Quality System Area for preparation best practices of radiopharmaceuticals in Nuclear Medicine

Description

• Radiopharmaceutical preparation best practices quality system and Accreditation and Quality Management System in Nuclear Medicine
• Quality Manuals
• Quality manual for radiopharmaceutical preparations obtained by means of kits
• Quality Manual accreditation and quality management system in nuclear medicine
• Management procedures
  • PG MN PI 1 Documentation Management
  • PG MN PI 2 Training, education and integration of personnel
    • Mod.1 Annual training plan
    • Mod.2 Training/coaching sheet
    • Mod.20 New recruit/newly hired training evaluation form
  • PG MN PI 3 Change Management
    • Mod.3 Request and evaluation of changes
  • PG MN PI 4 Management of non-conformities
    • Mod.4 Non-conformity report, available on google drive online
  • PG MN PI 5 Self-inspections
    • Mod.6 Annual self-inspection plan
    • Mod.21 Self-inspection checklist
    • Mod.23 Self-inspection report
  • PG MN PI 6 NBP Instrumentation management: qualification, calibration, use and maintenance
    • Mod.8 Calibration/maintenance report
    • Mod.9 Annual maintenance and calibration plan
    • Mod.10 Logbook
    • Mod.22 Instrument/equipment card
    • Attachment 1 List of instruments/equipment
  • PG MN PI 7 Validation Documentation
  • PG MN PI 8 Complaint Management
    • Mod.11 Reporting of complaints
    • Mod.12 Complaints register
  • PG MN PI 10 Preparation Best Practices Process Validation
    • Mod.31 Final report
    • Mod.31/A Final report
    • Mod.32 Investigation report and corrective actions for non-compliant media fill
  • PG MN PI 11 NBP Management of certificates of analysis
    • Mod.14 Analysis certificate
    • Mod.15 Analysis certificates record
  • PG MN PI 12 Preparation best practices out of specification results management
    • Mod.16 Investigation of out of specification results
    • Mod.17 Out of specification results log
  • PG MN PI 13 NBP Microbiological validation of cells
  • PG MN PI 14 Nominal and functional organisational chart
    • Attachment 1 Preparation best practices quality system functional organisation chart
    • Attachment 2 Preparation best practices quality system nominal organisational chart
    • Attachment 3 List of signatures and initials of relevant personnel
    • Attachment 4 Nuclear Medicine functional organisation chart accreditation and quality management system
    • Attachment 5 Nuclear Medicine nominal organisation chart of the accreditation and quality management system
  • PG MN PI 15 Process Indicators
    • Mod.41 Process Indicators
  • PG 16 Management of radioactive waste produced in the Nuclear Medicine Unit
    • Mod.45 Radiopharmaceutical waste form
    • Mod.46 Radiopharmaceutical waste disposal register
    • Mod.49 Radioactive waste disposal plant operation control log
    • Mod.50 Solid waste contamination control log
  • PG MN PI 17 Management of imaging equipment: use and maintenance
    • Attachment1 List of Imaging equipment
    • Mod.51 Maintenance report/quality control
    • Mod.52 Annual maintenance programme and quality control of imaging equipment
    • Mod.53 Imaging equipment logbook
    • Mod.54 Imaging equipment card
• Operational procedures
  • PO MN PI 1 Management of classified areas
  • PO MN PI 3 Batch record management
    • Mod.13 Worksheet
    • Mod.13A Ready-to-use radiopharmaceuticals worksheet
    • Mod.14 Analysis certificate
    • Mod.19 Daily spect radiopharmaceutical work schedule
    • Mod.27 Daily pect radiopharmaceutical work schedule
  • PO MN PI 4 Use of the Astrim computer system for the management of the activity of the Nuclear Medicine Unit
  • PO MN PI 5 Management of access to the computer systems of the Nuclear Medicine Unit
  • PO MN PI 6 MN Myocardial Tomoscintigraphy
