A nationwide descriptive study of obstetric claims for compensation in Norway

A nationwide descriptive study of obstetric claims for compensation in Norway
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  AOGS  MAIN RESEARCH ARTICLE A nationwide descriptive study of obstetric claims forcompensation in Norway STINE ANDREASEN 1 , BJØRN BACKE 2 , 3 , ROLF GUNNAR JØRSTAD 4 & P ˚AL ØIAN 5 , 6 1 Department of Obstetrics and Gynecology, Haukeland University Hospital, Bergen,  2 Department of Obstetrics and Gynecology, St. Olav Hospital, Trondheim,  3 Institute for Laboratory Medicine, Women’s and Children’s Health, NorwegianUniversity of Technology and Science, Trondheim,  4 The Norwegian System of Compensation to Patients, NPE, Oslo, 5 Department of Obstetrics and Gynecology, University Hospital of North Norway, Tromsø, and   6 University of Tromsø,Tromsø, Norway  Key words Anal sphincter tear, asphyxia, compensation,delivery, fetal monitoring, human error, injury,obstetrics, substandard health care, systemfailure Correspondence Stine Andreasen, Department of Obstetricsand Gynecology, Haukeland UniversityHospital, 5021 Bergen, Norway.E-mail: Conflict of interest The authors have stated explicitly that thereare no conflicts of interest in connection withthis article.Please cite this article as: Andreasen S, BackeB, Jørstad RG, Øian P. A nationwide descriptivestudy of obstetric claims for compensation inNorway. Acta Obstet Gynecol Scand2012;91:1191–1195.Received: 10 October 2011Accepted: 12 March 2012DOI: 10.1111/j.1600-0412.2012.01409.x Abstract Objective.  To describe causes of substandard care in obstetric compensation claims. Design and setting.  A nationwide descriptive study in Norway.  Population.  All ob-stetricpatientswhobelievedthemselvesinflictedwithinjuriesbytheHealthServiceand applying for compensation.  Methods  . Data were collected from 871 claims toThe Norwegian System of Compensation to Patients during 1994–2008, of which278 were awarded compensation.  Main outcome measures.  Type of injury and causeof substandard care.  Results  . Of 871 cases, 278 (31.9%) resulted in compensation.Of those, asphyxia was the most common type of injury to the child (83.4%).Anal sphincter tear (29.9%) and infection (23.0%) were the most common typesof injury to the mother. Human error, both by midwives (37.1% of all cases givencompensation) and obstetricians (51.2%), was an important contributing factorin inadequate obstetric care. Neglecting signs of fetal distress (28.1%), more com-petent health workers not being called when appropriate (26.3%) and inadequatefetal monitoring (17.3%) were often observed. System errors such as time conflicts,neglecting written guidelines and poor organization of the department were in-frequent causes of injury (8.3%).  Conclusions  . Fetal asphyxia is the most commonreasonforcompensation,resultinginlargefinancialexpensestosociety.Humaner-ror contributes to inadequate health care in 92% of obstetric compensation claims,although underlying system errors may also be present. Abbreviations:  NPE, Norwegian System of Compensation to Patients ( Norsk  pasientskadeerstatning  ); CTG, cardiotocography; STAN, CTG combined with STwaveform analysis. Introduction The Norwegian System of Compensation to Patients (NPE –Norsk pasientskadeerstatning) was established in 1988 and isorganized as a public body under the Ministry of Health andCare Services.The Norwegian compensation system, as in the otherNordic countries, is a no-blame system. This implies thatthe patient can receive full compensation without anyonebeing proven guilty of malpractice.To be eligible for compensation according to the Act onPatient Injury Compensation in Norway, a patient injury must have occurred and the patient must also have sustaineda financial loss. Compensation is awarded if the injury isassumed to be a result of an error or omission in treatment.Whendecidingwhetheranerrororomissionhastakenplace,NPE considers whether the health services provided werecompatible with the quality level which can reasonably beexpected by the injured party.As a rule, compensation is granted if the injury is causedby infection even if the care has been adequate, except whenthe infection is assumed to have been caused by the pa-tient’s condition or illness. In special cases it is possible toaward compensation even when the treatment is found to beprofessionally and medically sound, but