11. Appendices

• Medical examination/diagnostics: this includes incidents concerning all types of somatic examinations and diagnostic procedures. Patients/service users and next of kin accounted for the highest percentage of incident reports in this category. Examples of incidents: possible delayed diagnosis of serious illness; death shortly after physical or telephone contact with a healthcare professional.
• Falls includes different types of falls in own home or institution.
• Unknown/undetermined cause of death generally denotes incidents where the patient/user was unexpectedly found dead, and where the cause of death was not known when the organisation reported the incident. In some of these incidents, suicide was suspected.
• Medication use: this includes any incidents involving the use of medication, ranging from prescribing, preparing, administering and effect to observed adverse reactions.
• Suicide among patients/users who received services in municipal health and care services.
• Acute life-saving interventions are incidents in which a patient/user died suddenly and unexpectedly while under medical care, typically without known risk factors. These are also incidents where patients died or were seriously injured after being found in poor condition and despite initiation of a life-saving intervention.
• Medical care was mainly reported by employees in organisations and by next of kin and concerned, for example, injury following surgical intervention or catheterisation, injury in connection with personal care or moving and handling and possible delayed initiation of relevant therapeutic interventions.
• Physical assault includes incidents in which physical harm was inflicted on fellow patients/residents or on next of kin or friends.
• Infection: many of these incidents concerned COVID-19 related factors. These incidents generally concerned, for example, non-compliance with infection control rules resulting in infection or concerns about treatment for suspected or test-positive infection
• Other denotes incidents not otherwise classified under one of the options available. Examples of such incidents included harm caused by structural factors on the premises, accidents during transportation between organisations, fire in the home of a user of a municipal health and care service, allegations of medical record errors, a report of potentially ongoing risks and unsafe circumstances in the services.
• Use of medical devices includes any incident involving the use of medical devices, including apparatus for moving and handling, prosthetic devices and the use of tubes and catheters.
• Burns/scalds: the majority of these incidents involved patients/users injured during bathing in a bathtub, shower or handbasin because the water was too hot. This also includes burn injuries from use of a hot water bottle placed on a person with paralysis. Most of these incidents were reported by municipal health and care services.
• Complaint regarding service/rights/treatment offered: Most of these reports were from individuals. They included a complaint from next of kin concerning the type or standard of care offered, a complaint concerning lack of access to medical care and a complaint regarding the child welfare services.
• Overdose/intox: Many incident reports concerned overdose of illicit drugs by users/patients undergoing treatment. There were also a few reports concerning overdosing of prescribed therapeutic drugs.
• Complications related to feeding/ingestion: these incidents concern patients who got food in their airways either because they were given the wrong type of food (for example, not mashed food where this had been determined) or where patients suffered blocked airways when being fed/eating.
• Suicide attempt/self-inflicted harm: all these incident reports were from organisations. Many incidents concerned jumps from a height.
• Nursing, personal care or observation include incidents related to wound care, personal care/hygiene assistance, follow-up of basic needs of a user with a mental disability, nutritional follow-up of long-stay inpatient and procedures for issuing advice in connection with discharge from an institution to own home.
• Disappearance/abscondment concerns incidents where the patient/use went missing from their home or institution and were subsequently found dead or in poor condition.
• Homicide: mainly includes patients/users under a mental health order who commit homicide.
• Suspicion/alleged sexual assault by employee was reported both by patients/users, next of kin and both the patient/user, relatives and managers at municipal activities. These alerts relate to suspected/alleged sexual assault of a patient/user by an employee.
• Surgical procedure/operation: includes surgery-related complications and/or deaths.
• Patient/home care safety alarm includes both technical failure of the alarm system and lack of staff response to sounding of an alarm.
• Fall/jump from height: many of the reports described that it was unclear whether the incident was an accident or suicide. The incidents occurred both inside an institution and outdoors.
• Use of force (physical, mechanical or chemical restraint) includes harm caused by restraints to prevent, restrict or subdue movement for behavioural control and complaints about the use of force.

