the monthly publication for or decision...

November 2013 Vol 29, No 11

The monthly publication for OR decision makers

Best practices lead to greater consistency in vendor credentialing

Wisdom, inspiration, and passion capture spirit of annual conference

When OR Manager ex-amined vendor creden-tialing in 2009, hospi-

tals had a hodgepodge of require-ments. OR managers and pur-chasing departments were making their first forays into third-party software for managing credential-ing, and there was a crying need for standardization.

Four years later, progress has been made in developing creden-tialing standards, and hospitals are finding success with technol-ogy and policies as both vendors

and hospitals work to meet a shared goal—patient safety. How-ever, challenges remain, particu-larly as regards consistency of re-quirements.

“Our members are seeking con-sistency,” says Dennis Orthman, senior director for Strategic Mar-ketplace Initiative (SMI), a consor-tium of executives from provid-ers, manufacturers, distributors, and IT companies focused on the healthcare supply chain. “Consis-

Perioperative nurse lead-ers from across the US and other countries packed the

Gaylord National Resort & Con-vention Center at National Har-bor, Maryland, to participate in the 26th annual OR Manager Con-ference held September 23 to 25.

Approximately 1,000 attendees heard a wide range of talks, met with poster presenters, networked with speakers and colleagues, and enjoyed a record number of ex-hibits displaying the latest in OR equipment and supplies. Educa-tional programs offered by several exhibitors enhanced opportunities to obtain CE credits during the conference.

Attendees chose from a wide

array of preconference seminars, general sessions, and breakout sessions. Three tracks—business management, new OR manager, and ambulatory surgery center—helped ensure participants could attend sessions that directly ad-dressed their needs.

Benefits of transparencyOutstanding speakers, starting with keynoter Marty Makary, MD, on Monday afternoon, deliv-ered thought-provoking messages about what’s going on in the field today and how to prepare for the future.

“There is no greater problem

OR Manager Conference

Patient safety

Continued on page 12

STANDARDS & REGULATIONSFDA issues Unique Device Identification final rule ...........5

PATIENT SAFETYFast action, team coordination critical when surgical fires occur .......9

Successful vendor/OR partnership yields more than $1 million in savings .... 11

Surgical readmissions linked with quality of care ...15

SALARY/CAREER SURVEYOR business managers steadily gaining clout, financial rewards ...................16

OR BUSINESS PERFORMANCEBusiness managers’ skill sets strengthen return on investment ............19

ECRI INSTITUTE PERSPECTIVESRise in office-based surgery and anesthesia demands vigilance over safety .............22

Continued on page 6

APIC guide highlights role of ambulatory care in disaster response ........... 27

Why not?

TMTM

“Streamlining Patient Care”

We asked hundreds of Perioperative Directors who solely use grease boards why they haven’t made the switch to an electronic whiteboard yet?

The number one reason: “Electronic whiteboards lack needed functionality.”

Introducing PatientStream, the �rst and only cloud-based, evidence-based display and decision support system. It has the needed functionality. Functionality like integrated messaging, automated rules-based noti�cation, real-time reporting, full customization, inclusion of information not found in surgical systems, role-based views, evidence-based recommendations and much more.

If you’ve been challenged to reduce costs and to improve e�ciency, then we strongly encourage you to learn about PatientStream. It has what you need to improve communication, coordination and decision-making. It is cloud-based so nearly no IT support required. PatientStream is even priced to �t most any budget.

Learn more at www.patientstreaminc.com/whynot

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ORMGRFULLPGR_November.pdf 1 10/7/13 9:43 PM

3OR Manager Vol 29, No 11November 2013

Editorial

www.ormanager.comPUBLISHER, AI HEALTHCARE GROUPJennifer Green-Holmes • 301-354-1696

[email protected]

EDITORElizabeth Wood • 301-354-1786 • [email protected]

CLINICAL EDITORJudith M. Mathias, MA, RN

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[email protected]

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ART DIRECTORDavid Whitcher

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ADVERTISING

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Account Executive, OR Manager301-354-1814

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Vol. 29, No. 11, November 2013 • OR Manager (ISSN 8756-8047) is published monthly by Access Intelligence, LLC. Periodicals postage paid at Rockville, MD and additional post offices. POSTMASTER: Send address changes to OR Manager, 4 Choke Cherry Road, 2nd Floor, Rockville, MD 20850. Super subscription (includes electronic issue and weekly electronic bulletin) rates: $209 (plus $10 shipping for domestic and Canadian; $20 shipping for foreign). Single issues: $29. For subscription inquiries or change of address, contact Client Services, [email protected]. Tel: 888-707-5814, Fax: 301-309-3847. Copyright © 2013 by Access Intel-ligence, LLC. All rights reserved. No part of this publication may be reproduced without written permission.

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It’s too soon to measure the suc-cess or failure of the Afford-able Care Act (ACA), which

was signed into law in 2010 but is just beginning to be imple-mented. . . sort of.

Enrollment in health insurance exchanges got off to a rocky start on October 1 because of techno-logical problems, and demands to defund or delay the law helped lead to a shutdown of the federal government.

Just how the ACA will affect the OR is unclear, but during the OR Manager Annual Conference in September, 2 experts looked at the law in depth and explained how to meet the new require-ments.

The main changes underway to reduce costs and provide insur-ance coverage for everyone are to replace the fee-for-service pay-ments with performance-based in-centives, standardize care based on evidence, increase transpar-ency, and strengthen primary care, explained Mary Jane Edwards, RN, CNOR, FACHE, during her session on healthcare reform.

Edwards, who is director of provider performance improve-ment at Deloitte Consulting, ex-plained value-based purchasing (VBP) criteria. Eight of the 13 di-mensions in the processes of care for Fiscal Year 2014 will be surgi-cal. Measures such as adherence to SCIP (Surgical Care Improve-ment Project) protocols, timing of antibiotics, performing time-outs, and anesthesia will play into VBP, and ensuring compliance will demand a team effort.

“Value-based purchasing fi-nancially incentivizes the deliv-ery of quality patient care—these are the right things to do,” she said.

Greater focus on first-case on-time starts, patient charts, and standardization will be increas-ingly important. For example,

more detailed H&Ps will be needed to justify medical ne-cessity for procedures and en-sure reimbursement, according to Randy Heiser, president and CEO of Sullivan Healthcare Con-sulting, Inc.

During his preconference ses-sion, Heiser said that thus far, 20% of hospitals have made no changes relative to the ACA; 40% have joined accountable care or-ganizations, employed more phy-sicians, or entered into joint ven-tures; and 30%-40% have made everyone an employee.

Both Edwards and Heiser noted that primary care will play an increasing role in transpar-ency. For example, Heiser said about 20% of hospitals are track-ing to see whether the surgery recommended by primary care physicians is being performed at their in-network facility.

In August 2013, the Meaning-ful Use Workgroup issued draft recommendations for meaning-ful use stage 3 goals and criteria. Scheduled for 2016 to 2017, these draft recommendations focus on using technology implemented in stages 1 and 2 to improve pa-tient outcomes through electronic tracking systems for medication orders and implants, Edwards said.

A 2006 Harvard Business Re-view article estimated that just 15% of physician decisions are evidence-based, according to Ed-wards.

She encouraged everyone to challenge long-standing tradi-tions by looking for new knowl-edge and skills, and to make in-formed decisions.

Whether the ACA will send an influx of newly insured surgical patients to your hospital remains to be seen, but even if that doesn’t happen, you need to understand the new rules of the game. ❖

—Elizabeth Wood


Standards & regulations

The Food and Drug Admin-istration (FDA) on Septem-ber 24 published the final

rule for its Unique Device Identi-fication (UDI) system to provide a consistent way to identify medical devices throughout their distribu-tion and use.

“A UDI system for medical de-vices is an important step towards increasing patient safety, modern-izing postmarket surveillance, and facilitating medical device innova-tion,” says Jay Crowley, the FDA’s senior advisor for patient safety, center for devices and radiological health.

Once implemented, the UDI system is expected to have many benefits for the healthcare sys-tem and the device industry, says Crowley, including:•improved visibility as devices

move through the distribution chain up to the point of patient use

•enhancedability toquickly andefficiently identify marketed de-

vices during recalls and other safety actions

•enhanced ability to accuratelyidentify devices and adverse event reports

•strengthened support for elec-tronic health records through a standard way to document de-vice use.

UDI core elementsThe UDI system has 2 core ele-ments:•A unique number assigned by

the device manufacturer, called a unique device identifier, which includes information such as lot or batch number, serial number, expiration date, and manufac-turing date. A distinct identifica-tion code will be used for human cells, tissues, or cellular- and tis-sue-based products regulated as devices.

•Apublicly searchabledatabaseadministered by the FDA, called the Global Unique Device Identi-fication Database (GUDID), that

will catalogue device informa-tion for every device required to bear a UDI. No identifying pa-tient information will be stored in this database.Crowley says he expects the

FDA, medical device industry, healthcare systems, clinicians, patients, and others will use the GUDID to obtain important de-scriptive and use information and to find similar devices in cases of recalls or shortages.

“The GUDID will be used as a foundation for improving the quality of device public health reporting and medical device re-calls,” he says.

“The new UDI rule will—over time—impact all medical devices used in the hospital,” says James P. Keller, Jr, vice president, health technology evaluation and safety, ECRI Institute. “Some of the first to be affected are key parts of a surgery department’s operations (ie, implants). It’s important for OR managers to first become fa-miliar with the gist of the rule and work with materials management and clinical engineering profes-sionals to consider how medical devices with new UDI labeling will be recorded in their inven-tory management and purchasing systems.”

Phased-in implementationImplementation of the UDI system will take place over 7 years, focus-ing first on high-risk devices and extending to most other devices. Some low-risk devices are com-pletely exempt from the rule.

In general, the rule requires:•1 year after publication of the

final rule—labels and packages of Class III devices and devices licensed under the Public Health Service Act must bear a UDI.

FDA issues Unique Device Identification final rule

Advisory Board

Mark E. Bruley, EIT, CCE Vice president of accident & forensic investigation, ECRI, Plymouth Meeting, Pennsylvania

Lori A. Coates, BSN, RN, CNOR Manager, perioperative surgical services, Weiser Memorial Hospital, Weiser, Idaho

Stephanie S. Davis, MSHA, RN, CNOR Vice president of surgical services opera-tions and service line group, Hospital Cor-poration of America, Nashville, Tennessee

Brian Dolan, MHSA, RHIA, CHDA, SSGB Director, business operations, surgical services, University of Kansas Hospital, Kansas City, Kansas

Linda R. Greene, MPS, RN, CIC Infection preventionist, Rochester, New York

Jerry W. Henderson, MBA, RN, CNOR, CASC Assistant vice president, perioperative ser-vices, Sinai Hospital, Baltimore, Maryland

Lisa Morrissey, MBA, RN Associate chief nurse, perioperative ser-vices, Brigham and Women’s Hospital, Boston, Massachusetts

John Rosing, MHA, FACHE Vice president and principal, Patton Healthcare Consulting, Milwaukee, Wis-consin

Kathryn Snyder, MM, BSN, RN, CGRN Nurse manager, endoscopy/bronchos-copy/motility departments, University of Virginia Health System, Charlottesville, Virginia

Martha Stratton, MSN, MHSA, RN, CNOR, NEA-BC, Director of nursing, surgical services, AnMed Health, Anderson, South Carolina

David E. Young, MD Medical director, perioperative services, Advocate Lutheran General Hospital, Park Ridge, Illinois


6 OR Manager Vol 29, No 11 November 2013


than the wide variations in Amer-ican medicine”—variations that include quality, safety, behavior, and patient experience, said Dr Makary. However, he added, ex-citing developments are occurring in the spirit of transparency.

He noted a study of hospital CEOs that found 26% of nurses fear retribution. That’s because an-onymity promotes disruption, he said, and it’s important to break that barrier. Using a surgical check-list is a way to break down barriers, he explained, because team mem-bers introduce themselves and thus become active participants.