where the injury hasexceeded the risk element which must be accepted by the C  2012 The Authors  Acta Obstetricia et Gynecologica Scandinavica  C  2012 Nordic Federation of Societies of Obstetrics and Gynecology  91  (2012) 1191–1195  1191 ACTA Obstetricia et Gynecologica  Obstetric claims for compensation in Norway  S. Andreasen et al. patient from a legal point of view. This is referred to as thereasonability rule.Afterreceivingacompensationclaim,NPEobtainsastate-ment from the involved hospital department and a copy of the medical record. In most obstetric cases, NPE requests anexpert statement from an independent specialist in the rel-evant medical specialty. The NPE decisions can be appealedto the Patient Injury Compensation Board and, if rejectedby the Board, the claimants and their attorney can choose topursue the process to a court of law.The annual birth rate in Norway is about 60 000 and NPEreceives approximately 100 claims for compensation in ob-stetricseveryyear,orabout1.6per1000births.Thisincludesinjury during pregnancy, labor or in the postpartum period.Theseclaimsconcerninjurytothechildin60%andinjurytothe mother in 40%. In obstetrics the compensations awardedare large, especially when there is an injury to the child. Since1988, a total of about € 120 million has been paid by NPE ascompensation for obstetric claims.Despite the considerable volume of information in thesecases,theyhaveneverbeenreviewedwiththeintentiontoim-prove the quality of obstetric care and patient safety. Basedon the recognition that the information on cases with unfa-vorable outcomes should be utilized, the Norwegian Society for Obstetrics and Gynecology has established a formal co-operation with NPE with the aim to improve the quality of care. The aim of the present study was to review theseclaims, focusing mainly on those receiving compensation, toexplorewhichtypeofobstetriccasesareinvolvedandtherea-sons for compensation, and to suggest measures for quality improvement. Material and methods Between1January1994and13November2008,871obstetricclaims were made to the NPE, of which 278 claims resultedin compensation. There were 193 cases involving injury ordeath of the child and 87 cases of maternal injury, and twocases with injuries both to mother and child. In all 278 casesgrantedcompensation,thewomenorparentswerecontactedby mail and asked to give their consent to participate in thestudy. We obtained consent in 193 cases, and reviewed allavailable information from these. For the 85 women whodid not respond or declined to participate, we had access toanonymous versions of the expert statements and the casesummaries provided by NPE.To compare claims resulting in compensation to those inwhich compensation was denied, anonymous informationabout denied cases were provided by NPE. The denied caseswere reviewed according to type of injury and reason fordenial.Demographic and medical information were recorded ina form designed for this study, including age, parity, pre-vious deliveries, chronic diseases and complications duringpregnancy. The gestational age at birth, mode of delivery,induction, cardiotocography (CTG) or CTG combined withSTwaveformanalysis(STAN),oxytocinaugmentation,anes-thesia,birthweight,Apgar score and umbilicalcordsamplingor early fetal blood sampling were recorded. The profession(midwife, obstetrician or others) involved in the obstetriccare was also recorded from the expert statement (Support-ing Information Appendix S1).We categorized the cause of substandard care in eightgroups: failures in obstetrical or surgical treatment, inade-quate fetal monitoring, errors in drug administration, morecompetent health personnel not being called when needed,non-compliance with written guidelines, poor organizationof the department, lack of written guidelines, and time con-flicts in the delivery unit. The expert statements determinedwhether the health care was adequate. Although the treat-ment was in compliance with guidelines and national stan-dards, according to the medical experts consulted by NPEor the Patient Injury Compensation Board, 37 patients re-ceived compensation, either due to strict liability (infection)(14/278),courtdecision(16/278),disagreementinthePatientInjuryCompensationBoard(4/278)orthereasonabilityrule(3/278).Injuries to the infant were classified as asphyxia, infection,fracture of skull or long bones, shoulder dystocia, brachialplexus injury, intracerebral