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Quality and Risks Management in Hong Kong Health Care Service

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Quality and Risks Management in Hong Kong Health Care Service


With reference to a recent report on health related incident, discuss the process of applying the system evaluation approach to identify the areas for improvement, preventive measures and to propose an action plan.

1.0 Introduction

Clinical risk management refers to the approach of improving the quality and safe delivery of health care through two ways: first, by emphasizing the necessity of identification of circumstances that put patients at risk of harm and acting to prevent and/or control those risks. Within the medical setting, risk management is increasingly becoming the yardstick of quality health care priorities. This is specifically carried through accident investigation and event-reporting systems with the goal of redesigning processes and developing improvement strategies. This would be very important considering the further negative consequences of the emergent and actual risks in the clinical setting which would affect not just a community but all the population of a specific region, putting the quality of lives of the people at an unstable position.

Further, the health care sector in Hong Kong makes use of a quality and risk management framework wherein a safety culture is cultivated through reporting systems. In this way, associated risks to the incidents and/or events could be monitored, prevented and controlled. The risk management framework follows six steps such as information through a bottom-up approach, corporate capabilities, risk register, specific priority areas, standards through a top-down approach and policy and strategies. At the hospital level, the Hospital Authority (HA) makes use of an MIRP reporting mechanism. As such, quality and risk management is particularly important for the health care sector since it is increasingly becoming prone to medical scandal and crisis from SARS to formula milk to AH1N1. Reducing the risk, promoting readiness and responding to the crisis are then critical.     

There are risks management tools appropriate for different needs such as near misses, incident, adverse event and sentinel event that HA also made use of. Some of these tools are root cause analysis (RCA), failure mode effect analysis (FMEA) and the new innovative tool which is system evaluation of reported adverse events (SEREA). In this essay, comparisons for the first two tools will be discussed as well as an analysis the recent report on health related incident using the third.   

2.0 Comparison of RCA and FMEA

All of the tools mentioned are intended for risk management of adverse events, or simply untoward events or accidents. These events are unintended injury or complication which results in either disability, prolonged hospitalization or death. Oftentimes, adverse events are caused by health care management rather than the disease process hence system failures. Adverse events could occur in areas of medication, patient identification, mislabeling, surgery and procedures, medical devices and equipments, diagnostic errors and overuse, under use and misuse of interventions and treatments. After the occurrence of an adverse event, RCA is conducted as it is the process of identifying the most basic or causal factor(s) leading to that event.

Pozgar (2008, p. 304) referred to RCA as the chronological review of an event for the purpose of identifying what, how, why, when and where an unwanted event occurred in order to prevent reoccurrence of the event.  As it focuses of systems and processes, the basic objective is to improve organizational performance outcomes. It follows a specific procedure from thoroughly investigating an unfortunate occurrence to determine the main cause of the event to researching and reviewing literature to liaising with other organizations that have implemented best practices to limit the likelihood of such event from occurring again. Changes that can be made are then identified followed by determining how these changes will be communicated to key stakeholders.

Zerwekh and Claborn (2006) also noted than an RCA is often conducted by the hospital’s risk management department and the results are presented to the quality improvement department for follow-up action, highlighting the interplay between risk and quality in the process. The latter’s role is important as it become proactive at finding ways of preventing similar incidences from occurring. Therefore, an RCA provides an incentive for the organization to improve their operations and the care they provide through probing and addressing the roots of such problems. In fact, it answers the question what should we do to prevent this in the future and not what we have done with improving systems at its core (Joint Commission Staff, 2005, p. 10).

Not wanting to arrive at the occurrence of adverse event, on the other hand, means to use FMEA which is defined as the process of evaluating the elements and/or structure of a process and thereby the entire system.  Lighter and fair (2004, p. 84) maintain that FMEA is applied to existing or proposed processes which purport to anticipate errors and design systems to avoid mistakes. As it involves a study of a process, either existing or proposed, FMEA aims to determine where a failure may occur and what effect that failure will have on the process or an outcome. Aspden (2004, p. 481) states that the evaluation of potential failures and their causes means to prioritize potential failure according to risk, pointing to actions to eliminate or reduce the likelihood of occurrence.

FMEA, just like RCA, also follows a standard procedure of choosing high risk process for review, assembling a team of people, calculating criticality index which helps prioritize action plans for change. Quality improvement processes, as according to Lighter and Fair (2004, p. 85), typically falls into three categories as high risk, high cost or high volume. Criticality index, on the other hand, considers three parameters as severity, occurrence and detection. Implementation, recalculation and reevaluation of criticality index are the necessary next steps, all of which aimed at optimizing the process and make the changes as part of the process.  

