Foundation For the accreditation oF cellular therapy

Justfacts

th

e

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

0

5

10

15

20

25

30

35

40

45

50

#Tra

nspl

ants

Reim

burs

emen

t

Peer

Per

cept

ion

Inst

itutio

n At

titud

e

Qua

lity

Enha

ncem

ent

Rese

arch

Fun

ding

Clin

ical

Tra

ils

positive negative none not applicable

Impact of FACT Accreditation

Num

ber o

f Res

pond

ents Impact:

Justfacts

th

e Spring 2010

�|Spring2010

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.”

Justfacts

th

e Spring 2010

Spring2010|4

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.

Justfacts

th

e Spring 2010

5|Spring2010

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

•

•

•

•

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.

•

•

Justfacts

th

e Spring 2010

Spring2010|6

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.

Justfacts

th

e Spring 2010

7|Spring2010

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.

Justfacts

th

e Spring 2010

Spring2010|8

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.