**Analysis of case**

The death of Mrs. M, a fit 69-year-old lady, who underwent an elective procedure, is a classic case of clinical futile cycles (CFC) [1–3]. This term has been borrowed from biochemistry where two (or more) always on enzymatic systems change one chemical to another and then back to the original chemical with no net output but the use of much energy. In Mrs. M's case, there was certainly a lot of clinical activity from all levels of the medical and nursing hierarchy; yet, the net outcome was a preventable death. The ward doctor on day 2 did all the right things, IV fluids, ordered labs, and requested an urgent surgical review. The surgical team certainly had this patient on the radar, performed a CT scan, and got the theatre organised and the post op ICU bed. The surgical registrar gave good instructions over the phone and the consultant agreed with all of the above and undertook the re-operations.

However, if we 'scratch the surface' a bit more in this case sadly, Mrs. M found herself in the midst of an unintended CFC:


So, at four levels above in the traditional hierarchal referral model of care, everyone is doing the right thing. CFC is the explanation for all this activity, whilst appropriate for the individual practitioner concerned was not sufficient to get Mrs. M to theatre more urgently to have the problem fixed. In addition to the CFC, we have become accustomed to the naïve expectation that some sort of track and trigger system (Medical Emergency Team, Rapid Response System) will fix the problem by getting the patients deterioration alerted. However, that is all they do. The rest is up to the clinicians on the ground to make the right diagnosis, determine the level of severity of the condition, initiate management, notify the right people and with all pressures of the job to do this in a timely fashion to prevent patient catastrophe [4, 5]. All too often, it is only patient physiological reserve that defends patients from a system of care that is designed to fail them.

#### **1. Introduction**

*overnight observation due to some shoulder tip pain and nausea. That afternoon, she was transferred without the consultation of the surgical team from the surgical ward to a low dependency rehabilitation unit. By the following morning (Day-2), she was tachycardic, diaphoretic and had a distended abdomen. The ward medical officer reviewed Mrs. M and prescribed intravenous (IV) fluids and analgesia, ordered blood tests, and requested an urgent surgical review. The surgical team then saw Mrs. M as part of their usual morning ward round, and she still had generalised abdominal tenderness and abnor-*

*Mrs. M continued to deteriorate over the day. Another set of abnormal vital observations was taken sometime after the ward round, yet no doctor was informed. Mrs. M was seen by the two interns attached to the surgical unit. They were called to review her in the CT room due to concerning vital signs and contacted their registrar for assistance. They prescribed IV therapy and analgesia following* 

*Upon discussion of the CT results between the consultant and registrar midday, it was decided that Mrs. M was to return to theatre later that day for explorative laparotomy, and then to transfer to ICU for post-operative observation. Mrs. M was therefore assessed by the intensivist on-duty who diagnosed peritonitis and renal failure, and prescribed triple antibiotics and rapid IV fluid therapy, and strict monitoring of fluid balance. She was concurrently seen by the anaesthetist on-duty for pre-anaesthetic assessment. As Mrs. M had single IV access, only one antibiotic was administered by the time she was* 

*Once in the operating theatre, surgery was delayed by an hour and ten minutes when Mrs. M becoming profoundly hypotensive upon anaesthetic induction. A bile leak was found intra-operatively and the abdomen lavaged. It was not discovered until her arrival in ICU later that evening that Mrs. M had only received one of the three prescribed antibiotics. By then, Mrs. M was severely septic, requiring inotropes, dialysis and mechanical ventilation. A second laparotomy, 2 days (Day-5) later found widespread bowel and hepatic ischaemia, and Mrs. M died the next day of multi-organ failure (Day-6).*

The death of Mrs. M, a fit 69-year-old lady, who underwent an elective procedure, is a classic case of clinical futile cycles (CFC) [1–3]. This term has been borrowed from biochemistry where two (or more) always on enzymatic systems change one chemical to another and then back to the original chemical with no net output but the use of much energy. In Mrs. M's case, there was certainly a lot of clinical activity from all levels of the medical and nursing hierarchy; yet, the net outcome was a preventable death. The ward doctor on day 2 did all the right things, IV fluids, ordered labs, and requested an urgent surgical review. The surgical team certainly had this patient on the radar, performed a CT scan, and got the theatre organised and the post op ICU bed. The surgical registrar gave good instructions over the phone and the

However, if we 'scratch the surface' a bit more in this case sadly, Mrs. M found herself in the

consultant agreed with all of the above and undertook the re-operations.

*mal vital signs. An abdominal X-ray and CT scan were ordered.*

*their registrar's phone advice.*

34 Vignettes in Patient Safety - Volume 3

*called to the operating room.*

**Analysis of case**

midst of an unintended CFC:

