Manufacturing is more than just putting parts together. It’s coming up with ideas, testing principles and perfecting the engineering, as well as final assembly.
Introduction
Systems engineering (SE) is a “semantic container” dynamically updated with new tools from various disciplines having in common the aim to solve complex problems, and build systems capable of meeting requirements within often opposing constraints (PCAST 2014). The Joint Recommendations from the National Academy of Sciences and National Academy of Engineering (Reid et al. 2005) rely on a thorough application of ergonomics (see Chapter 47) and systems engineering for improving and when necessary redesigning healthcare practices and facilities: in short, redesigning healthcare culture.
Tested and experimental methods and tools of SE are presented here, split into two chapters (48 and 49) because of practical reasons of presentation: this chapter is dedicated to a “mature” branch of SE, management systems; the next chapter is dedicated to a new, more sophisticated tool of SE being testing in healthcare: modeling and simulation techniques.
The aim of this chapter is to provide an overview of both methodological and practical aspects of management systems (MS), quality systems (QS) and integrated systems (IS) in optimizing care processes; some possible uses will then be considered in reference to geriatric surgery and finally, some keys will be offered to healthcare personnel to interacting best with engineers and quality experts, in the interests of both patients and society.
Managing Complexity
Today, patient safety, comfort and effective management are elements of paramount importance. Optimizing resources, reducing both risks and costs, increasing safety, improving the outcome and satisfying patients are the daily imperative of any healthcare organization (see also Chapter 47).
Complexity is quoted as one of the distinctive elements of modern medicine; geriatric surgery, which applies complex tools to complicated patients, is a typical example.
Managing complexity requires the appropriate tools and knowledge, and in recent years a number of different actions have been undertaken internationally that showed great benefit from the implementation of apparently distant disciplines in the healthcare field.
Solving Complex Issues
In everyday experience, breaking down complex tasks in more simple sub-tasks is a key strategy and is often the first step put in place. Understanding whether an older patient may benefit from surgery is a complex task, and splitting it up (specialist evaluation, interviews, documentation analysis, lab tests, etc.) is just the start of reaching the answer. Defining sub-tasks leads to understanding of how to arrange the correct sequence; clinical pathways are a widely used example of such a procedure. Dividing and performing single tasks is a necessary but not a sufficient condition; the sub-tasks should be reassembled, rebuilding links to restore the complexity of the issue. In the simple example of the cost–benefit analysis above, to reach a considered evaluation, the case should be reviewed through interactions, looking for a trade-off among the patient’s wishes, objective conditions and risks. To reach the desired goals, processes need to be first separated into their components, before criticalities are identified and prevented, maintaining strict control on processes themselves.
Identifying Criticalities
Criticalities are circumstances that hamper the process flow, bringing it to a halt until their removal. For instance, the patient is ready for discharge, but no care transition has been guaranteed in the community. Office queuing may become a criticality when waiting times exceed patients’ needs, or a missing informed consent is discovered when a cognitively impaired patient is in the operating theater. Detecting criticalities is one of the scopes of management systems, and SE in general.
Keeping Processes Under Control
Splitting complex processes, reanalyzing them as a whole, pinpointing criticalities and addressing risks is the basic way to keep processes under control. Performing such schemes routinely and systematically should be the basis of any organization, and this is obtained through the “simplest” SE tool, a “real” quality system (QS, see later in this chapter), “real” meaning that such powerful tools often fall into disrepute due to their too often “formal,” practically meaningless implementation.
A performing QS requires education and the capacity of staff to work effectively beyond technical skills, which means that the top management should promote non-technical skills and awareness, achieving:
watchful understanding of patient needs and requirements
team-working ability
a keen attitude to conflict management
clear definition of outcomes
unequivocal definition of communication, review and decision channels.
Whenever such skills are not deployed, no process will be completely under control.
Management Systems and Quality Systems
QS are “low-technology,” attitude-intensive tools defining the organization’s capabilities to satisfy the implicit and explicit needs of its “clients,” as stated in ISO 9001:2015. Other purposes are often considered (environment, operators’ health and safety, energy: ISO 14000 and 50000, OHSAS 18000 series), integrated into a unique MS. QS/MS consist in documented self-determined rules and procedures that are standards-compliant and are meant to be certified by a certification body, which checks coherence between:
declarations in documents about variables to control, and procedures to keep them under control
methods and rules declared in documents, and the requirements of the standard(s)
contents of documents, and effective implementation of methods, rules and procedures into workflows (Yih 2016).
