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Storage of autologous bone flaps Locked Topic 0 A. Kerstner ORIGINALLY POSTED 07-19-2001 Should blood banks store autologous bone flaps in their freezer? ADDENDA July 22, Aug. 1 & Dec. 17, 2001; Oct. 9 & 13, 2006 ·         A blood banker in Colorado asked if it was acceptable practice for a hospital to store bone flaps in the blood banks -80C freezer for extended periods of time.  The flaps are portions of skull bone removed to perform surgical procedures in the brain and, as such, are autologous; these flaps are intended for re-implantation in the skull after a few weeks, but some flaps are never re-implanted.  The hospital's risk management requests that the blood bank draft a policy for entering the autologous bone flaps into their computer database and to 're-issue' them as they would a unit of blood. The hospital risk management feels that surgery has not had adequate procedures for labeling, storage and returning these grafts to the patient.  They reasoned that, since the blood bank has all the appropriate systems in place, they would be the logical place to ensure proper storage and handling, especially since this procedure would occur only a few times a year.  The inquiring blood banker asked the e-network for a discussion as to what should be mandated in terms of proper storage containers, labeling, storage conditions, etc., and what sort of regulatory pitfalls should not be overlooked.   Her facility is registered with the FDA for blood products, but not to store/dispense bone or tissue. ·         ADDENDUM Dec. 17, 2001: According to the AABB (AABB Pulse Points 499), the AABB's Food and Drug Administration (FDA) Liaison Committee met on Nov. 30, 2001. At that meeting Ruth Solomon of the FDA discussed the registration of tissue facilities; she stating that as of the date of the meeting, 401 facilities had registered, increasing the inventory of registered facilities by 200 since the new rule went into effect. A list of all registered facilities is available for view. In response to an inquiry about whether FDA has a way to identify facilities that should be registered, but have not, the FDA has been advised by competing tissue establishments when a facility has failed to register. FDA also can compare the list of facilities in the FDA's ORA database against the registration database, and compare the American Association of Tissue Banks (AATB) and the Eye Bank Association (EBA) membership lists to determine if every facility that should have registered with the FDA has actually registered. Solomon indicated that FDA will accept voluntary registration of cord blood and progenitor cell collection sites even though those facilities are not currently required to register. Forty-four of these facilities have already voluntarily registered. Elaine Cole outlined the FDA priority for inspections of registered tissue facilities: ·         Last inspection had a violation ·         Complaints received ·         Stand-alone testing establishments ·         Never had an inspection - first those non-accredited and then accredited ·         Previous inspection had no problems ·         She also noted that of 132 facilities that have been inspected, 4 1/2 percent were classified as Official Action Indicated. Solomon also explained that, as noted in the Unified Agenda published in the Federal Register, the FDA expects to finalize the tissue GTP and donor suitability regulations by January 2003. FDA is currently reviewing the comments that were received to the proposed rules. The final rule is expected to require tracing of each tissue product back to the recipient. No decision has been made about adopting Product Standards as opposed to requiring the use of an IND. Data have been submitted in support of establishing Standards and it is quite likely that some facilities may receive licensure by certification to Standards. Any decision will be announced in the Federal Register. ·         There were several responses to the above question, and here is a sampling: ·         A hospital in Detroit accepts bone flaps from surgery, enters them into their inventory, and then issues them as they would any other tissue or blood product.  They have a memorandum of agreement with surgery that the bone is accepted "as is," no additional testing or manipulation occurs in the Blood Bank, and that surgery is responsible for ensuring that the bone was properly handled and wrapped for storage.  The above procedure rarely happens.  However, the blood bank seems to be involved in keeping track of these pieces of tissue, as many months can pass after which the blood bank must contact the surgeon to remind them if a bone flap is still in the inventory, and that it is time to discard the bone.  If the patient is deceased, the bone is discarded.  