JCAHO Tissue Standards

[bbbirder]

With the new JCAHO standards for tissues, our surgery department is having a difficult time tracking all of the tissues used, other than by a manual method.

Our present plan is for ALL of these (including the room temperature storage ones) to come to BB and we will use our computer system to track them as a blood product. This is not a great solution, as it takes more time for us and the surgery staff, but is the only way we have come up with to assure the tracking will meet the standards.

Does anyone else have a better system within their facility? I am interested in computer programs that can be used by the OR staff (hopefully something that can interface with our Meditech computer system)

Thanks,

Linda Frederick

[John C. Staley]

Linda, why not make it simple. Let OR use a simple computer spread sheet like excel and set it up with columns for all the required info. An other option would be a data base like access that could have a simple form developed with reports and queries if needed. (No I'm not a real microsoft fan they are just what I'm familiar with.) Why would you need it to interface with your Meditech computer system? All they need to be able to do is to track it. It would take a little effort on their part to keep the info up to date but there is no reason you need to get drug into their problems.

[Lcsmrz]

I think it depends on what kind of volume you're encountering. A manual system works well up to a certain point, then computerization is almost a necessity. Many places use the BB computer system, since it's already validated and set up to track things easily. It would introduce yet another task for the BB staff, though.

I haven't done tissues for years, but I suspect that the testing, tracking and tracing requirements apply to them, just like blood products. Using a spreadsheet for anything other than an automated clerk would introduce control functions that would make the system subject to the dreaded validation.

[Cliff]

Our institution has a bone / heart valve bank, and had a separate tissue bank on a burn floor. Both of those areas had repeated concerns with JCAHO surveys. It's more than just tracking, it's also a storage issue. Both places had fridges, freezers and room temp storage.

The easiest solution for the institution was to move the tissue from the burn floor into the blood bank, the volume is rather small. The bone bank in the OR is not staffed all of the time and there is a log book that nursing is "supposed" to use to track products. It's a lot of work for the bone staff to try and reconcile the products each month. The institution approved a significant amount of money to install a medication cabinet (http://www.omnicell.com/solutions/medication_use_process/medication_dispensing_systems/medication_cabinets/unit_dose_center.asp) to assist in tracking the products. We are waiting for an upgrade to our pharmacy server to install it. It will attach directly to the hospital IS system.

[matt]

My name is Matthew Judd.

I have for the last two years worked to help facilities with Policy and Procedure as well as compliance issues for human allograft. I am not a sales rep, just interested in helping with the knowledge and products needed to have a compliant environment in our OR's, Blood Banks, and Risk Management Departments.

As of July 1, 2005 the new JCAHO requirements are indeed difficult to meet using a manual tissue tracking method. The solution is the available and easily attainable. Through computerized tracking, I know of the system which allows you to not only track your allograft through final disposition, which is needed for your facility to be compliant, but also has the ability to assign a unique identifier for tissues that have only a donor specific lot identification number. Dbm and Dbx puttys and pastes fall into this catagory for example.

Please feel free to contact me anytime for more information regarding solutions for your allograft storage, transportation, and usage questions.

I have worked closely with facilities from all over the southeastern US in helping them to confront compliance issues. No type 1's have been issued to any facilities following the implementation of my proposed suggestions for compliance.

Please feel free to contact me at any time for consultation or information regarding this matter.

Matthew Judd

C.E.O. / President

(205) 266-7402

I will be in Cincinnati, Ohio the week of the 29th. Please call to set up a meeting.

[Geriann]

Hi Matthew,

Our trasfusion service has applied for a california tissue licence. We are now responsible for tissue since our last JACO inspection. So far my department is responsible for storage of Frozen Tissue both allogeneic and autologous bone flap. Problems encountered so far:

1. Heart valves must be kept at temps lower than our -70 C freezer....the OR therefore orders them and does not open the containers....return to vendor if not implanted.....I found this out by accident.

2. Tissues that we do store---how long can the tissue be out of the transfusion service and still returned to storage. We send the tissue out in an Igloo or the original container with gel packs frozen at -70 C. With blood if it is greater than 10 C it cannot be put back into inventory....what are the regulations on tissue? At what temperature can I accept the tissue back? How do I know if the tissue was out of the container too long....are there hemotemp monitors that measure temps this low?

The manufacture is of no help....all they say is that they will not accept tissue back if the original container has been opened.

3. A refrigerated tissue showed up in my blood bank refrigerator the other day.....rather have it there than in the or frig....but do we need to amend our tissue licence?

I only have inventory control over the tissues that we freeze at -70 C and now 1 refrigerated tissue.....how do I monitor the ambient temp tissue and refrigerated tissue pastes etc. that the OR is still incontrol of????

Please help!!!!!!!!!!!!!!!!!!

Thanks,

Geri Ann

[bbbirder]

Geri,

This is why we took over all the tissues from surgery. If we had to do it over again, I am not sure we'd do it the same way.

They told me they had 5-6 kinds of room temp products and 2-3 kinds of refrigerated products. It turned out to be more like 20-30 different kinds.

For their room temp storage, you could suggest they buy one of those inexpensive temp monitors that download to a PC. For their refrigerated storage, same thing... make sure they have a monitored refrigerator.

That still does not solve all of the problems of tracing everything that JCAHO wants (receipt, issue, etc.)

Now that we have everything in place, it works well for us, but it was a difficult transition. One of the surgery nurses took photos of all of the packages and boxes and put this into a notebook, with information about where they are stored in the BB (refrig, RT, etc.). When the surgical tech comes down to pick it up, they bring the sheet out of the notebook and we, or they, find it quickly. (Then there are the times when the surgeon orders something directly and a sales rep shows up with something to implant...).

