SUBCHAPTER 22The Official Web Site for The State of.docx
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SUBCHAPTER22TheOfficialWebSiteforTheStateof
REGULATION:
QUALITYASSURANCEPROGRAMS
FORMEDICALDIAGNOSTICX-RAYINSTALLATIONS
N.J.A.C.7:
28-22
NewJerseyDepartmentofEnvironmentalProtection
BureauofRadiologicalHealth
POBox415
TrentonNJ08625
FAX609-984-5811
Website:
http:
//www.state.nj.us/dep/rpp
TableofContents
SectionSectionTitlePage(s)
22.1Purpose,Scope,andApplicability3
22.2Definitions3
22.3GeneralProvisions4
22.4QualityAssuranceProgramManual7
22.5QualityAssuranceProgramForMedicalDiagnosticRadiographic
Equipment8
22.6QualityAssuranceProgramForMedicalDiagnosticFluoroscopic
Equipment12
22.7QualityAssuranceProgramForMedicalDiagnosticComputed
TomographyEquipment15
22.8MedicalPhysicist’sRadiographicQCSurvey19
22.9MedicalPhysicist’sFluoroscopicQCSurvey22
22.10MedicalPhysicist’sComputedTomographyQCSurvey25
22.11QualityAssuranceForX-rayBoneDensitometer28
22.12QualificationsofMedicalPhysicistsandMedicalPhysicist28
Assistants
22.13CertificationandDecertificationofQualifiedMedicalPhysicists32
andQualifiedMedicalPhysicistAssistants
22.14ComplianceSchedule33
22.15Severability34
NewJerseyDepartmentofEnvironmentalProtection
BureauofRadiologicalHealth
AdoptedandEffectiveonJanuary16,2001
SUBCHAPTER22QUALITYASSURANCEPROGRAMSFORMEDICALDIAGNOSTICX-RAYINSTALLATIONS
7:
28-22.1PURPOSE,SCOPEANDAPPLICABILITY
(a)ThepurposeofthisSubchapteristoincreaseprotectiontothepublicandradiationworkersfromunnecessaryexposuretoradiationandtoreducetheoccurrenceofmisdiagnosiscausedbyfaultyequipmentandoperatorerror.
(b)ThisSubchapterestablishesrequirementsforthedevelopmentandimplementationofqualityassurance(QA)programstoensurethatregistrantsofdiagnosticx-rayequipmentwhoperformdiagnosticx-rayproceduresinthehealingartsachieveconsistenthighqualityimagingandimprovediagnosiswhilereducingunnecessaryradiationtothepatientsandworkers.ThisSubchapterfurtherestablishescertainresponsibilitiesofregistrantsofradiationsourcesusedinthepracticeofdiagnosticradiology.ThisSubchapteralsoestablishesthequalificationsandtrainingrequirementsformedicalphysicists,medicalphysicistassistantsandqualifiedindividualsdesigningorimplementingQAprogramsinaccordancewiththisSubchapter.Certificationrequirementsandassociatedfeesarealsoestablishedformedicalphysicistsandmedicalphysicistassistants.
(c)Allregistrantsofmedicaldiagnosticx-rayimagingequipmentandcomputedtomographyequipment,whichisusedforperformingdiagnosticradiography,fluoroscopy,x-raybonedensitometry,orcomputedtomographyinthehealingarts,arerequiredtodevelopandcontinuallyimplementqualityassuranceprograms.Suchequipmentincludes,butisnotlimitedto,equipmentusedinperformingdiagnosticradiologyproceduresinhospital,medical,podiatric,chiropractic,industrial,school,andgovernmentfacilities.
(d)TheprovisionsofthissubchapterarenotapplicabletodiagnosticradiographicmammographyequipmentthatmustcomplywiththeFederalMammographyQualityStandardsAct,42U.S.C.A.§263(b),orN.J.A.C.7:
28-15.4.
7:
28-22.2DEFINITIONS
Thewordsandtermslistedbelow,whenusedinthissubchapter,shallhavethefollowingmeanings,unlessthecontextclearlyindicatesotherwise.
“Dedicatedinterventionalspecialproceduresuite”meansaroomdedicatedtotheperformanceoffluoroscopicinterventionalspecialprocedures.Theseproceduresincludebutarenotlimitedto,angioplasty,angiography,cardiaccatheterization,etc.
“Immediatesupervision"meansinroomsupervision.
“Initially”meansnolaterthanthedateoftherequiredimplementationofthequalityassuranceprogramspecifiedinN.J.A.C.7:
28-22.14orwithin60daysofthedatethex-raymachineisacquired.
"Qualifiedmedicalphysicistforthesupervisionofqualityassuranceprogramsforcomputedtomographyequipment"meansanindividualwhomeetsthequalificationsfora"Qualifiedmedicalphysicistforthesupervisionofqualityassuranceprogramsforcomputedtomographyequipment"inN.J.A.C.7:
28-22.12(b).
"Qualifiedmedicalphysicistforthesupervisionofqualityassuranceprogramsfordiagnosticxrayimaging"meansanindividualwhomeetsthequalificationsfor"Qualifiedmedicalphysicistforthesupervisionofqualityassuranceprogramsfordiagnosticxrayimaging"inN.J.A.C.7:
28-22.12(a).
"Qualifiedmedicalphysicistassistantinfluoroscopy"meansanindividualwhomeetsthequalificationsfor“Qualifiedmedicalphysicistassistantinfluoroscopy”inN.J.A.C.7:
28-22.12(d).