If the patient is alive, the surgeon is contacted to obtain permission to discard the bone. Most of the bone flaps are discarded, few are used. ·         Editor's NOTE: The individual providing this first response did not indicate if the hospital's tissue banking practice had been inspected by JCAHO; please see comments in responses #2 and #3. ·         An institution in Boston has a separate bone bank that is directed by operating room personnel. However, the hospital's blood bank works closely with this bone bank, to ensure regulatory compliance, including compliance with JCAHO standards. The Boston hospital is of the understanding that FDA does NOT regulate autologous bone or tissue at this time, so long as that bone or tissue is not distributed outside of the hospital in which it was harvested. (If any FDA e-network member knows this statement to be false, please speak up!) The reporting member commented that even if FDA does not regulate autologous bone and tissue, one still MUST comply with JCAHO standards. The JCAHO Standards that apply are QC 5.11, QC 5.11.1 and QC 5.11.2 (all found in the Blood Bank section of CAMPCLS) address the log in, storage, traceability and ability to investigate adverse reaction of tissue. These are the issues that hospital risk management tends to be concerned about. In the reporting member's opinion, the blood bank is in the best position to transfer their knowledge of product management to the storage of bone flaps (or other tissues). At the Boston hospital, autologous bone flaps have the patients name and medical record number attached to the outside of the plastic wrapping that protects the bone. The flaps are logged on to a log sheet with this same information and inspection criteria defined in the SOP are applied. A corresponding practice exists for the dispensing of this flap to the donor/patient. They have SOPs for all of these practices including as trivial as how to maintain the freezer these products are stored in. They operate similar to a mini blood bank. Their bone bank also manages cadaver bone. In the Boston hospital the bone bank staff inquire about a year after acquisition of the autologous bone flap if it will be needed and request written permission from the patient’s physician to discard the product. If it hasn't been used by then, it's not likely it will be, in fact it's likely the patient has expired. ·         An e-network member in Los Angeles also mention that the e-Network Forum should be aware of the JCAHO Standards for Clinical Laboratories that apply to tissue banking. These are the JCAHO Standards that apply: ·         QC 5.11 The organization uses standardized procedures to acquire, log in and store (emphasis added) tissue.  The intent of QC 5.11 is that the organization: ·         Assigns responsibility for handling the tissue program ·         Coordinates ordering and storage (emphasis added) throughout the facility ·         Conforms transportation and storage to the source facilities' written directions; ·         Logs all incoming tissue; and ·         Has temperature monitoring for storage refrigerators and freezers, alarms, and emergency back-up as required. ·         Main types of storage used are room temperature, deep freezing colder than -60C, and liquid nitrogen. ·         QC 5.11.1 the organization's record keeping permits the traceability of all tissues.  The intent of QC 5.11.1 is that the organizations' records: ·         Permit tracing of any tissue from the donor or source facility to all recipients or other final dispositions; ·         Identify the staff involved in preparation or issue of tissue, who accepts the tissue, and the dates involved; ·         Include documentation of tissue use in the patient's clinical record; ·         Include storage temperatures, control testing, and all superseded procedures, manuals and publication, and are retained for a minimum of 5 years, or as required by applicable state and federal laws; and ·         Document the source facility, the original numeric or alphanumeric donor and lot identification, and all recipients or other final dispositions of each tissue.  These documents are retained indefinitely. ·         The member who submitted reply #3 mentioned that he does "pre-surveys" for clinical laboratories to help them prepare for CAP, CLIA and the JCAHO. It is his opinion that the above JCAHO standards apply to ANY tissue that is in the hospital (including autologous) that will or may be used for patients at a later date. Questions that the responding member would ask in his surveyor role include: (1) how do you know this tissue belongs to the patient, (2) how do you know the tissue is sterile, (3) how do you assure the quality of the tissue (i.e., it is not degraded due to storage). Since there are established standards for storage of tissue (bone and skin), this member would expect that the hospital's policies and procedures for storage would be at least as rigorous as those proposed by JCAHO standards. ·         [Editor's Note: The issue of bio burden-type testing of autologous tissue does not seem to be addressed directly by JCAHO, based on the information in reply #2 or #3, but may be important just the same.  It would be nice if one of the e-Network members who work for JCAHO could comment on this point.] ·         A representative of the California Department of Health and Human Services commented (in response to a related autologous tissue question) that there is no California law prohibiting the storage of autologous bone flaps. Bone flaps (or parathyroid tissue for that matter) may be stored, provided that the tissue type is disclosed in an existing license (you must have a license to collect, store and dispense tissues in California).  To add bone flaps to a hospital's inventory would require the review of any additional policies and procedures that are needed to properly handle a new tissue type, and the hospital's tissue license would need to be modified and approved by the state. The reporting member cautioned that to take on a new tissue type might require extensive processing and bio burden-type testing. ·         Editor's NOTE: For specific questions about all sorts of tissues and their proper storage requirements, a fantastic resource is Mr. Clint Venable, at the California Department of Health Services.  