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Recommended Practices for Surgical Tissue Banking

March 3, 2006

By Anonymous

The following recommended practices were developed by the AORN Recommended Practices Committee and have been approved by the AORN Board of Directors. They were presented as proposed recommended practices for comments by members and others. They are effective Jan 1, 2006.

These recommended practices are intended as achievable recommendations representing what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice settings and/or clinical situations that determine the degree to which the recommended practices can be implemented.

AORN recognizes the numerous settings in which perioperative nurses practice. These recommended practices are intended as guidelines adaptable to various practice settings. These practice settings include traditional operating rooms, ambulatory surgery centers, physicians’ offices, cardiac catheterization suites, endoscopy suites, radiology departments, and all other areas where operative and other invasive procedures may be performed.

PURPOSE. Surgical tissue banking encompasses procuring, processing, preserving, and/or storing selected human cells and tissue. Human tissue includes, but is not limited to, bone, cartilage, ligaments, tendons, fascia, dura mater, sciera, corneas, heart valves/conduits, bone marrow, vessels, and skin. It is beyond the scope of these recommended practices to address all areas of tissue banking, solid organ transplantation, or nonhuman tissue. These recommended practices provide guidance for developing organizational policies and procedures that are specific to the needs of surgical patients and address the perioperative practice setting and expertise required of personnel.

A tissue bank should be established only where a need exists. Before the decision is made to establish a tissue bank, consideration should be given to personnel, equipment, and practical operational requirements for providing safe, reliable, and biologically useful products.

In 1997, the US Food and Drug Administration (FDA) announced a program for comprehensive regulatory oversight of tissue banking.1 In support of this program, the FDA has published proposed guidance documents that were later clarified as final rules.2″6 The agency intends to propose more regulations in the future in the form of guidance documents. Adherence to these regulations is required during the development and ongoing operation of a human tissue bank. In addition, the standards published by the American Association of Tissue Banks (AATB)7 should be referred to for additional direction.

Effective July 1, 2005, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards for tissue banking have been updated in the laboratory accreditation program and additionally applied to ambulatory care, critical access hospital and hospital accreditation programs, and office-based surgery practices. The standards apply to organizations that store or issue human, nonhuman, and synthetic tissue, including surgery and outpatient centers.8

RECOMMENDED PRACTICE I

Facilities procuring, processing, and/or preserving tissue, and facilities storing tissue for potential transfer to a different facility, must register as tissue banks with the FDA.4

1. A list of types of human cells, tissue, and cellular and tissue-based products must be submitted with the application to the FDA.4 Facilities that recover, screen, test, process, label, package, and/or distribute human cells or tissue for implantation, transplantation, or infusion must register with the FDA. The registration form includes a list of tissues and cells to be used in this process.4 Facilities must register within five days after beginning operations, notify the FDA within six months of changes in products, and update the registration annually in December. Facilities storing only purchased tissue for use within the same facility, or those who recover autologous skin or skull bone flaps for later reimplantation into the same patient, are not required to register as tissue banks. Additional clarification is available from the FDA.

2. Facilities should verify that tissue and cells acquired from outside sources have been procured, processed, stored, and distributed by tissue banks registered with the FDA and licensed by state agencies.8 Depending on the type of tissue being acquired, outside sources of cells or tissues also should be accredited by the AATB, the Eye Bank Association of America (EBAA), or the AABB (formerly known as the American Association of Blood Banks). Accreditation by any of these agencies demonstrates that these sources periodically pass inspections by the accrediting agency and provides minimum assurance of quality control for the recovery, screening, testing, processing, storage, and distribution of the tissue. Some tissue banks purchase tissue procured or processed by other tissue banks and have limited registration or accreditation. All tissue banks involved in handling the tissue must be registered and should be accredited. Copies of current certificates should be requested annually and kept on file.

RECOMMENDED PRACTICE II

Facilities procuring, processing, preserving, storing, or distributing tissue to other facilities should have defined oversight with authority and accountability for all activities performed.8

1. A facility performing any tissue-banking activities should appoint an administrator or oversight group accountable for these activities. The administrator of a tissue bank is accountable for all aspects of the tissue bank’s activities, including compliance with regulations. This role requires a broad understanding of the processes and responsibilities involved.

2. Administrative personnel should be knowledgeable about

* all applicable federal, state, and local regulations;

* applicable standards of the AATB, EBAA, and AABB;

* accrediting agency requirements;

* screening and testing criteria;

* the grieving process;

* aspects of informed consent;

* donor and recipient rights;

* quality control;

* documentation and record-keeping requirements;

* confidentiality and release of information;

* requirements for release of tissue;

* adverse event reporting; and

* ethical considerations.

3. A physician or medical advisory committee should be available to provide direction for medical decisions. The AATB recommends that a medical director be appointed.7

4. Tissue ordering and receiving, procuring, processing, preserving, storing, and distributing should be coordinated throughout the health care facility.8 Centralized oversight of all aspects of tissue banking is necessary to ensure that all tissue received and stored is safe for implantation, that processes are validated and monitored on an ongoing basis, and that all tissue can be traced back to the source or easily recalled if necessary.

RECOMMENDED PRACHCE III

Surgical tissue bank personnel must be knowledgeable about the aspects of tissue banking in which they participate.6

1. Personnel should be knowledgeable about the importance of the tissue bank products and services. An understanding of the importance of tissue bank activities instills an attitude of attention to detail, and may minimize errors.

