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Foundation For the accreditation oF cellular therapy
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In this Issue:• Programswith10+YearsofAccreditation
• OutstandingAchievementServiceAwards
• ThirdEditionInspectorHandbook
• CoordinatorCommentary
• InspectionandAccreditationTimelines
• IndustryNews
• TrainingOpportunities
Thisnewsletterisacelebrationofsorts.First,itrecognizes
cellular therapy programs that have maintained ten or
moreyearsofcontinuousFACTaccreditation.Toremain
dedicated and committed to continuously improving
processesforthebettermentofpatientsforadecadeor
moreisaremarkableachievement.Inthepasttenyears,
FACThaspublishedfoureditionsoftheCellularTherapy
Standardsandhasparticipatedwithseveralcollaborative
organizations and committees in addressing standards
relatedtocelltherapy.Remainingawareofandadapting
to new accreditation requirements and industry-wide
publications,suchastheCircularofInformationandISBT
128 terminology, is a major but worthy endeavor. The
programshighlightedinthisnewsletterdeservenotonly
recognition for their accomplishments but our thanks.
Throughtheircommitmenttoquality,theyhavehelped
improve the FACT accreditation process. Some of their
wordsofwisdomareincludedtoprovidehelpfuladvice
totheirfellowaccreditedorganizations.
We also salute three outgoing Board members who
receivedOutstandingAchievementServiceAwards.Over
the years, the FACT Board of Directors has been filled
with experts in our field whose passion for improving
patientcareisinspiring.TheBoardmembershighlighted
in this letter are transformational leaders who have
helped shaped FACT into the influential and dynamic
organizationit istoday. Whilewearesuretomisstheir
leadership at the Board level, we will continue to tap
theirexpertiseonbehalfofFACTforyearstocome.With
thechangesinmembership,thecurrentFACTBoardof
DirectorsisplanningastrategicretreatinMay,whichwill
beanopportunitytocelebrateFACT’ssuccessandcreate
planstocarrythatsuccessintothefuture.
Sincerely,
C. Fred LeMaistre, MD
To remain dedicated and committed to continuously improving processes for the betterment of patients for a decade or more is
a remarkable achievement.C. Fred LeMaistre, MD
Spring 2010
Letter from the President
Accreditation ReportFournewbloodandmarrowtransplantprogramsearnedaccreditationandtwelveadditionalfacilitiesreceivedaccreditationrenewalduringthefirstquarterof2010.Thecompletereportofaccreditedorganizationsinthefirstquar-terisavailableatwww.factwebsite.org.
CellularTherapyPrograms
197ProgramsRegistered
182ProgramsAccredited
15ApplicationsPending
CordBloodBanks
41BanksRegistered
24BanksAccredited
17ApplicationsPending
Spring2010|2
Programs Recognized for ten or More Years
of Continuous FACt Accreditation
The FACT Program Relations Committee, led by Dr. Jean
Sanders,congratulates44cellulartherapyprogramsthathave
maintained their FACT accreditation continuously for ten or
more years. To celebrate this achievement, the committee
sentasurveytotheseprogramstoassesstheimpactofFACT
accreditation. Programs indicated that FACT accreditation has
had anoverallpositive impact.See thegraph titled Impact of
FACT Accreditation for details regarding the impact of FACT
accreditation.
Whenaskedwhatchallengesprogramshavefacedconcerning
accreditation, themostcommonlymentioned itemswerethe
effortrequiredtoprepareforandmaintainaccreditation; lack
of commitment from the affiliated institution for resources,
personnel, and funds; and keeping up with the Standards
anddocumentationrequirementsas theyhavechangedover
theyears.FACTwillusethisfeedbackinfuturepublicationsto
providetipsonhowtomanagethesechallenges.
