Chapter 35 Board Of Medical Examiners 99 13

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BOARDOFMEDICALEXAMINERS  LAWANDPUBLICSAFETY
Chapter35 Page1of362 LastRevisionDate:1/2/2018
NEWJERSEYADMINISTRATIVECODE
TITLE13
LAWANDPUBLICSAFETY
CHAPTER35
BOARDOFMEDICALEXAMINERS
BOARDOFMEDICALEXAMINERS  LAWANDPUBLICSAFETY
Chapter35 Page2of362 LastRevisionDate:1/2/2018
CHAPTERTABLEOFCONTENTS
SUBCHAPTER1.MEDICALSCHOOLS,COLLEGES,EXTERNSHIPSANDCLERKSHIPS...................12
13:35‐1.1Observershipprogram................................................................................................................12
13:35‐1.2FifthPathway..............................................................................................................................13
13:35‐1.3(Reserved)...................................................................................................................................14
13:35‐1.4MilitaryServiceinlieuofM.D.orD.O.internshiporpostgraduatetraining.............................14
13:35‐1.5Registrationandpermitrequirementsforgraduatemedicaleducationprogramsinmedicine
orpodiatry..................................................................................................................................................14
SUBCHAPTER1A.(RESERVED)................................................................................................24
SUBCHAPTER2.LIMITEDLICENSES:PODIATRY,DIAGNOSTICTESTINGCENTERSAND
MISCELLANEOUS...................................................................................................................24
13:35‐2.1Approvedcollegesofpodiatry....................................................................................................24
13:35‐2.2Podiatryinternshiporpostgraduatework.................................................................................24
13:35‐2.3MilitaryServiceinlieuofinternshipinpodiatry........................................................................25
13:35‐2.4Podiatristsupervisionandadministrationofhyperbaricoxygentherapy.................................25
13:35‐2.5(Reserved)...................................................................................................................................26
13:35‐2.6Medicalstandardsgoverningscreeninganddiagnosticmedicaltestingoffices;determinations
withrespecttothevalidityofcertaindiagnostictests...............................................................................26
13:35‐2.7(Reserved)...................................................................................................................................42
13:35‐2.8(Reserved)...................................................................................................................................42
13:35‐2.9(Reserved)...................................................................................................................................42
13:35‐2.10(Reserved).................................................................................................................................42
13:35‐2.11(Reserved).................................................................................................................................42
13:35‐2.12(Reserved).................................................................................................................................42
13:35‐2.13Limitedprivilegesandconditionsofpracticepermittedforagraduatephysicianpending
licensure......................................................................................................................................................42
13:35‐2.14(Reserved).................................................................................................................................42
SUBCHAPTER2A.LIMITEDLICENSES:MIDWIFERY.................................................................42
13:35‐2A.1Purposeandscope...................................................................................................................42
13:35‐2A.2Definitions................................................................................................................................42
13:35‐2A.3MidwiferyLiaisonCommittee..................................................................................................43
13:35‐2A.4Applicationforlicensure..........................................................................................................44
13:35‐2A.5Independentpractice...............................................................................................................45
13:35‐2A.6Affiliatedphysicians;clinicalguidelines...................................................................................45
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13:35‐2A.7Licensure;bienniallicenserenewal;licensesuspension;reinstatementofsuspendedlicense;
inactivestatus;returnfrominactivestatus................................................................................................47
13:35‐2A.8Antepartummanagement........................................................................................................48
13:35‐2A.9Managementofantepartumwomenatincreasedrisk...........................................................48
13:35‐2A.10Intrapartummanagement......................................................................................................51
13:35‐2A.11Managementofintrapartumwomenatincreasedrisk.........................................................52
13.35‐2A.12Postpartumcare.....................................................................................................................54
13:35‐2A.13Wellwomancare....................................................................................................................54
13:35‐2A.14Prescriptiveauthorization......................................................................................................54
13:35‐2A.15Limitedultrasoundexamination............................................................................................56
13:35‐2A.16Colposcopies...........................................................................................................................57
13:35‐2A.17Circumcisions..........................................................................................................................58
SUBCHAPTER2B.LIMITEDLICENSES:PHYSICIANASSISTANTS...............................................59
13:35‐2B.1Purposeandscope...................................................................................................................59
13:35‐2B.2Definitions................................................................................................................................59
13:35‐2B.3Practicerequirements..............................................................................................................60
13:35‐2B.4Scopeofpractice......................................................................................................................61
13:35‐2B.5Eligibilityforlicensure..............................................................................................................63
13:35‐2B.6Refusaltoissue,suspensionorrevocationoflicense..............................................................64
13:35‐2B.7Licenserenewal,continuingeducationrequirement..............................................................64
13:35‐2B.8Credit‐hourrequirements........................................................................................................64
13:35‐2B.9Waiverofcontinuingeducationrequirement..........................................................................65
13:35‐2B.10Supervision.............................................................................................................................65
13:35‐2B.11Recordkeeping........................................................................................................................66
13:35‐2B.12Requirementsforissuingprescriptionsformedications;specialrequirementsforissuanceof
CDS..............................................................................................................................................................67
13:35‐2B.13Eligibilityfortemporarylicensure..........................................................................................69
13:35‐2B.14Temporarylicensure;scopeofpractice.................................................................................69
13:35‐2B.15Supervisionoftemporarylicenseholder...............................................................................69
13:35‐2B.16Expirationoftemporarylicense;renewal..............................................................................70
13:35‐2B.17Licensure;bienniallicenserenewal;licensesuspension;reinstatementofsuspended
license;inactivestatus;returnfrominactivestatus...................................................................................70
13:35‐2B.18Sexualmisconduct..................................................................................................................72
13:35‐2B.19Credittowardslicensureforeducation,training,andexperiencereceivedwhileservingasa
memberoftheArmedForces
.....................................................................................................................74
SUBCHAPTER3.LICENSINGEXAMINATIONSANDENDORSEMENTS,LIMITEDEXEMPTIONS
FROMLICENSUREREQUIREMENTS;POSTGRADUATETRAINING............................................75
13:35‐3.1Licensingexamination;physicians..............................................................................................75
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13:35‐3.2Endorsement;physicians............................................................................................................76
13:35‐3.3Endorsement;podiatricphysicians............................................................................................77
13:35‐3.4(Reserved)...................................................................................................................................77
13:35‐3.5(Reserved)...................................................................................................................................77
13:35‐3.6Bioanalyticallaboratorydirectorlicense,plenaryorspecialty,grantedtophysicians..............77
13:35‐3.7Limitedexemptionfromlicensure;physicians...........................................................................78
13:35‐3.8Administrativeprocessingoflicenseapplication.......................................................................79
13:35‐3.9(Reserved)...................................................................................................................................79
13:35‐3.10Subversionorattempttosubvertthelicensingexaminationprocess.....................................79
13:35‐3.11Standardsforlicensureofphysiciansgraduatedfrommedicalschoolsnotapprovedby
Americannationalaccreditingagencies.....................................................................................................80
13:35‐3.11AStandardsforlicensureofphysiciansgraduatedfrommedicalschoolsapprovedby
recognizednationalaccreditingagencies...................................................................................................83
13:35‐3.12Standardsforlicensureofphysicianswithpost‐secondaryeducationaldeficiencies.............83
13:35‐3.13Criminalhistoryrecordinformation.........................................................................................84
13:35‐3.14Bienniallicenserenewal;licensesuspension;reinstatementofsuspendedlicense;inactive
status;returnfrominactivestatus.............................................................................................................85
13:35‐3.15Postgraduatetraining...............................................................................................................86
SUBCHAPTER4.SURGERY......................................................................................................87
13:35‐4.1Majorsurgery;qualifiedfirstassistant.......................................................................................87
13:35‐4.2Terminationofpregnancy..........................................................................................................88
SUBCHAPTER4A.SURGERY,SPECIALPROCEDURESANDANESTHESIASERVICESPERFORMED
INANOFFICESETTING...........................................................................................................92
13:35‐4A.1Purpose.....................................................................................................................................92
13:35‐4A.2Scope........................................................................................................................................92
13:35‐4A.3Definitions................................................................................................................................92
13:35‐4A.4Policiesandproceduresrequirements....................................................................................97
13:35‐4A.5Dutytoreportincidentsrelatedtosurgery,specialproceduresoranesthesiainanoffice...99
13:35‐4A.6Standardsforperformingsurgeryandspecialproceduresinanoffice;privilegesnecessary;
pre‐procedurecounseling;patientrecords;recoveryanddischarge........................................................99
13:35‐4A.7Standardsforadministeringorsupervisingtheadministrationofanesthesiaservicesinan
office;pre‐anesthesiacounseling;patientmonitoring;recovery;patientrecord;dischargeofpatient.102
13:35‐4A.8Performanceofgeneralanesthesia;authorizedpersonnel...................................................107
13:35‐4A.9Administrationofregionalanesthesia;authorizedpersonnel...............................................108
13:35‐4A.10Administrationofconscioussedation;authorizedpersonnel.............................................108
13:35‐4A.11Administrationofminorconductionblocks;authorizedpersonnel....................................109
13:35‐4A.12Alternativeprivilegingprocedure........................................................................................110
13:35‐4A.13Requirementsforanesthetizinglocations;emergencyequipmentandsupplies................115
13:35‐4A.14Requirementsforanesthetizinglocations;safetysystems,monitoringdevices.................116
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13:35‐4A.15Equipmentrequirementsforrecoveryareas.......................................................................117
13:35‐4A.16Maintenancerequirements.................................................................................................118
13:35‐4A.17Compliancetimetables.........................................................................................................119
13:35‐4A.18Enforcement.........................................................................................................................119
SUBCHAPTER5.EYEEXAMINATIONS;EYEGLASSES..............................................................119
13:35‐5.1Minimumeyeexamination;contactlenses.............................................................................119
13:35‐5.2Minimumstandardsandtolerancesofopticallenses..............................................................120
SUBCHAPTER6.GENERALRULESOFPRACTICE....................................................................122
13:35‐6.1Practiceidentification...............................................................................................................122
13:35‐6.2Pronouncementofdeath.........................................................................................................123
13:35‐6.3Sexualmisconduct....................................................................................................................125
APPENDIX..................................................................................................................................................128
13:35‐6.4Delegationofadministrationofsubcutaneousandintramuscularinjectionstocertified
medicalassistants.....................................................................................................................................130
13:35‐6.5Preparationofpatientrecords,computerizedrecords,accesstoorreleaseofinformation;
confidentiality,transferordisposalofrecords.........................................................................................132
13:35‐6.6Standardsforjointprotocolsbetweenadvancedpracticenursesandcollaboratingphysicians
..................................................................................................................................................................139
13:35‐6.7Minimumstandardsfortheperformanceofnewornovelproceduresintheofficesetting..141
13:35‐6.8Prescribing,administeringordispensingamygdalin(laetrile).................................................144
13:35‐6.9Referralforradiologicalservices..............................................................................................146
13:35‐6.10Advertisingandsolicitationpractices.....................................................................................147
13:35‐6.11Excessivefees.........................................................................................................................152
13:35‐6.12(Reserved)...............................................................................................................................153
13:35‐6.13Feeschedule...........................................................................................................................153
13:35‐6.14Delegationofphysicalmodalitiestoalicensedhealthcareprovideroranunlicensed
physicianaide............................................................................................................................................156
13:35‐6.15Continuingmedicaleducation................................................................................................158
13:35‐6.16Professionalpracticestructure...............................................................................................160
13:35‐6.17Professionalfeesandinvestments,prohibitionofkickbacks.................................................168
13:35‐6.18Medicalmalpracticecoverage;letterofcredit......................................................................176
13:35‐6.19Dutytoreportchangesinstatus............................................................................................177
13:35‐6.20Physiciandelegationoftaskstoradiologictechnologistsandnuclearmedicinetechnologists
..................................................................................................................................................................182
13:35‐6.21Hairreplacementtechniques.................................................................................................187
13:35‐6.22Terminationoflicensee‐patientrelationship.........................................................................188
13:35‐6.23Presenceofchaperones.........................................................................................................190
13:35‐6.24Reportingofcommunicablediseasesbylicensees................................................................190
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13:35‐6.25Culturalcompetencytraining.................................................................................................191
13:35‐6.26Proceduresforphysicianorderedimmunizationsperformedbylicensedpharmacists........193
13:35‐6.27Standardsforcollaborativepracticefordrugtherapymanagementwithlicensedpharmacists
..................................................................................................................................................................195
SUBCHAPTER6A.DECLARATIONSOFDEATHUPONTHEBASISOFNEUROLOGICALCRITERIA
............................................................................................................................................199
13:35‐6A.1Purpose...................................................................................................................................199
13:35‐6A.2Definitions..............................................................................................................................200
13:35‐6A.3Requirementsforphysiciansauthorizedtodeclaredeathonthebasisofneurologicalcriteria
..................................................................................................................................................................200
13:35‐6A.4Standardsfordeclarationofbraindeath...............................................................................200
13:35‐6A.5Organdonation......................................................................................................................201
13:35‐6A.6Exemptiontoaccommodatepersonalreligiousbeliefs.........................................................201
13:35‐6A.7Pronouncementofdeath.......................................................................................................201
SUBCHAPTER7.PRESCRIPTION,ADMINISTRATIONANDDISPENSINGOFDRUGS................201
13:35‐7.1Definitions.................................................................................................................................201
13:35‐7.1AExaminationofpatient'sconditionrequiredpriortodispensingdrugsorissuinga
prescription;exceptions...........................................................................................................................203
13:35‐7.2Requirementsforissuingwrittenprescriptionsformedicines................................................205
13:35‐7.3Verbalprescriptions(Reserved)...............................................................................................206
13:35‐7.4Facsimiletransmittedprescriptions.........................................................................................206
13:35‐7.4AElectronicallytransmittedprescriptions................................................................................208
13:35‐7.5Requirementsforthedispensingofdrugsandspeciallimitationsapplicabletothedispensing
ofdrugsforafee.......................................................................................................................................209
13:35‐7.5ALimitationsonprescribing,administeringordispensingofdrugsforthetreatmentofobesity
..................................................................................................................................................................212
13:35‐7.6Limitationsonprescribing,administering,ordispensingofcontrolleddangeroussubstances;
specialrequirementsformanagementofacuteandchronicpain..........................................................214
13:35‐7.7Prohibitionsonprescribing,administeringordispensingofcontrolledsubstancesfor
detoxification;limitedexceptions............................................................................................................219
13:35‐7.8Prohibitionsandlimitationsintheprescribing,administeringordispensingofamphetamines
andsympathomimeticamines..................................................................................................................220
13:35‐7.9Prohibitionsandspeciallimitationsonprescribing,administeringordispensinganabolic
steroidsandhumangrowthhormoneoritssimilaranalogs....................................................................221
13:35‐7.10Enforcement...........................................................................................................................225
SUBCHAPTER7A.COMPASSIONATEUSEMEDICALMARIJUANA..........................................226
13:35‐7A.1Purposeandscope.................................................................................................................226
13:35‐7A.2Definitions..............................................................................................................................226
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13:35‐7A.3Requirementforphysicianparticipation...............................................................................227
13:35‐7A.4Certificationrequirements.....................................................................................................228
13:35‐7A.5Writteninstructionrequirements;reassessment;records....................................................229
13:35‐7A.6DutytoreportinformationtotheDivision............................................................................231
SUBCHAPTER8.HEARINGAIDDISPENSERS.........................................................................232
13:35‐8.1Purpose.....................................................................................................................................232
13:35‐8.2Definitions.................................................................................................................................232
13:35‐8.3Trainingandexperiencerequirements....................................................................................233
13:35‐8.4Trainingpermits;issuanceandpractice...................................................................................234
13:35‐8.5Temporarylicenses;issuance...................................................................................................234
13:35‐8.6Temporarylicenses;practice....................................................................................................235
13:35‐8.7Sponsors...................................................................................................................................235
13:35‐8.8Scopeofpractice......................................................................................................................236
13:35‐8.9Fittinganddispensingofdeepearcanalhearingaiddevices..................................................237
13:35‐8.10Supervisinglicensee................................................................................................................238
13:35‐8.11NotificationtotheCommittee;bienniallicenserenewal;licensesuspension;reinstatementof
suspendedlicense;inactivestatus;returnfrominactivestatus..............................................................238
13:35‐8.12Equipment..............................................................................................................................240
13:35‐8.13Hearingtesting.......................................................................................................................240
13:35‐8.14AdvertisingandSolicitation....................................................................................................241
13:35‐8.15Abandonment;excessivefees................................................................................................242
13:35‐8.16Itemizationofservicesandequipment;retentionofrecords................................................242
13:35‐8.17Licensingexamination............................................................................................................243
13:35‐8.18ViolationoftheRules.............................................................................................................244
13:35‐8.19Feeschedule...........................................................................................................................244
13:35‐8.20Licenserenewal;continuingeducationrequirement.............................................................245
SUBCHAPTER9.ACUPUNCTURE..........................................................................................246
13:35‐9.1Purposeandscope....................................................................................................................246
13:35‐9.2Definitions.................................................................................................................................246
13:35‐9.3Credentialsrequiredforcertification.......................................................................................248
13:35‐9.4Educationrequiredforlicensure..............................................................................................249
13:35‐9.5NewJerseyacupuncturesafetyandjurisprudenceexamination............................................251
13:35‐9.6(RESERVED)...............................................................................................................................251
13:35‐9.7Prohibitedtitles........................................................................................................................251
13:35‐9.8Feeschedule;refunds...............................................................................................................252
13:35‐9.9Bienniallicenserenewal;licensesuspension;reinstatementofsuspendedlicense;inactive
status;returnfrominactivestatus...........................................................................................................253
13:35‐9.10Displayoflicense....................................................................................................................255
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13:35‐9.11Informedconsent;medicalmalpractice.................................................................................255
13:35‐9.12Scopeofpractice....................................................................................................................256
13:35‐9.12AHerbology.............................................................................................................................259
13:35‐9.13Guestacupuncturist...............................................................................................................260
13:35‐9.14Unlicensedpracticeofacupuncture.......................................................................................261
13:35‐9.15Precautionaryandsterilizationprocedures...........................................................................261
13:35‐9.16Preparationofpatientrecords;computerizedrecords;accesstoorreleaseofinformation;
confidentiality,transferordisposalofrecords.........................................................................................262
13:35‐9.17(RESERVED).............................................................................................................................266
13:35‐9.18(RESERVED).............................................................................................................................266
13:35‐9.19(RESERVED).............................................................................................................................266
13:35‐9.20Continuingprofessionaleducationrequirements..................................................................266
APPENDIXA(RESERVED).....................................................................................................270
SUBCHAPTER10.ATHLETICTRAINERS.................................................................................270
13:35‐10.1Scopeandpurpose.................................................................................................................270
13:35‐10.2Definitions...............................................................................................................................270
13:35‐10.3Applicationforlicensure.........................................................................................................271
13:35‐10.4Licensure;bienniallicenserenewal;licensesuspension;reinstatementofsuspendedlicense;
inactivestatus;returnfrominactivestatus..............................................................................................272
13:35‐10.5Planofcareguidelines............................................................................................................273
13:35‐10.6Practiceoutsideofschoolsandprofessionalteams..............................................................274
13:35‐10.7Scopeofpractice....................................................................................................................274
13:35‐10.8Records...................................................................................................................................276
13:35‐10.9Useofpersonalorothercomputertopreparerecords.........................................................277
13:35‐10.10Releaseofrecords................................................................................................................278
13:35‐10.11Advertisingandsolicitationpractices...................................................................................279
13:35‐10.12Advertisingfreeordiscountedservices;requireddisclosures.............................................281
13:35‐10.13Testimonialadvertising........................................................................................................282
13:35‐10.14Minimumcontent.................................................................................................................282
13:35‐10.15Advertisingbyabusinessentityofferingathletictraining...................................................282
13:35‐10.16Advertisingrecordretention................................................................................................283
13:35‐10.17Useofprofessionalcredentialsandcertifications...............................................................283
13:35‐10.18Violations..............................................................................................................................283
13:35‐10.19Fees.......................................................................................................................................283
13:35‐10.20Sexualmisconduct................................................................................................................284
13:35‐10.21Continuingeducation...........................................................................................................286
13:35‐10.22Continuingeducationprograms...........................................................................................287
13:35‐10.23Continuingeducationaudits;recordsofcontinuingeducation...........................................288
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13:35‐10.24Waiverofcontinuingeducationrequirements....................................................................288
13:35‐10.25Additionalcontinuingeducationrequirements...................................................................289
SUBCHAPTER11.ALTERNATIVERESOLUTIONPROGRAM....................................................289
13:35‐11.1Definitions...............................................................................................................................289
13:35‐11.2CreationofImpairmentReviewCommittee..........................................................................290
13:35‐11.3Dutiesofanapprovedprofessionalassistanceprogram.......................................................291
13:35‐11.4DutiesoftheImpairmentReviewCommittee........................................................................293
13:35‐11.5Professionalassistanceprogram:approvalanddiscontinuance...........................................295
13:35‐11.6Colleaguereferrals..................................................................................................................296
13:35‐11.7(Reserved)...............................................................................................................................296
SUBCHAPTER12.ELECTROLOGISTSADVISORYCOMMITTEE;LICENSUREOFELECTROLOGISTS
ANDELECTROLOGYINSTRUCTORS;ELECTROLOGYSTANDARDSOFPRACTICE.....................296
13:35‐12.1Purposeandscope.................................................................................................................296
13:35‐12.2Definitions...............................................................................................................................297
13:35‐12.3OfficeoftheCommittee.........................................................................................................298
13:35‐12.4Notificationofchangeofaddress...........................................................................................298
13:35‐12.5(Reserved)...............................................................................................................................298
13:35‐12.6Licensingrequirementsforelectrologist................................................................................298
13:35‐12.7Licensingrequirementsforelectrologyinstructor.................................................................299
13:35‐12.8Applicationforlicense:electrologist......................................................................................300
13:35‐12.9Applicationforlicense:electrologyinstructor.......................................................................300
13:35‐12.10Licensingrequirementsforofficepremises.........................................................................300
13:35‐12.11Infectioncontrolstandards..................................................................................................303
13:35‐12.12Postingoflicensesandrequirednotices..............................................................................306
13:35‐12.13Examinationrequirements;reexamination..........................................................................306
13:35‐12.14Licenseissuance,renewal;changeoflicensestatus:inactivetoactive;reinstatementof
suspendedlicense.....................................................................................................................................307
13:35‐12.15Unlicensedpractice..............................................................................................................309
13:35‐12.16Licensurebycredentials(comitylicense).............................................................................310
13:35‐12.17Suspension,revocationorrefusaltorenewlicense.............................................................310
13:35‐12.18Recordkeeping......................................................................................................................313
13:35‐12.19Continuingeducation,programs,standards........................................................................314
13:35‐12.20Sexualmisconduct................................................................................................................318
13:35‐12.21Advertisingandsolicitationpractices...................................................................................319
13:35‐12.22Feeschedule.........................................................................................................................322
SUBCHAPTER13.PERFUSIONISTSADVISORYCOMMITTEE....................................................323
13:35‐13.1Purposeandscope.................................................................................................................323
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13:35‐13.2Definitions...............................................................................................................................324
13:35‐13.3OfficeoftheCommittee.........................................................................................................326
13:35‐13.4Notificationofchangeofaddressandrecord........................................................................326
13:35‐13.5Licensureundergrandfathering.............................................................................................326
13:35‐13.6Licensingrequirementsforperfusionist.................................................................................327
13:35‐13.7Graceperiodforpracticingwithoutlicensurependingapplication.......................................328
13:35‐13.8Licensurebyreciprocity..........................................................................................................328
13:35‐13.9Licenserequiredfordesignationasperfusionist...................................................................329
13:35‐13.10Temporarylicense;supervision............................................................................................329
13:35‐13.11Licenserenewal....................................................................................................................331
13:35‐13.12Changeoflicensestatus:inactivetoactive..........................................................................331
13:35‐13.13Reinstatementofsuspendedlicense....................................................................................332
13:35‐13.14Dutytoreportchangeinstatus............................................................................................333
13:35‐13.15Suspension,revocationorrefusaltorenewlicense.............................................................334
13:35‐13.16Continuingeducation...........................................................................................................336
13:35‐13.17Feeschedule.........................................................................................................................341
SUBCHAPTER14..................................................................................................................342
GENETICCOUNSELINGADVISORYCOMMITTEE...................................................................342
13:35‐14.1Purposeandscope................................................................................................................342
13:35‐14.2Definitions.............................................................................................................................343
13:35‐14.3Applicationforlicensure.......................................................................................................344
13:35‐14.4Practicepriortopassingtheexaminationforlicensure.......................................................344
13:35‐14.5Out‐of‐Stategeneticcounselor............................................................................................345
13:35‐14.6Renewaloflicense................................................................................................................346
13:35‐14.7Continuingeducation............................................................................................................348
13:35‐14.8Scopeofpractice..................................................................................................................350
13:35‐14.9Sexualmisconduct................................................................................................................350
13:35‐14.10Changeinaddressofrecordorname.................................................................................352
13:35‐14.11Advertisingandsolicitationpractices.................................................................................353
13:35‐14.12Advertisingfreeordiscountedservices;requireddisclosures...........................................355
13:35‐14.13Testimonialadvertising.......................................................................................................356
13:35‐14.14Minimumcontent...............................................................................................................356
13:35‐14.15Recordkeeping....................................................................................................................356
13:35‐14.16Clientaccesstorecords......................................................................................................357
13:35‐14.17Confidentiality.....................................................................................................................358
13:35‐14.18Feeschedule.......................................................................................................................358
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SUBCHAPTER 1.