2. Personnel soliciting tissue donations must be knowledgeable about

* federal and state regulations,

* screening and testing criteria,

* the grieving process,

* aspects of informed consent,

* donor and recipient rights, and

* ethical considerations.

Requesting authorization for donation of tissue requires unique interpersonal communication skills to ensure that donations are legally and ethically solicited and accepted.

3. Personnel screening potential donors must be knowledgeable about

* the grieving process;

* screening and testing criteria;

* sources of information for screening (eg, relevant medical records, knowledgeable historian);

* techniques to obtain accurate and complete information; and

* resources and options available when screening results are ambiguous or unclear.

Screening requires specific training to learn the best sources of medical history and behavioral risk assessment information. This source may be friends rather than family members. Obtaining the most accurate information requires strategies for interviewing. At times, the results of screening may not be clear. The screening individual needs to know what resources are available to assist with the determination of suitability.

4. Personnel processing and/or packaging tissue must be knowledgeable about

* environmental conditions required,

* steps in the processing procedures,

* labeling requirements,

* packaging,

* documentation,

* appropriate measures to be taken when tissue is compromised, and

* disposal of unsuitable tissue.

Understanding the steps of tissue processing is essential to preventing errors that may alter the integrity and/or function of the tissue, contaminate it, or negatively affect the outcomes of transplantation. Disposal of human tissue must be done in compliance with federal and state regulations. Complete and accurate documentation for tracing tissue disposition is required by the FDA.

5. Administrators should ensure that initial and ongoing educational opportunities are provi\ded to meet the needs of personnel who perform tasks within the surgical tissue bank. Regulations and standards affecting tissue bank activities are evolving. Initial education provides a baseline to support a beginning level of job performance. Ongoing education offers personnel an opportunity to enhance skills and learn about changes in regulations and standards. An introduction and review of tissue banking policies and procedures should be included in the orientation and ongoing education of personnel to assist in the development of knowledge, skills, and attitudes that positively affect patient outcomes.

6. Administrators should ensure that the employees performing tasks within the surgical tissue bank are competent to perform these tasks. Competency assurance is essential because errors may cause breaches in regulations, compromise the integrity or function of the tissue, contaminate it, and/or lead to negative outcomes of transplantation.

RECOMMENDED PRACTICE IV

Potential donors, their families, and recipients of tissue should be treated with respect, dignity, and sensitivity, and their rights should be protected.

1. Personnel approaching living donors or families of potential deceased donors to request consent for donation should be sensitive to the level of distress the situation may cause and respect the individual’s rights. Tissue donation is frequently requested at the time of an unexpected death. This event creates distress in the survivors and is emotionally charged. Sensitivity to the needs of the survivors is essential to a successful donation. Perioperative personnel also should recognize that the deceased donor is an individual with the same rights that would be afforded to any other patient. At times, donation is requested of a living relative. This situation also may trigger strong emotions and ethical dilemmas. The person’s rights should be honored.

2. Personnel should obtain informed consent from the donor or donor’s responsible party before tissue recovery. Permission to retrieve tissue from nonliving donors should be sought from next of kin in order of legal precedence. If the next of kin is unavailable, local, state, and federal regulations should be followed. The Uniform Anatomical Gift Act (UAGA) of 1968, passed in all 50 states, provides guidelines within which consent may be obtained upon death of the donor, including an order of priority for the potential donor’s next of kin. Additional guidelines concerning donations appear in the 1987 amendments to the UAGA and were clarified in 2001 by the Department of Health and Human Services.9 Individual state laws may vary. Some states expressly honor the donor’s documented wishes (eg, donor registry, driver’s license, donor card or directive) as legal consent in lieu of obtaining additional authorization from the next of kin. Key elements of an informed consent include

* identification of tissues to be recovered;

* explanation of the potential uses of the tissue (eg, transplantation, research, education);

* a general description of the recovery process; and

* explanations that the family may limit or restrict the use of the tissue.”

3. Personnel should provide the family with written materials disclosing the intended uses of the tissue and the nature of the donation, including

* a copy of the signed consent form,

* instructions on how to follow up with the tissue bank should concerns arise,

* a description of the uses for which donated tissue may be applied, and

* a list and description of other companies and entities with which the tissue bank has relationships for processing and distributing tissue.

The tissue bank is responsible for ensuring that accurate, sensitive, and appropriate information is shared with the person giving consent. Using written materials ensures consistency and allows the person providing consent an opportunity to review the material again.2

4. Allograft donations from living donors should be accepted only if the medical, legal, and ethical conditions surrounding the donations meet approved criteria. Questionable conditions include undue medical risk to the donor, coercion, promises of monetary gain, and the diminished capacity of the donor to evaluate the medical or surgical risks.7

5. Informed consent should be obtained from patients receiving tissue transplants, following a discussion of the risks, benefits, and alternatives.

RECOMMENDED PRACTICE V

Tissue for transplantation must be recovered only front suitable donors.

1. A responsible individual(s) must determine allograft donor suitability based on results of required screening and testing for risk factors or the presence of relevant communicable disease agents and diseases.5,7 Individuals making the determination of donor suitability must be knowledgeable about the legal requirements and medical risks involved and must have the formal authority to make this determination. This responsibility may rest with a medical director or a medical advisory committee.

2. A responsible individual should screen donors of allografts for risk factors and clinical evidence of relevant infectious agents and diseases before recovery of tissues. Screening includes documenting the review of relevant medical records, performing a strict physical assessment, and conducting detailed interviews with a knowledgeable historian. Donor screening minimizes the risk of transmission of infectious agents and diseases to the recipient and minimizes the risk of retrieving tissue that is not suitable for transplantation.

