FOUNDATION FOR THE ACCREDITATION OF CELLULAR THERAPY

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In this Issue:• LindaMiller,MPANamedCEO

• RelationshipBetweenStandardsandRegulations

• TranslatingDocumentstoEnglish

• PurposeofDataAudits

• FACTWebUpdate

• FACTInspectorPolicies

Editor: Kara Wacker, MBA, RAC

FACT recently celebrated its 15th

birthday and although it is now

entering young adulthood, it has

had only two Presidents. EJ Shpall

ledFACTforthefirst7yearsthrough

the challenging task of convincing

blood and marrow transplanters

and laboratory scientists that they

wantedbothtodevelopstandardsacrossallprogramareasof

clinical care, processing and collection and also to pay to be

inspectedforcompliancewiththesestandardsbytheirpeers.

EJ and her colleagues on the first FACT Board persuasively

articulatedtheirvisiontothecommunity.Fromthefirstmeeting

to train inspectors in Nebraska in 1996, FACT has now grown

to an organization that accredits more than 90% of facilities

in the United States as well as facilities in Australia and New

Zealand. EJ often says that her two major accomplishments

werepersuadingPhyllisWarkentintoserveasMedicalDirector

andFredLeMaistretosucceedherasPresident.Fredtookover

fromEJin2002,andhasusedhisconsiderableleadershipskills

to guide FACT though significant organizational growth and

extensionofitsqualityimprovementmission.Itisanhonorto

succeedtheseaccomplishedleadersasthethirdPresident.

When I went on my first FACT inspection as a trainee, Frank

Smith was my mentor and he had many good tips, such as

limosaremorereliablethantaxis(youcanreadmoreabouthis

philosophyforinspectionsontheInspectorSpotlightsectionof

theFACTwebsite).Perhapshismostimportantadvicewasthat

thegoalofthe inspection isto improvethequalityofcareat

alltransplantcentersbyensuringthateveryonemetminimum

standards, while emphasizing that there are many ways to

meet the Standards and that the process should be collegial

and collaborative. I think these imperatives encapsulate why

somanyindividualsinthetransplantcommunityvolunteerto

performinspectionsandalsotoserveontheFACTBoardand

committees. I know the process has improved the quality of

careatmyowninstitutionandIinvariablylearnaboutdifferent

approachesandsolutionswhileinspectingotherprograms.In

anerawhenchangesinheathcaredeliverywillplaceincreasing

importanceondefiningandmeetingvalidatedqualitymetrics,

thefieldofbloodandmarrowtransplantationhaspioneeredan

accreditationsystemthatcouldbeadaptedbyotherspecialties.

AnotherreasonFACThasbeensuccessfulisthatthe

inspectorateandBoardissupportedbyanoutstandingcadre

ofindividualsintheFACTofficeledbytheChiefMedical

Officer,PhyllisWarkentin,andtheChiefExecutiveOfficer,Linda

Miller,whoarehighlypassionateabouttheFACTmission.

continued on page two

Winter 2012Inaugural Letter from the President

Accreditation ReportTwenty-fivebloodandmarrowtransplantprogramsreceivedaccreditationrenewalduringthefourthquarterof2011.Thecompletereportofaccreditedorganiza-tionsinthefourthquarterisavailableatwww.factwebsite.org.

CellularTherapyPrograms

201ProgramsRegistered

185ProgramsAccredited

16ApplicationsPending

CordBloodBanks

53BanksRegistered

32BanksAccredited

21ApplicationsPending

It is an honor to succeed accomplished leaders as the third President.- Helen Heslop, MD

Winter2012|2

Dr. Heslop’s Inaugural President’s Letter

continued from page one

Inthelastyear,theyhavedevelopedseveralnewinitiativesto

provideaddedvaluetocenters.Inthisnewsletter,youcanread

aboutthenewFACTWebaccreditationsystem,whichwillfacilitate

bothsubmissionofdocumentsandthereviewprocess,thereby

savingmanytrees.FACThasalsobenefitedfromstrongsupport

fromitstwoparentprofessionalorganizations,ASBMTandISCT,

andfromitsaffiliationwiththeUniversityofNebraska,whichhas

hostedFACTsinceitsinception.

