Risk and Safety Management (RSM) in Infertility and ART: A Proactive Recipe

(1)Université Paris Descartes, Paris Sorbonne Cité – Assistance Publique Hôpitaux de Paris, CHU Cochin, Department of Obstetrics and Gynecology, Division of Reproductive Medicine, Paris, France. (3)Department of Obstetrics and Gynecology, Division of Reproductive Medicine, Hopitaux Universitaires de Genève, Genève Switzerland. (4)Department of Biomedicine, Research Group on Gynecological Endocrinology, University Hospital, University of Basel, Basel, Switzerland
Address for correspondence: Dom de Ziegler, MD This email address is being protected from spambots. You need JavaScript enabled to view it.

Summary

     It has become commonplace to proffer that medicine lags behind other industries when it comes to safety records. These are indeed deplorable in medicine worldwide, even if significant efforts have been deployed for curbing the mega-mistakes – wrong patient, wrong side, wrong organ – notably, by implementing checklists and other aviation-derived products.

     Five articles recently published in the Views-and-Reviews section of Fertility and Sterility address the issues pertinent to implementing an effective risk and safety management (RSM) in infertility and ART, a problematic rarely tackled in this field. These articles throw in new twists into this issue notably, by underscoring the fact that inspiration from aviation – an ultra-sure industry – should be targeted at the helicopter operations rather than the most visible airlines segment. Indeed, while airline operations drastically differ from medicine as a whole, helicopter operations by the diversity of their nature and occasional confrontation with extreme conditions are much closer to medicine and more prone to yield fruitful inspiration and practical help.

     Infertility and ART, a test bench for risk and safety management in medicine

     The new editorial team of Fertility and Sterility – under the joined baton of Tony Pellicer and Craig Niederberger – has instituted monthly series of articles that focus on a given topic, but through the different facets of multiple articles. This Views-and-Reviews section of the Red Journal has won instant applaud from the readers who praise the thoroughness and broad scope of these multiple-article, multiple-authors series.

In the 2013 December issue, five articles in the Views-and-Reviews section of Fertil Steril address an issue of utmost pertinence for our daily practices in infertility and ART but yet poorly known, Risk and Safety Management (RSM) 1 2 3 4. Together with Professor David Meldrum, I had the privilege of coordinating these articles and will attempt to summarize here the core message of these articles.


     Aviation, medicine and infertility-ART

     Medicine and aviation are two industries that have gone through ground-shaking technological changes, as each benefited from some of the most spectacular achievements of mankind in modern times. Medicine and aviation differ however when it comes to their safety records. On the one side, aviation has raised itself to become the safest mean of transportation just 110 years after the Wright Brothers took off for the first time at Kitty Hawk. This good fortune, most improbable considering the sum of risks existing, did not happen by chance however. The safety performances of aviation actually resulted from the relentless and remarkably coordinated efforts of all the actors involved (the pilots, airplane manufacturers, controllers and government regulators). In the mean time, medicine has lagged behind in the most pitiful way, dragging on with deplorable safety records.

     Because of its remarkable accomplishments in the field of safety, aviation should stand as a source of examples and inspiration for medicine. It is therefore not truly a surprise that the senior authors of all these articles on RSM published in Fertil Steril are not only renowned experts in infertility and ART, but are also pilots who hold commercial to airline transport (ATP) licenses.

     As it is thoughtfully reminded by Pr Richard Scott and Cpt Nathalie de Ziegler 4, comparisons between aviation and medicine commonly stumble when trying to carry out beyond the entry steps that bank on introducing the known checklists in medicine. Pre-takeoff and pre-landing checks amend themselves very well to be adapted and implemented prior to undertaking any crucial step in the operating room (OR) and intensive care units (ICU). And indeed, these measures – the aviation derived checklists and briefings – have been remarkably effective at curbing if not eliminating the mega mistakes that are known as the Triple-W, wrong patient, wrong side, wrong organ.

