Case #

Brief Summary of Case

Recommendations

2005- 01

This 65 year old male died on post-operative day 6 following aortic aneurysm repair. Prior to his death, he had a significant nosebleed and a period of unexplained hypotension; there were issues identified with communication between staff surrounding these events.

He subsequently became lethargic, and was found to have an intracerebral hemorrhage which ultimately caused his death. There was evidence of supratherapeutic anticoagulation with elevated partial thromboplastin time (PTT).

Root cause analysis revealed that it is likely that the decedent’s central line was flushed with high-concentration heparin solution (1000 U/mL or 10000 U/mL) rather than with the intended 100 U/mL solution

1. Heparin 10000U/mL concentration should be removed from hospital wards. Any heparin of this concentration should be locked in a narcotic cupboard and strictly controlled.
2. Hospitals should consider the use of pre-mixed bags for heparin administration (flushing of lines) wherever possible.
3. Central lines should be removed at the earliest possible time. It is recommended that a medical directive be developed stating that the physician must justify the continuance of the line or the line is automatically removed at a specified point in time, similar to policies regarding antibiotic discontinuation. Hospitals should review evidence-based guidelines regarding optimum time for removal. It is known that central intravenous line insertion and maintenance represent significant opportunities to enhance patient safety.
4. Where possible, the hospital should employ central venous catheters which can be flushed with saline. These catheters are widely available and cost should not be a barrier to such an implementation.
5. The Chief of Staff of the hospital and the Chief Nursing Officer should emphasize to staff that significant changes in a patient’s condition (e.g. hypotension) require timely and direct physician assessment. It is recommended that the hospital undertake a review of the team environment on this unit in response to concerns identified by the family.
6. The hospital should examine whether the team climate on the ward is conducive or not to nursing staff reporting concerns to physicians. The committee is aware of situations elsewhere wherein nurses may be fearful of physician reactions when they notify them of important issues on wards. In this case, based on the review of records, the committee had difficulty discerning reasons that the physician did not attend a hypotensive, bleeding patient.
7. Medication errors and other errors should always be considered as part of the differential diagnosis when working up adverse events including an unknown source of bleeding. This fact should be taught to staff as part of a hospital-wide educational initiative on patient safety.

2005-02

This 48 year old man was transported to hospital in the evening after being found unresponsive in an apartment. Early the next morning, a Respiratory Therapist (RT) was paged to intubate him in the Emergency Department when he developed increasing respiratory distress and neurological deterioration.

Following successful intubation, the RT connected the endotracheal tube (ETT) to the ventilator with a mechanical airway consisting of the ETT, an ETT connector, a swivel elbow, a filter and a piece of corrugated tubing, which was connected to the ventilator. The decedent developed increasing respiratory distress and bradycardia, and died shortly following intubation.

After the patient was pronounced dead, the RT observed a thin piece of plastic between the swivel elbow and the ETT connector, which had obstructed the patient’s mechanical airway and prevented him from being ventilated. It was determined that a piece of the plastic bag in which the swivel elbow was packaged tore away when the swivel elbow was removed from it, and became caught on the end of the swivel elbow at its attachment to the ETT connector.

1. The hospital reviewed this case and the procedures to be followed when an intubated patient appears to have an obstructed airway, including the most appropriate person to intubate a patient who still has vital signs.
2. The hospital responded in writing, advising that they had reviewed the case and that the following measures had been taken to prevent similar problems in the future:

3. This case should be brought to the attention of The Canadian Society of Respiratory Therapists, so that it may serve as an educational opportunity for other RTs.
4. The Executive Director of the Canadian Society of Respiratory Therapists responded in writing, advising that a summary of this case (without any identifying information) would be published in the issue of its journal to be published on February 28, 2006.
5. This case should be discussed with the manufacturer of the swivel elbow, asking them to consider packaging it in tear away or peel away material to decrease the likelihood of similar problems in the futures.
6. The manufacturer responded in writing, advising that they had reviewed the matter. The manufacturer advised that over 40,000 similar connectors packaged in the same manner had been sold, and that there was no known previous adverse incident associated with the use or packaging of these connectors. The manufacturer found no basis to suggest that the connector, or the packaging of the connector, is inappropriate for its intended use. It has no plans to change the packaging for the elbow connector.
7. This case be discussed with the Medical Devices Branch of Health Canada.
8. The Medical Devices Branch investigated this matter, and concluded that there was no basis to suggest that the connector, or the packaging for the connector, was inappropriate for its intended use.

2005-03

A 78 year-old man, resident at a long term care home, was receiving outpatient hemodialysis three times per week through a tunneled subclavian dialysis catheter.

Approximately one month after starting outpatient hemodialysis, the patient was found in his nursing home bed with extensive bleeding from the catheter site. The catheter had been torn. Pressure was applied to the wound by nursing staff. Emergency medical services (EMS) attended the patient and continued to apply pressure.

When the patient arrived at hospital, he had developed significant respiratory distress. Air was observed to enter the catheter, after which the catheter was clamped. The patient developed progressive cardiorespiratory failure and died.

No autopsy was performed due to strong family objections. The cause of death was determined to be probable air embolism.

1. Hospitals that insert central lines should develop and provide clear care policies and procedures related to the care of the catheter, including management of catheter-related emergencies.
2. Nursing homes that provide care for patients with central lines must train staff on appropriate catheter care and management of catheter related emergencies.
3. EMS personnel should be trained on management of catheter emergencies.
4. Catheter emergency kits should be stored in the patient’s room and at the nursing station, and should be available to EMS personnel. This kit should include a checklist of procedures, clamps, and barrier dressings

2005-04

A 59 year old female had undergone an aortic and mitral valve replacement with St. Jude mechanical prostheses for rheumatic valvular heart disease 12 years prior to her death.

She died as the result of cardiogenic shock due to severe aortic stenosis and acute myocardial infarction due to failure of the aortic valve prosthesis. Fibrous tissue had formed on the aortic valve prosthesis, causing it to be fixed in a semi-open position.

On review of the decedent’s records, it was found that there were a number of opportunities to improve upon her care, and potentially to have identified and managed this complication differently. The areas of concern included:

Documentation and communication issues related to her emergency department care and subsequent admission

Lack of effective communication between the echocardiography technologist, interpreting echocardiography physician, and treating physician

Issues with the timing, format, generation and communication of echocardiography reports

1. That Hospital A’s Chief Executive Officer, Chief of Staff, Vice-President of Patient Care and Chief Nursing Officer, Professional Practice Leader and Chief of Internal Medicine receive a copy of this report.
2. That Hospital A conduct a quality of care review under the Quality of Care Improvement Protection Act. (QCIPA)
3. That the quality of care review should have access to this report and consider the following recommendations;

4. That the Department of Cardiology and the Department of Pathology of Hospital A liaise and report to the manufacturer of the St. Jude prosthetic heart valve the clinical and pathological details of this patient so that the data base of valvular complications can be expanded for future reference.
5. Revise Section 3.2, “Components of the Report” to reflect the addition of the following study information:

6. Communicate with the College of Physicians and Surgeons of Ontario and request that the College consider developing mandatory standards for the training of physicians seeking to interpret echocardiograms consistent with the policies of the Provinces of British Columbia, Alberta, Saskatchewan, Manitoba and Quebec.
7. Communicate with all hospitals and independent healthcare facilities;

2005-05

An 82 year old female, resident in a long term care home, underwent open reduction and internal fixation of a fractured hip sustained as the result of a fall. She received low molecular weight heparin injections for four weeks following the surgery for venous thromboembolism prophylaxis.