AgreatstrengthofFACTisitsphilosophyofinclusion,providing

multipleopportunitiesforengagementofinspectors.Forexample,

FACThasanumberofcommitteesandtheofficewillsooncirculate

arequestfornewmembers.Anyonewhowishestolearnmore

abouttheprocessorhasideasforimprovementsornewdirection

iswelcometovolunteerandparticipate.

Atthemostrecentstrategicplanningmeeting,theFACT

committeesalldevelopedgoalsforthenextthreeyears.Onegoal

oftheLeadershipCommitteewastodevelopfutureleadersandto

thatend,AlanLeahighranaverywellreceivedLeadershipCourse

attherecentTandemmeetings.Anothergoalwastodevelopa

successionplan,soyoucanfeelreassuredthatIwillnotfollow

FredinservingforadecadeasDennisGastineauisalreadyslated

toserveasthe4thPresident.ButwhileIaminpost,Iwillbe

delightedtoreceiveyoursuggestionsorfeedback.Ilookforward

toworkingwithyouall.

Sincerely,

HelenHeslop,MD

Linda Miller Named FACT CEO

TheFACTBoardofDirectorsrecentlyappointedLindaMiller,MPAasChiefExecutiveOfficer(CEO).Through

herleadershipsince1997,shepositionedFACTasaleadingaccreditationorganization.Ms.Miller’sdedication

tooperationalizingthevisionoftheBoardofDirectorshasmadetheFACTaccreditationprogramaneffective

meanstoqualitycellulartherapy.HelenHeslop,MD,FACTBoardPresident,says,“LindahasledtheFACToffice

fromitsearlydaysandhasalwaysexemplifiedthecommitmentoftheofficestafftotheFACTmissionof

ensuringthehighestqualitycareforpatientsreceivingcelltherapies.AsFACThasgrown,shehastakenon

increasingadministrativeandstrategicplanningresponsibilities.IamdelightedthattheFACT

A Word from Linda Miller, MPA, FACT CEO

I am honored to be appointed as FACT’s Chief Executive

Officer.Ioncereadastatementthatsaid,“Justbecauseyou

areCEO,don’tthinkyouhavelanded.Youmustcontinually

increaseyourlearning,thewayyouthink,andthewayyou

approachtheorganization.”I’veneverforgottenthat.

The key to any successes we’ve achieved at FACT has

beencollaboration.Andwhilemanybelievethiswordhas

beenusedfartoooften, Ithinkintruth,there’smoretalk

about collaboration than there is actual collaborating.

I believe there is a circle around each of us.We can’t see

it,but it’s there. It’s thecircle thatdefinesour role…our

responsibilities … the things that we’re expected to take

care of in our businesses. My circle is FACT. My primary

responsibility,thethingIneedtodofirstandforemost, is

take responsibility for ensuring that our standard-setting

and accreditation program delivers outstanding service

totransplantcentersandcordbloodbanksworldwideto

benefitourpatients.

I’ve discovered over the years that making things work

insidethiscircleofteninvolvestakingastepoutside.FACT’s

transformation into a leading accreditation organization

would not have been possible without its involvement

in so many different initiatives through the collaborative

effortsofourdevotedvolunteers.Thecommitmentofour

volunteers has allowed FACT to grow exponentially over

thelastdecade.Continuingtostrengthenourrelationships

withourpeerorganizationsinthefieldofcellulartherapy

willbeaprioritythisyearasweallexploretheaccelerating

advancements in the areas of regenerative medicine. In

collaboration,wewilldowellbydoinggood. Iameagerto

sharewiththosewhosharemycircle.

leadership has recognized Linda’s contributions and role by

appointinghertothepositionofChiefExecutiveOfficer.“

Winter2012|3

The5theditionoftheFACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration, with

itsaccompanyingAccreditationManualandonlineFACTWebcomplianceapplication, willbepublishedonMarch1,2012.Atthat

time,theStandardsandAccreditationManualwillbeavailablefordownloadand/orpurchaseonline,thecomplianceapplication

(formallyknownasinspectionchecklists)willbepublishedinthenewonlineFACTWebaccreditationportal,andancillary

documentsincludingguidesandcrosswalkswillbepostedintheFACTWebuserarea.

