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Advising Southern Health-Santé Sud (SH-SS) clinical staff regarding the following BBraun Infusomat intravenous (IV) tubing product updates:

BBraun Infusomat – Backcheck Valve Malfunction-Resolved
BBraun Infusomat – Straight Set (no port) IV Tubing-Resolved

Submitted by: Tamara Burnham, Collaborative Practice Lead, and Tim Siran, Regional Manager-Logistics and Supply Chain Management.
For more information contact: Tim at 431-356-0217 or

From: Monika Warren, COO, Provincial Coordinated Health Services & CNO and Dr. Jose Francois, Provincial Chief Medical Officer

This alert is to highlight the importance of communicating which acetylcysteine (also known as N-Acetylcysteine, or NAC, or Mucomyst) dosing protocol is initiated upon any transfer between We are aware of a large volume of product complaints and reported patient safety events related to the B. Braun Infusomat pumps. Concerns reported include pump performance, tubing quality and impact to both patient and staff safety.

These pumps are in use at facilities and in various clinical environments across the province.

All reported safety events are being actively reviewed and managed and we cannot overstate the importance and value of continuing to document, report and respond to these safety events.
We recognize that completing the necessary documentation is an additional burden being placed on our clinical staff and we are sorry that it is adding to workload. Input from staff and clinicians is identifying issues across the system so that we may investigate and recommend mitigation strategies to support ongoing safe patient care. We continue to encourage staff and clinicians to raise and document these events as they occur.

We have been in contact with colleagues in other Canadian provinces and in other jurisdictions around the world. We can share that the feedback received mirrors what has been shared during these conversations and we are working provincially to share knowledge and information gained from those who have been managing these risks as effectively as possible for their staff and patients.

We are regularly engaging with the vendor to share our concerns and identify areas where we require their support and remediation but are also looking at all possible longer-term solutions, including potential fleet replacement.

We have heard the concerns shared over the past number of months from teams across the province and acknowledge the efforts have made to support immediate solutions and other mitigation strategies. We share your frustration with the ongoing challenges.

It is important to acknowledge that longer-term solutions will take time, requiring supply chain logistics, fleet testing, creation of drug library and pump deployment strategies, so while all options are being considered for the long-term, we continue to identify, test and implement interim measures, processes and workarounds to ensure the safety of our patients and to support all staff and clinicians working with this equipment.

A number of these processes have been developed and are recommended for use provincially, with implementation at the discretion of each site/SDO.

We are currently trialing the following measures:

  • Other jurisdictions in Canada have suggested use of a port below the level of the pump to purge air in line as a syringe method (for non-hazardous medications or fluids only);
  • We are trialing and adapting the use of ported IV sets for norepinephrine, so we can use a syringe method to remove air in line; and
  • We have implemented a two-pump protocol for norepinephrine; this provides a backup medication delivery option if an air in line alarm occurs and stops the infusion.
  • We have tested Fresenius pumps in select environments and will be recommending a further trial of this equipment in locations across the province to allow for your input and experiences to be contributed to our longer-term planning.

These are the latest in a long line of mitigation efforts that have been taken to address the challenges with this equipment. We recognize these strategies are not sustainable for the long-term and will share more information as longer-term options are identified.

Safety reports and product complaints strengthen our communication with Health Canada and provide the details that we need in order to identify and advocate for better solutions. Please continue to submit these.

We care for the professional integrity and wellbeing of our teams and clinicians. We know that these challenges are creating concerns for clinical and patient safety that is felt deeply.

We are moving as quickly as possible to identify interim and longer-term solutions and thank you for your ongoing commitment to patient safety and quality of care during this challenging time. We commit to keeping you updated and apprised as we work through the issues and long term possible solutions.

Please continue to raise concerns or suggestions for management of these practice concerns to your manager, team lead or to myself or Dr. Francois directly.

