Challenges of risk and safety management（RSM）in infertility and ART：A proactive recipe

Dominique de Ziegler，Pietro Santulli ，Isabelle Streuli ，Rebecca Monfat，Anna Raggi ，Alexandra Ambrosetti ，Paul Pirtea，Charles Chapron

1．UniversitéParis Descartes，Paris Sorbonne Cité-Assistance Publique Hǒpitaux dep aris，CHU Cochin，Department of Obstetrics ＆Gynecology，Division of Reproductive Medicine，Paris，F(xiàn)rance．

2．Department of Obstetrics ＆ Gynecology，Division of Reproductive Medicine，Hopitaux Universitaires de Genève，Genève，Switzerland．

3．Department of Biomedicine，Research Group on Gynecological Endocrinology，University Hospital，University of Basel，Basel，Switzerland．

Safety in medicine：Infertility and ART as test bench

Medicine and aviation share in common the fact that both gone industries have gone through ground-shaking technological changes，as each has incorporated some of the most spectacular and ground-shaking man-made achievement of modern times．Yet in this process，medicine and aviation differ on at least one point，their respective safety records，a difference that is not in the honor of medicine．Indeed，whereas aviation has followed an improbable path that took it to become the safest mode of transportation on earth，medicine has most dreadfully lagged behind when it comes to safety records．The remarkable accomplishments made by aviation in the field of safety did not happen by chance，but on the contrary resulted from an active design and relentless efforts that for years has put safety first．Public concerns for airline safety，pro-active intelligent will，industry-sensitive and reactive government regulations，as well as the fact that the pilots’lives are at stake each played an important role in today’s levels of safety achieved by aviation．

Medicine however suffered from lesser levels of concern and lack of similar universal standards and reactive unified and intelligent regulations，as compared to aviation．Awareness is now rising however，with an increasing number of seminal publications．Notably，the Institute of Medicine（IOM）documenting how unsafe medical practice is and outlining steps that must be taken to improve safety outcomes．In the field of infertility and assisted reproductive technologies（ART）alone，five dedicated articles on risk and safety management were recently published as part of a coordinated series［1－3］．

In a newly launched pursuit for safer medicine，infertility and ART stands in the position of possibly playing a unique and particularly important role for the following reasons：

1．Women needing infertility and ART are generally healthy，yet are exposed to serious medical risks．For male factor infertility，the woman assuming those risks likely suffers no problems of her own．

2．Due to lasting exposure to the news media and legislative scrutiny，ART was one of the first domains of medicine to be confronted to high-level regulations and controls．Infertility and ART has been exposed for example，to mandatory training requirements，laboratory accreditation，and guidelines for patient care．

3．Because of results still hover between 0%and 100%-despite improvements-and sometimes misleading use of intermediate outcomes （e．g．，clinical pregnancy rather than delivery rates），ART has been required to report its results to government agencies in a standardized fashion．Only several other medical activities are required to report such detailed treatment outcomes．

4．A variety of quality control processes are often mandated because outcomes can be significantly affected by minute environmental and procedural factors．

Rather than seeing the regulatory obligations that befell on infertility and ART solely as burden，one should consider on the contrary that ART might constitute an ideal field of medicine for further development and implementation of a global risk and safety management（RSM）program．

Hazards and risks

Prefatory to addressing the pertinent recipes for improving the practical efficacy of RSM in in-fertility and ART，it is important to define two closely related yet different concepts，hazard and risk．Hazards，are defined as‘intrinsic and‘potential sources of danger’．This therefore refers to the immutable conditions of a given activity or situation．For example，in mountain climbing the hazard stems from 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 that a slip occurs and causes a fall of possibly dreadful consequences．

Practically therefore，the hazards that are inherently linked to a given activity－possible vascular and bacteriological breaches in case of surgery，as a result of introduction instruments in the bodyhave to identified．The consequences of known risks that may exist in relation with such hazardsi．e．hemorrhage and／or infection-must be fully reviewed in order to proactively prevent their occurrence by enacting proper defense mechanisms and／or countermeasures．

Practically，defense mechanisms in medicine consist of procedures aimed at minimizing the probability that errors-analyzed in the context of the prevailing risks and hazards-will result in patient harm［8］．These efforts at prevention of harm to patients and providers that might result as consequences of hazards and risks are the essence and primary goals of RSM．

Clinical risks in ART

The consequences of clinical risks-known as adverse events（AEs）-encountered while managing infertility and dispensing ART protocols are generally of three types：（i）Certain AEs stem from the generic risks commonly associated with all invasive procedures（hemorrhage and infections）；（ii）Other AEs are associated with the so-called controlled ovarian stimulation（COS）treatment used in ART for assuring the multiple harvests known to enhance pregnancy chances and：（iii）a remaining category of AEs are simply associated with personal characteristics of certain individuals undergoing ART．

AEs associated with all invasive procedures

Hemorrhage and Damage to Adjacent Organs

Hemorrhage is encountered in＜1%of ART cases，with bleeding occurring intra or extra-peritoneally．The former causes abdominal pain and distension，typically 2-6hours after the retrieval，with abundant intra peritoneal blood seen on ultrasound examination．Retroperitoneal bleeding generates prompter and more severe symptoms．In the latter case，ultrasounds show normal amounts of fluid and often an area of retroperitoneal distension with blurred limits and exquisite tenderness．Unless spontaneous resolution is witnessed，both forms of bleeding are commonly cured surgically．

Likewise，damage to the bowel，bladder and ureter may occur during the oocyte retrievals．Serious consequences can follow if early symptoms are ignored．

Infection

The risk of infection after oocyte retrievals is real and higher when endometriomas are present［4］．Direct complications of tubo-ovarian abscesses may even include caused consumption coagulopathy［5］．Clinical symptoms are classically extremely variable，usually occurring a few days after the retrieval，but sometimes with late onset（weeks or months，including during pregnancy）［6］．Surgical exploration and at times adnexectomy may be needed［7］．Generally utmost efforts must be deployed for not entering these cysts during retrieval if at all possible［8］．

AEs Unique to ART

Examples of AEs that are due directly to treatments unique to ART include ovarian hyperstimulation syndrome（OHSS），multiple pregnancies and disorders of placentation．

Ovarian Hyperstimulation Syndrome（OHSS）

While the risk of OHSS has greatly decreased with antagonist protocols，its discussion is appropriate because OHSS has for so long been the emblematic complication of ART，sometimes with dreadful complications．Anticipating COS responses based on age，body weight，menstrual cycle irregularity and hormonal profile leads to treatment adjustments．Yet in spite of tailoring COS regimens，excessive responses resulting in OHSS may still occur．

During COS，when the risk of OHSS is imminent，further development toward more serious stages can be stopped or controlled by series of possible measures．These notably include：withholding human chorionic gonadotropin（hCG）injection，‘coasting’without administrating any medication or deferring embryo transfer（Dif-ET）to a subsequent cycle．If OHSS nonetheless occurs，modern treatment（i．e．water and electrolyte management，repetitive paracentesis，intravenous albumin，prophylactic heparin，etc．）effectively averts the dreadful and possibly fatal consequences of thromboembolism or organ failure that might otherwise occur．Significant AEs most often result from poor management of OHSS，rather than OHSS itself［9］，making the promotion of proper management of OHSS the single most effective measure for curbing the dreadful consequences of this complication of ART treatments．

