Japan Obstetric Compensation System

Japan Obstetric Compensation System -No-fault compensation / causal analysis and prevention of recurrence- Shin Ushiro, MD, PhD Executive Board Member, JCQHC Professor, Division of Patient Safety, Kyushu University Hospital 九 州 大 学 UIプロジェクト Kyudai Taro,2007

Background for the Launch of the System Challenges of Japan s Obstetric Care Severe working environment, Increasing medical conflicts regional gap of obstetric care provided number of young obstetricians on the decline Improve shortage of obstetricians Secure regional obstetric care system Expedited introduction of a no-fault compensation system in obstetric care

Study on the system to settle dispute by Japan Medical Association(JMA) Report on Legal resolution of conflict in medicine and its theoretical ground (Mar. 1972) If the physician proved to be liable for the adverse event through intensive review, he/she should compensate for damage. JMA Doctor s Liability Insurance (1973) For serious adverse event which inevitably happened without physician s negligence, the national compensation system should be build. A new national dispute resolution system apart from the existing judge system should be established. 2

Study on the system to settle dispute by Japan Medical Association(JMA)(Cont d) Study group on compensation for disability associated clinical practice(jan, 2006) Toward the launch of the compensation system for disability associated with clinical practice It is preferable that the system is to be applied to entire realm of medical specialties. Realistically, introduction of the system to neurological injury and sequela i.e. cerebral palsy possibly due to delivery precedes. Ad-hoc committee on the launch of the no-fault compensation system for neurological injury and sequela i.e. cerebral palsy possibly due to delivery (Aug, 2006) Launch of the no-fault compensation system for neurological injury and sequela i.e. cerebral palsy possibly due to delivery Specific elements preliquisite for the system(eligibility criteria, Operating organization, Monetary compensation, Financial resorce for the monetary compensation) are listed. 3

Framework of No-fault Obstetric Compensation System Liberal Democratic Party Review Meeting on How to Handle Medical Disputes(Nov. 29, 2006) Often difficult to determine whether or not malpractice was involved in obstetric adverse events, leading to contention in court. Frequent conflicts in obstetrics are one reason for shortage of obstetricians. In order to prepare the environment in which obstetric care can be provided without worry, Framework 1) Relieve patients who developed disability, etc., due to obstetric adverse events 2) Settle conflicts early, 3) Establish a mechanism that improves quality of obstetric care by analyzing causes of adverse events. pregnancy / delivery Malpractice by the Medical Institution Liability (Doctor s Liability Insurance, etc.) A child develops cerebral palsy No malpractice by the Medical Institution No Compensation

Purposes of the Japan Obstetric Compensation System Compensation Causal analysis and prevention of recurrence Prompt compensation for economic burden on the child with CP and family Cause analysis of the child with CP and provision of information Prevention and early settlement of conflicts Improvement of quality in obstetric care

Management of Obstetric Compensation System Steering Committee Obstetricians, pediatricians, patient representatives, lawyers, etc. Review Committee Cause Analysis Committee Objection Review Committee Recurrence Prevention Committee Adjustment Committee

Review, Cause Analysis, Recurrence Prevention 1.Application from a delivery facility App. Form 2.Review Committee examines eligibility 3.Compensation payment 4.Cause Analysis, Recurrence Prevention 5.Publishing information, improving quality in obstetric care Results accumulated

Financial Mechanism of Compensation (1) Amount of compensation is defined. Compensation Pregnant woman / baby Compensation agreement Delivery fee Childbirth Facility Registration Insurance premium J C Q H C Japan Council for Quality Health Care JCQHC Insurance contract Insurance premium Indemnity Insurance Firm Compensation money (Insurance money)

Monetary Compensation (total of 30million Yen ) Lump-sum 6 million yen For expenses to establish a base such as housing renovation, purchasing assistive products, etc. + Installment total 24 million yen (1.2M / year) For expenses to provide nursing care

Okinawa Study for verifying CP incidence in Japan Okinawa prefecture with geographical feature of archipelago which brings relative isolation and immobile population suitable for CP incidence research. Outstanding interest and effort has been brought to Okinawa study thanks to several leading pediatric neurologists and their associates in Okinawa. It is probable that few CP case is left un identified in Okinawa.