Dr Makary recounted a time when he ordered a CT scan for the wrong patient, and the pa-tient who was supposed to get the scan didn’t get it. He apologized to both patients for the mistake, and the patient who hadn’t got-ten the scan ended up becoming a Facebook friend with Dr Makary. “Our relationship improved be-cause of honesty,” he said.

On a broader scale, he shared a transparency success story about dramatically improved car-diac surgery outcomes at the Erie County Medical Center following release of a New York State report on mortality rates for coronary artery bypass grafting. Until the rates were measured, he said, Erie County didn’t know they were that bad. When hospital leaders asked staff what was needed to improve things, they learned that a dedicated cardiac ICU, a dedi-cated cardiac anesthesiologist, and a regular morbidity and mor-tality conference were needed—as well as a replacement for a poorly performing surgeon. “Mortality came down to the state average of 4%—the massive variations in quality were eliminated with a little transparency,” he said.

Golden opportunitiesNursing is ready to start a “golden age,” according to Kathleen San-ford, DBA, RN, CENP, FACHE, who spoke on Tuesday morning. Sanford, senior vice president and chief nursing officer for Catholic Health Initiatives (CHI), credited futurist Leland Kaiser, PhD, with coining the phrase several years ago and said, “I’m absolutely sure Leland Kaiser was right.”

Sanford acknowledged that, at first glance, the current age hardly seems to be golden. “Your span of control has gotten out of control,” she said, noting that she had spo-ken with some audience members who supervise more than 150 em-ployees. Adding to that challenge, perioperative leaders are coping with retention and recruitment issues in a rapidly changing envi-ronment.

But Sanford said we are in the golden age of patients, which translates into the golden age for nurses. “It’s about the people we serve,” she said. One indication of how nursing is “coming into its own” is the number of new job ti-tles that require a nursing degree. Examples from CHI include con-tinuing network director, medical

home quality director, and post-acute advanced practice RN.

Of course, change isn’t—and never has been—easy. Sanford cited the example of vitamin C and scurvy. Scottish physician James Lind first proved that citrus fruits prevented scurvy in 1753, but it wasn't until 1795 that the British navy took action, and it wasn’t until 1907 that the link be-tween vitamin C and scurvy be-came accepted.

Similarly, in healthcare, some problems haven’t changed in many years. Sanford said that around 1920, identified prob-lems included high costs and in-fections. However, Sanford said, “We’re finally figuring out that there are ways of doing these things, and it’s going to depend on our profession to get them done.” Hospitals also need to un-derstand that the number of in-patients is shrinking by about 3% each year, with the only growth in orthopedics, women’s services, and oncology.

Sanford cited an example of how education can empower nurses to speak out on behalf of patients, even in trying circum-stances. A patient cut his thumb.

OR Manager ConferenceContinued from page 1

Keynoter Marty Makary, MD, shared insights and personal experience to make a compelling case for transparency in healthcare.

Kathleen Sanford, DBA, RN, CENP, FACHE, inspired listeners with her talk on the “golden age of nursing.”



The surgeon said it had to be am-putated, but the nurse thought the thumb might be saved. Although the surgeon argued with the nurse, she left the OR to find the chief of surgery. The other nurse refused to give the surgeon the scalpel. The outcome? The chief surgeon said the thumb could be saved.

What made this episode special was that the nurses said they felt comfortable speaking out because the organization had adopted a culture of safety. Before then, they would have said nothing. San-ford said praise goes not only to the nurses in the OR but “to the leader who said it’s OK to speak up; you will be celebrated.”

Safety and quality will be

challenged by rising costs, with healthcare expected to soon reach 17% of the gross national prod-uct. “We must get costs down and keep quality up,” Sanford said.

Sanford noted that 3 ingre-dients will help leaders lead in this time of change: courage, a sense of humor, and love. Leaders need “courage to change [their] culture and courage to face the unknown,” she said. A sense of humor helps people to have fun at work. It helps to love yourself and those who work with you, under-standing, as Sanford said, “There isn’t such a thing as a ‘jerk-free’ environment.”

OR leaders need to understand some hard facts. In the past, San-

ford said, requests from the OR automatically “went to the top of the list” even when there wasn’t evidence to back up the need. From now on, “the OR will be-come more of a cost center than it’s ever been,” said Sanford.

Sanford is excited to move for-ward in this golden age of nursing and hopes OR leaders will stay in the field to enjoy this time. “You have so much wisdom,” she said. “I hope you plan to stick around for a while.”

That wisdom will be needed, she says, because “the stress of high-velocity change is here to stay.”

Shift in attitudeAttitudes and “comfort zones” can make or break the perioper-ative environment, and today’s leaders must understand the com-munication and learning styles of their staffs.

For the first time in history, we have 4 generations working to-gether in perioperative services—

Retiring education coordinator Judy Dahle received a plaque commemorating her years of service from Ellie Schrader (left) and Jess Tyler (right).

Pamela Smith, BSN, RN, CNOR, from Bon Secours St Francis Hospital in Charleston, South Carolina, received the OR Manager of the Year award.

Attendees packed the Exhibit Hall during the Welcoming Reception on Mon-day evening.

Continued on page 8



Traditionalists or Veterans, Baby Boomers, Gen X, and Gen Y, said Rose Sherman, EdD, RN, NEA-BC, FAAN, associate professor and di-rector, Nursing Leadership Insti-tute, Christine E. Lynne College of Nursing, Florida Atlantic Univer-sity, Boca Raton. She shared pearls for leading a multigenerational pe-rioperative workforce during her presentation on Tuesday.

Each generation has different attitudes, beliefs, work habits, and expectations. Learning to under-stand each generation and how it approaches the world and work is crucial to avoiding conflict, she emphasized.

Managers can capitalize on their various nursing generations’ strengths. For example, Gen Y nurses are very comfortable with technology. They may be the best group to test-drive and evaluate new technology, and then they can coach older nurses in learning how to use it.

This will also be true for the Gen Z nurses who will be join-ing the workforce in the next few years. They are the first gener-ation to be born with complete technology—PCs, mobile phones, gaming devices, MP3 players, and the Internet.

The Baby Boomers currently occupy many leadership posi-tions. They will be retiring soon, and the transfer of their knowl-edge is a very critical issue.

Positive actionAnyone experiencing fatigue at the end of the conference was bound to feel reenergized from the inter-active and engaging “Time Out!” presentation by closing speaker Vicki Hess. Drawing on personal experience, humor, and wisdom, Hess “empowered” everyone with a simple 5-step “SHIFT” checklist to use as a coping mechanism for the daily challenges all periopera-tive leaders face: Stop and breathe, Harness reactions, Identify emo-tions, Find new options, and Take one positive action.

To that end, mark your calendar now for next year’s OR Manager Annual Conference, which will be held September 17-19, 2014, at Long Beach Convention Center in Long Beach, California. ❖

—Cynthia Saver, RN, MS

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

Vicki Hess, MS, RN, CSP, told at-tendees how to turn tough times into “wow” experiences, leaving everyone feeling reenergized at the end of the conference.

Continued from page 7

Call for Conference Presentation Proposals for the2014 OR Manager Conference

OR Manager Conference 2014September 17-19Long Beach Convention CenterLong Beach, CA

Deadline to submit proposals:

November 8, 2013The OR Manager Conference provides high-level education and content for OR managers and directors, OR business managers, clinical directors, and others concerned with the management of the surgical suite. We strive to offer relevant information presented by experts to meet the needs of our audience.

Things to keep in mind when proposing speakers or session topics:

• Presentations should focus on practical topics related to surgical services management, such as OR throughput, staffing, and cost management.

• Avoid sales pitches or commercial presentations.

• Each presentation should include at least one take-home tool that the participants may use in their work following the conference.

• Willingness to be interviewed and/or featured in an OR Manager article or webinar at a future pre-arranged date.

How to submit your proposal:Online Use the online submittal form at www.ORManagerConference.com/call_for_presentations.php

Email Send your proposal to [email protected]

Mail Send your proposal to:

OR Manager Conference Attn: Jess Tyler 4 Choke Cherry Road, 2nd Floor Rockville, MD 20850 Ph: 301-354-1777

www.ORManagerConference.com

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22503_ORMC 1/3 Vertical Ad.indd 1 7/30/13 9:23 AM


Fast action, team coordination critical when surgical fires occur

New information on surgical fires sheds light on risk fac-tors, patterns of injury, and

why OR teams need to plan for their occurrence.

A May 2013 study led by Karen B. Domino, MD, MPH, is the first to assess closed malpractice cases of surgical fires. Dr Domino, pro-fessor of anesthesiology and pain medicine and adjunct professor of neurological surgery at the Uni-versity of Washington, Seattle, and colleagues analyzed 103 OR fire claims in the American Society of Anesthesiologists (ASA) Closed Claims Database from 1985 to 2009.

Most claims involved patients who had monitored anesthesia care (MAC) with open oxygen de-livery for upper chest, neck, and head procedures. Electrosurgical instruments were responsible for fires in 90% of claims.

Recognition of the fire triad (oxidizer, fuel, and ignition source), particularly the role of supplemental oxygen by an open delivery system during use of electrosurgical instruments, is key to prevent OR fires, says Dr Domino. Prevention is important because fires occur so quickly in the presence of oxygen, she says.

A December 2012 report from the Pennsylvania Patient Safety Authority analyzed 70 reports of OR fires submitted to its database from July 1, 2004, to June 30, 2011.

The fires occurred on the surgi-cal field or in the patient’s airway.

Of 65 reports with information about the ignition source, an elec-trosurgical unit was the source in 58%, a fiberoptic light cord in 38%, and a laser in 3%.

The role of oxygen was high-lighted in 7 reports, with 2 spe-cific mentions of nasal cannulas, 1 “leak” in the oxygen tubing, 1

oxygen mask over a tracheostomy stoma, and 1 using an electrosur-gical instrument to incise a tra-chea during a tracheostomy.

The data shows a slight down-ward trend in the number of fires—ranging from 1 per 157,545 procedures from 2007 to 2008 to 1 per 309,305 procedures from 2010 to 2011—but there is still a need for vigilance, says Mark Bruley, CCE, vice president, accident and forensic investigation at ECRI In-stitute, coauthor of the report.

Role of MAC, oxygenIn her study, Dr Domino found that malpractice claims related to electrosurgical-ignited fires during MAC increased from 6% of such claims between 1985 and 1989 to almost one-third of claims related to MAC between 2000 and 2009.

“We are seeing more fires in MAC cases in recent years be-cause we are doing more MAC cases,” she explained. MAC has become a lot more popular, es-pecially in the ambulatory set-ting, because patients have less nausea and vomiting and are less sedated; thus, they can be dis-charged more quickly.

A contributing factor is that many MAC patients are given propofol, which can result in more respiratory depression more quickly, so anesthesia providers put oxygen on these patients—whether they need it or not—just out of fear they might desaturate, she says.

Anesthesia personnel also give more oxygen now than in the past, says Dr Domino, because of pulse oximetry. “They are more cogni-zant of the oxygen saturation, and they give more oxygen,” she says.

According to the ASA Task Force on Operating Room Fires

and the Anesthesia Patient Safety Foundation, the most important practice for managing fire risk is to determine if supplemental oxy-gen is needed during the proce-dure. This is especially important when oxygen is administered via a nasal cannula or face mask, which would saturate the surgical field with high oxygen concentrations.

To reduce risk, keep oxygen concentrations at less than 30% because there is less combustion at this level, says Dr Domino.

Risk can be reduced further by using open draping techniques to prevent accumulation of oxygen under the drapes.

When there is a risk of fire and the patient requires oxygen, anes-thesia personnel should consider a general anesthetic with an endo-tracheal tube or laryngeal mask, rather than expose the patient to a heightened risk, Dr Domino says.

Other recommendations include not using regular monopolar elec-trosurgical instruments, if possible, in high-risk situations. If used, the power settings should be as low as possible, consistent with clinical needs, says Bruley. Instead, con-sider using bipolar electrosurgical instruments, if they will meet the needs of the procedure, he says.