Multiple Pregnancies

Today，systematically transferring 2embryos carries a twin pregnancy rate of 30%-50%，while systematic single embryo transfers lower pregnancy success．Opting for elective single embryo transfer（eSET）when all parameters are highly favorable minimizes twin pregnancy rates，with a minor impact on the odds of pregnancy being achieved．Recently，trophectoderm biopsies performed at the blastocyst stage associated with comprehensive chromosome screening（CSS）allows to systematically transferring single euploid blastocysts with pregnancy rates equaling those achieved with dual unscreened blastocyst transfers［10］．

Placentation Disorders

Recently，converging reports have concurred to describe an increase in the incidence of certain obstetric complications in ART．These include notably，（e．g．，preeclampsia，bleeding episodes，small for）in singleton ART pregnancies．While the respective roles of ART and infertility are difficult to establish，a lower incidence of these problems is encountered following frozen embryo transfers（FET）［11］．

Indeed，most if not all of the obstetric problems encountered after ART may stem from disordered placentation due to endometrial abnormalities seen in COS，but not with FETs．Finding larger placentas and higher placental weight／birthweight ratios in ART as compared to spontaneous pregnancies supports this concept［11］．

AEs favored by Personal Risk Factors

The third category of AEs encountered in ART encompasses those that are due to the unique risks or predispositions that an individual woman undergoing ART may have．Examples of AEs due to personal risks include adverse vascular events，cytogenetic abnormalities leading to AEs and uterine defects that may lead to AEs．

Vascular AEs（venous）

Certain patients may be predisposed to vascular thrombosis-embolism （VTE）events．These individuals，typically identified by apersonal and／or family history of VTE，require heparin prophylaxis during ART．While routine checking of hemostasis-related mutations is not warranted，recognizing that OHSS induces a 100-fold increase in VTE risk is crucial．However，no increased risk is seen with FETs，further fueling the interest in deferring embryo transfers．

Failure to identify women at particular risk for VTE upfront could be fatal，because unlike OHSS there are usually no obvious clinical signs prior to a VTE adverse event．Protective barriers must concentrate on not failing to identify individuals at risk who may need heparin prophylaxis during ART．Considering the seriousness of the issue，we suggest that all ART candidates should be asked the same question using the exact same terms：“have you personally had a blood clot，or were there people in your family who died under age 50of a heart attack or without any apparent reason？”While not aguarantee，a negative answer may be more reliable when a standardized question is used．

The risks from each of these conditions（OHSS and VTE）have different dynamics．Each risk therefore needs different protective defenses to effectively prevent their respective AEs．

Cytogenetic AEs

Chromosomal and genetic risks leading to AEs are personal conditions bearing possible threats for 1）the child，e．g．，fragile-X pre-mutation leading to fragile-X mental retardation in a male offspring，or 2）the patient，e．g．，Turner syndrome，possibly exposing the patient to fatal rupture of the aorta during pregnancy，an SE．

AEs due to Uterine Malformations

Risks due to uterine malformations，such as fibroids or prior scars can put the pregnancy at a higher risk for obstetric complications，sometimes dictating eSET or surrogacy to avoid the risks．As with other personal risks，identification

From aviation to medicine

AS recently reviewed in sets of articles in a lead journal in the field［1－3］，it has become commonplace to praise the aviation-inspired measures aimed at enhancing safety．This notably includes the famous checklists that pilots are known go through prior to undertaking any of the crucial steps of flights．Such safety-minded measures inspired from aviation have been already enacted in medicine，including checklists， pre-procedural briefings and medical teamwork［12］．In many but far from all operating rooms（OR）and intensive care units，these tools have been adopted and have been highly successful at eliminating the mega mistakes-eg．the“triple W”consisting of operating on the wrong patient，wrong side and wrong organwhere they have been implemented．In the OR，a simple preoperative checklist reduced surgical mor-tality by 47%worldwide at study institutions［13］．

The aviation-inspired safety measures that have proven to be so highly effective in the OR have not entered the doctor’s office however．Hence，the measures described above did little to dent the more fundamental errors of medicine such as making the wrong diagnosis or wrong surgical indication that still constitute a significant problem and remains the cause of lots of unnecessary harm．In 2008，the American College of Obstetricians and Gynecologists（ACOG）established a task force to study and make recommendations for the implementation of safety tools and procedures in the outpatient setting．This initial effort led in part to the development of ACOGs more comprehensive Safety Certification in Outpatient Practice Excellence（SCOPE）program．The RSM process discussed here aims at addressing risk and safety issues in the sub-specialty of infertility，inclusive of the doctor’s office where procedures involving risks are initiated and often performed．In that，RSM is to be seen as a complement and not a competing system to existing quality systems such as the International Organization for Standardization certification programs［7］and other certification processes that already exist in ART．For the reasons outlined above，we believe that infertility and ART may constitute an ideal field of medicine for further development and implementation of a global risk and safety management（RSM）program．

Medical education with‘safety inside’

Academic and professional training

A lasting confusion has existed in medicine between academic education and professional training．Medicine in general involves highly complex and scientifically rooted processes that imply a full understanding of cutting-edge biological sciences and mastering an array of high-tech innovations in medicine．These notably include what has become today’s by-excellence field of scientific achievements，medical genetics．Proficiency for navigating through the meanders of all the technical novelties is in essence the domain of and the justification for academic education that is offered through years of medical school．

Conversely，professional education-the mastering of the medical specialty or sub-specialty-has needs for structured and controlled training，which must to be dispensed with asafety-insidephilosophy．The latter needs are largely unmet to date．Certain supervising boards and education councilsi．e．the American Board of Obstetrics and Gynecology and others in Europe，Australia and Canada-have defined the perimeter of the educational needs（or，the training curriculum）that must accompany the hands-on orfellowship-typetraining in infertility and ART．But，the practical supervision that the appropriate training is provided is still primarily resting on solely，or mainly，testing the candidate．A more effective way of controlling the quality of professional training would consist in instituting more stringent supervising schemes overseeing the trainers．Such controls would assure that proper means are deployed for effectively covering the whole educational curriculum during the fellowship program so as to fulfill the requirements defined by the regulatory board or council．In cases where part or all of the educational curriculum can not be provided in house（lack of sufficient personal），it would be perfectly acceptable that such training is subcontracted to another teaching institution．

An example of ad hoc education support of fellowship-type training is illustrated in Fig．1．In this model，the educational support in infertility and ART is given in the form of two 1-week courses（initial and validation）and 9advanced education modules given throughout the fellowship training．The 9advanced educational modules address the following topics．

The nine three-day advanced education modules will cover the following topics：

★ Module＃1

Physiology of ovulation and pathophysiology of ovulatory dysfunctions．Ovulation，oligo-anovulation，induction of ovulation，controlled ovarian stimulation（COS），luteal phase support（LPS）．

★ Module＃2

Surgery and infertility：Endometriosis，ovarian cyst，fibroids，uterine and tubal malformations．Define the role played by the exploratory laparoscopy in the infertility work up．

★ Module＃3

Ovarian function and dysfunction and aging．Concept of ovarian reserve，menopause and premature menopause

★ Module＃4

Epidemiology of fertility and infertility and secular trends．Inter-racial and ethnical differences．

★ Module＃5

Embryology，reproductive histology of infertility and ART

Genetics（I），trophectoderm biopsies for preimplantation genetic screening（PGS）and embryo／oocyte quality assessment．

★ Module＃6

Risk and safety management（RSM）in infertility and ART．Define hazards and risks．Principles of error and error management．