Programs with 10+ Years of Accreditation
Adult and Pediatric Autologous and Allogeneic Programs
BarbaraAnnKarmanosCancerCenterBloodandMarrowStem
CellTransplantProgram
BloodandMarrowTransplantProgramofUCSD/SharpLLCand
RadyChildren’sHospitalofSanDiego
H. Lee Moffitt Cancer Center & Research Institute Blood and
MarrowTransplantProgram
Hackensack University Medical Center Blood and Marrow
TransplantationProgram
Northwest Marrow Transplant Program at Oregon Health &
Science University, Legacy Good Samaritan Hospital and
MedicalCenterandDoernbecherChildren’sHospital
OncologyGroupandFortSandersRegionalMedicalCenter
SeattleCancerCareAlliance
ShandsHospitalattheUniversityofFlorida
StanfordUniversityMedicalCenterBloodandMarrowTransplant
Program
Strong Memorial Hospital Blood and Marrow Transplant
Program
TexasTransplantInstitute
TuftsMedicalCenterBoneMarrowandHematopoieticStemCell
TransplantProgram
University of Alabama Adult and Pediatric Bone Marrow
TransplantationandCellTherapyProgram
UniversityofChicagoStemCellTransplantProgram
UniversityofLouisvilleBloodandMarrowTransplantProgram
University Medical Center/Arizona Cancer Center Blood and
MarrowTransplantationProgram
UniversityofMinnesotaBloodandMarrowTransplantProgram
UniversityofTexasMDAndersonCancerCenterDepartmentof
StemCellTransplantationandCellularTherapy
UniversityofUtahStemCellTransplantandMyelomaProgram
Adult Autologous and Allogeneic Programs
AdultHematopoieticStemCellTransplantProgram,Dana-Farber
CancerInstitute/BrighamandWomen’sHospital
BaylorUniversityMedicalCenter
CancerInstituteofNewJerseyRobertWoodJohnsonUniversity
HospitalBloodandMarrowTransplantProgram
ChristianaCareHealthServices
Coleman Foundation Blood and Marrow Transplant Center at
RushUniversityMedicalCenter
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Impact of FACT Accreditation
Num
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FoxChase-TempleBoneMarrowTransplantProgram
IndianaBloodandMarrowTransplantation(IBMT)
Massachusetts General Hospital Bone Marrow Transplant
Program
OttawaHospitalBloodandMarrowTransplantProgram
OurLadyoftheLakeRegionalMedicalCenterHematopoietic
ProgenitorCellTransplantProgram
UMass Memorial Medical Center Blood and Bone Marrow
TransplantProgram
University of Pittsburgh Medical Center Hematopoietic
StemCellTransplantProgram
Pediatric Autologous and Allogeneic Programs
Children’s Hospital of Philadelphia Blood and Marrow
TransplantProgram
Children’sMemorialHospitalStemCellTransplantProgram
Dana-FarberChildren’sHospitalCancerCarePediatricStem
CellTransplantationProgram
Adult Autologous Programs
BloodandMarrowTransplantCenterofKansasatViaChristi
Hospital
Marshfield Clinic, Saint Joseph’s Hospital Hematopoietic
ProgenitorCellTransplantProgram
ProvidencePortlandMedicalCenterAutologousStemCell
TransplantProgram
TexasTech University Health Sciences Center & University
MedicalCenterSystem,BloodandMarrowTransplant
Program
Thompson Cancer Survival Center, Thompson Oncology
GroupandFortSandersRegionalMedicalCenter
TSUNYUpstateMedicalUniversity,BoneMarrowTransplant
Program
Walter Reed Army Medical Center Autologous Stem Cell
TransplantProgram
Independent Cellular Therapy Collection and Processing Services
American Red Cross Pacific Northwest Region, HCT/P
Program
CanadianBloodServices-Ottawa
Independent Cellular Therapy Processing Services
ProgenitorCellTherapy,LLC;Hackensack,NJandMountain
View,CAFacilities
Words of Wisdom from Accredited Programs
While challenges were identified, the majority of programs felt
thatthebenefitsofFACTaccreditationwereworththeeffort.The
followingaretheirperspectivesregardingFACTaccreditation:
“Maintaining a highly functioning quality program requires
significanteffort,butFACTprovidestheframeworktomakethis
successful.”
“We have received support and guidance for creating and
maintainingstandardoperatingprocedurestopromoteexcellent
qualitycare.”
“Theamountoftimerequiredfortheapplicationandpre-FACT
preparationatlargercentersisresourceintensive.”
“Accreditation is a process best to not aim high to start with
butrathermeetthestandardsandthenslowlybuildonthem-
donotcommit to things just to finalizeachecklistbut build a
sustainableplatform.”
“ItischallengingtomeettherequirementsoftheFACTstandards
with a small program and limited resources. Try to organize
your program so that one undertaking can meet many of the
standards.”
“Make[FACTaccreditation]ahighpriorityandeverystaffmember
shouldparticipate;partnerwiththeinstitutionalQIdepartment
andengagemorepeopleoutsideoftheprogram.”
“HavingphysiciansfromourprograminvolvedasFACTinspectors
has greatly increased their understanding and commitment to
ourpreparedness.”
