Med­i­cal er­ror

Af­ter a Dutch hos­pi­tal failed to di­ag­nose Adri­enne Cullen’s cancer, she lost her chance of re­cov­er­ing. Now she – and the doc­tors who failed her – have gone pub­lic

The Irish Times - Weekend Review - - FRONT PAGE - A pa­tient and her doc­tors dis­cuss the mis­di­ag­no­sis of her cancer. Page 3

Adri­enne Cullen was at work near Am­s­ter­dam when the phone call came. It was her doc­tor, call­ing from his hos­pi­tal in Utrecht. An Ir­ish­woman in her 50s, Cullen had been liv­ing in the Nether­lands for sev­eral years.

She had been treated at the hos­pi­tal – the Univer­sity Med­i­cal Cen­tre Utrecht (UMCU) – in 2011, but had been as­sured by her doc­tor that she seemed healthy. Now, two years later, he wanted to see her ur­gently.

Early in the sum­mer of 2013, she vis­ited the hos­pi­tal, where the doc­tor gave her shock­ing, ter­ri­ble news. A re­view of old pathol­ogy test re­sults had found that a test for can­cer­ous tis­sue which he had con­ducted two years pre­vi­ously had, in fact, been pos­i­tive.

De­spite be­ing told that she seemed healthy, she had had cancer all along. A gru­elling course of surgery, ra­dio­ther­apy and chemo­ther­apy fol­lowed. By 2015, tests showed that it had spread. The cancer which had lain un­treated for two years was go­ing to kill her.

Seven years to the day af­ter the bun­gled cancer test, and five years af­ter she was be­lat­edly di­ag­nosed, Cullen is ready to tell her story. The set­ting she’s cho­sen is an un­usual one: a sym­po­sium held at the very hos­pi­tal where her di­ag­no­sis was mis­laid, UMCU.

The univer­sity- style lec­ture hall is packed with sev­eral hun­dred hos­pi­tal staff, doc­tors, med­i­cal stu­dents, aca­demics and cam­paign­ers. The Ir­ish am­bas­sador to the Nether­lands, Kevin Kelly, sits at the front, close to se­nior man­agers from the hos­pi­tal and the head of the Dutch health in­spec­torate.

Small and af­fa­ble, dressed in a green jacket and black trousers, she sits qui­etly at the side of the stage, and fin­ishes her prepa­ra­tions. Along­side her, her gy­nae­col­o­gist, Prof Huub van der Vaart, and his former boss, Prof Arie Franx. They, too, will speak.

All three look un­ruf­fled, but their pres­ence is, in its own way, rev­o­lu­tion­ary. This will be the first time in the Nether­lands – per­haps in the world – that a pa­tient who has been se­ri­ously harmed by a med­i­cal er­ror ap­pears in pub­lic, to­gether with her doc­tors, to jointly talk about what went wrong, and the ter­ri­ble ef­fect it had on all three of them.

The first to present is Huub van der Vaart, the gy­nae­col­o­gist. He looks the part – smartly pro­fes­so­rial in a blue blazer and khakis – but is vis­i­bly ner­vous. “These next two hours will be the most dif­fi­cult of my career,” he says.

With typ­i­cal Dutch di­rect­ness, he makes a re­mark­able con­fes­sion. “I am the doc­tor who is re­spon­si­ble for a de­lay of two years in di­ag­nos­ing the cer­vi­cal cancer of Adri­enne Cullen and by do­ing so greatly re­duced her chances of sur­vival. She will not be cured from this dis­ease and that hurts ev­ery day.”

On the face of it, there would ap­pear to be few bet­ter places for a pa­tient such as Cullen to be treated than UMCU, a vast teach­ing hos­pi­tal on the edge of one of the Nether­lands’ most beau­ti­ful cities.

Since 2006, the Dutch health sys­tem has been based on the idea that all Dutch cit­i­zens – along with ex­pats – are obliged to buy in­surance. Pa­tients usu­ally have to pay the first few hun­dred euro a year of any in­surance claim, but those on low in­comes re­ceive gen­er­ous sub­si­dies and most health­care is free at the point of de­liv­ery.

In­evitably, the sys­tem isn’t with­out its prob­lems. Among other things, many Dutch peo­ple com­plain about the ex­pense of their i nsurance poli­cies. Over­all, though, it works well and is praised for its equal­ity. For cancer pa­tients, out­comes are usu­ally good. Ac­cord­ing to a re­cent re­port in the Lancet med­i­cal jour­nal, the five- year sur­vival rate for cer­vi­cal cancer in the Nether­lands is higher than in Ire­land, the UK, the US or Ger­many.