Following this four-week period, the treating physician at the long term care home elected to maintain the decedent on warfarin; the rationale for this decision was not clear. She was continued on her previous medications, which included ASA and diclofenac –misoprostol.

Over the following 11 months, the decedent had a number of complications related to the warfarin therapy, including vaginal and rectal bleeding. One month prior to her death, she was treated with a macrolide antibiotic for a urinary tract infection. Her International Normalized Ratio (INR) rose to 12.7. Despite treatment with vitamin K, the decedent died of complications of her anticoagulation.

1. Through the use of journals and other educational forums, physicians should be educated as to the following:

2. Hospitals, physicians and health care institutions should consider computer assisted prescribing programs for physicians.
3. Health care institutions, especially long term care facilities, should arrange adequate and regular review of medications by a qualified pharmacist, especially high-risk medications such as warfarin.
4. Discharge documents from hospitals should be clear about ongoing management plans and should be provided in a timely manner.
5. Health care institutions should ensure institutional protocols deal with circumstances where nurses’ concerns are not allayed by physician response.
6. Case management of patients by Primary Care Nurse Practitioners should be considered in nursing homes.
7. Long-term care institutions should utilize regular patient reviews. These should be multidisciplinary with all key members of the health care team present.
8. Health care institutions should establish a non-threatening process for family members to follow if they are concerned about medical care in a long-term care institution.

2005-06

The decedent is a 22 year old female who was receiving treatment for a psychiatric illness which included an eating disorder. At the time of her death, among other medications, she was prescribed lamotrigine and lithium. She was documented to have episodes of hypokalemia, thought to be related to vomiting. She died suddenly, of an apparent cardiac arrhythmia.

While there was some controversy as to the role played by the combination of medications and hypokalemia, versus an underlying cardiac abnormality, a number of areas were identified where the care of the decedent could have been improved upon. These concerns included:

Lack of coordination of care between providers

Challenges with the sharing of relevant medical records

Awareness and follow-up of potential adverse drug reactions

1. The importance of identifying a coordinating physician or “quarterback” for patients with complex medical problems should be emphasized by the College of Physicians and Surgeons of Ontario and included in their education materials that are sent to all members in the province.
2. The Ministry of Health and Long-Term Care, working with the Ontario Medical Association, should move ahead with initiatives to support hospitals, health care clinics and all physicians with the development of electronic medical records as quickly as possible as one method to improve the timely and seamless transfer of medical information amongst medical care givers and other members of the health care team.
3. The Office of the Chief Coroner should establish a mechanism to ensure that all adverse drug reactions (or potential adverse drug reactions) identified during coroner’s investigations be forwarded to Health Canada to ensure that Health Canada is receiving as much information as possible with respect to these real or potential adverse events. This would ideally be done at a central location to ensure completeness, consistency and uniformity of reporting.
4. The Office of the Chief Coroner should prepare a short paper highlighting the potential risks associated with Lithium in the setting of hypokalemia for publication in “Dialogue” a publication sent to all physicians in the Province of Ontario through the College of Physicians and Surgeons of Ontario.

2005-07

The decedent is a 94 year old female receiving palliative care in a long term care home for cancer. She had been ordered and was receiving, subcutaneous morphine 1 to 2mg every 3 to 4 hours as needed.

Two hours prior to her death, the patient was given 10mg of morphine in error. The registered practical nurse drew up and administered 0.7 mL of morphine solution in instead of the correct dose of 0.07 mL as intended to deliver morphine 1 mg. The patient died shortly thereafter.

1. Ontario Drug Benefit purchasing guidelines should provide for more appropriate concentrations of morphine to be supplied to health corporations such as long term care facilities e.g. 2 mg/mL and 10mg/ml, which are easier to dilute and provide enough volume when diluted to allow accurate volume measurement.
2. Health corporations should post charts showing dose/administration of high alert medications.
3. Health corporations should require that independent and double checks should be used when high alert medications are being administered.
4. Agencies should have policies and procedures to ensure that they employ registered nursing staff members who are familiar / competent with high alert medications and how to administer them.

2006-01

The decedent was an 83 year old male with coronary artery disease who was admitted for coronary artery bypass graft surgery. He was taken to the operating room where central lines were placed in preparation for surgery. Shortly after placement of a pulmonary artery catheter, he developed massive hemoptysis. Despite resuscitation efforts, the decedent died on the operating table prior to the start of surgery. The cause of death was rupture of the pulmonary artery due to the pulmonary artery catheter.

No new recommendations.

2006-02

Special investigation for Province of New Brunswick.

No new recommendations.

2006-03

This 35 year old male presented to the emergency department (ED) with left shoulder pain following an episode of vomiting. He was also noted to be tachycardic, but was afebrile with a normal blood pressure. He had tenderness over the left chest wall which increased with movement of the left arm. An electrocardiogram and chest x-ray were both normal. He was assessed and discharged with analgesic for musculoskeletal pain.

He returned to the ED four hours later with worsening pain, now severe. Some tenderness was again noted over the chest wall. Vital signs were normal except for mild tachycardia. Blood work, including a D-dimer, was ordered. Both the white blood cell count and the D-dimer were elevated. A computerized tomography (CT) scan of the chest was performed. This was negative for pulmonary embolus and the aorta was normal. The radiologist’s impression on the CT report was: “left pectoralis minor tear, small left pleural effusion with small amount of left base atelectasis/pneumonia.” He was discharged home with analgesia.

The decedent returned to the ED a few hours later with respiratory distress, cyanosis and an oxygen saturation of 70% on room air. He suffered a cardiac arrest shortly after arrival.

Post mortem examination determined the cause of death to be sepsis due to necrotizing fasciitis due to Group A Streptococcus.

1. Emergency physicians and emergency nurses must be extra cautious in patients with abnormal vital signs. Their presence signals autonomic dysfunction which should prompt clinicians to determine the underlying cause. Abnormal vital signs call for close monitoring and thorough documentation. Should vital signs remain abnormal during an emergency department visit through to discharge, the cause should be apparent and should be expected to resolve.
2. Patients who have an unusual pattern of presentation such as repeated visits to the Emergency Department with unexplained symptomatology and abnormal vital signs within a short period of time, should be regarded as high-alert patients. In such situations, clinicians should be reminded of the increased potential for occult serious disease.
3. Transfer of care is well recognized as a high risk event. Clinicians need to be mindful of the potential risks and caution should be exercised at handover periods. An appropriate reassessment of each transferred patient should occur at a fitting time after transfer of care.
4. Clinicians should be reminded of the importance of pain that is out of proportion to physical findings. This can be a harbinger of serious conditions that lack other findings early in their course (e.g. vascular emergencies, compartment syndromes and necrotizing fasciitis).
5. Radiologists need to be careful to consider a broad differential diagnosis in interpreting films. This is especially true in situations where there are unusual findings and when the findings are inconsistent with the clinical scenario. In unusual situations, a direct discussion with a clinician can be very helpful in the diagnostic process. The most serious possibilities for each radiological finding must be considered.

2006-04

This 79 year old male died following surgery for a repeat aortic valve replacement and coronary bypass grafting.

