Themonthlypublication · calsite,andmaintainingnormal bodytemperatureduringsurgery. Adheringtoall6measureswas linkedtoreducingthelikelihoodof apostoperativeinfectionfrom14.2 to6.8per1,000discharges,astatis-ticallysignificantresult.Butthe3

August 2010 Vol 26, No 8

The monthly publicationfor OR decision makers

In this issue

PERFORMANCEIMPROVEMENT.What comes next forSCIP measures? ..........................5

Recession’s impact lingersfor hospitals ................................7

OR PERFORMANCE.Data sparks on-timeimprovements...........................11

Higher SSI rate withrobotics in new study ..............15

TECHNOLOGY FORSURGERY.Robotics: Little data,much debate .............................16

TECHNOLOGY FORSURGERY.Beyond robotics: What toexpect next?...............................18

PATIENT SAFETY.Breakthroughs on wrong-sitesurgery.......................................20

STERILIZATION &INFECTION CONTROL.Don’t overlook reprocessinginstructions ...............................23

AMBULATORY SURGERYCENTERS.Meeting an ASC’sfinancial targets ........................26

AT A GLANCE.........................32

ASC section on page 26.Team agreement, competitionboost record for on-time starts

Considering robotics? Plan for aprogram, not just procedures

Robotic surgery has becomepart of the OR landscape,partly driven by marketing,

as competing hospitals purchaserobots and advertise them to con-sumers eager for the latest technol-ogy.“It’s definitely a consumer-dri-

ven health care offering,” saysLynda Petty, RN, director of peri-operative education, policy, andprocess improvement at The OhioState University (OSU) MedicalCenter in Columbus. OSU was thefirst hospital to use the da Vincirobot, manufactured by Intuitive

Surgical, which remains the onlysurgical robot brand on the market.For teaching and academic hos-

pitals like OSU, robotic surgery isalmost a requirement, despite lin-gering questions about its cost andeffectiveness compared to standardsurgery. For other hospitals, it canbe a way to prevent a high-volumesurgeon from taking business else-where or to recruit surgeons whoexpect a robot in a hospital’s arse-nal.Whatever your reasons for start-

ing a robotics program, experts say

Third in a series on OR performance.

With health care reformlooming and the finan-cial picture for hospitals

uncertain, perioperative leadersknow senior executives will look tothe OR as a major source of rev-enue. That’s likely to increase pres-sure to improve OR performance.Starting cases on time in the morn-ing is one way surgeons judge anOR’s customer service and respon-siveness.For a Harrisburg, Pennsylvania-

based health system, a team agree-ment and some friendly competi-

tion have helped improve on-timestarts. PinnacleHealth launched theprogram in January 2010 after ayear-long effort to collect data,streamline preoperative care, andforge a team agreement for on-timestarts among the surgeons, anes-thesia providers, and perioperativestaff.“We did not implement this until

we felt we were a hundred percentready in each area,” says SusanComp, RN, BSN, MS, CNOR, direc-tor of surgical services for Harris-burg-based PinnacleHealth, whichhas 2 campuses.

Continued on page 13

OR performance

Technology for surgery

Continued on page 8

1. BioScience Laboratories, Inc. Data on file. © 2010 CareFusion Corporation or one of its subsidiaries. All rights reserved. ADV-FastOR0810

Remove hair 50%fastOR

Glide through preoperative skin preparation 50% faster than 3M clippers.A recent comparative study showed CareFusion Surgical Clippers consistently outperformed 3M Surgical

Clipper Model 9661 (purple) and removed hair more than 50% faster (p<0.05) while maintaining

skin integrity.1 You’ll feel the difference as CareFusion Surgical Clippers remove hair in a single pass for

less patient skin irritation. And reducing skin disruption can help minimize the risk of infection.

Visit www.clippers.chloraprep.com/fastor3 today and register for a free, no-obligation OR Trial Kit,

which includes a clipper handle with charging adapter, three types of easy-to-change blades, ChloraPrep®

Hi-Lite Orange skin preparation, training materials and more!

carefusion.com | 800.523.0502

Put orange in your OR

3ORManager Vol 26, No 8August 2010

SCIP—the SurgicalCare ImprovementProject—will cele-

brate its fifth birthdaythis month. Rolled outin 2005, SCIP is a na-tional effort to reducepreventable surgicalcomplications by 25%by 2010.Evidence on how

much difference SCIPhas made in patientoutcomes still isn’t clear. A newstudy in the June 23/30, 2010, JAMAfound the individual measures did-n’t make a difference in the postop-erative infection rate, though themeasures taken together did (relatedarticle, p 5).There are questions about the

study’s methodology, includinghow well the researchers were ableto capture data on infections.But one thing is clear—the na-

tion’s hospitals are a lot fartherahead than they were 10 years agoin using evidence-based practice toprevent surgical infections.

Sacred cows hit the roadLong-time readers may remem-

ber the OR Manager “sacred cow”surveys, which asked about ritualsblessed by time that don’t necessar-ily improve patient outcomes. Ex-amples are shaving the patient’sskin and wearing shoe covers in theOR to prevent infections.Among other issues the survey

asked about were wearing covergowns when leaving the OR andtime-versus event-related shelf life.It may seem shocking now, but in

the survey results in the September2000 OR Manager, 50% of respon-dents said razors were still used toremove hair before surgery. This sa-cred cow hung around for years,though studies had shown it washarmful. In 1994, when the sacredcow survey was first conducted,55%were shaving the operative site.

Yet today, 97% of hospitals reportthey comply with the SCIP measureon appropriate hair removal; that is,not using razors.Compliance with another SCIP

measure, giving the antibiotic ontime before surgery, is now at 91%,compared to 56% in a 2001 study.What’s more, hospitals’ adher-

ence with SCIP’s infection preven-tion measures is posted online. Any-one can go to the Hospital Comparewebsite and see how the local hospi-tal is doing on practices like givingantibiotics within 60 minutes ofsurgery and removing hair appro-priately.What comes next for SCIP? There

will continue to be discussion anddebate about how much differencethe individual measures make andhow helpful they are to patients inselecting a hospital. And how mucheffort should hospitals continue topour into SCIP measures once com-pliance reaches 90% and above?Stakes will soon be higher. Begin-

ning in 2013, a percentage of hospi-tals’ DRG payments will be tied totheir performance on quality out-come measures. That will take qual-ity reporting to awhole new level.Meanwhile, look at how far hos-

pitals have come.�—Pat Patterson

Upcoming

August 2010 Vol 26, No 8ORManager is a monthly publication forpersonnel in decision-making positions inthe operating room.

Elinor S. Schrader: PublisherPatricia Patterson: EditorJudithM.Mathias, RN, MA:Clinical editor

Kathy Shaneberger, RN, MSN, CNOR:Consulting editor

Paula DeJohn: Contributing writerKaren Y. Gerhardt: Art directorORManager (USPS 743-010), (ISSN8756-8047) is published monthly by ORManager, Inc, 1807 Second St, Suite 61,Santa Fe, NM 87505-3499. Periodicalspostage paid at Santa Fe, NM and addi-tional post offices. POSTMASTER: Sendaddress changes to ORManager, PO Box5303, Santa Fe, NM 87502-5303.

ORManager is indexed in the CumulativeIndex to Nursing andAllied Health Lit-erature andMEDLINE/PubMed.

Copyright © 2010 ORManager, Inc. Allrights reserved. No part of this publica-tion may be reproduced without writtenpermission.

Subscription rates: Print only: domestic $99per year; Canadian $119 per year; foreign$139 per year. Super subscriptions (in-cludes electronic issue andweekly elec-tronic bulletins): domestic $149 per year;Canadian $169 per year; foreign $179 peryear. Single issues $24.95. Subscribe onlineat www.ormanager.com or call800/442-9918 or 505/982-1600.Email: [email protected]

Editorial Office: PO Box 5303, Santa Fe,NM 87502-5303. Tel: 800/442-9918.Fax: 505/983-0790.Email: [email protected]

AdvertisingManager:Anthony J. Jannetti,Inc, East Holly Ave/Box 56, Pitman, NJ08071. Telephone: 856/256-2300;Fax: 856/ 589-7463. John R. Schmus,national advertising manager.Email: [email protected]

Editorial

The monthly publicationfor OR decision makers

Staff vacancies, turnoverRead about national staffing

trends from our annual OR Man-ager Salary/Career Survey.

Onboarding perioperativeRNsLearn the secrets of success for at-

tracting and keeping RNs in theOR.

ORManager’s sacred cowmascot drives outdated OR rituals

out to pasture.

Neptune® 2Waste Management System

SmartPump®

Tourniquet System

Stryker’s innovative products and fully integrated solutions bring efficiencies to the people we touchwithin our continuum of care. These efficiencies canreduce costs, maintain order and help you restoreyour patients to active, satisfying lives.

800-253-3210www.stryker.com

For additional information please contact your local Stryker Representative

Confidence.

9100-001-364 Rev. None

Visit us at MTORS – Booth 101


As the Surgical Care Improve-ment Project (SCIP) reachesits fifth anniversary, a large

new study shows mixed results forthe SCIP measures. There’s also dis-cussion about what comes next.That could include action by theJoint Commission to weave hospi-tals’ performance on SCIP core mea-sures into the accreditation process.SCIP, rolled out in 2005, is a na-

tional effort with the goal of reduc-ing preventable surgical complica-tions by 25% by 2010.The new study, published in

the June 23/30 JAMA and involv-ing more than 400,000 patients,showed that boosting hospitals’adherence with individual SCIPmeasures such as giving the an-tibiotic on time before surgerywasn’t associated with a lowerpostoperative infection rate. Butcomplying with all 6 SCIP infec-tion-prevention measures, taken

together, was linked to lower in-fection rates.The 6 SCIP infection prevention

measures that were in effect duringthe study period from 2006 to 2008included 3 prophylactic antibioticmeasures, glucose control, appro-priate hair removal from the surgi-cal site, and maintaining normalbody temperature during surgery.Adhering to all 6 measures was

linked to reducing the likelihood ofa postoperative infection from 14.2to 6.8 per 1,000 discharges, a statis-tically significant result. But the 3

antibiotic measures scored togetherwere not statistically significant intheir association with decreased in-fections. Nor did the individualSCIPmeasures make a difference.

Multiple measures matterWhy did multiple measures

make a difference, but the individ-ual ones did not?The lead author, Jonah Stulberg,

MD, PhD, MPH, of Case WesternReserve University, Cleveland,thinks it may have to do with a cul-ture of quality.“When you are getting at multi-

ple procedures—you have to makesure the antibiotic is given within60 minutes of incision, the hair isremoved correctly, and the temper-ature is controlled appropriately—you have multiple people whohave to work together,” he told ORManager in an interview.“If you are trying to identify in-

stitutions that have really taken onthat concept and started to changetheir processes across the board,then you are able to capture theirbehavior better with multiple mea-sures.”The news that the individual

measures didn’t make a differencecould be discouraging to thosewho have spent enormous timeand resources on improving SCIPperformance.Dr Stulberg says he hopes that’s

not the message readers take away.There could be reasons why the

study didn’t show a difference, henotes. One reason is that caremight already have improved be-fore the time period studied. An-other is that myriad factors con-tribute to patient outcomes. Nar-rowing those into a few processmeasures may not be adequate tomeasure quality.

