Healthcare associated infections (HAIs) are a major global public health concern. Numerous reports demonstrate that HAIs result in increased morbidity, mortality and also increase healthcare costs.
Healthcare associated infections (HAIs) are a major global public health concern. Numerous reports demonstrate that HAIs result in increased morbidity, mortality and also increase healthcare costs. In the United States of America, it has been estimated that 5 of the most common HAIs resulted in an additional USD 9.8 billion in healthcare costs in 2012. The US Centres for Disease Control and Prevention estimates that 1.7 million patients admitted annually acquire HAIs and an estimated 98,000 die due to HAIs. In a point prevalence study of 5415 patients conducted between 2015 to 2016 in Singapore hospitals, 1 in 9 adult inpatients had at least one HAI.1 Many HAIs are considered preventable and must be considered a patient safety issue for the healthcare institutions and healthcare workers.
Despite these alarming figures, Robert Steinbuch reported that written legal judgements concerning HAIs were few.2
In this article, we will highlight the relevant medicolegal concerns which relate to HAIs, so as to improve the practice of doctors in the increasingly litigious environment of medical negligence cases.
As a starting point, HAI is defined as an infection that developed more than 48 hours after admission to a health care facility and which was not present or incubating at the time of admission. Simply put, HAIs are those infections that patients acquire while receiving healthcare. It is usual to subcategorize HAI according to the target organ/tissue system affected such as urinary tract, lung, bloodstream and wound infections etc. HAI is the preferred term rather than nosocomial infections.
The term ‘medical negligence’ generally refers to claims of negligence under tort law, which involves healthcare institution and/or worker as the respondent. It is therefore helpful to break down medical negligence into its component legal doctrines, before we discuss how it relates to HAIs. The three components are:
a) duty of care;
b) causation; and
Duty of Care
A duty of care in medical law generally refers to the intrinsic responsibility of a healthcare worker when taking care of a patient. While there are many important sub-questions to be answered when asking whether a duty of care exists, the most relevant question for discussion is what legal standard the healthcare worker or institution is held to when administering their services. This obviously varies greatly depending on one’s specialisation or position held within the institution, and with the recent amendments to the Civil Law Act 1909 (thereafter ‘CLA’), what kind of service is being provided by the healthcare worker.
For diagnosis and treatment, the duty is set out in the simple Bolam-Bolitho (BB) test which has two stages: first, the court will ask whether the doctor acted in accordance with responsible medical opinion; and if yes, that the medical opinion must be capable of withstanding logical analysis.3,4
For the provision of medical advice, the test was formerly the Modified-Montgomery (or MM) test,5 which is now codified under Singapore law in section 37 of the CLA. Per the wording of the statute, it seems to echo similar sentiments as the BB test, mentioning both ‘reasonable professional practice’ (s. 37(1) CLA), and such practice being ‘logical’ (s.37(5) CLA). The key difference however is the supplementary requirement that for a professional opinion to be relied upon, it must contain all ‘material’ (s. 37(3) CLA) information to the patient, and must also justify any non-provision of information to the patient (s.37(2)(b) CLA). Moreover, the ‘logical’ portion of the test explicitly states that the opinion must, inter alia, have been made after considering the ‘comparative risks and benefits’ of the medical issue at hand (s. 37(5)(a)). This slightly raises the bar of the BB test to be more ‘patient-centric’, as confirmed by the court in their landmark judgment.6
The second important aspect of medical negligence is proving causation, which as its common sense meaning suggests, that it must be shown it was the breach of the duty of care (i.e., failing to reach the professional standard of reasonable care) which caused harm to the patient. Causation is more relevant when considering claims made against negligent treatment or diagnosis, but is likely quite straightforward for cases involving negligent advice. This is easy to illustrate with an example: in an English case, a patient visited a hospital due to arsenic poisoning, but was negligently refused treatment due to a shortage of staff; he eventually died from the poisoning, but the issue was proving whether the delay in treatment caused his death – it was not clear whether he would have survived even with timely treatment.7 Conversely, if a healthcare worker failed to administer the appropriate advice to a patient, the court has generally believed a patient’s claim that if not for the failure to provide proper advice, they would not have undertaken the action (or omitted to take an action) which caused them harm.8
Lastly, the final important aspect of a medical negligence claim is harm – specifically, harm that is caused by the specific breach of duty by the healthcare worker. This is quite a straightforward aspect, and rarely do we see medical negligence cases involving non-physical harm. Harm can include complications, deterioration of one’s condition, and of course, HAIs.