The first chapter in this series of Patient Safety Vignettes [6] gives an overview of adverse events in health care and provides a standardised glossary of the various definitions that are used. An adverse event is defined as an injury resulting from a patient's medical management rather than a consequence of the patient's underlying medical condition or conditions [6–10]. Adverse events are common and costly to both the affected patients and the healthcare system [6, 11–18]. In the last two decades, the incidence, aetiology and outcomes from adverse events have been documented mostly in the hospital setting [6, 11–23]. Taking these studies together, approximately 10% of hospital patient admissions have some sort of adverse event. Of these, half result in no long-term harm to the patient. However, 10% (of the 10%, i.e., 1% of all hospital admissions) of the affected patients suffer significant harm such that they either die of or are left with some sort of permanent disability as a result of the adverse event (**Table 1**) [37]. In 1995, the cost of adverse events to the Australian health-care system was estimated at \$2 (AUD) billion dollars [8]. Attempts to reduce the incidence of adverse events and make hospitals safer have been largely unsuccessful [38–41]. Like other diseases and conditions, an understanding of the underlying aetiology or 'pathophysiology' of adverse events is important for the development of preventative strategies. To date, the predominant


theory to explain adverse events in health has been the 'Swiss Cheese' model developed by James Reason from his analysis of large-scale industrial and organisational accidents [42]. In this chapter, we examine the theory and, in particular, its limitations when applied to hospital systems, with specific reference, to the 'deteriorating patient', the final common pathway for most adverse events when patients suffer harm. We then propose an alternative called CFC within the traditional hierarchical referral system of care, to explain hospital setting adverse events which takes into account some of the unique cultural systems that exist in health care, but in hospitals in particular [43, 44]. Finally using this model, we then propose some funda-

mental reforms for the prevention of these adverse events in hospitals.

**adverse events**

**Study (year of study)**

Italian acute care hospitals (2008) [34]

Portuguese hospitals (2009) [35]

Swedish Hospitals (2009) [36] Two-stage random sample retrospective case note review

Two-stage random sample retrospective case note review

Three-stage random sample retrospective case note review

**Table 1.** Epidemiology of adverse events.

**Methodology Setting Sample Incidence** 

1 acutecare hospital

3 acutecare hospitals in Lisbon

28 acutecare hospitals **(%)**

1501 3.3

**Outcome death**

**Outcome permanent disability**

Adverse Events in Hospitals: "Swiss Cheese" Versus the "Hierarchal Referral Model of Care and…

1669 11.1 10.8% 53.2% Euro

1967 12.3 3.0% 9.0% 70% N/A 63,0000

**Preventability Negligent care**

http://dx.doi.org/10.5772/intechopen.75380

**Cost (annual)** 37

470,380 Direct costs

hospital bed days

**2. The 'Swiss cheese' model of health care and hospital setting** 

James Reason in his book 'Managing the Risks of Organizational Accidents' states that organisational accidents, as opposed to individual accidents, are predictable events [42]. An individual accident is one in which a person or a group of people makes an individual slip, lapse or error of judgement with the net result being an adverse outcome either to the person or the people who erred, or to the person or people in the immediate vicinity. As such, there is usually a relatively tight, simple explanation for cause and effect in an individual accident. On the other hand, organisational accidents have 'multiple causes involving many people at different levels of an organization' [42]. These events, whilst usually infrequent, are often catastrophic. Analyses of such organisational accidents often reveal that the defences an


**Table 1.** Epidemiology of adverse events.

**Study (year of study)**

California medical association (1977) [24]

Harvard medical practice study (1991) [25, 26]

Utah and Colorado study (1992) [27]

Quality in Australian Health Care Study (1992) [28]

New Zealand public hospitals (1998) [29]

United Kingdom (1999) [30]

Canadian health care study (2000) [31]

Brazilian hospitals (2003) [32]

Dutch hospitals (2004) [33] Random sample retrospective case note review

36 Vignettes in Patient Safety - Volume 3

Two-stage random sample retrospective case note review

Random sample retrospective case note review

Two-stage random sample retrospective case note review

Two-stage random sample retrospective case note review

Random sample retrospective case note review

Two-stage random sample retrospective case note review

Random sample retrospective case note review

Three-stage random sample retrospective case note review

**Methodology Setting Sample Incidence** 

51 acutecare New York State hospitals

28 general hospitals

28 acutecare hospitals of different sizes in 2 Australian states

13 general acute hospitals

2 acutecare London hospitals

1 teaching, 1 large community and 2 small community hospitals

3 teaching hospitals in Rio de Janeiro

21 acutecare hospitals **(%)**

6579 11.2 15% for

3745 7.5 20% for

7426 5.7 12.8%

both categories

both categories

for both categories

**Outcome death**

**Outcome permanent disability**

4.2 N/A N/A N/A 19.1%

30,121 3.7 13.6% 2.6% 58% N/A N/A

14,179 16.6 4.9% 8.9% 51% N/A \$2

15,000 2.9 6.6% 8.5% 53% 30%

1014 11.7 8.2% 6.3% N/A N/A

1103 7.6 N/A N/A 66.7% N/A

**Preventability Negligent care**

N/A N/A

36.9% N/A

40.3% N/A

**Cost (annual)**

billion (AUD)

> theory to explain adverse events in health has been the 'Swiss Cheese' model developed by James Reason from his analysis of large-scale industrial and organisational accidents [42]. In this chapter, we examine the theory and, in particular, its limitations when applied to hospital systems, with specific reference, to the 'deteriorating patient', the final common pathway for most adverse events when patients suffer harm. We then propose an alternative called CFC within the traditional hierarchical referral system of care, to explain hospital setting adverse events which takes into account some of the unique cultural systems that exist in health care, but in hospitals in particular [43, 44]. Finally using this model, we then propose some fundamental reforms for the prevention of these adverse events in hospitals.
