A report to PA-PSRS indicated that a facility had implanted a cornea that may have come from a donor with hepatitis B. Upon further investigation, the facility determined that the patient did not receive the cornea from that donor. The actual error was that the paperwork did not match the cornea. This incident prompted the organization to review its tissue procurement policy and procedure and become aware of the new JCAHO standards.

In another reported event, an implanted cornea tested positive for enterococcus on the transplant culture obtained at the time of surgery. However, few organisms were detected, and the cornea recipient was asymptomatic. Both the eye bank and the hospital concluded that the contamination probably occurred during specimen transfer.

A recently reported case resulted in endopthalitis:

A patient who had a corneal transplant developed a case of endopthalmitis one day postoperatively. The patient was treated by a retinal specialist and did well. Two months post-procedure, the patient developed a lesion on the cornea and required corneal biopsy and cultures.

These cases bring to attention the inherent risks associated with any transplant, whether it is an organ, a tissue, or a cornea. The patient, staff, physician, and receiving organization trust and have confidence that the transplant is safe for implantation as presented and that it has been obtained with the consent of the donor’s next of kin. This trust was violated in the recently reported scandal in which implants were acquired illegally and with none of the medical safety practices in place.^1,2

Efforts to protect the public from similar transplant issues have been initiated by the Eye Bank Association of America (EBAA), the American Academy of Ophthalmology (AAO), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the U.S. Food and Drug Administration (FDA). The standards in place to protect patients undergoing corneal transplants are reviewed below.

Eye Banks

The first eye banks were established in the 1940s. In the following decades, eye banks flourished and the American Academy of Ophthalmology and Otolaryngology (which later separated into two organizations) recognized the need for standardization. In 1961, EBAA was established.^3,4 Eye banks remained self-regulated until 1993, when FDA oversight began.³ Since 1998, Medicare has required hospitals to maintain a contractual relationship with organ procurement organizations and tissue and eye banks.⁵

Eye banks maintain operational standards for recovery, storage, evaluation, and distribution of corneal, scleral, and whole-globe tissue.⁴ AAO’s policy statement supports maintaining “current quality control efforts in eye banks” instead of imposing “more general standards and costly federal certification.”⁶ EBAA’s medical standards provide both the operational and practice framework for a consistent level of quality. These standards have the approval of AAO’s Eye Banking Committee and are discussed in this article.⁷

Corneas are the most commonly transplanted solid tissue.³ In 2004, eye banks provided more than 51,500 corneas for keratoplasties.⁶ The rate of cornea transplantation success (indicated when the recipient can read with vision of 20/50 or better) is greater than 90%.⁴

Cornea Procurement

The Association of periOperative Registered Nurses (AORN) recommends that tissue be procured in “clean, controlled environments, appropriate for sterile surgical procedures.”⁸ To minimize contamination, facilities consider traffic patterns when designating an area for procurement. The environment is cleaned according to AORN’s “Recommended Practices for Environmental Cleaning in the Surgical Practice Setting.”⁸ In addition, clinicians wear surgical attire and use powder-free gloves and, when indicated, latex-free supplies.⁸ EBAA accepts AORN’s recommendations as an “acceptable standard for using aseptic technique during tissue procurement, processing and storage of ocular tissues.”⁷

Corneas are sensitive tissue with an abbreviated window during which they can be retrieved.⁴ Corneas can be retrieved using two methods: in situ corneoscleral rim excision, in which only the cornea is retrieved, or bilateral enucleation.^4,9 Retrieval is performed as soon as possible after death, and the acceptable interval from death to preservation may vary according to the circumstances of death and storage of the body.⁷ One article suggests parameters of up to 12 hours after death, but retrieval preferably occurs within 6 to 8 hours.¹⁰ Cornea recovery generally takes 45 minutes to an hour and cannot occur after embalming.⁴ To remain viable, corneas are maintained at 2° to 8°C.^4,7,11 Other methods of preservation exist besides cold storage, such as storage in a nutrient medium, cryopreservation, and long-term incubation at 37°C.³

In France the annual demand for corneas exceeds the availability of donor corneas.¹² A recently published study of changes in retrieval and storage practices resulted in a reduction in the number of lost corneas due to contamination by 50%. The use of sterile physiological saline when closing the deceased eyelids in acute care settings was implemented along with changes to mortuary and eye bank practices.¹²

Managing Cornea Transplantation (Keratoplasty)

Penetrating keratoplasty is a surgical procedure in which diseased corneal tissue is removed and replaced with donor corneal material. This procedure can be done to improve visual clarity or to provide structural support.³ Keratoplasty is “one of the most common transplantation procedures performed in the United States.”³

When arrangements are made for keratoplasty, the surgery is scheduled, and either the ophthalmologist’s staff or the staff from the facility where the procedure is performed orders the cornea. Usually, this occurs six weeks before surgery.⁴ Upon the cornea’s arrival, the facility verifies that the cornea is acceptable and appropriate for the recipient. Safe tissue storage and management are essential. Additionally, the facility provides the supportive laboratory services if culturing of donor eyes is to occur, either before or during surgery.

