MEDICO LEGAL ASPECTS OF INFECTION CONTROL IN HEALTHCARE SETTINGS

Enhancing quality, promoting patient safety and ensuring value is the healthcare industry's current trifecta, but there are many more imperatives from a regulatory perspective, including shifting from volume-based to value-based reimbursement, enhancing transitions and reducing hospital readmissions, and improving patient satisfaction and engagement. In concert with these efforts comes the prevention of adverse events and infections. In today's environment of transparency and reform, understanding legal liability for healthcare-acquired infections (HAIs) is more critical than ever for infection preventionists as they assist their risk managers and patient safety officers with quality improvement initiatives

What do we mean by Healthcare associated infections?

According to World Health Organization (WHO), HAI, also referred to as “nosocomial” or“hospital” infection, is an infection occurring in a patient during the process of care in a hospital or other healthcare facility which was not present or incubating at the time of admission. They are unrelated to the original illness that brings patients to the hospital and are neither present nor incubating as at the time of admission. HAI can also appear after discharge.

A particular infection should be considered healthcare associated, only if:

? It was not present or incubating when the patient was admitted to the hospital.

? The infection does not represent a complication or extension of an infectious process that was present at the time of admission.

? The infection occurred more than 48–72 hours after admission, and within 10 days following discharge or longer if it is related to a surgical procedure, a Clostridioides

difficile infection or an antibiotic-resistant organism.

The  infections that are not considered to be associated with healthcare includes:

? Those infections which are associated with complications or extensions of infections already present at the time of admission; unless a change in pathogen or presenting symptoms strongly suggests that the infection has been acquired after hospital admission.

? Infections like herpes simplex, toxoplasmosis, rubella, Cytomegalovirus, or syphilis among infants which are acquired transplacentally and manifest in less than 48 hours after birth; and

? Reactivation of a latent infection [e.g. herpes zoster (shingles), herpes simplex, syphilis, or tuberculosis].

The conditions which are not infections includes:

? Colonization, i.e. presence of microorganisms on skin, on mucous membranes, in open

wounds, or in excretions or secretions but there are no clinical signs or symptoms; and

? Inflammation as a tissue response to injury or stimulation by noninfectious agents, e.g. chemicals.

How we can prevent and control Healthcare associated infections?

It’s a saying that “If you know how to prevent infections, you know how to protect patients from most adverse events”.

Many preventive measures have been recommended. These measures are applied to reduce morbidity, length of hospital stay, mortality, and hospital costs. Among the published guidelines three main approaches includes:

1. Elimination of endogenous healthcare-associated pathogens to reduce oropharyngeal, intestinal, and skin colonization.

2. Use of methods to prevent cross contamination and to control various sources of healthcare-associated pathogens that can be transmitted from patient-to-patient or from personnel to patient, i.e. proper disinfection and care of catheters, respiratory equipment, humidifiers, endotracheal tube, and dialysis systems.

3. Use of antibiotic prophylaxis in postoperative and high-risk patients (burn patients, patients in ICUs, etc.). Aerosolized polymyxin-B and/or endotracheal aminoglycosides can be given to prevent Pseudomonas and/or Acinetobacter pneumonia which have the highest mortality rates.

Medico legal aspects of hospital infection control:

Healthcare-associated infection is the infection that occurs in a patient in whom it was not present or incubating at the time of admission to the hospital. The very definition of HAI itself implies a potential for medicolegal problems.

Liability for HAIs depends on multiple factors including the following:

? Failure to provide a clean and safe environment during patient care.

? Failure/delay in implementing the infection control measures.

? Failure to carry out routine pre-screening for MRSA or C. difficile negative prior to surgical or other admissions.

? Failure/delay in identifying and treating the infection when it has been acquired.

The guidelines on prevention and control of hospital infections provided by various national and international health organizations like WHO may be included as a criterion to determine whether a reasonable care as expected by law has been provided or not. The WHO has recommended the following to reduce HAIs:

? Providing direct patient care using practices that minimize infections.