3. Allograft donor exclusion criteria include the following:

* active systemic viral, bacterial, or fungal infection;

* disease history of unknown etiology;

* risk associated with human transmissible spongiform encephalopathy (eg, Creutzfeldt-Jakob disease [CJD], a blood relative with noniatrogenic CJD, rapidly progressive dementia, receipt of human pituitary-derived hormones, receipt of human dura mater grafts, travel/residency risks associated with variant CJD);

* certain autoimmune diseases;

* fever associated with a possible infectious etiology; and

* meeting any of the high-risk criteria for relevant communicable disease agents identified by the FDA, including

* physical evidence for risk of sexually transmitted diseases such as genital ulcerative disease, herpes simplex, syphilis, chancroid;

* for a male donor, physical evidence of anal intercourse, including perianal condyloma;

* physical evidence of nonmedical percutaneous drug use, such as needle tracks, (note any tattoos that may be covering needle tracks);

* physical evidence of recent tattooing, ear piercing, or body piercing;

* disseminated lymphadenopathy;

* oral thrush;

* blue or purple spots consistent with Kaposi’s sarcoma;

* unexplained jaundice, hepatomegaly, or icterus (note that hepatomegaly may not be apparent in a physical assessment unless an autopsy is performed);

* physical evidence of sepsis, such as unexplained generalized rash;

* large scab consistent with recent smallpox immunization;

* eczema vaccinatum;

* generalized vesicular rash (ie, generalized vaccinia);

* severely necrotic lesion consistent with vaccinia necrosum; and/ or

* corneal scarring consistent with vaccinial keratitis.10

The medical director or medical advisory committee should evaluate potential donors with metabolic or bone disease, malignancy or malignant neoplasm, or disease of unknown etiology on a case-by- case basis. Some diseases have a range of severity that may cause the tissue to be appropriate or inappropriate for donation. A physician with knowledge and oversight responsibilities should evaluate these potential donors and make this determination. Potential donors are screened to minimize the risk of transmission of infection or disease. Recipients of pituitaryderived human growth hormone, human dura mater, or gonadotropin, as well as those who meet the travel/residency parameters associated with an increased exposure risk to the human form of bovine spongiform encephalopathy (BSE), may be at risk of carrying the agent causing C]D or variant CJD and should be excluded from consideration for tissue procurement.5,10 Xenotransplantation recipients and their intimate contacts should be excluded from potential transplantation because xenotransplants may harbor infectious agents from the donor animal. These infectious agents also may have been transmitted to intimate contacts of the xenotransplant recipient. The FDA considers these individuals not to be suitable donors.5,10

Donor screening minimizes the risk of transmitting infectious agents and diseases to tissue recipients through transplantation.10 Contraindications and exclusion criteria are evolving as new knowledge is gained and infectious disease threats are identified. Tissue bank administrations should remain informed of changes in the recommendations of the Centers for Disease Control and Prevention (CDC), FDA, and AATB and incorporate these changes into screening criteria.

4. Donors of allografts must be tested with PDA-approved, cleared, or licensed tests by laboratories compliant with the Clinical Laboratory Improvement Amendments of 1988 and found negative for relevant infectious agents and diseases, including, but not limited to

* HIV type 1 and type 2 (anti-HIV-1 and anti-HIV-2);

* hepatitis B virus (HBV) surface antigen (HBsAg);

* total antibody to hepatitis B core antigen (antiHBc)- (IgG+IgM);

* hepatitis C virus (HCV) (anti-HCV);

* Treponema pallidum (syphilis) confirmatory test;

* human T-lymphotropic virus (Types I and II); and

* cytomegalovirus.”

Living donors should be tested for hepatitis HBc core antibody (anti-HBc) and should be retested 180 days after recovery before tissues are released for allogenic use. Testing for these infectious agents minimizes the risk of transmission and is required by the FDA final rule.1 Donors of dura mater grafts also must be tested for the infectious agent that causes CJD; this in\cludes a recommendation that a qualified pathologist perform an examination of the donor’s entire brain.5

RECOMMENDED PRACTICE VI

Tissue must be recovered, processed, and transplanted in clean, controlled environments appropriate for sterile surgical procedures.

1. Traffic patterns should be established and maintained in accordance with AORN’s “Recommended practices for traffic patterns in the perioperative practice setting.”11 Traffic control in the OR minimizes the potential for contamination of the tissue retrieved. Eyes usually are procured with intact corneas in less controlled environments; however, the corneas should be removed from the eyes, processed, and transplanted in an OR-type environment.

2. The environment should be cleaned in accordance with AORN’s “Recommended practices for environmental cleaning in the surgical practice setting.”12 Cleaning should be performed on a routine basis and as needed to reduce the amount of organic and inorganic debris and microbial load that can potentially contaminate the tissue. The FDA requires that the facility for tissue recovery be controlled to minimize the risk for contamination or cross-contamination through the introduction or transmission of communicable disease.6(p68683)

3. Surgical attire should be worn during recovery and transplantation of tissue in accordance with AORN’s “Recommended practices for surgical attire.”13 Clean surgical attire minimizes contamination of the tissue.