Submitted by: Tamara Burnham, Collaborative Practice Lead

From: Mary-Ellen Lee, Provinicial Patient Safety Lead

This alert is to highlight the importance of communicating which acetylcysteine (also known as N-Acetylcysteine, or NAC, or Mucomyst) dosing protocol is initiated upon any transfer between hospital or medical services.

Acetylcysteine parenteral infusion is used to treat toxic ingestion of acetaminophen. Variations in protocols exist and rapid infusions can lead to acetylcysteine toxicity resulting in serious patient harm and even death.

See/print page 3 for recommendations

Situation

Manitoba patients presenting with acetaminophen toxicity are often transferred between sites.

Manitoba sites are using different acetylcysteine dosing protocols.

  • Rural sites use a one-bag–2-dose protocol endorsed by Ontario Poison Centre (OPC).
  • Winnipeg sites use a three-bag–3-dose protocol.

Miscommunication and/or lack of knowledge about acetylcysteine dosing protocols are known contributors to adverse patient safety events that have resulted in serious harm including acetylcysteine toxicity or fluid overload.

Risk is highest at transitions of care, including transfers between hospital units and facilities.

Background

There is a lack of consistency in acetylcysteine dosing protocols within Manitoba and nationally across toxicology services. There are two different toxicology consultations pathways in Manitoba and Saskatchewan uses a third service. Each service utilizes a different acetylcysteine dosing protocol for the management of acetaminophen toxic ingestions. All protocols include stepwise adjustment of infusion rates of the medication.

There is no standard acetylcysteine dosing protocol within Manitoba and variations in dosing protocols, including how doses are ordered and documented into charts and on to medication administration records (MARs), contribute to serious patient safety risks.

Use of a one-bag–2-dose protocol to administer both steps (loading dose and maintenance infusions) has been identified as a contributing factor for acetylcysteine overdose. The risk of continuing the loading dose infusion rate beyond the intended 4-hour time, without decreasing to the lower maintenance rate, is a known concern for adverse drug safety events and potential patient harm.

ISMP Canada called for collaboration across Canada to develop a consistent approach for the treatment of acetaminophen toxic ingestion. Manitoba continues to determine a pathway towards a standard acetylcysteine dosing protocol.

Assessment

The greatest risk to patient safety is at points of transfer of care and between facilities, where different acetylcysteine dosing protocols are used based on recommendations from Poison Control consultation services and hospital protocols. There is also higher risk when pump programming drug libraries are not customized to the dosing protocol ordered.

Confusion may also arise when healthcare providers work at different sites that follow different consultation pathways and/or dosing protocols.

Work is ongoing to standardize acetylcysteine treatment in Manitoba. Until standardization occurs, teams must remain aware of patient safety risks.

Variations in Intravenous Acetylcysteine Protocols can Lead to Infusion Errors and Serious Harm

RECOMMENDATIONS – Identified in consultation with Pharmacy and Medical Leadership

Use clear documentation (order writing, MARs, chart notes, etc.) and communication to confirm mutual understanding of the patient care plan at points of transition in care.

  1. Do not write or activate an order written as “per acetylcysteine / NAC Protocol”. Orders must include weight-based dosing, the separate steps of the dosing protocol being used and time frames for duration of infusions.
  2. Transcribe each step of the dosing protocol onto the MAR.
  3. Ensure clear, consistent resources are available for staff on acetylcysteine dosing protocols, including order sets and parenteral drug monographs.
    Monitor patients for signs and symptoms of acetylcysteine toxicity, hyponatremia and/or fluid overload.
  4. Clearly communicate the acetylcysteine dosing protocol that is being followed at transitions of care (change of shift, staff breaks, transfers between units or facilities). Communication must include which step and dose of the protocol the patient is currently receiving, the dose(s) ordered, and next steps of treatment.
  5. Complete independent double checks for dose, dose preparation and pump programming, per high alert medication policy.
  6. Partner with patient/family – share the steps and timelines of the dosing protocol being used. Share the signs and symptoms of concern and encourage them to alert the healthcare team of any concerns.