"Qualifiedmedicalphysicistassistantinradiography"meansanindividualwhomeetsthequalificationsfor“Qualifiedmedicalphysicistassistantinradiography”inN.J.A.C.7:
28-22.12(c).
“Registrant”meansapersonwhoisrequiredtoregisterasourceofradiationwiththeDepartmentpursuanttothischapter.
7:
28-22.3GENERALPROVISIONS
(a)Nopersonshallperformorpermittheperformanceofadiagnosticx-rayprocedureinthehealingartsusingradiographic,fluoroscopic,x-raybonedensitometry,orcomputedtomography(CT)equipmentunlesstheregistranthasdevelopedandcontinuestoimplementaqualityassuranceprograminaccordancewiththecompliancescheduleinN.J.A.C.7:
28-22.14andthatsatisfiestherequirementsofthissubchapter.
(b)Subjectto(c)below,thequalityassuranceprogramshallcontainthefollowingelements:
1.AqualityassuranceprogrammanualasspecifiedinN.J.A.C.7:
28-22.4;2.QualitycontroltestsasspecifiedinN.J.A.C.7:
28-22.5,22.6or22.7(asappropriateforthediagnosticx-rayequipment);3.Aninitialandannual(nottoexceed14months)MedicalPhysicist’sQCSurveyasspecifiedinN.J.A.C.7:
28-22.8,22.9,or22.10;and4.AcorrectiveactionplanasrequiredbyN.J.A.C.7:
28-22.4(a)4.(c)Registrantsofx-raybonedensitometerequipmentarerequiredonlytoimplementandcontinuetocarryoutthequalityassuranceprogramsforsuchequipmentwhicharerequiredbyN.J.A.C.7:
28-22.11.
(d)TheDepartmenthaspreparedComplianceGuidanceDocuments,listedbelow,whichmaybeusedbytheregistrantsasassistanceindevelopingandimplementingqualityassuranceprogramsrequiredbythisSubchapter.TheComplianceGuidanceDocumentsarelistedbelow:
1.ComplianceGuidanceforaMedicalDiagnosticX-rayQualityAssuranceProgramManual,
2.ComplianceGuidanceforRadiographicQualityControl,
3.ComplianceGuidanceforFluoroscopicQualityControl,
4.ComplianceGuidanceforComputedTomographyQuality
Control.
(e)TheComplianceGuidanceDocumentslistedinN.J.A.C.7:
28-22.3(d)areavailablefromtheDepartment,andmaybeobtainedbycontactingtheDepartmentatTheBureauofRadiologicalHealth,P.O.Box415,Trenton,NJ08625-0415andcanbeobtainedfromtheRadiationProtectionProgramwebpageat“http:
//www.state.nj.us/dep/rpp”.
(f)AregistrantoranorganizationrepresentingagroupofregistrantsmayrequestapprovalfromtheDepartmentofanalternativequalityassuranceprogramtobeusedbythatspecificregistrantoraspecifiedlistofregistrants.TheapplicationmustfullydocumenttheprovisionsofthealternativequalityassuranceprogramandidentifyhowthealternativeprogramdiffersfromtherequirementsinthisSubchapter.TheapplicantmustdemonstratethatthealternativeprogramwillbeequallyeffectiveinachievingconsistenthighqualityimagingandimprovingdiagnosiswhilereducingunnecessaryradiationtothepatientsandworkersasthequalityassuranceprogramrequiredbythisSubchapter.Theapplicantmayrequestthataspecificqualitycontroltestorotherqualityassuranceprovisionbeexcludedfromtheapplicant'squalityassuranceprogramifperformingthetestorprovisionisnotpossibleorisinappropriatebecauseofthenatureoftheapplicant'sequipmentorpractice.
(g)TheDepartment,withapprovaloftheCommissiononRadiationProtection,mayapprove,orapprovewithconditions,arequestforanalternativequalityassuranceprogram.Tobeapproved,thealternativeprogrammustbeequallyeffectiveinachievingconsistenthighqualityimagingwhilereducingunnecessaryradiationtothepatientsandtheworkersasthequalityassuranceprogramrequiredbythisSubchapter.
(h)TheDepartmentmaydenyarequestforanalternativequalityassuranceprogramshoulditdeterminethatthealternativeprogramwouldnotbeequallyeffectiveinachievingconsistenthighqualityimagingandimprovingdiagnosiswhilereducingunnecessaryradiationtothepatientsandtheworkersasthequalityassuranceprogramrequiredbythisSubchapter.
(i)AnyregistrantwhoreceivesapprovalfromtheDepartmentforanalternativequalityassuranceprogramshallcomplywiththetermsofapproval.
(j)AnyregistrantmayuseformsorproceduresthatdifferfromanyformsorprocedurescontainedintheComplianceGuidanceDocumentsreferencedinN.J.A.C.7:
28-22.3(d)withoutapprovalprovidedtheformorprocedureissufficienttodemonstratecompliancewiththeregulatoryprovision.
(k)AnyregistrantwhosubmitsanapplicationforanalternativequalityassuranceprogramshallcomplywiththequalityassuranceprogramrequirementsofthisSubchapteruntilsuchtimeastheapplicationforanalternativequalityassuranceprogramisapprovedbytheDepartment.
(l)Nopersonshallengageintheuseoremploymentofdishonesty,fraud,deception,misrepresentation,falseprom
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