healthcare · 2 july 2016 • healthcare purchasing news • hpnonline.com special focus 6...

INSIDE...PPE progress, performance

ASCs push for acute winsShip to be fi scally square

Universal SPD certifi cation?

Physicians Understanding, Respecting and Engaging Supply Chain 2016 P.U.R.E. Awards

Li Ern Chen, MD, MSCS, Scott & White Health

Jimmy Chung, MD, FACS, CHCQM, Providence Health & Services

Sean Lyden, MD, FACS, Cleveland Clinic;

Chief Medical Offi cer, Excelerate Strategic Health Sourcing

David Reiter, MD, MBA, FACS, Center for Healthcare Entrepre-neurship & Scientifi c Solutions

CLINICAL INTELLIGENCE FOR SUPPLY CHAIN LEADERSHIP®

www.hpnonline.com

July 2016 • Vol. 40 No. 7$7.00

PURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASING ®®EWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSwww.hpnonline.comEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASINGPURCHASING EWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSEWSNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNN

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July 2016 • HEALTHCARE PURCHASING NEWS • hpnonline.com2

SPECIAL FOCUS6 Newswire/Fast Stats

10 PHYSICIAN PREFERENCE: SUPPLY CHAIN MATTERS FOR PATIENT, INDUSTRY HEALTH

Four MDs dismantle professional stereotypes about attitudes, motives and business relationships.

OPERATING ROOM18 PPE — PREPARED FOR PREVENTION EVERY TIME

Facilities and manufacturers are working to step up compliance and adjust to new requirements. Vendor Listings ..................24Product Spotlights .............26

INFECTION PREVENTION28 COMPLIANT AND COMPETITIVE IN THE ASC

Winning in the ambulatory surgery center arena means fi nding ways to implement and execute best practices and standards similar to those practiced by hospitals.

28 Prevention Update

CS CONNECTION36 UNCOMMON SENSE

CS/SPD certifi cation and training should be universal, but the pathway to reach that aim includes a lot of curves.

36 Instrumental News42 Self-Study Series

TCO in the SPD: Forethought can lead to more economical equipment ownership and operationby Melissa Gonsalves and Sarah Lazzara

46 IAHCSMM ViewpointWorkplace bullying: what it is, how to stop itby Julie E. Williamson

47 CS Solutions Medical grade air; dry vs. moist instrument transport; multiple inspection magnifi ers by Ray Taurasi

PRODUCTS & SERVICES 48 STRIVING FOR SHIP, SHIP HOORAY! MOMENTS

Freight and shipping management can generate easy wins after diffi cult searches, so why isn’t it more prevalent?

48 New Technology 57 New Products

EXPERT EXCLUSIVES4 Fast Foreward54 People & Opinions

Supply Chain, physicians bond around new technology

54 Worth Repeating56 Standard Practices

The human side of UDIby Karen Conway

58 Having My Say The perfect purchased services program. Last of a multi-part seriesby Fred Crans

60 Back Talk Taking stock of capital acquisition proceduresby David S. Kaczmarek

59 Advertiser Index/Classifi ed

July 2016 • Volume 40, No. 7

10

48

IN THIS ISSUE...

18

HEALTHCAREPURCHASING EWSN

28

36

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Copyright 2016 by KSR Publishing Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage-and-retrieval system, without permission in writing from the publisher. Healthcare Purchasing News is a registered trademark used herein under license.Offi ce of publication: Periodicals Postage Paid at Sarasota, FL 34242 and at additional mailing offi ces. Postmaster: Send address changes to: Healthcare Purchasing News, P.O. Box 17517, Sarasota, FL 34276-9801.

KSR Publishing Inc.

Printed in USA • Paper manufactured in USASoy ink made in USA • Keep jobs in USA

EDITORIALPublisher/Executive Editor Kristine Russell [email protected] Senior Editor Rick Dana Barlow [email protected] Managing Editor Valerie J. Dimond [email protected] (941) 927-9345, ext. 202 Contributing Editors Kara Nadeau [email protected] Susan Cantrell [email protected]

ADVERTISING SALES East Coast Blake and Michelle Holton (407) 971-6286 Midwest Donna Boatman-Riley (815) 393-4624 West Coast Blake and Michelle Holton (407) 971-6286

ADVERTISING & ART PRODUCTIONAd Contracts Manager Tiffany Coffman (941) 927-9345, ext. 203 Graphic Design Tracy Arendt MAILING LIST RENTALS Laura Moulton (941) 927-9345, ext. 201

CORPORATE President Kristine Russell Healthcare Purchasing News (ISSN: 1098-3716) is published monthly by KSR Publishing Inc., 2477 Stickney Point Road, Suite 315B, Sarasota, FL 34231, Phone: (941) 927-9345, Fax: (941) 927-9588, www.hpnonline.com, Business hours: 8:00 a.m.-5:00 p.m. EST.

EDITORIAL ADVISORY BOARDJoe Colonna, Vice President, Supply Chain, Piedmont Healthcare, Atlanta, GA; Karen Conway, Executive Director, Industry Relations, GHX, Louisville, CO; Michele De Meo, CRCST, (Ret.); Dee Donatelli, RN, CMRP, CVAHP, Navigant, Wichita, KS; Mary Beth Lang, Vice President, HC Pharmacy and SCM Commercial Services, UPMC, Pittsburgh, PA; John Mateka, Director, Materials Management, Clarendon Health System, Manning, SC; Melanie Miller, RN, CNOR, CSPDM, Consultant, CA; Dennis Orthman, Senior Director, Strategic Marketplace Initiative (SMI); Jean Sargent, CMRP, FAHRMM, Vice President, Healthcare Strategy and Implementation, USDM Life Sciences, Santa Barbara, CA; Rose Seavey, RN, BS, MBA, CNOR, ACSP, Seavey Healthcare Consulting Inc.; Richard W. Schule, MBA, BS, FAST, CST, FCS, CRCST, CHMMC, CIS, CHL, AGTS, Director, Clinical Education, STERIS Corporation; Robert Simpson, CMRP, President and CEO, LeeSar Regional Service Center and Cooperative Services of Florida, Fort Myers, FL; Barbara Strain, Director, Value Management, University of Virginia Health System, Charlottesville, VA; Deborah Petretich Templeton, R Ph., MHA, Chief of Care Support Services, Geisinger Health System, Danville, PA; Ray Taurasi, Eastern Regional Director of Clinical Sales and Services, Health-mark Industries; Brian Viele, R.N., BSN, CCRN, Director, ICU/ BHU/Clinical Consultants/Inpatient Cardiopulmonary, Mid Coast Hospital, Brunswick, ME

SUBSCRIPTION RATESU.S.: $74.00 for one year (prepaid orders only)Canada: $90.00 Single copies: $7.00Foreign: $122.00 Industry Guide: $49.95Special issues and back issues: $11.00 per copy, prepaid. Certain individuals qualify for free subscriptions.

CHANGE OF ADDRESSSubscribers: For change of address, send your old and new addresses to Healthcare Purchasing News, 2477 Stickney Point Road, Suite 315B, Sara-sota, FL 34231. Fax: (941) 927-9588, Email: [email protected]. Allow 4 to 6 weeks for correction. All other inquiries, call Tiffany Coffman at (941) 927-9345, ext. 203.

The most expedient policy covering validation of the twin compo-nents of sterile processing procedures — cleaning and disinfection/sterilization — calls for good parenting skills.

Actions lead to consequences.When an auto racer fails to follow the rules and commits an error on the track — acci-

dentally or fl agrantly — he or she earns a black fl ag. That driver then must leave the track, regardless of position, return to his or her pit, bring the car to a complete stop and then return to the track. The risk? The driver may lose hard-earned positioning and be taken out of contention for the win. But that’s the price you pay for violating a rule.

Within the last few weeks, we’ve spotted several news reports shining a spotlight on breakdowns in the sterile processing fi eld.

For one article, a reporter and her editor questioned whether bioburden left on a surgi-cal instrument after the cleaning process poses any problems once the instrument exits the sterilization process. Certifi ed, experienced and forward-thinking sterile processing experts know the answer.

In another article, a hospital failed to notify patients that contaminated duodenoscopes were used on them, leading to post-operative infections. Furthermore, the hospital failed to follow proper cleaning guidelines. To wit: They used canned compressed air from an offi ce supply store to dry scopes.

In yet another article, the FDA issued mixed messages about a prominent manufacturer of automated washers, originally ordering a recall based on questions about the equipment’s effectiveness and how it handles duodenoscopes, but then backpedaling from that recall to allow the equipment to be used on “instruments including most endoscopes — just not duodenoscopes.” Call this “in-dispute” technology.

For both cleaning and sterilization, effectiveness should be the prerequisite for effi ciency — and certainly cleaning fi rst and foremost. Nothing should be left behind in the cleaning process; only a completely clean instrument can be sterilized with the fi nished product being an instrument ready for duty with absolutely no residual moisture. Many sterile processing pros know this. Others apparently need reminding: Only a completely clean instrument should be sent through the sterilization process.

This philosophy has been the mantra for decades, even before the debut of more complex minimally invasive instruments in the 1980s.

One challenge with MIS instruments is that their guts cannot be visualized easily, typi-cally requiring disassembly and/or running a tiny camera through them, if necessary. But that can add time to the reprocessing process, which affects patient throughput and revenue. To compensate, facilities either invest in more costly MIS instruments or cut corners and hope for the best.

It’s more important to be effective fi rst than to be effi cient. Once you can demonstrate effectiveness, then and only then should you concern yourself with effi ciency. If you don’t accept that then you should not be allowed to practice medicine or be in the business of delivering healthcare. Quibbling hospital executives who tacitly value revenue over safety should be forced to partake personally in this game of surgical Russian roulette. Ask them to think of any of their loved ones on the surgical table. Or themselves. Watch how fast opinions, policies and procedures change when their long-term health security is called into question.

This is as it should be. The only way to make change is to personalize the consequences of doing nothing.

Everyone needs to share in the responsibility.First, the FDA must require validation of cleaning and sterilization of all surgical instru-

ments and the sterile processing equipment through which they’re run — preferably via certifi ed independent, third-party laboratories.

Second, hospitals should be required to tell patients in advance of a surgical procedure whether they are using recalled or “in-dispute” products.

Third, to infl uence patients with their decision, the insurance companies — including Medicare and Medicaid — should issue a directive denying reimbursement (e.g., coverage) for any procedure where recalled or “in-dispute” products are used or any product is used without proper validation credentials. This gives the patient the opportunity to choose another healthcare provider or assume the risk if they don’t.

We need to act responsibly. And fast.

Think of your loved onesFAST FOREWARD


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July 2016 • HEALTHCARE PuRCHAsing nEWs • hpnonline.com6

Fast stats nEWsWiRE

730 deaths per 100,000 people occurred last

year, an increase of seven deaths per 100,000 people in 2014. this is the first

death rate increase in a decade, which is due in part to more accidental injuries,

stroke and other causes.

167heart disease deaths per 100,000 people

occurred last year, which remains flat from 2014. Heart disease remains the No.1 killer.

27.6 million adults are diagnosed with heart disease and every year about 735,000

americans suffer a heart attack.

29alzheimer’s disease deaths per 100,000

people occurred in 2015, an increase of 4 deaths per 100,000 people the previous

year. Non-Hispanic white women have the highest mortality rate from alzheimer’s disease, followed by non-Hispanic black

women.

15drug overdose deaths per 100,000 people occurred last year, up from 14 deaths the

previous year. since 2000, the rate of deaths from drug overdoses has increased 137%, including a 200% increase in the rate of

overdose deaths involving opioids (opioid pain relievers and heroin).

11 alcohol-related deaths (chronic liver disease and cirrhosis) per 100,000 people occurred

in 2015, up slightly from 2014. alcohol-related deaths in general (all causes,

including accidents) are the fourth leading preventable cause of death.

Source: Centers for Disease Control and Prevention, National Center for Health Statistics, Vital Statistics Rapid Release, June 2016.

NQF, CDC release antibiotic stewardship guide to help organizationsExperts from the public and private sectors have released a tool to help U.S. acute-care hospitals implement strategies to promote appropriate, safe use of antibiotics. The National Quality Forum (NQF), Centers for Disease Control and Prevention (CDC) and Hospital Corporation of America (HCA) created Antibiotic Stewardship in Acute Care: A Practical Playbook — based on CDC’s Core Elements of Hospital Antibiotic Stewardship Programs — a practical guide to significantly reduce antibiotic overuse and other misuse.

The CDC estimates that the inappropri-ate use of antibiotics causes antimicrobial resistance that leads to 2 million illnesses and 23,000 deaths annually. Examples of strategies in the tool include:• Assessing when patients need antibiotics

and when treatment should be adjusted• Educating staff, family and patients about

appropriate antibiotic use• Tracking and reporting antibiotic pre-

scribing, use and resistanceThe Joint Commission is currently work-

ing on a standard to address antimicrobial stewardship after having conducted an ex-tensive field review in late 2015, which involved key stakeholders that include The Joint Commission’s accredited hospitals, critical access hospitals, ambulatory care, office-based surgery settings, and nursing care centers.

Medicare makes enhancements to the shared savings program The Centers for Medicare & Medicaid Ser-vices (CMS) released a final rule improving how Medicare pays Accountable Care Or-ganizations (ACOs) in the Medicare Shared Savings Program for delivering better pa-tient care. Medicare is moving away from paying for each service a physician provides towards a system that rewards physicians for coordinating with each other. ACOs are a major part of that transition, rewarding providers that deliver high-quality, efficient, and coordinated care for patients.

Medicare bases ACOs’ payments on a va-riety of factors, including whether the ACO can deliver high-quality care at a reasonable cost. The final rule should help more ACOs successfully participate in the Medicare Shared Savings Program by improving the shared savings payment methodology and providing a new participation option for certain ACOs to move to the more advanced tracks of the program.

This final rule changes how Medicare pays ACOs by basing one of the payment factors on whether theACO is able to deliver

high-quality care at a lower cost compared to other providers in their region.

This change recognizes that health cost trends vary in communities across the coun-try and will give ACOs more opportunities to be successful. In addition, the rule pro-vides a smoother and quicker transition to the more advanced tracks for certain ACOs by allowing an extra year under their first agreement before the organization takes on financial risk.

The Administration’s next goal is tying 50 percent of Medicare payments to alternative payment models by 2018. The Health Care Payment Learning and Action Network established in 2015 continues to align efforts between government, private sector pay-ers, employers, providers, and consumers to broadly scale these gains in better care, smarter spending, and healthier people.

Healthcare supply chain leaders and visionaries honored at 16th annual GHXcellence awardsGlobal Healthcare Exchange, LLC (GHX) announced the GHXcellence Award win-ners at the 2016 GHX Healthcare Supply Chain Summit awards banquet in Austin, TX. The awards, presented to provider and supplier organizations for the past 16 years, recognize the leaders and visionaries that are leveraging supply chain automation to remove waste, cut costs and improve patient care.

This year GHX added the new Millen-nium Club award for provider and supplier organizations that generate over one million automated transactions annually through the GHX Exchange, as well as eight new provider awards to the 2016 GHXcellence program, which blend quantitative and qualitative criteria to honor true healthcare supply chain leaders and innovation.

GHX selected the winners based on quantifiable performance metrics around success in automating business processes. This year’s winners include:• Supply Chain Leadership (Provider): Bill

Mosser, Franciscan Missionaries of Our Lady Health System

• Supply Chain Leadership (Supplier): Carol Stone, C.R. Bard Inc.

• Provider of the Year (Large): Hackensack University Medical Center

• Provider of the Year (Small to Medium): Seattle Children’s Hospital

• Supplier of the Year (Large Volume): St. Jude Medical

• Supplier of the Year (Small Volume): Merit Medical

• Canadian Healthcare Supplier of the Year: Medtronic of Canada

• Canadian Healthcare Provider of the Year: Transform Shared Service Organization

1607-Newswire.indd 6 6/9/2016 1:34:37 PM

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nEWsWiRE• European Union Healthcare Supplier of the Year: Smiths Medical

International Ltd.• Trading Partner Pair of the Year: Montefiore Health System and

Zimmer Biomet• Excellence in Content Management: Integris Health• Excellence in Contract Management: Lane Regional Medical

Center• Excellence in eProcurement: Berkshire Health Systems• Excellence in ePayables: Phoebe Putney Health System• Excellence in Vendor Credentialing: Sharp Healthcare • Impact Industry Supplier for Credentialing: Teva Pharmaceu-

ticals USA• Most Improved Provider: Henry Ford Health System• Rookie of the Year: Health Sciences North

WHO: Defining the syndrome associated with congenital Zika virus infectionThe World Health Organization (WHO) defines the Zika virus infection in humans as usually mild or asymptomatic. However, some babies born to women infected with Zika virus have severe neurological sequelae.

An unusual cluster of cases of congenital microcephaly and other neurological disorders in the WHO Region of the Americas, led to the declaration of a public health emergency of international concern by the WHO on February 1, 2016. By May 5, 2016, reports of newborns or fetuses with microcephaly or other malformations — presumably associated with Zika virus infection — have been described in the following countries and territories: Brazil (1271 cases); Cabo Verde (3 cases); Colombia (7 cases); French Polynesia (8 cases); Martinique (2 cases) and Panama (4 cases). Additional cases were also reported in Slovenia and the U.S., in which the mothers traveled to Brazil during their pregnancies.

Zika virus is an intensely neurotropic virus that particularly tar-gets neural progenitor cells but also — to a lesser extent — neuronal cells in all stages of maturity. Viral cerebritis can disrupt cerebral embryogenesis and result in microcephaly and other neurological abnormalities.

Zika virus has been isolated from the brains and cerebrospinal fluid of neonates born with congenital microcephaly and identified in the placental tissue of mothers who had had clinical symptoms consistent with Zika virus infection during their pregnancies.

Existing evidence and unpublished data shared with WHO highlight the wider range of congenital abnormalities probably associated with the acquisition of Zika virus infection in utero. In addition to microcephaly, other manifestations include craniofacial disproportion, spasticity, seizures, irritability and brainstem dys-function including feeding difficulties, ocular abnormalities and findings on neuroimaging such as calcifications, cortical disorders and ventriculomegaly. Similar to other infections acquired in utero, cases range in severity; some babies have been reported to have neurological abnormalities with a normal head circumference. Preliminary data from Colombia and Panama also suggest that the genitourinary, cardiac and digestive systems can be affected.

The range of abnormalities seen and the likely causal relationship with Zika virus infection suggest the presence of a new congenital syndrome. WHO has set in place a process for defining the spectrum of this syndrome. The process focuses on mapping and analysing the clinical manifestations encompassing the neurological, hearing, visual and other abnormalities, and neuroimaging findings.

The scope of the syndrome will expand as further information and longer follow-up of affected children become available. The surveillance guidance has been expanded to include a spectrum of congenital malformations that could be associated with intrauterine Zika virus infection besides microcephaly.

Thirty-seven countries and territories in the Region of the Ameri-cas now report mosquito-borne transmission of Zika virus and risk of sexual transmission. With such spread, it is possible that many thousands of infants will incur moderate to severe neurological disabilities. Therefore, routine surveillance systems and research protocols need to include a larger population than simply children with microcephaly. The health system response, including psycho-social services for women, babies and affected families will need to be fully resourced.

A coordinated approach to data sharing, surveillance and research is needed. WHO has thus started coordinating efforts to define the congenital Zika virus syndrome and issues an open invitation to all partners to join in this effort. Visit www.who.int/bulletin/volumes/94/6/16-176990/en/.

Unapproved wound care products flood the marketTreating nonhealing, unresponsive wounds requires that physicians have an intimate knowledge of the products available to stimulate healing and stop chronic wounds from advancing to the point of widespread infection and limb amputation. But in order for clini-cians to do their jobs to the best of their ability, it is imperative that the wound care products they use do what they say they do.

An array of wound care products has flooded the marketplace in recent years, with untested and unproven claims about their wound healing capabilities. The manufacturers of these allograft products have effectively bypassed years of careful research and clinical trials requiring hundreds of millions of dollars in investment, as well as the regulatory authorizations necessary to be legally marketed as wound healing therapies.

On the flip side, a small number of manufacturers have done things the right way and developed products that are rigorously tested and FDA-approved. These advanced living-cell products have been scientifically proven to heal chronic wounds when less expensive and less sophisticated options have failed.

Due to a current regulatory loophole, non-FDA-approved prod-ucts are able to make the same wound healing claims as FDA-approved living cell therapies, and many doctors do not know or understand the difference because of the way the products are marketed. Allograft products have flown largely under the regula-tory radar due to a longstanding FDA process that’s long overdue for revision. Under this process, companies are permitted to self-designate their own products under one of two categories: either human cell and tissue products (“HCT/Ps”) that require FDA premarket approval, or those that do not (referred to as “Section 361 HCT/Ps”).

By self-designating “Section 361” status for products that do not, in fact, qualify as such, allograft distributors have been able to skirt the FDA approval process while making unproven claims about their wound healing capabilities. Doctors and their patients need to know this, and the FDA has an opportunity — and a responsibil-ity — to stop it from happening.

The real-life consequences of this muddy policy issue are pretty straightforward: When presented with two products claiming the same outcomes, providers will of course lean toward choosing the less expensive option. But making the wrong choice when a com-pany has offered misleading efficacy claims ultimately impacts the patient. When unproven or clinically inferior products are used, patients lose healing time, infection can worsen, and the risk of amputation becomes greater.

The FDA must act to make regulatory changes to keep patients safe. The agency has the opportunity to do so as it works to finalize industry guidance that will clarify what qualifies as a true Section 361 HCT/P. HPn

1607-Newswire.indd 8 6/9/2016 1:34:37 PM

She’s heading home. Happy and healthy.3M can help you reduce the risk of I.V. site complications that can extend hospital stays.

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© 3M 2016. All rights reserved. 3M, “3M Science. Applied to Life.” Avagard, Cavilon, Curos, and Tegaderm are trademarks of 3M Company. Used under license in Canada.

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2016 PuRE AWARds

Back in 2005, Healthcare Purchasing News launched an annual award that recognized and honored healthcare

organization CEOs and presidents who Support, Understand, Recognize and Em-power Supply Chain Management. They are S.U.R.E. about the importance of supply chain operations to the health and well-being of an organization and the quality of patient care it delivers.

Starting this year HPN decided to launch a brand extension to honor those profes-sionals a bit closer to supply chain manage-ment activities — physicians. Why? We’re witnessing more doctors and surgeons par-ticipating in supply chain operations with more depth than ever before so we want to share their ongoing stories with the industry.

Our goal with this inaugural award is twofold: We want to rec-ognize physicians who have made solid contributions to supply chain operations — activities, practices and thinking — and we want to further solidify and strengthen the clinical bonds between physicians and supply chain professionals.

We selected four to profile and receive the first annual Physicians Understanding, Respecting and Engaging Supply Chain profes-sionals or “P.U.R.E.” award to enhance their clinical practices and the patient care they deliver.

HPN’s 2016 Supply Chain-Focused physicians are: • Li Ern Chen, MD, MSCS, Vice President, Surgery, Baylor Scott

& White Health, Dallas• Jimmy Chung, MD, FACS, CHCQM, Director, Medical Products

Analysis, Providence Health & Services, Seattle• Sean Lyden, MD, FACS, Professor and Chairman, Department

of Vascular Surgery, and Medical Director of Supply Chain, Cleveland Clinic, and Chief Medical Officer, Excelerate Strategic Health Sourcing, Lyndhurst, OH

• David Reiter, MD, MBA, FACS, Vice President and Executive Director, Center for Healthcare Entrepreneurship & Scientific So-lutions, and Professor (Otolaryngology - Facial Plastic Surgery), Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia.HPN’s wide-ranging interview explored how all four emerged

as a supply chain champion and share like-minded, unselfish pas-sion about the people, processes and products that impact patient outcomes and operational stability.

