AORN JOURNAL SEPTEMBER 1984, VOL 40, NO 3

Recommended Practices STORING, PRESERVING, AND MAINTAINING

SKIN, BONE, CARTILAGE, AND BLOOD VESSEL TISSUE

he following recommended practices were developed by the AORN Recom- T mended Practices Subcommittee and

have been approved by the AORN Technical Practices Coordinating Committee and the AORN Board of Directors. They were published as proposed recommended practices in the April 1982 AORN Journal for comment by members and others. They are intended to represent a consensus of AORN members.

These recommended practices are intended as achievable recommendations representing what is believed to be an optimal level of practice. Institutional policies and procedures will reflect variations in institutional environment and/or clinical situations that determine the degree to which the recommended practices can be ful- filled.

Purpose. These recommended practices reflect current medical and technical methodology for processing, preserving, and storing selected human tissue. These recommended practices will provide guidance for developing institu- tional procedures that are specific and compati- ble with the institution’s physical facility, pa- tient’s needs, and personnel capabilities or ex- pertise.

These recommended practices are not in- tended as criteria to be used in a regional tissue banking facility. They are intended for the operating room nurse who is delegated to de- velop an individual institutional operating mom banking facility for storage of tissue or who has an interest in the institution’s banking facility.

Not every medical facility will have a need to establish a tissue bank. Before making such a decision, consideration should be given to per- sonnel, equipment, and practical operational re- quirements for providing safe, reliable, and biologically useful tissue grafts.

There are two types of human tissue grafts. Auzograjis are grafts taken from one part of a person’s body to fill in another part, and allo- grajb are grafts taken from a living or cadaver donor for transplantation to a recipient. These grafts can be taken and transplanted immediately without storage or preservation or may require preservation and storage for later transplanta- tion.

There are also two methods to preserve tissue for transplantation-viable and nonviable. Via- ble tissue should be handled in such a way as to preserve living tissue and to prevent contamina- tion. Nonviable tissue is not living tissue at the time of grafting and may or may not be sterilized prior to grafting. Therefore, nonviable grafts may be used with a minimal or insignificant immune response and may be handled prior to sterilization.

Recommended Practice I

Tissue for transplantation should be har- vested from suitable donors.

Interpretive statements 1. The donor or the donor’s responsible

next-of-kin should sign a tissue donor in- formed consent prior to harvest of tissue.

2. Cadaver donors whose deaths have re-

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sulted from trauma or unknown circum- stances should be released according to local, state, or federal regulations when applicable.

3. A history and physical assessment of the donor should be obtained to identify rela- tive or absolute contraindications prior to implantation of tissue.

Rationale 1. All states within the United States have

legislation protecting the rights of potential donors.

2. The donor should not have transmissible infection. (Examples include tuberculosis, viral hepatitis, rabies, seropositive syphilis) .z

3. The donor should not have transferable malignan~y.~

4. The donor should not have an autoimmune disease (example, systemic lupus erythe- matosus) or other disease of known or un- known etiology which may be transferred to the recipient? Transplant tissue should not be taken from persons who have died of neurologic disease of unknown cause.s

Recommended Practice II

The procedure for collecting tissue for viable graPting or nonviable grafting which will not be sterilized should be performed under asep- tic conditions.

Interpretive statements 1. A sterile field is established and main-

tained in accordance with A0R”s m- ommended practices for basic aseptic techniques in the OR.6

2. The donor site and/or operative site should be prepared in accordance with A0R”s recommended practices for preoperative skin preparation of the patient.’

3. Cultures for aerobic and anaerobic bac- teria, mycobacteria and fungi should be done when harvesting allografts and may be done for autografts.

Rationale 1. Aseptic technique is utilized to prevent

contamination of the tissue.*

2. Adequate skin preparation may reduce bacterial count of the tissue?

3. Infection and/or disease may be transferred to the recipient from the donor tissue.I0

Recommended Practice III

Viable and nonviable grafts should be stored in a controlled, safe environment.