Mr. Venable (in the EDITOR's opinion) is the tissue bank guru for California. ·         A blood banker in Michigan, who used to work at a state hospital in New York State, says that her previous facility stored bone flaps, mostly for neurosurgical patients. It was a better and cheaper alternative then having prosthetics made for these patients.  It was not necessary to freeze these flaps. They could be processed, sterilized and stored at room temperature.  The responding member would suggest contacting the State University of New York at Syracuse, Neurosurgery Dept. for details.  According to the member, the storage of bone flaps can be done through a centralized facility and need not involve the blood bank at all ·         A blood banker in Texas reports that they used to store bone flaps, but that some of the bone in their freezer was more than 3 years old. Finally, it was decided that OR would get their own ultra-low temperature freezer for the bone, and that the labeling or lack thereof would be handled as a separate issue from blood bank.  The responding member is not sure that the "problem" is fixed but at least the blood bank does not need a license to store and dispense bone and tissue. ·         Editor's Note: Does it really make sense for the blood bank to be 'off the hook' when the entire institution is at risk of non-compliance? ·         A blood banker in Seattle commented that it is certainly acceptable for the blood bank to store bone flaps.  It does, however, make them a tissue bank as defined by FDA, and if they distribute the tissue outside of their facility, they would need to register as a tissue bank and follow regulations that apply to tissue banking. (Again, FDA readers, please let us know if this is correct!) Right now, that only includes the "Human Tissue Intended for Transplantation; Final Rule" and the "Human Cells, Tissues, and Cellular and Tissue Based Products; Establishment Registration and Listing; Final Rule". These can be found on the FDA web site. They should use AATB Standards and the FDA proposed rules (Donor Suitability and GTPs) as guidelines for handling, packaging, storage and labeling.  If that were all they planned to do, it would be a simple addition to their blood banking operations. It makes sense for the flaps to be stored at the hospital rather than at a remote tissue bank site, although some places do that to avoid having to deal with regulations.  They need to set some time limitation on the storage period and have an adequate consent and release for discard of the flaps if not used after a certain period of time. The replying blood banker's experience is that flaps can be forgotten and will be a problem to maintain if limitations are placed on their storage. Consent from the donor may not be possible in many instances and the consent could be signed by the legal next of kin who is consenting to surgery. ·         A hospital in Ann Arbor reports that they store bone flaps in a "quarantine area" on a special shelf in their reagent freezer. These tissues are not stored with tested tissues. The autologous bone flaps are given a three-month outdate, and they are reserved in the computer for the specific patient. They have not had a problem, even at their most recent FDA inspection. They have written policies and procedures that describe this process. ADDENDA July 22, 2001 ·         A blood banker from the Midwest reported that a new doctor Cooling recently came on staff at her facility from SUNY (Syracuse University),  This new doctor indicates that if you autoclave the cranial bone flaps they can be stored at room temperature. It is suggested that anyone interested in this protocol should contact SUNY. ·         (Editor's NOTE: I have not checked out this recommendation, so I can neither endorse it nor oppose it, but it does sound intriguing). ·         A blood banker in Los Angeles commented that her hospital's neurosurgeons have been asking the blood bank to provide autologous skull flap storage for some time.  The main concern has been the need to control the harvesting, labeling, packaging, sterility & testing of the product.  The blood bank does not want to end up with a freezer full of skull flaps that will not be used.   They have found an external tissue bank that will accept the skull flaps, test and process them, and then return them to the blood bank for storage.  This service comes with a fee of about $400.00 per bone flap.  The responding member's blood bank is in the process of reviewing the external tissue bank's SOP's and working with their OR Nurse Manager to develop an SOP for harvesting, labeling, packaging, and sending the skull flaps to the external Tissue Bank.  They are hoping that the product will be shipped directly from the harvesting OR, and that they will only be involved in the receipt and storage of already processed tissue.  (The responding member said that they do not relish the position of having to enforce labeling and packaging policies, and requirements for blood specimens for viral marker testing.) ·         A tissue banker in New York wanted the e-Network Forum to know that you must first determine whether your State department of health regulates tissue products and comply with those regulations. New York State regulates autologous tissue.  