Incident

A pregnant woman received antenatal care from her GP and midwife. There were language problems, and an interpreter was used. Foetal intrauterine growth restriction (IUGR) was detected (based on low symphysis fundal height (SFH). The woman was not referred to the specialist health service, but she was subsequently hospitalised due to an infection. The IUGR was not mentioned in her admission record. Later in the pregnancy, the midwife also measured a low SFH, but did not arrange for a foetal growth checkup appointment. The foetus was dead by the time the woman consulted the obstetrics department when she was about one week over term.

Regulatory topic

Our focus was to investigate how actors in the municipality and at the hospital arranged for women with high-risk pregnancies to receive the necessary antenatal follow-up.

Assessment

We concluded failure to refer the pregnant woman directly to hospital care as soon as the midwife had measured SFH as being under the 2.5 percentile was not in line with best practice. There was no record of the anomalous SFH measurement. This was information that should have been recorded and which should also have been stated in the hospital discharge notes sent to the midwife and GP. The Norwegian Board of Health Supervision also finds that the discharge notes should have provided specific advice on further follow-up concerning the low SFH. Not offering the woman a new consultation was not in line with best practice.

The woman received clinically responsible healthcare while she was hospitalised. The hospital had procedures in place to ensure that women referred due to low SFH were assured of medical follow-up.

Conclusion

Overall, the deviation from best practice was so severe that the woman received sub-standard healthcare.

Post-incident quality improvement

Following the incident, the municipality has worked systematically on quality improvement and patient safety.

Incident

A patient with a chronic disease was supposed to receive homecare service visits in the morning and evening to check that they were taking their medication. The homecare service was reduced to evening visits only. During the pandemic, the service was further reduced to an evening phone call from a healthcare professional.

Two months after the last service reduction, the patient was found unconscious in their home by relatives, by which time they were in severe decline. The patient brought to hospital where they died. It was discovered that the homecare service had not been in contact with the patient for three days. The homecare service had phoned the patient but had failed to reach them.

Regulatory topic

Had the municipality made a comprehensive assessment of the patient’s needs and facilitated that the user received correct drugs?

Assessment

No plans were made for how the patient should be followed up or for how the homecare service should liaise with other services in healthcare delivery to this patient. The homecare service had reduced its follow-up of the patient’s care without involving a GP or the specialist health service. When the pandemic took hold, the homecare service decided that daily home visits should be replaced by a telephone call to the patient, despite the fact that it was not possible to check that the patient was correctly medicated over the phone.

The municipality did not have procedures for what to do if the patient did not answer the call, and it was up to the individual healthcare professional to decide what to do when they were unable to make contact. During the inspection, it emerged that the municipality had not established adequate procedures and practices for how homecare patients/users should be followed up.

The municipal services did not ensure that important messages and information about the patients/users were transferred between healthcare professionals. The healthcare was provided mainly on the basis of the individual healthcare professional’s best judgement there and then without having any guidelines for decision-support or colleagues or managers to consult.

The municipal services had had a similar incident two years previously concerning non-response to a service user sounding a personal safety alarm at night. The user had been found dead in their home the following day. The County Governor’s conclusion was negligence in duty of care. This ruling was unknown to most of the homecare service and to senior municipal management.

Norwegian Board of Health Supervision opinion

The municipal services had not fulfilled their duty of care towards patients/users with complex needs who receive homecare services. We also concluded that the municipal services did not provide the patient with professionally responsible healthcare.

Post-incident quality improvement

The Norwegian Board of Health Supervision concluded that the municipal services have worked systematically on quality improvement and patient and user safety after the incident and have implemented measures to reduce the risk of incident recurrence.

Incident

We received two reports of patient incidents where seriously ill patients were transported by road ambulance instead of the air ambulance requested. In both cases, road transportation would take about three hours. The two serious incidents involved patients presenting at the out-of-hours medical centre with symptoms of severe infection. The condition of both patients deteriorated during road ambulance transportation, with one patient suffering cardiac arrest and dying in transit. The incidents occurred only four days apart during the summer holiday period and during the ongoing pandemic. In accordance with the organisation’s own practice, both patients should have been transported by helicopter. The patients’ treatment from the specialist health service was delayed by the decision to transport them by road ambulance.