MEDICAL SCHOOLS, COLLEGES, EXTERNSHIPS AND CLERKSHIPS
13:35-1.1 OBSERVERSHIP PROGRAM
"Observer" shall mean an undergraduate medical student of an allopathic or osteopathic
school accredited either by the Liaison Committee on Medical Education or the American
Osteopathic Association or a foreign medical school listed in either the World Health
Organization Directory published by the World Health Organization or the International
Medical Education Directory (IMED) published by the Educational Commission for
Foreign Medical Graduates (ECFMG) and whose graduates are accepted by the New
Jersey Board of Medical Examiners as eligible to sit for the licensure examination.
Observerships are limited to the student's vacation period in an extra-curricular
professional experience as delineated in this section.
An observership program shall be limited to:
1)
Observation of operative procedures;
2)
The taking of histories;
3)
The performance of physical examinations;
4)
The performance of non-invasive procedures under the direct supervision of and in
the immediate presence of the supervising licensed physician; and
5)
The participation in patient rounds and other organized patient care activities of the
supervising physician.
At no time shall the observer be delegated any responsibility for the care of the patient,
the patient's diagnosis or any aspect of the patient's treatment, including the prescription
of medication for the patient. An observer shall make no entries on the patient's
permanent record.
The observer shall at all times of patient contact wear an identifying badge inscribed
"Medical Student."
Prior to commencing participation in an observership program, the student shall have
obtained written permission from the Chief of Staff and the Administration of the
participating hospital and shall retain such letter.
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Under no circumstances shall the performance of any of the duties listed in (b) above by
an observer, while engaged in such a program, be construed as the practice of medicine.
The time spent in an observership program shall not be considered as part of or credited
toward fulfillment of any statutory academic or clinical requirements for licensure.
13:35-1.2 FIFTH PATHWAY
The Board shall accept application for licensure from an applicant who does not meet the
usual statutory prerequisites for educational background, in the following circumstances
to be known as the Fifth Pathway:
1)
The applicant has completed the entirety of the academic curriculum in residence at
a medical school in a foreign country located outside of the United States, Puerto
Rico or Canada or in a school-authorized clinical training program;
2)
The medical school was approved throughout the applicant's period of education by
the government of the country of domicile to confer the degree of Doctor of Medicine
and Surgery or its equivalent, and was listed in either the World Health Organization
Directory published by the World Health Organization or the International Medical
Education Directory (IMED) published by the Educational Commission for Foreign
Medical Graduates (ECFMG);
3)
The applicant has satisfactorily completed all the requirements for a matriculated
student of that foreign medical school to receive a diploma, except for internship
and/or social service;
4)
The applicant has achieved a passing score on a screening examination acceptable
to the Educational Commission on Foreign Medical Graduates (ECFMG) even though
not eligible for ECFMG certification; and
5)
The applicant has had his or her academic record reviewed and approved by a
medical school approved by the Liaison Committee on Medical Education, which
school has accepted the applicant in a one-academic-year program of supervised
clinical training under its direction, and the applicant has satisfactorily completed that
program as evidenced by receipt of a certificate issued by the sponsoring medical
school.
The applicant meeting the requirements in (a) shall thereafter be deemed by the Board to
be eligible to enter a graduate training program approved by the Accreditation Council for
Graduate Medical Education (ACGME) or the American Osteopathic Association (AOA).
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Upon satisfactory completion of the three years of post-graduate training required by
N.J.A.C. 13:35-3.11, the applicant may apply for licensure in this State.
13:35-1.3 (RESERVED)
13:35-1.4 MILITARY SERVICE IN LIEU OF M.D. OR D.O. INTERNSHIP OR
POSTGRADUATE TRAINING
The Board may grant a license to practice medicine and surgery to any person who shall
furnish proof, satisfactory to the Board, that such person has fulfilled all of the formal
requirements established by law, and who has served at least two years in active military service
in the United States Army, Air Force, Navy, Marine Corps, Coast Guard or the U.S. Public
Health Service as a commissioned officer and physician and surgeon in a medical facility which
the Board determines constitutes the substantial equivalent of the approved internship or
residency training program required by law; provided, however, that such military service
actively occurred subsequent to graduation from an approved medical school.
13:35-1.5 REGISTRATION AND PERMIT REQUIREMENTS FOR GRADUATE
MEDICAL EDUCATION PROGRAMS IN MEDICINE OR PODIATRY
The following words and terms shall have the following meanings unless the context in
this section indicates otherwise:
"Applicant" means a graduate of a medical or podiatric school, unlicensed in this State,
seeking authorization to engage in the practice of medicine or podiatry as a resident in a
graduate medical education program. A registration applicant is seeking authorization to
participate in the first year of a graduate medical education program. A permit applicant is
seeking authorization to participate in his or her second year (or beyond) of a graduate
medical education program.
"Director" means a physician holding a plenary license to practice medicine and surgery
in New Jersey who is responsible for the conduct of a graduate medical education program
at a hospital licensed in this State and whose responsibilities shall include generally
overseeing the selection, training and evaluation of residents. With respect to graduate
medical education programs in podiatry, the director shall be a podiatric physician licensed
to practice podiatry in New Jersey.
"Graduate Medical Education Program" means an education program, whether
denominated as an internship, residency, or fellowship, which is accredited by the
Accreditation Council on Graduate Medicine Education (ACGME) or by the American
Osteopathic Association (AOA) in which the graduates of medical schools participate for a
limited period of time under the supervision of plenary licensed physicians. With respect to
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podiatry, "Graduate Medical Education Program in Podiatry" means an education program,
whether denominated as an internship, residency, or fellowship, which is accredited by the
Council on Podiatric Medical Education of the American Podiatric Medicine Association
(APMA) in which the graduates of podiatric schools participate for a limited period of time
under the supervision of a licensed podiatric physician.
"Master list" means a list prepared by the director setting forth the name of each person
seeking to practice medicine or podiatry in that graduate medical education program in New
Jersey, designating the date of birth and medical or podiatric schools attended.
"Permit" means a document issued by the New Jersey State Board of Medical Examiners
authorizing the holder to engage in the practice of medicine or podiatry in the second year of
a graduate medical education program (or beyond) in medicine or podiatry in this State,
subject to the limitations set forth in this rule.
"Permit holder" means a person authorized to engage in the practice of medicine or
podiatry, as appropriate, while in the second year or beyond of a graduate medical education
program in medicine or podiatry in the State of New Jersey, subject to the limitations set
forth in this rule.
"Registered resident" means an applicant granted authorization to engage in the practice
of medicine or podiatry in the State of New Jersey in the first year of a graduate medical
education program, subject to the limitations set forth in this rule.
"Registration" means authorization to engage in the practice of medicine or podiatry in
this State in the first year of a graduate medical education program subject to the limitations
set forth in this rule.
"Resident" means a participant in training in a graduate medical education program in
medicine or in podiatry at a licensed hospital in this State. For purposes of this rule, persons
serving in internships and fellowships shall be deemed residents.
No unlicensed person shall engage in the practice of medicine or podiatry in the first year
of a graduate medical education program unless and until he or she is registered with the
Board. No unlicensed person shall engage in the practice of medicine or podiatry in the
second year of graduate medical education or beyond unless or until he or she has been
issued a permit by the Board.
A registration applicant shall certify that he or she:
1)
Has attained the preliminary educational prerequisites for licensure, including:
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i) Completion of at least 60 undergraduate level credits, at a college or university
attained prior to medical or podiatric school. With respect to medical residents,
the credits shall include at least one course each in biology, chemistry and
physics.
ii) With respect to medical residents, graduation from a medical school which, during
each year of attendance, was either accredited by the Liaison Committee on
Medical Education (LCME) or the American Osteopathic Association (AOA) or
listed in either the World Directory of Medical Schools published by the World
Health Organization or the International Medical Education Directory (IMED)
published by the Educational Commission for Foreign Medical Graduates
(ECFMG), and that the didactic training was completed in the jurisdiction where
the school is authorized to confer a medical degree. If the applicant has attended
more than one medical school, he or she shall certify that each school attended
was accredited or listed in either the World Directory of Medical Schools
published by the World Health Organization or the International Medical
Education Directory (IMED) published by the Educational Commission for Foreign
Medical Graduates (ECFMG) during the same time he or she was matriculated.
iii) With respect to podiatry residents, graduation from a college of podiatric medicine
accredited by the Council on Podiatric Medical Education (CPME) of the
American Podiatric Medicine Association (APMA). If the applicant has attended
more than one college of podiatric medicine, he or she shall certify that each
school attended was accredited or listed.
iv) Attendance at medical or podiatric school for at least 32 months prior to
graduation.
v) With respect to medical students, where clinical clerkships have been completed
away from the site of a medical school not approved by the LCME or AOA,
satisfactory completion of clinical clerkships of at least four weeks duration each
in internal medicine, surgery, obstetrics and gynecology, pediatrics and
psychiatry at hospitals that maintained at the time of the clerkship a graduate
medical education program in that field accredited by the ACGME or the AOA;
2)
Has never:
i) Been the subject of an administrative disciplinary proceeding by any state
professional licensing agency;
ii) Been convicted of a criminal offense of any grade or admitted to a pre-trial
diversionary program;
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iii) Been denied licensure eligibility to sit for an examination or eligibility to
participate in a postgraduate training program in this or any other state;
iv) Had privileges at a hospital terminated or curtailed for cause;
v) Been asked to resign from a graduate medical education program or hospital
staff;
vi) Had privileges to prescribe controlled dangerous substances curtailed or limited
by any regulatory authority; and
vii) Had privileges to participate in any state or Federal medical assistance program
(Medicare, Medicaid) curtailed or limited by any regulatory authority;
3)
Is not, at the time that the certification is executed, the subject of an administrative
disciplinary proceeding by any state professional licensing agency, or other Federal
or state regulatory authority (such as the U.S. Drug Enforcement Agency, Medicare
or Medicaid), or the subject of any criminal proceeding (under arrest, indictment or
accusation);
4)
Is not physically or mentally incapacitated to a degree which would impair his or her
ability to practice medicine or podiatry, as applicable, and is not at the time of
application habituated to alcohol or a user of any controlled dangerous substance
except upon good faith prescription of a physician; and
5)
Has obtained ECFMG or Fifth Pathway certification, if he or she is a graduate of a
foreign medical school.
The Director shall obtain a registration form from each registration applicant and shall
retain those forms, which may be subject to review by the Board. The Director shall
certify that he or she has personally reviewed the registration form of each registration
applicant who has accepted an offer of employment to ascertain that the registration
applicant has certified that he or she has attained the prerequisites set forth in (c) above
and that the Director is unaware of any information that would contradict any of the
representations contained in that registration application form. If the Director shall have
reason to question the veracity or reliability of those representations, he or she shall
direct the registration applicant to supply the supporting documentation. The Director
shall prepare a master list, which contains the names of all registration applicants and
the names and addresses of the institutions from which the applicants attended or
graduated and shall submit the master list to the Board, along with his or her certification,
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no later than one month before the registration applicants are to begin participating in the
graduate medical education program.
The Board shall review the Director's certification, and shall issue to the Director a list of
residents registered to engage in the practice of medicine or podiatry in the first year of
the graduate medical education program conducted by that hospital. The Board shall
provide to the Director a permit application for dissemination to each registered resident.
A registration applicant unable to certify that he or she has attained the prerequisites set
forth at (c) above shall state on the registration application form the reason that he or she
is unable to so certify. The Director seeking to offer employment to a registration
applicant unable to certify that he or she has attained all the prerequisites, may seek
from the Board a waiver which would enable the applicant to participate in the first year
of a graduate medical education program. The Board, in its discretion, may grant or
withhold such waiver for good cause. However, in no event may the applicant begin
participating until the waiver for good cause request has been granted and the
individual's name included on the list of registered residents or temporary authorization
has been granted pursuant to (g) below.
In the event that a registration applicant has been unable to submit the required
certification in a timely manner, the Director may grant that applicant temporary
authorization to participate in the first year of a graduate medical education program,
which will allow him or her no more than 30 days to complete the application process,
provided that notice of such a grant is provided to the Board within five working days.
A registered resident may engage in the practice of medicine or podiatry provided that
such practice shall be confined to a hospital affiliated with the graduate medical
education program and outpatient facilities integrated into the curriculum of the program,
under the supervision of licensed plenary physicians or licensed podiatric physicians, as
appropriate. All prescriptions and orders issued by registered residents in the inpatient
setting shall be countersigned by either a licensed physician or a licensed podiatric
physician, as applicable; or a permit holder at the minimum upon the patient's discharge,
or sooner if the Director so requires. All prescriptions issued by registered residents in
the outpatient setting which are to be filled in a pharmacy outside a licensed health care
facility shall be signed by either a licensed physician or licensed podiatric physician, as
appropriate.
The Board may refuse to register a registration applicant if he or she has not certified
that the prerequisites set forth in (c) above have been satisfied or if the Board is in
possession of any information contradicting the representation made in the registration
application form. The Board shall give the Director and the registration applicant notice of
its refusal, allowing the submission of documentary evidence in rebuttal. Upon a showing
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of good cause the applicant will be granted an appearance before a committee of the
Board.
In addition to any practice declared to be a basis for sanction,, pursuant to P.L. 1978,
c.73 (N.J.S.A. 45:1-14 et seq.), the practices listed below, upon proof, shall also provide
a basis for the withdrawal of the authorization to engage in the practice of medicine or
podiatry as a registered resident. Upon receipt of the notice of proposed withdrawal, the
registered resident may request a hearing, which shall be conducted pursuant to the
Administrative Procedure Act, N.J.S.A. 52:14B-1 et seq.
1)
Termination or withdrawal from the graduate medical education program.
2)
Failure to advise the Board of a termination or withdrawal from a graduate medical
education program.
3)
Engaging in any act or practice beyond the scope of those authorized pursuant to (h)
above.
Upon a duly verified application of the Attorney General, alleging a violation of any act or
regulation administered by the Board, which palpably demonstrates that the resident's
continued practice would constitute a clear and imminent danger to the public health,
safety and welfare, upon notice, the Board may enter an order temporarily suspending
the resident's authority to engage in the practice of medicine or podiatry pending a.
plenary hearing on the charge. If the Board determines that, although continued practice
would not constitute clear and imminent danger, the resident's continued practice could
pose a risk to the public health, safety and welfare, it may order the resident to submit to
medical or diagnostic testing and monitoring or psychological evaluation or an
assessment of skills to determine whether the resident can continue to practice with
reasonable skill and safety.
A permit applicant shall submit to the Director a permit application form certifying that he
or she has attained the prerequisites set forth in (c) above, and, in addition, shall forward
to the appropriate individuals requests for the production of the documentation listed
below. The documentation sought by the permit applicant shall be sent directly to the
director by the certifying individual. The permit applicant shall also submit to the director
a check or money order in the sum of $50.00 made payable to the New Jersey State
Board of Medical Examiners.
1)
Registrar's certification of attendance or college transcript from each college
attended;
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2)
Registrar's certification of attendance or school transcript from each medical or
podiatric school attended;
3)
With respect to medical residents, ECFMG or Fifth Pathway certification, if
applicable;
4)
Certification of successful performance during the first year of a graduate medical
education program to date.
The Director shall obtain from the permit applicant the application form and the $50.00
fee and shall also receive and retain certified documentation, set forth in (l) above. No
later than four months before the date on which the applicant is scheduled to begin
participating in the second year of a graduate medical education program (or beyond),
the Director shall submit to the Board a complete application packet for each person to
whom an offer of employment has been extended. The packet shall include:
1)
Permit application, completed by the applicant.
2)
Registrar's certification for each college attended or college transcript for each
college attended.
3)
Registrar's certification for each medical or podiatric school attended, or medical or
podiatric school transcript for each medical or podiatric school attended and the
jurisdiction in which the didactic training was conducted.
4)
With respect to medical residents, ECFMG or Fifth Pathway certification, if
applicable.
5)
Certification of successful performance during the first year of graduate medical
education to date.
6)
Permit fee of $50.00 in the form of check or money order made payable to the New
Jersey State Board of Medical Examiners.
The Director shall certify that he or she has offered a position to the applicant and has
personally reviewed the permit application form and all supporting documentation and is
unaware of any information which would contradict any of the representations in that
application form or in any of the supporting certifications. If the Director shall have
reason to question the veracity or reliability of those representations, he or she shall
direct the permit applicant to supply the supporting documentation.
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Upon receipt of the permit application packet, the Board shall review each permit packet
and if it is satisfied that the permit applicant has the necessary prerequisites, it shall
issue to the applicant a permit authorizing that person to engage in either the practice of
medicine or the practice of podiatry, as appropriate, in the second year (or beyond) of a
graduate medical education program.
A permit applicant unable to certify that he or she has attained the prerequisites set forth
at (c) above shall state on the permit application form the reason that he or she is unable
to so certify. In addition, if he or she is unable to produce the supporting documentation
set forth at (m) above, an explanation must be provided. A permit applicant who has
been unable to certify that he or she has attained all the prerequisites, or unable to
produce the required supporting documentation, may seek from the Board a waiver
which would enable the person to be issued a permit. The Board, in its discretion, may
grant or withhold such waiver for good cause shown. However, in no event may the
permit applicant begin to participate in the second year (or beyond) of a graduate
medical education program until the program waiver request has been granted and the
permit issued or a temporary permit issued.
In the event that a permit applicant has been unable to submit the required certification
or supporting documentation in a timely manner, the Director may grant the permit
applicant a temporary permit, which will allow him or her to participate in the graduate
medical education program for no more than 60 days, to allow for the completion of the
application process provided that notice of such a grant is provided to the Board within
five working days.
A permit holder may engage in the practice of medicine or podiatry provided that such
practice shall be within the context of an accredited graduate medical education program
conducted at a hospital licensed by the Department of Health and Senior Services
(DHSS). A permit holder may engage in practice outside the context of a graduate
medical education program for additional remuneration only if that practice is approved,
in writing, by the residency program director of the graduate medical education program
in which the permit holder is participating and the practice is supervised by a plenary
licensee who shall:
1)
Either remain on the premises of the health care facility or be available through
electronic communication if that practice is at or through a health care facility
licensed by the DHSS; or
2)
Remain on the premises if that practice is outside of a health care facility licensed by
the DHSS.
The residency program director shall:
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1)
Require each permit holder to complete and submit a verification of
supervision/employment form prior to approving practice outside of the approved
graduate medical education program. A verification of supervision/employment form
is required for each place of employment a permit holder practices outside the
context of a graduate residency training program. The form shall include, but not be
limited to, the following information:
i) Name of the permit holder;
ii) Field of practice;
iii) New Jersey physician license number of the supervising physician;
iv) Type of facility;
v) Telephone number; and
vi) Street address of the facility; and
2)
Retain the verification of supervision/employment forms for seven years, which may
be subject to review by the Board.
The supervising physician shall:
1)
Complete an affidavit accepting responsibility for reading and implementing the
Board's statutes, N.J.S.A. 45:9-1 et seq., and rules, N.J.A.C. 13:35, that pertain to
employment of permit holders outside the context of their approved graduate medical
education programs; and
2)
Provide evidence to the program director that arrangements have been made for
professional liability coverage of the permit holder that is consistent with the rules of
the Board, specifically N.J.A.C. 13:35-6.18.
Prescriptions and orders may be issued by permit holders in the inpatient setting without
countersignature. All prescriptions issued by permit holders in the outpatient setting,
which are to be filled in a pharmacy outside a licensed health care facility shall be signed
by a licensed physician or licensed podiatric physician, as appropriate.
The Board may refuse to issue a permit to a permit applicant if he or she has not certified
that the prerequisites set forth in (c) above have been satisfied, if the supporting
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documentation set forth in (/) above has not been produced or if the Board is in
possession of any information contradicting the representations made in the permit
application form or supporting documentation. The Board shall give the Director and the
applicant notice of its refusal, allowing the submission of documentary evidence in
rebuttal. Upon a showing of good cause the applicant will be granted an appearance
before a committee of the Board.
In addition to any practice declared to be a basis for sanction, pursuant to P.L. 1978,
c.73 (N.J.S.A. 45:1-14 et seq.), the practices listed below, upon proof, shall also provide
basis for the termination or suspension of a permit. Upon receipt of the notice of
proposed termination or suspension the permit holder may request a hearing which shall
be conducted pursuant to the Administrative Procedure Act, N.J.S.A. 52:14B-1 et seq.