The FDA Tissue Bank regulations are not covering this area at this time.  Blood Bank labeling and storage policies should cover all QA aspects of this storage. Most auto grafts are not serologically screened but your Director may desire to do that. At the responding member's institution, they do not screen their bone flaps, but label them appropriately with a warning and indicating Autologous Use Only. They store their tissue separate from any allogeneic tissue. Stringent discard policies are in effect requiring written physician notification for discard. As a Tissue Banker for > 10 years, autologous tissue has been her only Law suit. If mishandled or discarded inappropriately, patients have a great law suit. ·         One member submitted a mock tissue banking SOP. ADDENDA Aug. 1, 2001 ·         A member was quite concerned that some hospitals might actually use autoclaved bone flaps for patient care, as suggested in response #5. According to the concerned member, the use of autoclaved bone is a poor clinical practice, because the high temperatures and pressures reached during autoclaving destroys the osteoconductive and inductive properties of bone, not to mention the mechanical properties.   This same member was also concerned about using a tissue bank 'outside' a hospital for processing auto grafts, since if tissue is stored outside the facility and transferred, presumably testing requirements would then apply and a full virology battery would need to be conducted as is the case with autologous blood (although impacted e-network members might wish to verify this point).  The responding member suggests that autologous tissue storage by a tissue bank or someone other than the hospital requires registration and listing with the FDA.  A hospital may handle auto grafts internally, without registering with FDA (for now).   But, such a hospital must not do anything other than store the tissue for the same patient and must have good record keeping or problems are inevitable. This is addressed in comments from the FDA on “Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing." The concerned member suggested that the e-network forum examine the Federal Register: January 19, 2001 (Volume 66, Number 13) specifically the following statement by the FDA on registration of tissue banks.  Here is the text that the member wants the network to read: ·         (Comment 33).  "We received one comment on the proposed exception in Sec. 1271.20 (b) for establishments that remove human cells or tissues from an individual and implant such cells or tissues into the same individual during the same surgical procedure. The comment assumed that hospitals retaining autologous tissue, not used in a scheduled surgical procedure, to be used in a subsequent application on the same patient, are exempt from registration and listing because the two applications are essentially a single continuous procedure.  We agree that, so long as the hospital does not engage in any other activity encompassed with in the definition of 'manufacture,' the hospital would not be required to register or comply with the other provisions to be codified in part 1271. For example, if the hospital expanded the cells or tissues, it would not meet the terms of the exception. In reaching this conclusion, we note that hospitals that store autologous cells or tissues for subsequent application in the same patient must follow the guidelines of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for tissue storage, monitoring of storage devices, and tracking in order to obtain or maintain accreditation." ·         Finally, the chair of the Standards committee for the American Association of Tissue Banks, (AATB) graciously provided a response regarding the storage of surgically obtained bone flaps.  According to the chairperson, hospitals that have a program to harvest, store and re-implant AUTOgraft tissues should at least be familiar with the AATB tissue standards.  If an AUTOgraft might be used for any other patient than the individual from which it was obtained (i.e., become an ALLOgraft), the Blood Bank would be well advised to contact the FDA, to determine if registration as a tissue bank is necessary. If a hospital collects its ALLOgraft tissues for use within the hospital, it would be worth considering AATB membership.  At a minimum, hospitals that collect AUTOgraft and/or ALLOgraft tissue for their own use should obtain a copy of the most recent AATB tissue standards.  The AATB chairperson cautions the e-network forum membership to be aware of the risks and ramifications of handling a new tissue.  If the blood bank stores these items for surgeons, the blood bank needs a set of SOPs. Such SOPs need to address proper labeling of tissues obtained in the OR, training of OR and blood bank staff, transport of tissue to Blood Bank, quarantine of the tissue (it cannot be mixed with processed products), inventory maintenance and reissue.  Storage containers should be able to handle the ultra-low temperatures. Each of these areas is discussed in detail in the AATB standards and this would be a logical starting point to create their SOPs.  As specific questions arise, the AATB can act as a helpful resource.  Address questions to: [email protected] or [email protected] There are several members of AATB who run both Tissue Banks and Blood Centers who would also be happy to address questions concerning auto grafts stored in hospital blood banks. ·         FDA response to query on this subject by the AATB office: ·         "We generally allow storage of tissues in blood bank facilities, as long as they are somehow separated from the blood.  