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Aaron Han, MD,PhD, FCAP. Chief of Laboratory, American Hospital Dubai, Rana Nabulsi, PhD, MSc, CPHQ,SSGB. Managing Director, Elite Quality & Safety Consultancy, Tasnim Keloth, MBBS, MD, FIAC. Histopathologist and Laboratory Safety Officer, Dubai Hospital, Olivia Rodrigues, MLT, C.Cy. Technologist, American Hospital Dubai, 16 January 2017
Medical laboratories, whether in hospitals or in freestanding locations, have complex operations and procedures that require physical contact with patient samples and reagents. In addition to the risks of exposure to infectious materials and hazardous chemicals, environmental hazards include noise, fire incidents, chemical spills, adverse events of equipment malfunction, and ergonomics.
Laboratories are increasingly aware of quality and safety best practices. Failure in compliance can lead to customer dissatisfaction.
Taking into consideration the Joint Commission International Patient Safety Goals, Occupational Safety and Health Administration (OSHA) guidelines, and local regulatory bodies, each medical facility strives to meet or exceed the benchmark requirements.
In this article we will address some of the most common safety practice guidelinesand discuss risk management approach.
Handling blood specimens, body fluids and other laboratory specimens as daily practice by laboratory professionals is one of the main source of ongoing risk. Appropriate use of personal protective equipment (PPE) is one of the most effective tools to minimize exposure to hazardous materials. In addition, enhancing phlebotomy practices by appropriate use of PPE, engineering controls such as self-sheathing needles, along with avoiding re-capping of needles will lower the incidence of needle stick injury.
Regular and continuous in house training, and a robust competency assessment program is essential to ensure ongoing compliance with best practices in safety. Monitoring incident reporting, analyzing data for trends, having preventive measures will prevent reoccurrences and ensure safe laboratory practice for patients and staff.
Likewise, awareness of engineering control can mitigate the likelihood of injury during sharp disposal. Design and usage of waste disposal container, location and ease of use, and size of containers are important factors in creating a safe process for sharp disposal. Functioning eyewash and showers are required elements in the laboratory in case of exposure to body fluids. Dedicated rest and eating areas for employees should be clearly identified.
Post-exposure response, investigation, and treatment also need to be adequately addressed for the affected employee. Hospitals may want to establish an employee health service department to specifically attend to these incidents. The laboratory shall optimize its procedures to handle all types of incidents along with appropriate investigations and root cause analysis (RCA) to identify preventive measure .
In addition to infectious materials, the laboratory is home to many hazardous non-infectious materials including, chemicals, carcinogens, flammables, corrosives, toxins, and radioactive materials. All chemicals must be properly stored and labeled. The Material Safety Data sheets (MSDS) are usually provided with chemicals from the manufacturers, and laboratory staff shall be aware of the hazards mentioned in these sheets. Where applicable, monitoring to assess compliance with the permissible exposure limits (PELs) must be documented.
The National Fire Protection Association (NFPA) hazard identification system uses a color-coded diamond to represent four different hazards (Figure 1). These colors represent three different types of hazard that may be associated with chemicals, blue for health, red for flammability, and yellow for reactivity. A white color represents other hazards such as violent reactivity with water or an oxidizer. Numbers in the blue, red and yellow diamonds are used to indicate the severity of the hazard for that category as follows,
0 = no or minimal hazard
1 = slight hazard
2 = moderate hazard
3 = serious hazard
4 = extreme hazard
Storage, shipping, management of spills, and transport of chemicals must be addressed in procedures with adequate controls. OSHA, part of the Department of Labor in the United States specifies that a Chemical Hygiene Plan (CHP) must include discussion of eight basic elements that will indicate specific measures to ensure employee protection. These mandatory elements include:
1. Standard Operating procedures;
Particularly hazardous substances include at least three groups: select carcinogens, reproductive toxins, and substances which have a high degree of acute toxicity. Lists of these chemicals can be found in the OSHA specific standard 29 CFR 1001. Some examples of chemicals requiring special procedures include lead, hydrofluoric acid, methylene chloride, perchloroethane, and thiourea.
Laboratory fires are one of the most devastating avoidable incidents. Laboratories have all the requisite elements that can lead to ignition and fire. Monitoring environmental factors, temperature controlled instruments, electrical hazards, flammables are key elements in preventing fire. Regular maintenance with attention to faulty or worn electrical wiring and circuits will avert preventable electrical fires due to negligence. Flammable agents need to properly labelling, and storage in separate and adequately ventilated space. Laboratory design requires attention to appropriate number and location of fire exits, staff awareness of escape routes, and unobstructed access is critical for successful evacuation in case of fire and prevent loss of life. Conducting regular fire drills and training lab professionals on the proper use of fire extinguisher is essential part of fire safety plan. Acronyms commonly used to facilitate appropriate response in a fire include RACE (rescue, alert, contain, evacuate), and these should be known by all employees and the response should be automatic and second nature.
