Proposed recommended practices for

storing, preserving, and maintaining

skin, bone, cartilage, and blood vessel

tissue

934 AORN Journal, Apr

he following draft is being published for review and comment by AORN T members. The AORN Recommended

Practices Subcommittee of the Technical Practices Coordinating Committee (TPCC) is interested in receiving comments on this pro- posal from the members.

These are intended as achievable recom- mendations representing what is believed to be an optimal level of practice. Variations in institutional environment and clinical situations may determine the degree to which the rec- ommended practices can be fulfilled.

Although nonmembers may submit com- ments, the subcommittee's intent is to reach a consensus among AORN members. All com- ments from members will be acknowledged and considered by the subcommittee before the final approval of these recommendations by the TPCC and the AORN Board of Direc- tors. Comments should be sent to

Recommended Practices Subcommittee AORN 10170 E Mississippi Ave Denver, Colo 80231 Attention: Colleen K Harvey, RN

The deadline for comments is June 15, 1982.

Purpose. These guidelines reflect current medical and technical methodology for pro- cessing, preserving, and storing selected human tissue. These recommended practices will provide guidance for developing institu- tional procedures that are specific and compat- ible with the institution's physical facility, pa- tients' needs, and personnel capabilities or expertise. If criteria in the recommended prac- tices cannot be met, then the institution should reevaluate its current practices.

These recommended practices are not in- tended as criteria to be used in a regional tissue banking facility where research and clin- ical investigation are used to determine allo- grafts' clinical usefulness. The methodology of procuring and preserving tissue grafts is gen- erally determined at each tissue bank. The most widely accepted method for preserving nonviable grafts is freeze-dryinghyophilizing. This method allows for irradiation to sterilize tissue that must be removed during unsterile procedures.

Not every medical facility will have a need to establish a tissue bank. Before making such a

d- .il1982, Vol35, No 5

decision, consideration should be given to personnel, equipment, and practical opera- tional requirements for providing safe, reliable, and biologically useful tissue grafts.

The objective of these guidelines is to provide individual health care institutions that collect and preserve tissue for transplantation with information essential to achieving a safe, effective, transplantable product.

The recommended practices are provided to ensure compliance with nationally accepted standards and guidelines when individual facilities are securing autogenous and allograft tissues for future grafting. The recommended practices will provide information relating to skin, bone, cartilage, and blood vessel grafts, recognizing that there are many other forms of tissue, organs, and cells to be considered in a total tissue bank concept.

Recommended Practice 1. The procedures for collecting tissue for grafting must be performed under aseptic conditions and should meet the recommended practices established for operating rooms.

Interpretive statements 1. A sterile field is maintained in accordance

with established procedures. 2. The donor site and/or operative site is

prepared in accordance with established policies and procedures of the institution.

3. Documentation and a sterilizer-load re- trieval system are established and main- tained for each sterile item used in pro- cessing, packaging, and/or preserving tissue for transplantation.

4. In the operating room physical environ- ment, risk of contamination must be mini- mal.

5. Donor tissue should be obtained and sent to the microbiology laboratory for aerobic and anaerobic bacteria, mycobacteria, and fungi cultures.

Rationale 1. There are two ways to preserve tissue,

and both are used in current tissue bank- ing.' a. Viable tissue is handled in such a way

as to preserve viability essential to its function.

b. Nonviable tissue is not handled in

ways so as to preserve viability, be- cause viability is not essential to func- tion.

c. Nonviable allografts can be used with a minimal or insignificant immune re- sponse.

2. Quality control protocols must be con- cerned with contamination and donor his- tory, eg, cancer, venereal disease, hepa- titis, mycobacteria, and autoimmune dis- eases.* Patients with neurologic diseases of unknown causes should not be used as donor^.^ This protocol is similar to a blood donor history.

Recommended Practice II. Donor tissue is stored in a controlled, safe environment.

interpretive statements 1. All containers used for tissue storage are

sterile. 2. Tissue from the donor is transferred to the

storage container using aseptic tech- nique.

3. Skin is stored in a sterile and isotonic solu- tion (eg, normal saline or balanced salt solution).

4. Skin may be stored under refrigeration for 24 hours between 1 C and 10 C. A 72-hour storage is recommended if antimicrobial solutions have been added, but data are inconclusive for recommending the type of antimicrobial solutions that are effec- tive.

5. Bone identified as a graft material must be frozen and stored at -15 C and must re- main frozen until thawed for use.

6. Thawed bone graft tissue must remain re- frigerated at 4 C and used within 24 hours.

7. Preservation and storage for cartilage, dura, and blood vessels are the same as outlined for bone.

8. If solutions are used in storage containers, containers should be labeled indicating the solution composition.

9. The refrigeration and freezer units used for storage of tissue are closely monitored for accuracy and deviations in tempera- tures. If the temperature fluctuates out- side the recommended temperatures, the specimen grafts may need to be de- stroyed.

10. A daily verification of the refrigeration and

938 AORN Journal, April 1982, Vol35, No 5

11.

freezer temperature ranges is recorded and initialed by the responsible person. The unit should also be equipped with an automatic temperature warning system. These units are to be used solely for the storage of tissue.

Rationale 1. Storage methods such as refrigeration

and freezing should inhibit degradation of the graft material by autolysis or microbial growth.

Recommended Practice 111. Documentation and records should be kept to ensure that the pertinent data are retrievable.

Interpretive statements 1.

2.

3.

4.

