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Records to be kept in relation to donated anatomical specimens
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76. (1) A responsible person shall cause to be maintained in writing or such other form as he or she considers appropriate, or the Medical Council may from time to time specify, a record (in this section referred to as “the record”) in respect of the bodies received by the licensed institution for purposes of anatomical examination at the institution.
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(2) Without prejudice to the generality of subsection (1), the following documents relating to a body received by a licensed institution shall be retained as part of the record:
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(a) a copy of the anatomical consent;
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(b) a copy of the medical certificate of the cause of death.
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(3) The record shall be—
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(a) maintained in a secure and permanent form, and
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(b) made available for inspection by the Medical Council or its officers duly authorised as authorised officers.
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(4) Where an anatomical specimen is loaned or transferred to another licensed institution or a like institution outside the State, a copy of the record shall be transferred with the specimen and retained by each of the other institutions where that specimen is loaned or transferred, however a copy of the records shall also be retained by the responsible person at the licensed institution which first received such specimen for anatomical examination.
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(5) Where an anatomical specimen is disposed of by a licensed institution, the records in respect of the specimen shall be kept and maintained in accordance with law.
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(6) The responsible person shall prepare and maintain a written statement specifying the policies and procedures in place in the licensed institution to ensure that—
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(a) there is in place in the licensed institution—
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(i) a record management system sufficient to ensure data protection and confidentiality, and
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(ii) a documented internal audit system, with an appropriate schedule and accountability,
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and
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(b) members of staff of the licensed institution are appropriately qualified and trained in respect of the duties to which they are assigned or delegated as the case may be.
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(7) A copy of the written statement referred to in subsection (6) shall be made available for inspection by the Medical Council or its officers duly authorised as authorised officers.
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