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Higher Standards in Hospital Policies
Posted On 2007-01-28 , 12:02 PM
In the decision Latin v. Hospital for Sick Children, 2007 CanLII 34 (ON S.C.) released January 3 2007 the Ontario Superior Court of Justice reviewed the issue of what weight is to be given to hospital policies and any failure to adhere to them in assessing whether hospital staff is negligent.
In this case the plaintiffs placed great emphasis on a triage nurse's departure from the hospital policy which provided a pre-printed space on the triage form for the nurse to record vital signs. The plaintiffs took the position that the triage nurse fell below the standard of care in failing to obtain a full set of vital signs. The defence presented testimony that this hospital's policy exceeded the triage standard at that time as the triage nurse was expected to obtain only relevant vital signs based on her nursing judgment.
While the court affirmed that a hospital has a duty to establish appropriate systems and protocols to promote patient safety and provide good patient care and that a policy is one method of achieving this it relied on precedent to rule that a departure from a policy is not prima facie evidence of negligence. The reasoning behind this rule is that hospital policies are to be considered guidelines that do not set inflexible rules and are subject to the exercise of discretion, by both doctors and nurses, depending on the needs of the patient. Medical professionals must be allowed to exercise competent and prudent judgment and not to have their hands bound by rigid policies.
While the breach of a hospital policy does not amount to prima facie negligence, the policy is nonetheless a factor to be considered in determining what is the requisite standard of care and whether there has been a failure to meet it. The hospital policy should be examined to see if it sets up a useful standard of reasonable care and a departure from a policy must be viewed in light of what was reasonable and prudent conduct in the circumstances.
In this particular case the court was influenced by 2 factors in coming to a decision. The first was the purpose of triage which is not to arrive at a diagnosis through a comprehensive assessment but is an aid to determine how sick is the patient and in what priority should the patient be seen. To a large extent this is a matter of judgment.
Secondly the court felt it was also important to consider the policies and procedures that were in place at comparable institutions at the relevant time. The court concluded that nurses ought not to be held to a higher standard of care simply because their employer developed more comprehensive written triage policy guidelines as it was concerned to hold otherwise would have the invidious effect of discouraging hospitals from developing written policies that set high standards and result in different standards of care at comparable hospitals.
The expression of this second consideration by the court is somewhat troubling as it was not necessary to the disposition of the case particularly in light of the Court of Appeal's direction in an earlier case that the issue of causation is to be determined by the trial court first in cases of medical negligence. One of the functions of tort law is to stimulate safer practices and to excuse compliance with a higher standard as expressed by the hospital itself fails to promote that objective. Although a comparative study of practices at different institutions is an important element in establishing the standard of care the result of the comparison should not be the preponderant factor without a consideration of the context in which the higher standard arose. Contextual factors to be considered should include the promotion by the institution to the public of the existence of a higher quality of care and expertise provided by it, the perception and reliance by patients on this image, the recruitment and staffing of better qualified and better paid staff by the institution, the development of special expertise and whether there was any practical impediment to compliance with the higher standard (this last point was considered by the court) An examination of that context may lead to the conclusion that the higher standard should be imposed.
The full text of the decision can be found at http://www.canlii.org/on/cas/onsc/2007/2007onsc10010.html.
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Promotion of Patients' Rights of Regulatory Concern
Posted On 2006-12-13 , 10:35 PM
On December 12 2006 the Ontario government introduced a bill into the legislature that will amend the Regulated Health Professions Act intended to enhance the health professional regulatory colleges' complaints procedures by giving patients increased access to information, improved communications and streamlined processes. At the present time the 23 colleges (to become 27 under the legislation) each has its own committee structure which will now be standardised into one committee for each college to be known as the Inquiries, Complaints and Reports Committee. Additionally the colleges will be required to share practice and disciplinary information with complainants and where the public is at risk make public the existence of an ongoing investigation and on the completion of the investigation suspend a member pending a hearing where the college believes the continued practice of the professional poses a serious public risk.