A form attached to the tissue container includes the following information: donor name; hospital identification number; any pertinent medical information, including history of infectious diseases, ie, slow virus, persistent virus, pathology reports, type and anatomic site of tissue being preserved, and date and time of collec- tion. The culture report, when returned from the microbiology laboratory, is attached to the tissue container. A record is maintained in accordance with the institution's policies and procedures containing the following information: donor name; hospital identification number; any pertinent medical informa- tion, including history of infectious dis- eases, pathology reports, type and anatomic site of tissue, and date and time collected; storage solution and composi- tion; recipient's name; hospital identifica- tion number; and date, time, and anatomic site of transplantation. A consent form must be signed in accordance with the institution's policies and procedures designating knowledge of the donor or next-of-kin that donated tissue is being preserved for future trans- plantation.

Recommended Practice IV. A written policy and procedure will be developed for each type of tissue collected, preserved, and stored to constitute a formal quality control protocol.

Interpretive statements The written policy and procedure will de- termine the responsibility and account- ability for tissue banking in the institution. The policy and procedure will provide a detailed reference for staff use. The use of tissue transplantation pro- tocols will be reviewed by the institution's human use review committee. The policy and procedure must be re- viewed at predetermined intervals and updated in accordance with changing sci- entific data.

Guidelines These guidelines represent general informa- tion to be used when implementing the preced- ing

1.

2.

3.

4.

5.

6.

7. 8.

recommended practices. Specific quality control measures and pro- tocols must be instituted to document the need for each graft. All the methods and materials used in col- lecting, preserving, and storing of tissue must be available and functional. Composition of the storage solution must be considered with regard to the donor's and recipient's antimicrobial hypersen- sitivities. Final results of cultures must be docu- mented prior to tissue graft use. Positive culture reports indicate that tis- sue is not to be used. That tissue should be disposed of in accordance with policy. Culture reports should be filed in the re- cipient's medical record. Fresh osteoarticular grafts are not stored. For tissue obtained from contract tissue banks, supplied directions are to be fol- lowed for storage, reconstitution, and documentation of individual specimens.

Notes 1. Joseph Mathews, MD, Tissue Bank Division,

Department of Clinical and Experimental Immunol- ogy, Naval Medical Research Institute, Bethesda, Md, personal interview with Darlene McLeod, July 22, 1980.

2. /bid. 3. "Human-to-human transmission of rabies via

corneal transplant-Thailand,'' Morbidity and Mor- ta/ity Week/y Report 30 (Sept 25, 1981) 473-474.

Suggested reading Bright, Robert W; Friedlaender, G E; Sell, K W; "Tis-

sue banking: The United States Navy tissue

AORN Journal, April 1982, Vol35, N o 5 939

bank."Mi/itaryMedicine 141 (July 1977) 503-510. Craig, Charles P. 'Infection control practices in tis-

sue banks." In Infection Control and Urological Care (Deerfield, 111: Travenol, Inc, 1979) 14-17.

Friedlaender, G E. "The antigenicity of preserved allografts." Transplantation Proceedings 8 (2 supplement 1) (June 1976) 195-200.

Friedlaender, G E. "Personnel and equipment re- quired for a 'complete' tissue bank." Transplanta- tion Proceedings 8 (2 supplement 1) (June 1976) 235-240.

Friedlaender, G E, et al. "The impact of tissue bank- ing on the treatment of musculoskeletal system trauma." Military Medicine 142 (November 1977)

Prolo, D J, et al. "Ethyleneoxide sterilization of bone, dura mater, and fascia lata for human transplanta- tion." Neurosurgery 6 (May 1980) 529-539.

Sell, K W. "Tissue banking for transplantation in perspective." Transplantation Proceedings 8 (2 supplement 1) (June 1976).

858-861.

NLN sponsors program for nurse executives The National League for Nursing's Division of Continuing Education will sponsor a series of continuing education programs for nurse administrators. The "Nurse Executive Series," to be held from April through June at the Grand Hyatt Hotel in New York City, will bring a broad, multidisciplinary perspective to issues affecting the role of executives in nursing service and education. Speakers will be prominent authorities in health care, the corporate world, and the political sphere.

Carolyne Davis, RN, administrator of the Department of Health and Human Services' Health Care Financing Administration, will initiate the series on April 1. Davis, who administers funds for the federal Medicare and Medicaid programs, will analyze why the nurse executive needs a global perspective on today's complex and diverse health care delivery system.

vice-president of Blue Cross of Greater New York, will present a perspective on reimbursement systems, examining methodologies nurse executives should be familiar with to understand the health care marketplace, assume responsibility for budget development, and create an environment for professional nursing practice.

"The Nurse Executive's Influence on Electoral Politics: The Nursing Vote," will be offered by Carol Bellamy, president of the New York City Council, on May 13. At a time of federal cutbacks and increasing emphasis on state and local legislative arenas, Bellamy will offer practical advice

On April 22, Jack Farmer, MD,

on effectively influencing the political system.

Management challenges posed by such significant trends as the rapid growth of multihospital systems will be examined on June 3 by Kathy Mershon, RN, vice-president of nursing for Humana Corporation. Mershon's presentation, "Nursing is a Business: The Corporate Perspective," will address nursing's role in one of the largest and costliest businesses in the United States-the health care industry.

Dorothy del Bueno, RN, associate dean for continuing education at the University of Pennsylvania, Philadelphia, will discuss personal money management for the nurse executive on June 17. Del Bueno will focus on the growing responsibilities and influence of the nurse executive and the related organizational and fiscal management needs and opportunities.

The format of the programs will allow opportunities for dialogue with peers and will provide a common meeting ground for interaction among many of the nation's foremost nurse executives.

Further details may be obtained from Frank Shaffer, director, Division of Continuing Education, National League for Nursing, 10 Columbus Cir, New York, NY 10019, (212) 582-1022.

AORN Journal, April 1982, Vol35, No 5 943