Challenges regarding HAIs
From the above discussion on medical negligence cases, a few important issues can be identified regarding HAIs which would be of interest to the readers, namely:
a) Causation and Probability
b) ‘Right’ and ‘Wrong’ medical opinions
c) Personal vs Institutional Liability
Causation and Probability
The practice of medicine is based on science and data but it is ultimately the application of this that many treatments are derived. A difficulty that arises with causation in medical negligence cases is that the typical situation is not one of binary outcomes but probabilistic ones – ‘ there is a 1% chance of this occurring’; ‘it occurs in a likelihood of 5 in 250 cases’; ‘the data from study X suggest…’. It is not uncommon to have heard these phrases used in medical practice, and it accurately reflects the reality of practicing medicine. As such, it is hard to accurately quantify how much of a risk the patient was exposed to as a result of the healthcare worker’s actions, and thus the proportion of liability that should be subsequently attached to the healthcare worker. It is for this reason that negligence claims involving HAIs from a healthcare institution or worker are often challenging. The potential sources and origins of the bacteria, virus, or fungi that resulted in the HAI also constitute major hurdles in establishing causality. It is for this reason that Plaintiffs and judges instead focus on legal arguments such as negligence in diagnosis and delayed treatment of HAI, or failure to disclose risk of infection to strengthen their claims for liability. The bottom line however, is that risk will eventually materialise, and it might not necessarily be the fault of the healthcare worker involved. How healthcare institutions and workers can subsequently ‘protect’ themselves in the case of such materialisation of risk is covered below in the section: Safeguards and Standards. A comforting note is the fact that courts are quick to recognise the various acute clinical and emergency situations doctors find themselves in, and adjust their expectations of the appropriate standard of care accordingly.9
‘Right’ and ‘Wrong’ medical opinions
When talking about the negligent behaviour of the healthcare institution or worker, it is not helpful to discuss actions that are clearly negligent, and clearly fails to meet even a common sense standard that is obvious even to laypersons and judges. This is covered by the doctrine of res ipsa loquitur – that the wrong speaks for itself. In such cases, it is likely that an out of court settlement will be sought by the healthcare institution or worker.
The focus of this discussion is thus the borderline diagnosis, treatment or advice that generates controversy and disagreement; that can be argued either way; that is the driving force of medicolegal suits. A pertinent question to ask then is: is there a ‘right’ or ‘wrong’ opinion? While there are some situations where one could answer with a resounding ‘Yes’, it is likely that most healthcare workers would avoid stating categorically that their (or another’s) opinion is indisputably right or wrong.
The difficulty then is how this will be dealt with by the courts. In the case of HAIs, it is always possible that even despite following all the ‘right’ guidelines and practices, it would still lead to the ‘wrong’ outcome resulting in HAI. It is for this reason that the courts and the law choose to adopt a different kind of language, one of reasonability rather than right or wrong. Nonetheless, reasonability is an equally indeterminate and controversial concept – after all, doctors can only do so much with their limited time, information, and knowledge of the human body. In a battle of two ‘reasonable’ opinions however, in truth there is no battle – all that matters to the judges is whether there is a reasonable and logical opinion supporting the healthcare worker or institution’s practice in question. In fact, the court summarily rejected an argument that Singapore courts should follow the UK approach of accepting ‘right’ and ‘wrong’ opinions when looking at possibly negligent diagnosis.10 It reaffirmed that the ‘reasonable’ and ‘logical’ BB test still prevails.9
Personal vs Institutional Liability
On the topic of personal and institutional liability, one may expect HAIs to be solely the subject matter of the former – after all, any failure to prevent infection falls on the onus of the healthcare worker rather than the institution, who merely instructs and manages such workers. Nonetheless, there are two ways in which institutional liability may link back to HAIs.