Renae Battié, RN, MN, CNORRegional director of perioperative services,Franciscan Health System, Tacoma, Washington

Mark E. Bruley, EIT, CCEVice president of accident & forensicinvestigation, ECRI, Plymouth Meeting,Pennsylvania

Jayne Byrd, RN, MSNAssociate vice president, surgical services,Rex Healthcare, Raleigh, North Carolina

Robert G. Cline, MDMedical director of surgical services, MunsonMedical Center, Traverse City, Michigan

Franklin Dexter, MD, PhDProfessor, Department of anesthesia and healthmanagement policy, University of Iowa, IowaCity

Dana M. Langness, RN, BSN, MASenior director, surgical services,Regions Hospital, St Paul, Minnesota

Kenneth Larson, MDTrauma surgeon, burn unit director,Mercy St John’s Health Center,Springfield, Missouri

Kathleen F. Miller, RN, MSHA, CNORPresident, senior consultant, PeriopRxConsultants, Gilbert, Arizona

David A. Narance, RN, BSN, CRCSTManager, sterile processing, MedCentralHealth System, Mansfield, Ohio

Shannon Oriola, RN, CIC, COHNLead infection control practitioner, SharpMetropolitan Medical Campus, San Diego

Marita Parks, RN, BS, MHAVice president, performance consulting, ROi/Sisters of Mercy Health System, St Louis, Missouri

John Rosing, MHA, FACHEVice president and principal, Patton HealthcareConsulting, Milwaukee, Wisconsin

Cynthia Taylor, RN, BSN, MSA, CGRNNurse manager, endoscopy & bronchoscopyunits, Hunter Holmes McGuire VA MedicalCenter, Richmond, Virginia

Dawn L. Tenney, RN, MSNAssociate chief nurse, perioperative services,Massachusetts General Hospital, Boston

Judith A. Townsley, RN, MSN, CPANDirector of clinical operations, perioperativeservices, Christiana Care Health System,Newark, Delaware

Terry Wooten, Director, business &material re-sources, surgical services & endoscopy,St Joseph Hospital, Orange, California

Advisory Board

Performance improvement

What comes next for SCIP measures?

Continued on page 6

“

“Large studyshows mixed

results.

What has SCIP achieved?Dale Bratzler, DO, MPH, of the

Oklahoma Foundation for MedicalQuality, which manages SCIP forthe Centers for Medicare and Med-icaid Services (CMS), told ORMan-ager he was not surprised by thestudy findings.“We know that just measuring a

limited process of care doesn’t do agood job of measuring hospitalperformance,” he says. “There areso many things we don’t measurethat affect outcomes. That doesn’tmean the process measures aren’timportant.”The good news, he says, is that

when all of the SCIP measures wererolled together, hospitals did better.“There was a 15% relative reductionin surgical infection rates, which Ithoughtwas a strong finding.”The study results do not mean

SCIP has been a failure, he adds.“I think it has resulted in

tremendous improvements nation-wide in surgery. We now have3,600 hospitals actively reportingon surgical quality measures.“I think many hospitals are

doing a lot of other things besidesthe SCIP process of care mea-sures,” he adds, pointing to surgi-cal checklists and better infectionsurveillance as examples.“I think it has created a culture

that results in improving quality ofcare beyond what we are measur-ing in SCIP.”

The study’s limitationsJoint Commission President

Mark B. Chassin, MD, MPP, MPH,said the study has a serious limita-tion because it uses Medicarebilling codes to determine whetherpatients developed infections. Thecodes, he said, are a “wastebasket”for any infectious complication, notjust those related to surgery.

Though the study is “an attemptto get some information,” he toldOR Manager, “you can’t concludefrom that study that the prophylac-tic antibiotic measures that are partof SCIP don’t work.”The same week that the JAMA

study was published, Dr Chassinannounced that the Joint Com-mission is considering ways to in-clude performance expectationson certain quality measures in theaccreditation process. The com-mission says it will seek inputfrom hospitals over the next 6months on the best ways to dothis.The commission says its new

approach will help hospitals pre-pare as Medicare and other payersplace more reliance on quality

measures in determining reim-bursement.In the June 24, 2010, New Eng-

land Journal of Medicine, Dr Chassinand his colleagues outline 4 criteriafor judging measures to be used foraccountability purposes, such asaccreditation, public reporting, andvalue-based purchasing. The crite-ria include:1. There is a strong evidence baseshowing the care process leads toimproved outcomes.

2. The measure accurately captureswhether the evidence-based careprocess has, in fact, been pro-vided.

3. The measure addresses a processthat has few intervening stepsthat must happen before the im-proved outcome is realized.

6 ORManager Vol 26, No 8 August 2010


Continued from page 5

Sixty minutes may not be themagic number for giving the an-tibiotic before surgery to preventpostop infection, according to theJAMA study on the Surgical CareImprovement Project (SCIP) andother research.Hospitals have strived to meet

the SCIP measure for patients toreceive prophylactic antibioticswithin 1 hour prior to the surgi-cal incision (2 hours for van-comycin).The original evidence behind

the measure examined whetherthe antibiotic was given at all,not the timing, notes MaryHawn, MD, MPH, who wrote aneditorial accompanying theJAMA study.Since then, she says, there has

been:• little if any evidence that pa-tients who received the antibi-oticmore than 60minutes be-fore the incision had higher in-fection rates than patients who

received it within 60minutes ofthe incision

• evidence from 3 studies that an-tibiotics given 15 to 30minutesbefore the incisionwere associ-atedwith higher infection ratesthan antibiotics given 30 to 60minutes before the incision.Pushing to give the antibiotic

close to the incision time to complywith SCIPmight explain, at least inpart, why better adherencewithSCIP has not lowered infectionrates.“Proponents of thismeasure feel

that the closer you give it to thetime of incision, the better becauseit will be around longer during thecourse of the operation. But I thinkthere is some interesting data toprovide a good counter-argumentto that,” she says.She adds, “I think there needs to

bemore discussion ofwhetherweare really doing the right thing forhospitals and for patients by push-ing through thesemeasures.”

60 minutes not magic for antibiotics



4. Implementing the measure haslittle or no chance of adverse con-sequences.All 8 SCIP measures that are

Joint Commission core measureswould meet the criteria, they said.These include the measures forprophylactic antibiotics, blood glu-cose control, appropriate hair re-moval, perioperative beta blockerprotocol, and venous thromboem-bolism prophylaxis.

What’s next for SCIP?Work is already underway to

develop composite measures thatcould be used for public reportingfor SCIP as well as acute myocar-dial infarction, heart failure, andpneumonia, Dr Bratzler notes.A lot of work is also being done

to develop surgical outcome mea-sures, such as mortality, infections,and unplanned returns to the OR.“Ultimately, that’s what patients

care about—getting the best out-come, not necessarily the individ-ual processes of care,” he says.The challenge, he adds, is that

outcome measures have to be risk

adjusted, and that requires a lot ofdata collection. The Centers forDisease Control and Preventionand other investigators are tryingto find ways to identify patientswho develop complications usingclaims data.“We are working toward that—

getting measures that don’t requiresuch substantial data collection yetwould provide meaningful infor-mation for consumers,” Dr Bratzlersays.

When should SCIPmeasures be retired?A big discussion, he says, “Is

how long do you have hospitalscollect data on measures that areclose to being topped out?”Delivering the antibiotic within

60 minutes of the surgical incisionhas reached 91% compliance, a bigleap from the 56% reported in 2001.Some hospitals are spending a

lot of resources collecting datawhen there isn’t much room to im-prove. “One of the concerns I’vehad is that some hospitals are in-vesting huge amounts of resources

to get to that top decile of perfor-mance, which isn’t always the bestthing for patient care,” he says.“That’s one of the unintended

consequences of performance mea-surement we have to address—thecost of continuing to collect data onmeasures with little opportunityfor improvement.”CMS in its proposed Inpatient

Prospective Payment System rulefor 2011 asked for comments on thecriteria for deciding when to retireperformance measures.�

ReferencesChassin M R, Loeb J M, Schmaltz SP, et al. Accountability measures:Using measurement to promotequality improvement. N Engl JMed. Online first. June 23, 2010.DOI: 10.1056/NEJMsb1002320.

Stulberg J J, Delaney C P,Neuhauser D V, et al. Adherenceto surgical care improvementproject measures and the associ-ation with postoperative infec-tions. JAMA. 2010;303:2479-2485.Accompanying editorial, pp2527-2528.

Despite signs of an economic re-covery, few hospitals reported theyare in a position to return to prere-cession staff and service levels, theAmerican Hospital Associationfound in a survey.• 98% have not restored services orprograms.

• 89% have not added back staff orincreased hours.

• 67% have not started or contin-ued capital projects, such asadding new capacity or renova-tion.In all, 76% have cut administra-

tive costs, 53% have reduced staff,and 25% have cut services.

Recession’s impact lingers for hospitals

Increased bad debt andcharity care as a

percent of total grossrevenue

Fewer electiveprocedures

Depressed overallpatient volume

Increased percentageof patients covered byMedicaid, CHIP, and/or

other programs

Source: American Hospital Association Telling the Hospital Story survey, Marchand April 2010.

Percent of hospitals feeling effects of recession

87%

72%

70%

65%

“Prior to this project, we did notsee any urgency in getting patientsprepared for surgery. Now I seethat everyone is helping eachother.”When the project began, only 13%

of cases at the 19-OR HarrisburgCampus and 7% at the 9-OR Com-munityCampus started on time.Surgeons were unhappy. In a

survey, they said overwhelminglythat it was very important to themto start on time.By April 2010, 100% of ORs had

s ta r t edon timefor 4 outof 5 daysat Har-r isburgand 3 outof 5 daysat Com-munity.

In June, Comp said theORswere stillmeeting 100%onmost days.

On-time reports“Our goal was for 90% of first-

case patients to be wheeled into theOR on time. We never expected toachieve 100% as many times as wehave,” she says. The goal remainsat 90% because some delays are in-evitable.“There are still reasons for late

starts, such as patient issues. Butthe staff, anesthesia providers, orsurgeon being late is no longer thenumber one reason we are not ontime.”The help of a Six Sigma Black

Belt, Cindy Wilson, RN, which Pin-nacleHealth provided, was instru-mental, Comp says.“The Six Sigma process is one of

the best I’ve been involved in. Youdefine, measure, analyze, improve,and control the entire project.

“We now have the data whenwe are questioned by a physicianwho says, ‘I wasn’t late thosedays.’”Under the team agreement,

physicians sign in when they ar-rive so the time is captured.Wilson created an on-time re-

port that is sent to the surgeonseach week. After she moves on toother projects, an OR staff memberwill keep up the data collectionand reporting.These are major features of the

program.

Team agreement on starttimeA cornerstone of the project is a

team agreement that spells out re-quirements as well as rewards andconsequences for surgeons, anes-thesia providers, and staff.A key step was reaching consen-

sus on the definition of an on-timestart. Polling the staff and physi-cians, the project team found a con-sensus that 7:30 am should be thestart time, with patients wheeledinto the OR by 7:25 am. Other timeelements were also set (sidebar).In the survey, the surgeons said

they thought the only way toachieve on-time starts was to havea penalty system. The conse-quences are outlined in the teamagreement. Once consensus wasreached, the formal team agree-ment was endorsed by the ORcommittee, which consists primar-ily of surgeons and serves as theOR’s governing body. The senioradministration also endorsed theproject, so leaders knew they hadsupport if a surgeon complained.Large copies of the team agree-

ment are posted throughout thedepartment.

Improving the preopprocessOne factor in late starts was a

preop process that needed a tuneup.

Gathering data, the project teamfound the time it took to prepareoutpatients and same-day admis-sions “was all over the board,”Comp says. Consulting with thestaff, they learned there was nosystematic way of assigning anurse to a patient, and many RNsthought certain activities weren’ttheir job.“We came to the conclusion that

it’s everybody’s job to take care ofa patient,” Comp says.Steps were taken to streamline

the process and define responsibili-ties for RNs and clinical assistants(sidebar, p 10).“One thing we struggle with is

time management,” Comp says.Some staff knew while othersneeded more guidance.Now completed patient charts

are placed in a file. Nurses take thefirst chart from the file and begincaring for the patient. Previously,nurses went through the file to se-lect the patient they wanted to takecare of.Leaders are setting up produc-

tivity measures for the number ofadmissions a day an RN is ex-pected to complete.

