Cleve­land Clinic cases high­light flaws in safety over­sight

Modern Healthcare - - NEWS - By Joe Carl­son

Nearly four years ago, govern­ment in­spec­tors in­ves­ti­gat­ing a com­plaint by re­tired Air Force Col. David An­toon threat­ened to cut off Cleve­land Clinic from re­ceiv­ing Medi­care pay­ments af­ter be­ing stonewalled by hospi­tal of­fi­cials. The Viet­nam com­bat vet­eran had ac­cused the hospi­tal of fail­ing to fully in­ves­ti­gate his charge that some­one other than his au­tho­rized sur­geon had per­formed prostate cancer surgery and left him gravely in­jured.

Hospi­tal of­fi­cials re­fused to show the in­spec­tors all of the notes in An­toon’s com­plaint file, and the doc­tor who claimed to have done the pro­ce­dure de­clined to talk to sur­vey­ors about how the hospi­tal han­dled the case, CMS in­spec­tion re­ports show.

An­toon, a commercial 747 pi­lot in civil­ian life un­til the oper­a­tion left him in­con­ti­nent, is baf­fled that medicine has no or­ga­ni­za­tion like the Na­tional Trans­porta­tion Safety Board to ad­dress safety fail­ures. “You can­not keep things con­cealed in avi­a­tion,” he said. But in health­care, “They’re just gath­er­ing data points from pa­tient com­plaints. And ev­ery data point is a dam­aged life or a death.”

Early 2010 wasn’t the last time the flag­ship hospi­tal of the pres­ti­gious Cleve­land Clinic Health Sys­tem was threat­ened with the ul­ti­mate sanc­tion by CMS-backed state in­spec­tors for not ad­dress­ing prob­lems ini­tially brought to light by pa­tient com­plaints. In 2012, in­spec­tors threat­ened to shut off its nearly $1 bil­lion per year in Medi­care pay­ments af­ter hospi­tal of­fi­cials ad­mit­ted they hadn’t fully in­ves­ti­gated a com­plaint that doc­tors had im­planted a heart stent with­out first get­ting the pa­tient’s con­sent.

And last July, Ohio hospi­tal in­spec­tors again threat­ened to sus­pend Cleve­land Clinic’s par­tic­i­pa­tion in Medi­care af­ter hospi­tal of­fi­cials told a pa­tient they had no ev­i­dence that a sur­geon ne­glected to re­move a su­ture nee­dle af­ter surgery. It was only un­der ques­tion­ing by a govern­ment

in­spec­tor that a hospi­tal om­buds­man later ad­mit­ted hav­ing an X-ray on file show­ing the left-in nee­dle, ac­cord­ing to in­spec­tion re­ports on file with the CMS.

Cleve­land Clinic of­fi­cials did not make any top-rank­ing of­fi­cials avail­able to com­ment on the is­sues raised by its re­sponses to these and other pa­tient com­plaints. “Cleve­land Clinic sees more than 5 mil­lion out­pa­tient vis­its per year, has nearly 160,000 ad­mis­sions and the high­est acu­ity of pa­tients in the coun­try (mean­ing the sick­est of the sick),” hospi­tal spokes­woman Eileen Sheil wrote in an e-mail. “We are com­mit­ted to pro­vid­ing the best care and safest en­vi­ron­ment for our pa­tients.” Cleve­land Clinic of­fi­cials also say quirks in the state’s in­spec­tion sys­tem lead to a higher num­ber of CMS de­fi­cien­cies.

A three-month Mod­ern Health­care anal­y­sis of hun­dreds of pages of federal in­spec­tion re­ports re­veals the 1,268-bed hospi­tal spent 19 months on “ter­mi­na­tion track” with Medi­care be­tween 2010 and 2013 as a re­sult of more than a dozen in­spec­tions and fol­low-up vis­its trig­gered by pa­tient com­plaints.

The Cleve­land Clinic is far from alone in fac­ing the only sanc­tion the CMS can ap­ply to hos­pi­tals when se­ri­ous safety prob­lems and vi­o­la­tions of in­formed con­sent rules are brought to light by pa­tient com­plaints. An anal­y­sis of Medi­care in­spec­tion data found that be­tween 2011 and 2014 there were at least 230 val­i­dated se­ri­ous in­ci­dents—dubbed “im­me­di­ate jeop­ardy” com­plaints—that led the agency to threaten hos­pi­tals with los­ing their abil­ity to serve Medi­care pa­tients un­less they im­me­di­ately fixed the prob­lems.

Over­all, there were at least 9,505 CMS com­plaints lodged in that time against 1,638 hos­pi­tals, which in­cluded low-sever­ity “stan­dard level” vi­o­la­tions; mi­dlevel “con­di­tion level” vi­o­la­tions; and the less com­mon but most se­ri­ous “im­me­di­ate jeop­ardy” com­plaints. Only the most se­ri­ous and con­di­tion-level com­plaints can lead to threats of be­ing cut off from govern­ment fund­ing.

