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Store Info:

Address
Truckee Meadows Community Tissue Bank 6110 Plumas Street Ste B Reno, NV 89519
Operating Hours
We are open twenty four hours a day, seven day week, three hundred & sixty five days a year! Speed and convenience is a top priority with us which is why no matter what time of day you call, you'll talk to a representative immediately. No voicemail here!
Fax
775.829.9330
Phone Number
775.750.2994
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Guidelines for Storage, Usage and Tracking of Allograft Tissue

Based on JCAHO Standards, the FDA Current Good Tissue Practices (cGTP) Regulation, and AORN’s Recommended Practices for Surgical Tissue Banking General

  • Hospitals will formulate policies on the overnight of the tissue program throughout the organization including tissue ordering, receipt, storage, issuance and record keeping activities.
  • Documentation of each grafts implantation, including the unique graft identification number, will be placed in the applicable patient’s medical record.
  • Hospitals will promptly report to the tissue provider the final disposition (whether implanted, discarded, or expired) of each graft.
  • Hospital records relating to the final disposition of tissue grafts will be maintained a minimum of ten years beyond the date of distribution, transplantation, other disposition, or expiration (which ever is latest), or longer if required by state and/or federal laws.
  • Tissue grafts will be handled, stored, and transported within the hospital according to the tissue provider’s written directions.
  • Hospitals will validate that tissue providers who supply grafts are licensed by state agencies and/or registered as a tissue establishment with the Food and Drug Administration (FDA).
Documentation:
  • Document in the hospital allograft tracking log, the tissue source facility, the unique numeric or alphanumeric identity of each graft, a description of the tissue, the expiration date of the tissue, the date of the receipt of the tissue, the name of the person receiving and inspecting the tissue, a statement that the tissue and its packaging passed inspection and were received at the proper temperature.
  • Document in the tissue recipient’s operative report the name of the person who received the tissue in the operating suite, the names of all involved in preparing the tissue and the date and times of these activities.
  • Document the materials used in the preparation with lot numbers where appropriate.
  • Document 24/7 the temperature of graft storage appliances.
  • Document daily the temperature of the storage area for freeze dried grafts.

Record Retention:

  • Retain for a minimum of 10 years past the date of distribution, implantation, expiration or other final disposition (or as required by state and/or federal laws) all records relating to the receipt, usage and traceability of allograft.
  • Retain for a minimum of 10 years (or as required by sate and or federal laws) allograft records relating to storage and temperature control as well as any superseded policy and procedure manuals and hospital publications relating to allograft tissues.

Storage Requirements

General:

  • Inspect grafts on receipt and document that labels and packaging have remained intact.
  • Document that grafts have arrived in the proper temperature range. (Frozen grafts should arrive with dry ice still in the transport container. Frozen grafts shipped from TMCTB must be implanted or transferred to a freezer within 24 hours of receipt.)
  • Store Grafts at proper temperatures.
  • Maintain grafts under controlled access.
  • Document that graft storage appliances are never used for the storage of food or liquids for human consumption.
  • Rotate graft inventory and use in order of expiration dates.
  • Produce daily records to show proper temperatures have been maintained for all grafts. Freeze-dried grafts
  • Record storage temperature daily even on grafts kept at ambient room temperature.

Frozen grafts:

  • Produce daily records to show that frozen grafts are stored at -40 C or colder.
  • Frozen grafts temporarily removed from freezers must be held or transported in a storage container validated to maintain proper temperature unless the graft is being thawed for immediate implantation.
  • Storage freezers must have continuous temperature recorders and systematic alarms to alert designated staff if grafts stray from acceptable temperatures.
  • An emergency notification system must be in place 24/7.
  • A loss of refrigeration plan must be in hospital protocols.

Adverse Events:

  • Hospitals must establish a defined process to investigate recipient adverse events including disease transmission or other complications suspected of being directly related to diseases.
  • Cases of post-transplant infections or adverse events must be promptly reported to the tissue supplier.
  • Procedures must be in place for identifying and informing recipients of infection risk if donor tissue is found to harbor infectious diseases subsequent to implantation.

Sharing Grafts with Other Hospitals:

     The Food & Drug Administration (FDA) has clearly stated that hospitals that send grafts to other facilities (even those with their same hospital system) will no longer be exempt from FDA regulations. As of May 25, 2005, if a hospital transfers a graft to another hospital, the transferring facility will be considered a tissue “distributor” and, therefore, will be required to register as such with the FDA. The hospital then will be expected to comply with all federal regulations relating to human tissue and cellular based products.