Theme

Care of sepsis patients in need of rapid transportation to the specialist health service for treatment. We investigated whether the patients received professionally responsible healthcare and whether the organisation ensures professionally responsible care for patients affected by time-critical medical conditions and who need transportation.

Conclusion

For one patient, an alternative plan was made to reverse the original decision and instead transport the patient by air ambulance helicopter in case of deterioration in their condition. We therefore concluded that transportation by road ambulance was not clinically responsible. For the other patient, we concluded that the patient was not transported to the right place in time, and that the healthcare was not clinically responsible.

For both patient incidents, we concluded that failures were revealed that indicated lack of organisation, management and supervision of the service. The review revealed issues related to decision-making when requesting an air ambulance helicopter, including inadequate decision support for staff in prioritising and fulfilling air ambulance helicopter transportation. There was a risk of failure in that the same individual in the organisation has a dual role in the process (doubling as Air Ambulance doctor and Emergency Medical Coordination Centre (EMCC) doctor), and there was no system in place to avert the risk of decision-making failures in situations where the need for infection control had to be weighed up against the need for rapid transportation.  The investigation also revealed deficient record-keeping practices concerning medical assessments versus resource and stand-by status in assigning a mode of ambulance transportation.

The organisation had thus not ensured the patients of clinically responsible services in the event of serious illness and the need for transportation by air ambulance helicopter.

Incident

The patient was receiving follow-up care for severe mental illness. In the hours leading up to the incident, the patient and neighbours had repeatedly contacted the out-of-hours medical centre due to a deterioration in the patient’s condition. The patient died in an incident in which the patient was perceived to pose a threat.

Regulatory topic

Whether the specialist health service and the municipal health and care service had jointly arranged for patients with serious mental illness who are followed up by Flexible Assertive Community Treatment (FACT) to receive clinically responsible healthcare in response to a deterioration in their condition.

The opinion of the Norwegian Board of Health Supervision

The patient was followed up at several different service locations within municipal services and the specialist health service. This requires clearer lines of responsibility, coordination and expertise within the various organisations. The combined services were deficient in that they failed to facilitate systematic observation, diagnosis and assessment of changes in the patient’s condition, including familiarising themselves the patient’s psychiatric history. This includes the Board’s conclusion that the manner in which telephone calls to the out-of-hours medical service were dealt with was sub-standard. Furthermore, no essential measures were taken or arrangements made to facilitate the necessary coordination between the various service locations.

Conclusion

The specialist health service and the municipal health and care service as a whole did not provide the patient with clinically responsible healthcare during the time period in question.

Post-incident quality improvement

The Norwegian Board of Health Supervision has concluded that the municipality and the specialist health service have jointly worked on systematic quality improvement and patient safety after the incident to reduce the risk of failure in healthcare following a deterioration in the condition of patients with serious mental illness. We have nevertheless asked the municipal services to report in more detail on their quality improvement efforts as regards their out-of-hours medical centre.

Incident

The incident report concerned an elderly patient in a state of confusion (delirium). The patient was first attended to in hospital and was then transferred to primary care for further care in the short-stay unit of a nursing home.

Regulatory topic

We investigated whether the patient had received clinically responsible healthcare and whether the organisations had facilitated their services so that staff are in a position to deliver clinically responsible healthcare. Our main concern was whether the organisations have arrangements in place for clinically responsible assessment, treatment and care management for patients with delirium.

Assessment

A cooperation agreement exists between hospitals and the municipal services in question to ensure care continuity and clinically responsible patient care in transfers from hospital to further follow-up in primary care. The focus here is on reliable hospital discharge procedure and information transmission. The hospital and municipal services have committed to making the care coordination agreement known to their own staff and service users. At the incident-based inspection, it emerged that there was little familiarity with the agreement within the organisations, and that it was not fulfilled in this specific case. This may have compromised the care management of a seriously ill and highly vulnerable patient.

The hospital had not arranged for reliable clinically responsible assessment and treatment of patients with delirium. The municipal service had not ensured that national guidelines for the assessment and management of patients with delirium were understood and followed. The municipal service had also not ensured that healthcare professionals were aware of, had understood or fulfilled the existing cooperation agreement between the hospital and the municipality for the transfer of patients to primary care.

