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Baxler International Inc.One Baxter ParkwayDeerfield, Illinois 60015-4633847.948.2000Fax. 847.948.3948Writer's Phone: 847-948-4879Writer's Fax:847-948-2552EaxterApril 9, 2008U.S. Nuclear Regulatory CommissionAttn: Regional AdministratorRegion I475 Allendale RoadKing of Prussia, PA 19406Re:Confirmatory Order (EA-07-132)Training Documents as agreed to under OrderLicense No.: 52-21 175-01Baxter Healthcare of Puerto Rico, Aibonito, Puerto RicoryruDear Sir,On March 28, 2008, we sent you a draft of our training document as agreed to in the abovereferenced Confirmatory Order (Item D(2)). The training focuses on a safety conscious workenvironment and raising issues without fear of retaliation.After some helpful comments from NRC staff on April 7, 2008, we revised the presentationslides.Enclosed please find the revised presentation that Baxter intends to provide.As noted previously, it is our intention to translate part or all of the presentation to Spanish,based on the audience. As appropriate, we may make slight revisions or enhancements to theenclosed material before or during the training to facilitate better learning.The training will be completed before June 30, 2008, as agreed to in the OrderPlease contact me at 847-948-4879 or the Plant General Manager, Mr. Enrique Moran, at 787735-8021, extension 2261, if you have any questions regarding this letter.Sincerelv.Peter EtienneSenior CounselPE:Ifbcc: Enrique Moran, BaxterKarl Farrar, NRC/enclosure146015-1

How can we collaborate to createa safe and compli nt workplace?BaxterAibonito, Puerto Rico2008

What “happened”?Some employees chose not to follow proceduresregarding radiation safety at the irradiatorThese employees did not conduct required inspectionsbut prepared documents saying that they didThere were allegations of falsified training recordsThe Nuclear Regulatory Commiss on (NRC) uncoveredat least three violations during inspections last MarchInspectors attributed the violations to “deliberate acts” byemployees2

What “happened”?i--” -I.-.--I* l l.--.--- --- -I.1-- ---- Baxter HealthcareCorporation of PuertoRico-Aibonitonhonored forEnvironmentalAchievements in 2002-J-.“.!1--LxI“ lll-.-.x- l lll-lI--”-- - --I-- “ l ll lNRC documented sixviolations of requirements in2005Baxter To Pay 15,000 FineFor Lax Testing in 20083

What “happened”?Employees did not alert management about issues withthe procedures or about other employees not followingthe proceduresBaxter incurred fines of 15,000, on top of 31,000 forviolations in 2004Some people have lost their jobs over itThe regulatory status of the irradiator and the plant is putat risk by these behaviorsNow our work is under scrutinym m munnecessarily4

What “happened”?PLEASE NOTE:This was our own doingNot an “act of God”Not a random or unavoidableaccidentUntil we accept responsibilityfor this, we cannot assure itwon’t happen again5

What “happened”?Learning?Actions of individuals take place within specific culturalcontexts. The cultural context we create will either promotecompliance and safety, and make it easy for all of us to dothe right thing-or erode it and increase risk.Bottom line:As a team and as a community, we failed to create the rightcultural context for full compliance, to help our comradessucceed, and to protect the people who use our products.6

“Everybody makes mistakes.It’s what we make of our mistakesthat makes us what we are.”. Anonymous

Do you know who you are?You are part of a plant that:Employs about 1,100 employeesManufactures about 110 million units of over 200different finished product codes each year.Is a global supplier of intravenous solution sets, bloodsets, and components for customers worldwide. Thank You!8

If you see someone doing something unsafe e.g., like afellow employee in the irradiator area who does notfollow procedure, talk to that employee and help him/herunderstand that all procedures must be followed.If you or the employee have a suggestion to improve aprocedure or any other suggestion to improve safety,share that with a supervisor or any manager.If you see an employee, visitor or contractor intentionallydoing something unsafe, including not followingprocedure, politely ask the person not to do so. If theperson refuses, tell a supervisor or any manager.9

