Tar­get­ing ad­verse events

Ef­fort aims to en­sure health IT caus­ing no harm

Modern Healthcare - - THE WEEK IN HEALTHCARE - Joseph Conn

The health­care in­dus­try, with the fed­eral govern­ment at the helm, is try­ing to find whether health in­for­ma­tion tech­nol­ogy sys­tems are do­ing pa­tients se­ri­ous harm, and if so, to what ex­tent.

Ex­perts say only about 10% of ad­verse events are re­ported, with most re­ported as caused by some­thing else.

Last week, the Of­fice of the National Co­or­di­na­tor for Health In­for­ma­tion Tech­nol­ogy at HHS re­leased its Health In­for­ma­tion Tech­nol­ogy Pa­tient Safety Ac­tion and Sur­veil­lance Plan, which calls for a pro­gram to gather data about health IT-re­lated pa­tient safety events.

The plan calls for thou­sands of health­care providers, hun­dreds of health in­for­ma­tion tech­nol­ogy ven­dors and dozens of pa­tient safety or­ga­ni­za­tions to vol­un­teer, while fed­er­ally se­lected health IT ac­cred­i­ta­tion bod­ies in­clud­ing the Joint Com­mis­sion and the Agency for Health­care Re­search and Qual­ity are drafted into pa­tient safety ser­vice.

Once suf­fi­cient data is col­lected—af­ter a year or so—the 50-page ONC plan calls for par­tic­i­pants to use the knowl­edge they have gained about health IT-linked risks and their causes to fix those prob­lems.

The ONC plan in­sists health IT tools such as drug in­ter­ac­tion alerts and best prac­tice pro­to­cols re­main vi­tal pa­tient safety re­sources. But as $15.1 bil­lion in fed­eral IT in­cen­tive pay­ments have swelled the ranks of health IT users, sev­eral re­ports and ar­ti­cles have been pub­lished in re­cent years point­ing to anec­do­tal in­ci­dents about er­rors linked to th­ese sys­tems. Th­ese re­ports have uni­formly de­cried the lack of data and rig­or­ous re­al­world anal­y­sis of the pa­tient safety im­pli­ca­tions of health­care IT.

Last month, an Amer­i­can Col­lege of Emer­gency Physi­cians re­port said a “rush to cap­i­tal­ize on the huge fed­eral in­vest­ment” has yielded “an alarm­ing num­ber of clin­i­cians … anec­do­tally re­port­ing a sub­stan­tial in­crease in the in­ci­dence of wrong or­der/wrong pa­tient er­rors” us­ing IT. But the ACEP re­port, like sev­eral pre­de­ces­sors, noted there are “few con­sis­tent data on how com­monly th­ese er­rors oc­cur, and few stud­ies are ac­tu­ally fo­cused on col­lect­ing ev­i­dence of th­ese er­rors.”

In Jan­uary, the Food and Drug Ad­min­is­tra- tion, work­ing with the ONC and the Fed­eral Com­mu­ni­ca­tions Com­mis­sion, is ex­pected to re­lease rec­om­men­da­tions on es­tab­lish­ing a “risk-based reg­u­la­tory frame­work for health IT.” The FDA re­port, man­dated by the 2012 Food and Drug Ad­min­is­tra­tion Safety and In­no­va­tion Act (FDASIA) could lead to di­rect FDA reg­u­la­tion of health IT sys­tems.

Since Jan­uary 2011, more than $15.1 bil­lion

“One hos­pi­tal I vis­ited had three dif­fer­ent, dis­tinct sys­tems just for med­i­ca­tion rec­on­cil­i­a­tion. You can see the risk of some type of er­ror oc­cur­ring.”

—Dr. Ron Wyatt Med­i­cal di­rec­tor of health­care im­prove­ment di­vi­sion Joint Com­mis­sion

in fed­eral spend­ing un­der the elec­tronic health-record in­cen­tive pay­ment pro­gram has pro­duced what Dr. Ron Wyatt, med­i­cal di­rec­tor of the health­care im­prove­ment di­vi­sion at the Joint Com­mis­sion, called “al­most an ex­plo­sion of health IT” adop­tion.