Health econ­o­mist Michiel Verk­oulen con­firms: “There are maybe one or two places in the world where you get bet­ter health­care than the Nether­lands, but not many.”

In Cullen’s case, how­ever, there is lit­tle doubt that the sys­tem failed.

A com­mon pro­ce­dure

Some of the de­tails of what hap­pened re­main un­clear, but van der Vaart ex­plains the back­ground. In April 2011, he says, dur­ing an­other pro­ce­dure un­der gen­eral anaes­thetic, Cullen un­der­went an en­do­cer­vi­cal curet­tage – a com­mon pro­ce­dure duri ng which a small sam­ple of tis­sue is checked for signs of cer­vi­cal cancer.

The pro­ce­dure was not nec­es­sar­ily stan­dard for some­one in Adri­enne Cullen’s po­si­tion, and there was no par­tic­u­lar rea­son to ex­pect a pos­i­tive re­sult. How­ever, test­ing in the UMCU pathol­ogy lab­o­ra­tory showed signs of cer­vi­cal car­ci­noma – cancer.

This re­sult should have led to fur­ther ex­am­i­na­tion, and prob­a­bly im­me­di­ate treat­ment. How­ever, van der Vaart never saw it.

Aca­demics of­ten ex­plain pa­tient safety us­ing the ex­am­ple of Swiss cheese. Hu­man sys­tems, they say, are like slices of Swiss cheese, stacked on top of one an­other. Small er­rors or weak­nesses in the sys­tem are like holes in the cheese, but they only add up to a se­ri­ous er­ror when the holes line up per­fectly through the pile.

In Cullen’s case, it seems this kind of chain re­ac­tion is prob­a­bly what hap­pened. The pre­cise chain of events that led to the fail­ure to com­mu­ni­cate the test re­sults to her doc­tor has never been defini­tively es­tab­lished, but Cullen’s doc­tors be­lieve the mis­take oc­curred be­cause the hos­pi­tal was, at the time, in the process of tran­si­tion­ing from pa­per to elec­tronic med­i­cal records.

As van der Vaart ex­plains: In 2011, “the sys­tem in place to be no­ti­fied about re­sults was partly elec­tronic, but I al­ways re­ceived the re­sults on pa­per at the out­pa­tient clinic. I would read them, sign them and then they were en­tered into the pa­per file.” He would sign a pa­per copy of the test re­sults to show he’d read them.

In this case, though, the re­sults of the cancer screen­ing ap­par­ently were en­tered into the file with­out be­ing signed, and it seems likely van der Vaart never saw them. “I had the di­ag­no­sis in the palm of my hands, in 2011, but I missed it,” he says.

In April 2013, al­most ex­actly two years af­ter the test was car­ried out, the mis­take was dis­cov­ered by a re­searcher go­ing through old files.

Van der Vaart is not an on­col­o­gist, but was ex­pe­ri­enced enough to re­alise the im­pli­ca­tions. “I was in a state of shock and de­nial for a cou­ple of min­utes,” he says.

He con­tacted Cullen to give her the bad news, and she un­der­went a se­ries of tests which ul­ti­mately con­firmed she had a large cer­vi­cal car­ci­noma. In July 2013 she had surgery to re­move it, fol­lowed by ra­dio­ther­apy and chemo­ther­apy.

At this point, there was still a chance that Cullen might be cured and the mis­take would turn out to be un­pleas­ant rather than fa­tal. How­ever, the orig­i­nal er­ror was com­pounded by the way the hos­pi­tal han­dled it.

Van der Vaart re­turns to his seat, and the next speaker takes the stage: Dr Arie Franx, who was at the time med­i­cal man­ager of the woman and baby divi­sion, which in­cluded the gy­nae­col­ogy depart­ment, mak­ing him van der Vaart’s ul­ti­mate boss.

Franx is softly spo­ken and clearly un­com­fort­able talk­ing about the case, but doesn’t shy away from say­ing he ini­tially did not han­dle Cullen’s case ap­pro­pri­ately, and didn’t ad­e­quately sup­port her or his col­league. He later says it was only months later that he re­alised “how much I and UMC Utrecht had failed”.

“I felt deep guilt and shame,” he adds.

