2017

TISSUEBANKSPECIALISTCERTIFICATIONEXAMINATIONSTUDYGUIDE

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INTRODUCTIONThe AATB CertifiedTissue Bank Specialist Examination is comprisedof 130 multiple-choicetestitemsintended to assess the comprehensiveknowledge, understandingand applicationof thecurrentStandards for Tissue Banking, regulations, and best practices associated withtissuebanking. Theexam isnot limited tomemorization of facts alone, rather it ismeant toassess the ability of the candidate to apply the subject materials and concepts. Studymaterials are not only limited to the current Standards; rather additional study materialswill be necessary to adequately prepare for the exam. These additional studymaterials areincludedinthereferencesectionofthisStudyGuide.The list of general knowledgematerial is further divided into five (5) related categories.Although anexamcandidatemaynot regularly perform tasks inallofthese categories, it isexpected that Tissue Bank Specialists develop a general knowledge of the materials, andare capable of applying that knowledge.Therefore, the candidate will be required, as partofthisnational certification program, todemonstratebasicknowledgefromeachcategory.The candidate is permitted3 hours to complete the exam.Duringtheexam,theproctorwillannounce when half of the time has expired andwhen there are 30minutes remaining tocomplete the exam. Candidates maywear awatch during the exam tomonitor theirpace.Alltestingmaterials, includingpencils,willbeprovided.ApictureIDmustbeprovided,aswellastheconfirmation lettermailedtoeachcandidateforadmission to the test site. Plan to arrive at least 20 minutes prior to the scheduledexamination start timetocompleteyourregistrationbysigninginandshowingyourphotoID.Candidateswhoarriveaftertheexamhasstartedwillnotbeallowedtomakeuptheirlosttime.ThisStudyGuideconsistsof:1)AlistofgeneralknowledgematerialsrelatedtoaTissueBankSpecialist’s job

performance,whichmaybeincludedintheexam.

2)Alistofpublicationsusedinexamdevelopmentaswellasrecommended studymaterials.

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CRITICALKNOWLEDGEGENERALKNOWLEDGEItemslistedbelowapplytoeachofthesubjectcategories thatarelistedinthesubsequentsections.Acandidateshouldhavegeneralknowledge inthefollowingareas:

1.Humananatomy&physiology

a. Typesoftissuesrecovered

i. Skin(functions, layers)

ii. Cardiac/Vascular(heart/bloodvesselsandfunctions)

iii. Musculoskeletal system(bone,tendon,fascia,ligamentsandfunctions)

b.Acandidatemayalsoprepareforthissectionbyreviewinganatomytextbooksorotherrelatedmaterialsavailable intheirworkplace

2.Recovery techniquesandprocedures

3.Recoveredtissuepreparation,packagingandtransport

4.Clinicalapplicationsoftissuegrafts

5.Medicalterminology commonly foundinmedicalcharting6. CommonLaboratoryTestsandtheir normalvalues(WBC,differential)

7.Ethicalandlegalissuesinvolvedintissuebanking

8.Infectiousdiseases,bacteria,parasites, fungi,andtheirimplications for

infectionandtransmittal throughtissuegrafts9.Donorconfidentiality (HIPAA)

10.Documentation requirements11. InformedConsent/Authorization12. Post-donation concerns 13. Interactionswithotherrelateddonation&transplantorganizations, including,but

notlimitedto:

a.Eyebanks

b.Organprocurementorganizations

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c. Funeralhomes

d.MedicalExaminersandCoroners14. RegulatoryandStandardsdocuments including:

a.CurrentGoodTissuePractices (cGTPs)includingFDA21CFRPart1270andPart1271andAATBGuidanceDocumentNo.3,CurrentGoodTissuePractice(June27,2006)andFDAcGTP’s2011

b.CurrentGoodManufacturing Practices (cGMPs)c. OSHAStandardsd.QualitySystemRegulations (QSRs)FDA21CFRPart820

e.UniformAnatomicalGiftAct

f.AATBStandards forTissueBanking,(currentedition)includingpublishedupdatesg.CurrentAORNGuidelinesforPerioperativePractice,SterileTechnique,Surgical

