The Burden Caused by Administrators and Managers: a Euro-American Jumble

We argue that a jumble of rules, protocols, checklists has emerged, ‏which jeopardises not only the pivotal relationship between doctor and ‏patient, but also the quality and costs of care, and the quality of future ‏healthcare workers. It must be emphasised that the introduction of ‏protocols and checklists in clinical medicine has improved care at some ‏points and in some places, and it has similarly contributed to a reduction ‏in errors. However, the onerous bureaucratic rules, regulations, protocols, ‏certifications and credentialing imposed by administrators and ‏“oversight” organisations have become disproportionate to its original ‏objectives. We plead that clinicians realise that the time has come to ‏rebel against this and come into action.

Caring for the sick and dying is a ‏privilege that society has bestowed ‏upon physicians. Patients and their ‏families trust physicians with their lives and ‏health. Physicians spend years in training and ‏ongoing professional development with the goal ‏of providing the highest quality of care with ‏compassion and humility. However, the culture of ‏modern medicine has rapidly eroded the unique ‏and time-honoured relationship the physician ‏has with his/her patients.

Increasingly, hospital administrators, insurance ‏providers, quality organisations and a myriad of ‏regulatory agencies are dictating how physicians ‏should practise medicine. Unfortunately, too many ‏of the individuals creating and enforcing these ‏regulations have little or no knowledge of the ‏complexity of the practice of medicine. They regard ‏physicians as labourers working in a widget factory. ‏Consequently, physicians have lost autonomy and ‏the sacred patient-physician relationship has ‏been corroded. In this new environment, the ‏dehumanisation of the patient-physician relationship ‏is at risk of being exacerbated by the new ‏generation of healthcare providers, trained in ‏this—in our view—undesirable environment. ‏This new generation of clinicians is at risk of ‏being brought up lacking the concept of hard ‏work and dedication, “patient ownership” and ‏responsibility.

With the exponential growth of medical ‏knowledge and technology, clinicians are ‏continuously being challenged by complex ‏new diagnostic and therapeutic interventions. ‏Simultaneously the organisation of patient care ‏is changing with an ever-increasing number ‏of organisations and non-medical individuals ‏involved in the delivery of healthcare. Society ‏demands, and rightly so, accountability regarding ‏the quantitative, qualitative and financial ‏aspects of patient care. In response to these ‏demands, hospital managers and administrators, ‏individuals with little or no knowledge of ‏medicine, have become increasingly involved ‏in almost all aspects of the delivery of care. In ‏order to have—apparent—total control over ‏the entire patient experience, these managers ‏demand the use of numbers and measurements ‏as a reflection of the quality of care delivered. ‏An additional factor that is emerging in Europe, ‏which has followed the movement in the United ‏States, is the regulatory demand that all possible ‏adverse outcomes be outlawed. At first sight ‏this would seem reasonable; however, medicine ‏is not a perfect science and sick patients will ‏develop complications no matter how hard ‏one tries to avoid them. The sicker and more ‏complex the patient the greater the likelihood ‏that a complication will occur. The institution ‏of punitive measures (financial, otherwise or ‏in terms of reputation damage) in response to ‏a bad outcome will frequently lead to changes ‏in behaviour which may compromise patient ‏care, e.g. not doing blood cultures in a case of ‏suspected catheter-related bloodstream infection ‏to prevent the diagnosis being made.

Another misunderstanding is the belief that ‏there is only one truth. Diversity in medicine, ‏patients and diseases is so big that it seems ‏inconceivable that one solution for complex ‏syndromes like sepsis, with many possible ‏underlying diseases, in the form of a protocol ‏and checklists, is advocated. Yet what we see, with ‏the intention to rule out all possible risks and ‏errors, is an increasing number of rules, legislation ‏and protocols. Oddly enough, professional ‏medical societies have not protested against this ‏movement; on the contrary, they have frequently ‏endorsed and perpetuated this approach. The ‏result is a jungle of rules and protocols from medical and scientific societies, governmental ‏and other non-medical bodies such as insurance ‏companies. Physicians and clinical leaders are ‏confronted with more and more requirements, ‏rules, audits, inspections, compliance training ‏and protocols, imposed by governmental and ‏non-governmental organisations, insurance ‏companies, accreditation organisations, inspectorates ‏and boards of directors of hospitals. ‏With all the regulatory administrative tasks ‏that physicians are forced to undertake, it is ‏not rocket science to realise that less and less ‏time remains available for the primary process: ‏patient care. Apart from impacting patient care, ‏the time wasted jeopardises clinical research, ‏education and the training of students and ‏registrars. Additionally, research and training ‏are hampered by an increasing number of rules, ‏regulations and mandatory non-functional ‏courses. Many of these mandatory courses are ‏not only meant for the teachers, but also for ‏their PhD students. The distance between workers ‏on the shop floor, the healthcare workers, and ‏on the other hand those people who make the ‏regulations is growing and they speak different ‏languages. All kinds of bodies and committees ‏in hospitals offer training programmes, ‏the additional value of which is questionable ‏in terms of patient outcome or educational ‏quality. It might come to one’s mind that these ‏bodies are mainly preoccupied with providing ‏new work for themselves, creating rules, work ‏and training programmes of unclear benefit. ‏

See Also: Medical Documentation: Fair Return on Time Investment?