Adri­enne Cullen takes the stage. As she be­gins telling her story, she makes an im­pres­sive, dig­ni­fied fig­ure: small, but with the calm con­fi­dence of some­one who’s ut­terly in com­mand of the facts. Cullen grew up in Dublin and Lim­er­ick, and had a suc­cess­ful career as a jour­nal­ist and au­thor in Ire­land be­fore mov­ing to France and then the Nether­lands, where she worked for a travel web­site.

It’s clear she’s still grap­pling to un­der­stand how she was treated by UMCU af­ter the calamity was dis­cov­ered. “I was met with the world’s great­est in­dif­fer­ence,” she says. “No one was in­ter­ested. The care staff I in­ter­acted with didn’t know about the mis­take and there didn’t seem to be much en­thu­si­asm to in­ves­ti­gate.”

Dire con­clu­sion

In the years fol­low­ing the di­ag­no­sis, Cullen’s health de­clined. The cancer metas­ta­sised. Early in 2015, Cullen was ex­am­ined by an in­de­pen­dent med­i­cal ad­viser – a pro­fes­sor at an­other lead­ing Dutch hos­pi­tal. His con­clu­sion was dire. “Cu­ra­tive treat­ment is no longer pos­si­ble,” he wrote. “There will only be fur­ther de­te­ri­o­ra­tion and even­tu­ally Mrs Cullen will die.”

The two-year de­lay in act­ing on the test re­sults was go­ing to cost Adri­enne Cullen her life. Ac­cord­ing to Cullen, UMCU was sent a copy of the ad­viser’s re­port, but made no at­tempt to con­tact her about it.

When med­i­cal mis­takes oc­cur, there are well- es­tab­lished in­ter­na­tional ex­am­ples for how hos­pi­tals should re­act. Prue Vines, a law pro­fes­sor who helped Cullen with her case, ex­plains: “In a re­ally short time there should be an apol­ogy and an ex­pla­na­tion given to the pa­tient by the peo­ple in­volved, backed up with proof that sys- tems have been changed so it won’t hap­pen again.”

In prac­tice, though, open dis­clo­sure still isn’t rou­tine. Hos­pi­tals strug­gle to bal­ance the need for trans­parency and ac­count­abil­ity with the need to main­tain pub­lic con­fi­dence in their ser­vices. Their lawyers worry about ad­mit­ting li­a­bil­ity, and doc­tors worry about dam­ag­ing their rep­u­ta­tions.

Dutch health­care ex­pert Mar­cel Canoy ex­plains: “Health­care in gen­eral doesn’t have a big tra­di­tion of in­ter-col­le­gial crit­i­cism. There’s not an open cul­ture of ad­mit­ting and dis­cussing and cor­rect­ing mis­takes.”

In the Nether­lands, health­care providers are man­dated by law to re­port se­ri­ous med­i­cal er­rors to the na­tional health in­spec­torate, the Health and Youth Care In­spec­torate. How­ever, the in­spec­torate re­quires hos­pi­tals to con­duct their own in­ves­ti­ga­tions, and re­port what they’ll do to pre­vent er­rors hap­pen­ing again. This means hos­pi­tals are, to some ex­tent, trusted to mon­i­tor their own performance.

In Cullen’s case, it’s clear things were not han­dled well. The in­spec­torate says UMCU only re­ported the mis­take with her test re­sults in June 2015 – more than two years af­ter it was dis­cov­ered. They did not sub­mit an of­fi­cial in­ci­dent re­port, but a de­scrip­tion of what had hap­pened and why they’d de­cided not to re­port it in 2013.

The in­spec­torate con­cluded the hos­pi­tal had taken ap­pro­pri­ate mea­sures to pre­vent a sim­i­lar in­ci­dent.

For Cullen, grap­pling with a ter­ri­ble di­ag­no­sis, the hos­pi­tal’s flat-footed re­sponse made an al­ready im­pos­si­ble sit­u­a­tion even worse. “I felt as though the hos­pi­tal was an ocean liner sail­ing on, and somebody had just un­tied the rope and we were set off to sea to fend for our­selves.”

As her health de­clined, Cullen was also shocked to dis­cover she wasn’t the only pa­tient to have been harmed at UMCU. In Novem­ber 2015, Dutch current af­fairs tele­vi­sion pro­gramme Zem­bla broad­cast an ex­posé which al­leged that UMCU’s ear, nose and throat depart­ment op­er­ated in a “cul­ture of fear”, which had put pa­tient safety in jeop­ardy and that the hos­pi­tal had failed to re­port se­ri­ous med­i­cal er­rors to in­spec­tors.