? Following appropriate practices of hygiene (e.g. hand washing and sterilization of

instruments and surfaces).

? Protecting patients from other infected patients and hospital staff who may be infected.

? Complying with the practices approved by the infection control committee.

? Obtaining appropriate microbiological specimens when an infection is present or

suspected.

? Notifying the infection control team of cases of HAI, and the admission of infected patients.

? Complying with the recommendations of the antimicrobial use committee regarding

antibiotic use.

? Advising patients, visitors, and staff on techniques to prevent the transmission of infection.

? Instituting appropriate treatment for any infections that they have.

? Taking steps to prevent such infections in staff from being transmitted to other persons, especially patients.

In a malpractice lawsuit with allegation of harm suffered as a result of HAI, the complainant may be required to prove that a reasonable healthcare provider/hospital would have foreseen the likelihood of such harm in the absence of certain steps necessary to prevent the infection, and that the healthcare provider/hospital failed to foresee the impending harm, and take the preventive steps. Healthcare providers and hospitals will be held liable for failing to implement adequate infection control measures where such a failure resulted in harm to the patient.

The evaluation for negligent conduct in this context is measured against the behaviour of a reasonably competent healthcare provider/hospital in a similar position.

An intentional failure to implement adequate infection control measures may indicate

that the hospital or hospital managers concerned had either “actual” or “eventual” intention not to implement such measures (e.g. infection control measures are minimized to save costs).

In cases where “actual” or “direct” intention is present, the wrongdoers decide not to provide certain infection control measures and know that this is wrong. On the other side, in cases where “eventual” intention is present, the wrongdoers subjectively foresee the likelihood of harm to patients if adequate infection control measures are not implemented and do not care whether or not such harm occurs, i.e. they act with reckless disregard for the consequences of such failure.

Legal provisions applicable to healthcare associated infections in India?

Many countries like UK, US, and Germany have specific legislations and protocols related to HAI which is considered to be in the domain of public health legislation. No such legislation exists in India.

Several provisions of The Indian Penal Code which could be applicable in case of HAIs includes:

·        Section 304A IPC (Causing Death by Negligence)

·        Section 337 IPC (Causing Hurt by Act Endangering Life or Personal Safety of Others)

·        Section 338 IPC (Causing Grievous Hurt by Act Endangering Life or Personal Safety of Others)

·        Section 269 IPC (Negligent Act Likely to Spread Infection of Disease Dangerous to Life)

·        Section 270 IPC (Malignant Act Likely to Spread Infection of Disease Dangerous to Life)

Healthcare providers owe a legal duty of care to their patients. They must exercise the degree of care and skill that could reasonably be expected of a normal and prudent practitioner, and they also have an ethical obligation to act in the best interest of patients. On the similar pattern, the healthcare organizations should also provide a safe environment for the patients so as to prevent them from harm in the course of receiving care. The organizations have a dual duty of setting up of standard protocols for improving patient safety, and then, ensuring that the healthcare staff complies with systems, protocols, policies, and procedures.

The healthcare organizations should have standard updated well-documented protocols for prevention of infection according to the recent evidence of disease virulence, transmission routes, and key control methods. There are many guidelines and recommendations for prevention of infection, and failure to meet those indicates a failure in appropriate standard of care. Even the court of law looks for guidelines and then compares whether those have been followed or not. Proper communication of the lawsuit summaries to the healthcare providers can help the Infection Control Committee in enhancing patient safety and prevention of HAI.

If a patient has been harmed or exposed to risk of harm, providers have a duty to disclose that information to the patient or family. When errors have occurred, or when some risk of harm exists, there must be hospital policies available to guide disclosure of patient identifiable health information to regulatory authorities, accrediting bodies, or other government agencies. Greater awareness needs to be created so as to highlight the potential legal implications of HAI.