| Radiation Safety Policy Manual 
UMDNJ NEWARK CAMPUS RADIATION SAFETY POLICY MANUAL
Prepared by
Venkata K. Lanka
Radiation Safety Officer
UMDNJ Newark Campus
January 1999
Mission Statement Table of Contents Chapter 1. Organization of Responsibilities Section 1.1 Radiation Safety Committee 1.1 (a) General Information
1.1 (b) Membership
1.1 (c) Human Use Subcommittee membership
1.1 (d) Licensing Subcommittee membership
1.1 (e) Education and Training Subcommittee membership
1.1 (f) Meeting requirements
1.1 (g) Committee responsibilities
1.1 (h) Human Use Subcommittee responsibilities
1.1 (i) Licensing Subcommittee responsibilities
1.1 (j) Education and Training Subcommittee responsibilities Section 1.2 Radiation Safety Officer 1.2 (a) General Information
1.2 (b) Radiation Safety Officer responsibilities Section 1.3 Radioactive Material Licensee (Non-Human Use) 1.3 (a) General Information
1.3 (b) Non-human Use licensee responsibilities Chapter 2. Radioactive Material Licenses Section 2.1 General Information 2.1 (a) Restriction on individual NJDEP and NRC licenses
2.1 (b) Use of NJDEP and NRC training and experience requirements Section 2.2 Application for a Non-human Use License 2.2 (a) Requirements to submit an application
2.2 (b) Availability of applications
2.2 (c) Submission of an application to the Office of Radiation Safety Services
2.2 (d) Criteria for approval of application by the Licensing Subcommittee
2.2 (e) Approval for "Routine Use"
2.2 (f) Expiration of a license
2.2 (g) Information submitted in support of a license application
2.2 (h) Authorization to use Cs-137 irradiator
2.2 (i) Transfer of a license
2.2 (j) Termination of a license Section 2.3 Application for a Human Use License 2.3 (a) Requirements to submit an application
2.3 (b) Availability of applications
2.3 (c) Submission of an application to the Office of Radiation Safety Services
2.3 (d) Interim Approval
2.3 (e) Criteria for approval by the Human Use Subcommittee
2.3 (f) Submission of evidence of Board Certification or preceptor statement of training
2.3 (g) Expiration of Human Use licenses Section 2.4 Registration to Perform In-Vitro Clinical Assays Using Radioactive Material 2.4 (a) Availability of Registration forms
2.4 (b) Submission of Registration forms to the Office of Radiation Safety Services
2.4 (c) Review by the Radiation Safety Officer
2.4 (d) Criteria for Approval by the Radiation Safety Committee
2.4 (e) Expiration of Approved Registrations Chapter 3. Authorized Use of Radioactive Material Section 3.1 Non-Human Use Radioactive Material 3.1 (a) Restrictions on use
3.1 (b) Compliance with license conditions
3.1 (c) Limitations on human use
3.1 (d) Authorized users Section 3.2 Human Use Radioactive Material 3.2 (a) License limitations
3.2 (b) Determination of radioactive material to a patient
3.2 (c) Authorization to determine radiopharmaceutical and/or radiation dosages and to interpret medical results
3.2 (d) Quality Management Program (QMP)
3.2 (e) Restrictions on use of Iodine-131
3.2 (f) Uptake, dilution, and excretion studies
3.2 (g) Imaging and localization studies
3.2 (h) Use of radiopharmaceuticals for therapy
3.2 (i) Brachytherapy procedures
3.2 (j) Authorized users for diagnostic procedures
3.2 (k) Authorized users for therapy procedures Section 3.3 Human Use Research Protocols 3.3 (a) Radioactive material used for medical research
3.3 (b) Compliance with protocol conditions and limitations
3.3 (c) Authorized users
3.3 (d) Compliance with provisions of Section 3.2 Chapter 4. Radiation Safety Requirements Section 4.1 General Information 4.1 (a) Purpose of safety requirements
4.1 (b) Compliance with safety requirements Section 4.2 Restricted and Unrestricted Areas 4.2 (a) Definition of a restricted area
4.2 (b) Definition of an unrestricted area
4.2 (c) Limiting access to a restricted area
4.2 (d) Exemptions Section 4.3 Permissible Limits of Radiation Exposure 4.3 (a) Limits to members of the general public
4.3 (b) Limits to individuals occupationally exposed
4.3 (c) Restricted exposure of individuals with high radiation doses
4.3 (d) Restrictions on exceeding annual limit
4.3 (e) Restrictions on assigning a task
4.3 (f) Declared pregnant employees
4.3 (g) Exposure of pregnant employees Section 4.4 Personal Monitoring Requirements 4.4 (a) Individuals required to use film badges
4.4 (b) Individuals required to use card monitors
4.4 (c) Individuals required to use finger monitors
4.4 (d) Use of auxiliary personal monitors
4.4 (e) Individuals caring for therapy or implant patients
4.4 (f) Occasionally exposed
4.4 (g) Exchange frequency of personal monitors