The5theditionbecomeseffectiveonMay31,2012.Allaccreditedcellulartherapyprogramsmustbeincompliancewiththe

Standardsbythatdate.Toassistwiththetransition,acomprehensiveoutlineofchangesisavailable.Whilethisoutlinedoesnot

addresseverychange,itdoeshighlightthemajorrevisionstotheStandardsandprovidesexplanationsandreferences.

CellulartherapyprogramsareencouragedtocontacttheFACTofficewithanyquestionsregardingthe5theditionStandards.

The Relationship between FACT Standards and Regulatory Requirements for Research Studies

FACTisastrongproponentofcellulartherapyresearchandisanenthusiasticsupporteroftheresearchconductedbyitsaccredited

organizations.Researchstudiesareundertheclosescrutinyofregulatoryagencies,suchastheFDAInvestigationalNewDrug(IND)

requirementsintheUnitedStates.Asthenumberofresearchactivitiesataccreditedorganizationsincrease,theseorganizations

becomemoreawareoftheneedtoestablishprocessesthatmeetbothregulatoryrequirementsandFACTStandards.Thefollowing

aresomepiecesofadviceonhowtosatisfyFACTrequirementsforresearchstudies:

• WhenacertainpracticeisforbiddeninanINDstudy(ornon-U.S.equivalent),thatpracticemustnotbeperformedevenifit

isrequiredoftheFACTStandards.Thatis,theFACTstandardrequiringcompliancewithapplicablelawsandregulationstakes

precedence(CellularTherapy(CT)StandardsB1.3,C1.2,D1.2andCordBlood(CB)StandardB1.2).

• IfapracticeisnotrequiredinanINDstudy(ornon-U.S.equivalent)butisrequiredoftheFACTStandards,thatpracticemust

be performed. A common difference between IND requirements and FACT Standards are labeling requirements – even if a

FACT-requiredelement isnotrequiredofthe IND,theaccreditedorganizationmust includetheelement.Anothercommon

differencethat is likelytoresolveunderthe5theditionCellularTherapyStandardsaretestingrequirementsforautologous

donors(communicablediseasetestingforautologousdonorsisnotrequiredunderthe5thedition).

• Outcome data evaluation for Phase I studies and blinded studies is required by FACT Standards; however, it is understood

thedatawillbedifferent.Forexample,PhaseIoutcomedatawilllikelybelimitedtosafetydata.Blindedstudieswillrequire

outcomeanalysisonanaggregatelevel.

• IfadeviationfromFACTstandardsisunavoidable,theaccreditedorganizationmustcomplywithplanneddeviationrequirements

(CTStandardsB4.10.5,C4.10.5,D4.10.5andCBStandardB2.10.5).

IfyouhaveanyquestionsregardinghowtoapplyFACTStandardstoresearchstudies,pleasecontacttheFACToffice.Wecommend

all organizations pursuing new and improved uses for cellular therapy and look forward to celebrating your discoveries and

accomplishments.

5th Edition Cellular Therapy Standards to be

Published March 1st

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Winter2012|4

Translating Documents to English

TheinternationalnatureoftheFACTinspectionandaccreditationprocessisexciting,butdoespresentchallengeswhenthereare

language differences between the inspectors and the organization being inspected.The FACT process is conducted in English,

requiring some document translation for many of our applied and accredited organizations. It is not intended to be overly

burdensome,andFACTdoesnotwantthisconcepttodeterorganizationsfrompursuingprestigiousFACTaccreditationorcause

themtoutilizepreciousresourcestotranslatealldocuments.