Rewards andconsequencesA voluntary reward system has

been a surprise hit with surgeonsand staff, injecting a bit of fun. Re-wards are spelled out on cards per-sonnel carry in their badge holders.Being on time earns a star sticker.Anyone who earns 15 stars is eligi-ble for a small prize, such as a pen.The maximum number of stars is50, which earns a jacket embroi-dered with the winner’s name.“I’ve never seen surgeons so ex-

cited,” Comp says. “They pusheach other to earn the stars.”There are also consequences,

spelled out in the team agreement.


OR performance


OR

Per

form

ance

‘05‘06

‘07‘08

‘09

On-time startsContinued from page 1


OR performance

Surgeons who are late 3 times in aquarter are at risk to lose onemorning block for a month.A surgeon is documented as late

when the patient is unable to betaken to the OR at 7:20 am becausethe surgeon arrived after 7:15 amand was not finished with the pa-tient in time for the patient to ar-rive in the OR by 7:25 am.Data for surgeons with 3 late ar-

rivals is sent to the OR committeefor review. Surgeons may submitan appeal form, which is reviewedby the committee before reaching adecision about the penalty. If a sur-geon to be penalized is part of agroup that has a block, the groupwill lose access to the block timefor a month.Consequences for anesthesiolo-

gists and staff are governed by hos-pital policies.Though some physicians ob-

jected to the penalties, Comp saysadministrators backed the decision,and a few surgeons lost block time.“It only takes one physician to

lose a block to make everyone think,‘Wow, they’re serious,’” she says,adding that nearly all surgeons areon time.“The surgeons who are on time

every day are happy, and they havebeen supporting this,” she says.“Our managers have also been

excellent. They have taken a lot ofheat and stood their ground. Thishas been more successful than weever thought it would be.”

Lessons learnedComp offered this advice for

other OR teams addressing on-time starts:• Take the time, 6 months or even ayear, to evaluate your process tounderstand the barriers to start-ing on time.

“We wanted to move forwardquicker, but we knew that if wedidn’t fix our process before westarted, we would not be success-ful,” Comp says.• Make sure the project has seniorleadership support.

• Involve the physicians from thebeginning. Seek agreement onthe on-time start initiative fromthe OR’s governing body, includ-ing representatives of each surgi-cal specialty.

• Communicate often. “Everyonewas tired of seeing letters in themail and posters in the lounges.Still, there were a few who saidthey didn’t know about it,” shesays.The program was pilot-tested in

January 2010 and fully rolled out inFebruary. In June, the team plannedto start the next project—on-timestarts for 12:30 pm cases.�


OR performance

These are steps taken by PinnacleHealth.

Barriers• Timewasted at the desk and at the time of handoff.• OR staff complaints about delays in completing paperwork.• Inconsistent process by the staff.

First steps to improvement• Timed 5 staff members for 10 same-day admits and short procedurepatients.

• Watched the process and gathered data for 6weeks.

Plan• Set time frames for preop preparation:—55minutes for same-day admit patients—35minutes for short-procedure patients.

Prioritized daily tasks• Bring patients into unit using visual cues from the patient trackingsystem.

• Standardize the chart process. Place charts that are ready in a desig-nated rack.

• If a bay is empty, any available staff member (RN or clinical assistant)cleans it and brings in a stretcher and a patient.

• Begin the admission process.

Before patient assessment• Review chart only for information needed, not thewhole chart.• Gather supplies.

At the bedside• Begin perioperative charting.• Look up lab test results.

Followup• Provide patient education.• Finalize preoperative checklist and prepare patient for surgery.

Improving the preop processOn-time starts



Data sparks on-time improvementsOR performance

As with most busy ORs, wewere looking to improveour efficiency. Consultants

were brought in and gave recom-mendations, but it did not changeour culture or improve our on-timestarts. We had meetings with anes-thesia providers, surgeons, andnurses. The results were differingopinions on the definition of an“on-time start,” the lack of credibil-ity of the data, who determined thecause of the delay, potential bias,and lack of accountability.As someone who has heard

many of these conversations overthe years, I wanted to make achange. I wanted to provide accu-rate data that reflected the truecauses of our delays.As a pediatric tertiary referral

center and Level I trauma centerwith 12 staffed ORs, we performcomplex surgery, including open-heart procedures, cranial recon-structions, and posterior spinal fu-sions. Our patients may have sev-eral comorbidities, with more thanone service involved in their care.These factors contribute to compli-cated setups and multidisciplinarycoordination, which also affectsfirst case on-time starts.

Involving nursing staffI knew the nursing staff would

be integral in offering insight, pro-viding suggestions and helping toinfluence change.I had several conversations

with the nursing staff, explainingthat the purpose of collecting datawas to identify areas for improve-ment. I wanted to ensure they un-derstood there were not negativeconsequences for them if nursingwas the cause of the delay. The in-tent was to help them to get first-case patients into the ORs on time

by providing the support theyneeded.

Collecting dataIn January 2009, I started manu-

ally collecting data on a daily basis.I reviewed the charts of each pa-tient who had a first-case start,documenting the date, surgeon,anesthesiologist, time scheduled,time in room, cause of delay, andnursing/technologist staff in theroom. The causes of delays are doc-umented in the perioperative nurs-ing information system.The average first-case on-time

start for January 2009 was 21%,meaning the patient arrived in theOR room on time. In February2009, 22% of first cases were in theOR room on time. (Previously, wehad reached consensus that a casewould be considered late if the pa-tient arrived into the OR more than5 minutes past the scheduled in-room time.)

Data starts discussionsThe percentage of on-time starts

was posted daily on the add-onboard at the front of the depart-ment. Posting the on-time startsgenerated discussion and broughtthe data to everyone’s attention.I continued to have conversa-

tions with the nursing staff andstarted to meet with the chief ofanesthesia and chief of surgery. Iasked that we set aside differences

and blame and trust each other. Wehad to have a starting point andtake action on what we could im-prove.After I had collected a few

months of data, trends became evi-dent. I met with the chief of anes-thesia and reviewed the data I hadcollected. He started having dis-cussions with his group, which iscontracted with the hospital.I also met with the chief of

surgery and reviewed the data. Heasked for a separate report thatshowed delays by individual sur-geon. He followed up with indi-vidual surgeons, often that sameday, and helped to bring awarenessto unnecessary delays. He alsoasked that each surgeon receive acopy of his or her individual delaydata. Our CEO and the departmentchairs helped provide leadership insetting expectations.As the months passed, and the

data spoke for itself, it helped to re-inforce that we were on the righttrack. Throughout the year, datawas presented to the nursing staffand the OR committee. This en-abled everyone to see the progressbeing made. It also offered an op-portunity to hear feedback andsuggestions for improvement.

Results show improvementFrom January through Decem-

ber 2009, we improved on-timestarts from 21% to a 60% high, withan average of 47.25% for the year.Comparing the first quarter of 2009(25%) to the first quarter of 2010(62%), we have improved by 37%.I am also very proud to say wehave had several days that 100% offirst cases started on time.

Nursing makes changesAs we collected the data and

“

“Data generatesdiscussion and

interest.


our on-time starts improved, we re-alized nursing would need to makesome changes. Issues were dis-cussed at staff meetings and duringrounds. We brainstormed for ideasand solutions that would help andimplemented the following:• A third staff member was addedto the night shift so there wouldbe adequate staff to manage firstcases and prepare the rooms.

• Staffing in the postanesthesiacare unit was adjusted to havenurses arrive earlier for thenumber of ORs finishing at 8 amto 8:30 am.

• First-case patients and same-daysurgery staff were scheduled to

arrive one-half hour earlier be-cause, with surgeons and anes-thesia providers arriving earlier,nurses had less time with pa-tients.

• Having patients ready on timeplaced more pressure on the ORnurses to prepare rooms for com-plex cases. Nurses have used thattime but feel rushed and stressedto get into the room on time. Weare having discussions on how toimprove this situation, which in-cludes providing a second circu-lator for complex cases, havingnight shift staff assist the circula-tor with opening supplies, con-firming implants with sterile pro-cessing the night before, checkingon blood, and possibly providingmore ancillary support.We have also discussed having

OR staff arrive earlier or changingour expectation for OR nurses to bein the room by 7 am instead of 7:10am. Through all the discussions, wehave reinforced that the goal is toprovide what is needed to helpnurses bring patients to the ORsafely and on time.

A special challengeOur craniofacial patients often re-

quire a multidisciplinary team andpresent a challenge in getting themprepared on the morning of surgery.To allow for preop preparation, wewould like these patients to be seenin the preop clinic the day before tosurgery, but many families cannotafford the extra expense of a hotel.We are exploring possible housingoptions and financial assistance forthese patients and families so any is-sues can be addressed and resolvedthe day before instead of causing adelay on themorning of surgery.

On-time incentivesAt this point, our incentives in-

volve giving a lot of positive feed-back on improvements and recog-nizing those efforts. Regarding

penalties, surgeons have been noti-fied recently that if they are consis-tently late, their 7:30 am start timewill be given to another surgeon.

Advice for other managersMy advice for other managers is

to start with accurate data collec-tion and to post the percentage ofon-time starts. I did not have anyformal meetings or discussionswith physicians.In retrospect, I would have had

even more conversations with nurs-ing staff on all shifts to explain thegoal and intent of the data collec-tion. Some physicians expect thecharge nurses to have an immediatefix or hold them accountable for anydelay problem. The staff nurses canbe caught in the middle betweenanesthesia providers and surgeonsbecause they are documenting thereason for the delay. The nursingstaff has to know they are sup-ported, and there will be followup ifthey are verbally harassed or feelpatient care is compromised.Data generate discussion and in-

terest. Review the data with any-one who will listen and gain sup-port from physician leadership. Beprepared for questions and push-back, because some individualswill be defensive, and some willnot want to change.When facing resistance, I sug-

gested that we could continue torehash the same conversations wehave had for years, or we could allmake a choice to take action andmake improvements. I also rein-force that it takes the whole teamworking together to be successfulin improving on-time starts.�

—LeAnn Northam, RN, MSN,CNOR

Clinical Manager,Riley Operating Room

Riley Hospital for ChildrenIndianapolis


OR performance

Examplesof delays

Surgeon: 58Late: 26No consent: 21Working elsewhere: 11

Anesthesia: 23Consent: 14Anesthesia late: 5Talk with family: 2Needed in another OR: 1Complex setup: 1(Anesthesia equipment: 6)

Patient/family: 43Had questions: 30Late: 9Speak with doctor: 4

Preop medication/testing: 16

OR: 13Complex setup: 11Change in assignments: 2

Transport: 18Inpatient unit not ready: 11Delay: 7



to do your homework if you wantto create a thriving program in-stead of having a robot that gathersdust.

A program, notequipment“Don’t look at this as a new

surgery; it must be a program,” saysSteve Stout, RN, BSN, surgical ser-vices business associate at PoudreValley Hospital (PVH) in FortCollins, Colorado. PVH started itsrobotics program in 2004 and doesabout 300 cases a year using therobot.To build that program, Petty

says, “You have to have great lead-ership, a vision and commitmentto that vision, recruitment of greatphysicians, support from market-ing, and an excellent OR team.”More than 25 surgeons use

OSU’s 4 robots for specialties in-cluding urology, gynecology, gyne-cology oncology, ENT, thoracic, gen-eral surgery, and cardiac surgery,performing about 100 surgeries amonth. Petty says the variety of sur-gical services contributes to the sus-tainability of the program.

Commitment is keyCommitment is key, agrees

David Burns, MHA, director of pe-rioperative services for RoswellPark Cancer Institute in Buffalo,New York, which started its robot-ics program in 2004 and doesabout 300 robotic cases a year.“You don’t dabble in robotics. Ifyou don’t have that commitment,you are half off the horse.”A return on investment is possi-

ble even in smaller facilities. VickyAnderson, RN, BSP, manager ofsurgical services at Saint Luke’sEast in Lee’s Summit, Missouri,runs a robotics program in a 4-

room OR. “We were able to reachour projected ROI (return on in-vestment) in a reasonable timeframe,” she says.