  • PO PM PI 7 MN Radioisotopic balance ventriculography
  • PO MN PI 8 MN Thyroid scintigraphy
  • PO MN PI 9 MN Lung perfusion scintigraphy
  • PO MN PI 11 MN Cerebral scintigraphy with 123I-FP-CIT
  • PO MN PI 12 MN MIBG Myocardial Scintigraphy
  • PO MN PI 13 MN MIBG scintigraphy
  • PO MN PI 14 MN Bone scan
  • PO MN PI 15 MN Renal Scintigraphy
  • PO MN PI 16 MN Parathyroid Scintigraphy
  • PO MN PI 17 MN Positron emission tomography
• Operating instructions
  • IO MN PI 1 NBP Access and behaviour of personnel in the radiopharmaceutical preparation area
  • IO MN PI 2 NBP Cleaning and disinfection of premises and equipment
    • Mod.18 Monthly premises cleaning sheet
    • Mod.18A Monthly PET premises cleaning sheet
    • Mod.24 Monthly cleaning sheet for instrumentation and PET radiopharmaceutical fractionation room hood
    • Mod.25 Monthly instrumentation and room hood cleaning sheet: spect preparations
    • Mod.25/A Monthly screen cell cleaning sheet
    • Mod.44 Monthly sheet for local contamination control
    • Attachment1 List of products used by technicians for cleaning
    • Attachment2 Cleaning type
  • IO MN PI 3 NBP Warehouse and raw material management
    • Mod.43 Verification of expiry of raw materials and cold kits
    • Attachment1 List date of last revision of the text of package leaflets for cold kits
  • IO MN PI 4 Instructions for aseptic preparation of ready-to-use radiopharmaceuticals
    • Mod.19 Daily SPECT radiopharmaceutical work schedule
    • Mod.27 Daily PET radiopharmaceutical work schedule
    • Mod.28 PET radiopharmaceuticals worksheet
  • IO MN PI 5 NBP Preparation and fractionation of simple aseptic kits
    • Mod.13 Worksheet
    • Mod.19 Daily spect radiopharmaceutical work schedule
    • Attachment1 Stability of marked kits Annex 1 II 5
  • IO MN PI 6 NBP Use of radio-TLC
    • Mod.8 Calibration/maintenance report
  • IO MN PI 7 NBP Using the dosage calibrator
  • IO MN PI 9 NBP Preparation of the Myoview radiopharmaceutical
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 10 NBP Preparation of Datascan radiopharmaceutical
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 11 NBP Preparation of the Pentacis radiopharmaceutical
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 12 NBP Technescan Preparation
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 13 NBP Preparation of the Technescan Lyomaa radiopharmaceutical
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 15 NBP; Myoview radiopharmaceutical quality control
    • Mod.14 Analysis certificate Rev.2 of 20/10/2016
  • IO MN PI 16 NBP Pentacis radiopharmaceutical quality control
    • Mod.14-B Pentacis analysis certificate
  • IO MN PI 17 Technescan radiopharmaceutical quality control
    • Mod.14 HDP analysis certificate
  • IO MN PI Technescan Lyomaa radiopharmaceutical quality control
    • Mod.14 Lyomaa analysis certificate
  • IO MN PI 19 NBP Using the Technetium Drytec generator
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 20 NBP Quality control of Technetium Drytec generator
    • Mod.14-A Draytec analysis certificate
  • IO MN PI 21 NBP Preparation of radiopharmaceutical 123I sodium iodide solution for injection
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 22 NBP Preparation of Andreview Iobenguane (123I) MIBG radiopharmaceutical
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 23 NBP Preparation of the Technemibi radiopharmaceutical
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 24 NBP Preparation of the Osteocis radiopharmaceutical
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 26 NBP Quality control of the Thechnemibi radiopharmaceutical
    • Mod.14-D Technemibi analysis certificate
  • IO MN PI 27 NBP Quality control of the Osteocis radiopharmaceutical
    • Mod.14-E Osteocis analysis certificate
