Autologous Recordkeeping Q & A



We were recently asked by a hospital if they really need to keep the pink copy of the Autologous Tissue Preservation form.

The question was:

The information form we fill out in the autologous kits are three pages.  The form states that the pink copy is to go to the Operating Room Nurse Coordinator.  Is there some mandate that I hold on to the pink forms? The Blood Bank controls all of the paperwork on these skull flaps and presently are sending the pink forms back to the OR not to send them and follow the instructions; I thought the Blood Banks was holding on to them.

Below is our response to them:

Thank you for contacting me about this. Most (like almost all) hospitals do not involve the blood bank in the release of the tissue from the operating room to California Transplant Services. Other blood banks just don’t want the responsibility. I actually think that the blood bank is a good gatekeeper for all tissue coming in and out of a hospital. That being said, our storage agreement is with the operating room.

The operating room is sending the tissue to us and our responsibility is to the operating room. We consider the blood bank as just the location for pick up.

I can not point specifically to a requirement that you keep the pink form, however I am pretty sure that Joint Commission has requirements for record keeping for the O.R. that do not release you from keeping the records just because the bone is sent to us through the blood bank.

At minimum hospitals should have a binder (labeled Autologous Tissue Storage Logbook), with an autologous tissue log sheet that is manually logged with the following information:

    1. Date of removal
    2. Patient name
    3. PF/Medical Record number
    4. initials and date of person completing the logbook
    5. Date of re-implant or disposal
    6. initials and date of person completing the log book when re-implanted
    7. A copy of the Autograft Tissue Preservation Service form 40-2000-1 (the pink copy)
    8. A copy of the patients face sheet

The Autograft Tissue Preservation Service form 40-2000-1 pink copy is your verification that the tissue is recovered and stored on a patient. When you want to know if there is a skull flap sent for storage all you need to do is look at the log book and the pink copy for verification.

We have designed the form with all of the relevant information that a regulatory agency may request.

There are several regulatory agencies that may show up un-announced and will want to see records for the tissue recovered and sent to us. These agencies include, California Department of Public Health Tissue Bank Licensing, US Food and Drug Administration, and the Joint Commission.

The log book helps in the federal requirement of tracking of tracking listed in 21 CFR 1271.290 (e) for documentation of final disposition of the tissue.

Recordkeeping requirements under 21 CFR 1271.270 (a) require you to maintain records concurrently with the performance of each step, accurately and indelible and legible. Therefore, the Autologous Tissue Preservation Service form 40-2000-1 must be completed along with your Operating Room Tissue Storage Log and you need to keep the pink copy in the binder with the log sheet.

Retention requirements 21 CFR 1271.270 (d) mandate that the records be kept for 10 years after the date of use or expiration.

Contracts and agreements 21 CFR 1271 (e) You must maintain the name and address and a list of the responsibilities of any establishment that performs a manufacturing step for you. This information must be available during an inspection conducted under 1271.400, We, California Transplant Services are performing the storage and distribution on your behalf and this is all outlined in your hospitals service contract with CTS.

As I mentioned on the phone, the blood bank is not the department that is removing the skull flaps from the patient, packaging and labeling them. This is an operating room function and therefore the log book must be maintained by the operating room. This is the standard of care in operating rooms.

If you don’t already have a logbook I have attached sample pages in MS Word that you can edit for your own log book, and a template for a binder cover and binder spine.

Call us if you have additional questions at 760-804-6890.