Good luck!

Linda Frederick

[gwendamckee]

There are a number of commercial tissue tracking computer programs available on the market. Currently, our Blood Bank uses the Cerner Millennium system to track tissue - but our hospital system is looking at a commercial program for surgery to use.

[Mabel Adams]

Anyone know the names of these computer systems for tissues? We have similar problems as everyone else is mentioning.

[Franklyn]

I have been looking at tissue systems for the last two years (long story) the industry is VERY new but the major products currently available are (I cannot remember the name of one of them, sorry):

Tracks4Life

Tissue Track Core

Rosebud

QSight (Owens and minor)

And Mediware has one too.

Just Google the names to find the websites. I have been looking at these to build a tissue services lab in the current blood bank and it was recently complicated by desire to pull other implanatables into the mix (artificial knees, screws, pins, breast implants, etc). It has become very complicated very quickly and the system that will best work for you depends on your scale and scope. Make certain to ask a lot of questions and ask for what "other facilities" they had done (fill in the blank) at. Many of the vendors will tell you their system can "interface with..." but on detailed inquiry you learn that they are certain they can do that but haven't had the opportunity yet.

[jhaig]

I have heard of many blood banks now taking over their institution's tissue departments. Our O.R. and Medical VP has suggested moving the tissues into our blood bank. Is this part of a national trend? Is it because they (whoever THEY are) think the blood bank will do a better job keeping up with regulations, especially since we are used to keeping up with all of the various regulatory agencies? Maybe I've been out of the loop on this one, but the blood bank does seems like a good place to handle tissues (job security:cool:)

[gwendamckee]

So Far I know of three commercial tissue tracking programs

IMS - ReadyTracker Tissus - www.imsready.com

Tissue TrackCore (LPiT Solutions) = www.TissueTrackCore.com

Tracs4life (Biomedical Synergies)

[skopti]

We are on Cerner Millennium, and we treat tissue just like blood products and are able to track them in the system.

[bbville]

Earlier this year we started entering tissues into inventory in the Lab LIS (Sunquest). OR is still responsible for all aspects of the process, but I could help with the entering, assigning and issuing in the computer if needed. There are 2 people from OR who were trained with limited functions in Sunquest and I and our LIS person developed the system with them. I get calls occasonially, but it seems to be working OK and it was a no cost solution to a cumbersome manual procedure. Our AABB assessor did ask about the process and would have liked to visit the OR, but due to time constraints could not. She reccommended I do my own internal inspeciton, which I will.

[Franklyn]

The new "Tissue Management" regs apply the same sort of inventory management requirements blood banks have lived with for years, to tissue products. As there is no testing, it is just inventory management with receipt to death tracking that includes inspections at key points, Manufacturer, Lot#, Exp date tracking, etc. It doesn't need an MT to do it, but the blood banks expertise is an (almost) exact fit.

There are so many players using tissue, however, that developing a model that fits you institution is the real trick...

[bxcall1]

I realize this is an old subject but I just joined this forum this week.

We have been tracking tissues for several years now. What I did was to create product names in Meditech and treat the tissue products as blood products as far as tracking and disposition. The refrigerated products are in one of the BB refrigerators. The frozen products are in my -80 freezer. FYI - at temps <-40 frozen products are good until the expiration date of the p[ackeged product. If >-40 they are good for only 6 months.

The room temp products are stored in 3 different locations in surgery. The temps for each location are monitored using a wireless temperature sensor system. Upon receipt of each product we assign a unique 'donor number'. The products that are stored in OR also get a Tissue request form attached to the product. After the product is used the tissue request form is returned to Blodd Bank/Tissue Bank and we assign the product and issue it to the recipient.

Since we have a California tissue bank license as well as a JCAHO assessment this Feb. I wrote/compiled a Tissue Bank Manual that covers all of the policies and procedures associated with tissues. I had input from OR staff as well, since this manual also covers tissue prep in the OR.

[rfm]

With the new JCAHO standards for tissues, our surgery department is having a difficult time tracking all of the tissues used, other than by a manual method.

Our present plan is for ALL of these (including the room temperature storage ones) to come to BB and we will use our computer system to track them as a blood product. This is not a great solution, as it takes more time for us and the surgery staff, but is the only way we have come up with to assure the tracking will meet the standards.

Does anyone else have a better system within their facility? I am interested in computer programs that can be used by the OR staff (hopefully something that can interface with our Meditech computer system)

Thanks,

Linda Frederick

I would suggest checking out LPiT's website for tissue track core, a web based tissue tracking service that is very inexpensive and using a bar code hand held scanner, can read any tissue source's bar code, track in coming and outgoing tissues, fully in compliance with Joint Commission. MTF will even help fund in many cases. email me at Robert_mayes@mtf.org

[rfm]

With the new JCAHO standards for tissues, our surgery department is having a difficult time tracking all of the tissues used, other than by a manual method.

Our present plan is for ALL of these (including the room temperature storage ones) to come to BB and we will use our computer system to track them as a blood product. This is not a great solution, as it takes more time for us and the surgery staff, but is the only way we have come up with to assure the tracking will meet the standards.

Does anyone else have a better system within their facility? I am interested in computer programs that can be used by the OR staff (hopefully something that can interface with our Meditech computer system)

Thanks,

Linda Frederick

Linda, try LPIT's website as they have a tissue tracking system bob Mayes 440 781 4234