Okinawa Study for verifying CP incidence in Japan Estimated incidence of CP in Japan 2007 Estimation (At the launch of the system) 500-800 / yr 2013 Estimation (Revision of the 2007 Estimation) 481 / yr (340-623*) *95% confidence interval

Participation of Childbirth Facilities for the Compensation System As of Mar 31, 2015 No. childbirth facilities No. participating facilities % Participation Hospital 1,202 1,202 100.0 Clinic 1,658 1,654 99.8 Birth center 444 444 100.0 Total 3,304 3,300 99.9 Non-participants: 4 clinics

Eligibility standard or Compensation A. Criteria for eligibility is provided in the Standard Conditions of the Japan Obstetric Compensation System. B. To be eligible, a case should 1 be consistent with the definition of cerebral palsy 2 fulfill all criteria as follows 1 gestational week and birth weight 2 n/a for exclusion criteria 3 severity criteria Definition of cerebral palsy in the system Cerebral palsy means disturbance of motor function or posture of infants that is perpetual or may vary. The disturbance is based on non-progressive cerebral lesion that has been developed anytime from conception to neonatal period (within 4 weeks after birth). However, motor retardation that is transient or may normalize in future, is excluded.

Exclusion Criteria for Compensation When cerebral palsy is determined not to be caused by obstetric adverse events, but by exclusion criteria below at the review committee, the case is excluded from compensation. 1. Congenital causes bilateral broad cerebral malformation, chromosomal disorders, genetic disorders, congenital metabolic disorders or other congenital abnormalities 2. Neonatal causes infections after birth etc.

Eligibility Criteria for Compensation Gestational week and birth weight Degree of Severity Born after 33 gestational weeks and Birth weight more than 2,000 grams Certified as 1st or 2nd degree of severity according to the Japanese Social Welfare System Babies delivered from 28 to 32 gestational weeks may be compensated on a case-by-case review based on the evidence of hypoxic conditions.

Image of eligible CP i.e. CP possibly due to delivery Cerebral palsy Eligible (Square in yellow) CP in accordance with i. General standard (Gestational week, Birth weight) or Individual standard And ii. Degree of severity(1 st -2 nd degree of impairment in accordance with public social welfare system in Japan) CP in accordance with exclusion standard 16

Image of eligible CP i.e. CP possibly due to delivery Cerebral palsy Eligible (Square in yellow) CP in accordance with i. General standard (Gestational week, Birth weight) or Individual standard And ii. Degree of severity(1 st -2 nd degree of impairment in accordance with public social welfare system in Japan) CP in accordance with exclusion standard 17

Case Review for Compensation Review committee (obstetricians, pediatricians, lawyers) Application Preliminary Internal review Review committee Payment If it is determined that the case was caused by malpractice of the delivery facility, the case is eligible for Doctor s Liability Insurance. However, receiving payment from both insurance policies is not allowed, and the amount of payment is adjusted in that case.

Status of the CP Cases Reviewed As of Oct.1, 2014 Eligibility Birth year No. cases processed Eligible Not Eligible Too early for reviewing Resubmission allowed In process 2009 461 364 87 4 6 2010 295 258 25 11 1 2011 230 201 19 10 0 2012 154 144 3 7 0 2013 46 43 2 1 0 Total 1,186 1,010 136 33 7

The Reason for Revision of the System in 2015 In order to promptly secure obstetric care system, the System was designed with limited data, and was established early by utilizing private insurance. The System was launched in 2009 under the condition that it is to be inspected about the content and revised as needed at least in five years. Revision from January 2015

Revised Eligibility Criteria Terms and Conditions Before After General criteria Limited criteria Gestational week 33 weeks 32 weeks Birth weight 2,000g 1,400g 28 weeks umbilical arterial blood ph 7.1 and/or highly restricted pattern of decerelation on CTG 28 weeks umbilical arterial blood ph 7.1 and/or less restricted (usually observed) pattern of decerelation on CTG Time limit for petition by the child's fifth birthday by the child's fifth birthday Amount of monetary compensation Degree of severity of impaired trunk and/or extremities correspondiing to the severity level under the "Law for the Welfare of Physically Disabled Persons" 30million Yen 292,400 USD) 30million Yen 292,400 USD) 1st or 2nd degree of severity 1st or 2nd degree of severity

Cause Analysis 1.Inspection and analysis of the cases based on sufficiently collected information from exclusively medical point of view 2.Feedback of the results report in each case to the family and the delivery facility Aims at prevention and early settlement of conflicts It is indispensable to get cooperation from delivery facilities, children and their families, doctors and relevant organizations.