Coordinated approachThe Pennsylvania Patient Safety Authority says a coordinated ap-proach to surgical fire preven-tion and response by the surgical team is important to eliminate fire hazards and to minimize the time needed to extinguish the fire.

Three elements are necessary for a fire: a heat source, oxygen, and fuel:•The surgeon isusually in con-

Patient safety


trol of the heat source (eg, elec-trosurgical unit) and can re-move it from the field.

•Anesthesia personnel are usu-ally in control of the oxygen source and can turn it off.

•Thecirculatingnurseandscrubtechnician can help ensure that alcohol-containing skin-prep solutions are meticulously ap-plied; the skin is dry before applying surgical towels and drapes; moist sponges, tow-els, and aqueous solutions are available; and exposed ends of fiberoptic light cords are kept off the field.The end of the fiberoptic light

cord is as dangerous as a lit cigar on the surgical field, with tempera-tures reaching 670° F, Bruley notes.

If a fire occurs, the surgeon and other team members can remove burning materials and extinguish the fire with water or saline, their hands, or a wet sponge or towel. Ideally, a wet sponge or towel is always available for an emergency.

Anesthesia personnel should minimize the availability of oxy-gen. Burning materials that have been removed can then be extin-guished by other team members, if needed, with water, saline, or—in extreme cases—with a fire extinguisher.

Of the 70 OR fire reports the Pennsylvania Patient Safety Au-thority analyzed, 23 named ways in which fires were extinguished.

These included:•removinga surgicaldrape and

dousing it with saline•moving a surgical sponge to a

basin of saline•removing, disconnecting, or

turning off the light cord when it was the ignition source

•dousing the firewith saline orwater

•extinguishing the firewith tow-els (1 noted the towels were wet)

•puttingout a bone cement firewith the hand

•extinguishing a fire caused bythe electrosurgical unit entering the trachea with use of the sur-geon’s hand, dousing the site with saline, and discontinuing supplemental oxygen.

Risk assessmentThe Pennsylvania Patient Safety Authority recommends a simple fire risk assessment score, such as the one Christiana Care Health System, Wilmington, Delaware, developed to identify procedures likely to pose an increased risk for surgical fires. A score showing the following 3 elements are pres-ent indicates high risk:•surgeryabovethexiphoid•openoxygensource•available ignition source (eg,

electrocautery, unit, laser, fi-beroptic light cord).A score of 3 indicates high risk;

2 indicates low risk, with poten-tial for conversion to high risk; 1 indicates low risk.

The score can be included in

the World Health Organization’s Surgical Safety Checklist preop-erative briefing or the Universal Protocol time-out.

OR teams need to have a stan-dardized plan and discussion, notes Dr Domino. “You can have fire risk on your checklist, but if the team doesn’t communicate that the surgeon will announce to the anesthesiologist when he is going to use the electrocautery, the anesthesiologist won’t know and will leave the oxygen run-ning,” she says.

Continuing education and communication along with fire prevention protocols are key to reducing OR fires. ❖

—Judith M. Mathias, MA, RN

ReferencesMehta S P, Bhananker S M, Posner K

L, et al. Operating room fires. An-esthesiology. 2013;118:1133-1139.

Clarke J R, Bruley M E. Surgical fires: Trends associated with prevention efforts. Pennsylvania Patient Safety Authority Safety Advisory. 2012;9;130-134.


Patient safety


Fire Prevention Algorithm*

Is patient at risk for surgical fire? (Procedures involving the head, neck and upper chest/above T5 and use of an ignition source in proximity to an oxidizer.)

Proceed but reassess for changes in fire risk frequently.

Nurses and surgeons avoid pooling of alcohol basedskin preparations and allow adequate drying time.Communication between surgeon and anesthesiaprofessional prior to initial use of electrocautery.

Does patient require oxygen supplementation? Room air sedation.

Is >30% oxygen concentration required to maintain oxygen saturation?

Secure airway with endotracheal tube or supraglottic device.†

Use delivery device such as blender or common gas outlet to maintain oxygen below 30%.

NO

NO

YES

YES

YES

NO

† Although securing the airway is preferred, for cases where using a device is undesirable or not feasible, oxygen accumulation may be minimized by air insufflation over the face and open draping to provide wide exposure of the surgical site to the atmosphere.

www.apsf.org

®

PROVIDED AS AN EDUCATIONAL RESOURCE BY THE

Anesthesia Patient Safety Foundation

*The following organizations have indicated their support for APSF’s efforts to increase awareness of the potential for surgical fires in at-risk patients: American Society of Anesthesiologists, American Association of Nurse Anesthetists, American Academy of Anesthesiologist Assistants, American College of Surgeons, American Society of Anesthesia Technologists and Technicians, American Society of PeriAnesthesia Nurses, Association of periOperative Registered Nurses, ECRI Institute, Food and Drug Administration Safe Use Initiative, National Patient Safety Foundation, The Joint Commission

©Anesthesia Patient Safety Foundation 3/10/2013

Reprinted with permission from the Anesthesia Patient Safety Foundation.


Successful vendor/OR partnership yields more than $1 million in savings

An innovative program at The University of Kansas Hospital (TUKH), Kansas

City, for managing vendor part-nerships has saved the hospital $1.9 million in just 8 months of operation. “We’ve found that pric-ing and inventory management re-quires key partnerships with sup-pliers,” says Brian Dolan, MHSA, CMRP, RHIA, CHDA, SSGB, di-rector of business operations for perioperative services at TUKH. The Above the Line Campaign has helped forge those partnerships.

Setting expectations“What does a partnership mean to the supplier and the organiza-tion?” is a key question to ask, says Dolan. A vibrant partnership requires established goals, feed-back mechanisms that help assess if the relationship is succeeding, and a system of continuous im-provement.

To achieve that type of partner-ship, TUKH started the Above the Line Campaign in January 2013. Dolan and his team brought to-gether key stakeholders (surgeons, anesthesia providers, clinical staff, business operations staff, and ser-vice line administrators) who iden-tified these drivers of vendor per-formance: competition, transpar-ency, clear customer expectations, recognition, business growth and potential market share improve-ment, and “preferred status” with an organization. Preferred status seemed to be the most important element to vendors.

The Above the Line Cam-paign’s expectations for vendors have their roots in the findings. Dolan notes that vendors under-stand the program information is a “living document” that the hos-pital can modify at any time.

A key component of the cam-paign is public recognition. “Once they meet our criteria, we put their name and photo in a hall-way where people walk daily, and we recognize them at lead-ership meetings,” Dolan says. “We’ve created a culture where the sales reps ask, ‘Why isn’t my company on there?’ They are then motivated to become part of the campaign.”

Campaign componentsThe campaign has 4 components:•Credentialing compliance.Ven-

dors must have completed their profile in TUKH’s third-party vendor management system. This includes acknowledging that they have read relevant policies and manuals. “We re-mind them that if they don’t follow our policies, they can be suspended for 2 weeks or lon-ger, depending on the infrac-tion,” Dolan says.

•Use of theMedApproved sys-tem. “This is a single portal of entry for any new product into the hospital,” Dolan says. The vendor, who has to register for MedApproved, submits the general product information, answers any assessment ques-tions from the hospital, provides supplemental documentation such as product brochures and

clinical studies, and uploads contract and product cost data. Once the information is com-pleted, a TUKH business ana-lyst reviews the information and sends an email to the identified project sponsor to verify his or her knowledge of the proposal. The business analyst then meets with the appropriate stakehold-ers to evaluate the product.

•Pricebenchmarking.“Suppliersmust fall in the top quartile on pricing to be considered Above the Line,” says Dolan. TUKH uses the SpeedLINK manufac-turing data, which benchmarks the hospital against other orga-nizations. Currently the hospital is at 0.40 on the price competi-tive index (PCI), which ranges from 0 (highly competitive) to 1 (least competitive).

•Customer service. This is as-sessed through customer sur-veys. “They (vendors) need to provide good front-line service and clinical support, adhere to the handbook, and address any issues with product availability promptly,” says Dolan.

Recognizing the bestVendors who meet the 4 com-ponents are eligible for the Ven-dor Recognition Program. “We wanted to find a way to make them (vendors) feel we value them,” Dolan says.

Each quarter, a vendor is cho-sen as the “Perioperative Services Vendor of the Quarter,” and at the end of the calendar year a “Vendor of the Year” award is presented to one of the quarterly winners. Any member of the peri-operative services team can nomi-nate a vendor.

Patient safety

“

“Public recognition

program spurs compliance.



Patient safety

tency can lead to efficiency on the part of both industry and hospi-tals.”

As is the case in many areas of medicine, identifying best prac-tices can reduce inconsistencies. At the same time, best practices let organizations tailor policies and procedures to their specific needs.

Best practices definedIn 2006, SMI published “Manage-ment Guidelines for Vendor Ac-cess,” and in 2009, AORN and the Advanced Medical Technology Association (AdvaMed), which represents medical device man-ufacturers, released “Joint Best Practices Recommendations for Clinical Health Care Industry Representative Credentialing.” The Coalition for Best Practices in Healthcare Industry Representa-tive (HCIR) Requirement began meeting in 2010 and has built on those earlier efforts to create the “Joint Recommendation for Healthcare Industry Representa-tive Credentialing Best Practices” (see p 13). Coalition members, who represent a wide range of stakeholders from healthcare or-ganizations and industry associa-tions, obtained input from many organizations, associations, and advocacy groups as they devel-oped the best practices.

The recommendation, first re-leased in July 2012, “is meant to be a living document,” says Rhett Suhre, cochair of the coalition and director of HCIR credentialing for Abbott. The coalition reviews and updates the best practices each year to ensure they reflect the cur-rent environment.

Suhre calls for hospitals, in-dustry, and credentialing compa-nies to align themselves with best

practices. “By aligning on best practices, we can meet the com-mon goals of patient safety and confidentiality while reducing healthcare costs,” he says. “Unfor-tunately, if we don’t do this, we’ll continue to add resources that may or may not provide benefit for patients but will drive health-care costs up.”

The Mayo Clinic piloted the best practices and has now imple-mented the “heart and soul” of them, says Bruce Mairose, MHA, BBA, vice chair of operations for supply chain management at Mayo. “The reason we use the recommendations is that they make sense.” Mayo, a large or-ganization across multiple states, saw states expressing interest in legislating what vendors should do. “We thought national stan-dards were already developing and recommended to one state to wait and see if industry could co-alesce around recommendations,” he says.

The request and the efforts of the coalition seem to have made a difference; Suhre says currently no state has such legislation.

UHC, an alliance of 118 aca-demic medical centers and 298 of their affiliated hospitals, has voted to support the recommen-dations, and Suhre expects adop-tions to continue increasing.

The coalition also plans to pro-vide free materials to support

companies in educating their ven-dors, starting with a program on fire safety training.

Joint Commission weighs inAlthough the Joint Commission doesn’t require vendor creden-tialing, it has “expectations” for healthcare industry representa-tives who come into the hospital, which it outlined in April 2012 and updated in July 2012:•takestepstoensurethatpatient

rights are respected, including communication, dignity, per-sonal privacy, and privacy of health information

•obtain informed consent in ac-cordance with organization pol-icy

•implement infection controlprecautions

•implement the patient safetyprogram.Despite this information, Mai-

rose says, “The challenge is that it can be hard to interpret what regulatory agencies are saying. Getting compliance officers, infec-tion control, employee health, and others all in agreement as to what the recommendations mean is dif-ficult.”

At the coalition’s August 2013 meeting, Suhre says a representa-tive from Joint Commission Re-sources, the educational arm of the Commission, clarified that because vendors don’t provide patient care, they don’t have the same responsibilities as those who do. The speaker also had a slide indicating that following the “Joint Recommendation for Healthcare Industry Representa-tive Credentialing Best Practices” would meet Joint Commission standards.