hemorrhage and others. It wasrecorded whether the injury was related to events duringpregnancy,intrapartumorpostpartum.Ifthechildhadcere-bral palsy, the criteria for a causal relation to intrapartumevents were used (1).Injury to the mother was classified as severe hemorrhage,anal sphincter tear, intestinal or urinary tract damage, infec-tion, thromboembolism and others. For each condition theextent of the damage and sequelae were recorded. Cause of death was recorded from the autopsy report, if possible.Statistics were performed in SPSS 18.0. The Data Inspec-torate at the University Hospital of North Norway approvedthe project. Results Of the 871 claims in obstetrics, compensation was given in278(31.9%)cases.Inall,284(32.5%)oftherejectedcasesap-pealed to the Patient Injury Compensation Board, and 43 of the appealed cases (15.1%) were approved. A total of 41 werebroughtbeforethecourtsoflaw,and16ofthesecases(39.0%)received compensation. There was no significant increase inthe number of obstetric claims during the study period, andthe share of compensation similar.Failures in obstetrical or surgical treatment (anal sphinc-ter tear not diagnosed at delivery, postoperative complica-tions ignored or insufficient obstetrical skills) were the main 1192 C  2012 The Authors  Acta Obstetricia et Gynecologica Scandinavica  C  2012 Nordic Federation of Societies of Obstetrics and Gynecology  91  (2012) 1191–1195  S. Andreasen et al.  Obstetric claims for compensation in Norway Table 1.  Injury to mother and child and proportion of compensation.Mother Compensation 87/352 (24.7%)Anal sphincter tear 26 / 92 (28 . 3%)Infection 20 / 59 (33 . 9%)Pain after delivery 0 / 49 (0 . 0%)Hemorrhage 7 / 42 (16 . 7%)Injury of intestines or urinary tract 12 / 23 (52 . 2%)Uterine rupture 7 / 14 (50 . 0%)Thromboembolism 3 / 12 (25 . 0%)Others 12 / 61 (19 . 7%)Child Compensation 193/521 (37.0%)Asphyxia 161 / 315 (51 . 1%)Shoulder dystocia 12 / 104 (11 . 5%)Neglected supervision in pregnancy 4 / 23 (17 . 4%)Infection 2 / 10 (20 . 0%)Malformations 0 / 10 (0 . 0%)Others 14 / 59 (23 . 7%) reason in 27.0% and contributing factor in another 34.5%.Inadequate fetal monitoring (CTG/STAN registration notperformed in risk patients or misinterpreted) was the mainreason in 11.9% and a contributing factor in 5.4%. Errors indrug administration (for example inappropriate use of oxy-tocin) was the main reason in 4.3% and a contributing factorin 10.8%. More competent health personnel not being calledwhenneededwasthemainreasonin7.6%andacontributingfactor in 18.7% and non-compliance with written guidelineswasseenin14.4%andacontributingfactorinanother19.5%.We defined these reasons as mainly human error and accord-ing to this definition, human error was evident in 92% of thecases.System error was defined as poor organization of the de-partment,seenasthemainreasonin2.5%andacontributingfactor in 2.9%, lack of written guidelines, registered in 0.4%and a contributing factor in 0.7%, and time conflicts in thedelivery unit, seen in 0.7% and a contributing factor in an-other 1.1%. System errors were the main reasons in only 8%of the claims.Type of injury to mother and child is shown in Table 1.Compensation was given in 24.5% of the maternal casesand 36.9% of cases involving injury to the child. The mostcommon reasons for compensation to the mother were analsphincter injuries, infections and injury to the intestines orthe urinary tract. The most common injury to the child wasasphyxia.Theinjurycauseddeathin61/193(31.6%)childrenand in 4/87 (4.6%) women.An obstetrician was directly involved or responsible in141/278 (51.2%) of the cases, a trainee obstetrician in 17/278(6.1%) of the cases, a midwife in 103/278 (37.1%) of thecases and other professions (anesthesiologist/pediatrician)in12/278(4.3%)ofthecases.In27/278(9.7%)bothmidwifeand obstetrician were involved.The most common reasons for rejecting claims were lack of a causal relation between the care provided and the injury (66%) and care found to be adequate (28%). In 6%, com-pensation was not granted because no financial loss resulted.In cases involving injury to the child, the mean amountof compensation was € 430 000 (range 670–1 068 000). Themostextensivecompensationswereawardedincaseswithin-trapartumhypoxiaandpermanentneurologicalimpairment.The mean amount of compensation in maternal injuries was € 38 000 (range 600–346 000). Discussion The introduction of a no-fault