US C3PO study also showed that treating patients with CCP pre-hospital but within 7 days of onset of symptoms did little to reduce disease progress .
Similarly, the preliminary clinical trials using hyperimmune immunoglobulins isolated from CCP have been similarly disappointing and most have been stopped at this point. Again, this probably has more do to with when the patient received the product.
Convalescent plasma may yet have a population of patients that it will help and those are patients who do not mount a robust antibody response because they are immunosuppressed either by underlying disease or immunosuppressive drugs taken by organ transplant recipients, for example. We should soon know if this is the target patient population for convalescent plasma therapy or if we need to develop strategies to identify patients much earlier in their disease course.
1. Luke TC, Kilbane EM, Jackson JL et al. Meta-Analysis: Convalescent Blood Products for Spanish Influenza Pneumonia: A Future H5N1 Treatment? Ann. Intern. Med. 2006;145:599-609.
2. Bégin P, Callum J, Heddle NM, et al. Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial. Trials. 2021 May 4;22(1):323
3. Bégin P, Callum J, Jamula E, et al. Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial. Nature Medicine 2021 Sep 9. doi: 10.1038/s41591-021-01488-2. Online ahead of print.
4. Estcourt LJ, Turgeon AF, McQuilten ZK et al. Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial. JAMA 2021 Oct 4;e2118178. doi: 10.1001/jama.2021.18178. Online ahead of print.
5. Libster R, Marc GP, Wappner D et al. Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults. N Engl J Med 2021 Feb 18;384(7):610-618
6. Korley FK, Durkalski-Mauldin V, Yeatts SD et al. Early Convalescent Plasma for High-Risk Outpatients with Covid-19. N Engl J Med 2021 DOI: 10.1056/NEJMoa2103784. On line ahead of print.
Major clinical trial finds convalescent plasma does not help patients with COVID-19
Dimpy Modi, Sunnybrook Health Sciences Centre, University of Toronto QUEST Transfusion Research Program, Research Analyst.
While the race to develop antivirals and vaccines for COVID-19 had begun in early 2020, virus-specific antibodies were seemingly the next best therapy for patients recovering from COVID-19. COVID-19 convalescent plasma (CCP) is donated from people who have recovered from COVID-19 which contains antibodies specific to SARS-CoV-2. It was thought that the transfusion of CCP holds potential to suppress virus replication in patients as it was historically used as treatment for other viruses (e.g., SARS-CoV-1, MERS-CoV, and influenza). However, there was not enough evidence to suggest that it was an effective therapy for patients with COVID-19. To answer this question, the Canadian-led international CONCOR-1 trial was launched in May 2020 by Drs. Donald Arnold at the McMaster Centre for Transfusion Research, Jeannie Callum at the University of Toronto QUEST transfusion research program, and Philippe Bégin at the Centre Hospitalier de l’Université de Montréal.
CONCOR-1 was a randomized controlled trial comparing the treatment of CCP with standard-of-care in hospitalized adults with COVID-19 respiratory illness. This trial included 940 patients across 72 hospitals in Canada, the United States, and Brazil. The study investigators had hypothesized that the early administration of CCP would reduce intubation or mortality. The trial stopped enrolment in January 2021 and the study investigators concluded there was no benefit to receiving CCP. A higher number of serious adverse events were observed in the CCP arm of the study in comparison to standard-of-care. The donated plasma used in this trial consisted of highly variable antibody content allowing for unfavourable (low antibody titres and non-functioning antibodies) to be transfused to the study group. While contradicting other CCP major studies, this finding suggested that high-titre CCP is not helpful, but rather low-titre convalescent plasma is harmful. There is speculation that these unfavourable antibody profiles can be attributed to competing with the patient’s own antibodies and essentially causing a negative or no impact on disease progression. Further investigations are necessary to understand potential risks and benefits of CCP. At this moment, the CONCOR-1 investigators are cautioning against using CCP as a treatment for patients with COVID-19 outside of the setting of a clinical trial.
For more information the publication can be accessed here:
Bégin, P., Callum, J., Jamula, E. et al. Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial. Nat Med (2021). https://doi.org/10.1038/s41591-021-01488-2
Patient Engagement in the CONCOR-1 Trial: Formation and Involvement of the Community Advisory Committee
Emily Sirotich BSc, PhD candidate, McMaster Centre for Transfusion Research.
