Risk management and legal liability of waste management in healthcare:
Infection control / Occupational Health perspective.
Ms. Nell Browne
Director, Pro Active Risk Management (PTY) Ltd.
PROFILE
A well qualified Medical Risk Consultant whose career has shown significant achievement both in the practical aspects of the discipline and in the academic field. Industry experience has been with an international insurance company, NOSA, the mining industry and contains periods spent in general nursing.
Special talents lie in the assessment of risk, particularly as relates to medical negligence/malpractice and the development and introduction of appropriate correctional interventions as well as good exposure in the field of Occupational Health and Safety which includes extensive experience in auditing in both healthcare and other industry sectors
Has a significant record in the presentation of well-received public lectures/workshops, in the delivery of papers at both local and international conferences and in the publication of a series of articles in professional journals
Achieved the Certificate in Medicine and Law (Cum Laude) only the 4th person to do so, and was the first, and to date the only Professional Nurse to be admitted to the SA Medico Legal Society.
Honoured by an employer for Outstanding Professional Achievement
ABSTRACT:
This paper will look at the legal structure in South Africa to identify the occupational health and infection control aspects of legislation that cannot be separated from waste management. Risk management often focuses purely on the financial component of risk without taking into account the broader legal aspects. Evaluation of the employer and employees duties as defined in the Occupational Health and Safety Act (OHSAct) No 85 of 1993, from a risk management legal liability perspective in conjunction with the Hazardous Chemical Substances and Hazardous Biological Agent regulations will be discussed in relation to waste management in healthcare.
Risk management and legal liability of waste management in healthcare:
Infection control / Occupational Health perspective.
Risk management is the practice of identifying risk, analysing the severity of the risk and evaluating the impact it could have on the organisation and then developing and implementing the necessary risk reduction and control measures. It is a systematic process that is dynamic and if applied to all aspects of an organisation can contribute significantly to good corporate governance, productivity and profitability.
In order to discuss risk management we need to define a few key terms.
· A Hazard is a source of, or exposure to danger.
· Pure risk is the probability that injury, ill health and / or damage will occur
· Pollution is the change in environment which may be due to substances, radioactive or other waves, noise, odours, dust or heat. Pollution causes adverse effects on human health / well being, ecosystems, materials valuable to man etc.
In looking at the infection control and occupational health aspects of waste management we need to consider not only the specific Environmental laws and guidelines but also some critical sections of the Occupational Health and Safety Act. No 85 of 1993 (OHSAct) and the supporting regulations.
OHSAct S 16 Chief Executive Officer (CEO) duties
As soon as a person accepts a post of CEO they accept the legal duties imposed by the laws of the country. The OHSAct states in Section 16 that the CEO will properly discharge his duties i.e. he takes full responsibility for ensuring the organisation complies with all aspects of the Act. As this is a mammoth task he may assign duties to other staff members to carry out some of these functions. However he still retains full legal liability. This means that should an adverse event occur or an Inspector from the Department of Labour finds a non-compliance situation the CEO may be prosecuted personally in a criminal court. Civil action may also be instituted against the organisation as a legally entity as well as the CEO personally.
OHSAct S 8 General duties of employers.
The general duties of the employer are broad and in each organisation it is the employer’s responsibility to define and interpret the law as applied to that organisation. These duties include but are not limited to:
· Providing and maintaining a safe and healthy working environment with equipment that is not hazardous to the employees or any other person. In the context of waste management we can relate this to the example of providing a waste anaesthetic gas extraction system. This in turn will lead to the need for compliance with the National Environmental Management Act (NEMA) Air Quality Bill once enacted. This may include monitoring and controlling emissions as the carrier gas for anaesthesia is nitrous oxide, a greenhouse gas.
· Removing hazards where possible. Ethylene oxide (EO) is a hazardous chemical used for gas sterilisation but there are other alternatives. Switching to a less hazardous option will remove the need for air monitoring in the EO environment and also the need for medical surveillance of the exposed staff. EO is usually exhausted from the steriliser into the air.
· Reduce risk where possible. If there is a device such as the safety syringe that automatically retracts its needle to reduce the risk of needle stick injury, the employer must look at the overall benefits and not only at a possible increase in operating costs. It is not only the health professional who is at risk of a needle stick injury but the risk follows the route of disposal of the device.
· The employer is tasked with controlling the risks at a tolerable level when the risk is inherent to the business. This means that ongoing assessments need to be made of the way in which work is done, policies and procedures and other control measures such as job evaluation; self audits etc. are effective in controlling the risks.
· This leads to the next duty of monitoring the controls to ensure efficacy.
· Medical surveillance is prescribed where certain hazardous exposures occur, notably noise above 85 decibels (dB), chemical and biological agent exposure.
· There is a legal duty to inform employees of the nature and severity of the risks to which they are exposed and the necessary safe working procedures which include the use of appropriate personal protective equipment (PPE). The employees must know and understand the risks. This is one area that is seriously neglected in the health sector in SA.
· There is a duty to train employees in safe working procedures and the correct use of PPE.