Interpretive statements 1. Tissue which will not be sterilized should

be transferred to the sterile storage con- tainer using aseptic technique.

2. If solutions are used in a storage container, the container should be labeled indicating solution composition.

3. The refrigeration and freezer units used for storage of tissue should be monitored for deviations in temperature. If the tempera- ture fluctuates outside the recommended temperature range, the grafts should be inspected and may need to be destroyed.

4. The refrigeration and freezer units should be equipped with automatic temperature alarms.

5 . A daily verification of a continuous record of refrigeration and freezer temperatures should be initialed by the responsible per- son.

6. Designated refrigeration and freezer units should be used solely for the storage of grafts.

Rationale Tissue stored in solution may require copious

rinsing to prevent recipient reacti0n.l’

Recommended Practice IV

Each institution should develop donor, graft, and recipient records to ensure that pertinent data are retrievable.

Interpretive statements 1. A form attached to the graft container

should include the following information: donor name; hospital identification num- ber; pertinent medical infomation and pa- thology reports; type and anatomical site of tissue being preserved; date, time, and

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method of collection. 2. The final culture report should be main-

tained with the banked tissue. 3. A record should be maintained in accor-

dance with the institution's policies and procedures containing the following in- formation: donor name; hospital identifica- tion number; pertinent medical informa- tion including history, pathology reports, type and anatomical site of tissue, and date, time, and method of collection; stor- age solution and composition; recipient's name; hospital identification number; and date, time, and anatomical site of trans- plantation.

4. The informed consent (donor and recip- ient) should be filed in accordance with the institution's policies and procedures.

Rationale 1. Record-keeping facilitates communica-

tion. 2. Records aid in clinical evaluation and in

protecting a potential recipient if donor tissue has proved unsatisfactory in a prior recipient .I2

Recommended Practice V

Skin processed for transplantation should be obtained from a suitable donor, collected under aseptic conditions, transplanted im- mediately or stored in a controlled, safe envi- ronment.

Interpretive statements 1. Skin may be maintained viable in low tem-

perature storage. One acceptable method of storage is to place skin in an isotonic solution (example-normal saline or bal- anced salt solution), refrigerate at l "C to 10 "C for up to 14 days. Viability declines in direct proportion to storage time.I3 Data is inconclusive on the addition of antimi- crobial solution^.'^ Other methods of low temperature storage are available and may be utilized after appropriate evaluation.

2. Skin may be maintained by long-term stor- age methods. One acceptable method of storage is to place skin in a cryoprotectant

(example-dimethyl sulfoxide and glyc- erol, ethylene glycol, dimethyl acetamide, etc) for one to two hours at 4 "C, pour off excess solution, reseal container, and freeze. Freeze by cooling skin to at least -70 "C at a rate of decline between 1 O to 5 "C per minute. The skin can then be stored in a liquid nitrogen freezer. Other methods are available for long-term storage and may be utilized after appropriate evalua- tion."

3. Skin may be processed by freeze-drying. This method is generally too costly for inhouse processing. Banking facilities utilize this method.I6

Recommended Practice VI

Bone processed for transplantation should be obtained from a suitable donor, collected under aseptic conditions if viable graft is de- sired, transplanted immediately or stored in a controlled, safe environment.

Interpretive statements 1. Bone for grafting may be autograft-viable

(example-rib for mandible). This graft is surgically removed and aseptically reim- planted.

2. Bone for grafting may be allograft- nonviable. This bone may be processed by three methods: freezing, freeze-drying, or sterilization.

3. Bone may be maintained for grafting by freezing. One acceptable method of stor- age is to culture the-bone, place the bone, cut to desired shape and size, into a sterile container which retards moisture loss, and freeze. A cryoprotectant may be utilized. Short-term storage (less than six months) at -15 "C has been reported." Long-term storage (indefinite) has been reported at -20 "CI8, -70 "CI9, and -170 with clin- ical success. Bone should remain frozen until utilized and may be thawed in a warm physiologic solution. Other methods are available and may be utilized after appro- priate evaluation.

