We’ve Lost Our Lab Director, Now What?

You’ve just been informed that your CLIA laboratory director is resigning. You know that this role is mandatory in order to continue providing compliant laboratory testing to your patients. So, what do you do? First, don’t panic. Second, follow the below advice, and you’ll be in a better position than most who are navigating a laboratory director transition.

Step 1: Offboarding the current lab director

For most employees, departures and offboarding is a human resources function. However, for your CLIA personnel, especially the lab director, there are key things to keep in mind and actions to take. The first consideration when offboarding your current lab director is whether or not they’ve given resignation notice and, if so, the length of notice they’ve provided.

If no notice is given (for example, your lab director leaves on poor terms either via termination or immediate resignation), the Clinical Laboratory Improvement Amendments of 1988 (CLIA) dictate that testing must immediately be ceased when a laboratory director is no longer involved and that your regional CLIA office be notified. Also notify any accrediting bodies (i.e., COLA, College of American Pathologists [CAP], etc.), if applicable. Next, as quickly as possible, secure a referral lab partner who can run your patient samples while testing is ceased in your facility; this ensures the least impact to your patients. Once you have secured a new, qualified lab director, you can, of course, bring all testing back in-house.

Ideally, your outgoing lab director has provided notice and is committed to seeing the transition through to the new lab director. This action is regarded as the expected standard in the industry due to the implications such a transition has for other lab staff, operations, and patient care. Most laboratory directors give a 30- or 60-day notice, as is dictated in their contracts or employment agreements. If this is the case, great! You will not need to cease in-house testing, nor will you need a referral lab partner to run your samples—all you need to do is secure another qualified lab director before the outgoing director’s notice is completed. Thereafter, the only additional step is sending a notification regarding your new lab director to your regional CLIA office and/or your accrediting bodies, if applicable.

Step 2: How to determine the qualifications your lab director needs

CLIA determines the possible pathways for qualifying as a lab director, but these can be tricky to navigate if you are not familiar. Here are a few things to consider:

1. What complexity of testing does your lab offer? CLIA certifies waived, moderately complex, and highly complex facilities and sets forth personnel qualification requirements, including those for lab directors, based on the complexity of testing performed.
2. What subspecialties of testing do you offer in-house? CLIA regulations dictate certain qualifications for the laboratory director for certain types of testing. For example, you must have a laboratory director who is a board certified and licensed pathologist to oversee any blood banking activities (immunohematology).
3. Do you need the incoming lab director to fulfill other CLIA mandated personnel roles? Many lab directors fulfill the clinical consultant role, too. If your outgoing director is doing so, you will want to ensure your incoming lab director can also meet the qualifications and fulfill the responsibilities of any additional CLIA personnel roles if you do not have other in-house staff who qualify.
4. What are the lab’s future goals? If you are considering adding subspecialties of testing, you will want to determine how this would impact the credentials required of the lab director you’re seeking.
5. Accrediting bodies and state requirements can also have an impact on what qualifications your incoming director will need to possess. For example, there is a requirement for all CAP accredited labs who process more than 500,000 samples annually to have a high complexity qualified CLIA lab director, even if they are only performing waived or moderately complex tests in-house. Additionally, while waived labs are required to name a laboratory director on the application for certificate, CLIA does not set forth any specific qualification requirements for this individual; however, some states, like California, have specific qualification requirements that your lab director will need to meet to oversee waived testing in a lab sited there.

Step 3: Finding the best possible replacement director

If you’re on a budget, and particularly if you are a small-to-moderately-sized facility without a huge test menu, the best way to secure a qualified replacement lab director who won’t break the bank is on a part-time basis. You can hire someone full-time if that makes economic sense for your lab and its future plans, but full-time involvement of the director is not a CLIA requirement. In fact, CLIA outlines all tasks that can be delegated to appropriately trained and competent on-site laboratory personnel, which paves the way for the CLIA lab director to serve on a part-time basis. Hiring a part-time director can save overhead costs, but you will need to ensure you have adequately trained staff in the lab to handle the tasks delegated to them. The laboratory director’s job is to determine competency and to communicate said delegated tasks effectively, as well as follow up to ensure those tasks have been completed. Delegation can allow the lab director to focus on the tasks that only he or she can perform as per CLIA guidelines, and to fulfill said duties in a part-time manner.

Since the director’s main job is compliance and this affects all aspects of the laboratory’s operation, you may be wondering how you determine who is the “best” fit for this role. One important aspect to consider is communication ability, particularly if you are hiring the lab director on a part-time basis. You will want to ensure the hired director can interact effectively with your team and delegate appropriate tasks, so involving key employees in the interview and decision-making process for the laboratory director hire is the best way to achieve that. Emphasizing that strong communication skills are the priority for your key players to evaluate in a potential director candidate will result in the most useful feedback to utilize when making the hiring decision. Besides communication, ensuring the replacement director has the appropriate qualifications is of highest importance.

There are a variety of considerations when replacing your lab director, given that each lab has a unique set of circumstances. This can become overwhelming, so focusing on determining the credentials you require and ensuring your incoming lab director possesses strong communication skills are the two best things you can do to positively influence this process. LinkedIn is a good source for connecting with qualified directors and other lab personnel you may need. Don’t be afraid to ask your network if they can recommend or connect you with anyone they may know. The LinkedIn search feature can also be invaluable for finding specific qualifications.

Editor’s Note: See our related “Guide for Assessing Lab Director Candidates” tool for further tips to ensure the choice of the right director for your lab.