The clarification addresses a thorny problem—what hospitals should expect from vendors. Mai-rose emphasizes that OR leaders

“

“Vendor manage-

ment systems widely used.

Vendor credentialing Continued from page 1


Patient safety

“need to understand that sup-plier reps should not be put into the same category as employees when it comes to safety. Reps should know about fire exits but should not be trained to evacuate patients. Your instructions to reps should be to follow the instruc-tions of your employees.”

Third-party programs popular“The use of third-party compa-nies for vendor credentialing has exploded,” says Orthman. The growth has resulted in some con-solidation into 4 main national companies (VCS, VendorMate, Reptrax, and Parallon), but Suhre says, “There are a lot of regional players out there, too.”

According to a survey of 200 hospital CEOs and senior admin-istrators conducted by L.E.K., an international consulting com-pany, 49% of hospitals use a ven-dor management system. These systems are designed to ensure that vendors meet credentialing requirements, including reading policies and procedures regarding vendor access and conduct (see p 14). But it’s important to use man-agement systems to their fullest.

“The first couple of years, we weren’t using it as effectively as we could,” says Coleen Norberg, purchasing manager for Ellis Medicine, a 3-campus health sys-tem in Schenectady, New York, that includes a community hospi-tal. Ellis, which has used Reptrax since 2008, finds that monitoring reports daily provides the most benefit. Automatic notification also helps with tracking. If a ven-dor who is not fully credentialed signs in, an email is sent to pur-chasing. “We revoke his or her ac-cess to the system and also copy the OR so they know, too,” she says.

Mayo uses its third-party pro-gram, which Mairose declines to name, to require that vendors read its “Supplier Briefing.” The newsletter contains notices of price increases, changes in vendor expectations, policy updates, and other information vendors need to know. “We ask reps to also convey the information to the ap-propriate party in their company because it might not always relate to the salesperson,” he says.

An organization doesn’t have to sign up with a credentialing company to have a successful pro-gram, says Orthman. “It’s possible for organizations to have a strong access program on their own with-out signing up with third-party credentialing companies.” Some hospitals, such as Oneida Health-care in New York (http://www.oneidahealthcare.org/our-hospi-tal/vendor-information), have also put vendor information online.

When vendors go off trackMost vendors bring significant value to ORs through their prod-uct expertise and ability to ensure that ORs have the products they

need, Mairose says. Norberg adds that the reimbursement informa-tion vendors provide can help smooth the path of a new product entering the hospital system.

But what happens when a ven-dor doesn’t adhere to guidelines? “If we have any issues with a rep, whether it’s behavioral, skills, or something else, we use a formal escalation process with the rep-resentative and their employee,” says Mairose. The Mayo proce-dures mirror the coalition’s best practices.

First, a verbal warning is given and an email is sent to the ven-dor’s manager. If the problem is not resolved or another offense occurs, the supply chain depart-ment sends a letter notifying the vendor and his or her manager of a suspension, the length of which varies according to the infraction. (Note: The coalition best practices refer to “potential” suspension.)

If the problem continues, the coalition best practices recom-mend notifying the vendor and manager of a suspension until

About best practices“Joint Recommendation for Healthcare Industry Representative Cre-dentialing Best Practices” outlines best practices for 3 levels of repre-sentatives. •LevelIrepsdon’thaveaccesstopatientcareareas.•LevelIIrepshaveaccesstopatientcareareasbutnottosterileor

restricted areas.•LevelIIIrepshaveaccesstopatientcare,sterile,andrestrictedareas

such as the OR. Requirements are tailored to the level of access.Elements of the best practices document include credentialing re-

quirements (eg, proof of liability insurance, immunization, proof of criminal background check, training requirements), what should not be required (eg, electrical safety training), and enforcement.

Training requirements specific to the OR (sterile and aseptic tech-niques), which are required only for Level III reps, should be based on guidelines from AORN and the American College of Surgeons.Source: Joint Recommendation for Healthcare Industry Representative Cre-dentialing Best Practices. Available for download at http://www.hcirbestprac-tice.org.



Patient safety

the issue is resolved. At the Mayo Clinic, the vendor may be per-manently barred from the facility if a problem is left unresolved. “We notify the supervisor ahead of time so they can bring another resource in to support the organi-zation,” Mairose says. Of course, for a serious offense like a theft, the vendor may be suspended im-mediately. “We will bar suppliers if we suspect that their behavior or skills aren’t in the best interest of our patients,” Mairose adds.

Norberg says Reptrax helps manage discipline. First, the sys-tem automatically prevents a ven-dor from signing in if he or she hasn’t met credentialing require-ments. At the second level, the purchasing department has to re-store access even if the vendor has obtained credentials. The third level is a ban, with the length of time depending on the infraction. Purchasing works with the clini-cal department to determine what is appropriate, but 30 to 60 days is typical.

Suhre says using best practices to help ensure a consistent set of

requirements makes it easier for the vendor’s employer “to take corrective action not only for their facility but for all facilities that the individual may interact with.” For a serious infraction such as violation of patient privacy, the vendor will likely be suspended immediately.

Get involvedSuhre encourages OR nurse leaders to get involved with the coalition by reviewing the best practices to see if they fit their needs and by encouraging those responsible for credentialing in their organization to get involved, too. “The only group that has the authority to implement the best practices is the healthcare organi-zations themselves,” he says.

“It’s a privilege, not a right, for the rep to come into the facility,” Norberg says. “We stress that with reps—and employees.” She adds that OR managers and staff need to send a consistent message to staff and vendors: “Vendor policies and procedures are about bringing facilities in line with pa-tient safety.” ❖

—Cynthia Saver, MS, RN

Cynthia Saver, a freelance writer, is president, CLS Development, Inc, Columbia, Maryland.

ReferencesAORN. The role of the health care

industry representative in the perioperative/invasive proce-dure setting. AORN Position Statement. March 2011.

IMDA Update. Vendor credential-ing signs of progress. Septem-ber 2012. http://www.imda.org/news/update/201209.htm#vendor. Accessed August 22, 2013.

Lavoie B. Hospitals adopt new strategies to boost profitability, but still face deep challenges: A new imperative for medtech. Ex-ecutive Insights. 2013;15(4):1-6.

Mairose B. Mayo Clinic supply chain management: A review for consideration & implementation. Standardizing Credentialing Re-quirements for Healthcare Indus-try Representatives. June 15, 2012.

The Joint Commission. Non-li-censed, non-employee individu-als. July 9, 2012. http://www.jointcommission.org/mobile/standards_information/jcfaqde-tails.aspx?StandardsFAQId=423&StandardsFAQChapterId=66. Accessed August 26, 2013.

Managing vendor accessIn addition to computer systems, here are other ac-tions you can take to regulate vendor access:• Requirevendorstowearadifferentcolorof

scrubs.• Lockupscrubsandmakevendorsshowtheir

badge to obtain them.• Givevendorsaspecialcoloredbadgetowear

that is timed and dated.• Requirevendorstocallandscheduleanappoint-

ment. “Reps who drop in are interrupting patient care,” says Coleen Norberg, purchasing manager for Ellis Medicine. According to a survey by L.E.K., 75% of hospitals require vendors to make an appointment.

• Getsurgeonsonboard.Norbergsaysshowingthe requirements to the surgeons and explaining that it’s a patient safety issue has helped improve

cooperation. “Once we gained the surgeons’ sup-port, they helped to convert the most difficult vendors.”

• Getstaffonboard.Educatingstaffaboutthere-quirements and emphasizing the need for patient safety helps improve staff buy in, Norberg says. “Those in the OR department need to be the eyes and ears for credentialing compliance success,” she adds.

“Vendor credentialing has to be a cultural ap-proach, just like safety and infection control,” says Bruce Mairose, MHA, BBA, vice chair of operations for supply chain management at the Mayo Clinic. “Employees in the organization need to be watching, and if there is a problem, they need to let the supply chain management department know so we can han-dle it in collaboration with the clinical department.”



Patient safety

Surgical readmissions linked with quality of care

Hospitals with high surgical volume and low surgical mortality have lower rates

of surgical readmissions, research-ers from Harvard School of Public Health found in a new study.

The findings suggest that focus-ing on surgical readmissions may be a smart policy approach to im-prove care and reduce unneces-sary spending, the authors say.

To date, the Centers for Medi-care & Medicaid Services (CMS) has focused on reducing readmis-sions for medical conditions, such as heart failure and pneumonia, for which discharge planning and care coordination are often subop-timal. CMS plans to include surgi-cal procedures as it expands its readmissions penalty program.

Using medical readmission rates as a measure of hospital quality has been controversial be-cause rates are generally uncorre-lated with measures used to iden-tify high-quality hospitals, such as volume, mortality, and adherence to process measures. In addition, among studies showing the high-est readmission rates for hospitals with the sickest and poorest pa-tients, it’s unclear whether read-missions measure hospital quality or whether they reflect social and clinical factors unrelated to hospi-tal care.

The researchers postulated that surgical care might differ from medical care.

Using Medicare data from 2009 and 2010, the researchers calcu-lated 30-day readmission rates after 6 major procedures: coronary artery bypass grafting (CABG), pulmonary lobectomy, endovas-cular and open repair of abdomi-nal aortic aneurysm (AAA), colec-tomy, and hip replacements. In-cluded in the study were 479,471 discharges from 3,004 hospitals.

Results showed that approxi-

mately 1 in 7 patients discharged was readmitted within 30 days. •Hospitalsinthehighestquartile

for surgical volume had a sig-nificantly lower readmission rate than hospitals in the lowest quartile (12.7% vs 16.8%).

•Hospitalswiththelowestsurgi-cal mortality rates had a signifi-cantly lower readmission rate than hospitals with the high-est mortality rates (13.3% vs 14.2%).

•High adherence to surgicalprocess measures was only marginally associated with re-duced readmission rates (high-est quartile, 13.1% vs lowest quartile, 13.6%).Patterns were similar when

each of the 6 procedures was ex-amined individually.

Taken together, these findings

offer evidence that surgical read-mission rates are indeed linked with measures of surgical quality, the authors say.

Medical patients may return to the hospital because of poor social support, inability to access primary care, or general poor health, but surgical patients are more likely to be readmitted as a consequence of complications from the surgery. Hospitals with higher volumes and lower mor-tality rates are better at protecting patients from postoperative com-plications, they note. ❖

ReferenceTsai T C, Joynt K E, Orav E J, et al.

Variation in surgical-readmis-sion rates and quality of hospital care. N Engl J Med. September 19, 2013;369:1134-1142.

A Vendor Recognition Team determines the winners. The team comprises staff from the front desk (eg, volunteer ser-vices), contracts and procurement department, clinical area (includ-ing surgeons, OR managers, and OR staff), perioperative services supply chain, sterile processing, education, and perioperative ser-vices administration.

Vendors are evaluated on the 4 components and from the per-spectives of both the clinical and the business operation teams. For example, the clinical staff evaluate the vendor’s accessibility for sup-port, while the business staff eval-uate whether the vendor follows new product request procedures.

Chosen vendors are recognized by the perioperative services di-vision leadership team during a luncheon or dinner. The vendor

receives a plaque, and a second plaque with the vendor’s name, company, and date is hung in the hallway of the surgery department.

A team effort“Our suppliers’ efforts and sup-port help us provide the highest quality care and satisfaction to our patients while helping us meet our financial goals,” Dolan says. The Above the Line and Vendor Recognition Programs recognize the efforts of vendors in that vital vendor/hospital partnership. ❖


Cynthia Saver, a freelance writer, is president, CLS Development, Inc, Columbia, Maryland.

Editor’s note: For more information about this program, access a webinar, “Supplier Partnerships: Enabling Cost and Quality Improvements,” at http://store.ormanager.com/by-sub-ject-area.html.

