The Commissioner received a complaint from the complainant on behalf of his late wife, the consumer. The complaint was that:
- The consumer was admitted to the first public hospital in November 1997 for surgery on her knees as a result of a fall. The consumer, who suffered from partial kidney failure, was required to carry out her own peritoneal dialysis both before and after surgery. She was sometimes assisted by nursing staff who were apparently ignorant of the complicated and sterile procedures involved.
- Pethidine injections were administered on a regular basis, despite pethidine not being a preferred drug for renal patients.
- The pethidine resulted in the consumer becoming drowsy and inattentive, and not capable of maintaining high standards of sterility required for carrying out her dialysis.
- When the consumer began to vomit, the family expressed concerns over the consumer's condition and were told that it would be three to four days before a new house surgeon would be able to assess her condition and progress.
- The consumer was transferred to the second public hospital's renal unit with a peritoneal infection and died of respiratory failure in early December 1997. The first hospital did not inform the second hospital that they had admitted and carried out surgery on one of the second hospital's renal patients until late November 1997, which was well after the infection had occurred.
The complaint was received by the Commissioner on 22 December 1997 and an investigation was undertaken. Information was obtained from:
The Complainant (the Consumer's Husband)
The Consumer's Son
The Chief Medical Officer at the First Public Hospital
The Orthopaedic Surgeon/Provider at the First Hospital
The House Surgeon/Provider at the First Hospital
A Representative of the Department of Renal Medicine at the Second Public Hospital
The Renal Physician
The Orthopaedic House Surgeon
The Charge Nurse
Other information contained and considered included; the consumer's medical records, the report of the investigation into the consumer's death carried out by the first hospital and information provided to the Accident Compensation Corporation ("ACC"). Advice was obtained by the Commissioner from an independent renal specialist.
Information Gathered During Investigation
The consumer was admitted to the first hospital in mid-November 1997 having slipped and injured both knees in a fall. She was seen by the consultant orthopaedic surgeon, the orthopaedic surgeon, who arranged surgery for the following morning. The consumer was in severe pain and was given pethidine to control the pain. The consumer's surgery was performed on the following day and post operative pain was controlled using pethidine and morphine.
The consumer had end-stage renal (kidney) failure, and she had been on Continuous Ambulatory Peritoneal Dialysis ("CAPD") for fifteen months. She carried out the CAPD procedures herself four times a day. She was assisted by a district nurse who visited her at home twice a week and she was monitored by the second hospital's renal unit. While a patient at the first hospital the consumer continued to carry out her own dialysis.
The day after the operation the consumer's medical notes indicated that she suffered from nausea and vomiting and the morphine (suspected to be the problem) was discontinued. Five days after the operation the records indicated that the consumer's behaviour was becoming agitated, uncooperative and confused. By the afternoon of the following day she was noted to be, "in good frame of mind ... although fed up with bedrest". The consumer continued to receive pethidine for pain relief throughout this period.
Further to this, in a discussion held with the Commissioner's office, the orthopaedic house surgeon stated he was the orthopaedic house surgeon when the consumer was admitted after her mid-November 1997 accident. He stated he saw her on the ward round on the day after her operation and also on the following day. He stated his last day at the first hospital was two days after the consumer's operation. The orthopaedic house surgeon stated that he remembered the consumer as the chief medical officer had contacted him when the first hospital was doing an internal investigation. Further, he remembered the consumer required bed rest and pain relief post operatively, however, she seemed alert and well, and her blood tests were fine. He remembers specifically asking the consumer if she was able to carry on with her CAPD, and the consumer commenting that she was fine to do it with support from the nursing staff, if needed. The orthopaedic house surgeon stated that any instructions he received from the orthopaedic surgeon were written into the consumer's medical notes, however, he does not remember anything specific being requested.