A simple recent survey that the first author ‏(AG) conducted among some board directors of ‏hospitals, demonstrated that they have insufficient ‏insight into the huge number of obligations ‏imposed by different bodies on medical specialists ‏and nurses. Table 1 provides an incomplete ‏but illustrative overview of the Dutch situation.

The quality movement has imposed the ‏increased use of protocols and checklists with ‏the intention to improve quality of care. This is ‏accompanied by obligatory ticking off and securing ‏of lists that go through implicit procedures. While ‏protocols were initially intended to provide up-todate ‏medical knowledge translated into clinically ‏and practically applicable information, currently ‏all kinds of procedures need to be embodied in ‏protocols, which need to be secured by checklists ‏and repeated evaluation according to a plan-docheck- ‏act cycle. Subsequently, compliance to the ‏protocol is used as a marker of quality. Undeniably ‏this approach has induced improvement on certain ‏fronts (Girbes et al. 2015; 2016). But it is now ‏getting out of control. Moreover, a trend can be ‏observed that for every rare incident a new protocol ‏is created, without taking into account how a new ‏protocol might induce new errors. For example, ‏in addition to double checking the preparation ‏of a medicine by an intensive care nurse, a new ‏additional obligatory protocol was introduced ‏(in the Netherlands) without any evidence or ‏calculation of the consequence. This protocol ‏requires that immediately after the double check ‏of the medication an additional double check ‏is required at the time of administration of the ‏medicine. This of course requires another ICU ‏nurse to abandon their current activity, move to ‏another patient, check what is given, and then ‏go back to continue the interrupted work. It ‏is beyond doubt that frequent interruption of ‏work will induce other errors (Westbrook et al. ‏2010). Of course continuous double checking ‏would be a dream scenario, if feasible in terms ‏of human factors. This would however require ‏double the number of nurses: one nurse to do ‏the work and another to check the work. Considering ‏the pressure on and shortage of human ‏resources, one wonders whether this is the most ‏effective way to save lives. Furthermore, one of ‏the nurses would surely become bored, which is ‏not conducive to good concentration on doing ‏the best work they can.

By no means do we want to argue that errors, ‏mistakes and undesirable outcomes should not ‏be investigated to recognise the “holes” in the ‏system. However, the solution is not always the ‏introduction of a new protocol or checklist. ‏

We strongly believe that the policy of increasing ‏the number of protocols and checklists should ‏be reversed if we want to keep good medical ‏care affordable. An issue that is easily forgotten ‏is that we must be able to keep and attract young ‏talented people. Increasing rigidity of the system ‏is, to say the least, not an incentive to motivate ‏young talents to work in medicine. We argue ‏that protocols and checklists are comparable to ‏medicines: it is the dose that makes poison and ‏the indication always remains pivotal. The dose ‏has now reached the level of poison and the ‏indication is too often wrong.

Jumble of Protocols and Checklists

The purpose of clinical protocols is to translate ‏the best possible up-to-date medical knowledge into practical, clinically applicable instructions. ‏Several studies have shown an improvement ‏in patient outcome with the introduction of ‏a protocol or checklist. Whether a protocol or ‏checklist will introduce an improvement in ‏care largely depends on how good or bad the ‏situation was before the introduction of the ‏protocol. Introduction of a protocol is therefore ‏especially useful in situations of suboptimal ‏circumstances or where inexperienced or less ‏trained healthcare workers are employed. Furthermore, ‏checklists are not universal. Checklists ‏need to be intrinsically supported by staff, based ‏on the local applicability of the checklist and ‏support from the leadership.

Protocols will by definition lead to regression ‏to the mean and mediocrity. Rigid application of ‏protocols will hamper progress and innovation, ‏and protocols are by definition not up-to-date. ‏Finally, many protocols are made on the basis of ‏insufficient scientific data, insufficiently possible ‏external validation of studies or even only on ‏the basis of the judgement of self-proclaimed ‏“experts”. Unfortunately, healthcare managers, ‏“organisations for quality”, supervisory bodies ‏and healthcare insurance companies mandatorily ‏impose the introduction of protocols and ‏checklists for all kinds of aspects of care. The ‏forced introduction on a national level of the ‏Surviving Sepsis Campaign in the United States ‏and in the Netherlands, apart from many other ‏examples, is a tragic example of this. There is ‏insufficient scientific evidence to impose per ‏protocol treatment according to the surviving ‏sepsis guideline in all hospitals and even evidence ‏that it might be harmful (Marik 2016a).