HPN: Are you surprised that it’s taken so long for doctors to become more directly involved in supply chain issues? Why?

Physician preference: Supply Chain matters for patient, industry healthFour MDs shatter professional stereotypes about attitudes, motives and business relationshipsby Rick Dana Barlow

Li Ern Chen, MD MSCS, Vice President, Sur-gery, Baylor Scott & White Health, Dallas

Tradit ional ly, physicians are not schooled in supply chain activities. As the end user, physicians have largely been able to use the products of their choice, and therefore have not personally felt the need to engage with the supply chain. However, in this era of cost con-tainment, it is only natural that physi-cians are now increasingly involved in supply chain activities.

Jimmy Chung, MD, FACS, CHCQM, Direc-tor, Medical Products Analysis, Providence Health & Services, Seattle

I’m not surprised at all. Physicians have historically been shielded from business decisions at hospitals where administrators have bent over backwards to give them what they want and “let them do what they do best.” Most medical schools don’t teach the business of healthcare, which has always been portrayed as be-ing “beneath” doctors. Now that doctors are feeling the squeeze personally with bundled payments and value-based care, they are becoming more interested.

Sean Lyden, MD, FACS, Professor and Chairman, Department of Vascular Surgery, and Medical Director of Supply Chain, Cleveland Clinic, and Chief Medical Officer, Excelerate Strategic Health Sourc-ing, Lyndhurst, OH

No. Many physicians are unaware of how devices get into the hospital until it affects them directly. I have found that physicians just assume it all happens without much effort. Once physicians become aware of the process and that their involvement is critical, they become very engaged.

David Reiter, MD, MBA, FACS, Vice President and Executive Director, Center for Healthcare Entrepreneurship & Scientific Solutions, and Professor (Otolaryngology - Facial Plastic Surgery), Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia

No. Physicians have historically approached equipment and sup-plies as necessities and entitlements to be provided in accord with their personal preferences and beliefs. Timely availability at the point of care was the sole consideration. How, from where and at what cost they got there were not relevant.

How — and when — did you decide to get involved with supply chain issues?

1607-SF-PURE.indd 10 6/14/2016 2:47:44 PM

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2016 PuRE AWARdsCHEN: In 2014, when I joined the Surgical Services leadership at Baylor Scott & White Health, there were several ongoing efforts in product rationalization. It was natural for me to become involved, bringing a clinical perspective to decision making and facilitat-ing communication between supply chain and the clinicians.

CHUNG: This was totally by accident. I was looking for a career change into healthcare management, especially in quality improve-ment, and I found this job that appeared to require a surgeon. I didn’t really understand supply chain when I applied, but I knew the job required skills to educate other physi-cians about cost reduction and resource management. In reality, it was only after I started my job that I really started to under-stand supply chain.

LYDEN: My original involvement with cost control came back in 2003 when the Chair-man of Vascular Surgery, Kenneth Ouriel, MD, challenged me to work on reducing our cost base for devices in Vascular Surgery. I started working with Supply Chain to help reduce the cost bases for Vascular Surgery. Over the next five to six years, I eventu-ally knew everyone in Supply Chain. It was because of that relationship and unique involvement with Supply Chain that our Chief Medical Officer, Mark Harrison, MD,

asked me to become the Medical Director of Supply Chain and help engage physicians in our health system to do similar processes.

REITER: I always had likes and dislikes as a facial plastic surgeon. But I was never picky about most equipment and supplies until I learned microsurgical reconstruction in 1992, in which flap failure is almost always techni-cal. Comfort and confidence facilitate suc-cessful microvascular surgery, so I wanted to use everything on which I learned this skill exactly as I was taught.

As I was the first head & neck surgeon to do this at my center, my department’s reputation — and the future of free flap reconstruction in the head and neck at my institution — depended on my success. Our hand & general plastic surgeons were already using free flaps, so we had a lot of equipment that — as I learned — did exactly the same thing as the variants I wanted, but at less cost for reasons as disparate as list prices and contracting schema. So I quickly learned to evaluate performance and out-comes as criteria for both product selection and price negotiation. After I got my MBA a few years later, I was asked to take a formal leadership role and helped achieve better outcomes at lower cost through evidence-based supply chain management.

What’s a myth about your profession — and your colleagues — that you’d like to bust for supply chain readers?CHEN: That surgeons are obstinate and irrational. The practice of medicine is data-driven, and surgeons are extraordinarily comfortable making decisions based on data every day in their clinical activities. Many surgeons respond well to good data.

CHUNG: Everyone in supply chain com-plains that physicians don’t want to change. If that were true, we’d all still be using Palm Pilots. Physicians definitely want to change for the better. We just have to figure out how to convince physicians what “better” is by finding a shared vision.

LYDEN: Physicians don’t care. Physicians always will pick what is best for them and not what is best for the hospital.

REITER: Docs are human, too — so we’re subject to the same emotions and concerns that affect everyone else, although we’re expected to remain aloof and dispassionate. Many changes in healthcare have affected docs adversely, from a growing body of licensed independent non-physician practi-tioners to sharply reduced reimbursement to significant loss of autonomy in many areas. A kind word and a bit of understanding will go a long way toward overcoming the most common reaction to loss of yet more that we valued in our workplace. In this context, it’s not hard to understand feelings of “Oh no!

You’re taking something else away from me?!” We may still be more fortunate than most, but we’re human.

What convinces, inspires, motivates you to be willing to cut costs, even if it means switching to a brand of product with which you may not be comfortable or favor for whatever reason?CHEN: More so than ever before, there are economic pressures to reduce cost of care delivery. Product selection in the hospital is no different than product selection at home. Just as one can be nimble and price-sensitive in purchasing laundry detergent, one can explore more cost effective options in the hospital. Of course, the non-negotiable is that patient outcomes cannot be compromised.

CHUNG: During medical school, I spent three months in Kenya and two months in Papua New Guinea working at village hospitals. You quickly learn to help patients

CHEN UNPLUGGEDUnlikely source of inspira-tion: Sunshine.Most creative thing you’ve ever done: Holding exhibi-tions of my photography.What makes you laugh: Children being silly.Best and worst advice someone ever gave you: Best — Every experience is valuable. Half of what you see, you will choose to emulate. The other half? You will choose not to incorporate into your practice. Worst — Just put your head down and do the work. That was code for “this place has so many problems, don’t even think about fixing them.”Must-have accessory: Smartphone…that’s an accessory, right?Favorite thing to do on a day off: Not answer email.Surprising fact about you: I can’t dance.Describe yourself with three words: Do the right thing (okay, that’s four words…)Favorite object you keep in your office: Ce-ramic mushroom — A reminder that sometimes people will keep you in the dark and feed you [insert expletive].What you would tell yourself if you trav-eled back in time to when you just started in healthcare: It’s about to get a whole lot more fun!

CHUNG UNPLUGGEDUnlikely source of inspira-tion: Quote from [television show] “Futurama” about humility: “When you’ve done things right, people won’t be able to tell if you’ve done anything at all.”Most creative thing you’ve ever done: Not sure if this is “creative” per se, but while I was in medical school, I auditioned to be on a beer commercial — didn’t make it, though.What makes you laugh: My kids when they tell goofy jokes. They are 8 and 9, so their jokes are mostly about bodily functions. Best and worst advice someone ever gave you: A professor once told me that to be a sur-geon you have to have thick skin. This was both the best and worst advice. You do have to have thick skin to survive the abusive environment of surgery residency, but then again, being emotion-ally closed can prevent you from getting close to your coworkers, your family and your patients.Must-have accessory: My watch… it has a life of its own and keeps me company when I’m alone.Favorite thing to do on a day off: Get on my bicycle and ride 50 miles…or bake chocolate chip cookies.Surprising fact about you: I have a tattoo and used to ride a motorcycle during my surgery residency. Describe yourself with three words: Self-reliant, thoughtful, respectful. Favorite object you keep in your office: Basket of candy — it attracts coworkers to come visit me.What you would tell yourself if you traveled back in time to when you just started in healthcare: Slow down, don’t be in such a hurry to finish school. Take time to make more friends outside of medicine.

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2016 PuRE AWARdswith whatever supplies you might have on hand — or without what you don’t have. I still think of those days when physicians get indignant about their preferences.

In my opinion, a physician’s skills are intrinsic. I always told hospitals that I can use any product to get the same outcome — most of the time — because what if some-day I moved to another hospital or another country where those products were unavail-able? Being stuck on one brand makes you a less capable surgeon, again in my humble opinion.

LYDEN: The fact that we have always put patients first and outcomes first, and the fact that the industry continues to be very prof-itable despite hospitals running on a much lower margin. At the end of the day, industry is still profitable, but hospitals have become the greatest risk of this over time. As long as patients are first, I think there is plenty of fat in the system to be caught.

REITER: Evidence that others have been able to achieve equally good patient out-comes. Most of us can work with a variety of similar products and will do so as long as we know that quality of care will not change.

Why do you believe physicians are so reluc-tant to change product brands?CHEN: It boils down to physician comfort and patient risk. Physician comfort includes an understanding and predictability of the indications for using the product, how the product will behave, how it will act in the patient, and how to rescue the situation if something goes awry. For these reasons, switching to a new product can take a physi-cian out of their comfort zone and may have the capacity to put a patient at risk. Neither of these is desirable to the physician.

CHUNG: Mostly it’s the “N=1” factor. You have one bad experience with a brand, and you never go back. Perception beats any statistical evidence. You see that with nearly every product out there. Some people believe physicians stick to one brand because of their relationship with the rep, and that may be the case for some specialties, but in general, that is a very rare situation.

LYDEN: Because we have become very comfortable, and unfortunately live by an-ecdote, and we are uncomfortable with new technology and are unhappy to give up what we are comfortable in using. We are likely to try new products and new innovations because we do not want to be left behind.

REITER: Many are truly concerned that they won’t be able to maintain quality out-comes. Some have physical characteristics like larger, stronger hands that make one device more comfortable for them to use than another. Some are brand-loyal for the same reasons that car buyers and chees-esteak lovers are brand-loyal — something about the chosen maker or supplier simply pleases them more than the others do. And a few receive nonclinical benefits from as-sociation with their brands of choice, e.g., free marketing through “preferred doc” lists, consulting fees, etc.

When you hear the excuse used to justify physician preference items, “because that’s what I was trained on in med school or residency” or “if I don’t get this I’ll take my patients somewhere else,” what goes through your mind?CHEN: We really need a culture shift toward nimbleness. The current economic and market forces have mandated a critical look at cost and constant reassessment of value.

CHUNG: First, most surgeons trained in multiple facilities during med school or residency, so in reality they have had expo-sure to multiple items. Usually they follow

a favorite professor’s choice. In most other professions, people have to be prepared to use various different brands of products, so medicine shouldn’t be any different, as long as there is no difference in quality.

If a physician threatens to go to another hospital because of a particular device, there is something else going on that they are un-happy about. Surveys show that physicians leave hospitals mostly because they are dis-satisfied with OR efficiency and operations, quality of the nursing care, how they are treated, etc. The device is just the last straw, if they leave. Most surgeons don’t want to leave a hospital that they are used to, since that is inconvenient for their patients and logistically hard to do.

LYDEN: When physicians have this reac-tion it really is that they have not had to make this hard choice before. It is almost 95 percent of the time after the time after they have actually made a switch that they say it was not so hard and my outcomes did not change and that it was actually pretty simple.

LYDEN UNPLUGGEDUnlikely source of inspira-tion: My wife. She actually has a PhD in Business, and I used to laugh at all the organizational behavior and human resources things she did. Little did I know that I would actually need all of these things, and she has really been great at helping me understand all of the business model issues that I did not understand before. Most creative thing you’ve ever done: I built a zip-line in my backyard that was 25 feet high just last year.What makes you laugh: Some of the silly mis-takes I make and get away with on a daily basis.Best and worst advice someone ever gave you: My father’s best advice was your word is your honor — don’t give it away because no one can give it back to you. The worse advice is that life should be fair — it is not. Must-have accessory: My dictaphone because I type so slow.Favorite thing to do on a day off: It is a tie between golf and watching my daughters do competitive cheerleading. Surprising fact about you: That I spend a lot of my days going to competitive cheerleading competitions. Describe yourself with three words: Account-ability, fairness and respect. Favorite object you keep in your office: A picture of my four daughters walking in front of the golden dome at Notre Dame. What you would tell yourself if you traveled back in time to when you just started in healthcare: That I arrived 10 years too late — the good days are gone. Now it is a lot of hard work and hard effort.

REITER UNPLUGGED Unlikely source of inspira-tion: Miles Davis: “If you don’t have anything to say, don’t say anything.” “Don’t play what’s there, play what’s not there.” “If you under-stood everything I say, you’d be me!”Most creative thing you’ve ever done: Facial plastic surgery can be cosmetic, reconstructive or both. I hope I was sufficiently creative to help each patient achieve what he or she wanted and needed rather than what I would have wanted if I were the patient.What makes you laugh: Irony.Best and worst advice someone ever gave you: Best — Don’t waste energy on things you can’t change. Worst — Don’t bother learning a modern language. You need to study Latin to be a doctor.Must-have accessory: A guitar.Favorite thing to do on a day off: Plan, prepare and enjoy a long, leisurely meal with my wife with good wine and good music.Surprising fact about you: I’ve been a working musician for almost six decades and still play jazz and blues in dive bars.Describe yourself with three words: In the pocket. Thank you, Wilson Pickett!Favorite object you keep in your office: The photo gallery on my walls — each picture brings a great moment from my life back to me.What you would tell yourself if you traveled back in time to when you just started in healthcare: You made the right decision. Just stay flexible and roll with the punches — we never promised you a rose garden.

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2016 PuRE AWARdsREITER: For the former: “So you can never

adopt advances in care because you weren’t taught to use them in med school or residency? Will you abandon that procedure when the product in question is no longer available?” And for the latter: “If that’s the strength of your association with our organization, perhaps you should do so anyway. A relationship so fragile that one product substitution would break it is not much of a relationship.”

Will you describe some of the challenges that physicians have in working with Supply Chain?CHEN: Since physicians have not been to “Sup-ply Chain School,” they will need to gain a fundamental understanding of the structure and functions of supply chain. A recognition of the value of the clinical perspective will allow physicians to be embraced much more quickly by Supply Chain. Clinicians and the Supply Chain have different data needs, and develop-ment of a strong partnership is necessary so that data collected is meaningful clinically and financially.

CHUNG: There is no formal education that physicians can receive in supply chain, so it takes a long time to really get a good under-standing of what is happening. Many physi-cians are too proud to admit that they might not understand something that is healthcare-related when they have already reached the top of their own profession. The other problem is that there is no defined career path in supply chain for physicians. Suppose a physician gets a job as an advisor or medical director for sup-ply chain. Where would they go from there? No one knows, because no one has done this yet.

LYDEN: Getting physicians to the table, get-ting them involved, helping them to understand that tough choices need to be made to keep hospitals viable.

REITER: Supply Chain staff and management are often perceived as being totally disinterested in outcomes and unconcerned with physician needs. A growing number of Supply Chain Management people are empowered by senior management to take a more active role in product selection. The attitude that “we have to do it — to cut costs — because you won’t” is an immediate turnoff. Supply Chain person-nel who are truly and demonstrably interested in how they can improve care are engaging. If they present themselves to the medical staff as colleagues respectful of the docs’ time and knowledge while offering complementary knowledge, skill and experience, they become an integral part of the team. HPn

Editor’s Note: To learn how all four P.U.R.E. win-ners forecast Supply Chain teaming up with physi-cians in the future — including physicians in Supply Chain leadership and staff positions — read the full interview at www.hpnonline.com/inside/2016-07/1607-SF-PURE.html.

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OPERATING ROOM

Last year, when Ebola made its way into the United States, serious concerns about personal protective equipment

(PPE) landed front and center. Healthcare facilities scurried to stock up on what was available while healthcare workers (HCWs) complained of not having access to the right kind or that they lacked suffi cient training and knowledge on how to use it properly.

“There were many lessons learned with Ebola about PPE and preparedness,” said Laura Buford, RN, BSN, CIC, APIC Communications Committee Chair. “Mainly, we learned we were not pre-pared. Now, we know what to do but it has to be practiced. It is very diffi cult to get in and out of the suits without contaminat-ing yourself. If you don’t practice doing it, it’s pretty definite you’ll have an exposure.”

Poor compliance with donning and doffi ng of all types of PPE is still a significant — and preventable — problem, as indicated in a study published last December in the American Journal of Infection Control. 1

Researchers found that even when HCWs wore gloves when handling patients with Clostridium diffi cile (C. diff.) they still had spores on their hands because of poor donning and/or doffi ng. The upside is that after HCWs participated in an educational intervention on correct techniques and disinfection of gloves with bleach, they experienced zero contamination. Finding a more tolerable alternative to bleach would likely improve compliance as well, according to the authors.

“The biggest obstacle to PPE compliance is attitude; healthcare workers have this idea that they’re bulletproof,” suggested Buford, also an Infection Preventionist/Employee Health Nurse at Lakeway Regional Medical Center, Lakeway, TX. “’I don’t need that stuff’ or ‘I’m just going in there for a min-ute’ or other things are heard frequently as reasons why they aren’t compliant with PPE. Education is done to explain what the PPE is for … but it’s still a battle. Doing compli-ance rounds on the patients on isolation

PPE — Prepared for Prevention Every time by Valerie J. Dimond

and watching to see if people are using PPE appropriately have helped to shift attitudes and improve practices.”

Promoting compliance Finding tools and products that make wear-ing PPE less onerous might also help in the effort to improve compliance — whether it’s improving access, simplifying steps or providing important reminders.

Healthmark Industries’ Cool Aids line now includes a single-use disposable vest to help manage core body temperature. “When worn under protective barrier at-tire, they are ideal for use by staff during surgery, reprocessing of devices and other activities because cooling is achieved with the reusable cooling packs rather than with

a system of hoses and an external source,” explained Healthmark Marketing Manager Matt Smith. “This innovative design allows

for greater freedom of move-ment without worrying how

to get them laundered and returned.”

To encourage proper mask and respirator use, last year

APIC released new educational fl iers based on current guidelines that describe the Do’s & Don’ts of using procedure masks and N95 respirators.

“The tools were inspired from a conversa-tion our committee was having about people not wearing masks appropriately,” Buford recalled. “We thought it would be a good idea to make an easy-to-use tool for infection preventionists or any others in healthcare facilities of any kind to use for educating on proper usage.” (You can download and print the fl i-ers from the APIC website.2)

One of the more recent innovations in face/re-spiratory protection is the SpectraShield 9500 Surgical Mask by Nexera. The product contains sil-ver- and copper-based antimicrobial technol-ogy by Sciessent to

deliver what they say is the fi rst FDA-approved antimi-crobial surgical respiratory mask. According to a press release issued in April, the SpectraShield 9500 kills 99.99 percent of tested bacteria after one hour and will inac-tivate 99.99 percent of tested infl uenza viruses after fi ve minutes of contact. “Our SpectraShield 9500 Surgi-cal Mask has proven to be safe for fi rst responders and hospital workers and highly

effective in killing airborne pathogens,” said James Morrell, CEO, Nexera. “In fact, it was cleared for eight hours of use, which is more than double the time required by NIOSH and OSHA.”

Badge Buddies by RapidRecalling.com is another helpful product line designed to keep HCWs mindful of the importance of compliance and assist them on the spot with tips on handling a variety of healthcare-relat-ed tasks, includ-ing PPE use. “Our badges, worn with their ID badges, serve as a ready reference to rapidly recall important in-formation health-care staff needs to know on a daily ba-sis,” said John Sammons, Partner, Designer, Rapidrecalling.com. “All of our badges are

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OPERATING ROOM

Insightful eye defense During last year’s Association of periOp-erative Registered Nurses (AORN) Surgi-cal Conference & Expo, TIDI Products conducted an informal postcard survey of clinicians on eye splash incidence and eye protection compliance. The responses were a little unsettling, indicating that while eye splash incidences are a common result of not wearing PPE — 59 percent reported an eye splash or near miss — 36 percent also felt the incidents were underreported. Research shows eye exposure accidents outpace other blood and body fl uid exposures.

Evelina Leece, Direc-tor of Marketing, Acute Care Consumables, TIDI Products, said there were three top reasons for non-compliance given by survey respondents. They said eye protection is not readily available and on the wall next to the gloves; it required time-consuming assem-bly and some parts are often missing (they have the lenses but no frames and vice versa); and they don’t feel there is enough time to locate and don the eyewear.

“From tradeshows and survey data [HCWs tell us] eyewear wasn’t easy to fi nd, or it required a technical degree to put the eyewear together,” said Leece. “Staff is using their own prescription eyewear as protective eyewear. We have a clinical study that shows the levels of contamina-tion for reusable eyewear are staggering. Staff members have mentioned at trade-shows that they just don’t have the time to fi nd the eyewear when they are rushing

into a patient’s room, or during emergency situations. This is more pervasive in all HCW situations due to availability, but especially clinicians that tend to deal with more emergency situations.”

TIDI’s lightweight Grab ‘n Go preas-sembled eyewear offers a solution with a convenient dispenser at point of use and wraparound design with optical grade shield. The eyewear also fi ts over prescrip-tion glasses. “A hospital in Southern Cali-fornia reported they successfully avoided 15 eye splashes by wearing TIDI’s Grab ‘n Go eye shields in a three-month period,” said Leece. “TIDI Products offers a process im-provement program EyeSplash Zero that as-sists in reducing eye splashes and improving healthcare worker’s safety.” The TIDIShield EyeSplash Zero Process Improvement Pro-gram also provides a calculator that facilities can use to determine the impact eye splash incidents have on worker safety and costs. For example, by avoiding 19.2 eye splash incidents facilities can save an average $113,664 or more per year. (Access the cal-culator on the TIDI website.3)

Product integrity As compliance issues remain a challenge, another prominent theme in this year’s conversa-tion involves questions about the quality and safety of PPE itself, particularly gloves and gowns.

The TV news program 60 Min-utes caused a stir earlier this year when a whistleblower claimed that Halyard Health sold defective, strikethrough-prone surgical gowns to hospitals during and after the Ebola outbreak.

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The former employee said the company’s MICROCOOL surgical gowns, which pur-port to provide AAMI Level 4 protection, did not meet those industry standards but were “recommended aggressively” anyway. The company vehemently denies the allega-tions and says the gown “meets ASTM 1671 testing for all critical zones, including gown fabric, tie attachment, and sleeve seams, per its cleared standard (AAMI PB70:2003) and per the current, more demanding, AAMI PB70 standard, which was revised in 2012 and recognized by the Food and Drug Ad-ministration (FDA) in 2013.”

Yet, in the wake of such an unsettling re-port — whether true or false — it’s fair to say that clinicians and supply chain profession-als have a right to feel concerned. Healthcare Purchasing News asked Chris Lowery, Senior Vice President and Chief Operating Offi cer, Halyard Health, to answer a few questions shortly after his appearance on the program.

“The 60 Minutes story essentially retold allegations about our MICROCOOL sur-

gical gowns that have been the subject of an ongoing litigation that began in October 2014,” Lowery said in an email. “We reject those allegations. We understand, however, that the 60

Minutes story may have given the im-pression that MICROCOOL gowns have been the subject of frequent complaints of strikethrough by healthcare providers and that the gowns pose a safety risk. This is simply not true. MICROCOOL is and has always been safe and effective for its intended use and has an excellent

track record in the fi eld.”The program also featured disturbing

photos of surgeons with blood on their skin after doffi ng the MICRO-COOL gowns, something Lowery

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Glove Powder Can Cause1:• Post-operative adhesions• Granulomas• Delayed wound healing• Increased risk of infection• Occupational asthma• Allergic reactions

Biogel® is the only major surgical glove brand with an exclusively powder-free range. By developing the world’s fi rst polymer coating with hydrophilic properties, Biogel was able to eliminate powder from surgical gloves while still delivering easy donning.