Please: Use these processes to ask questionswhenever something doesn’t seem right to you!This is the responsibility of each and every Baxteremployee, whomever or wherever you may be.9,10

What are “these processes”?One or more of us should have noticed that wewere not being diligent and alerted managementIn case of any ethics or compliance issue,please: voice your concern!FirstIf not, thenIf not, thenOryour supervisor, manager, or RSOHuman ResourcesPlant General ManagerEthics and Compliance Office11

.What are “these processes”?Baxter is utilizing EthicsPoint, an outside vendor toprovide you with ways to confidentially reportconcerns or seek advice on ethics and complianceissues.This service is available 24 hours a day, 7days aweek with representatives who can consult with youin Spanish.Baxcerlnvestiyators b -cYou are currently In the confidenbalan0 Secure reporbno structure of EthicsPOinl Below are the choices available toyou Pleaseckkonthe arrow()loselectthetypedreponywMuldlHre0meke.Ask a aucsllonEthics andMake a Report OnlineCompliance Helpline-- Select Ocganizarton -The work thatwe do is important-applying innovative science todevelop specialty therapeuticsand medical producrs that saveBaxter.The inaccurate recording and analysis ofthe business and financialuansacflons assonatad wiM generally accepted aocountlng practicesAccounting and Audkhg Matters (Earnpies indude miSSPdtamntof revenues. tniwatement ofexpenses. misstatement of assets. misapplicationsof GAAP principles.Brlbes, Kkkbacks, FCPAwrongful transacttons)Any unlawful payment of money or anything ofvalue. to influence thejudgment or conducf or to ensure a desired outcome or adion ofanyulnla.lnnr n i &ha. r n r r i i eIndlirwi tsi FMaking GtrgllshCasrc,c,.opca4,,,.2I I C M m m n s n u -I n m n o n rnnFooonlitmin ‘nnxrommanhl

What are “these processes”?You can contactBaxter’s Ethics andCompliance Helplinetoll-free, and request tospeak to someone inSpanish. Let’s try it now13

What are "these processes"?This wcbpage IS hmtcd or EthicsPoirt's sccurcd scrvcr ardISrot part of !hc Baxtcr wcb sib or irtrorctEthics andCompliance HelplineAsk a QuesllonSubmiiCall the Elhlcs 8 ComplianceHolpllnaDornalic Calk:U S , Canada. Guam. 8, PucrfoRWDUI 1.en.ma373tntematknat calls:Choose a CountryFrom ap u t l dlma dtalAt the prompt, dal877.1258373Chock tho Status Of YourReportReport Key or UsemamcPassword.'iubrnit Baxtcr's Ethics andCompllancs StandardsFraquanllyAskod QuestionsThe work rhai we do is important-applying innovative science todevelop specialty therapeuticsand medical productsthat saveand sustain patients' livesworldwide But equally importantis how we work-the behaviorsthat we demonstrate and thejudgments that we make on adaily basissubmit a question orconcern to the Ethicsand ComplianceHelpline via onlineform:Baxtefs corporate reputation isachieved by our individualbustnesscondua Every day ourco-workers. customers.suppliers, investors. and thecommunittes in which we liveand work evaluate us Everyinteramon is an opportunityforus to demonstrate that integrityis central to our businesssuccess-that "integrity workshere "The Baxter Ethics andCompliance Helpline is amethod for reporting actual orsuspected conduct that mayinvolve violatton of applicablelaws, rules, regulations.standards, poliues. andaccountmg procedures orotherwise inconsistentwithm a aLet's try it now14