AttireandHandHygiene

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DONORSCREENINGandTESTING 26-32Itemsor20-25%Knowledgeof:

1. Physicalassessmentofthetissuedonor

2. DonorRiskAssessment Interv iew(DRAI) criteriaandrationale(e.g.,medical

historyandsocialbehavior) includingavailableresourcesandterminologysufficienttoobtaindonorhistoryinformation throughmedicalrecordreview,attendingphysician, familydoctor,family,lifepartner,andotheralternatesources

3. Tissueseligibleforrecovery

4. Required infectiousdiseasetestinganddisclosureoftestresults

5. RiskFactorsforRelevantCommunicableDiseaseAgentsorDiseases(RCDADs)

6. Thepurposeandinterpretation oflaboratory testsconductedondonorspecimens

7. Applicable lawsandregulationsassociatedwithInformed

Consent/Authorization fordonationandtissuerecovery8. Procedures forobtaininganddocumenting InformedConsent/Authorizationfortissue

donation(e.g.,thestepstofollow)9. Plasmadilutionalgorithmfordetermining theacceptability ofbloodsamples

forinfectiousdiseasetesting10. Archivedsamples11. Information sharingKeywordsandconcepts

• AIDS• Hepatitis

o HVC,HVB&HVA• Antibody• Antigen• Asbestosis• Autoimmune disease

o Polyarteritis nodosao Rheumatoid arthritiso Systemic lupuserythematosiso Sarcoidosis

• Autopsy

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• Bacteriao Chlamydiatrachomatis(Chlamydia)o Clostridium sp.(potential forsporulation)o Neisseriagonorrhoeae(Gonorrhea)o Drugresistantorganisms

§ Vancomycin ResistantEnterococcus (VRE)§ Methicillin resistantStaphylococcus aureus(MRSA)

o GroupAStreptococcus(Rheumatic fever)o Streptococcus pyogeneso Treponemapallidum(Syphilis)

• ClottingFactorConcentrate• Dementia• Diabetes• Ebola• Endocarditis• Epilepsy• Fungus• Immunoglobulins:IgMvs.IgG• Malignancy• Marfan’sSyndrome• MultipleSclerosis• Mycoses• Normalflora• NucleicAcids:NucleicAcidTesting(NAT)• Parasite:Protozoan

o Chagasdiseaseo Leishmaniosiso Malaria

• Parkinson• Plasmadilution• Prions:Transmissible SpongiformEncephalopathies(TSEs)

o Creutzfeldt-JakobDisease(CJD)• Seizures• Sepsis• Steroids• ToxicSubstances• ConditionswithUnknownEtiology• Vaccines• Viruses

o EpsteinBarrVirus(EBV):Mononucleosiso HepatitisA,B(HBV),&C(HCV)o HumanImmunodeficiencyVirus(HIV)o WestNileVirus(WNV)o Zika

• Viralwindowperiod

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RECOVERY 30-35Itemsor23-27%Knowledgeof:

1. Verificationprocedures fortissuerecovery

2. Hospital/recovery siterequirements asdescribed inAATBGuidanceDocumentAppendixII.CriteriaforpreventingtransmissionofRelevantCommunicableDiseaseAgentsandDiseases(RCDADs)throughtransplantationofhumantissue.(January1,2017)

a. HospitalOperatingRoomsandMorgueb. DedicatedRecoverySuitesc. MedicalExaminerOfficesd. FuneralHomes

3. Pertinenthospitaland/ormedicalrecordsreview(includingpolice,autopsy,andEMS

reports)4. Donorphysicalassessmentasdescribed inAATBGuidanceDocumentNo.1v2Tissue

DonorPhysicalAssessmentForm(June27,2005) a.TissueDonorPhysicalAssessmentForm&Requirements:AppendixIII:(January1,

