Last updated: June 15th, 2022
When it comes to medical testing and equipment, the time and resources you spend struggling to understand unclear medical 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.
The consequences of regulatory compliance mistakes
Failure to comply with regulations carries tough consequences. In fact, CAREDATA, a leading healthcare technology organization, found that one of the top risks for laboratory managers is regulatory compliance issues. Within this highly regulated field, strict adherence and compliance is a must.
A lack of rigorous standards and carefully followed regulations is also causing disastrous results for patients. For example, the FDA warned that noninvasive prenatal blood tests for screening pregnant people for signs of genetic abnormalities could be providing false or misleading information. A New York Times investigation reported that many of these tests produce false-positive results for rare conditions such as Prader-Willi syndrome.
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 uniform regulation 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.
The need for rigorous standards and carefully followed regulations are also needed for medical devices. For example, researchers estimate that within six months, more than half of wheelchairs break down. Furthermore, people can end up waiting six months or longer for a wheelchair repair. This leaves wheelchair users stuck at home and at risk of medical complications.
So how can your organization 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 labelling, packaging and documentation requirements;
- Infectious substances: learn about required training and specific protocols for handling and transportation; and
- Emergency response plans: learn which substances, such as dangerous goods, 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 and equipment 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.
Furthermore, medical equipment should arrive at its destination:
- In temperature-controlled packaging solutions;
- Intact in a proper container, without breakage;
- Ready for immediate use;
- 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;
- Real-time end-to-end shipment visibility through the latest tracking technology;
- Superior temperature control and packaging in compliance with Transport Canada;
- Extended service hours including evening pick-ups which allow additional time to accommodate late-day orders;
- Multispeed solutions including express service that can reach most hospitals across Canada before 10:30 AM; and
- Service across Canada, including remote areas.
For the most urgent shipments where every minute counts, Purolator offers a Mission Critical service. With optimized routes, next flight out capabilities, best-in-class tracking visibility and 24-hour access to experienced Mission Critical specialists, leverage Purolator’s fastest shipping solution.
With urgent shipments, it’s especially important for packages such as medical devices needed for next day surgery move through the shipping network swiftly and seamlessly. This is why we’ve enhanced our network to easily identify healthcare packages through visual and digital markers when entering our network. With these identifiers, we can ensure healthcare shipments arrive at their destination on time.
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. With the right courier, you can enhance patient outcomes, support clinician experiences, diagnose quicker and improve hospital operational performance.