compensation system lim-its the number of cases brought before the courts of law,and compensation was granted to only 1.8% by court de-cision. Similar numbers are seen in Finland (2) and Den-mark (JK Christoffersen, Danish Patient Insurance Associ-ation, 010112, personal communication) where the systemfor compensation is virtually identical. Arguments could bemade that all cases of injury should be compensated equally,independent of adequate care and known risk to the patient,but this remains a political and economic issue (3). Due toan increasing number of obstetric malpractice lawsuits andthe resulting strain, stress and expenses for both patients andcare providers, some states in the US and other countries(Netherlands, Japan) have tried to implement a similar no-blamesystem,butdespitethis,mostclaimsforcompensationare still litigated in the courts of law (4,5).This is a descriptive study but with a firm study protocol.The study data are complete national data of all compensa-tion claims. Some of the differences between the compen-sation versus denied groups are described, but we do notthink that this or any other control group could improve theinterpretation of our results.The most important finding in our study is that humanerrorisanimportantcontributingfactorinsubstandardcare,and the health worker is almost as often a midwife (37.1%)as an obstetrician (51.2%). However, it is difficult to distin-guish between system and human errors, and in many casesprobably a combination is present.One could for example argue that misinterpretation of CTG/STANregistrationsiscausedbylackofsystematictrain-ing and thus represents a system error. Lack of competenceto such an extent that the obstetrician is unable to diagnoseor treat an obstetric complication could also be viewed assystem error that should have been identified and correctedbefore injury occurred. One should also bear in mind that inobstetric emergencies, decisions are frequently made underthe pressure of time. However, in most compensated casescaused by human error, guidelines were present, the chain of command was clear, and time conflict and there was no needof urgent action.A study of surgery also revealed that human error wasthe main reason (96%) underlying poor surgical technique. C  2012 The Authors  Acta Obstetricia et Gynecologica Scandinavica  C  2012 Nordic Federation of Societies of Obstetrics and Gynecology  91  (2012) 1191–1195  1193  Obstetric claims for compensation in Norway  S. Andreasen et al. System errors and communication errors were identified inonly 2% each (6). Quality control studies conclude systemfailure to be the most important factor (7).In our study we found that inadequate fetal monitoringwas an important cause of substandard care, occurring in17% of all cases, which is also seen in similar studies (8,9).Errors in drug administration did occur, but this was the pri-mary reason in only 5% of the cases, which is low comparedwith other studies (8,10).Clinicians are usually held responsible in obstetric mal-practice cases. We were surprised to find that midwives wereinvolved in a large proportion of cases. In Norway, as in theother Nordic countries, midwives are responsible for normalvaginal deliveries. Midwives are authorized to conduct deliv-eries on their own, and to decide when to involve a doctor.The system is based on the assumption that midwives recog-nize when labor deviates from normal, and in such cases callthe obstetrician. According to our results, midwives fail torecognizepathologyinlaborinasignificantnumberofcases,either by failing to perform fetal monitoring or neglectingsigns of fetal distress, and thereby fail to call the obstetricianwhen needed. In other studies of obstetric claims involvingmidwives,failedfetalsurveillanceandshoulderdystociawerethe most frequent reasons, representing 84% of compensa-tion (11).In obstetrician cases, the clinician did not have the skillsrequired to offer the expected obstetric care or was un-able to take correct decisions under time pressure. Otherreasons for substandard care were actions not complyingwith the department’s procedures or neglecting signs of fetalasphyxia.The compensations awarded in maternal cases are oftendue to delayed diagnosis or treatment, especially in analsphincter injuries and uterine ruptures. Compensation wasgiven due to the reasonability rule in two cases of injury of intestines or urinary tract and one case