Patient and public engagement in research is a growing movement to involve diverse stakeholders who bring relevant knowledge and experience to a research team. Partnerships between stakeholders are strengthened by joint development of the research design, implementation, analysis, and dissemination of results. Studies that engage stakeholders will improve generalizability, increase uptake of research findings, and integrate knowledge translation strategies; resulting in high quality research, informed by stakeholders that is more likely to be embraced by the community.
During the initial stages of the CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1) trial design, the Steering Committee recommended collaboration with community members to ensure the inclusion of diverse perspectives and lived experiences throughout the trial. It was especially important to engage with members from marginalized groups or populations who are underrepresented in research, as well as those most affected by COVID-19, to help advocate for their access to recruitment and results of the trial. The Community Advisory Committee (CAC) of the CONCOR-1 trial was formed prior to recruitment to engage with key stakeholders throughout the trial.
Trial investigators and CAC members collaborated to identify aspects of the clinical trial where community input would be beneficial. These areas included the: CONCOR-1 website, patient recruitment information and strategies, the patient consent process, plasma collection and distribution, challenges at the hospital level, public communication and knowledge translation strategies, as well as the final analyses. Throughout the CONCOR-1 trial, CAC members attended virtual, monthly meetings where study updates were provided, and CAC member input was sought into various aspects of the trial. Investigators recognized the importance of incorporating diverse perspectives and provided CAC members with the knowledge needed to understand the trial through educational sessions about COVID-19 antibodies, data safety monitoring and how to interpret study results.
The many available resources on patient and public engagement can help guide the process. However, the method of applying patient and public engagement strategies is unique to each research team and study. My experience joining the CAC team within the CONCOR-1 trial exemplified the benefits and importance of engaging with community members with diverse perspectives and lived experiences, especially through formal clinical trial study advisory groups. This learning experience highlighted that research will continue to improve when we invite more voices to the table.
Featured Resource: Transfusion Handbook Committee
University of Toronto Transfusion Medicine Rounds
December 16th, 2021 @ 12:00 pm – 1:00 pm
MLT Session: Challenging Serology Cases, presented by Ms. Minda Agpalo, Dr. Waseem Anani, Dr. Celina Montemayor
In this Issue
- Choosing Wisely for Perinatal Transfusion Medicine
- Checking in on Immunoglobulin Utilization Practices at Ontario Hospitals
Choosing Wisely for Perinatal Transfusion Medicine
Gwen Clarke MD FRCPC, Transfusion Medicine Physician, Canadian Blood Services
In 2020 members of the Canadian Obstetrical and Pediatric Transfusion Network (COPTN), worked with Choosing Wisely Canada to create a list of recommendations for immunohematology testing in perinatal women.
The first of the recommendations advises against routinely performing a group and screen prior to delivery. Very few women require transfusion during or following delivery, with studies showing a transfusion rate for vaginal and Caesarian section deliveries on the order of 0.5 – 1%. For those who do need very urgent transfusion, just like in any other life-threatening bleeding, use of O negative uncrossmatched blood is appropriate until pre transfusion testing has been completed. The safety of unmatched blood in this setting is enhanced when there is documentation that the antenatal antibody screening was negative.
Although a routine group and screen is not recommended, pre delivery testing is indicated if antenatal testing results are not available. If the mother is known to have a clinically significant alloantibody, is anemic or is at risk for bleeding then a group and screen prior to delivery is recommended. For example, women with placenta previa would benefit from testing prior to delivery. In addition, if fetal anemia is suspected, a maternal pre delivery group and screen may allow for rapid crossmatch of red cell units for the neonate post- delivery, if transfusion is required.
The second Choosing Wisely recommendation for perinatal testing refers to avoiding serological “weak D” testing in prenatal women.
Individuals with serologically weak or variably reactive RhD typing may have an RHD gene variant. These variants are often associated with an amino acid substitution of the RhD protein resulting in decreased expression of RhD on the cell. The frequency of such variants depends on ethnicity. Estimates in North America range from 0.2 – 1% of individuals (0.4% in a Canadian prenatal population) and include a large variety of RHD gene variations. Of these, weak D type 1, 2 and 3 are the most common.