Fundamentals ofevolutiveknowledge．Basic knowledge in clinical research．Conception of protocols，practical implementation，data analysis and reporting（oral and written）．Fundamentals of critical reading．

★ Module＃7

Body-mind harmony，fertility and reproduction．Psycho and psychosocial issues．

★ Module＃8

Genetics（II），screening for embryo anomalies and fetal malformation．Pre-implantation genetic diagnosis（PGD）．

★ Modules＃9

Fundamentals of‘medicalship’，a novel concept defined by analogy to seamanship and airmanship．Management，interpersonal relationship，interaction with outside institutions and professional societies．

A3D Central Education Unit（CEU）

Classically，the educational material used as support for professional as well as academic teach-ing is offered in book-type format in the form of syllabus or other type of documents．Departing from this traditional strategy，we developed a central education unit（CEU）serving for all the educational support offered as complement to the hands-on orfellowship-typetraining in infertility and ART．The primary originality of the CEU as compared to the classical book-type support lies in the fact that the CEU stores all the relevant educational materials in 3Dformat，using depth for grading materials of increasing complexity．As illustrated in Fig．2，three primary depth levels reflect the‘need-to-know’，‘nice-to-know’and ‘expert’levels of knowledge．

From‘a(chǎn)irmanship’to the new concept or‘medicalship’

By analogy to the conceptseamanshipthat refers to the skills，techniques，or practice of handling a ship or boat at sea，people have created the word ofairmanshipfor describing a similarly global notion encompassing all the skills and knowhow involved in flying an aircraft．Airmanshipis further defined as covering the consistent use of good judgment and well-developed skills to accomplish flight Objectives．Airmanship therefore implies a high state of situational awareness encompassing the knowledge of one’s self，aircraft，environment，team and risk．In that，airmanshipis not simply a measure of skill or technique，but also a measure of a pilot’s awareness of the aircraft，the environment in which it operates，and of his own capabilities．Aside of defining the ability to operate an airplane with competence and precision both on the ground and in the air，airmanshipalso implies the exercise of sound judgment that results aimed at securing optimal operational safety and efficiency．

Considering the high degree of efficacy and safety that aviation has managed to secure，the operating systems that have been developed to that end and have been instrumental for achieving these goals deserved to be expanded to other territories such as notably，medicine．With this Objective in mind，we coined the word of‘medicalship’for en-compassing a similarly global concept of defining the skill and knowledge necessary for safely and efficiently perform as a physician．Medicalshipimplies accomplishing the tasks of caring for our patients’needs-in infertility，the couples’desires for a family-and if need be take them through and offer the most appropriate treatments．

Reporting errors

The reporting of errors，irrespective of whether harm occurs，is a key step in RSM．Making this a habit however needs to overcome traits of 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 of all errors 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．

Automatic Reporting

Automatic error reporting was instrumental in raising the safety level in aviation．The automatic nature of error reporting plays a crucial role，as it allows counteracting the human tendency for either ignoring or blaming，depending on outcome．In aviation，flight recorders are set for automatically reporting certain non-ordinary events occurring in flight such as for example，an excessively steep approach to landing．The first question asked generally is what happened？Sometimes good reasons for these errors exist．More often however，an excessively steep approaches results from sets of or-dinary blunders．The crucial initial step however is to know what exactly happened，so that an analysis can be conducted and that ultimately，individual or collective remediation take place．The information gained from investigations sparked by the automatic reporting of unusual event is confidentially shared with others in the industry so that all can learn from anyone’s mistakes．An important point is that all crewmembers-pilots and non-pilots-are exposed to a similar scrutiny，which sets the basis for a so-called‘just culture’．This ultimately nurtures a voluntary mode of error reporting and treating all errors regardless of outcome as events that need to be investigated［14］．

Automatic reporting-still rudimentary in infertility and ART-aims at changing people’s attitude about error analysis．In that，implementing different forms of automatic reporting aims at moving toward instituting and maintaining a‘fair and just culture’．

Mandatory Reporting

Certain events need to be reported and analyzed even if they are not necessarily due to errors．In ART，for example，each program should have mechanisms in place to review instances where no oocytes were retrieved or fertilization failed．These two events may not be due to medical error but rather to patient characteristics．However，when either of them occurs the clinical and laboratory processes should be reviewed．When patients undergo ART who are at higher risk（advanced age／poor responders and male factor）for these disappointing‘process outcomes’an expected result based on reported results elsewhere should be compared to the actual outcomes as a way of benchmarking the results．Benchmarking can be a powerful tool to compare results and evaluate performance，especially when error is not likely．

Disclosure of medical error to patients，including any unexpected adverse events，is or should be required by regulatory groups．A voluntary process for full disclosure to patients should be built into any RSM for infertility and ART．

Voluntary Reporting

Voluntary non-punitive reporting is a key to safety in medical operations．A culture favoring non-punitive reporting will allow earlier discovery of medical errors and AEs and permit actions，such as systems redesign when needed．In the U．S．，the Federal Aviation Agency（FAA）has enacted an‘Aviation Safety Action Program（ASAP）’that allows pilots（or controllers）to report an incident confidentially．Voluntary reporting，however，will not happen out of the blue in medicine．Strong leadership and incentives for voluntary reporting are needed．We personally believe that in medicine，voluntary reporting ought to be sealed in a protective domain that could not be used in court．The model that secludes the exchanges of information taking place between lawyers and clients could serve as constructive model．

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 have defined and standardized procedures that need to be applied and complied with．This is necessary for monitoring and detecting deviations．However，the art of drafting and following ad hoc procedures is inconsistent in clinical medicine，a fact that has been a stumbling block for implementing safety systems that go beyond the mere checklist and the like measures．

Some aspects of ART practice are getting entangled in ever-tighter meshes of‘top-down’rules and regulations that are expanding to the possible point of hindrance．Regulations are excessively complex，not up to date and impractical to implement．As in other industries，impractical and outdated measures are prone to pave the way for unlawful deviations and violations in order to simply keep the system working and maintain practice flow．Further expansion of rules and regulations，however noble the safety purpose，can add insult to injury to an already entangled system．Simply adding more rules and regulations is not，as we see it，the best way toward 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．

ART and Certification Systems

In many countries，the vulnerability and riskexposed nature of ART led the supervising authorities to recommend traditional quality assurance systems such as notably，certification according to the International Organization for Standardization（or ISO certification）［15］．

The certification documents such as the protocols and SOPs describing ART processes are starting points for RSM．They offer a“say what you do”approach upon which RSM can be built．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 are like a computer program and its operating systemsthey work together，but each is different．

Conclusion

Although not bound to be that way when the Wright Brothers took off 110years ago in their makeshift airplane at Kitty Hawk，aviation has become today the safest mode of transportation on earth．This improbable achievement did not occur by chance，but rather resulted from relentless efforts from the side of the aircrews，operators and regulators．Today，medicine has much to learn from the realm of aviation if not necessarily from the sole airline segment of aviation．

Practical definition and implementation of RSM processes inspired from aviation and intelligently adapted to medicine can be instrumental in bringing medicine and its clinical operation to higher levels of safety than currently achieved．In this process，we believe that the medical domain of infertility and ART may serve as a unique test bench for proceeding through these changes．This is because ART is already under an uncommon degree of scrutiny from governmental agencies to which yearly reports of activity are requested．

Fig．1 Professional Education in infertility and ART

Fig．2 The central education unit（CEU）

［1］ Meldrum DR，de Ziegler D．Introduction：Risk and safety management in infertility and assisted reproductive technology［J］．Fertil Steril，2013，100：1497-1498．