of anal sphinctertear. Infections granted compensation were all due to strictliability.The main purpose of this study was to identify typical ar-eas with substandard care in obstetrics with the intention toimprovethequalityoftreatmentandpatientsafety.Themostcommon cause for compensation is neurological sequelae inthe neonate after intrapartum asphyxia (Table 1). Based onourresults,animportantrecommendationistoimprovefetalmonitoringwithCTGandSTAN.Thereisevidencethatupto20% of obstetricians and 30% of midwives are not able to in-terpretCTGcorrectly.Thismaybecausedbylackofacriticalpatternrecognitionability(12).Thisknowledgeisimportantto both the individual health worker and the team, makingcooperationimportant.Midwivesandobstetricianscarryoutannual assessments of a number of CTG interpretations toimprove quality (13). This is routine in most departments inthe UK (14).To improve obstetric care a system approach may be bet-ter than focusing on human error. This is consistent withresearch on human errors, which recommends limiting theincidence of dangerous situations and creating systems thatarebetterabletotoleratetheoccurrenceoferrorsandcontaintheir damaging effects (15). Recently, a multicenter interven-tional study focusing on systematic training of all delivery room personnel to better assist delivery of the crowning in-fant, was able to show a dramatic decrease in anal sphinctertears from 4–5% before the intervention to 1–2% after train-ing (16).Practical training in obstetric emergencies such as shoul-der dystocia and postpartum hemorrhage also reduces com-pensation claims (17). Proper interaction between midwife,obstetrician and other medical personnel is important in any difficult medical situation. It will probably improve outcomeandreduceseriouscomplications.Askingacolleagueforhelpshould not be considered a defeat, but a sign of quality andresponsibility.Training on acute and unexpected situations is important.Still,weshouldbeawarethatthiswillnotsolveeveryproblem.The pilot analogy is popular in explaining the importanceof quality control systems, but has been criticized by healthpersonnel.Ifaviationnavigationsystemswereascomplicatedto interpret as CTG, there would probably be more planeaccidents. Health workers often face unforeseen situationsand have to improvise according to each patient, the medicalproblem and the given location (18). This must also be keptin mind when evaluating compensation claims.Quality procedures are important in every medical prac-tice. To prevent similar cases in the future, we recommendannualreviewsofobstetricclaimsandauditsofdifficultcasesin clinical practice to improve quality of care in these situa-tions (19). A reporting system of all misses and near-missescouldimprovepatientsafetywithouthavingconsequencestoinvolvedhealthpersonnel.Updatesofwrittenproceduresandpresentation to all employees, including temporary employ-ees, will probablyalso reduce substandard care. Introductionof a checklist in labor is a possibility to assure control andcooperation in every step of the labor process. These toolshave proved effective in obstetrics (20) and surgery (21) andsuggested obstetric checklists have been developed (22).National focus to increase the number of claims for com-pensation to NPE should be encouraged. Not only wouldthis ensure that every patient has their case assessed, healthpersonnel,andespeciallytheaffectedwards,wouldalsolearnfrom compensation cases and thus improve quality. Conclusion Fetal birth asphyxia, anal sphincter tear and infection arethe most common injuries where compensation is awarded.Substandard care like failure in fetal monitoring, and not 1194 C  2012 The Authors  Acta Obstetricia et Gynecologica Scandinavica  C  2012 Nordic Federation of Societies of Obstetrics and Gynecology  91  (2012) 1191–1195  S. Andreasen et al.  