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Section onSection onSection onAnesthesiologyAnesthesiologyAnesthesiology& Pain Medicine& Pain Medicine& Pain MedicineNEWSLETTER Winter 2012

www.aap.org/sections/anes

EXECUTIVE COMMITTEE ROSTER

Carolyn F. Bannister, MDChairpersonStone Mountain, GA

Joseph D. Tobias, MD

Chairperson-ElectColumbus, OH

Corrie T. M. Anderson, MDNewsletter EditorSeattle, WA

Kenneth R. Goldschneider, MDCincinnati, OH

Jeffrey L. Koh, MDLake Oswego, OR

David M. Polaner, MDAurora, CO

Constance S. Houck, MDImmediate Past Chairperson

Boston, MA

LIAISONS/REPRESENTATIVES

Mark A. Singleton, MDLiaison, ASA Committee on Pediatrics

Jeffrey L. Galinkin, MDLiaison, AAP Committee on Drugs

STAFF

Jennifer Riefe, MEdSection Manager

[email protected]

Happy New Year, everyone! As I begin the role of chair of ourSection, I first must thank those who have helped guide and

mentor me in preparation for this position. Connie Houck hasbeen and continues to be a wonderful friend, an inspiration anda tireless leader. Tom Mancuso and Joe Cravero also havebeen great chairpersons and friends. Jen Riefe, our Sectionmanager, keeps the Section organized and helps me stay ontask and on time for deadlines. We congratulate Jen on the arrival of her new babygirl, and we will welcome her return from maternity leave! I also want to thank thecurrent members of the Executive Committee of our Section who dedicate their timeto serve the Section and its mission. David Polaner and Jeff Koh will rotate off theExecutive Committee as of November 1; we are grateful for their many years ofservice.

I am going to keep my article brief as the newsletter is full of important material. I willguide you to a few important issues that need attention as we head into the AAP/SPAwinter educational meeting.

This year we will continue to focus on the membership pilot that was launched inAugust 2010. We still strive to achieve 558 Specialty fellows in order for all to enjoy a50% reduction in our dues for the next year and beyond as long as we maintain thetarget membership level. We have added 86 new members since the program beganand currently have 365 active members.

From the Education subcommittee: Dr Joe Tobias has assumed the chair position.Please refer to separate articles in the newsletter that address AAP-sponsored eventsat the upcoming AAP/SPA winter meeting in Tampa. Also take note of the announce-ment of the winners of the resident research abstracts and the winner of the 2012Robert M. Smith Award to be presented at the winter meeting.

Chairperson's ReportCarolyn F. Bannister, MD, FAAP

Continued on Page 2

Chairperson's Report 1

Upcoming Meetings, Conferences & Workshops 2

New! SOA Speaker's Bureau 3

Call for Robert M. Smith Award Nominees 3

First Ever Surgical Plenary in 2012 4

Welcome New Members 4

AAP-Sponsored Events & Awards at the 2012 WinterMeeting 5

SOA 2012 Elections Coming in March 7

2011 NCE "Robotic Surgery" Plenary Report 7

The Next Frontier in Patient Safety Effective Useof Checklists 8

Committee on Drugs Report 13

The Subspecialist and Maintenance of Certification 14

How Drug Shortages Are Affecting Pediatrics 15

Robert M. Smith Award Nomination Form 17

In This Issue


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Nominations are currently being accepted for the 2013 RobertM. Smith award (see announcement on page 3).

The SOA also continues to work with SPA and COPA (theASA Committee on Pediatric Anesthesia) to develop educa-

tional resources for families on websites and in hard copyform. The AAP website is HealthyChildren.org. Dr Houckhas volunteered to work with the SPA CommunicationsCommittee and Dr Dean Kurth on this initiative. Dr Houckalso is responsible for planning the anesthesia content for thefirst-ever Surgical Plenary Session at the AAP NationalConference and Exhibition in New Orleans October 20, 2012.The topic is anesthetic neurotoxicity and the faculty for thesession are Drs. Randy Flick and Sol Soriano. See page 4for more details.

The Section will work with the Board-appointed Vision ofPediatrics 2020 Task Force as the group tries to identifytrends that will significantly influence the future of pediatrics.

The Board has asked all sections and committees to spendtime discussing several key megatrends and share how it isfelt the AAP can be prepared to advocate for children in thefuture. The SOA felt that creating the surgical home of thefuture is an area in which we have expertise and will beinvolved in the implementation of such. Also as we havebeen specifically asked by the FDA to educate and provideinformation on neurotoxicity of anesthetics and sedativeagents in children, we will be called upon to educate ourcolleagues, patients, families and the public about this veryimportant issue.

Another valuable means of educating our colleagues andpatients is participation in the newly evolving SOA Speakers

Bureau. Please see the announcement in this newsletter andconsider submitting your name and topic to be listed with the

AAP for those who are planning meetings and are seekingexpert speakers.

Section members and the executive committee will also bereviewing section-specific policy statements for updates andrevisions and will be submitting an article for the August 2012

AAP News in the Focus on Subspecialties section. Thisarticle will focus on the Wake Up Safe initiative and thePediatric Regional Anesthesia Network (PRAN).

Please take note of the upcoming election for open positionson the SOA executive committee and go online to vote for

candidates. See page 7 for photos and information about thecandidates. CVs will be made available with the ballot. We arealways eager to recruit individuals who are interested in servingon the executive committee or section task forces. Please emailDr Bannister at [email protected] if you wish to be aparticipant. I look forward to a productive year!

Carolyn Bannister, MDChair, Section on Anesthesiology and Pain Medicine

Chair's Report (continued from Page 1)

CallingfornewsletterarticlesforournextSOAnewsletter,

Upcoming Meetings, Conferences andWorkshops

SAMBA 26th Annual MeetingMay 3-May 6, 2012Loews Miami Beach Hotel, Miami, FL

http://www.sambahq.org/index.php?src=gendocs&ref=Meetings&category=Professional

Society for Pediatric Sedation Conference 2012May 22-24, 2012Wyndham Cleveland at Playhouse Square, Cleveland, Ohiohttp://www.pedsedation.org/sections/meetings/

5th Annual Pediatric Anesthesiology and Critical CareSponsored by Harvard Medical School and ChildrensHospital BostonMay 23-25, 2012The Fairmont Copley Plaza Hotel, Boston, Massachusettshttp://www.cme.hms.harvard.edu/index.asp?SECTION=CLASSES&ID=00322645&SO=N

6th Annual Pediatric Anesthesia ReviewSeptember 24-27, 2012The Boston Plaza Park Hotel and Towers, Boston, MAhttp://www.nwas.com/boston/12sbst.html

International Assembly of Pediatric AnesthesiaOctober 10-12, 2012Marriott Wardman Park Hotel, Washington, DChttp://www.internationalassembly2012.org/

ANESTHESIOLOGY 2012 American Society ofAnesthesiologists Annual MeetingOctober 13-17, 2012Washington, DChttp://www.asahq.org/Annual-Meeting.aspx

American Academy of Pediatrics National Conferenceand Exhibition (NCE)October 20-23, 2012New Orleans, Louisianahttp://www.aapexperience.org/

SOA NewsletterWinter 2012 Page 2

Corrie AndersonNewsletter Editor

[email protected]

theFalledition!Pleasesendproposals

byJune4,2012toCorrieAnderson

at


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Call for Ideas, Suggestions

and Volunteers toCommemorate the SOAs

50th Anniversary

The AAP Section on Anesthesiologyand Pain Medicine was first formed in1965, which means we will be com-memorating our Golden anniversary in2015.