［2］ de Ziegler D，Gambone JC，Meldrum DR，et al．Risk and safety management in infertility and assisted reproductive technology（ART）：from the doctor＇s office to the ART procedure［J］．Fertil Steril，2013，100：1509-1517．

［3］ Scott RT Jr，De Ziegler N．Could safety boards provide a valuable tool to enhance the safety of reproductive medicine？［J］．Fertil Steril，2013，100：1518-1523．

［4］ Benaglia L，Somigliana E，Iemmello R，et al．Endometrioma and oocyte retrieval-induced pelvic abscess：a clinical concern or an exceptional complication？［J］．Fertil Steril，2008，89：1263-1266．

［5］ Kelada E，Ghani R．Bilateral ovarian abscesses following transvaginal oocyte retrieval for IVF：a case report and review of iterature［J］．J Assist Reprod Genet，2007，24：143-145．

［6］ Moini A，Riazi K，Amid V，et al．Endometriosis may contribute to oocyte retrieval-induced pelvic inflammatory disease：report of eight cases［J］．J Assist Reprod Genet，2005，22：307-309．

［7］ Younis JS，Ezra Y，Laufer N，et al．Late manifestation of pelvic abscess following oocyte retrieval，for in vitro fertilization，in patients with severe endometriosis and ovarian endometriomata［J］．J Assist Reprod Genet，1997，14：343-346．

［8］ Tsai YC，Lin MY，Chen SH，et al．Vaginal disinfection with povidone iodine immediately before oocyte retrieval is effective in preventing pelvic abscess formation without compromising the outcome of IVF-ET［J］．J Assist Reprod Genet，2005，22：173-175．

［9］ Madill JJ， Mullen NB， Harrison BP ． Ovarian hyperstimulation syndrome：apotentially fatal complication of early pregnancy［J］．J Emerg Med，2008，35：283-286．

［10］ Forman EJ，Hong KH，F(xiàn)ranasiak JM，et al．Obstetrical and neonatal outcomes from the BEST Trial：single embryo transfer with aneuploidy screening improves outcomes after in vitro fertilization without compromising delivery rates［J］．Am J Obstet Gynecol，2014，210：157．e1-6．

［11］ Haavaldsen C，Tanbo T，Eskild A．Placental weight in singleton pregnancies with and without assisted reproductive technology：apopulation study of 536，567pregnancies［J］．Hum Reprod，2012，27：576-582．

［12］ Neily J，Mills PD，Young-Xu Y，et al．Association between implementation of a medical team training program and surgical mortality［J］．JAMA，2010，304：1693-1700．

［13］ Haynes AB，Weiser TG，Berry WR，et al．A surgical safety checklist to reduce morbidity and mortality in a global population［J］．N Engl J Med，2009，360：491-499．

［14］ Emanuel L，Berwick D，Conway J，et al．What exactly is patient safety？［A］In：Henriksen K，Battles JB，Keyes MA，Grady ML，eds．Advances in Patient Safety：New Directions and Alternative Approaches（Vol 1：Assessment）［M］．Rockville（MD），2008．［15］ Alper MM．Experience with ISO quality control in assisted reproductive technology［J］．Fertil Steril，2013，100：1503-1508．

【編者注：為方便讀者閱讀，附上齊格勒教授文章的中文譯文】

一、醫(yī)療安全：不育和輔助生殖技術(shù)（ART）試點(diǎn)

醫(yī)學(xué)和航空有許多相同點(diǎn)，兩者都是經(jīng)由重大技術(shù)突破帶來更新與發(fā)展，都采用了眾多當(dāng)代最令人震撼的發(fā)明創(chuàng)造。然而，醫(yī)學(xué)和航空至少有一點(diǎn)不同，那就是各自的安全記錄，這也是醫(yī)學(xué)為之汗顏的差別。航空業(yè)循著一條不可思議的道路前行，到如今變成了地球上最為安全的運(yùn)輸模式，而醫(yī)學(xué)在安全性方面極大地落后于航空。航空業(yè)在安全領(lǐng)域的非凡成就并非出于偶然，而是緣于多年來安全至上理念的主動(dòng)設(shè)計(jì)和不懈努力。公眾對(duì)飛行器安全性的關(guān)注、積極主動(dòng)的意愿、深具行業(yè)敏感性及行業(yè)反應(yīng)性的政府管理?xiàng)l例、以及飛行員自身安全的利益攸關(guān)，都在當(dāng)今良好的航空安全性上起著重要作用。

然而，相對(duì)于航空而言，醫(yī)療安全受到的公眾關(guān)注程度較低，也缺乏類似的通用標(biāo)準(zhǔn)及統(tǒng)一的智能管理?xiàng)l例。不過，隨著越來越多深具影響力的研究資料的發(fā)布，對(duì)于醫(yī)療安全的認(rèn)識(shí)也在與日俱增。其中，最值得提出的是，美國醫(yī)學(xué)研究所（I O M）匯文展示了醫(yī)療實(shí)踐的不安全程度，并歸納出為改善安全結(jié)局所必須采取的行動(dòng)步驟。單就不育和A R T而言，就有多個(gè)專于安全風(fēng)險(xiǎn)管理（R S M）的文章于近期發(fā)布［1－3］。

在新推出的“更安全的醫(yī)療”運(yùn)動(dòng)中，不育和ART處于一種絕無僅有的獨(dú)特地位，理由如下：（1）需求ART治療的不育婦女大體上是健康的，但置身于嚴(yán)重的醫(yī)療風(fēng)險(xiǎn)之中，而那些因男性因素不育的婦女自身可能毫無問題，但承擔(dān)著這些醫(yī)療風(fēng)險(xiǎn)；（2）因?yàn)槭艿叫侣劽襟w和立法審查等長期不懈的監(jiān)督，ART成為首個(gè)遭遇高水平管理和監(jiān)控的醫(yī)療領(lǐng)域。例如，不育治療和ART一直需要遵循強(qiáng)制性培訓(xùn)規(guī)定、實(shí)驗(yàn)室評(píng)審，以及患者保健規(guī)范等；（3）ART治療結(jié)局雖然得到了很大的改善，但依然徘徊在0～100%之間，而且存在著對(duì)中間結(jié)局的錯(cuò)誤使用（例如采用“臨床妊娠率”而非“分娩率”），因此，要求ART以標(biāo)準(zhǔn)化的格式向政府機(jī)構(gòu)報(bào)告其治療結(jié)局。特別規(guī)定了這樣詳細(xì)上報(bào)程序的醫(yī)療實(shí)踐活動(dòng)只不過有限的幾個(gè)，ART位列其中；（4）ART通常被強(qiáng)制實(shí)行各類質(zhì)量控制程序，原因在于其治療結(jié)局可能因微小的環(huán)境因素和操作因素而受到顯著的影響。

我們不要將加諸于不育和ART的監(jiān)管政策視為單純的負(fù)擔(dān)，而要看到ART有可能成為未來醫(yī)療領(lǐng)域開發(fā)并實(shí)施全球性RSM項(xiàng)目的理想試驗(yàn)點(diǎn)。

二、危險(xiǎn)和風(fēng)險(xiǎn)

本文將描述用于改善不育和ART治療中RSM實(shí)際效能的一些適宜的方案。在此之前，有必要對(duì)兩個(gè)密切相關(guān)的不同概念（即危險(xiǎn)和風(fēng)險(xiǎn)）進(jìn)行澄清。