Vendor/OR partnershipContinued from page 11

Business managers have seen a rise in salaries and num-ber of direct reports over

the past 5 years, but their overall role remains consistent, accord-ing to the 23rd annual OR Man-ager Salary/Career Survey. More than a third (34%) of respondents have a business manager on their team. The average annual salary for a business manager is nearly $84,000, up from $73,000 in 2008. The higher salary correlates with greater responsibility; 60% of business managers now super-vise 4 or more direct reports, com-pared with 50% in 2008.

Most business managers con-tinue to work in teaching hospi-tals (60%), and 59% serve facili-ties with 10 or more ORs. Nearly half of business managers work in the South (45%), followed by the Midwest (36%), West (29%), and Northeast (14%).

About the surveyData for the OR Manager Salary/Career Survey was collected from March to May 2013. The survey list comprised 775 OR Manager subscribers who are directors (or equivalent) of hospital ORs. The survey was closed with 160 us-able responses—a 21% response rate. To ensure representation of the target audience, results were filtered to include only the 155 re-spondents who work full time in a hospital. The margin of error is ±7.0 percentage points at the 95% confidence level.

Annual salaryBusiness managers earn an av-erage annual salary of $83,900, up slightly from the 2012 aver-age salary of $81,900, with those in teaching hospitals earning an average of $21,200 more ($98,500

vs $77,300). As expected, those working in facilities with 10 or more ORs earn more than those in facilities with fewer ORs.

Job structureAs in previous surveys, most business managers report to the OR director (71%). In teaching hospitals, 61% report to the OR director, compared to 76% in com-munity hospitals. The next high-est response was vice president (22% of teaching hospitals and 12% of community hospitals). The

reporting structure for business managers in facilities where the survey respondent supervised 1 to 4 ORs was equally distributed among OR director, vice presi-dent, and chief financial officer (33% for each).

More than half (60%) of busi-ness managers oversee 4 or more direct reports, with 23% oversee-ing 1 to 3. Only 17% have no di-rect reports.

As expected, and consistent with 2008, the most common areas of responsibilities for busi-


OR business managers steadily gaining clout, financial rewards

Salary/career survey

By facility type

Community30%

(n = 33)

Teaching60%

(n = 18)

By number of ORs1 to 4 5 to 9 10+

(n = 3) (n = 5) (n = 42)

7% 14% 59%

Degree requiredBachelor's 50%

MBA 30%

Other master's 18%

Other 0%

Does your OR have a business manager?

Yes 34%(n = 52)

No 66%(n = 102)

pie chartsDoes your OR have a business

manager?

Yes 34%n = 52No 66%n = 102No response 1%

Is a specific degree required for a business manager?


Is a clinical background required for a business manager position?

Yes (n = 20) 38%No (n = 31) 60%

Is a specific degree required for a

business manager?

Yes 77%(n = 40)

No 21%(n = 11)

No resonse

2%


manager?





Yes (n = 20) 38%No (n = 31) 60%

Is a clinical background required for a

business manager position?

Yes 38%(n = 20)

No 60%(n = 31)

No resonse

2%


manager?





Yes (n = 20) 38%No (n = 31) 60%


ness managers are financial: value analysis/product selection pro-cess (79%), financial analysis/reporting (77%), annual budget (69%), and purchasing OR sup-plies/equipment (63%). Areas of responsibility not directly related to finance include OR scheduling (44%) and surgical services infor-mation system (38%).

Profile of a business managerIn all, 77% of respondents say that business managers are required to have a degree (94% in teaching hospitals and 67% in community hospitals). Only a third of respon-dents who oversee 1 to 4 ORs re-port requiring a degree for the business manager role.

Of those who require a degree, half specify a bachelor’s degree, 30% a master’s degree in busi-ness administration, and 18% any other type of master’s degree. In 2008, 65% required a bachelor’s degree, but the percentage requir-ing a master’s degree in business administration or any other type of master’s degree was only 17% for both.

A total of 38% of respondents require the business manager to have a clinical background (44% of teaching hospitals and 36% of

community hospitals). Business managers working in smaller ORs were more likely required to have a clinical background (67% for 1 to 4 ORs vs 36% for 10 or more ORs).

Room to growBusiness managers continue to provide valuable services to OR leaders. In a challenging health-care environment, business man-agers can provide valuable finan-cial analysis that promotes effec-tive decision-making. Although the percentage of OR leaders with a business manager is much higher than in 2004 (34% vs 24%), there is plenty of opportunity for growth in the role. ❖


Cynthia Saver, president of CLS De-velopment, Inc, is a freelance writer based in Columbia, Maryland.

Salary/career survey

Number of direct reports

4 or more60%1 to 3

23%

None17%

To whom does the business manager report?OR director 71%

Nursing executive 0%

Vice president 15%

Chief financial officer 6%

Chief operating officer 0%

Other 8%

Average annual salary(n = 52)

Mean = $83,900

Median = $86,200

$100K+ 27%

$90K-$99,999 10%

$80K-$89,999 12%

$70K-$79,999 13%

$60K-$69,999 6%

<$60K 10%

Don't know 15%

No answer 8%

What are the OR business manager's responsibilities? (n = 51)

2013 2008

Value analysis/product selection 79% 66%

Financial analysis/reporting 77% 89%

Purchasing OR supplies/equipment 63% 57%

Materials management 58% 58%

Billing/reimbursement 52% 69%

OR scheduling 44% 43%

Strategic planning 40% 38%

Surgical services information system 38% 55%

Quality improvement 13% 17%

Other 6% 2%

Comparison of 5-year data2013 2008

Respondents who have a business manager 34% 38%

Average salary $83,900 $73,000

Report to OR director 71% 77%

Degree required 77% 73%

Clinical background required 38% 39%

4+ direct reports 60% 50%

Teaching hospitals with business managers 60% 59%

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Business managers’ skill sets strengthen return on investmentOR Business Performance is a series intended to help OR managers and directors improve the success of their business.

Hospitals depend on surgical services to generate more than half their revenue and

profit. Yet according to the latest OR Manager Salary/Career Sur-vey, only one-third of hospitals employ an OR business manager. This means most OR leadership teams lack a professional with for-mal training in accounting, finan-cial analysis, strategic forecasting, and revenue cycle management.

Why do hospitals decide not to hire an OR business manager? If the decision is based on the desire to save salary costs, it is shortsighted. ORs across the country have demonstrated that experienced business managers more than earn their keep. An ef-fective OR business manager typ-ically generates significant return on investment through improve-ments in revenue and expenses (sidebar p 20).

Hiring a professional to man-age the OR’s business operations also frees the nursing director to focus on patient care, clinical excellence, and overall strategy. This allows the OR to develop as a high-quality patient care organization while the hospital secures better financial perfor-mance from its most important revenue center.

Monitor operationsAn OR business manager’s most important function is to help the OR director run the surgery de-partment like a business. Effec-tive business managers carefully monitor operations to identify performance shortfalls and op-

portunities to improve. They de-velop decision tools that allow department leadership to manage the OR efficiently.

Utilization. Low OR utilization represents wasted resources and leads to low revenue. Better-per-forming ORs create an effective block schedule system and en-force utilization standards among surgeons. One of the business manager’s core responsibilities should be to establish systems for capturing utilization data, crunch-ing the numbers, and creating regular utilization reports that analyze surgeon performance.

Supply spending. Nonlabor costs represent approximately 60% of surgery department ex-penses. Most strategies for con-trolling supply spending involve analytical techniques that the typical OR director has neither the time nor the expertise to use. Business managers, however, know how to analyze supply ex-penses and develop data-driven cost reduction strategies.

Experienced business manag-ers can also apply professional management practices to the sup-ply inventory to decrease carrying costs. According to this year’s OR Manager Salary/Career Survey, business managers are increas-ingly involved in value analysis—a positive trend considering the

expansion of new OR products and technology.

Operational efficiency. Busi-ness managers should also focus on tracking operational metrics such as same-day cancellation rates, first-case on-time start rates, and average turnover time. These measures allow OR leadership to identify problems in preopera-tive processes, nursing protocols, scheduling, and other areas.

Surgeon performance . Ef-ficiency measures form the core of many surgeon dashboard re-porting strategies. Increasingly, surgeon dashboards are evolving into comprehensive performance reports. Innovative business man-agers are developing dashboards that report individual utiliza-tion, case volume, cancellations, and on-time starts, plus quality metrics like SCIP (Surgical Care Improvement Project) measures, infection rates, and readmission rates. Under new Medicare pay-ment models, business manag-ers play a key role in helping OR and surgical staff optimize perfor-mance on these metrics.

Advanced financial supportThe best business managers func-tion as the CFO of the OR. They provide advanced financial plan-ning and analysis to support exec-utive decision making and high-level financial improvement.

Budgeting. An experienced business manager can apply so-phisticated budgeting systems to OR operations. For example, forecasting surgical volume is critical to annual planning. In many ORs, the volume forecast is a simple calculation involv-ing current case volume and

OR Business Performance

“

“Strong strategic partner of the OR director.


high-level revenue goals. Effec-tive business managers create a comprehensive surgical volume forecast based on a wide range of performance measures and variables—including historical service line volumes, individual surgeon practice patterns, and overall market trends. A simi-lar approach can benefit complex budgeting areas such as staffing, depreciation, capital purchasing, and contracted services.

Contracting. The OR Manager Salary/Career Survey finds that business managers are becom-ing less involved in billing and reimbursement. This is unfortu-nate because the revenue cycle and charge capture are critical elements of surgery department performance. One of the biggest opportunities is in managed care contracting.

Most hospital managed care departments lack a full under-standing of OR operations. This tends to create unfavorable situa-tions in contracting. For example, hospital managed care staff may not be aware of all the costs in-curred in joint replacement pro-cedures. Contracted rates may not take into account expenses related to radiology, pharmacy, and other cost centers. A business manager who carefully monitors payment and expenses will spot the problem, quantify the impact, and present the data to OR and finance leadership. The managed care team can then use this data to negotiate more favorable joint replacement rates.

Serve as a strategic partnerAccording to the OR Manager Sal-ary/Career Survey, only 40% of business managers are involved in department strategic planning.

This is a poor use of their expertise.In most successful ORs, the

business manager is a strong strategic partner of the OR direc-tor. The business manager un-derstands the director’s strategic goals and provides the analysis and tools to achieve them. Orga-nizationally, the business man-ager acts as a liaison between the OR and hospital administration, establishing credibility for the OR

with executive and financial lead-ership.

Analyzing prof i tabi l i ty .Through careful analysis of demo-graphic, clinical, operational, mar-ket, and reimbursement trends, business managers identify high-margin, high-growth service lines. This background support is criti-cal to steering the OR toward a better case mix and stronger stra-tegic position.



Making the Business Case for a Business ManagerCan your department afford to hire an OR business manager? As the ROI matrix shows, even modest improvements in revenue and expenses produced by an effective business manager can generate a significant return on investment.

OR expenses and profitORs operational 10

Annual inventory spend $1,600,000

Annual inventory valuation $800,000

Staffing costs (2.5 FTEs per OR) $2,000,000

Average surgical case volume 10,000

Average annual contribution margin per case $1,800

Profitability $18,000,000

Business manager employment costsAverage salary 85,000

Average benefits 17,000

$102,000

ROIReduction in non-labor costs

1% 2% 3% 4% 5%

Re

du

cti

on

in

la

bo

r c

ost

s

1% 112% 127% 143% 159% 175% 1%

Inc

rea

se in

c

ase

volu

me

2% 308% 324% 339% 355% 371% 2%

3% 504% 520% 535% 551% 567% 3%

4% 700% 716% 731% 747% 763% 4%

5% 896% 912% 927% 943% 959% 5%



For example, the OR business manager at a large hospital in the Midwest calculated contribution margin by service, procedure, and surgeon. This analysis identified several service lines with a higher margin per case, including pe-diatric surgery and pediatric GI procedures.

Over 3 years, OR leadership consciously grew these service lines. Orthopedic volume held flat, but the OR deemphasized total joint replacements and focused on profitable procedures such as ar-throscopies. Overall, volume de-creased 5% in 3 years. Most of the decrease, however, was in lower-margin procedures. During the same period, net revenue increased by nearly 15% overall, while net revenue per case increased 20%. Total OR contribution margin in-creased more than $11 million.