Coherence assessments are called “audits” (not “clinical” audits), performed by external assessors.
An MS may bring positive, negative or unchanged values, i.e., improvement, deterioration or status quo. What makes the difference is the level of bureaucracy within the organization. Consequently, an MS may be:
customer-focused, seeking to obtain the approval of the “final customer” (or to convey this impression…)
up-focused, oriented to satisfy the “ownership”
in-focused, or self-indulgent (reforms apparent rather than substantial).
A system may start as “customer-focused” and turn into “self-indulgent.” Johnston (1993) plainly shows hindrance to the development of customer-focused pathways: at first, the negative effects of bureaucracy are noticeably reduced, then bureaucracy becomes a barrier.
In healthcare, we have widespread examples of formalized, often certified, management systems dedicated to medical devices, clinical laboratories and specimen examination or, at best, to single clinical departments or units. MS applied to healthcare facilities as a whole are relatively rare: only 15% of 73 hospitals investigated in Europe were ISO certified (Shaw et al. 2014). Very few case studies have been found in literature, often stating that “further research is necessary.” Indeed, doubts have been advanced (Mumford et al. 2013) that even accreditation, a process akin to MS certification, has a positive impact on quality. With costs increasing 0.2–1.7%, the authors concluded that “studies were inconclusive in terms of showing clear evidence that accreditation improves patient safety and quality of care”. This position is probably too extreme, and such a conclusion is due to the small sample considered, as well as to the lack of statistical tools suitable for investigating such complex issues (Campbell et al. 2000).
Moreover, no specific references were found in the literature to MS applied in geriatric healthcare; this might lead one to rule out MS as useful tools, but logic and common sense prevent that conclusion.
Certified MS are widely used in the industry, and significant numbers of positive outcomes are noted in contract stipulations between client and provider. MSs developed as an answer to a law-enforced obligation give less clear satisfaction levels. The only possible explanation for the gap between industry and the “healthcare industry” lies in lack of confidence and trust of professionals in QS and in their reliance in technical more than in non-technical skills. This is hopefully bound to change; it is not the certification process itself that makes a geriatric surgery structure a good one, but the organization’s attitude to the process of establishing the MS. Even if they are not experts, professionals should become familiar with them, and strongly support their correct deployment.
Planning Techniques
Gantt Chart
Planning techniques are self-consistent tools for any activity where time is critical. Progressively assimilated by MS, the most popular tool – the Gantt chart – was a revolution; conceived by Adamiecki in 1896 (Marsh 1975), who regretfully published in Polish, it went under the name of the North-American, Henry Gantt (1910, Clark and Gantt 1922; Figure 48.1). Known as also a “crono-program” or “timebar schedule,” its purpose is to schedule tasks, resources, production processes and employee rostering (Karuppan et al. 2016). A powerful tool for project/process management, it was used by the USA military during WW1.
PERT Diagram
Gantt’s idea was further developed by the US Navy after WW2 for the design and construction of nuclear submarines. The result was a tool, code-named PERT (Program Evaluation and Review Technique), where the concept of a “critical path” is essential (Figure 48.2). PERT takes into account precedent relationships, and a graphical code distinguishes activities that cannot start before the completion of others (serial activities) from activities that are independent (parallel activities). As a result, cells representing activities are connected, left to right, by links showing the dependence. As a consequence, many pathways may lead from start to end, but at least one is critical; any delay in any of its activities results in a delayed project (Karuppan et al. 2016). Today the difference between Gantt/Pert is smaller: the dependence may be considered in both and, starting from an alphanumeric data-table, a computer or tablet can instantly render a reticular output (PERT) or a bar output (Gantt) with the same information. Perhaps the Gantt view helps to evaluate the state of advancement of a project, whereas the strong points of PERT still lie in:
immediately perceived visualization of the task sequences and precedence
computational capacity of the probability to meet scheduled dates
simulation ability of the effects of options for “deciding before deciding.”