1．危險(xiǎn)（Hazards）：定義為“內(nèi)在”和“潛在的危害源”，指的是某一特定活動(dòng)或特定局面下的一些“不可變”條件。以登山為例，“危險(xiǎn)”源自于“高度”，這是山本身所固有的特征。因此，從性質(zhì)上而言，“危險(xiǎn)”不可能改變。

2．風(fēng)險(xiǎn)（Risks）：指的是“不愉快或不受歡迎的事件發(fā)生的可能性”。還是以登山為例，“風(fēng)險(xiǎn)”描述的是發(fā)生滑倒并導(dǎo)致可怕的摔落后果的可能性。

在實(shí)際運(yùn)作中，必須識(shí)別出某一特定活動(dòng)所內(nèi)在關(guān)聯(lián)的“危險(xiǎn)”，如手術(shù)時(shí)因需要在體內(nèi)使用工具所可能帶來的血管損傷和細(xì)菌污染等，而對(duì)于那些可能關(guān)聯(lián)于“危險(xiǎn)”的“風(fēng)險(xiǎn)”后果（如出血、感染等）需要充分地加以評(píng)估，以通過實(shí)施適當(dāng)?shù)姆婪稒C(jī)制和／或反制措施來前攝性地防止其發(fā)生。

醫(yī)療中的防范機(jī)制包含有多種程序，致力于最大限度減少有害于患者健康的錯(cuò)誤的發(fā)生［8］。而可能發(fā)生的有害于患者健康的錯(cuò)誤，可經(jīng)由對(duì)主要風(fēng)險(xiǎn)和危險(xiǎn)進(jìn)行分析來界定。對(duì)于因風(fēng)險(xiǎn)和危險(xiǎn)而來的、且有害于醫(yī)患健康的錯(cuò)誤進(jìn)行預(yù)防，即為RSM的核心內(nèi)容和主要目標(biāo)。

三、ART中的臨床風(fēng)險(xiǎn)

臨床風(fēng)險(xiǎn)的后果稱之為不良事件（AEs）。不育治療和ART實(shí)施過程中的AEs大體上分為三種類型：（1）凡侵入式操作所相關(guān)的尋常風(fēng)險(xiǎn)所致AEs（如出血和感染等）；（2）與ART中特有的控制性卵巢刺激（COS）相關(guān)的AEs；（3）與接受ART的特定個(gè)體的個(gè)人特質(zhì)相關(guān)的AEs。

（一）凡侵入式操作所相關(guān)的AEs

1．出血和鄰近器官損傷：ART病例中出血發(fā)生率不足1%，包括腹膜內(nèi)出血和腹膜外出血。前者會(huì)導(dǎo)致腹痛、腹脹，通常出現(xiàn)在取卵后2～6h，超聲檢查可見大量腹膜內(nèi)出血；而后者的超聲圖像顯示正常的腹腔液量，常有界限模糊的腹膜后腹脹區(qū)，有觸痛。兩種形式的出血通常需要外科治療，也有自發(fā)吸收者。

在取卵過程中也可能損傷到腸道、膀胱和輸尿管等內(nèi)部臟器，如果忽略了器官損傷的早期征象，可能會(huì)造成嚴(yán)重的后果。

2．感染：如果患者自身存在子宮內(nèi)膜瘤，那么取卵后發(fā)生感染的可能性現(xiàn)實(shí)存在，而且感染的風(fēng)險(xiǎn)還比較高［4］。輸卵管－卵巢膿腫甚至可能并發(fā)消耗性凝血?。?］。感染的臨床表現(xiàn)在不同個(gè)體間差異極大，癥狀通常出現(xiàn)在取卵后數(shù)天，但有時(shí)也可能遲發(fā)（數(shù)周、數(shù)月后，甚至在妊娠過程中）［6］。治療上或許需要手術(shù)探查，有時(shí)甚至需要行附件切除［7］。取卵過程中要盡可能地避免穿刺入這類囊腫［8］。

（二）ART特有AEs

與ART特有處理措施直接相關(guān)的AEs包括有卵巢過度刺激綜合征（OHSS）、多胎妊娠及胎盤形成異常等。

1．OHSS：隨著拮抗劑方案的應(yīng)用，OHSS風(fēng)險(xiǎn)已大幅度降低，但OHSS長久以來都是ART的代表性并發(fā)癥，在某些情況下甚至是嚴(yán)重的并發(fā)癥，所以有必要在這里進(jìn)行討論。臨床上，可根據(jù)患者年齡、體重、月經(jīng)周期的規(guī)律性以及激素水平來預(yù)測(cè)患者對(duì)COS的反應(yīng)程度，并作出相應(yīng)的治療調(diào)整。但就算對(duì)COS方案作出了適應(yīng)性調(diào)整，仍有可能出現(xiàn)導(dǎo)致OHSS的過度反應(yīng)。

在COS中，一旦OHSS風(fēng)險(xiǎn)來臨，可通過一系列的措施來控制或阻止其向更嚴(yán)重的階段發(fā)展。這樣的措施包括：延遲HCG注射、停藥“Coasting”或延期胚胎移植（Dif-ET）。如果OHSS還是出現(xiàn)，可采用科學(xué)治療（維持水／電解質(zhì)平衡、重復(fù)穿刺、靜脈輸入白蛋白、預(yù)防性使用肝素等）以有效地防止血管栓塞或器官衰竭等可怕甚至是致命性的后果。嚴(yán)重的AEs通常是來自于對(duì)OHSS處理不當(dāng)，而非OHSS本身［9］。對(duì)于OHSS而言，適宜的治療是阻止可怕后果的最有效手段。

2．多胎妊娠：現(xiàn)今的ART治療中，有兩個(gè)方面需要加以權(quán)衡。一方面是大多常規(guī)性移植2個(gè)胚胎，如此帶來了30%～50%的雙胎妊娠，而另一方面則是單胚移植的妊娠成功率相對(duì)較低。在各項(xiàng)指標(biāo)都非常有利的情況下，實(shí)施選擇性單胚移植（eSET）可最大限度地降低雙胎妊娠率，同時(shí)對(duì)臨床妊娠率的影響輕微。近年來，對(duì)囊胚期胚胎取滋養(yǎng)層細(xì)胞活檢進(jìn)行綜合性染色體篩查（CSS），然后移植單個(gè)整倍體囊胚，可取得等同于未經(jīng)篩查的雙胚移植的妊娠率［10］。

3．胎盤形成異常：近來有多篇文章描述了在ART治療中特定產(chǎn)科并發(fā)癥發(fā)生率的增高，包括如ART妊娠中先兆子癇、出血、小于胎齡兒等。雖然ART和不育在其中起何作用難以確認(rèn)，但有研究觀察到采用凍融胚胎移植（FET）者中這些問題的發(fā)生率要低得多［11］。

ART妊娠的產(chǎn)科問題絕大多數(shù)（甚至全部）可能來自于COS中子宮內(nèi)膜異常引起的胎盤形成異常，而FET則沒有這種問題。與自發(fā)妊娠相比，ART妊娠者觀察到更大的胎盤和更高的胎盤重量／出生體重比值，也為此提供了支持證據(jù)［11］。

（三）個(gè)體因素促成的AEs

ART中的第三類AEs是那些由接受ART治療的個(gè)體所特有的風(fēng)險(xiǎn)或易感性所致者。這類個(gè)體風(fēng)險(xiǎn)包括有可引發(fā)AEs的不良血管事件、細(xì)胞遺傳學(xué)異常以及子宮缺陷等。