Business development. The most skilled business managers are very effective at “selling” the OR to the surgeon community. They identify nonuser physicians and those who split their cases between hospitals, and then use a consultative approach to draw in more case volume. Business man-agers who excel at consultative selling know how to uncover the issues that prevent surgeons from performing more procedures in their OR. They also understand how to manage expectations while creating a healthy “give and take” with surgeons. Business managers with these skills are instrumental to growing surgical volume and market share.

Finding a strong candidateDoes an OR business manager need to have a background in clinical care? In our experience, a clinical background can be useful, but it has not proven to be nec-essary among better-performing

hires. More important is intellec-tual curiosity. Candidates who show a strong willingness to learn about OR clinical issues are often the most successful in this role.

While career experience can be varied, an advanced degree is mandatory. Strong candidates will have an MBA, an MHA, or another graduate degree or certi-fication in an area such as finance or accounting. Financial analysts recruited from other industries have done very well as OR busi-ness managers. Alternatively, you might find individuals within your hospital’s finance depart-ment who are willing to “dive deep” into the world of surgical services business and operations.

Strong analytical and computer abilities are essential. Top business managers are adept at extracting data from department informa-tion systems and creating Excel spreadsheets and Crystal dash-board reports. Capping it all off, the best OR business managers have strong interpersonal skills that allow them to interact effec-tively with hospital executives, OR staff members, and physicians.

Next monthA successful business manager will strengthen the OR as a busi-ness unit and allow the director to focus on improving care qual-ity. This will improve the depart-ment’s service to clinicians and

ultimately enhance patient satis-faction—an increasingly impor-tant factor in OR payment. The next “OR Business Performance” will examine strategies for boost-ing patient satisfaction by stream-lining patient flow and improving patient communication. ❖

This column is written by the peri-operative services experts at Surgical Directions (www.surgicaldirections.com) to offer advice on how to grow revenue, control costs, and increase department profitability.


These topics have been ad-dressed in previous columns:

Improving business performance (April 2013, p 20)

Block utilization (May 2013, p 21)

High-growth service lines (June 2013, p 23)

Supply costs (July 2013, p 21; August 2013, p 21)

Labor costs (September 2013, p 25)

Comprehensive dashboards (October 2013, p 18)

“

“Intellectual

curiosity is important.

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Advances in technology and anesthesia allow in-vasive procedures once

done only in hospitals or am-bulatory surgical centers to be performed in physician offices. The trend toward office-based surgery is evident in numerous specialties: otolaryngology, oph-thalmology, gynecology, derma-tology, general surgery, gastro-enterology, oral surgery, podia-try, and plastic surgery, among others. It is estimated that out of 80 million outpatient procedures performed in 2009, more than 12 million (15%) were performed in a doctor’s office (Midey).

However, research regarding patient safety in an ambulatory setting is still limited. A review conducted by the American Med-ical Association concluded that, though office-based surgery has been a focus of some such stud-ies in recent years, little is known about how to improve patient safety in an ambulatory setting, partly because of the unique na-ture of each practice setting (Lat-ner).

All operative or invasive pro-cedures, particularly those that use sedation or anesthetic agents, carry inherent risk. This article examines regulations, standards, and guidelines promulgated by states, state boards, accrediting agencies, and professional asso-ciations and presents examples of court cases that demonstrate the importance of creating strategies to mitigate risk in office-based surgical services.

AnesthesiaAnesthesia should be “adminis-tered only by a licensed, quali-fied, and competent practitio-ner,” according to the Ameri-

can College of Surgeons (ACS Guidelines). ACS continues to recommend that any registered nurse who administers anesthe-sia must be trained and have suf-ficient experience appropriate to the procedures being performed. Such competence should be doc-umented.

Also, the staff member admin-istering the anesthesia may not assist the procedure in any other way, recommends ACS. Both ACS and the Federation of State Medical Boards (FSMB) specify that administration should be overseen by a qualified physi-cian who is both in the room and aware of this responsibility.

The administering staff mem-ber should work within the scope of his or her practice, and when this staff member is a nonphysician, he or she should be under the supervision of an anesthesiologist or the operat-ing physician “unless state law permits otherwise” (FSMB). This physician is responsible for ensuring that an appropriate preexamination takes place—including developing a plan of care, educating the patient about it, and discussing all potential risks and safety precautions to be taken—prescribing the an-esthetic, ensuring the qualifica-tions of the administering staff member, and being immediately available in the event of any complication (ACS Guidelines).

FSMB agrees: this individual should be physically present and available before, during, and after the procedure, until the patient is discharged from anesthesia care (FSMB).

Informed consent“Informed consent for the nature and objectives of the anesthesia planned and surgery to be per-formed should be in writing and obtained from patients before the procedure is performed. In-formed consent should only be obtained after a discussion of the risks, benefits, and alternatives and should be documented in the medical record” (FSMB).

A discussion that includes the nature of the procedure offered, along with its risks (including any risks specific to the office set-ting compared with a hospital setting), benefits, and alterna-tives—as well as their risks and benefits—should take place well before the procedure is sched-uled to occur, when both the pa-tient and healthcare practitioner can focus on the discussion and address the patient’s concerns. This discussion should be doc-umented thoroughly, and the practitioner should verify, using a method such as teach back, that the patient understands the in-formation presented during the informed consent discussion and that all questions raised by the patient are answered.


Rise in office-based surgery and anesthesia demands vigilance over safety

ECRI Institute Perspectives

OR Manager, Inc., and ECRI In-stitute have joined in a collabora-tion to bring OR Manager readers quarterly supplements on topics such as medical technology management and procurement, risk man-agement, and patient safety. ECRI Institute is an independent non-profit that researches the best approaches to improving patient care.


Regulation and accreditationOffice-based surgery may be reg-ulated by state statutes or reg-ulations or through state medi-cal boards, though not in every state. According to the Accredi-tation Association for Ambula-tory Health Care, Inc. (AAAHC), Connecticut, Indiana, Nevada, New Jersey, New York, Ohio, Or-egon, Pennsylvania, Rhode Is-land, South Carolina, and Wash-ington require accreditation.

Other states’ requirements dif-fer; for example, Kansas practices must meet accreditation require-ments, California and Florida accept either state certification or accreditation, and Louisiana, North Carolina, and Texas allow accredited facilities to be exempt from surgery and anesthesia reg-ulations or guidelines. Colorado, Kentucky, Massachusetts, and Oklahoma have voluntary guide-

lines. Alabama, Illinois, Missis-sippi, New Jersey, Tennessee, and Virginia have implemented surgery or anesthesia regulations (AAAHC).

Facility leadership should be aware of state requirements, and these should be reviewed regularly to ensure that the fa-cility is in compliance. AAAHC provides up-to-date informa-tion on regulatory requirements at http://www.aaahc.org/en/news/aaahc-resources/laws-reg-ulations.

FSMB offers model guidelines for state boards and recommends that state boards follow these in addition to national accrediting organization standards and indi-vidual state standards. The FSMB model includes guidance on the administration of an office-based surgical practice, including the leadership and organizational structure of the facility and pa-

tients’ rights. FSMB also offers recommendations on personnel licensure, credentialing, and pa-tient evaluation (FSMB).

Another factor in accreditation is the individuality of patient care. This includes the preproce-dure anesthesia evaluation and anesthesia plan, as well as par-ticipation of qualified practitio-ners before, during, and after the procedure (FSMB).

Credentialing is addressed in some guidelines promulgated by professional associations. For example, ACS recommends that each practitioner have “an ap-propriate level of training and experience for the specific pro-cedure performed.” The group suggests the following (ACS Guidelines): •Review staffmembers’ specific

education regarding each pro-cedure to be performed, as well as his or her training, experi-ence, evaluations, and continu-ing medical education.

•Verify or review each staffmember’s board certification or eligibility.

•Considerstaffmembers’partici-pation in peer review and qual-ity improvement initiatives.

•Reviewstaffmembers’malprac-tice coverage, as well as their active hospital or surgical cen-ter privileges.



“

“Be aware of

different state requirements.

•Evaluate staff members’ ad-herence to professional society standards.Practices that meet certain re-

quirements for ownership, staff-ing, and types of procedures per-formed may also be eligible for Joint Commission accreditation under its office-based surgery standards. Organizations using this accreditation for Medicare cer-tification must be surveyed under criteria from the Comprehensive Accreditation Manual for Ambula-tory Care (Joint Commission).

Standards and guidelinesIn addition to regulatory and ac-creditation requirements, many medical specialty and professional associations promulgate guide-lines for office-based surgery and anesthesia. The most prominent include ACS, the American Soci-ety of Anesthesiologists (ASA), and FSMB.

ACS divides its guidance by the type of facility in which the procedure will be performed (ACS Guidelines):•Level I offices performminor

procedures under topical or local anesthetic only and are re-quired to maintain basic emer-gency equipment and have an emergency transfer plan.

•Level II officesperformproce-dures requiring up to moderate sedation that requires postop-erative monitoring; these fa-cilities must be accredited and have on-site full emergency equipment and medications, peer review, and performance improvement initiatives, in ad-dition to fulfilling the require-ments of a Level I facility. The surgeon and at least 1 assistant are required to be certified in basic life support, and the sur-

geon or at least 1 assistant is required to be certified in ad-vanced cardiac life support.

•Level III procedures requiredeep sedation or general anes-thesia. In these facilities, all the requirements of Levels I and II must be met, and patient re-covery should be monitored by a practitioner certified in ad-vanced cardiac life support. Procedures to be performed

within the facility should be within the scope of practice of the healthcare practitioners present, and the facility should have suf-ficient equipment to perform the procedure in question. The pro-cedure’s complexity and duration should be such that the patient will be able to recover and be dis-charged in a timely fashion ap-propriate to an office setting (ASA Guidelines).

Emergency planning is another significant portion of the ACS guidelines. In any emergency, such as complication with the surgery or anesthesia, all office personnel should know the facil-ity’s plan to safely and promptly transfer the patient to a hospital and be ready to fulfill their roles (ACS Guidelines). FSMB and ASA recommend a written policy that details the necessary staff, equipment, and procedures to handle any emergency that could arise in relation to the procedures performed and services offered

at the facility (FSMB; ASA Guide-lines).

ACS also specifies that any event involving anesthesia or re-lated to a surgical complication that requires resuscitation or transfer or results in patient death must be reported to the medical board within 3 days, though re-porting requirements vary among professional recommendations (ACS Guidelines). FSMB recom-mends that any incident following surgery or administration of anes-thesia that results in patient death within 30 days, unscheduled transport of patients to a hospital for observation or treatment for a period in excess of 24 hours, or unscheduled hospital admission of patients within 72 hours of dis-charge after office-based surgery should be required to be reported (FSMB).

ACS, ASA, and the American Medical Association joined to cre-ate guidelines for office-based an-esthesia and surgery. The 10 prin-ciples they agreed to addressed topics such as patient selection, accreditation, informed consent, physician privileges and board certification, and adverse event reporting; the ensuing statement was then agreed upon by many prominent professional associa-tions and accrediting bodies (ACS “Statement”).

Finally, ASA guidelines recom-mend that facility leadership ver-ify the licensure and certification of staff members and ensure that they practice solely within their scope of experience and training. Leadership is likewise responsible for ensuring the sufficiency of the facility for the procedures to be performed (ASA Guidelines).

In the courts In states where office-based sur-gery centers are not regulated,




“

“Verify licensure and certification

of staff.


negligence claims often focus on consideration of the healthcare practitioner’s experience, exper-tise, and certification, as well as facility equipment and available emergency supplies.