“All intraocular procedures have a risk of postoperative endophthalmitis, which is reported to be between 0.1% and 0.4% in the case of penetrating keratoplasty.”¹³ According to one published report, postkeratoplasty endophthalmitis did not occur in thirteen patients who received an implant from contaminated corneoscleral rims.¹³ Based on that reported experience, one can expect that 95% of similar experiences should show that patients who receive contaminated corneas have an infection rate less than 25% (one in four).

Microbiological culturing of donor eyes may be performed by the eye bank; however, this is not standard practice because “bacteriologic contamination of donor eyes does not necessarily lead to infection and pre-surgical or surgical cultures may not correlate with postoperative infection if it should occur.”⁷ Ultimately, the surgeon assumes responsibility for determining the suitability of the tissue for transplantation.⁷

To provide safe corneas, accredited eye banks must follow a structured process, which includes obtaining consent for retrieval, determining the cause of the donor’s death, obtaining the donor’s medical history, and performing various blood tests on specimens obtained from the donor. Facilities performing keratoplasty have, until recently, been left to map out their own policy or protocol in transplant tissue management.

Last summer, JCAHO issued new Provision of Care standards (effective as of July 1, 2005), with emphasis on acquiring, receiving, storing, and issuing tissue, as well as providing for the traceability of tissue and responding to related adverse events.¹⁴ Additionally, JCAHO plans to offer an Organ Transplant Center Certification starting in 2006.¹⁵ According to JCAHO, tissue specimens include “bone, cornea, skin, heart valves/conduits, tendons, fascia, dura, bone marrow, veins, arteries, cartilage, sperm, embryos, eggs, stem cells, cord blood, synthetic tissue (artificially prepared, human and non-human based), and other cellular- and tissue-based transplant or implant products.”¹⁶ The Provision of Care standards are summarized below.¹⁶

Standard PC.17.10 “The organization uses standardized procedures to acquire, receive, store, and issue tissues.”¹⁶ Elements of performance include:^16,17

• Organizational coordination of tissue processing.
• Ensuring that suppliers are FDA registered or state licensed.
• Adhering to the instructions for tissue care and storage provided by the tissue or eye bank.
• Logging all incoming tissue.
• Ensuring that the temperature of all storage refrigerators and freezers is monitored and recorded daily. (Units must be alarmed and have an emergency backup.)
• Ensuring state and federal regulations are followed verifying package integrity and suitable transport temperature when accepting tissue.

Standard PC.17.20 “The organization’s record keeping permits the traceability of all tissues from the donor or source facility to all recipients or other final disposition.”¹⁶ Highlights of the elements of performance include:^16,17

• Ensuring traceability of tissue from the donor to all recipients and final dispositions, including discarding of tissue.
• Tracking and identifying materials used to prepare or process tissues.
• Documenting which staff members were involved in preparing, issuing, and accepting tissue, as well as the date and time of receipt.
• Recording in the recipient’s record the type and unique identifier of the tissue.
• Maintaining records, including temperature logs, procedures, manuals, tissue detail, and publications, for a minimum of 10 years or as required by federal or state laws.
• Returning tissue information cards to the source facility.

Standard PC.17.30 “The organization has a defined process to investigate adverse events to tissue or donor infections.”¹⁶ Elements of performance include:^16,17

• Implementing procedures for investigating adverse events.
• Reporting all infections or adverse reactions to the source facility.
• Sequestering tissue that is reported as being potentially infectious.
• Notifying tissue recipients of possible infection.
• Ensuring that procedures have been followed when an adverse event has occurred or is suspected.

When determining whether a deceased individual is eligible for tissue donation, existing limitations include not only the cause of death, but also certain diseases or infections. FDA requires that potential donors be tested for HIV and hepatitis B and C.

