Modern Healthcare - - LEGAL - By Sabriya Rice

CAMDEN, S.C.—Sur­gi­cal team mem­bers shuf­fle in and out of the op­er­at­ing room pre­par­ing for the sec­ond pro­ce­dure of the day at Ker­shawHealth, a 120-bed hos­pi­tal in a town of about 7,000 in north cen­tral South Carolina.

With a man on the op­er­at­ing ta­ble for a la­paro­scopic gall­blad­der re­moval, an anes­the­si­ol­o­gist checks lev­els on a mon­i­tor. A nurse sets up ban­dages and other sup­plies on a tray. Dr. Ed­ward Gill, the sur­geon, takes a fi­nal look at mark­ings des­ig­nat­ing the sur­gi­cal area on the pa­tient’s stom­ach. Some make small talk about the risk of flood­ing be­cause of heavy rains as Christ­mas ap­proaches. “All right, let’s get started,” Gill an­nounces. It’s 7:35 a.m.

But then ev­ery­one stops. No scalpel is lifted. All eyes turn to a poster la­beled in jumbo print, “Ker­shawHealth Safe Surgery Check­list,” on the wall at the foot of the sur­gi­cal ta­ble.

The team goes over each item on the list aloud, and each mem­ber par­tic­i­pates. The regis­tered nurse con­firms the pa­tient’s name and date of birth, that X-ray equip­ment is in the room, and that the man is al­ler­gic to a com­mon pain medicine. The anes­the­si­ol­o­gist states the type of drug be­ing ad­min­is­tered and that there are no cur­rent is­sues with the air­way. The sur­gi­cal tech­ni­cian, cir­cu­lat­ing nurse and oth­ers also weigh in.

Fi­nally, Gill again con­firms the type of surgery, says it should last about an hour, and notes that the pa­tient has hy­per­ten­sion, a chronic health prob­lem that could af­fect the pro­ce­dure’s out­come.

“Does any­one have any­thing to add? Speak up,” Gill says as he looks around the room. When no one speaks, the op­er­a­tion be­gins at 7:37 am. The process lasted just un­der two min­utes.

The pause for the check­list is in­tended to help the team avoid ter­ri­ble mis­takes like op­er­at­ing on the wrong per­son or body part. It also fa­cil­i­tates com­mu­ni­ca­tion among clin­i­cians, who oth­er­wise say sur­pris­ingly lit­tle to one another be­fore, dur­ing or af­ter a pro­ce­dure. When used ef­fec­tively, pro­po­nents say check­lists im­prove ef­fi­ciency in the OR, an area con­sid­ered by some safety lead­ers to be among the most chaotic places in a hos­pi­tal.

Sur­gi­cal check­lists, an ap­proach drawn from com­mer­cial aviation and other high­risk in­dus­tries, gained pop­u­lar­ity when the World Health Or­ga­ni­za­tion pro­moted them in 2007 un­der the lead­er­ship of sur­geon and au­thor Dr. Atul Gawande. He fur­ther pop­u­lar­ized them in an in­flu­en­tial book, The Check­list Man­i­festo, pub­lished in 2009.

But they have yet to be­come widely or sys­tem­at­i­cally adopted. As a re­sult, there’s not much data on their ef­fec­tive­ness, which in turn com­pli­cates the sales pitch to per­suade or­ga­ni­za­tions to in­vest the time and re­sources re­quired to make them work.

South Carolina is now the test­ing ground for a much more fo­cused ap­proach. In 2013, the South Carolina Hos­pi­tal As­so­ci­a­tion, work­ing with Gawande and the Har­vard Univer­sity School of Pub­lic Health, launched a struc­tured ini­tia­tive to get ev­ery hos­pi­tal in the state to reg­u­larly use a pre-sur­gi­cal safety check­list process.

The lead­ers of the project es­ti­mated that do­ing so could save 500 pa­tient lives a year by avert­ing med­i­cal mis­takes. Har­vard re­searchers gath­ered ad­min­is­tra­tive data and data from the state’s death reg­istry to track mor­tal­ity out­comes in places that have adopted check­lists. Ini­tial find­ings have been sub­mit­ted for peer re­view and may be pub­lished this spring.

South Carolina was cho­sen for Har­vard’s project be­cause of the state’s previous in­vest­ment in an all-payer ad­min­is­tra­tive data set. In ad­di­tion, the state launched a mul­ti­year project with the Joint Com­mis­sion in 2013 to im­prove the over­all qual­ity and safety of pa­tient care.