4. Bone may be processed by ethylene oxide

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sterilization for grafting.2’ 5 . Bone may be processed by freeze-drying

or irradiation by a banking facility. These processes are generally too costly for in- house application.

Recommended Practice VII

Cartilage processed for transplantation should be obtained from a suitable donor, collected under aseptic conditions, trans- planted immediately or stored in a controlled, safe environment.

Interpretive statements 1. Study of fresh and unprocessed cartilage

allografts has demonstrated a viability of two years.”

2. Cartilage may be frozen by the method described for bone with variable

Recommended Practice VIII

Blood vessel tissue for transplantation should be obtained from a suitable donor, collected under aseptic conditions, transplanted im- mediately or stored in a controlled, safe envi- ronment.

Interpretive statements 1.

2.

orientation and ongoing education of all appropriate personnel in the institution.

Rationale Written guidelines shall be available for all

personnel involved with procedures that are commonly used in patient care and known to be associated with nosocomial infection potential.”

Guidelines These guidelines represent general informa-

tion to be used when implementing the preceding recommended practices.

1, All the methods and materials used in col- lecting, preserving, and storing of tissue should be available and functional.

2. Composition of the storage solution should be considered with regard to the donor’s and recipient’s antimicrobial hypersen- sitivities.

3. When practical, final results of cultures should be documented prior to tissue graft

4. Positive culture reports may indicate that tissue should not be used. Donor tissue should be destroyed in accordance with institution policies.

5 . Culture reports should be filed in the re- cipient’s medical record.

6. Tissue obtained from contract tissue banks

Use.

Fresh unprocessed autograft tissue has been utilized successfully for transplanta- tion. Blood vessel tissue may be processed for short-term storage in a chemically defined medium.”

should have directions for storage and re- constitution.

Notes I . Alfred M Sadler Jr. Blair L Sadler, and E

Blythe Stason, “The uniform anatomical gift act: A model for reform,” Journal of the American Medical Association 206 (Dec 9, 1968) 2501-2506.

2. Philip Duffy, et al, “Possible person-to-person transmission of Creutzfeldt-Jakob Disease,”The New England Journal of Medicine 209 (March 1975) 692;

Recommended Practice IX

Policies and procedures on storing, preserv- ing, and maintaining skin, bone, cartilage, and blood vessel tissue should be written, re- viewed annually, and readily available within the institution.

Interpretive statements 1. Policies and procedures establish author-

ity, responsibility, and accountability for evaluation, selection, and procurement of materials.

2. This information should be included in the

S A Houff, et al, “Human-to-human transmission of rabies virus by corneal transplant, ”The New England Journal of Medicine 300 ( I 1) (March 15, 1979) 603- 604; “Human-to-human transmission of rabies via corneal transplant-Thailand,” Morbidity and Mortal- ity Weekly Report 30 (Sept 25, 1981) 473-474; J 1 P James, “Tuberculosis transmitted by banked bone,” Journal of Bone and Joint Surgery 358 (1953) 578.

3. I Penn, “The incidence of malignancies in transplant recipients, ” Transplantation Proceedings 7 (June 1975) 323-326; R E Wilson, I k n n , “Fate of tumors transplanted with a renal allograft,” Trans- plantation Proceedings 7 (June 1975) 327-33 1.

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4. Robert W Bright, Gary E Friedlaender, Ken- neth W Sell, “Tissue Banking: The United States Navy Tissue Bank,”Military Medicine 142 (7) (July

5 . Morbidity and Mortality Weekly Report, “Human-to-human.transmission of rabies via corneal transplant,” 473-474.

6. “Recommended Practices for Basic Aseptic Technique,” AORN Standards and Recommended Practices for Perioperative Nursing (Denver: Associ- ation of Operating Room Nurses, Inc, 1983), Part III, Section 2, 1-4.

7. “Recommended Practices for the Preoperative Skin Preparation of the Patient,” AORN Standards and Recommended Practices for Perioperative Nurs- ing (Denver: Association of Operating Room Nurses, Inc, 1983) Part 111, Section 9, 1-3.

