Patient Care

Certain health care procedures require body parts or bodily substances to be removed or obtained. This may be from a living or a deceased patient. Those parts or substances may then need to be disposed of or preserved. It is important for doctors to make sure that patients (or their representative/guardian/family) are properly informed about their rights in relation to such procedures, and are careful to ensure that informed consent is properly obtained.

Removal of body parts and bodily substances from a patient when they are alive

Under right 7(9) of the Code of Health and Disability Services Consumers’ Rights, patients have the right to decide what happens to their body parts or bodily substances removed or obtained in the course of a health care procedure.

A decision about the disposal or removal of body parts or bodily substances can be of significant personal and cultural importance to a patient. It is essential then that the informed consent of the patient is obtained prior to any procedure.

MCNZ provides detailed guidance on informed consent in its statement “Informed Consent: Helping patients make informed decisions about their care”:

(https://www.mcnz.org.nz/assets/standards/55f15c65af/Statement-on-informed-consent.pdf)

After a body part or bodily substance has been removed or obtained, right 7(10) of the Code provides that it may not be stored, preserved or used otherwise than:

• with the informed consent of the patient; or
• for the purposes of research that has received the approval of an ethics committee; or
• for the purposes of 1 or more of the following activities:
  • a professionally recognised quality assurance programme:
  • an external audit of services:
  • an external evaluation of services

Removal of human tissue from a deceased patient

• In general, the Human Tissue Act 2008 does not cover consent for the collection and use of tissue from living people. However, it does close a gap in current regulation by requiring consent to the analysis of human tissue (including DNA analysis) taken from living people outside of a health care procedure.

When collecting or using human tissue from a deceased patient, the Human Tissue Act 2008 applies. As with collecting or using human tissue from a patient who is alive, with limited exceptions the Act requires informed consent to be obtained (and sets out who may object to such a procedure). It also requires decision-makers and the person collecting or using human tissue to take the immediate family’s cultural and spiritual needs, values and beliefs into account.

There are a number of circumstances provided in the Act in which tissue may be collected or used after a patient has died. It is important to be aware that there is not one set of rules as to who can give consent (or raise an objection) and how that should be obtained. Where consent may be obtained from individuals other than the donor, there is a “hierarchy of consent” to be followed. In other words, you need to work your way progressively through the hierarchy until instructions are obtained, one way or the other.

For example, in relation to the collection or use of tissue for “general purposes” as defined by the Act, the Act lists four persons who may give consent (or raise an objection). The primary consent or objection is that of the deceased, if formally recorded before he or she died. (Note: having ‘donor’ recorded on the person’s drivers license is not sufficient). If there is no consent given or objection raised by that individual then consent can be sought from the below persons in the following order:

1. That individual’s nominee(s);
2. A member of the individual’s family;
3. A close relative of that individual.

In other circumstances, the entitlement to give consent may be limited to the deceased only, or perhaps two of the above persons. (Usefully, there are a number of schedules to the Act which contain flowchart diagrams of the hierarchies of consent).

It is an offence to collect and use human tissue without informed consent, with a possible penalty of 1 years imprisonment or a $50,000 fine.

Even where informed consent is obtained, consideration should be given as to whether collection should proceed. Possible reasons why collection should not proceed may include if an individual’s organs and tissue are unsuitable for donation, or where the immediate family is aware that the deceased person had changed their mind since recording their consent.

In short, when dealing with tissue and body parts of a patient, it is essential to consider the purpose for which the tissue or body part is being collected or used, whether and how informed consent needs to be obtained, and the needs, values and beliefs of the patient and their family.

Current as at 27 June 2023

For more information about the rights of patients and your responsibilities as a doctor, get in touch with NZMII’s dedicated medico-legal advisory team.

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Maintaining clear and accurate patient records is a crucial part of good medical practice and continuity of care. This factsheet covers how to properly maintain and correct patient records, and what to do when a patient asks for health information to be left off their clinical record altogether.

When dealing with patient records it should always be remembered that health information is confidential and sensitive. The Health Information Privacy Code 2020 (HIPC) contains 13 rules which set out how health information should be handled. Doctors should be familiar with these rules.

Maintaining clear and accurate patient records

Doctors have a professional obligation to maintain clear and accurate patient records. MCNZ’s guidance provides that patient records must include:

• Clinical history;
• Relevant clinical findings;
• Results of tests and investigations ordered (including any referrals made);
• Information provided and options discussed;
• Decisions made and the reasons for them;
• Consent given;
• Any requests or concerns;
• The management plan (including advice about safety netting); and
• Medication or treatment prescribed, including any adverse reactions.

It is also recommended that any other relevant information, such as the patient’s donor status, or whether they have an enduring power of attorney, is recorded.

To ensure the accuracy of the record, notes should be made contemporaneously, or as soon as possible afterwards, and they should be clear and coherent. A good rule of thumb is to consider if another doctor was to read your notes, would they have sufficient information to be able to provide care for the patient, and would they be able to arrive at the same or similar conclusion as you did in terms of diagnosis and management plan.

Amending patient records

If, on reviewing a patient’s records, you consider that the record is inaccurate, incomplete, or potentially misleading, it may be appropriate to correct it.

When amending a record, it is important that the earlier entry is not deleted or changed. The amendment should appear as an addition to the relevant note and should state who amended the note and when. You should also consider whether there are other health practitioners (for example other practitioners involved in your patient’s care) who need to be made aware of the correction.

Under no circumstances should you amend a patient’s record following receipt of a complaint. Even if done innocently, it begs the question of why you made the change, and implies you may have had something to hide.

Requests by patients to access clinical records

As provided for in Rule 6 of the HIPC, patients have the right to access their clinical records. A request to access must be responded to within 20 working days.

Generally speaking, agencies cannot charge a patient for such a request. There are some limited exceptions to this that apply to private sector agencies, for example if the request is for a copy of something like an X-ray, or if the individual has requested the same health information previously within the last year. The charge must of course, be reasonable.

If records are to be provided to a patient, care should always be taken to first verify the individual’s identity, before making them available.

Requests by patients to correct clinical records

Rule 7 of the HIPC provides that patients have the right to request a correction of their health information if they believe it to be wrong. The agency or health practitioner will need to determine whether the correction is appropriate to make. If it is, the process for correcting records (discussed above) should be followed. If the decision is made not to correct the information, a note of the request and the response will need to be recorded in the relevant clinical record, if the patient requests it.

Requests by patients to omit information from clinical record

There can be occasions where a patient will request that health information be left off their clinical record altogether. As a general rule, such requests should be declined. An inaccurate patient record may jeapordise the provision of care to the patient, for example by compromising the continuity of care.

In very limited circumstances, with the informed written consent of the patient, it may be appropriate to exclude certain health information from the record. Very careful consideration would need to be given before a decision such as this could be made however, and it would be essential to seek legal advice through your medical indemnifier first.

In summary, doctors should always be guided by the requirement that patient records are clear and accurate. When making any addition, amendment, or deletion from a patient record, doctors should always consider whether in doing so, the record will still comply with those requirements. For further guidance, check the MCNZ statement Managing patient records:  

https://www.mcnz.org.nz/assets/standards/0c24a75f7b/Maintenance-patient-records.pdf

Current as December 2022

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