     Scott and de Ziegler 4 tell us that aviation derived measures failed to penetrate beyond the checklist level however, not denting the hardcore of medical errors that start in the doctor's office (wrong indication, wrong treatment). The failure of aviation bound measures to enter the doctor's office, the authors tell us, is rooted in part in the fact that airline and medical operations are actually much too unlike. On the one hand, medical operations are extremely different and variable in nature, ranging from procedures done under extreme conditions – surgery for cancer 'all over', emergency traumas, etc. – to others more repetitive and amendable to a by-protocol management. On the other hand, airline operations are of limited different types and highly repetitive in nature. The surgeon taking care of cancer situations or serious traumas is often confronted to extreme conditions, but is yet expected to do his very best under the circumstances. Transposing the conditions prevailing for the cancer surgeon to aviation would confront the captain of an airliner to a forecast of gale-force winds, severe icing, tornado watches, and the like. Predictably under such dreadful circumstances, the airline pilot would simply say: "We're not going. Flight cancelled, postponed until tomorrow". Indeed, medicine must sometimes deal with extremes conditions, whereas airlines rarely deal with extremes in normal operations. These characteristics make airline and medicine operations extremely different, as they navigate in two different worlds that rarely interconnect.

     Interestingly, Richard Scott and Nathalie de Ziegler underscore the fact that aviation as an industry encompasses much more than just its most visible segment, the airlines 4. Amongst the other existing segments of aviation, these authors point to the fact that helicopter operations are as a whole much closer to medicine than airlines are. Indeed like medicine, helicopter operations encompass various very different types of very variable missions. For example the search-and-rescue helicopter operations are like certain fields of medicine confronted to the extreme (accidents at sea or in mountains rarely occur in clear blue sky). In search and rescue missions, the helicopter pilot – like the cancer or trauma surgeon – has to confront the extreme for saving lives. Yet, other helicopter operations like for example the support missions flown to the offshore drilling platforms are repetitive in nature and therefore, amendable to be conducted by procedures. Over the years, the offshore helicopter operations have become extremely safe, reaching near-airline safety records through the use of airline methods.

     By taking the helicopter rather than airline operations as a reference, one is likely gain much more benefit from the aviation's knowhow in safety management. This approach is indeed likely to permit a deeper penetration of aviation lessons, possibly carrying all the way to the heart of medical operations, the doctor's office where most medical errors start.

     In medicine, we trust that infertility and ART because of a highly controlled nature, the reduced variability of its procedure and their repetitive nature could play the role that the offshore missions have plaid for helicopters operations, reaching near-airline safety records. Hence, infertility and ART bears the potential for being first to show the way toward an ultra-safe medicine.

     Hazards, risks and defenses: know and avoid

     Prior to addressing the practical principles of RSM in infertility and ART, we must define two closely related yet different concepts, hazard and risk. Hazards are defined as 'intrinsic and potential sources of danger'. Hazards therefore are inherently linked to a given activity or situation. For example, in mountain climbing the hazard comes from the height, a characteristic inherent to the fact that mountains are what they are. By nature therefore, hazards cannot be changed. Risks however, refer to 'the possibility that something unpleasant or unwelcome could happen'. In our mountain climbing example, the concept of risk describes the possibility of slipping, causing a possibly dreadful fall. The consequences of risks are globally designated as adverse events (AEs) and graded from (i) side effect, to (ii) incident and (iii) accident, pending on severity. The measures taken for avoiding that risks lead to AEs are the defenses.

     Practically therefore, the hazards that are attached to a given activity – possible vascular and bacteriological breaches in case of surgery – have to be known and identified. The consequences of the known risks that may exist in relation with such hazards – i.e. hemorrhage and/or infection – must be fully reviewed in order to prevent their occurrence by enacting proper counter measures or defense mechanisms.

     Practically, defenses in medicine are measures aimed at minimizing the probability that errors occurring in the context of given risks and hazards will result in patient harm. These efforts for preventing harm to the patient in spite of the prevailing hazards and risks are the essence and primary goals of RSM.