This legislation will provide an opportunity to test the application of the Supreme Court of Canada’s decision in Edwards v. LSUC, [2001] 3 S.C.R. 562, 2001 SCC 80 (CanLII) in which the court ruled that no prima facie duty of care arose between the governing body regulating lawyers and members of the public who deposited money into a solicitor’s trust account as participants in a third-party business promotion and in any case such a duty of care would have been negated by residual policy considerations outside the relationship of the parties. In assessing the risk of liability for failure to take steps upon the apprehension of risk to the public the colleges will do well to consider the subsequent decision of the court in Finney v. Barreau du Quebec, [2004] 2 S.C.R. 17, 2004 SCC 36 (CanLII). There the court held in the case of duties relating to the management of disciplinary cases, it would be contrary to the fundamental objective of protecting the public to require evidence of malice or intent to harm in order to rebut the presumption of good faith which would cloak the governing body with immunity from legal action from aggrieved members of the public. Evidence of serious carelessness or recklessness in the discharge of its duties would be sufficient to attract liability in failing to meet the standards required by the fundamental mandate of protecting the public. The proposed legislation makes no provision for modification of the immunity regime for the regulated health professional colleges.
The Health Professions Procedural Code is also amended to require mandatory reporting by a person who operates a facility where one or more members practise if the person has reasonable grounds to believe that a member who practises at the facility is incompetent or incapacitated, in addition to the current requirement that a mandatory report be made for suspected sexual abuse of a patient. While the term incapacitated is defined for the purposes of the legislation to mean a member is suffering from a physical or mental condition or disorder that makes it desirable in the interest of the public that the member’s practice be subject to terms, conditions or limitations, or that the member no longer be permitted to practise, no definition is provided for the term incompetent. If the inclusion of this term is intended to extend beyond issues of mental competency and impose a requirement related to the ability to carry out professional duties then this should be clarified in the final text of the legislation. In any event all health care facilities will now need to review their oversight mechanisms to account for this added requirement.
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Drug Safety
Posted On 2006-12-07 , 9:39 PM
The Institute of Medicine of the National Academy of Sciences in the United States issued a new report on September 22 2006 delivering a critical assessment of the US Food and Drug Administration's (FDA) drug safety system. According to the IOM, there are at least 1.5 million preventable adverse drug events in the US each year and the true number may be much higher. The report, The future of drug safety: promoting and protecting the health of the public, makes several recommendations including tighter labelling requirements and advertising limits for newly approved medications, increased communication of information relating to marketed products' risks and benefits and mandatory registration of clinical trial results and better public access to drug safety information.
The report comes at a time when Health Canada is undertaking a review to renew the Canadian federal drug regulatory system. Elements of the legislative and regulatory framework date back 50 years and are in need of modernisation. The 2003 federal budget allocated $190 million over five years to improve the timeliness of Health Canada's regulatory processes with respect to human drugs. It aims to achieve significant improvements to drug review performance through the Therapeutics Access Strategy and through the National Pharmaceuticals Strategy to improve Canadians' access to safe, effective, and affordable drugs through the health care system.
Lets hope for Canadians' sake that the review will result in oversight of the drug approval process that acts at arm's length from the pharmaceutical industry which has developed powerful marketing and public relations capabilities supported by the enormous cash flow created by drug sales. Particular emphasis should be placed on the need for clear labelling relating to instructions on use as well as risks.
A study report in the Annals of Internal Medicine found that many Americans, including those with college degrees, have trouble interpreting the instructions on prescription drug labels. Remarkably only 34.7 percent of people with lower literacy of grade level or below, interviewed for the study could determine the number of pills to take daily when faced with the instruction "take two tablets by mouth twice daily". This only emphasizes the need for clear, simple instructions aided by visual cues to be standardised so that patients will receive consistent information as a minimum that does not vary by pharmacy or physician.
The conclusions of a U.S. government study published in the Oct. 18 2006 issue of the Journal of the American Medical Association found that while many people take their medications without a problem, as many as 700,000 Americans wind up in the emergency room each year because of adverse reactions to drugs they've taken, with 117,000 of those people hospitalized because of reactions.The Vancouver Coastal Health Research Institute is currently conducting a prospective study to characterize the problem in Canada and to identify strategies to reduce and prevent adverse drug-related events The implementation of strategies to reduce these events will not only improve patient safety but may ultimately reduce emergency department overcrowding, reduce morbidity as well as costs to the Canadian health care system. More initiatives are needed to develop practices that will avoid preventable adverse drug reactions.