Laboratory personnel are at risk of repetitive movements and musculoskeletal disorders (MSD). In the USA, MSD is frequently seen in healthcare workers, and may cause up to a third of workplace injury and illness. Most complaints involve body areas such as the neck, extremities or lower back. Awareness and training are important to minimize the occurrence of MSD. Proper workplace design and choice of equipment and chairs can influence staff posture and minimizes repetitive action and decrease the likelihood of injury. Conducting workload study and avoiding prolonged repetitive activity is important to avoid MSD. Minimizing MSD in workplace will help to improve efficiency of laboratory staff and have more productive workforce.
Risk management is the process of identifying, addressing, prioritizing, and eliminating potential sources of risks to patients, staff and visitors. Risk management means more than preparing for the worst; it also means taking advantage of opportunities to improve services.
Risk management in health care organizations deals with the response to the malpractice incidents. One goal of risk management is to limit one’s liabilities, financial loss and preventable harm. As such, every defect in laboratory department is a treasure, and identifying a defect, finding the root cause, eliminating it, and improving patient outcomes.
How does one design a hospital and laboratory program to reduce the incidence of risks, defects and errors?
At its core, risk management is a paradigm shift from a reactive approach of controlling variances, to proactively eliminating potential sources of failure, enhancing the safety of patients, visitors, and employees. Education is critical, hospital-wide and department-specific, as one creates a culture of safety and awareness.
Categories of risks in the laboratory can be classified as non-infectious risks (like fire, burns, physical agents, chemical agents, sharp Injuries, MSD), and infectious risks (HIV, viral hepatitis, and other infections). The adverse results can lead to bodily injury, property loss, financial liability and loss.
A typical process for managing risks includes the following steps:
There are many tools commonly used for risk management including PESTLE analysis, and SWOT analysis primarily for managing projects and new initiatives. PESTLE examines risks from multiple, mostly external domains, including Political, Economical, Sociological, Technological, Legal, and Environmental factors. SWOT analyses looks at the competitive environment for risks in terms of Strengths, Weaknesses, Opportunities and Threats. Another framework is to examine all aspects of laboratory operations with regards to platform (technology), process (documents and actual practice), policy (governance), and people (training and competency), for systemic framework to identify high risk practices.
Upon planning and identification of different risks in the laboratory, these risks can be further analyzed in terms a matrix based on their probability of occurrence, and impact/consequence. A typical tool is the Failure Modes and Effects Analysis (FMEA). Teams brainstorm and develop an extensive list of potential modes of failure. Each failure mode is then scored based on three parameters which include:
1-Occurrence (O): The likelihood that a failure occurs by a specified cause or failure mode that is under current control.
2-Severity (S): The degree and significance or impact(s) of failure.
3-Detection (D): Our ability to preemptively and effectively detect, correct or mitigate the failure mode.
From these three parameters, a Risk Priority Number (RPN) is obtained by multiplying Occurrence, Severity, and Detection (O x S x D). Risks are then ranked, and prioritized for focused risk reduction strategies and failure mode prevention based on the RPN score.
Variations on the FMEA may include the likelihood and impact of occurrence (Figure 2). The highly-likely and high-impact failure are most critical (Figure 1, upper right, red boxes). These would require immediate attention with responses to reduce likelihood and impact (move from “green” to “blue” dots). Risk reduction and loss prevention techniques may encompass financing strategies (insurances and risk sharing schemes), risk avoidance (e.g. avoid mycobacterium cultures in non-equipped laboratory) and risk shifting (e.g. using referral laboratories for high complexity testing).
Occupational safety and health are important for moral, legal, and financial reasons. Healthy workers are productive assets for organizations. Occupational injury and illness are not only healthcare issues, but also economic issues. Good safety practice boost employee satisfaction and improve efficacy, reduce employee injury and illness related costs and liability. Thoughtful design of the laboratory working environment for safety contributes to efficiency, productivity, quality, and value.
Financial management of the laboratory is not just simply finding areas to cut costs. Identifying economic value requires examining efficient and effective use of resources, with an eye to quality and safety. Appropriate automation, especially of repetitive manual processes allow employees to work smarter, not just harder. A comprehensive hazardous material management plan can reduce the costs associated with procurement, handling, and disposal. Employee occupational health screening program will mitigate the impact of infectious pathogens and preventable outbreaks.
The clinical laboratory has a key role in providing health care services. The need for a safe working environment is essential for ongoing provision of service, and safety to employees and patients. This brief overview with suggested risk management approaches to address safety concerns in the laboratory will allow readers to examine their own setting and practices to improve the safety, and quality.
The medical technologists, are well trained and experienced professionals, they need initial training and ongoing refresher courses on safety - including how and when to use safety measures, infection prevention with use of proper PPE, biological and chemical spill management, and fire safety. A continuous system to monitor threats and incidents must be in place.
In the end, a safe environment is the one of the best benefits an organization can give an employee.