The introduction of protocols with doubtful ‏benefit may lead to waste of time, work and ‏money. The obligatory introduction of the ‏medical emergency team (MET) from the ICU, ‏implementation of all components of the time-out ‏procedure in the operating room, reporting ‏standard screening of feeding condition in the ‏elderly, and scoring of community-acquired ‏pneumonia, are examples of so-called safety ‏programmes that cost a lot of time and money, ‏but are of doubtful benefit for society and ‏individual patients.

Filling in all kinds of lists is promoted by ‏the introduction of electronic patient record ‏programmes. These have been designed for ‏administrative and financial reasons and not, ‏as one would expect, to improve patient care ‏and help healthcare workers to do their work ‏correctly. It is no surprise that the introduction ‏of such electronic health records has been shown ‏to increase the risk of professional burnout in ‏physicians (Shanafelt et al. 2016). ‏

Treating individual patients optimally will ‏always require aspects of craftsmanship with ‏an academic attitude and thereby individualised ‏treatment. Translating the use of protocols ‏and checklists to another craft, food preparation, ‏might clarify some aspects. Application of ‏protocols only works very well in the fast-food ‏industry. In “restaurants” where no chef is ‏needed the employees are easier to handle by ‏the management of the “restaurant” and can be ‏paid less. Food will always be according to the ‏guidelines and protocols and checklists, but in ‏the end will not fit everybody. Likewise, even ‏if written by a great chef, reading and following ‏the instructions of a cookery book will ‏not match the quality and craft of a real chef. ‏Proponents of the unrestrained use of ‏protocols and checklists often point to the ‏analogy and similarities between aviation and ‏building construction. We reject that comparison. ‏Patients are not airplanes and doctors are ‏not pilots. Pilots receive very specific training ‏in general for a single type of airplane. Since ‏every patient is different, it would pose serious ‏problems if doctors were trained like pilots.

Jumble of the Quality Movement

There should be no doubt that doctors and ‏nurses should be accountable to patients and ‏those who pay for them: society. And society ‏is all of us. The healthcare payer has the right ‏to know how their money is spent and where ‏to find quality for the money. However, this is ‏quite difficult to measure and instruments to ‏measure quality are readily available. Nevertheless ‏the “Quality Movement” has triggered a ‏“quality tsunami” where multiple organisations ‏have now become preoccupied with developing ‏quality tools, quality indicators and measuring ‏the “quality of outcomes.” These quality ‏indicators and scorecards are frequently publicly ‏reported and may influence reimbursement. The ‏scientific validity of most of these quality indicators ‏is highly questionable. It would appear that ‏those who expend the most resources measuring ‏quality provide the worst care (Thomson et al. ‏2013). The refuge that seems to be chosen now ‏by the administrators and managers can best ‏be described as: “If you can’t measure what ‏is important, you make important what you ‏measure”. So orthopaedic surgeons obligatorily ‏record and report on the rate of reoperations ‏for hip fractures. This of course will result in ‏a figure, but this figure is of course full of ‏confounders and biases (e.g. region, population ‏characteristics, referral pattern, etc.) and nobody ‏can tell what the figure means. A rapid survey ‏among chairmen of university departments of ‏orthopaedics in the Netherlands confirmed this. ‏Nevertheless, whenever criticism is expressed ‏about this obligation the answer is: “It is simply ‏an obligation” or “everybody complies with it”.

Registrations furthermore do not take into ‏account the pollution of data that is not expressed ‏in the data. Subjective data are reduced to figures ‏in a spreadsheet, suggesting that different figures ‏and outcomes can be compared. This becomes ‏most hilarious when comparing opinions. For ‏example, during regularly performed so-called ‏employee satisfaction measurements we add the ‏opinions of ambitious, looking for security, lazy, ‏adventurer, genius, hypochondriac, disappointed ‏(in private life or their career) people, divide ‏this by the number of participants and then we ‏conclude that the satisfaction is 7.3! (We do not ‏take into account the number of employees who ‏for several reasons do not wish to participate). ‏The manager will surely advocate a leadership ‏programme to fulfil the goal for next year: 7.8.