Hos­pi­tals and health sys­tems strug­gle to cre­ate the cul­ture re­quired to be­come high-re­li­a­bil­ity or­ga­ni­za­tions, Joint Com­mis­sion CEO Dr. Mark Chas­sin said in a re­cent in­ter­view, us­ing a term that de­scribes or­ga­ni­za­tions that are en­gaged in com­plex and high-risk ac­tiv­i­ties but still man­age to avoid cat­a­strophic events. “Health­care can get to that state where the op­er­a­tion of the or­ga­ni­za­tion is so good that zero harm is a byprod­uct of the way they do their work.”

But check­lists fail when they’re tossed into an en­vi­ron­ment that doesn’t fully sup­port the ef­fort or when the check­list ap­proach isn’t tai­lored to match the or­ga­ni­za­tion’s needs and cul­ture, Gawande said.

“It takes lead­er­ship sup­port at the top and en­thu­si­asts on the front­line,” he said. “You need both, be­cause en­thu­si­asm dies on the vine with­out a sys­tem be­hind you.”

In­deed, the South Carolina Hos­pi­tal As­so­ci­a­tion found that ac­cep­tance of the check­list process var­ied from hos­pi­tal to hos­pi­tal, but those that had the most suc­cess had com­mit­ted to fol­low­ing all of the steps needed to be­come high-re­li­a­bil­ity or­ga­ni­za­tions—they of­fered lead­er­ship sup­port, fi­nan­cial re­sources and cul­ti­vated staff mem­bers who were ded­i­cated to the en­ter­prise. They also al­lowed staff to cus­tom­ize the process.

“One size does not fit all,” said Lorri Gib­bons, vice pres­i­dent for qual­ity im­prove­ment and pa­tient safety at the as­so­ci­a­tion. To that end, the group brought in engi­neers with ex­per­tise in process im­prove­ment to visit ev­ery hos­pi­tal, ob­serve its pro­ce­dures, and make rec­om­men­da­tions to help each fa­cil­ity tai­lor the tool to meet its needs.

Ash­ley Childers, an in­dus­trial en­gi­neer from Clem­son Univer­sity, has driven over 19,000 miles to help more than 50 South Carolina hos­pi­tals with their check­list pro­cesses.


Many hos­pi­tals she vis­ited, in­clud­ing Ker­shaw-Health, thought their sur­gi­cal units were al­ready safe, even though sur­geons could start a pro­ce­dure with­out ut­ter­ing a word to the team, and staffers were afraid to speak up when they knew some­thing was wrong. “That hap­pened even if they al­ready had a check­list in place,” she said.

Jamie Thomp­son, the hos­pi­tal’s chief cer­ti­fied regis­tered nurse anes­thetist, said the OR teams were go­ing through the check­list process by rote with­out pay­ing close at­ten­tion to what peo­ple were say­ing.

There was very lit­tle pre-surgery com­mu­ni­ca­tion, agreed Rosa Canty, a charge nurse. “We’d just go in the room and start mak­ing an in­ci­sion.”

The sur­geons were one of the big­gest hur­dles. “‘This is go­ing to slow me down’ ” was the main com­plaint, said Dr. Ben­jamin Black­mon, an anes­the­si­ol­o­gist who championed the fa­cil­ity’s sur­gi­cal check­list pro­gram. “Peo­ple saw it as just another time in­tru­sion.”

Ker­shaw-Health up­dated its check­list in 2014, and its ap­proach quickly gained statewide recog­ni­tion. The hos­pi­tal’s cus­tom pre-surgery check­list has more than 25 boxes. While that seems like a lot, the team is able to go through them quickly. The hos­pi­tal’s process also in­cludes a re­quired post-surgery “de­brief.” Again, all mem­bers of the sur­gi­cal team have a speak­ing role. This time, spec­i­men la­bels are read out loud to con­firm their ac­cu­racy, and staff has a chance to speak up if a piece of equip­ment did not work prop­erly.

The sur­gi­cal pro­fes­sion has only be­gun to ap­pre­ci­ate the po­ten­tial ben­e­fits of the in­stru­ment, ac­cord­ing to the Amer­i­can Col­lege of Sur­geons, which in 2013 joined a cam­paign to en­cour­age the use of sur­gi­cal check­lists.

“We’re try­ing to change a cul­ture that has deep roots,” said Dr. Bill Berry, chief med­i­cal of­fi­cer for Ari­adne Labs, a not-for-profit health­care so­lu­tions group that op­er­ates in part­ner­ship with Brigham and Women’s Hos­pi­tal and the Har­vard School of Pub­lic Health. Gawande is the lab’s ex­ec­u­tive di­rec­tor.

“I may win some peo­ple over,” Berry said. But oth­ers, he said, will gripe, say­ing, “‘I’ve been prac­tic­ing for 40 years and never used this ... I don’t need no stink­ing check­list.’ ”

That per­va­sive at­ti­tude ex­plains why sur­gi­cal check­lists have pro­duced mixed re­sults so far.