4. Only powder-free gloves should be used. Glove powder is aerosolized when powdered gloves are used.14 Powder can contaminate recovered tissue and may lead to adverse reactions or rejections of the tissue by the recipient.15,23

5. When it is known that the potential tissue recipient has antibodies to natural rubber proteins, the tissue should be recovered with latex-free supplies in accordance with the “AORN latex guideline.”24 Transplanting tissue with an antigen to which the recipient is allergic can lead to adverse outcomes, including tissue rejection, impaired healing, and allergic reaction.

RECOMMENDED PRACTICE VII

Tissue must be recovered and processed in a manner that minimizes microbial growth, contamination, and crosscontamination .6(p68681)

1. Postmortem donors should be placed in refrigeration within 12 hours of asystole, and tissue should be procured within 24 hours of asystole. Refrigeration minimizes cell oxygen consumption and microbial growth. Prolonged times between cell ischemia and tissue recovery provides an opportunity for microbial proliferation. Recommendations for maximum duration of time between recovery and transplantation have been established by the AATB.7

2. A sterile field should be established and maintained in accordance with AORN’s “Recommended practices for maintaining a sterile field.”25 Aseptic practices are used to prevent contamination of the tissue and minimize the risk of subsequent infection. Sterile surgical drapes provide a barrier to minimize contamination of the recovered tissue.

3. The donor site and operative site should be prepared in accordance with AORN’s “Recommended practices for skin preparation of patients.”26 Adequate skin preparation reduces the microbial count of the skin that can lead to contamination of recovered tissue.

4. The surgical team should perform surgical hand antisepsis and wear sterile gowns and gloves during recovery of tissue, in accordance with AORN’s “Recommended practices for surgical hand antisepsis/hand scrubs.”27 Surgical hand antisepsis reduces microbial flora and may reduce the contamination of the tissue. Gowns and gloves provide a barrier to microbial contamination. When corneas are recovered, the sterile field is very small, and gowns may not be necessary.

5. Transplantation of tissue has resulted in transmission of viral, bacterial, and fungal infections. Inadequate tissue processing and quality controls have resulted in postoperative infections and graft failures.^sup 6(p68651)^In 2002, the CDC published an investigation of 26 reported cases of allograft- associated infections.28 During an investigation of voluntary reports, the FDA identified failure to validate procedures to prevent contamination and cross-contamination during processing in more than half of reported adverse events.^sup 6(p68652)^ Proper processing and quality controls minimize the risk of adverse events associated with transplanted tissue.

RECOMMENDED PRACHCE VIII

Tissue must be prepared, processed, and preserved in a manner that minimizes microbial growth and optimizes the condition of the tissue for transplantation.^sup 6(p68681)^

1. Aerobic and anaerobic tissue cultures should be collected when tissue is retrieved. Culture results may identify tissue that is inappropriate for transplantation and also provide a baseline for evaluation of processing and storage.

2. Tissue that will not undergo a sterilization process should be aseptically prepared and transferred to a sterile storage container. Aseptic technique is used to prevent contamination of tissue.

3. The package or container selected should provide an adequate barrier to microbial contamination and should be compatible with the type of sterilization, preservation, and storage conditions. Packages of refrigerated and frozen tissue become wet during storage and form condensation upon removal from storage. Containers should be impervious to moisture.

4. For sterilization of tissue, PDA-approved technology should be used in accordance with the PDA current good tissue practices6 and AATB standards for guidance. The PDA regulations and recommendations are evolving as new knowledge is gained. The AATB periodically reviews and revises the standards for tissue banking. It is important to review information from these sources to minimize risks of tissue processing.

5. Pooling (ie, commingling) of tissue from two or more donors must not Occur.^sup 6(p68681)^

6. When processing dura mater, a validated procedure must be used to minimize the risk of transmitting human transmissible spongiform encephalopathy (eg, prion disease, CJD).^sup 6(p68681)^ Transplantation of contaminated tissue has resulted in transmission of viral, bacterial, and fungal infections.6 Proper processing and quality controls minimize the risk of adverse events associated with transplanted tissue.

RECOMMENDED PRACTICE IX

Tissue must be labeled in a manner that provides direction for preparation and implantation and minimizes the risk of errors.6,7

1. Proper labeling of tissue minimizes the risk of errors. The allograft package/storage container should be labeled with the following information:

* tissue identification number (this may include a bar code);

* description of the tissue;

* name, address, and telephone number of the tissue bank responsible for determining donor suitability, processing, storage, and distribution of the allograft;

* recovery or distribution center that is responsible for determining donor suitability, processing, and distribution;

* recovery date and time;

* expiration date, if applicable, including the month and year;

* acceptable storage conditions, including recommended storage temperature and acceptable storage temperature range;

* the disinfection or sterilization method used, if applicable;

* if not sterilized, whether the tissue was procured and prepared under aseptic conditions;

* quantity of tissue expressed as volume, weight, dimensions, or a combination of these units of measure, if applicable;

* potential residues of processing agents and solutions (eg, antibiotics, ethanol, ethylene oxide, dimethyl sulfoxide); and

* package inserts containing instructions for use, indications and contraindications, preparation of tissue for use, expiration dates, and specific tests performed on tissues, warnings and potential adverse reactions, and instructions for opening packages or containers.6,7

2. The autograft package/storage container should be labeled with the following information:

* name, address, and telephone number of the tissue bank responsible for processing, storing, and distributing the autograft;

* the statements “For Autologous Use Only” and “Autologous Donation”;7(p86)

* disinfection/sterilization method, if used;

* if not sterilized, whether the tissue was recovered and prepared under aseptic conditions;

* the warning “Not Evaluated For Infectious Substances” if infectious disease testing has not been performed;

* the warning “Biohazard” if infectious disease tests were performed and found to be positive;

* two unique identifiers of the donor/ recipient (eg, name, medical records number), including bar code;

* description of the tissue;

* recovery date and time;

* expiration date, if applicable, including the month and year;

* acceptable storage conditions, including recommended storage temperature and acceptable storage temperature range;

* method of preservation, if applicable; and

* potential residues of processing agents and solutions (eg, antibiotics, ethanol, ethylene oxide, dimethyl sulfoxide).”7 This information is necessary for release of the autograft for reimplantation only into the same donor/patient, quality control, and appropriate tissue preparation for implantation.