Work Breakdown Structure (WBS)
WBS is the partition of a complex task/process into smaller components. Building a good WBS requires three simple rules:
items are not necessarily homogeneous (“Cognitive status evaluation,” “Place the identification bracelet on a patient” and “Cleaning and disinfecting operating theater before next surgery” are examples of valid WBS items)
no item is ever partially or totally overlapped with another
the sum of the items covers 100% of the task/process.
A WBS is always functional in implementing other tools and is the basis of analysis, scheduling and planning (Kaufman 2005), as mentioned above.
Workflow organization tools
Besides the above-mentioned, under this term we consider a large number of “simple” tools (Zaric 2013), fit for paper and pencil, albeit a computer may be helpful. Just a list is reported here, given that they are already diffused into every field of healthcare:
checklists
internal guidelines
procedures and work instructions
flowcharts, organization and “tree” charts.
Putting things together
Why and how might professionals in geriatric surgery be interested in these tools? The complexity inherent to geriatric surgery is the leitmotiv, together with time as the critical factor for efficiency and even more so for patient safety. The scheduling of activities in geriatric surgery is decisive, and is properly obtained by:
performing a WBS of complex tasks
detailing a completion time for each item, in terms of estimates of “most likely time,” “optimistic time,” and “worst case time”
putting back together the activities via Gantt diagram or PERT
improving activities along the critical path, in order to:
gain time for critical activities, or at least keep them under stricter control
increase resources for critical activities whenever possible
establish safer procedures and behaviors in critical sub-tasks where haste increases error risks
use the extra time tolerance in non-critical activities for redundancy checking, mostly at interface points.
Such an attitude does not necessarily demand engineering support, and requires some limited training at most. The intelligibility of the methods and the help of easily available, user-friendly software allow clear-minded professionals to manage the tools with autonomy to obtain sensible quantitative results.
A non-numerical fallout of the concepts above is also possible, setting the professional frame of mind in terms of what-if, and thinking in terms of monitoring the critical path with specific care.
Leading People to Work Together
Teams with Shared Goals
The team approach is a concept widely studied and investigated in the second half of the twentieth century, and its contribution to the engineering and re-engineering of any kind of workplace – healthcare facilities included – is remarkable. Teamworking is treated as a key success factor and a crucial asset in the good functioning of any organization. “Teams are considered to be on the leading edge of management and human resource development” (Harris and Harris 1996) and – from some 20 years ago – “properly functioning teams are now central to many organisations’ health” (Fisher et al. 1997). The amount of available literature, seminars and conferences is proof of the interest and expectations that rely upon team-working philosophies (Haupt and Smallwood 2005).
A team is more than a just group; it is a number of people with complementary skills, committed to common approaches, purposes and goals, for which they hold themselves mutually accountable (Bettelli 2005). Different roles, shared vision, common culture and high cohesion are pivotal, and Belbin (2010) had the great merit to “discover” how to beat a paradox, the “Apollo Syndrome,” affecting groups made up of highly capable, skilled individuals: unacceptable results may be obtained because seldom are these types of team-members not:
difficult to manage
inclined to unhelpful debate
likely to undertake individual actions
obstructing proper decision-making.
A systematic review of teamwork abilities in the medical field enumerates ten perceived features “underpinning effective interdisciplinary team work” (Nancarrow et al. 2013). Two main commitments should be addressed by:
top management, regarding:
communication strategies and structures
personal rewards
training and development policies
appropriate resources to ensure quality and care outcomes
professionals, regarding:
clarity of vision and perception of multicentered complexities
patient-centered focus
non-technical and technical skill mix
ability to maintain a good working climate
mutual respect and awareness
ability to step back in the patient’s interest.
As professionals are chosen for their technical abilities, not their teamwork attitude, supplemental education and training is required, and no general rule can be established a priori; team functioning should be implemented case by case, structure by structure. Actually, although in theory no one denies the importance of a proper team approach in healthcare, much less in geriatric surgery, this view is neither widely nor thoroughly applied. Generally speaking, even considering different situations in European countries, it is more likely to acknowledge an accountancy, book-keeping approach than a management-related, strategical view in healthcare steering. That’s why top management support and self-managed agreement of team-members – having no fear of exposing their strengths and weaknesses – is the starting point towards patient safety and wellbeing.
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