Startup investmentGetting into robotics requires a

large capital investment in addi-tion to ongoing costs. A robotcosts $1.7 million to $2.2 million,with maintenance costs of about$150,000 annually and additionaldisposable equipment costs of$1,500 to $2,000 per procedure ac-cording to an ECRI Instituteanalysis of da Vinci SurgicalRobot systems costs. You will alsoneed special instrumentation, in-cluding enough to do consecutivecases. ECRI Institute estimates thecosts for instrumentation alonefor startup at about $200,000.“Be careful about the instru-

ments you buy in the beginning,”Burns cautions. “If you are justdoing prostate surgery at first,there are many instruments youdon’t need to buy.”Next is ancillary equipment. For

example, robotic hysterectomies re-quire a special type of insufflatorand a morcellator for grinding upthe uterus, and partial nephrec-tomies need ultrasound. Andersonrecommends renting expensiveequipment until you have suffi-cient volume to justify purchase.“You have to have an OR table

that doesn’t interfere with therobot docking and that goes intosevere enough Trendelenberg posi-

tion for pelvic operations,” addsPetty.

Plan training“Use your physician training

vouchers wisely,” advises Ander-son. At Saint Luke’s East, the chieffinancial officer, the lead for the ro-botics project, and the medical staffoffice controlled the vouchers in-cluded in the purchase price.When the surgeon requested

training assistance, the CFOchecked with the medical staff of-fice about the surgeon’s currentvolume of surgery where the robotwould be used. If the surgeon did-n’t have sufficient volume, theCFOmight offer partial training re-imbursement instead.The medical staff office also

needs to determine credentialingrequirements.“Credentialing was one of the

things we struggled with,” saysAnderson. “We reached out toother hospitals in our system to seewhat they were doing. You need tonetwork.”

Plan for staff trainingFor OR staff, Anderson advises,

“Start with a few well-trained staffto begin your program, makingsure that the team is firm in theirdedication to complete cases thatrun late, come in on days off, andso on, until the program and pri-mary surgeons are over their learn-ing curve.”Anderson’s first team consisted

of 2 surgical technologists and 2RNs, who “created room diagramsfor each case they would do andworked to be sure the procedurecase card had what was needed.”The team recently doubled to pro-vide coverage for breaks, days off,and when a team member’s exper-tise is needed on another case.



“

“You don’tdabble inrobotics.

Robotic surgeryContinued from page 1

Training for the staffThe manufacturer provides one

day onsite training for OR staff.“We spent the whole day going

through cases, draping, installingthe wrists (for the robot), and mov-ing the robot,” saysAnderson. Later,the team’s lead RN attended a one-week troubleshooting class. Initialtraining included teaching sterileprocessing personnel how to prop-erly clean and care for the instru-ments. Reposable instruments lastfor 10 cases (after which they stopfunctioning), so OSU uses hash-marks to track the number of uses.The first few cases take the

longest and are the most nerve-wracking. “It takes 10 to 15 cases toget people relaxed and find a rou-

tine,” says Robin Ramsey, RN,BSN, CNOR, director of periopera-tive services at PVH. Surgeonshave to do a “dry run” before per-forming their first case at PVH.

Two-day training programOSU provides 2 training pro-

grams for OR nursing staff, alliedhealth, and administrators: a 2.5-daybeginner course and a 1-day inter-mediate-advanced course that fo-

cuses on efficiency and trou-bleshooting. Lynda Jayjohn, RN,BSN, CNOR, robotic coordinatorand nurse manager of robotics atOSU, is the course director. Nursesreceive continuing education credits.“We wanted to share our knowl-

edge and to include a curriculumfocused on nursing and alliedhealth personnel,” says Petty.Funds from the courses go into thehospital’s educational fund.A key part of training is patient

positioning, particularly for pelvicprocedures such as prostate andgynecological surgeries, says Petty:“The patient is in a steep Trende-lenburg position, and care must befocused on preventing the patientfrom slipping head-first off the ORtable and the intraocular and pul-monary pressures the patient expe-riences.”

The question ofprofitabilityIn addition to the initial invest-

ment, ongoing costs of roboticsurgery mount up quickly. Theseinclude patient positioning aids,proprietary drapes, instrumentsheathes, trocars, and expensive($100 to $300) specimen bags usedthrough the ports to safely removeexcised tissue.Then there is reimbursement.Because Roswell is a cancer cen-

ter, private insurers usually reim-burse on a per diem basis insteadof a fixed amount.“All of a sudden, a robotics hys-

terectomy turns 3 days into 1 day,and our reimbursement rate de-creases,” Burns explains. The hos-pital has been able to negotiate cus-tom reimbursement with payers soit doesn’t lose money on most of itscases.Most hospitals face a different

situation. Diane Robertson, direc-tor of health technology assess-ment information services at ECRI




Turnover time for robotic casescan bemanaged.An averageturnover time of 20minutes is aresult of an ongoing effort atPoudre ValleyHospital in FortCollins, Colorado.The staff held dry runs of

turnovers to identify reasons fordelay and then used the Leanmanagement process to eliminatethose delays.“Turnover is a team concept,”

says Robin Ramsey, RN, BSN,CNOR, director of perioperativeservices. “We discuss the logis-tics—who needs to bewheredoingwhat andwhere equipmentis placed, even down to the trashcan.”Asmany as 4 people (2 circula-

tors and 2 surgical technologists)turn over the room,with extrastaff coming from thosewho pro-vide breaks.KimMeeker, RN,MBA, of St

VincentMedical Center in Toledo,

agrees, noting their averageturnover time is 17minutes (13minutes for urology cases).“You need to do things simulta-

neously, and you need to be de-tailed. Each person has a role andneeds to absolutely understandthat role.”“We don’t have a dedicated

room,” says Lynda Petty, RN, ofOhio State UniversityMedicalCenter in Columbus, “butwehave roomswe alwayswork inbecause configuring the roboticroom takes 45minutes to anhour.”Help in reducing turnover time

can come fromunexpected places.“Students from the Fisher Collegeof Business (at OSU) did a SixSigma project with us,” says Petty.“Part of that wasworkingwith theconfiguration and sequencing ofcustompacks so time to set up fora casewas reduced.”

“

“Start withwell-trained

staff.

Turnover time with a robot


Institute, says the Centers forMedicare & Medicaid Services hasno national coverage policies forrobot-assisted surgery, and no pri-vate payers offer additional reim-bursement. She sees no trend to-ward establishing separate CPTcodes for reimbursement purposes.

Case volume needed“It’s scary at first because you

have invested a lot of money, andyou hope the program will be suc-cessful,” says Stout. “We foundthat with strong case volume, youcan get a positive return on invest-ment. We started the program bylowering the minute charge to ad-just for the learning curve andlonger case times. The goal was tonot have the total surgical chargesbe much higher than for a laparo-scopic procedure.“When case times became

shorter, we increased the rate; nowthe robotic procedures are about$1,000 more than the standard la-paroscopic procedures.”

Factoring in outcomesKimMeeker, RN, MBA, adminis-

trative director of surgical services atMercy St. Vincent Medical Center inToledo, says to avoid looking atprofitability from simply a cost percase in theOR perspective.“You have to help the finance

group understand that the cost ismore than what happens in thefour walls of the OR,” she says.Our cost per case has actually gonedownwith robotics.”Although disposable costs are

higher than with traditionalsurgery, outcomes such as lengthof stay and blood use decrease.“When you show that it lowerscosts and benefits patients, youcan get the administrative sup-port you need to market and de-velop the program,” says Meeker.The medical center’s robotics pro-gram started in 2002; the volume

is now about 340 cases per year.Petty notes it’s important to

track utilization. “We want eachrobot to have 2 cases assigned to iteach day to maintain profitability.”

Adding robotsRobot models are updated fairly

regularly. New robot purchases cancreate problems because each sur-geon wants to use the new robot.Peter Holdsworth, MBA, OR busi-ness manager for Roswell, saysfirst-come, first-served doesn’twork because the newer robot isneeded for certain types of cases,making scheduling a challenge.He advises, “Try to negotiate up

front how you will handle the pur-chase of your second robot downthe road. Try to set it up so thatyou would get a deep discount totrade in your original machine for2 new ones of the same modelwhen volume dictates.”Roswell went from 129 cases in

2005 to 293 cases in 2009 and pur-chased the second robot in Marchof that year.

The pay offSustaining and expanding a ro-

botics program require ongoing ef-fort. But the work can pay off. “Asa new manager, I wasn’t sure arobot in our 4-room OR was theright way to go,” says Anderson,“but this program has been a staff,surgeon, and patient satisfier. Weare very pleased with our invest-ment.”Robotics may also benefit pa-

tients. “We are performing surgicalprocedures with minimal bloodloss, decreased length of stay, posi-tive patient outcomes, and in-creased patient satisfaction,” saysPetty. �

—Cynthia Saver, RN, MS

Cynthia Saver, a freelance writer, ispresident of CLS Development, Inc,in Columbia, Maryland.

Technology for surgery Higher SSI ratewith robotics innew study

Anew study finds a higher in-cidence of surgical site infec-tions (SSI) after some types

of robotic surgery compared withopen surgery. The researchers saythe difference may be related to thelearning curve associated with usingthe robot.Development of SSIs was associ-

atedwith the duration of surgery.Researchers at the University of

Nebraska, Omaha, reviewed chartsfor patients who had robotic surgeryfrom 2000 through 2007, a total of 273proceduresperformedby22 surgeons.The overall incidence of SSI for

robotic surgery was 5.9% (16 of 273procedures). There were statisticallysignificant differences in SSI rates forseveral types of robotic-assisted pro-cedures compared with the nationalaverage for similar open procedures:• Prostate/genitourinary: 5.74% vs0.85%

• Gynecologic: 10.00% vs 1.72%• Colon: 33.33% vs 5.88%• Hernia: 37.50% vs 1.62%Patients with a clean-contami-

nated wound who had robotic-as-sisted surgery had an SSI incidenceof 6.1% vs 2.59% for the nationalmean for open procedures.The average duration of robotic

surgery was longer for patients whodeveloped an SSI than for patientswho did not, both for those who hadsurgery in 2000-2003 and in 2004-2007.The authors say they believe this

is the first published study compar-ing SSI after robotic-assisted surgerywith national data for open proce-dures.They say the study has limita-

tions because of the small samplesize.�

—Hermsen E D, Hinze T, SaylesH, et al. Infect Control Hosp Epi-

demiol. 2010;31:822-827.

Mention robotics in OR cir-cles, and you’re likely tospark a debate. Is robotic

surgery an innovative techniquewith wide application or mainly amarketing ploy to attract patients?Or does the truth lie somewherebetween these views?These questions are far from

academic. According to IntuitiveSurgical, manufacturer of the daVinci system, the only robot systemcurrently available in the US,136,000 da Vinci procedures wereperformed in 2008, a 60% increasefrom 2007. With that kind ofgrowth, it’s key for OR leaders tounderstand the state of roboticsurgery including outcomes, expe-rience, cost factors, and technicalevolution.

Outcomes evidenceAnalyzing the evidence for ro-

botic surgery presents challenges,says Diane Robertson, BA, directorof the Health Technology Assess-ment Information Service at ECRIInstitute, an independent, non-profit organization that researcheshealth care technology and ser-vices.Analyzing published data, the

institute found a lack of appropri-ately designed, randomized con-trolled trials to determine the com-parative effectiveness of surgicalapproaches.Robertson says that for most

clinical applications, the analysisfound “little definitive data on therelative effectiveness of robotic-as-sisted versus standard laparoscopyor open surgery; no conclusive evi-dence for superior outcomes for ro-botic-assisted surgery, such as lessblood loss, shorter hospital stay,and less pain, over traditional la-paroscopy; and longer operative

times, which exposes patients tolonger anesthesia time.”A study in the February 2010

Journal of Urology found laparo-scopic prostatectomy (with andwithout robot use) and open radi-cal prostatectomy “have similarrates of postoperative morbidityand additional treatment.”