This documentation is required for certification by the AATB. Some of the information also is required by the FDA. Autografts have not undergone testing for infectious agents and diseases and must be released only to the donor. Release to another recipient may cause serious injury. Using two unique donor/recipient identifiers is consistent with JCAHO’s safety goal of patient identification.29 The application of bar code labeling facilitates matching of tissue to the desired recipient and accurate record keeping. These strategies minimize the potential for errors. The FDA requires that a procedure be maintained to verify the accuracy of labels when labeling human tissue.6(p8684)

RECOMMENDED PRACHCE X

Allograft tissue obtained from an outside tissu\e bank should be handled in a manner consistent with the source facility’s or manufacturer’s written instructions.

1. Incoming tissue should be recorded, including the unique identifiers of the tissue and expiration date, the identification of the person accepting the tissue, and the date and time of receipt.

2. The packaging and transport conditions of incoming tissue should be examined to verify that the tissue integrity and temperature are acceptable and have been maintained during transport.

3. The tissue should be transferred to storage in manner consistent with the source facility’s and manufacturer’s written instructions.

RECOMMENDED PRAOICE XI

Tissue is transported and stored in a manner that minimizes the risk of compromise or contamination.6

1. Containers for transporting and/or temporarily storing tissue must protect the tissue from contamination and maintain tissue at appropriate temperatures during transport 6(p68660), 8(PC.17.10.C)

2. Tissue for transplantation at a later date should be contained and frozen as soon as possible after recovery. Warm tissue is a medium for microbial growth. Tissue contamination may be multifactorial, and no finite time frame has been established. Institutions should determine this time frame with consideration of the type of tissue and recovery conditions.

3. Tissue must be stored in a secure area, with access restricted to authorized personnel, to minimize the risk of mix-ups, contamination, or improper distribution of tissue.6(p68685)

4. Temperatures selected for storage should be consistent with the AATB standards.7

* Lyophilized or dehydrated musculoskeletal tissue should be stored at ambient temperature or cooler (but not be frozen).

* Refrigerated musculoskeletal and osteoarticular tissue should be aseptically recovered, stored in an isotonic solution containing suitable antibiotics, and stored at 33.8 F (1 C) to 50 F (10 C).

* Refrigerated skin should be stored at 33.8 F (1 C) to 50 F (10 C).

* Frozen musculoskeletal and osteoarticular tissue should be processed and stored at 0 -40 F (0 -40 C) or colder for long-term storage; and between -4 F (0 -20 C) to 0 -40 F (0 -40 C) for short- term storage (fewer than six months).

* Frozen or cryopreserved skin should be stored at 0 -40 F (0 – 40 C) or colder.

* Frozen, cryopreserved cardiovascular tissue should be stored at -148 F (0 -100 C) or colder.

* Reproductive cells should be frozen and cryopreserved in a liquid nitrogen freezer. Storage may be in either the liquid or vapor phase.

* Refrigeration minimizes oxygen consumption of cells and prolongs their life. Dead cells provide a medium for microbial growth. Refrigeration minimizes microbial growth.

5. Autologous tissue should be segregated from allografts.7 Autologous tissue usually has not undergone testing for infectious diseases or suitability screening for use for other patients, and its use is restricted to the donor only. Segregation minimizes the risk of error that may result in a negative outcome to a tissue recipient.

6. An expiration date for each tissue must be assigned. This expiration date must be based on tissue type, processing, preservation, storage, and packaging.6(p68683) The expiration time of tissue should not exceed the following recommendations of the AATB:7

* refrigerated musculoskeletal tissue: five days;

* refrigerated skin: 14 days;

* frozen and cryopreserved cells and tissue (-40 F [0 -40 C] or colder): five years; and

* lyophilized or dehydrated tissue: five years.

Safe duration of storage of autografts may be influenced by processing and packaging methods and should be defined by the facility, not to exceed the recommendations of the AATB listed above. A process should be in place to minimize the number of autografts in storage to those that will be reimplanted. This is facilitated by periodic communication with surgeons or review of medical records to determine whether patients have survived.

7. Refrigerator and freezer units used for storing tissue should

* be monitored and daily temperature checks recorded,

* have annual calibration checks, and

* have an alarm system that is continuously monitored and that sounds when the temperature is not within the acceptable range.

Restricted access is required to verify the safety and security of tissues. Maintenance of temperatures within the refrigerator or freezer unit ensures tissue integrity. Acceptable temperature range limits for the storage of tissue at each phase of the operation should be set in accordance with established standards and federal and state regulations. Temperature fluctuations outside the recommended temperature range may render tissue unsafe for patient use. The source facility should be consulted if this occurs. The alarm should sound in an area where an individual is present at all times to initiate immediate corrective action.