     Clinical risks in ART

     The clinical risks – possibly causing AEs, scaled from (i) side effect to (ii) incidents and (iii) accidents – encountered while managing infertility and dispensing ART protocols – are generally of three types:

     (i)    Certain AEs stem from the generic risks commonly associated with any invasive procedure.
          • Hemorrhage
          • Infection
     (ii)   Other AEs are associated with the treatment itself, the so-called controlled ovarian stimulation (COS) used in ART for assuring the multiple-egg harvests that enhance pregnancy chances.
          • Ovarian Hyperstimulation Syndrome (OHSS)
          • Multiple Pregnancies
          • Placentation Disorders
    (iii)  Still other AEs are simply associated with personal characteristics of certain individuals undergoing ART.
         • Vascular AEs (venous)
         • Genetic AEs
         • AEs due to Uterine Malformations


     Medical education conceived 'safety inside

     Academic and professional training

     A lasting confusion lurks in medicine between academic education and professional training. Medicine in general involves highly complex and scientifically rooted processes that require a full understanding of cutting-edge biological sciences and a proper mastering of an array of high-tech innovations used in medicine. These notably include what has become our modern-day scientific achievement by-excellence, medical genetics. Assuring that young doctors are capable of navigating through the meanders of these scientific novelties justifies the needs for the academic education offered through years in medical school.

     Conversely, professional education – mastering medical treatments and measures offered within the activity of a medical specialty or sub-specialty – has received lesser attention in medicine. We reckon that there is an urgent need for revamping the professional training in medicine, which must be offered using advanced educational skills while harboring a genuinely new safety-inside philosophy. Certain supervising boards of medical specialties and education councils – i.e. the American Board of Obstetrics and Gynecology and others in Europe, Israel, Australia and Canada – have defined the perimeter of the educational needs (the training curriculum). Such training must therefore accompany the hands-on or fellowship-type training in infertility and ART. But, the practical supervision of whether and how the appropriate training is actually provided is most often missing. In these countries, the quality control of specialty training still primarily if not solely rests on testing the candidate.

     For being truly effective, the control of the quality of professional training should rather focus on supervising and providing guidelines to the trainers. Supervision by specialty boards that would be primarily targeted on assessing the trainers and the training institution could better assure that the proper education means are deployed and effectively cover the whole educational curriculum during the fellowship program. In cases where part or all of the educational curriculum could not be provided 'in house' (lack of sufficient personal and/or patient load), it would be perfectly acceptable that such training is subcontracted to another teaching institution.

     Defining the new concept or 'Medicalship'

     Aviation has coined the term or Airmanship – itself derived from the older concept of Seamanship relating to sailing – to define the whole set of skills and aptitudes that are required for safely and efficiently operating an aircraft within its global environment (including the crew, operator, maintenance and traffic controllers). These skills and required aptitudes not only include those directly related to operating the aircraft itself – piloting skills – but also embrace all that is needed for properly interacting with the rest of the parties involved in the flight notably, the crew, airline operator and traffic controllers.

     Considering the crucial role of proper Airmanship skills for the safe operation of flights – thought as part of crew resource management (CRM) programs – we propose to create the concept of Medicalship for likewise embracing all that is needed for properly performing all the tasks expected from a doctor. Hence, Medicalship would include not only the sets of specific knowledge and manual skills needed to be proficient in a given specialty of medicine, but also all those different skills required for safely and efficiently interacting with all the parties encountered while practicing medicine. The latter would notably include: (i) The ability to properly interact with the rest of the medical personnel, including in crisis situations; (ii) An ability to adequately and critically access medical information through mastering the conduct intelligent literature (and internet) searches for medical information and an ability for astute and critical reading; (iii) Proper and updated basic knowledge in the art of clinical investigation and; (iv) Proper and knowledgeable ability to interact with the pharmaceutical industry.

     Reporting errors

     Errors exist by the shear fact that processes involved in medicine are operated by humans and that humans make mistakes. Hence, RSM should account for the fact that errors occur and recognize that ignoring errors is a cause of further errors, not a protection. Hence, we have to live with and deal with our errors. But for living with errors in an efficient and non-disrupting way, we need to know our errors. We understand therefore that a crucial step in proper RSM is to enact an efficient error reporting system.