Positive resultsSome reports have shown posi-

tive results, particularly for prosta-tectomy, the most common roboticprocedure. A widely reportedstudy in JAMA in 2009 found menhaving minimally invasive radicalprostatectomy, with or without ro-botics, had shorter stays and fewerrespiratory and other surgical com-plications compared to those whohad retropubic radical prostatec-tomy surgery. But they had moregenitourinary complications anddiagnosis of incontinence and erec-tile dysfunction.The more frequent diagnoses of

these conditions don’t necessarilyequate to worse urinary and sexualfunction, the authors said, becausemen who had higher expectationsmay be more bothered or engagein rehabilitation that may lead tomore frequent diagnoses.“The value of the study is that a

lot of outcomes in minimally inva-sive surgery and robotics werecoming from single centers, whichhave observer bias, and in some in-stances surgeons obtain industryfunding for consulting or sponsor-ship of courses,” says Jim Hu, MD,MPH, division of urologic surgeryat Brigham and Women’s Hospital,Boston, and lead author for thestudy. “The Medicare database(used in the study) is free of thesebiases.”

Need for logicalcomparisonsHiep Nguyen, MD, a surgeon at

Children’s Hospital Boston whoperforms robotic surgery 4 days aweek, calls for logical comparisons.He is the robotics program directorand runs a research and training lab.In pediatrics, for example, “We

need to compare robotics to opencases because conventional la-paroscopy isn’t really an option forwhat we do. The skill you need tosew isn’t possible though a scope.”Though most experts agree

more research is needed, DrNguyen says finding money for re-search and training is difficult.Donors provide some of the fund-ing, and Dr Nguyen does “a fairamount of fund raising.” He callsfor a greater commitment to robot-ics research.

The experience factorOne possible reason for out-

comes variation is surgeon experi-ence.


Robotics: Little data, much debateTechnology for surgery

Robotic surgicalprocedures

*Other21%

Robotic-assisted

hysterectomy25%

Robotic-assisted

prostatectomy54%

*Includes cardiothoracic, general,and other urologic and gynecologicprocedures.

Source: ECRI Institute, 2008.


Dr Hu, who performs 8 robotic-assisted prostatectomies (RAP) aweek and uses the robot in manyother procedures, says there is adefinite learning curve: “Most peo-ple doing robotic surgery didn’tlearn it in their residency and onlytook a 2-day course.”He would like to see credential-

ing requirements tightened. “WhenI looked at my own data, my out-comes didn’t really plateau untilabout 500 cases.” That’s in stark con-trast to the 15 to 30 cases required bymany hospitals.Research shows surgeon experi-

ence is an important factor inprostatectomy. Researchers at theMemorial Sloan-Kettering CancerCenter in New York City associ-ated surgeon experience withprostatectomy with the risk of re-currence and complications, al-though RAP wasn’t the only tech-nique examined. The study in theFebruary 2010 Journal of Urologyfound surgeon volume was “in-versely related” to hospital stayand genitourinary/bowel compli-cations.Another issue is that hospitals

are buying robots to stay competi-tive. “Everyone is pressured to buya robot, so there is pressure to usethem,” says Dr Hu. “Maybe pres-sure to overuse them.”

The cost factorThe cost of robotics is another

controversial issue and one of themain reasons, along with surgeontraining, that it hasn’t penetratedthe market more extensively.In a January 2010 review article

in Current Opinion in Urology, YairLotan, MD, department of urologyat University of Texas Southwest-ern Medical Center in Dallas,writes, “Robotic application is notcost effective compared with openor laparoscopic approaches, andfuture studies will need to deter-

mine whether there are indirectbenefits that will justify its use.”Dr Lotan, who has published ar-

ticles on decision analysis, says it’simportant to consider all costs, par-ticularly for a procedure that hasfew demonstrable benefits, such asRAP, with a costly device like arobot. ““When comparing robotic and

open prostatectomy, OR time isn’tshorter, room and board are notthat much shorter, and there isn’tthat much blood loss with an openprocedure,” notes Dr Lotan, whoanalyzed 640 prostatectomy pa-tients who had open, laparoscopic,and robotic techniques.He added that there is no added

reimbursement to the hospital forrobotic-assisted procedures. Sav-ings in pain medication are mini-mal, ongoing costs of a robot arehigh, and patients who receiveRAP are typically over 65 and notworking, so there is no societal eco-nomic benefit for returning pa-tients to work.Dr Lotan says hospitals bear the

increased costs: “Surgeons, pa-tients, and insurance companiesaren’t affected. ”

A different perspectiveDr Nguyen offers a different

perspective. When he pushed forChildren’s Hospital to purchasethe latest da Vinci robot, he says,“The hospital performed an evalu-ation of the financial impact of therobotic system. I was prepared to

present my case that roboticsurgery provides a lot of nonfinan-cial benefits including faster recov-ery and less pain for the patient tocounter the financial report. So I al-most fell off my chair when Ilearned that their results found therobotic cases to be 9% to 10% lessexpensive.”He learned that although robot-

ics procedures cost more up front,“We make it up on recovery timeand the time the patient is in thehospital.”The hospital had anticipated it

would take 5 to 7 years to pay backthe cost of the robot, but DrNguyen says in 4 months, “Wewere at 75% of the number, andwe’re predicting 150% of the num-ber in 1 year.”

Managing costs forroboticsDr Nguyen says his lab is a way

to cut costs for robotic surgery. “Wecan work things out first in the labbefore we get into the OR.”Adedicated team also aids inno-

vation and efficiency, further re-ducing costs.“I do not think every surgeon in

this country should need to per-form robotic surgery,” says DrNguyen. “Not every hospital inthis country needs a robotic systemwhen the volume does not warrantit.”

Market monopolyIntuitive’s monopoly of the

market likely affects costs. DrHu ac-knowledges the company’s role ininnovation, but adds, “It would behealthy for health care in general tohave a competitor. One should berewarded for innovation, but whenit’s a monopoly in the face of spiral-ing health care costs, it’s a problem.”Dr Nguyen agrees: “This com-

pany’s (Intuitive) primary goal is


“

“Littledefinitive data

was found.


selling the robotic system; all othergoals are secondary.” He too wouldlike to see a competitor and notesthat his team has used instrumentsas many as 25 times in the researchlab, although the company inacti-vates them after 10 uses.Kirby Vosburgh, PhD, an engi-

neer with the Center for Integrationof Medicine and Innovative Tech-nology (CIMIT) in Boston and assis-tant professor at Harvard MedicalSchool, takes a different view.“Intuitive has done an excellent

job of creating a platform for in-serting robotics in the OR. In orderto go to market at a profitablescale, you end up building wallsaround a device (in this case the daVinci robot), which tends to con-strain competition,” he says. “Onone side, they are doing exactlywhat they are supposed to—sup-porting their customers and build-ing their company equity. It wouldlikely be easier to advance the fieldthrough newer techniques, but

their approach is traditional andhas benefits as well. ”

Factoring in theintangiblesDr Nguyen points to an example

that illustrates the value of roboticsurgery. He recently performed a ro-botic repair of a ureter in a 15-year-old girl. “An open procedure wouldhave meant 4 to 5 days in the hospi-tal, with 3 to 4 weeks of recoverytime. Instead, she was up and walk-ing around less than 12 hours afterher surgery and went home in notmuch pain.”�

—Cynthia Saver, RN, MS

Cynthia Saver, a freelance writer, ispresident of CLS Development, Inc,in Columbia, Maryland.

ECRI Institute has published a num-ber of evidence reports on roboticsurgery and other minimally invasiveprocedures. Information is atwww.ecri.org

ReferencesHu J C, Gu X, Lipsitz S R, et al. Com-parative effectiveness of mini-mally open radical prostatectomy.JAMA. 2009;302:1557-1564.

LowranceW T, Elkin E B, Jacks LM,et al. Comparative effectiveness ofprostate cancer surgical treat-ments: Apopulation based analy-sis of postoperative outcomes. JUrol. 2010;183:1366-1372.

Savage C J, Vickers A J. Low annualcaseloads of United States Sur-geons conducting radical prosta-tectomy. J Urol. 2009;182:2677-2681.

Lotan Y. Economics of robotics inurology. Curr Opin Urol. 2010;20:92-97.


Beyond robotics: What to expect next?


APhiladelphia hospital isnow using the ViKY, devel-oped by EndoControl in

France, a single-arm device that ismuch smaller and easier to usethan the da Vinci surgical robotand doesn’t require a large OR orOR team for set up, notes DianeRobertson of ECRI Institute.Another focus is single-incision

surgery.“In the past 18 months, we’ve

seen an explosion in the number ofpublished articles on this and the de-velopment of special instrumentationto perform the surgery,” she says.

More versatile platformKirby Vosburgh, PhD, an engi-

neer with the Center for Integra-tion of Medicine and InnovativeTechnology (CIMIT) in Boston andassistant professor at HarvardMedical School, doesn’t see daVinci as a long-term platform.“You need an operating envi-

ronment that is stable and whereyou can easily change from oneprocedure to another,” he says.Several teams around the world

are examining “much lighter waysof facilitating surgery withoutadapting the OR to it,” Vosburghadds. “We want things that don’thave to come in with a forklift. DaVinci is a robot first and a deliverycare tool second, and it should bethe other way around.”

NOTES is the futureHe adds, “In the most general

sense, NOTES (natural orificetransluminal endoscopic surgery)is the future of surgery. The futureis going to be much smaller thingsgoing through body apertures.”“What’s important is learning

how to do complex surgical proce-dures in a way that is much easierfor the patient and has less surgicalinsult,” he adds. To accomplishthat goal, Vosburgh’s researchgroup has a “no instruction, notraining” rule for its equipment de-velopment. “The physician shouldbe able to use (the device) intu-itively. It places the physician, nottechnology, in the foreground.”�


“

“Hospitals bearthe increased

costs.

ManagingToday’sOR SuiteThe Walt Disney World Dolphin, Orlando

23rd Annual

September29 toOctober1, 2010

With theAORN Leadership

Specialty Assembly

Wrong-site surgery is astubborn problem acrossthe country. Rhode Is-

land Hospital in Providence hasused its well-publicized experiencewith wrong-site surgery to dissectthe process and learn how to pre-vent these events. The 719-bed hos-pital, which performs about 25,500surgical procedures a year, has had 3wrong-site surgeries in the OR and 2at the bedside in recent years.After the most recent incident

(sidebar, p 21), Rhode Island Hos-pital and Newport Hospital, a sis-ter facility in the Lifespan system,volunteered to be the first to workwith the Joint Commission’s new

Center forTransform-ing Health-care (CTHC)on a projectto preventwrong-sitesurgery. An-other Life-span facility,

Miriam Hospital, also collaboratedon the project.CTHC aims for breakthroughs

on some of health care’s toughestproblems, such as hand hygieneand wrong-site surgery, by team-ing with hospitals to apply sophis-ticated quality improvement tech-niques like Lean Six Sigma.

‘We had a choice’After the wrong-site incidents,

“We had a choice—to let themorale get worse and to feel badabout ourselves and our practice,or to say, ‘We are going to fix this,’”says Rhode Island Hospital’s ad-ministrative director of periopera-tive services, Diane Skorupsi, RN,MS, CNOR, NE-BC.An update on the project was

presented at the Joint CommissionConference on Quality and PatientSafety in June 2010 in Chicago.The CTHC team worked with

the hospital’s project team to usetools such as DMAIC (Define,Measure, Analyze, Improve, Con-trol), failure modes and effectsanalysis (FMEA), statistical processcontrol, and Lean management.The CTHC project on wrong-

site surgery isn’t finished. “Weneed to do more work to validatewhat was learned and the solu-tions,” says Erin DuPree, MD, amember of the CTHC team. Shecautioned hospitals not to thinkthey must adopt the steps taken atRhode Island Hospital.Rhode Island Hospital’s periop-

erative leaders talked with ORManager about the project so far.As in other ORs, the ultimate

goal is to move away from a hier-archy to a team-based culture thatencourages communication to ver-ify the surgical site and the plan forsurgery. In the meantime, theprocess is being standardized to re-duce opportunities for error.