In communication with the hospital concerning the transfer of the patient to primary care, based on the information available, no further assessment of the patient’s need for clinical assessment, treatment and follow-up was made. Further, other competent healthcare professionals within primary care were not consulted in assessing the information available. The municipal services did not discover that the hospital had notified the patient as ready to be discharged to their care without having been sufficiently assessed with a plan for their care.

The nursing home doctor was not summoned by the healthcare professional after the patient had been transferred to the short-stay unit at the nursing home. No other attempts were made to obtain more information about the patient, including about the patient’s care plan. There was no concern that that the medication initiated by the hospital was contrary to standard guidelines. When the patient was attended to by the nursing home doctor a day later, the patient was severely   reduced, and an overdose of the given drugs was suspected. While the patient was staying in the short-stay unit, no observations regarding the effect of the medication/adverse drug reactions were recorded, and records of the patient’s condition were deficient.

Conclusion

The Norwegian Board of Health Supervision concluded that the municipal health service had not facilitated clinically responsible management and care for patients with delirium. The municipal health and care service had not ensured that a healthcare professional on their staff had the requisite competence concerning clinical assessment and treatment of delirium, or that existing guidelines for monitoring inpatients were followed. The municipal health and care service also failed to ensure that healthcare professionals in the organisation were aware of and complying with the existing cooperation agreement between hospital and municipality.

This review case had not been closed at the time of writing. We therefore describe the main features of the incident and our assessments and conclusions only to a limited extent.

Incident

A user in a short-stay unit at a health centre jumped out from a second-floor balcony and sustained serious fractures.

Regulatory topic

We investigated whether the municipal health and care service facilitates clinically responsible healthcare for agitated users in need of round-the-clock supervision, including attending to an agitated user unwilling to receive healthcare and who had acted in a manner posing a risk to their own health and safety. We also investigated how the municipal health and care service has ensured effective communication and information flow concerning this type of user.

Assessments

Deficient measures for ensuring the physical safety of users is an area  in the health service that poses a high risk of failure and where such failure could potentially have serious consequences for users. Falling from a height is one such risk. It is therefore especially important to implement safeguards understood by all staff. Management must facilitate the implementation of safeguards by staff. Structures must be in place to ensure communication and information flows among staff, between different administrative levels and with relatives.

The municipal health and care service described its own assessment of the incident and both planned and implemented improvement measures.

Incident

A patient with chest pain was brought to the out-of-hours medical centre by ambulance. The patient was assessed as requiring clinical attendance within 10-20 minutes, but was found dead about an hour after arrival, and without having been examined by a clinician.

Regulatory topic

We investigated whether the patient had received clinically responsible healthcare and whether the municipal health and care service ensures that patients with chest pain and other acute conditions receive clinically responsible, reliable quality care so that care delivery is compliant. We also investigated whether the organisation had an adequate overview of and ability to manage risk areas related to waiting times for patients at the out-of-hours medical centre.

 Assessment

The organisation had not established procedures to ensure that patients presenting with chest pain and other acute conditions received clinically responsible healthcare in situations of high-volume attendance. The reason for this is that the out-of-hours medical centre did not have sufficient systems or arrangements to ensure clinical attendance within the expected time in the presence of high-volume patient attendance. The Norwegian Board of Health Supervision considers that the time elapsing between triage and clinical attendance entails an increased risk that patients with chest pain and other acute conditions will not receive the necessary healthcare during peak periods.

The organisation did not have a sufficient overview of risk areas in its service provision, and no targeted measures had been put in place for implementation in reduced capacity situations.

Conclusion

The patient did not receive clinically responsible healthcare because they waited too long in the out-of-hours medical centre with chest pain without receiving clinical attendance and without a pull cord for summoning emergency assistance.

Incident

Just over a month before her due date, a pregnant woman attended a municipal out-of-hours medical centre feeling unwell. The woman was unable to walk, had a sore throat and was short of breath. There were some communication issues. Her symptoms had been ongoing for six days and she attended the out-of-hours medical centre because her condition had deteriorated in the last 24 hours. She had recently moved to the municipality.