8. Personnel should have a specific contingency plan for refrigerator or freezer malfunction. Storage freezers and refrigerators should be attached to an emergency power system. In the event of failure of a refrigerator or freezer, the temperature of tissue should be monitored and maintained to prevent compromise of the tissue. All events should be properly documented.

RECOMMENDED PRACTICE XII

Tissue should be quarantined until all steps of the tissue banking process have been reviewed and found acceptable.

1. Allografts should be segregated and not released until all screening, testing, processing, labeling, and storage criteria have been reviewed and determined to be satisfactory. The tissue should remain in an area segregated from available tissue until this review has been completed and the tissue is available for implantation. Segregation minimizes the risk of implanting unsuitable tissue. A checklist of criteria for release provides a standardized method of verifying release criteria and minimizes the potential for errors.

2. Autografts should be segregated and not released until all processing, labeling, and storage criteria have been reviewed and determined to be satisfactory. Segregation minimizes the risk of implanting unsuitable tissue. A checklist of criteria for release provides a standardized method of verifying release criteria and minimizes the potential for errors.

3. Autografts meeting all criteria for release should be released only for reimplantation in the autologous donor. Two unique identifiers (eg, donor name, medical record number) should be used for release of autografts. Autografts usually have not undergone testing for infectious agents and diseases and must be released only for reimplantation in the donor. Release to another recipient may cause serious injury. Using two unique donor identifiers is in accordance with the JCAHO safety goal of patient identification.29 This strategy minimizes the potential for errors.

4. Tissue not meeting the release criteria should be considered compromised and should be destroyed in accordance with state and federal regulations. Regulations addressing human tissue disposal vary from state to state. Tissue that has not undergone sterilization is considered biohazardous.

5. Before dispensing tissue from the tissue bank, the processes used should be reviewed, and the suitability of the tissue for implantation should be determined. A standardized process should be in place to verify the donor tissue and recipient match, when applicable.

6. Verification of tissue availability should be incorporated into the verification process used to ensure the correct patient, procedure, site, position, and implants.30

7. The contents of the package, expiration date, and other pertinent information should be read back and verified before the tissue is dispensed onto the sterile field. Use of bar coding technology facilitates matching tissue to the desired recipient and keeping accurate records.

RECOMMENDED PRACTICE XIII

Each tissue bank must maintain donor, tissue, and recipient records to ensure that pertinent data are retrievable.

1. The surgical tissue bank should have a tissue identification system that allows for tracking of tissues from the donor source to the recipient patient or institution, and vice versa.” Quality control issues and infections from implanted tissue have been reported. An identification system provides a means to determine what tissue is affected, rapidly quarantine the tissue, and follow up with affected recipients to ensure timely intervention to minimize morbidity.

2. Surgical tissue banks procuring, processing, distributing, and storing tissues should keep accurate records of the distribution of each tissue according to donor identification number, tissue type and identifying number, and identifying information for the receiving center, along with the dates of recovery and distribution.” This information provides a means to recall tissue that may be compromised.

3. Records should be developed and maintained according to the recommendations of AATB and in compliance with FDA rules. Records should include the following information:

* FDA registration, if applicable;

* copies of FDA registration and AATB accreditation of outside vendors from whom tissue is obtained (EBAA for ocular tissue, AABB for stem cells);

* listing of all tissue products ordered, stored, and used;

* informed consent documents;

* donor suitability assessment criteria;

* recovery;

* processing;

* preservation;

* labeling;

* storage;

* quarantining;

* testing record review;

* releasing;

* distribution;

* ordering and receipt of tissue acquired from other sources:

* package integrity upon receipt,

* transport temperature controlled and acceptable, and

* source facility and unique identifier of the tissue;

* instructions/procedures for reconstitution;

* identity of personnel preparing, accepting, and issuing tissue;

* dates and times of preparing, accepting, and issuing tissue;

* documentation in the recipient’s health record of the unique iden\tifier of the tissue;

* quality management records;

* recall criteria and procedures; and

* disposal of tissue.

For tissue obtained from outside tissue banks, copies of pertinent records should be forwarded to the source facility. Documentation assists in clinical evaluation and in tracking recipients if an adverse event is identified.6

4. Records must be maintained for 10 years after tissue is dispensed or the tissue expiration date is reached, whichever is longer.6 Tissue may be used years after recovery. For that reason, the FDA requires that records must be maintained for 10 years.

RECOMMENDED PRACTICE XIV

A quality management program must be in place to evaluate the structure, processes, and outcomes of tissue bank services.6 (68682)

1. An initial program review should be performed by a multidisciplinary committee, comparing procedures with regulations and standards. Program review should be done annually to ensure ongoing compliance with regulations and ensure safe tissue banking practices.

2. Quality indicators should include, but not be limited to,

* donor screening and testing;

* tissue processing procedures;

* labeling procedures;

* storage requirements;

* criteria for release of tissue;

* the use of two unique donor identifiers for release of autografts; and

* adverse events (including posttransplantation infections), corrective action, and evaluation.

Tissue bank services involve significant risks to recipients if errors are made. The FDA requires any facility performing tissue banking to maintain a quality management program intended to prevent the introduction, transmission, or spread of communicable disease for every step of tissue banking performed.6(p68682) Ongoing quality management involves verifying that these steps are done in a safe, efficacious manner. These quality indicators address specific issues that may compromise the tissue. Specific quality indicators will depend on the services provided.