To request a sample or to learn more about Biogel surgical gloves, visit www.molnlycke.us

The Mölnlycke® Health Care and Biogel® names and logos are registered globally to one or more of the Mölnlycke® Health Care Group of Companies. Distributed by Mölnlycke® Health Care US, LLC, Norcross, Georgia 30092. ©2015 Mölnlycke® Health Care AB. All rights reserved. MHC-2016-14549

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Every single Biogel® surgical gloveis powder-free, and has been forover 30 years.

References: 1. Truscott W. “Citizens petition to the FDA to ban cornstarch powder on medical gloves.” Feb. 2009.

Glove Powder Can Cause1:• Post-operative adhesions• Granulomas• Delayed wound healing• Increased risk of infection• Occupational asthma• Allergic reactions

Biogel® is the only major surgical glove brand with an exclusively powder-free range. By developing the world’s fi rst polymer coating with hydrophilic properties, Biogel was able to eliminate powder from surgical gloves while still delivering easy donning.

To request a sample or to learn more about Biogel surgical gloves, visit www.molnlycke.us

The Mölnlycke® Health Care and Biogel® names and logos are registered globally to one or more of the Mölnlycke® Health Care Group of Companies. Distributed by Mölnlycke® Health Care US, LLC, Norcross, Georgia 30092. ©2015 Mölnlycke® Health Care AB. All rights reserved. MHC-2016-14549

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Every single Biogel® surgical gloveis powder-free, and has been forover 30 years.

References: 1. Truscott W. “Citizens petition to the FDA to ban cornstarch powder on medical gloves.” Feb. 2009.


Hibiclens®, the Hibiclens® logo and Mölnlycke® are registered trademarks of Mölnlycke® Heath Care AB. Distributed by Mölnlycke® Health Care US, LLC, Norcross, Georgia 30092. © 2016 Mölnlycke® Health Care AB. All rights reserved. 1-800-882-4582. MHC-2016-14551

References 1. Rupp ME, et. al. Infect Control Hosp Epidemiol. 2012;33(11). 2. Cima, Robert, et al. ”Colorectal Surgery Surgical Site Infection Reduction Program.” American College of Surgeons (2013): 23-33.

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OPERATing ROOmsuggests was potentially due to glove-gown channeling, not defec-tive product.

“Glove-gown channeling is a phenomenon that has been mistaken as strikethrough. Channeling can be observed in deep belly surgical cases, or trauma cases, where the surgeon may reach deep into the incision site and have significant exposure to bodily fluids around the glove-gown sleeve interface,” Lowery said. “Glove-gown channeling occurs when bodily fluids make their way between the surgical glove and gown sleeve as a result of a gap between the two. This causes fluid to get into the channel (ridges or folds) of gown sleeves, but the fluid does not pass through the fabric of the gown. Strikethrough, though, is when fluid passes directly through the gown, compromising the barrier. With MICROCOOL, reports of strikethrough are exceedingly rare with less than one complaint per million gowns sold.”

In December, the FDA issued the final version of its guidance document, “Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.”4 The docu-ment is intended to clarify and describe the premarket regulatory requirements for gowns regulated under 21 CFR 878.4040 and the performance testing needed to support liquid barrier claims for gowns. Gown manufacturers claiming high level protection of its products will need to provide premarket clearance and proof/data that they do in fact live up to barrier protection claims per ASTM/AAMI standards or an equivalent.

“Sample labeling should also be submitted; the provided label-ing should clearly identify the level of liquid barrier protection claimed,” said Scientific Reviewer Lauren Lilly during an FDA Webinar earlier this year. “Prior to the existence of ANSI/AAMI

PB70, moderate or high barrier protection claims included, but were not limited to, wording such as prevents strikethrough; high fluid protection; impervious; fluid-proof; fluid-resistant; highest level of protection; and impermeable. Because of the lack of specificity with respect to performance characteristics and test methods, FDA now discourages the use of such language, and no longer clears products with such labeling claims. Instead, manufacturers are encouraged to specify the level of liquid barrier protection as per ANSI/AAMI PB70 on all labeling. Labeling should also include the directions for use, the indications for use and, if applicable, validated reprocessing instructions.”

Buford says the FDA’s guidance is a “great idea” and that manu-facturers should be held accountable for validating claims. “If a company can’t give you a satisfactory response, I’d suggest looking for a different product,” she said.

Gloves point in new directions Moving on to the glove front, the FDA announced another proposal earlier this year to ban most powdered gloves and absorbable lubri-cating powder because they can cause respiratory allergic reactions and other potentially serious adverse events, including severe air-way and wound inflammation and post-surgical adhesions. “These side effects have been attributed to the use of glove powder with all types of gloves,” stated the FDA in a March 21 press release.

Edmund S. Tai, Assistant Vice President, Tronex Healthcare, says the powder debate has been going on for more than 20 years and that most recently the focus has been not only on powder but the quality of powder used. “There have been a number of incidents within the healthcare industry where the use of inferior-quality powder by manufacturers has been brought into focus with liability cases,” Tai said. “While Tronex Healthcare utilizes only highly regulated powder by featuring U.S. Pharmacopeia (USP) grade cornstarch, there are others in the industry who have not upheld such high quality standards. In the early stages of disposable glove manu-facturing, powder eased the effectiveness of donning, so gloves would not break from the force used to quickly don them, especially with damp hands. Tronex was at the forefront of the industry’s product advances in subsequent years, develop-ing highly evolved material formulations and implementing new manufacturing technologies, both of which ultimately led to powder-free exam glove options.”

Tronex powder-free exam gloves come in a variety of styles and material blends and innovative finishing processes that mimic powder and make donning easy. Tai says the #3166 Series Latex Powder-Free, Fully Textured Exam Gloves are crafted from an innovative natural rubber latex material formulation for superior elasticity and barrier protection and feature a smooth interior polymer coating to ease wet and dry donning. Its NEW AGE Powder-Free Exam Glove has a unique stretch-vinyl compound that provides material memory for a superior fit, stretch, and high tensile strength. Tai says these products also deliver a favorable performance-to-price ratio. “With all of the advancements in exam glove materials and technologies available today, there are a wide range of excellent powder-free alternatives available for this small percentage of users to transition to in eliminating powdered exam gloves entirely.”

Todd Karas, Senior Product Manager, Surgical Gloves, Cardinal Health, says its glove customers started transitioning from powder more than a year ago and that glove selection is influenced primar-ily by industry recommendations and wearer habits. “Some clini-

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hpnonline.com • HEALTHCARE PuRCHAsing nEWs • July 2016 23

identify a sharps breach and minimize exposure time. Cardi-nal Health offers two blue un-dergloves specifically designed for double-gloving, so using a powdered glove on top is no longer needed.”

Judith Seltzer, MS, BSN, RN, CNOR, Clinical Director, National Ac-counts, U.S. Surgical Division, Mölnlycke Health Care, suggests the ban isn’t likely to impact very many facilities as most have already stopped using powder. “The pow-dered glove segment has been declining at a rate of 15 percent year over year while powder-free synthetic surgical gloves are continuing to grow at a rate of 12 percent

year over year,”5 Seltzer said. “In today’s healthcare arena, hospi-tals are incentivized to reduce the risk of hospital-acquired infections (HAIs). Surgical site infections are the cause of nearly one-third of all HAI infections.6

Maintaining powdered gloves contributes to an increased risk of surgical site infections for patients.”

Stellar performance, protection and com-fort are equally important in a powder-free glove and Seltzer says Mölnlycke’s Biogel glove, the first to feature a polymer coat-ing with hydrophilic properties, delivers on all three. “Every glove is air-inflation tested for quality and safety, leading to

cians have worn the same gloves for many years and simply are not familiar with new advancements in glove coatings, infection prevention performance, fit and feel,” Karas said. “Ensuring that healthcare providers are using the right glove for the right reason is crucial for infection prevention.”

Nonetheless, for the few holdouts, a Cardinal Health infographic illustrating why making the switch is important also suggests change can be hard. “When a surgeon gets used to wearing a glove, and they like the way the glove performs (fit, feel and grip), they may not want to change to something new,” Karas said. “If they haven’t personally experienced a reaction to powder, they may know about the potential risks, but not be too concerned person-ally. After clinicians become educated about powder and the potential risks, and have a chance to experience and try powder-free alternatives, making the change usually isn’t difficult.

“Powder-free glove manufacturing technology creates more versatility to im-prove performance, such as the ability to meet specific surgical needs with stronger thickness and grip,” he continued. “In addition, modern double-gloving with a colored underglove helps clinicians quickly

Double-gloving with Protexis Powder-Free Surgical Gloves by

Cardinal Health

a reduced chance of a hole with an industry-leading AQL level of 0.65 compared to the FDA requirement of 1.5,” she said. “Biogel is a pioneer in developing barrier protection innovations, including double gloving systems that enable

an extra layer of protection. In 1993, Biogel introduced a groundbreaking puncture indication system to the double gloving offer, which features a clear, fast and large colored puncture indicator when the outer glove is punctured.”

Seltzer says puncture wounds go unde-tected as much as 90 percent of the time during surgical procedures.7 “Biogel Indica-tor Undergloves are engineered to provide the optimum level of contrast with Biogel Overgloves. If the top glove is punctured, fluid penetrates between the two gloves, and a dark patch alerts the wearer to the punc-ture,” she explained. “This visual indication is even faster with our new thinner glove additions to the product line, Biogel PI Micro and Biogel PI Micro Indicator Underglove.”

Halyard Health also supports the ban on powder and offers powder-free nitrile exam gloves which are designed with the

OPERATing ROOm


Mölnlycke Healthcare’s Biogel glove

Page 27Vendor Listings Page 24

Product Spotlights Page 26


APRONS/BIBS/ARM PROTECTORSAcute Care Pharmaceuticalswww.pharma-choice.comEncompass Groupwww.encompassgroup.netFashion Seal Healthcarewww.fashionsealhealthcare.comHalyard Healthwww.halyardhealth.comHenry Schein Inc.www.henryschein.comMedgluv Inc.www.medgluv.comMedline Industrieswww.medline.comPalmero Healthwww.palmerohealth.comTronex Healthcarewww.tronexcompany.com

BOOT COVERS/OVERSHOESAcute Care Pharmaceuticalswww.pharma-choice.comHalyard Healthwww.halyardhealth.comHealthmark Industrieswww.hmark.comHenry Schein Inc.www.henryschein.comMedgluv Inc.www.medgluv.comMedline Industrieswww.medline.comTronex Healthcarewww.tronexcompany.com

BOUFFANT/SURGICAL CAPSAcute Care Pharmaceuticalswww.pharma-choice.comFashion Seal Healthcarewww.fashionsealhealthcare.comHalyard Healthwww.halyardhealth.comHenry Schein Inc.www.henryschein.comMedline Industrieswww.medline.comMönlycke Health Carewww.molnlyckeusa.comTronex Healthcarewww.tronexcompany.com

CLIP-ON/ WRAP-AROUND LENSESAcute Care Pharmaceuticalswww.pharma-choice.comHenry Schein Inc.www.henryschein.comMedline Industrieswww.medline.comPalmero Healthwww.palmerohealth.comTIDI Productswww.www.tidiproducts.com

COVERALLS/JACKETSAcute Care Pharmaceuticalswww.pharma-choice.comFashion Seal Healthcarewww.fashionsealhealthcare.comHalyard Healthwww.halyardhealth.comHealthmark Industrieswww.hmark.com

Henry Schein Inc.www.henryschein.comMedline Industrieswww.medline.comTronex Healthcarewww.tronexcompany.com

EDUCATION/TRAININGRapid Recallingwww.rapidrecalling.com

FACE MASKS/SHIELDS3M Health Carewww.3m.com/medicalAcute Care Pharmaceuticalswww.pharma-choice.comAnsell Healthcarewww.ansellhealthcare.comCrosstex/ SPS Medical Supply Corp.www.spsmedical.comEncompass Groupwww.encompassgroup.netHalyard Healthwww.halyardhealth.comHealthmark Industrieswww.hmark.comHenry Schein Inc.www.henryschein.comKey Surgicalwww.keysurgical.comMedgluv Inc.www.medgluv.comMedline Industrieswww.medline.comMetrexwww.metrex.comNexera Medicalwww.nexeramed.comPalmero Healthwww.palmerohealth.comPCI Medicalwww.pcimedical.comRuhof Healthcarewww.ruhof.comTronex Healthcarewww.tronexcompany.comTIDI Productswww.www.tidiproducts.com

GLOVESAcute Care Pharmaceuticalswww.pharma-choice.comAnsell Healthcarewww.ansellhealthcare.comCardinal Healthwww.cardinalhealth.comClean Safety Inc.cleansafety.comHalyard Healthwww.halyardhealth.comHealthmark Industrieswww.hmark.comHenry Schein Inc.www.henryschein.comHygiewww.hygiecanada.com/enKey Surgicalwww.keysurgical.comMalaysian Rubber Export Promotion Councilmrepc.comMedgluv Inc.www.medgluv.comMedline Industrieswww.medline.com

PCI Medicalwww.pcimedical.comSupermax Healthcare Inc.www.supermaxhealthcare.comTronex Healthcarewww.tronexcompany.comTIDI Productswww.www.tidiproducts.com

GOGGLESAcute Care Pharmaceuticalswww.pharma-choice.comEncompass Groupwww.encompassgroup.netHenry Schein Inc.www.henryschein.comMedline Industrieswww.medline.comMetrexwww.metrex.comMönlycke Health Carewww.molnlyckeusa.comPalmero Healthwww.palmerohealth.comPCI Medicalwww.pcimedical.com

HOOD FILTERSAcute Care Pharmaceuticalswww.pharma-choice.comHenry Schein Inc.www.henryschein.comMedline Industrieswww.medline.comPCI Medicalwww.pcimedical.comSempermed USAwww.sempermedusa.com

ISOLATION GOWNSAcute Care Pharmaceuticalswww.pharma-choice.comAramarkwww.aramarkuniform.com/health-careFashion Seal Healthcarewww.fashionsealhealthcare.comHalyard Healthwww.halyardhealth.comHenry Schein Inc.www.henryschein.comMedline Industrieswww.medline.comTronex Healthcarewww.tronexcompany.com

LAB GOWNS/COATSAcute Care Pharmaceuticalswww.pharma-choice.comAramarkwww.aramarkuniform.com/health-careEncompass Groupwww.encompassgroup.netFashion Seal Healthcarewww.fashionsealhealthcare.comHalyard Healthwww.halyardhealth.comHenry Schein Inc.www.henryschein.comMedline Industrieswww.medline.comNexera Medicalwww.nexeramed.com

Prime Medicalwww.primemedical.comTronex Healthcarewww.tronexcompany.com

N95 MASKS3M Health Carewww.3m.com/medicalAcute Care Pharmaceuticalswww.pharma-choice.comAnsell Healthcarewww.ansellhealthcare.comCrosstex/ SPS Medical Supply Corp.www.spsmedical.comHalyard Healthwww.halyardhealth.comHenry Schein Inc.www.henryschein.comMedline Industrieswww.medline.comMönlycke Health Carewww.molnlyckeusa.comNexera Medicalwww.nexeramed.comTronex Healthcarewww.tronexcompany.com

PPE DISPENSING SYSTEMS/ORGANIZERSAcute Care Pharmaceuticalswww.pharma-choice.comAramarkwww.aramarkuniform.com/health-careHalyard Healthwww.halyardhealth.comHenry Schein Inc.www.henryschein.comMedline Industrieswww.medline.comTIDI Productswww.www.tidiproducts.com

RESPIRATORS3M Health Carewww.3m.com/medicalAcute Care Pharmaceuticalswww.pharma-choice.comAnsell Healthcarewww.ansellhealthcare.comHalyard Healthwww.halyardhealth.comHenry Schein Inc.www.henryschein.comMedline Industrieswww.medline.comTronex Healthcarewww.tronexcompany.com

SCRUBSAcute Care Pharmaceuticalswww.pharma-choice.comAramarkwww.aramarkuniform.com/health-careFashion Seal Healthcarewww.fashionsealhealthcare.comHalyard Healthwww.halyardhealth.comHealthmark Industrieswww.hmark.comHenry Schein Inc.www.henryschein.comMedline Industrieswww.medline.com

PPE VENDOR LISTINGS & SPOTLIGHTS

1607-OR-PPE.indd 24 6/13/2016 10:10:24 AM

call 800.541.7995 or visit keysurgical.com

While its resemblance to an orca may make the Silicone Sterilizer Mitt from Key Surgical® a great shadow puppet, its

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TRONEX HEALTHCARENitrile “NEW AGE” Chemo-Rated Exam Gloves Tronex is pleased to introduce our disposable #9128 Series Ni-trile “NEW AGE” Chemo-Rated, Powder-Free, Fingertip-Textured Exam Gloves. This innovative style is manufactured from an advanced material formulation to offer maximum dexterity, as well as excellent barrier protection and effi ciency. For more information or complimentary samples: 800-833-1181; [email protected]; or www.tronexcompany.com.


ANSELLENCORE Perry Style 42 PF latex surgical gloves provide excep-tional value in the powder-free category, and deliver the same clinical experience as the time-honored Original Perry Style 42. They also feature Ansell’s new SMART Pack packaging, a complete packaging redesign that makes it easier to store, manage, and use Ansell surgical gloves!


Acute Care Pharmaceuticals offers a full line of PPE. Providing our customers with protection is a primary goal thus the reason our apparel and merchandise is PE coated and follows the most rigorous of regulations. Our Pharma-Gloves continue to top sales in the healthcare industry as they offer many key benefi ts such as being validated sterile, latex and powder free, tested against chemotherapy and other hazardous drugs. Visit www.Pharma-Choice.com to view our full selection including Isolation and Chemo Gowns, Lab Coats, Shoe Covers, Coveralls, Bunny Suits, and more.


ACUTE CARE PHARMACEUTICALS

HEALTHMARK INDUSTRIESCool Aid Single-Use Vests are designed to manage the core body temperature. Worn under surgical attire, they are

ideal for use by staff during surgery because cooling is achieved with the reusable cooling packs rather than

with a system of hoses and an external source. This innovative design allows for greater free-

dom of movement without worrying how to launder them.


*Highlighted vendors are July Advertisers. Visit the index of advertisers, on page 59 to fi nd their ad.

Prime Medicalwww.primemedical.comTronex Healthcarewww.tronexcompany.com

SURGICAL GOWNS/APPARELAcute Care Pharmaceuticalswww.pharma-choice.comAramarkwww.aramarkuniform.com/health-careCardinal Healthwww.cardinalhealth.comCovidienwww.covidien.com

Encompass Groupwww.encompassgroup.netFashion Seal Healthcarewww.fashionsealhealthcare.comHalyard Healthwww.halyardhealth.comHealthmark Industrieswww.hmark.comHenry Schein Inc.www.henryschein.comMedline Industrieswww.medline.comNexera Medicalwww.nexeramed.comRuhof Healthcarewww.ruhof.com

Tronex Healthcarewww.tronexcompany.comTIDI Productswww.www.tidiproducts.com

SURGICAL MASKS3M Health Carewww.3m.com/medicalAcute Care Pharmaceuticalswww.pharma-choice.comAnsell Healthcarewww.ansellhealthcare.comHalyard Healthwww.halyardhealth.comHenry Schein Inc.www.henryschein.com

Medgluv Inc.www.medgluv.comMedline Industrieswww.medline.comMönlycke Health Carewww.molnlyckeusa.comNexera Medicalwww.nexeramed.comTronex Healthcarewww.tronexcompany.comTIDI Productswww.tidiproducts.com

KEY SURGICALTake PPE to new lengths with a 24” Nitrile Glove from Key Surgical. This cut-resistant, industrial strength nitrile glove provides full cover-age to protect and keep you dry while you reach in and out of sinks during surgical instrument cleaning. Textured fi ngers help you keep a grip on wet instrumentation and a springy-elastic cuff helps keep the glove in place on your upper arm. Designed to be reused, the 24” Nitrile Glove will become your new favorite accessory in decontamination. Call 800-541-7995 or visit www.keysurgical.com for more information.


MOLNLYCKE HEALTH CARE


The Biogel PI Micro Indicator Under-glove is a thinner synthetic glove, specifi cally designed to enhance tac-tile sensitivity while double-gloving.

• Can be worn alone or as part of the Biogel Puncture Indication System.

• Recommended for use with the Biogel PI Micro overglove to create a new thinner double-gloving system.

PPE VENDOR LISTINGS & SPOTLIGHTS

hpnonline.com • HEALTHCARE PURCHASING NEWS • July 2016 27

Laurie Clark, BS, MT, (ASCP), Senior Manager, Medical Sciences and Clinical Education, Halyard Health.

“This patented process affords Halyard gloves increased tensile strength and a reduction in glove thickness, resulting

in added comfort while providing pro-tection from exposure to bloodborne pathogens and other infectious materi-als,”8 Clark said. “In a highly competitive market such as exam gloves, quality can be a signifi cant point of differentiation. In order to deliver the highest quality possible, Halyard owns its own manufac-turing facility in Thailand and requires

the AQL specifi cations for all of its exam gloves to exceed ASTM standards. Moreover, by offering a portfolio of powder-free nitrile exam gloves at easy-to-understand graduated levels of protection, Halyard makes it easy to choose the right glove for the right task.”

Ansell’s glove portfolio, which includes two new nicely priced styles — the ENCORE Perry Style 42 PF and ENCORE Sensi-Touch PF — also provides a number of unique features. “Our curved anatomical formers create a glove with a more natural fi t, decreasing the probability of hand fatigue,” said Pam Werner, MBA, BSN, RN, CNOR, Clinical Consultant, Medical Solutions Global Business Unit, Ansell. “Grip choices allow for secure grip and our Surefi t Technology, a cuff enhancement feature to pre-vent cuff roll down during a procedure, helps prevent unintentional contamina-tion at the sterile fi eld. Our Derma Shield inner polymer coating enhances damp-hand donning.

“Rigorous testing to meet quality stan-dards, from both a regulatory and manu-facturer perspective, as well as internal testing and control measures, help assure the end user that the glove is providing superior barrier protection,” continued Werner.

Ansell also introduced its SMART Pack packaging technology, a customizable dispenser that gives users easy access to gloves with two opening choices and easier product identifi cation. It uses 45 percent less shelf space and reduces packaging waste and CO2 emissions.

“The bottom line is that end users want to be protected from blood and blood borne pathogens while still being able to func-tion effectively in the healthcare environment,” Werner said. HPN

References

1. Tomas, E., Sunkesula, V., et al, “An intervention to reduce health care personnel hand contamina-tion during care of patients with Clostridium diffi cile infection,” American Journal of Infection Control, Vol. 43, issue 12. http://www.ajicjournal.org/article/S0196-6553(15)00768-3/abstract?cc=y=.

2. New “Do’s and Don’ts” of procedure masks and N95 respirators fl iers, APIC, November, 10, 2013. http://www.apic.org/For-Media/Announcements/Article?id=93e57b8e-8405-4c7e-ab10-c61099a51402.

3. TIDIShield EyeSplash Zero Process Improvement Program, http://go.www.tidiproducts.com/tidi-eyesplash-zero-soft-cost-calculator.

4. U.S. Department of Health and Human Services, Food and Drug Administration, “Guidance for Industry and Food and Drug Administration Staff.” http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm452804.pdf.