At the centre, the receiving nurse recorded the patient’s temperature, blood pressure, pulse and blood oxygen saturation. In addition, a blood test was done for signs of infection. Her pulse was rapid. The other vital signs were normal, and the woman was judged to be in good general condition. The woman was not tested for Covid-19. She was asked to wait for a doctor, and she was told she was a priority patient as she was pregnant. After waiting for nearly three hours, the patient went home at her own risk. This was before she had been seen by a doctor.

During the waiting time, the patient had tried to summon the duty room using the call bell several times but with no response. She had pain in her back and was unable to wait any longer. Her husband, who had to remain outside the building due to the centre’s infection control rules during the pandemic, called the reception desk to explain this, and was informed that  that the patient had to wait until the doctor was available. The man then asked if they could go home as the wait was so long. According to the man, the reception desk staff stated that if they wished, they could go home and call their GP next day. A few days later, the woman went into labour and the term infant was discovered to have died in utero. Afterwards, the patients were informed that Covid-19 infection was the probable cause of death.

Regulatory topic

Whether the patient had received clinically responsible healthcare, and whether the municipal health and care service had ensured that pregnant women attending the centre with severe symptoms receive clinically responsible and reliable care.   

Assessment

This case demonstrated the necessity of good communication and triage of pregnant women attending an out-of-hours medical centre. The case also demonstrates the principles of general prenatal care for pregnant women moving to a new municipality, and the barriers to navigating the health service. Furthermore, it is important to ensure prompt and effective maternity care for new members of the community who make contact with the maternity care service.

Conclusion

The out-of-hours medical centre did not provide the patient with clinically responsible healthcare because it failed to ensure that she was examined by a clinician within a reasonable time. We concluded that the centre had not put procedures in place to ensure that expectant mothers presenting with severe symptoms were given priority and examined by a doctor. The Norwegian Board of Health Supervision considers that the waiting time at an out-of-hours medical centre poses an increased risk of pregnant patients with malaise not receiving essential healthcare during busy periods.

Post-incident quality improvement

The organisation has stated that it plans to increase its capacity by having a doctor in reception for ambulant patients (doctor in reception) and a doctor who receives patients together with a nurse in the ambulance reception (team triage). As of today, a pilot scheme has been started and the plan is to implement the new structure over the year. The Norwegian Board of Health Supervision finds this measure to be appropriate and has inquired into the further processes of this improvement programme and whether the new structure is working as intended.

Incident

A nursing home resident with dementia enjoyed walking and was capable of taking brisk, long walks. The resident was issued with a GPS tracker so that the nursing home could locate the resident if they left the premises undetected. One afternoon the resident went missing. When the healthcare professional attempted to trace the resident, the GPS tracker could not be contracted. The resident was found dead that night.

Regulatory topic

Whether the municipal health and care services had ensured professionally responsible use of GPS tracking for nursing home residents with dementia and whether the service user had received clinically responsible healthcare.

Assessment

The municipal health and care service had adopted welfare technology, but had not adequately ensured the necessary assessment of hazards and risks before implementing GPS tracking, or made a formal decision regarding the use of GPS tracking, as required by law. Management and staff were unsure of how the GPS tracker worked and the GPS tracker battery charge was not checked before use. Furthermore, no arrangements were made to ensure that managers and healthcare professionals at the nursing home had received sufficient training in use of GPS tracking.

Conclusion

The municipal health and care service had not facilitated professionally responsible healthcare concerning use of a GPS tracker for nursing home residents with dementia, and the user did not therefore receive clinically responsible health care. We concluded that after the incident, the municipal health and care service has worked systematically on quality improvement and user safety.

Incident

A child with a chronic illness staying at a refugee reception centre became acutely ill. The acute illness resulted in the child being hospitalised. The child died shortly after admission.

Regulatory topic

We examined the healthcare received by the child and how the municipal services facilitated healthcare for children with complex care needs staying at a refugee reception centre. We focused on the healthcare the child received in the primary care setting from arrival at the reception centre through to the healthcare provided when the acute illness occurred and until the child died.