Only in very rarest of cir­cum­stances has the CMS fol­lowed through on the threat. The CMS’ ul­ti­mate goal with hospi­tal in­spec­tions “is to en­sure com­pli­ance with Medi­care rules, not close down hos­pi­tals that are es­sen­tial to lo­cal com­mu­ni­ties,” a CMS spokes­woman said.

Un­like with nurs­ing homes, the CMS lacks the power to levy fines against hos­pi­tals that vi­o­late the rules. The ab­sence of mean­ing­ful sanc­tions pro­vides a loop­hole for of­fi­cials at some hos­pi­tals to en­gage in pro­longed ne­go­ti­a­tions with CMS in­spec­tors when con­fronted with pa­tient-safety com­plaints, which typ­i­cally con­clude with the hospi­tal promis­ing to re­vamp poli­cies and beef up staff train­ing. The re­sult, safety ad­vo­cates say, is a reg­u­la­tory sys­tem un­able to re­spond to prob­lems in a man­ner that en­sures the prob­lems won’t hap­pen again once the in­spec­tors have left the premises.

“There’s a lack of a kind of a graded set of con­se­quences,” said Dr. John Santa, med­i­cal di­rec­tor for Con­sumer Re­ports’ health di­vi­sion. “One of the chal­lenges in the sys- tem is there isn’t much in be­tween. It’s ei­ther a traf­fic ticket or a felony.”

One of the most heav­ily cited hos­pi­tals in the coun­try over the three years of CMS records re­viewed by Mod­ern Health­care was the well-known re­search-ori­ented UC San Diego Med­i­cal Cen­ter, which racked up 73 de­fi­cien­cies in that time pe­riod. The 25-bed crit­i­cal-ac­cess hospi­tal Atoka (Okla.) County Med­i­cal Cen­ter had 70 de­fi­cien­cies over the three years.

The Cleve­land Clinic, with 36 de­fi­ciency com­plaints, ranked 20th on the list of hos­pi­tals with de­fi­cien­cies stem­ming from pa­tient com­plaints. Other high-pres­tige med­i­cal cen­ters ranked sig­nif­i­cantly lower. Johns Hop­kins Hospi­tal in Bal­ti­more, for in­stance, re­ceived six de­fi­ciency notices dur­ing the three-year pe­riod.

If Dr. nom­i­nated White Cleve­land Toby House Cos­grove by Clinic to the be­come is CEO the Vet­er­ans next sec­re­tary Af­fairs, there of will likely be closer scru­tiny of the hospi­tal sys­tem’s over­all safety and qual­ity record on Capi­tol Hill.

CEO is VA can­di­date

The largest pri­vate em­ployer head­quar­tered in Ohio, the Cleve­land Clinic over the years has built a stel­lar rep­u­ta­tion for be­ing “pa­tient-cen­tered” and has con­sis­tently earned high rank­ings from some rat­ings groups. Last week, sources con­firmed that CEO Dr. Toby Cos­grove, who has headed the Cleve­land Clinic since 2004, is un­der con­sid­er­a­tion by the White House to be­come the next sec­re­tary of Vet­er­ans Af­fairs, a job that would have him run­ning the scan­dal-wracked, $55 bil­lion na­tional health sys­tem for mil­i­tary vet­er­ans.

His nom­i­na­tion will likely bring closer scru­tiny of his hospi­tal sys­tem’s over­all safety and qual­ity record on Capi­tol Hill. The busi­ness-backed Leapfrog Group, for in­stance, gave the Cleve­land Clinic a D when it ex­panded its safety grades in 2012 to in­clude fail­ing grades. The grade im­proved to C last year.

“We have been con­tin­u­ally dis­ap­pointed by their pa­tient-safety scores, al­though we have seen im­prove­ments,” said Leah Bin­der, CEO of the group.

Safety ex­perts note se­ri­ous in­ci­dents and re­sponses to in­di­vid­ual cases rarely af­fect hos­pi­tals’ over­all rank­ing in pa­tient-sat­is­fac­tion sur­veys and ap­pear to have lit­tle im­pact on ac­cred­i­ta­tion by the Joint Com­mis­sion, a vol­un­tary or­ga­ni­za­tion funded by hos­pi­tals whose only en­force­ment power is to with­draw ac­cred­i­ta­tion. Like the CMS, the Joint Com­mis­sion very rarely uses its ul­ti­mate pun­ish­ment. The com­mis­sion, whose in­spec­tion re­ports are not made pub­lic, has con­sis­tently awarded the Cleve­land Clinic good qual­ity-of-care rat­ings.

Yet the high level of pa­tient com­plaints leading to CMS de­fi­ciency re­ports at Cleve­land Clinic and other well-known hos­pi­tals is rais­ing alarm bells. “If you have these events in a place that has this kind of rep­u­ta­tion, it makes you won­der about your aver­age com­mu­nity or teach­ing hospi­tal,” said Dr. Wil­liam Jessee, a for­mer ex­ec­u­tive of the Joint Com­mis­sion and CEO of the Med­i­cal Group Man­age­ment As­so­ci­a­tion who is now a pro­fes­sor of health sys­tems man­age­ment at the Univer­sity of Colorado.