Analyzing failure modesFMEA is an analytical tool for

identifying where failures mightoccur and classifying them by thelikelihood and severity of the po-tential failures.The Rhode Island team con-

ducted an FMEA to identify poten-tial failure modes in its UniversalProtocol process. For example, onefailure mode was identifying im-plants during the briefing. Intraoc-ular lenses are the implant with thehighest risk of an error becausemore than one lens can be orderedper patient, and the lens is patientspecific.In the revised process, the pa-

tient and lens are matched throughprimary source verification: correctpatient, correct surgical consent,and correct implant request. Theverification is conducted prior tothe day of surgery and is reverifiedduring the preoperative briefing onthe day of surgery before the time-out.The perioperative leadership

team now uses the FMEA as aworking document, Skorupskisays, adding potential failuremodes and monitoring processes.Each department shares the top 3risks for failure with the clinicalstaff and solicits their input.The team has also conducted

FMEAs on specific parts of theprocess, such as scheduling, pread-mission testing, the preop processon the day of surgery, and the in-traoperative phase of care.

A Leaner time-outApplying Lean management

principles, the team streamlinedthe time-out. Lean involves analyz-ing work processes to improveflow and eliminate steps that don’tadd value.Previously, the time-out was

cumbersome, Skorupski notes, andwasn’t accomplishing its true pur-pose—to be a final verification stopbefore the incision and to promotecommunication among the ORteammembers.


Breakthroughs on wrong-site surgeryPatient safety

“

“We aregoing tofix this.


Patient safety

Now “we keep the time-outcrisp, with the patient identifica-tion, procedure, side, and site,” shesays.To streamline the process, the

primary documentation and pa-tient information are verified in thepreoperative area and again duringthe briefing in the OR prior toprepping and draping.

Auditing the processEvery time-out process is au-

dited for 14 components of surgicalsite verification. Examples are: Wasthe surgical site visible? Did thesurgeon initiate the time-out? Didthe surgeon use the wording speci-fied?The audits are required by the

state health department, whichmandated that for every proce-dure, the site marking and time-out are observed by a licensed clin-ical professional who is not part ofthe surgical team. Rhode IslandHospital added a behavioral com-ponent to the audits to monitorcultural change and ensure the sur-geon initiates the process.The audits also enable the team

to collect detailed data to highlightcompliance issues and aspects ofthe process policies don’t cover aswell as to monitor cultural change.Audits offer opportunities for

coaching and teaching.“Every time a surgeon has to be

prompted [to lead the time-out],we see that as an opportunity,”Skorupski says.Time-out audit results are

trended daily and graphs postedso OR personnel can see howthey’re doing.

Key observationsThe hospital’s work with Lean,

FMEA, and the audits has led tochanges that the leaders think haveincreased the safety and account-ability of the Universal Protocolprocess.One finding was the need for

OR teams to focus consistently onthe briefing and time-out. Rootcause analyses at Rhode IslandHospital and other hospitals havefound that even with a brief time-out, “there is an opportunity not tobe focused,” Skorupski says.In another change, the surgeon

must be present in the preopera-tive holding area for the site verifi-cation and marking of the surgicalsite. The surgeon, with the preopRN, initials the site in the preoparea using primary documentationprior to coming to the OR. The sur-geon must also initiate and leadthe time-out in the OR.Having the surgeon present in

the holding area “has been thekey” to getting surgeon buy-in forthe process, says the OR’s medicaldirector, EdwardMarcaccio, MD.He also believes the surgeon’s

collaboration with the preop nursein verifying the patient’s primarydocuments before entering the ORhas made the process safer.“I think nothing was more im-

portant than getting the surgeon tothe holding area to discuss withthe patient and the team whereand what exactly the procedurewas going to be,” he says. The up-date for the history and physicalalso takes place in the holding area.Surgeons have found there’s a

benefit for them—cases tend tostart on time when they are in theholding area.


“

“The surgeonmust lead the

time-out.

Compliance orderon wrong-sitesurgeryIn themost recent wrong-site

surgery incident at Rhode IslandHospital in October 2009, a sur-geonmistakenly performed 2procedures on the same finger ofa patient’s right hand instead of1 procedure each on 2 fingers ofthe hand. The state departmentof health found the sitemarkingsand time-outs had not been per-formed according to policy.The hospital was placed under

a second compliance order andfined $150,000. The complianceorder requires the hospital toamong other things:• ensure every surgical sitemarking and time-out is ob-served by a licensed clinicalprofessional who is not partof the surgical team

• mandate that surgeonsmarkthe site in the preop areawiththe assistance of a second li-censed professional

• require surgeons to use pri-mary sources such as the con-sent and history and physicalto verify the site

• develop a plan for educatingthe staff and implementingchanges based on data andobservations

• conductmandatory trainingof surgical site verificationprocedures

• install video and audiomoni-toring equipment in all ORstomonitor sitemarking, time-out, and teamdynamics.

Source: Rhode Island Departmentof Health. www.health.ri.gov


Patient safety

Engaging the teamDuring the time-out, 3 steps

were added to engage the entireteam:• All surgical team members areto view the surgical site.

• The surgeon is to point and touchthe site and say: “Can everyonesee my mark? This is where I ammakingmy incision.”

• The surgeon asks: “Does anyonehave any concerns?”“One important thing was

changing the surgeon’s role to amore active one,” Dr Marcaccionotes. “It is not the surgeon simplynodding when someone else isgoing through the checklist. Thesurgeon leads with the elements ofthe identification and the discus-sion of the procedure because onlythe surgeon really knows what theoperative plan is.

“Once the surgeons took own-ership of the process, I think it re-ally helped to facilitate communi-cation in the OR,” he says.

Leaving room for judgmentThe project team also learned

site-marking rules can’t be writtenfor every situation. There must beroom for judgment and situationsthat do not fit clear-cut guidelines.Examples are cystoscopy and otherprocedures conducted through nat-ural orifices.If a surgeon thinks the site can’t

be initialed, the policy states thatthe surgeon must document whythe site can’t be initialed and in-clude a reason beyond stating,“Site not marked.”“Again, the key is communica-

tion throughout,” Skorupski says.“If a patient arrives in the OR, andthe site isn’t marked, the surgeonwill say, ‘This is where I am goingto do my procedure. I did not markthe site because’ and gives a rea-son. The surgeon then gives the

staff an opportunity for feedbackand communication.”Leaders seek input from clini-

cians to clarify specific situations.Questions are reviewed by the sur-gical executive committee to pro-vide standardized answers. Themanagement team posts answersto frequently asked questions toguide practice.“The staff can apply their un-

derstanding and use the FAQs toguide them in unfamiliar situa-tions,” Skorupski says. “The policyprovides guidelines. Cliniciansneed to use their critical thinkingskills to apply the policy to eachsituation. Communication is thekey. The team must discuss eachcase and apply the process in an in-dividualized manner.”For example, recently a patient

had 2 procedures by 2 surgeons on awrist and the nose, raising questionsabout how to verify and documentthe sites. The surgical team held aconversation to make sure all mem-bers were in agreement about thebody parts to be operated on.“The biggest benefit of the

change in the process here is that itis a large step toward a change inthe culture from a hierarchy to inter-active communication,” she says.Skorupski says she is confident

that the project will demonstratewhat she and other leaders haveknown all along: “This is a greathospital, we are safe, and the com-munity should be glad Rhode Is-land Hospital is here.”�

—Pat Patterson

Representing CTHC on the Rhode Is-land project were Rick Morrow, a SixSigma Black Belt; Kate Ranft, a masterchange agent; and Erin DuPree, MD,a Six Sigma Green Belt. The Rhode Is-land team included Diane Skorupski,RN; Michele Serino, RN; Dave Pierel,RN; Pat Marshall, RN; Elaine Noren,RN; Rene Chiovitti, RN; and EdwardMarcaccio, MD.


“

“We keepthe time-out

crisp.

Studies highlightoutcomes ofbariatric surgery

Findings from 3 new studies onbariatric surgery were pre-sented at the annual meeting

of the American Society for Meta-bolic and Bariatric Surgery in June2010 in Las Vegas:• Patients required by their healthinsurer to complete a 6-monthweight loss program beforebariatric surgery did no betterthan patients without such a re-quirement in postoperativeweight loss, in research from Car-olinas Medical Center, Charlotte,North Carolina.

• Women, Caucasians, andHispan-ics had the fewest complicationsand shortest hospital stays aftergastric bypass surgery, accordingto a study of 38,000 patients fromthe University of Nebraska Med-ical Center, Omaha.

• Bariatric surgery helped lowercholesterol and improve the ratioof total cholesterol to HDL (good)cholesterol. Within 6 months ofgastric bypass nearly all patientswith high cholesterol had normallevels, and 91% of patients whowere on lipid-lowering drugs be-fore surgery were off medication,researchers from University ofIowa Hospital and Clinics, IowaCity, reported.


Don’t overlook reprocessing instructions

Sterilization & Infection Control

Like facilities around the coun-try, you are probably consid-ering alternatives to the Steris

System 1 (SS1) for reprocessingyour medical devices. The Foodand DrugAdministration (FDA) is-sued a notice in December 2009stating that the SS1 as currentlymarketed had not been approvedor cleared for its label claims, in-

cluding claimsthat it sterilizesmedical de-vices. The FDAadvised usersto transitionaway from SS1“as soon aspossible.” TheFDA has sincesaid it expects

the transition to be completewithin 18 months, or by August2011.One step in the decision-making

process that may be overlooked isto make sure the manufacturers ofyour medical devices have pro-vided you with up-to-date writteninstructions for use (IFUs) for eachof their devices that describe howto reprocess each device. This in-cludes processing methods vali-dated by the device manufacturerfor its devices.

Professional guidelinesFollowing manufacturers’ repro-

cessing instructions is a key part ofsterilization and disinfection guide-lines, including those of AORN, theAssociation for the Advancement ofMedical Instrumentation (AAMI),and the Centers for Disease Controland Prevention (CDC). The JointCommission and Centers forMedicare and Medicaid Services(CMS) also stress following manu-facturers’ instructions.

This column outlines steps toconsider to ensure alternative pro-cessing methods you select meetFDA requirements and profes-sional standards and guidelines. Inthe context of this column, aprocessor is a piece of equipmentused to reprocess medical deviceswith either a high-level disinfec-tant or a sterilant. Examples in-clude automated endoscope re-processors (AERs) and steam orlow-temperature sterilizers.

What devices do you needto reprocess?The first step is to determine

what items you will need toprocess and what type of process-ing is needed for these items. Agood place to start is with the fa-miliar Spaulding classification,which classifies devices as critical,semi-critical, and noncritical, ac-cording to the risk of infection ifthe device is contaminated. TheFDA recommendations are basedon the Spaulding classification, asare the professional standards andguidelines.There’s been some confusion

about the term “liquid chemicalsterilization.” A safety communica-tion from the FDA, CDC, and theDepartment of Veterans Affairs(VA) on November 9, 2009, stated:

Sterilization with a liquidchemical sterilant may not con-

vey the same sterility assuranceas sterilization achieved usingthermal or low temperaturechemical gas/plasma/vaporsterilization methods. Liquidchemical sterilants should belimited to reprocessing onlycritical devices that are heat-sensitive and incompatible withother sterilization methods.

Obtain manufacturers’instructions for useThe next step is to obtain up-to-

date written IFUs from the medicaldevice manufacturer (MDM) foreach device you reprocess that ex-plain how to process the device.Then determine if you have aprocessor available that will enableyou to reprocess the device accord-ing to the IFU.This is not as easy as it sounds.