Wed like to find ways to celebrate themany accomplishments of our Sectionand the many people who have shapedour Section over the last 50 years.

Also, let us know if youd like to be partof our 50th anniversary subcommittee!

Please send your thoughts and sugges-tions to Constance Houck, ImmediatePast Chairperson, at

[email protected].

Call for Robert M. Smith Award Nominees

As you know, each year at the SPA/AAP Winter Meeting, the Robert M. SmithAward is given to recognize an individual who has made outstanding contributionsto the field of pediatric anesthesiology. The AAP Section on Anesthesiology andPain Medicine established the Robert M. Smith Award in 1986 to honor Dr Smithfor his contributions in the fields of pediatrics and pediatric anesthesiology. DrSmith was one of the pioneers in anesthesiology who felt strongly that one of thegoals of the field should be to improve techniques and equipment for pediatricpatients.

At this time, the AAP Section on Anesthesiology and Pain Medicine NominationsCommittee is ready to review nominations for the 2013 Robert M. Smith Award.If

you have a potential nominee in mind, please complete a nomination form andsubmit it with a 2-3 page bio-sketch of the nominee to Jennifer Riefe, Manager,

AAP Section on Anesthesiology and Pain Medicine, by email [email protected] orby fax to 847-434-8000 by May 2, 2012. A nomination form is available on the lastpage of this newsletter or on the Section website athttp://www2.aap.org/sections/anes/default.cfm.

Thank you for your interest in the Robert M. Smith Award and for your considera-tion of becoming involved in the nominations process. The AAP Section on

Anesthesiology and Pain Medicine Nominations Committee greatly appreciates thefeedback of all pediatric anesthesiologists as it annually generates a list of potentialindividuals to receive this esteemed award.

Robert M. Smith Award Recipients

2012: Nishan Goudsouzian2011: Charles Cot2010: Juan Gutierrez2009: Ryan Cook2008: Federick Berry2007: Josephine Templeton2006: Al Hackel2005: Not Presented2004: Theodore Striker2003: Etsuro K. Motoyama2002: Dolly Hansen2001: David Steward2000: Not Presented

1999: George A. Gregory1998: John F. Ryan1997: C. Ron Stephen1996: John J. Downes1995: Leonard Bachman1994: Margery Van Norden Deming1993: Gordon Jackson-Rees1992: Joseph Marcy1990: Herbert Rackow and

Ernest Salanitre1988: A. W. Conn1987: William O. McQuiston1986: Robert M. Smith

Announcing the new Section on Anesthesiology

and Pain Medicine Speakers Bureau

Part of our mission as a Section of the American Academy of Pediatrics is to

educate our pediatric generalist, medical sub-specialist and surgical sub-specialist colleagues about areas of pediatric medicine where we are theexperts. The Executive Committee has identified the following five categorieswhere pediatric anesthesiologists and pain specialists particularly lead theway including: airway management, anesthesia (including anesthesia neuro-toxicity), sedation, pain management and crisis resource management/simulation. We would like to make it easier for our pediatric colleagues tofind us when they are looking for speakers on these and any related subjectsat the local or national level. Therefore, we are putting together a speakersbureau that we will post on the SOA website in the near future.

If you are interested in being a member of the SOA Speakers Bureau, pleasesend your name and a list of topics that you would be interested in presentingto your pediatric colleagues [email protected] by March 30, 2012. This list

will be readily accessible to members of your local Chapters and Districts whoare looking for speakers for their regional and statemeetings as well as to the Section ExecutiveCommittee when planning sessions at the NationalConference & Exhibition.

We look forward to hearing from you soon!

Jennifer Riefe, MEd, [email protected]

SOASpeaker'sBureau


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Welcome New

Members!

October 1, 2011

January 31, 2012

Adnan Bajraktarevic MD

Amy R Bouchard DO

Richard J Cartabuke MDEdward B Cooper MD

Christopher R Erkmann MD

Ruth Guinsburg MD

Nina A Guzzetta MD

John P Hagen MD

Mark G Indelicato MD

David E Meyer MD

Monika Modlinski MD

Aymen N Naguib MD

Mohamed A Rehman MD

Lena S Y Sun MD

Thomas A Taghon DO

AAP Surgical Advisory Panel Coordinates with the Section onAnesthesiology and Pain Medicine to Develop the First-Ever

Surgical Plenary at the AAP National Conference and Exhibition:

Anesthetic Neurotoxicity - Are we Poisoning Childrens Brains?

SAVE THE DATE!!October 20, 2012, 4:30 to 5:30pm

New Orleans, Louisiana

The Section on Anesthesiology and Pain Medicine, in collaborationwith the AAP Surgical Advisory Panel, has been asked to organizethe first-ever Surgical Plenary Session at the AAPs NationalConference and Exhibition (NCE) on the topic of anesthetic neuro-toxicity. The Surgical Plenary will take place on Saturday, October20, 2012, from 4:00 to 5:30pm, in New Orleans, and is expected todraw a large contingent of pediatric surgical subspecialists, medicalsubspecialists and general pediatricians. All of the AAP surgicalsections are planning to end their section educational programs by4:00 pm to so that there will be no overlap with this importantsession.

The surgical plenary session will be moderated by Constance S.Houck, MD, Immediate Past Chairperson of SOA and feature inter-national experts and Section members, Dr Randall Flick and DrSulpicio Soriano.

Participants in this session will be able to:

1) Describe the recent studies in infant rodents and non-humanprimates that have demonstrated neuronal apoptosis and longterm functional deficits after anesthetic exposure.

2) Summarize the recent human cohort studies that have shown apossible association between the exposure to multipleanesthetics before age 2 and subsequent learning disabilities.

3) Understand the potential neurotoxicity posed by anesthetic andsedative agents in vulnerable children and possible next stepsto reduce the risk.

The session will conclude with a highly interactive discussion of the implications of thesestudies on the current practice of anesthesia, procedural sedation and surgery and willfeature representatives from four AAP surgical sections: Otolaryngology, Urology,General Surgery and Orthopedics.

There is a great deal of excitement surrounding this new NCE Surgical Plenary, and itprovides a tremendous opportunity for the Section on Anesthesiology and Pain Medicineto demonstrate its leadership in this important area of research and child advocacy. Atthe March 2011 meeting of the Food and Drug Administration Anesthetic and LifeSupport Drugs Committee, the Committee members and the specialty organizationsrepresenting pediatric anesthesiologists (including the AAP Section on Anesthesiologyand Pain Medicine) were specifically asked by the FDA to educate clinicians and pro-vide information on current research (regarding potential neurotoxicity) that is availableso that prescribers can communicate the current research to parents and patients.Because of the all-inclusive nature of the AAP and the multidisciplinary pediatric educa-tion provided at the NCE, the SOA is in a unique position to carry out this mandate fromthe FDA and advocate for additional research funding in this area.

Sulpicio Soriano, MD

Randall Flick, MD

Connie Houck, MD


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AAP Advocacy LectureFriday, February 24, 201211:30 am 12:30 pmDisaster and Humanitarian Response, Kids Are Still Different

Dana Braner, MD, FAAP, FCCMChief, Division of Critical CareThe Alice K. Fax Professor of Pediatric Critical CareVice Chair, Inpatient Pediatrics, Doernbecher Children's Hospital

Dr Braner will discuss disaster planning and management when children are the focus.