The first hospital's internal investigation report records that six days after the consumer's operation, her son discussed his concerns that his mother's condition had deteriorated with the acting charge nurse, "he felt that she was pale and weaker and confused at times"
In his complaint to the Commissioner the complainant advised that the pethidine injections given to the consumer resulted in her, "becoming drowsy and inattentive" and that, "she was still required to perform her own dialysis treatment whilst in this impaired state". The complainant advised the Commissioner that his son:
"Voiced his concerns over [the consumer's] condition when he told a nurse ([ ... ]) that the dialysis was not working properly due to the pale colour of her face and general condition. She told him that as the house surgeon had just the left hospital it would be three or four days before the new house surgeon would be able to assess her condition and progress. The vomiting continued up until the time she was transferred to the [the second hospital], in a coma, [in late] November 1997."
The first hospital's internal investigation report stated that the nurse told the consumer's son that:
"[T]he house surgeon who had been working on the orthopaedic run had just left [the first hospital], and that a new house surgeon would be taking over the run on Monday. She did not feel it was necessary for the GP to come up, as the house surgeon working over the weekend could be called to see [the consumer] if there were any concerns about her condition. She thought he seemed satisfied with that".
Seven days after the operation the consumer was given two suppositories, "as bowels [have] not opened for six days. No result".
On the morning of the following day, the records described the consumer as being very unsettled, angry and agitated. The records stated that, "[t]he consumer appears very angry towards staff. (Just like a wound up spring.) Remains very tense". Further suppositories were administered, "with very small, very constipated result".
Eight days after her operation the consumer was reviewed by Dr Will McMillan for her pain relief. Pethidine was continued. On the same day, the medical records noted that the consumer was:
"[M]iserable ... not orientated to time, place or person, not responding to questions or following commands at time. Not able to manage CAPD, extremities jerky".
On the following day, the consumer was even more agitated, pale and sweaty, and complaining of some lower abdominal pain. Dr McMillan reviewed the consumer noting that she had, "many complaints this evening ... concerned re: dialysis; concerned she is not being weighed; wants sample of dialysate analysed". In the evening the notes registered the consumer's son's concern regarding his mother's confusion. He also expressed concern regarding the consumer's renal failure and her ongoing renal status management. He requested a review by a physician.
The consumer's community nursing service notes indicated that on the day following the complaint by the consumer's son, the ward staff spoke with the district nurse. The ward staff advised the district nurse that due to the consumer's increased confusion and agitation, her dialysis was not going well. The notes further indicated the district nurse discussed with the ward staff what times the consumer's dialysis should occur. The district nurse also liased with the CAPD unit in the second hospital regarding the consumer's condition who advised they would contact the ward staff. It was noted that on this day the consumer's case was discussed:
" ... [W]ith Unit Manager of Renal Unit, [the second hospital]. Pethidine not a good choice for analgesia, should be having morphine ... they prefer patients to return to them when they are having problems. Unit Manager will talk to Renal Physician and get back to us".
On the day the consumer's son complained, the dialysis bag taken off in mid-afternoon was cloudy. The nurse discussed the appropriate action to be taken with the consumer, and a specimen of the fluid was sent to the laboratory for cell count, gram stain and culture. On the following day, Dr McMillan recorded the content of a telephone conversation with the consumer's son, during which her son expressed concerns regarding his mother's health, her deterioration and the management of her care.
Dr McMillan consulted with a physician, which resulted in blood cultures, dialysis cultures and a repeat serum electrolyte test being conducted. By 11.00am on the day the consumer's son complained to Dr McMillan, the notes recorded the consumer's decreased level of consciousness accompanied by intermittent twitching and restlessness. On the following day the consumer still had a decreased level of consciousness, and her dialysis bag was blocked and unable to infuse fluid. The physician and the orthopaedic surgeon agreed to transfer the consumer to the second hospital's renal unit for her dialysis care.
The consumer was admitted to the renal unit at the second hospital, as her tenckhoff catheter had become blocked. On admission, the consumer was diagnosed as having pethidine toxicity and gram negative peritonitis. Despite intensive care at the second hospital, the consumer suffered a cardio-respiratory arrest (heart attack) in early December 1997, was transferred to the intensive care unit ("ICU"), and died seven days later.