1)
Termination or withdrawal from a graduate medical education program.
2)
Failure to advise the Board of a termination or withdrawal from a graduate medical
education program.
3)
Engaging in any act or practice beyond the scope of those authorized pursuant to (r)
above.
A permit shall be valid for the duration of the graduate medical education program in
which the permit holder is participating. If the permit holder seeks to change programs,
he or she must submit a transfer application form. All transfer applications must be
accompanied by a certification from the Director of the graduate medical education
program in which the applicant has been or is currently participating, attesting to
successful performance in the program.
Each hospital offering a program(s) in medicine shall designate one physician who would
qualify as a Director to fulfill the responsibilities set forth in this rule. Each hospital
offering a podiatry program shall designate one podiatric physician who would qualify as
a Director of a podiatry program to fulfill the responsibilities set forth in this rule. The
Director may delegate to individual program directors these responsibilities, so long as
the Director retains ultimate responsibility for the conduct of the program, except that the
Director may not delegate the authority to issue temporary authorizations. In addition to
the responsibilities placed upon any Director by this rule, he or she shall:
1)
Implement procedures to assure that all prescriptions and orders issued by residents
are countersigned or signed in accordance with the requirements of this rule.
2)
Provide broad oversight of the activities of all program participants.
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3)
Report to the Board any conduct by a resident which, if proven, would represent
cause for the withdrawal of registration or the suspension of a permit.
4)
Report to the Board if any resident is granted a leave of absence for any reason,
relating to a medical or psychiatric illness or to medical competency or conduct,
which would represent cause for the withdrawal of the authority to practice, providing
an explanation. This duty to report shall not apply if the resident is known to the
Board's Impairment Review Committee through participation in the Alternative
Resolution Program.
The authorization granted to an unlicensed person to participate in the first year of a
graduate medical education program shall not be construed to imply that that person will
be deemed eligible for the issuance of a permit or a license. The issuance of a permit
similarly should not be construed to imply that the permit holder will be deemed eligible
for licensure.
SUBCHAPTER 1A.
(RESERVED)
SUBCHAPTER 2.
LIMITED LICENSES: PODIATRY, DIAGNOSTIC TESTING CENTERS AND
MISCELLANEOUS
13:35-2.1 APPROVED COLLEGES OF PODIATRY
An applicant for podiatric licensure shall have graduated from a college or colleges of
podiatry approved during the entire course of the applicant's training by the American Podiatric
Association and approved by the Board.
13:35-2.2 PODIATRY INTERNSHIP OR POSTGRADUATE WORK
The applicant for licensure shall have successfully completed an internship or postgraduate
program fully approved by the American Podiatric Medical Association in a duly licensed clinic,
hospital or institution acceptable to the Board, which shall take into account the standards
adopted by the Advisory Graduate Medical Education Council (AGMEC).
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13:35-2.3 MILITARY SERVICE IN LIEU OF INTERNSHIP IN PODIATRY
The Board may grant a license to practice podiatry to any person who shall furnish proof,
satisfactory to the Board, that such person has fulfilled all of the formal requirements established
by the Podiatric Practice Act, N.J.S.A. 45:5-1 et seq., and has served at least two years in active
military service in the United States Army, Air Force, Navy, Marine Corps, Coast Guard or the
United States Public Health Service as a commissioned officer and podiatrist in a medical facility
which the Board determines constitutes the postgraduate training program required by law;
provided, however, that such military service actively occurred subsequent to graduation from an
approved school of podiatry.
13:35-2.4 PODIATRIST SUPERVISION AND ADMINISTRATION OF HYPERBARIC
OXYGEN THERAPY
The purpose of this section is to set forth standards for the supervision and/or
administration of hyperbaric oxygen therapy by a licensed podiatrist. A licensed podiatrist
who meets and complies with all requirements of this section may supervise and/or
administer hyperbaric oxygen therapy to his or her patient, for the purpose of treating
conditions of the lower leg, foot or ankle, provided such conditions are within the scope
of the practice of podiatry, as defined in N.J.S.A. 45:5-7.
For purposes of this section, “hyperbaric oxygen therapy” or “HBOT” means a treatment
in which a patient intermittently breathes 100 percent pure oxygen while inside a
treatment chamber at two to three times the atmospheric pressure at sea level.
A licensed podiatrist may supervise and/or administer HBOT treatment for conditions of
the lower leg, foot, or ankle, provided such conditions are within the scope of the practice
of podiatry, as defined in N.J.S.A. 45:5-7, and provided that he or she has:
1)
Received educational training in the administration of HBOT; and
2)
Been credentialed to perform the supervision and administration of HBOT by a
hospital licensed by the Department of Health pursuant to N.J.S.A. 26:2H-1 et seq.
A licensed podiatrist shall supervise and administer HBOT only:
1)
Within the confines of a hospital licensed by the Department of Health pursuant to
N.J.S.A. 26:2H-1 et seq., where a plenary licensed physician with knowledge of
hyperbaric medicine is physically present on-site and readily available to manage any
complications that may occur; and
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2)
When the patient has been cleared to receive HBOT by a plenary licensed physician
prior to the initiation of treatment. The podiatrist supervising and/or administering
HBOT shall maintain documentation of physician clearance to receive HBOT in the
patient’s medical record.
13:35-2.5 (RESERVED)
13:35-2.6 MEDICAL STANDARDS GOVERNING SCREENING AND DIAGNOSTIC
MEDICAL TESTING OFFICES; DETERMINATIONS WITH RESPECT TO THE
VALIDITY OF CERTAIN DIAGNOSTIC TESTS
As used in this section, the following terms shall have the following meanings, unless the
context clearly indicates otherwise.
"Board" means the New Jersey State Board of Medical Examiners.
"Clinically supported" means that a practitioner who has identified a need for a diagnostic
test, prior to personally performing or directly requesting that another practitioner administer
a specific test, has:
1.
Evaluated the findings of a physical and/or psychiatric examination, as applicable,
making an assessment of any current and/or historical subjective complaints,
observations, objective findings, and neurological indications;
2.
Considered any available previously performed test(s) relating the patient's medical
condition and the results; and.
3.
Documented in the patient record positive and negative findings, observations and
medical indications to justify the test.
“Closely allied health professional” means an individual licensed to practice a health care
profession by a regulatory board within the New Jersey Division of Consumer Affairs.
"Diagnostic office" means a practice location, whether stationary or mobile, not licensed
by the State Department of Health, which provides equipment and staff necessary for the
offering or performance of diagnostic tests and related services to any branch of the medical
profession or to the public.
"Diagnostic test" means a medical service utilizing biomechanical, neurological,
neurodiagnostic, radiological, vascular or any means, other than bioanalysis, intended to
assist in establishing a medical diagnosis, for the purpose of recommending a course of
treatment for the tested patient to be implemented by the treating practitioner or by the
consultant.
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"Emergency care" means all medically necessary treatment of a traumatic injury or a
medical condition manifesting itself by acute symptoms of sufficient severity such that
absence of immediate attention could reasonably be expected to result in: death; serious
impairment of bodily functions; or serious dysfunction of a bodily organ or part. "Emergency
care" includes all medically necessary care, immediately following a traumatic injury
including, but not limited to, immediate pre-hospitalization care, transportation to a hospital
or trauma center, emergency department care, surgery, critical and acute care and extends
during the period of initial hospitalization until the patient is discharged from acute care by
the attending physician.
"Normal" or "normally" means the usual, routine, customary or common experience and
conclusion, which may in unusual circumstances differ from the actual judgment or course of
treatment. The unusual circumstances shall be based on clinically supported findings of a
practitioner. The use of these terms is intended to indicate some flexibility and avoid rigidity
in the application of these rules and to recognize the good faith educated judgment of a
practitioner.
"Physician" means a medical or osteopathic physician holding a plenary license issued
by the New Jersey State Board of Medical Examiners.
"Practitioner" means a physician, podiatric physician, physician assistant or certified
nurse midwife licensed by or registered with the New Jersey State Board of Medical
Examiners.
"Screening office" means a practice location, whether stationary or mobile, not licensed
by the State Department of Health, which provides equipment and staff necessary for the
offering or performance of screening tests and related services to any branch of the medical
profession or to the public, either upon referral or by walk-in.
"Screening test" means a medical service utilizing biomechanical, neurological,
neurodiagnostic, radiological, vascular or any means, other than bioanalysis, performed in
the absence of apparent immediate need for medical treatment for the purpose of providing
medically useful information in circumstances where the anticipated benefits of the testing
for an appropriate category of individual care are reasonably believed to outweigh the
assessed risks, resulting in a health care evaluation, analysis or assessment; but does not
include screenings such as, but not limited to, hypertension or glaucoma screenings, offered
at no cost to examinees by community-sponsored public health services, hospitals or
nonprofit professional or civic organizations, providing some means is established to give
follow-up advice and referrals.
A practitioner who identifies a clinically supported need for a patient to undergo a
diagnostic test may:
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1)
If consistent with the practitioner's scope of practice, education, and training, perform
and interpret the diagnostic test;
2)
Directly request a specific diagnostic test, provided that the requesting practitioner:
i) Is capable of recognizing scientifically supportable and practical indications for
the test; and
ii) Understands how to integrate the test results into management of the patient's
condition; or
3)
Refer a patient for an evaluation to determine the appropriate diagnostic test(s) to a
practitioner who meets the criteria identified at (b)2i above and:
i) Has knowledge of the proper administration of the test; and
ii) Possesses skill in the proper interpretation of the test.
A practitioner, qualified pursuant to (b) above to perform a diagnostic test, may charge
the patient or bill a third-party payor for that test, except that:
1)
No practitioner shall bill for any diagnostic tests that are not recognized in the
scientific community as being capable of yielding data of sufficient clinical value in
the development, evaluation or implementation of a plan of treatment, including the
following:
i) Spinal diagnostic ultrasonography/ultrasound imaging of the spine;
ii) Iridology;
iii) Reflexology;
iv) Surrogate arm mentoring;
v) Brain mapping, when not done in conjunction with appropriate neurodiagnostic
testing;
vi) Surface EMG;
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vii) Mandibular tracking and stimulation;
viii) Videofluoroscopy; and
ix) Computer supported range of motion tests.
2)
The practitioner may bill for any of the following diagnostic tests which can yield data
of sufficient clinical value in the development evaluation or implementation of a plan
of treatment, when clinically supported, subject to the limitations relating to timing,
frequency and manner as follows:
i) Thermography when used to evaluate pain associated with reflex sympathic
dystrophy ("RSD"), in a controlled setting by a physician experienced in such use
and properly trained.
ii) Needle electromyography (needle EMG) when used in the evaluation and
diagnosis of neuropathies and radicular syndrome where clinically supported
findings reveal a loss of sensation, numbness or tingling. A needle EMG is not
indicated in the evaluation of TMJD and is contraindicated in the presence of
infection on the skin or cellulitis. This test should not normally be performed
within 14 days of a traumatic injury and should not be repeated where initial
results are negative. Only one follow-up exam is normally appropriate.
iii) Somasensory evoked potential (SSEP), visual evoked potential (VEP), brain
audio evoked potential (BAEP), or brain evoked potential (BEP), nerve
conduction velocity (NCV) and H-reflex Study when used to evaluate
neuropathies and/or signs of atrophy, but not within 21 days following the
traumatic injury.
iv) Electroencephalogram (EEG) when used to evaluate head injuries, where there
are clinically supported findings of an altered level of sensorium and/or a
suspicion of seizure disorder. This test, if indicated by clinically supported
findings, can be administered immediately following a traumatic injury. Repeat
testing is not normally conducted more than four times per year.
v) Magnetic resonance imaging (MRI) when used in accordance with the guidelines
contained in the American College of Radiology, Appropriateness Criteria to
evaluate injuries in numerous parts of the body, particularly the assessment of
nerve root compression and/or motor loss. MRI is not normally performed within
five days of a traumatic injury. However, clinically supported indications of
neurological gross motor deficits, incontinence or acute nerve root compression
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with neurologic symptoms may justify MRI testing during the acute phase
immediately post injury.
vi) Computer assisted tomographic studies (CT or CAT scan) when used to evaluate
injuries in numerous aspects of the body. With the exception of suspected brain
injuries, CAT scan is not normally administered immediately post injury, but may
become appropriate within five days of the trauma. Repeat CAT scans should not
be undertaken unless there is clinically supported indications of an adverse
change in the patient's condition.
vii) Sonograms/ultrasound when used in the acute phase to evaluate the abdomen
and pelvis for intra-abdominal bleeding. These tests are not normally used to
assess joints (knee and elbow) because other tests are more appropriate. Where
MRI is performed, sonograms/ultrasound are not necessary. These tests should
not be used to evaluate TMJD. However, echocardiogram is appropriate in the
evaluation of possible cardiac injuries when clinically supported.
3)
Notwithstanding the limitations set forth at (c)1 and 2 above, a practitioner may
perform an enumerated diagnostic test, for which there shall be no charge to the
patient or third party payor, after assuring that written informed consent has been
obtained.
4)
Notwithstanding the limitations set forth at (c)1 and 2 above, a practitioner may
perform and charge for diagnostic tests necessary to provide emergency care.
A practitioner who holds a financial interest or investment in a diagnostic or screening
office shall ensure that:
1)
The office is wholly owned through an authorized business structure, comprised of
practitioners alone or with closely allied health professionals, so long as a majority
interest is held by practitioners authorized to perform and interpret all of the tests
offered at the diagnostic or screening office;
2)
All test results are interpreted by a practitioner acting within that practitioner’s scope
of practice; and
3)
There is a designated physician (or practitioner if all the tests offered are within that
practitioner’s scope of practice), who has responsibility for the management of the
office and for compliance with the specific obligations set forth in this section.
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A practitioner designated to be responsible for the management of a diagnostic or
screening office not licensed by the Department of Health (DOH) shall:
1)
Establish and make available to personnel written policies and procedures
concerning the following:
i) The specific tests which may be performed in the office;
ii) The standards for equipment operation;
iii) The procedures to be followed in obtaining informed consent;
iv) The standards with regard to record documentation;
v) The procedures relating to follow-up reporting to examinees, patients, and/or
referring practitioners, as applicable; and
vi) Minimum safety precautions;
2)
Delineate or approve billing procedures;
3)
Ensure that any equipment which emits radiation shall conform to the applicable
sections of N.J.A.C. 7:28 and maintain documentation with respect to those
requirements at the office;
4)
Verify, through a documented review of credentials, upon hiring and on at least an
annual basis, that:
i) All personnel, other than physicians, operating testing equipment which emits
radiation are licensed by the New Jersey Radiologic Technology Board of
Examiners as shall be required by the Department of Environmental Protection in
accordance with N.J.S.A. 26:2D-1 et seq. and N.J.A.C. 7:28-19;
ii) All personnel, other than physicians, operating magnetic resonance imaging
equipment are licensed as may be required by the Department of Environmental
Protection (DEP), or demonstrate technical training to perform MRIs and are not
otherwise precluded by any requirements of the DEP; and
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iii) All personnel, other than physicians, operating ultrasound equipment are certified
by the American Registry of Diagnostic Medical Sonographers or by the American
Registry of Radiologic Technologists, or demonstrate technical training to perform
ultrasounds and are not otherwise precluded by any requirements of the
Department of Environmental Protection; and
5)
Implement on an ongoing basis a quality assurance program as required by (f) below.
Every diagnostic or screening office shall have a quality assurance program which:
1)
On at least a quarterly basis, requires the following:
i) An evaluation of personnel skills and performance;
ii) An assessment of the supervision being provided to employees; and
iii) A review of test performance techniques, accuracy and data recordation; and
2)
On at least an annual basis, requires the following:
i) An audit of billing records for accuracy; and
ii) Documented regular inspections of equipment.
In addition to the obligations set forth in (e) and (f) above, any practitioner designated to
be responsible for the management of a screening office shall:
1)
Ensure that all bills accurately describe screening tests performed and do not
misrepresent tests to be diagnostic;
2)
Establish a written protocol identifying professionally recognized criteria to be
evaluated in accepting eligible examinees for each type of screening test and
providing a procedure for excluding examinees who do not meet the criteria. For
example, for bone densitometry, mammography, and other screening tests, the
protocol shall include specific criteria relating to age, family history, personal medical
history, and permissible frequency of testing and shall specify contraindications and
foreseeable risks;
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3)
Designate in writing those employees who have been assigned responsibility for the
implementation of the protocol and quality control review, reflecting the type of
credentials held;
4)
Develop informed consent forms or other mechanisms to provide information to
examinees;
5)
Devise a system by which screening office records are maintained in accordance with
the basic information standards set forth in N.J.A.C. 13:35-6.5; and
6)
Upon the request of the Board, prepare statistical reports reflecting the total number
of screening examinees, and the total number of abnormality reports issued and the
advisory letter required by (h) below.
In addition to the obligations set forth in (e) through (g) above, any practitioner
designated to be responsible for the management of a screening office at which
mammography is offered shall:
1)
Ensure that mammography screening tests are performed only under the supervision
of a physician who meets the requirements as mandated by the Mammography
Quality Standards Act (MQSA), 42 U.S.C. §§ 263(b) et seq., and that such tests are
interpreted only by a physician who meets the MQSA requirements. The supervising
and interpreting physician(s) shall maintain proof on the premises of having attained
such credentials;
2)
Establish a written protocol in compliance with the requirements of the
Mammography Quality Standards Act, 42 U.S.C. §§ 263(b) et seq., and 21 CFR
900.1 et seq., which protocol shall also include:
i) Guidance to the performer of the test with respect to appropriate positioning
preparatory to the test;
ii) Methods for providing instruction in breast self-examination, which may include
written materials;
iii) Advice regarding referrals concerning follow-up care with respect to any person
who presents as a self-referral for "screening" but who also mentions awareness
of symptoms which may be indicative of abnormality, including, but not limited to,
nipple discharge, pain or suspicion of a lump. A person who mentions awareness
of such symptoms shall be specifically advised to seek follow-up care; and
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iv) Procedures for providing in lay language written advice at the time of testing, and
on the testing report, that a screening mammography is not a comprehensive
examination nor sufficient to detect all abnormalities and that examinees should
seek a complex examination from a physician; and
3)
Retain baseline mammography images and periodic images for seven years from the
date of issuance of the last test interpretation report, except that the physician shall,
upon request, release the original of any image, provided that signed documentation
thereof is retained in the examinee's file and an interpretation report is retained.
In addition to the obligations set forth in (e) and (h) above, at any screening office which
operates without a practitioner on the premises, the practitioner designated to be
responsible for the management of a screening office shall also:
1)
Specify certain screening tests that may be performed when the responsible
physician is not physically present;
2)
Designate another licensed health care professional, such as a registered
professional nurse or a radiologic technologist, to perform tasks consistent with the
test procedure and the delegated person's scope of licensed practice; and
3)
Identify tasks of a non-medical nature that may be delegated to non-licensed
employees under the supervision of a licensed employee, where not inconsistent with
applicable laws or rules, and consistent with accepted standards of practice pertinent
to that screening test.
A practitioner designated to be responsible for the management of a screening office not
licensed by the Department of Health shall ensure that reports with respect to screening
tests, which yield abnormal results are prepared in writing, include clear direction as to
necessary follow-up, and are issued within three business days from the date of receipt
of the report by the testing entity.
1)
With respect to those patients who have identified a referring or treating practitioner,
the reports are to be sent to the identified practitioner and upon request, sent also to
the examinee or other authorized person, to the extent authorized by N.J.A.C. 13:35-
6.5. A report delayed pending receipt of additional material shall be issued as soon
as possible after the report is complete;
2)
With respect to any abnormality warranting follow-up care, the referring practitioner
shall be contacted in writing, and, if immediate follow-up care is clinically indicated,
shall additionally be contacted promptly by other means (which may be a verbal
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communication contemporaneously documented in the examinee record) to insure
notification to the examinee;
3)
When an abnormality has been discovered and no referring or treating practitioner is
identified by the examinee, the written notice of abnormality which shall be provided
to the examinee shall contain a clear advisory concerning the need to seek follow-up
medical consultation as well as appropriate referral information;
4)
In the circumstances set forth in (j)3 above and where immediate clinical follow-up is
warranted, efforts shall be made additionally to personally contact the examinee by
telephone to confirm that the examinee was made aware of the need to follow up,
which efforts shall be documented in the examinee record. When efforts to contact
the examinee have been unsuccessful over a period not to exceed 10 days, a letter
shall be forwarded to the examinee's address of record by certified mail, return
receipt requested, or other proof of delivery, with a copy maintained in the chart,
advising of the abnormality and the need for follow-up and referral; and
5)
If the examinee with a discovered abnormality cannot be reached as required by (j)4
above, but the examinee has listed the name and address of a treating practitioner,
efforts shall be made to contact the treating practitioner listed. The treating
practitioner shall be requested to make reasonable efforts to notify an examinee, last
seen by that practitioner within the last 12 months, about the report.
In addition to the obligations set forth in (e) above, a practitioner responsible for the
management of a diagnostic office shall ensure, through the adoption and dissemination
of policies and procedures, or standing orders, that:
1)
All personnel performing diagnostic tests are familiar with the methods to be used in
the performance of the test;
2)
The tasks that may be delegated to other licensed health care professionals;
3)
The timing and manner of issuance of the practitioner's oral and written report; and
4)
Timely notification to the patient or requesting or referring health care professional of
results or the need to repeat the test.
In addition to the obligations set forth in (e) and (k) above, a practitioner responsible for
managing the diagnostic office shall ensure that appropriate practitioner supervision or
availability is provided. Specifically, a practitioner responsible for managing the
diagnostic office shall ensure that:
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1)
Needle electromyography testing is personally performed and interpreted by a
plenary-licensed physician with necessary education and training after a focused
physical examination;
2)
Invasive tests, including transesophageal echocardiography, are personally
performed by a plenary-licensed physician with the necessary education and training,
or are delegated by such physician to a physician assistant or advanced practice
nurse with the necessary education and training;
3)
Diagnostic tests requiring anesthesia are performed in compliance with N.J.A.C.
13:35-4A;
4)
Diagnostic tests that, although not invasive, require a sequential analysis, such as
nerve conduction studies, somatosensory evoked potentials, and similar studies, are
conducted by trained personnel, subject to physician supervision and interpreted by a
physician;
5)
Cardiovascular stress tests are directly supervised by a physician who is immediately
available in the office suite;
6)
Diagnostic tests with contrast, when delegated to a trained radiologic technologist
(LRT(R)), are scheduled to be, and are, performed when a physician or a physician
assistant or advanced practice nurse, with necessary education and training is
present in the office suite, unless there is a documented emergency; and
7)
Diagnostic tests, which are not invasive, not conducted with anesthesia or contrast,
or which do not require sequential analysis, such as plain film radiology, are
performed by a trained radiologic technologist (LRT(R)), with a supervising physician
immediately available by telephone or other electronic means, if not in the office
suite.