The first involves a concept called vicarious liability – that an employer can essentially be sued for an employee’s wrong, so long as such wrong was committed in the course of their employment. This is typically used to prevent corporations from escaping liability for any harm they caused, and is typically less relevant in medicolegal negligence suits.
The more relevant, and illustrative example of what institutional liability for HAIs can look like can be derived from the case of Noor Azlin Binte Abdul Rahman v Changi General.9 Here, the personal liability of each doctor, as well as the institutional liability of the healthcare institution was considered in turn. Notably, two of the three doctors did not breach their duty, while instead the healthcare institution was liable for a breach of their duty. The specific duty in such case, was to ‘ensure proper follow-up on a [patient’s]’ medical treatment.9(-) A logical extension of such a duty would be for the healthcare institution to ensure that there is not only written protocols and processes but ensuring adequate enforcement of infection prevention and control practices, sterilisation of equipment, etc., and training provided to the healthcare workers to minimise the risk of HAIs.
An actual case study that we can learn from was in 2015, when there was an outbreak of Hepatitis C infection in the Renal Wards at Singapore General Hospital (SGH). There were 8 deaths in this cluster, of which 7 were thought to be related to the infection. After the cluster of infection was reported to the Minister of Health, an independent review committee was convened and their findings indicated multiple overlapping factors and gaps in the surveillance system that led to the outbreak.11 Four MOH and 12 SGH senior staff in leadership positions were disciplined, which may point towards the possibility of healthcare institutions being held liable for future HAIs.
Safeguards and Standards
To reduce the risk of HAIs in healthcare facilities, the Ministry of Health has published national guidelines on infection prevention and control for acute healthcare institutions in 2017, which were recently updated in 2022.12 Similar national guidelines for infection prevention and control specific for community hospitals, long term care facilities and dialysis centres have also been published .13,14,15
To reduce the risk of HAIs in surgical procedures, the National Surgical Antibiotic Prophylaxis Guideline (Singapore) was published in September 2022 by the Academy of Medicine (AM), National Centre for Infectious Diseases, College of Surgeons (AM), College of Anaesthesiologists (AM) and Chapter of Infectious Disease Physicians, College of Physicians (AM) (reference).16
These guidelines provide the standard of care expected and will likely form the basis for any regulatory or medicolegal action if the healthcare institution and/or surgeon or physician deviates and/or falls short of these guidelines.
Much has already been discussed on the role of informed consent in medicine and where relevant, it will be important to incorporate “infection” as a known complication for the surgical procedure. Unless it has been expressly stated, it should not be assumed that the consent process for the surgical procedure will also cover postoperative complications that occur in “high risk surgery” including need for prolonged mechanical ventilation, multiple catheters and parenteral nutrition which all increase the risk for HAIs. It is less clear on where to draw the line on “informed consent” with respect to HAIs associated with “simple, common” ward procedures like placement of a nasogastric tube, intravenous line or indwelling urinary catheter.
Even if all the standards are adhered to, HAIs may still occur. It is the authors’ opinion that good communication forms the core safeguard against complaints and legal action by the patient and/or relatives. This is elaborated below.
An Argument from Perspective
To many doctors, even receipt of a complaint letter would cause one much frustration and anxiety, let alone that of a civil suit of negligence. They might feel that it is unfair that a patient can essentially engage in frivolous complaints or lawsuits on the basis of mere medical disagreement, especially in the rise of compensation culture and medicolegal litigation. Feelings may arise that the patient and /or relatives were particularly ungrateful, or merely finding someone to blame. Such feelings are exacerbated by time constraints, excess patient workload, guideline overload and excessive focus on documentation rather than direct patient care. Lack of autonomy and medicolegal liabilities all add to healthcare worker “burnout”.
On the other hand, the patient (or family member) likely sees their personal loss as a result of the medical service as front and center to their claim. Moreover, tertiary medical care can be expensive to the layperson, and financial compensation of any unexpected loss may be justified in their eyes. Other considerations for patients and relatives pursuing negligence include lack of transparency and ‘accountability’ for any harm which occurred, and “expecting” an accompanying explanation or apology for the conduct leading to such harm.