Assessment

Despite the fatal outcome, the Norwegian Board of Health Supervision concluded that the clinical examinations and assessments made on the day before the child’s death were in line with the requirements for clinically responsible healthcare. We found no indications to account for emergency hospitalisation, and the out-of-hours doctor had consulted the paediatrician at the nearest paediatric care department. Care management when the child’s condition deteriorated on the next day when they were taken to hospital by ambulance personnel was considered to be in line with clinically responsible healthcare. By that stage, the child was febrile, had increasing abdominal pain and the abdomen was distended and non-palpable.

Conclusion

The municipal services provided the child with clinically responsible healthcare for the child’s chronic condition. The municipal services also provided clinically responsible healthcare following onset of the abdominal pain/acute illness while the child was at the refugee reception centre.

The municipal service’s facilitation of healthcare for a child with special needs at the refugee reception centre was clinically responsible. Various relevant measures were implemented to facilitate clinically responsible healthcare for a child in need of healthcare. Coordinated healthcare had been arranged for the child both when the interventions were provided within primary care and within the specialist health service habilitation service.

Incident

An elderly patient living in their own home died following mismedication in hospital and in a nursing home. The patient was taking blood thinning tablets for heart disease. While the patient was hospitalised, the tablets were replaced for a time by blood thinning injections. When tablet therapy was to be resumed, it was forgotten to withdraw administration by injection. As a result, the patient was mistakenly treated with a double dose of blood-thinners for nine days The mismedication took place during a stay in hospital and during two stays in a nursing home short-stay unit.

Regulatory topic

We investigated whether the patient received clinically responsible healthcare, and whether the organisations had ensured that medication was administered in accordance with legal requirements, ensuring that patients receive clinically responsible, reliable and quality care.

Assessment

Both the hospital and the nursing home had procedures and routines in place for medication management, but these were not sufficient to guarantee clinically responsible medication of the patient. The organisations had not put in place adequate safeguards to ensure that healthcare professionals practised clinically responsible medication management in line with their own procedures and routines. Both the hospital and the nursing home used support tools to detect and assess the risk of drug interactions, when therapies were added that should not be given in combination, without ensuring well-defined routines and common practices for use of the tool.

Conclusion

Neither the hospital nor the nursing home had sufficiently reviewed and assessed the patient’s medication despite the fact that the patient’s condition was deteriorating. Discharge notes containing records of mismedication were repeatedly transferred between the nursing home and hospital without the mismedication being discovered. On this basis, the Norwegian Board of Health Supervision concluded that neither the hospital trust nor the municipal health and care service provided the patient with clinically responsible inpatient medication management.

Post-incident quality improvement

The organisations have initiated efforts to introduce measures to rectify the sub-standard conditions. The Norwegian Board of Health Supervision will be following up on the organisations’ implementation of improvement measures to ensure that they have the intended effect.

Incident

The incident reported by next of kin concerned failure to refill an essential blood-thinning medication prescription for the homecare service user The user was covered by an agreement on medication assistance. This was not followed up and the user was thus not dispensed the essential medication. This failure occurred despite fact that healthcare professionals and management in the organisation had been made aware that the user had no medication by the user, next of kin and homecare staff visiting the user in the time period in question. The medication was ordered for delivery to the organisation, but was not brought out to the user for several days. On the day the user received the medication, the user suffered a massive stroke and was hospitalised.

Regulatory topic

Whether the municipal health and care service has ensured reliable communication and information flow in the homecare services concerning medication management assistance.       

Assessment

The homecare service was run at too high a risk of failures in medication management. We believe that the failure of the service could occur due to the lack of management and facilitation of communication and information flow in the unit. There were various formal and informal structures to communicate and manage medication management information to persons receiving homecare services. The systems for internal checks of medication management were deficient both at the time of receipt of drugs in the unit and dispensing to users and in records of healthcare delivery.

The fact that the organisation was unable to verify if users had been dispensed medication supports the conclusion that deficient organisation and management posed a risk of failures in homecare delivery. Previous reports of similar irregularities in the service stating that users had not received medication as agreed had not resulted in measures to reduce the risk of recurrence. The majority of nonconformity cases reported were closed without information about the corrective actions taken.

In the weeks leading up to the incident in question, there had been a reorganisation of homecare services in the municipality. No additional resources or measures were put in place to reduce the risk of failure in performance when the unit acquired a great many new service users, while they had to transfer service users to other units. This additional load on the unit created an additional risk that had not been adequately planned for. No risk assessment of the reorganisation was carried out in advance.

