In a recent note, I discussed the idea that Epic is providing incentives for larger hospitals to serve as hosting sites and consultants for smaller ones (see: Epic Helps Convert Its Large Hospital Customers into Epic Hosting Sites/Consultants).The overarching strategy is obvious for hospital CEOs/CIOs -- it binds the smaller hospital to the larger one. Healthcare reform is stimulating many such mergers/realignments (see: Hospital Executives Search for the Formula for an Accountable Care Organization). However, the question should to be raised whether there are any unanticipated surprises when entering into such relationships. Below is an on-point item copied from a lab/pathology web forum (see: Epic (Beaker) Lab Module):
THintz: At our facility we use Epic for our HIS and Sunquest for our LIS. Our Hospital Info Service area is rolling out Epic to a small area hospital (not a part of our company-somehow we have an agreement with Epic to be able to do this). The lab in this small area hospital does not currently have an LIS so as part of the "total Epic package" they are getting with our help they want to install Beaker, the Epic lab software. Beaker does not have a blood bank module that is 510K cleared for use. However this small lab does do some blood banking and were told by someone (unsure who) that it would be "ok" for them to enter blood bank results in Beaker as the process used to result other lab work like heme or coag could be "tweaked" to allow BB results too. By this I assume they mean the interpretation of blood bank testing documented on the current paper system, not actual reaction results as there is no logic in the system for QA checks, etc. The statement was qualified with "but if they do more than a little blood bank work (define little...) then this small lab would need to get a separate BB software to interface with Beaker. Thoughts on this? If they enter BB test interpretations into Beaker is this ok to do in a system not specifically cleared for BB? What about if they did enter some reaction results for types and screens or DAT's? This I am really uncomfortable about. I've been asked to give my opinion on this by our LIS staff who are working with the small lab on the Beaker implementation. Something about the whole thing makes me a bit uneasy. For reference, the lab implementing Beaker is accredited by Joint Commission. Thanks for your input
Suzanne Butch: My thoughts are that Beaker can be used as a billing mechanism as well as a display of information. It is not doing any checking of results, it is simply passing along the conclusions. It does mean manual entry of data so there should be some mechanism to assure the data entered is correct.
tbostock: My two cents (we are going live with Epic, including Beaker, shortly). Correct, [Epic Beaker does] not have a 510K approved Blood Bank system. Their Blood Administration module for nursing is also not 510K approved, so the transfusion side will also have to remain on paper or be automated with an FDA approved module. Having a hospital wide electronic medical record and keeping Blood Bank manual (on paper) is not a good plan in my opinion. One of the most high risk procedures done to a patient should require the logic and QA checks that computers provide in order to prevent serious error. Transcription of data manually into another system is just asking for mistakes. I feel for you, because it is quite the expense to implement a stand alone Blood Bank LIS especially if you are a small hospital.
Here is what I take away from these comments:
- A blood bank medical technologist from a larger hospital, running a Sunquest LIS, has been asked to advise her local LIS support personnel about the deployment of the Beaker LIS Blood Bank module in an area smaller hospital. This individual vaguely understands that his/her hospital has an agreement with Epic and the smaller hospital but is unsure of the details or responsibilities. I will assume that this is one of the Epic hosting/consulting relationships described in my previous note.
- The discussion reveals that the Beaker Blood Bank and Blood Administration module to be deployed in the smaller hospital is not 510K approved (see: A Pathologist Describes His Firsthand Experience with a Demo of Epic's Beaker LIS; Details about Epic's Beaker LIS, Supplied by the Company). It is therefore recommended that the smaller hospital, after installing Beaker and its blood bank software, continue to use paper records for its blood bank and transfusion service. Alternatively, it is suggested that the smaller hospital could buy/install a FDA-approved blood bank and transfusion system and run it in in parallel with the Beaker LIS (see: Assessing the True Cost of Serving as a Beta Test Site for the Beaker LIS).
- In summary, we see a med tech in a larger hospital being asked to serve as a consultant to lab personnel in a smaller hospital without apparently understanding the underlying contractual obligations. It also appears to me that he/she is being asked to advise the lab personnel in the smaller hospital about the consequences of installing a non-510K blood bank module.
- Healthcare EMR vendors protect themselves with "hold harmless" contractual clauses (see: The Ethics of EHR Vendor). I am wondering if there is a similar clause in the contract when larger hospitals host the Epic EMR for smaller neighboring hospitals? I should add that such clauses have come under close scrutiny lately.