Ministry of Health
NZ Government

Physiotherapy Inquiry

FINDINGS & CONCLUSIONS
ON THE TERMS OF REFERENCE

Contents

TERM ONE

Whether changes were introduced to the provision to chest physiotherapy treatment (the treatment) provided to pre-term babies at NWH in or around April 1993?

Conclusion

Changes were introduced to the provision of chest physiotherapy treatment ("the treatment") provided to pre-term babies at NWH. These changes were:

• The treatment of chest physiotherapy was available 24 hours a day, namely a maximum of six times a day, compared to a maximum of four times a day for the period 1989 to 1993 and a maximum of five times a day between 1985 to 1989.
• Nurses were introduced to the provision of chest physiotherapy by being trained in the technique of positioning and percussion. Those nurses (and physiotherapists) undertook this technique, following completion of the training of the nurses, the first of which occurred in June 1993.

• TERM TWO

If changes were made:

• What key differences were there in the way in which the treatment was performed prior to April 1993 and during the period April 1993 and December 1994, including comparisons with other selected hospitals?

Conclusion

The reference to April 1993 is not particularly relevant as the change in practice began to be phased in from June 1993.

• There were two changes at NWH after June 1993 as indicated under Term of Reference One: the treatment was available 24 hours per day, and nurses began to perform the treatment, namely chest physiotherapy by the technique of percussion.
• The percussions were given with greater vigour at NWH than at other hospitals.
• The duration of percussion was greater at NWH than at other hospitals.
• The stability limits of the baby during physiotherapy were allowed to vary to a greater degree than at other hospitals.
• The trend of decreasing need for physiotherapy during 1992-1994 at other hospitals was not evident at NWH.

• Did the changes result in patients being given treatment in a manner which failed to meet the protocols which existed at that time either in New Zealand or internationally governing the intensity and duration of this form of treatment?

Conclusion

The changes did not result in patients being given treatment in a manner that failed to meet the protocols in New Zealand or internationally at the time.

The protocols were of variable quality. Although the physiotherapy treatment at NWH was substantially different from the treatment in other units, this difference would not have been apparent from inspection of other protocols.

• Why did NWH change its policy on the administration of this form of treatment?

Conclusion

NWH changed its policy on the administration of this form of treatment to provide 24 hour care to the babies to prevent overnight deterioration of their condition. The financial considerations and physiotherapy resources were secondary to the clinical reasons for the change.

• What steps were taken before and after the changes in treatment were introduced, including the:

clinical assessments (if any) which were carried out of the need or reason for the change, or any review of the treatment;

Conclusion

• No specific clinical assessments were made of the need, but the evidence from the medical, nursing and physiotherapy witnesses indicated it was clinically motivated.
• The only clinical assessment or review of the treatment after the change was the informal review of nurses following their training.
• assessments (if any) of the risks associated with the change in treatment including the steps taken to minimise any risks;

Conclusion

• Before the changes were introduced there was an assessment of the risks associated with the change. They were that nursing staff, untrained in physiotherapy would carry out the chest physiotherapy technique of positioning and percussion, and that the treatment might not be carried out appropriately. Steps taken to minimise these risks were that only senior nurses undertook the training, there was a planned training programme for nurses, and detailed nursing protocols were developed. In addition, detailed record keeping was required, and the daytime physiotherapist would leave written instructions regarding the overnight chest physiotherapy to be performed by the nurses.
• After the change there were no assessments of the risk of the chest physiotherapy treatment until December 1994 when the association was suspected. This is regrettable because a variety of factors arose which in hindsight can be seen to be indicators of risk. These were the Registrar's complaint, the IVH comment and the neck and shoulder pain of the nurses.

• At the time, NWH did not perceive any risk from the treatment, as evidenced by its omission from the 50 factors identified in the first case-control study. Once the association with the treatment was suspected, a detailed assessment of the risk of the treatment was undertaken.

assessments carried out of the training needs of the staff who would be called upon to provide the treatment;

Conclusion

In June 1993 there were three categories of staff providing the treatment:

• One health professional, who had paid informal visits to overseas units but who was not formally assessed with respect either to training or to practice.
• Physiotherapists, who were assessed annually by the staff member mentioned in (a).
• The nurses had their training needs assessed and set by the Physiotherapy Working Party prior to the change and were trained by the staff member mentioned in (a).
• assessments made of the need to seek parental consent for the change in treatment proposed?

