Harold Shipman was an English doctor who killed approximately 15 patients while working as a junior hospital doctor in the 1970s, and another 235 or so when working subsequently as a general practitioner.¹ Is it possible to learn general lessons to improve patient safety from such extraordinary events? In this paper we argue that it is not possible fully to understand how Shipman came to be such a successful and prolific serial killer, nor to learn how the safety of healthcare systems can be improved, unless his diabolical activities are studied using approaches developed to investigate patient safety.

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The World Health Organization (WHO) defines a patient safety occurrence as ‘an event which resulted in, or could have resulted in, unintended harm to a patient by an act of commission or omission, not due to the underlying medical condition of the patient’.² Whatever the complexity of his actual motives³ when Shipman administered massive doses of diamorphine he clearly intended harm. Breach Of Patients Safety By Using Of Medical DevicesEssay. But on the WHO’s definition Shipman’s practice falls outside questions about patient safety. We argue on the contrary that Shipman’s case precisely requires to be understood within a patient safety framework (in addition to relevant legal and criminal frameworks).

The Shipman story – a brief outline

A detailed investigation of the deaths of Shipman’s patients has been undertaken by a public Inquiry. After meticulous review of all the surviving material, it was possible to piece together with reasonable confidence the key events in Shipman’s career, to identify most of the killings, and estimate the total number of patients whom he unlawfully killed. It is clear that he began to kill patients from very early in his career, and continued to do so until he was arrested. The first certain killing occurred in 1972 while he was a junior hospital doctor (paragraph 7.47 of the Inquiry’s sixth and final report).¹ On leaving the Infirmary in 1974, he became a general practitioner at a practice in Todmorden in Yorkshire. The Inquiry concluded that in 1976 he had unlawfully killed one patient and it suspected him of the unlawful killing of six others (appendix F of the first report),⁴ but by September of that year he had been discovered by his GP colleagues in the practice to have been abusing pethidine, an opiate analgesic drug. He was ejected from the partnership and practice, and following a police investigation was convicted of dishonestly obtaining drugs, forgery of NHS prescriptions and unlawful possession of pethidine. After spending a short period in a private hospital Shipman took up a post as a clinical medical officer, then, in 1977, he applied for and was appointed as a partner in a group practice in Hyde, Greater Manchester. During 1978, he killed at least four patients and is suspected of killing five others,⁴ and he continued to kill patients throughout his time as a partner in the practice, reaching a total of at least 71 deaths before he left that practice in 1992. He moved to a single-handed practice in Hyde, where he was able to accelerate the rate of killing, so that by 1997 he was killing at a rate of one patient every 10 days. No one raised questions about what he had been doing until March 1998, by which time Shipman had murdered^a more than 240 people.Breach Of Patients Safety By Using Of Medical DevicesEssay.  In that month, on the basis of her own concerns about the number of cremation certificates she had been asked to sign, reinforced by the concerns of a local funeral director (the Inquiry’s second report, paragraphs 1.20 to 1.36),⁵ a general practitioner in a neighbouring practice raised the issue with the coroner, who asked the police to investigate. After a cursory investigation, the police concluded there were no grounds for concern. The last murder took place in July 1998, and Shipman was arrested in September of that year, after suspicions that he had forged the will of that patient were reported to the police by her daughter.

Shipman killed patients with intravenous injections of diamorphine. Typically, the patient was alone at home in the afternoon, when Shipman made a home visit on some pretext and while there he administered a lethal injection. Shipman would either report the death as occurring in his presence, for example from a heart attack or stroke, or would leave the body to be found by a relative or friend later in the day. He would complete the death certificate and cremation form, giving a plausible but often fabricated story of pre-existing disease.

Errors and violations

Violations are deliberate deviations from proper procedures or rules, whereas errors are unintentional deviations.^6,7 The violation of rules or procedures can sometimes lead to major accidents, as in the case of the sinking of the boat, The Herald of Free Enterprise, when to save time, the bow doors of the cross-channel ferry were not fully closed before leaving harbour, as a result of which 187 people died.^8,9 While most violations are used as short cuts and do not arise from harmful intentions,¹⁰ Shipman’s actions were intentionally lethal, and errors by others sometimes assisted his purposes, as did defective systems and procedures for monitoring the activities of GPs.