The health in­spec­torate in­ves­ti­gated and even­tu­ally con­cluded that while UMCU was gen­er­ally safe, there were “im­por­tant short­com­ings in sev­eral depart­ments” and that in sev­eral cases “there was no ques­tion of safe and good qual­ity care”.

‘Con­trol freak­ery’

Back in the lec­ture hall, Cullen continues telling her story. Her doc­tors are un­der­stand­ably sombre, but she has a wry, self-dep­re­cat­ing sense of hu­mour, and the au­di­ence reg­u­larly breaks out in laugh­ter as she pokes fun at her own talkative­ness and “con­trol freak­ery”.

Only once does her com­po­sure break, when she shows a se­ries of pho­tos of things she en­joyed be­fore she be­came ill: hol­i­days in Jerusalem and Is­tan­bul; the Christ­mas tree she dec­o­rates ev­ery year; her gar­den; her much- loved cat. Men­tion­ing her hus­band, Cullen briefly sti­fles tears, but swal­lows hard and continues her story.

She re­peat­edly pays trib­ute to the hon­esty and brav­ery of her doc­tors and, asked if she has for­given them, re­sponds firmly: “With­out a doubt . . . it’s a no-brainer. I am awed by . . . the courage and in­tegrity that they have shown,” she says.

Franx and van der Vaart are both acutely aware that com­pared to Adri­enne Cullen, they have lit­tle to com­plain about. How­ever, Cullen’s case has clearly dealt a heavy blow. Both doc­tors are vis­i­bly up­set as they the tell story of what hap­pened. “Doc­tors, we’re sup­posed to be tough,” Franx says, look­ing any­thing but. It’s also clear that the doc­tors, like Cullen, were poorly sup­ported by the hos­pi­tal.

Af­ter the news that her cancer would be ter­mi­nal, Cullen set about trying to se­cure fi­nan­cial com­pen­sa­tion. “I wasn’t set­ting out to get rich,” she tells the au­di­ence, “I just wanted our lives to con­tinue on the same fi­nan­cial foot­ing that they had be­fore I got sick.”

How­ever, it quickly be­came clear that se­cur­ing com­pen­sa­tion would in­volve an­other up­hill strug­gle with the hos­pi­tal. Ac­cord­ing to Cullen, she was told by a lawyer that she’d be un­likely to re­ceive much more than about ¤ 130,000. She was shocked. “There were cars in the UMC Utrecht car park, be­ing driven by hos­pi­tal lead­ers, that were worth more than that,” she says, pro­vok­ing wry laugh­ter from the doc­tors and nurses in the au­di­ence.

Had she known then what she knows now about the Dutch le­gal sys­tem, Cullen might have been less sur­prised. In some coun­tries, com­pen­sa­tion pay­ments for med­i­cal er­rors are rel­a­tively high. In Ire­land, for ex­am­ple, a mother who was di­ag­nosed with cer­vi­cal cancer af­ter a smear test was wrongly in­ter­preted re­port­edly was awarded dam­ages of ¤ 500,000 in 2006.

In the Nether­lands, though, things are rather dif­fer­ent. Rel­a­tively few com­pen­sa­tion claims make it to court, and big pay­outs are ex­tremely rare. One rea­son for this is the dif­fi­culty of prov­ing li­a­bil­ity for a mis­take that hap­pens in a hos­pi­tal. Rolinka Wi­jne, a Dutch spe­cial­ist in med­i­cal li­a­bil­ity, ex­plains: “With things like traf­fic ac­ci­dents it’s of­ten easy to prove who was to blame, but in most med­i­cal cases, it’s very dif­fi­cult to prove. Even if a pa­tient does prove li­a­bil­ity, they have to prove that their current sit­u­a­tion is dif­fer­ent than if an­other doc­tor had han­dled the case dif­fer­ently.”

Cullen and her hus­band even­tu­ally set­tled with UMCU for ¤545,000, in­clud­ing ¤350,000 to com­pen­sate for pain and suf­fer­ing, and the rest for loss of earn­ings. The cou­ple were ini­tially relieved, but then dis­mayed when they were asked to sign a “gag­ging clause”.

“We were hor­ri­fied,” Cullen says, “There was no way that we were ever go­ing to sign some­thing which meant I couldn’t speak freely about what had hap­pened to me.” She re­fused to sign, and the hos­pi­tal even­tu­ally backed down, and re­moved most of the clause.