A study pub­lished in the New Eng­land Jour­nal of Medicine in 2014 found that sur­gi­cal safety check­lists used in more than 100 hos­pi­tals in On­tario, Canada, did not sig­nif­i­cantly re­duce com­pli­ca­tions or deaths. The On­tario Min­istry of Health and Long-Term Care had re­quired all hos­pi­tals in the prov­ince to in­cor­po­rate check­lists by July 2010.

A ret­ro­spec­tive, lon­gi­tu­di­nal study pub­lished in JAMA Surgery in 2015 ex­am­ined the sur­gi­cal out­comes among 64,891 pa­tients in 29 Michi­gan hos­pi­tals from 2006 through 2010. Re­searchers looked at whether im­ple­men­ta­tion of a check­list-based qual­ity im­prove­ment pro­gram called Key­stone Surgery was as­so­ci­ated with im­proved 30-day mor­tal­ity rates, fewer sur­gi­cal-site in­fec­tions and re­duced rates of other com­pli­ca­tions. They found no as­so­ci­a­tion.

“The story of sur­gi­cal qual­ity im­prove­ment has be­come a saga of high hopes fol­lowed by dashed ex­pec­ta­tions,” Dr. David Ur­bach, of the Univer­sity Health Net­work in Toronto, wrote in an ed­i­to­rial ac­com­pa­ny­ing the JAMA Surgery study. It was “one more dis­ap­point­ment to this boule­vard of bro­ken dreams.”

To change the cul­ture so that sur­geons and ev­ery­one else were on board, Ker­shaw-Health re-eval­u­ated the items on the orig­i­nal check­list first pro­moted by the WHO and in­spired by Gawande’s work.

They no­ticed, for ex­am­ple, that the check­list in­cluded tasks that their hos­pi­tal per­formed in the hold­ing area in­stead of the OR, so some sur­geons didn’t think the check­list items were rel­e­vant, or they would try to mem­o­rize the parts they needed. Black­mon, the “physi­cian cham­pion” at Ker­shaw-Health, also used what he calls old­fash­ioned peer pres­sure to get col­leagues to buy in to the pro­gram.

“No­body wants to be seen as the out­lier,” Black­mon said. “Sur­geons are com­pet­i­tive.”

The fa­cil­ity made the full check­list process manda­tory for ev­ery sur­gi­cal pa­tient, in­stead of op­tional as be­fore. It im­ple­mented the hos­pi­tal as­so­ci­a­tion’s rec­om­men­da­tion that ev­ery staffer in the OR say some­thing dur­ing the pre-surgery pause and post-surgery de­brief, from the sur­geon to the sur­gi­cal as­sis­tant.

The Ker­shaw-Health staff also added a fi­nal box to the check­list, which asks: “What could have been done to make this case safer or more ef­fi­cient?” In ad­di­tion, the hos­pi­tal posted check­list re­minders in prom­i­nent places. A check­list hangs in each OR, and its jumbo font is large enough for ev­ery­one to clearly see. Re­minders about time­outs and de­briefs are posted at the en­trance and exit of each sur­gi­cal suite.

The fa­cil­ity now has nearly 100% com­pli­ance, which is tracked through monthly as­sess­ments of how of­ten the check­list process was skipped.

Some South Carolina hos­pi­tals have had less suc­cess, ac­knowl­edged Childers, the in­dus­trial en­gi­neer coach­ing the state’s hos­pi­tals on check­list im­ple­men­ta­tion. One of the big­gest chal­lenges is a lack of data that proves us­ing them makes a dif­fer­ence in pa­tient out­comes.

“It’s go­ing to take a huge num­ber of op­por­tu­ni­ties be­fore we see any kind of sta­tis­ti­cal change,” Childers said. “Peo­ple ask where the data is, but the feel­ing comes first.”

And un­til Ari­adne Labs has find­ings to share from the data col­lected in South Carolina, Berry ar­gues that the day-to-day ben­e­fit of bet­ter com­mu­ni­ca­tion among team mem­bers and the prom­ise of a more ef­fi­cient OR (and, with it, the abil­ity to book more pro­ce­dures) should be com­pelling sell­ing points for clin­i­cians.

“In the end it’s worth it be­cause they end up tak­ing bet­ter care of their pa­tients,” Berry said. “And I think we’re go­ing to be able to show that in data over time.”

A check­list is dis­played on a poster in op­er­at­ing rooms at Ker­shawHealth for sur­gi­cal teams, and team mem­bers go over the list to­gether be­fore each pro­ce­dure.

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