During a recent Joint Commission inspection, we were told performance of therapeutic phlebotomies met their definition of a donor center.  We collect the blood and immediately discard it.  We don't store it, and we most definitely don't transfuse it.  Has anyone heard of this?  If so, can you explain the rationale?

Nope, therapeutic phlebotomy is considered a clinical procedure.

Agree with MAGNUM.  

We have joint commission visit again early next year so interested in your post mla. I don't know how they justify this stance. The only time we see it is when the nurses come in to discard the bag into our rigid infectious waste bins. Nothing to do with the lab or bloodbankiing activities as far as I am concerned, definitely clinical as they are never used, just discarded. Willlet you know if they raise it. I certainly won't be asking them.

Cheers

Eoin

Have never experienced this issue, but haven't seen the joint in over 10 yrs. Did you see their standard or was it just an inspector's bias?

This was a somewhat frustrating inspection, obviously.  We weren't cited for anything.  My manager was told that she needed to change our application (during the inspection) to reflect that we qualified as a donor center because we collected therapeutic phlebotomies.  Like most of you, we perform the procedure and discard the blood.  I just wanted to know if anyone else had ever run into this situation. I appreciate the feedback because it is nice to know that others find this as odd as I do.

Give the job to the nursing service - I handed ours off to Outpatient Infusion. We have never had that kind of issue when JC has inspected in the past. We are due again any time soon, though, so we'll see what happens.

We were just inspected by the JC, and yes, they cited us for this. They wanted the arm prep done just like a donor (our procedure was a little vague). And even though they do this in our Outpatient Infusion Center, they want Blood Bank oversight, Medical Director involvement, etc.

There is no specific JC reg for this, but they generally follow the AABB regs.

I am pretty sure that JC doesnt care whether the lab is doing therapuetics, or nursing, or environmental services, for that matter.  If JCAHO inspects for the facility -- a failure for any special department (Lab for instance) is a failure for the hospital -- which is the entity that holds the CLIA licenses.  If you have an inspection and the Lab director tries to dismiss deficiencies by saying that the job was "given to nursing services", the hospital is still stuck with a deficiency.

 

In a simular vein, at our hospital, OR was doing such an inconsistant job with tracking bone and other tissues that they kept getting cited by the FDA for making the same mistakes over and over.  Finally we turned tissue tracking over to Blood Bank (using HCLL).  Now all tissue is checked in and out of BB.  More work for us but we had to do it.  We couldnt just tell the FDA that its not our problem -- its our hospital's problem and we were the right department to take care of it.

 

Scott

Our local donor center will come in and do the occassional therapeutic phleb when needed. That way it is under their medical director and we avoid any issues that way.

I posed the question to Jennifer Rhamy of The Joint Commission. Her is her reply.

"Yes, it is just a marker for the surveyors to prioritize their time and apply the therapeutic phlebotomy standards. There isn’t a separate area to designate the therapeutic or autologous collections from allogeneic since our purposes are for process review, not FDA registration. I hope this helps explain the comment."

Jennifer Rhamy MBA, MA, MT(ASCP)SBB, HP

Executive Director

Laboratory Accreditation Program

The Joint Commission

Lab STAT News – November 2013

Some quick news for labs interested in accreditation or currently accredited by The Joint Commission.

A helpful tip for your organization

Q. We perform therapeutic phlebotomy procedures. Since this isn’t a CLIA regulated process, do we have to let The Joint Commission know?

A. Yes, The Joint Commission reviews therapeutic phlebotomy procedures during the laboratory survey. To ensure that the surveyors have sufficient time to do a tracer, you should indicate this service on your laboratory application. In response to customer feedback, we just updated the application to make this notification more apparent (see screen shot below). If you have questions about where on the application to indicate that your lab performs therapeutic phlebotomy procedures, please contact your account executive.

We were just inspected by the JC, and yes, they cited us for this. They wanted the arm prep done just like a donor (our procedure was a little vague). And even though they do this in our Outpatient Infusion Center, they want Blood Bank oversight, Medical Director involvement, etc.

There is no specific JC reg for this, but they generally follow the AABB regs.

JC did not tell us that we qualified as a donor center because we draw therapeutic phlebotomies, but we were told that lab staff should not do the vital signs because it is outside of our scope of practice. As a result, we now have a lab person do the actual procedure but a nurse assess the patient before and after the procedure (during too, if it lasts >30 min.) This has become quite cumbersome, but we are trying to make it work. Is anyone else doing a hybrid process like this? If so, does your organization have 2 procedures - 1 for nursing and 1 for lab?

We recently passed another JC inspection. Not a word about the therapeutic phlebotomies, which are done by the Infusion Clinic nurses. Glad it wasn't an issue for us.

We also involved nursing for vitals. At our last JC inspection, it was brought up. Since we do very few, we opted to discontinue this service. We now refer patients to the Red Cross.