About 30 minutes into the procedure, while on extracorporeal circulation, it was noted that there was decreased arterial pump flow, decreased mean arterial pressure followed by decreased venous oxygen saturation. The flow could not be increased by adjustment of the centrifugal pump or by switching to a hand pump. Therefore, the decision was made to switch over to a roller pump. The period of absent flow that occurred during this time was documented as between four and seven minutes.

At the time that the patient was placed back on extracorporeal circulation, air was observed entering the aorta from the arterial line. A number of techniques were employed in an effort to minimize the presumed embolic event, but the patient unfortunately never regained consciousness and died thirteen days later in the ICU.

There was some disagreement by experts who analyzed this case as to the root cause(s). One theory involved a phenomenon called “High Pressure Excursion” (HPE) which occurs when the fine pores in the membrane oxygenator used to oxygenate blood in the heart-lung machine become clogged with aggregates of protein and platelets. The decedent’s platelets were elevated pre-operatively, which would contribute to the development of HPE. Another theory involved the entrainment of air into the circuit due to a decreased level of blood in the venous reservoir of the bypass machine.

1. Platelets should be reduced prior to cardiac bypass surgery to reduce the likelihood of HPE.
2. The absence of documentation of the critical events made analysis of this case more difficult. It is recommended that critical incidents be documented in sufficient detail in the health record to allow later reviewers to adequately understand events.
3. The manufacturer and the cardiac surgical team should review and consider the likelihood of the venous reservoir level dropping too low. Strategies both from the hardware and personnel to prevent this occurring should be developed.
4. The cardiac surgical multi-disciplinary team should review this report, and develop a checklist for dealing with unexpected low-flow states which occur during extracorporeal circulation. This checklist should include key steps such as the sequence of checks, the formation of an AV loop, and surveillance for and prevention of air embolization. It is recognized that these will all be very elementary and familiar to these personnel. However, the use of the checklist may prevent omission of key steps or the development of avoidable complications.
5. There appears to have been a failure of the critical incident reporting system in this case from OR personnel to senior administrators at the hospital. This case occurred during a holiday period, which may have contributed. The hospital should consider how such reporting can be ensured.
6. The extracorporeal circuit should be set up so as to “stop-link” the cardioplegia pump to the main arterial pump to prevent negative pressure accumulation when the arterial pump is not operating

2006-05

This 56 year old woman presented to the emergency department with severe abdominal pain, back pain and vomiting. Investigations included blood work (essentially normal apart from a mildly elevated white blood cell count), chest and abdominal x-rays (interpreted by the emergency physician as normal) and an abdominal ultrasound (negative for abdominal aortic aneurysm).

She was admitted to hospital and treated with narcotic analgesic and antiemetics. She seemed somewhat improved and was discharged home the next day. She reportedly experienced increasing abdominal pain at home during the day and died at home.

Post mortem examination showed evidence of necrotic small bowel due to torsion from adhesions resulting from previous surgery.

The admission radiographs were interpreted by a radiologist (working at another facility, and receiving the images electronically) and reported some 56 hours after they were obtained. The radiologist noted evidence of mechanical bowel obstruction. The radiologist did not inform the treating physician of these findings (other than via the dictated radiology report).

1. The medical and administrative staff of Hospital A must set reasonable expectations regarding the timing of radiological reports and opinions when the PACS system is used so as to ensure optimal patient care outcomes.
2. The action plan identified by the Quality of Care Committee at Hospital A be followed and an urgent completion date for these actions be identified. Further, there must be review and acceptance by the medical staff at Hospital A of this committee report.
3. The Medical Advisory Committee review the physician process for admission of inpatients to the Hospital A, specifically with respect to its compliance with the Public Hospitals Act of Ontario in the area of documentation of a patient history, physical examination and treatment plan.
4. The medical and nursing staff will review and make recommendations regarding the purpose and intent of late entries to the health record (if any) for any patient admitted to Hospital A.

2007-01

and

2007-16

The Committee reviewed two cases of post operative deaths following elective surgery. Both individuals underwent relatively minor operative procedures and died about a week postoperatively.

Through examination of the medical records performance of post mortem examinations, both decedents were recognized as having significant medical co-morbidities which were not fully appreciated preoperatively. In both cases, the investigating coroner noted an apparent lack of significant preoperative screening and written protocols.

1. It is recommended that a system be developed to identify patients with significant anesthesia risk factors.
2. Patients with significant anesthesia risk factors should be seen pre-operatively and evaluated appropriately.
3. Patients who have significant risk factors should have a written anesthesia plan which would include the plan for post-operative pain management both in the hospital and on return to the community.
4. The post-operative pain management plan should be communicated to the family and the family physician, especially in cases where the patient may be at risk, i.e., patients with narcolepsy, obesity, sleep apnea.
5. Ongoing continuing medical education for community anesthetists regarding co-existing conditions that place patients at higher risk for anesthesia and post-operative recoveries.

2007-02

This is a 5 month-old child who had been diagnosed with a congenital inguinal hernia at two months of age. A surgical specialist assessed the child, and indicated that he should be followed up for the hernia after three months. It does not appear that a follow up appointment was booked at that time.

Approximately three months later, the child was seen in a walk-in clinic for a fever and vomiting. There is no documentation of examination of the abdomen, and no mention of a hernia at the time of that visit. The next day, the child’s condition worsened and he became vital signs absent at home. Post mortem examination determined the cause of death to be complications of an incarcerated inguinal hernia.

No recommendations from the Patient Safety Review Committee

[NB: This case had previously been reviewed by the Pediatric Death Review Committee of the Office of the Chief Coroner]

2007-03

The decedent is an 87 year old male who was admitted to hospital with chest pain. An electrocardiogram in the emergency department was abnormal. Troponin I (cardiac enzyme) testing was reported as normal. Three days after admission, he suffered a cardiac arrest and died.

It was later identified that the initial troponin I level was, in fact, elevated at several times the normal value. This error in reporting occurred as a consequence of a modification in the Laboratory Information System on the same day as the decedent was admitted. This modification led to the system erroneously reporting abnormal troponin I tests as normal. This affected 13 patients, one of whom was the decedent; his was the only death.

The hospital took a number of actions to prevent a similar situation occurring with future modifications to the laboratory system.

1. The Committee recommends that this incident be drawn to the attention of the Ontario Hospital Association so as to ensure other hospitals are aware of the potential risk.

2007-04

This 31 year old female had a history of chronic pain syndrome, panhypopituitarism and borderline personality disorder.

She was receiving narcotic medications prescribed by two different providers and filled through different pharmacies. She was also receiving a number of other psychoactive and hormone replacement medications prescribed by other physicians. She died suddenly, with no anatomic cause of death and elevated (but non-fatal) levels of hydromorphone and diphenhydrinate, as well as therapeutic levels of lorazepam and olanzapine.

1. The College of Pharmacists of Ontario, in collaboration with the Government of Canada and the Government of Ontario, should re-examine methods to enhance patient safety by sharing critical information about drugs with a high potential for abuse. Consideration should be given to maintaining a central computerized database of narcotic prescriptions so as to allow verification of all elicit / licit sources of narcotics for a given patient.
2. Pharmacists should be reminded of the importance of verifying the medication profile of all patients, particularly with respect to opiates. Patients should be asked if they are receiving opiates from any other source each time opiates are dispensed or prescribed.

2007-05

This 93 year old female was a resident in a long term care home (LTCH). She had a history of prior falls resulting in significant head injury, and was considered high-risk for further falls.