Instead of serologically testing those with weak RhD reactions at the IAT phase (a weak D test), genotyping is the preferred evaluation for pregnant women with a weak RhD type. Genotyping will usually predict a specific weak or partial RhD type. Those with weak D type 1, 2 or 3 can be confidently treated as RhD positive, with no need for RhIG prophylaxis. Those with other variants should be treated as though RhD negative, as they may be at risk for alloimmunization to the RhD antigen. The need for RhIG prophylaxis for those with weak D type 4.0 is controversial. Most Canadian experts would recommend RhIG for this group of women.
The third recommendation suggests that noninvasive testing for prediction of the fetal antigen status should be performed if possible.
Alloimmunization impacts approximately 1% of pregnancies. When antibodies capable of contributing to Hemolytic Disease of the Fetus and Newborn (HDFN) are present, antibody titrations are regularly performed to evaluate the amount of antibody present. When titers rise to a lab determined “cut off” and/or are increasing, clinical monitoring for fetal anemia with doppler ultrasound and ongoing monitoring by a maternal fetal medicine physician are recommended.
For some alloimmunized women, however, this frequent monitoring is unnecessary: if the father is heterozygous for the implicated red cell antigen gene the fetus may or may not express the cognate antigen.
Non- invasive testing of maternal plasma, with amplification of fetal DNA from the maternal sample can predict the fetal red cell antigen status. If the fetus is antigen negative – there is no risk for HDFN despite the maternal alloantibody, and high- risk pregnancy monitoring is not required.
Non- invasive testing for prediction of fetal red cell antigen status is not currently available in Canada, however funding for such testing at reference labs is under consideration. In many provinces there is provision for sending blood samples from alloimmunized pregnant women to international reference labs for this testing. Indications for referral of samples to an international reference lab depend on the specific antibody present and may take into account the antibody titer and paternal phenotype.
When this assessment is feasible and predicts that the fetus is cognate antigen negative, the pregnancy requires only routine monitoring with no need for high-risk maternity care. This is both a cost-effective approach and one that improves the quality of care in pregnancy.
Transfusion Medicine Laboratories managing samples from alloimmunized prenatal patients are encouraged to work with their obstetrical and perinatal providers to determine whether reference testing for non- invasive determination of fetal blood group antigen status is feasible from their location.
The final Choosing Wisely Recommendation indicates that routine Direct antiglobulin testing (DAT) of neonatal cord samples should be avoided. The DAT does not predict which infants will develop hyperbilirubinemia nor those who require phototherapy. It may be positive in cases of maternal fetal ABO incompatibility that are not clinically significant. In short, it is not a good screening test with neither adequate specificity nor sensitivity as a predictor for significant jaundice.
The DAT should be performed on cord samples only when anemia or jaundice are identified as it can help pinpoint the cause (immune or non- immune). The DAT is also a valuable test in the setting of known maternal alloantibodies as it can determine whether the neonatal red cells express the corresponding antigen and the possibility of hemolysis and hyperbilirubinemia.
The topics covered by these Choosing Wisely recommendations along with a number of other controversial topics in perinatal testing will form the basis of a Consensus Conference hosted by ORBCoN in May 2022. Following this conference consensus guidelines determined by 3 expert panels will be developed and will provide guidance for perinatal testing in Canada. Details, as they are released can be found here.
References for Recommendation 1
Stock O, Beckmann M. Why group & save? Blood transfusion at low-risk elective caesarean section. Aust N Z J Obstet Gynaecol 2014;54:279-82
Patterson JA, Roberts CL, Bowen JR, et al. Blood transfusion during pregnancy, birth, and the postnatal period. Obstet Gynecol 2014;123:126-33.
Einerson BD, Stehlikova Z, Nelson RE, et al. Transfusion Preparedness Strategies for Obstetric Hemorrhage: A Cost-Effectiveness Analysis. Obstet Gynecol 2017;130:1347-55.
Chua SC, Joung SJ, Aziz R. Incidence and risk factors predicting blood transfusion in caesarean section. Aust N Z J Obstet Gynecol 2009;49:490-3.
References for Recommendation 2
Sandler SG, Flegel WA, Westhoff CM, et al. It’s time to phase in RHD genotyping for patients with a serologic weak D phenotype. College of American Pathologists Transfusion Medicine Resource Committee Work Group. Transfusion 2015;55:680-9.