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FACt Extends Outstanding Achievement service Awards to Outgoing Board Members
FACThasbenefitedfromtheoutstandingleadershipofthreeoutgoingBoardMemberswhoparticipatedintheirlast
Board of Directors meeting on February 2�, 2010. Each contributed to FACT via countless hours as Board Members,
committeechairsandmembers,inspectors,andpersonnelataccreditedinstitutions.BoardPresident,Dr.FredLeMaistre,
acknowledgedeachofthemandprovidedthemwithOutstandingAchievementServiceAwards.
Frank smith, MDBoardofDirectors:2001-2009
Otherpreviousandcurrent
appointments:
Treasurer
ExecutiveCommittee
Helen Heslop, MDBoardofDirectors:2001-2009
Otherpreviousandcurrent
appointments:
VicePresident
ExecutiveCommittee
Chair,ProfessionalRelations
StandardsCommittee
Nancy H. Collins, PhDBoardofDirectors:1996-2009
Otherpreviousandcurrent
appointments:
Chair,CellularTherapyStandards
Chair,CordBloodStandards
CellularTherapyandCordBlood
AccreditationCommittees
third Edition FACt Inspector Handbook Provided to Inspectors
FACTupdateditsFACTInspectorHandbookinJanuary2010toencompass
feedbackandexperiencesgainedbyFACTinspectorsandorganizations
that have been inspected.The handbookpasses on the guidelines and
wisdom that inspectors and accredited programs and banks have
developedsincetheinceptionofFACT.
TheInspectorHandbookis intendedtoprovidetipsto inspectors inan
easy-to-readguidethatcanaccompanythemoninspections.Thegoalof
thehandbookistostrengthenandcontinueFACT’straditionofdeveloping
effective,positive,andcollegialinspectorstobetterthefield.
Thegoaloftheinspectorhandbookistostrengthenand
continueFACT’straditionofdevelopingeffective,positive,andcollegial
inspectors.
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Don’t Let Your Accreditation Lapse! Follow the Inspection and Accreditation timeline
Remember to follow the Cellular Therapy or Cord Blood
Inspection and Accreditation Timeline to ensure your
organization maintains continuous FACT accreditation.
FACT created this timeline to assist organizations with
knowing when to submit what in a manner that will
ensuretheyarereviewedbytheAccreditationCommittee
prior to expiration of accreditation. Cathy Matuella, FACT
Accreditation Coordinator, reminds organizations that the
day of inspection is not the date of accreditation; rather,
thedaytheAccreditationCommitteeawardsaccreditation
is the accreditation date. Therefore, organizations are
encouraged to submit their pre-inspection submissions
nine months prior to expiration with the goal of being
inspected six months prior to expiration. Failure to follow
thetimelineplacesorganizationsatriskofbeingremoved
fromtheFACTwebsite.
ThefollowingtimelinesareavailableontheFACTwebsite
for reference while completing the inspection and
accreditationprocess:
CellularTherapyInitialAccreditationTimeline
CellularTherapyRenewalAccreditationTimeline
CordBloodInitialAccreditationTimeline
CordBloodRenewalAccreditationTimeline
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A Note from the FACt Cord Blood Accreditation
Committee
Linda Cave, Cord Blood Accreditation Committee Staff
Liaison, encourages all cord blood banks to continue to
make improvements in their Quality Management (QM)
programsandto remaincurrent in today’severchanging
cordbloodbankingfield.QMrequirements,specificallythe
QMPlanandvalidationstudies,arecommonlycitedduring
inspections.
Coordinator Commentaryshipping and transportation
Sarah Litel Smith, BSMT(ASCP)
The terms shipping and transportation are often
used interchangeably as both terms refer to the
movement of products between or within facilities.
FACTdifferentiatesbetweenthetermsbasedonhow
theproductismoved.
AccordingtoFACTdefinitions,movementbetweenor
withinfacilitiesis:
Shipping if the product/unit leaves the control
oftrainedpersonnelofeithertheorganizationit
camefromorisgoingto.
Transporting if the product/unit does not leave
the control of trained personnel of either the
organizationitcamefromorisgoingto.
So,whilebothshippingandtransportationrefertothe
movement of products between or within facilities,
thedifferenceliesinwhetherornotaproductleaves
the control of trained personnel. For example; if a
product is sent by taxi, a courier not trained by the
organization,FedEx,USPS,orUPS,itisbeingshipped,
whetheritisgoingtoanotherfacilitythatisanintegral
partoftheorganizationoritisgoingtoanunrelated
organization.However,whenaproductisgoingfrom
theProcessingFacility(locatedon-oroff-site)tothe
patient’sbedsideandtheprocessingtechnologist is
takingtheproduct,itisbeingtransported.