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Whither Medical Malpractice Compensation?
Posted On 2006-11-04 , 1:07 PM
In a letter to the CMAJ (Canadian Medical Association Journal) published October 10 2006 John Gray Executive Director and Chief Executive Officer of the CMPA (Canadian Medical Protective Association) in response to a published report of the merits of the New Zealand no fault medical liability system indicates the CMPA's view that Canada should retain the tort based liabilty system. He states in commenting on the efficacy of the tort system of compensation for injured patients which is aimed largely at seeking restoration or mitigation of the consequences of the adverse event that although some cases progress through to court system, a great many are resolved through settlement, often through alternate means of dispute resolution such as mediation. What is not mentioned is that the great majority of cases are dismissed. Generally speaking these cases are dismissed as they are were either unmeritorious or the plaintiff or injured plaintiff abandoned the action due to lack of resources or evidence. The 2003 statistics show that 814 actions werer dismissed, 448 settled and 125 went to trial of which only 22 resulted in judgments for the plaintiff. The statistics for Ontario where almost half of the cases originate are similar although success in court was even less as only 6 cases were decided in favour of the plaintiff. In light of these statistics it is unlikely that the CMPA will wish to withdraw its support for a tort liabilty system. Indeed any sentiment to the contrary while legislation amending the Courts of Justice Act to provide for the structuring of large future care cost awards in Ontario in medical malpractice actions would have been a disopportune occasion. The issue of tort or no fault compensation appears to be headed for further review by the Health Council of Canada and it will be interesting to observe whether they approach the issue from the perspective of patient safety and accountability only or whether they will also consider the social justice aspect of the inevitable occurrence of medical error.
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Medical Research Under Scrutiny
Posted On 2006-09-20 , 9:44 PM
On August 8 2006 Mr. Justice Browne of the Ontario Superior Court of Justice issued a decision with wide reaching implications for policy makers and researchers in the health care field. The relevant facts are:
The plaintiff was diagnosed with having Acute Lymphoblastic Leukemia when she was a young child. In February 1995, the plaintiff was entered into a study referred to as protocol 9405 being a study of the Pediatric Oncology Group (“POG”). It was alleged that she received chemotherapy treatment, which included the drug Methotrexate at a higher dosage than for all patients having a standard treatment or being treated at a lower dosage under a prior protocol and that as a result she sustained brain damage. An issue of informed consent arose as it was alleged that there was no information given by way of the consent form or otherwise as to the relative risk between treatment under this protocol, the prior protocol or standard treatment. There was no issue that the drug dosage would increase toxicity. The pleadings allege that the chair of the POG group who was not involved in the care of the plaintiff was responsible for the POG treatment protocol 9405 and that she was negligent in failing to manage and supervise the development of the protocol; in failing to provide the research institution, the hospital, with adequate consent forms for the purpose of obtaining an informed consent to treatment, in failing to warn of all risks reasonably anticipated, specifically dealing with toxicity and brain damage and specifically, the increased likelihood of toxicity by a failure to warn of the relative increase in risk between the protocol use of Methotrexate and other treatments even using the same drug. It was also pled that the chair of the POG was vicariously liable and that she had breached a contractual and a fiduciary obligation.
The court refused to strike the claim brought against the chair of the POG thereby allowing the issues to go to trial to be decided on a full evidentiary record. The ruling is significant as the court rejected arguments that the fact that the chair as a researcher and administrator not in a relationship of direct treatment and/or research vis a vis the particular patient was protected from liability. Indeed the court concluded that the bright light of day would be beneficial in an overall policy sense to researchers and the public generally in finding that the claim disclosed a recognised and reasonable cause of action. The full text of the decision may be found at http://www.canlii.org/on/cas/onsc/2006/2006onsc15875.html.
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