Flegel WA, et al. It’s time to phase out “serologic weak D phenotype and resolve D types with RHD genotyping including weak D type 4. Transfusion 2020; 60:855-9
Lieberman, Lani, MD; Flegel, Willy Albert, MD; Bodnar, Melanie, MD; Clarke, Gwen, MD; Hannon, Judith, MD. What constitutes the most cautious approach for a pregnant person with weak D type 4.0? CMAJ; Ottawa Vol. 193, Iss. 24, (Jun 14, 2021): E916
Wagner FF, Gassner C, Müller TH, et al. Molecular basis of weak D phenotypes. Blood 1999;93:385-393.
Garratty G. Do we need to be more concerned about weak D antigens? Transfusion 2005;45:1547-51.
References for Recommendation 3
De Haas M, van der Schoot E. Prenatal screening. ISBT Science Series 2013;8:6-10.
Scheffer et al. Noninvasive fetal blood group genotyping of rhesus D, c, E and of K in alloimmunised pregnant women. BJOG 2011; 118(11): 1340-8
Clausen FB. Integration of noninvasive prenatal prediction of fetal blood group into clinical prenatal care. Prenat Diagn 2014;34:409-15.
Non-invasive fetal genotyping for mothers with red cell antibodies and non-invasive fetal sex typing. https://ibgrl.blood.co.uk/services/molecular-diagnostics/fetal-genotyping-diagnostic/
References for Recommendation 4
Amy Keir, Minda Agpalo, Lani Lieberman, Jeannie Callum. How to use: the direct antiglobulin test in newborns. Archives of disease in childhood – Education & practice edition Aug 2015, 100 (4) 198-203; DOI: 10.1136/archdischild-2013-305553
American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyper bilirubinemia in the newborn infants 35 or more weeks of gestation. Pediatrics 2004;114: 297-316. Erratum in: Pediatrics 2004;114:1138.
Barrington KJ, Sankaran K, Canadian Paediatric Society Fetus and Newborn Committee. Guidelines for detection, management and prevention of hyperbilirubinemia in term and late preterm newborn infants. Paediatr Child Health 2007;12(Suppl B):1B-12B.
Queensland Health. Maternity and neonatal clinical guidelines. [Available from: https://www.health.qld.gov.au/qcg/publications#neonatal (accessed August 9, 2021).]
Checking in on Immunoglobulin Utilization Practices at Ontario Hospitals
Wendy Owens, Rebecca Barty, Laurie MacLeod, Alison Wendt, Ontario Regional Blood Coordinating Network (ORBCoN)
During the summer months of 2020, following the onset of the COVID-19 pandemic, concerns were raised regarding the ongoing supply of Intravenous Immune Globulin (IVIG) due to decreased plasma collections in the United States. Because Canada is not self-sufficient in collections of plasma to produce Immune Globulin (IG) products, it leaves us more vulnerable to fluctuations in the global market. As a result of these concerns, the National Advisory Committee on Blood and Blood Products drafted an Interim National Plan to help prepare for a possible disruption in the supply of Immunoglobulins.1
In December 2020 the Auditor General’s Office released the results of a value for money audit on the blood system in Ontario.2 Thirteen recommendations were made. Three of them related to utilization of immunoglobulins. It was recommended that the Ministry of Health:
- collect more complete data from hospitals on how immunoglobulins are being used
- eliminate use outside of guidelines
- monitor Ontario hospital’s adoption of the provincial Immunoglobulin Utilization Guidelines
- identify alternatives for immunoglobulins
- prepare for the event of limited supply of immunoglobulins and protect Ontarians who rely on these products to live
In response to these audit recommendations, and in light of increased supply pressure due to the COVID-19 pandemic, ORBCoN worked with hospital colleagues to develop two surveys to gather information on hospital compliance with the Ontario IG Utilization Strategy as well as awareness and preparedness of a potential supply disruption. In this article, we will share some of the preliminary findings from these surveys.
The first survey was issued to 370 hospital contacts in transfusion service laboratories to ask their perspective on receiving and reviewing orders for immunoglobulin. The second survey was issued to 180 physicians that request immunoglobulin.
We received 109 responses to the first survey (representing 148 hospital sites). Responses were received from small (40.4%), community (45.9%) and teaching (13.8%) hospitals. Five respondents indicated they do not issue immunoglobulin.