· The employer also has a duty to not permit a contravention of the OHSAct. So they cannot use the excuse that PPE was provided or safe working procedures defined but the employees do not work in the correct manner. This supports the legal duty to enforce compliance with the Act. This means that where the employer has provided the means for compliance with OHSAct but employees are unco-operative that the disciplinary code must be invoked or the employer is negligent!
OHSAct S 14 General duties of employees.
The Act is fair in that it also places legal duties on the employees. These duties include:
· The employee must take reasonable care when carrying out work and to co-operate with the employer in creating a safe and health working environment.
· The employees must comply with the procedures of the organisation in the interests of safety and health.
· There is also a duty for all employees to report unsafe conditions. This is not restricted to the elected SHE (safety, health and environment) representatives.
· Another important duty is to report incidents or injury on the self - same shift.
· Although it does not fall into section 14, Section 15 specifies a legal duty not to interfere / misuse any equipment that may be provided to reduce a risk.
Unrecognised legal liability.
There are several risks in healthcare that are often not identified as such and therefore not managed accordingly. We tend to focus on patient care areas and neglect the support services. The following pure risks need to be assessed as sources of pollution. They have both OHSAct and NEMA legal implications.
· Noise levels greater than 85dB. This is a source of noise induced hearing loss (NIHL) which is caused by damage to the auditory nerves and is irreversible. The main sources of damaging noise will be in areas like boiler houses, compressor rooms and electrical power tools but we need to be alert to noise from medical equipment e.g. lithotripsy units.
· Waste anaesthetic gases are seldom identified as a risk. Many hospitals do not have adequate gas scavenger systems and these also discharge the gases directly into the atmosphere. Nitrous oxide which is the main carrier gas for anaesthetic agents is listed as a hazardous chemical and therefore all of the Hazardous Chemical Regulations (HCS) apply. Nitrous oxide affects the central nervous system (CNS) and exposure at high enough levels is fatal. Coupled with this are the other anaesthetic agents used which are toxic to the liver. Poor air quality, due to the WAG, in the operating theatre suite can give rise to a host of medical problems seldom linked to the occupational source. Some years back the UK was considering legislation to make hospitals filter the discharge from WAG systems to reduce the pollution levels where there is a high concentration of hospitals in a relatively small area.
· Disposal of packaging materials. The advent of disposable medical devices was heralded as a major time saver and a boon to infection control. As with many developments the problems are not always obvious at inception. Many of the disposable items are made of a variety of plastic materials or are packed in some form of plastic. This again contributes to both the volume and content of waste, much of which is classified as medical waste as it may have been in contact with the patient body fluids etc.
In a May 2003 report on medical devices the opinion was expressed that the growth in pre-packaged medical devices will continue increasing at about 5.9% per annum. Te report predicted that polyvinyl chloride (PVC) will remain the most commonly used sterile goods packaging resin whilst thermoplastic polyesters will show the biggest growth. The increasing use of bags and pouches will also mean an increase in the use of low density polyethylene. All this equates to an increase in volume of pollutants that will need to be managed. If the concept of ‘polluter pays’ is followed, is it the manufacturer of the product who supplies to healthcare or the consumer, the healthcare facility, who should carry the cost of the environmentally friendly disposal?
Hazardous Chemical Substance Regulations
These regulations form part of the OHSAct and are certainly one aspect of the law that is not complied with in the healthcare sector. The key problems identified at audits are:
· Unmarked containers, even in 20 litre units supplied by a manufacturer / distributor.
· Lack of Material Safety Data Sheets (MSDS) that comply with the legal standard as per General Administration regulation S 7.
· No medical surveillance is done as the health risk is not identified.
· No or very limited information provided to employees on the chemical risk or training on safe working procedures and PPE.
· Inappropriate PPE provided which is a waste of financial resource and provides a false sense of protection to the employee.
· As no medical surveillance is done the legal requirement of keeping records for 30 years is not met.
· As no risk assessments, which include air monitoring, are done and the record keeping requirement of 30 years is not met. This includes the WAG!
· Because of the casual attitude to chemicals there is pollution of storm water and therefore ground water. Many hospitals wash air conditioner filters with chemicals and water which runs off into storm water drains. Floor stripper and housekeeping cleaning waste is frequently poured into storm water drains. This is a direct violation of HCS S (4) (a) regarding the prevention of the release of hazardous chemicals.
· Mixing of various chemicals and decanting into assorted cold drink and milk / juice bottles brings a myriad of risk.
· The utilisation of empty chemical containers by staff for storing water in rural areas is another hazardous practice.
Hazardous Biological Agents Regulations. (HBA)
These regulations were passed in December 2001 and legally entrench infection control. Very few of the healthcare facilities audited during 2002 and 2003 were aware of these regulations and compliance is dismal.
An HBA is defined as any micro-organism, cell culture, and human endo-parasite, genetically modified which may cause infection, allergy, toxicity, or create hazard to human health.
The HBA are classified into four groups of which Groups 3 and 4 are most important to the healthcare sector.
Group 1 HBA are:
Unlikely to cause human disease
Group 2 HBA are:
May cause human disease
Hazard to exposed persons
Unlikely to spread to community
Effective prophylaxis & treatment
Group 3 HBA defined as:
May cause severe human disease
Serious hazard to exposed persons
Risk of spread to community
Effective prophylaxis / treatment