For many years we have looked at the classic "All Hazard Disaster Plan," which had its beginnings in the military, and as suchconsiders disaster victims to be 70kg young men in excellent health. Disasters (and this is part of the reason for their generallybad reputation) do not, however, occur in a vacuum (unless you are thinking about Apollo 13, and, hey, that worked out well);they affect the young, the old, the well, the sick, the rich and the poor relatively indiscriminately. Disaster planning mustinclude preparation to take care of children in their proportion to the population, and in certain kinds of disasters, perhaps moreso.

This lecture will look at the current state of pediatric disaster planning in this country. We will define basic terms and move onto specific ideas dealing with improving pediatric disaster planning and making sure that pediatric disaster planning is part ofevery response scenario.

Participants should come away with a better understanding of disaster preparation and response in general and the role of thepediatric specialist in particular. Pediatric anesthesiologists should leave the lecture with an even greater appreciation for theroles they can play in disaster preparation and response.

AAP-Sponsored Events and Awards at the 2012 Winter Meeting

The AAP Section on Anesthesiology and Pain Medicine takes great pleasure in having the opportunity to partner with theSociety for Pediatric Anesthesia (SPA) each year in offering the SPA/AAP Winter Meeting. This years joint meeting will takeplace February 23-26 in Tampa.

The program for the meeting can be viewed athttp://www.pedsanesthesia.org/meetings/2012winter/PA12-program.pdf.

The AAP proudly sponsors a number of events and awards at the annual Winter Meeting. Please read on for informationabout the 2012 AAP Ask the Experts Panel and Lunch, the 2012 AAP Advocacy Lecture, the 2012 John J. Downes ResidentResearch Award winners, and the esteemed 2012 Robert M. Smith Award winner.

Dana Braner, MD

Continued on Page 6


For up-to-date program and

registration information,

please visit

WWW.PEDSANESTHESIA.ORG

A meeting co-sponsored by the Societyfor Pediatric Anesthesia and theAmerican Academy of Pediatrics

Section on Anesthesiologyand Pain Medicine


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2011 AAP John J. Downes Resident Research Award WinnersSaturday, February 25, 201210:00 to 10:45 amOral abstract presentations, discussion, questions & award presentations

Each year, the AAP Section on Anesthesiology and Pain Medicine selects three

abstracts to receive the John J. Downes Resident Research Award. This yearswinners are:

1st

Place Benjamin Bruins, MDChildren's Hospital of PhiladelphiaEffect of Vasopressor Selection on Cerebral Blood Flow and IntracranialPressure in a Swine Model of Pediatric Critical Care

2nd

Place Angela Cambic, MDChildren's Memorial HospitalPharmacokinetics of Bupivacaine Following Femoral and Popliteal Nerve Blocks with SubsequentContinuous Femoral Nerve Catheter Infusions for Adolescents undergoing Anterior CruciateLigament (ACL) Repair

3rd Place Jaspreet Sangha, MDWayne State University Medical CenterInhalational Induction with Vasoparalytic Sevoflurane: Are We Hyperoxygenating While Anesthetizing Developing Brains?

AAP Ask the Experts Panel and LunchSaturday, February 25, 201212:30 1:30 pmHematologic Disorders: New Strategies for Anesthesia Management

Sponsored by the Departments of Anesthesia at Nationwide Childrens Hospital,The Childrens Hospital of Oklahoma and Medical University of South Carolina

Ask the ExpertsPanelists

AAP-Sponsored Events and Awards (continued from Page 5)


Angela Cambic, MD

Jaspreet Sangha, MD

Benjamin Bruins, MD

Nina Guzzetta, MD, FAAPModerator, Ask the Experts

PanelAssociate Professor of

AnesthesiologyEmory University School of

MedicineAtlanta, Georgia

Ilka Theruvath, MD, PhDExpert, Use of Whole Blood

Coagulation Assays in PediatricAnesthesia

Medical University of South CarolinaCharleston, South Carolina

Mohanad Shukry, MDExpert, Activated Recombinant Factor

FVII in ChildrenChildren's Hospital of Oklahoma

Oklahoma City, Oklahoma

Aymen Naguib, MD, FAAPExpert, Post-CPB Coagulopathies

Nationwide Children's HospitalColumbus, Ohio

2012 AAP Robert M. Smith Award WinnerFriday, February 24, 201212:30 12:45pm

The 2012 AAP Robert M. Smith Award presentation to Dr Nishan Goudsouzian will take placeimmediately following the AAP Advocacy Lecture.

Dr Goudsouzian has been a consistent voice not only in the care of patients in the operatingroom and offsite, but also in the education of future leaders in pediatric anesthesia, and the AAPSection on Anesthesiology and Pain Medicine is thrilled to honor him with the Robert M. Smithaward for his outstanding contributions to the field.

Nishan Goudsouzian,MD, MS, MA


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Section on Anesthesiology andPain Medicine 2012 Elections are

coming in March!

Constance S. Houck, MD, FAAP

Chair, SOA Nominations Committee

In March all current members of the Section onAnesthesiology and Pain Medicine will receive a ballot to votefor 3 open positions on the SOA Executive Committee. Thevoting period will be from March 23 to April 13.

Dr Corrie Anderson will be running for re-election to hiscurrent seat and 5 enthusiastic members will be running forthe two seats that will become available November 1 as DrKoh and Dr Polaner complete their 7 years of excellentservice and rotate off the Committee.

We are pleased to present the following candidates for these

2 open positions in alphabetical order:

The ballot will be sent electronically so it will only take a fewminutes of your time to vote. Please show your support forthe Section and your favorite candidate by voting in March!

Arvind Chandrakantan, MD, FAAPLe Bonheur Childrens Medical

Center, Memphis, TN

Courtney A. Hardy, MD, FAAPChildrens Memorial Hospital

Chicago, IL

Mohamed A. Rehman, MD, FAAPChildrens Hospital of Philadelphia

Philadelphia, PA

David A. Rosen, MD, FAAPWest Virginia University

Morgantown, WV

Continued on Page 9

Plenary Session at 2011 AAP NationalConference & Exhibition Sponsored bythe AAP Section on Anesthesiology andPain Medicine and the AAP Section on

Urology

Robotic Surgery: Wave of the Future Available Now

Can robots do a better job at surgery than humans, askedHiep Nguyen, MD, FAAP, in his plenary session at the 2011NCE, "Minimally Invasive Robotic Surgery: The Future isNow!" "Not long ago the answer was no,' but more recently,we've seen giant strides in robotics and technology that allowthis to be possible," said Dr Nguyen, co-director of the Centerfor Robotic Surgery and director of robotic surgery researchand training in the Department of Urology at the Children'sHospital Boston.

Before the advent of robotic surgery came laparoscopicsurgery, providing advantages over open surgery. Those

advantages included lesspain for the patient, quickerrecoveries, shorter hospitalstays, better cosmeticincisions and less scarring.However, laparoscopicsurgery is technicallydemanding and employstwo-dimensional imagingand rigid instruments thatmake dexterity difficult, DrNguyen said. Roboticsurgery uses two cameras

that enable three-dimensional imaging with better visualiza-tion of tissue and better hand-eye coordination. Surgerycould be done in another room or from another state.

"There are things we can do to make robotic surgeryless expensive and more cost-effective."