A practitioner performing a diagnostic test in any location, whether or not licensed by the
Department of Health, shall:
1)
Retain test results (such as the images, raw data, graphs or tracings of nerve
conduction studies, as appropriate to the test performed) arising out of a diagnostic
test administration, unless that data is part of the patient record at a licensed health
care facility, at which secured custody is maintained; and
2)
Prepare a comprehensive report, which shall include at least the following:
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i) The practitioner's full name, degree designation, street address, and telephone
number;
ii) The date on which the test was performed;
iii) The location at which the test was performed;
iv) The patient’s name and a summary of any available pertinent medical and/or
psychological history;
v) An identification of the specific test(s) performed;
vi) The start and stop time of electrodiagnostic tests (including EMG and NCV) and
invasive procedures, unless maintained in the patient record;
vii) A description of the pertinent findings, diagnosis, or impression and any
recommendations;
viii) Cross-references to any other tests performed at that diagnostic office or
provided along with the direct request or referral, on the same patient, which, in
the opinion of the practitioner, are pertinent to the patient's presenting medical
condition or injuries; and
ix) The date on which the report was prepared.
Pursuant to (b) above, in circumstances not involving emergency care, a practitioner in
any location, whether or not licensed by the Department of Health, who:
1)
Directly requests that another practitioner perform specific diagnostic tests, shall
convey that request via a prescription or other writing (which may be faxed or
transmitted electronically) or by a personal communication documented in the patient
record, setting forth:
i) The patient's reported symptoms and objective signs, if any, pertinent to the
problem;
ii) A suspected medical condition to be confirmed or ruled out; and/or
iii) A diagnosis, if known; and
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2)
Refers a patient for evaluation to another practitioner to determine the diagnostic
test(s) to be performed, shall transmit that referral via a prescription or other writing
or by a personal communication documented in the patient record, setting forth
information as required by subsection (n)1i, ii, and iii above, and:
i) A brief history of the reported medical condition or the clinical reason for the
referral; and
ii) An indication of prior testing or ancillary studies relating to the medical
condition and results thereof.
A practitioner, in circumstances not involving emergency care, in any location, whether,
or not licensed by the Department of Health, who:
1)
Accepts a direct request for the performance of a specific diagnostic test, shall:
i) Require that the direct request be preceded by delivery of the prescription or
other writing (which may be faxed or transmitted electronically), or a personal
communication documented in the patient record, as set forth in (n) above;
ii) Retain a copy of the request or document the personal communication in the
patient record;
iii) Personally consult with the requesting practitioner in advance of performing the
test if, in the opinion of the accepting practitioner, additional information is
needed to determine whether the diagnostic test requested is the most
appropriate test to elicit the clinical information sought;
iv) Assure that an explanation has been provided to the patient and, where there is
significant risk or likelihood of side effects, obtain informed consent;
v) Prepare a report containing the information set forth in section (m) above; and
vi) Make inquiry of the requesting practitioner as to the appropriateness of the
testing or decline to perform the test if the pattern of requests is suggestive of
fraud, or improper sequencing of testing, as may be reflected by an inordinate
number of patients presenting for the performance of the same test, repetitive
selection of complex testing, when less complex testing would be likely to
generate comparable clinical data, or the frequent ordering of testing unlikely to
generate useful information; and
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2)
Accepts a referral for the evaluation and the determination as to the appropriate
diagnostic test shall, in addition to meeting the obligations of (o)1 above, shall also:
i) Institute a procedure to assure that sufficient clinical data has been provided to
assist in determining the appropriateness of testing, determining which tests to
perform, and generating the clinical information necessary to inform treatment
decisions; and
ii) Perform a focused clinical examination if, in the practitioner's discretion, such
examination is necessary and the practitioner has the competency to perform the
examination.
A practitioner performing a diagnostic test in all locations, whether or not licensed by the
DOH, shall promptly issue the results of the test, by preliminary verbal report when
immediate follow-up care is indicated and in any event no later than three business days
from the date of receipt of the report by the testing entity, to the referring practitioner and
upon request to the patient or other authorized person, to the extent authorized by
N.J.A.C. 13:35-6.5. An interpretation delayed pending receipt of additional material shall
be issued as soon as possible thereafter. All abnormalities shall be clearly identified for
the attention of a physician or other treating practitioner.
Bills for diagnostic or screening tests submitted for payment to either the patient or a
third party payer shall reflect:
1)
The name of provider and licensure status;
2)
The office address of the billing practitioner;
3)
The location where the test was performed, if different from the billing practitioner's
office addresses;
4)
The date on which the test was performed; and
5)
No charge for any test:
i) Designated pursuant to (c) above to be without apparent clinical value and thus
lacking validity;
ii) Performed at a stage or frequency or in a manner not consistent with the
limitations set forth in (c) above; or
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iii) Where the result is professionally incomplete as to the intended view or study or
non-diagnostic due to inadequate equipment or technique, except that when the
reason for the deficiency relates to an unanticipated physical condition of the
patient which precludes completion of the intended examination, such study shall
not be deemed professionally incomplete for billing purposes.
A practitioner responsible for the management of a diagnostic or screening office may
arrange to utilize or lease testing equipment owned by another person or entity or, if
permissible as to a given test, to utilize or engage unlicensed technicians who are not
employed by the practitioner, and subject to professional supervision, provided that the
practitioner shall:
1)
Be responsible for ascertaining and documenting, identifying the indications for and
the medical necessity of the diagnostic or screening test;
2)
Understand the purpose and use of the equipment including benefits, risks and
contraindications for the patient;
3)
Recognize proper calibration and other functioning of the equipment used;
4)
Be capable of properly using the equipment in the performance of the diagnostic
testing;
5)
Be competent to interpret the resulting data;
6)
Ensure that no technician or other unlicensed person conducts an intake inquiry
through direct questioning or by the use of a "checklist" of sample signs and
symptoms to elicit information from the patient as the sole historical or other basis for
the performance of a diagnostic test which shall be determined by the practitioner
pursuant to (r)1 above;
7)
Not provide the lessor with a "certificate of medical necessity" or any document which
implies authority to issue a bill for services to anyone other than the leasing
practitioner;
8)
Not allow the lessor entity or its technician prior or subsequent access to any portion
of a patient or examinee record regarding treatment or billing or financial information;
9)
Not allow the technician to conduct a clinical interview of the patient or to make any
decisions regarding which tests are to be performed or their sequence or the method
of performance of the test;
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10)
Not be a party to a contract, whether written or verbal, with the lessor of the
equipment, its technicians or any other agent, whereby the lessor or agent would
recommend or provide a consultant practitioner to read or overread and interpret the
test data;
11)
(Reserved);
12)
Be fully responsible for the reasonableness of the fee charged.
Consistent with N.J.A.C. 13:35-6.17(c), a consulting practitioner shall not request or
receive, offer or pay, directly or indirectly, any form of remuneration from the practitioner/
professional office for accepting a referral of a patient.
1)
A referring practitioner shall not request or receive, offer or pay, directly or indirectly,
any form of remuneration from the consulting practitioner for providing a referral.
2)
A practitioner shall not request or receive any form of remuneration from the
company providing testing equipment or technicians to that practitioner or to his or
her office, whether in the form of a shared fee, or for "rent" (whether on premises or
off-premises) or for "administrative services" or under any other description.
3)
A referring or consulting practitioner shall not be deemed an independent contractor
to anyone associated with the testing of a specific patient; thus, the bill, if any, for
any component of the testing shall be submitted solely in the name of the referring or
consulting practitioner, as applicable.
A practitioner who transmits diagnostic test data/records, other than bioanalytical
specimens to a clinical laboratory under the jurisdiction of the Department of Health and
Senior Services pursuant to N.J.S.A. 45:9-42.27 et seq., for interpretation by a consultant
who is not a licensee of the Board shall assure that advance written consent for such
interpretation service by such consultant has been obtained from the patient/third party-
payor. Utilization of the provisions in this subsection shall be consistent with the
requirements of (l) above. This subsection is intended to be available for special,
occasional or emergent consultations only. A consultant or consultant entity rendering
medical services interpreting diagnostic test data/records, whether in or out of this State,
by means of any media, for 10 or more patients under treatment in New Jersey on an
annual basis is deemed to be rendering medical services in this State and requires
licensure by the Board. However, the exchange of information, which may include patient
specific information, between a licensee and a physician licensed in another state, a
possession of the United States or the District of Columbia shall not be deemed to be
rendering medical services.
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13:35-2.7 (RESERVED)
13:35-2.8 (RESERVED)
13:35-2.9 (RESERVED)
13:35-2.10 (RESERVED)
13:35-2.11 (RESERVED)
13:35-2.12 (RESERVED)
13:35-2.13 LIMITED PRIVILEGES AND CONDITIONS OF PRACTICE PERMITTED
FOR A GRADUATE PHYSICIAN PENDING LICENSURE
Persons who are graduates of medical schools recognized by the Board may commence
a period of supervised post-graduate training in a licensed hospital with an Accreditation
Council on Graduate Medical Education (ACGME) or American Osteopathic Association
(AOA) approved residency training program in this State immediately upon graduation. A
training period commencing prior to the start of a formal ACGME or AOA approved post-
graduate year term shall not exceed six months and shall be documented in the hospital
record.
Persons who are graduates of foreign medical schools recognized by the Board but who
are not yet deemed eligible for licensure in this State because of the requirements of
N.J.S.A. 45:9-8 and N.J.A.C. 13:35-3.11 may sit for the USMLE Step 3 upon completion
of one year of approved post-graduate training and satisfaction of all other requirements
of N.J.S.A. 45:9-1 et seq. and N.J.A.C. 13:35-3.1.
13:35-2.14 (RESERVED)
SUBCHAPTER 2A.
LIMITED LICENSES: MIDWIFERY
13:35-2A.1 PURPOSE AND SCOPE
The rules in this subchapter are intended to protect the health and safety of the public
through licensure of midwives, pursuant to N.J.S.A. 45:10-1 et seq.
This subchapter prescribes standards for midwifery licensure and for the renewal,
suspension or revocation of that licensure.
13:35-2A.2 DEFINITIONS
The following words and terms, when used in this subchapter, shall have the following
meaning, unless the context clearly indicates otherwise:
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"Affiliated physician" means a person who holds a plenary license to practice medicine and
surgery in New Jersey, issued by the Board, who adheres to clinical guidelines with a licensed
midwife.
"Board" means the New Jersey State Board of Medical Examiners.
"Certified midwife (CM)" means a person who is not a registered nurse and who holds
certification from the American College of Nurse Midwives Certification Council (ACC) or its
successors.
"Certified nurse midwife (CNM)" means a person who is a registered nurse and who holds
certification from the American College of Nurse Midwives (ACNM) or the ACC or their
successors.
"Certified professional midwife (CPM)" means a person who holds certification from the
North American Registry of Midwives (NARM) or its successor.
"Clinical guidelines" means a document, which sets forth patterns of care and which provides
for consultation, collaboration, management and referral as indicated by the health status of a
woman receiving care from a licensee.
"Committee" means the Midwife Liaison Committee of the New Jersey State Board of
Medical Examiners.
"Licensee" means any person who holds a license from the Board to practice as a midwife.
"Midwife" means a person licensed by the Board as a certified midwife (CM), certified nurse
midwife (CNM) or certified professional midwife (CPM).
13:35-2A.3 MIDWIFERY LIAISON COMMITTEE
The Midwifery Liaison Committee shall consist of eight members who shall serve as
consultants to the Board and who shall be appointed by the Board. The Committee shall
include at least one certified nurse midwife, at least one certified professional midwife, at
least one certified midwife, and two other midwives, all of whom shall hold licensure from
the Board. The Committee shall also include one certified nurse midwife who is a
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member of the Board and two physicians, one of whom shall be a member of the Board
of Medical Examiners and one of whom shall be Board-certified by either the American
Board of Obstetrics and Gynecology, the American Osteopathic Board of Obstetrics and
Gynecology or any other certification organization with comparable standards.
The Board shall appoint each member for a term of three years. Committee members
may be reappointed.
Functions of the Committee shall include the following:
1)
Advising and assisting the Board in the evaluation of applicants for midwifery
licensure and certified nurse midwife applicants for prescriptive authorization;
2)
Investigating complaints against licensees and unlawful conduct by licensees;
3)
Approving professional education programs; and
4)
Advising and assisting the Board in drafting and reviewing rules to govern midwifery
practice.
13:35-2A.4 APPLICATION FOR LICENSURE
An applicant for licensure as a midwife shall submit to the Committee:
1)
A completed application for licensure requesting information regarding the applicant's
address, telephone number, date of birth and social security number;
2)
Proof that the applicant is 18 years old or older;
3)
An official transcript from a midwifery program, accredited by the Accreditation
Commission for Midwifery Education (ACME), ACC or the Midwifery Education
Accreditation Council (MEAC), or their predecessors or successors;
4)
A notarized copy of Certification from either ACNM, ACC, NARM or their
predecessors or successors;
5)
The applicant's curriculum vitae;
6)
Three photographs of the applicant, signed, dated and notarized; and
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7)
The application fee pursuant to N.J.A.C. 13:35-6.13.
Once the applicant has been approved, he or she shall submit the initial license fee
pursuant to N.J.A.C. 13:35-6.13.
13:35-2A.5 INDEPENDENT PRACTICE
Certified nurse midwife and certified midwife practice shall include the provision of
maternity care and well woman care within a health care system which provides for
consultation, referral and collaboration, and:
1)
For licensees without prescriptive authority, administering or dispensing those
medications listed in the clinical guidelines; or
2)
For licensees with prescriptive authority pursuant to N.J.A.C. 13:35-2A.14,
prescribing, ordering, administering or dispensing medications.
Certified nurse midwives and certified midwives shall conduct their practice pursuant to
standards set forth by the ACNM in Standards for the Practice of Midwifery 2003, as
amended and supplemented, available from the American College of Nurse-Midwives,
8403 Colesville Rd., Suite 1550, Silver Spring, MD 20910, which is incorporated herein
by reference as part of this rule.
Certified professional midwife practice shall include the provision of maternity care within
a health care system which provides for consultation, referral and collaboration with a
licensed physician and the administration or dispensing of those medications listed in the
clinical guidelines.
Certified professional midwives shall conduct their practice pursuant to standards set
forth by the NARM in the Midwifery Model of Care (2000), as amended and
supplemented, available from North American Registry of Mid-wives, 5257 Rosestone
Drive, Lilburn, GA 30047, which is incorporated herein by reference as part of this rule.
13:35-2A.6 AFFILIATED PHYSICIANS; CLINICAL GUIDELINES
Prior to beginning practice as a midwife, a licensee shall enter into an affiliation with a
physician who is licensed in New Jersey and who:
1)
Holds hospital privileges in operative obstetrics/gynecology;
2)
Has a binding agreement with a physician who holds operative privileges in operative
obstetrics/gynecology; or
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3)
Holds hospital privileges in gynecology, if a licensee limits his or her practice to non-
obstetrical.
The licensee shall establish written clinical guidelines with the affiliated physician which
outlines the licensee's scope of practice.
The clinical guidelines shall set forth:
1)
An outline of routine care;
2)
Procedures the licensee will perform or provide;
3)
Procedures to follow if one of the risk factors from N.J.A.C. 13:35-2A.9 and 2A.11 is
encountered;
4)
The circumstances under which consultation, collaborative management, referral and
transfer of care of women between the licensee and the affiliated physician are to
take place, and the manner by which each is to occur;
5)
If the licensee is a certified nurse midwife with prescriptive authority pursuant to
N.J.A.C. 13:35-2A.12, a formulary listing the categories of drugs, which may include
controlled dangerous substances, the certified nurse midwife may order, prescribe,
administer or dispense;
6)
If the licensee does not hold prescriptive authority pursuant to N.J.A.C. 13:35-2A.14,
a list of all medications the licensee may dispense or administer pursuant to the
directions of the affiliated physician;
7)
A mechanism for determining the availability of the affiliated physician, or a substitute
physician, for consultation and emergency assistance or medical management when
needed; and
8)
The manner by which emergency care for newborns will be provided.
A licensee shall provide clinical guidelines and the identity of his or her affiliated
physician(s) to the Board upon request.
The clinical guidelines shall include provisions for periodic conferences with the affiliated
physician for review of patient records and for quality improvements.
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A licensee who practices without establishing clinical guidelines with an affiliated
physician commits professional misconduct as proscribed by N.J.S.A. 45:1-21(e).
13:35-2A.7 LICENSURE; BIENNIAL LICENSE RENEWAL; LICENSE SUSPENSION;
REINSTATEMENT OF SUSPENDED LICENSE; INACTIVE STATUS; RETURN FROM
INACTIVE STATUS
All licenses issued by the Board shall be issued for a two-year biennial licensure period.
A licensee who seeks renewal of the license shall submit a completed renewal
application and the renewal fee as set forth in N.J.A.C. 13:35-6.13 prior to the expiration
date of the license.
The Board shall send a notice of renewal to each licensee at the address registered with
the Board at least 60 days prior to the expiration of the license. If the notice to renew is
not sent at least 60 days prior to the expiration date, no monetary penalties or fines shall
apply to the holder for failure to renew.
If a licensee does not renew the license prior to its expiration date, the licensee may
renew the license within 30 days of its expiration by submitting a renewal application, a
renewal fee and a late fee, as set forth in N.J.A.C. 13:35-6.13. During this 30-day period,
the license shall be valid, and the licensee shall not be deemed to be practicing without a
license.
A license that is not renewed within 30 days of its expiration shall be automatically
suspended. An individual who continues to practice with a suspended license shall be
deemed to be engaged in unlicensed practice and shall be subject to the penalties
prescribed by N.J.S.A. 45:9-22 for practicing without a license.
A licensee whose license has been automatically suspended for five years or less for
failure to renew pursuant to (d) above may be reinstated by the Board upon completion
of the following:
1)
Payment of the reinstatement fee and all past delinquent biennial renewal fees
pursuant to N.J.A.C. 13:35-6.13; and
2)
Submission of an affidavit of employment listing each job held during the period of
suspended license which includes the name, address, and telephone number of each
employer.
In addition to the fulfilling the requirements set forth in (e) above, a licensee whose
license has been automatically suspended for more than five years who wishes to return
to practice shall reapply for licensure and shall demonstrate that he or she has
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maintained proficiency. An applicant who fails to demonstrate to the satisfaction of the
Board that he or she has maintained proficiency while suspended may be subject to an
examination or other requirements as determined by the Board prior to reinstatement of
his or her license.
Renewal applications shall provide the licensee with the option of either active or inactive
status. A licensee electing inactive status shall pay the inactive license fee set forth in
N.J.A.C. 13:35-6.13 and shall not engage in practice.
A licensee who elected inactive status and has been on inactive status for five years or
less may be reinstated by the Board upon completion of the following:
1)
Payment of the reinstatement fee; and
2)
Submission of an affidavit of employment listing each job held during the period the
licensee was on inactive status which includes the name, address, and telephone
number of each employer.
In addition to the fulfilling the requirements set forth in (h) above, a licensee who has
been on inactive status for more than five years who wishes to return to practice shall
reapply for licensure and shall demonstrate that he or she has maintained proficiency. An
applicant who fails to demonstrate to the satisfaction of the Board that he or she has
maintained proficiency while on inactive status may be subject to an examination or other
requirements as determined by the Board prior to reinstatement of his or her license.
13:35-2A.8 ANTEPARTUM MANAGEMENT
A licensee's scope of practice during antepartum stages includes:
1)
Ordering medical, therapeutic and diagnostic measures in accordance with clinical
guidelines; and
2)
Identifying women with medical, obstetrical or gynecological risk factors outlined in
N.J.A.C. 13:35-2A.9.
13:35-2A.9 MANAGEMENT OF ANTEPARTUM WOMEN AT INCREASED RISK
A licensee may participate in the management of antepartum patients at increased risk
under the following conditions:
1)
The affiliated physician and licensee shall have agreed to include the woman at
increased risk in the caseload;
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2)
The affiliated physician and licensee shall have established and documented a
management plan for all women identified as at increased risk, which shall delineate
the role of both the affiliated physician and the licensee in the care of the woman.
The management plan shall set forth the following:
i) Frequency of physician visits;
ii) Timing of indicated diagnostic and evaluative procedures;
iii) Specific parameters for consultation; and
iv) A proposed plan for the birth, including the type, place and provider.
3)
The management plan shall be reviewed periodically by the licensee and the
affiliated physician and revised when necessary.
The following are risk factors that require management as outlined in (a) above:
1)
Maternal health status:
i) Acute and/or chronic hypertension;
ii) Congenital or acquired heart disease;
iii) Anti-phospholipid syndrome;
iv) HIV positive or AIDS;
v) Chronic renal disease;
vi) Seizure disorder requiring medications;
vii) Chronic anemia and/or hemoglobinopathy;
viii) Diabetes mellitus;
ix) Drug addiction;
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x) Psychosis;
xi) Asthmatic on daily oral medication;
xii) Any connective tissue disorder;
xiii) Multiple sclerosis;
xiv) History of cerebrovascular accident; or
xv) History of cancer.
2)
Maternal reproductive health history:
i) Incompetent cervix;
ii) Two or more second or third trimester fetal losses;
iii) Preterm labor and/or delivery;
iv) Parity of six or more;
v) Previous cesarean delivery;
vi) Surgery involving the uterine wall;
vii) Previous placental abruption;
viii) Previous postpartum blood transfusion;
ix) Previous cervical surgeries including Loop Electrosurgical Excision Procedures
(LEEP), cone biopsies or three or more surgical cervical dilitations; or
x) Intra-uterine growth restriction and/or delivery of an infant weighing less than
2,500 grams at 36 weeks or more.
3)
Current maternal obstetrical status:
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i) Obstructive uterine myomata;
ii) Polyhydramnios or oligohydramnios;
iii) Isoimmunization;
iv) Multiple gestation;
v) Intrauterine growth restriction;
vi) Current evidence of fetal chromosome disorder confirmed by amniocentesis
and/or congenital anomaly;
vii) Gestational diabetes;
viii) Maternal age less than 14 years or more than 40 years;
ix) PAP smear indicating dysplasia;
x) Placenta previa;
xi) Medicated pre-term labor; or
xii) Preeclampsia.
13:35-2A.10 INTRAPARTUM MANAGEMENT
A licensee's scope of practice during intrapartum stages includes:
1)
Managing labor and birth for women not classified as being at increased risk
pursuant to N.J.A.C. 13:35-2A.11, in accordance with clinical guidelines;
2)
Performing immediate screening of the newborn and resuscitation of the newborn
when necessary. The licensee shall refer newborns with acute medical conditions to
a physician trained in the care of a newborn;
3)
Performing an episiotomy;
4)
Repairing first and second degree episiotomies and lacerations; and
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5)
Using local anesthesia.
Every licensee shall ensure that at the birth site:
1)
There is a person who is certified in Basic Life Support (BLS) and in Neonatal
Resuscitation Program (NRP) by the American Academy of Pediatrics; and
2)
The following equipment is present:
i) Oxygen;
ii) A neonatal bag and mask;
iii) An adult oxygen mask;
iv) Suction equipment;
v) IV fluids; and
vi) Oxytoxics.