In any case involving tort law, the key consideration of the court is compensation on the basis of risk apportionment. Therefore, the law is theoretically concerned about who should bear the burden of the materialised risk, and so who should compensate for the loss which emanated. For HAIs, there are also other arguments from policy – that the court wants to discourage and deter any ‘bad practice’ in the individual or the “system” leading to such HAIs, or at the very least provide some form of monetary justice to patients who suffer from HAIs.
The key takeaway here is that all of us are human – patient, healthcare worker, and judge included. It may be hard to do so, but taking the perspective of another can help us to empathise and understand their plight – though litigation is ultimately an adversarial affair, we should not let such attitudes exemplify the healthcare relationship.
Ultimately, healthcare is about the patient, though we cannot leave the doctor’s ‘stake’ out of the equation; HAIs are a bad outcome measure that requires healthcare workers to reflect and re-look at the unfortunate outcome to improve patient safety. As healthcare workers it is our responsibility to restore trust when HAIs occur, as it is this trust which forms the cornerstone of the doctor-patient relationship.
Dr Wong Sin Yew is an infectious disease physician in private practice. In addition to providing direct patient care, he has served on several Singapore Medical Council disciplinary tribunals and has provided medicolegal advice on matters relating to infectious diseases. In the past 30 years of clinical practice, he has also borne the brunt of numerous complaints from patients and their relatives.
Mr Wong Tai Shen completed his law degree in the United Kingdom in July 2022 and is currently training to be a lawyer in Singapore.
1. Cai Y, Venkatachalam I, Tee N, Tan T, Kurup A, Wong S, et al. Prevalence of Healthcare-Associated Infections and Antimicrobial Use Among Adult Inpatients in Singapore Acute-Care Hospitals: Results From the First National Point Prevalence Survey. Clinical Infectious Diseases [Internet]. 2017 May [cited 2022 Sep 27];64(Suppl 2):S61-S67. Available from: https://pubmed.ncbi.nlm.nih.gov/28475790 / doi: 10.1093/cid/cix103
2. Steinbuch R. Dirty Business: Legal Prophylaxis for Nosocomial Infections. Kentucky Law Journal [Internet].2009 [cited 2022 Sep 27];97(3):505-519. Available from: https://uknowledge.uky.edu/klj/vol97/iss3/4/
3. Bolam v Friern Hospital Management Committee  WLR 582
4. Bolitho v City and Hackney HA  4 All ER 771
5. Montgomery v Lanarkshire Health Board  UKSC 11
6. Hii Chi Kok v Ooi Peng Jin London Lucien  SGCA 38
7. Barnett v Chelsea and Kensington Hospital Management Committee  3 All ER 1068
8. Chester v Afshar  UKHL 41
9. Noor Azlin Binte Abdul Rahman v Changi General Hospital  SGCA 13
10. Muller v King’s College Hospital  EWHC 128
11. Independent Review Committee. Hepatitis C Cluster in the Renal Ward of Singapore General Hospital. Singapore (SG): Ministry of Health; 2015 Dec 5. 81p.
12. Ministry of Health. National Infection Prevention and Control Guidelines for Primary Care 2022. Singapore (SG): Ministry of Health; 2022. 89 p.
13. Ministry of Health. National Infection Prevention and Control Guidelines for Long Term Care Facilities, Revised 2021. Singapore (SG): Ministry of Health; 2022. 120 p.
14. Ministry of Health. National Infection Prevention and Control Guidelines for Community Hospitals, 2021. Singapore (SG): Ministry of Health; 2021. 56 p.
15. Ministry of Health. National Infection Prevention and Control Guidelines for Outpatient Dialysis Centres, 2020. Singapore (SG): Ministry of Health; 2020. 83 p.
16. Somani J, Chung WT, Shafi H, Seah J, Lee WP, Tay V, et al. National Surgical Antibiotic Prophylaxis Guideline (Singapore). Singapore (SG): National Centre for Infectious Diseases, Antimicrobial Resistance Work Group; 2022 Sep 1. 158 p.
© Singapore Medical Association. This article was originally published in SMA News 2023 March issue.