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A fan of science and math since high school, Nora’s school counselor suggested she look into medical technology. After some research, Nora agreed that it seemed like a great path. She went to school for clinical lab science, then started part-time in a hospital lab, where she worked her way up to lab director.

As a lab director, I was responsible for the regulatory compliance of the lab that I ran. From there, I got into other areas of compliance. The hospital where she worked, a 250-bed community hospital, gave her the opportunity to take on roles and learn things outside of a narrow job description.

The next step was to take what she had learned and use it to help organizations that were struggling with regulatory compliance. She became a consultant for Chi Solutions, and her first task at Chi was to be an onsite lab director at a Baltimore hospital that had had significant regulatory failures. Chi Solutions was advertising for a lab director to come onsite and be there for a year, to make sure that all of the fixes held. That position was a great learning ground for all of the regulatory requirements. I knew them but having experienced them in a lab that had failed was a terrific learning experience.

Helping labs stay ahead of regulatory changes

According to Nora, ensuring compliance comes down to two different components. The first is to make regulatory readiness a part of everyday laboratory operations. You want to be thinking regulatory all the time. It’s not something you can put off until the inspection that you have to have every two years. It’s something that you live every day. From staffing decisions or equipment decisions, to writing job descriptions and ongoing monitoring activities, the goal should be to be ready for an inspection at all times.

Second, stay up to date on new regulations through the relevant accrediting agency. If you’re accredited by CMS, for instance, or CAP, or The Joint Commission, they provide great updates for labs about what’s coming, what’s new, what they’re looking at. There are also professional meetings that deal with these subjects. The regulations haven’t really changed much, but the interpretation of them has. That’s where labs can get hung up sometimes, is not recognizing that the interpretation of the rules has changed.

 Compliance in the age of COVID-19

COVID-19 has presented many challenges for regulatory compliance. For example, many hospitals developed their own COVID-19 testing mechanisms. And basically, these are homegrown lab developed tests or LDT’s that somebody created in their lab. Now the regulations for these LDT’s  are not as clear as they are for the more common lab tests, and so that’s a challenge. I foresee some  new regulations and guidance coming out around laboratory-developed tests as an after-effect of COVID in the next two years.

Another effect of COVID-19 was a disruption in the inspection process. All labs are supposed to be inspected every two years. Many accrediting organizations were experiencing delays in getting to hospitals to do the inspections. In some cases, the hospitals wouldn’t let inspectors in. In other cases, the hospitals were in areas where they wouldn’t send their inspectors to because it was too much of a COVID hot spot. So, inspections have been delayed.

Going forward, Nora expects that the market will have more commercially available tests. There are some on the market now already for doing antigen testing and antibody testing. I think we’ll see more of the PCR testing as well, going forward. And that will have to go through the rigorous controls and approvals that FDA runs for all the other tests. This is very unusual for them to approve so many tests for emergency use. More than 200 tests now have emergency-use authorization.

Lab leaders will have to stay tuned and see what the regulatory fallout from all this is. I think the regulatory agencies will do their best to educate everyone.

Staying regulation ready during COVID-19

Throughout the pandemic, Nora and her colleagues have continued to support clients. We’re talking to our clients on a regular basis. We’re hearing about their struggles. We’re understanding, and we’re giving them information as we get it on things that may change down the road.  

Because consultants can’t go onsite as normal, the team has had to innovate. A lot of what we do is actually visualizing processes within labs, staffing and those things. We’ve moved to a video visit, where we’re actually videoing the labs, which has worked out well. The team plans to continue using video to supplement their work, even after COVID-19.

Nora sees her role functioning as a conduit of information for hospital labs. As part of our consulting engagements, whether it’s regulatory or any other kind of consulting engagements, I do interviews with lab leaders that are at hospitals and health systems around the country. And often I ask them to name their three biggest challenges. I’m able to incorporate my work into helping remove barriers and helping them address those challenges as they evolve. It’s very rewarding to do that.