2017)b. Donoridentification

i. Typesofproperidentification andverificationii. Methodsforverifying identificationiii. Minimalrequirements

c. Highriskbehaviorsandinfectionsi. Areastoassessii. Signs&symptomstoobserve

d. Tissuequalityi. Traumaii. SurgicalHistoryiii. Levelofdecomposition

e. Whattodowithinformationobtainedi. Reportii. Investigateiii. Closeiv. Document

5. MedicalExaminer/Mortuaryinsightrelatedtotissuerecovery

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a. Donorreleaseforrecovery b. Recoveryobservationsandreportingrequirements c. Donorreconstruction6. Operatingroometiquetteandterminology (AORNStandards) a. Cleanvs.dirtyareas

b. ORequipmentc. Preandpostrecoverycleaning

7. Handlingofbiohazardmaterialandoccupational safety

procedures

a. OSHArequirements forbiohazardmaterialsb. Requiredhandling,disposal,anddocumentation.

8. Personalprotectiveequipmentandappropriate surgicalattire

a. Typesandtheirpurpose(i.e.,facemasks,haircover,etc.)

9. Normaltissueappearanceorcharacteristics (anatomy)

10. Donorrefrigeration andtissuerecovery timelimitsasdescribed inAATBGuidanceDocumentNo.7,EvaluationofBodyCoolingatStandardD5.400(December9,2013)

11. Obtainingqualifiedbloodsamplesforlaboratory test

a.Requiredtestingb.Testkitmanufacturer’s requirementsc.Qualifying (Plasmadilution,timeframes,hemolysis,etc.)

12. Zoneorsequencerecoveryasdescribed inAATBGuidanceDocumentNo.2v2,

AppendixIV:PreventionofContamination andCross---contamination atRecovery:PracticesandCultureResults(January1,2017)

a.Zonetypesanddefinitionsb.Orderoftissuesrecovered (cleantodirty)c.Requirements fordrapingd.Separationofinstrumentsandequipmente.Requirements forrecovery techniciansoperating inseparatezonesf.Movement fromonezonetoanother

13. Sterileequipmentandsupplyset---upprocedures (Ref.AORNStandards)

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a.Definitionsofsterility,aseptictechnique,contaminationb.Identification ofsterilevs.dirtyc.Methodsofaddressingcontaminated supplies, instruments, fields,etc.

14. Aseptic/sterile surgical(recovery) techniquesandprocedures15. Operativesitepreparationandsteriledrapingtechniques16. Recoveryprocedures (e.g.,theappropriateorder,dissection technique,backtable)17. Donorreconstruction techniquesandprocedures

a. Impactonautopsyandtofuneralhomeandfamilyviewing18. Requirements forculturingtissuesandwrappingandlabelingtissuesfortransport

and/orinterimstorageasdescribed inAATBGuidanceDocumentNo.2,v2PreventionofContamination andCross---contamination atRecovery:PracticesandCultureResults(May29,2007)

a.AppendixIV:Preventionofcontaminationandcross-contaminationatrecovery:practicesandcultureresultsrequirement(January1,2017)

19. Documentingallaspectsoftissuerecoveryanddonorreconstruction20. Properhandling,transportingandshippingofrecovered tissuesanddocuments

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RECOVERY/SKINKnowledgeof:

1.Anatomyandphysiologyoftheskin(functions,partsoftheskini.e.,different layers)

2.Safehandlingofequipment (e.g.dermatome, sharps)

3.Normalappearanceofskinandunderlyingsofttissues

4.Timelimitsforrecovery

5.Skinprocessorspecificationorworkinstruction

6.Recovery techniquesandprocedures tomeetprocessorspecifications

7.Properhandling,transport/shipment ofrecoveredtissueanddocuments

8.Clinicalapplicationsofsplit---thickness andfull---thickness dermalskintissues.Keywordsandconcepts