Patient safety distinguishes between active and latent failures. Active failures are the immediate causes of safety incidents, in Shipman’s case his unlawful and lethal violations. Latent failures rest in the systems, procedures and culture of the organizations.^6,7 Interactions between active and latent failures and errors or violations are well illustrated by the classic Swiss cheese diagram. However, in this case the hazard was not a chance occurrence depicted by an arrow passing through holes that just happen, on rare occasions, to be aligned throughout all the layers of cheese (Figure 1). Shipman, snake-like, was able to slip through non-aligned holes.

If the systems are poorly designed (‘full of holes’), latent failures are likely to occur when the coincidence of several independent factors takes place (or is engineered by a violator). Individuals will make errors, but the errors will be more common and more difficult to identify and remedy if the systems themselves are poor. The interaction between latent and active failures leads to breakdown in the defences or layers of cheese.

The Shipman Inquiry was instructed by Parliament to conduct an investigation of the defences, barriers and safeguards designed to protect patients, in addition to merely investigating the actions of Shipman himself. The outcome has been the most searching public investigation into the regulation and monitoring of doctors that has been undertaken in the last 100 years. Some of the latent failures highlighted by the Inquiry are discussed below.

The latent failures

There were failures in several fields,^11–14 but here we concentrate on four: the handling of complaints, monitoring of general practitioners, controlled drug procedures and cremation certification.

Discussion

As a hospital doctor, Harold Shipman appears initially to have killed people occasionally and opportunistically, but as a GP, he subsequently found he could murder relatively freely and effortlessly. He could obtain supplies of diamorphine easily and as a doctor with domiciliary care responsibilities, he could gain access to the privacy of peoples’ own homes by self-invitation. In these comfortable, private and domestic circumstances patients held out their arms to be ‘given’ an injection which, unbeknownst to them, would kill them, after which Shipman lied plausibly to their families, saying he had called for an ambulance but had cancelled it when it became clear the death of their relative was irreversible. As the official custodian of their loved one’s medical history, Shipman could persuade shocked relatives that the victim had died both expectedly and understandably of natural causes, which he would certify.

For Shipman, killing became a routine, yet serial killing can only ever become routine where obstacles to its accomplishment have been fully and comprehensively overcome and where all, or almost all, health service and civil systems for monitoring a doctor’s activities – especially around the time of a patient’s death – are so inadequate (in systems terms, so suffused with latent defects) as to allow murder in the same way, by the same means, by the same man, to become repeated and established over decades.

The Inquiry revealed the ways Shipman operated and brought to light a series of latent safety failures in several different UK systems of regulation, some of which have been the subject of further investigation and inquiry.Breach Of Patients Safety By Using Of Medical DevicesEssay.  For example, new procedures for handling controlled drugs are being introduced,¹⁸ medical regulation is being reformed,¹⁹ and there are plans for reform of the coroner service system and death certification system.^20,21

The fact that the Inquiry found failures in so many health service systems indicates that we need to do more than simply put these failures right. We must also learn how to minimize the risk of avoidable latent failures in these and other systems in the future. The patient safety framework offers an approach. To begin with, the WHO definition of a patient safety event should be broadened to include healthcare violations. Although little is known about the extent and frequency with which healthcare violations are committed it is correct to class them as safety events. By definition, violations are intentional transgressions of rules, regulations, policies or agreed procedures undertaken, for the most part, to achieve beneficial and positive ends as seen from the perspective of the violator. Although deliberately performed, violations are usually not intended to have a harmful outcome. Yet there is a category of violations that is clearly intentionally harmful and which carries lessons for patient safety in the same way that errors and other violations do. It is not sufficient to rely on criminal or regulatory investigation procedures to identify and respond to these lessons. Health professionals and organizations share responsibility for learning from intentionally harmful violations, and the involvement of organizations’ patient safety systems provides the right mechanism. Breach Of Patients Safety By Using Of Medical DevicesEssay.

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There are practical implications for health professionals. First, we need to become skilled in identifying the convenient violations we adopt ourselves in order to cut corners and get the job done on time. These should be reported to safety systems in the same way as errors should, in order to enable better, efficient and safer methods of work to be introduced. Second, we should remind ourselves of the duty to report suspicions of poor performance through whatever cause, and the rare deliberately harmful violations by others. While performance management will be involved in these instances, the patient safety teams of healthcare organizations should be involved as well.

Footnotes

Acknowledgements