The regulatory divide: improving laboratory and epidemiology communications

CAP, CLIA, ISO, oh my! How regulation and accreditation requirements impact lab:epi communications

Cross-disciplinary relationships

Laboratory scientists and epidemiologists are two professions that work side-by-side in public health. In an ideal situation, there is open and clear communication and both sides have a good understanding of the abilities and constraints of the other side. In practice, this can be challenging, for a host of reasons. Leadership structures may be set up that encourage independent decision-making and prioritization, physical distance may make forging personal connections challenging, and heavy workloads leave little time for intentional partnership building.

Despite the challenges, cultivating good relationships and fostering understanding between the laboratory and epidemiologists is critical to effective public health work. Based on my experience working in both roles, there are some key things that I think are important for epidemiologists to understand about their laboratory colleagues - today we’ll address regulatory environments.

Regulations rule in the laboratory

I started working in a public health laboratory (PHL) after spending time working in a university research laboratory and as an epidemiologist. The biggest difference that stood out to me immediately in my new PHL environment was the highly-regulated nature of…everything! In the research lab, if I was feeling impatient (which is often a fault of mine), I might crank the voltage on the gel up a bit to get it to run faster. In the PHL (or any other clinical laboratory), everything has to be done by the book. And by the book I mean the Standard Operating Procedure (SOP). Every aspect of a test is governed by the SOP, and there are paper and electronic means of guiding the scientists through every step of testing and documenting results.

This doesn’t mean that laboratorians are just robots that mindlessly follow checklists - in many instances they’re the ones that developed or validated the protocols! And even when following established protocols, it takes critical thinking, great attention to detail, and usually pretty good manual dexterity (watch your lab friends hold a bottle in one hand unscrew the cap with the same hand - it’s a skill!) to complete the testing.

What is does mean is that there are requirements around everything in the laboratory - training requirements, proficiency testing, SOPs, and qualifications for scientists who can run a test and who can approve results. This may mean that a result may be generated, but can’t be shared with epidemiologists until reviewed and approved by another scientist. Following these requirements is not optional if a laboratory wants to maintain their certification, whether that’s CLIA, CAP, ISO or others.

Epidemiologists are not bounded by any accreditations, while the laboratory may be subject to many different regulatory frameworks that affect how they must conduct their work and whether they have any flexibility to make exceptions.

The field epidemiologist’s perspective

As an epidemiologist, there are guidelines (example from Washington State here) for how to investigate cases of illnesses and outbreaks, but they are definitely guidelines not enforceable regulations. If a laboratorian’s motto is “follow the SOP” then an epidemiologist’s motto might well be “it depends.” Because it does! Field epidemiology doesn’t operate under controlled conditions, depends on the input and behavior of public, and each response will be tailored to the situation at hand.

This doesn’t mean that there aren’t standards and expectations, but rather that within those guidelines there is the flexibility to change as needed based on individual circumstances. Importantly, there is no one performing an audit on your outbreak response with the ability to take away your outbreak-investigation accreditation if you didn’t properly document your adherence to protocols (well, maybe whoever is funding the grant that pays for your position, but that’s a topic for another day).

How are epidemiologists like fictional pirates?

First, your return to shore was not part of our negotiations nor our agreement so I must do nothing. And secondly, you must be a pirate for the pirate's code to apply and you're not. And thirdly, the code is more what you'd call "guidelines" than actual rules. Welcome aboard the Black Pearl, Miss Turner .

~Barbarossa, Pirates of the Caribbean: The Curse of the Black Pearl

The benefits of regulations

As I spent more time in the laboratory, I came to better understand and appreciate the regulations. They ensure that testing is reproducible and of the highest quality, and also that the documentation is in order to ensure that the right specimens are attached to the right patient data and the right results. Regulations like two matching identifiers on the specimen and paperwork exist to ensure the integrity of the test and results, not to annoy epidemiologists by delaying or rejecting specimens. Ouch, maybe that’s a little harsh on my epi colleagues (I’ve been there - it’s always the most key specimens for an outbreak that have something wrong, right!?), but I think it’s important to understand that the laboratorians are not being bad public health partners if they have to reject specimens. They are preserving their laboratory’s ability to maintain accreditation so they can continue to provide you with all the other test results you need.

Take home message

Whether a group has a regulating and accrediting body has far-reaching impacts on the way the profession operates. Within public health, it’s especially important for those outside the laboratory to understand the regulatory framework and limitations upon the laboratory staff. Asking laboratory staff to share a result with you that hasn’t been approved for release is not being a good investigator, it’s a breach of trust of your colleagues. For laboratorians, understanding that epidemiologists are not accustomed to working in a regulated environment can aid in understand their perspective and realizing that they don’t always know what they are asking from you, and why it might not be possible.

Action items

Now that we’ve laid out one barrier to productive lab:epi relationships, how can we being to address it?

Education! Often laboratories will host tours of the lab for epidemiologists, but this typically doesn’t include any information about the regulatory framework and requirements. This tour could be expanded to a classroom section which might include:

• Sharing a SOP for a test, along with the testing worksheets completed by the scientists

• Overview of what it takes for a scientist to become trained on an assay and maintain proficiency

• Presentation on the background of which accreditations are held by the laboratory and some of the requirements to maintain those

• Overview of an audit

This content could also be brought into other meetings such as statewide epidemiology calls or conferences. Proactively coming up with joint educational materials for submitters can be helpful as well - when epidemiologists and submitters have clear specimen submission instructions (multimedia can help too, as in this example from Virginia) the need for specimen rejection can be reduced.

Another way you can provide education is by sharing this newsletter if you found it helpful! I’ll be continuing to share ideas for productive lab:epi relationships in future editions.

This is based on my experiences working in one public health laboratory, and as an epidemiologist working closely with two different public health laboratories. I’m sure there are many perspectives and experience beyond my own. Have questions, comments, disagreement, or things to add? Hop over to my LinkedIn page for discussion.