5. GHX Q12016 Surgical Glove Market Data.

6. CDC Surgical Site Infection (SSI) Event. Procedure-associated Module SSI. January 2014. Available at: http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf.

7. Timler D, Kusinski M, Iltchev P, et al. “Glove failure in elective thyroid surgery. A prospective randomized study.” International Journal of Occupational Medicine and Environmental Health.

8. Kimberly-Clark Health Care Press Release. “Kimberly-Clark Granted U.S. Patents for Nitrile Exam Glove Technology.” April 26, 2013.

Ansell Non-Latex PI Green gloves with

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Prevention uPdate infECTion PREvEnTion

Ambulatory surgery centers (ASCs) are surfacing across the country with greater speed than ever before as

healthcare providers — and patients — seek ways to cut costs and improve efficiencies.

“The number of outpatient procedures has risen dramatically since 1981, and the majority of surgeries performed in the United States now take place in outpatient settings,” wrote the authors of a study published in Health Affairs.1. Outpatient surgeries cost less at ASCs than they do in hospitals and can save time as well, ap-proximately 32 minutes less per procedure, on average. “[Our] findings suggest that ASCs provide an efficient way to meet future growth in demand for outpatient surgeries and can help fulfill the Affordable Care Act’s goals of reducing costs while im-proving the quality of health care delivery.”

Winning in the ASC arena means find-ing ways to implement and execute best practices and standards similar to those practiced by hospitals. Although ASCs are working with fewer assets compared to large medical centers, they can find sup-port from a variety of resources specifically designed to help ASCs succeed.

The Ambulatory Surgery Center Associa-tion (ASCA) represents ASCs and provides advocacy and resources to assist ASCs in delivering high-quality, cost-effective am-bulatory surgery to its patients. Kay Tucker, Director of Communications, ASCA, said they are dedicated to assisting ASCs to operate efficiently while maintaining a focus on patient safety. Highlighting the similarities between the stringent standards of hospitals and ASCs, she said there should be no question as to whether ASCs are inferior in any way to hospitals — because hospitals and ASCs play by the same rules.

“ASCs are well-recognized for their out-standing patient outcomes, patient safety, customer service, and staff and cost efficien-cies,” Tucker said. “ASCs are highly regu-lated and subject to extensive oversight, just like hospitals. Medicare-certified hospital outpatient departments must comply with

Compliant and competitive in the aSCBest practices keep costs down, standards highby Susan Cantrell, ELS

Centers for Medicare and Medicaid Ser-vices’ (CMS) Conditions of Participation, while Medicare-certified ASCs must comply with CMS’s Conditions for Coverage. Both include rigorous requirements regarding patient safety, governance, operational policies and procedures, and more.

“ASCs follow the same nationally and internationally recognized infection-prevention guidelines as hospitals,” con-tinued Tucker. “As one small example, Medicare quality-reporting data released recently shows that more than 99 percent of Medicare-certified ASCs use a safe-surgery checklist. All Medicare-certified ASCs are required to comply with infection- prevention requirements specified in Medicare’s Conditions for Coverage and the Interpretive Guidelines for ASCs.” Visit ASCA’s web site at http://www.ascas-sociation.org/asca/federalregulations/medicarecertification.

accreditation An important step in establishing credibility is for ASCs to seek accreditation and remain committed to always following those stan-dards. “ASCs seek accreditation for many reasons, including demonstrating the high quality of care they provide, to qualify for Medicare-deemed status, and, in some cases, to meet state licensing requirements,” Tucker noted. “ASCs routinely tell us that the best way to prepare for an accreditation survey is to live according to the standards at all times.”

The American Association for Accredi-tation of Ambulatory Surgery Facilities

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discovery of first MCr-1 gene in e. coli bacteria found in a human in united StatesThe Centers for Disease Control and Prevention (CDC) is part of a coordinated public health response after the Department of Defense (DoD) announced the discovery of the first MCR-1 gene found in bacteria in a human in the United States.

E. coli bacteria carrying the MCR-1 gene was found in a urine sample from a Pennsylvania woman with no recent travel outside of the U.S. The MCR-1 gene makes bacteria resistant to the antibiotic colistin, which is used as a last-resort drug to treat patients with multi-drug-resistant infections, including carbapenem-resistant Enterobacteriaceae (CRE).

The MCR-1 gene exists on a plasmid, a small piece of DNA that is capable of moving from one bacterium to another, spreading antibiotic resistance among bacterial species.The CDC and federal partners have been hunting for this gene in the U.S. ever since its emergence in China in 2015.

Despite some media reports, the Pennsyl-vania State Health Department investigation has determined that the woman did not have CRE and the bacteria identified is not resistant to all antibiotics (referred to as a pan-resistant infection). The presence of the MCR-1 gene, however, and its ability to share its colistin resis-tance with other bacteria such as CRE raise the risk that pan-resistant bacteria could develop.

The investigation is currently focused on iden-tifying close contacts, including household and healthcare contacts, of the Pennsylvania patient to determine whether any of them may have been at risk for transmission of the bacteria containing the MCR-1 gene.

Beginning in fall 2016, CDC’s Antibiotic Resistance Lab Network will provide the infra-structure and lab capacity for seven to eight regional labs, and labs in all states and seven major cities/territories, to detect and respond to resistant organisms recovered from human samples. State labs will be able to detect new forms of antibiotic resistance — including muta-tions that allow bacteria to survive the effects of the last-resort drugs like colistin — and report these findings to CDC.

With this comprehensive lab capacity, state health labs and regional labs that are part of the network will be able to investigate emerg-ing resistance faster and more effectively, generating better data for stronger infection control among patients to prevent and combat future resistance threats. CDC will also provide new resources to state health departments to support their efforts to stop antibiotic-resistant outbreaks and prevent the spread of antibiotic-resistant pathogens across communities.

For more information on the MCR-1 discovery, see http://www.hhs.gov/blog/2016/05/26/early-detection-new-antibiotic-resistance.html.

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INFECTION PREVENTION(AAAASF) is another or-ganization ASCs look to for keeping the bar high on patient care in the outpa-tient setting. Gary Brown-stein, MD, Vice President of Education, talked about the organization’s purpose and AAAASF’s goals for ASCs, both of which center on creating a safer patient environment and experience. “The mission of AAAASF is patient safety,” said Brown-

stein. “Our accreditation programs help facilities demonstrate a strong commitment to patient safety, standardize quality, pro-mote services to patients, and collaborate with other healthcare leaders.”

Brownstein said AAAASF requires that ASCs hold offi ce-based surgery settings to hospital standards with board-certifi ed surgeons who have hospital privileges for any procedure performed and employ an-esthesia professionals for deeper levels of anesthesia. ASCs must also provide a safe

surgical environment, equipment, drugs, etc., through specifi c standards regarding hand hygiene, asepsis, sterilization, and sterile supplies, etc., and must implement peer review (peer oversight) and tracking of data (complications, mortalities, etc.).

“At AAAASF, we believe there should not be a gap between acute versus non-acute facilities,” asserted Brownstein.

Technology aids compliance Ensuring ASCs are in compliance with ac-creditation organizations’ standards is no small task. To help keep its ASCs effi cient and compliant with accreditation organiza-tions’ standards, Mercy, a health system in Missouri with 700 physician practices and outpatient facilities, uses advanced analyt-ics technology. Betty Jo Rocchio, CRNA, MS, Vice President of Perioperative Per-formance Acceleration at Mercy, explained that making an abundance of easy-to-access data available to caregivers supports efforts to follow best practices at all times.

“Mercy’s analytics program, powered by SAP, provides a custom perioperative dashboard that enables monitoring and tracking of all surgical implants across Mercy’s seven ASCs in four states,” said Rocchio. “This includes visualization of implant use for clear insight delivered the next day and granular detail into regula-tory- and compliance-related information. For example, the dashboard shows all the details related to implants and allows them to be tracked to specifi c patient data in our electronic health record. All of this infor-mation is readily available for extract and reporting for any regulatory or compliance organization or for when there is a national recall. With Mercy’s dashboards, we can quickly and dynamically group and fi lter based on criteria such as physician and procedure type for leaders to easily identify variance and determine standards in sup-plies based on the best cost and outcome.

“Mercy uses the dashboard to identify best practices through a transparent ap-proach that creates visibility into outcomes and cost per case across Mercy’s regions, locations, and physicians, down to the im-plant used,” continued Rocchio. “Tracking

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In some ways the ambulatory surgery center (ASC) operates like a standard operating room, and in many ways it doesn’t. There are certain aspects of the ASC that make it unique. Facilities that

overlook those differences could be missing out on opportunities to improve patient care, ramp up effi ciencies, and save money. The key is in knowing where to look and how to act.

ASCs and ORs operate at dissimilar paces, with different turn-around times and patient throughput. IT capability may also differ with the ASC often working on a less sophisticated system, which can impact the EMR, inventory management and more. Clinical practice also tends to change due to surgeons who come and go along with their preference for supply usage. In fact, the entire ASC staff can vary dramatically from a hospital OR staff, not just in terms of size but in how it functions.

“ASC staff often wears many hats — the materials manager is also the scrub tech or the clinical director may also scrub and circulate,” said Bilinda Garlock, RN, BSN, Manager of Clinical Operations,

Ambulatory Surgery Centers, Cardinal Health. “Staffi ng is also very tight and there’s a need to cross train between the perioperative departments such as PACU and Pre Op nurses. The PACU nurse may also be cross trained as the Endo suite nurse.”

Clearly, running a smooth ASC means keeping the dots connected — and there are a lot of dots to connect. Many ASCs will experience gaps along the way. Sometimes these gaps are easy to overlook or just hard to recognize. Uncovering hidden waste and discovering areas of real savings and positive outcomes can be achieved by reevaluating internal processes. Here are three ways ASCs can cut waste by taking a second look:

1. Improved OR supply utilizationNeglecting to routinely review your pack programs can lead to poorly supplied high volume procedure packs, particularly when new procedures have been added to the case mix and staff are left to “make do” with what they have. “I was in an ASC where they were using a Hand Pack for the majority of their procedures because that was the procedure the pack was created for,” recalled Garlock. “But over time other procedures were added to their case mix without reviewing the supplies needed to start that case. There was approximately $30 of waste each time that pack was opened for a procedure other than a hand procedure.”

2. Reduced SKU countASCs often feel they have to keep the doctor happy in order to attract and retain the best surgeons and maintain case volume. So it’s easy to see how a surgeon’s personal preference for specifi c products can drive up SKU counts. “The type of surgeons’ gloves used by ASCs may not be preferred by that surgeon so the ASC orders a different type of glove, often at full retail price, to satisfy that surgeon’s preference,” said Garlock. “Too many SKUs can be just a matter of looking at duplication of supplies from different vendors; do you have the right mix of gloves and surgical gowns, can standardization of suture types be worked on?”

3. Product standardization Standardizing your ASC products can actually be a simpler task than you might think and, as Garlock suggests, surgical gowns and gloves are just two areas where opportunities are often identi-fi ed. For example, it may be that you’re stocking your ASC with multiple types of gowns, all with the same AAMI rating levels. A careful comparison and product review could help you make more informed decisions as to the types and number of gowns on hand. Surgeon’s gloves are another example. Garlock points out that a typical case mix in an ASC can do well with three to four types of gloves: An overall general use surgical glove, an underglove option, an ortho glove, and a more tactile-sensitive glove depending on the case mix.

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INFECTION PREVENTIONthis information through the dashboard helps Mercy ensure the right patient has the right procedure using the right implant for the best outcome.”

Rocchio also related that Mercy’s system elevates the level of patient care while considering fi nancial constraints, which is especially helpful given that ASCs tend to operate on limited budgets and a smaller staff. “Mercy’s perioperative analytics platform provides leaders insight into

our own operations, while enabling us to compare Mercy’s ASCs to other like-size surgery centers to fi nd benchmarks and best practices. Additionally, ASCs often have working managers who are spending time with the patient, not leaving time to scour data and reports. These managers benefi t from the dashboard’s automation and instant insight.”

The system’s cost and outcomes analysis feature is also a valuable tool that helps to

identify which surgical products are the most cost-effective and deliver the best clini-cal outcomes for Mercy’s surgical patients while eliminating those deemed unsuitable or less effective. “We were able to reduce the use of the ultrasonic devices, a surgical technology used to minimize intraoperative blood loss,” said Rocchio. “Where there was no clinical evidence of its benefi t, Mercy was able to steward resources and pass on cost savings to surgical patients.”

Tracking surgical activities with imaging technology is another way for ASCs to ad-here to best practices. Eddie Mitchell, CEO, Image Stream Medical, said some facilities are using the company’s technology to improve clinical collaboration through the sharing of surgical video and pictures. “For example, AAAASF requires ASC commit-ment to quality assessment and improve-ment,” Mitchell said. “Recording surgical imagery and clinician activities during a case allows ASCs to highlight examples of clinicians performing best practices and modeling ways of communicating that improve teamwork and outcomes. Image Stream content management capabilities give ASCs secure access to this information for all kinds of quality improvement, staff review, onboarding, research, and educa-tional purposes.”

To underscore how patient safety is just as important in an ASC as it is in the acute-care environment, Mitchell drew a parallel line between acute-care versus non-acute care and inpatient versus outpatient activities, explaining how Image Stream technology supports compliance with best practices. “AAAASF requires a ‘surgical-pause’ or ‘time-out’ protocol be conducted prior to each procedure to avoid wrong-surgery and wrong-site errors. Image Stream builds a time-out function right into the room’s pre-operative workfl ow, so that it’s not missed. The time-out function automatically brings the ASC’s specifi c pause protocol up on all displays in the room, and it adjusts the lights and music so that everyone can pay attention during this important step in a procedure.”

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their surveys. As they visit more and more ASCs, noting practices that do not follow ST79 standards, that reality is being recog-nized. Every facility, including ASCs, that reprocesses instruments, should own and follow ST79.”

Nies strongly recommends taking ad-vantage of education provided at related organization meetings, to keep best prac-tices strong and updated. “Attending IAHCSMM conferences and networking with colleagues from other facilities, both local and national, is a great way to keep in touch with current best practices and can help make The Joint Commission visit go smoother. Of course, the most important end result is a better process, which keeps the patient safer.”

Sore-spot solutionsAs the patient population ages and ASCs become more ubiquitous — and busy — the risk of patients developing pressure ulcers is another important consideration. Even shorter procedures can put certain patients at risk. Pressure ulcers are costly, too.

Debra Meixsell, Wound Care and Bar-iatric, TSS Marketing, Getinge Group, Americas, said the RIK Fluid Overlay with Skin IQ Microclimate coverlet offers a safer environment for their patients who may be at risk of developing pressure ulcers. “The RIK products both contain a viscous fluid that conforms to ‘micro’ contours of the body to relieve pressure and ‘flow’ with patient movement to help prevent friction and shear,” explained Meixsell. “It’s like lying in pudding, where the fluid envelops the patient, protecting them from the operating room table, and then as they move into the recovery room. The Skin IQ is a microclimate coverlet that fits right over the RIK Overlay and draws mois-ture away from the patient’s skin using negative-airflow technology. Simply put, it’s a mighty coverlet, pulling moisture away from the patient at a higher level than traditional low air-loss products, which are

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Reference

1. Munnich EL, Parente ST. Procedures take less time at ambulatory surgery centers, keeping costs down and ability to meet demand up. Health Aff (Millwood). 2014;33(5):764-769.

infECTion PREvEnTionASCs. “Image Stream provides highly modular, procedure-space integration so-lutions that include room control, surgical video recording, image capture, collabora-tion, and content-management functions. These visual collaboration tools support more efficient clinician workflows; for example, streamlining patient registration and case-close processes, which make them well-suited to a high-volume ASC. Since many ASC clinicians also will practice at associated full-service hospitals, it’s im-portant to be able to access patient surgi-cal video and image data wherever they are. Image Stream’s content-management system supports this kind of ‘anywhere’ access easily and securely across an enterprise. In addition, Image Stream supports the kind of cost-effective scalability needed in the market, scaling easily from a couple of rooms in a single ASC to hundreds of suites for a nationwide organization.”

Henry Schein Medical is another resource that assists with compliance require-ments by offering a variety of products and services that target the unique needs of the ASC. “We actively monitor ASCA discussion boards to ensure our products and solutions address unmet needs,” said Scott Jackson, Healthcare Services General Manager, ASCs. “One such solution is an application that streamlines and automates ASC facility compliance. This application allows an ASC to more efficiently manage ongoing compliance requirements.”

Other ASC-specific solutions include revenue-cycle management, electronic med-ical record, practice marketing, controlled- substance medication-management sys-tems, inventory management, and medical-waste disposal. “Each of these solutions are tailored specifically to meet the needs of an ASC,” declared Jackson. For example, Henry Schein Medical’s network of ASC solutions also make it easier for ASCs to implement best practices for managing medication. “Henry Schein’s medication-management system offers ASCs the ability to manage controlled substances within their center more effectively, leading to better control and controlled-substance recordkeeping, ul-timately reducing the chances for diversion. We recently placed three such systems in a three–operating-room multispecialty ASC that had experienced issues with diversion in the past. Our system greatly reduced this center’s probability for future diversion issues, due to the enhanced controls now in place.”

ASCs that are looking to gain greater con-trol over their medical-products inventory can also find support. “Our multi-vendor ASC materials-management system allows ASCs the ability to reduce days on hand of product, automates the physical-inventory count process, and enhances the ASC’s abil-ity to manage preference cards and perform case costing in a more accurate manner. Henry Schein Medical also offers ASCs the ability to place low unit-of-measure orders late in the day and receive them the next day, which helps to facilitate just-in-time inventory management.”

Clean and compliant ASCs also strive to hold the bar up high when it comes to sterile-processing activities and aim to follow the same standards and best practices as do hospitals — and oftentimes with much less.

“The ASC has the same re-processing requirements and cost

constraints as a sterile-processing department in an acute-care hos-pital,” said Joe Smith, Director

of Marketing, Belimed Inc. “The primary difference is the ASC has tighter space requirements, lower instrument volumes, and quicker turnaround times.”

To comfortably fit the space constraints common to ASCs, Belimed’s MST V 446 sterilizer, new Be-limed Protect cleaning solutions, and WD 200 washer/disinfector are part of a comprehensive portfolio of products for the ASC’s sterile-processing area. “Each of these products offers a smaller footprint and chamber capacity, mak-ing them more suitable to the lower volumes of an ASC,” Smith said. “To meet the quicker turnaround requirements, the WD 200 cycles have been optimized for minimum time, when used in combination with the Belimed Protect detergent.”

John Nies, Product Manager, Belimed Inc., and an AAMI ST79 Committee Mem-ber, dispelled rumors that ASCs are not subject to AAMI’s recommended practice for hospital steam sterilization. “I have heard stories that some ASCs believe that AAMI ST79, the standard for best practices in sterile processing, may not be applicable to them, as they are different from acute-care facilities; nothing could be further from reality,” Nies affirmed. “The Joint Commis-sion uses ST79 as a guidance document for

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Instrumental news Cs ConnECTion

With greater recognition of the patient safety risks presented by improperly processed surgical

instruments and devices, the spotlight on central sterile/sterile processing departments (CS/SPD) grows. Many different parties to the healthcare industry, including hospitals, manufacturers and industry associations, are making concerted efforts to increase CS/SPD education and training, as well as ensure the profession has the resources it needs to suc-cessfully protect patients.

In this article, we provide an overview of current CS/SPD state certification require-ments, both bills that have passed and legis-lation currently in progress. We also provide insights from CS/SPD professionals, industry thought leaders and manufacturers on what is needed to advance the profession in terms of establishing a CS/SPD career path, on-the-job training and continuing education. Lastly, we offer resources that CS/SPD professionals can access to expand their knowledge and further their careers in this up-and-coming profession.

the state of certificationAt the time this article was written (May 2016), Connecticut, New Jersey and New York require new central service technicians entering the profession to obtain certification in order to work in the profession within those states; however, all central service tech-nicians, whether grandfathered in or not, are required to complete a minimum of 10 hours of continuing education annually.

Josephine Colacci, Esq., Director of Govern-ment Affairs for the International Associa-tion of Healthcare Central Service Materiel Management (IAHCSMM), notes how there has been progress on the legislative front in both Massachusetts and Pennsylvania as well. According to Colacci, the Massachusetts legislation regarding certification for central service technicians successfully passed out of the Joint Health Care Financing Committee on May 5, 2016. This legislation is now before the Senate Rules Committee. In Pennsylvania, IAHCSMM continues to meet with legislators serving

uncommon senseCS/SPD certification and training should be universal, so why isn’t it?by Kara Nadeau

on the House Health Committee to educate them regarding certification for central ser-vice technicians.

“The field of healthcare is constantly changing, with new procedures and new medical devices being introduced at a rapid rate,” said IAHCSMM’s Education Director Natalie Lind, CRCST, CHL, FCS. “Those changes have a profound impact on the central ser-vice department. All those involved in the reprocessing of medical devices must keep up with changes as they occur. Along with learning about new devices and procedures, we are also evolving in our understanding of the science of sterilization. What was an acceptable practice a few years ago may be unacceptable now. Keeping cur-rent is critical for patient safety.”

Grassroots effortsBob Marrs, Director of Consulting Services/Field Operations for Aesculap, believes hos-pital leadership in sterile processing, surgical services and administration should be leading the charge for certification.” He states:

“Did you know that the person who cuts your hair, works on your car, does your nails, does your taxes and sells your house all require certification? Yet, the folks who clean, decontaminate, inspect for qual-ity and functionality, sterilize, store and transport the surgical instruments that will go into you or your loved ones’ bodies, does not require certification. How did this happen and how does it continue to happen? In the country that boasts the ‘best’ healthcare in the world, our third leading cause of death is medical errors. What are you doing as a CS/SPD professional to support this effort and to keep the momentum going? Our profes-sion needs this but more importantly, our PATIENTS need this!”

Jo M. Wood, Compliance & Education Supervisor for Boston Medical Center, has taken an active role in supporting the Mas-sachusetts legislative efforts. Wood explains how those working on the Massachusetts leg-

Josephine Colacci

Natalie Lind

Bob Marrs

why is a hospital machine tied to superbugs still in use?Six months ago, the Food and Drug Administration (FDA) said a machine tied to a deadly superbug outbreak should be taken off the market “as soon as possible” to protect public health. Twice. But the machine, which uses water, disinfectant, and sound waves to clean certain surgical instruments, remains in use for some of those instruments after FDA officials backed down. And no one is saying precisely why.

The FDA ordered Custom Ultrasonics Inc. to take its 2,800 System 83 Plus machines out of service. The automated washing machines are used across the U.S. to clean endoscopes including duodenoscopes. The use of the equipment was one of several factors that “likely contributed” to dan-gerous infections spread by inadequately cleaned duodenoscopes, according to a 2016 report by Senate Democratic staff investigating the incidents.

In its November 2015 correspondence with the company demanding a recall, the FDA raised concerns about the device's compatibility with dis-infectants, whether it works with duodenoscopes, and whether it properly eliminates microorganisms from water. In pulling back that recall demand, the regulator now says it’s working with the company to ensure that the machines “are validated in a timely manner,” according to an agency spokes-woman. “Validated” means the company has to prove the devices work as advertised. In the meantime, the machines can still be used to clean instruments including most endoscopes—just not duodenoscopes.

With the new FDA position, Custom Ultrasonics said in a notice posted on its website that it will send hospitals a label to affix to the washers that will warn medical staff not to use the machines to clean duodenoscopes.

The FDA's scrutiny of Custom Ultrasonics pre-dates the recent outbreaks. Inspections as far back as 1991 found “significant violations” of federal rules meant to ensure quality manufacturing and timely reporting of patient harm, according to a 2006 complaint filed by federal prosecutors in Philadelphia. Similar violations were documented in 1992, 1995, 2005, and 2006, according to the lawsuit, which led to a consent decree in January 2007 that remains in force, and was the legal basis for the latest recall.