What are “these processes”?EaxterWorldwidewww.baxter.com Doing Business with Baxter Business PracticesYou can contact the Ethicsand Compliance Helpline viaphone: 1-877-229-8373. Oryou can contact the CorporateResponsibility Office viapostal mail or e-mail as notedbelow. Let’s try it nowupervisor, manager or department leadersxterand its FoundaoonContribute Nearly,3 Million in 2007 to Address Critical Neebsically and Globally [ ’ h - ,l r C r ’* b’ 7Functional expertsRecent LinksinforniationUPDATE Baxter’sCOLLEAGInfusionPump With Links to CCustomer Letters(e.g., legal counsel,controller, H R,quality VP, etc.)Ethics & ComplianceHelpline1.877.BAXTER3(1.877.229.8373)On line atwww.baxter.com/complianceCopyrigM &Legal Disclaimer I PrivacyCorporate Responsibility OfficeCRO P.O. Box 154Deerfield, IL 60015 r.com15

What are “these processes”?.You can call anyoneon our Ethics andCompliance team!Dave Resnicoff847-948-4424Julie Brautigam847-948-2387Peter Etienne847-948-4879Brenda Hildreth847-948-4633Sheri Rudberg847-948-316616

Key TopicsYou can call or writethe NRC directly.(Phone number 1-800695-7403).Emergency PreparednessIrradiated GemstoresNevi Reactors.Radiatw ProtectionRadatton Source Securityand ReplacementReactor License Renewalrn-tlw navwdmmatl- on nactnequipmedweld. th.t raisedw s b o t m about whether mspeE(I011syore msded IM01mvtng plannedshuMmm this spring moreFor the RecordPrevious Key TopicsHighlightsRegulatory Information Conference on March 11 13,2008We encourage you toexpress your concernto someone at theplant or at Corporate.k TeachenNews Releases and SpeechesBudgetFV07 Performance &AccountaWlty ReportI& DieestMarch 14, ZOOSPhotoGalleryStatement of NRC Chairman Dale E Klem on theConfirmation of Gregory Jacrko to a Second TermStatement of NRC Chairman Dale C Klem on theConfirmation of Kristine Svinlckl as an NRCCommissionerNRC to Discuss 2007 Performance Assessment lorPalo Verde Nuclear Generatzng Statson17

The NRC and BaxterWhat is Baxter’s responsibility to the NRC?rn What is each employee’s responsibility to the NRC?rn What would happen if I was personally responsible for aviolation?rn Can / may I talk to an NRC inspector?Can / May I request an inspection?Both the law and Baxter policy prohibits retaliationagainst employees who raise safety concerns to theNRC. So you can raise concerns without fear ofretaliation.18

What do “confidential” and “anonymous”mean, exactly?See Frequently Asked Questions atQi. f f f r e p o an issue anline, can yc3u identify me thmugh my IP address?Art Internet portal never rdentfies a wisimr by xreer1 name. l ’ k Elhirs and Compliance Helplinesyshtzrn we use thruuyh our thiru party wndor kthicspuinl’ strips away 1P add-ssaanonymity is maintarred.Q, Is the telephone Ethics 8r Compliance Helpline system canfidential and ananymaus tm?Yes. You wll be a s M to provide the same infarmtion that you would pmide in an internelbawd rejmrt and an interuiwer will type your respansles into the Ethics and t crmplraneeHelplinesystem, These reports have the same sxurity and rmfidefitiali‘ly measures applied to them asthe Internet reports.

Afraid of reotalioaition?Harmful action to someone who has harmedYOUAction taken in return for an injury or offenseThe act of retaliating: reprisal, retribution,revenge, vengeanceIdioms:An eye for an eye. Tooth for a tooth.Like for like. Measure for measure. .20

Afraid of reotalioa'tion?Retaliation can take many forms:Demotion, firing, or harassed to quitDenial of raises or proper compensationSudden decline in performance ratingsExclusion from meetings and social activitiesAssignment of less desirable workTreatment as malcontents or trouble-makers21

Baxter’s NO RETALIATION PolicyNo one will be punished for asking about possiblebreaches of law, regulation, or company policy.Any allegation of a reprisal will be investigated.Baxter managers, as well as the CorporateResponsibility Office enforce this policy.Retaliatory actions must be reported immediately.Retaliatory behavior is subject to disciplinary action.22