1．血管性AEs：有些患者可能有發(fā)生血管栓塞（VTE）的傾向性。這類患者，尤其是有個(gè)人／家族VTE史者，在ART過程中需要給以肝素預(yù)防性治療。在做不到對(duì)止血相關(guān)的基因變異進(jìn)行常規(guī)檢測(cè)的情況下，特別關(guān)鍵的是需要認(rèn)識(shí)到，OHSS能將VTE風(fēng)險(xiǎn)提升100倍之多。不過，F(xiàn)ET中并未觀察到增高的VTE風(fēng)險(xiǎn)，由此進(jìn)一步支持臨床上對(duì)于延遲胚胎移植的選擇。

如果未能預(yù)先辨識(shí)出那些有VTE特定風(fēng)險(xiǎn)的婦女，可能會(huì)帶來致命的后果。不良VTE事件發(fā)生之前，通常并沒有明顯的臨床癥候，這一點(diǎn)同OHSS不一樣。所以，預(yù)防的關(guān)鍵在于鑒別出那些可能需要在ART中給以肝素預(yù)防性治療的風(fēng)險(xiǎn)個(gè)體。考慮到問題的嚴(yán)重性，我們建議，對(duì)于每一位擬行ART治療者，都必須用完全相同的語句問及同一個(gè)問題：“你有過凝血塊么？你家族中有人因心臟病或是沒有任何明顯原因而死于50歲之前么？”使用標(biāo)準(zhǔn)化的問句時(shí)，所得到的否定回答或許更為可靠，但不保證一定如此。

各種AEs風(fēng)險(xiǎn)有著不同的發(fā)展變化，因而每種風(fēng)險(xiǎn)需要有不同的防范機(jī)制來有效地加以預(yù)防。

2．細(xì)胞遺傳學(xué)AEs：引發(fā)AEs的遺傳風(fēng)險(xiǎn)指的是那些帶有可能性威脅的個(gè)體病癥，如脆性X前突變可導(dǎo)致男性子代脆性X智力遲緩、特納綜合征患者可能在孕期發(fā)生致命性主動(dòng)脈破裂等。

3．子宮形態(tài)異常所致AEs：子宮形態(tài)異常（如肌瘤、瘢痕等）可能給妊娠帶來更高的產(chǎn)科并發(fā)癥風(fēng)險(xiǎn)，某些情況下需要采用eSET甚至代孕來規(guī)避這類風(fēng)險(xiǎn)。

四、航空安全對(duì)醫(yī)療安全的啟示

正如最近的系列文章所綜述［1－3］，受航空業(yè)安全舉措的啟發(fā)，在醫(yī)療上帶來了廣受贊譽(yù)的各類安全措施，其中就包括了著名的“檢查清單”（Checklist），這是飛行員在執(zhí)行飛行之前所必須完成的各項(xiàng)安全檢查細(xì)則。這類心系安全的措施已經(jīng)被用于醫(yī)療行業(yè)，包括檢查清單、術(shù)前討論會(huì)、醫(yī)療團(tuán)隊(duì)配合［12］。在許多（但遠(yuǎn)非全部）手術(shù)室和監(jiān)護(hù)室已經(jīng)采納了這些手段，并且在根除重大錯(cuò)誤（如3W，即錯(cuò)誤的患者、錯(cuò)誤的體側(cè)、錯(cuò)誤的器官）方面取得了高度的成功。一份簡(jiǎn)單的術(shù)前檢查清單就降低了47%的手術(shù)死亡［13］。

然而，這些受航空安全啟發(fā)的安全措施雖在手術(shù)室證明為高度有效，但并未進(jìn)入醫(yī)生的辦公室。因此，上面提到的那些措施對(duì)于減少更基礎(chǔ)性的醫(yī)療錯(cuò)誤（如誤診、不正確的手術(shù)指證等）并未起到多少作用，而正是這類基礎(chǔ)錯(cuò)誤構(gòu)成了重大的問題，并且依然是導(dǎo)致很多不必要傷害的原因。在2008年，美國婦產(chǎn)科學(xué)會(huì)（ACOG）成立了一個(gè)特別工作組，針對(duì)在門診設(shè)施中實(shí)施安全措施和程序進(jìn)行研究并提出推薦意見，其在一定程度上促成了更全面性《卓越門診實(shí)踐的安全性認(rèn)證》（SCOPE）項(xiàng)目的開展。本文所討論的RSM程序旨在應(yīng)對(duì)不育專業(yè)中的風(fēng)險(xiǎn)和安全性問題，并將醫(yī)生辦公室納入其中，因?yàn)樯婕帮L(fēng)險(xiǎn)的操作通常是在那里啟動(dòng)并執(zhí)行。需要注意的是，RSM是被視為對(duì)已經(jīng)存在于ART之中的現(xiàn)有質(zhì)量控制系統(tǒng)（如國際標(biāo)準(zhǔn)化組織的認(rèn)證項(xiàng)目［7］及其他認(rèn)證程序）的補(bǔ)充，而非一個(gè)競(jìng)爭(zhēng)性系統(tǒng)。出于前面給出的理由，我們相信，不育和ART有可能成為進(jìn)一步開發(fā)和實(shí)施全球性RSM項(xiàng)目的理想的醫(yī)療領(lǐng)域。

五、“安全為本”的醫(yī)學(xué)教育

（一）學(xué)術(shù)教育及職業(yè)培訓(xùn)

在醫(yī)學(xué)教育中，一直存在著學(xué)術(shù)教育和職業(yè)教育的困惑。一般而言，醫(yī)學(xué)包含有高度復(fù)雜且具科學(xué)根源的各類程序，這就意味著需要對(duì)于前沿性生物科學(xué)的全面理解和對(duì)于一系列高科技醫(yī)學(xué)發(fā)明的熟練掌握，比如當(dāng)今科學(xué)成就的衍生品——醫(yī)學(xué)遺傳學(xué)等。在本質(zhì)上，學(xué)術(shù)教育的目的是經(jīng)由對(duì)各種相關(guān)分支技術(shù)的廣泛學(xué)習(xí)而達(dá)成知識(shí)的融會(huì)貫通，這需要在醫(yī)學(xué)院校數(shù)年的學(xué)習(xí)。

相反，職業(yè)教育追求的是對(duì)醫(yī)學(xué)?？苹騺唽？萍寄艿恼莆眨枰哂辛己媒M織和管理的培訓(xùn)，并且必須植入“安全為本”（safety inside）的教學(xué)理念，目前在后一點(diǎn)上還差得很遠(yuǎn)。一些監(jiān)督委員會(huì)和教育理事會(huì)（如美國婦產(chǎn)科醫(yī)學(xué)委員會(huì)及歐洲、澳大利亞和加拿大的等同機(jī)構(gòu)）明確規(guī)定不育及ART培訓(xùn)課程必須有實(shí)際操作培訓(xùn)（Hands-on training）或進(jìn)修培訓(xùn)（Fellowship-type tranining）環(huán)節(jié)，但針對(duì)是否開展了合適的培訓(xùn)進(jìn)行實(shí)際監(jiān)督時(shí)，主要（甚至完全）依靠是對(duì)學(xué)員進(jìn)行考試，而更有效地監(jiān)控職業(yè)培訓(xùn)質(zhì)量的措施則還需要有對(duì)于培訓(xùn)機(jī)構(gòu)更嚴(yán)格的監(jiān)管計(jì)劃，由此確保在培訓(xùn)項(xiàng)目實(shí)施過程中，對(duì)整個(gè)培訓(xùn)課程進(jìn)行監(jiān)管，以達(dá)成管理委員會(huì)或理事會(huì)所規(guī)定的各項(xiàng)要求。