Conclusion

The user did not receive clinically responsible healthcare from the municipal health and care service. For a service user covered by an agreement on medication assistance, it is absolutely essential that the service ensures that necessary medication is made available for the service user to take.

Incident

Follow-up and management of an elderly patient affected by acute deterioration during a stay in a municipal acute inpatient unit after multiple falls. The patient died the day after admission to the municipal acute inpatient unit, after being transferred to hospital.

Regulatory topic

We investigated how the municipal health and care service facilitates clinically responsible care at its out-of-hours medical centre and municipal acute inpatient unit. In addition, we investigated and assessed whether the patient received clinically responsible healthcare, and whether relevant actions have been taken to reduce future risk based on this incident.

One main focus was on management of patients affected by acute deterioration post-admission. We also examined admission procedure, staff training and competences, observation and management of patients, coordination procedures, documentation procedure and management of record-keeping systems.

Assessment

Overall, the municipal health and care service did not ensure clinically responsible healthcare for patients admitted to municipal acute inpatient units with somatic disease and at risk of acute deterioration. Relevant national guidelines have been established to ensure clinically responsible healthcare for patients admitted to a municipal acute inpatient unit. However, the organisation has not ensured that healthcare staff attending to the patients are familiar with the guidelines and understand and comply with them. The organisation has not provided adequate staff training in procedures and use of ICT systems to ensure patient safety and reliable nurse-physician coordination.

Conclusion

The overall healthcare received by the patient at the municipal acute inpatient unit was sub-standard. There were failures in examination and management of the patient in ambulance triage at the out-of-hours medical centre and on transfer of the patient to the municipal acute inpatient unit. Further, the unit failed in its observation/monitoring duty in the ward and in its management of the acute deterioration in the patient’s condition.

Post-incident quality improvement

After the incident, the municipal health and care service implemented and planned additional relevant measures to reduce the risk of any recurrence or similar incident. We have requested that the service reports on and submits a copy of relevant records that the measures have duly been implemented. We have also requested a description of how the organisation monitors whether the measures are instrumental in achieving the necessary and lasting adjustment to practices.

Incident

A user was found dead in their home, after they had been left unsupervised for an extended period by homecare staff. In advance of the serious incident, the user had returned from a short stay in hospital, and for this reason the homecare had been put on hold.

Regulatory topic

Whether the municipal health and care service has ensured proper communication and information flow in its homecare services.

Assessment

The user was served under a daily attendance order, but was not attended for a period of almost two weeks. This happened despite the fact that a record had been made that the user had been discharged to their home following a short stay in hospital, and that the homecare for the user was to be initiated. The user was attended on two consecutive evenings after returning home and it was reported that at these visits the user’s general condition had deteriorated. Information about the user was reported orally and in writing, but was not followed up in the days that followed, and among other things, the user was not placed on task lists for further follow-up. Lack of attendance by the homecare service was not discovered until the homecare service received medication the pharmacy prescribed for the user. When staff then visited the user’s home, they user was found dead.

The department was run with a high risk of failure in connection with the resumption of homecare after returning from a temporary stay at an institution. In order for a user under a homecare order to receive professionally responsible homecare, it is absolutely essential that the homecare service has procedures in place to ensure that staff actually visit the home of those requiring attendance.

We believe that the failure of the service stemmed from a lack of management and facilitation of communication and information flow in the department. There was a high risk that important information did not reach the staff concerned, or that messages about needs were not forwarded and assessed. There were no procedures and agreed practices to ensure reliable management of information that the service to the user was to be resumed after the user was discharged from a stay at an institution. There were a number of different formal and informal structures, both for the receipt and use of such information. There was also a lack of a clear division of tasks and responsibilities. Training and ongoing improvement activities had been underprioritised for some time. Previous reports of similar nonconformities in the service, where users had not been attended as agreed, had not resulted in actions to reduce the risk of further failures.

Conclusion

The user did not receive clinically responsible healthcare service from the municipal services.