Arrangements were made by her family for a hospital bed because of her care needs and the family requested side rails on the bed to prevent falls. The LTCH had a restraint-free policy and the side rails requested were considered to be restraints and therefore prohibited. However “M rails” were suggested as an alternative that the LTCH would accept.

An ”M rail” is a temporary, detachable hand-rail device that is anchored by a support piece that is placed between the mattress and box spring of a bed. It is described by the manufacturer as “an ergonomic leveraging system for people that experience difficulty sitting up and getting out of bed on their own.” In other words, it acts as a grab-bar to help the user to pull themself to sit up and stand; it is not designed to prevent the user from getting out of bed.

In the early hours one morning, the woman was found deceased on the floor beside her bed, entrapped in the “M rail” with the mattress of the bed on top of her and her wrist wrapped in a strap that was used to secure the “M rail” to the bed frame.

The cause of death was determined to be probable mechanical asphyxia.

1. “M rails” should not be used on hospital beds.
2. Institutions that use “M rails” should ensure that their staff are educated and oriented to their installation and reattachment.
3. Manufacturer’s instructions about use and installation of side rails should be communicated to purchasers and those leasing the equipment.
4. If a device is used to restrict freedom of movement or normal access to one’s body, it must be considered a restraint and protocols for monitoring both the individual and the restraint need to be developed and followed.
5. If an institution has a restraint free policy and a resident requires restraint, restraint should be avoided.
6. Recommendations from professional mobility assessments should be acted on.

2007-06

The decedent is a 77 year old female who had a history of prior biliary surgery and who presented with ascending cholangitis. Attempts at endoscopic treatment at a tertiary care academic health science centre were complicated by espohageal perforation which was treated non-operatively.

Following medical treatment for the espohageal perforation, she was discharged home, but presented to her community hospital a few days later with signs of sepsis.

There was difficulty in contacting the original treating physician (and other physicians from that physician’s clinical service) at the tertiary care centre. She was ultimately admitted to a different tertiary care centre in the same city, but died of complications of sepsis due to neck and mediastinal abscesses resulting from the initial espohageal perforation.

1. The team at Hospital A should review the management of traumatic esophageal perforation. There are points to be learned from this case that could inform the development of a management algorithm. This is an uncommon problem that can be a complex issue with some specific nuances that need to be addressed. Most of the issues will not be addressed by Level 1 randomized controlled trials, making it difficult to develop a clinical practice guideline.
2. There should be a process for the admission and discharge of very ill patients from within the region. This is especially important for patients with complex problems that are best managed in the tertiary or quaternary center. Such a process should address but not be limited to the following issues:

2007-07

The deceased is a 66 year old male with a history of sciatica. He had been receiving codeine (Tylenol #4) from his family physician, which was not effective in controlling his pain.

He returned to his family physician who prescribed hydromorphone (2 mg tablets, 1-2 every 4 hours as needed) and arranged for computerized tomography imaging of the spine. The next day, the decedent went to the emergency department (ED) with severe back pain. He was started on a transdermal fentanyl patch (75 micrograms per hour) in the ED and discharged with a prescription for same, and instructions to continue his pain medications.

Three days later, he returned to his family physician who increased his transdermal fentanyl to 125 micrograms per hour, with instructions to continue the hydromorphone for breakthrough pain. He was seen again the next day by the family physician and was noted to have some improvement in his pain.

The following day, he was found vital signs absent at home; resuscitation was un-successful.

The cause of death was determined to be fentanyl toxicity.

1. Transdermal fentanyl should not be available in ED stock (or night cupboard). If required for admitted patients in ED, transdermal fentanyl should only be provided from the pharmacy one dose at a time (e.g., q3 days) and only after a pharmacist review. (Fentanyl patch is never required urgently or in an emergency.)
2. Review and revise ED forms to provide appropriate prompts for practitioners to write a complete medication history (drug, dose, frequency and last dose).
3. Review and revise ED forms to provide sufficient space for prescribers to write medication orders and for practitioners to document their administration.
4. Enhance communication between the hospital and family physicians. Consider providing a copy of the ED record to the family physician directly or to the patient.
5. Financially support the implementation of a 24-hour telephone hotline for health care practitioners to access for questions or assistance in the management of transdermal fentanyl (and other opioids).
6. Include a checklist for initiation and titration of transdermal fentanyl in the product monograph, all product packages and on an easily accessed web-site (similar principle to a checklist a pilot would use prior to take-off). Alternatively, an algorithm would be helpful.
7. Review and revise the equianalgesic charts provided for transdermal fentanyl to highlight the reference to the chronic dose equianalgesic potency. The chronic dose conversion factor for morphine should be prominent in the eqianalgesic potency table in the transdermal fentanyl product monograph – transdermal fentanyl is only indicated in management of chronic pain and in opioid tolerant patients.
8. Human factors engineering expertise is recommended to enhance the ease of use of the equianalgesic chart for the purpose of conversion to oral morphine equivalence and to address the need to reduce the number of calculation steps (e.g., potentially following a T-chart format as provided to convert oral morphine dose to transdermal fentanyl dose), and to ultimately make the chart intuitive (i.e., reduce the level of training needed to use the chart).
9. Include additional information in the transdermal fentanyl product monograph to assist practitioners to assess opioid tolerance.
10. Implement computerized alerts in pharmacy information systems for any new order or titration order for transdermal fentanyl that is greater than 25 mcg/hour, to prompt pharmacists to confirm the appropriateness of the fentanyl patch order (i.e. for new prescriptions, whether the patient is opioid tolerant…etc.). [NOTE: Other automated systems such as computerized order entry should at minimum have alerts for prescribers.]
11. Consider sharing this case widely with healthcare professionals for the purposes of learning and preventing a recurrence.

2007-08

A 43 year old male with a history of schizoaffective disorder was admitted to the inpatient psychiatry service at an academic health science centre. On admission, he was on several medications which included olanzapine, ciprofloxacin and fluconazole. Neither a physical examination nor an electrocardiogram was performed at the time of hospital admission.

Nine days after admission, he was found deceased in his bed. Post mortem examination did not identify an anatomic cause of death. Toxicology testing showed an elevated (but not fatal) level of olanzapine (although it was noted that olanzapine degrades after death, and the actual ante-mortem level may have been higher than that measured in post mortem blood samples).

Expert review of the case concluded that death likely resulted from a cardiac arrhythmia. Both fluconazole and ciprofloxacin are known to increase the concentration of olanzapine. In addition, olanzapine, fluconazole and ciprofloxacin are all known to increase the QT interval on the electrocardiogram, and therefore predispose to lethal arrhythmias.

1. Written communication about this incident to health care professionals might be useful. Despite the fact that there is no conclusive evidence that the combination of ciprofloxacin and olanzapine (or fluconazole and olanzapine) contributed to this patient’s death, it would be useful to inform health care professionals about the potential for increased olanzapine levels with drugs such as ciprofloxacin and fluconazole. Increased olanzapine levels can increase the risk of side effects such as sedation, orthostatic hypotension and, possibly (though not proven) increase the QTc interval (as indicated by case reports in the literature).
2. It should be recommended that all pharmacies (in community and hospital settings) have a psychiatric pharmacy reference textbook (such as the Clinical Handbook of Psychotropic Drugs) because it can provide information that might not appear on computerized drug-interaction systems.
3. There should be communication by this Committee with manufacturers of computerized drug-interaction detection systems recommending that the ciprofloxacin-olanzapine interaction be added to their databases (if not already present).
4. Where a patient in an institutional setting is receiving multiple medications, a pharmacist should review the medications with a view to detecting and preventing adverse interactions between the medications.
5. Mental health professionals, e.g. the Canadian Psychiatric Association, should give consideration to the development of guidelines for the assessment and surveillance of cardiac side effects in patients who are prescribed novel antipsychotic medications such as olanzapine and clozapine. Such guidelines should also refer to potential drug-drug interactions when these medications are used.