     For being effective, an error reporting system must acknowledge the sum of mechanisms inherent to the human nature that tend to avoid coming forward after errors are committed and/or a rule is violated. Each and every one of us seems hardwired to minimize errors and safety lapses that result in limited to no consequences. Neither an undue tolerance of errors, seemingly without consequences, or individual blame when an error leads to significant harm, do little to enhance safety.

     On the contrary, errors cannot be ignored and should be dealt with. It has been clearly demonstrated in aviation that awareness about errors as they occur is key to improving safety. Error awareness therefore implies initiating effective means of error reporting. Three primary modes of error reporting are recognized in aviation: 1) automatic, 2) mandatory and 3) voluntary. All three methods need to applied to ART as well, but in ways that remain confidential – not anonymous – and non punitive.

     The 'say what you do' approach to keep the Doctor in charge

     Procedures Within Accepted Guidelines

     A core issue in RSM is the necessity to define and standardize operating procedures that need to be applied and complied with. Having defined procedures is key for monitoring and detecting deviations. However, the art of drafting and following such procedures is poorly developed in clinical medicine, a fact that has impeded the implementation of RSM in clinical medicine

     Adding ever-tighter meshes of 'top-down' rules and regulations is likely to be ineffective, while impeding the daily practice. Regulations that are excessively complex, not up to date and impractical to implement will harm rather than help RSM. As in other industries, impractical and outdated measures will lead to unlawful deviations and violations in order to simply keep the system working and maintain practice flow. Hence the 'let's write another procedure' attitude, which is too often encountered today, is simply not the best way for mowing forward toward a safer ART.

     Rather than just making more rules, RSM needs to invent new modes of doctor-regulator interaction that promote safety and embed reliability into the culture of practice. This we believe starts by asking doctors and other people working on the sharp en of the process to actually describe their procedures in a 'bottom-up' mode of processing.

     ART and Certification Systems

     In many countries, the supervising authorities have recommended or required to enact traditional quality assurance systems such as notably, certification according to the International Organization for Standardization (or ISO certification) 3.

     The certification documents such as the protocols and SOPs describing ART processes are starting points for RSM. They offer a "say what you do" – a "bottom up" process – way of approaching RSM. Yet, risk management is not always an inherent part of quality and certification processes. RSM, with its own safety-minded agenda, will work with ISO but is not simply ISO. RSM and quality systems have to be seen a little like a computer program and its operating systems – they work together, but each is different.

     Conclusion

     The set of articles published in the December series of Views-and-Reviews of the Red Journal deal with issues that were unknown to many of us until not too long ago. We know today that the safety records of medicine as a whole – it is a worldwide problem – are mediocre to say the least, by comparison to other human industries. Aviation is one of these industries, which has achieved remarkable safety performances as improbable as it might have seemed in its heydays.

It is now a blatant fact that the safety problems of medicine need to be addressed. To date however efforts for exporting to medicine the safety measures developed in aviation have not gone much beyond the introduction of checklists – however useful for avoiding the mega-mistakes – and has been stumbling when trying to go beyond. These articles point to the fact that the helicopter segment of aviation is closer to medicine than its most visible one – the airlines. This is because the great variety of the helicopter operations better resembles the variety of medical procedures and is therefore a better source of inspiration for medicine. Due to the highly regulated nature of infertility and ART and the somewhat limited number of issues and processes involved, ART holds the potential for spearheading modern RSM in medicine thus, becoming an example for other specialties. This is indeed possible but implies, we believe, the need to implement a form of structured professional training in ART that is conceived 'Safety Inside'

     References
1.    Meldrum DR, de Ziegler D. Introduction: Risk and safety management in infertility and assisted reproductive technology. Fertil Steril 2013;100:1497-8.
2.    de Ziegler D, Gambone JC, Meldrum DR, Chapron C. Risk and safety management in infertility and assisted reproductive technology (ART): from the doctor's office to the ART procedure. Fertil Steril 2013;100:1509-17.
3.    Alper MM. Experience with ISO quality control in assisted reproductive technology. Fertil Steril 2013;100:1503-8.
4.    Scott RT, Jr., De Ziegler N. Could safety boards provide a valuable tool to enhance the safety of reproductive medicine? Fertil Steril 2013;100:1518-23.

 

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