Many MDMs recommend only oneprocessing method in their IFU. Ifthat method includes the SS1, that’sa problem. The FDA has said de-vices labeled for usewith the SS1 are“misbranded” under section502(f)(1) of the Federal Food, Drug,Cosmetic Act because they fail tobear adequate directions for use.In a February 2010 letter, the FDA

said MDMs must take immediateaction to validate at least one repro-cessing method using a legally mar-keted product. The MDMs shouldcomplete this testing and relabelingby February 2011.

Device makers need toprovide instructionsSome facilities are depending on

processor manufacturers to directthem to what processor to use. Butthe FDA is clear that the MDMs,not the reprocessor manufacturer,have the responsibility to provideyou with a validated processing


“

“What type ofprocessing is

needed?

method. That’s because the proces-sor manufacturer does not knowwhen a device manufacturerchanges the product material, andnew testing is needed.A good example of this situation

is when Advanced SterilizationProducts (ASP) in about 2000 pro-vided a compatibility device list forproducts that could be processedin the Sterrad system. Then on No-vember 13, 2007, ASP sent an “Ur-gent: Product Correction” letter tousers stating:

Advanced Sterilization Products(ASP) would like to inform youthat all brand- and model-spe-cific compatibility lists and asso-ciated instrument assessmentsprovided to STERRAD Steril-ization System customers arenow out-of-date. Information re-lated to specific brands and mod-els of medical devices, over time,can become outdated as manu-facturers introduce new tech-nologies and make materials,manufacturing and repairprocess changes.

To determine if a specific brandand model of device will remainfunctional following sterilizationin your STERRAD System,please contact the MDM or referto the Instructions for Use (IFU)for the device. Even if the MDM’sIFU references the STERRADSystem, we recommend that youcontact the MDM to ensure theIFU is up-to-date.

If recommendations from thedevice manufacturers seem to dis-agree with recommendations fromthe processor manufacturer, theFDA says to “follow the instruc-tions from the manufacturer of thedevice to be processed.”

What if no instructionsare available?If your facility identifies critical

medical devices for which no re-processing information is available,notify the FDA to express yourconcerns using this website: www.fda.gov/Safety/Medwatch. Theinformation may be lacking be-cause the device was cleared formarketing before the reprocessinginstructions were required and hasbeen grandfathered into the FDAsystem, or the MDM has not vali-dated an alternative process to theSS1.

Why one reprocessingmethod?Why do some MDMs recom-

mend only one processing method?Because that is all the FDA requiresand because it is expensive and timeconsuming to validate a processingmethod. For example, for sterilizers,FDA-required testing includes thefollowing:• Biocompatibility testing to deter-mine that amaterial will not havetoxic or injurious effects on thebody.

• Materials compatibility testing todetermine any material effectsthat may compromise use of adevice.

• Device functionality testing toverify that the medical devicemeets specifications and is fitfor use. The device manufac-turer is responsible for validat-ing functionality of a deviceafter processing for a specified

number of cycles in a specificprocess.

• Sterilizer efficacy testing to vali-date that reusable devices canbe repetitively sterilized usingthe process defined in the IFU.In addition, sterilizer manufac-

turers are required to test a rangeof materials and actual devices aspart of the FDA 510(k) process.Their recommendations to usersregarding device processing arebased on this rigorous testing.For liquid chemical disinfec-

tants, for a manufacturer to make ahigh-level disinfection and/or ster-ilization claim, validation testingincludes microbiological qualifica-tion testing, stability testing toshow the high-level disinfectant iseffective under its storage condi-tions and recommended use pat-terns, and material and devicecompatibility testing.In some cases, a MDM may rec-

ommend only a particular proces-sor it markets. That is because thecompany understands its proces-sor and high-level disinfectant orchemical sterilant method and itseffects on devices better than othersystems.When determining a reprocess-

ing method, work with processormanufacturers that provide abroad list of medical devices, in-cluding lumen restrictions andmedical device materials, whichhave been tested according to FDAvalidation requirements. If applica-ble, the testing should includecompatible packaging materialsalong with FDA-cleared biologicaland chemical indicators and aprocess challenge device.Determine if the processor man-

ufacturer is willing to work withthe MDM to assist in providingyou with the written informationyou need to make a decision aboutthe processor to use for the devicesin question. Remember, the MDM




“

“Obtaininstructions for

each device.


has the responsibility to provideyou with this information.

Making future decisionsIn the future, when evaluating

the purchase of new devices orprocessors, consider Recommenda-tion 1 from the AORN Recom-mended Practices for Product Se-lection in Perioperative PracticeSettings, which says “to selectfunctional and reliable productsthat are safe, cost-effective, and en-vironmentally conscious and thatpromote quality care and avoidduplication or rapid obsolescence.”As part of the purchasing agree-

ment for a device, you should ex-pect the manufacturer to provideone or more validated processes(eg, high-level disinfection or ster-ilization) in addition to a validatedcleaning process. If those validatedprocesses are not available withinyour system, you will need to ne-gotiate with the MDM to performthe validation testing for theprocesses you use or work with theprocessor manufacturer, whichmay be willing to perform the vali-dation testing for the MDM. If nei-ther is possible, you may not wantto purchase the device.A lesson learned is not to put all

your eggs in one basket but to usemultiple types of processors thathave been validated for the repro-cessing of individual endoscopesand other medical devices.�

—Martha Young, MS, CSPDTPresident, Martha L. Young, LLCSAVVY Sterilization Solutions forHealthcare, Woodbury, Minnesota

Martha Young is an independent con-sultant with long experience in med-ical device sterilization and disinfec-tion.

ReferencesAORN. Recommended Practices for

Product Selection in Periopera-tive Practice Settings. In Perioper-ative Standards and RecommendedPractices. Denver, CO: AORN,Inc: 2010.

Food and Drug Administration.Content and format of premarketnotification [510(k)] submissionsfor liquid chemical sterilants/high level disinfectants.Rockville, MD:FDA. January 3,2000. Guidance for Industry andFDAReviewers.

Food and Drug Administration.FDA questions and answersabout the Steris 1 processor forhealthcare facilities.www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm192685.htm

Food and Drug Administration. La-beling reusable medical devicesfor reprocessing in health care fa-cilities. Rockville, MD: FDA,April 1996a. FDAReviewerGuidance.

Food and Drug Administration.Letter to endoscope manufactur-ers: Possible misbranding ofreusable devices labeled for re-processing by the STERIS System1 Processor. February 22, 2010.www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm201497.htm

Food and Drug Administration.Preventing cross-contaminationin endoscope processing: Safetycommunication from FDA, CDC,and the VA. November 19, 2009.www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm190273.htm


“

“Instructionsmust be

validated.

Equipment-related incidentscommon inoperating room

Equipment-related incidents inthe OR occurred in nearly16% of surgical procedures in

a study from The Netherlands pub-lished online inQuality and Safety inHealthcare.Most incidents involved instru-

ments (46%) or medical devices(28%). In all, 98% of events werecharacterized as “equipment un-available” (often instruments) or“failing equipment” (often medicaldevices.) Percentages of incidentswere above average in specialtieswith advanced equipment, such asneurosurgery, orthopedics, urology,and thoracic surgery.No direct physical harm to pa-

tients was reported, although indi-rect harm, such as longer anesthe-sia time and postponed proce-dures, did occur.

Extra work, delaysThe incidents resulted on aver-

age in 12 minutes of extra workand 5 minutes of delay per inci-dent, with 10% of incidents leadingto a delay longer than 15 minutes.Management decisions were themost frequent root cause for inci-dents, causing delays longer than15 minutes. Examples were inven-tory capacity planning, schedulingissues, and configuration of instru-ment sets.Methods to reduce incidents,

such as a checklist including atime-out and proper equipmentmaintenance, were already in place“but did not seem to be water-tight,” according to the authors.�

—Wubben I, van Manen J G, vanden Akker B J, et al.Qual Saf HealthCare. Published online June 16, 2010.

DOI: 10.1136/qshc.2009.037515


Meeting an ASC’s financial targets

Every ambulatory surgery cen-ter (ASC) needs a financialcompass to help chart its

course. Is revenue per case up ordown? What about expenses percase? How does the center’s per-formance compare with nationalbenchmarks?A financial dashboard helps lead-

ers at Harmony Surgery Center inFort Collins, Colorado, see trends ata glance. They track trends on a col-orful chart that one physician termsthe “Dow Jones index” (illustration,p 27). Amonthly variance gives clin-ical coordinators a picture of howtheir department is doing comparedwith the budget.Harmony’s chief financial offi-

cer, Darcy Thor, MBA, CMRP,says she strives for readable re-ports that are useful managementtools. The center, with 4 ORs, 2 GIendoscopy rooms, a pain manage-ment room, and 6 overnight re-covery suites, is a joint venturebetween physicians and thePoudre Valley Health System.

Dashboard indicatorsThe monthly one-page dash-

board tracks key financial indica-tors (illustration, p 28). The dash-board is part of an Excel spread-sheet with tabs that allow leadersto drill down for more detail.These are the dashboard’s key

indicators.

Cases per dayDefinition: Average number of

cases per day for the month. Casesare defined as patients admittedto the ASC that day.The average number of cases

per day tracked by month is moreuseful than cases per month, Thornotes, because it accounts for the

number of days the center wasopen.For example, which is better?

• April = 939 cases• May = 884 cases.It may look like April was bet-

ter. But in April, the center wasopen 22 days, while it was open 20days in May. Cases per day tells adifferent story:• April = 939 cases/22 days = 43cases per day

• May = 884 cases/20 days = 44cases per day.Using this measure, May was a

better month.Thor also tracks the number of

procedures per case. She knows,for example, that pain patients andendoscopy patients have an aver-age of 3.1 procedures, defined aseach billable CPT code.“We know that if we see more

procedures per patient, we willhave a good month,” she says, be-cause there will be more revenueper patient.The center also looks at daily

trends. For example, if only 5 casesare done consistently on the third

LLeeee AAnnnnee BBllaacckkwweellll,, RRNN,, BBSSNN,, EEMMBBAA,,CCNNOORRDirector, clinical resources and educa-tion, Surgical Care Affiliates, Birmingham, Alabama

NNaannccyy BBuurrddeenn,, RRNN,, MMSS,, CCAAPPAA,, CCPPAANNDirector, Ambulatory Surgery, BayCareHealth System, Clearwater, Florida

LLiissaa CCooooppeerr,, RRNN,, BBSSNN,, BBAA,, CCNNOORRExecutive director, El Camino SurgeryCenter, Mountain View, California

RReebbeeccccaa CCrraaiigg,, RRNN,, BBAA,, CCNNOORR,, CCAASSCCCEO, Harmony Surgery Center, FortCollins, Colorado and MCR SurgeryCenter, Loveland, Colorado

SStteepphhaanniiee EElllliiss,, RRNN,, CCPPCCEllis Medical Consulting, IncBrentwood, Tennessee

RRiikkkkii KKnniigghhtt,, RRNN,, BBSS,, MMHHAAClinical director, Lakeview Surgery Center, West Des Moines, Iowa

RRoosseemmaarryy LLaammbbiiee,, RRNN,, MMEEdd,, CCNNOORRNurse administrator, SurgiCenter of Baltimore, Owings Mills, Maryland

LLeeeeAAnnnn PPuucckkeettttMaterials manager, Evansville SurgeryCenter, Evansville, Indiana

DDoonnnnaa DDeeFFaazziioo QQuuiinnnn,, RRNN,, BBSSNN,, MMBBAA,,CCPPAANN,, CCAAPPAADirector, Orthopaedic Surgery CenterConcord, New Hampshire

Ambulatory Surgery Advisory Board

“

“A dashboardtracks key indicators.

27OR Manager Vol 26, No 8August 2010

AmbulatorySurgery Centers

Monday of the month, the centerconsiders closing for that day.