• Anatomyo Layers

§ Epidermis• Waterproof• Skintone

§ Dermis• Connective Tissue• Vessels• Hairfollicles• SweatGlands

§ Hypodermis (subcutaneous)• Connective Tissue• Fatcells

• Physiologyo Consideredanorgan(largestorganofthebody)

o Protectivebarrier(1stdefensetoprevent infection)o Insulationandregulationofbodytemperatureo Sensoryfunction

• Eligibilityandexclusionary criteriaforskindonationo Conditionsanddiseasesthataffectskintissueso Cultureresultso Contraindicationstoskinrecoveryo Tattooso Rasho Trauma

• TypesofSkinRecovery

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o Split-Thickness SkinGraft(STSG)§ Epidermisandpartofthedermis

o Full-Thickness SkinGraft(FTSG)§ Epidermis,allofthedermisandpartofsubcutaneous

• Equipmentutilizedforskinrecovery

o Scalpel(FTSG)o Dermatome (STSG)

• Components ofadermatome

o Heado Handleo PowerSupplyo Disposableblades

§ Standards forculturecollectionofskin§ SettingsforSTSGrecovery§ Optimalrange§ Angles

o Skinprocessingapparatus:mesher• ClinicalApplications ofdonatedskin

o SingleThicknessSkinGrafto Burnvictimso WoundCareo FullThicknessSkinGrafto HerniaRepairo Evisceration

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RECOVERY/CARDIOVASCULAR (CardiacandVascular)TISSUEKnowledgeof:1. Anatomyandphysiologyoftheheartandbloodvessels2. Safehandlingofequipment (e.g.sharps)3. Normalappearanceofheartandbloodvessels4. Timelimitsforrecovery5. Heartandvesselprocessorspecificationorworkinstruction6. Recovery techniquesandprocedures tomeetprocessorspecifications7. Properhandling,transportandshipmentofrecoveredtissueanddocuments8. ClinicalapplicationsofCVtissuesKeywordsandconcepts

• Generalandrelativeanatomyofthehearto Apexo Endocardiumo Esophaguso Left&rightbronchio Lungso Myocardiumo Pericardiumo Pleuralspaceo Thymusglando Trachea

• Majorvesselsofthehearto Aortao Brachiocephalic artery&veino Coronaryarteryo InferiorandSuperiorvenacavao Leftcommoncarotidarteryo Leftsubclavianarteryo Pulmonary trunko Pulmonaryarteriesandveins

• Chambersofthehearto Rightandleftatriao Rightandleftventricles

• Valvesofthehearto Bicuspidvalveo Aorticandpulmonaryo Mitralvalve

• Cardiaccycle/circulation ofbloodthroughtheheartandlungs• Mid---linevs.“V”incisions

o Knowthelandmarksusedtomaketheseincisionsandtherelated

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MedicalExaminer/FuneralHomeconcerns foreachincision§ SternalNotch§ Xiphoidprocess

• Sternum/Sternotomy• Clinicalapplicationofheartgrafts:RossProcedure• Bloodvessels

o Greatersaphenous veino Femoralveino Knowthekeydifferencesbetweenanarteryandvein

§ Directionofbloodflowrelativetotheheart§ Physiological differences (understandwhyvalvesexistinveins

andnotarteries)• Clinicalapplicationofvessels:CoronaryArteryBypassGraft(CABG),Peripheral

VascularDisease(PVD)• Eligibilityandexclusionary criteriaforCVdonation

o WarmIschemicTime(WIT)o ColdIschemicTimeo ConditionsandDiseases thataffectCVtissuesexclusively

• Instrumentation usedtoperformaheartrecoveryo Kellyclampo Lebscheknifeo Mayoscissorso Metzenbaum scissorso Mosquitoclampo Non-traumatic tissueforceps(Debakey)o RibShearo Right-angle clampo SternalRetractor