Two letters dated Nov. 12, 2015 and Jan. 29, 2016 indicated that, given the company’s “lengthy regulatory history,” merely trying to fix the machines wouldn’t suffice. The first letter instructed the company to recall all of them, at its own expense, and figure out how hospitals could “transition from the System 83 Plus as soon as possible.” The second letter said the company’s response to the first letter was insufficient because it only offered to correct the machines “rather than to remove those devices from use.” The agency wrote, in bold text, “FDA orders Custom Ultrasonics to immediately recall all System 83 Plus devices by removing them from use.”(Bloomberg)

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Cs ConnECTion

islation spent the first term educating elected officials on the role of CS/SPD. They are now shaping the legisla-tion and moving it forward during the third year.

While most states do not require CS/SPD technician certification at this time, many healthcare facilities are taking the matter into their own hands and requiring it of their CS/SPD employees. For example, Jewish Hospital & University of Louisville Hospital’s CS/SPD department, which was named the Healthcare Purchasing News 2016 SPD Department of the Year, requires all of its employees to earn their Certified Registered Central Service Technician (CRCST) certification within the first 12 months of the hire date (read Jewish SPD bolsters package deal within regional IDN in the May 2016 issue of HPN).

“The impact of a ‘certification culture’ in a department can be earth shaking, send-ing positive shockwaves into every corner of surgical services,” said Weston “Hank” Balch, CRCST, CIS, CHL, Director of Sterile Processing Operations for Jewish Hospital & University of Louisville Hospital. “Physi-cians see a commitment to growth in your CS team, nurses and surgical technicians notice the level of professional communication rise among your staff, and the patient ultimately gets a higher and more consistent standard of care with every instrument set. Every hour spent pursuing certification and CS education pays dividends in safe, high quality OR minutes. And that’s a lan-guage our C-suite and broader community can understand.”

According to Stephen M. Kovach, Direc-tor of Education for Healthmark Industries, certification of staff members who reprocess medical devices is the first step towards being consid-ered a professional.

“What amazes me some-times is that many who work in the field feel that a state must require they be certi-fied before they will take that step, where others realize the importance of certification as it shows they have taken upon themselves to let everybody know that they take pride in saying, ‘I am certified,’” said Kovach.

Speaking on the professional value of certi-fication, Joel Benge, CRCST, CIS, CHL, OR Li-aison for Sterile Processing, Jewish Hospital & St. Mary’s HealthCare in Louisville, Ky states:

“Being triple-certified as a sterile pro-cessing technician lends me a great deal of

credibility within my own department and amongst the OR staff. The education I have received allows me to communicate profession-ally and technically (when needed) with my peers and with the OR. Each day when I interact with OR staff, I am dealing with certified, educated individuals who know his/her given field. I can more effectively gain their trust and respect — and I can more effectively meet their needs and answer ques-tions — when I am also a certified, educated expert in my own field.”

Industry supportThomas Overbey, Director of Marketing for Ultra Clean Systems, encourages CS/SPD professionals to get involved in certification efforts on the state level. He also urges manufacturers to support state CS/SPD legis-lative efforts as well.

“The days of certification are coming — it’s just a mat-ter of when,” said Overbey. “Don’t wait for the ‘when’ — go ahead and make this the best process you can today because it’s all about patient safety. CS/SPD professionals shouldn’t lead the certification charge alone. Industry also needs to get involved. My per-sonal goal is to help steer Florida to become the next certified state.”

In the state of Tennessee, Senate Majority Leader Mark Norris and Shawn M. Flynn, Co-Founder/SVP of Customer Operations for Restore Medical Solutions, carried out a campaign that led to passing of Senate Bill 2581, which requires new central sterile technicians entering the profession to pass a nationally accred-ited central sterile exam. All central service technicians, whether grandfathered in or not, are required to com-plete a minimum of 10 hours of continuing education annually. Tennessee Governor Bill Haslam signed the bill on April 27, 2016, and it goes into effect on January 1, 2017.

“When Senator Norris and I were discuss-ing the background of the OR-SPD relation-ship, the Senator quickly understood that there was a ‘gap’ in the circle of care and that we could impact positive change through legislation,” said Flynn. “Advocacy, in my opinion, begins with creating that spark nec-essary to accomplish the change you desire. Our current and future patients depend on industry professionals and subject matter experts having the specialized skills neces-

sary to aid in combating HAIs/SSIs. They also need to be vigilant in raising the bar for central sterile technicians.”

Building a CS/SPD career ladderMany feel it is important to take a step back and build a better support network for those entering CS/SPD, in addition to those already working in the profession. Wood explains how it is difficult to attract and retain talented CS/SPD technicians because many young people don’t know the field exists, the career ladder is not well defined and the profession is underrated.

“Every hospital has its own CS career path and it varies widely,” said Wood. “You end up with people who make great techs but then they want to grow out of CS and go someplace else because there is no line of sight for advancement. You can only have so many managers in the world so where do you go from there? How do you keep those quality people within the profession? More and more as people begin to accept CS as part of the surgical team — and I think required certification bills are going to help that — people will be a little more inclined to seriously consider CS as a career path.”

Another challenge according to Wood is that many healthcare facilities do not employ a formal CS/SPD educator. Furthermore, those in educator roles have limited resources at their disposal to train their staff members.

“My facility has a very robust CS train-ing program, but while I was attending the IAHCSMM conference this year, I discovered not every department has someone in the educator position. So who does that work fall to? You can train on the fly but it may be more difficult to be proactive. Speaking as an educator myself, there is no formal training available for CS educators. I have to go out there and find the information myself and determine the best way to teach it out to our team. I’ve thought about taking college courses for classroom teachers but they don’t correspond well to our role.”

Balch points out that while the model of a dedicated CS/SPD educator is successful in many contexts, CS/SPD front-line technicians must become “continual self-educators” and certification supports this. He states:

“What certification brings to the table is the ability to spread out this expertise to every team member in the department, so each individual can become competent enough to hold an in-service on how to inspect bi-polar forceps or train each other in process improvement techniques,” said Balch. “Suc-cessful onboarding programs for CS depart-ments should include a certification study component that allows technicians who are not already certified to prepare for the exam

Weston “Hank” Balch

Stephen M. Kovach

Thomas Overbey

Joel BengeJo M. Wood

Shawn M. Flynn

EXPERIENCE

1607-Belimed.indd 39 6/10/2016 11:32:17 AM


“Preparation is key in any endeavor,” said Lind. “Those wishing to enter the field of central service must understand the re-quirements of the job and be prepared to meet those requirements. Certification helps those aspiring for a career in central service to enter employment with an understanding of the job tasks and requirements. Those cur-rently employed in central service will benefit from both certification and continuing educa-tion. Certification helps the CS professional understand why each step in the process is important, and it helps keep both patients and employees safe.”

Kovach points out that those CS/SPD professionals who have achieved certifica-tion have a competitive edge when seeking employment.

“When you are looking for a position in this field, the interviewer knows you have a basic foundation of knowledge so your training curve at the facility will be shorter as you ap-ply your knowledge to their specific process,” said Kovach. “You have an understanding of why you need to follow the instructions for use (IFU) or why you need to put an indicator into every item sterilized. Overall, certifica-tion lets everybody know that the certified person has taken pride in what they are do-ing and we all know that improves patient outcomes and that is what it is all about.”

Resources for CS/SPD professionals“What makes this industry really exciting right now is that it is finally coming to the surface,” said Wood. “Over the past two years we’ve determined what we really need in terms of resources to advance the profes-sion. Now we are paving the way to greater patient safety.”

Overbey urges CS/SPD personnel to join and be active in the various professional or-ganizations (e.g., IAHCSMM, AAMI, CBSPD, AORN) to maximize their knowledge, have an impact on the industry and increase the safety of patients.

“Continuing education is a must in health-care, and that’s certainly the case for central service,” said Lind. “Not keeping abreast of changes has the potential to cause harm to a patient or coworker. There are so many op-portunities to gain knowledge and expertise in the field of central service. Whether it is an article such as this one, standards and regulation information, internal in-services or information provided by outside sources, savvy professionals will take advantage of every opportunity to learn. It is that type of thirst for knowledge that will help prepare them for additional responsibilities and ca-reer advancement.”

Here are just a few of the industry re-sources available to CS/SPD professionals

Cs ConnECTionwho are seeking to gain certification, ad-vance their knowledge and training, and earn continuing education credits.

AesculapThe Aesculap Academy has a world-wide reputation for medical training of physi-cians, senior nursing staff and staff in OR, anesthesia, ward and hospital management. The courses consist of hands-on workshops, management seminars and international symposia. Courses are of premium quality and accredited by the respective medical societies and international medical associa-tions.

Case Medical Inc.“The need for SPD training and certification has become not just a requirement but a necessity. There is simply so much informa-tion to learn to keep up with new technology and challenges,” said Case Medical CEO Marcia Frieze. “We are committed to edu-cation and training as well as developing products that meet the needs of SPD professionals.”

According to Frieze, Case Medical supports these efforts with educa-tional programs on-line and on-site, as well as in-services with its clinical specialists to reinforce best practices. The company’s online Case Academy features programs with CEUs for CS/SPD and other healthcare professionals who wish to further educate themselves and their teams.

Circle of CareCircle of Care, an organization whose objective is the reduction of healthcare-acquired infect ions (HAIs) through education and collaboration, is active-ly involved in organizing interprofes-sional collaborative educational (ICE) conferences in various cities throughout the U.S. with industry organizations such as IAHCSMM, the Association of periOp-erative Registered Nurses (AORN), the Association for Professionals in Infection Control and Epidemiology (APIC) and the Association of Surgical Technologists (AST). Circle of Care also offers an on-site and e-learning certification preparatory course tailored towards CS technicians with years of on the job experience and knowledge but no formal theoretical training. The course provides CS professionals with the skills necessary to provide excellent patient care and opportunities for career advancement. The e-learning courses are available 24/7 and are accessible on any device. According to the organization’s Founder and Director of Collaborative Education Kisha Miller,

Circle of Care’s online pro-gram is comprehensive, affordable, convenient, and effective. She states:

“As a result of CS profes-sionals obtaining certifica-tion, job-related knowledge and skills acquired are ac-tively transferred to the point of care to meet the growing demand and complexities of the CS department. The organizational benefits range from highly engaged employees, improved clinical processes and improved quality patient outcomes. Everybody wins!”

HealthmarkThrough its website www.crazy4clean.com, Healthmark Industries offers fun and educa-tional games focused on proper cleaning of surgical instruments. All of the company’s educational games and departmental in-ser-vice programs feature continuing education credits (CEUs) from both IAHCSMM and the Certification Board for Sterile Process-ing and Distribution (CBSP). Participants receive a free CEU credit after completing the quiz at the end of each game.

Mobile Instrument Service and RepairMobile Instrument Service and Repair of-fers educational programs which offer one credit towards IAHCSMM, CBSPD annual certification. The company’s programs cover general and laparoscopic instrument care and handling, rigid and flexible scopes, powered surgical equipment, electrosur-gical equipment, and video equipment. Mobile Instrument combines its CE pro-grams with hands-on education focused on reducing repairs and proper inspection of surgical devices and instruments. Ac-cording to Product Manager Lisa Hawley, clinical staff benefit from the CE credits and the facility benefits from better equipment readiness, reduced downtime, and reduce inventory and repair spend. The company also provides online learning tools for its customers with staff who are studying for their certification.

Ruhof Healthcare Corp.Ruhof Healthcare presently offers a pro-gram of free accredited continuing educa-tion at both national and local trade shows for nurses and CS/SPD technicians alike. According to Marketing Manager Noreen Costelloe, these CE opportunities have been very well received. As a result, the company is setting up online CE programs to help its customers benefit by continually advancing their knowledge. “We strongly believe that ongoing education, training and mentor-ing are critical to the success of any clinical department,” said Costelloe. HPn

Marcia Frieze

Kisha Miller

1607-CS-Certification.indd 40 6/8/2016 4:22:16 PM

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SELF-STUDY SERIES Sponsored by

July 2016The self-study lesson on this central service topic was developed by STERIS. The lessons are administered by KSR Publishing Inc.

Earn CEUsThe series can assist readers in maintaining their CS certifi cation. After careful study of the lesson, complete the examination at the end of this sec-tion. Mail the complete examination and scoring fee to Healthcare Purchasing News for grading. We will notify you if you have a passing score of 70 percent or higher, and you will receive a certifi cate of completion within 30 days. Previous lessons are available on the Internet at www.hpnonline.com.

Certifi cationThe CBSPD (Certification Board for Sterile

Processing and Distribution) has pre-approved this in-service for one (1) contact hour for a period of fi ve (5) years from the date of original publication. Successful

completion of the lesson and post test must be documented by facility management and those records maintained by the individual until re-certifi cation is required. DO NOT SEND LESSON OR TEST TO CBSPD. For additional information regarding certifi cation contact CBSPD - 148 Main Street, Suite C-1, Lebanon, NJ 08833 • www.sterileprocessing.org.

IAHCSMM (International Association of Health-care Centra l Service Materiel Management)

has pre-approved this in-service for 1.0 Continu-ing Education Credits for a period of three years, until June 7, 2019. The approval number for this lesson is HPN 160706.

For more information, direct any questions to Healthcare Purchasing News (941) 927-9345, ext. 202.

LEARNING OBJECTIVES1. Explain the concept of total cost

of ownership and how it relates to medical devices in the sterile processing department.

2. Discuss direct and indirect costs of TCO for different types of sterilization and disinfection equipment.

3. Discuss recurring costs and other factors that impact TCO for reprocessing departments.

Sponsored by:

HEALTHCAREPURCHASING EWSN

When buying a car, we are often motivated to purchase by its looks and its fi nal negotiated price. We

don’t always consider what it’s going to cost to buy insurance for that make and model, how long the car is expected to operate reli-ably, how much the maintenance, parts and service are going to cost as it ages, how much gas, oil and other operating fl uids are going to cost for its daily operation, and how much depreciation we can claim over time. These additional factors are part of the total cost of ownership or TCO, which is defi ned in Wiki-pedia as “a fi nancial estimate intended to help buyers and owners determine the direct and indirect costs of a product or system.”

In healthcare systems, TCO comes into play for many types of major purchases. In the category of medical devices, TCO is defi ned as a cost-benefi t analysis used to compare medical devices before purchase. Healthcare purchasing decision-makers assess the direct costs, indirect costs and benefi ts associated with a particular medical device over its useful life expectancy, and develop a value that will refl ect the full short and long-term cost of a purchase.

What does TCO mean in today’s healthcare environment, particularly when a major

TCO in the SPDForethought can lead to more economical equipment ownership and operationby Melissa Gonsalves and Sarah Lazzara

capital expenditure is being considered for a sterile processing department? TCO analysis should involve looking beyond the price of the unit, which might or might not include additional immediate and long-term costs to the buyer.

Let’s investigate sterile processing and disinfection systems to understand what the hidden costs could be and how they should infl uence the overall purchasing practices of a department.

A TCO primer for disinfection and sterilization equipmentA long-term asset is one that is expected to be used for more than one year. In the SPD, most of the sterile processing equipment has a useful expected life of multiple years, or even decades, depending on the equipment and its design. When considering the total cost of ownership for any capital asset*, it’s important to consider direct, indirect, recur-ring, energy, depreciation, and end-of-life costs in addition to the capital acquisition price.

TCO can also be affected by the type of process the equipment runs, since specifi c cost factors may be necessary for one sys-tem that are not needed for another. Let’s compare the cost factors for some typical

Cost Terms and Defi nitionsDIRECT COST An expense that can be traced directly to a specifi c cost object such as a

department, process or product.INDIRECT COST An expense incurred in joint usage that is diffi cult to assign or identify with

a specifi c department, process or product.RECURRING COST A regular cost incurred repeatedly, or for each item produced or service

performed.ENERGY COSTS Monetary and non-monetary (e.g., environmental impact) associated with

the production, transmission and consumption of energy.DEPRECIATION The gradual conversion of the cost of a tangible capital asset into an opera-

tional expense over the asset’s useful life. The purpose of depreciation is to: • refl ect reduction in its book value because of obsolescence or wear and tear;• spread a large expenditure proportionately over a fi xed period to match the

benefi t received from it; and• reduce taxable income by charging depreciation against the organization’s

total income.END-OF-LIFE COST(residual value, salvage value)

The estimated residual or salvage value at the end of a product’s useful life. This may include disposal costs (cost of selling, incinerating, donating, dumping).

1607-CE-STERIS.indd 42 6/14/2016 9:00:48 AM


Sponsored by sELf-sTudy sERiEsSelf-Study Test Answers: 1. D, 2. E, 3. E, 4. A, 5. B, 6. A, 7. A, 8. C, 9. D, 10. A

reprocessing systems found in a central services department:

Steam sterilizersSteam sterilizers are still considered the gold standard for sterilizing medical instruments and other items that can withstand the high temperatures of steam cycles without sustaining damage. However, since “au-toclaves” were first developed more than 100 years ago, manufacturers and users have learned that more is required for ef-fective, consistent steam sterilization than the “box,” a power source and a water supply. In today’s department, the direct costs for steam sterilizers must include not only the installation and plumbing costs for the sterilizers; it must potentially include the purchase and installation of additional systems for filtration, high quality water and steam production, and drainage cool-ing. These costs will vary depending on the quality of incoming municipal water. Many steam sterilizers have a long useful life — 20 years or more if properly maintained. This allows a long depreciation period that can be factored into the TCO. They can also be remanufactured (rebuilt to their original specifications), which makes them valuable to the original manufacturer as trade-ins. Recurring expenses for steam sterilizers typically include biological/chemical indi-cators and sterilization wraps/containers for daily use, maintenance contracts and services, and standard replacement parts. Departments also need to provide ongoing personnel training to assure proper opera-tion and maintain compliance with current best practices.

Ethylene oxide (ETO) sterilizersThis method has been available since the 1950s as a low-temperature alternative to steam sterilization for delicate devices. At that time, it was the gold standard for low-temperature sterilization and was compat-ible with many device materials. ETO is an effective sterilant, but it requires extremely long cycle times (2 ½ hours plus 8-12 hours of aeration time) to allow desorption of toxic residual ETO from the loads. In addition to the unit itself, direct costs for an ETO system include the purchase and installation of special ventilation, exhaust, and disposal systems. It also requires the use of specific validated sterilization containers. In addi-tion to maintenance costs, required recur-ring costs include the sterilant, personnel monitoring and testing supplies, biological

monitoring and testing supplies, and special wraps to package devices. The use of an ETO system can also result in the need to invest in additional device inventory, which as-sures enough instruments to maintain the surgical schedule while accommodating the longer cycles.

Hydrogen peroxide (H2O

2) sterilizers

These systems, designed for heat and moisture-sensitive devices, have been in the healthcare marketplace long enough that there are now a number of system options to evaluate for use in your department. Un-like steam sterilizers, H2O2 sterilizers have no costs related to major installation, special plumbing, special exhaust systems, or special water quality equipment (water is not used in H2O2 sterilizers). But there will be cost con-siderations based on your needs, your device inventory and other factors specific to your department. Let’s explore what to consider for a thorough evaluation of H2O2 systems.

TCO in detail: hydrogen peroxide sterilizer example

Direct Costs to includeThese are costs that your department is responsible for when you acquire the new system.• Capital acquisition cost: This refers to the

direct cost of the capital equipment alone. Some sterilizer manufacturers may offer to trade in existing equipment for newer technology, which reduces the acquisition cost.

• Installation costs: In some cases, a depart-ment may need to make changes to its available space and/or utilities to accom-modate a new sterilizer. Consider the following:° Electrical requirements: do you have the

right outlet and voltage, or will you need to pay for additional work to meet the requirements of the new sterilizer?

° Space/footprint: Do you have the floor space needed for the sterilizer and related convenience products such as loading carts?

° Additional utilities: Does the steril-izer require any additional utilities? For example, if an oxygen tank is needed, is additional plumbing or installation necessary?

• Training costs: All new sterilizers require that the staff using the equipment be trained on the safe and proper operation of the sterilizer. This is often offered at a cost

by the equipment manufacturer or a third party, but is also offered online by some at no added cost. If your clinical engineering team will be servicing and performing maintenance on the system, they will need to purchase certified training, usually from the original equipment manufacturer or an authorized agent, to maintain the system’s warranties and operational compliance. They may also be required to participate and pay for annual re-certification.

• Packaging costs: H2O2 sterilizers require spe-cific validated sterilization packaging such as containers, wraps and pouches. If you are not already using the same system in your SPD, you will need to purchase new containers, trays, wraps or pouches for the new sterilizer. When considering trays, select the products that will allow you to maximize use of shelf space in the sterilizer chamber. Getting more out of each cycle will allow you to increase productivity and possibly reduce the number of cycles (and consumable costs) needed to achieve the same throughput.

Indirect costs to consider• Device inventory costs: You will need to

review your devices to determine whether or not they are compatible with the type of sterilant being used by the target system. All “gas” sterilants are not created equal — ETO is not the same as H2O2 and H2O2 is not the same as H2O2/ozone. You may

Page 44

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sELf-sTudy sERiEs Sponsored by

therefore need to consider either purchas-ing a different sterilizer, or buying new compatible instruments and devices.

•Device repair/replacement costs related to ma-terial compatibility: A sterilization process can impact the material components of your reusable devices if it introduces new chemicals or processes. It is important to understand the potential costs of repair or replacement of your devices, and the impact on useful life of the device.

•Special equipment costs for temperature con-trol, area monitoring or drying: It’s important to check with the sterilizer manufacturer to confirmanyadditionalcostrequirements.For example, all devices have to be dry to be processed in H2O2 sterilizers, but some systems are more sensitive to moisture and temperature. This may mean that ad-ditionalequipmentfordryingthedevicesand maintaining the optimal temperature will be recommended by the manufac-turer.

•Connecting to tracking systems: If you are currently using an instrument tracking system, you will need to determine if the sterilizeryouareassessing isequippedto talk to your tracking system. If not, you must determine what you will need to purchase to get the new equipmentconnected.

Recurring costs to add inIt is crucial to understand what you are go-ing to be paying over the life of a piece of equipment.Herearesomerecurringcoststoevaluate for your prospective system:•Consumables costs: sterilant, biological

indicators, chemical indicators and other accessories such as a sterilant disposal box. BE AWARE: the cost of the consumables can vary by sterilizer manufacturer. Some companies will heavily discount the capital equipment, but the consumablespriceswill be much higher than those of others.

•Cycle costs: to get an accurate value, look at the big picture of what it is going to cost you to run your sterilizer. The overview includes:° Productivity: Manufacturers’ cycle claims

can help determine the number of cycles you can run per day and your yearly cost for consumables. It can help you calculate turnover time on surgical case sets and determine the number of steril-izers you need to meet your throughput requirements.

° Aborted cycles: They happen, and they can cost you time in terms of reprocessing delays, and money for wasted supplies. Some sterilizers can experience a higher

number of aborted cycles, so it’s impor-tant to investigate the sterilizer design and determine if it could impact your aborted cycle costs.

•Service and parts costs: Connect with your clinical engineering team to understand their goals for maintaining the system. If they want to take care of the unit, what are the maintenance and training options? If you are considering a service contract with the sterilizer manufacturer, what are the annual service contract costs, including planned replacement parts? What is and is not covered under your service contract? This will determine potential out-of-pocket costs. Is the company’s service team large enough, and local enough, to provide a quickresponsetimesoyoucanoptimizeyourequipmentuptime?Thiscouldhelpprevent loss of productivity and delayed/cancelled surgical cases.