The biggest limitation to the use of robotic surgery is its highcost, Dr Nguyen said. The initial investment in the robot,instruments and drapes is high, as are the maintenance feesrequired to keep the equipment in top shape. Robotic surgeryalso requires more operating room time and specializedtraining. "Does the future of robotic surgery end with itscosts? We don't think so. There are things we can do to

make robotic surgery less expensive and more cost-effect-ive," he said. "First and foremost is that surgeons should beresponsible for what they spend. We should be mindful aboutthe instruments and the drapes that we use. We also have tobe prepared and become efficient in how we operate. Thatrelies on forming a team of radiologists, nurses, surgeonsand anesthesiologists, all working together to decrease theoperative time and increase efficiency," Dr Nguyen said.

In a study of a multidisciplinary approach to robotic surgeryover six years at Children's Hospital Boston, he and hiscolleagues found that "by working together, we were able toreduce the cost of robotic surgery to the point that it costs


Thomas A. Taghon, DO, FAAPNationwide Childrens Hospital

Columbus, OH


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The Next Frontier in Patient Safety Improving Outcomes Throughthe Effective Use of Checklists in the Operating Room Environment

Carlyle Jai Rampersad, ATP, Captain, US AirwaysDaniel K-W Low BMedSci BM BS MRCPCH FRCA, Acting Anesthesiologist, Seattle Children's Hospital &University of Washington School of Medicine

Sally Rampersad MB FRCA, Attending Anesthesiologist & Associate Professor, Seattle Children's Hospital &University of Washington School of Medicine

One weekend, a family set off to the skislopes. When they arrived one child wasmissing a glove, Dad was missing his skilift pass, and his son had no coat. Aftera 3 hour drive, there was no going back,so they bought a coat, a pair of glovesand a day pass an expensive day!

For subsequent trips they instituted achecklist. Once the car is packed, theoldest son calls out each item and Dadverifies the location of each item, point-ing to each item as it's called out to

avoid automated responses. This is achallenge-response type of checklist.The work is complete before they startthe checklist, which then serves thepurpose of confirming that everything isdone before they depart. Their trips tothe ski slopes now involve fewer tearsand less emptying of Dad's wallet. Thechecklist is not recorded. Confirmationthat it is complete is obtained when theyarrive at the slopes with everything thatthey need.

Checklists are not intended to "tell some-

one how to do their job." Nor is this typeof checklist intended to serve the pur-pose of slowing people down while eachwaits for the other to complete theirtasks. Some tasks, however, are tooimportant to omit and too important notto tell other team members about. Inaddition, a checklist, completed in thismanner, serves the purpose of increas-ing "situational awareness," gettingeveryone on the same page, with thesame mental model. When the anes-thesiologist confirms that blood is avail-

able for a patient prior to surgery, it is notbecause he does not trust the surgeonsto do their job, but knowing that blood isavailable is important for all members ofthe OR team and for the safety of thepatient, so that item rightly belongs on achecklist.

Why should we look to aviation for guid-ance on this topic? As aircraft have be-come increasingly complex, checklistshave evolved as necessary tools to en-able the pilots to safely operate them.Some tasks have been taken over byautomated systems, and much has beenlearned in aviation about the complexinteractions between 2 or 3 pilots andthe automated systems that they use. Inmedicine, we have the ultimate complex"machine" to operate, the human body.

Automation has increased in our worldtoo, programmable infusion pumps,ventilators for example. As in aviation, itis very apparent that it is the interactionsbetween people that determine successor failure. We know that human memoryis notoriously unreliable, and any toolthat can help people effectively to dealwith the dynamics of a complex systemis worthy of adoption. Checklists are justone of the tools from crew resourcemanagement that may be adapted to theoperating room.

The Size of the ProblemThe Joint Commission analyzed sentinelevents from 1995-2005, and the leadingroot cause of the events was a failure in

teamwork and communication. Thelatest data from the first three quarters of2011 for 914 sentinel events againshows the leading root causes of theseevents are human factors (n=655),leadership (n=599), and communication(n= 549).

Current State in Medicine Education /

TrainingMost undergraduate and postgraduatemedical, nursing and pharmacy curriculastill fail to address human factors train-ing. Encouragingly, we've seen a medi-cal CRM training program in the form of"Team STEPPS" roll out nationallyover the last few years. Team STEPPS(Strategies and Tools to Enhance Per-formance and Patient Safety) is a pro-gram sponsored by the Agency forHealthcare Research and Quality. It is ateamwork system designed for health-care professionals using over 20 years

of expertise in studying teamwork princi-ples. Developed by the Department ofDefense's Patient Safety Program, itaims to bring aviation safety perform-ance, attitudes and knowledge to health-care. Despite a strong start, penetrationin existing widespread medical culture isweak.

Crew Resource Management (CRM)CRM is a system designed to makeoptimum use of resources (people,equipment,

(Continued on Page 9)

Captain Jai and Dr Sally Rampersad

Dr Daniel Low

Young Skier Rampersad


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processes) to optimize the safety andefficiency of flight operations. It hasbeen embedded in the culture of aviationfor over 20 years and has directly led to

the aviation safety that we witness today.

The components of CRM can be dividedinto the following sub-disciplines; situa-tional awareness, communication,leadership, teamwork, problem solvingand decision making. Each of thesedisciplines can be taught, practiced, andobjectively assessed. Most airlines have6 monthly mandatory check flights fortheir crews when they are assessed ontheir technical skills as well as their "non-technical skills," including all of the do-mains of CRM. Checklists are one tool

that can increase situational awareness,communication and teamwork. A teamthat is well versed in CRM will usechecklists effectively.

Can CRM Work in Healthcare?In 2000, Sexton and others (1) reportedon "error, stress and teamwork in medi-cine and aviation." They found that, atthat time, although most intensive caremedical staff were in favor of a flat hier-archy, only 68% of surgeons favored thisapproach. A flat hierarchy is not theanswer to all of our communication diffi-culties in the operating room. In fact, it isimportant that decisions are made and,at times, each of us may need toassume the role of team leader. How-ever, favoring a flat hierarchy may be anindicator of how open we are to receivinginput from others, including trainees andothers whom we may consider to be in arole subordinate to our own. Almost allpilots surveyed at that time were in favorof flat hierarchies.

Pronovost et al (2) showed that the useof a simple 5 item checklist reduced theincidence of catheter-associated bloodstream infection. Winters et al (3) re-viewed the use of checklists in the ICU,confirming their usefulness in this com-plex and constantly changing environ-ment. Neily et al (4) reported in 2010 an18% reduction in annual surgical mortal-ity following introduction of the VHAmedical team training program. Theycompared 74 Veteran Health Administra-tion (VA) facilities who had received thetraining against a control group of 34 VAfacilities who had yet to receive thetraining. Over the same time period the

control group experienced a 7%reduction in annual surgical mortality.

Checklists in HealthcareThere has been much publicity recentlyabout using checklists to improve patientoutcomes. Most surgical facilities haveadopted a version of the WHO standard-ized pre-operative checklist, yet adoptionhas not been uniform and there continueto be cultural barriers to implementation.Part of the problem is training. Check-lists are a tool or a process designed tobe used within a CRM framework. Thereare different types of checklists, whichrequire different styles of execution to beused reliably. They also require a shift inattitude, often moving away from aphysician-centric team model. Executedcorrectly they can create a shared men-tal model, encourage team members tocross-monitor each other's work, shareinformation to help teams anticipate andplan for potential emergencies, makingunspoken implicit knowledge explicit.

