Tissue Management Using SoftBank Terri Bostock, Blood Bank Manager, ORMC Brenda Duff, Clinical Lab Technologist, ORMC

Reasons Blood Banks are Taking over Tissue Management Blood Banks are already set up for Tissue Management needs. Continuous temperature monitoring is available. Proficient in meeting stringent regulatory requirements. Currently possess necessary equipment for storage at different temperature ranges. Blood Banks are staffed 24/7 and have expertise with inventory management, tracking products, recalls, adverse events, etc.

Regulatory Agencies The regulatory agencies that are responsible for governing tissue compliance: FDA The Joint Commission AABB CAP AATB EBAA State Dept of Health

Regulatory Requirements Documentation of delivery temperature and package integrity Documentation of storage temperatures Documentation of recalls, adverse events, quarantine, etc. Disposition (implanted, returned to supplier, expired) Audit trail documentation of all personnel involved.

AABB Survey Article about Hospital Oversight of Tissues Changes in Hospital Human Tissue Oversight in the United States between 2005 and 2011: Results of a Follow-up of AABB Survey. Transfusion Vol 54, Issue 1, pp. 224-230, Jan 2014 Background: In 2005 the Joint Commission started to regulate tissues. This follow up survey looked at progress since then, surveying 1069 hospitals in 2011. Results: 336 total responses. The Department of Surgery had responsibility of tissue storage and distribution, followed by the Blood Bank. Since 2005, more Blood Banks have become responsible for more types of tissue and also for reporting adverse events. Cord blood and stem cell management were also increasing in the Blood Bank.

AABB Survey Article about Hospital Oversight of Tissues Conclusion: Blood Banks are more involved in the regulatory aspects of human tissue oversight and remain involved in many operational aspects of hospital tissue management.

Giddyup!!!! Soft Bank already has what we need to document tissues, we just have to learn what needs to be worked around and improved because the system was not designed with the intention of tissue tracking. THE BUILD!

Building the Tissue as a Blood Product To begin the build of tissues you need to first make main product codes. We used the following:…. (Next slide)

Main Product Codes EYE- Eye products SKN- Skin products CARD- Cardiac products MSK- Musculoskeletal products SEAL- Sealants

Building the Tissue as a Blood Product In Setup-Blood you build each tissue like a blood product. In order to keep them separate, we decided to give tissues codes that started with the letter Z. (describe the details of the build)

Building the Tissue as a Blood Product Source Codes will also need to be built. These will be the suppliers of the tissues.

Building the Tissue as a Blood Product Collected by is a field you have to fudge a little bit. For blood products we have the W codes with the ISBT labeling. Tissues do not have this yet so we built a generic “tissue collection facility center”

Be sure to build it in Lab too! Remember to build every tissue in lab. We are not billing through SOFT so we do not have a lot of information to fill out but it still needs to be done.

Building the Tissue as a Blood Product Don’t forget to do “Setup Check” to check for any missing elements in your build. Build in TEST area first, then LIVE. Keep screenshots of each tissue built, or capture on Camtasia, etc. Validate in TEST area thoroughly.

What’s next??? THE WORK FLOW…….

Delivery of Tissues We use batch delivery for all deliveries. Fill in the source, collection center (TISS) expire time, and temperature. F12 accept.

Duplicate lot numbers Apligraf is used very often and always comes with the same lot numbers. In order to enter them you have to choose option F8 and add a suffix letter. You would click OK and then F8 to add the suffix and move on to the next tissue.

Adding a suffix

Volume must be entered whether defaulted or not. Volume must be entered whether defaulted or not. We set all of our tissues to have a default of 1mL

“Blood Product Order” Our nursing staff is not currently ordering the tissues in EPIC therefore we have to go to New Add or Modify and add the product. Once Epic is set up for orders, they just have to map the order codes with the blood product codes for the tissues in the interface.

Select the Tissue After the tissue is ordered go to Inv. POS Select and select the tissue to the patient. You will get messages that the T&S isn’t completed on this specimen and ABO Rh is unknown but continue selecting the units.

Issue from Menu Select F7 Once the unit is selected you can go to Issue and issue the tissue using the F7 Menu Sel. key.

No ABO/RH testing  SOFT will tell you no ABO Rh testing has been completed do you want to Issue? Yes

Fill in the required fields Fill in the required fields to issue and F12 Accept

Tissue Issue You will then get an exception box because there was no T&S done. We just type in “TISSUE” and when the supervisor goes through the exceptions she knows that it was a tissue issue.

Supply Option Tissues can be built as a supply however, there are certain things that can not be documented as easily as if it were a blood product. Arrival Temperature Package integrity Recalls Quarantine Return to supplier *Much more flexibility to build them as blood products

SOFTBANK Limitations The most recent version of Bank allows 16 characters for the product number. We currently need as many as 21. Tissues are not yet mandated to be ISBT labeled. This means typing in unit numbers twice if HOSPARAMS are set that way. Exceptions when they are set up as blood products because of not having a blood type on file. In some ways setting tissues up as supplies like RhIg would be better but the documentation would not be as detailed.

Limitations cont’d Some tissues have the same lot number for MANY different tissues which leads you to have to add a suffix. We have even gone through the entire alphabet and had to add A to the lot number and THEN a suffix on top of that. ISBT labeling will correct this. Temperatures can be acceptable at >-99C soft will only allow -99C or warmer due to character limits. SoftBank requires a temperature range, some tissues only say “ambient”. Have to default a volume of 1mL for all tissues.

QUESTIONS