• Cannula• Tributary• Infusion• Perfusion

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RECOVERY/MUSCULOSKELETAL TISSUEKnowledgeof:1. Theanatomyandphysiologyofthemusculoskeletal tissues(e.g.bone,tendon,fascia)2. Safehandlingofequipment (e.g.,sharps)3. Normalappearanceofmusculoskeletal tissues4. Timelimitsforrecovery5. Properhandling,transportandshipmentofrecovered tissueanddocuments6. ClinicalapplicationsofMStissuesKeywordsandconcepts:

• Positiono Anatomico Supine(faceup)o Prone(facedown)

• Planeso Coronal(frontal)o Sagittal(median)o Transverse (Horizontal)o Oblique(angle)o Variations (suchasmid---sagittal)

• Locationo Anterior(infrontof)o Posterior (behind)o Superior(above)o Inferior(below)

• RelativeLocation(canbecombinedwithaboveex:posteromedial)o Medial(towardthemidline)o Lateral(awayfromthemidline)o Proximal(close)o Distal(faraway)

• UpperExtremitieso Humerus(associationwithscapulaandclavicle)

§ BicepsMuscle§ RotatorCuff

o Radiuso Ulna

• UpperTorsoo Sternumo XiphoidProcesso CostalCartilageo Ribso Clavicle(knowassociationwithclavicleandhumerus)

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o Pericardium• LowerTorso

o Vertebralbodieso Ilium(vs.Hemi-pelvis)o Sacrumo Coccyxo Femur(knowassociationoffemurtoilium)

• LowerExtremitieso Fascia(akaIliotibialband)o Femur

§ GracilisTendon(shouldthetendonsbegroupedwiththeir“associated”bone)

§ Semitendinosus Tendono Tibia

§ AnteriorTibialisTendon§ PosteriorTibialisTendon§ PeroneusLongusTendon

o Fibulao Knee

§ Quadriceps tendon§ Patella§ PatellarTendon§ Tibia§ Meniscus§ Cartilage§ AnteriorCruciateLigament§ PosteriorCruciateLigament§ MedialCruciateLigament§ LateralCruciateLigament§ TibialPlateau

o AchillesTendon§ GastrocnemiusMuscle§ Calcaneus§ Talus

o SaphenousVeino AdditionalTermsAssociatedwithAnatomy

§ Diaphysis§ Metaphysis§ Epiphysis§ Periosteum§ Endosteum§ Tendonvs.Ligament§ “Origin”vs.“Insertion”ofatendonormuscle

• Bonefunctiono Attachment forsofttissueso Hematologicalo Calciumstorehouse

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o Protection• Maturelongboneanatomicareas

o Diaphysiso Metaphysico Epiphysis (andepiphysealplate)

• Bonestructureo Cortical(akacompact)o Cancellous (akatrabecularorspongy)

• Wolff’sLaw• Boneremodeling, repairandreplacement

o Osteoclastso Osteoblastso Osteocytes

• Boneregenerationo Osteogenesiso Osteoinductiono Osteoconductiono CreepingSubstitution

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PROCESSING 24-29itemsor18-22%Knowledgeof:1. Asepticprocessingenvironmentandfacilityset-upandprocedures (e.g.,

equipmentnecessary,suppliesneeded)2. "Clean"processingenvironmentandfacilityset-upandprocedures (e.g.,necessary

equipmentandsupplies)3. Care,preparation,anduseofinstruments/equipmentusedintissueprocessing4. Biohazardcontainmentanduniversalprecautions5. Sterileareaclassifications andrequirements (e.g.,ISO5/GradeA/Class100laminar

flowunitorworkarea)6. Sterilization techniques forappropriate tissues7. Graftacceptability requirements (e.g.,howtotest/determine theacceptability ofa

graft)8. Cryopreservationmethods/techniques andproblemrecognition/trouble-

shooting(e.g.,supercooling, verification, crystallization, etc.)9. Tissuerefrigerationprocedures (e.g.,methods,tissuehandlingprocedures, its

effectsontissues)10. Lyophilizationprocess(e.g.,methods,procedures)11. Tissueprocessingqualityassurance/control techniques (e.g.,bacteriological culturing,

testing)12. Tissuestoragetechniquesandprocedures (e.g.,freshfrozen,cryopreserved, etc.)13. Dispositionproceduresassociatedwithtissueforresearchordiscard14. Procedures forhandlingsharps/instruments andcontaminated tissues