The Commissioner was forwarded a copy of the first hospital's internal investigation report from the chief medical officer (parts of which are referred to above). The report looked at each of the issues raised in the complaint sent to the Commissioner.
The report concluded that the consumer's self medication and carrying out of her CAPD procedures was common practise where a patient is competent to carry out such care. It was believed that maintaining patient independence, and participation in care, is important and that the consumer both understood and was competent to carry out her CAPD procedures. When the consumer was "shaky" a nurse took over and completed the CAPD. The investigation also found that the second hospital's renal unit confirmed that it is appropriate for patients to continue to perform their own CAPD whilst bed-bound, receiving assistance as required, provided they are capable of performing the procedure in a sterile manner.
The first hospital's investigation found that the source of the consumer's peritonitis was undetermined, but given that the consumer had only one cloudy dialysis bag in late November, and no further cloudy bags, the consumer was not suffering infective peritonitis at that stage. Peritonitis was not connected with the consumer's orthopaedic problem or the surgery and was very resistant to treatment in the second hospital. The first hospital noted that without intra-abdominal surgery it might not have been resolvable even if identified during the consumer's stay.
The family was also concerned that the consumer had not had any bowel motions during her stay at the first hospital and that insufficient remedial action was taken. The first hospital's investigation found that regular administration of laxatives and suppositories, and monitoring of the situation on a bowel chart, indicated that the nurses were very aware of the issue and were taking appropriate steps to manage the situation.
The first hospital's investigation found that there appeared to be differing opinions on the appropriateness of the use of pethidine in patients with renal failure and that leading texts on the subject put forward slightly different views. The first hospital accepted that while the role pethidine played in contributing to the consumer's deterioration was uncertain, a higher level of awareness of the potential for toxicity in renal patients was required.
In summary the first hospital accepted that documentation in the consumer's case was largely inadequate. In particular, consistent documentation of the consumer's CAPD procedures would have better reflected the care she was given and supported the first hospital's policy of self-administration. The first hospital noted that documentation of the occurrence of the dialysis, and the volumes, would have removed any doubt on the part of the family that it had been done correctly. The first hospital accepted that the presence of the cloudy bag in late November should have been documented in the clinical notes and the second hospital's renal unit contacted for advice on further management. The first hospital also accepted that earlier involvement of a physician could have provided reassurance to the family.
The first hospital noted that the role pethidine may have played in contributing to the consumer's decreased mental function is difficult to assess, as she did not appear to show the classical symptoms of pethidine toxicity. The first hospital accepted that the level of awareness of the potential for problems with narcotics and analgesics in patients with renal failure needs to be improved amongst nursing and medical staff.
The first hospital report made a number of recommendations regarding the improvement of documentation, communication with tertiary centres, staff training on CAPD procedures, drug self-administration policy standardisation, education regarding narcotics in renal failure and the importance of family consultation in the development of the nursing care plan.
Independent Advice to Commissioner
The Commissioner also sought and obtained advice from an independent expert who reviewed:
- the complainant's complaint;
- the first hospital's internal investigation report;
- responses from the various providers involved in the consumer's care;
- the second hospital's renal unit's CAPD manual;
- the consumer's medical records;
- the consumer's district nursing records; and
- records of interviews conducted by the Commissioner's investigators.
Prescribing of Pethidine as Pain Relief for the Consumer
Pethidine is listed in most text books and pharmacopoeias as contraindicated in chronic and end-stage renal failure cases:
"[D]ue to the fact that the active metabolite norpethidine requires functional kidneys for elimination. Norpethidine is incapable of being eliminated through dialysis techniques. The consequent increase in this metabolite in patients with chronic renal disease/on dialysis has neurotoxic effects including seizures and delirium".
However, the most common pharmacopoeia available to junior doctors in New Zealand hospitals is the New Ethicals Catalogue, which does not list the problems associated with use of pethidine in patients with renal impairment. Patients with impaired renal function ought to be provided with a list of medications they should avoid, and that all hospitals should have available a standard evidence-based formulary:
"[W]hich sets out those drugs which should not be used in particular conditions or which might cause adverse interactions with other prescribed and required drugs".