2007-09

A 67 year old woman was admitted to hospital with an acute ST-elevation myocardial infarction which was treated with thrombolysis using tenecteplase in the emergency department (ED). As part of thrombolytic therapy, she also received low molecular weight heparin (fondoparinux). She was intubated and had a temporary pacemaker inserted before transfer to the Coronary Care Unit (CCU).

In the CCU, the treating physician initiated intravenous heparin. It does not appear that the physician was aware of fondoparinux having been given in the ED. She subsequently developed bleeding in her oropharynx, and her partial thromboplastin time (PTT) was noted to be elevated. A computerized tomography (CT) scan of the head showed an intracerebral hemorrhage. Her condition continued to deteriorate and she was pronounced brain dead.

1. Consideration should be given to requiring the mandatory use of preprinted orders whenever appropriate, and specifically in the case of complex thrombolytic protocols. Preprinted orders serve to (a) standardize complex treatment protocols, thus reducing unnecessary variability in their application (b) ensure adherence to complex clinical treatment guidelines, resulting in reduced unintentional deviations, and (c) provide an easily accessible record of critical pharmacologic administration.
2. Consideration should be given to formalizing the handover process between all units and between all care providers in this hospital, with specific consideration given to the transfer of patients from the Emergency Department to Critical Care units. This can and should include consideration of formal handover tools, such as mnemonic aids, and of clear documentation of all details in the chart of patient particulars, including medications received and confirmation of the use of preprinted and standardized protocols.

2007-10

A 55 year old male was admitted as a voluntary patient to the psychiatry inpatient service of a hospital. He had a history of chronic pain, for which he used large amount of morphine sulphate which he had reportedly been tapering prior to admission. He was admitted with an exacerbation of chronic pain and possible suicidal ideation.

On the day prior to his planned discharge, the decedent was noted by other patients to have a large quantity of 100 mg tablets of morphine sulphate in his possession. They noted that he appeared to be showing signs of toxicity. At one point during the day, he was allowed to leave the unit on a grounds pass.

At 0440 hours, staff performing routine rounds found him vital signs absent in his bed. Post mortem determined the cause of death to be an acute mixed drug overdose (morphine and amitriptyline).

18. made from Regional Coroner’s Review
1. Development of a complex case management program for use with particularly challenging mental health patients.
2. Implementation of point of care drug screen urine testing with immediate results to minimize contraband drug use within the unit.
3. Development of a “Safety is Up to Us” type of program that could be included in the inpatient brochure to make inpatients aware that contraband such as weapons, illicit drugs, as well as smoking and inappropriate behaviour, should and could be identified by the patients and reported to staff while remaining totally confidential. The program could be introduced by nursing as part of an admission procedure.
4. Increased in-house training/education with respect to withdrawal/intoxication symptomatology.
5. Development of a strict policy for dealing with contraband where there is reasonable grounds to believe such exists.
6. Implementation of an education program for staff with respect to psychodynamic transference.

2007-11

The decedent is a 68 year old female, diagnosed with gastric cancer, who underwent surgery consisting of a total gastrectomy, Roux-en-Y, and a feeding jejunostomy. She was initially managed in the ICU and then transferred to the ward on post-op day 3.

The next day, she became more ill and was again transferred to the ICU. She became progressively hypoxic with signs of Acute Respiratory Distress Syndrome, and following discussion with the family, was extubated.

Post mortem examination determined the cause of death to be “Acute pancreatitis complicating total gastrectomy for gastric carcinoma.”

9. Not Available

2007-12

The decedent is a 93 year old female with a history of atrial fibrillation. She was admitted to hospital from her long term care home for treatment of a femoral arterial embolus. At that time, she was started on warfarin therapy.

One month later, she was treated with antibiotics (moxifloxacin and metronidazole) for pneumonia. She developed a large, spontaneous hemorrhage into the soft tissues of her neck. Her International Normalized Ratio (INR) was found to be greater than 10. She died as the result of a cardiac event, thought to have been precipitated by the neck hemorrhage and resulting anemia.

This case was felt to raise similar issues to a previous case [2005-05] reviewed by the Committee. The previous case report was published in the College of Physicians and Surgeons of Ontario “Dialogue”.

No new recommendations.

2007-13

The decedent is a 68 year old male who sustained a knee (tibial plateau) fracture. Surgical repair was performed four days later. No anticoagulation was administered between the date of injury and the surgery.

The day after surgery, low molecular weight heparin and warfarin were initiated for thromboprophylaxis. Later that day, the decedent was noted to have slurred speech. Anticoagulants were held, pending computerized tomography (CT) scan the following day. This showed evidence of an ischemic stroke. Anticoagulation was re-started.

Approximately two weeks post-operatively, the decedent collapsed suddenly and was found to be vital signs absent. Resuscitation was unsuccessful. Post mortem examination determined the cause of death to be a massive pulmonary embolism.

1. The committee endorses the hospital’s plan to develop an automatic referral process for assessment of patients who might require thromboprophylaxis. It is recognized that the reality of a smaller community Hospital is that it may not be possible to dedicate a full-time practitioner to this task but automatic referral to a knowledgeable individual such as an internist with an interest in thrombosis would likely result in more appropriate thromboprophylaxis application.
2. The hospital should review its A, B and C pre-operative categories to ensure that cases are appropriately triaged. Further, the committee believes no patient should wait longer than the 48 hours recommended by the Expert Panel on Trauma with a closed lower extremity fracture, including hip fracture. C category cases should be upgraded to B once the 48-hour mark has been reached.

2007-14

The decedent is a 56 year old female with an extensive past medical history which included chronic obstructive pulmonary disease (COPD), hypertension, diabetes and recurrent deep venous thromboses. She presented to hospital with shortness of breath with bilateral lung infiltrates.

She was admitted to the medical short-stay unit and started on therapy for pneumonia and exacerbation of COPD; investigations for venous thromboembolic disease were negative.

When the decedent developed a fever and worsening respiratory status on the short stay unit, she was moved to the Emergency Isolation Unit (EIU; an 8-bed negative pressure isolation unit adjacent to the Emergency Department). Here her condition continued to worsen over the next approximately 48 hours. She required 50% oxygen in order to maintain her oxygen saturation. She was subsequently found vital signs absent in her bed, and resuscitation was unsuccessful.

On review of the case, issues were identified with respect to:

Use of the EIU as an isolation unit for inpatients (which was not its intended use)

The level of staffing and experience of nursing staff in the EIU relative to the severity of illness of patients treated there

Apparent lack of appreciation and communication of the decedent’s worsening condition to the responsible physician and/or charge nurse.