If the flap is for autologous use and no other manipulations are done to the tissue such as adding cryopreservation fluids, then the exemption under 1271.15b. Applies and they don't register. You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P's from an individual and implants such HCT/P's into the same individual during the same surgical procedure. We have interpreted same surgical procedure in comment 33 of the preamble to the rule as a scheduled subsequent application.  If the flap is for allogeneic use - then registration/listing is required as well as adherence to the 21 CFR Part 1270 and 1271 requirements - and yes they would be subject to inspection as a tissue establishment - they should fill in form 3356 and indicate their blood registration number." ·         A member who directs a busy community hospital laboratory wanted to tell the network that his blood bank used to perform this service for surgery, but there were significant problems related to the inventory leaving the blood bank to surgery. While in surgery, they had no idea of temperature control, and the orthopedists would actually have new grafts delivered for their cases, so sometimes the blood bank would get more tissue back than what they sent out!  The blood bank was never told what was old and what was new. This lab director felt that the total lack of oversight while in surgery precluded their responsible handling of this storage function. They felt that the individuals who would be handling and shuffling the inventory needed to be responsible for it entirely, so the function went back to the OR. The member did not comment on how well the OR was performing the bone banking function now that it was their responsibility. ADDENDA Oct. 9, 2006 ·         An Infection Control Coordinator at a hospital in the Northern USA reports that for the first time in anyone's memory during a neurosurgical re-implantation procedure, an autologous cranial bone flap (about 2 x 2 inches in dimension) was dropped on the floor in the operating room (OR). Normally, such a bone flap is stored in a sterile plastic container at less than 0 degrees Fahrenheit in a freezer that is located in the OR. The bone flap is usually re-implanted within a few months. The inquiring Infection Control Coordinator wonders if there is any guidance on what should be done to clean/disinfect the dropped flap for safe use for the patient? She acknowledges that her hospital is also interested to know if others feel that they need to be more formal about logging and tracking the autologous bone flaps. They are also considering storing the bone flaps in a "double" sterile container (one inside another) at -80 degree Fahrenheit in a blood bank freezer. No testing or attempt at processing bone flaps is done at the present time, except perhaps for an initial cleansing in sterile water in the OR. ADDENDA Oct. 13, 2006 ·         Dr. Judith E. Woll, Clinical Professor of Pathology and Internal Medicine at Wright State University School of Medicine and CEO of Community Blood Center/Community Tissue Services in Dayton, Ohio (attribution used with permission) addresses maintenance of autologous tissue and management of a dropped flap. According to Dr. Woll: "The American Association of Tissue Banks Standards (www.aatb.org) has detailed requirements for proper management of autologous tissue. In summary, AATB allows bone tissue, if stored for six months or less, to be kept at minus 20° C to minus 40° C. If longer storage is required, then the temperature requirement is minus 40° C or colder. Bone tissue can be kept for no longer than 5 days from recovery at refrigerated temperatures between 1-10° C. At the time of recovery, the flap should be cultured and placed in a sterile container. The tissue should be individually and aseptically wrapped in a manner to prevent contamination of the contents, and allow for aseptic delivery of the specimen for storage and/or reimplantation. The receptacle shall be labeled immediately with the donor's name, age, sex, hospital medical record number and/or SSN, and institution name. It should also be prominently labeled 'FOR AUTOLOGOUS USE ONLY'. Retrieval records shall include: name and address of the institution in which the autograft was retrieved, date and time the autograft was collected, name of the physician recovering the autograft, donor name, age, sex, hospital medical record number/or SSN, and type of tissue recovered. A log should be kept that establishes complete tracking of the graft and storage situations. The graft should be kept in a quarantined setting in a freezer that is continuously monitored. There are also JCAHO requirements for handling of tissue grafts in the hospital setting. A similar discussion is on the AORN website and in the September/October AABB News."   ·         As far as methods of disinfection for a skull flap, Dr. Woll offers several options. "Tissue banks frequently gamma irradiate potentially contaminated grafts at 15-25 kGy (1.5-2.5 MRads). This usually takes several days lead time before implantation. The hospital may have other methods to disinfect the grafts as well."   ·         Finally, Dr. Woll concludes saying that "If your local tissue bank does not have an autologous tissue program, Community Tissue Services™ would be happy to help."