In addition to the tasks outlined in (a) above, a Certified Nurse Midwife (CNM) or
Certified Midwife (CM) may:
1)
Repair third degree lacerations upon the direction of the affiliated physician;
2)
Repair fourth degree lacerations under the direct supervision of a physician who has
hospital obstetrical privileges; and
3)
Administer pudendal anesthesia in a licensed healthcare facility, which includes
birthing centers. No licensee shall administer pudendal anesthesia in any other
setting.
13:35-2A.11 MANAGEMENT OF INTRAPARTUM WOMEN AT INCREASED RISK
If a woman receiving care from a licensee evidences any of the following conditions, the
licensee shall only participate in the birth if it takes place in a licensed hospital:
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1)
Pre-term labor less than 37 weeks. If pre-term labor is less than 34 weeks, an
affiliated physician shall be present at the birth;
2)
Premature rupture of membranes more than 24 hours before onset of regular
contractions;
3)
Assessment of infant weight less than 2,500 grams or more than 4,500 grams;
4)
Vaginal birth after previous cesarean delivery;
5)
The need for prescriptive medication to induce or augment labor;
6)
Post-datism (greater than 42 weeks completed gestation);
7)
Multiple gestation;
8)
Malpresentation; or
9)
Evidence of chorioamnionitis.
If a woman receiving care from a licensee evidences the following during the intrapartum
phase the licensee shall arrange for the presence of an affiliated physician at the
hospital; or, if the woman is not in a hospital, arrange for the immediate transfer of the
woman to a hospital obstetric unit:
1)
Development of hypertension or preeclampsia;
2)
Non-reassuring fetal heart pattern, unresponsive to conservative measures;
3)
Prolapse of cord;
4)
Intrapartum hemorrhage;
5)
Multiple gestation;
6)
Malpresentation; or
7)
Any condition requiring operative intervention.
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13.35-2A.12 POSTPARTUM CARE
A licensee's scope of practice during the postpartum stage includes:
1)
Assessment and treatment; and
2)
Contraceptive services.
13:35-2A.13 WELL WOMAN CARE
A certified nurse midwife or certified midwife may provide well woman care throughout
the life cycle which shall include:
1)
Gynecological and primary health care screening, assessment and treatment; and
2)
Contraceptive services.
13:35-2A.14 PRESCRIPTIVE AUTHORIZATION
A CNM who is licensed with the Board of Medical Examiners may apply for authorization
to prescribe drugs (as used within this section, the term "drugs" shall include drugs,
medicine and devices). The CNM shall make application on forms prescribed by the
Board and shall demonstrate:
1)
Current registration with the Board;
2)
A.C.N.M. or A.C.C. certification in good standing; and
3)
Evidence of satisfactory completion of a minimum of 30 contact hours in
pharmacology, which included instruction in fundamentals of pharmacology and
therapeutics, including principles and terminology of pharmacodynamics and
pharmaco-kinetics, which was either:
i) Part of the midwifery program the CNM completed pursuant to N.J.A.C. 13:35-
2A.4(a)3; or
ii) A pharmacology course offered by, or affiliated with, a college or university
accredited by an accrediting association recognized by the U.S. Department of
Education.
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If the 30 contact hours in pharmacology required pursuant to (a)3 above was included as
part of the midwifery program the CNM completed pursuant to N.J.A.C. 13:35-2A.4(a)3,
the CNM shall have graduated from the midwifery program within the two years
immediately preceding the date on which the application for prescriptive authority is
made.
If the 30 contact hours in pharmacology required pursuant to (a)3 above was not part of
the midwifery program the CNM completed pursuant to N.J.A.C. 13:35-2A.4(a)3, the
CNM shall have completed the pharmacology course within the two years immediately
preceding the date on which the application for prescriptive authority is filed.
Notwithstanding (a), (b) and (c) above, a CNM who holds prescriptive authorization in
another state shall be authorized to prescribe drugs in New Jersey, if the CNM submits
proof to the Committee that he or she:
1)
Holds current prescriptive authorization, without disciplinary restrictions, in another
state; and
2)
Has completed 30 contact hours in pharmacology, which meets the requirements of
(a)3 above.
Notwithstanding (a), (b) and (c) above, a CNM who also holds certification as an
advanced practice nurse from the New Jersey Board of Nursing shall be authorized to
prescribe drugs pursuant to N.J.S.A. 45:10-17 et seq., if the CNM submits proof to the
Committee that he or she:
1)
Holds current, unencumbered certification as an advanced practice nurse from the
New Jersey Board of Nursing; and
2)
Has completed 30 contact hours in pharmacology, which meets the requirements of
(a)3 above.
A CNM who is authorized to prescribe drugs may prescribe only those drugs which are
categorized in the formulary of drugs established in the clinical guidelines.
A CNM's authorization to prescribe drugs, medicine, or devices may, upon notice and an
opportunity for a hearing pursuant to the Administrative Procedure Act, N.J.S.A. 52.14B-
1 et seq. and 52:14F-1 et seq., be revoked or otherwise limited by the Board if the CNM:
1)
Fails to maintain current licensure and registration with the Board;
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2)
Fails to maintain certification in good standing with the ACNM or ACC, or their
successors;
3)
Uses prescriptive authorization for other than therapeutic purposes; or
4)
Uses prescriptive authorization to prescribe substances or devices not included in the
formulary of drugs established in the CNM's clinical guidelines.
Prescriptions written by a CNM shall conform to the dictates of N.J.S.A. 45:14-14 et seq.
and N.J.A.C. 13:35-7.2.
When prescribing controlled dangerous substances, a CNM shall comply with all of the
requirements and limitations as set forth in N.J.A.C. 13:35-7.6 and 13:45H.
13:35-2A.15 LIMITED ULTRASOUND EXAMINATION
A licensee who has completed a course as required in (b) below may perform a limited
ultrasound examination. For purposes of this section, "limited ultrasound" shall mean the
use of ultrasound to assess any of the following: fetal number, fetal cardiac activity, fetal
position and presentation, placental location, amniotic fluid parameters, biophysical
profile parameters, uterine position, uterine size, the number and size of early gestational
sac and the presence and length of embryonic poles.
A licensee who wishes to perform limited ultrasound shall complete a 12-hour course
given by a college or university accredited by an accrediting association recognized by
the U.S. Department of Education or an organization which grants ACNM, American
College of Obstetrics and Gynecology (ACOG), American Osteopathic Association (AOA)
or American Medical Association-Physicians Recognition Award (AMA-PRA) category
one continuing education credits.
Limited ultrasound course instruction shall include:
1)
Ultrasound instrumentation;
2)
Accountability of the licensee;
3)
Components of informed consent;
4)
Principles of anatomy and physiology relevant to limited ultrasound examinations;
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5)
Elements of antepartum and intrapartum fetal surveillance;
6)
Components of ultrasound examination:
i) Fetal number;
ii) Fetal cardiac activity;
iii) Fetal position and presentation;
iv) Placental location;
v) Amniotic fluid evaluation; and
vi) Biophysical profile parameters;
7)
Components of gynecological ultrasound examination:
i) Identification of uterine position;
ii) Evaluation of uterine size;
iii) Assessment of number, size and location of early gestational sac(s) and
presence and length of embryonic pole(s); and
iv) Recognition of early fetal cardiac activity; and
8)
Formulation of a plan of care based on assessments made, including the need for
consultation, referral and follow-up.
A licensee who intends to perform limited ultrasound examinations pursuant to (a) above
shall amend the clinical guidelines to include circumstances when the licensee may
perform limited ultrasound examinations.
13:35-2A.16 COLPOSCOPIES
A CNM or CM who has completed a course as required by (b) below and clinical
experience required by (c) below may perform colposcopies for the purposes of
evaluating and diagnosing abnormal cervical findings.
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A CNM or CM who wishes to perform colposcopies shall complete a 20-hour colposcopy
course, given by a college or university accredited by an accrediting association
recognized by the U.S. Department of Education or given by an organization recognized
by either the American Society of Colposcopy and Cervical Pathology, the American
College of Obstetrics and Gynecology, the American College of Nurse Midwives or the
National Association of Nurse Practitioners in Reproductive Health.
A CNM or CM who intends to perform colposcopies independently shall first complete 50
colposcopies under the supervision of a CNM or CM who has met the requirements of
this section or an individual who has received education and training substantially similar
to that required by this section.
A CNM or CM who has successfully completed a colposcopy course shall maintain a
certificate from the sponsor of the colposcopy course indicating that the CNM or CM has
completed the course.
A CNM or CM who intends to perform colposcopy pursuant to (a) above shall amend the
clinical guidelines to include circumstances when the midwife may perform colposcopy.
13:35-2A.17 CIRCUMCISIONS
A licensee who has completed a course as required by (b) below and clinical experience
as outlined in (c) below may perform circumcisions.
A licensee who intends to perform circumcisions shall complete a course given by a
licensed physician or licensed midwife who has privileges to perform circumcisions in a
licensed health care facility. The circumcision course shall include:
1)
The theory of circumcisions, including the procedure's benefits and risks, and
alternatives to the procedure;
2)
Providing informed consent to the parents;
3)
Indications and contraindications for circumcision; and
4)
Potential complications.
Prior to performing any circumcisions independently as permitted by this section, the
licensee shall observe five circumcisions and perform 20 circumcisions under the direct
supervision of a licensed physician or a midwife qualified to perform independently
pursuant to this section. For purposes of this subsection, "direct supervision" means the
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presence of, and observation of the procedure by, a licensed physician, or midwife
qualified to perform circumcisions, in the location where the circumcision is being
performed.
A licensee who intends to perform circumcisions pursuant to (a), (b) and (c) above shall
maintain, as part of the licensee's records, documentation which indicates that the
licensee has met the education requirements of (b) and (c) above.
A licensee who intends to perform circumcisions pursuant to (a), (b) and (c) above shall
amend the clinical guidelines to include circumstances when the licensee may perform
circumcisions.
SUBCHAPTER 2B.
LIMITED LICENSES: PHYSICIAN ASSISTANTS
13:35-2B.1 PURPOSE AND SCOPE
The rules in this subchapter implement the provisions of the Physician Assistant
Licensing Act, P.L. 1991, c.378, as amended by P.L. 1992, c.102.
This subchapter shall apply to all physician assistants licensed pursuant to the provisions
of this subchapter and to anyone within the jurisdiction of the Physician Assistant
Advisory Committee.
13:35-2B.2 DEFINITIONS
The following words and terms, when used in this subchapter, shall have the following
meanings unless the context clearly indicated otherwise:
"Board" means the State Board of Medical Examiners.
"Committee" means the Physician Assistant Advisory Committee.
"Designated physician assistant" means a physician assistant, other than a temporary
license holder, who is assigned by a supervising physician or a physician designee to supervise
a temporary license holder.
"Direct supervision" means supervision by a plenary licensed physician which shall meet all
of the conditions established in N.J.A.C. 13:35-2B.10(b) or N.J.A.C. 13:35-2B.15, as applicable.
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"Director" means the Director of the Division of Consumer Affairs.
"Licensee" means a physician assistant licensed pursuant to this subchapter.
"Licensed personnel" means health care practitioners licensed in the State of New Jersey to
perform specific duties in the health care field.
"Physician" means a person, either an M.D. or D.O., who holds a current, valid license to
practice medicine and surgery in this State.
"Physician assistant" means a person who holds a current, valid license to practice as a
physician assistant in this State.
"Physician designee" means a plenary licensed physician who is assigned by the supervising
physician in case of his or her temporary absence and whose scope of practice encompasses
the duties assigned to a physician assistant.
"Supervising physician" means a plenary licensed physician in good standing who, pursuant
to N.J.S.A. 45:9-27.18, engages in the direct supervision of physician assistants whose duties
shall be encompassed by the supervising physician's scope of practice.
13:35-2B.3 PRACTICE REQUIREMENTS
A licensee may engage in clinical practice in any medical care setting provided that:
1)
The licensee is under the direct supervision of a physician pursuant to the provisions
of N.J.A.C. 13:35-2B.10;
2)
The licensee limits his or her practice to those procedures authorized pursuant to
N.J.A.C. 13:35-2B.4;
3)
Upon initial involvement in a patient's course of care or treatment, the licensee or the
supervising physician advises the patient that authorized procedures are to be
performed by the physician assistant;
4)
The licensee conspicuously wears an identification tag using the term "physician
assistant" whenever acting in that capacity; and
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5)
The licensee complies with the recordkeeping requirements set forth in N.J.A.C.
13:35-2B.11.
The licensee shall file with the Committee a notice of employment for each full-time, part-
time or per diem place of employment, on forms provided by the Committee, within 10
days after the date on which employment commences. Furthermore, the licensee shall
report to the Committee any change in employment and/or supervising physician within
10 days of the change.
13:35-2B.4 SCOPE OF PRACTICE
A licensee who has complied with the provisions of N.J.A.C. 13:35-2B.3 may perform the
following procedures on a discretionary and routine basis:
1)
Approaching a patient to elicit a detailed and accurate history, perform an appropriate
physical examination, identify problems, record information, interpret and present
information to the supervising physician, determine and implement therapeutic plans
jointly with the supervising physician and compile and record pertinent narrative case
summaries;
2)
Suturing and follow up care of wounds including removing sutures and clips and
changing dressings, except for facial wounds, traumatic wounds requiring suturing in
layers and infected wounds;
3)
Providing patient counseling services and patient education consistent with directions
of the supervising physician;
4)
Assisting a physician in an inpatient setting by conducting patient rounds, recording
patient progress notes, determining and implementing therapeutic plans jointly with
the supervising physician and compiling and recording pertinent narrative case
summaries;
5)
Assisting a physician in the delivery of services to patients requiring continuing care
in a private home, nursing home, extended care facility, private office practice or
other setting, including the review and monitoring of treatment and therapy plans;
6)
Facilitating the referral of patients to, and promoting their awareness of, health care
facilities and other appropriate agencies and resources in the community;
7)
Collecting fluids for diagnostic purposes, including, but not limited to, blood, urine,
sputum and exudates;
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8)
Placing and utilizing access catheters and tubes for diagnostic, therapeutic or
interventional purposes, including, but not limited to, intravenous, arterial,
nasogastric and urinary;
9)
Performing minor surgical procedures such as simple excisions, incision and
drainage, debridement and packing of wounds;
10)
Applying and removing medical and surgical appliances and devices such as splints,
casts, immobilizers, traction, monitors and medication delivery systems;
11)
Management of emergency and life threatening conditions;
12)
Performing low-risk obstetrical deliveries in a licensed hospital with the supervising
physician or physician designee on premises and available to respond immediately;
and
13)
Subject to review by the Board, such other written procedures established by the
employer, provided the procedures are within the training and experience of both the
supervising physician and the physician assistant.
A licensee who has complied with the provisions of N.J.A.C. 13:35-2B.3 may perform the
following procedures, provided the procedures are within the training and experience of
both the supervising physician and the physician assistant, only when the supervising
physician directs the licensee to perform the procedures or orders or prescribes the
procedures, or the procedures are specified in a written protocol approved by the Board.
1)
Performing non-invasive laboratory procedures and related studies or assisting
licensed personnel in the performance of invasive laboratory procedures and related
studies;
2)
Giving injections, administering medications and ordering diagnostic studies;
3)
Suturing and caring for facial wounds, traumatic wounds requiring suturing in layers
and infected wounds;
4)
Ordering and prescribing medications and writing orders to implement therapeutic
plans identified pursuant to (a)4 above;
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5)
In the operating room, assisting a supervising surgeon as a first assistant or as a
second assistant when deemed necessary by the supervising surgeon and when a
qualified assistant physician is not required by N.J.A.C. 13:35-4.1;
6)
Performing other procedures for diagnostic, therapeutic or interventional purposes
such as, but not limited to, introduction of contrast material for radiologic studies, use
of endoscopic instruments and aspiration of fluid from joints and body cavities,
collection of cerebrospinal fluid, biopsy of tissues, placement of central venous
catheters or chest tubes, and endotracheal intubation.
i) The supervising physician or physician designee shall be available on premises
for those procedures requiring intravenous or intra-arterial injection of contrast
material, endoscopic biopsy of tissue, and elective endotracheal intubation.
ii) The supervising physician shall maintain documentation, or ensure that
documentation is maintained, evidencing that the physician assistant has the
training, experience and proficiency to perform such procedures; and
7)
Subject to review and approval by the Board, such other written procedures
established by the employer, provided the procedures are within the training and
experience of both the supervising physician and the physician assistant.
13:35-2B.5 ELIGIBILITY FOR LICENSURE
An applicant for licensure shall submit to the Board, with the completed application form
and the required fee, evidence that the applicant:
1)
Is at least 18 years of age;
2)
Is of good moral character, evidence of which shall require the applicant for licensure
to respond to such inquiry as the Board deems appropriate regarding past and
present fitness to practice, and issues pertinent thereto;
3)
Has successfully completed an education program for physician assistants which is
approved by the Accreditation Review Commission on Education for the Physician
Assistant, Inc. (ARC-PA), or its successor; and
4)
Has passed the examination administered by the National Commission on
Certification of Physician Assistants (NCCPA), or its successor, except as set forth in
(b) below.
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An applicant who submits satisfactory proof that he or she holds a current license,
certification or registration to practice as a physician assistant in a state which has
standards substantially equivalent to those of this State shall be deemed to satisfy the
examination requirement set forth in (a)4 above.
13:35-2B.6 REFUSAL TO ISSUE, SUSPENSION OR REVOCATION OF LICENSE
The Board may refuse to issue or may suspend or revoke any license issued by the
Board for any of the reasons set forth in N.J.S.A. 45:1-21.
Prior to any license suspension or revocation, the licensee shall be afforded the
opportunity for a hearing pursuant to the Administrative Procedure Act, N.J.S.A. 52:14B-
1 et seq. and 52:14F-1 et seq., and the Uniform Administrative Procedure Rules,
N.J.A.C. 1:1.
13:35-2B.7 LICENSE RENEWAL, CONTINUING EDUCATION REQUIREMENT
The Board shall not issue a biennial license renewal unless the applicant submits, with
the renewal application, proof that he or she completed courses of continuing
professional education of the types and number of credits specified in N.J.A.C. 13:35-
2B.8.
Falsification of any information submitted with the renewal application may result in an
appearance before the Board or a duly appointed Committee thereof and, after due
notice to the licensee and the opportunity for a hearing pursuant to the Administrative
Procedure Act and the Uniform Administrative Procedure Rules, penalties and/or
suspension or revocation of the license.
The Board will, from time to time, conduct inquiries among licensees on a random basis
to determine compliance with continuing education requirements.
13:35-2B.8 CREDIT-HOUR REQUIREMENTS
Each applicant for a biennial license renewal shall be required to complete, during the
preceding biennial period, a minimum of 50 continuing education credit hours in category
1 courses approved by the American Medical Association, the American Academy of
Physician Assistants, the American Academy of Family Physicians, the American
Osteopathic Association or the Accreditation Council on Continuing Medical Education.
The Board reserves the right to review and approve continuing education courses offered
by entities other than those set forth above.
Fifteen credits may be carried over into a succeeding biennial period only if earned
during the last six months of the preceding biennial period.
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13:35-2B.9 WAIVER OF CONTINUING EDUCATION REQUIREMENT
The Board may, in its discretion, temporarily waive continuing education requirements on
an individual basis for a period of time designated by the Committee for reasons of
hardship, such as illness or disability, or other good cause.
Any licensee seeking a waiver of the continuing education requirements must apply to
the Board in writing and set forth with specificity the reasons for requesting the waiver.
The licensee shall also provide the Board with such additional information as it may
reasonably request in support of the application.
13:35-2B.10 SUPERVISION
A physician assistant shall engage in practice only under the direct supervision of a
physician.
The physician assistant shall not render care unless the following conditions are met:
1)
In an inpatient setting, the supervising physician or physician-designee is
continuously or intermittently present on-site with constant availability through
electronic communications for consultation or recall;
2)
In an outpatient setting, the supervising physician or physician-designee is constantly
available through electronic communications for consultation or recall;
3)
The supervising physician regularly reviews the practice of the physician assistant;
4)
The supervising physician or physician designee personally reviews all charts and
patient records and countersigns all medical orders as follows:
i) In an inpatient setting, within 24 hours of the physician assistant's entry of the
order in the patient record; and
ii) In an outpatient setting, within a maximum of seven days of the physician
assistant's entry of the order in the patient record, except that in the case of any
medical order prescribing or administering medication, a physician shall review
and countersign the order within 48 hours of its entry by the physician assistant;
and
5)
The supervisory ratio shall be no more than four physician assistants to one
physician at any one time.
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Upon application to the Board, the Board may alter the supervisory ratios set forth in (b)
above.
A supervising physician may assign physician assistants under his or her supervision to
a physician designee, who shall be responsible for the practice of the physician assistant
during the assignment.
13:35-2B.11 RECORDKEEPING
Licensees shall make contemporaneous, permanent entries into professional treatment
records which shall accurately reflect the treatment or services rendered. To the extent
applicable, professional treatment records shall reflect:
1)
The dates and times of all treatments;
2)
The patient complaint;
3)
The history;
4)
Findings on appropriate examination;
5)
Any orders for tests or consultations and the results thereof;
6)
Diagnosis or medical impression; and
7)
Treatment ordered. If medications are ordered, the patient record shall include:
i) Specific dosages, quantities and strengths of medications;
ii) A statement indicating whether the medication order is written pursuant to
protocol or specific physician direction. Acceptable abbreviations are "prt" for
protocol and "spd" for specific physician direction;
iii) The physician assistant's full name, printed or stamped, and the license number;
and
iv) The supervising physician's full name, printed or stamped.
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If the information required pursuant to (a)8iii and iv appears at least once in the patient
record, it need not be repeated each time a medication order is entered in the patient
record.
The physician assistant shall sign each entry in the patient record and record the
designation "PA-C" following his or her signature.
To the extent a physician assistant is charged with independent responsibility for the
provision of information used to prepare bills and claims forms, such information shall
accurately reflect the treatment or services rendered.
13:35-2B.12 REQUIREMENTS FOR ISSUING PRESCRIPTIONS FOR MEDICATIONS;
SPECIAL REQUIREMENTS FOR ISSUANCE OF CDS
A physician assistant may issue prescriptions for medications only in accordance with
the requirements contained in this section.
A physician assistant shall provide the following on all prescription blanks:
1)
The physician assistant's full name, professional identification ("PA-C"), license
number, address and telephone number. This information shall be printed on all
prescription blanks;
2)
The supervising physician's full name, printed or stamped;
3)
A statement indicating whether the prescription is written pursuant to protocol or
specific physician direction. Acceptable abbreviations are "prt" for protocol and "spd"
for specific physician direction;
4)
The full name, age and address of the patient;
5)
The date of issuance of the prescription;
6)
The name, strength and quantity of drug or drugs to be dispensed and route of
administration;
7)
Adequate instruction for the patient. A direction of "p.r.n." or "as directed" alone shall
be deemed an insufficient direction;
8)
The number of refills permitted or time limit for refills, or both;
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9)
The signature of the prescriber, hand-written;
10)
The words "substitution permissible" and "do not substitute" and shall contain space
for the physician assistant's initials next to the chosen option, in addition to the space
required for the signature required by (b)9 above; and
11)
The physician assistant's Drug Enforcement Administration (DEA) registration
number, if the physician assistant is authorized to issue CDS.