1. Consideration should be given to developing a policy for when EIU is used for care of inpatients and the expectation for regular reassessment of options to limit this.
2. Consideration should be given to ensuring there is understanding at the level of ED charge nurse and ED manager of patients in this area and their associated care needs and whether staffing needs to be adjusted to accommodate for higher care needs. This information should be considered in developing the staffing assignments.
3. Assessment of primary nurse’s knowledge in relation to this patient condition is recommended. Consideration should be given to providing a case presentation of this and similar cases to educate staff of the significance of such clinical deterioration and appropriate actions to take.
4. Staff should be educated of the expectation that the most responsible physician should be advised expeditiously of significant clinical changes. In addition, there should be protocol to advise the charge nurse of significant clinical changes.
5. Nurses need to be encouraged to express concerns to leadership when care needs are expected to exceed their capacity and to seek direction and further support.
6. Experienced nurses who are working with novice nurses should be encouraged to be directive in making suggestions in situations where patient condition is deteriorating. If action is not proceeding as expected, in the patient interest, they should be encouraged escalate concerns to the charge nurse or others in leadership.
7. Reassessment of the equipment located in this area and formal identification of the patient conditions that are appropriate and those that are not appropriate for the EIU is recommended.

2007-15

This 78 year old male was admitted to an inpatient palliative care service with metastatic melanoma. Part of the therapeutic intervention was pain management which included narcotic medications. The amount of narcotic medication administered had increased during his admission, but had been decreased due to concerns about over-sedation. He was found vital signs absent approximately two hours after having last been seen alive.

The decedent’s family raised concerns as to the possibility that the death may have resulted from narcotic toxicity, based on the decedent’s clinical course prior to death. Post mortem blood samples were not obtained prior to embalming, and therefore toxicology testing was not able to resolve this issue.

The hospital conducted a quality of care review and implemented a number of recommendations arising from that review.

1. It is noted that the hospital identified and implemented recommendations in response to this incident. One example is the introduction of a new flow sheet for documentation of medications and infusions. Such changes are useful. It is recommended that the hospital also review its communications policies and procedures in palliative care, particularly as these relate to caregiver-next of kin-patient conflict or disagreement.

2007-16

[See case 2007-01]

[See case 2007-01]

2007-17

The decedent is a 47 year old female with a history of chronic obstructive pulmonary disease. She was admitted to hospital with a diagnosis of bilateral lobar pneumonia (which was later proven on autopsy). At the time of her admission, she required supplemental oxygen. There was apparently difficulty keeping the oxygen on the decedent, and she would desaturate when the oxygen was removed.

Due to all of the acute care beds being occupied in the hospital, the deceased was placed in a palliative care bed on an inpatient unit, at the far end of the corridor from the nurses' station. She was subsequently found vital signs absent, and did not respond to advanced life support.

1. The institution should consider developing a policy/procedure, which sets out the process to be followed when there is no appropriate bed to deal with the patient requires admission. This policy should include but not be limited to:

2007-18

A 68 year old male with a history of prior bioprosthetic aortic valve replacement was admitted to hospital with a diagnosis of endocarditis and aortic abscess. He had been assessed by cardiovascular surgery as well as a number of other specialists, and a decision had been reached to manage the decedent non-surgically with antibiotic therapy and close follow up. He died suddenly and unexpectedly prior to discharge home.

No recommendations.

2007-19

An 81 year old female was admitted to hospital for emergent surgical treatment of a colonic perforation complicating a diagnostic colonoscopy. She had a complicated post-operative course.

On post-operative day #17, a nurse was administering pain medication which was ordered as hydromorphone 1 mg subcutaneously every 4 hours as needed. The nurse obtained a 2mg/mL vial of hydromorphone, but dropped the vial. She obtained what she believed to be another vial of 2 mg/mL hydromorphone from the narcotic drawer and drew up and administered what she believed to be the prescribed dose of hydromorphone.

Medication counts at end of shift led to the conclusion, however, that the second vial was in fact 50 mg/mL morphine. This meant that the decedent received 25 mg sc of morphine; an approximately 6-fold overdosage of narcotic. The decedent’s condition continued to deteriorate and a decision was made to withdraw care.

Post mortem examination determined the cause of death to be complications related to her colonic surgery and multiple medical co-morbidities. The morphine level in post mortem blood was within or below the therapeutic range. While the medication error did not in itself cause death, it was felt that it may have contributed to hastening the death. It was also felt to highlight a potentially preventable error that would benefit from recommendations aimed at preventing similar event in future.

1. Assess staff competencies regarding the usage of units (e.g. mg) to express the dose of medications.
2. Assess risk associated with narcotic stock in patient care areas.
3. Remove morphine ampoules or vials with concentration greater than 15 mg/ml.
4. Add labels to reduce confusion, consider including the brand name equivalent (e.g. hydromorphone – for Dilaudid).
5. On an ongoing basis, evaluate the contents of the narcotic stock drawer or cupboard for look-alike products and packaging.
6. The Regional Supervising Coroner of this case is to be commended for adopting a medication system based approach in investigating the medication error. This is evident from his questions to the hospital (e.g. “How were doses of morphine and Dilaudid stored in the ICU at the time of the death?”). Other coroners are encouraged to take in consideration the role of medication system failures when investigating medication errors.

2007-20

The Patient Safety Review Committee reviewed two deaths in young persons (a 30 year old female, and a 26 year old male) who were taking clozapine for management of schizophrenia. In both cases, the cause of death was felt to be sudden cardiac death.

The 30 year old female had been investigated for “irregular heartbeats” in the days prior to her death. She died suddenly at home. Post mortem did not identify an anatomic cause of death; clozapine level was higher than therapeutic, but not at a level expected to cause death. Serious arrhythmias are a rare, but recognized complication of clozapine. Other factors, such as hypokalemia, may increase the likelihood of such arrhythmias.

The 26 year old male had experienced significant (100 lb) weight gain since starting on clozapine (which is a recognized side effect of the medication). He died suddenly in hospital while being investigated for a paralytic ileus. Post mortem demonstrated dilated cardiomyopathy, as well as ischemic bowel. Both dilated cardiomyopathy and ileus are recognized complications of cloxapine. Additionally, weight gain, medical comorbidities and unhealthy lifestyle can cause or contribute to the development of dilated cardiomyopathy.

1. Education should be given (and reinforced) about how to follow a healthy lifestyle such as smoking cessation, healthy diet and exercise (although it can be very difficult to change behaviours in patients with schizophrenia).
2. Report similar cases in the future to the Canadian Adverse Drug Reaction Monitoring Program.

2008-01

A 48-year-old male underwent catheterization of the right internal jugular vein in preparation for renal transplant. After the procedure, the line was transduced and the waveform was noted to be arterial and consistent with that of the noninvasive blood pressure reading. The catheter was removed with pressure applied for five minutes. There was no bleeding or hematoma. An internal jugular catheter was inserted on the left side without incident.

Unfortunately, some hours later, the patient developed profound left-sided weakness while in the intensive care unit, and subsequently had dilation of the right pupil. Computerized tomography (CT) scan revealed a large right-sided cerebral infarct with mass effect and evidence of clot in the right internal carotid artery. The patient developed hemodynamic instability followed by cardiac arrest from which he could not be resuscitated.

At autopsy, the most important finding was that the patient had suffered a large cerebral infarct in the middle cerebral artery territory with thrombus from the origin of the right internal carotid artery up to the right middle cerebral artery. There was a 3 mm transverse tear of the common carotid about 5.5 cm above the origin of the common carotid with associated peri-arterial hemorrhage.

The expert reviewer identified that the risk of such complications can be mitigated through the use of ultrasound guidance during central catheter insertion.