RequirementsforEnglishtranslationareincludedintheapplicableDocumentChecklist,whichcanbefoundinFACTWeb>Resources

>DocumentLibrary(chooseeithercellulartherapyorcordbloodasapplicable).OncetheonlineFACTWebaccreditationportalgoes

live,therewillbeareminderwitheachindividualstandardrequiringEnglishtranslation.Alsoatthattime,theDocumentChecklist

willbereplacedwithasupplementaloutlineofdocumentsthatmustbetranslated.

While FACT requires a minimal number of documents to be translated, it does not reduce the responsibility of the applied or

accreditedorganizationtopresentevidenceanddocumentationofcompliancewiththeStandards.FACTmakeseveryeffort to

includeatleastoneinspectoronaninspectionteamthatspeaksandreadsthelanguageoftheorganizationbeinginspected,but

thisisnotguaranteed.

Applicantandaccreditedorganizationsareresponsibleforensuringthat:

1. Someoneisalwaysavailabletointerpretconversationsandtranslatedocumentsfortheinspectorsduringtheon-siteinspection.

2. Documentationiscopiouslyorganizedinamannerthatenablestheinspectorstodeterminewhatdocumentstousetoverify

compliancewithspecificstandards.

3. Personnelispreparedtodemonstrateprocessesandproceduresasmuchaspossibletopromoteinspectors’understanding,

evenifthestaffdoesnotspeakEnglish.

InspectorsalsohavearesponsibilitytogiveorganizationseveryopportunitytodemonstratecompliancewiththeStandards.Ways

todothisinclude:

1. Using a variety of question types to obtain needed information. Sometimes phrasing a question differently can promote

understanding.Talkinglouderdoesnotusuallyhelp!

2. Askingpersonneltofindneededinformationindocumentsratherthanalwaysattemptingthiswithouttheirhelp.

3. Providingpersonnelopportunitiestodemonstrateprocessandprocedureswhenwrittendocumentationisnotconclusive.

ThekeytoFACT’ssuccess,andthesuccessoftheorganizationsitaccredits,isthecollegialandhelpfulnatureofourinspectorsandof

thepersonnelseekingaccreditation.Thisconceptappliesverywelltointernationalinspections.Enjoytheopportunitytoworkwith

peoplefromothercountries,andrememberthatwewanteveryonetoachievecompliancewiththeStandardsandreceiveFACT

accreditationforthebenefitofpatientsaroundtheworld.

The key to the success of FACT and the successful accreditation of organizations around the world is the collegial and helpful nature of

the FACT accreditation process.

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Winter2012|5

Data Audits: Audit the Data, Not Medical Decisions!

ThedataauditportionofClinicalPrograminspectionshasalwaysbeenachallengingandtime-consumingpartoftheinspection

day.Theprogramsbeinginspectedareadvisedtoorganizetheirdata(mostoftenonCIBMTRTEDforms)andtheirprimarysource

records(laboratoryreports,clinicalnotes,etc.)inamannerthatmakesitveryeasyforinspectorstomatchthedatatothesource

record.Thisisoftenachievedwiththeuseofstickynotes,shadowcharts,etc.

Whileproperorganizationofthedocumentationisaverynecessaryprerequisiteforanefficientdataaudit,inspectorsmustfollow

throughwithaneffectivestrategyforperformingtheaudit.DuringFACT’sregularreviewoffeedbackontheinspectionprocess,a

commontrendisemerging:thepurposeofthedataauditisuncleartosome.

Therearenostandardsforpatientoutcome,nordotheFACTstandardsprescribemedicalpractices,includingthediagnosingof

patients.Thus,thepurposeofthedataauditisnottoreviewhowadiagnosisisdeterminedorhowoutcomesareclassified.