Acetylcysteine Infusion Toxicity

  • Toxic dose of acetylcysteine as a result of too much drug administered too quickly
  • Intravenous fluid overload and/or hyponatremia as a result of incorrect mixing and/or administration of acetylcysteine infusion(s)

Patient Impact

  • Cerebrotoxicity, hemolytic uremic syndrome, anaphylactoid reactions, vomiting, seizures, cerebral edema, and/or death
  • Variable depending on weight and comorbidities, especially concerning for pediatric patients
  • Hyponatremia – symptoms are similar to those described above

Thank you for your attention to this safety matter. Please reach out to your clinical practice leads (e.g., nurse educator) and your pharmacy team members with any questions or suggestions.

Submitted by: Tamara Burnham, Collaborative Practice Lead

Reminder that Southern Health-Santé Sud (SH-SS) will be converting to Kangaroo OMNI enteral feeding pumps next week, on December 10th, 2024. The documents below are intended for leadership and clinical staff in Acute Care and Heritage Life PCH leadership and clinical staff. Applicable sites are requested to ensure that new pumps and supplies are ready to go following instructions the memo below.

  • Memo with conversion details for sites using enteral feeding pumps
  • Poster for communicating upcoming conversion to clinical staff

Submitted by: Tamara Burnham, Collaborative Practice Lead

Background Information:
During the COVID-19 pandemic, Shared Health laboratories generating a positive test for SARSCoV-2 (COVID-19) by GeneXpert® telephoned nursing units (inpatients and ER admits) with thepositive test result.

Update:
Starting December 1, 2024, Shared Health hospital laboratories will no longer telephone nursing units (inpatients and ER admits) with positive SARS-CoV-2 (COVID-19) test results in order to bring SARS-CoV-2 result reporting in-line with influenza A, influenza B, and RSV reporting. Nursing units are expected to review results for nasopharyngeal (NP) swabs submitted on symptomatic patients for the SARS-CoV-2 result as well as the results for influenza A, influenza B and RSV included in the GeneXpert® Quadruplex (SARS-CoV-2/Influenza A & B/RSV) PCR test.

Shared Health hospital laboratories currently provide GeneXpert® Quadruplex testing following the current provincial algorithm (https://sharedhealthmb.ca/files/covid-19-testing-table.pdf). 

Contact Information:
Dr. James Karlowsky, Medical Director, Clinical Microbiology, Shared Health, 204-237-2105, email
Joelle Carlson, Technical Director, Clinical Microbiology, Shared Health 204-237-2073, email

Submitted by: Tamara Burnham, Collaborative Practice Lead

FROM: Ayn Wilcox, Executive Director – Klinic & Lee Heinrichs, Lead – Provincial Clinical Integration, Shared Health

On July 7, 2024, Manitoba Health, Seniors and Active Living announced important changes to how patients can access Gender Affirming Care in Manitoba. Province of Manitoba | News Releases | Manitoba Government Improving Access to Gender-Affirming Care Below are the key updates relevant to your practice. Please review them carefully.

Referral Process for Gender Affirming Procedures:

Referrals for hair removal, chest masculinization, breast augmentation, hysterectomy/oophorectomy and orchiectomy: Patients aged 18 and older no longer require two assessments from approved providers for referral for these procedures. Primary Care Providers (MD or NP) can now directly refer patients for these procedures. Providers can still refer to Klinic Community Health Centre (or an Approved Adult Transgender and Gender Diverse Health Care Provider outside of Klinic) if they do not feel they have the necessary knowledge base to initiate these referrals, or if a psychological assessment is deemed to be beneficial.