A physician assistant may order or prescribe controlled dangerous substances (CDS) if:
1)
A supervising physician has authorized a physician assistant to order or prescribe
Schedule II, III, IV, or V controlled dangerous substances in order to:
i) Continue or reissue an order or prescription for a controlled dangerous substance
issued by the supervising physician;
ii) Adjust the dosage of an order or prescription for a controlled dangerous
substance originally ordered or prescribed by the supervising physician, provided
there is prior consultation with the supervising physician;
iii) Initiate an order or prescription for a controlled dangerous substance for a
patient, provided there is prior consultation with the supervising physician if the
order or prescription is not pursuant to iv below; or
iv) Initiate an order or prescription for a controlled dangerous substance as part of a
treatment plan for a patient with a terminal illness, which for the purposes of this
subparagraph means a medical condition that results in a patient's life
expectancy being 12 months or less as determined by the supervising physician;
2)
The physician assistant has registered with and obtained authorization to order or
prescribe controlled dangerous substances from the appropriate State and Federal
agencies; and
3)
The physician assistant complies with all of the requirements and limitations as set
forth in N.J.A.C. 13:35-7.6 and 13:45H.
Only one controlled dangerous substance shall appear on a prescription blank.
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Written prescriptions shall be issued only on New Jersey Prescription Blanks (NJPB),
secured from an approved vendor and subject to the required security mandates of the
prescription blank program pursuant to N.J.S.A. 45:14-55.
13:35-2B.13 ELIGIBILITY FOR TEMPORARY LICENSURE
An individual who has filed an application for licensure and is waiting to take the next
scheduled examination administered by the National Commission on Certification of
Physician Assistants (NCCPA) or awaiting the results of the examination may apply to
the Board for a temporary license to be employed under the direct supervision of a
physician, as defined in N.J.A.C. 13:35-2B.2 and 2B.15.
An applicant for temporary licensure shall submit to the Board, with the completed
application form, the documents required pursuant to N.J.A.C. 13:35-2B.5, the required
fee, and evidence that the applicant has filed an application for the NCCPA examination.
13:35-2B.14 TEMPORARY LICENSURE; SCOPE OF PRACTICE
A temporary license holder who has complied with the practice requirements set forth in
N.J.A.C. 13:35-2B.3 may perform all of the procedures within the scope of practice of a
physician assistant, as set forth in N.J.A.C. 13:35-2B.4(a) and (b) and subject to the
limitations therein, except that a temporary license holder shall not issue prescriptions. A
temporary license holder may write orders for medication, treatment, or testing consistent
with the provisions of N.J.A.C. 13:35-2B.15.
A temporary license holder shall engage in practice only under the direct supervision of a
physician pursuant to the provisions of N.J.A.C. 13:35-2B.15.
13:35-2B.15 SUPERVISION OF TEMPORARY LICENSE HOLDER
A temporary license holder shall not render care unless the following conditions are met:
1)
In any setting, the supervising physician, physician designee or a designated
physician assistant:
i) Is continuously present on-site; and
ii) Countersigns, immediately after its entry in the chart, any order for medication,
treatment, or testing written by the temporary license holder.
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2)
In the event that the countersignature in (a)1 above is that of a designated physician
assistant, the supervising physician or physician designee, within the appropriate
conditions set in N.J.A.C. 13:35-2B.10(b) 4, shall:
i) Personally review all charts and patient records and the temporary license
holder's entry in the chart and record; and
ii) Countersign any order for medication, treatment, or testing written by the
temporary licensee.
13:35-2B.16 EXPIRATION OF TEMPORARY LICENSE; RENEWAL
A temporary license shall expire 30 days after the temporary license holder has received
notification of successful completion of the examination or immediately upon the
applicant's receipt of notification of failure to pass the examination referenced in N.J.A.C.
13:35-2B.13(a).
An applicant who fails an examination shall cease and desist from the performance of his
or her duties.
Except in extenuating circumstances such as the applicant's critical illness or
incapacitation, a temporary license may not be renewed. An applicant seeking to renew
based upon extenuating circumstances shall be required to present to the Board
satisfactory documentation of the basis for the renewal request.
13:35-2B.17 LICENSURE; BIENNIAL LICENSE RENEWAL; LICENSE SUSPENSION;
REINSTATEMENT OF SUSPENDED LICENSE; INACTIVE STATUS; RETURN FROM
INACTIVE STATUS
All licenses issued by the Board shall be issued for a two-year biennial licensure period.
A licensee who seeks renewal of the license shall submit a renewal application and the
renewal fee set forth in N.J.A.C. 13:35-6.13 prior to the expiration date of the license.
The Board shall send a notice of renewal to each licensee at the address registered with
the Board at least 60 days prior to the expiration of the license. If the notice to renew is
not sent at least 60 days prior to the expiration date, no monetary penalties or fines shall
apply to the holder for failure to renew.
If a licensee does not renew the license prior to its expiration date, the licensee may
renew the license within 30 days of its expiration by submitting a renewal application, a
renewal fee and a late fee, as set forth in N.J.A.C. 13:35-6.13. During this 30-day period,
the license shall be valid, and the licensee shall not be deemed to be practicing without a
license.
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A license that is not renewed within 30 days of its expiration shall be automatically
suspended. An individual who continues to practice with a suspended license shall be
deemed to be engaged in unlicensed practice and shall be subject to the penalties
prescribed by N.J.S.A. 45:9-22 for practicing without a license.
A licensee whose license has been automatically suspended for five years or less for
failure to renew pursuant to (d) above may be reinstated by the Board upon completion
of the following:
1)
Payment of the reinstatement fee and all past delinquent biennial renewal fees
pursuant to N.J.A.C. 13:35-6.13;
2)
Completion of the Board-approved continuing education units required for each
biennial registration period for which the licensee was suspended; and
3)
Submission of an affidavit of employment listing each job held during the period of
suspended license which includes the name, address, and telephone number of each
employer.
In addition to the fulfilling the requirements set forth in (e) above, a licensee whose
license has been automatically suspended for more than five years who wishes to return
to practice shall reapply for licensure and shall demonstrate that he or she has
maintained proficiency. An applicant who fails to demonstrate to the satisfaction of the
Board that he or she has maintained proficiency while suspended may be subject to an
examination or other requirements as determined by the Board prior to reinstatement of
his or her license.
Renewal applications shall provide the licensee with the option of either active or inactive
status. A licensee electing inactive status shall pay the inactive license fee set forth in
N.J.A.C. 13:35-6.13 and shall not engage in practice.
A licensee who elected inactive status and has been on inactive status for five years or
less may be reinstated by the Board upon completion of the following:
1)
Payment of the reinstatement fee;
2)
The completion of the Board-approved continuing education units required for each
biennial registration period for which the licensee was on inactive status; and
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3)
Submission of an affidavit of employment listing each job held during the period the
licensee was on inactive status which includes the name, address, and telephone
number of each employer.
In addition to the fulfilling the requirements set forth in (h) above, a licensee who has
been on inactive status for more than five years who wishes to return to the practice of
medicine shall reapply for licensure and shall demonstrate that he or she has maintained
proficiency. An applicant who fails to demonstrate to the satisfaction of the Board that he
or she has maintained proficiency while on inactive status may be subject to an
examination or other requirements as determined by the Board prior to reinstatement of
his or her license.
13:35-2B.18 SEXUAL MISCONDUCT
The purpose of this section is to identify for physician assistants licensed by the State
Board of Medical Examiners conduct which shall be deemed sexual misconduct.
As used in this section, the following terms have the following meanings unless the
context clearly indicates otherwise:
"Patient" means any person who is the recipient of a professional service rendered by a
physician assistant relating to treatment.
"Patient-physician assistant relationship" means a relationship between a physician
assistant and a patient wherein the licensee owes a continuing duty to the patient to render
physician assistant services consistent with his or her training and experience.
"Sexual contact" means the knowing touching of a person's body directly or through
clothing, where the circumstances surrounding the touching would be construed by a
reasonable person to be motivated by the licensee's own prurient interest or for sexual
arousal or gratification. "Sexual contact" includes, but is not limited to, the imposition of a
part of the licensee's body upon a part of the patient's body, sexual penetration, or the
insertion or imposition of any object or any part of a licensee or patient's body into or near
the genital, anal or other opening of the other person's body.
"Sexual harassment" means solicitation of any sexual act, physical advances, or verbal
or non-verbal conduct that is sexual in nature, and which occurs in connection with a
licensee's activities or role as a provider of physician assistant services, and that either: is
unwelcome, is offensive to a reasonable person, or creates a hostile workplace environment,
and the licensee knows, should know, or is told this; or is sufficiently severe or intense to be
abusive to a reasonable person in that context. "Sexual harassment" may consist of a single
extreme or severe act or of multiple acts and may include conduct of a licensee with a
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patient, co-worker, employee, student or supervisee whether or not such individual is in a
subordinate position to the licensee. "Sexual harassment" may also include conduct of a
nonsexual nature if it is based on the sex of an individual.
"Spouse" means either the husband or wife of the licensee or an individual involved in a
long-term committed relationship with the licensee.
A licensee shall not engage in sexual contact with a patient with whom he or she has a
patient-physician assistant relationship. The patient-physician assistant relationship is
ongoing for purposes of this section, unless:
1)
Physician assistant services are actively terminated by way of written notice to the
patient and is documented in the patient record; or
2)
The last physician assistant services were rendered more than one year ago.
A licensee shall not seek or solicit sexual contact with a patient with whom he or she has
a patient-physician assistant relationship and shall not seek or solicit sexual contact with
any person in exchange for professional services.
A licensee shall not engage in any discussion of an intimate sexual nature with a patient,
unless that discussion is related to legitimate patient needs. Such discussion shall not
include disclosure by the licensee of his or her own sexual relationships.
A licensee shall provide privacy and examination conditions which prevent the exposure
of the unclothed body of the patient unless necessary to the professional services
rendered.
A licensee shall not engage in sexual harassment whether in a professional setting such
as an office, hospital, residence or health care facility, or outside of the professional
setting.
A licensee shall not engage in any other activity, such as, but not limited to, voyeurism or
exposure of the genitalia of the licensee, which would lead a reasonable person to
believe that the activity serves the licensee's personal prurient interest or is for the
sexual arousal, the sexual gratification or the sexual abuse of the licensee or patient.
Violation of any of the prohibitions or directives set forth in (c) through (h) above shall be
deemed to constitute gross or repeated malpractice pursuant to N.J.S.A. 45:1-21(c) or
(d) or professional misconduct pursuant to N.J.S.A. 45:1-21(e).
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Nothing in this section shall be construed to prevent a licensee from rendering physician
assistant services to a spouse, as defined in (b) above, providing that the rendering of
such physician assistant services is consistent with accepted standards of physician
assistants and that the performance of physician assistant services is not utilized to
exploit the patient spouse for the sexual arousal or sexual gratification of the licensee.
It shall not be a defense to any action under this section that:
1)
The patient solicited or consented to sexual contact with the licensee; or
2)
The licensee is in love with or held affection for the patient.
13:35-2B.19 CREDIT TOWARDS LICENSURE FOR EDUCATION, TRAINING, AND
EXPERIENCE RECEIVED WHILE SERVING AS A MEMBER OF THE ARMED FORCES
a) An applicant who has served in the Armed Forces of the United States (Armed Forces) and
who does not meet all of the training, education, and experience requirements for licensure
under N.J.A.C.13:35-2B.5 may apply to the Board for recognition of the applicant’s training,
education, or experience received while serving as a member of the Armed Forces, which the
Board shall consider, together with any training, education, and experience obtained outside of
the Armed Forces, for determining substantial equivalence to the training, education, and
experience required for licensure.
b) The Board shall issue a license to the applicant, if the applicant presents evidence to the
Board that:
1) The applicant has been honorably discharged from active military service;
2) The relevant training, experience, and education the applicant received in the military,
together with any training, education, and experience obtained outside of the Armed Forces,
is substantially equivalent in scope and character to the training, experience, and education
required for licensure under N.J.A.C. 13:35-2B.5.
i. An applicant seeking credit for military training and experience shall submit to the
Board the applicant’s Verification of Military Experience and Training (VMET) Document,
DD Form 2586 or a successor form, as amended and supplemented.
ii. An applicant seeking credit for education courses and/or training completed while in
the military who has not successfully completed an education program for physician
assistants that is approved by the Accreditation Review Commission on Education for the
Physician Assistant, Inc. (ARC-PA), or its successor, shall submit to the Board a Joint
Services Transcript of his or her education/training for a determination that the education
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courses and/or training completed are substantially equivalent in level, scope, and intent
to the educational requirements under N.J.A.C. 13:35-2B.5. For the purpose of
determining substantial equivalence of the applicant’s military education and/or training,
the Board shall consider only those education courses and/or training relevant to the
practice of a physician assistant that have been evaluated by the American Council on
Education for substantial equivalence to civilian postsecondary curricula; and
3) The applicant complies with all other requirements for licensure, including successful
completion of the examination administered by the National Commission on Certification of
Physician Assistants (NCCPA), or its successor, as set forth in N.J.A.C. 13:35-2B.5.
c) It is the applicant’s responsibility to provide timely and complete evidence of the education,
training, and/or service gained in the military for review and consideration.
d) If the applicant’s military training, education, or experience, or a portion thereof, is not
deemed to be substantially equivalent to that required for licensure, the Board shall credit
whatever portion of the military training, education, or experience that is substantially equivalent
towards meeting the requirements under N.J.A.C. 13:35-2B.5 for the issuance of the license.
e) Satisfactory evidence of such education, training, or service shall be assessed on a case-by-
case basis.
SUBCHAPTER 3.
LICENSING EXAMINATIONS AND ENDORSEMENTS, LIMITED
EXEMPTIONS FROM LICENSURE REQUIREMENTS; POSTGRADUATE
TRAINING
13:35-3.1 LICENSING EXAMINATION; PHYSICIANS
Effective December 1994, the standard medical and surgical licensing examination in the
State of New Jersey shall be the United States Medical Licensing Examination (USMLE),
Step 3. The licensing examination administered by the National Osteopathic Board of
Examiners shall also be recognized as an alternative standard licensing examination for
graduation of American Osteopathic Association-approved Osteopathic Medical Schools.
Prior to January 1995, the Federation Licensing Examination (FLEX) shall serve as one
of the two standard medical and surgical licensing examinations in the State of New
Jersey.
A candidate for examination who has met all other requirements of law for medical
licensure shall be admitted to USMLE, Step 3, upon appropriate demonstration to the
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Board of successful completion of one of the following examination sequences.
Completion of the examination sequence includes attainment of a passing score on each
portion of the sequence. (The passing score for each portion of the examination
sequence will be the score that was deemed passing by the Board at the time the
examination was administered.)
1)
USMLE Step 1 or National Board Part 1 and USMLE Step 2 or National Board Part II;
or
2)
FLEX Component I.
The entire examination sequence shall be passed within a seven-year period. The seven-
year period begins when the first portion of the examination is passed. No passing credit
shall be carried beyond the seven-year period. Candidates shall be required to repeat
the entire USMLE sequence if the entire examination is not passed within seven years of
the initial date of passage.
No candidate shall be permitted more than five attempts to pass Step 3 of USMLE
without demonstration of additional education, experience or training acceptable to the
Board.
13:35-3.2 ENDORSEMENT; PHYSICIANS
The Board shall grant without examination a license to practice medicine and surgery to
any person who shall furnish proof that he or she can fulfill the requirements of law
relating to applicants for admission by examination and who:
1)
Has presented certification of either the National Board of Medical Examiners or
Osteopathic Examiners that the applicant has attained diplomate status from either of
those organizations;
2)
Has been licensed in another state upon successful passage of a non-FLEX written
plenary examination taken in English prior to December 31, 1972, and submits proof
of active and reputable practice of medicine and surgery for 10 or more years;
3)
Has been licensed in another state upon successful passage of a non-FLEX written
plenary examination and presents proof of certification as a diplomate of any
specialty board recognized by the American Board of Medical Specialties or the
American Osteopathic Association;
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4)
Has taken the FLEX exam prior to January 1981, and attained a FLEX weighted
average of 74.5 or better;
5)
Has taken the FLEX exam between January 1981 and June 1985, and attained a
weighted score of 75 or better;
6)
Has taken the FLEX exam between June 1985 and December 1994 and attained a
FLEX weighted average of 75 or better in each of the two components;
7)
Has presented certification from either the National Board of Medical Examiners or
Osteopathic Examiners that the applicant has successfully passed the first two parts
of the examination administered by those entities, as well as proof of the attainment
of a score of 75 or better on Component II of the FLEX or passing scores on Step 3
of the USMLE; or
8)
Has taken the full USMLE examination sequence in a manner consistent with New
Jersey standards, as set forth in N.J.A.C. 13:35-3.1.
13:35-3.3 ENDORSEMENT; PODIATRIC PHYSICIANS
The Board shall grant without examination a license to practice podiatry to any person who
shall furnish proof of satisfaction of the requirements of law relating to applicants for admission
by examination and who shall further furnish proof of certification by the National Board of
Podiatric Medical Examiners certifying that the applicant has attained a passing score in said
examination.
13:35-3.4 (RESERVED)
13:35-3.5 (RESERVED)
13:35-3.6 BIOANALYTICAL LABORATORY DIRECTOR LICENSE, PLENARY OR
SPECIALTY, GRANTED TO PHYSICIANS
The Board shall grant to any person licensed in this State to practice medicine and
surgery a plenary license to direct and supervise a registered bioanalytical laboratory,
without examination, provided that:
1)
Such person is certified in clinical pathology by a specialty board approved by the
A.M.A. or the A.O.A.; or
2)
Such person is certified in anatomic pathology or is Board-eligible, and can
demonstrate to the satisfaction of the Board appropriate training, including
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completion of a residency program in pathology in a laboratory or laboratories
acceptable to the Board, and not less than three full years of post graduate general
bioanalytical laboratory experience in a laboratory or laboratories acceptable to the
Board.
The Board shall grant to any person licensed in the State to practice medicine and
surgery, a specialty license in one or more of the following: toxicological chemistry,
microbiology (including bacteriology, parasitology, virology and mycology), cytogenetics,
biochemical genetics, clinical chemistry (including urinalysis, endocrinology and
toxicology), andrology, diagnostic laboratory immunology, embryology, hematology
(including flow cytometry), serology and molecular diagnostics, without examination,
provided that such person is certified by a national accrediting board in one of the above
specialties, which board requires a doctorate degree plus experience, such as the
American Board of Pathology, the American Osteopathic Board of Pathology, the
American Board of Medical Microbiology, the American Board of Clinical Chemistry, the
American Board of Bioanalysis, the American Board of Histocompatibility and
Immunogenetics, the American Board of Molecular Genetics and the American Society of
Cytogenetics, or any other national accrediting board recognized by the State Board of
Medical Examiners. The specialty license shall authorize the licensee to perform and
supervise only those tests which are within the scope of the specific specialty license
issued by the Board.
Nothing herein shall be construed to waive registration and fees required by the
Bioanalytical Laboratory and Laboratory Directors Licensing Act, as amended (N.J.S.A.
45:9-42.1 et seq.).
It shall be deemed to be professional misconduct for a bioanalytical laboratory director to
accept a request for examination of material from the human body unless the request
originates from a licensed plenary physician, dentist, podiatrist, chiropractor or any other
health care professional authorized by Board rule, public health officer or agency or local
board of health. The reports of the scientific data obtained shall be submitted in writing
bearing the original, rubber stamp or electronic signature of a licensed laboratory director
and shall be addressed to individuals who originate a request pursuant to this
subsection.
13:35-3.7 LIMITED EXEMPTION FROM LICENSURE; PHYSICIANS
"Exempt physician" means a person holding the academic degree of M.D. or D.O.,
currently employed or pending employment on a salary basis at a State or county
institution on its medical staff or as a member of the teaching or scientific staff of a State
agency, who has patient care responsibility and who does not conduct any type of private
medical practice.
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"Exemption" means the exercise of discretion granted to the State Board of Medical
Examiners of New Jersey pursuant to law to permit a physician unlicensed in the State of
New Jersey to engage in the limited practice of medicine and surgery under the
conditions set forth in said statute without being in violation of the Medical Practice Act,
N.J.S.A. 45:9-1 et seq.
Any physician employed or to be employed under an exemption from licensure must:
1)
Satisfy all statutory and regulatory requirements preceding examination required by
law;
2)
Take and pass the earliest USMLE Step 3 examination given subsequent to the
physician's start of employment;
3)
Make application for licensure within 10 days after notification of successfully passing
USMLE or cease employment.
Following the physician's start of employment, the exemption will automatically terminate
either on the date of the earliest USMLE Step 3 not taken or on the date the physician is
notified of failure on the earliest USMLE Step 3 taken, whichever is later.
13:35-3.8 ADMINISTRATIVE PROCESSING OF LICENSE APPLICATION
In the case of candidates who are graduates of professional schools or colleges
approved by the Board and whose required documents (for example, complete
application form, diploma, transcript and license in foreign countries, with attested
translations thereof (if not in English) by an official translator approved by the Board) are
in the possession of the Board and apparently authentic, the Executive Director of the
Board shall be authorized to admit such candidate to the licensing examination.
Any applicant who fails to satisfy the documentary requirements set forth in (a) above
may be reviewed individually by the Board.
13:35-3.9 (RESERVED)
13:35-3.10 SUBVERSION OR ATTEMPT TO SUBVERT THE LICENSING
EXAMINATION PROCESS
The purpose of this rule is to enhance the security of licensing examination materials and
to discourage certain types of conduct in the licensing examination process, whether by
applicants or by current license holders subject to regulation by the Board.
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Any individual found by the Board to have engaged in conduct which subverts or
attempts to subvert the licensing examination process may, at the discretion of the
Board, have his or her scores on the licensing examination withheld and/or declared
invalid, be found ineligible for licensure, be disqualified from the practice of the pertinent
profession, and/or be subject to the imposition of other appropriate sanctions pursuant to
N.J.S.A. 45:1-22.
Conduct which subverts or attempts to subvert the licensing examination process
includes, but is not limited to:
1)
Conduct which violates the security of the examination materials, such as removing
from the examination room any of the examination materials; reproducing or
reconstructing any portion of the licensing examination; aiding by any means in the
reproduction or reconstruction of any portion of the licensing examination; selling,
distributing, buying, receiving or having unauthorized possession of any portion of a
future, current or previously administered licensing examination.
2)
Conduct which violates the standard of test administration, such as communicating
with any other examinee during the administration of the licensing examination;
copying answers from another examinee or permitting one's answers to be copied by
another examinee during the administration of the licensing examination; having in
one's possession during the administration of the licensing examination any books,
notes, written or printed materials or data of any kind, other than the examination
materials distributed.