•Operator Maintenance: Many manufactur-ersrecommendspecifictasksforoperatormaintenance, such as running a special diagnostic cycle weekly or replacing a vaporizer plate. If you are switching to a new sterilizer, be sure to understand these recommendations and calculate in any related costs.

Value-added services that save on costs•Workload assessment and recommendation on

workflow: This service, offered as part of the purchase by some manufacturers, is helpful because it will aid in selecting the appropriate type and number of sterilizers to cover present needs and expected future growth.

•Operator training: If this is offered as an addedbenefitofpurchase,itwillsaveonthe cost of training for operators.

•Engineering training: This may be offered as an economical option to allow in-house staff tomaintainyour equipmentwhilekeeping the system in compliance with warranties and best practices.

•Trade-in services: If a manufacturer negoti-ates a trade-in as part of the purchase, this could save on purchase cost and on end-of-life costs to dispose of or move an old system.

Ready for your next TCO analysis?Although this module is not exhaustive in scope, it does provide some typical examples of the types of potential costs and factors in-volved in a sterile processing long-term asset acquisition.Itcanhelpsettheframeworkfora thorough TCO evaluation before you make amajorequipmentpurchase.

Purchasing a healthcare capital asset can seem like a huge undertaking, but there is support available. And, by conducting a thorough TCO analysis, you will avoid un-necessary costs and select the optimal system for your needs and budget. Membership organizations like MD Buyline (mdbuyline.com) and ECRI Institute (ecri.org) may be able to provide useful comparative informa-tion. In addition, someequipmentmanu-facturers are willing to provide a wealth of added support. Check to see if your prospec-tivesystem’sequipmentmanufacturerwillhelp you by providing TCO information, assisting with low or no-cost in-servicing and education, providing measurements and information to help with workflow design, shipping and installation, reviewing your device inventory, and providing tools such as competency checklists and work instructions to make the transition smooth and painless. HPn

*A capital asset is one that is not easily sold for cash, and that typi-cally plays a role in the organization’s productivity or ability to turn a profit. In addition, a capital asset is expected to provide benefits that extend beyond a calendar year.

**Semi-critical medical devices are those that come into contact with intact mucous membranes and do not ordinarily penetrate sterile tissue. Reusable semi-critical devices should receive at least high-level disinfection, which is defined as the destruction of all vegetative microorganisms, mycobacterium, small or nonlipid viruses, medium or lipid viruses, fungal spores, and some bacterial spores.

Melissa Gonsalves, BS, MEM, is the product manager of Low Temperature Sterilization Solu-tions at STERIS Corporation. She is responsible for the development and distribution of hydrogen peroxide gas sterilizers. Melissa holds a B.S. in Biomedical Engineering from Michigan Techno-logical University and a Master of Engineering and Management from Case Western Reserve University.

Sarah Lazzara, BS, MBA, director of IPT Marketing at STERIS Corporation, is responsible for the management of sales and marketing for the Company’s Vaporized Hydrogen Peroxide (VHP) technologies. She received her BS. in Management Information Systems from Penn-sylvania State University and her MBA from Lake Erie College. Sarah is also a certified Lean Six Sigma Black Belt.

References

1. http://bmet.wikia.com/wiki/Total_Cost_of_Ownership.

2. http://www.investopedia.com/terms/c/capitalasset.asp.

3. https://practicegreenhealth.org/initiatives/gsc/tco.

4. http://www.businessdictionary.com.

5. http://www.cdc.gov/hicpac/Disinfection_Sterilization/13_02sterilization.html#a1.

6. http://www.cdc.gov/hicpac/Disinfection_Sterilization/13_11sterilizingPractices.html.

7. http://www.asge.org/uploadedFiles/Publications_and_Prod-ucts/Technology_Reviews/Automated%20Endoscope%20Repro-cessors.pdf.

1607-CE-STERIS.indd 44 6/10/2016 8:38:31 AM


Continuing eduCation test • July 2016

Sponsored by sELf-sTudy sERiEs

TCO in the SPD

1. TCO in the healthcare environment can be defined as:a. A cost-benefit analysis used to compare medi-

cal devices before purchaseb. An assessment of the direct costs, indirect

costs and benefits associated with a particular medical device over its useful life expectancy

c. A value that will reflect the full short- and long-term cost of a purchase

d. All of the abovee. a and b

2. TCO analysis should involve: a. The price of the unitb. Immediate and long-term costsc. Energy costsd. a and be. All of the above

3. The purpose of depreciation is to: a. Reflect reduction in value because of obsoles-

cence or wear and tearb. Spread a large expenditure over a fixed period

to match the benefit receivedc. Increase taxable income by adding deprecia-

tion to total incomed. None of the abovee. a and b

4. Direct costs are costs that can be traced di-rectly to a specific sterilizera. Trueb. False

5. Direct costs include those for the system, installation, sterilization packaging, room cleaning, and training.a. Trueb. False

6. Expenses for biological indicators, sterilant, wraps and maintenance parts are recurring costs.a. Trueb. False

7. Aborted cycles, if they occur frequently, could carry an ongoing recurring cost for wasted supplies.a. Trueb. False

8. If the H2O

2 system you select is highly sensitive

to moisture and temperature, it may require added expense in the form of ______ recom-mended by the manufacturer.a. Pre-cleaning equipment b. Soft drying towelsc. Device-drying and temperature control equip-

mentd. Sterilization wraps

9. Some manufacturers of fer services that reduce overall cost or add value. These may include:a. Device audits and workflow assessmentsb. Training for operators and in-house engineersc. Additional installation requirementsd. a and be. None of the above

10. To achieve an accurate TCO, it’s important to understand what you are going to be paying over the useful life of a piece of equipment.a. Trueb. False

Circle the one correct answer:

Request for Scoringo I have enclosed the scoring fee of $10 for EACH test taken. (Payable to KSR Publishing Inc.

We regret that no refunds can be given. Multiple submissions may be submitted in bulk and paid with a single check for the bulk sum.)

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Name

Title

Hospital Name

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Apt/Suite

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The approval number for this lesson is HPN 160706.

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1607-CE-STERIS.indd 45 6/10/2016 8:38:32 AM


IAHCSMM VIEWPOINTWorkplace bullying: what it is, how to stop itby Julie E. Williamson

Bullying behaviors are all too common in the workplace, including in the Central Service (CS) department. When allowed to continue without effective or targeted interven-

tion, this behavior can diminish employee self-esteem and team morale, impede productivity, contribute to work withdrawal, illness and absence, increase staff turnover and open the door for facility liability/lawsuits, among other negative outcomes.

Before bullying can be identifi ed and corrected, it’s fi rst necessary to clearly defi ne what bullying behavior is and isn’t. As Natalie Lind, CRCST, CHL, FCS, Education Director for the International Association of Healthcare Central Service Materiel Management (IAHCSMM), explained during her workplace bullying session at the 2016 IAHCSMM Annual Conference, bulling is “unwelcomed or unreasonable behavior that demeans, intimidates or humiliates others, either as individuals or a group.” This can include abusive or offensive language, insults, teasing, unreasonable criticism, the spreading of rumors, and trivialization of work and achievements.

Equally important is outlining what bullying isn’t. Performance appraisals, job direction, counseling, constructive criticism, and disciplinary action are not considered bullying behaviors, as long as they are delivered respectfully, fairly and according to facil-ity policy. At the same time, playful banter, respectful jokes and other exchanges that are welcomed and not negatively or unfairly targeting one person or group also are not bullying behaviors. The same is true of respectful disagreements that are a normal part of working as a team.

“It’s okay to have fun at work, but not at the expense of others. It is also perfectly normal to have disagreements from time to time, as long as those disagreements are handled respectfully,” said Lind.

Many faces of bullyingWorkplace bullying can assume many forms, including, but not necessarily limited to:• The joker/teaser - This person says hurtful things and/or plays

hurtful pranks on co-workers. When challenged, they often reply, “I was only joking/teasing.”

• The fragile co-worker - This person is easily angered. Co-workers “walk on eggshells” to avoid confl ict with this person.

• The unpredictable team member - This person’s mood changes frequently and erratically. Co-workers never know what kind of workday it will be until they gauge this person’s mood.

• The crybaby - This person is so sensitive that anything said or done may lead to tears; as a result, co-workers may go out of their way to avoid those tears. Crybaby behavior is a form of manipulation.

• The accuser - This person uses “in-your-face” confrontation to catch co-workers off guard.

• The secret keeper - This person likes to know more than others and uses that information to feel superior.

“Bullying behavior, however it is demonstrated, upsets the balance of the workgroup, shifts the focus away from the patient, erodes teamwork and promotes other negative behaviors,” Lind explained.

Banishing bullyingThe fi rst step in addressing and eliminating bullying behaviors is to acknowledge that a bullying problem exists. From there, CS leaders can devise a plan to educate members of the work group and create a Code of Conduct that clearly defi nes unacceptable behaviors and includes policies and procedures for appropriate response.

“Members of the work group or team should be involved to gain their participation and buy in,” Lind explained, adding that these team members can help identify the most appropriate working conditions for their area.

Managers should be aware of workplace challenges that may lead to bullying behaviors. Resource constraints, high (and sometimes unrealistic) job demands, organizational changes, job insecurity, inadequate training, poor communication, and a lack of policies or standards outlining acceptable and unacceptable workplace behaviors may all increase employee stress, anxiety and pressure. Although these scenarios are no excuse for bullying or aggressive behavior, it is vital that managers recognize these triggers and work to address them.

The goal is to eliminate as many stressors as possible and then help workgroup members deal with the remaining stressors ap-propriately, according to Lind.

Recruiting assistance from Human Resources and the Education department can also go a long way toward furthering the educa-tion plan and outlining next steps. When educating employees, Lind reminded that it’s essential to keep the training and related discussions professional, and to schedule follow-up education and communication to promote long-term positive change.

“Bullying behavior will not be eliminated overnight,” she stressed. Setbacks should be expected and managers should consistently and promptly address them. “Eliminating bullying behaviors and creating a work environment and culture that is not bully friendly takes commitment and understanding from everyone involved.” HPN

1607-Viewpoint.indd 46 6/8/2016 11:22:14 AM


CS QUESTIONS • CS ANSWERSMedical grade air; dry vs. moist instrument transport; multiple inspection magnifi ers by Ray Taurasi, Eastern Regional Director, Clinical Sales and Services, Healthmark Industries.

SUBMIT YOUR QUESTIONSemail: [email protected]: (941) 927-9345 ext. 202

Q I am an infection control manager and recently attended an infection control

conference. One of the speakers talked about various utility requirements for the sterile processing area and had emphasized the need to have medical grade air readily available. I don’t quite understand exactly what medical grade air is or its application in sterile process-ing. Does this apply to the environmental air that is circulated through the department or is it oxygen for emergency carts?

A Medical grade air, sometimes referred to as instrument air, is basically a medical gas

that must meet the requirements set forth by the National Fire Protection Association, NFPA 99: Health Care Facilities Code. This air is not respired and must be compliant with American National Standards Institute and International Society of Automation ANSI/ISA S-7.0.01. That is the quality standard for instrument air, which is fi ltered to 0.01 micron, free of liquids, and hydrocarbon vapors and dry to a dew point of -40°F (4.444°C). There are medical devices such as those with lumens that require drying and instrument air is blown through the channels; instrument air may also be used for testing the perfor-mance of some medi-cal devices. (See Figure 1.)

Q I am the perioperative educator and quality assurance specialist for our offsite

ambulatory care and surgery centers. During a recent accreditation inspection the surveyor issued a citation because cleaned instruments were being returned to the main hospital dry and in a closed tote container. The surveyor referenced an infection control standard that said instrumentation should be kept moist during transportation for fi nal processing. I questioned the citation and told her our policy was for the satellite centers to manually clean all instruments, in accordance with IFUs, and then place them in a covered bin for return to the main hospital where they are packaged and sterilized. The surveyor held fi rm on the citation and further recommended that we assess our entire process for the handling and transporta-tion of instrumentation between the satellite locations and the main hospital campus. I really feel that the citation is unwarranted and believe our method of handling “clean” instrumenta-tion is appropriate. Am I wrong? What am I missing here?

A Without knowing the standard, source and reference for the citation I cannot really

fully address or respond to your issues and concerns. In general, I can see no rationale for or need to keep clean instruments moist during transportation. There are several recommenda-tions, guidelines and standards relative to the transportation and handling of soiled, clean and sterile medical devices. The accrediting bodies and their surveyors are very watchful and concerned regarding proper handling and transportation of medical devices in accordance with standards of practice. It seems to me that the surveyor may not have fully understood your protocol or likely saw practices that were questionable or confl icting. You should be able to obtain the reference standard for which you were cited as non-compliant in order to respond with a corrective action plan.

When assessing your current protocol you should include the following:• Does your process allow for complete segre-

gation of clean, sterile and soiled items from one another?

• Are all items properly contained in covered, rigid, puncture-proof containers?

• Are all containers clearly labeled and identifi -able as clean, sterile, soiled and/or biohazard-ous?

• Are the conditions of the soiled and clean pro-cessing rooms in compliance with standards?

• Are the manual cleaning procedures strictly enforced and in compliance with the device manufacturer’s IFUs?

• Are all the personnel responsible for process-ing /cleaning the instruments at the various satellite centers trained and competent to perform these functions?

• Are personnel following the proper use of personal protective equipment (PPE)?

• Are the processing protocols consistent throughout the organization?

• Are the transportation vehicles in compliance with various DPH, DOT regulations?

• Are policies and procedures readily accessible to personnel at all locations?

• Are quality assurance protocols for cleaning verifi cation and documentation in place?

Q I am the lead Central Sterile Processing (CSP) technician and report to the OR

nurse manager. We only have one magnifi er in

our department which I know is not suffi cient. I would like to have one at every work station and we really need a borescope to inspect our shaves and small instruments with channels. Every time I bring this up to my manager she says the one we have should be enough and that there is no requirement to have one at every station. She says that the budget is tight and that there is no way we can spend several thousand dollars on magnifi ers. What can I do to convince her that we do need more inspection devices?

A You are absolutely correct — one magni-fi er is not enough to conduct the inspec-

tions of your instruments and other medical devices properly. There are many different types of visual inspection tools that should be used in CS to thoroughly inspect devices. (See Figure 2.) One type of visual inspection device cannot meet all of your needs. Most instrument manufacturers’ IFUs include a visual inspection step. Inspection is of course necessary to ensure that visual soils are removed but instruments also need to be inspected to be certain they are not damaged. Many instruments have small parts, recessed crevices, channels and other areas that cannot been seen by the naked eye or reached without the use of a borescope.

Just about all of the professional organi-zations that have guidelines or standards including AAMI, AORN, SGNA, emphasize the need for visual inspection. I would suggest that you review these documents for support as well as the IFUs of your instrument manu-facturers, especially orthopedic devices such as arthroscopic shavers. To help get you get started here is an excerpt from ANSI / AAMI ST79 Section –7.5.5: “After completing the clean-ing process, personnel should visually inspect each item carefully to detect any visible soil. Inspection using magnifi cation might identify residues more readily than the unaided eye.”

I recommend that you gather all of the in-formation necessary to support your need for additional visual inspection tools and share it with your manager, along with a request for the devices you need. HPN

Figure 1

Figure 2

1607-CSsolutions.indd 47 6/14/2016 3:11:11 PM


New TechNology PRoduCTs & sERviCEs

Let’s face it: For many Supply Chain pro-fessionals freight and shipping matters may not be as scintillating a function to

manage as, say, product evaluations, value analysis projects or dare we mention inven-tory data cleansing?

While freight and shipping may not pique interest, mismanagement and negligence can generate a peak in the expense column and scorn from the C-suite. It also remains a topic drawing interest around budget times.

Freight and shipping represent one of those so-called “low-hanging fruit” opportunities that inspire yawns and motivate many Supply Chain pros to reach beyond for some reason.

Whether esoteric or mundane, freight and shipping is a task that must be fulfilled as a key component of supply chain operations driven by materials, pricing and services.

Supply Chain pros saw their pulses ac-celerate a bit in the first quarter of this year as prices for fuel, then containerboard and linerboard declined. Their pulses revved more when freight and shipping prices failed to follow suit. After all, such a domino effect seems logical, right?

Maybe not.“While these prices have declined, there is

still a lot of concern for their volatility,” said Christopher DiBernardi, Director, Business & Product Development Healthcare, Ryder. “For one thing, fuel prices are begin-ning to rise again. There is also an increasing cost to operate — from driver and warehouse worker salaries to the manufacturing of goods. So a decrease in the price of fuel is just one variable in the equa-tion.”

Jake Crampton, Founder and CEO, Med-Speed LLC, expressed mild surprise that the economics didn’t pan out.

“It is unclear to me why freight and ship-ping prices wouldn’t decrease with the decrease in fuel prices,” Crampton said.

Striving for ship, ship hooray! momentsFreight and shipping management can generate easy wins after difficult searchesby Rick Dana Barlow

“We believe in a reciprocal approach to fuel costs. We work with our clients to establish ranges around the prevailing fuel charge in the region and set surcharge and rebate targets when prices exceed or drop below that range.”

Still, Marc Mullen, Vice President and General Manager of OptiFreight Logistics, a Cardinal Health company, said he believes the industry is benefiting overall from these pricing moves.

“Aggregate freight costs have benefited from declin-ing fuel costs,” he indicated. “These reductions are re-flected in the historically low fuel surcharges from this past year, even hitting zero lately. This represents significant savings for ship-ments and freight.”

Brandin Parrett, Vice President of Opera-tions, Onsite Management Group LLC, of-fered a few reasons why Freight and shipping prices are not following suit and decreasing in line with fuel, containerboard and linerboard, the largest and most obvious of which is the “ability for shippers to increase revenue in a very competitive market.

“While this might seem opportunistic, and in some cases might be, the stronger economic growth has increased demand for cargo space while the number of drivers is quickly shrinking,” Parrett continued. “This provides an added element to the competiveness of the shipping companies to provide better benefits to retain valued employees. Salaries and healthcare are one aspect, but you must also take into consideration the new regula-tions that limit driving hours as well, therefore increasing delivery times and/or the need for more drivers to keep up with the demand. All

Christopher DiBernardi

Jake Crampton

Marc Mullen

Brandin Parrett

oNc unveils new videos empowering patients to learn their rights under hIPAAAs part of the 2016 Office of the National Coordinator for Health Information Technol-ogy (ONC) Annual Meeting, ONC unveiled a series of consumer-oriented videos about the rights patients have to access their health information, as well as a Patient Engagement Playbook for Providers designed to help clini-cians and office staff better engage patients through the use of health IT. The final day of the meeting was focused on empowering individuals to become better partners in their health and care.

“Many people are not fully aware of their right to access their own medical records under the Health Insurance Portability and Account-ability Act (HIPAA), including the right to access a copy when their health information is stored electronically,” said Lucia Savage, J.D., ONC’s chief privacy officer. “The videos we released today highlight the basics for individuals to get access to their electronic health information and direct it where they wish, including to third party applications.”

The videos released were produced by ONC in collaboration with the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). The videos highlight what an individual needs to know about their rights to access their health information. The first video describes the basics of the HIPAA access regulation, including what medical records are, when access is allowed, and when a provider may not share information, such as if a bill has not been paid.

The second video takes a deeper dive into what incurred costs are acceptable and an expected wait time for copies of the records. The third video takes a look at the rights of indi-viduals to ask that their information be shared with a third party, such as family members.

The Playbook is part of ONC’s effort to develop more user-friendly tools that can help clinicians and other providers in sharing health information with their patients. The Playbook outlines considerations for engaging patients with health IT, including best practices and case studies which clinicians and their office staff can utilize to enhance their efforts to use health IT to better engage their patients.

This first edition of the Playbook centers primarily on the use of patient portals and information to:• facilitate easy enrollment to achieve greater

portal adoption;• meet patient needs online, while also streamlin-

ing practice workflow;• involve caregivers in an appropriate way; and• integrate patient-generated health data to

improve clinical decision-making and care.Visit ONC for the playbook:https://www.healthit.gov/playbook/pe/.

1607-PS-Freight.indd 48 6/14/2016 10:43:03 AM


Sponsored Content

Imagine reducing one of your large in-bound freight bills from $1,764 to $307* without having to change a thing about

the shipment except how it’s being man-aged. Now imagine similar savings on every large freight shipment, every time. This is what supply chain can achieve when it stops relying on a DIY freight management ap-proach and works with a third-party logistics provider such as OptiFreight® Logistics, a Cardinal Health company.

It makes sense to use a freight manage-ment providerEven your most dedicated efforts to compare and negotiate rates and terms among multiple carriers can’t deliver the discounts and other benefi ts typically delivered by a freight man-agement provider. The most obvious reason is the ability to leverage high freight volume to lower costs, but a freight management provider also has broad carrier relationships with the top national and regional players in the freight industry. Using advanced technol-ogy combined with a deep knowledge and understanding of the business gives freight management providers like OptiFreight®

Logistics the negotiating power and expertise required to save money and prevent costly mistakes that most hospitals would struggle with alone.

“There are so many things that factor into successful freight management. Price is only a small piece of the puzzle,” said Chris Mathew, Director of Transportation, OptiFreight®

Logistics. “People need to be dedicated to managing activities such as auditing freight invoices, paying carriers, resolving issues, working with suppliers to ensure compliance, reviewing program results, evaluating carrier performance, negotiating rates and analyzing all of these activities to ensure ongoing opti-mization and savings realization.”

But does your supply chain department really have the time, resources and expertise required to do all of that effectively? On the other hand, can it really afford not to? A freight management provider is in the best position to take on that responsibility and drive savings with minimal time needed from your organization.

Where large freight dollars end up (if you’re not paying attention)The fi rst step is to recognize and understand the nuances of large freight handling and use it

to your advantage. “Fewer people are exposed to the details of how to ship large freight, so it tends to be something not well understood,” explained Mathew. “Because it’s not as well understood, many customers aren’t as vigilant about ensuring there is program compliance for appropriately using large freight for their inbound and outbound needs.”

For example, “With large freight, there are literally thousands of carriers who have differ-ent specialties in either service or geography,” he continued. “Less-than-truckload (LTL) carriers can be national or regional. Most of your shipping may be within a region your main LTL carrier covers. But the fi rst time you have a shipment originating outside of the region they may have no solution to offer, or they may work through another carrier who covers that region at an additional cost.Large freight carriers — even those who oper-ate nationally — tend to have very different cost structures from market to market, so optimization requires working with multiple carriers.”

Another expensive mistake facilities make is treating large freight the same way they do small parcel shipments. Consider the variables involved when ordering different quantities of the same product month to month where you might need 20 cases in January and 34 cases in July.

“Even though one of the shipments quali-fies as large freight the customer doesn’t typically view it differently since they are still ordering Product A,” said Mathew. Another common oversight is to use one carrier for every shipment. “They may assume that a national parcel carrier is their only or best option for everything that needs to be shipped regardless of size, weight and service require-ments. PCs and monitors are another great example,” Mathew continued. “When there is a capital refresh for a department, many hardware suppliers will choose to ship each item as an individual ground shipment. For large orders, the shipping fees can add up to a signifi cant amount of freight spend. We have had examples where consolidation of those individual shipments to palletized/LTL shipments saved 40 percent or more in freight spend.”

Are you managing your freight budget and related activities as well as you could be? OptiFreight® Logistics saves customers mon-ey by bringing visibility to a facility’s freight spend and assisting with a comprehensive

analytical review of current shipping strate-gies, so that better solutions can be identifi ed and implemented.

Know the rules, leverage the language Understanding how the transportation indus-try operates — inside and out — is the best way to navigate freight management success-fully, but it can get complicated.