The purpose of the data audit is to verify that the data on the TED forms matches the primary source records.

No more, no less.

For example, during the data audit, an inspector finds a patient’s diagnosis as indicated on the TED form, and then looks for

documentationinthechart(orshadowchartifonewascreated)thatconfirmsthatsamediagnosis.Duringthecourseofthereview,

theinspectorseesthatthediagnosesontheTEDformandinthechartmatch,butalsoseesthatotherinformationmaypointtoa

differentdiagnosis.Thisisnotacitation,sincethediagnosesmatch.Inspectorsmayincludetheirthoughtsaboutthisasasuggestion

intheinspectionreport,butitisnotacitation.

The5theditionCellularTherapyStandardsCommitteemadesomechangestotheStandardstopromoteunderstanding.Inspectors

andClinicalProgramsareencouragedtocontacttheFACTofficewithanyquestionsaboutthedataaudit.Itisthehopethatbetter

understandingofthepurposeofthedataauditwillresultinmoreefficientinspectionsandamorepleasantexperienceforboth

inspectorsandClinicalPrograms.

Coordinator Commentary - The Exit InterviewSarah Litel-Smith, BSMT(ASCP)

Thelastpartoftheon-siteinspectionistheexitinterview.Duringtheexitinterview,theinspectionteampresentsasummaryof

theirfindingstotheprogramorbank.Itisimportanttokeepinmindthatanaccreditationdecisioncannotbeimpliedandcitations

cannotbestatedwithcertaintyuntilreviewbytheAccreditationCommittee.TheFACTinspectionandaccreditationprocesshas

severallayersofoversighttoensureconsistencyandobjectivity,andchangesmaybemadetotheinspectionreportbetweenthe

inspectionandtheaccreditationdecision.

During the exit interview, each inspector summarizes the major findings in the area he or she inspected. It is important to be

constructivebutrealisticduringtheexitinterview.Theprogramorbankshouldnotbesurprisedbywhatisinthefinalreport.Try

toindicateareaswherethereisclearcomplianceorexcellence.Pointoutmajorareasofdeficiencyifyouarecertainthattheseare

inclearviolationoftheStandardsandnotopentootherinterpretation.Thereisadelicatebalancebetweenlistingallexpected

citationsandsummarizingthem.Inspectorsshouldprovidesufficientinformationtogivetheaccreditedorganizationafeelforwhat

theinspectionreportwillinclude,butorganizationsneedtorememberthateverycitationwilllikelynotbementioned.

Winter2012|6

Transition to Online AccreditationRamona Repaczki-Jones, MSE

TheFACTWebAccreditationPortal isalmosthere!OnMarch1,2012,FACT’s inspectionandaccreditationprocesswillbeonline,

providingbenefitssuchasreducedprinting,copying,andshippingcosts;streamlinedreviewandcommunication;andreal-time

updates.Whenprogramsbegintheprocesseitherforaninitialapplicationorrenewalapplication,theywillnowusetheportal.Those

programsalreadyintheprocesswillcontinuewiththeexistingpaper-basedproceduresuntiltheyapplyforrenewalaccreditation.

ThefollowingisabriefoverviewofthemajorfeaturesofFACTWeb:

EligibilityApplication:Theonlineapplicationforaccreditation.Thepurposeofthisapplicationistodetermineifanorganizationis

eligibleforaccreditationandtogatherinformationnecessarytocreateapersonalizedchecklist.

ComplianceApplication:Thecomplianceapplicationcombinestheformerinspectionchecklistsanddocumentchecklistsintoone

application.Inthecomplianceapplication,applicantswillindicateiftheycomplywithastandardanduploadevidencedocumenting

compliance.Applicationsarecustomizedtotheorganizations,meaningthatonlychecklistsanddocumentationapplicabletothe

organizationwillberequired.