3)
Conduct which violates the credentialing process, such as falsifying or
misrepresenting educational credentials or other information required for admission
to the licensing examination; impersonating an examinee or having an impersonator
take the licensing examination on one's behalf.
13:35-3.11 STANDARDS FOR LICENSURE OF PHYSICIANS GRADUATED FROM
MEDICAL SCHOOLS NOT APPROVED BY AMERICAN NATIONAL ACCREDITING
AGENCIES
An applicant for a license to practice medicine and surgery in this State, who is a
graduate of a medical school not eligible for and not accredited by the Liaison Committee
on Medical Education (LCME) or the American Osteopathic Association (AOA), shall
satisfy the conditions in this section to be deemed eligible for New Jersey licensure by
examination or to be licensed by endorsement of a sister-state license.
During the course of the applicant's medical training, and at the time of graduation, the
medical school(s) was listed (or notified of eligibility for listing) in either the World
Directory of Medical Schools published by the World Health Organization or the
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International Medical Education Directory (IMED) published by the Educational
Commission for Foreign Medical Graduates (ECFMG), or the medical school(s) was
approved and authorized by the country of domicile to confer the degree or certificate
evidencing completion of a medical curriculum for the plenary practice of medicine and
surgery.
The applicant shall demonstrate successful completion of the full medical curriculum,
didactic elements and clinical training prescribed by the medical school and by the
country in which the medical school is located and within which the training took place,
and successful completion of all of the educational requirements to practice medicine in
that country.
If the applicant is a national of the country in which the medical training was received, the
applicant shall have obtained an unrestricted license or certificate of registration to
practice medicine and surgery in that country.
An applicant who has successfully completed the full basic science studies (or the
equivalent of the first two years of an American medical school) in the foreign medical
school located in the country of domicile authorized to confer the degree or certificate
and has been given academic credit for successful completion of clinical training
programs in United States hospitals, with residency programs approved by the
Accreditation Council on Graduate Medical Education (ACGME) and the AOA in that
field, shall demonstrate that the medical school was approved by the New Jersey State
Board of Medical Examiners (Board) to conduct such a program in this State, or that the
program was performed in a sister-state and recognized as acceptable by the Board.
A graduate of a foreign medical school shall demonstrate to the satisfaction of the Board
that he or she holds certification issued by the Educational Commission for Foreign
Medical Graduates (ECFMG) which was granted following the attainment of a passing
score on an acceptable examination and verification of his or her credentials by ECFMG.
The Board shall accept certification of successful completion of an approved Fifth
Pathway program in lieu of issuance of the ECFMG Certificate.
The applicant shall demonstrate satisfaction of all other requirements of law.
The applicant shall demonstrate attainment of a passing grade on an examination
approved by the Board for purposes of medical licensure in this State.
An applicant who has successfully completed the full basic science studies, or the
equivalent of the first two years of an American medical school, in the foreign medical
school located in the country of domicile authorized to confer the degree or certificate,
but who has completed clinical training in the United States in a program not specifically
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approved by the Board, shall demonstrate prior licensure in another state and
compliance with all other provisions of this section and of law, and may then be eligible
to be considered for licensure in this State by endorsement. An applicant from a program
specifically disapproved by the Board or conducted outside of an available approved-
program procedure shall not be eligible under this subsection.
An applicant, who has graduated from a medical school on or after July 1, 1916 and
before July 1, 1985 and has received a medical degree from a medical school which is
not eligible for and not accredited by the LCME or the AOA, shall demonstrate to the
Board, through submission of documentation, that after receiving a medical degree the
applicant has successfully completed at least one year of post-graduate training in a
program accredited by the ACGME, the AOA, or any other equivalent group or agency
which the Board, upon review, has determined has comparable standards.
An applicant, who has graduated from a medical school on or after July 1, 1985 and
before July 1, 2003 and has received a medical degree from a medical school which is
not eligible for and not accredited by the LCME or the AOA, shall demonstrate to the
Board, through the submission of documentation, that after receiving a medical degree
the applicant has successfully completed a three-year post-graduate training program
accredited by the ACGME, the AOA, or any other equivalent group or agency which the
Board, upon review, has determined has comparable standards.
An applicant, who has graduated from a medical school on or after July 1, 2003 and has
received a medical degree from a medical school which is not eligible for and not
accredited by the LCME or the AOA shall demonstrate to the Board, through the
submission of documentation, that after receiving a medical degree the applicant has
completed and received academic credit for at least two years for post-graduate training
in a program accredited by the ACGME, the AOA or any other equivalent group or
agency which the Board, upon review, has determined has comparable standards, and
has a signed contract for a third year of post-graduate training in a program accredited
by the ACGME, the AOA or any other equivalent group or agency which the Board, upon
review has determined has comparable standards. At least two of the three years of
post-graduate training shall be:
1)
In the same field; or
2)
In different fields, if when considered together, the post-graduate training fields would
be credited toward the criteria for certification by a single specialty board recognized
by the American Board of Medical Specialties (ABMS), the AOA or any other
equivalent group or agency which the Board, upon review, has determined has
comparable standards.
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13:35-3.11A STANDARDS FOR LICENSURE OF PHYSICIANS GRADUATED FROM
MEDICAL SCHOOLS APPROVED BY RECOGNIZED NATIONAL ACCREDITING
AGENCIES
An applicant, who has graduated from a medical school on or after July 1, 1916 and
before July 1, 2003 and has received a medical degree from a medical school approved
by the Liaison Committee on Medical Education (LCME) or American Osteopathic
Association (AOA) or other recognized national accrediting agency, shall demonstrate to
the Board, through submission of documentation, that after receiving a medical degree
the applicant has successfully completed at least one year of post-graduate training in a
program accredited by the Accreditation Council on Graduate Medical Education
(ACGME), the AOA, or any other equivalent group or agency, which the Board, upon
review, has determined has comparable standards.
An applicant, who has graduated from a medical school on or after July 1, 2003 and has
received a medical degree from a medical school approved by the. LCME or AOA or
other recognized national accrediting agency, shall demonstrate to the Board, through
the submission of documentation, that after receiving a medical degree the applicant has
completed and received academic credit for at least two years for post-graduate training
in a program accredited by the ACGME, the AOA, or any other equivalent group or
agency, which the Board, upon review, has determined has comparable standards, and
has a signed contract for a third year of post-graduate training in a program accredited
by the ACGME, the AOA, or any other equivalent group or agency, which the Board,
upon review, has determined has comparable standards. At least two of the three years
of postgraduate training shall be:
1)
In the same field; or
2)
In different fields, if when considered together, the post-graduate training fields would
be credited toward the criteria for certification by a single specialty board recognized
by the American Board of Medical Specialties (ABMS), the AOA or another
certification entity which the Board, upon review, has determined has comparable
standards.
13:35-3.12 STANDARDS FOR LICENSURE OF PHYSICIANS WITH POST-
SECONDARY EDUCATIONAL DEFICIENCIES
An applicant for licensure to practice medicine and surgery in this State shall submit
proof to the Board that, prior to having commenced medical school studies, he or she
has successfully completed a satisfactory course of at least two years, at a college or
university accredited by an agency recognized by the Board, during which period he or
she shall have earned at least 60 credits, and passed at least one three-credit course in
each of the following subjects: chemistry, physics and biology.
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The Board in its discretion may waive any or all of the pre-medical requirements set forth
in (a) above if the credentials presented include proof of the following:
1)
Certification by a specialty board approved by the American Board of Medical
Specialties (ABMS) or the American Osteopathic Association (AOA);
2)
Award of a Ph.D. degree in a health-related field from a college or university
accredited by an agency recognized by the Board;
3)
Award of an M.P.H. degree from a college or university accredited by an agency
recognized by the Board; or
4)
Award of a National Institute of Health Research Award.
The Board in its discretion may waive up to 30 of the required credits and/or all or part of
the required subjects if the credentials presented include:
1)
Proof of successful completion of the full term of a fellowship program accredited by
the Accreditation Council on Graduate Medical Education (ACGME) or the AOA
acceptable to the Board; or
2)
Satisfactory completion of at least three years' clinical training gained through either
a residency program or programs that satisfy three years of a nationally prescribed
course of training in one discipline pursuant to ACGME or AOA accreditation
standards for a particular specialty.
The Board in its discretion may waive any or all of the required subjects if the credentials
presented include proof of a score of 80 on each part of the Federation Licensing
Examination (FLEX) or the Uniform State Medical Licensing Examination (USMLE).
If the Board identifies substantive deficiencies, and none of the credentials identified at
(b), (c) or (d) above have been presented, the applicant may be provided leave to secure
such credentials and the Board, upon request, may provide guidance to applicants
seeking to remediate deficiencies.
13:35-3.13 CRIMINAL HISTORY RECORD INFORMATION
An applicant for initial licensure in the State by the Board shall submit his or her name,
address and fingerprints for purposes of a criminal history background check to be conducted by
the State of New Jersey pursuant to P.L. 2002, c. 104 (N.J.S.A. 45:1-28 et seq.) to determine
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whether criminal history record information exists that may be considered by the Board in
determining whether the applicant shall be licensed in the State. Fees for criminal history record
checks shall be paid by applicants for licensure in conformity with P.L. 1994, c. 60 (N.J.S.A.
53:1-20.6), P.L. 2002, c. 104 (N.J.S.A. 45:1-31) and N.J.A.C. 13:59-1.3 and 1.4. In addition to its
use in evaluating an application for initial licensure, the Board may obtain criminal history record
information from the Division of State Police for any other purpose authorized by statute or
regulation.
13:35-3.14 BIENNIAL LICENSE RENEWAL; LICENSE SUSPENSION;
REINSTATEMENT OF SUSPENDED LICENSE; INACTIVE STATUS; RETURN FROM
INACTIVE STATUS
All licenses issued by the Board shall be issued for a two-year biennial licensure period.
A licensee who seeks renewal of the license shall submit a renewal application and the
renewal fee set forth in N.J.A.C. 13:35-6.13 prior to the expiration date of the license.
The Board shall send a notice of renewal to each licensee at the address registered with
the Board at least 60 days prior to the expiration of the license. If the notice to renew is
not sent at least 60 days prior to the expiration date, no monetary penalties or fines shall
apply to the holder for failure to renew.
If a licensee does not renew the license prior to its expiration date, the licensee may
renew the license within 30 days of its expiration by submitting a renewal application, a
renewal fee and a late fee, as set forth in N.J.A.C. 13:35-6.13. During this 30-day period,
the license shall be valid, and the licensee shall not be deemed to be practicing without a
license.
A license that is not renewed within 30 days of its expiration shall be automatically
suspended. An individual who continues to practice with a suspended license shall be
deemed to be engaged in unlicensed practice.
A licensee whose license has been automatically suspended for five years or less for
failure to renew pursuant to (d) above may be reinstated by the Board upon completion
of the following:
1)
Payment of the reinstatement fee and all past delinquent biennial renewal fees
pursuant to N.J.A.C. 13:35-6.13;
2)
Completion of the continuing education units required for each biennial registration
period for which the licensee was suspended, if appropriate; and
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3)
Submission of an affidavit of employment listing each job held during the period of
suspended license which includes the name, address, and telephone number of each
employer.
In addition to the fulfilling the requirements set forth in (e) above, a licensee whose
license has been automatically suspended for more than five years who wishes to return
to have his or her license reinstated shall reapply for licensure and, in accordance with
N.J.S.A. 45:5-9b or 45:9-6.1, whichever is appropriate, shall demonstrate that he or she
has maintained proficiency. An applicant who fails to demonstrate to the satisfaction of
the Board that he or she has maintained proficiency while suspended may be subject to
an examination or other requirements as determined by the Board prior to reinstatement
of his or her license.
Renewal applications shall provide the licensee with the option of either active or inactive
status. A licensee electing inactive status shall pay the inactive license fee set forth in
N.J.A.C. 13:35-6.13 and shall not engage in practice.
A licensee who elected inactive status and has been on inactive status for five years or
less may be reinstated by the Board upon completion of the following:
1)
Payment of the reinstatement fee;
2)
The completion of the continuing education units required for each biennial
registration period for which the licensee was on inactive status, if appropriate; and
3)
Submission of an affidavit of employment listing each job held during the period the
licensee was on inactive status which includes the name, address, and telephone
number of each employer.
In addition to the fulfilling the requirements set forth in (h) above, a licensee who has
been on inactive status for more than five years who wishes to return to practice shall
reapply for licensure and, consistent with N.J.S.A. 45:5-9b or 45:9-6.1, whichever is
appropriate, shall demonstrate that he or she has maintained proficiency. An applicant
who fails to demonstrate to the satisfaction of the Board that he or she has maintained
proficiency while on inactive status may be subject to an examination or other
requirements as determined by the Board prior to reinstatement of his or her license.
13:35-3.15 POSTGRADUATE TRAINING
Postgraduate training shall be taken under the auspices of a hospital or hospitals accredited
for such training by the Accreditation Council for Graduate Medical Education (ACGME) or by
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the American Osteopathic Association (AOA) or by the American Podiatric Medical Association
(APMA), as applicable to the profession.
SUBCHAPTER 4.
SURGERY
13:35-4.1 MAJOR SURGERY; QUALIFIED FIRST ASSISTANT
A major surgical procedure is one with a substantial hazard to the life, health or welfare
of the patient. By way of example, but not limitation, major surgical procedures include:
1)
A procedure performed where the anatomic locality, the condition, the difficulty or the
length of time required to operate would constitute a direct hazard to the life of the
patient; and
2)
A procedure in which an opening is made into any of the three major body cavities
(abdomen, chest or head), if the facility's credentials committee, in conjunction with
the chair or chief of the relevant department or division, has delineated the procedure
as one requiring a qualified first assistant.
A major surgical procedure shall be performed by a duly qualified surgeon with a duly
qualified assisting physician who may be a duly qualified resident in or rotating through a
training program approved by the Accreditation Council on Graduate Medical Education
or the American Osteopathic Association.
In addition to those individuals listed in (b) above who may act as qualified first
assistants, in a health care facility licensed by the Department of Health and Senior
Services, a duly qualified registered nurse first assistant (RNFA), a duly qualified
physician assistant or a licensed podiatric physician may so act. A duly qualified certified
nurse midwife (CNM) may also act as a qualified first assistant in the performance of
cesarean sections. For purposes of this subsection, a licensed CNM shall be deemed to
be "duly qualified" provided that the CNM has taken and passed a 30-hour didactic
training course that includes anatomy, physiology, surgical technique (including wound
closure), and direct observation of cesarean sections. Following the completion of the
course, a CNM shall serve and be supervised as a second assistant on 10 cesarean
sections and complete a supervised preceptorship as a first assistant in 20 cesarean
sections.
A duly qualified surgeon, duly qualified assistant physician, duly qualified resident, duly
qualified registered nurse first assistant, duly qualified physician assistant, or duly
qualified certified nurse midwife (CNM) shall be determined by the hospital credentials
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committee in conjunction with the chairman or chief of the appropriate committee in
conjunction with the chairman or chief of the appropriate department or division
consistent with the requirements of law or applicable rule.
Licensees shall comply with the rules as promulgated by the medical staff at the health
care facility and shall cooperate to assure compliance with the rules of the Board as well
as any rules of the Department of Health and Senior Services which licenses the facility.
In all instances in which a registered nurse first assistant, a physician assistant, or duly
qualified certified nurse midwife (CNM) may act as first assistant pursuant to (c) above,
the operating surgeon shall have discretion to determine whether to utilize such an
individual as a first assistant, despite the fact that they are permitted to so act pursuant
to this rule.
In the event of incapacity or unavailability of the operating surgeon during a major
surgical procedure, the functions of a first assistant who is not a physician shall be
limited to maintaining the status of the patient while a substitute operating surgeon is
summoned, except in matters of dire emergency. "Dire emergency" shall include only
those circumstances posing a significant risk of imminent death or serious bodily injury to
the patient, such as uncontrolled bleeding.
13:35-4.2 TERMINATION OF PREGNANCY
This rule is intended to regulate the quality of medical care offered by licensed
physicians for the protection of the public, and is not intended to affect rules of the
Department of Health and Senior Services establishing institutional requirements. To the
extent that rules of the two agencies may overlap, the Medical Board recognizes and
relies upon the regulatory procedures of the Department of Health and Senior Services in
establishing minimum acceptable standards for non-physician personnel, equipment and
resources, the adequacy of the physical plant of the facility in which surgical procedures
shall be performed and the facility's interrelationship with an adequate network of health
care-related resources, such as ambulance service, etc.
The termination of a pregnancy at any stage of gestation is a procedure, which may be
performed only by a physician licensed to practice medicine and surgery in the State of
New Jersey. "Procedure" within the meaning of this subsection does not include the
issuing of a prescription and/or the dispensing of a pharmaceutical.
Provisions of this rule referring to stage of pregnancy shall be in terms of weeks from
start of last menstrual period or "weeks LMP." For example, the stage of pregnancy at 12
weeks' gestational size, as determined by a physician, is the equivalent of 14 weeks from
the first day of the last menstrual period (LMP).
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After 14 weeks LMP, any termination procedure other than dilatation and evacuation (D
& E) shall be performed only in a licensed hospital.
Fifteen weeks through 18 weeks LMP: After 14 weeks LMP and through 18 weeks LMP,
a D & E procedure may be performed either in a licensed hospital or in a licensed
ambulatory care facility (referred to herein as LACF) authorized to perform surgical
procedures by the Department of Health and Senior Services. The physician may
perform the procedure in an LACF, which shall have a Medical Director who shall chair a
Credentials Committee. The Committee shall grant to operating physicians practice
privileges relating to the complexity of the procedure and commensurate with an
assessment of the training, experience and skills of each physician for the health, safety
and welfare of the public. A list of the privileges of each physician shall contain the
effective date of each privilege conferred, shall be reviewed at least biennially and shall
be preserved in the files of the LACF.
Nineteen weeks through 20 weeks LMP: A physician planning to perform a D & E
procedure after 18 weeks LMP and through 20 weeks LMP in an LACF shall first file with
the Board a certification signed by the Medical Director that the physician meets the
eligibility standards set forth in (f)1 through 7 below and shall comply with its
requirements.
1)
The physician is certified or eligible for certification by the American Board of
Obstetrics-Gynecology or the American Osteopathic Board of Obstetrics-Gynecology,
and the physician satisfactorily completes at least 15 hours of Continuing Medical
Education each year in obstetrics-gynecology.
2)
The physician has admitting and surgical privileges at a nearby licensed hospital
which has an operating room, blood bank, and an intensive care unit. The hospital
shall be accessible within 20 minutes driving time during the usual hours of operation
of the clinic.
3)
The procedure shall be done in a location that is designated by the Department of
Health and Senior Services as a licensed ambulatory care facility (LACF) authorized
to perform surgical procedures as in subsection (e) above. The LACF shall be
licensed by the Department of Health and Senior Services as an ambulatory care
facility authorized to perform surgical procedures. The facility shall be in current and
good standing at all times when surgical procedures are performed there. The LACF
shall have a written agreement with an ambulance service assuring immediate
transportation of a patient at all times when a patient has been admitted for surgery
and until the patient has been discharged from the recovery room.
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4)
The procedure shall be done in an LACF which shall have a Medical Director and a
Credentials Committee which have duly evaluated the training, experience and skill
of the physician at continuous and successive levels of complexity of the D & E
procedure in pregnancies advancing in stages from 18 weeks LMP through 19 weeks
LMP through 20 weeks LMP, and the physician has been granted successive practice
privileges consistent with management of the increased risk to the health and safety
of the patient at that stage documented in the personnel file maintained for that
physician. (Where the applicant physician is also the Medical Director, the physician
shall submit a certificate from the Administrator or Chief of Department of a hospital
or the Medical Director of an LACF where the applicant has been evaluated and
credentialed in a comparable manner.) The physician new to the LACF shall have his
or her operating technique evaluated initially and at least yearly by the Medical
Director or his or her designee who shall possess appropriate experience with D & E
procedures at least as advanced as those for which the applicant physician seeks
approval. The applicant shall be evaluated during that number of procedures which
shall be adequate to achieve a sufficient professional skill, and the evaluation
procedure shall be documented in the personnel file maintained for that physician.
The Medical Director shall agree to review the charts of all patients who suffer
complications and in addition shall review charts at random, and shall calculate the
complication rate of each physician.
5)
The physician shall perform the procedure only on a patient who has been examined
and found to be within the eligibility criteria established for advanced D & E
procedures in the LACF setting.
6)
The procedure shall be performed in an LACF providing adequate staff support and
resources for the operative procedure as well as interim follow-up and post-operative
care, and where a physician is available and readily accessible 24 hours/day to
respond to any post-operative problem.
7)
The physician shall cooperate with the Medical Director to maintain
contemporaneous and cumulative statistical records demonstrating the utilization and
safety record of each stage procedure and of each surgeon. Said records shall be
available for inspection by the Board and copies shall be submitted to the Board
semi-annually. These records shall include the following information and data shall
be maintained in records compiled monthly, but individual patients comprising the
lists shall be identified only by date and by initials and/or case number:
i) Number of patients who received termination procedures;
ii) Number of patients who received laminaria or osmotic cervical dilators who failed
to return for completion of the procedure;
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iii) Number of patients who reported for post-operative visits;
iv) Number of patients who needed repeat procedures;
v) Number of patients who received transfusions;
vi) Number of patients suspected of perforation;
vii) Number of patients who developed pelvic inflammatory disease within two weeks;
viii) Number of patients who were admitted to a hospital within two weeks of the
procedure;
ix) Number of patients who died within 30 days.
Subparagraphs ii. through ix. above shall be summarized by number and percentage of
monthly total for post-18 week procedures. The Board shall inspect such reports monthly for
the first five months and at such further monthly intervals as it deems necessary.
After 20 weeks: A physician may request from the Board permission to perform D & E
procedures in an LACF after 20 weeks LMP. Such request shall be accompanied by
proof, to the satisfaction of the Board, of superior training and experience as well as
proof of support staff and facilities adequate to accommodate the increased risk to the
patient of such procedure.
The physician shall make suitable arrangements to insure that all tissues removed shall
be properly disposed of by submission to a qualified physician for pathologic analysis or
by incineration or by delivery to a person/entity licensed to make biologic and/or tissue
disposals in accordance with law, including rules of the Department of Health and Senior
Services applicable to an LACF.
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SUBCHAPTER 4A.
SURGERY, SPECIAL PROCEDURES AND ANESTHESIA SERVICES
PERFORMED IN AN OFFICE SETTING
13:35-4A.1 PURPOSE
These rules are designed to promote the health, safety and welfare of the members of the
general public who undergo surgery (other than minor surgery), special procedures and receive
anesthesia services in an office setting.
13:35-4A.2 SCOPE
This subchapter establishes policies and procedures, staffing and equipment
requirements for practitioners and physicians who perform surgery (other than minor
surgery), special procedures and administer anesthesia services in an office setting.