Man hours per caseDefinition: Total hours worked

divided by total cases.This is a measure of staff effi-

ciency; that is, how well staffingwas matched to the workload com-pared with prior periods. The indi-cator is tracked overall as well asfor the OR, GI endoscopy, painmanagement, pre- and postopera-tive care, sterile processing, andbilling departments.The indicator is influenced by

the length of cases. If more longcases are performed in a month,total worked hours per case will behigher than in other months.“I send this to the clinical direc-

tors to have them look at the vari-ances,” Thor notes. If the indicatoris high, they may know it was be-cause Dr Smith had 4 8-hour casesin a month, higher than average. A related indicator is cases per

FTE, measured by the formula:Cases/(total hours worked/daysopen), a measure of staffing effi-ciency.“We like to use both of these indi-

cators because either one can beswayed by the length of cases,” shesays.

Accounts receivableDefinition: Two amounts are

tracked: • AR gross ending balance• AR net + bad debt.Thor explains that AR gross is a

hybrid number that includes thenet amount that reflects discountsin the major managed care con-tracts plus the gross amounts ofother AR such as self-pay and out-of-network amounts. AR net addsin the bad debt.

Days in accounts receivableDefinition: AR balance x 60 days

divided by 2 months of billings.Harmony prefers to use a net

amount that reflects the contractdiscounts, which differs from theASC Association benchmark.

RevenueDefinitions: Total gross and net

revenue as well as gross revenue/case and net revenue/case.


0

500

1000

1500

2000

2500

3000

3500

Net income/case - actual

Total expense/case - actual

Net revenue/case - actual

150Apr09

May09

Jun09

Jul09

Aug09

Sep09

Oct09

Nov09

Dec09

Jan10

Feb10

Mar10

200

250

Total cases

$$/c

ase

2009-2010 per case summary & trend

28 OR Manager Vol 26, No 8 August 2010


Ambulatory Surgery Center dashboard

Note: The numbers in the chart are examples.

29OR Manager Vol 26, No 8August 2010


This indicator helps administra-tors see at a glance what was billed(gross) for cases and what the cen-ter actually expects to collect (net).

ExpensesDefinitions: Total expenses: All

costs of running the business.Total expense/case: Total costs percase.This set of indicators also in-

cludes benchmarks for medicalsupplies per case.Implants are listed as a separate

indicator. “We individually track implants

costing over $5,000 to be sure ourreimbursement at least covers ourcosts,” Thor says. The most expen-sive implants typically are in or-thopedics and spinal surgery,though prices also can be high inother specialties. Recently, a newtype of mesh from a bovine source(TEI Biosciences) used in breast re-construction was priced at $14,000per sheet.

Net incomeDefinitions: Includes net in-

come, net income/case, and profitmargin.

What are our case costs? Harmony captures case costs in

detail, which helps not only intracking financial performance butalso in engaging staff and physi-cians in managing costs. Computerized preference lists

include line-item pricing so clini-cians can see costs of supplies at aglance, raising cost awareness. Anurse might point out to a physi-cian, for example, “Did you knowthat catheter costs $225?” To capture case costs during a

case, the circulating nurse highlightsitems used on the preference list.Other case costs are captured manu-ally on a case history sheet, includ-ing preop and postop supplies,medications, and nursing time bysegment of the case. A part-time po-

sition (32 hours a week) is dedicatedto entering the cost data in Har-mony’s AdvantX software. The soft-ware, owned by SourceMedical, haspreference card and inventory mod-ules as well as scheduling, billing,



In addition to trending their ownfinances, ASCs want to know howtheir performance stacks up withtheir peers. Some questions to ask when

benchmarking:

Who are you beingcompared to?Are the benchmarking results

reported by type and size ofASC? Or they aggregated? Inother words, does the bench-mark include all types of ASCs,multispecialty as well as singlespecialty? If so, how well doesthat reflect your ASC’s experi-ence? In a multispecialty ASC,for example, FTEs per case willbe higher than in a facility thatperforms only GI cases.

How many participantsare there?How many facilities partici-

pate in the benchmarking ser-vice? The ASC Association Out-comes Monitoring Project has650 participants. The MedicalGroup Management Association(MGMA) 2009 report based on2008 data had 193 participantsbut reports data by type of ASC.Nationally, there are about 5,000Medicare-participating ASCs.

What’s included in thenumbers?It’s important to know the defini-

tions for indicators the benchmark-ing service is using. Are the defini-tions the same as yours? For exam-ple, how is FTEs per case defined?If your ASC includes business of-fice personnel in that figure, but thebenchmarking service includesonly direct-care personnel, thenumbers will not be comparable.

Benchmarking resources

ASC AssociationOutcomes Monitoring Project.ASC Association members can

participate for free. ASCs must par-ticipate to get the results. The pro-ject has 650 participants and bench-marks 38 key indicators. Partici-pants receive quarterly reportswith individual summaries. —http://ascassociation.org/outcomes/

Medical Group ManagementAssociation2009 ASC Financial Performance

Survey: 2009 Report Based on 2008Data. Item 8140.Includes information on revenue,

expenditures, patient volume, prof-itability, and more. Price $310MGMA members; $440 nonmem-bers.

—www.mgma.com

Benchmarking with other ASCs

AORN – Our Nurses Make the Difference!Improving Patient Safety Outcomes Is What We Do!

AORN is the leader in advocating for excellence in perioperative practice and healthcare. Our members rely on us for our educational programs, recommended practices and standards, and guiding principles that support them in their profession.

Want to work at AORN?AORN is currently hiring experienced perioperative nurses who would contribute to AORN’s development of Recommended Practices and Standards, educational programs, and a host of other products and services that we offer. AORN is also hiring for a nursing leader, to oversee these areas of focus.

To learn more about AORN’s current openings, visit www.aorn.org/CareerCenter/JobsAtAORNTo apply to AORN, send your resume in confidence to [email protected]

AORN is an equal opportunity employer (EOE). We offer a competitive compensation and benefits package, in a state of the art facility, in beautiful Denver, Colorado.

and other functions. To keep price data in the prefer-

ence cards up to date, the materialsmanager updates the prices in theinventory module when orderingsupplies, and the updates flowthrough to the preference cards.Thor assigns per-case costs for cap-ital items such as instruments andequipment based on expected lifeand depreciation. She also factorsin overhead costs.

Engaging the staff Harmony’s reports are tools

managers and coordinators can useto keep their departments on trackand engage the staff in meeting fi-nancial objectives.The variance reports help clini-

cal coordinators focus on areas thatneed investigation. Perhaps theOR’s supply spending was $76,318for the month when expectedspending would have been $56,924

based on the actual case volume.What accounted for the overage? Anumber of explanations are possi-ble. Maybe the OR bought supplypacks or another expensive supplythat actually will be used over sev-eral months. “We expect these numbers to

fluctuate, but we need to knowwhat’s going on,” Thor says. A monthly newsletter builds cost

awareness with a column that asks,for example: “Did you know thecost of Brand X catheter is $250?”

Building cost awarenessFundamentally, says Thor, cost

awareness stems from engagedemployees who have patients andthe center’s success at heart.Building that awareness starts

with the interview process.“In the interview, we ask, ‘Who

or what department is most impor-tant to making the organizationsuccessful?’” she says. “We like

people who understand that every-one is essential—patients, physi-cians, and staff in all departments.“The OR staff can be knocking

themselves out, but if the preopstaff isn’t, the center isn’t going tobe successful.”One of the center’s best invest-

ments is in employee recognition. Recognition comes through the

employee bonus program, whichgives everyone an incentive to becost-effective. Also, rather than setting aside

separate weeks to recognize nurses,technologists, and other staff, Har-mony holds an annual EmployeeAppreciation Week, reinforcing theidea that all employees together areimportant.The most essential message is a

focus on patient care.“We also communicate that this is

a business, but our patients comefirst,” Thor says. “I want to be able tobring my mother or father here.” �



New Webinars!Management Development ProgramA series of 12 webinars to help new and aspir-

ing managers move successfully into surgicalservices management. • August 26: Managing Productivity Standards• September 9: Creating a Safe Environment ofCare: New Managers

• September 23: So Now You Have Responsibil-ity for SPD

• October 7: Introduction to Lean in the OR• October 21: Turnover Time: The Challengethat Never Disappears!

• November 4: Developing Your Business Plan• November 18: Legal Competencies for Man-agement of Perioperative Services

• December 2: Ladders to Professional Success

Registered participants and additional listen-ers earn contact hours.

For more information and to register go towww.ormanager.com/webinar-series

Evolutionof Liquid Chemical Sterilization

the

Environmentallyfriendlier

Ensuresa more consistent process

Easyquick process for on-time starts

Excellentmaterial compatibility

Effi cientfaster turnaround of devices

For more information visit System1E.com


P O Box 5303Santa Fe, NM 87502-5303

The monthly publication for OR decision makers

The monthly publication for OR decision makers Periodicals

At a Glance

Staph infections morefrequent after chest, brainsurgeryPostoperative Staphylococcus au-

reus surgical site and bloodstreaminfections were most frequentamong patients who have had car-diothoracic or neurosurgery, a studyfinds.Analyzing 81,267 patients having

orthopedic, cardiothoracic, plastic,or neurosurgical procedures, re-searchers found 454 patients withinvasive Staph infections, of whichhalf were methicillin resistant.The highest bloodstream infec-

tion rates were after cardiothoracicsurgery, and the highest rates of sur-gical site infections were after neuro-surgery.“The key message is that one pre-

vention strategy does not fit all,” thelead researcher said. Additional pre-vention may be needed for cardio-vascular or neurosurgical proce-dures.

—Anderson D J, Arduino J M, ReedS D, et al. Infect Control Hosp Epi-

demiol. 2010;31:701-709.

Decisions about after-hoursanesthesia staffingWhy would many hospitals rou-

tinely have a surgeon’s add-on case

submitted at 7 pm wait 7 hours andnot start until 2 am, yet go to greatlengths to prevent a 7 am scheduledcase from starting 7 minutes late? Thismakes no economic sense in societalcost, hospital cost, or “surgeon as cus-tomer,” according to an article and ed-itorial in Anesthesia & Analgesia.The authors suggest a simple sta-

tistical method for monitoring after-hours staffing for anesthesia cover-age.—Ledholter J, Dexter F, Wachtel R E.Anesth Analg. 2010;111:196-203.

Coalition calls for FDA toissue UDI rulesThe Advancing Patient Safety

Coalition on July 7 urged the FDA toadopt regulations to establish aunique device identification (UDI)notification system for medical de-vices. The system would help moni-tor adverse events; prevent implan-tation of faulty, recalled, or counter-feit devices; and track recipients ofrecalled devices.

—http://advancingpatientsafety.org

Employers encouragedomestic medical travel tocut costsMedical tourism is going domes-

tic. Some employers and insurers

are offering workers financial incen-tives to travel to other US cities forsurgery, Kaiser Health News reports. By steering workers to hospitals

with high-quality care and lowerprices, employers can reduce theircosts 20% to 40%, more than enoughto cover the travel expenses. Employ-ers with domestic travel programssave money in part by negotiating asingle rate, which includes fees forsurgeons, anesthesiologists, and allcare until the patient is discharged.

—www.kaiserhealthnews.org/Stories/2010/July/07/domestic-

medical-tourism.aspx

FDA launches drug andbiologic safety websiteThe Food and Drug Administra-

tion has launched a website wherepatients and health care profession-als can go to for safety informationabout recently approved drugs orbiologics, such as vaccines. On the site, the FDA will share

what it has learned about the safetyof a new drug or biologic 18 monthsafter approval or after 10,000 pa-tients have used it. �

—www.fda.gov/Drugs/Guidance-ComplianceRegulatoryInformation/

Surveillance/ucm204091.htm

Documents

Themonthlypublication · calsite,andmaintainingnormal bodytemperatureduringsurgery. Adheringtoall6measureswas linkedtoreducingthelikelihoodof apostoperativeinfectionfrom14.2 to6.8per1,000discharges,astatis-ticallysignificantresult.Butthe3