This review case had not been closed at the time of writing. We therefore describe the main features of the incident and our assessments and conclusions only to a limited extent.

Incident

A user under a home assistance order (“User 1”), including assistance for medication management, was dispensed medication prescribed for another service user (“User 2”). User 1 was taken to hospital. Several hours passed before the hospital was alerted by the municipal health and care service that User 1 had been taking User 2’s medication.

User 1 activated their personal safety alarm. When homecare reached User 1, they were lethargic, had speech difficulties and dozed off during their conversation. The health and care assistant called for a nurse. On arriving at the home of User 1, the nurse called for an ambulance. EMCC asked if User 1 had taken any medications or was over-medicated. The staff present in the home of User 1 believed that this could not be the case, as User 1 would not have been dispensed medication.

In the hospital, User 1 was initially treated for suspected stroke, and next of kin had been informed that only palliative treatment could be offered, and that they believed that User 1 was likely to die. After the hospital received information about the misdispensing of medication, targeted therapy was initiated with good effect. User 1 was discharged to their home, but next of kin describe that the patient suffered physical and mental effects from the care received.

Regulatory topic

Whether the municipal health and care service facilitated and ensured safe medication dispensing in the homecare service. Medication management is an area of the health service with a high risk of failure, and where failure can have severe adverse consequences for the user. This makes it imperative to establish structures for communication on medication management, and the area requires special facilitation and checks.

Assessment

We have requested a written statement from the organisation. The purpose of preparing the written feedback for us is to shed light on the incident and ensure that the organisation has commitment to making improvements in the aftermath of this serious incident.

Incident

The incident involved a patient in a nursing home. The patient did not receive the breathing aid needed. The patient died. The municipal health and care service asserted that the incident was related to lack of experience and training in use of medical devices in the nursing home.

Regulatory topic

Whether the municipal health and care service had ensured that healthcare involving medical devices was legally compliant to ensure that patients receive safe and effective care, and whether this patient received clinically responsible healthcare.

Assessments and conclusions

The municipal health and care service had not ensured that expectations and guidelines were understood, and there were no systems to monitor compliance with guidelines. The municipal health and care service did not have systems in place to ensure that staff had received adequate training and expertise in using medical devices and thus in providing clinically responsible healthcare to patients requiring medical devices.

Conclusion

The patient did not receive clinically responsible healthcare at the nursing home. A review of the medical device would have detected that it had been connected incorrectly with the result that the patient failed to receive essential supplemental oxygen. This regulatory case demonstrates the importance of organisations’ responsibility for ensuring that the users of medical devices are trained to give them the necessary skills and knowledge of correct and safe use at all times. The training must be systematic and documented.

The municipal health and care service has not sufficiently implemented measures to reduce future risk of events caused by a lack of skills in the use of medical devices.

We will therefore be following up with the service to ensure that they implement such measures, and verify that the measures have duly been implemented.

There was very varying content in the incident reports that did not meet  reporting scheme criteria. Those that occurred most frequently concerned:

• Medication: Two-thirds of these reports were from individuals. Many of them were complaints that they were not prescribed the medication they wanted. There were also incident reports concerning vaccination logistics
• Documentation/record-keeping/privacy: The vast majority of incident reports were submitted by individuals and concerned errors in care records, access to records and unlawful records access.
• Complaints concerning the child welfare service by next of kin: lack of service, unwelcome interventions or a complaint against an expert.
• Complaints concerning rights: Many patients or relatives submitted reports describing their general frustration with the healthcare or care services they received or did not receive.
• Complaints concerning staff conduct or service delivery by individuals concerned, for example, allegations of substandard care by a general practice clinic and improper conduct by healthcare/care staff.
• Complaints concerning treatment offered from individuals concerned, for example, dissatisfaction with a clinical assessment and treatment, long waiting times for a medical appointment, long waiting times for enrolling with a new GP, complaint concerning care provision within 24-hour care services.
• Description of problematic communication between a patient and healthcare professional was described by individuals. This mainly concerned doctor-patient communication.
• “Frustration statements” made by individuals concerning cases already assessed by the County Governor or the Norwegian Board of Health Supervision. This mainly concerned a request to have a reassessment of a closed or ongoing review case.