For example, the Supreme Court of North Carolina upheld guidance issued by the state med-ical board that called for physi-cian supervision as a standard of anesthesia care in office-based surgery. The board of nursing challenged the medical board’s position statement on office-based surgery recommending physician oversight of nurse anesthetists, but the court of appeals ruled that “physician supervision of nurse anesthetists providing anesthesia care, when that care includes pre-scribing medical treatment regi-mens and making medical diag-noses, is a fundamental patient safety standard required by North Carolina law” (ASA “North Caro-lina”).

A Las Vegas jury awarded a plaintiff more than $420,000 for a failed breast implant proce-dure. The defendant reportedly performed the procedure in his office without general anesthe-sia or intravenous sedation over the course of 7-1/2 hours. The incision on the patient’s right breast reopened and was re-paired by the defendant over an additional 8 hours. The incision opened again, at which point the plaintiff was admitted to the hospital for removal of the im-plants and a regimen of intra-venous antibiotics (Bernstein & Poisson, LLC).

In a case presented to the Or-egon medical board, a physician administered a fatal overdose of local anesthetic to a patient dur-ing an after-hours procedure. The board found that the physician, an internal medicine specialist,

failed to perform a patient evalu-ation before the procedure; per-formed the surgery alone, with no support staff or crash cart; failed to recognize the symptoms of a drug overdose; and failed to have the necessary drugs available to address such an emergency. The board determined the physician had improperly performed proce-dures and treatments for friends and had administered treatments with no medical justification (Budnick).

Office leadership should moni-tor litigation, state regulations, and state board guidance and en-sure that the facility remains up to date with these requirements and recommendations.

ReferencesAccreditation Association for

Ambulatory Health Care, Inc. (AAAHC). State laws and regulations. 2012. http://www.aaahc.org/en/news/State-Laws-and-Regulations

American College of Surgeons (ACS): Guidelines for office-based surgery. 2003 Dec [cited 2012 Sep 3]. http://www.facs.org/ahp/kyOBSguide12-03.pdf

Statement on patient safety prin-ciples for office-based surgery utilizing moderate sedation/analgesia, deep sedation/anal-gesia, or general anesthesia. 2004 Apr [cited 2012 Sep 10]. http://www.facs.org/fellows_info/statements/st-46.html

American Society of Anesthesi-ologists (ASA): Guidelines for office-based anesthesia. 2009 Oct 21 [cited 2012 Sep 3]. http://www.asahq.org/~/media/For%20Members/documents/Standards%20Guidelines%20Stmts/OfficeBased%20Anesthe-sia%20Guidelines%20for.ashx

North Carolina Supreme Court de-nies appeal of physician super-vision ruling. 2006 Oct 5 [cited

2012 Sep 10]. http://www.asahq.org/for-members/advo-cacy/office-of-governmental-and-legal-affairs/north-carolina-supreme-court-denies-appeal-of-physician-supervision-ruling.aspx

Bernstein & Poisson, LLC. Las Vegas personal injury lawyer at Bernstein & Poisson wins trial against a doctor arising from a breast augmentation surgery. 2012 Aug 4 [cited 2012 Sep 17]. http://www.reuters.com/arti-cle/2012/08/04/idUS20143+04-Aug-2012+MW20120804

Budnick N. Oregon medical board sheds light on cosmetic surgery by Northeast Portland doctor that led to woman’s death. The Oregonian 2012 Jan 14 [cited 2012 Sep 10]. http://blog.oregonlive.com/portlandcity-hall/2012/01/oregon_medi-cal_board_sheds_new.html

Federation of State Medical Boards (FSMB). Report of the special committee on outpatient (office-based) surgery. 2002 Apr [cited 2012 Sep 17]. http://www.fsmb.org/pdf/2002_grpol_Outpa-tient_Surgery.pdf

Joint Commission. Facts about of-fice-based surgery accreditation. 2011 Feb 4 [cited 2012 Sep 3]. http://www.jointcommission.org/assets/1/18/Office_Based_Surgery_Accreditation_2_11.pdf

Latner AW. Patient safety studies in ambulatory care settings lacking. Clin Advis 2012 Mar 19 [cited 2012 Sep 17]. http://www.clini-caladvisor.com/patient-safety-studies-in-ambulatory-care-set-ting-lacking/article/232708

Midey C. Doctor’s offices doing more surgeries. The Arizona Republic 2010 Nov 7 [cited 2012 Sep 10]. http://www.azcentral.com/arizonarepublic/news/ articles/2010/11/07/20101107 doctors-office-surgery.html


A 1-year extension may be re-quested; submission must be no later than June 23, 2014.

•2 years—labels and packagesof implantable, life-supporting, and life-sustaining devices must bear a UDI, and the UDI must be permanently marked on the device if it is intended to be used more than once and reprocessed before each use. Data for these devices must be submitted to the GUDID data-base.

•3years—Class IIIdeviceswitha UDI on the label and package must be permanently marked if intended to be used more than once and reprocessed before

each use. Labels and packages of Class II devices must bear a UDI, and data for these de-vices must be submitted to the GUDID database.

•5 years—Class II devices re-quiring a UDI on the label or package must be perma-nently marked if intended to be used more than once and reprocessed before each use. Labels and packages of Class I devices and devices that have not been classified must bear a UDI, and these devices must be submitted to the GUDID database.

•7 years—Class I andunclassi-fied devices with a UDI on the label and package must bear a permanent UDI marking if in-tended to be used more than

once and reprocessed before each use.The UDI system, which builds

on current device industry stan-dards and processes, reflects sub-stantial input from the clinical community and the medical de-vice industry, says Crowley. By building on systems already in place, the FDA strives to reduce the burden on the medical device industry. ❖

—Judith M. Mathias, MA, RN

Referenceshttp://www.fda.gov/Medical

Devices/DeviceRegulation andGuidance/UniqueDevice Identification/default.htm

https://www.federalregister.gov/ articles/2013/09/24/2013- 23059/unique-device- identification-system

Standards & regulations

UDI final ruleContinued from page 5



APIC guide highlights role of ambulatory care in disaster response

A new publication by the As-sociation for Professionals in Infection Control and

Epidemiology (APIC) zeros in on the role of outpatient care facili-ties in responding to disasters—specifically, how they can prevent infection in their patients, staff, and the community at large.

The guide, “Infection Preven-tion for Ambulatory Care Cen-ters During Disasters,” applies to all types of outpatient facilities, including ambulatory surgery centers (ASCs). It is available for download at no charge at www.apic.org.

The 112-page document, which covers a wide range of natural and human-caused disasters, em-phasizes that infection is more than a disease state introduced by bioterrorists; it is a potential byproduct of any kind of disrup-tion of modern living conditions. For example, a major storm may cause flooding or structural dam-age, resulting in water contamina-tion, which is an infection hazard.

In a disaster, ASCs are likely to cancel elective surgical proce-dures. They may, however, be called upon to perform emer-

gency surgery for disaster victims or community members that local hospitals cannot accommodate. The guide warns, “The risk of surgical site infections will likely be higher during disasters if re-sources become limited and cri-sis standards of care are imple-mented.”

Detailed directionsAccording to Terri Rebmann, PhD, RN, CIC, the guide’s author, APIC wanted to offer outpatient facilities the same comprehensive guidance that hospitals have long relied on for disaster planning. Rebmann is an associate professor at Saint Louis University’s Col-lege for Public Health and Social Justice. “According to research,” she says, “hospitals are continu-ally getting better at disaster plan-ning, but that’s not true of non-hospital settings. Most are not as prepared as hospitals. They may not have the resources.”

In addition, the regulatory re-quirement to develop a disaster plan is not followed up by specific details, she notes. “For example, the Joint Commission says a facil-ity needs to be able to handle an

influx of patients, such as having extra beds and supplies. There are so many elements that go into that 1 standard. That’s a starting point.”

The APIC guide provides de-tails and practical tools, such as checklists, posters, and policies that can be adopted directly from the document.

The focus is on infection, but the guide also stresses that disas-ter planning must involve many disciplines. Not only should med-ical and administrative staff par-ticipate, but the ASC should work with public health and emergency management agencies as well as nonprofit groups such as the Red Cross.

The guide draws on US and international agencies, including the World Health Organization, for its material.

ASCs, like all healthcare orga-nizations, must adhere to stan-dard infection control practices. When the unexpected happens, normal procedures may not be practical or adequate. The guide outlines “crisis standards” that may take effect in emergencies.

Ambulatory Surgery Advisory BoardLee Anne Blackwell, EMBA, BSN,

RN, CNOR Vice president, clinical services, Practice Partners in Healthcare, Inc, Birmingham, Alabama

Nancy Burden, MS, RN, CAPA, CPAN Director, Ambulatory Surgery, BayCare Health System, Clearwater, Florida

Rebecca Craig, BA, RN, CNOR, CASC CEO, Harmony Surgery Center, Fort Collins, Colorado

Stephanie Ellis, RN, CPC Ellis Medical Consulting, Inc Brentwood, Tennessee

Rikki Knight, MHA, BS, RN Clinical director, Lakeview Surgery Center, West Des Moines, Iowa

Donna DeFazio Quinn, MBA, BSN, RN, CPAN, CAPA Director, Orthopaedic Surgery Center Concord, New Hampshire

Mary Stewart, BSN, RN Chief Clinical Officer, Springfield Clinic, Springfield, Illinois

Debra Stinchcomb, BSN, RN, CASC Consultant, Progressive Surgical Solu-tions, LLC, Fayetteville, Arkansas


Ambulatory Surgery Advisory BoardLee Anne Blackwell, EMBA, BSN,

RN, CNOR Vice president, clinical services, Practice Partners in Healthcare, Inc, Birmingham, Alabama

Nancy Burden, MS, RN, CAPA, CPAN Director, Ambulatory Surgery, BayCare Health System, Clearwater, Florida

Rebecca Craig, BA, RN, CNOR, CASC CEO, Harmony Surgery Center, Fort Collins, Colorado

Stephanie Ellis, RN, CPC Ellis Medical Consulting, Inc Brentwood, Tennessee

Rikki Knight, MHA, BS, RN Clinical director, Lakeview Surgery Center, West Des Moines, Iowa

Donna DeFazio Quinn, MBA, BSN, RN, CPAN, CAPA Director, Orthopaedic Surgery Center Concord, New Hampshire

Mary Stewart, BSN, RN Chief Clinical Officer, Springfield Clinic, Springfield, Illinois

Debra Stinchcomb, BSN, RN, CASC Consultant, Progressive Surgical Solu-tions, LLC, Fayetteville, Arkansas


AmbulatorySurgery Centers

Helping handsFor outpatient facilities, local di-sasters may trigger preexisting plans that call on them to lend staff, beds, operating rooms, or medical-surgical supplies to sup-port first responders and hospi-tals. Those that remain open and accept patients may face short-ages and need to stretch or substi-tute resources.

Whenever facilities, people, and materials are used in unusual ways or places, the danger of in-fection is present. Gurneys in hall-ways? Power outage? No running water? Insects in the building?

Even shared toys in waiting rooms can be dangerous in a situ-ation where maintaining normal hygiene has become difficult, and the APIC guide contains a section on toy management.

Whatever the circumstances, when an unusually large number of patients arrives, infection will always be a concern. The new ar-rivals must be screened for infec-tion, then segregated or possibly isolated when serious infection is present. One way to do this when space is limited, the guide suggests, is through scheduling: see the infectious group first, and then treat the others.

ASCs, like all healthcare pro-viders, must have designated infection prevention specialists and must comply with Centers for Disease Control and Preven-tion (CDC) rules regarding re-portable diseases. These include potential bioterrorism agents such as plague, anthrax, botulism, and viral hemorrhagic fever.

Even when the disaster is not related to bioterrorism, infectious outbreaks may result from con-taminated water or food. Natu-ral pandemics occur regularly

throughout the world and may become serious. A recent example is West Nile virus, a neuroinva-sive disease transmitted by mos-quitoes. There have been several outbreaks in the United States, most recently in the Midwest. An-other virus of concern to the CDC, Rebmann says, is Middle East Re-spiratory Syndrome Coronavirus (MERS CoV) because it occurs in Middle Eastern countries and may be carried back by travelers to that area. The virus emerged recently in Saudi Arabia, at a time when large numbers of individu-als were making the pilgrimage there during Ramadan.