It will be important to confirm in the referral letter to the surgeon/dermatologist the diagnosis of Gender Dysphoria/Gender Incongruence, and how the individual meets the WPATH (World Professional Association of Transgender Health, Standards of Care vs 8) criteria for referral for the gender affirming procedure requested.

Referrals for Genital Reconstructive Surgeries and Facial Feminization: Referrals for these procedures now require only one letter of referral/recommendation by an approved Adult Transgender and Gender Diverse Health Care Provider. Referrals can be sent to Klinic Community Health Centre for assessment (or an Approved Adult Transgender and Gender Diverse Health Care Provider outside of Klinic).

Referrals for legal minors

Patients Aged 16-17: For individuals aged 16-17, referrals to Klinic are still required, and they must receive approval from providers on Klinic’s approved list.

Patients Aged 15 and Under: For patients aged 15 and under, referrals should be directed to the Gender Diversity and Affirming Action for Youth (GDAAY) program. For more information, please visit GDAAY – Shared Health

Provider Training and Support

In the coming months, Klinic will offer regular comprehensive training sessions for providers to ensure inclusive care for patients seeking Gender Affirming Care. Additionally, monthly Zoom-based community of practice sessions will be available to support providers in delivering safer and more inclusive care. Training dates and details will be shared through various channels.

For further guidance, please refer to the World Professional Association for Transgender Health Version 8 guidelines.

To become an Approved Adult Transgender and Gender Diverse Health Care Provider, please contact the Coordinator of the Klinic Trans Health program. Please visit, Health Care Providers – Trans Health Klinic – Klinic Community Health

Submitted by: Tamara Burnham, Collaborative Practice Lead

Date effective: December 2, 2024

Please see memo and poster.

Submitted by: Tamara Burnham, Collaborative Practice Lead

Date effective: December 2, 2024

Background Information: Cerebrospinal fluid (CSF) and non-CSF body fluid testing for automated cell count have been validated and in use across Manitoba Hematology Laboratory sites beginning in November 2023 with the introduction of updated Sysmex CBC analyzers. Effective December 2 2024, the new middleware platform (CaresphereWS) will be fully integrated into body fluid processing.

Clinical Practice Change:

  • All Serous and Peritoneal Dialysate fluids for Cell Count will be performed only by automation.
    • Minimum Volume of 500uL (0.5mL)
  • Reporting units are standardized:
    • Automated WBC/TNC x 10^6/L
    • Manual WBC/RBC x 10^6/L
    • Automated RBC x 10^12/L
    • Note: x10^6/L is equivalent to #/uL
  • Absolute differential values will be included in the patient report and reported at x 10^6/L
  • Introduction of new Critical Values of non-CSF fluids recommended by the Emergency Room (ER) and Nephrology clinical user groups:
    • Synovial – Absolute Neutrophil Count (ANC) >50,000 x 10^6/L
    • Peritoneal – ANC >250 x 10^6/L
    • Peritoneal Dialysate (also known as Dialysis fluid, peritoneal dialysis effluent) –
      WBC >100 x 10^6/L together with Neutrophil % >50 %
  • CSF Critical Values remain unchanged.
  • Stability, sample requirements, and reference ranges remain unchanged.

References/Resources: Please refer to the Laboratory Information Manual (LIM)
CSF: Lab Information Manual Serous: Lab Information Manual Synovial: Lab Information Manual

Patient Impact:

  • Immediate alert of clinically defined critical results to ensure prompt recognition of possible septic peritonitis/arthritis.

System Improvements:

  • Standardization of lab processing through automation
  • Improved laboratory workflow with middleware integration and streamlined registration processes
  • Real time data review and interlaboratory support

Contact Information:

Andrew Hartel, Provincial Technical Director, Hematology, Shared Health
Email
204-599-3275

Dr. Ping Sun, Provincial Medical Director, Hematology, Shared Health
Email
204-787-4682

Submitte by: Tamara Burnham, Collaborative Practice Lead

Healthier people. Healthier communities. Thriving together.