For purposes of this subchapter, the standards set forth at N.J.A.C. 13:35-4A.6 do not
apply to those performing non-invasive special procedures, such as non-invasive
radiologic procedures. However, the standards set forth at N.J.A.C. 13:35-4A.7, including
the privileging standards set forth at (a) above, do apply to the anesthesia services
provided in connection with all special procedures, whether invasive or non-invasive.
13:35-4A.3 DEFINITIONS
The following words and terms, when used in this subchapter, shall have the following
meanings, unless the context clearly indicates otherwise.
"Advanced cardiac life support trained" means that a licensee has successfully completed an
advanced cardiac life support course offered by a recognized accrediting organization
appropriate to the licensee's field of practice. For example, for those licensees treating adult
patients, training in advanced cardiac life support (ACLS) is appropriate; for those treating
children, training in pediatric advanced life support (PALS) or advanced pediatric life support
(APLS) is appropriate.
"Anesthesia services" means administration of any anesthetic agent with the purpose of
creating conscious sedation, regional anesthesia or general anesthesia. For the purposes of this
subchapter, the administration of topical or local anesthesia, minor conduction blocks, pain
management or pain medication shall not be deemed to be anesthesia services.
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"Anesthesiologist" means a physician who has successfully completed a residency program
in anesthesiology approved by the Accreditation Council of Graduate Medical Education
(ACGME) or the American Osteopathic Association (AOA), or who currently is a diplomate of
either the American Board of Anesthesiology or the American Osteopathic Board of
Anesthesiology, or who was made a Fellow of the American College of Anesthesiology before
1982.
"Anesthetic agent" means any drug or combination of drugs administered with the purpose of
creating conscious sedation, regional anesthesia or general anesthesia.
"Anesthetizing location" means any location in an office where anesthetic agents are
administered to a patient.
"Board" means the New Jersey State Board of Medical Examiners.
"Certified registered nurse anesthetist" (CRNA) means a registered professional nurse who
is licensed in this State and who holds current certification under a program governed or
approved by the American Association of Nurse Anesthetists (AANA), and who meets the
conditions for practice as a nurse anesthetist as set forth at N.J.A.C. 13:37-13.1.
"Complications" means an untoward event occurring at any time within 48 hours of any
surgery, special procedure or the administration of anesthesia services which was performed in
an office setting including, but not limited to, any of the following events: paralysis, nerve injury,
malignant hyperthermia, seizures, myocardial infarction, renal failure, significant cardiac events,
respiratory arrest, aspiration of gastric contents, cerebral vascular accident, transfusion reaction,
pneumothorax, allergic reaction to anesthesia, wound infections requiring intravenous antibiotic
treatment or hospitalization, unintended return to an operating room or hospitalization, death or
temporary or permanent loss of function not considered to be a likely or usual outcome of the
procedure.
"Conscious sedation" means the administration of a drug or drugs in order to induce that
state of consciousness in a patient which allows the patient to tolerate unpleasant medical
procedures without losing defensive reflexes, adequate cardio-respiratory function and the ability
to respond purposefully to verbal command or to tactile stimulation if verbal response is not
possible as, for example, in the case of a small child or deaf person. For the purposes of this
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subchapter, conscious sedation does not include an oral dose of pain medication or minimal pre-
procedure tranquilization such as the administration of a pre-procedure oral dose of a
benzodiazepine designed to calm the patient. Within the context of this subchapter, "conscious
sedation" shall be synonymous with the term "sedation/analgesia" as used by the American
Society of Anesthesiologists.
"General anesthesia" means the administration of a drug or drugs which cause loss of
consciousness as the result of which the patient is unable to make meaningful responses but
may still display reflex withdrawal from a painful stimulus.
"Health care personnel" means any office staff member who is licensed by a professional or
health care occupational licensing board such as a professional registered nurse, licensed
practical nurse or physician assistant.
"Hospital" means a hospital licensed by the state in which it is situated.
"Local anesthesia" means an agent which produces a transient and reversible loss of
sensation in a circumscribed portion of the body.
"Minor conduction block" means the injection of local anesthesia to stop or prevent a painful
sensation in a circumscribed area of the body (that is, local infiltration or local nerve block), or
the block of a nerve by direct pressure or refrigeration. Minor conduction blocks include, but are
not limited to, retrobulbar blocks, peribulbar blocks, pudendal blocks, digital blocks, metacarpal
blocks and ankle blocks. "Minor conduction block" does not include regional anesthesia that
affects larger areas of the body, such as brachial plexus anesthesia or spinal anesthesia.
"Minor surgery" means surgery which can safely and comfortably be performed on a patient
who has received no more than the maximum manufacturer recommended dose of local or
topical anesthesia, without more than minimal preoperative medication or minimal intra-operative
tranquilization and where the likelihood of complications requiring hospitalization is remote.
Minor surgery specifically excludes all procedures performed utilizing anesthesia services as
defined in this section. Minor surgery also specifically excludes procedures which may be
performed under local anesthesia, but which involve extensive manipulation or removal of tissue
such as liposuction or lipo-injection, breast augmentation or reduction, and removal of breast
implants. Minor surgery includes the excision of moles, warts, cysts, lipomas, skin biopsies, the
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repair of simple lacerations, or other surgery limited to the skin and subcutaneous tissue.
Additional examples of minor surgery include closed reduction of a fracture, the incision and
drainage of abscesses, certain simple ophthalmologic surgical procedures, such as treatment of
chalazions and non-invasive ophthalmologic laser procedures performed with topical anesthesia,
limited endoscopies such as flexible sigmoidoscopies, anoscopies, proctoscopies,
arthrocenteses, thoracenteses and paracenteses. Minor surgery shall not include any procedure
identified as "major surgery" within the meaning of N.J.A.C. 13:35-4.1.
"Monitoring" means continuous visual observation of a patient and continuous observation of
the patient using instruments to measure, display and record the values of certain physiologic
variables, such as pulse, oxygen saturation, blood pressure, end-tidal carbon dioxide and
respiration.
"Office" means a location at which medical, surgical or podiatric services are rendered and
which contains only one operating room and which is not subject to the jurisdiction and licensure
requirements of the New Jersey State Department of Health and Senior Services.
"Operating room" means that location in the office dedicated to the performance of surgery
or special procedures.
"Pain management" means the administration to a patient, by any route, of pharmacologic
agents or drugs which are not intended to result in a loss of consciousness, awareness or
defensive reflexes, but which are intended to alleviate pain. It includes the use or application of
other modalities and medical devices such as, but not limited to, heat or cold, massage,
transepidermal nerve stimulation (TENS), and neurolytic techniques such as radiofrequency
coagulation and cryotherapy.
"Pain medication" means, for the purpose of this subchapter, the administration to a patient,
by any route, of pharmacologic agents or drugs which are not intended to result in a loss of
consciousness, awareness or defensive reflexes, but which are intended to alleviate pain
occurring in the absence of an invasive, operative or manipulative procedure.
"Physical status classification" means a description of a patient used in determining if an
office surgery or procedure is appropriate. The American Society of Anesthesiologists
enumerates classifications: I—Normal healthy patient; II—A patient with mild systemic disease;
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III—A patient with severe systemic disease limiting activity but not incapacitating; IV— A patient
with incapacitating systemic disease that is a constant threat to life; and V—Moribund patients
not expected to live 24 hours with or without operation.
"Physician" means an individual holding an M.D. or D.O. degree licensed pursuant to
N.J.S.A. 45:9-1 et seq.
"Podiatrist" means an individual holding a D.P.M. degree licensed pursuant to N.J.S.A. 45:5-
1 et seq.
"Practitioner" means a physician or a podiatrist.
"Privileges" means the authorization granted to a practitioner or physician by a hospital
licensed in the jurisdiction in which it is located to provide specified services or alternatively by
the Board pursuant to N.J.A.C. 13:35-4A.12, such as surgery or the administration or the
supervision of administration of one or more types of anesthetic agents or procedures.
"Recovery area" means a room or limited access area of an office dedicated to providing
medical services to patients recovering from surgery or anesthesia.
"Regional anesthesia" means the administration of anesthetic agents to a patient to interrupt
nerve impulses without loss of consciousness and includes epidural, caudal, spinal and brachial
plexus anesthesia. Regional anesthesia does not include minor conduction blocks as defined in
this section.
"Special procedure" means patient care which requires anesthesia services because it
involves entering the body with instruments in a potentially painful manner, or requires the
patient to be immobile, for a diagnostic or therapeutic procedure. Examples of special
procedures include diagnostic or therapeutic endoscopy or bronchoscopy performed utilizing
conscious sedation or general anesthesia; invasive radiologic procedures performed utilizing
conscious sedation; pediatric magnetic resonance imaging performed utilizing conscious
sedation; or manipulation under anesthesia (MUA). The term special procedure does not include
a procedure which only requires medication to reduce anxiety such as oral benzodiazepine
unless the dose given is intended to provide conscious sedation.
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"Supervision" means responsibility by a credentialed physician who is immediately available
to oversee the administration and monitoring of anesthesia by health care personnel authorized
by this rule to render anesthesia services in an office.
"Surgery" means a manual or operative procedure, including the use of lasers, performed
upon the body for the purpose of preserving health, diagnosing or treating disease, repairing
injury, correcting deformity or defects, prolonging life or relieving suffering. Surgery includes, but
is not limited to: incision or curettage of tissue or an organ; suture or other repair of tissue or an
organ; a closed or open reduction of a fracture or extraction of tissue from the uterus.
"Topical anesthesia" means an anesthetic agent applied directly or by spray to the skin or
mucous membranes, intended to produce a transient and reversible loss of sensation to a
circumscribed area.
13:35-4A.4 POLICIES AND PROCEDURES REQUIREMENTS
Practitioners who perform surgery (other than minor surgery) or special procedures and
physicians who administer or supervise the administration or monitoring of anesthesia
services in an office shall establish written policies and procedures concerning the
following:
1)
The specific surgical or special procedures which may be performed in the office;
2)
The specific anesthesia services which may be performed in the office;
3)
The responsibilities of the health care personnel providing services to patients in the
office;
4)
The infection control practices to be followed, including lawful disposal of hazardous
waste;
5)
The procedures to be followed in the event that a patient experiences a complication;
6)
The procedures to be followed if the patient requires transport for emergency
services, including the identity and telephone numbers of the ambulance service if
one is to be utilized and the hospital to which the patient is to be transported, and the
functions to be undertaken by health care personnel until a transfer of the patient is
completed;
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7)
The procedures to be followed in the event that a surgery or special procedure needs
to be terminated because of an equipment malfunction or other complication;
8)
The procedures to be followed while a patient is recovering in the office;
9)
The objective criteria for discharging patients; and
10)
The procedures to be followed to review records, and to ensure follow-up on
complications and outcomes.
The written policies and procedures shall also contain the identity of the specific
practitioners within the office who are responsible for ensuring that:
1)
All healthcare personnel providing services to patients possess the qualifications
required by this subchapter and are currently licensed, registered or certified, as
applicable;
2)
All equipment and instruments utilized in the performance of surgery are maintained
in proper working order and in accordance with such sterilization techniques as are
required for safe medical practice;
3)
All equipment and safety systems utilized in the administration and monitoring of
anesthesia as required by N.J.A.C. 13:35-4A.14 are maintained in proper working
order;
4)
All emergency equipment and supplies as required by N.J.A.C. 13:35-4A.13 are
available and are not outdated; and
5)
All medical records are audited on at least an annual basis to assess quality of care
and complications.
The written policies and procedures are to be reviewed annually and revised as needed
with the person conducting the review or making the revision recording the date thereof.
Written policies and procedures shall be presented to the Board upon request.
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13:35-4A.5 DUTY TO REPORT INCIDENTS RELATED TO SURGERY, SPECIAL
PROCEDURES OR ANESTHESIA IN AN OFFICE
Any incident related to surgery, special procedures or the administration of anesthesia within
the office which results in a patient death, transport of the patient to the hospital for observation
or treatment for a period in excess of 24 hours, or a complication or untoward event as defined
in N.J.A.C. 13:35-4A.3, shall be reported to the Executive Director of the Board within seven
days, in writing and on such forms as shall be required by the Board. Such reports shall be
investigated by the Board and will be deemed confidential pursuant to N.J.S.A. 45:9-19.3.
13:35-4A.6 STANDARDS FOR PERFORMING SURGERY AND SPECIAL
PROCEDURES IN AN OFFICE; PRIVILEGES NECESSARY; PRE-PROCEDURE
COUNSELING; PATIENT RECORDS; RECOVERY AND DISCHARGE
A practitioner who performs surgery (other than minor surgery) or special procedures in
an office shall be privileged to perform that surgery or special procedure by a hospital. If
a practitioner is not privileged but wishes to perform surgery or special procedures in an
office, the practitioner shall apply to the Board pursuant to N.J.A.C. 13:35-4A.12 to seek
Board-approved privileging.
Before any practitioner may perform surgery (other than minor surgery), or special
procedures, the practitioner shall have:
1)
A written transfer agreement with a licensed hospital with acute care capabilities
which can be reached within 20 minutes during all hours in which surgery or special
procedures are performed in the office, if the hospital where the practitioner is
privileged is not reachable within 20 minutes or if the practitioner is privileged by the
Board; and
2)
A written policy for handling emergency transport to a hospital at which the
practitioner is privileged through 9-1-1 call or a written transfer agreement with a
licensed ambulance service which assures immediate transport of patients
experiencing complications to the hospital which the practitioner has established a
transfer agreement. The written transfer agreement shall be posted in the office and
all health care personnel in the office shall specifically be informed of the procedure
to be followed.
A practitioner who performs surgery (other than minor surgery) or special procedures in
an office shall provide pre-procedure counseling and preparation as follows:
1)
The practitioner shall appropriately assess, or review a referring physician's
assessment of, the physical condition of the patient on whom surgery or a special
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procedure is to be performed. The practitioner shall refer a patient who, by reason of
pre-existing medical or other conditions, are at undue risk for complications (for
example, morbidly obese patients; patients with severe cardiac, pulmonary, airway or
neurological problems; substance abusers) to an appropriate specialist for a pre-
procedure consultation or to another treatment setting or other appropriate facility for
the performance of the surgery or the special procedure. Only patients with an
American Society of Anesthesiologists (ASA) physical status classification of I or II
are appropriate candidates for an office surgery or special procedure for which
general or regional anesthesia are to be used. Patients with an ASA physical
classification of I, II or III are appropriate candidates for conscious sedation.
2)
A history and physical examination shall be performed within the 30 days preceding
the proposed surgery either by the practitioner performing the surgery or procedure
(as appropriate to that practitioner's scope of practice) or by another physician or
physician assistant under the supervision of a physician. Necessary laboratory tests,
as guided by the patient's underlying medical condition, shall be conducted within
seven days preceding the proposed surgery;
3)
The risks and benefits of the surgery or special procedure and alternative methods or
treatments shall be fully explained by the practitioner or other health care personnel,
and written informed consent for the specific surgery or special procedure
contemplated shall be obtained from the patient, guardian or authorized
representative;
4)
An appropriate fasting protocol shall be explained and provided to the patient;
5)
If the history and physical are not done on the same day as the procedure, an interim
assessment shall be performed by the practitioner or a physician assistant under the
supervision of a physician immediately prior to the procedure, which assessment
shall be documented and dated; and
6)
Prior to surgery, the practitioner shall ensure that the patient removes all cosmetics,
jewelry, contact lenses, dental appliances and prosthetic devices which might
reasonably jeopardize patient safety.
A practitioner who performs surgery (other than minor surgery) or special procedures in
an office shall ensure the following during recovery and prior to discharge:
1)
Immediately after the surgery or special procedure, the patient shall be evaluated by
either the practitioner who performed the surgery or the physician or CRNA who
administered the anesthesia;
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2)
At least one practitioner shall remain on the premises until the patient is discharged
from the recovery area;
3)
The patient shall be provided with written and verbal instructions for follow-up care
and with advice concerning possible complications; and
4)
The patient shall be discharged into the company of a responsible individual.
A practitioner who performs surgery (other than minor surgery) or special procedures in
an office shall prepare a patient record which shall include the following:
1)
A pre-procedure medical history and physical, appropriate to the practitioner's scope
of practice, including such data as allergies, physical and mental impairments, vital
signs, drug use, mobility limitations and, as applicable, electrocardiogram results,
radiologic findings, laboratory values and the identity of the examining practitioner;
2)
Documentation reflecting that informed consent has been obtained;
3)
A description of the surgery or special procedure performed, including pre-operative
diagnosis, techniques used, names and titles of medical personnel participating,
complete findings, post-operative diagnosis, and any unusual occurrence,
complications or untoward events. Where similar procedures are performed at the
office routinely, partially pre-printed forms may be utilized as a guide, provided that
original data and conclusions applicable to the specific patient are
contemporaneously entered to create a complete report;
4)
A post-procedure note, entered prior to discharge from the office, which shall include
at least such post-procedure data as the patient's general condition, vital signs, any
treatments ordered, and all drugs prescribed, administered or dispensed including
dosages, quantities and strengths;
5)
The identity of healthcare personnel providing services, as evidenced by a legible
signature following that staff member's notation in the patient's record; and
6)
The plan for follow-up care and documentation of results of follow-up efforts.
No practitioner who performs surgery (other than minor surgery) or special procedures in
an office shall:
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1)
Prescribe, or advise a patient to take, an anesthetic agent to be administered prior to
arrival at the office or outside of the anesthetizing location; or
2)
Accept for the performance of surgery or a special procedure a patient to whom an
anesthetic agent had been administered for that surgery or special procedure prior to
arrival at the office or outside of the anesthetizing location, other than in life
threatening circumstances, unless the patient is accompanied by medical personnel
from an acute care facility.
13:35-4A.7 STANDARDS FOR ADMINISTERING OR SUPERVISING THE
ADMINISTRATION OF ANESTHESIA SERVICES IN AN OFFICE; PRE-ANESTHESIA
COUNSELING; PATIENT MONITORING; RECOVERY; PATIENT RECORD;
DISCHARGE OF PATIENT
A practitioner who administers or supervises the administration and monitoring of
anesthesia services in an office shall be privileged by a hospital to provide the particular
anesthesia service. If a practitioner is not privileged but wishes to administer or
supervise the administration of anesthesia services, the practitioner shall apply to the
Board pursuant to N.J.A.C. 13:35-4A.12 to seek Board-approved privileging.
A practitioner who administers or supervises the administration and monitoring of
anesthesia services in an office shall provide pre-anesthesia counseling and preparation
as follows:
1)
Any patient to whom anesthesia services are to be provided shall be appropriately
screened by the individual administering anesthesia services. Patients who, by
reason of pre-existing medical or other conditions, are at undue risk for complications
(for example, morbidly obese patients; patients with severe cardiac, pulmonary,
airway or neurological problems; substance abusers) shall be referred to an
appropriate specialist for a pre-procedure consultation or to another treatment setting
or other appropriate facility. Only patients with an ASA physical status classification
of I or II are appropriate candidates for an office surgery or special procedure for
which general or regional anesthesia are to be used. Patients with an ASA physical
classification of I, II or III are appropriate candidates for conscious sedation.
2)
A medical history shall be conducted including a review of abnormalities in any organ
system; previous adverse experience with anesthesia services; any history of stridor,
snoring or sleep apnea, or of advanced rheumatoid arthritis or spinal disorder;
current medications being taken; drug allergies; or any history of substance abuse;
3)
The risks and benefits of anesthesia and alternative methods or treatments shall be
fully explained by the physician or certified registered nurse anesthetist (CRNA), and
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written informed consent for the anesthesia services contemplated shall be obtained
from the patient, guardian or authorized representative;
4)
An appropriate fasting protocol shall be explained and timely provided to the patient,
guardian or authorized representative;
5)
Pre-procedure laboratory test results shall be reviewed and recorded;
6)
A focused physical examination shall be conducted, including auscultation of the
heart and lungs, and an evaluation of the airway, particularly an assessment of
anatomical abnormalities (that is, jaw, mouth, head and neck) which may increase
the likelihood of an airway obstruction;
7)
A plan of anesthesia shall be developed by the physician administering anesthesia
services or personally reviewed by the supervising physician if the plan has been
developed by other authorized personnel;
8)
A patient shall be counseled prior to the procedure that the procedure will be
canceled if the patient plans to drive home after the procedure and has not made
arrangements to be accompanied home by an individual who accepts responsibility
for the patient; and
9)
Prior to the administration of anesthesia services, the physician shall ensure that the
patient removes all cosmetics, jewelry, contact lenses, dental appliances and
prosthetic devices which might reasonably jeopardize patient safety.
A physician who administers or supervises the administration or monitoring of any
anesthesia services (general anesthesia, regional anesthesia or conscious sedation) in
an office shall ensure that monitoring is provided as follows when clinically feasible for
the patient:
1)
Direct observation of the patient and, to the extent practicable, observation of the
patient's responses to verbal commands;
2)
Pulse oximetry shall be performed continuously. Any alternative method of measuring
oxygen saturation may be substituted for pulse oximetry if the method has been
demonstrated to have at least equivalent clinical effectiveness;
3)
An electrocardiogram monitor shall be used continuously on the patient;
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4)
The patient's blood pressure, pulse rate, and respirations shall be measured at least
every five minutes; and
5)
The body temperature of a pediatric patient shall be measured continuously.
In addition to the monitoring requirements in (c) above, a physician who administers or
supervises the administration or monitoring of general anesthesia services in an office
shall ensure that additional monitoring is provided as follows:
1)
End-tidal carbon dioxide monitoring shall be performed on the patient continuously
during endotracheal anesthesia;
2)
An in-circuit oxygen analyzer shall be used to monitor the oxygen concentration
within the breathing circuit, displaying the oxygen percent of the total inspiratory
mixture;
3)
A respirometer (volumeter) shall be used to measure exhaled tidal volume whenever
the breathing circuit of a patient allows;
4)
The body temperature of each patient shall be measured continuously; and
5)
An esophageal or precordial stethoscope shall be available and utilized on the patient
when indicated.
A practitioner who administers or supervises the administration and monitoring of
anesthesia services in an office shall establish within that office a recovery area and
ensure that recovery services are provided as follows:
1)
Immediately after the surgery or special procedure, the practitioner who performed
the surgery or the individual, who administered the anesthesia shall evaluate the
patient;
2)
The individual responsible for the administration or monitoring of anesthesia shall
accompany the patient into the recovery area;
3)
Healthcare personnel who were present with the patient at the anesthetizing location
shall remain with the patient in the recovery area at least until the patient's vital
signs, including blood pressure, pulse, and respiration are recorded;
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4)
An oral report on the patient's condition shall be given to any healthcare personnel in
the recovery area not present in the anesthetizing location;
5)
Whenever a patient is present in the recovery area, the recovery area shall be staffed
by at least one registered professional nurse or physician assistant who is trained
and experienced in advanced cardiac life support and post anesthesia care. This
includes recognizing the actions and interactions of anesthetic techniques, managing
of airway and vent