Greetings,

We have acquired a very small hospital for which there will be limited services. The VP wants to terminate their full service transfusion service and only offer either 1) units for emergency release or 2) do all the pre-transfusion testing (including crossmatching) at our hospital and then transport crossmatched units to the smaller site or 3) both.

I am curious to hear if any others have dealt with any of these scenarios and if so, point me towards the regulatory requirements for such a set-up.

Thanks,

Amelia

I cant' speak to the regulatory requirements, but we do 'satellite' blood banking. We keep stock inventory at the small site and all samples come to our site for testing. We then perform testing and print unit tags off at their printer at the small site. We also keep pretagged O neg emergency release units at the small facility too. The techs at the smaller site simply tag the units and issue. Our night shift is responsible for rotating product to manage inventory effectively.

We have two hospitals for which we perform blood bank testing.  Both send us a sample and we perform the type and screen, crossmatch, and any additional work necessary and then ship them the units, fully tagged with the reports.  Neither of these hospitals stock any blood products.  They have hospital volunteers act as couriers.  Regs I don't know about, sorry.

We have two smaller rural hospitals that we work with, they do perform T&S s and crossmatches, but they do not work up any positive screens.  We do that.  If they need antigen negative blood based on our results, they order it from our supplier.

As mentioned above, be careful with JCAHO, FDA etc, regulations in all of this if you are going to make a changes.

Scott

Scott,

Which Joint Commission Standards are you referring to and which CLIA regs?

Thanks,

Amelia

Our facility became the Transfusion Service for 2 smaller hospitals.   In addition to supplying their blood products, I reviewed all their procedures that pertained to blood transfusion/sample collection. 

If you need to re-label units for emergency release Digi-Trax (info@digi-trax.com) has a PC Stand-Alone ISBT128 on-demand labeling system (HemaTrax-SA)

I'm curious if anyone knows of specific regulations. I'm assuming there is some type of contract of services that covers CLIA licenses and other regulatory issues? Also, how are the satellite sites inspected? 

A good place to start would be to call your state public heath department with questions about CLIA requirements. 

I have learned that the small hospital we acquired has it's own CLIA number, so I am wondering how that will affect our decision. They are not going to have an ER but will be doing minor procedures. In envision the facility being much like a surgical center. And I know for a fact, that the other surgical center in our community does not have a blood bank/transfusion service.

We will do crossmatches for a small neighbor when they have problem patients. We don't own them but we do all their reference work. Our medical director is their medical director/consultant and signs off on all their SOPs and competencies. We have a contract with them for the reference work. They have an SOP that spells out what happens when they have that problem patient, that the work is referenced to us and that we provide the crossmatched blood, though we don't tag it for the patient. We send a report with all the crossmatch info, including types, crossmatch results, unit numbers, patient ID, etc. etc. Once they receive the unit(s), their SOP spells out what they do about tagging and reporting. At their recent CLIA inspection (our medical director and I were present as representatives for our lab - as consultants.), the inspector had no problem with the arrangement. I think the important thing is that the whole process is spelled out in their SOPs and they had documentation that they followed their SOPs. State law may vary, so be sure to check out your local requirements. They give blood about once a month at most and we assist them about twice a year.

We used to do this for a sister hospital 20 miles away. We still do sometimes.  The reg that caught us at one time was AABB's requirement that a serological XM be done from "an integrally attached segment" so we had to start doing electronic XM rather than use the segments we had stored for their inventory for IS XMs.  We do all AHG XMs for them still and then send the units over.  They got too busy and the time to send the T&S specimen to us caused too much delay so now they do their own T&S and electronic XMs. Most there had not done BB in 20 years so we started small. They have no serofuge so we trained them to do an IS XM in manual gel using the reverse wells on an ABD/Reverse card so they had an option during the rare computer downtime.  We will someday teach them to do gel XMs but usually we have to do an ID and screen units so it works for us to do it for them.  The time they need this capability most is OB patients with RhIG anti-D which doesn't require us to screen units.  They could at least give AHG XM compatible while waiting for the ID.  

Beyond that, what those above said.

We do any antibody ID's, screen and crossmatch for our sister hospital,  They do T&S and IS any non problem patients.  We have a courier to run 3 times a day.  We also do their Micro.  After hours they have a courier.

We provide blood products for smaller hospitals as well.  I recently had an AABB inspector go through our records and the one question that kept coming up was "Do you have a contract?" If your facility is providing the testing/blood then your Medical Director is ultimately responsible, even if there is no contract. 

I think this can become a muddy process in that the labs follow the "rules", but they have different procedures.

 

4 hours ago, tkakin said:

We provide blood products for smaller hospitals as well.  I recently had an AABB inspector go through our records and the one question that kept coming up was "Do you have a contract?" If your facility is providing the testing/blood then your Medical Director is ultimately responsible, even if there is no contract. 

I think this can become a muddy process in that the labs follow the "rules", but they have different procedures.

 

We have a very similar setup. We have set up contracts with small rural hospitals hours away and provide emergency xm and compatibility testing for them. If they do use RBCs that we sent to them confirmed as emergency or incompatible xm our Medical Director (not theirs) is signing the review and paperwork. There are also two different types of contracts we utilize. Another is set up for emergency air Med/helicopter service only and they only transfuse Os with the expectation that no compatibility sample will be sent to us after the fact. 

4 hours ago, tkakin said:

We provide blood products for smaller hospitals as well.  I recently had an AABB inspector go through our records and the one question that kept coming up was "Do you have a contract?" If your facility is providing the testing/blood then your Medical Director is ultimately responsible, even if there is no contract. 

I think this can become a muddy process in that the labs follow the "rules", but they have different procedures.

 

We have a very similar setup. We have set up contracts with small rural hospitals hours away and provide emergency xm and compatibility testing for them. If they do use RBCs that we sent to them confirmed as emergency or incompatible xm our Medical Director (not theirs) is signing the review and paperwork. There are also two different types of contracts we utilize. Another is set up for emergency air Med/helicopter service only and they only transfuse Os with the expectation that no compatibility sample will be sent to us after the fact. 

13 hours ago, tkakin said:

We provide blood products for smaller hospitals as well.  I recently had an AABB inspector go through our records and the one question that kept coming up was "Do you have a contract?" If your facility is providing the testing/blood then your Medical Director is ultimately responsible, even if there is no contract. 

I think this can become a muddy process in that the labs follow the "rules", but they have different procedures.

 

This small hospital has been acquired by my hospital system. Would we still need a contract if they are part of the same hospital organization? Thanks.

On ‎1‎/‎20‎/‎2017 at 5:32 AM, kirkaw said:

This small hospital has been acquired by my hospital system. Would we still need a contract if they are part of the same hospital organization? Thanks.

Yes I do believe you still should have a contract even if it is within the same organization.

I also have a question about doing partial testing for a cancer center in our health system. Their lab works under a separate CLIA license.

Currently we do all the blood bank testing and send the crossmatched units to them every day by courier.

They want to start storing products there and want to do the electronic crossmatch there after we have done the type and antibody screen.  Is this acceptable practice?

I would say, no because you have to verify electronic crossmatch per site. (This is according to Joint Commission.) I would also be wary of allowing them to store blood products there. You would certainly have to ensure appropriate monitoring.