Pa­tient-safety ex­perts say that in­di­vid­ual vi­o­la­tions can

All of the vi­o­la­tions were re­ported to the hospi­tal’s board of gov­er­nors and to Cos­grove, who in at least one case was per­son­ally cited for sys­temic man­age­ment fail­ure.

hap­pen in any hospi­tal. But pat­terns of re­peated types of vi­o­la­tions are rarer and more con­cern­ing be­cause they may be a sign that a hospi­tal is fail­ing to do the deep anal­y­sis re­quired to pre­vent fu­ture oc­cur­rences of the same prob­lems. But nei­ther the federal hospi­tal in­spec­tion sys­tem nor the ac­cred­i­ta­tion process is de­signed to track or pun­ish re­cur­rent vi­o­la­tions.

For each case the CMS cited at the Cleve­land Clinic, hospi­tal of­fi­cials even­tu­ally cor­rected the prob­lems to the sat­is­fac­tion of state sur­vey­ors, who in­spect hos­pi­tals on Medi­care’s be­half. All of the vi­o­la­tions were re­ported to the hospi­tal’s board of gov­er­nors and to Cos­grove, who in at least one case was per­son­ally cited for sys­temic man­age­ment fail­ure. They cited him for fail­ing to en­force an ad­e­quate in­formed-con­sent sys­tem af­ter he ad­mit­ted some pa­tients were not told a ro­bot would be used in their pro­ce­dure.

The threat­ened fund­ing ter­mi­na­tions also cov­ered a se­ries of six op­er­at­ing-room fires dat­ing to 2009 and 2010 that left three pa­tients with phys­i­cal in­juries, in­clud­ing sec­ond-de­gree burns to a pa­tient with a cere­bral hem­or­rhage and an­other get­ting a small-bowel trans­plant. “Al­though a root-cause anal­y­sis was done on the first fire in April of 2009, the hospi­tal con­tin­ued to have fires caused by the same type of ig­ni­tion,” in­spec­tors wrote.

They con­cluded elec­tric sur­gi­cal tools were set­ting skin an­ti­sep­tics on fire, pos­si­bly be­cause op­er­at­ing-room hu­mid­ity wasn’t be­ing mon­i­tored ac­cord­ing to federal hospi­tal fire codes. “A re­view of the hu­mid­ity read­outs re­vealed that many of the read­ings were lower than what is re­quired,” ac­cord­ing to the re­port. Safety ex­perts say re­peat vi­o­la­tions are a warn­ing flag. “If there was no additional in­ves­ti­ga­tion or ac­tions taken af­ter the first root-cause anal­y­sis failed to pre­vent sub­se­quent fires, that would ap­pear to be an in­dict­ment of man­age­ment and lead­er­ship,” said Dr. Jim Ba­gian, a for­mer as­tro­naut and na­tion­ally known hospi­tal-safety ex­pert at the Univer­sity of Michi­gan. “That would in­di­cate there is no ro­bust safety sys­tem, which (raises) the ques­tion, if there was no sys­tem for these fires in the OR, is there a safety sys­tem that op­er­ates any­where in the hospi­tal?” said Ba­gian, who was found­ing di­rec­tor of the Na­tional Cen­ter for Pa­tient Safety at the Vet­er­ans Health Ad­min­is­tra­tion.

The fires trig­gered a two-day “im­me­di­ate jeop­ardy” warn­ing by the CMS. Even­tu­ally, the Cleve­land Clinic re­sponded by mak­ing op­er­at­ing room pol­icy changes and con­duct­ing staff train­ing ses­sions, the re­ports show.

Jessee, the for­mer Joint Com­mis­sion ex­ec­u­tive, said health­care ex­perts be­lieve in­ci­dents that af­fect pa­tient safety are far more com­mon than re­ported. A se­ries of re­cent re­ports by HHS’ Of­fice of the In­spec­tor Gen­eral also con­cluded the na­tion’s reporting sys­tem for pa­tient-safety in­ci­dents was in­ad­e­quate.

“The in­dus­try has been wrestling with the pa­tient-safety is­sue for at least 15 years,” Jessee said. “It’s been a high-vis­i­bil­ity pol­icy is­sue since 1999, and yet you hear about events and you won­der how much progress has been made.”

An­toon, the mil­i­tary vet and for­mer commercial pi­lot, has since gone on to be­come a pa­tientsafety ad­vo­cate well-known in the hall­ways of health­care reg­u­la­tors across the coun­try for his ag­gres­sive in­quiries. He has an on­go­ing med­i­cal-mal­prac­tice case against the Cleve­land Clinic and his physi­cians there, but he says no amount of money will re­pair his phys­i­cal or emo­tional dam­age.

“This stopped be­ing about me a long time ago. This is about a fraud­u­lent, bro­ken med­i­cal sys­tem where pa­tients are in­jured and no­body is ac­count­able,” he said. “The air­planes are still crash­ing. Doesn’t any­body care?”

Re­tired Air Force Col. David An­toon be­came a pa­tient-safety ad­vo­cate af­ter he says was gravely in­jured dur­ing surgery at the Cleve­land Clinic. He says no one is held ac­count­able in the U.S. health­care sys­tem.

STAN BULLARD

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