The majority of respondents to the transfusion service survey were supervisors or managers and some provided responses for multiple sites.
Thirty-nine responses were received from the second survey issued to 180 prescribing physicians (representing 16 large community and teaching hospital sites). All regions of the province were represented. All of the physicians responding to the prescriber survey confirmed they order IVIG for their patients. The following specialties were represented:
– Internal Medicine
– Infectious Diseases
– Critical Care
A summary of results from the two surveys appears in Table 1 below:
Survey 1 – Transfusion Service Laboratories (issued July 2021)
|Aware of potential IVIG supply disruption||98.1% (102/104)|
|Believe clinicians who request IVIG are aware of a supply concern||60.6% (63/104)|
|Are aware of the National Plan for Management of Shortages of Immunoglobulin Products||90.4% (94/104)|
|Have reviewed the National Plan for Management of Shortages of Immunoglobulin Products||74.5% (70/94)|
|Require physicians to submit an MOH IG order request form||92.3% (96/104)|
|Review MOH IG order request form to ensure request conforms to Ontario IVIG Guidelines||91.3% (95/104)|
|Require requesting physician to provide justification if indication is outside of Guidelines||80.8% (84/104)|
|Potential IVIG supply disruption was discussed at Hospital Transfusion Committee meeting||70.2% (73/104)|
|Have developed a hospital plan to manage shortages of IVIG||20.2% (21/104)|
|Hospital plan to manage shortages of IVIG is in development||30.8% (32/104)|
Survey 2 – Physicians who prescribe Immunoglobulins (issued September 2021)
|Aware of potential disruption in supply of IVIG||79.5% (31/39)|
|Aware that should a shortage occur there may not be sufficient product to meet all patient’s needs||74.4% (29/39)|
|Are aware of the National Plan for Management of Shortages of Immunoglobulin Products||51.3% (20/39)|
|Have reviewed the National Plan for Management of Shortages of Immunoglobulin Products||65.0% (13/20)|
|Submit the Ontario IG Request Form as directed in the Ontario IG Utilization Strategy||97.4% (38/39)|
|Follow Ontario IG Utilization Guidelines||97.4% (37/39)|
|Use the Dose Calculator to determine patient dose (all adults)||94.9% (37/39)|
|There are viable alternative therapies for the conditions I prescribe IVIG for||33.3% (13/39)|
|Consider all IVIG products provided from Canadian Blood Services interchangeable||76.9%* (30/39)|
|For patients you treat with a chronic condition, would you consider transitioning your patient to Subcutaneous IG if there is a shortage of the intravenous product?||87.5%** (28/32)|
*reasons cited included variability in IgA levels, adverse reaction rates, patient tolerance
**some physicians treat only patients where use of Subcutaneous IG would not be indicated
Of those that provided responses to these two surveys, the majority of transfusion medicine laboratory personnel that issue immunoglobulin products and physicians who prescribe them were aware of the possibility that a supply shortage of IVIG exists. Both laboratory personnel and prescribing physicians responding to the surveys indicated that a very high percentage are following the Provincial IG Utilization Strategy, ensuring requests for IG comply with the Provincial Guidelines.
While the majority of laboratory personnel consider all brands of IVIG to be interchangeable, only about three quarters of prescribing physicians agreed.
A high percentage of laboratory personnel reported they were aware of the National Plan for the Management of Shortages of Immunoglobulins however only about half of prescribing physicians that responded to the survey were aware of the National Plan. Current communication strategies to share information regarding supply constraints for this product should be reviewed to determine if there is a more effective way to ensure that the physicians who prescribe this product are better engaged. A full report of both of these surveys will be released.
1. National Advisory Committee on Blood and Blood Products. The National Plan for Management of Shortages of Immunoglobulin Products (Ig) – Interim Guidance. 2021-07-27. https://www.nacblood.ca/resources/shortages-plan/The%20National%20Plan%20for%20Management%20of%20Shortages%20of%20Immunoglobulin%20Products%20(Ig)%20%20Interim%20Guidance_July%2027%202020.Published.pdf
2. Office of the Auditor General of Ontario. Value-for-Money-Audit. Blood Management and Safety. 2020-12-07. https://www.auditor.on.ca/en/content/annualreports/arbyyear/ar2020.html
University of Toronto Transfusion Medicine Rounds
November 25th, 2021 @ 12:00 pm – 1:00 pm
Use of plasma and platelets prior to interventional radiology procedures (SIR guidelines) presented by Dr. Alexandre Menard
Welcome to the ORBCoN Learning Management System
By Troy Thompson, Regional Manager ,ORBCoN CE Region
ORBCoN is pleased to announce the launch of our new Learning Management System (LMS) in September through collaboration with Surge Learning Inc. The new LMS hosts the Bloody Easy eLearning resources that were previously available to facilities for their education and competency requirements. Both the Bloody Easy Lite and Bloody Easy Blood Administration eLearning course are now available to users. The newly revised Bloody Easy Blood Administration program will be available by the end of the year, with the Technologist Assessment program available at a later date. More information to follow in the near future.