3. The FDA final rule for current good tissue practices requires the following aspects of quality management:6

* ensuring that required procedures are established and maintained;

* ensuring the appropriate analysis and sharing of information that could affect the potential contamination of the product or the potential transmission of communicable disease by the product;

* ensuring that appropriate corrective actions are taken and documented;

* ensuring proper training and education of personnel;

* establishing and maintaining appropriate monitoring systems;

* establishing and maintaining a system of records;

* investigating and documenting product deviations and making certain required reports; and

* conducting evaluations, investigations, audits, and other actions necessary to ensure compliance with the regulations.6

This quality framework is required by the FDA. Administrative personnel should be familiar with this requirement and its application to the components of tissue banking performed.

4. Facilities should report adverse events, including infections for which there is a reasonable possibility that the transplanted tissue caused the event. The tissue bank manufacturing the tissue is required to report adverse events to the FDA.6 These reports are submitted through MedWatch at http://www.fda.gov/medwatch/report/ instruc.htni. For events that result from tissue acquired from an outside tissue vendor, the report should be sent to the vendor and also may be submitted to the FDA.

RECOMMENDED PRAOICE XV

Policies and procedures for preserving, storing, and maintaining tissue should be established, reviewed annually, and readily available in the practice setting.

1. Policies establishing authority, responsibility, and accountability for tissue handling and appropriate donor testing within the practice setting must be established and maintained for all steps performed by the facility.6(p68683) These policies may include, but are not limited to,

* authority and accountability for processes;

* screening and testing criteria;

* obtaining informed consent from the donor;

* providing information and obtaining informed consent from the allograft recipient;

* evaluating culture and serology tests with appropriate interventions for positive results;

* processing and preserving tissue;

* packaging and labeling tissue;

* sterilizing processes, if applicable;

* monitoring temperature during storage;

* maximum storage duration;

* handling frozen tissue if there is a freezer malfunction or power outage;

* warming or reconstituting preserved tissue;

* rinsing solutions from tissues;

* criteria for return of unused tissue into inventory;

* disposal of tissue;

* documenting implanted and discarded tissue in a retrievable format, and notifying recipients or recalling released tissues;

* responses to adverse events; and

* responses to recalls of tissue from tissue vendors.

2. Before implementation, procedures must be approved by the responsible authority within the health care organization.6(p68683) Institutional policies and procedures may seriously affect patient safety and should be reviewed by designated authorities within the facility (eg, infection control committee, pathology department). Tissue may be used years after recovery. For that reason, the FDA final rule for good tissue practices requires that policies and procedures be reviewed periodically, be readily available in the practice setting, and be archived for 10 years after recovery or the expiration date of the tissue, whichever is longer.6(p68685) These recommended practices should be used as guidelines, along with the standards of the AATB and regulations and recommendations of the FDA, for the development of policies and procedures for surgical tissue banking in the practice setting. Policies and procedures establish authority, responsibility, and accountability and serve as operational guidelines.

3. The uniform perioperative nursing vocabulary should be used to document perioperative nursing care of the transplant donor and recipient on the intraoperative patient record. The perioperative nursing vocabulary is a clinically relevant and empirically validated standardized nursing language. This standardized language consists of the Perioperative Nursing Data Set (PNDS) and includes perioperative nursing diagnoses, interventions, and outcomes. The expected outcome of primary importance to these recommended practices is outcome O10, “The patient is free from signs and symptoms of infection.” This outcome falls within the domain of Safety (Dl). Interventions that might lead to the desired outcome include 198, “Protects from cross-contamination”; 1121, “Assesses susceptibility for infection”; and 1188, “Monitors for signs and symptoms of infection.”31

Editor’s note: The American Association of Tissue Banks can be reached at 1320 Old Chain Bridge Road, Suite 450, McLean, VA 22101; telephone (703) 827-9582.

GLOSSARY

ALLOGRAFTS: Grafts taken from a living or nonliving donor for transplantation to a different individual.

AMERICAN ASSOCIATION OF TISSUE BANKS (AATB): A nonprofit organization that defines the standards for tissue banking.

AUTOGRAFTS: Tissue derived from an individual for implantation exclusively on or in the same individual.

DONOR SCREENING: Review of the donor’s relevant medical records and physical assessment for evidence of past or present risk factors for relevant infectious agents or disease.

DONOR TESTING: Laboratory tests on blood specimens collected from a potential donor.

PRION DISEASES: A classification of infectious diseases, including Creutzfeldt-Jakob Disease (CJD), caused by a unique proteinaceous agent.

TISSUE BANK: A facility that participates in procuring, processing, preserving, and/or storing human cells and tissue for transplantation.

XENOTRANSPLANT: Cells or tissue from a nonhuman animal source that are transplanted, implanted, or infused into a human.

XENOTRANSPLANTATION: Any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source (eg, bovine heart valves); or (b) human body fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.

NOTES

1. US Food and Drug Administration, Proposed Approach to Regulation of Cellular and Tissue-eased Products (Rockville, Md: US Food and Drug Administration, Feb 28,1997) 1-37.

2. US Food and Drug Administration, “Current good tissue practice for manufacturers of human cellular and tissue-based products; inspection and enforcement; proposed rule,” federal Register 66 (January 8, 2001) 1507-1559. Also available at http://www.fda.gov/ OHRMS/DOCKETS/98fr/010801 c.pdf (accessed 13 Sept 2005).

3. US Food and Drug Administration, “Suitability determination for donors of human cellular and tissue-based products; proposed rule,” Federal Register 64 (Sept 30, 1999) 52696-52718. Also available at http://www.fda.gov/OHRMS/DOCKETS/98fr /093099a.pdf (accessed 13 Sept 2005).