1. The Patient Safety Review Committee recommends that hospitals and practitioners review the potential use of ultrasound-guided central catheter insertion. We believe that serious consideration should be given to adopting this technique of central venous catheterization more widely.

2008-02

The Patient Safety Review Committee reviewed the deaths of two patients who died following hypoglycemic episodes in an acute care hospital setting. Both patients were elderly and critically ill with complex medical conditions. Both patients had percutaneous gastrostomies and were receiving intermittent enteral feedings (16-18 hours each day). Intermediate acting insulin was administered twice daily supplemented with sliding scale regular insulin for blood glucose levels in excess of 8 mmol/L. Point-of-care glucometry was conducted twice daily.

Both patients developed severe hypoglycemia following a period of suspended enteral feeding with devastating neurological consequences. Each patient died without regaining consciousness in the hours to days following these events.

1. The Patient Safety Review Committee wishes to emphasize that the decision to adopt more aggressive glycemic control practices must be accompanied by review and revision of diabetic management protocols, relevant clinical care guidelines and education programs to ensure that appropriate safeguards are in place to mitigate the associated risk of hypoglycemia. Physicians and hospitals (and their respective Medical Advisory Committees and Professional Practice leaders) should ensure that the adoption of tighter glucose control is accompanied by a review of educational and clinical management programs for critically ill patients to ensure that they reflect current recommendations for the safe implementation of these practices.

2008-03

The decedent is an 83 year old female with multiple medical co-morbidities. She died in hospital as the result of complications of acute renal failure resulting from obstruction of her solitary kidney.

On review of this case, a number of areas of concern were identified; the themes included:

Lack of effective communication between the emergency physician, hospitalist and cardiologist involved in the care of the decedent.

Timeliness of consultations

Nursing assessment and communication; and specifically, a perceived reluctance on the part of nursing staff to raise concerns with physicians.

Barriers to effective investigation and treatment of patients, particular over weekends.

1. The Medical Advisory Committee and/or Emergency Department Chief should review the circumstances surrounding the decedent’s admission and the apparent discord between the expectations of the emergency physician and attending Hospitalist including the processes and policies that guide the admission of patients and the transfer of responsibility for care with a view to ensuring that any systemic impediments to the smooth transfer of care are addressed.
2. The Medical Advisory Committee should review the availability and/or criteria for engagement of specialty consultation services to support the care of patients with complex medical conditions.
3. If the absence of documentation does not reflect a deficiency in the material available for review, Nursing Administration should review the policies and practices pertaining to the monitoring and recording of fluid input and output for patients who are actively being treated for dehydration / volume depletion.
4. Nursing Administration should review the policies, practices and criteria used by nursing staff to ensure that any systemic impediments to the timely notification of the attending physician when significant changes in a patient’s condition arise are addressed.
5. The Medical Advisory Committee and/or the service Chief responsible for hospitalist care, in collaboration with hospital administration, should review the circumstances surrounding the decedent’s death to identify and address factors that impeded the timely investigation and treatment of her medical conditions over the weekend.

2008-04

The decedent was a 77 year old female who present to hospital with atraumatic left hip pain. She had a history of chronic atrial fibrillation and was on warfarin. She was admitted from the emergency department to an inpatient unit that evening.

An International Normalized Ratio (INR) value at admission was markedly elevated (indicating over-anticoagulation). This result was sent to the inpatient unit to which the decedent was admitted, but the result was not directly communicated from the laboratory to the treating physician or nursing staff caring for the decedent.

Early the following morning, the decedent was found lifeless in bed. Post mortem examination showed evidence of left pyelonephritis, as well as a 1.5 L hematoma arising from the left perirenal space and extending into the inguinal canal and thigh.

1. The Committee recommends that the Regional Supervising Coroner discuss this case with appropriate hospital personnel to clarify whether or not the communication, as depicted in the chart, reflects what really happened. Further, in this conversation, the committee recommends that the hospital be reminded of the requirement for direct and clear communication from the laboratory staff to clinical staff when a significantly abnormal laboratory value is received.

2008-05

The deceased is a 75 year old male who was treated in the Emergency Department (ED) for back pain after suffering a fall two days previously. He was assessed and diagnosed with musculoskeletal pain, and was discharged home on hydromorphone 2mg tablets for pain. The decedent’s family state that they had informed the ED staff that the decedent had had “bad reactions” to morphine-based analgesics in the past.

Over the next few days, the decedent became delirious, and developed urinary retention. He was admitted to hospital and had a computerized tomography (CT) scan which revealed a stable lumbar compression fracture. CT scan of the head was normal. He died suddenly in hospital the next day. Post mortem revealed extensive atherosclerotic coronary and cerebrovascular disease. Mechanism of death was felt to be a cardiac dysrhythmia, and concerns were raised as to whether the apparent adverse reaction to the narcotic medication had contributed to his death.

No new recommendations.

2009-01

The decedent was a 24 year old woman who was admitted as to an inpatient mental health facility. She had taken a multiple medication overdose on a background history of prior suicide attempts (including a number of prior admissions to that psychiatric facility). She was admitted with a diagnosis of overdose, depression and social pressures. The Axis I diagnosis of major depressive episode due to dysthymia was made. A possibility of borderline personality trait was noted, but the diagnosis was not made.

The decedent made some progress in hospital in that she became more involved with social situations and accepted quetiapine for her anxiety. However, there were episodes where she was anxious, angry and would not participate in groups. On at least one occasion, contraband was removed from her living quarters.

When she did not appear for a scheduled woman's group, staff went in search for the patient and found her unresponsive on the hospital grounds. She had taken a massive overdose of diphenhydramine was not able to be resuscitated.

It was determined that her death was due to overdose of diphenhydramine, and the manner of death was deemed to be suicide.

1. Providers of mental health care services in the inpatient setting should be reminded of the guideline that mental status examinations including evidence of suicidal thought should be done during each shift for each patient.
2. Institutions which provide healthcare, and mental health care particularly, should consider developing a policy which would require that the patient be offered the opportunity to either consent or refuse to consent to the sharing of information with persons he/she wishes to involve his/her care. This might be the next-of-kin or a significant other person. Consent should be sought at an opportune time during treatment when the patient is capable of considering the matter. Further, it is recommended that the policy require that an appropriately qualified staff member be designated as the family liaison for each case.
3. In this case, there was evidence of sub-optimal communication between the family and the institution. A useful strategy employed in other settings has been to implement a community/patient/family advisory body designed to give a forum for discussion of relationships between the institution and the community that it serves. The Patient Safety Review Committee is aware of literature endorsing the precept of family involvement in care, and believes that this is important in all health care settings. Family involvement enhances the safety of patients.
4. The Regional Supervising Coroner should conduct a Regional Coroner's Review with the institution to share the foregoing recommendations and seek their input and response.

2009-02

A 45 year-old male with hemophilia A presented to a medium-sized community hospital at 0700 hours with a two day history of diffuse abdominal pain, nausea and vomiting, and loose stools. Initial vital signs were stable.

The decedent was seen promptly, and treatment with intravenous fluids, analgesic and antiemetic medication was commenced. A number of laboratory investigations and a computerized tomography (CT) scan of the abdomen and pelvis were ordered. Initial blood work showed a decreased haemoglobin (94 g/L) and a mildly elevated creatinine. Bicarbonate was decreased at 12 mMol/L with an elevated anion gap. Coagulation studies were not obtained at this time.