The new LMS enables users to electronically document completion of any of our eLearning courses and has additional features including:
- The ability to select multiple affiliations for both site administrators and registered users
- The ability to schedule completion dates for the eLearning courses based upon user roles
- Automated messaging for completion of courses based upon renewal duration (annually, biannually, etc.)
- Comprehensive reports for site administrators
For more information on the new LMS please visit www.transfusionontario.org . If you are a current site administrator and haven’t already been contacted or want to register as the site administrator for the eLearning programs at your facility, please fill out the following form https://form.jotform.com/212574199537062
A site administrator has access to participation reports for the eLearning courses and can schedule/track participation at each of the affiliations they are linked to.
If you have any additional questions, please contact email@example.com
New Online Reporting System for Redistribution of Plasma Protein and Related Products
By Tracy Cameron, MLT and Alison Wendt, MLT ORBCoN
The Ontario Regional Blood Coordinating Network (ORBCoN) and the Factor Concentrate Redistribution Program (FCRP) are very excited to announce that after many months of building and testing, the new online reporting system was launched on September 27th, 2021.
As mentioned in previous communications, this new online reporting system will streamline the reporting process for both ORBCoN/FCRP and the hospital users.
Here are some facts that will help you understand and be ready to report your near to expiring plasma protein and related products (PPRP) for your site.
How does our site report our near to expiring PPRP?
An email invitation will be sent out to all pre-defined main redistribution contacts every two months with a link. This link is unique to the hospital site and can be completed by the main contact of that site. The main contact can forward the email with the link to other designated staff at the same facility who can complete it on their behalf.
How often are we supposed to report our near to expiring PPRP?
An email invitation will be sent out every two months with the survey link to complete with your near to expiring PPRPs. A reminder email will be sent to those sites that have not completed the survey after one month.
What should hospitals report in the ORBCoN/FCRP Reporting System?
Hospitals are only required to report products that need to be redistributed. These are products that have 6 months left to expiry and/or will not be used by a patient. Hospitals are no longer required to report products that expired, were wasted or broken to ORBCoN / FCRP through this online reporting system. Hospitals are encouraged to report their expired, wasted and broken products to Canadian Blood Services (CBS) through the Blood Component and Product Disposition System
- If you know the near to expiring product will be used by a patient before expiry, please do not include this in your reporting. Only report those near to expiring products that will not be used.
Once you click on the Bi-Monthly Survey link you will have one to 3 forms to complete. The first form contains the prepopulated hospital demographics and fields where the submitter will enter information on who is completing the survey, date of completion and if there are or are not PPRPs to redistribute. The second form captures PPRPs that need to be redistributed, and the third form is the confirmation summary of PPRPs to be redistributed for the submitter to review for correctness before submitting.
Is there training material that I can review before I start to report our near to expiring products?
Will we still receive a list of what products will be expiring in the next 6 months?
No, you will now have to rely on your Laboratory Information System (LIS) expiry reports or physically check your inventory to identify those products expiring in the next 6 months and will not be issued to a patient before expiry.
If you have any questions in regards to the new reporting system please reach out to your ORBCoN Regional Project Coordinator or FCRP Coordinator or send an email to Transfusion Ontario.
NEW RESOURCES AVAILABLE AT TRANSFUSIONONTARIO.ORG
ORBCoN’s Provincial Redistribution Toolkit
This toolkit features:
- Procedures for redistributing blood components and plasma protein and related products (PPRP)
- Validation Reports on the shipping containers used for redistribution of components and PPRP
- Packing configuration job aids for shipping containers used for redistribution of components and PPRP
And Much More