RequestsforInformation:RequestsforInformation(RFIs)areafunctionalityofthecomplianceapplicationthattheFACTOfficeand

inspectorscanusetorequestmoreinformationordocumentationfromtheapplicant.RFIsenablereal-timecommunicationtoall

partiesinvolvedandallowtheadditionalinformationanddocumentationtobeuploadedrightintothecomplianceapplication.

AccreditationOutcome:TheaccreditationoutcomewillbeemailedviatheFACTWebaccreditationportaltopersonnelspecifiedby

theapplicantprogram.Withthisnotificationwillbeinstructionsforsubmittingresponses,additionalinformation,etc.

InspectorDashboard:Uponloggingintotheaccreditationportal,inspectorswillarrivetoanonlinedashboardthatincludesallof

theircurrentandupcominginspections.Throughthisdashboard,inspectorswillbeabletoaccessthecomplianceapplicationsthey

needtoreview,sendoutRFIstoorganizationstheyareinspecting,andindicatewhetherornottheapplicantisincompliancewith

theindividualstandards.

ApplicantOrganizationDashboard:Uponloggingintotheaccreditationportal,applicantswillarrivetoanonlinedashboardthat

includesalloftheircurrentapplications.Throughthisdashboard, individualsfromapplicantorganizationswillbeabletoaccess

andreviewcomplianceapplications, submitevidenceto indicatewhetherornot theapplicant is incompliancewith individual

standards,replytoRFIs,andcheckthestatusoftheirapplication.

InspectionandAccreditationReports:Inspectionreportswillbeautopopulatedwithinformationfromthecomplianceapplication,

includingdemographicdataandcitations.Inspectorswillbeabletoreviewandedittheirreports.UponsubmissiontotheFACT

office,theFACTAccreditationCoordinatorswillbeabletoeditthereportsasdirectedbytheFACTAccreditationCommittee.

TheFACTWebaccreditationportalcontainsanenormousamountoffeaturesintendedtomodernizeandimprovetheinspection

andaccreditationprocess.Thebestwaytolearnaboutalltheportalhastoofferistoattendaworkshop.Trainingenvironmentswill

beavailableinthefuture–staytunedformoreinformation!

Winter2012|7

Shadow Charts: A Useful Tool in Today’s Digital World

What,exactly,isashadowchart?Ashadowchartisasubsetofdocumentationfromapatient’smedicalrecord.Organizationsoften

useshadowchartsduringon-siteinspectionssothattheinspectoronlyhastogothroughthepagesofnotes,forms,reports,and

recordsnecessarytoverifycompliancewithFACTStandards.Shadowcharts’relevancehasexpandedintotheworldofelectronic

medical records. Inspectorsshouldnotbeexpectedtonavigateelectronicmedical recordsonhisorherownbecausetheywill

oftennotbefamiliarenoughwiththesystemstolocatedocumentation.Toincreasetheefficiencyofinspectionsandthelikelihood

thatinspectorswillbeabletolocateevidenceofcompliance,organizationscananticipatewhatportionsofamedicalrecordan

inspectorwillneedtosee,andthencopythatdocumentationtocreateashadowchart.

InlinewithFACT’smovementtowardsdigitalprocessesand“green”operations,organizationsshouldnotattempttocreateshadow

charts for each of their patients. A common rule of thumb is to create shadow charts for the patients for whichTED forms are

submittedand, ifnecessary,additionalshadowchartsforpatientsforwhichthedonorwas ineligible,anonconformingproduct

wasused,etc.Ifaninspectorwishestoseedocumentationonadditionalpatients,heorshecanrequesttoseetheelectronicrecord.

InspectorswillstillneedtoseetheelectronicrecordsystemtodetermineifitmeetsFACTStandards,andorganizationswillstillneed

tobepreparedtohavesomeoneavailabletoassisttheinspectorwithusingelectronicsystems.Ifyourorganizationuseselectronic

recordsystems,werecommendthatyoucommunicatewithyourinspectionteamregardinghowtobestshowcaseyourprocesses

andprovidedocumentationforreview.