圖1給出了就進(jìn)修培訓(xùn)中的教輔材料特別示例。在該模式中，針對(duì)不育和ART的教育含兩次為期一周的課程（初始及驗(yàn)證科目）以及貫穿于整個(gè)培訓(xùn)的9個(gè)高級(jí)教育模塊。這9個(gè)模塊包括如下主題（每個(gè)模塊為期3天）：

模塊1：排卵生理學(xué)及排卵異常病理學(xué)。排卵、排卵過少及無排卵、誘發(fā)排卵、控制性卵巢刺激（COS）、黃體支持（LPS）。

模塊2：外科與不育：子宮內(nèi)膜異位癥，卵巢囊腫、子宮肌瘤、子宮及輸卵管形態(tài)異常；腹腔鏡探查術(shù)在不育癥診治中的作用。

模塊3：卵巢功能及功能異常與年齡老化。卵巢儲(chǔ)備概念、絕經(jīng)及過早絕經(jīng)。

模塊4：生育與不育流行病學(xué)及長期趨勢(shì)。種族差異、族群差異。

模塊5：胚胎學(xué)，不育及ART中的生殖系統(tǒng)組織學(xué)；遺傳學(xué)（I）：用于植入前遺傳學(xué)篩查（PGS）的滋養(yǎng)層活檢和胚胎／卵母細(xì)胞質(zhì)量評(píng)估。

模塊6：不育和ART中的安全風(fēng)險(xiǎn)管理（RSM）：確定危險(xiǎn)和風(fēng)險(xiǎn)，錯(cuò)誤及錯(cuò)誤管理原則。知識(shí)演進(jìn)原則：臨床研究基礎(chǔ)知識(shí)，方案的概念、實(shí)際運(yùn)作、數(shù)據(jù)分析及報(bào)告（口頭及書面）；評(píng)讀原則。

模塊7：身心和諧，不育與生殖。心理學(xué)及社會(huì)心理學(xué)問題。

模塊8：遺傳學(xué)（II）：胚胎異常及胎兒畸形篩查，植入前遺傳診斷（PGD）。

模塊9：“Medicalship”原理。這里的 Medicalship是一個(gè)類同于“航海技藝”（seamanship）和“飛行技藝”（airmanship）的新概念。

（二）三層次中心教育單元（CEU）

用于職業(yè)培訓(xùn)及學(xué)術(shù)教育的教輔材料傳統(tǒng)上是課本式的教學(xué)大綱或其他形式的文檔。我們拋開傳統(tǒng)的做法，開發(fā)出一種中心教育單元（CEU），用于不育及ART的實(shí)際操作培訓(xùn)或進(jìn)修培訓(xùn)的各個(gè)環(huán)節(jié)。與傳統(tǒng)的課本式教輔材料相比，CEU的獨(dú)到之處在于它將所有的相關(guān)教學(xué)材料存儲(chǔ)于循序漸進(jìn)的三層次格式。如圖2所示，三個(gè)知識(shí)層次從淺入深分別為“必須了解”（Must know level）、“最好了解”（Nice to know level）及“專家級(jí)”（Expert level）。

（三）從“飛行技藝”導(dǎo)出新概念“醫(yī)療技藝”

航海技藝（Seamanship）指的是與水上操縱船舶相關(guān)的才能、技術(shù)及業(yè)務(wù)活動(dòng)，人們以此類推創(chuàng)造出“飛行技藝”（Airmanship）一詞，用來描述涉及操控飛行器的全部技能和專項(xiàng)技術(shù)。飛行技藝的定義后來又進(jìn)一步擴(kuò)展到涵蓋“始終堅(jiān)持運(yùn)用良好的判斷和充分的技能來完成飛行任務(wù)”，由此，飛行技藝一詞也就意味著對(duì)于環(huán)境的高感知狀態(tài)，這里面包括了對(duì)于自身、飛行器、團(tuán)隊(duì)以及風(fēng)險(xiǎn)等的充分了解。因此，飛行技藝不僅僅是對(duì)于技能或技術(shù)的衡量，也表現(xiàn)出飛行員對(duì)于飛行器、操作環(huán)境以及對(duì)于自身能力的理解。除了表示有能力以充分的技能和精準(zhǔn)度來操控飛機(jī)之外，飛行技藝還暗示了行使準(zhǔn)確的判斷力以保障最大限度的安全有效操作。

鑒于航空業(yè)運(yùn)轉(zhuǎn)體系在保證高度安全性和高度效能方面的非凡成效，值得將其拓展到包括醫(yī)療在內(nèi)的其他領(lǐng)域。出于這種考慮，我們創(chuàng)造出類同于飛行技藝的“醫(yī)療技藝”（Medicalship）一詞，用于定義醫(yī)師執(zhí)行安全有效操作所必備的技能和知識(shí)?！搬t(yī)療技藝”在不育和ART專業(yè)則意味著有能力對(duì)那些不育但有生育意愿的患者提供專業(yè)性關(guān)愛，并提供最恰當(dāng)?shù)闹委煛?/p>

六、報(bào)告錯(cuò)誤（Error reporting）

將實(shí)際操作中出現(xiàn)的錯(cuò)誤上報(bào)是RSM的關(guān)鍵步驟，而無論這些錯(cuò)誤是否帶來了傷害性后果。要養(yǎng)成報(bào)告錯(cuò)誤的習(xí)慣就必須克服人們天性中在出錯(cuò)或犯規(guī)后的避隱特質(zhì)。對(duì)于那些未造成后果的錯(cuò)誤及安全過失，我們每個(gè)人的天然反應(yīng)似乎都是趨向于盡力弱化。然而，對(duì)于那些看上去未造成不良后果的錯(cuò)誤給以不當(dāng)容忍，或是當(dāng)錯(cuò)誤導(dǎo)致傷害性后果時(shí)譴責(zé)個(gè)體責(zé)任人，都無助于提升安全性。

出現(xiàn)錯(cuò)誤時(shí)絕不應(yīng)不管不顧，而應(yīng)當(dāng)進(jìn)行處理。航空業(yè)已經(jīng)清楚地表明，認(rèn)識(shí)錯(cuò)誤是改善安全性的關(guān)鍵。要認(rèn)識(shí)錯(cuò)誤就意味著需要啟動(dòng)有效的錯(cuò)誤報(bào)告手段。航空業(yè)所認(rèn)同的錯(cuò)誤報(bào)告模式有自動(dòng)報(bào)告、強(qiáng)制報(bào)告和自愿報(bào)告三種。