An Aviation StoryOne night, not long ago; we settled incomfortably on our flight from Philadel-phia, PA, USA, on our way to Aruba, offthe coast of South America. A couple ofhours after midnight as we passed Haitiand headed out over the Caribbean Sea,a Master Warning chime rang out on theflight deck. Our Electronic Centralized

Aircraft Monitoring (ECAM) displayed acritical situation of "Right Wing FuelTemp 480 C" which required immediatecrew action. The warning was followedby a list of directives displayed on theelectronic screen; the first of which was

"Start the APU." The APU (auxiliarypower unit) is a small jet engine in thetail of the aircraft which supplies elec-trical power and compressed air whenthe aircraft is on the ground. The logic ofstarting the APU was to provide an addi-tional electrical generator to replace theone on the right wing, which would belost when we followed the next step onthe checklist, shutting down the rightengine. The copilot questioned "ECAMaction?" which was an appropriate re-sponse. To which I replied. "No, hold ona minute, this does not make sense. Ifthat fuel temp was really 480 C, wewould not be here discussing this; thatwing would have exploded by now!" Aspurious electronic signal had triggeredthe warning and the central monitoring

The Next Frontier in Patient Safety (continued from page 8)

less than open surgery," Dr Nguyensaid. "The primary reason is that inopen surgery, we spend a lot of money

on patient hospitalization, but withrobotic surgery, we are able to getpatients out of hospital sooner. How-ever, the cost of the robot will offset thatsaving unless you become very mindfulof how you use the robot and theinstruments. By decreasing the numberof instruments and drapes used and theOR time, we can make robotic surgerycost-effective," he said.

Dr Nguyen also urged surgeons to en-courage competition in the robotmanufacturing industry to help reduce

the cost of the equipment.

In his lab, Dr Nguyen is developingfluorescent imaging to improve visuali-zation during surgery. "We are actuallyseeing urine peristalsing from thekidney to the bladder. We never seethat in white light. We even can see anarea of blockage or damage," he noted.

For the future, Dr Nguyen sees theadvent of automated robots capable ofresecting the liver on their own. He alsoenvisions robots that can be sent homewith patients after surgery to provideround-the-clock video communicationbetween parents and health careproviders.

Article reprinted courtesy of the AAPExperience (National Conference &

Exhibition) 2011 eDailies.

2011 NCE Plenary Session:Robotic Surgery(continued from page 7)


Captain Jai Rampersad

computer, following the programmed log-ic, had generated the appropriate "ECAMaction" crew response. If we had follow-ed the instructions of the ECAM withoutthought we would have shut down agood engine.


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In aviation, this sort of situation is be-coming commonplace, as we transitionfrom paper checklists into the realm ofmobile applications and electronicchecklists, which are used not only toverify what has been done but whatneeds to be done next, with algorithmscreated by engineers, who design thesemachines and their systems. It shouldserve as a warning to other High Reli-ability Organizations of the pitfalls whichmay develop with their increasing use ofelectronic checklists on complex sys-tems, coupled with a younger generationof individuals who lack experience andare increasingly reliant on computergenerated guidance instead of intelligentsystematic analysis of a situation. Ananalogy would be if our EKG monitorinterpreted the EKG signal and called forcompressions, when the "cause" of theasystole seen on the screen was a looselead. An experienced anesthesiologistwould verify the condition by checkingthe pulse. The younger "technically-minded" anesthesiologist might continueto look at the monitor for guidance.

In one form, checklists are proceduralsteps which are designed to assist us indealing with complex situations but theycannot replace human thinking. We mustalways ask ourselves if each subsequentstep on the checklist makes sense. Inaddi-tion, one must take the time toanalyze the situation and to verify thatthe appro-priate checklist is beingfollowed. In ACLS there is an algorithmfor ventricu-lar tachycardia with a pulse,but if the patient is pulseless, one shouldfollow the algorithm for ventricularfibrillation instead. The EKG looks thesame, but examination of the patientguides the next steps.

In the United Kingdom, the Royal AirForce pilots are always taught to take

the time "to wind your watch." In otherwords; stop and think before you pro-ceed. Sometimes American pilots jokethat for British Airways pilots the firststep on the checklist for an Engine Fireis to have the flight attendants make acup of tea. The medical equivalent is theadvice that at a cardiac arrest "the firstprocedure is to take your own pulse."

Types of Checklists

Read and Do

In doing this checklist, a single pilotreads the item and does what he is re-quired to do. It does not require corrob-oration with another. Checking the posi-tion of landing gear and flight controlsprior to powering up the aircraft would bean example. In anesthesia, the equiva-lent would be an anesthesia machinecheck, or a simple check, such as look-ing at the oxygen pressure gauge priorto using a tank for transport. Commondeviations which lead to unreliable per-formance are:

1. Not using the checklist at all:performing checks from memory

2. Batching: doing the action items frommemory, then referring to thechecklist to see if anything has beenmissed

3. Presuming someone else has per-formed this checklist, so failing to dothe work at all.

Flow Patterns Followed by Challengeand ResponseFlow patterns are used by 2 or 3 pilots,Captain, Copilot, and/or Flight Engineer,in Normal and Non-Normal situationsfrom "Before Start" to "Parking andShutdown." The pilot flying sets therespective flight controls and switchesrequired for the phase of flight. Eachpilot configures the items for which theyare responsible and then one pilot readsthe item (Challenge) and the pilotresponsible for that item responds(Response) as appropriate.

The equivalent situation in the OR is thethree phases of the WHO surgicalchecklist. At our hospital, the preopera-tive checklist is performed by thecirculating nurse and anesthesiologist.The nurse reads the item (Challenge)and the anesthesiologist responds withinformation about that item (Response).Items such as allergies and bloodavailability are checked and confirmedthrough this process.

In aviation, aircraft move through aseries of physical "gates," e.g. pushback, taxi, take-off, landing etc. Beforepassing through each gate, the aircraftneeds to be optimally configured for thatsequence of flight.

In the operating room the patient movesthrough a similar series of "gates," some

physical, some physiological: eg. holdingarea to OR, induction, surgery, emer-gence, OR-PACU, PACU ICU. Thepatient and the team need be optimallyconfigured for each gate in the patient

journey. Checklists at critical points,especially where a handoff occurs, canhelp to ensure that the patient is in opti-mal condition before progressing to thenext phase of care. At our hospital'sstand-alone surgery center we havesuccessfully implemented checklists foranesthesia room departure, OR arrival,OR departure and PACU arrival. Theyhave made our processes highly reliable,improved team awareness of whatneeds to be done for each phase of thepatient journey, encouraged mutualsupport, made errors of omissionobvious, and have simplified orientationof new staff members.

Common deviations which lead to sub-optimal performance include:

1. Using the "challenge response"checklist as a "read do." This dis-rupts the established flow patternsand slows the team down. It is betterto give the team time to perform theirtasks and then trigger the "challenge

response" checklist to confirm thateverything is as it should be.

2. Single user "challenges" and givesresponse. This turns a team conver-sation into a monologue and is anineffective method of informationsharing.

3. Batching items multiple challengesare batched together, anticipating theresponses. This risks low frequency/high acuity events being missedwhen they eventually occur.

4. Short cutting the checklist stoppingearly, missing items. This is done inthe belief it is not needed. The unin-

tended consequence is that the teamis led into a pattern of performing thechecklist, missing items. Again, a lowfrequency/high acuity event mayeventually be missed.

5. Not recognizing that a checklistneeds to be formatted and presentedas a "challenge response" checklist

leads to confusion as to how itshould be executed.