(e.g.,safetyconcerns)15. TissuepackagingandlabelingmethodsandproceduresKeywordsandconcepts• Ambienttemperature• Aseptic• Audit

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• Autoclave• Bioburden• Biohazard• CleanRoom• Calibration• Contamination• Decontamination• EthyleneOxide(ETO)• EnvironmentalMonitoringProgram• Gammaradiation• Irradiation• ISO• Lyophilization• Osteobiologics (OB)• Residualcalcium• Supercooling• Validation• Variance• Verification• Workinstruction

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QUALITYASSURANCE 25-33itemsor19-25%Knowledgeof:1. Labelingandrecord-keeping procedures2. Productintegritycontrolprocedures (e.g.,tissuestorage, laboratory testing,

bacteriologicalcultures)3. Thepurposeandinterpretation ofmicrobiology laboratory testsconductedontissue

samples4. Thepurposeandinterpretation ofserologylaboratory tests5. Tissuebanksafetyprocedures (e.g.,typesofsafetyhazards,methodstoavoid

problems,OSHArequirements)6. Controlmeasuresforworkwithhazardouschemicals, includingcarcinogens,

potentialcarcinogens,andbiohazards7. Procedures forthereleaseoftissue(e.g.,typeofdocumentation required

intermsofserology,microbiology, andpathology, transplant recordsfortissueutilizationdocumentation)

8. Recall,complaintandadversereactionrequirements fromAATB,FDAandother

regulatoryagencies9. CurrentGoodManufacturing Practice(cGMPs)astheyrelatetotissueprocessing

(e.g.,materialsusedinprocessing,expirationdates,anddocumentation procedures)10. CurrentGoodTissuePractice(cGTPs)11. Typesandusesofcolloidandcrystalloid solutionsandbloodproducts indonor

management12. Responsibilities ofQualityAssuranceandQualityControlprograms13. Donorinformationsharingprocess14. Documentcontrolrequirements

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DISTRIBUTION 11-15itemsor8-12%Knowledgeof:1. Typesofallografttissuesandtheirapplication (e.g.,types,functions,andbiology)

a. Musculoskeletalgrafts(bone,connectiveandsofttissue)b. Skingraftsc. Cardiacvalveandvasculargrafts

2. Shippingtechniques (e.g.,validation,dryiceamounts,andexpirationdatesof

productsandshippingcontainers)3. Propermanufacturing oftissuegrafts(e.g.,identityofgrafttypes,properpackaging,

properlabeling)4. Procedures forreturnedgrafts(e.g.,documentation)5. Appropriate storageforalltypesofgrafts6. Basicsurgicalproceduresutilizingtissuegrafts7. Tissuetraceability requirements8. Typesofstorage(shortandlongterm)andacceptable temperature andtimeranges9. OCgraftsandtheirapplicationsKeywordsandconcepts:

• Allograftvs.Autograft/Xenograft/Synthetic• Packagelabelvs.packageinsert• Returnedgraftprocedure

o Requirements forinspection, temperature, anddocumentation required• Shippingtechniques

o Shipping/transport containervalidation§ Quantityofwetordryice§ Productandshippingcontainerexpiration§ Requirements forfinishedproduct