As a friendly reminder, a policy or procedure,
applicable for each facility (i.e. the sending and
receiving facilities), that addresses shipping and/or
transportationisrequiredbyFACT.
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Circular of Information for the use of Cellular therapy Products Published
The Circular of Information for the Use of Cellular Therapy
Products (Circular) was published in February 2010 and is
intendedtobeanextensionofthecellularproductlabel.Asan
extensionofcontainerlabels,eachprocessing/issuingfacility
has the option and is encouraged to provide more facility
orproductspecific information inthespaceprovided inthe
Circular. The organizations involved in writing the Circular
limitedthescopetominimallymanipulatedcellularproducts
suchasperipheralbloodprogenitorcells,bonemarrow,cord
blood,andleukocytes.Thegrouprecognizesthefactthatthere
are other cellular products which could not be adequately
coveredintheCircular.TheelectronicversionoftheCircular
has been enhanced to allow for addition of facility-specific
informationattheendofthedocument.
2009 AsHI standards Available
The 2009 ASHI Standards were approved by CMS and are
availabletotheFACTcommunityontheASHIwebsite.Cellular
therapy programs and cord blood banks are suggested to
reviewtherequirementsanddiscussanythatarepertinentto
theiroperationswiththeirHLAtestinglaboratoriestoensure
theircurrentagreementsareappropriateandthatallparties
areincompliancewithapplicablerequirements.
AsHI Harmonization Group Includes FACt and other
standards-setting Organizations and Registries
TheAmericanSocietyforHistocompatibilityandImmunogenetics
(ASHI) created a harmonization group to clarify HLA-related
terminology and promote communication between standards-
settingorganizations(includingFACT)andregistries.Thisgroup
isa resultof feedbackprovidedtoASHI regardingtheneedto
communicate with related organizations that may be affected
by its standards. FACT thanks ASHI for creating this group and
acknowledges FACT-accredited organizations who provided
feedbackregardingtheworthyendeavorforharmonization.
upcoming Meetings Related to Cellular therapy
Thefollowingmeetingswillcontainexciting,pertinent
informationrelatedtocellulartherapy.Participationis
encouraged.(Note:FACTworkshopsrequireseparate
registration.)
16th Annual IsCt Meeting
May22-26,2010
Philadelphia,Pennsylvania
2010 AsFA Annual Meeting
May26,-29,2010
NewOrleans,Louisiana
Annual International umbilical Cord Blood
transplantation symposium
June�-6,2010
SanFrancisco,California
FDA Cord Blood Workshop Discusses Pathway to Licensure
The FDA, with AABB, FACT, and other organizations,
hostedaworkshoponMarch8-9,2010todiscussthe
pathway to cord blood licensure or Investigational
New Drug (IND) approval. Participants from around
the world represented cord blood banks, registries,
transplant physicians, and other stakeholders.
Presentations from the FDA, cord blood banks,
and physicians provided explanations and
recommendations regarding the FDA licensure
guidanceanddraftINDguidance,withconsiderable
timereservedforquestionandanswersessions.The
insightful information from these sessions is under
reviewbytheFACTProfessionalRelationsCommittee,
which intends to provide accredited and applicant
cordbloodbanksadetailedsynopsisofthisvaluable
knowledge.
Biologics License Applications (BLA) and INDs are due to the FDA by October 2011. Cord blood banks
are urged to begin preparations for submissions.
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Congratulations to New Active FACt Inspectors!
Becoming an active FACT inspector requires considerable time and effort on a voluntary basis. FACT thanks and
congratulatesthefollowingindividualswhocompletedtheirfirstofficialFACTinspectioninthefirstquarterof2010:
Cellular therapy Inspectors
SergioGiralt,MDClinical
ShakilaKhan,MDClinical
MitchellCairo,MDClinical
PatriciaShi,MDApheresis Collection
MaryMooney,MSHA,MT(AMT)Processing
ElzbietaSmogorzewska,PhD,MSc,CLSProcessing
Cord Blood Inspectors
*Also a current Cellular Therapy Inspector
HelenHeslop,MD*
ChitraHosing,MD*
AbbaZubair,MD,PhD*
TizianaBonfini,MD
MichaelMueller-Steinhardt,MD
MicheleCarbone,MS,CLS,MT(ASCP)*
New Approach to updating Inspection-Related Documents
FACT continuously improves its inspection-related documents to ensure they remain complete and accurate as
improvementsaremadetotheinspectionandaccreditationprocess.Becauseupdatestothesedocumentsmayoccur
whileanorganizationisinthemiddleoftheprocess,FACTwillnowpostupdatestothesedocumentsonaquarterly
basisandannouncethemintheJusttheFACTsnewsletter.Furthermore,theeffectivedatesandrevisionswillbeincluded
onthewebsite.ThischangeisintendedtoassistorganizationswithkeepingupwithnecessarychangestotheFACT
process.Thefollowingaredocumentsthathavebeenupdatedsincethelastnewsletter:
CellularTherapyInitialAccreditationTimeline CordBloodInitialAccreditationTimeline
CellularTherapyRenewalAccreditationTimeline CordBloodRenewalAccreditationTimeline
CellularTherapyInspectionChecklist
Quality Corner: Outcome AnalysisJill Hempel, MS, ASQ-CMQ/OEOutcomeanalysisisaformalassessmentandfocusesontheresultsoftherapy.Analyzingpatientoutcomesrequires
thoughtfulplanning,datacollection,evaluation,investigation,andfollow-up.Inordertomeettheseaspectsofoutcome
analysis,thePlan,Do,Study,Act(PDSA)cyclecanbeutilizedtostreamlinetheprocessofanalyzingoutcomes:
Step1:PlanPlanthetestorassessment,includingaplanforcollectingdata.Statetheobjectiveoftheassessment.Makepredictionsaboutwhat
willhappenandwhy.