Obstetric claims for compensation in Norway contacting more competent health workers when needed,is often observed. According to our results, human erroris present in more than 90% of cases given compensation,although underlying system error may also be present. Mid-wives are involved in almost as many claims awarded com-pensation as are obstetricians.To improve quality and prevent substandard care, we rec-ommendincreasedtraininginfetalmonitoringandobstetricemergency situations, as well as annual local and nationalaudits of difficult cases. Funding NPE and the Norwegian Medical Association. Acknowledgments We thank the involved NPE officers for helping us to requestinformed consent from patients and for supply of patientrecords. We especially thank Mads Morten Nøjd and MetteWillumstadThomsenforsupplyinguswithallrelevantstatis-ticsandguidingusthroughtheprivacyprotectionlegislation. References 1. MacLennan A. A template for defining a causal relationbetween acute intrapartum events and cerebral palsy:international consensus statement. Br Med J.1999;319:1054–9.2. Kurki T. Analysis of obstetric complications reported to theNational Patient Insurance Association in Finland from 1987to 1995. Acta Obstet Gynecol Scand. 1997;76:839–42.3. Skolbekken JA. Shoulder dystocia–malpractice or acceptablerisk? Acta Obstet Gynecol Scand. 2000;79:750–6.4. Siegal G, Melo MM, Tuddert DM. Adjudicating severe birthinjury claims in Florida and Virginia. AJLM. 2008;4:493–537.5. Uesugi N, Yamanaka M, Suzuki T, Hirahara F. Analysis of birth-related medical malpractice litigation cases in Japan:Review and discussion towards implementation of a no-faultcompensation system. J Obstet Gynecol Res. 2010;36:717–25.6. Fabri PJ, Zayas-Castro JL. Human error, not communicationand systems, underlies surgical complications. Surgery.2008;144:557–63.7. Jacobi JV, Huberfield N. Quality control, enterprise liability,and disintermediation in managed care. J Law Med Ethics.2001;3:305–22.8. Berglund S, Grunewald C, Petterson H, Cnattingius S. Severeasphyxia due to delivery-related malpractice in Sweden1990–2005. Br J Obstet Gynaecol. 2008;115:316–23.9. Williams B, Arulkumaran S. Cardiotocography andmedicolegal issues. Best Pract Res Clin Obstet Gynaecol.2004;18:457–66.10. Jonsson M, Nord´en SLHU. Analysis of malpractice claimswith a focus of oxytocin use in labor. Acta Obstet GynecolScand. 2007;86:315–9.11. Angelini DJ, Greenwald L. Closed claims analysis of 65medical malpractice cases involving nurse-midwives. JMidwifery Womens Health. 2005;50:454–60.12. Beckley S, Stenhouse E, Greene K. The development andevaluation of a computer-assisted teaching programme forintrapartum fetal monitoring. Br J Obstet Gynaecol.2000;107:1138–44.13. Draycott T, Sibanda T, Owen L, Akande V, Winter C, ReadingS, et al. Does training in obstetric emergencies improveneonatal outcome? Br J Obstet Gynaecol. 2006;113:177–82.14. Steer PJ. Surveillance during labour. J Perinat Med.2009;37:451–6.15. Reason J. Human error: models and management. West JMed. 2000;172:393–6.16. Hals E, Oian P, Pirhonen T, Gissler M, Hjelle S, Nilsen EB,et al. A multicenter interventional program to reduce theincidence of anal sphincter tears. Obstet Gynecol.2010;116:901–8.17. Weaver SJ, Lyons R, DiazGranados D, Rosen MA, Salas E,Oglesby J, et al. The anatomy of health care team trainingand the state of practice: a critical review. Acad Med.2010;85:1746–60.18. Kane RL, Mosser G. The challenge of explaining why quality improvement has not done better. Int J Qual Health Care.2007;19:8–10.19. Stalnaker BL, Maher JE, Kleinman GE, Macksey JM, FishmanLA, Bernard JM. Characteristics of successful claims forpayment by the Florida Neurologic Injury CompensationAssociation Fund. Am J Obstet Gynecol. 1997;177:268–71.20. Clark SL, Belfort MA, Byrum SL, Meyers JA, Perlin JB.Improved outcomes, fewer cesarean deliveries, and reducedlitigation: results of a new paradigm in patient safety. Am JObstet Gynecol. 2008;199:105–7.21. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH,Dellinger EP, et al. Changes in safety attitude and relationshipto decreased postoperative morbidity and mortality following implementation of a checklist-based surgical safety intervention. Br Med J Qual Saf. 2011;20:102–7.22. Fausett MB, Propst A, Van DK, Clark BT. How to develop aneffective obstetric checklist. Am J Obstet Gynecol.2011;205:165–70. Supporting Information Additional supporting information may be found in the on-line version of this article: Appendix S1:  Study form designed including demographicand medical information.Please note: Wiley-Blackwell are not responsible for the con-tent or functionality of any supporting materials supplied by theauthors.Anyqueries(otherthanmissingmaterial)shouldbe directed to the corresponding author for the article. C  2012 The Authors  Acta Obstetricia et Gynecologica Scandinavica  C  2012 Nordic Federation of Societies of Obstetrics and Gynecology  91  (2012) 1191–1195  1195
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