  • IO MN PI 29 NBP Refrigerator management
    • Mod.26 Monthly refrigerator temperature measurement sheet. Available online on google drive
  • IO MN PI 31 NBP Aseptic process validation with INTEGO automatic fractionator
    • Mod.33/A Media fill worksheet for Intego
    • Mod.31/A Final report validation of aseptic handling by media fill for automatic fractionation and infusion systems
  • IO MN PI 32 NBP Validation of aseptic handling using media fill kit (FILL-SAFE)
    • Mod.33 Media fill worksheet
  • IO MN PI 33 Use of the intego infusion system
    • Mod.28 PET radiopharmaceuticals worksheet quick guide to SAS installation
  • IO MN PI 34 NBP Patient access to controlled area and preparation for examination
    • Mod.34 Withdrawal of nuclear medicine report
    • Mod.35 Withdrawal of PET report
    • Mod.36 Nuclear Medicine informed consent
    • Mod.37 PET informed consent
    • Mod. 37/A Brain PET/CT informed consent
    • Mod.38 Cardiac stress informed consent
    • Mod.47 “FREI” Consent and Information
    • Mod.48 Anaesthesia informed consent for minor patients
    • Attachment1 Letter to prescribers
  • IO MN PI 35 MN Verification of diagnostic appropriateness
  • IO MN PI 36 MN Urgent patient acceptance
    • Mod.39 Urgent patient acceptance
  • IO MN PI 37 MN Criteria for control, completeness and quality of examination
  • IO MN PI 38 MN Patient discharge
    • Mod.40 Patient attendance certificate
  • IO MN PI 39 MN Drafting of the report
  • IO MN PI 40 MN Report archiving/consents
  • IO MN PI 41 MN Control of nuclear medicine gamma cameras
    • Attachment1 List of nuclear medicine equipment
  • IO MN PI 42 MN PET/CT Discovery VCT Maintenance
    • Attachment1 List of PET equipment
  • IO MN PI 43 Procedure for using the PRP13 automatic programmable eluter
    • Mod.8 Calibration/maintenance report
  • IO MN PI 44 Preparation of the MAASOL radiopharmaceutical
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 45 Quality control of the MAASOL radiopharmaceutical
    • Mod.14 Analysis certificate
  • IO MN PI 46 NBP Preparation Best Practices
    • Mod.8 Calibration/maintenance report
    • Mod.42 Refrigerator temperature report
  • IO MN PI 47 MN Alcione machine control
    • Attachment1 List of 2016 equipment
  • IO MN PI 48 Using the Tekcis Technetium Generator
    • Mod.19 Daily SPECT radiopharmaceutical work schedule
  • IO MN PI 49 Tekcis Technetium generator quality control
    • Mod.14 Analysis certificate
  • IO MN PI 50 Visitor access to controlled area
    • Mod.55 Nuclear medicine controlled area visitor access request
    • Mod.56 Visitor log
    • Attachment1 Visitor information sheet and consent
  • IO MN PO 51 Control of personal contamination
    • Mod.57 Communication of personal contamination
    • Attachment1 Contamination control procedure
  • IO MN PI 52 Emergency procedure in case of contamination by radioactive substances
    • Mod.57 Communication of personal contamination
    • Mod.58 Object contamination communication
  • IO MN PI 53 Procedure for entering and leaving the controlled area
  • IO MN PI 54 Preparation of Technescan DTPA radiopharmaceutical
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 55 Quality control of the Technescan DTPA radiopharmaceutical
    • Mod.14-H DTPA analysis certificate
  • IO MN PI 56 Preparation of the Mibispect radiopharmaceutical
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 57 Quality control of the MIBISPECT radiopharmaceutical
    • Mod.14-N Mibispect analysis certificate
  • IO MN 58 NBP Using the Ultra-Technekow Technetium Generator
    • Mod.19 Daily spect radiopharmaceutical work schedule
  • IO MN PI 59 NBP Quality control of the Ultratechnekow Technetium generator
    • Mod.14 M Ultratechnekow analysis certficiate
    • Mod.14 O Tc99m from Ultratechneko analysis certificate