Quality Corner: Mature QM Systems - Focusing on the FutureJill Hempel, MS, ASQ-CMQ/OE

Amaturequalitymanagementsystemcontainsseveralprinciplesthattogethercanbeapowerfulguideforfutureorganizational

behavior.ThefollowingoperationalprinciplesdevelopedbyWestandCianfrani(2005)providepersonnelwithactionsthatshould

betakentoimprovetheorganizationfromabusinessperspective:

ProvideVision:Organizationsshouldcontinuouslymonitorthesatisfactionofcustomers(patients)andotherstakeholders,andbe

preparedtoactontheresultstoimproveforthefuture..

AlignObjectives:Ensureallpersonnelwithintheorganizationareawareofhowheorshecontributestotheorganizationalobjectives

toenhancetheabilitytoachievepositiveresults.

ManagetheSystemofProcesses:Understandingtheinteractionsoforganizationalprocessesasawholesysteminsteadofindividual

componentsallowstheorganizationtobemoreeffectiveandefficientinmeetingitsobjectives.

Make Decisions Based on Fact: Create methodologies to collect and analyze data that allow the organization to continuously

monitoritsobjectives,makedecisions,solveproblems,andidentifyareasofimprovement.

Learn, Improve, and Innovate: Personnel in the organization are essential to innovation. The organization should identify and

encourageplannedlearningandopportunitiesforimprovementonallpersonnellevelstofosterinnovation.

DevelopPersonnel:Personnelshouldbefullyengagedintheirworkandinvolvedinmeetingorganizationalobjectives.

DevelopStakeholders:Identifyingkeypartnersandtheroletheyplayintheorganization’sdevelopment

helpgeneratevalueforallstakeholders.Creatingarelationshipwitheachstakeholderbasedon

mutualtrustandsharingofrelevantinformationimprovesqualityforall.

Winter2012|8

FACT Policies Help Inspectors Understand Expectations

Recruiting and retaining the best and brightest of cellular

therapyisintegraltoFACT’speer-reviewprocessofinspection

andaccreditation.Itisimportanttothesuccessofourinspectors

andthecredibilityofFACTaccreditationthatexpectationsare

transparentandobvious.

FACTinspectorpoliciesareontheFACTwebsiteatFACTWeb>

FACTPoliciesandProcedures>FACTInspectors.Allinspectors

are encouraged to review the policies that were updated in

November 2011.These policies were reorganized and revised

toupdateourprocessesandclarifyinspectorrequirements.The

policiesare:

• Initial Inspector Qualifications: This policy outlines the

experienceandeducationrequiredforanindividualtobe

approvedasatraininginspector.

• Inspector Status Qualifications: This policy outlines what

constitutes an inspector status, including trainee, active,

pending,andcancelled.

• InspectorTrainingProgram:Thispolicydescribestheinitial

inspector training program and continuing inspector

educationrequirements.

New Requirement for Active Inspectors!

Active inspectors must participate in at least one FACT

educational session in each calendar year. Inspectors can

chooseawebinar,anonlinetutorial,oranin-personworkshop.

Thepurposeofthisrequirementistokeepinspectorsuptodate

on FACT Standards, how the FACT Accreditation Committee

interprets those requirements, and how to conduct effective

inspections.

FDA Releases Final cGTP Guidance

In December 2011, the FDA released the final guidance

document,“CurrentGoodTissuePractice(CGTP)andAdditional

Requirements forManufacturersofHumanCells,Tissues,and

Cellular and Tissue-Based Products (HCT/Ps).” This guidance

provides recommendations for complying with cGTPs for

products regulated under 361 of the Public Health Service

(PHS)Act,andmayalsobehelpfulforproductsregulatedunder

351ofthePHSAct(thoughitdoesnotincludeallrequirements

for these products). The 67-page document provides insight

intohowtheFDAinterpretstheregulationsandincludesmany

examples.

