Ocular tissue provided by Sierra Donor Services Eye Bank is superior. Single-minded adherence to excellence and safety in the handling of every graft recovered at our eye bank, translates into the highest quality tissue, allowing you to focus on your patient.
Safety for Patients
Displaying an extraordinary commitment to quality and excellence, the Sierra Donor Services Eye Bank adheres to the highest standards for safety and efficacy of tissues, ensuring that all recovered corneas are optimum for transplantation. SDS Eye Bank’s robust quality systems ensure that each ocular graft meets or exceeds stringent regulatory requirements. The SDS Eye Bank is accredited to procure, process, evaluate and distribute all ocular tissue by the Eye Bank Association of America (EBAA). The SDS Eye Bank also meets and exceeds all standards set by the US Food and Drug Administration (FDA).
SDSEB has strict donor screening and eligibility criteria to mitigate the risk of disease transmission. This involves obtaining and reviewing a comprehensive social and medical history of the donor. This process adheres to rigorous guidelines set by all governing bodies, including the Centers for Disease Control (CDC) and the FDA.
To further enhance the safety of ocular tissue, serum samples obtained from the donor are tested by a CLIA certified laboratory. SDSEB performs a hemodilution assessment of each donor blood sample to ensure absolute accuracy of infectious disease testing results. We screen for the following:
- HIV-I & II Antibodies
- Hepatitis B surface antigen
- Hepatitis B core total antibody
- Hepatitis C antibody
- HIV-I, HCV and HBV Nucleic Acid Test by Transcription Mediated Amplification
Tissue is processed and released for transplantation only after all serological test results are negative.
Tissue Processing and Evaluation
At Sierra Donor Services Eye Bank, every cornea goes through multiple evaluation steps, utilizing the newest technology in specular and slit lamp bio-microscopy.
The SDS Eye Bank ocular tissue processed for EK use undergoes the same aforementioned examinations, as well as a fourier-domain optical coherence tomography exam, to ensure precise microkeratome preparation of lamellar grafts. The tissue is aseptically prepared in an ISO 5/class 100 environment, which undergoes routine environmental monitoring and exceeds EBAA standards. Reagents, equipment, instruments, and packaging materials utilized in the processing meet operating room standards.
In addition, all processes and equipment are validated by our medical directors to ensure consistent results and adherence to high standards. And finally, our eye bank technical staff is routinely evaluated by our medical directors to ensure consistent, optimum outcomes.
Focal Point – Quality
“You won’t get any better quality tissue than you receive from Sierra Donor Services Eye Bank. By mobilizing the power of people and the potential of technology, we are honored to extend the reach of each donor’s gift and share the Gift of Sight.”
Dr. Mark J Mannis
Sierra Donor Services Eye Bank is the preferred provider of ocular tissue in the communities from where our donor tissue is recovered. We are driven by a team of professionals who are passionate about assuring that quality ocular grafts are delivered on time to meet surgical needs and enhance the lives of patients.
Specifically, the SDS Eye Bank Quality Department performs a full quality audit of every procedure, including a review of all medical and hospital reports for each donor. This exhaustive review includes a thorough examination of: hospital records, laboratory and pathology reports, donor recovery records, tissue processing and any other pertinent information to determine suitability of tissue for transplant. Our quality department also ensures that laboratory space, equipment, and materials are in compliance with maintenance, monitoring and storage requirements of all regulatory bodies.
Sierra Donor Services Eye Bank’s entire Quality Department staff has received multiple certifications through the American Society of Quality (ASQ), the national body which oversees quality. All staff members have successfully completed the Certified Quality Improvement Association’s (CQIA) exam. This degree of quality certification is rare within the eye bank industry.
The SDS Eye Bank’s relentless focus on quality and attention to every detail plays a key role in process improvement. This allows for progressive change that translates into full confidence in the safety and quality of our tissue — on the part of our surgeons, partners and patients.