“You just look at the vol­ume and you start think­ing about what are the po­ten­tials and risks of some­thing oc­cur­ring with all that data,” Wyatt said. “One hos­pi­tal I vis­ited had three dif­fer­ent, dis­tinct sys­tems just for med­i­ca­tion rec­on­cil­i­a­tion. You can see the risk of some type of er­ror oc­cur­ring.”

The Joint Com­mis­sion, un­der the ONC plan, will in­ves­ti­gate health-IT re­lated ad­verse events, de­velop fol­low-up and cor­rec­tive ac­tion plans and cre­ate a data­base of events for fur­ther re­search. “We want to look at where is health IT caus­ing an un­safe con­di­tion, or a near miss or a close call, not just sen­tinel events,” Wyatt said.

Cur­rently, there are no good data on the in­ci­dence of IT-re­lated events, said Dr. Wil­liam Mu­nier, di­rec­tor of the Cen­ter for Qual­ity Im­prove­ment and Pa­tient Safety at HHS’ Agency for Health­care Re­search and Qual­ity.

AHRQ has de­vel­oped com­mon for­mats for the stan­dard­ized re­port­ing of pa­tient safety in­ci­dent in­for­ma­tion by providers to fed­er­ally char­tered pa­tient safety or­ga­ni­za­tions.

Hos­pi­tals whose safety re­port­ing sys­tems use the lat­est AHRQ ver­sion of the stan­dards, ver­sion 1.2, can re­port IT-linked cases to their PSOs now, he said.

The ONC plan also calls for AHRQ to gather IT-linked pa­tient safety event data from the na­tion’s 77 PSOs into a cen­tral data source. That national data­base is al­ready func­tional and should be re­ceiv­ing de-iden­ti­fied data this year, Mu­nier said.

Even so, the process is un­likely to pro­duce a list of glitch-prone health IT ven­dors caus­ing pa­tient safety events. “Most IT-re­lated events don’t present the IT it­self as the cause,” Mu­nier said. They are typ­i­cally re­ported as some­thing else, maybe as an ad­verse drug event, or a pa­tient fall, and “it takes some sleuthing af­ter the event” to find an IT con­nec­tion.

“If there is some­thing in­her­ently danger­ous, a clear-cut glitch, about a piece of soft­ware, the ven­dor is go­ing to find out about it and fix it,” Mu­nier said. What the data­base is likely to gather is a slew of hu­man fac­tors linked to IT and con­tribut­ing to pa­tient safety prob­lems, Mu­nier said.

As stated in its plan, the ONC hasn’t lost faith that “health IT has enor­mous po­ten­tial to im­prove the qual­ity and safety of care.”

One of the “most chal­leng­ing” IOM rec­om­men­da­tions—re­jected by the ONC—was a call for HHS to cre­ate an in­de­pen­dent fed­eral en­tity to in­ves­ti­gate health IT-linked pa­tient safety in­ci­dents, said Dr. Paul Tang, chief in­no­va­tion and tech­nol­ogy of­fi­cer at the Palo Alto (Calif.) Med­i­cal Foun­da­tion.

“It’s in­ter­est­ing they picked on a pri­vate or­ga­ni­za­tion, the Joint Com­mis­sion,” Tang said. “That cov­ers hos­pi­tals; it doesn’t cover the am­bu­la­tory sec­tor. But that’s a rea­son­able ap­proach.”

Dr. Ja­cob Rei­der, chief med­i­cal of­fi­cer at the ONC, will con­tinue to lead im­ple­men­ta­tion as over­seer of the ONC Safety Pro­gram. He said the still-de­vel­op­ing FDASIA frame­work “will be com­ple­men­tary” to the ONC ef­fort, the plan’s au­thors said.

Rei­der is un­clear of the im­pact the FDASIA work group or the FDA re­port might have on pos­si­ble re­vi­sions of the ONC plan. “It’s a mas­sive task we’re start­ing to take on here, and FDASIA will be one of the many in­puts into the fi­nal struc­ture,” he said.

Physi­cian in­for­mati­cist Dr. Scot Sil­ver­stein said he’s wor­ried about how long it will take the Joint Com­mis­sion to get up to speed on health IT and would rather see the FDA take over reg­u­la­tion of the health IT in­dus­try.

“Of all the or­ga­ni­za­tions that have ex­pe­ri­ence in IT val­i­dat­ing, they are the best of the bunch,” he said.

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