Test Taking 101 for Medical Directors: Preparing for an EBAA Site Inspection

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Test Taking 101 for Medical Directors Preparing
for an EBAA Site Inspection
Michael L. Nordlund, MD,PhD Co-Chair
Accreditation June 20, 2009
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Brief History of Eye Banking

• Pre-Eye Banks
• Cornea surgeon
• Determined donor eligibility
• Recovered tissue
• Processed tissue
• Evaluated tissue
• Stored/Transported tissue
• Distributed tissue
• Maintained records
• Transplanted tissue

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The Medical Director

• Solely responsible for ensuring the quality of
  the tissue
• Donor Eligibility
• Tissue Evaluation
• Recovery
• Processing
• Storage
• Distribution

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The EBAA Site Inspection

• Purpose To evaluate compliance with the EBAA
  medical standards.
• Rationale EBAA medical standards are a
  compilation of the minimum processes and policies
  determined by a consortium of corneal surgeons
  and eye bankers (the MAB) to be prerequisite for
  appropriate determination of donor eligibility
  and the recovery, processing, storage, evaluation
  and distribution of quality corneal tissue.

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The Medical Standards

• The Medical Director shall oversee and provide
  advice on all medical aspects of the Eye Bank
  operations. These include but are not limited to
• 1. Formulation, approval, and implementation of
  medical policies and procedures.
• 2. Participation in training and oversight of
  technical staff with regard to tissue recovery,
  tissue preservation, tissue processing, and
  tissue evaluation.
• 3. Participation in establishment and operation
  of a quality assurance program.
• 4. Responsibility for verification of competency
  for tissue procurement and preservation by
  personnel applying for CEBT certification

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Inspection

• 1. Formulation, approval, and implementation of
  medical policies and procedures.
• Review of policy and procedures manual for
  medical director signature.
• Is there documentation that the Director
  consulted with the Medical Director to address
  routine medical operations?
• Is there documentation that the Medical Director
  has met with the eye bank's administrative and
  technical staff within the last six months?

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Inspection

• 2. Participation in training and oversight of
  technical staff with regard to tissue recovery,
  tissue preservation, tissue processing, and
  tissue evaluation.
• Is there documentation that the Medical Director
  participated in the oversight and training of
  technical staff?
• Is there a written statement from the Medical
  Director or Medical Director designee specifying
  which procedures each individual staff member is
  qualified to perform independently, including
  determination of suitability and release of
  tissue for transplant?

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Inspection
PT!!
PT!!

• 3. Participation in establishment and operation
  of a quality assurance program.
• Does the QA program include participation by the
  Medical Director in establishment of operations
  and review of the QA program?
• Is there written documentation that the Medical
  Director has reviewed all adverse reactions that
  were reported since the last site inspection,
  evaluated the potential causes of those adverse
  reactions, and taken corrective actions (if
  indicated) to prevent future occurrences of
  similar events?

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Medical Director Interview
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Preparing for the Inspection

• Review policies and procedures
• Age limits and other details
• Be involved year round in personnel training and
  evaluation
• Treat like residents in surgery
• Be involved year round in QA
• Perform your own mock inspection

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Conclusions

• The medical director is the eyes and ears of
  every transplanting corneal surgeon that receives
  tissue from their bank and needs to be
  sufficiently involved in the daily operations of
  the eye bank to be comfortable attesting for the
  quality of the corneal tissue.