Consultation and Documentation
There was lack of appropriate consultation between nursing staff and both junior and senior medical staff and lack of appropriate documentation.
The CAPD patient manual produced by the second hospital's renal unit provides no guidelines relating to the management of patients requiring hospital admission for unrelated problems to their dialysis.
The advisor concluded that:
"[C]areful review of the supplied notes indicates that no consultation was undertaken between [the first hospital's] clinicians and the [second hospital's] renal team ... until [late] November just prior to her transfer to [the second hospital].
No record of CAPD exchanges, including bag checks, heating procedures, the actual exchange procedures, the weight of the bags post-procedure or any fluid issues were found in the notes. No mention could also be found on a regular daily basis describing [the consumer's] tenckhoff catheter exit site.
There is no written record of any plans by [the orthopaedic surgeon] to provide for ongoing review and management of [the consumer's] complex medical problems by a suitably knowledgeable medical practitioner or by the [the second hospital's] renal unit ... even when [the consumer's son] expressed concern with regard to his mother's condition, there was no evidence that this was given any degree of urgency with regard to contacting the appropriate medical opinion."
A careful review should be made of the quality of staff communication within the first hospital. Protocols and procedures need to be developed which stress the importance of this communication, the appropriate handover of clinical information from nursing caregivers to medical practitioners and between medical practitioners.
There are dangers associated with infection in any patient receiving CAPD.
"[I]f appropriate strategies including knowledge of potential adverse problems, communication between responsible clinical staff and surveillance measures had been undertaken at [the first hospital], more attention would have been paid to the type and use of narcotics, the need for stool softeners and gentle laxatives and review of bowel habits. If all of this had been performed in a more stringent way, given the high risk in [the consumer's] case of developing severe constipation, it is possible that the subsequent events leading to her death might have been prevented."
While the level and standard of care provided to the consumer for the management of her acute injuries (to her knees) was within the perimeters required by current practise, the care and management of her total health needs:
"[S]pecifically the management of her complex metabolic condition and CAPD treatment and the risk of that management, fell below the requisite standard of care. It is also likely that this contributed to her ultimate demise".
Response to Provisional Opinion
In response to my provisional opinion, the orthopaedic surgeon advises on the three days after the operation he requested his house surgeon to transfer the consumer to the care of the medical team. The orthopaedic surgeon further states he checked with the charge nurse to ensure the transfer had been arranged.
The orthopaedic house surgeon was the orthopaedic house surgeon when the consumer was admitted after her mid-November 1997 accident. He advised the Commissioner he saw the consumer on his ward rounds on the two days following the November 1997 operation, and that his last day at the first hospital was two days after the consumer's operation. The orthopaedic house surgeon remembered the consumer as the chief medical officer had contacted him when the first hospital was doing an internal investigation. The orthopaedic house surgeon recalled the consumer required bed rest and pain relief post operatively but she seemed alert, well and her blood tests were fine. The orthopaedic house surgeon remembered specifically asking the consumer if she was able to carry on with her CAPD with the consumer commenting that she was fine to do it with support from the nursing staff, if needed. The orthopaedic house surgeon stated that any instructions he received from the orthopaedic surgeon were written into the consumer's medical notes, however, he does not remember anything specific being requested.
The charge nurse was the orthopaedic charge nurse on the consumer's ward, working Monday to Friday during the day shift. She advised the Commissioner she met the consumer on the Monday after the consumer's operation. The charge nurse stated it was difficult to remember specific details however she recalled the consumer was uncomfortable and in pain after her operation. She further stated she remembered the orthopaedic surgeon discussing the consumer's CAPD with the house surgeon and requesting the house surgeon check with the medical physician if the CAPD was being done correctly. The charge nurse stated she thought that discussion had taken place as discussions were held with the consumer, the medical and nursing teams to ensure the consumer's CAPD was done correctly. The charge nurse further stated all instructions from the medical team were usually written up in the patient medical notes.