4. US Food and Drug Administration, “Human cells, tissues, and cellular and tissue-based products; establishment registration and listing; final rule,” Federal Register 66 (Jan 19,2001) 5447-5469. Also available at http://wwio.fda.gov/OHRMS/DOCKET’S /98fr/ 011901a.pdf (accessed 13 Sept 2005).

5. US Food and Drug Administration, “Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products; final rule and notice,” Federal Register 69 (May 25, 2004) 2978529834. Also available at http://www.Jda.goO/OHRMS /DOCKETS/ 98fr/04-11245.pdf (accessed 13 Sept 2005).

6. US Food and Drug Administration, “Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement; final rule,” Federal Register 69 (Nov 24, 2004) 68612-68688. Also available at http:// www.fda.goO/cber/rules/gtp.pdf(accessed 9 Sept 2005).

7. American Association ofTissue Banks, Standards for Tissue Banking, 10th ed (McLean, Va: American Association of Tissue Banks, 2002).

8. Joint Commission on Accreditation of Healthcare Organizations, “Standards approved for transplant and implant tissue storage and issuance,” Joint Commission Perspectives (!February 2005) 8-11.

9. Office of Inspector General, Informed Consent in Tissue Donation: Expectations and Realities, publ OEI01-00-00440 (Boston: US Department of Health and Human Services, January 2001).

10. US Food and Drug Administration, Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance (Rockville, Md: US Food and Drug Administration, May 2004) 1-52.

11. “Recommended practices for traffic patterns in the perioperative practice setting,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2005) 483-485.

12. “Recommended practices for environmental cleaning in the surgical practice setting,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2005) 361-366.

13. “Recommended practices for surgical attire,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2005) 299- 305.

14. D Beezhold, D Kostyal, J Wiseman, “The transfer of protein allergens from latex gloves: A study of influencing factors,” AORN Journal 59 (March 1994) 605-613.

15. D Abeck et al, “Latex allergy and repeated graft rejections,” The Lancet 339 (June 27,1992) 1609.

16. D Beezhold, W Beck, “The absorbability and immunology of starch glove powders,” Complications in Surgery (July/August 1992) 36-40.

17. C Bene, G Kranias, “Possible intraocular lens contamination by surgical glove powder,” Ophthalmic Surgery 17 (May 1986) 290- 291.

18. I Singh, W L Chow, L V Chablani, “Synovial reaction to glove powder,” Clinical Orthopaedics and Related Research 99 (March/April 1974) 285-292.

19. P H McKee, E F McKeown, “Starch granulomata of the endocardium,” Journal of Pathology 126 (October 1978) 103-105.

20. S Moriber-Katz et al, “Contamination of perfused donor kidneys by starch from surgical gloves,” American Journal of Clinical Pathology 90 (July 1988) 81-84.

21. D I Vage et al, “Elutable factors from latexcontaining materials activate complement and inhibit cell proliferation: An in vitro biocompatibility study of medical devices,” Complement Inflammation 7 (January-February 1990) 63-70.

22. C M Ruhl et al, “A new hazard of cornstarch, an absorbable dusting powder,” The Journal of Emergency Medicine 12 (January/ February 1994)11-14.

23. DAA Verkuyl, “Glove powder introduced in the circulation by autotransfusion and severe cardiac failure,” The Lancet 340 (Aug 29,1992) 550.

24. “AORN latex guideline,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2005) 117-132.

25. “Recommended practices for maintaining a sterile field,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2005) 453-457.

26. “Recommended practices for skin preparation of patients,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2005) 443-446.

27. “Recommended practices for surgical hand antisepsis/hand scrubs,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2005) 377-385.

28. Centers for Disease Control and Prevention, “Update: Allograft-associated bacterial infections-United States,” Morbidity and Mortality Weekly Report 51 (March 15, 2002) 207-210. Also available at http://wimv.cdc.gov/mmwr/prnnciv /mmwrhtml/ nim5110a2.htm (accessed 13 Sept 2005).

29. “2005 Hospitals’ National Patient Safety Goals,” Joint Commission on Accreditation of Health Care Organizations, http:// www.jcaho.org /accredited+organizations/paticnt+safeti//05+npsg/05_ npsg Jiap.litm (accessed 13 Sept 2005)

30. “Universal protocol for preventing wrong site, wrong procedure, wrong person surgery,” Joint Commission on Accreditation of Health Care Organizations, http://im.mo. jcalio.org/accredited +organizations/patient+safety/universal+protocol / nniversal_protocol.pdf (accessed 13 Sept 2005).

31. S C Beyea, ed, Perioperaiive Nursing Data Set: The Perioperative Nursing Vocabulary, second ed (Denver: AORN, Inc, 2002).

RESOURCES

Bren, L. “Keeping human tissue transplants safe,” FDA Consumer Magazine 39 (May/June 2005) 30-36.

Verble, M; Worth, J. “Cultural sensitivity in the donation discussion,” Progress in Transplantation 13 (March 2003) 33-37.

Verble, M; Worth, J. “Fears and concerns expressed by families in the donation discussion,” Progress in Transplantation 10 (March 2000) 48-55.

Originally published September 1984, AORN journal. Revised April 1991.

Published as proposed recommended practices, February 1994.

Revised November 1998; published March 1999, AORN Journal. Reformatted July 2000.

Revised November 2003; published February 2004, AORN Journal.

Copyright Association of Operating Room Nurses, Inc. Feb 2006




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