1．自動(dòng)報(bào)告：自動(dòng)報(bào)告在提升航空安全性上發(fā)揮了重要作用。自動(dòng)報(bào)告在性質(zhì)上可消解人們?cè)阱e(cuò)誤發(fā)生后根據(jù)后果程度進(jìn)行決定的傾向性。在航空管理中，設(shè)置有飛行記錄儀來自動(dòng)報(bào)告飛行中的一些不尋常事件，如過大角度著地等。出現(xiàn)問題時(shí)通常首先要問的是發(fā)生了什么？有些情況下錯(cuò)誤的發(fā)生有著充分的理由，但更多的情況則是過大角度著地是出自于一系列普通錯(cuò)誤。關(guān)鍵性的第一步是去了解到底發(fā)生了什么，由此展開分析并最終做出相應(yīng)的修正。由自動(dòng)報(bào)告的不尋常事件所引發(fā)的調(diào)查，所獲信息在行業(yè)內(nèi)共享，由此所有人都能從他人的錯(cuò)誤中汲取經(jīng)驗(yàn)和教訓(xùn)。重要的一點(diǎn)是，航班所有成員（飛行員及其他空乘人員）都受到類似的監(jiān)察，即所謂的“公平文化”。這最終有助于促成自愿性的錯(cuò)誤報(bào)告模式以及將所有錯(cuò)誤（無論后果如何）均作為需要加以調(diào)查的事件來對(duì)待的文化氛圍［14］。

自動(dòng)報(bào)告的目標(biāo)在于改變?nèi)藗儗?duì)于錯(cuò)誤分析（error analyssi）的態(tài)度，但在不育和ART領(lǐng)域，自動(dòng)報(bào)告仍處于相當(dāng)初級(jí)的階段。實(shí)施不同形式的自動(dòng)報(bào)告，目的在于促進(jìn)建立并維持一種“公平公正的文化”。

2．強(qiáng)制報(bào)告：一些特定事件必須加以報(bào)告和分析，即便是那些不一定是錯(cuò)誤所致者。例如在ART中，任何治療項(xiàng)目都應(yīng)有相關(guān)機(jī)制，用來對(duì)于未獲卵或受精失敗等事件進(jìn)行回顧分析。未獲卵或受精失敗可以是出于醫(yī)療錯(cuò)誤，也可能出于患者的個(gè)人特質(zhì)，一旦發(fā)生都必須對(duì)臨床和實(shí)驗(yàn)室操作進(jìn)行回顧分析?；颊咴诮邮蹵RT治療時(shí)處于不良“流程后果”（process outcomes）的高風(fēng)險(xiǎn)之中，應(yīng)當(dāng)將實(shí)際結(jié)局同基于已發(fā)表資料的預(yù)期結(jié)局進(jìn)行比較（基準(zhǔn)校驗(yàn)）?；鶞?zhǔn)校驗(yàn)是比較結(jié)果和評(píng)估效能的重要手段，尤其是在沒有錯(cuò)誤發(fā)生的情況下。

管理機(jī)構(gòu)應(yīng)要求醫(yī)療機(jī)構(gòu)向患者披露醫(yī)療錯(cuò)誤（包括任何的意外不良事件）。在不育和ART的RSM中應(yīng)當(dāng)內(nèi)置有針對(duì)患者的自愿性全面披露程序。

3．自愿報(bào)告：非懲罰性自愿報(bào)告是保障醫(yī)療操作安全性的關(guān)鍵。支持非懲罰性報(bào)告的文化氛圍將有助于醫(yī)療錯(cuò)誤和AEs的早期發(fā)現(xiàn)，并帶來改進(jìn)行動(dòng)（如必要時(shí)重設(shè)系統(tǒng)等）。如美國聯(lián)邦航空管理局（FAA）頒布的“航空安全行動(dòng)項(xiàng)目”（ASAP）準(zhǔn)許飛行員（或操作員）秘密提交事故報(bào)告。然而，在醫(yī)療實(shí)踐中不會(huì)自然出現(xiàn)自愿報(bào)告，需要有強(qiáng)力的領(lǐng)導(dǎo)和激勵(lì)措施。我們的個(gè)人意見是，醫(yī)療中的自愿報(bào)告應(yīng)當(dāng)封印于某個(gè)受保護(hù)區(qū)間，不得用于法庭證據(jù)。這樣隔絕律師和當(dāng)事人之間信息交換的模式可做為建設(shè)性模式。

七、“說你所做”（Say what you do）方案讓醫(yī)生負(fù)起責(zé)任

1．公認(rèn)準(zhǔn)則之內(nèi)的操作程序：RSM中的一個(gè)核心問題是對(duì)于那些拿來運(yùn)用并加以遵循的操作程序進(jìn)行界定并標(biāo)準(zhǔn)化的必要性。這一點(diǎn)對(duì)于檢測(cè)和監(jiān)控偏差是必要的。然而，對(duì)于特定程序的制訂和遵守在臨床醫(yī)療中并不能做到始終如一，由此成了貫徹實(shí)施安全系統(tǒng)（其內(nèi)容遠(yuǎn)超檢測(cè)清單及類似措施）的絆腳石。

ART實(shí)踐在某些方面就陷入了規(guī)則和條例的麻煩之中。有的管理?xiàng)l例過于復(fù)雜，不符合當(dāng)前形勢(shì)，或不便于實(shí)際執(zhí)行。在管理措施不切實(shí)際或過時(shí)的情況下，為了維持系統(tǒng)的運(yùn)作和程序的流轉(zhuǎn)，就只好做出一些非法偏離和違規(guī)操作。此外，以安全性為目的而進(jìn)一步拓展規(guī)則和條例，更是為已經(jīng)糾結(jié)的系統(tǒng)雪上加霜。正如我們所觀察到的，簡(jiǎn)單地添加規(guī)則和條例并不是通向更安全ART實(shí)踐的最好路徑。

RSM需要?jiǎng)?chuàng)造出醫(yī)生－管理者間新的互動(dòng)模式，以提升安全性并將可靠性深植于實(shí)踐文化之中，而非僅僅去制定出更多的規(guī)則。

2．ART與認(rèn)證制度：在許多國家中，監(jiān)管當(dāng)局推薦采用傳統(tǒng)的質(zhì)量保證體系，如國際標(biāo)準(zhǔn)化組織的認(rèn)證體系（ISO認(rèn)證）來應(yīng)對(duì)ART所固有的弱點(diǎn)和風(fēng)險(xiǎn)［15］。

這類針對(duì)ART程序的認(rèn)證文件如協(xié)議書和標(biāo)準(zhǔn)操作程序（SOPs）是RSM的良好起點(diǎn)，它們提供了一種讓RSM可建立在其上的“說你所做”方案。然而，風(fēng)險(xiǎn)管理并不總是質(zhì)量保證和認(rèn)證程序的固有元件。RSM自身有深具安全意識(shí)的日程，可與ISO協(xié)同運(yùn)作，但不僅限于ISO。RSM與質(zhì)量系統(tǒng)就像是計(jì)算機(jī)程序與操作系統(tǒng)，它們協(xié)同工作，但各自不同。

八、結(jié)語

110年前懷特兄弟在小鷹城進(jìn)行了人類第一次駕機(jī)飛行，到如今航空飛行成了地球上最為安全的交通模式，這一不可思議的成就并非出自于偶然，而是來自于包括操作者和管理者相關(guān)各方的不懈努力。今天，醫(yī)學(xué)需要向航空領(lǐng)域?qū)W習(xí)的地方太多太多。

受航空安全管理的啟發(fā)并智慧地應(yīng)用于醫(yī)療領(lǐng)域，RSM程序可以幫助將醫(yī)療安全提升到遠(yuǎn)高于目前狀態(tài)的水平。我們相信，在此進(jìn)程中，不育和ART領(lǐng)域可以成為一個(gè)獨(dú)特的先驅(qū)試點(diǎn)，因?yàn)锳RT早已置于政府機(jī)構(gòu)罕見的監(jiān)察之下（如要求提交開展ART活動(dòng)的年度報(bào)告）。