One of the fundamental differences of the two is that RCA is a retrospective process review while FMEA is a prospective process (Lighter and Fair, 2004, p. 84). Whereas RCA is a reactive approach to systems analysis, FMEA is a proactive approach to the prevention of systems-related failures. Nevertheless, both are very important tools for health care organizations for the sole reason that these are a key to an organization's performance improvement efforts. At the onset, RCA and FMEA are both qualitative methods of analysis which aim to reduce the possibility of harm to patients in the future. RCA and FMEA are both processes that involve the practice of identifying conditions that lead to harm achieved through team activities. Therefore, RCA and FMEA both require people, time, materials and support (Joint Commission Staff, 2005, p. 8).          

The Joint Commission (2005, p. 9) also recognizes that these processes are interrelated given that RCA could be used during portions of the FMEA and vice versa. In fact, FMEA can be used during an RCA to assist in evaluating various proposed improvement strategies that resulted from an RCA. It is the job of FMEA to discover the specific processes might fail and identify any new failure modes than have been introduced as a result of new process designs. RCA, however, can be used to help identify processes that need FMEA and can more specifically determine the roots of an identified problem. Although a complete RCA is not required, a critical look at how a failure could occur and what actions could be taken to prevent or mediate the effects of the failure is appropriate.   

Further, the Joint Commission (2005) made mention that the use of both RCA and FMEA should be a part of an organization’s comprehensive performance improvement process. One reason behind this is that the analyses of processes after an event occurs should be carried from a prospective outlook at what could probably go wrong with processes and procedures throughout the organization. Organizations that do not use these approaches only endangers their own processes as the tendency is to be reactive to the occurrence of the events without addressing the need to change and identifying what really causes such event.   


Yet another proactive approach is SERAE which is also a team-based and systematic process that is used to prevent systems problems. Just like the FMEA, SEREA is also conducted before an event occurs by means of analyzing adverse events reported and described in other hospitals. It has been said that the limitations of FMEA are the foundations of SERAE whereas FMEA is based on theories or hypothetical and is rather difficult to integrate into the organization-wide systems; SEREA has actual reference point as its underpinning as it is based on actual data on interaction of failures. The mindset that SEREA cultivates is one of prevent and learn compared to the find and fix mindset of FMEA (Ching, n.d.).  

Moreover, the decision whether to hold or conduct SEREA stems from the reported adverse event in hospital or institution. It is determined first, however, if systems are available in the hospital and when these are available, SEREA would be possible. If there are no systems to back SEREA, it would be more appropriate to suggest systems improvement, perhaps through FMEA, for the purpose of preventing future occurrence of adverse events. In conducting SERAE, the review of the existing system will be also performed particularly specific activities that concern handling of similar situation. When improvements are already suggested, review and feedback with the action plan are the necessary next steps. Documentation is an important process in the risk management and documents and reports should be submitted to the risk management and quality improvement departments.

Basically, SEREA means to answer the question of why such an event happened relating to the adverse event that had occurred in other hospitals and medical institutions. This would be suitable to answer the unyielding question of what is the probability of that similar adverse event happening in our hospital or institution. Proximate causes, processes and systems that will define the future occurrence of that adverse event are then critical. Through such process also there is the high possibility of knowing the readiness of the hospital or institution to respond to the adverse event. The review of the processes will reflect the capability of the hospital to reduce or totally eliminate the possibility of the event since it determines the failure modes from which the adverse event could arise from.  SEREA essentially yields to evidences of the possible occurrence of the event. Strongest point of SEREA is that it also leads to determining corrective actions that feature improvements to the systems and processes even before the event occurs (Ching, n.d.).

4.0 SERAE and related health

In March 2009, Hong Kong was faced with drug safety scandal that threatened the public’s confidence on its drug safety system. Six drug blunders were in focus which involved expired medicines, illegal packaging, fake expiry dates on drugs and illegal level of fungi in drugs that led to deaths of the patients involved. Specifically, there are ten patients who received expired cough medicine from a public clinic. The President of Hong Kong Medical Association, Tse Hung Hing, said that people rely on dug regulations and in the case that they are getting medicine from the doctors or from the hospital with medicines that could not be trusted, they are just putting their very lives at risk. The Health Minister also noted that the government should take responsibility. A committee of experts was appointed to review the drug regulation system and suggested than constant reviews should be carried out. However, Mr. Tse said that the review of drug regulation system after the blunder was not acceptable. HA, on the other hand, had worked overtime to conduct extensive inspections on all drugs given to patients.  