4.4 (h) Responsibilities of personal monitor users
4.4 (i) Use of monitors during medical examinations
4.4 (j) Personal monitor costs
4.4 (k) Thyroid monitoring requirements
4.4 (l) RSO actions following positive thyroid uptake results
4.4 (m) Urinalysis for radionuclide ingestion
4.4 (n) Labeling urine specimen containers
4.4 (o) RSO actions following positive urinalysis results Section 4.5 Acquisition of Radioactive Materials 4.5 (a) Authorized receipt
4.5 (b)Conditions for authorized receipt and preparation of purchase requisitions for radioactive materials
4.5 (c) Acquisition of radioactive material through transfer
4.5 (d) Receipt, inspection, and release of radioactive material packages
4.5 (e) Prevention of unauthorized access of radioactive material by the licensee Section 4.6 Disposal of Radioactive Material 4.6 (a) Acceptable categories of waste for disposal by the Office of Radiation Safety Services
4.6 (b) Separation of radioactive waste categories prior to transfer to the Office of Radiation Safety Services
4.6 (c) Storage for decay and subsequent unrestricted disposal
4.6 (d) Acceptable waste for storage for decay
4.6 (e) Limitations for decay in user's laboratories
4.6 (f) Release to normal trash
4.6 (g) Monitoring disposable items
4.6 (h) Labeling radioactive waste containers
4.6 (i) Release to the sanitary sewer system
4.6 (j) Failure to maintain adequate disposal Section 4.7 Licensee Facility Requirements 4.7 (a) Authorized locations
4.7 (b) Laboratory requirements
4.7 (c) Additional laboratory requirements Section 4.8 Resource and Equipment Requirements 4.8 (a) Minimum resource and equipment requirements
4.8 (b) Additional equipment and resource requirements Section 4.9 Posting requirements 4.9 (a) Radiation warning symbol
4.9 (b) Room posting requirements
4.9 (c) Posting radiation areas
4.9 (d) High radiation areas
4.9 (e) Very high radiation areas
4.9 (f) Airborne radioactive material
4.9 (g) Posting rooms having airborne radioactivity
4.9 (h) Posting refrigerators, freezers, and cabinets
4.9 (i) Labeling containers of radioactive material
4.9 (j) Labeling waste containers
4.9 (k) Labeling radioactive material work areas
4.9 (l) Documents requiring posting
4.9 (m) Removing or defacing radioactive material labels Section 4.10 Radiation Safety Surveys 4.10 (a)Contamination survey requirements
4.10 (b)Frequency of contamination surveys
4.10 (c)Spot checks for contamination 4.10 (d)Action limits for contamination
4.10 (e)Radiation survey requirements
4.10 (f) Spot checks for radiation levels
4.10 (g)Action limits for radiation levels
4.10 (h)Air surveys
4.10 (i) Leak tests of sealed sources Section 4.11 General Rules of Safety 4.11 (a)Safety requirements in research laboratories
4.11 (b)Notification requirements
4.11 (c)Notification at the time of routine inspection Section 4.12 Emergency Procedures 4.12 (a)General information Section 4.13 Special Requirements with Research Animals 4.13 (a)Authorization from the Director of the Research Animal Facility
4.13 (b)Segregation of radioactive animals
4.13 (c)Posting requirements
4.13 (d)Responsibility for care of animals
4.13 (e)Survey and decontamination requirements
4.13 (f) Radioactive animal room close out
4.13 (g)Disposal of radioactive animal carcasses Section 4.14 Record Keeping Requirements 4.14 (a)License and correspondence files
4.14 (b)Inventory and survey records Chapter 5. Special Requirements for Medical Use of Radioactive Material Section 5.1 Authorized Use 5.1 (a) Authorized users for diagnostic procedures
5.1 (b) Authorized users for therapy procedures
5.1 (c) Compliance with departmental policy and procedures manuals Section 5.2 Administration of Radioactive Material 5.2 (a) Authorized forms and routes of administration
5.2 (b) Requirements with nuclear medicine examinations
5.2 (c) Procedures prior to administration of diagnostic dosages
5.2 (d) Procedures prior to administration of therapeutic dosages
5.2 (e) Unacceptable therapy requests
5.2 (f) Presence of Radiation Safety Officer during therapy procedures Section 5 .3 Safety Requirements during Routine Preparation and Administration of Diagnostic Dosages 5.3 (a) Use of shielding during unpacking and preparation of radiopharmaceuticals
5.3 (b) Use of shielding during generator elutions
5.3 (c) Molybdenum-99 assays
5.3 (d) Shielding requirements for patient dosages
5.3 (e) Radioiodine storage
5.3 (f) Syringe shield requirements
5.3 (g) Administering radioactive capsules
5.3 (h) Shielding radioactive waste
5.3 (i) Use of Radioactive gases and aerosols
5.3 (j) Logging patient dosages