The CT scan (done without contrast due to the elevated creatinine) showed intraperitoneal fluid and a distended gall bladder. Hemoperitoneum was included in the differential diagnosis.

Blood work was repeated at 1715 hours; this showed a hemoglobin of 64 g/L, International Normalized Ratio (INR) =1.4, Partial Thromboplastin Time (PTT) greater than 180 seconds; serum ketones were negative but serum lactate was reported at 21 mmol/L. Transfusion with packed red blood cells was started at 1800 hours, and factor VIIa administration was started at 1815 hours.

The decedent subsequently developed signs of hemodynamic instability, requiring aggressive resuscitation with crystalloid and colloid fluids and the use of pressors. Despite ongoing efforts, he developed multisystem organ failure and died. A post mortem was not performed.

1. The Medical Advisory Committee and the clinical service Chief responsible for medical care in the Emergency Department should ensure that the circumstances surrounding this tragic event are fully investigated and addressed. The deceased was not the beneficiary of timely diagnosis and treatment in the ED. The Committee was troubled that a known diabetic haemophiliac with undiagnosed abdominal pain, metabolic acidosis, and anemia waited in excess of 10 hours to have INR/PTT measured and an assessment performed by Internal Medicine. Available information led the Committee to conclude that this was not an issue of missed diagnosis, but failure to the system of care. There is little evidence available to suggest that the deceased received more that cursory medical attention for many hours following his presentation to the ED. The hospital should seek to understand and address the factors that contributed to this situation, potentially including:

2. The hospital and its medical leadership should assess whether its available facilities and expertise were adequate to manage the deceased’s emergent, complex care needs and, if appropriate, develop strategies to address gaps. It is unknown from the material reviewed if the deceased was familiar with the care team, the number of haemophiliac patients treated at the hospital, or the familiarity of staff with the management of complex haemophiliac patients. Response to treatment with Factor VIIa is primarily directed by clinical evidence of control of bleeding as traditional measures of coagulation, such at PTT, are not as reliable in this context. Evaluating ongoing bleeding is challenging when the source is intra-abdominal and particularly retroperitoneal. Despite these circumstances, available information offers little insight with respect to whether haematology advice was available, or requested, to guide management although a preterminal request for Hematology consultation was noted. Alternatively, there is also no record that consideration was given to escalating care to another centre.
3. The Laboratory Director should review quality performance dad to ensure that turn-around-times (TATs) for critical laboratory specimens, particularly those originating in high acuity environments, are appropriate. Despite controversy regarding the definition and appropriate value for TATs, the material reviewed in relation to this case suggests that lab performance is inconsistent and at times markedly prolonged relative to clinical care needs.

2009-03

The decedent is a 61 year old male who was admitted to hospital for treatment of community acquired pneumonia. Past medical history included dilated cardiomyopathy, atrial fibrillation, hypertension and alcoholic cirrhosis. At the time of admission, his International Normalized Ratio (INR) was noted to be 2.1. He was taking aspirin, but not warfarin.

On admission, he was started on antibiotics, as well as low molecular weight heparin. His aspirin was continued.

He remained stable until the fifth day following admission, at which time he developed left flank pain. The following day he became hypotensive, with a drop in haemoglobin. A computerized tomography (CT) scan of the abdomen revealed a massive left retroperitoneal hematoma.

Despite attempts to correct his coagulopathy and stabilize him hemodynamically, he developed multisystem organ failure thought to be on the basis of abdominal compartment syndrome, and care was ultimately withdrawn. A post mortem examination was not performed.

1. Anticoagulants have been classified as high-alert medications. Numerous recommendations have been advanced to enhance the safety profile of these drugs. If it has not done so, the hospital should review its policies and practices related to the ordering and administration of anithrombotic therapy to ensure that they are consistent with current best practice. The Institute for Safe Medication Practices (ISMP) has published a hypothetical Failure Mode and Effects Analysis (FMEA) for anticoagulants that may be a helpful aid in identifying potential opportunities to enhance safe practices.
2. The hospital should consider adopting an anticoagulation checklist or standardized approach to prescribing antithrombotics (such as a preprinted order set) that includes appropriate demographic information and a review of high risk conditions to enable the prescriber and other members of the care team (especially nursing and pharmacy) to confirm dosing and the presence of high risk conditions prior to implementing the order. It is clear that the deceased had a serious cardiac condition. However, the Committee members noted that despite high risk conditions for bleeding complications there is no documentation to suggest that the indications for continuing antithrombotic therapy were re-evaluated by the attending physician following admission. It also noted that there is no documentation to suggest that the administration of combination of antithrombotic therapy to a patient with a well documented coagulopathy and low platelet count was questioned by any of the members of the healthcare team (physicians, nurses, pharmacists, etc) over the six days of inpatient care that preceded the hemorrhagic event.

2009-04

The decedent is a previously-well 21 year old male who was admitted to hospital with acute upper back pain. He was admitted for treatment of possible sepsis, and for observation and pain management. He was started on antibiotics and morphine. The morphine was initially ordered as 1 – 5 mg intravenously (IV) every 2 hours as needed, and later was increased to 5 – 10 mg IV every 2 hours as needed.

The following day, his pain was still not well-controlled and in the early evening, an order was written to discontinue morphine and to start hydromorphone 5-10 mg IV every 4 hours as needed.

The next morning, he was found vital signs absent and resuscitation efforts were unsuccessful. Cause of death was determined to be mixed drug overdose (morphine and hydromorphone).

In the analysis of this case, it was noted that hydromorphone is roughly 5 times more potent than morphine, and the use of hydromorphone ordered in the same dose as morphine, in a non-opiate-tolerant individual, was felt to contribute to his death. In addition, it was felt that there was an opportunity to improve upon the clinical monitoring of patients receiving narcotic medication in order to facilitate the early detection of signs of toxicity.

Prescribing:

1. Used standards protocols (e.g., preprinted orders, electronic order sets) for parenteral opioids whenever possible
2. Ensure that orders are reviewed by a pharmacist prior to administration whenever possible.

Monitoring and Documentation:

3. Implement guidelines and practices for assessment, monitoring and documentation (e.g., vital signs, pain and sedation scales) for opioid therapy. Consider the use of standardized forms (order sets, protocols and flow sheets). Include clear criteria for the identification and treatment of toxicity. Include criteria for when to hold opioid therapy and when to use naloxone, so that it can be given quickly when needed, even before calling the physician.
4. When developing protocols for assessment and monitoring, the following circumstances should be considered:
5. The initial period of opioid therapy (e.g., 24hours or longer) and especially at night when nocturnal hypoxia can occur;
6. The use of concomitant medications that may further depress respiration (e.g., sedatives.
7. Consider the manner in which patients are assessed. Patients experiencing opioid-induced respiratory depression or over-sedation can easily be temporarily stimulated to an increased level of consciousness and respiratory rate. This observed momentary level of consciousness and respiratory rate may mask symptoms of toxicity and once this stimulus is removed, patients quickly fall back into an over-sedated state. The respiratory rate needs to be assessed without disturbing the patient. Monitoring a patient’s level of consciousness accurately appears to be an extremely important assessment component as it has been noted to be the only predictor of an impending opioid-related adverse event.

Educate and Inform Practitioners:

8. Ensure that analgesic equivalency charts are readily available to prescribers and other practitioners. Include examples of typical starting doses for opioid-naïve patients.
9. Educate practitioners about the differences between morphine and hydromorphone.