“Routing freight requires freight indus-try knowledge: Hazmat, DOT regulations, seasonality concerns, capacity availability,” Mathew asserted. “Customers must under-stand specialty equipment that the freight industry uses and the costs associated with accessorial charges: lift gate, inside delivery, trash removal, excess liability, etc.”

It’s also helpful to insert freight language in a prominent place on every purchase order (PO) and supplier contract. Including shipping instructions on the PO holds sup-pliers accountable and increases program compliance signifi cantly without affecting the activities of procurement teams or buyers.

Sounds like simple stuff, but it’s easy to see how a facility might overlook the practice.

“If a facility did not belong to our program, the buyer would typically not discuss or relay freight preferences or terms to a supplier — or freight may or may not be discussed or negotiated at all,” said Mathew. “The sup-plier would have control of how the order is shipped and how much they charge the customer for shipping. With our program, the buyer does not change their process. When the supplier is entering the order in their system, the PO note instructs them how to direct the shipment to ensure third-party party billing benefi ts are provided to our mutual customer.”

Why OptiFreight® Logistics Managing large freight is a big job. OptiFreight® Logistics can take on that re-sponsibility, so you can free up valuable time, resources and ultimately dollars for where they’re needed most.

“Achieving real savings in supply chain is dependent on many things,” said Mathew. “A strong and well-performing transporta-tion system is one foundational component.”

It’s time to start managing large freight the right way.Visit cardinalhealth.com/largefreight. *Based on an individual OptiFreight® Logistics customer’s large freight invoice savings during April 2016. Individual savings may vary.

Managing large freight the right way Invest smart, save big

CARDINAL.indd 49 6/14/2016 4:22:21 PM


PRoduCTs & sERviCEsof these factors combined provide the bulk of the resistance to lowering shipping and freight prices.”

Mitch Blau, Regional Director, The Audit Group Inc., an accounts payable and purchas-ing audit services firm for healthcare orga-nizations, pinpointed labor as a convenient crutch, too, even as freight and shipping companies are just beginning to dabble in driverless vehicles.

“There has been a de-crease in demand and an increase in supply for con-tainerboard and linerboard, which is why price of those materials has gone down,” Blau observed. “Fuel costs, which have declined in the first quarter, could rise at any time. That being said, consumers are accustomed to volatility at the pump but not to changes in shipping costs. It’s difficult and unpopular with customers to decrease prices if you’ll only have to increase them later when the price of fuel increases.

“While costs for fuel and materials are lead-ing indicators to freight and shipping prices, they are not the only catalysts,” he added. “Labor, equipment, and state and federal fuel surcharges are also major indicators that seem to be increasing rather than decreasing.”

But Tracy Leatherman, Vice President, Sales, TRIOSE Inc., linked declining freight volumes as a reflection of a sputtering economy with overall declining growth.

“Although fuel surcharges may be lower, the volatility associated with these costs creates additional uncertain-ty in the marketplace, which forces carriers to adjust via their bottom line,” he said. “It will take time for any impact on corrugated raw materials to have an impact on shipping costs if at all.”

Pricing threatsSo what are the biggest threats to freight and shipping prices this year, besides, of course, a savvy, well-informed Supply Chain leader? Freight and shipping firm executives tallied the score.

“Transparency is a big threat to freight and shipping prices,” insisted MedSpeed’s Crampton. “Many times these costs are hid-den or embedded into the cost of goods so there isn’t visibility into what an organization is actually paying in freight in shipping. By being transparent with these costs, they can be addressed on their own — outside of the cost of goods.”

Meanwhile, OMG’s Parrett pointed to pure market competitiveness as the culprit.

“Oversupply, better supply chain manage-ment and low fuel costs have made the market

so competitive over the last 18 months that ‘what’s in the box’ has no foothold in pric-ing negotiations,” he emphasized. “There are simply too many boxes chasing too few spaces. Negotiations for pricing have been based on weight or measure and what’s in the box. Everything was designed to bring maximum revenue to the carrier without regard for the customer.”

Smart Supply Chain leaders are moving more towards short-term contracts, or spot-rate hunting, according to Parrett. “Those that have been utilizing this strategy have been getting much better deals than those with long-term contracts,” he said. “Even those that are infrequent shippers can use today’s Internet-based technology to comparison shop among the many excellent regional and national shipping service providers.”

Parrett further noted that customers are becoming smarter — and more skeptical — about the notion of free delivery.

“If delivery is included in the price of the merchandise that you buy, it would be a good idea to have the shipment quoted with and without free delivery,” he said. “You can then price the shipping cost as a stand-alone transaction to see if you are overpaying for delivery. Suppliers may also be willing to share any in-bound or out-bound shipping discounts that they have negotiated with their shipping/freight companies. Utilizing the technology at your fingertips provides the single most devastating threat to pricing, sim-ply due to the fact that you are an informed customer and know your options.”

Concentrating on rates simply isn’t enough, according to OptiFreight’s Mullen, especially when you overlook the big picture.

“Everyone likes to focus on rates, but truly maximizing savings is all about the breadth of your freight management program,” he said. “A high discount looks great, but if only a portion of your suppliers actually participate, then your percent of ‘unmanaged’ freight will be high — and discounts don’t apply to your ‘unmanaged’ freight. You need to focus on managing your vendors or work with a freight management provider that can maximize vendor participation.”

Developments in fuel efficiency may shift some of the costs, The Audit Group’s Blau predicted.

“As vehicles — both consumer and commercial — are increasing their fuel efficiencies, less gas is being purchased, which means fuel-based highway taxes are decreasing,” he indicated. “As a result, many states are looking to increase their fuel surcharges in order to pay for neces-sary maintenance of bridges and roads. Ultimately, this increase in shipping costs will be passed on to the end-user.”

Look to labor, Ryder’s DiBernardi insisted.

“Trucking remains a labor-intensive in-dustry,” he said. “Trucks don’t go anywhere — and freight doesn’t move — without pro-fessional drivers, and they won’t stay in ser-vice without skilled maintenance technicians. Yet more and more companies are finding trucks idle and shipments delayed because of a shortage of drivers and technicians.

“It all comes down to supply and demand,” DiBernardi continued. “Experts predict that demand for commercial truck drivers will grow by 21 percent through 2020. But the supply of drivers is shrinking. The American Trucking Associations (ATA) estimates the trucking industry is short 40,000 professional drivers today, and the shortage is expected to grow to 330,000 by 2020. Ninety percent of transportation carriers report they cannot find enough drivers to meet their requirements. And tougher government safety regulations being put in place to help reduce accidents have already made the shortage worse. The core issue is that the number of drivers retiring or leaving the business is higher than the number of new drivers entering the profession. The median age of a professional driver today is 50 years old. Fewer than 11,500 people are trained to be drivers every year.”

TRIOSE’s Leatherman noted that healthcare organizations simply should improve inven-tory management processes to make a differ-ence, along with certain regulation changes.

“Typically, an overall increased focus on inventory management can allow transporta-tion costs to be lowered by bundling orders and by allowing the shipper to use a standard service level rather than an expedited, and more costly, service level,” he said. “Potential future changes to government regulations surrounding hours of service would lead to additional costs for extra trucks and extra drivers for the same shipments that needed less previously.”

Focusing on a metricWhile some may feel that freight and ship-ping represents a massive and monumental auditing task, industry experts and observ-ers acknowledge that starting with a spe-cific metric to benchmark third-party logistics company performance may be just what the dock ordered.

“Your freight management services pro-vider must be able to deliver competitive rates and drive down your cost per pack, but that’s not possible unless they have a comprehen-sive process or system to manage your vendor participation,” Mullen said. “You can have a low cost-per-pack and feel good about your freight management, but if your percent of freight outside of your program is increasing, so are your costs and the cost-per-pack is only part of the story. You’ve got to be looking at both metrics, cost-per-pack and unmanaged

Mitch Blau

Tracy Leatherman


JOB #:CLIENT:MEDIA:

LIVE:TRIM:

BLEED:PUBS:

NOTES:

CD: AD: CW: CM: AB: AP: PM: PR: DA: QC:

GustavoSsDanielPaMattDsMaryAnneKnKerstenVyHeatherPn TaylorBsCamilleJnJodyMnDarrylTt

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RYDER0002055RYDUSPrint Magazines7.5” x 10.25”8” x 10.75”8.25” x 11”Healthcare Purchasing NewsJuly 2016

INKS: Cyan, Magenta, Yellow, Black

FONTS:Helvetica Neue LT Std (107 Extra Black Condensed Oblique, 57 Condensed, 77 Bold Condensed, 55 Roman)IMAGES:GettyImages-597664361_F4-CMYK.tif (CMYK; 393 ppi; 76.18%), Ryder_CurveTab.eps (100%), RyderLogo_EverBetter_RedBlack_CMYK.eps (24.28%), Solutions Lockup - 8pt text.eps (103.52%)

SAVED: 6-14-2016 2:27 PM BY: Darryl Tait PRINTED AT: None

We were making caremore affordable long before there was an act requiring it.The demands on your supply chain are expanding as quickly as, well, healthcare. Which is why more businesses turn to Ryder than any other for improved uptimes, cost-savings, and end-to-end visibility. In fact, on average, we save clients 10 to 20% by driving efficiency in their supply chain. Discover how outsourcing with us can improve your supply chain performance at Ryder.com.

Ryder and the Ryder logo are registered trademarks of Ryder System, Inc. Copyright ©2016 Ryder System, Inc. Ever better is a trademark of Ryder System, Inc.

1607-Ryder.indd 51 6/15/2016 10:40:38 AM


PRoduCTs & sERviCEsfreight, and be sure your freight manage-ment provider is driving improvement in both areas.”

For DiBernardi, the “best-in-class” metric is as simple as the “perfect order” — on-time, in full, right condition/quality and at the right cost combined with “total cost to serve.”

Crampton emphasized the comprehensive. “We believe a logistics company should be measured for its quality, experience and ability to provide strategic value beyond just transportation itself,” he said. “We look at the logistics we handle, intra-company logistics, as a strategic asset that works as a means to help healthcare organizations achieve greater operational efficiencies, reduce risk, more ef-fectively utilize scale, eliminate redundancies and centralize services.”

Bonni Kaplan DeWoskin, MedSpeed’s Vice President, Marketing, and Crampton’s col-league, chimed in metaphorically that “freight doesn’t stop at the water’s edge — with the water’s edge being the bubble around the health system.”

Parrett urged Supply Chain pros to watch out for “accessorials as a percent of total freight,” cleverly billed to cover up sins.

“Many freight carriers will charge extra fees to help offset costs,” he said. “These can be extra fees for trailer detention/demurrage, re-delivery, fuel increases/surcharges and any other expenses or extra services. Often, these are extra costs incurred due to inefficient processes. The biggest difference between accessorials and surcharges, special service codes, and other fees that the major carriers charge is that, for the most part, they are as-sessed and applied post-shipment. You can plan and budget for surcharges to a certain degree, but accessorials, which are typically neither applied at the point of manifest nor included in regular invoices, can be extremely difficult to factor into your company’s logis-tics and supply chain budgets. For this reason and others, they can be a major thorn in your side when you have to answer for losses that are nearly impossible to pre-determine, dif-

ficult to uncover, and at the same time, very hard to ignore.”

Accessorials account for a major portion, (20 to 50 percent), of a carrier’s total annual revenue, according to Parrett. “Carriers have almost no incentive to reduce accessorials or provide detailed billing,” he noted. “As you continue to try and manage transportation costs, you’ll soon understand that most car-riers are using accessorials to make money. By performing thorough analyses of your company’s shipping history and character-istics internally or with the assistance of a qualified third-party logistics provider, it is possible, to see that your accessorials are discounted or waived entirely. By making it a priority to manage supply chain and logistics by optimizing processes, implementing cost-saving ideas, and creating solutions, you can combat the accessorials that may be causing you to go over your shipping budget or forc-ing you to cut corners that you don’t need or want to cut.”

Michelle Robbins, Vice President of Product Management, Life Sciences & Healthcare, DHL Supply Chain, advised Supply Chain pros to step back first and determine whether they have “true visibility” into their freight costs before moving forward.

“Having been a consul-tant for many years, this is where I believe the true struggle lies for many health systems,” she observed. “Typically freight is being charged or allocated to different general ledgers or strictly buried in the cost of product, inconsistent across departments or facilities. Does the health system have a strategy that details how freight is captured, charged or reported? The first step to a good benchmark is having true line of site to the process and total costs. Has the hospital/health system worked with finance and ac-counts payable to develop a process to ensure freight is captured and visible?

Marc Mullen, Vice President and General Manager of OptiFreight Logistics, a Cardinal Health company. Overt:• Inbound rates• Outbound shipping processes• Selecting the right mode of service (mode optimization)

For these methods, it’s all about making sure you’re shipping the right way. For example, with mode optimization you can determine how to ship packages fast-est at the lowest rate possible without impacting the delivery date. Why choose overnight service if a lower cost ground service will get your package there the next day as well?

Covert:• Supplier compliance• Purchase order instructions• Analytics/visibility to aggregate spend — then manage

These are all strategies that need to be implemented to ensure the long term success of your program:• Make sure all your suppliers are compliant with the program, so you can attain

a discounted rate on every shipment. • Reinforce this compliance by including instructions on every purchase order, every

time. To ensure suppliers use a third-party account number for every shipment, remind them on every purchase order you issue.

Overt, covert freight and shipping costs revealedHealthcare Purchasing News asked freight and shipping experts what they see as the most overt cost areas to watch and covert areas to find. Here’s what they shared.

“There are many statistics out there that range from the best freight cost based on spend or even bed count, but more importantly I think the best benchmark is against one’s self,” she continued. “Where are you starting from? Can you account for your freight and shipping cost by type, such as shipping costs — both inbound and outbound, distribution costs for med/surg and pharmacy, lab, food, radiol-ogy, etc., and other miscellaneous distribution costs? I also like to be able to see my overnight shipping cost overuse because it can point to other supply problems. Once you have your baseline, how are you performing? Is it consis-tent? Are you saving money? How much? If you’re reviewing your metrics on a regular basis you should be able to identify spikes, deviations from process and quickly adjust to account for or fix underlying problems.”

Robbins further noted that for those hospitals with a self-distribution platform an important metric to monitor would be “the perfect order,” which includes the percent of orders with on-time delivery, the percent of orders shipped complete, the percent of orders shipped damage-free, and the percent of orders sent with the correct documentation, including bills of lading, packing lists, and an accurate freight invoice based on the freight terms.

Leatherman cautioned against searching for a simple, single solution.

“I don’t believe any one single metric is most important,” he said. “They all have to work and be in line together. For example, it’s great if the health system can save money, but if the carrier is unreliable then Supply Chain gets a black eye. When looking at logistics compa-nies for freight and shipping services it is of paramount importance the depth of services and management the company provides is reviewed. A good logistics company should have an enterprise-wide view of health sys-tems logistics needs and build business plans to drive behaviors.” HPnVisit www.hpnonline.com/inside/2016-07/1607-PS-sidebars.html for “When freight hovers behind the 8-ball.”

Michelle Robbins

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PRoduCTs & sERviCEs• Finally, you can’t manage your freight unless you

have full visibility to what you’re spending. Analytics will help you gain access to a high level of transpar-ency that can help provide insights to inform better decisions in the future.

Tracy Leatherman, Vice President, Sales, TRIOSE Inc.Overt areas (readily apparent)• Prepay and add-freight expense. At a high level

this is a good indicator. If a health system’s volume of patients and services has not increased, but their vendors prepay and add shipping costs have increased dramatically, you should take a closer look at what could be driving those costs.

Covert areas (hidden)• Shipping that is bundled in the cost of the product.

Just because you can’t see it doesn’t mean it doesn’t exist.

• Priority Services charged prepay and add by your vendor. Most invoices with prepay and add-freight costs provide little-to-no information on the particu-lars of that shipment and how it was shipped. How do you know if priority and next-day air services are being overused if you can’t identify how frequently it happens? Reducing use of priority services levels can save upwards of 65 percent on a single shipment.

• Claims are another area where costs are not readily tracked by the health system. When packages are lost or damaged, who manages the process to

ensure that the claim paperwork is filed on time and ensures that claims get settled? Unless you have a third party managing this function, it is likely that the health system doesn’t know what costs are getting recouped versus the ones that aren’t.

Christopher DiBernardi, Director, Business & Product Development Healthcare, RyderThree of the most overt areas are on-time delivery, empty miles, and customer service levels. The most covert to find are driver turnover, missed deliveries and poor routes.

Michelle Robbins, Vice President of Product Management, Life Sciences & Healthcare, DHL Supply ChainOvert: When it comes to managing freight the overt areas I would watch are my distribution fees across modalities, such as am I bringing in a pharmaceutical through my med/surg channels and now are paying cost-plus instead of cost-minus, have I looked to pairing with a pure-play logistics carrier, the use of overnight and other specialty modes and lastly my internal processes to ensure I have line-of-site to my actual freight costs. All of these are ways the hospital can easily take charge and manage their freight spend and reduce costs.

Covert: The more covert areas are more difficult for a hospital to manage and take effort, processes

and sometimes systems to manage, and that’s why most health systems either accept them as they are and they often go unchanged. First, look outside of the typical Supply Chain scope, including engineering, food, marketing, etc. Next, look into the capital pur-chasing program as most health systems just accept the vendors shipping methods for large capital items when there could be large savings in challenging. Lastly, if I was using a transportation management company or distributor/wholesaler, learn whether you are matching your vendor contract shipping methods, mode and price or just accepting that these other companies are providing you best price. Additionally, look at hard at things like fuel surcharge for over the road, insurance per load — particularly important for high-value products — and less-than-truckload (LTL) rate components in combination, class, discount, and minimum charge.

Jake Crampton, Founder and CEO, MedSpeed LLCWe see the biggest underlying areas to watch as being hidden/embedded costs, over utilization of service (using more than is truly needed) and utility (not getting the most out of the transportation that is being used).

Visit www.hpnonline.com/inside/2016-07/1607-PS-sidebars.html for additional contributors.


1607-PS-Freight.indd 53 6/14/2016 2:36:07 PM


Worth repeating PEoPLE & oPinions

While physicians and surgeons al-ways carry their clinical and profes-sional intelligence and know-how,

they expect high-tech and standard devices and equipment to be accessible to them at all times.

This is where Supply Chain comes in and consistently delivers, hopefully satisfying those expectations.

Many times the process works smoothly; sometimes, less so.

To explore the ins and outs of this process, members of Vizient Inc.’s Large IDN Supply Network (LISN) conducted some extensive research on “Managing New Technology.” Their objective: To identify the critical com-ponents of the structures and processes for managing new medical technologies, identify key elements considered leading or innova-tive and share successes and challenges.

Vizient’s LISN includes Supply Chain executives from 21 of the group purchasing organization’s largest IDNs. Formed in 2004 under one of Vizient’s heritage GPOs, Nova-tion, LISN aims to share leading practices and data to help address IDN challenges, drive supply chain performance improve-ment across the industry and assist in the development of high-value, differentiating supply chain solutions.

Supply Chain executives from two LISN members — Mayo Clinic, Rochester, MN, and Novant Health, Winston-Salem, NC — agreed to share their insights on their technol-ogy evaluation and procurement structure and processes with Healthcare Purchasing News Senior Editor Rick Dana Barlow.

hpn: how do you see Supply Chain’s professional relationship changing with physicians and surgeons when it comes to technology horizon scanning and evaluat-ing “new” technology?Jim Francis, Division Chair, Supply Chain, Mayo Clinic: Over the last 10 years, we’ve seen the relationship with physicians become much more collaborative. Physi-cians used to simply want the latest technology because it was “new.” Now they want to have Supply Chain involved in the process much earlier to evaluate the necessity of that technology. This early in-volvement helps support the physicians and

Supply Chain, physicians bond around new technologyby Rick Dana Barlow

ensure that purchasing decisions are on track organizationally and clinically.

Mark Welch, Senior Vice president, Supply Chain, novant health: Our CEO instituted the practice of including physicians in lead-ership and decision-making across the organization —

not just supply chain. When we have a business issue, the physicians are included from the beginning and this helps us achieve results quickly. We certainly see this new, more collaborative relationship with physicians in the Supply Chain department. Historically, physicians would request new technology and then simply expect Supply Chain to bring it in. Today, we have formed a true partnership with physicians that allow us to collaboratively vet new products and make strategic decisions that ultimately benefit patients. Physicians are now deeply embedded in our supply chain processes — they have a seat at the table. To-gether, we look at how the new technologies can benefit clinicians and patients, while also lowering costs for the organization.

What benefits can Supply Chain gain by working so closely with physicians and surgeons to identify and evaluate new technology?FranCiS: In short, Supply Chain will benefit by buying fewer things that do not work out operationally or clinically. Often in the past when new products came to market, Supply Chain would buy immediately — usually due to physician/clinician request — but then quickly realize just because it was “new,” it was not the best for the patient. Now, in contrast, we first ask the physician what the business need is before buying new technologies. What does the physician need the technology to do to enhance patient care? What technology at-tributes are important? Then Supply Chain can compare those desired features with “new” technology to see if clinical needs will be met before making any purchases. We no longer act in isolation, but in concert.

alisha hutchens, Senior Director, Supply Chain administration, novant health: Supply Chain ben-efits by learning how physi-cians differentiate products and technology, how a prod-

“in my opinion, a physician’s skills are intrinsic. i always told hospitals that i can use any product to get the same outcome — most of the time — because what if someday i moved to another hospital or another country where those products were unavailable? Being stuck on one brand makes you a less capable surgeon, again in my humble opinion.”

Jimmy Chung, MD, FACS, CHCQM, Director, Medical Products Analysis, Providence Health

& Services, Seattle

“i have heard stories that some aSCs believe that aaMi St79, the standard for best practices in sterile processing, may not be applicable to them, as they are different from acute-care facilities; nothing could be further from reality. every facility, including aSCs, that reprocesses instruments, should own and follow St79.”

John Nies, Product Manager, Belimed Inc.,

“the biggest obstacle to ppe compli-ance is attitude; healthcare workers have this idea that they’re bulletproof. Doing compliance rounds on the pa-tients on isolation and watching to see if people are using ppe appropriately have helped to shift attitudes and im-prove practices.”

Laura Buford, RN, BSN, CIC, APIC Communi-cations Committee Chair; Infection Preven-

tionist/Employee Health Nurse, Lakeway Regional Medical Center

“each day when i interact with or staf f, i am dealing with certified, educated individuals who know his/her given field. i can more effectively gain their trust and respect — and i can more effectively meet their needs and answer questions — when i am also a certified, educated expert in my own field.”

Joel Benge, CRCST, CIS, CHL, OR Liaison for Sterile Processing, Jewish Hospital & St.

Mary’s HealthCare, Louisville, Ky

“While these prices have declined, there is still a lot of concern for their volatility. For one thing, fuel prices are beginning to rise again. there is also an increasing cost to operate — from driver and warehouse worker salaries to the manufacturing of goods. So a decrease in the price of fuel is just one variable in the equation.”

Christopher DiBernardi, Director, Business & Product Development, Healthcare, Ryder

1607-PO-Vizient.indd 54 6/14/2016 3:20:42 PM


PEoPLE & oPinionsuct impacts current patient populations or how new technologies could open up new service opportunities. Partnering with physicians and working collaboratively helps appropri-ately address any issues or questions related to products or services. They support Supply Chain and help us get things done. We can go straight to the physicians to understand what works well and what needs to be improved. They are our valued partners of Supply Chain.

Conversely, what benefits can physicians and surgeons gain by working with Supply Chain to identify and evaluate new technology?Terri Nelson, Director, Val-ue Analysis, Mayo Clinic: Physicians are realizing that “expense management” is not a bad thing. Rather, physicians are considering financial impact as part of the care equation. As healthcare organizations feel more financial pressures and weather lowered reimbursement, we can collectively choose not the cheapest products, but rather the most ef-fective products. Physicians work with supply chain to look at value analysis, technology at-tributes and patient outcomes to find the most clinically effective and cost-efficient options. Now physicians enjoy a productive relation-ship with Supply Chain, where both parties work together early to find positive solutions. Physicians now feel they are being heard.