Challenge / Response and ResponseThis is used by




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2 or 3 pilots during an emergency andusually involves a few memory itemsrequiring immediate action, followed by aread and do checklist for the rest of thesteps. Studies in human performanceindicated that after the first few items,steps are not remembered accurately, sothe pilots need to know how to start thechecklist from memory, but then refer toa Quick Reference Handbook (QRH) forthe rest of the steps.

One pilot says the "Challenge" andgives the applicable "Response."The other pilot then confirms the"Response" and does the item. Forexample,

Engine Fire, Handle/Pull .............

Pull (pulls handle).One pilot gives the challenge andindicates the appropriate response;the other pilot confirms the responseand pulls the fire handle.

An equivalent situation for anesthesi-ologists is the role of the team leaderat a code. That individual calls out thechallenge and the required response.The responder "reads back" theresponse and then performs the item.

"Rhythm is asystole, give 1mgepinephrine iv push" ........ "giving

1mg epinephrine iv push" (givesepinephrine)

Flowchart AlgorithmFlowchart Algorithms are not fixedresponses, but are based on a decisiontree format. These are used in situationsof adverse weather. For example, aflowchart algorithm would be used whendeciding whether it is safe to take offwith a thunderstorm in the vicinity of theairport. It depends on how far away fromthe aircraft operational area the thunder-storm is. The aircraft configuration

changes (flap and power settings, etc.),flight path, and a host of other factors,including but not limited to length of run-way, equipment on the aircraft, path ofthe thunderstorm and its speed, are fac-tored in the decision tree. Subsequently,it will be determined if it is appropriate orsafe to takeoff.

An anesthesia equivalent would be thedifficult airway algorithm, a decision treeused to guide actions when a difficultairway is encountered. The exact path,however, is determined by success or

failure at each step, with not everypatient ending up with a surgical airway.

Categories of checklistsIn the Normal category, you will find thechecklists which are utilized for normaloperations in all the phases of flight.The phases of flight consist of Safetyand Power On, Receiving, Before Start,Taxi, Before Takeoff, After Takeoff,Descent and Approach, Landing, AfterLanding, Parking and Shutdown, Secur-ing and Power Off. The names maychange at the various airlines, but thesteps and the phases of the flight staythe same. Depending on the aircraft,these checklists may be in a laminatedpaper format or on an electronic screen,or a combination of both. The surgicalchecklist is an example of this type ofchecklist.

Non-Normal checklists deal with singleor multiple failures of redundantsystems. By systems, we are referringto the systems on board the aircraft,which consist of Hydraulic, Electrical,Navigation, Flight Controls and manyothers. For example, to power theelectrical system of an aircraft, there is agenerator on each engine. If one fails,the duplicate on the other engineassumes the electrical load, but certainhigh electrical use items, such as ovens,will be shed. Even if the remainingelectrical generator fails, there is a small

jet engine in the tail of the aircraft calledthe APU (Auxiliary Power Unit), whichcan be started in flight to provide electri-cal power. Supposing there is a failure ofall of these sources of power; a Ram AirTurbine (RAT) is deployed to power theelectrical system, but at a reducedcapacity. In this situation, checklists areused at each step of the power failure toconfigure the aircraft for safe flight.These procedures use the challenge andresponse checklist format. They arefound in either a Quick Reference Hand-book (QRH) or in the Pilot Manual.Examples would include ACLS, PALSand difficult airway algorithms.

Supplemental Non-Normal checklists areexpanded forms of Non-Normal check-lists. They provide additional in-depthinformation of the effect of the systemfailures, and sometimes follow analgorithm to assist the pilot in his or herdecisions. These checklists, showing

the subsequent operation limitations andperformance of the aircraft, can be foundin their own dedicated manual.

An example would be the supplementalinformation that is needed to treat acardiac arrest due to local anesthetictoxicity.

Checklist ExceptionsChecklists are dynamic. They are al-ways changing and being modified dueto unfolding events, which shed new lighton the operation of complex aircraft.One such event led to the formation ofExceptions to the Electronic Checklist,with an unprecedented 15 day manda-tory compliance period for all operatorsof the Airbus family of aircraft. Theintroduction of the Electronic Checkliston the newer aircraft and its integrationinto system failures and warnings weredeveloped to address the issue of usingthe wrong or inappropriate checklist for agiven situation. However, as we shallsee, this created a new problem.

On August 24th, 2001, Air Transat, Flight236 (Airbus 330-243), en route fromToronto, Canada, to Lisbon, Portugal,experienced a failure of both its engines,and became a "glider" with 306 peopleaboard, over the North Atlantic. Thecause was fuel exhaustion.

Unbeknownst to the pilots, the rightengine was repaired using the wrongpart, and a leak had developed, causingexcessive fuel loss from the right tank. Afuel imbalance developed between theright and left wing tanks, and the ECAM(Electronic Centralized Aircraft Monitor-ing-Electronic Checklist) directed thepilots to open the cross-feed betweentanks to feed fuel from the heavier sideand correct the imbalance. This cross-feed is there to shift fuel in the event ofan engine failure, or when one engineconsumes more fuel than the other. Thiscreates a fuel imbalance over an extend-ed period of operation. The pilots did notverify the fuel burn on each engine tosee if it matched with the total fuel pres-ently on the aircraft and with what theyhad departed with from Toronto. They"blindly" followed the electronic checklistand opened the cross-feed. All the fuelon the aircraft was now being diverted tothe two engines and the leak. Whenthey realized




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that their fuel was dangerously low, theydiverted to a tiny island, the site for Lajes

Air Base in the Azores. An emergencywas declared with Santa Maria Oceanic

Control, and 28 minutes later, the rightengine quit. "Mayday" was transmittedand 13 minutes later, the other remain-ing engine quit also. Powered now bythe Ram Air Turbine, which deployedautomatically, the crip-pled airliner drift-ed down. The Captain ordered prepara-tion for a ditching in the North Atlantic,but within 15 minutes of hitting the water,they saw the tiny island and its air base.They were able to make the runway, andafter several violent bounces due toexcessive speed, they finally stopped.They had blindly followed the checklist

without really analyzing what was trans-piring and without thinking about howmuch sense it made to do what theywere being told to do.

Checklist InterruptionsThe passengers and crew of British Mid-land Flight 92, traveling on January 8th,1989, from London, Heathrow to Belfast,Ireland, were not so fortunate. A crosswiring of the Engine Fire Warning Sys-tem gave the false information. Therewere, however, other indications availa-ble to make the correct decisions. Whilstthe Captain was in the process of con-firming which engine was giving himtrouble by checking the correspondinggauge indications, he was interrupted bythe Air Traffic Controller clearing him to alower altitude. The Captain did not callfor a "hold" on the checklist and thenrestart it from the point when they wereinterrupted by Air Traffic Control. It mayseem onerous to hold and restart achecklist because of an interruption, butas this incident showed, it can be critical.They then proceeded to shut down aperfectly good engine and to keep the

engine, which was failing and about todisintegrate, as the sole source of pro-pulsion. Crew coordination was poorand ineffective during the use of thechecklist, compounded by an interruptionduring the use of the checklist, and 37people died.

Air Traffic Control cannot be blamedbecause it is analogous to carrying on atelephone conversation while drivingdown the freeway. If a situation developswhich requires immediate action on yourpart, the other person on the line will

continue speaking with the same toneand volume, blissfully unaware of what isdeveloping. On the other hand, whilecarrying on a conversation with someone

next to you in the car, seeing what ishappening, they will immediately lowertheir voice, change tone or stop talkingall together. Currently, one of the mostcommon incidents, or near-miss inci-dents, in aviation relate to improper pro-gramming of the computer before the air-craft has even left the gate. This is dueto checklist interruptions usually by othercrew members or the gate agent duringthis critical inputting of information.