Flow of Causal Analysis Childbirth facility Cause Investigation Committee Medical records, midwife records examination data, etc. Additional information of the medical care system, etc. Information from the child/family Operating organization 1 4 <Sub-committee> Report Draft 2 5 3 6 Report <Committee> Report

Basic Idea for Cause Analysis (1) 1. The purpose of the cause analysis is not to look for someone who is to blame, but to identify the causes why it happened from a medical point of view. At the same time, the causal analysis is meant to provide suggestions that may contribute to prevention of future similar cases. 2. The Cause Analysis Report should be written to be easily understood by and reliable for children and their families, citizens, and lawyers, etc.

Basic Idea for Cause Analysis (2) 3. The cause analysis considers not only causes during delivery but also causes in past history, during pregnancy, etc. 4. For medical evaluation of clinical course, the case is analyzed only in the given conditions at the point when an event happened, from the viewpoint of what would be appropriate medical procedures or treatment in management of delivery.

Basic Idea for Cause Analysis (3) 5. The Cause Analysis Report is asked to contribute to improvement of quality of obstetric care. Therefore, the report points out problems that are analyzed retrospectively with known facts if it is considered useful for prevention of recurrence.

Table of contents of Cause Analysis Report 1. Case summery A) Basic information of the mother B) Pregnancy course C) State at the admission for delivery D) Delivery course E) Neonatal course F) Post partum course G) Perinatal care system 2. Cause of Cerebral Palsy 3. Medical evaluation of clinical course 4. Suggestion for improvement

Code for Descriptive Words Applied to Medical Evaluation Level of clinical practice High Low 優 れている 適 確 である 医 学 的 妥 当 性 がある 基 準 内 である 一 般 的 である 選 択 肢 のひとつである 選 択 肢 としてありうる Phrse/Words 医 学 的 妥 当 性 は 不 明 である(エビデンスがない) 医 学 的 妥 当 性 には 賛 否 両 論 がある 選 択 されることは 少 ない 一 般 的 ではない 基 準 から 逸 脱 している 医 学 的 妥 当 性 がない 劣 っている 誤 っている Words to preserve uniformity and comparability between reports are exemplified in the manual. e.g. 優 れている(Excellent) 一 般 的 である(Common) 基 準 から 逸 脱 している (Out of standards) 劣 っている(fall behind) 12

Web-based system of compiling peerreview report at multiple work place Web-based compilation system Support system of report compilation CTG(Cardiotocography) Draft report (by Obstetrician) Commentary sheet 2Compilation 3Confirmation 4Comment Documents 1 Summary of event 2 recordings Medical chart Midwife s chart Blood analysis data, etc. 1mail Sub-committee members working at remote work places Chair(Obstetrician) Obstetrician (Drafting member) Obstetrician, Midwife, Neonatologist, Lawyer Sub-committee held at JCQHC office Draft report Commentary sheet Other materials 32

Website of the Japan Obstetric Compensation System for Cerebral Palsy Manual of compiling peer-review report (A) / Report (Summarized version) (B) are posted on the website. (A) (B) 30

Recurrence Prevention 1.The results of each cause analysis are systematically organized, accumulated, and epidemiologically studied. 2.Widely open gained information to the public >Annual publication of the report on recurrence prevention >Irregular publication of educational materials >Cooperation with relevant organizations and administrative organs Prevent Recurrence of future cerebral palsy Improve quality in obstetric care Enhance public confidence in obstetric care

Flow of Analysis in Recurrence Prevention Image of difference in analysis Cause Analysis Committee Recurrence Prevention Committee <Analyze each case> From medical point of view Cause analysis report <Analyze accumulated cases> From epidemiological point of view Recurrence prevention report Educational Materials Suggestio n and proposals from epidemiol -ogical findings Delivery facilities, relevant academic societies, administrative organs

Report on prevention of Cerebral Palsy -Toward the Quality Improvement of Obstetric carehttp://www.sanka-hp.jcqhc.or.jp/pdf/saihatsu_report_0_all.pdf, (Available ONLY in Japanese)

Technical Topics focused in the Report on Recurrence Prevention of Cerebral Palsy 1 2 3 4 5 6 7 Neonatal resuscitation Fetal heart rate monitoring during delivery Administration of uterine contraction agent Management of Umbilical prolapse Vacuum-Assisted Delivery Prophylactic maternal education on placental abruption Medical recording worth to be on expert analysis

Project of preventing cerebral palsy Epidemiological and Quantitative Analysis Basic element of individual case such as current physical status and past history of pregnant woman, history of current pregnancy, progress and procedures of delivery and neonatal care and institutional resources prerequisite for childbirth care are collectively tabulated and presented. Qualitative Analysis on Specific Theme Individual theme which deserves further research is focused and the result of research including preventive measure is presented. 35