The guide recommends that ASCs participate in local syn-dromic surveillance programs to help with early identification of infectious disease threats in their communities. Appendix C in the guide lists symptoms to be re-ported and can also be used as a triage tool for incoming patients.

Few ASCs are likely to have space suitable for isolation, which is especially required for diseases with airborne transmission, but the guide recommends begin-ning protective measures before transferring patients to a hospital. Diseases to watch for and isolate include tuberculosis, chicken pox, measles, smallpox, viral hemor-rhagic fever, and severe acute re-spiratory syndrome (SARS).

The APIC guide describes per-sonal protective equipment that facilities should have available. An ASC may be well stocked with surgical masks, but it should also have a plan to distribute respira-tors, which fit tightly to the face and protect against very small particles such as viruses.

Protecting staffStaff may be overlooked in pro-grams designed to protect patients.

An upcoming quality-reporting rule will require ASCs to inform the Centers for Medicare & Med-icaid Services (CMS) whether staff members have been immunized for influenza. As part of disaster planning, the APIC guide recom-mends all staff be brought up to date for adult immunizations as directed by the CDC or public health agencies. If an outbreak of any kind occurs, they should be given any appropriate vaccines.

The guide also stresses that em-ployees should not come to work when they are ill, despite the nat-ural tendency to want to help in time of need. “[ASC] staff should not work while ill because they can contribute to disease transmis-sion,” the guide states. “This is im-portant for all disasters, but will be essential during infectious disease disasters because infected staff can contribute to disease transmission to patients and other staff.”

The same caution applies to staff members who are more sus-ceptible to disease, such as those who are pregnant or whose im-mune systems are compromised. The danger increases if the infec-tious disease is transmitted by air or droplets.

In addition to staff, visitors may also be a source of infection. The guide advises discouraging children and family members with compromised immune sys-tems or symptoms of illness from accompanying patients.

Food and drug safetyVaccines and drugs should be on hand or readily available in case of disease outbreak. However, di-sasters often are accompanied by power loss or damage to storage areas. Civil authorities may des-ignate an ASC or other outpatient




ASCs dodge wind, water, and infection riskRecent disasters such as bridges collapsing, mass shootings, bombs, and explosions have led to mass injuries that have been particularly challenging for local hospitals to treat.

Natural disasters—windstorms, fires, and floods—likewise wreak havoc, damaging or destroying healthcare facilities and disrupting supply distribu-tion just when those resources are critically needed.

During Colorado’s major flooding from heavy rains in September 2013, communities found them-selves isolated because of washed-out roads, and water supplies were at risk of contamination. The state health department warned Boulder-area resi-dents to boil water before drinking it.

Yet some locations were spared any damage. According to Chris Skagen, JD, MELP, execu-

tive director of the Colorado Ambulatory Surgery Center Association (CASCA), the “vast majority” of ambulatory surgery centers in the flood area were able to remain operational. CASCA participates in emergency planning with the Federal Emergency Planning Agency and the Colorado Department of Public Health and Environment, he says.

Harmony Surgery Center in Fort Collins, Colo-rado, is located on 1 of the few roads not closed by floods. Nearly all staff and patients were able to reach the center, which was not damaged. “Our pa-tients did not want to cancel,” recalls CEO Rebecca Craig, BA, RN, CNOR, CASC.

Infection control is always critical following a disaster, and proactive response is vital, she notes. “During the storm we were in disaster mode,” she says. “If we had had damage, we would have had to cancel all our cases to protect both staff and pa-tients.”

In fact, earlier in the summer Harmony faced an increased risk of infection because of a heat wave. After a very warm weekend, the staff returned to find the rooftop ventilation units had shut down but the humidifiers had continued to run. “It was like a little rain forest in there,” Craig recalls.

The center canceled all OR cases for the day while HVAC crews made repairs and staff worked to mitigate water damage.

Following the incident, Harmony conducted haz-ard risk assessments that included repeated mold testing, visual inspection of ductwork, and ventila-tion studies. Harmony’s quality resource director, Cassie Seiler, RN, CSHA, notes, “Post-event activi-ties were just as imperative as initial response to ensure long-term patient safety.”

Preparation pays off One spring day in 2011, Tuscaloosa [Alabama] Sur-gery Center administrator Jeffrey Hayes walked out

on the loading dock at 5 pm. A series of tornadoes had been harassing the Southeast, and now the city was under a warning with a massive tornado on the ground headed for the center of the city. After losing local television coverage, Hayes wanted to see the situation for himself.

“I could hear it and see the rotation,” he recalls. “I really thought we were about to get hit.”

The center’s disaster plan was already in effect. One patient remained in the recovery room with her 2 visitors, a child and a teenager. The staff had quickly moved the patient to a “safe room” in the building’s interior, where there were no windows. The young visitors were directed to stay inside to avoid the storm.

“We were all hunkered down in the corner,” Hayes says of the tense minutes that followed. The storm swept by 2 miles to the south and caused no damage to the facility.

Hayes called 1 of the surgeons to report they were safe and to offer help to the nearby medi-cal center because an early report stated that the hospital had been hit. That report turned out to be untrue. Several center employees were not so fortunate; the nurse manager lost her home to the storm.

The center was not immune to infection risk, how-ever. The electrical power failed, and a generator switched on. One of the refrigerators inadvertently had been left off the circuit powered by the generator, and this was not discovered even during an inspec-tion using a checklist.

The refrigerator contained drugs. “They had to be thrown out,” Hayes says. “[The refrigerator] was on the checklist, but somehow we missed it.”

Tuscaloosa’s experience shows how critical planning and communication are in averting tragedies, includ-ing infection outbreaks, when disaster strikes. The center, a 20,000-square-foot brick-and-steel structure with 5 ORs, accommodates about 8,000 cases a year. With low volume and few staff when the storm struck late in the day, it was possible to shelter the staff and remaining patient in the center’s sturdy, windowless interior.

Hayes notes that Tuscaloosa Surgical Center, al-though not part of the disaster relief network centered on the city’s 2 hospitals, regularly participates in plan-ning and drills. In fact, he notes, with the frequency of tornadoes in the area, all too often the drills coincide with real-life events.

To those who have not yet experienced a disaster first hand, he advises, never lose sight of the need for vigilance.

“Pay attention to warnings,” he says. “Double-check everything.” —Paula DeJohn


AmbulatorySurgery Centers

facility as a “closed point of dis-pensing” during a disaster, mean-ing it would serve as a source of medication for patients, staff, and the families of staff members. The disaster plan should provide for alternative means of temperature regulation (such as a cold storage unit) following a loss of power for refrigeration. “The cooling system for medications/vaccines must be separate from refrigeration used for food,” the guide notes.

It may be necessary to store food on site as well, for patients and employees who are caring for them. As part of the disaster plan, an ASC should work with com-munity and public health organi-zations to arrange for delivery of food as needed.

What about waste?Caring for additional patients will generate more waste, both ordi-nary and infectious. Meanwhile, waste disposal may be hampered by conditions following a disas-ter. The guide warns of the poten-tial for trash to attract insects and rodents, creating another possible source of infection.

APIC advises separating regu-lar and infectious waste, and stor-ing both types in a holding area. The holding area for disposal of waste materials should be safe, clean, and free of access by ver-min and insects. After trash and recycling items are picked up for disposal, the holding area should be cleaned and disinfected to re-move accumulated organic mate-rial; this will prevent infestation by insects, animals, and vermin.

Disposing of human waste may present a different challenge if sewer or water lines are dis-rupted. Toilets may be unusable or supplies may run short for in-

continence hygiene. The guide warns, “If any part of the ASC is flooded with potentially con-taminated water or fluid, immedi-ate steps must be implemented to prevent infection spread.”

In a section called “Postmor-tem care,” the guide says a disas-ter may result in more deaths than facilities are used to handling and that a deceased body may be a source of infection. Work with the coroner and health department to develop a plan for managing fa-talities. The plan should include arrangement for supplies such as body bags.

Wounds should be packed and bandaged to prevent exposure to body fluids. Bodies should be stored or transported in accor-dance with state health codes.

Planning for the unimaginableBecause every disaster is unique in some way, no plan can cover all possibilities. Rebmann notes that most plans, including those at the community level, focus on natu-ral disasters. “There are so many pieces to the puzzle,” she says.

The APIC guide aims to make it easier to control infection risks in any disaster. However, the in-fection control coordinator must participate in overall design and testing of disaster plans, within and outside of the organization. “Try to be involved in disaster drills in the community,” Reb-mann says.

“It needs to be a group pro-cess.” ❖

—Paula DeJohn

ReferenceAssociation for Professionals in

Infection Control and Epidemi-ology. Infection prevention for ambulatory care centers during disasters, 2013. www.apic.org.


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Lean Management in the OR: Perioperative teams share their “lean” approach to thinking, operating, and managing. Lean management makes improvement goals easier to achieve by inspiring CEOs, clinicians, and staff alike to ask, “Does this add value?”

Patient Safety: Aiming for Zero Surgical Site Infections: This downloadable special report focuses on stopping surgical site infections. Perioperative teams can find information on SSI prevention, national SSI rates, and OR cleaning that will help protect their patients from these potentially deadly infections.

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The monthly publication for OR decision makers Periodicals

At a Glance

OR Manager Vol 29, No 11 November 2013

Much work needed to make hospitals highly reliableTo achieve a goal of zero patient harm, hospitals must adopt les-sons from high-risk industries, finds a Joint Commission report.

The authors say hospital lead-ership must•commit to thegoal of zeropa-

tient harm rather than viewing it as unrealistic

•stop intimidation and blame,and emphasize accountability

•implementacombinationofSixSigma, Lean, and change man-agement to eliminate patient harm.The Joint Commission tested

the high-reliability framework at 7 hospitals.

—http://www.pwrnewmedia.com/2013/joint_commission/mil-

bank_quarterly/index.html

Nurse staffing linked to readmissionsHospitals with higher nurse staff-ing had a 25% lower odds of being penalized for readmissions compared to hospitals with lower staffing, a study finds.

Policy makers and hospital administrators should consider investing in nursing as a way to reduce readmissions and avoid

penalties associated with read-missions, the authors say.

—http://content.healthaffairs.org/content/32/10/1740.abstract

CMS drops bariatric surgery certification requirementThe Centers for Medicare & Medicaid Services will no lon-ger require Medicare patients to undergo bariatric surgical proce-dures at accredited facilities.

CMS says evidence shows that requiring certification for bariatric surgery facilities would not im-prove health outcomes for Medi-care beneficiaries.

The American Society for Metabolic and Bariatric Surgery (ASMBS) and the American Col-lege of Surgeons (ACS) voiced their disappointment with the ruling. —http://www.facs.org/news/2013/bariatric0913.html

Auditors to delay scrutiny of ‘two-midnight’ ruleGovernment recovery auditors will delay scrutiny of short inpa-tient stays for 90 days while pro-viders get acclimated to the new policy, officials at the the Centers for Medicare & Medicaid Services announced.

Under the policy, if a physi-cian expects treatment to require a two-night hospital stay and ad-mits the patient on that basis, the stay would be covered by Medi-care Part A.

The policy presumes that stays spanning less than two midnights should have been provided on an outpatient basis (ie, outpatient observation), a level of care for which Medicare pays less and that could result in high copayments for the ben-eficiary.—http://www.modernhealthcare.com/article/20130926/NEWS/309269945/

High blood glucose raises surgical wound complication riskThe risk of serious wound com-plications was more than 3 times higher in patients with high blood glucose before and after surgery and in those with poor long-term diabetes control, a study finds.

Wound complications included dehiscence, surgical site infec-tions, and repeat surgery.

—http://journals.lww.com/plas-reconsurg/Fulltext/2013/10000/

The_Role_of_Chronic_and_Periop-erative_Glucose.49.aspx

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