The consumer's medical notes, prior to the day before she was transferred to the second hospital, do not note any specific instructions regarding the consumer being referred to in discussions being held with the medical team.
The orthopaedic surgeon further responds to my provisional opinion stating:
"A number of factors contributed to these circumstances:
1. [The consumer], a patient on dialysis, was unlucky to suffer a rare combination of injuries;
2. The treatment of her injuries masked intra-abdominal pathology which subsequently developed independent of the two known conditions for which she was being managed;
3. Her care coincided with the change-over of house surgeons, my house surgeon being on leave and my not knowing that my house surgeon was on leave;
4. My instructions apparently not being acted on and my not being aware of this because of a reassurance given.
[The consumer's] death is an immense tragedy from which lessons must be taken. I have expressed concern to the hospital regarding the level of junior staff cover over this time. Since this event, I have also developed a system of not relying on verbal reassurances but insisting on checking the paperwork to ensure that instructions have been carried out. I follow this system even when the reassurances are given by a responsible doctor or, as was the case for [the consumer], by a senior nurse.
I am truly sorry that [the consumer] died. I am happy to apologise in writing, not because I am required to by the Health and Disability Commissioner, but because that is an appropriate thing to do. I have already apologised to [the consumer's son] during a lengthy meeting with him - C recording in writing what I said is an appropriate step to take."
Code of Health and Disability Services Consumers' Rights
Right to Services of an Appropriate Standard
2) Every consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant standards.
3) Every consumer has the right to have services provided in a manner consistent with his or her needs.
5) Every consumer has the right to co-operation among providers to ensure quality and continuity of services.
Opinion: No Breach - The House Surgeon
Rights 4(2) and 4(3)
In my opinion The house surgeon did not breach Rights 4(2) and 4(3) of the Code in prescribing pethidine for the consumer's pain relief.
While pethidine was not an appropriate choice of analgesia to use in the consumer's case, as it requires functional kidneys for elimination, in her letter to the Commissioner, the house surgeon advised that the drug information books she had been using (another CHE's Health Preferred Medicines List 1997 and the New Ethicals Guide), "gave no indication that the use of Pethidine was contra indicated in patients with renal failure".
Therefore, in my opinion because the house surgeon received inadequate guidance from the texts available to her with regard to this issue, and in the circumstances she made a competent decision based on available information.
Opinion: Breach - The Orthopaedic Surgeon
Rights 4(3) and 4(5)
In my opinion, the orthopaedic surgeon breached Rights 4(3) and 4(5) of the Code.
The orthopaedic surgeon was the senior specialist responsible for the ongoing management of the consumer's care. While the orthopaedic surgeon competently addressed the consumer's acute orthopaedic injuries and her ongoing care in relation to those injuries, he took no steps regarding the treatment of her other medical problems.
My advisor stated:
"The orthopaedic surgeon has a duty of care to refer [the consumer] to another medical practitioner in situations where he lacks the necessary specialist information, training and competencies to manage either new or existing medical problems. In [the consumer's] case, [the orthopaedic surgeon] owed [the consumer] a duty of care to appropriately refer her to another medical practitioner, or team of practitioners, with the necessary knowledge and skills to manage her complex medical problems. He failed to do this in a timely manner, not doing so until the very end of her stay in [the first hospital]."
The orthopaedic surgeon advised the Commissioner he had, "verbally requested contact" with the physician he believed was managing the consumer's medical care. However, there is no evidence in the consumer's medical notes to confirm this occurred. Further, there is no evidence, in the medical notes, that the orthopaedic surgeon followed up to find out who was managing the consumer's medical care, or why she remained on the surgical ward undertaking her own dialysis. The orthopaedic surgeon continued to take responsibility only for the consumer's orthopaedic needs until he was finally contacted by the house surgeon to say that the consumer was unwell. At this point The orthopaedic surgeon suggested contacting the physician and the consumer was eventually transferred to the the second hospital's renal unit.
The orthopaedic surgeon's failure to ensure overall management of the consumer's needs, and to co-operate with other providers at the first hospital as demanded by Right 4(5), led to a deterioration in the consumer's condition as a result of her chronic renal problems.