Register for the ISCT Annual Meeting

The ISCT Annual Meeting will be from June 5-8, 2012 at the

Sheraton Seattle in Seattle, Washington. Objectives of the

meetinginclude:

• The translational aspects of and issues involved with all

typesofcellandtissue-basedresearch.

•Topromotecross-disciplinaryparticipationfromscientists,

clinicians, laboratory personnel, regulatory professionals, and

keyopinionleadersfrombothacademiaandindustry.

•Toidentifyandaddressthescientific,clinical,laboratory,and

regulatory issues relatedtoeachtypeofcell-basedresearch/

therapy.

•Aforumforthetransferofknowledgeandexperiencesfrom

seniorpractitionersandkeyopinionleaderstoyoungscientists

inthefield.

Congratulationstoournewinspectors!

CordBloodBankInspector

Theofanis Chatzistamatiou, PhD

HellenicCordBloodBank

CordBloodBankInspector

Bipin Savani, MD VanderbiltUniversityMedicalCenter

Winter2012|9

FACT Workshops to Demonstrate FACTWeb! The2012FACTworkshopscontinuetobuzzwithexcitementthisyearasweunveiltheNEWonlineaccreditationportal,

FACTWeb,andgiveparticipantsanopportunitytowatchthesysteminaction!AllFACTinspectorsandpersonnelresponsiblefor

coordinatingFACTinspectionsarestronglyencouragedtoattend.Thefollowingworkshopsareopenforregistration:

Cellular Therapy Collection WorkshopAtlanta, GA on April 11, 2012In conjunction with the ASFA Annual Meeting

ThisworkshopwillbeaFULLday in2012!Theworkshopwillbeginat8amthisyear inorder toprovideattendees

practiceusingtheFACTWebaccreditationportal.AttendeesmustbringalaptoptouseduringtheFACTWebexercises.

Cellular Therapy Inspection and Accreditation WorkshopSeattle, WA on June 5, 2012In conjunction with the ISCT Annual Meeting

Twotracksareavailable:TheFACTWebtrackandtheIntroductiontoCellularTherapytrack.TheFACTWeb Trackprovides

detailedinformationanddemonstrationofFACT’snewonlineaccreditationportal.AllFACTinspectorsandpersonnel

responsible forcoordinatingFACT inspectionsarestronglyencouragedtoattend.FACTWebAttendeesmustbringa

laptoptouseduringtheFACTWebexercises.

TheIntroduction to Cellular Therapy Inspections Trackprovidesintroductoryinformationrelatedtotheinspection

ofclinical,collection,processing,andqualitymanagementfunctionswithinacellulartherapyprogram.Registrantswho

are new to the FACT inspection and accreditation process, such as new personnel and organizations seeking initial

accreditation,areencouragedtoattend.

Cord Blood Inspection and Accreditation WorkshopSan Francisco, CA on June 10, 2012In conjunction with the International Cord Blood Symposium

Atthisworkshop,ademonstrationofFACTWebwillbeprovidedinadditiontosessionsrelatingtotheNetCord-FACT

CordBloodStandardsandtheinspectionandaccreditationprocess.Attendeesmustbringalaptoptouseduringthe

FACTWebexercises.

Applications for Clinical Research Training Course Accepted through March 1st

TheAmericanSocietyforBloodandMarrowTransplantation(ASBMT)isacceptingapplicationsthroughMarch1,2012foritsClinical

ResearchTrainingCourseforfellows-in-trainingandjuniorfaculty.ThecoursewillbeinParkCity,UtahfromJuly11-16.TheClinical

ResearchTrainingCoursecoversprinciplesofresearchandhowtomoveresearchfindingsfromthelaboratorytotheclinic.Formal

presentationswithfollow-updialogueandsmall-groupdiscussionincludesmanytopicsrelatedtoclinicalresearch.

See other related opportunities by logging into FACTWeb and selecting “Related Opportunities”

Visit the FACT store for educational recordings of webinars, tutorials, and virtual roundtables!