For this paper, I have chosen the adverse event of wrongful administration of medication, that is, the expired medicines to the patients. This happened in a public clinic that HA chose not to be named. From a pharmaceutical perspective, the care provided aimed at effective drug therapy, safe drug therapy and economic drug therapy, all of which might effectively lead to improved quality of life for the patients. Medication errors accounts for a significant portion of incidents that threaten patient safety. With this said, there are various sources of error that could be accounted for our case such as prescribing error, supply error, administration error and lack of user education. As such, all of these errors could occur in any specific clinic or even in reputable hospitals with well-established operating procedures, standards, regulations and policies.

Hypothetically, a large hospital will be considered for this which will be named as the Wong Tai Sin Hospital, a medium-sized public hospital with 300 beds. Using SERAE, the necessary first step is to determine the likeliness of the occurrence of such an adverse drug event to a hospital. Would there be a similar adverse drug advent in Wong Tai Sin Hospital is the question. There are so many reasons why wrong administration might happen such as the high possibility of selecting the wrong or inappropriate drug, dose, formulation and duration among others. Another area to be looked at is the communication practices of the nursing staff since they are the ones administering the medicines. Having said this, administration errors are also likely such as timing, wrong route and wrong rate/technique.    

Evidence-based approach to clinical practice aims at delivering appropriate care in an efficient manner to individual patients. Such a process entails the utilization of research evidence as well as clinical expertise and interpretation of patient's needs which in turn will inform decision-making. A known fact is that the nursing care involves a wide range of interventions and hence draws on diverse evidence base. To wit, there is the necessity for individual nurses to develop key skills for the purpose of accessing and using evidence appropriately in clinical practice. In the case when evidence is not available, to make considered decisions. According to Craig and Smyth (2002), sources of synthesized evidence are evolving and are being made accessible to nurses. When it comes to developing nurse researchers, there are issues which will be encountered and must be dealt with in order to come up with quality evidences. These issues include organizational culture, management support and career paths that accommodate both clinical and research work need to be addressed.

Clinical decisions need to consider the current best evidence available. A process that undergoes a series of steps, it would be inevitable for nurses to start with formulating a clearly defined question. Such question drives each step of the process and should therefore be carefully considered at the outset. The rationale behind this is that a well-formulated question maximizes the potential of finding relevant evidence which can be applied to specific patient in a specific setting (Macnee and McCabe, 2006). Questioning is also critical in deciding the relevance of evidence-based practice for nursing and its place within contemporary health care. Notably, there is the unyielding need for nurses to develop an identity based upon a solid understanding of its position within a health service which is modern and dependable.

With this said, the goal of nursing research is also changing and now includes the establishment of scientifically defensible reasons for activities and provision of an increased repertoire of scientifically defensible intervention options. Nursing research also aims at increasing cost-effectiveness of activities, providing a basis for standard setting and quality assurance, providing evidence of weaknesses and strengths, providing evidence in support for demand for resources, satisfying academic curiosity and facilitating interdisciplinary collaboration. What has been the most pressing though is to earn and defend their professional status. This points to the essential value of evidence-based nursing practice is the emphasis it places on rational action through structured appraisal of empirical evidence, rather than the adherence to blind conjecture, dogmatic ritual or private intuition. As such, the value for the delivery of effective health care interventions is unquestionable.

However, there are barriers for nurses in implementing new knowledge. Lack of awareness of new evidence and the absence of relevant and/or quality research are two among these barriers. There is also the tendency of nurses to rely on out-of-date information especially when nurses are anxious over the idea of changing practice (Hamer and Collinson, 1999). In evidence-based practice, nonetheless, even where evidence is hard to find the practitioner is still expected to find and assess what evidence there is, appraise it, utilize it and evaluate its use. These barriers and the expectations from nurses requires new set of skills for nurses. Such abilities consist of the ability to define criteria such as effectiveness, safety and acceptability, to assess the quality of evidence, to assess whether the results of the research are generalisable and to assess whether the results of the research are applicable.



Aspden, P. (2004). Patient safety: achieving a new standard for care. National Academics Press.

Ching, P. T. (n.d.). Proactive Ways of Mitigating Patient Safety Risk – Application of FMEA and SERAE. Retrieved on 13 November 2009, from

Joint Commission Resources, Inc. (2005). Failure mode and effect analysis in health care: proactive risk reduction, 2nd ed. Joint Commission Resources.

Joint Commission Resources, Inc Staff. (2005). Root Cause Analysis in Health Care: Tools and Techniques, 5th ed. Joint Commission Publisher. 

Lighter, D. E. & Fair, D. C. (2004). Quality management in health care: principles and methods. Jones & Bartlett Publishers. 

Pozgar, G. D. (2008). Legal aspects of health care administration, 10th ed. Jones & Bartlett Publishers.

Zerwekh, J. G. & Claborn, J. C. (2006). Nursing today: transition and trends, 6th ed. Elsevier Health Sciences. 

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