Last updated: May 27, 2020
When it comes to medical testing, the time and resources you spend struggling to understand unclear regulatory compliance obligations can distract you from caring for patients. The COVID-19 pandemic showed us just how critical timely testing is to the safety of the global community. However, if you are like many laboratory managers today, dealing with regulations and compliance can be a real challenge, especially if your facility operates in more than one province and must navigate a patchwork of rules. This not only impacts your ability to run your lab effectively but can very well mean the difference between life and death in extreme cases due to delays in a testing capacity.
Failure to comply with regulations carries tough consequences. In fact, when medical lab Dynacare submitted a filing with the U.S. Securities and Exchange Commission a few years ago, it listed “extensive, complex and changing government regulation,” both in the United States and Canada, as the top risk to its business.
A lack of rigorous standards and carefully followed regulations is also causing disastrous results for patients. For example, a Newfoundland laboratory was recently found to have misinterpreted the test results of nine breast cancer patients. And this was not an isolated incident. Similar errors have occurred at labs in British Columbia, Manitoba, Ontario, Quebec and New Brunswick.
The heart of the problem is a lack of consistency in compliance rules from coast to coast. According to The Globe and Mail: “there are no national standards; standards vary from province to province, and sometimes from one lab to the next.” Many medical professionals are calling for regulation uniformity across Canada, but this is proving difficult to do. Each province has different requirements and unique privacy laws protecting patient confidentiality, depending on the lab’s location. And these standards also apply to the handling of specimens by your chosen courier. In addition to complying with all the regulations of your province, your lab must also meet federal rules. It’s no wonder managing and maintaining regulatory compliance can lead to complications that impact you and the patients you serve.
So how can your lab avoid regulatory compliance mishaps and testing errors?
1. Understand Transport Canada’s federal guidelines
Transport Canada is a great resource to shine a light on many of your legal obligations. This federal body oversees the packaging and transportation of all diagnostic specimens, cultures and biological products. Look to them for clear guidance on:
- Storage containers: learn the requirements for content and durability;
- Test samples: learn labeling, packaging and documentation requirements;
- Infectious substances: learn about required training and specific protocols for handling and transportation; and
- Emergency response plans: learn which substances require a plan to be in place in case of an accident.
2. Partner with a courier that possesses a proven track record in medical specimen transport
An experienced medical courier will ensure your specimens arrive at the testing facility:
- At the correct temperature;
- Intact in a proper container, without breakage or leakage;
- In the shortest possible time; and
- In compliance with all applicable regulations.
… A trusted medical courier should also deliver:
- A deep understanding of the needs of critical deliveries;
- End-to-end shipment visibility through the latest technology; and
- Superior temperature control and packaging in compliance with Transport Canada.
3. Seek expert help to keep up with regulation changes
- Look to provincial resources to understand specific compliance requirements and to help establish protocols for activities like documentation, testing, storage and specimen disposal;
- Contact Transport Canada regional personnel for specific answers to your compliance questions; and
- Get private expertise for added insight and professional guidance. Be sure to contact one of the many private companies who work with labs like yours to identify regulatory obligations and help you develop comprehensive compliance strategies.
In an industry where mistakes simply shouldn’t happen, regulatory awareness must be a top priority. By relying on a specialized courier and a good team of experts, you can steer clear of clinical errors and compliance mistakes, while still delivering the service levels your patients deserve.