‏In the U.S. Medicare has embarked on ‏hundreds of “quality initiatives”, and records ‏over 1000 “quality measures” with the purported ‏goal of improving the “quality of care” (Casalino ‏et al. 2016). It has been reported that physicians ‏and their staff spend 15.1 hours per physician ‏per week dealing with external quality measures ‏at an annual cost of over $40, 000 per physician. ‏There is scarce data that these quality measures ‏improve patient outcomes. In 2006 the Centers ‏for Medicare and Medicaid Services (CMS) ‏developed the “Surgical Care Improvement ‏Project” (SCIP), which became federally mandated and linked to pay for performance in 2007 ‏(Joint Commission 2015). SCIP incorporated a ‏number of measures, including glycaemic control ‏and strict timing of prophylactic antibiotics ‏that were required to be performed in every ‏patient undergoing elective surgery. In January ‏2015 the SCIP project was quietly “retired” ‏(Joint Commission 2015), after it became clear ‏that this very expensive and time-consuming ‏endeavour did not improve patient outcomes ‏(Hawn et al. 2011; Dua et al. 2014; McDonnell ‏et al. 2013). In 2015 CMS adopted the “SEP-1 ‏Early Management Bundle for Severe Sepsis and ‏Septic Shock” for the Hospital Inpatient Quality ‏Reporting Programme. Most alarmingly, it is ‏likely that this “quality” programme” will harm ‏patients (Marik and Varon 2016). In the U.S. and ‏progressively in the Netherlands, physician’s ‏medical records are scrutinised by individuals ‏with limited educational training to ensure ‏that all elements of the history and physical ‏examination are documented, no matter how ‏irrelevant. Rather than being a tool to communicate ‏medical information, the medical record ‏is used as a quality indicator and a means to ‏punish physicians for incomplete documentation. ‏And again a new industry is filling this ‏created gap: a “quality company”. Their slogan ‏is: “Let me measure if you have a quality issue, ‏all your colleagues did it already. Indeed you ‏have a problem and we know people who can ‏solve it”. ‏

Jumble of Obligatory Training

Fortunately, the time of “see one, do one, teach ‏one” is over. Many skills can be learned and ‏improved with good training programmes and ‏simulation sessions. This includes not only hard ‏skills and knowledge but also so-called “soft” ‏skills such as advanced life support in a team, ‏team performance, bringing bad news to families ‏and patients, and calling someone to account. ‏Complex tasks with a low incidence cannot be ‏dealt with in a training programme. Intentional ‏publication fraud cannot be prevented with a ‏course on ethics in science and neither will a ‏course, obligatory in the Netherlands, with a ‏duration of more than one week on regulations ‏and organisation of clinical research prevent that. ‏However, these rules mean that professors with ‏many publications in leading journals, and with ‏a research desk to guarantee all responsibilities ‏and compliance with regulations, fail an exam ‏because they do not know by heart how many ‏years all records need to be stocked. The goal ‏of good clinical practice and research, will also ‏be missed whenever those who conduct the ‏courses get too much influence on making it ‏an obligation to follow these courses. This again ‏will result in a “course industry” both within ‏and outside the hospital, whose sole purpose ‏is that of self-preservation. In the Netherlands, ‏PhD students in medicine have been guided and ‏supported for decades by established researchers ‏and professors during their PhD study. The ‏study outline and the interpretation of data were ‏discussed almost on a daily basis. They participated ‏in international congresses and presented their ‏data during national and international meetings. ‏However, all of a sudden specific time-consuming ‏courses have been made obligatory for PhD ‏students with no data to support impact on ‏student outcome. Another remarkable obligatory ‏regulation without any supporting data ‏was the introduction of the Basic Qualification ‏for Education (BQE). This training programme ‏consists of 5 full days training, 165 hours of ‏study, 90 hours of which are with the help of ‏an assigned mentor. Someone with more than ‏30 years of educational experience, educational ‏diplomas outside the field of medicine, who ‏has students who value the courses and applaud ‏during presentations and over 260 international ‏presentations is called to follow this obligatory ‏BQE training programme.

A long list can be generated of time-consuming ‏training programmes with concomitant registration ‏obligation, which can be related to demands ‏by health insurance companies, legal authorities ‏and accreditation programmes. It is beyond the ‏scope of this paper to discuss the benefit-time ‏ratios of these programmes, but in general we ‏would challenge those who make these regulations ‏to demonstrate their benefit.

The question remains of how to make progress ‏in medicine and how to prevent errors and wrong ‏treatment. We think the key is good training ‏programmes and a culture where healthcare ‏workers continuously give feedback to each other. ‏Medicine has to stay attractive for young people ‏with an academic mindset that is challenged by ‏all the complex problems encountered in healthcare. ‏Whatever protocol or checklist, it should ‏be used as a mental support for highly educated ‏professionals and never get the force of law. ‏

Conflict of interest

Armand Girbes declares that he has no conflict ‏of interest. Jan Zijlstra declares that he has no ‏conflict of interest. Paul Marik declares that he ‏has no conflict of interest.