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LISTOFREFERENCEPUBLICATIONSThe following listofpublications isnotacomprehensivelisting ofstudymaterial, butrather it reflectsthebasicmaterials fromwhichwesuggestyoustudy:AATBStandardsforTissueBanking(currentedition)includingpublishedupdatesCurriculumGuidefortheAATBCertifiedTissueBankSpecialistTrainingCourseAATBGuidanceDocumentNo.1v2,TissueDonorPhysicalAssessmentForm(June27th2005)AATBGuidanceDocumentNo.2v2,AppendixIV.PreventionofContamination andCross-Contamination atRecovery:Practices&CultureResults(January1,2017)AATBGuidanceDocument:No.3,CurrentGoodTissuePractice(June27,2006)AATBGuidanceDocumentNo.4,ProvidingServicetoTissueDonorFamilies(March10,2007)AATBInterimGuidanceDocumentNo.5,StandardK2.210Pre-Sterilization/Pre-DisinfectionCultures(January4,2011)AATBGuidanceDocumentNo.6,RecoveryPartnerAuditToll(September1,2011)AATBGuidanceDocumentNo.7,v2EvaluationofBodyCoolingatStandardD5.400(December9,2013)AATB/ICCBBA InterimGuidanceDocument,ForUseofISBT128byNorthAmericanTissueBanks(January2011)CenterforDiseaseControl-http://www.cdc.govAssociationofperiOperativeRegisteredNurses(AORN)GuidelinesforPerioperativePractice-CurrentVersion–(SterileTechnique,HandHygieneandSurgicalAttire)www.aorn.orgGuidanceforIndustryEligibilityDetermination forDonorsofHumanCells,Tissues,andCellularandTissue---BasedProducts(HCT/Ps),FDA,August27,2007http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm073964.htmFinalRule:HumanTissueIntendedforTransplantation (21CFR,Part1270)FederalRegister/Vol.62,No.145/Tuesday,July29,1997http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1270

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FinalRule:RegistrationandListingRegulations; (21CFR,Part1271,SubpartB)FederalRegister/Vol.66,No.13/Friday,January19,2001FinalRule:EligibilityDetermination forDonorsofHumanCells,Tissues,andCellularandTissue–BasedProducts; (21CFR,Part1271,SubpartC)FederalRegister/Vol.69,No.101/Tuesday,May25,2004FinalRule:GoodTissuePractices (CGTPs);(21CFR,Part1271,SubpartD)FederalRegister/Vol.69,No.236/Wednesday,November24,2004http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271NationalOrganTransplantActhttp://www.organdonor.gov/legislation/Occupational SafetyHazardousAdministrationhttp://www.osha.govUniformAnatomicalGiftActhttp://www.uniformlaws.org/ActSummary.aspx?title=Anatomical%20Gift%20Act%20%282006%29UnitedNetworkofOrganSharinghttp://www.unos.orgGuidanceforIndustry:CurrentGoodTissuePractice(CGTP)andAdditionalRequirementsforManufacturersofHumanCells,Tissues,andCellularandTissue-BasedProducts(HCT/Ps).(PDF-265KB)-2011http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM285223.pdf

GuidanceforIndustry:RegulationofHumanCells,Tissues,andCellularandTissue-BasedProducts(HCT/Ps)-SmallEntityComplianceGuide–2007http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm073366.htm

GuidanceforIndustry:Compliancewith21CFRPart1271.150(c)(1)–ManufacturingArrangements-2006http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm073991.htm

GuidanceforIndustry:MedWatchFormFDA3500A:MandatoryReportingofAdverseReactionsRelatedtoHumanCells,Tissues,andCellularandTissue-BasedProducts(HCT/Ps)-2005http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm074000.htm

GuidanceforIndustry:RecommendationsforObtainingaLabelingClaimforCommunicableDiseaseDonorScreeningTestsUsingCadavericBloodSpecimensfromDonorsofHumanCells,

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Tissues,andCellularandTissue-BasedProducts(HCT/Ps)-2004http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm073972.htm

GuidanceforIndustry:ValidationofProceduresforProcessingofHumanTissuesIntendedforTransplantation-2002http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm073429.htm

GuidanceforIndustry:AvailabilityofLicensedDonorScreeningTestsLabeledforUsewithCadavericBloodSpecimens–2000http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm073976.htm

CommunicableDisease&TravelReference

https://wwwnc.cdc.gov/travel/diseases/