ConclusionsIn conclusion, we see that the checklistis an invaluable tool in operation of verycomplex aircraft in dynamic situations.Their format and use may vary, depend-ing upon the situation; the simple stepsof identifying, checking and verifyingwhat you have done or are about to docan determine whether your team suc-ceeds or fails and whether your patient issafe or is harmed.

So, do checklists enhance safety? Theevidence from Provonost's (2) workwould indicate so. Some high valuebenefits are hard to measure though.Provonost suggests that the strongestpredictor of healthcare excellence is ifproviders feel comfortable speaking up ifthey perceive a problem with patientcare. (5) Gawande describes "activationphenomenon" (6) in team members afterthey are allowed to speak and introducethemselves during a team brief.

In a sad, high profile case (7) where apatient had the wrong kidney removedone wonders what the teamwork waslike in that operating room. Did anyonehave doubts that they were performingthe correct procedure? Did team mem-bers feel comfortable voicing those con-cerns? Were they fearful of a negativeresponse if they raised their concerns?Did the culture encourage or discouragecross monitoring of each other's work?Were team members activated?

Harm to patients occurs as a result ofpoor training in human factors, communi-cation, leadership and teamwork. We inthe medical community look to otherhigh-risk industries, such as aviation, tounderstand how they have improved

their safety profiles. One obvious proc-ess we can easily see and adopt is thechecklist. However, if checklists areimplemented as just another piece of

paper for the team to fill out, without theteamwork, leadership behaviors, andattitudes which make this tool useful,they will fail to change behavior and willnot improve safety. These "non-techni-cal" skills can be taught, but widespreadadoption is inhibited by the currentculture within healthcare. We need totransform our culture and truly embraceteamwork. Only then will our "teams ofexperts" become truly "expert teams."

References(1) Sexton JB, Thomas EJ, Helmreich RL:

Error, stress, and teamwork inmedicineand aviation: cross-sectional surveys.Br Med J 320:745-749, 2000.

(2) Pronovost P, Needham D, Berenholtzet al: An intervention to decreasecatheter-related bloodstream infectionsin the ICU. N Engl J Med355 (26):2725-2732, 2006.

(3) Bradford D Winters, Ayse P Gurses,Harold Lehmann et al. Clinical review:Checklists - translating evidence intopractice. Critical Care:13 (6):210, 2009.

(4) Neily J, Mills PD, Young-Xu Y et al:Association Between Implementation ofa Medical Team Training Program and

Surgical Mortality. JAMA 304(15):1693-170, 2010.(5) Peter J Pronovost, Sean M Berenholtz,

Christine A Goeschel et al. CreatingHigh Reliability in Health CareOrganizations. Health Serv Res. 2006August; 41(4 Pt 2): 15991617.

(6) Gawande A. The Checklist Manifesto:How to Get Things Right Picador ISBN978-0-312-43000-9.

(7) Doctors Suspended for RemovingWrong Kidney. BMJ 2004;328:246.2.

October 20-23, 2012Ernest N. Morial Convention Center | New Orleans, LA


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The Committee on Drugsmet on November 2ndand 3

rdin Washington,

DC.

POLICIES-IN-PROGRESSThese are policies from the AAP that theCommittee on Drugs has been asked toeither revise, comment upon or create.

Transfer of Drugs and Selected Thera-peutics into Human Milk

Iatrogenic Withdrawal in AdolescentsThis statement is being written as a jointeffort between the Section on Anesthesiaand the Committee on Drugs

Off Label Uses of Drugs in Children

Generic Prescribing, Generic Substitu-tion, and Therapeutic Substitution

Procedural Sedation and Analgesia inthe Emergency DepartmentThe COD was asked to comment on thisstatement. This statement by the AAPCommittee on Pediatric EmergencyMedicine (COMPE) commented on theCMS guidelines requiring credentialingfor sedation practices. The SOA workedin an advisory capacity to the COD inaddressing the COMPE statement.

Washington ReportA substantial amount of time was spent

discussing government responses to DrugShortages. Below is a summary of thisinformation and a link to the FDA responseto President Obamas call to address drugshortages.

Summary of Activity on Drug Shortages atthe Federal Level

Klobuchar Drug Shortages BillSenators Amy Klobuchar (D-MN) and BobCasey (D-PA) introduced a bill lastFebruary to address drug shortages. Thebill is a first step and the staff of theseSenators have indicated they are open to

hearing feedback and suggested changesfrom experts.

The key components of the bill include:

Establishment of an official definition of adrug shortage to be a period of timewhen the total supply of all versions of adrug does not meet the current demandfor the same drug at the user level.

Expansion of the requirement to reportdiscontinuances of products to FDA fromsole producer or a life-saving, medicallynecessary product to non-sole source

manufacturers.

The bill will also require reporting ofinformation on any type of adjustment

or interruption that is likely to result ina change of production.

Adjustments or interruptions includechanges related to supply of rawmaterials or active pharmaceuticalingredients (API), alterations toproduction capabilities, businessdecisions that may affect themanufacture of a drug (i.e. mergers,discontinuations, change inproduction output), and otheradjustments as determined by theSecretary.

The bill would place timetables on the

reporting requirement for manufac-turers which the Secretary hasdiscretion to modify:

For discontinuances or plannedinterruptions/adjustments, themanufacturer must report at least 6months in advance;

For any other interruption oradjustment, manufacturers mustreport as soon as practicable.

For enforcement, the bill requiresthe Secretary to issue regulations toestablish civil monetary penal-tiesfor manufacturers who fail to report.

Publication of notifications of a discon-tinuance, planned interruption oradjustment and any actual drug short-age on its website and work to distributethis information to appropriate healthcare providers and patient organizations.

The FDA will also create an evidence-based criteria for identifying drugs thatmay be vulnerable to shortages andwork with manufacturers of thosedrugs to create continuity ofoperations plans that include aprocess for addressing drugshortages.

A requirement that FDA perform expe-

dited reinspections of manufacturers(within 90 days once the manufacturercertifies to the FDA they have ad-dressed the problem) in the case of adrug shortage.

DeGette-Rooney Drug Shortages BillRepresentatives Diana DeGette (D-CO)and Tom Rooney (R-FL) introducedcompanion legislation in the House in lateJune. Their bill is similar to the Klobucharlegislation but contains some importantdistinctions. The DeGette bill limits thenotification requirements on manufacturers

only to the on-label use of the drug or bio-logic (the DeGette bill adds biologics butneither bill includes medical devices). The

DeGette bill alters the notification require-ment by allowing manufacturers to self-certify to the Secretary that good causeexists for the shortage, interruption or dis-continuance and therefore not be subject tothe notification requirements. It treats anyinformation reported to the Secretary astrade secret or confidential making it un-clear what the Secretary would be makingpublic. It strengthens the enforcementmechanism by spelling out the civil mone-tary penalties. The bill explicitly limits theSecretary from requiring a manufacturer tomanufacture a drug in the event of a dis-continuance or interruption or to delay or

alter a discontinuance or interruption.

Government Accountability Office (GAO)ReportIn early May, Senators Casey, Harkin, andBlumenthal wrote to the GAO asking themto examine how the FDA identifies andresponds to drug shortages and to identifywhat steps the FDA could take under itscurrent authority to better identify and re-solve drug shortages. The letter also asksGAO to identify what additional authority, ifany, is needed to help prevent and addressdrug shortages. The report is not expectedto be released until this fall, at the earliest.In the Senate, there is a bipartisan workinggroup comprised of offices with an interestin addressing drug shortages issues.