Major cause of CP approved in the compensation system Identified single cause in individual case 43 Placental abruption 14 Factors related to umbilical cord Umbilical cord prolapse 5 Othres 11 Uterine rupture 4 Intrauterine infection Chorioamnionitis 1 Others 1 Fetomaternal transfusion 2 Twin to Twin Transfusion Syndrome(TTTS) 1 Intracranial hemorrage 1 Subgaleal hematoma due to traction 1 Baby born with a caul due to precipitate labor 1 Maternal cardiac arrest due to insufficient ventilation during induction of anesthesia 1 Identified multiple causes in individual case 15 Placental abruption 4 Factors other than those related to umbilical cord 9 Chorioamnionitis 4 Subgaleal hematoma due to traction 1 Placental dysfunction 3 Unknown and/or unidentified cause 21 Total Japan Council *Cited for from Quality 2012 Report Health on prevention Care of (JCQHC) CP 36 79

Educational Statement from Recurrence Prevention Committee Educational statement on standard for neonatal resuscitation. Evidence-based procedure of neonatal resuscitation developed by the society of neonatology is timely introduced into the society of obstetrician and midwife.

Publish of educational material Cardiotocography of cerebral palsy Cardiotocography of cerebral palsy ~ FHR Patten and focus of correct interpretation ~

Publish of educational material Cardiotocography of cerebral palsy Timepoint (before delivery) A case of Placental abruption 4hr 24min FHR with normal baseline variability 1hr 18min Late deceleration 1hr 1min 38min prolonged deceleration 遷 延 一 過 性 徐 脈 bradycardia Cesarean section 39

Year to-year Change in Number of Petitions Filed for Damage Number of petition filed 50 45 40 35 30 25 20 15 10 5 0 No-fault compensation system has been launched. 2005 2006 2007 2008 2009 2010 2011 Year of petition filed

Lawsuit Trend of OB-GY Compared to Whole Medical Specialties whole medical specialties obstetrics & gynecology Sharper drop observed in OB-GY 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Statistics of the committee on lawsuit related to health care, the supreme court of Japan

Current Status of Claims and Lawsuits As of December, 2013 1. Out of 687 eligible cases for the compensation system, 41 cases(6.0%) claimed damage. 2. Out of 41cases above, 19 cases filed a lawsuit and 22 cases chose settlement out of court. 1. Out of 347 cases to whom the causal analysis report was sent, 9 cases(2.6%) claimed damage after the day when the report was sent. 2. Out of 9 cases above, 5 cases filed a lawsuit and 4 cases chose settlement out of court.

Survey Results for Cause Analysis (for Delivery Facilities ) Q. Was it good that the cause analysis has been done? Yes and No 24 cases(19%) Not so good 4 cases(3%) Very good 43 cases(34%) Poor 0(0%) Fairly good 57 cases(45%) Reasons for Very good and Fairly good groups (100) Rate of answer:128/225(=56.9%) Reasons for Not so good and Poor groups (4) Analysis was done by a third party 94 Lead to improvement of obstetric care 49 Cause was identified 22 Relieve sense of distrust against delivery facilities and doctors 18 Others 4 Never Lead to improvement of obstetric care 4 Increased sense of distrust against delivery facilities and doctors 3 Doubtful about fairness or neutrality in evaluation 2 Cause was not identified after all 2 Others 1

Survey Results for Cause Analysis (for Families ) Q. Was it good that the cause analysis has been done? Not so good 18(18%) Very good 30(30%) Poor 2(2%) Yes and No 17(17%) Fairly good 32(32%) Reasons for Very good and Fairly good groups (62) Rate of answer:99/195(=50.7%) Reasons for Not so good and Poor groups (20) Analysis was done by a third party 49 Lead to improvement of obstetric care 33 Cause was identified 27 Relieve sense of distrust against delivery facilities and doctors 9 Others 10 Cause was not identified after all 16 Increased sense of distrust against delivery facilities and doctors 10 Never Lead to improvement of obstetric care 8 Doubtful about fairness or neutrality in evaluation 7 Others 5

Conclusion The Japan Compensation System for Cerebral Palsy was launched with public nature in Jan 2009. It is a breakthrough system in patient safety in Japan in a sense that it is the first compensation system on no-fault basis in healthcare in Japan. The amount of monetary compensation depends on the size of Japanese mid-sized social security payment and compiling causal analysis report has been willingly accepted in Japanese society preferring elucidating scientific cause of cerebral palsy to imposing liability on physicians and midwives. For the reason above, the unique system is expected to expand along with the preference of Japanese society.

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