Conclusion

There were no such assessments made.

• (e) Were the steps taken by NWH, before and after introducing the change in the way in which the treatment was performed, consistent with relevant New Zealand or international clinical or ethical guidelines for affecting changes to treatment protocols?"

Conclusion

• Treatment Protocols

The implementation of the changes did not require ethical review or approval, on the wording of the 1991 National Standard, which was applicable in 1993. It would have been outside standard practice to seek ethical review at the time of implementing the change in treatment.

• Parental Consent

For treatment or the change in treatment

Parental consent was not obtained for either the treatment of chest physiotherapy or for the change in treatment. The consent for a change in treatment was not required, but the issue of consent to treatments given or undertaken needs to be addressed. Apart from treatments which contain a degree of risk or treatments being used for research purposes, the present practice of NWH and other units in New Zealand is not to seek consent for treatment.

The various treatments and procedures undertaken in a neonatal intensive care unit, given the exigency of the situation and the developing technology, requires the issue of informed consent from parents on behalf of their babies, particularly in the neonatal intensive care unit, to be properly addressed for the future at a national level.

• For Training

Parental consent for training was not sought. The relevant guidelines require parental consent for training, although no distinction is drawn between training of clinical staff and training of students.

Because of the divergence between national practice and the guidelines, further clarification of this issue at a national level is required.

• Research

The case-control study being a retrospective review of medical records was research but also conformed to the definition of "internal clinical audit" contained in the 1991-1994 Ethical Standard. It therefore did not require referral to the Ethics Committee.

• Patient Advocacy

The Patient Advocacy Service was not involved in assisting the parents in this Inquiry. Positive steps must be taken to ensure that referrals of patients, including parents receiving news such as in this Inquiry, to the Patient Advocacy Service is undertaken and encouraged to ensure full accessibility by patients to a service which may assist them in obtaining information and liaising with the clinicians of the relevant section of the Hospital. The positive role which the Patient Advocacy Service can plan in assisting patient should be encouraged.

• Peer Review

To ensure safe practice at all levels within the health profession including specialist senior experts, effective peer review must be undertaken, even if access to overseas experts is required in some circumstances.

• (f) Were the changes in treatment implemented as planned by NWH?

Conclusion

The changes in treatment were implemented as planned with two exceptions.

• The training of the nurses appeared to take longer than had originally been anticipated
• The clinical audit planned for 1994 did not take place.

• (g) Was there any training and ongoing supervision provided to staff carrying out the treatment and was this training and supervision in accordance with relevant New Zealand or international standards or protocols?

Conclusion

(a) (i) The training of nurses at NWH in the treatment was thorough.

(ii) The supervision of the nurses was informal and consistent.

• The training and supervision of the staff physiotherapists was satisfactory.
• The health professional responsible for the treatment learnt it by observing other pioneers in the technique and introducing it to NWH. This occurred without technical supervision and without peer review, which was not required in any relevant New Zealand Code of Ethics or practice guideline at the relevant time. This was consistent with the international practice, in that international standards did not appear to require ongoing supervision for that particular category of health professional

There are no relevant standards and protocols for training and supervision of staff carrying out this treatment.

• What steps were taken by NWH (if any):

(i) to assess the safety and efficacy of the treatment provided during April 1993 to December 1994;

Conclusion

The steps taken by NWH to research and publicise the results of the link between chest physiotherapy treatment as practised at NWH and the brain lesion were timely and appropriate. NWH deserve commendation for their openness in acknowledging the tragic occurrence within their unit, to alert others of the potential consequences.

• to inform and support parents with respect to the onset of brain damage in their children if such steps were necessary?

Conclusion

(a The initial steps taken by NWH staff to inform parents of the brain damage to their children were appropriate, professional and timely, with the exception of the omission to involve the Patient Advocacy Service.

• Referral to the Patient Advocacy Service could have assisted in providing further information and support to those parents requiring it.