Sharply crit­i­cal

Cullen is also sharply crit­i­cal of the on­go­ing lack of in­ves­ti­ga­tion into her case. Seven years af­ter the er­ror oc­curred, many facts re­main un­clear. Her voice ris­ing, Cullen tells the au­di­ence: “Many ques­tions still re­main unan­swered. Was the calamity the re­sult of the move to elec­tronic files? Were there ad­e­quate, or in­deed, any safety mea­sures put in place dur­ing this pe­riod to give ex­tra pro­tec­tion to pa­tient data? Were out­side com­pa­nies in the hos­pi­tal han­dling this pa­tient data? If so, who were they, who was su­per­vis­ing them, and what train­ing were they given?”

With­out an in­ves­ti­ga­tion, UMCU can­not an­swer these ques­tions, but ar­gues that it has learned from Cullen’s ex­pe­ri­ence. The lec­ture event in­cludes a brief pre­sen­ta­tion from Prof Jan-Willem Lam­mers, UMCU’s head of pa­tient safety, who ex­plains that the hos­pi­tal has re­formed its pro­ce­dures for in­ves­ti­gat­ing and re­port­ing po­ten­tial med­i­cal er­rors, and im­proved train­ing and sup­port for pa­tients and staff.

The Adri­enne Cullen Lec­ture – the first in a se­ries which will cover open dis­clo­sure is­sues – also rep­re­sents an im­por­tant step to­wards build­ing a cul­ture where trans­parency is au­to­matic.

From Cullen’s per­spec­tive, though, the hos­pi­tal’s changes are too lit­tle, too late. It’s also not clear that the prin­ci­ples of “open dis­clo­sure” have been adopted in full. The lec­ture is open to the pub­lic, cam­era­men are told to leave early in the pro­ceed­ings, but no of­fi­cial record­ing of the speeches is made.

When a doc­tor in the au­di­ence calls for Mar­griet Sch­nei­der and the hos­pi­tal’s lead­er­ship to re­sign, a mod­er­a­tor quickly in­ter­jects to say the is­sue is ir­rel­e­vant. A Dutch TV jour­nal­ist who tries to film the lec­ture is turned away, and later ar­rested for tres­pass af­ter trying to film out­side with­out the hos­pi­tal’s per­mis­sion. UMCU ar­gues that all jour­nal­ists were wel­come, in­clud­ing ones rep­re­sent­ing ma­jor Dutch tele­vi­sion sta­tions, and says it was merely con­cerned to pro­tect its staff from un­due pres­sure or crit­i­cism. Nev­er­the­less, the tone of the event is tense at times.

As the speeches draw to a close, there’s an awk­ward mo­ment when a hos­pi­tal rep­re­sen­ta­tive presents Cullen with a big bunch of flowers, which she po­litely but very f i rmly de­clines. “What we’re dis­cussing here is deep, it’s nasty, it’s of­fen­sive,” she ex­plains. “I know that peo­ple have apol­o­gised, but we’re not best friends.”

To a spec­ta­tor, Cullen might ap­pear in good health, but she’s of­ten in pain, has had reg­u­lar surg­eries, and knows she may not have long. Now her fo­cus is on shar­ing her story, and trying to pre­vent oth­ers from suf­fer­ing as she has. Her great hope is that the lec­ture, and the ones which will fol­low, can help drive change, in Utrecht and else­where.

“It’s too late for me”, she says, “I’d like to think this is the be­gin­ning of a new chap­ter in open­ness and trans­parency at UMCU, but there’s still a very long way to go.”

The au­di­ence erupts in thun­der­ous ap­plause, and she qui­etly re­turns to her seat.

He makes a re­mark­able con­fes­sion. ‘I am the doc­tor who is re­spon­si­ble for a de­lay of two years in di­ag­nos­ing the cer­vi­cal cancer of Adri­enne Cullen’

I felt as though the hos­pi­tal was an ocean liner sail­ing on, and somebody had just un­tied the rope and we were set off to sea to fend for our­selves

Adri­enne Cullen: a test which re­vealed cer­vi­cal cancer was not seen by her gy­nae­col­o­gist un­til it was too late, prob­a­bly be­cause the Univer­sity Med­i­cal Cen­tre Utrecht was in the process of tran­si­tion­ing from pa­per to dig­i­tal records. PHO­TO­GRAPH: JU­DITH...

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