HUTCHENS: Physicians now see and un-derstand the critical information that Supply Chain can provide that a sales rep doesn’t give them. We give them third-party clinical per-spectives, financial analysis, price benchmarks and other insights that they otherwise wouldn’t have. Another benefit comes in the area of bud-geting for new technology. We track changes related to new technology to understand the ROI and demonstrate how a new technology is improving care and lowering costs.

Theoretically, physicians and surgeons want the “best” products to provide the highest quality care while Supply Chain also wants care delivered cost-ef fectively. Why the disconnect and how might it be eliminated?NELSON: Supply Chain now brings evidence-based purchasing to the table. Value Analysis departments can synthesize literature to look at evidence and outcomes, and Supply Chain can now more closely speak the same language as physicians and clinicians as a result. We’ve heard of other facilities that just hire value anal-ysis staff, but do not put the proper processes in place to help that value analysis staff interact with supply chain or physicians. Without those processes in place, it’s just another headcount.

WELCH: In the past — and in some organiza-tions still today — physicians would request new technology and supply chain would

immediately say no because they were only looking at the cost of the product, rather than also considering clinical data, reimbursements, analytics, etc. If the decision is always just about cost then there will always be a disconnect. We have eliminated that disconnect by col-laboratively looking at the clinical and financial landscape when vetting new technology. In some cases, new technology, while it may cost more, improves patient outcomes and lowers overall costs. In other cases, new technology provides no incremental benefits. So decisions should be thoroughly reviewed from different angles by both physicians and Supply Chain working in tandem.Additionally, we follow up with physicians to understand how the product is performing. If it is not performing or delivering the value expected then we will take it out of the system. The goal is always to benefit patients and that result comes from collaboration.

What impresses a physician or surgeon the most about working with Supply Chain?NELSON: In our experience, it has been the leadership. Because of the collegial relation-ship between our Supply Chain leaders and the physician liaison who works with Supply Chain, Supply Chain is very well respected among the physicians and clinical staff at our organization. Supply Chain has also built re-lationships with the different practice chairs, and this has led to an environment of mutual respect and trust.

WELCH: The data and insights we can pro-vide on products — they really appreciate the transparency and it builds a high level of trust between the two groups. We have also found that they appreciate it when Supply Chain reaches out to them directly with a problem or a question about the products they are us-ing. In the past we assumed they would be too busy. However we’ve found they appreciate and enjoy the direct contact. They also enjoy that Supply Chain can now provide data that includes clinical findings and outcomes. And they appreciate when we provide transparent timelines.

Conversely, what ticks them off?FRANCIS: The thing that will irritate our physi-cians the most is when they are not included in a purchasing decision. We never want a physician to hear about a decision after it’s been made. We want them to participate in the evaluation process. Physicians want to be fully engaged from the beginning so they have a complete understanding, can help implement new technologies and get their colleagues on board.

HUTCHENS: They are frustrated when they do not have a seat at the table or when they do not understand how product decisions are made. They also are frustrated if they feel Sup-

ply Chain has not taken the time to understand the patient population they are serving. It’s critical that Supply Chain take the time to un-derstand their perspectives and clinical needs. Bottom line, Supply Chain has to remember that physicians have the responsibility for providing care to the patient so they should have a voice in product decisions.

How might the concept of value analysis/management bridge any gaps between Supply Chain and physicians and surgeons?FRANCIS: Value analysis is absolutely a step in the process. Once that step occurs, questions the physicians may have had are now off the table. It’s important to keep the process consis-tent and rely on data findings.

NELSON: Value analysis also helps Supply Chain stay consistent in its decisions. One of the worst things Supply Chain can do is im-mediately switch products after a decision is made when a physician complains. This under-mines the process. Instead Supply Chain is best served to engage value analysis when a physi-cian complains so everyone can understand the process and the rationale for the decision. Everyone may decide a change is necessary, but that decision should be deliberate and thoughtful. Ultimately, our collective goal is optimal patient care and outcomes.

WELCH: Everyone handles this differently. We’ve found it invaluable to have clinicians embedded in our supply chain supporting our value analysis process. They assist with translating product features/benefits between clinicians and Supply Chain to help ensure communications are clear and consistent. When we have challenges with conversions or clinical applications of new products, they im-mediately speak directly with our physicians and clinicians to fully understand and address the issues. Finally, they are critical to successful new product conversions and implementa-tions. We could not be as successful without our value analysis colleagues.

Where does the emerging “repless” model for “physician-preference items” and new technology fit into the developing relation-ship between Supply Chain and physicians and surgeons?NELSON: I think the real question here is why is the supplier missing from this equation? Suppliers must also work in collaboration with Supply Chain and physicians. If all stakehold-ers can engage in the product development and marketing — moving sales out of the way — then we can support common goals of patient care. But all stakeholders must come together to build a relationship.

HUTCHENS: The short answer is it is the wave of the future. We aren’t there yet, but I believe we will get there within the next two-to-five years. HPn

1607-PO-Vizient.indd 55 6/14/2016 3:20:43 PM


STANDARD PRACTICES

The human side of UDIby Karen Conway, Executive Director, Industry Relations, GHX

SUBMIT YOUR QUESTIONSemail: [email protected]: (941) 927-9345 ext. 202

As the Food and Drug Administration (FDA) rolls out its Unique Device Identification rule that requires

manufacturers to assign and label their prod-ucts with unique device identifi ers (UDIs), the complexities of the regulatory landscape and the variation in processes across the healthcare delivery system continue to be illuminated.

Take human cells, tissues and cellular and tissue-based products, better known as HCT/P, as an example. These include a wide range of tissue and cellular products including arteries and veins, bone grafts, heart valves, cornea, skin and tendons. The production and distribution of these prod-ucts are regulated by the FDA Center for Biologics Evaluation and Research (CBER), one of six main centers within the FDA, but separate from the Center for Devices and Radiological Health (CDRH), which is responsible for the UDI rule. However, a few HCT/P, such as tendons with sutures attached, demineralized bone products combined with certain handling agents and femoral veins intended as A/V shunts, are considered medical devices and therefore covered by the UDI rule. The use of these products falls under the jurisdiction of The Joint Commission, which requires health-care organizations to create standardized processes around the acquisition, receipt, storage and issuance of these products. The Joint Commission also requires that systems document the use of HCT/P in a recipient’s medical record; if the HCT/P is considered a medical device, that documentation must use the UDI. Also, while individual health-care delivery organizations might have standardized processes, there is signifi cant variation among facilities, even within the same parent system.

The 2015 Edition Health Information Technology Certifi cation Criterial Final rule also requires that the UDIs for implantable devices — including those for implanted HCT/P that are considered medical devices — be represented with a UDI in a patient’s electronic health record (EHR), and the UDI must be able to be parsed into the device identifi er (DI) and the production identi-fi er (PI). For most medical devices, the PI includes the lot, batch or serial number

and the expiration date — whatever the manufacturer uses to control production of the product. For HCT/P, the production identifi er must also include a distinct iden-tifi cation code (DIC) that can be traced back to the donor. ICCBBA, one of UDI issuing agencies authorized by the FDA and special-izing in HCT/P, has a dedicated production identifi er for the DIC, known as the Donor Identifi cation Number, which is embedded in the ISBT 128 (ICCBBA’s UDI compliant code). A single Donor Identifi cation Num-ber can be used to identify all of the tissue products prepared from a particular donor by a specifi ed tissue processor. The only time there is a different PI for tissue from the same donor is when that tissue is processed by a different tissue bank.

Despite safety precautions, tissues have been implanted into recipients, only later to have it discovered that the donor had an infection that can be transmitted through transplantation. The ISBT 128 is designed to rapidly identify affected HCT/P by minimiz-ing the numbers associated with tissue from the same donor. In the event of a recall, a single Donor Identifi cation Number can be used to fi nd all of the impacted tissue from that donor that was processed by a specifi c tissue bank. Without the Donor Identifi ca-tion Number, every piece of tissue has a different lot and/or serial number, even if it came from the same donor, greatly increas-ing the complexity of recall management.

In 2011, when it was discovered that tissue donated by a man infected with hepatitis C virus (HCV), it took a month for the tissue processor to notify all of the surgeons who had implanted some of the infected donor’s tissues into their patients. Because data on the surgeons was not uniformly available, tissue from the infected donor continued to be used after the infection was first discovered. This is another consequence of lack of standardization: When different facilities or individual clinicians manage HCT/P differently, it becomes more dif-

fi cult to take effective action quickly. And when tissue products are handled manu-ally, it is very diffi cult to distinguish the DIC. Electronic systems, on the other hand, can be programmed to recognize the Donor Identifi cation Number in the ISBT 128 code.

Further complicating things are the multiple regulatory agencies and evolving requirements, e.g., UDI, and variation as to which departments or functions within healthcare delivery organizations have re-sponsibility for HCT/P. Sometimes it is the blood bank, other times the OR or materials management. Hospitals and other healthcare providers are facing increasing regulatory requirements, from multiple agencies.

Once again, I believe the UDI rule, while aimed at manufacturers, creates an oppor-tunity to break down some of the silos that exist in the provider environment. Who has responsibility for HCT/P in your hospital? Who will be responsible for ensuring UDIs are captured in EHRs for implantable de-vices? Have you begun considering how you will use UDIs to better manage supply chain and revenue cycle processes? Are your IT systems capable of handling UDIs or are you still managing implantable devices and HCT/P manually? Are you collaborating with different departments and clinicians to solve for new regulatory, technology and process challenges, or are you problem solv-ing in silos? Please share your challenges and solutions, even if they are works in progress. We are all in this together and can learn from one another. HPN

As the Executive Director, Industry Relations at GHX, Karen Conway works with industry associations, standards bodies, government agen-cies, analyst fi rms, academic institutions and the media to identify opportunities for hospitals and suppliers to optimize supply chain operations and improve business and clinical performance. Conway is chair-elect of the board of directors of AHRMM, the supply chain organization for the American Hospital Association. Conway is cur-rently writing a book on the Accountable Health-care Leader, drawing upon the concepts developed in her 2013 global leadership book, Leading from the Edge, which she co-authored with the former chief talent offi cer of Cisco. Conway serves on the editorial board of Healthcare Purchasing News.

1607-Standard Practices.indd 56 6/8/2016 11:19:01 AM


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HAVING MY SAY HAVING MY SAY

ADVERTISER INDEX

The perfect purchased services programLast of a multi-part seriesby Fred W. Crans

Years ago, a famous Chicago-based troubadour named Steve Goodman wrote a satirical number co-penned

with John Prine, titled, “You Never Even Called Me By My Name.” The song was re-corded and made famous by Outlaw singer David Allan Coe, who called it, “The Perfect Country and Western Song” after it was modi-fi ed to include every element necessary for a country song to be great:• Momma• Trains• Trucks• Prison• Getting Drunk

With that in mind, let’s outline the elements of The Perfect Purchased Services Program. They are:• Organizational support and oversight• A core team• Resource allocation• Project management templates and method-

ologies• Results measurement and reporting

Using the Food and Nutritional Services (FNS) example from my previous article as a starting point, let’s see how these elements come together.

Organizational supportIn the FNS example, the CFO chose to attack the overall operating costs of the department, not simply a re-negotiation of the existing model and the existing agreement. Such a decision, if not managed correctly, is guaran-teed to cause discord, if not open revolt in the workplace. Therefore, the development of a comprehensive Purchased Services Program needs to be seen as a strategic operational plan whose genesis is in the C-suite, as opposed to being the idea of a Supply Chain Leader with aspirations of grandeur.

What the program will look like and how it will work must be carefully planned and clearly articulated, preferably by the CEO, to the entire management team. People must be educated, informed and brought on board be-fore a single initiative is begun. This means that all the communicative tools of the organization need to be employed to guarantee success.

The core teamOnce implemented, the management of Purchased Services will become an ongoing element of the organization’s operational strategy. This is unlike the “World Famous

10 Percent Solution,” where a fast-talking consultant is brought in to take costs quickly out of the system and chooses a methodology that brings every supplier into a meeting room in the administrative offi ces (to impress them with the gravity of the situation), and then demands an immediate 10 percent reduction in prices, and expects to get those reductions because, “We are XYZ IDN and if they (the suppliers) don’t comply, we will take our business elsewhere.”

The stupidity of such an approach was driven home to me a few years ago by Brent Johnson, then the Supply Chain Leader at In-termountain Healthcare. Johnson is known for being one of the most infl uential supply chain voices in the industry. He led an organization with tremendous purchasing power, yet he said (and I paraphrase), “I think I’m a big guy with lots of infl uence, but I realize that when it comes to someone like J&J, my demand is just a rounding error.” This is coming from one of the most infl uential people around, and yet every IDN with 500 or more beds thinks they can move the market all by themselves. That, my friends, is the height of arrogance and stupidity.

The effective way of approaching the issue is by naming a core team, headed by a senior member of leadership to develop and imple-ment the Purchased Services strategy. That core team should have both permanent and rotating members — the permanent ones to include representation from Finance, Supply Chain, Legal Services and the C-Suite, with rotating members selected to serve rotating terms and ad hoc representatives as needed. The core team should be charged with devel-oping a short-term process implementation strategy as well as a long-term functional one.

Allocation of necessary resourcesGetting a successful Purchased Services Pro-gram started is not as simple as buying some software or purchasing a subscription service from a third party and appointing Joe the former buyer to “go get ‘em.” It requires an allocation of resources in both the short and long term, and requires a continuation of that allocation going forward. Here are some things for which you will need to provide funds:• Centralization of all contracts in a single

repository. Before services can be success-fully managed, the contracts related to those services need to be aggregated and managed under a single auspice at a single site. How

this will be done and by whom becomes one of the fi rst problems to be solved. Most likely, this will require the purchase and implementation of contract management software if none is currently present, or at the very least, a comprehensive effort to ensure that all contracts reside in one place.

• The use of a third-party purchased services database. No one has the wherewithal to compile the necessary data to compare exist-ing practices to best practices. A single IDN, no matter how many entities reside under its roof, is just that — a single IDN. Its data is limited to itself. Perspective requires more than a single data point, and there are several purveyors in the market place, including the GPOs, that can provide an organization with effective and credible information to help that organization optimize the opportuni-ties in the Purchased Services space. Most of these organizations operate through the sales of an annual subscription.

• Bodies — short term and long term. The single biggest mistake organizations make when approaching the Purchased Services opportunity is by taking the “Penny Wise and Pound Foolish” approach and buy-ing a third-party tool, then assigning the category “Purchased Services” to a current employee to “run.” It isn’t that simple. Managing Purchased Services requires special skill sets. The necessary skills can range from simple contract re-negotiation or bidding to complex project management skills as in the Food and Nutritional Services example. People with those skill sets don’t grow on trees and they are very unlikely to be masquerading as buyers or contract specialists. You are going to have to spend money in the long term and the short term to build a successful program. The short term costs will probably include the use of a consultant with project management skills and a knowledge of the third-party tools to be engaged for a specifi c period to set up the program, implement the tools from the third-party provider, interview, hire and train the ongoing Purchased Services leader and turn the program over at the end of the engagement.

• Development and continued use of proj-ect management templates: As with any successful program the success of the Purchased Services program is dependent on its replicability. In order to ensure rep-licability, consistency of practice must be

1607-HMS-Fred.indd 58 6/14/2016 3:37:21 PM

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Having my Say

advertiSer indeX

implemented. That can be obtained by the purchase and use of good project manage-ment software tools.

Results measurement and reportingAn add-on to most project management tools is a “Results Reporting” module. Results must be reported to senior leadership on a regular basis.

Before he sings the last verse of “You Never Even Called Me By My Name,” David Al-lan Coe says, “My friend, Steve Goodman, wrote this song. He told me it was the perfect country and western song. I wrote him back and told him it was not the perfect country and western song because he hadn’t said anything at all about momma, or trains, or trucks or prisons or getting drunk. Well, he wrote another verse and after reading it I re-alized that my friend had written the perfect country and western song and I felt obliged

to include it on my next album. The last verse goes like this here: ‘Well, I was drunk the day my mom got out of prison, and I went to pick her up in the rain. But before I could get to the station in my pick-up truck, she got run over by a damned old train.…’”

In that vein, once you get organizational commitment, bring together a core team, se-cure the resources you need, implement proj-ect management methodologies and measure your results, you will succeed beyond your wildest dreams and just may create, develop and manage the perfect purchased services program. HPn

Fred W. Crans is is a veteran supply chain con-sultant, the co-founder of Consilium Healthcare Management Services and a frequent contributor to Healthcare Purchasing News. Crans has spent the last decade specializing in evidence-based decision-making methodologies. He can be reached at [email protected].

Advertiser Page RS# Web

3M ...............................................9 11 www.3m.com/ivcareAcute Care Pharmaceuticals ..........23 1 www.pharma-choice.comAHRMM .......................................33 31 www.ahrmm16.org/collaborationAnsell Professional Healthcare .......19 22 www.ansell.com/powderfreeBD Genesis ...................................27 24 www.bd.com/GenesisLowTempBelimed ........................................39 12 www.belimed.comBoston Scientific ........................... IBC 4 www.bostonscientific.com/gastroservices/hcpnCardinal Health .............................20 26 www.cardinalhealth.com/wehaveyoucoveredCardinal Health .............................31 19 www.cardinalhealth.comCardinal Health .............................49 20 www.cardinalhealth.com/largefreightConstruction Specialties ................7 27 www.c-sgroup.comContec Inc. ...................................32 3 www.contechealthcare.comCS Medical ...................................35 13 www.csmedicalllc.comDale Medical Products Inc. ............BC 21 www.dalemed.comDetecto.........................................15 28 www.detecto.comHealthmark Industries ...................37 6 www.hmark.comHealthTrust Purchasing Group .......17 5 www.healthtrustpg.comIMS ...............................................41 41 www.imsteris.comKey Surgical ..................................25 14 www.keysurgical.comMolnlycke Health Care ..................21 33 www.molnlycke.usMolnlycke Health Care ..................21 37 www.hibiclens.comPDI ...............................................29 35 www.pdihc.com/prevanticsdevicestripPegasus Medical ...........................16 10 www.pegasusmedical.netPure Processing .............................13 30 www.pure-processing.com/video/Ruhof Corporation ........................1 8 www.ruhof.comRuhof Corporation ........................ IFC 7 www.ruhof.comRyder System Inc. .........................51 16 www.ryder.comSage Products ...............................30 32 www.sageproducts.comSherwin-Williams ..........................5 17 www.swpaintshield.comTRIOSE..........................................53 36 www.triose.com/thenewlogisticsTronex Healthcare Industries .........22 9 www.tronexcompany.comTru-D .............................................3 38 www.tru-d.comVizient ..........................................11 29 www.vizientinc.com

1607-HMS-Fred.indd 59 6/14/2016 4:52:54 PM


BACK TALKTaking stock of capital acquisition proceduresby David S. Kaczmarek

In some organizations hundreds of mil-lions of dollars can be spent on capital acquisitions each year. Because it does

not affect the expense budget, the process for allocating the funds, releasing the funds, and making the purchase is very different from the normal expense process.

While the budget process is theoretically fairly simple — users identify what they want/need, a group of executives determine what on the list can be purchased with the available funds, and the purchases are made — in practice, it becomes very complex and fraught with problems. Among these are:• Decisions are often made without having

all the facts.• Funds are reserved based on inaccurate

cost projections.• Decisions are unduly affected by politically

infl uential physicians or executive leaders.• Some departmental wants are purchased

instead of other true needs.• Equipment replacement is not approached

from a long-term perspective.• Replaced equipment gathers dust in a

closet or storeroom.Ultimately all these problems result in poor

decisions and wasted money.Best-practice organizations have capital

budget and acquisition processes that are fair and comprehensive. They include a forecasting process, a submission process that gathers all the information needed for a reasoned decision, a budget selection process that assures capital funds are used in the best way, and a procurement process that ensures that the maximum value is generated from the purchase.

ForecastingI am continuously surprised by the number of organizations I fi nd that do not maintain a three- or fi ve-year capital projection. This is a relatively easy document to compile. The organization will have a list of capital equipment as part of its asset management program. The list is normally sortable based on department and will have the acquisi-tion date of the equipment. Annually each department gets a copy of their list and then updates the estimates for the life of each piece of equipment using normal asset deprecia-tion tables and professional judgment. This would include such factors as the service

history of the item, actual usage, potential functional obsolescence, etc. This list then becomes part of the justifi cation in the bud-geting process.

Budget processThe formal part of the capital budgeting process starts with the budget request. A well-composed request includes all the in-formation needed to accurately measure the immediate and long-term cost of the equip-ment as well as the other information needed by the selection group to make an informed decision. In particular, it should include:• Total estimated procurement and instal-

lation cost. This should be a reasonably accurate estimate of the cost for the equip-ment, not list price or even a budget quote from a supplier. Procurement should help with this. The estimate should include all ancillary costs like delivery, installation, facilities changes like plumbing, systems customization, etc.

• Sign-off by purchasing, facilities, biomed, and/or IT that they agree with the cost projections. They would also comment on any other concerns such as systems com-patibility.

• Estimated operating costs. This should include service, additional costs of dispos-ables, and additional cost of labor.

• Projections of any new revenue.• Any costs that would be eliminated if the

equipment were purchased.• A detailed justifi cation. This often will in-

clude a business case for the acquisition. As applicable, all aspects should be covered including things such as safety, patient satisfaction, increased revenue, planned replacement schedule, ability to attract new physicians, etc.

• For replacement equipment, what will be done with the existing equipment.Finalized requests then go through an ap-

proval process. Fully approved requests end up with the selection group. This would typi-cally consist of senior executives, key physi-cians, and Supply Chain. The group would review the requests, prioritize them, and select those high-priority submissions that can be purchased with the allocated capital funds. This list goes to Finance, which will create a tentative month-by-month acquisi-tion schedule.

Procurement processFor budgeted capital the process should be:• Upon publication of the approved capital

list, Supply Chain will contact all managers who have capital items approved to discuss procurement procedures. They will make a preliminary decision as to the method of procurement (e.g., bid, RFP, negotiation, combination), competition, when to start the process and who will be on the negotia-tion team.

• Department managers will re-initiate capital requests far enough in advance of the planned acquisition month so that suffi cient time is provided to source, bid, and/or negotiate. These will go through Finance, which will confi rm the availability of the funds.

• Any signifi cant changes to the request must be re-approved.

• Procurement works closely with the re-questor to complete the acquisition.

• Any savings from the budgeted cost will be returned to the capital fund for use on other requests that were not approved due to lack of funds.The process for unbudgeted capital is

essentially the same except that the re-questing department will complete the normal capital request form and obtain all approvals. There will not be a preliminary plan in these cases.

New and emerging technology would not normally be part of this process. This requires a very different and more involved approval process and is a best practice in itself (see “Getting a handle on technology,” Healthcare Purchasing News, May 2006). Organizations that commonly consider the purchase of new technologies often have funds set aside for this purpose.

A great process does not guarantee con-stant success. But best practice organizations fi nd that their capital dollars go farther and that their requesters are more satisfi ed that the process is equitable. HPN

David S. Kaczmarek, FAHRMM, CMRP, is a se-nior director at Chicago-based Huron Healthcare. Kaczmarek has more than 40 years of experience in healthcare administration and supply chain, including director positions at several hospitals and systems. He can be reached via email at [email protected].

1607-BackTalk-DK.indd 60 6/8/2016 11:18:10 AM

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