5.3 (k) Written instructions to diagnostic outpatients Section 5.4 Safety Requirements for Administration of Therapeutic Amounts of Radiopharmaceuticals 5.4 (a) Activities requiring hospitalization
5.4 (b) Release of radioactive patients from the hospital
5.4 (c) Room requirements
5.4 (d) Requirements prior to administration of therapy dosages
5.4 (e) Shielding patient dosages
5.4 (f) Presence of the licensee during administration
5.4 (g) Presence of authorized physician for the entire procedure
5.4 (h) Logging therapy procedures
5.4 (i) Requirements following administration of therapy dosages Section 5.5 Safety Requirements for Patients Receiving Radiopharmaceutical Therapy 5.5 (a) Requirements when crossing the "2 mR" line
5.5 (b) Pregnant hospital workers
5.5 (c) Isolation of therapy patients
5.5 (d) Restrictions for visitors
5.5 (e) Housekeeping restrictions
5.5 (f) Removal of items in patient's room
5.5 (g) Labeling of laboratory specimens
5.5 (h) Use of Radioactive waste containers
5.5 (i) Requirements for discharge from hospital
5.5 (j) Clearing radiotherapy rooms
5.5 (k) Instructions to radiopharmaceutical patients who are breast feeding Section 5.6 Administration of Sealed Sources for Therapy 5.6 (a) Requirements prior to administering sealed sources
5.6 (b) Restrictions on sealed source therapy
5.6 (c) Dosimetry requirements
5.6 (d) Hospitalization of temporary implant patients
5.6 (e) Instructions to patients given permanent implants
5.6 (f) Use of the operating room for administration of interstitial implants
5.6 (g) Afterloading brachytherapy sources
5.6 (h) Notification of the Radiation Safety Officer
5.6 (i) Room requirements
5.6 (j) Procedures following administration of sealed sources Section 5.7 Safety Requirements with Patients Containing Sealed Sources 5.7 (a) Requirements when crossing the "2 mR" safety line
5.7 (b) Minimizing personal exposure
5.7 (c) Pregnant hospital workers
5.7 (d) Restrictions for visitors
5.7 (e) Restricting patient movement
5.7 (f) Removal of temporary implants
5.7 (g) Follow-up surveys following source removal
5.7 (h) Discharge of patients
5.7 (i) Returning reusable sources Section 5.8 Leak Test and Inventory Requirements for Sealed Sources 5.8 (a) Leak Test
5.8 (b) Physical inventory requirements Section 5.9 Routine Safety Surveys in Nuclear Medicine 5.9 (a) Personal monitoring requirements
5.9 (b) Contamination surveys
5.9 (c) Spot checks for contamination
5.9 (d) Radiation level surveys
5.9 (e) Contamination surveys following cardiac stress tests
5.9 (f) Inspection of radioactive packages Section 5.10 Calibration Procedures for Nuclear Medicine Instrumentation 5.10 (a)Calibration of portable survey instruments
5.10 (b)Dose calibrator tests
5.10 (c)Limitations in using dose calibrator
5.10 (d)Calibration of imaging devices
5.10 (e)Calibration of uptake instrumentation Section 5.11 Quality Management Program (QMP) 5.11 (a)QMP for Brachytherapy
5.11 (b)QMP procedures for treatment of sodium iodide I-125 or I-131>30 microcuries Section 5.12 Routine Safety Procedures During In-Vitro Clinical Assays 5.12 (a)Authorized locations
5.12 (b)Radiation safety requirements
5.12 (c)Authorized forms of radioactive material
5.12 (d)Authorized test procedures Chapter 6. X-Ray Producing Machines Section 6.1 Notification to the Office of Radiation Safety Services
6.1 (a) Notification prior to purchases
6.1 (b) Office of Radiation Safety Services approval
6.1 (c) Registration with NJDEP
6.1 (d) Modifications to existing x-ray machines
6.1 (e) X-ray machine survey
6.1 (f) Change in location
6.1 (g) Disposal of x-ray machine Section 6.2 Individual Radiation Safety 6.2 (a) Safety requirements in operating x-ray machine Chapter 7. Inspection and Enforcement Section 7.1 Inspection by the Office of Radiation Safety Services 7.1 (a) Authorization to perform inspections
7.1 (b) Scope of inspections
7.1 (c) Availability of records
7.1 (d) Licensee's obligation to continue surveys
7.1 (e) Requirements in vacating a laboratory Section 7.2 Inspection by State and Federal Authorities 7.2 (a) General Information Section 7.3 Enforcement Procedures 7.3 (a) Requirement to report safety violations
7.3 (b) Investigations by the Office of Radiation Safety Services
7.3 (c) Preparation of violation notices
7.3 (d) Use of NRC Severity Categories Appendix A Tables of Allowable Limits of Intake (ALI) Derived Air Concentrations (DAC) Appendix B Emergency Procedures Appendix C Severity Categories for Violations Appendix D Quality Management Program - Prescription Sheets Back to: ORSS Mission Statement
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