by A. Kerstner
Wednesday, March 8, 2017
Management and Compliance Locked Topic 0 A. Kerstner ORIGINALLY POSTED 08-04-2006   Management and ensuring compliance of "tissue banking/tissue dispensing services"   A transfusion medicine physician from New England asks how the different aspects of tissue banking is coordinated. In her facility, there are three separate "tissue banks"/"tissue dispensing services": 1) the Blood Bank, responsible for autologous tissue (i.e. bone flaps), frozen allogeneic orthopedic tissue, and vessels that accompany livers for transplantation; 2) the OR, responsible for freeze-dried bone products kept at ambient temperatures; and 3) the Cardiac Center, responsible for heart valves. At her hospital, some believe that the Blood Bank should be responsible for all regulatory issues relating to tissues, while the surgeons (cardiac, orthopedic, etc.) should have "control" of the tissues regarding location and dispensing.   Given that there are a variety of ways to coordinate the process, how are other facilities managing their tissues and ensuring they are in compliance with current regulations? Do other institutions have a designated Operating Room Tissue Coordinator that is responsible for creating, implementing, and maintaining their tissue/quality program? How is the Blood Bank/Transfusion service involved?   ADDENDA Aug. 9, 2006   ·        Dr. Brad Eisenbrey, Chairperson of the AABB Tissue Committee and HLA Laboratory Director at Gift of Life Michigan (attribution used with permission) reports that there are a number of current and forthcoming resources for hospitals for managing tissues. AABB members who attended the 2005 AABB Annual Meeting in Seattle can download the presentations from the Tissue Program and the AABB Tissue Management Guide will be available for purchase at the 2006 AABB Annual meeting in Miami. In addition, the Tissue Committee is sponsoring a session on hospital tissue management and regulatory issues at the 2006 AABB Annual Meeting. Furthermore, the AABB Consultation Service has offered their services to help hospitals meet the new Joint Commission and updated AABB Standards for tissue management. The AABB Tissue Committee also has subject matter experts from hospitals with "dispensing services," AATB and/or EBAA accredited tissue banks, Joint Commission and hospital blood bank directors and tissue coordinators who have dealt with the issues. ·        Dr. Eisenbrey continues saying that Joint Commission requires that there be oversight and responsibility for all the tissues transplanted in the accredited facility but does not dictate a system or identify who should have the responsibility. Tissue distribution can be decentralized but that makes management much more difficult. A centralized system following the blood bank model allows for a single point of entry and distribution for all of the tissues in the facility. Inventory management, tracking and traceability is much easier. This model works whether the single point is the blood bank, pharmacy or operating suite. The obvious advantage of the blood bank is the comfort with regulatory issues, recalls, tracking, inventory management, storing products at room, refrigerator, freezer and liquid nitrogen temperatures, and a pre-existing system (blood products) which can easily be adapted to the new products (tissues). ·        Finally, he reports that 21CFR1271 treats hospital tissue services as consignees ("end users") of tissues and many regulatory issues do not apply. Everything changes if the hospital collects, processes, and distributes tissues. If the hospital sends tissues (bone flaps, vessels, valves, etc) to other hospitals on anything other than a very rare basis, the institution needs to register with the FDA as a tissue manufacturer and is then subject to full regulatory authority. Another good argument for bringing responsibility for the tissue program to the blood bank.
by A. Kerstner
Tuesday, March 7, 2017
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