Opinion: Breach - The CHE
The CHE, as the employing authority of the orthopaedic surgeon and the house surgeon, is liable for their actions or omissions under Section 72 of the Health and Disability Commissioner Act 1994. The CHE has not provided evidence that it took such steps as were reasonably practicable to prevent a breach of the Code.
The CHE carried out its own internal investigation into the consumer's death. The report reached a number of conclusions, which are discussed above. In my opinion the first hospital did not ensure that the necessary procedures and protocols were in place to manage the consumer's overall care. There were no systems in place to check upon the medication the consumer was prescribed, nor were there any procedures for co-operation between surgical and medical providers to ensure that the consumer received the appropriate care she needed for her chronic renal problems in addition to her orthopaedic injuries. Further, failure to contact the second hospital's renal unit and to ensure that the consumer's CAPD exchanges were managed with the required degree of skill, contributed to the consumer's deterioration. Communication between providers within the hospital was poor and documentation is not complete.
In my view the standard of care that the consumer received while a patient at the first hospital was not consistent with her overall health needs and the lack of co-operation between providers within the first hospital and between the first hospital and the second hospital's renal unit, had a significant impact on the standard of care received by the consumer.
Actions: The Orthopaedic Surgeon
I recommend that the orthopaedic surgeon takes the following actions:
- Ensures that orthopaedic patients with coexisting medical conditions are referred to a competent provider who can manage the consultation and that he continues to co-ordinate with that provider to ensure that his patient's overall health management is appropriately managed.
- Communicates effectively with other providers within the hospital and with other health services and documents his actions to ensure patients are receiving the quality and continuity of services required.
- Sends the consumer's family a written apology for breaching Rights 4(3) and 4(5) of the Code of Rights. This apology is to be sent to the Commissioner who will forward it on to the consumer's family.
Actions: The CHE
I recommend that the CHE takes the following actions:
- Implements the recommendations and conclusions from the internal investigation carried out at the first hospital. In particular, it is crucial that nursing staff are provided further training on CAPD procedures, and that systems are developed for managing surgical patients who have specialised medical conditions, such as end-stage renal failure, so that appropriate care can be given.
- Revises its self-administration policy and documents significant clinical events such as CAPD exchanges.
- Develops a Standard Documentation Policy for all staff outlining what should be documented in patient medical notes.
- Audits patient medical notes regularly to ensure all staff are documenting significant clinical events within the policy.
- Ensures all medical and nursing staff are given sufficient information about the use of analgesics in patients with end-stage renal failure.
- Reviews its internal systems of communication between surgical and medical providers to ensure that the highest standard of overall care is provided to surgical patients with coexisting medical conditions.
- Apologises in writing to the consumer's family for breaching the Code of Rights. This apology is to be sent to the Commissioner within one month and will be forwarded to the family.
Actions: Adis International
Adis International, the New Zealand publisher of the New Ethicals Catalogue will be sent a copy of this opinion. I suggest Adis International ensures that information related to known drug interactions and toxicity in patients with organ function failure such as kidney and liver disease, be included in this publication. Specifically, it should be asked to address the deficiency with regard to chronic renal dysfunction being a contraindication to the use of pethidine for pain relief.
Actions: Renal Unit
A copy of this opinion will be sent to the second hospital's renal unit, with the suggestion that the CAPD patient handbook be updated to more explicitly define the level of care required for a patient such as the consumer, outlining appropriate care protocols and in particular stipulating a list of medications that patients should avoid and the reasons for avoiding them. I also suggest that the second hospital's renal unit consider designing and revising its protocol specifying when other health providers ought to contact the renal unit when a renal patient comes under their care. These protocols will improve risk management and should ensure a greater degree of co-operation between providers.
A copy of this opinion will be sent to the Medical Council of New Zealand, the Nursing Council of New Zealand, the Coroner, the second hospital's renal unit, Adis International Limited, the Ministry of Health and the Crown Company Monitoring Advisory Unit.