Managing Multiple Clinic Lab Directors

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I’m a newish POCC for a medium sized hospital with 5 outlying clinics. For each clinic, I have to coordinate a physician on-site to be the lab director. Most of these sites have just certificates of waiver, but one has a PPMP certificate. My main question is, is it common practice to have a different person be the lab director over each site in a hospital system? Why can’t the main lab’s director be the director over all satellite labs as well? It’s my understanding that it was set up like this before my time, but was never explained to me why it was changed. I’m having a very hard time finding providers at each clinic who are interested or even willing to take on this role, and they generally have no knowledge over lab practices. It seems like it would be easier on everyone for the main lab’s director to be listed on each sites’ certificate, but I’d like others opinions and experience on this matter.

11 Replies

Diane Burford

Mon May 02, 2022 at 10:04AM

Rachel:
If you meet the following requirements you may be the CLIA Director over your Clinic labs, except for the PPMP which needs to be a provider . You can hold 5 CLIA certificates over Clinics that have non-waived testing ( including a mix of waived and non waived) . If they are only waived you can hold more. Here's requirements below:
*Have earned a bachelor's degree in a chemical, physical, biological science, or medical technology from an accredited institution and: Have at least two years of laboratory training or experience or both in non-waived, and. In addition, have a least two years of supervisory laboratory experience in non-waived testing.

Danyel Olson

Mon May 02, 2022 at 10:17AM

We find that the issue with non-waived sites, is that our medical directors in the lab get maxed out on sites. Like Diane said, they can only be on 5 non-waived certificates. Waived doesn't have those restrictions.
We do have a physician from our primary clinics on their CLIA - thankfully we do have 1 that is invested but that is not common. Even so, it does create difficulties when larger decisions or testing decisions need to be made as ultimately that physician has the say so. Then what we get is clinics performing testing that the lab discouraged.

Kathleen David

Mon May 02, 2022 at 10:24AM

We have over 100 clinics that are part of the hospital systems. For the most part, they are waived and all have their own CLIA medical director. Usually it's the clinical medical director, and we haven't had any problems with the clinics naming their own medical directors.

Erika Deaton-Mohney BS, MT(ASCP), CPP

Mon May 02, 2022 at 10:51AM

It might also be prudent to understand what the role of a laboratory medical director for waived or PPMP physician office laboratories (POL) is. What are the responsibilities and who should they belong to? In order for any CLIA medical director to fulfil those responsibilities, they would need to be an active provider (or qualified personnel) at the POL. We use a physician at each of the practices and we have 80. It can be accomplished, especially if they want to run tests. Does your Point of Care policy speak to this dilemma?
The following link will help you and the POLs understand what you are looking for.
CMS Manual System Subject: Medical Director Guidance

Good Luck!

Dawn Grose

Mon May 02, 2022 at 11:03AM

The previous posts have good advice. The clinic medical director is most often the CLIA Lab director for our clinics. We have >100 waived sites we support, along with 8 hospitals. The lab directors do get maxed out and most likely would not be visiting clinics to provide that general oversight. We have put tools in place to help the clinic lab directors so that their jobs are a bit easier. We have a strong quality program which nursing and CNA/MA help support as well.

Rachel Blevins

Mon May 02, 2022 at 11:19AM

Thank you for the comments, everyone. It seems my organization may have some structural differences which make it a little more challenging. The medical director over each site does sound like the best choice, however I don’t believe there is a medical director for each clinic, I think we just have one for the organization as a whole.

Kathleen David

Mon May 02, 2022 at 12:08PM

If these are all at different addresses, then you'll need to name a CLIA medical director for each CLIA number/address. We do have a medical director who is over POCT as a whole, and who makes overarching decisions for our program as a whole, but each site has their own CLIA medical director. Although i suppose there is nothing stopping your main lab medical director to be named on all the waived CLIA certificates. It's a case of legal responsibility for the testing, and we feel it's better for the clinics to have some responsibility for their testing.

Peggy Mann

Mon May 02, 2022 at 1:39PM

Rachael, we also use (typically) a medical director of the practice (especially faculty practices which have different specialties as well as Fam Med or Pedi. But it can be a practicing MD.
We also have used NPs.

Wan Yung Bhowmik

Mon May 02, 2022 at 5:02PM

Our POCT team oversees 40-some sites, including two hospitals. With the exception of 4 of those sites that have a clinical pathologist as a lab director (under the Department of Pathology and Lab Medicine) but also perform moderately complex testing, the rest of them (whether waived or PPMP) have lab directors who are providers on-site. Also, depending on the state, you might actually not be able to have the same lab director for more than x number of sites. For example, PA does not allow a lab director to hold the CLIA for more than 2 laboratories. However, the Bureau of Labs can grant exceptions to this, depending on the situation, and if approved, the director can oversee unlimited CLIA labs.

Rachel Blevins

Mon May 02, 2022 at 5:36PM

How does the selection process work if the provider serving as director leaves the clinic?

Peggy Mann

Mon May 02, 2022 at 5:47PM

We do not have a written plan or policy or process on selecting CLIA LD and there is no succession concept (for anything but I digress!).

Each time, truthfully, with this many PPMP and COWs, and turnover (Houston is a huge healthcare market and competitive for talent), I start over when a LD leaves… “Who gets lab testing and has a CV that qualifies?” “Who has the bandwidth? Who may stay at least a few years?” (is a big question these days).

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Managing Multiple Clinic Lab Directors