Step2:DoExecutethetestorassessment.Documentproblemsandunexpectedobservations.Beginanalysisofthedata.
Step�:StudyCompleteathoroughanalysisofthedata.Comparethedatatoyourpredictions.Summarizeandreflectonwhatwaslearned.
Step4:ActRefinethechange,basedonwhatwaslearnedfromthetest.Determinewhatmodificationsshouldbemade,ifany.Prepareaplanfor
thenexttest.
Sincetheoutcomesanalysisprocessisnotlinear,itallowsforseveraltestsofchangebeforetheexpectedoutcomeis
achievedtoensureoptimaloutcomesaretheresult.ThePDSAcycleisasimplebuteffectiveprocessforanalysisand
actionthatacceleratesimprovement,andcapturesthecorephilosophyofcontinualimprovement.
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Give us the FACts Poll
Whattypesofelectronicsystemsdoesyourprogramor
bankuse?
Last month’s poll: How does your organization train
personnel to obtain donor medical history?
Wedidnotreceiveanyanswerstothisquestion . . .one
reason may be because training personnel to obtain
donormedicalhistoryisadifficulttaskcompoundedby
thefactthatstaffturnoveriscommon.TheFACTTraining
andDevelopmentCommitteeplanstocreateatutorialon
thistopicinFall2010asaresourceforpersonneltraining.
GiveUstheFACTs!
In Your Opinion . . .
HowhasFACTaccreditation improvedyourprogramor
bankovertheyears?
Last month’s survey: What is the most important
characteristic of a great FACT inspector?
Headsup,inspectors!Readthefollowingideasfromour
readersaboutwhatmakesagreatinspector!Knowledge of the Standards Well prepared Attentive Asks appropriate questions Creates a list of questions
based on Standards and documents ahead of time Does not simply sit and look through SOPs Allows the facility
to demonstrate compliance Able to clearly explain what he/she is looking for Provides understandable examples
InYourOpinion...
CellularTherapyWorkshopattheISCTAnnualMeetingMay 23, 2010 from 8 am to 5 pm in Philadelphia, PA
A new focused track will include information on storage,
release, and distribution; process controls; labeling; and
qualitymanagementissuesuniquetoProcessingFacilities!
CollectionWorkshopattheASFAAnnualMeetingMay 25, 2010 from 12 pm to 5 pm in New Orleans, LA
Now open to Collection Facilities as well as inspectors!
In addition to general inspection and accreditation
process information, special sessions will address quality
managementfromacollectionperspectiveanddistribution
fromaCollectionFacility.
CordBloodWorkshopattheInternationalUmbilical
CordBloodTransplantationSymposiumJune 6, 2010 from 8 am to 5 pm in San Francisco, CA
Registertodaytolearnaboutthenewfourthedition
CordBloodStandards,inspectionofvariouscordblood
bankingstructures,requiredinteractionsbetweena
cordbloodbankandaclinicalprogram,andmore!
Note: Separate registration for FACT workshops is required.
time is Running Out! Register today for upcoming FACt Workshops!
Example Assessment Programs the topic of the Next FACt Virtual RoundtableJune 11, 2010 at 1 pm ET
Registertodaytolearnaboutthequalityassessmentprogramsataccreditedcellulartherapyprogramsandcordblood
banks!ThisvirtualroundtablewillconcludetheQMSeriesModule2:QualityAssessmentActivities.
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