HearingsAlthough no hearings have been sched-uled yet, there is interest in the HouseEnergy and Commerce Committee and theSenate Health, Education, Labor andPensions Committee in possibly holdinghearings on the issue of drug shortages.Congress will consider FDA legislationsometime in 2012 since key drug anddevice user fee programs as well as

several pediatrics programs at FDA mustbe reauthorized. This FDA legislation isviewed as a vehicle by which to includeadditional FDA-related policies such asthose dealing with drug shortages.However, it remains unclear whether thecurrent political environment will beconducive to policies outside of the userfee and pediatrics programs.

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM277755.pdf

Committee on Drugs ReportJeffrey L. Galinkin MD, FAAP


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You arrive home, pullyour mail out and finda letter from the

American Board ofPediatrics (ABP). You are due to com-plete your Maintenance of Certification(MOC) by the end of next year. You lookat your 401K and realize that in this

economy you cant retire by the end ofnext year. What are you going to do?

Why do Quality Improvement?If one were to query their colleagues,most if not all of us would say we deliverabove average quality of care to ourpatients. Of course, common sense dic-tates that half of us are indeed deliveringbelow average quality of care. The ideabehind QI is to continuously improve thequality of care that you and your teamare delivering, no matter where you areperforming relative to your peers. To im-

prove, you must measure your perform-ance and work towards improvementgoals. MOC is now formalizing this QIprocess into physician practice throughPart 4 activities.

What are your web-based options forMOC Part 4 as a pediatricsubspecialist?

As of September, 2011, there are 25web-based QI activities for MOC Part 4credit on the ABP website. The majorityare directed at improving care providedby general pediatricians. Some of themodules developed for general pediatri-cians could be used by subspecialists(e.g. asthma, GER/GERD, ADHD); how-ever, these modules have best practicesfocused on the care by general pediatri-cians, rather than subspecialists. Severalmodules have been developed withspecific subspecialty tracks (breast milkuse, influenza vaccination, and Chlam-ydia screening) and two modules couldwork for virtually all pediatricians (handhygiene and safe prescription writing).However, there is still a shortage of

specialty specific modules for many sub-specialties.

I do have one caution on simulated data,which ABP PIM modules and AAPEQIPP modules allow as an option. Inmy opinion, using simulated data, ratherthan actual data from your patients, falls

short of the basic goal of Part 4 MOC to improve care. The simulated dataoption is specifically intended for use byphysicians who are not clinically activeor see very few patients (not enoughpatients to complete a module).

Who is looking out for pediatricsubspecialists?Unfortunately, at present, pediatric sub-specialists have relatively limited optionsfor MOC Part 4. To date, the AAP hasfocused on their largest customer group,primary care pediatricians. Subspecialty

organizations (e.g. American College ofCardiology) focus their MOC Part 4 ontheir internal medicine constituency be-cause that is the majority of their mem-bership. Thankfully, several collaborativeimprovement projects approved for Part4 are avail-able nationally and areincreasing for example, the AmericanCollege of Medical Genetics NewbornScreen Positive Infant ACTion Project;the National Pediatric Cardiology QICollaborative; the National Associationof Children's Hospitals and RelatedInstitutions Pediatric ICU and Pediatric

Hematology/Oncology Blood StreamInfection Collaboratives; and theVermont Oxford Networks numerousNICU Collaboratives. Of the 123 local,state, regional and national QI projectsapproved by the ABP for Part 4 credit asof September 2011, 67 (over half) applyto subspecialty care. However, currentoptions still need to be greatly enhancedin order to support MOC Part 4 acrossthe breadth of pediatric subspecialties.

To paraphrase Tip ONeil - All Quality

is Local:Now for some good news. In addition tothe web-based and approved collabora-tive improvement project options, a newmethod exists for MOC Part 4 approval the Portfolio Program. The ABP is pilot-ing this new approach for sponsororganizations that can manage numer-

ous MOC-approved QI projects. The pro-gram is designed to reduce the applica-tion burden and costs for sponsor organ-izations (by requiring only one applica-tion at the same cost [$500 applicationfee]). In the Portfolio Program, thesponsor organization evaluates its ownQI projects against ABP standards andsubmits as many QI projects as theywant (a minimum of five) for MOC creditin a 2-year period. Annually, the sponsorprepares a report for each of the ap-proved projects, which the ABP reviewsto ensure alignment with ABP standards.

For a large group of subspecialists and/or academic centers, it makes sense foryour organization to become a portfoliosponsor for MOC Part 4.

Whats a pediatric subspecialist to do?In the current MOC cycle, it will be difficultfor some subspecialists to select a usefulMOC QI project due to the paucity ofapproved MOC activities. Here is what youcan do to facilitate a better future for sub-specialists completing MOC Part 4:

Work with your local organizations,hospitals, practice plans, medical

schools, etc. to encourage applicationfor the Portfolio Program. Futurecycles for MOC will be easier andmore effective in improving care oncethese local options are in place.

Focus your Part 4 efforts on what willmake a difference in the care of yourpatients and make sure that there areclear, quantifiable measures to guideimprovements.

Make sure physicians are involved inthe evaluation of data anddevelopment of improvements to testwith each PDSA cycle.


THESUBSPECIALISTANDMAINTENANCEOFCERTIFICATIONPART4:WHATSAPHYSICIANTODO?WayneFranklin,MD,MPH,FAAPMember,AAPSteeringCommitteeonQualityImprovementandManagement

Reprinted with permission from AAP Quality Connections, Fall 2011, Vol 7, p 4.


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Continued on Page 13


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(Reprinted with permission ofAAP News, Dec. 2011)


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Section on Anesthesiology and Pain Medicine

Robert M. Smith Award Nomination Form 2013

The Robert M. Smith Award has been awarded since 1986 to honor an individualwho has made outstanding contributions to the field of pediatric anesthesiology.

If you know of a pediatric anesthesiologist who meets these criteria, please complete and return

this nomination form.

I hereby nominate the following member to receive the Robert M. Smith Award:

Nominee: ______________________________________________ from: ______________(please print) (state)

Please include a 2-3 page bio-sketch with your nomination form. Only one nomination per

Section member will be accepted.

ALL NOMINATIONS MUST BE RECEIVED BY MAY 2, 2012.

Nominated by: __________________________________________ from: ______________(please print) (state)

E-mail Address: ____________________________________

Please return this nomination form and 2-3 page bio-sketch by May 2, 2012 to Jennifer Riefe

via fax to 847-434-8000

or via email to [email protected]

The previous Robert M. Smith Award Winners are:

2012: Nishan Goudsouzian2011: Charles Cot2010: Juan Gutierrez2009: Ryan Cook2008: Federick Berry2007: Josephine Templeton2006: Al Hackel2005: Not Presented

2004: Theodore Striker2003: Etsuro K. Motoyama2002: Dolly Hansen2001: David Steward2000: Not Presented1999: George A. Gregory1998: John F. Ryan1997: C. Ron Stephen1996: John J. Downes

1995: Leonard Bachman1994: Margery Van Norden Deming1993: Gordon Jackson-Rees1992: Joseph Marcy1990: Herbert Rackow and

Ernest Salanitre1988: A. W. Conn1987: William O. McQuiston1986: Robert M. Smith

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