Hepatitis B transmission was reported in 1984 prior to the changes in the EBAA and FDA standards requiring donor testing. “Since 1986, when the EBAA initiated the requirement, there apparently have been no reports or publications documenting transmission of hepatitis B by way of corneal transplantation.”¹⁸

The following are selected additional exclusion criteria for an allograft (living or nonliving) donor for human tissue:

• Having possible transmissible spongiform encephalopathy, such as Creutzfeldt-Jakob disease (CJD) (Exclusion also applies to individuals with a blood relative with noniatrogenic CJD, individuals with rapidly progressive dementia, recipients of human pituitary-derived hormones, and recipients of human dura mater grafts.)^5,8,16
• Having autoimmune disease.⁸
• Having fever lasting at least seven consecutive days immediately before cardiac death.⁸
• Being ventilator dependent, immobile, or confined to bed for more than seven consecutive days immediately before cardiac death.⁸
• Having received a xenotransplant (a transplant from a nonhuman animal source) or being a xenotransplant recipient’s close contact (because infectious agents from the donor animal may exist).⁸
• Demonstrating any of the high-risk criteria for HIV.^5,8
• Specific to cornea tissue donors, having any intrinsic eye disease or prior intraocular or anterior segment surgery.⁷

When metabolic or bone disease, malignancy or malignant neoplasm, or disease of unknown etiology exists, AORN recommends that the medical director or medical committee review potential donors on a case-by-case basis.⁸

Reporting requirements for eye banks and surgical facilities are similar in that adverse events related to the transplant must be reported to EBAA. The EBAA medical standards require that any disease transmitted by and attributed to the transplant be reported. These recipient diseases include infections, biologic dysfunction, and even development of a systemic infectious disease such as HIV, hepatitis, syphilis, or CJD, regardless of whether the implanted tissue is the suspected cause.⁷

Cornea transplants provide the gift of sight, and essential in providing this opportunity is adherence to a regimen that is rigorous in providing oversight for each step in the procurement and transplantation process. Confidence in an eye bank’s commitment to excellence stems from decades of successfully providing corneas for transplantation with minimal issues. Today, the expectations of facilities are heightened to include accountability for transplants, a structured process, documentation of tissue management, and archival of this documentation for at least a decade. Optimal transplants and process management are the ultimate goal in ensuring the safety of corneas for implantation.

Notes

1. ECRI. Alleged illegal recovery of human tissue for transplantation [special report]. S0101. Health Devices Alerts 2005 Nov 18;29(46):1-2.
2. Powell M, Segal D. In New York, a grisly traffic in body parts. Washington Post 2006 Jan 26;Sect.A:3.
3. Mian S, Kamyar R, Sugar A, et al. Regulation of eye banking and uses of ocular tissue for transplantation. Clin Lab Med 2005 Sep;25(3):607-24.
4. Deluhery C. Eye banking: The business of restoring sight. Insight 1999 Oct-Dec;24(4):125-31.
5. ECRI. Organ and tissue donation. Healthc Risk Control 2003 Mar;Suppl A:Special clinical services 11:1-18.
6. American Academy of Ophthalmologists. Tissue procurement for corneal transplantation [policy statement online]. [cited 2006 Jan 5]. Available from Internet: http://www.aao.org/about/policy/upload/Tissue_Procurement.pdf.
7. Eye Bank Association of America. Medical standards. 2005 Nov.
8. Recommended practices for surgical tissue banking. AORN J 2004 Feb;79(2):462, 465-70, 473-8 passim.
9. Heartland Lions Eye Banks. About eye donation [online]. [cited 2006 Feb 8]. Available from Internet: http://www.hleb.org/
   Educational/donationprocess.html.
10. Cook L. Eye donation, corneal transplantation and the Lions NSW Eye Bank. Lamp 1998 Mar;55(2):42-3.
11. Net M, Trias E, Navarro A, et al. Cold chain monitoring during cold transportation of human corneas for transplantation. Transplant Proc 2003 Aug;35(5):2036-8.
12. Builles, N, Perraud M, Reverdy ME, et al. Reducing contamination when removing and storing corneas: a multidisciplinary, transversal, and environmental approach. Cornea. 2006 Feb;25(2):185-92.
13. Albon J, Armstrong M, Tullo AB. Bacterial contamination of human organ-cultured corneas. Cornea. 2001 Apr;20(3):260-3.
14. Complying with the new tissue standards. Jt Comm Source 2005 Dec;3(12):6-7.
15. Joint Commission on Accreditation of Healthcare Organizations. Joint Commission to develop organ transplant center certification program [news release online]. 2005 Aug 9 [cited 2006 Feb 3]. Available from Internet: http://www.jcaho.org/news+room/
    news+release+archives/jc_080905.htm.
16. Standards approved for transplant and implant tissue storage and issuance. Jt Comm Perspect 2005 Feb;25(2):8-11.
17. Moore DT. National Patient Safety Goals; do-not-use abbreviations; tissue banking; patient skin preparation; patient attire [online]. AORN J 2005 Apr [cited 2006 Jan 5]. Available from Internet: http://www.aorn.org/journal/2005/augci.htm.
18. Hoft RH, Pflugfelder SC, Forster RK, et al. Clinical evidence for hepatitis B transmission resulting from corneal transplantation. Cornea. 1997 Mar;16(2):132-7.