8. Lewis Coriell. “Contamination control,” Organ Preservation for Transplantation, ed. A Karow (New York: Marcel Dekker, Inc, 1981) 85-99; Samuel H Doppelt, et al, “Operational and financial aspects of a hospital bone bank, ” The Journal of Bone and Joint Surgery 63 (December 1981) 1472-1481.

9. AORN, “Recommended Practices for the Pre- operative Skin Preparation of the Patient. ”

10. William W Monafo, et al, “Bacterial contami- nation of skin used as a biological dressing. A poten- tial hazard,” Journal of the American Medical Asso- ciation 235 (March 22, 1976) 1248-1249; Duffy, “Possible person-to-person transmission of Creutzfeldt-Jakob Disease, ” 692; Houff, “Human- to-human transmission of rabies virus by corneal transplant,” 603; James, “Tuberculosis transmitted by banked bone,’’ 578.

11. John Ninneman, Jack Fisher, “Skin and chorioamnion, ”Organ Preservation for Transplanta- tion, ed. A Karow (New York: Marcel Dekker, Inc,

12. Gary E Friedlaender, “Current concepts re- view bone-banking, ” The Journal of Bone and Joint Surgery 64 (February 1982) 307-311.

13. Ninneman, “Skin and chorioamnion,” 41 1. 14. Ibid. 15. S Randolph May, Frederick A DeClement,

“Skin banking methodology: An evaluation of pack- age format, cooling and warming rates, and storage efficiency,” Cryobiology 17 (1980) 33-45.

1977) 503-5 10.

1981) 41 1-427.

16. Ninneman, “Skin and chorioamnion,” 411. 17. T I Malinin, “University of Miami tissue bank:

Collection of postmortem tissues for clinical use and laboratory investigation, ” Transplantation Proceed- ings 8 (June 1976) 2 Supplement 1, 53-58.

18. Frank Panish, “Allograft replacement of all or part of the end of a long bone following excision of a tumor,” The Journal of Bone and Joint Surgery 55

19. Bright, “Tissue banking: The United States (January 1973) 1-22.

Navy tissue bank,” 503-510.

20. Philip J Boyne, “Review of the literature on cryopreservation of bone,”Cryobiology 4 (May-June

21. Ralph B Cloward, “Gas-sterilized cadaver bone grafts for spinal fusion operations-A simplified bone bank,” Spine 5 (January-February 1980) 4-10; Donald J h l o , Peter W Pedrotti, David H White, “Ethylene oxide sterilization of bone, dura mater, and fascia lata for human transplantation, ” Neurosurgery (May 1980) 529-539.

22. Kenneth P H Ritzker, et al, “Articular cartil- age transplantation, “Human Pathology 8 (November

23. Friedlaender, ‘‘Current concepts review bone-banking,” 307-31 1; Doppelt, “Operational and financial aspects of a hospital bone bank,” 1472.

24. Malinin, “University of Miami tissue bank Collection of postmortem tissues for clinical use and laboratory investigation,” 53.

25. Accreditation Manual for Hospitals I983 (Chicago: Joint Commission on Accreditation of Hos- pitals, 1982) 76.

1968) 341-357.

1977) 635-65 1.

Sigma Theta Tau Installs Officers The seven member Council of Sigma Theta Tau was elected and installed for the 1983-1985 biennium during the Society’s 27th Biennial Convention in Boston.

Lucie Young Kelley, RN, PhD, FAAN, was installed as Resident. Currently, Kelly holds a dual appointment as professor of public health and nursing at Columbia University, New York City. She is the editor of Nursing Outlook and has served as senior editor of I m g e , the official journal of Sigma Theta Tau. Vemice Ferguson, RN, MS, was elected to serve a two-year term as president-elect. Dr Angela B m n McBride, associate professor and chairperson, graduate department of psychiatric/mental health nursing, Indiana University School of Nursing, Indianapolis, was elected first vice-president, and Dr Beth Vaughan-Wrobel, associate professor and coordinator of graduate studies, Texas Women’s University, Dallas Center, was reinstalled as second vice-president.

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