Guidelines for starting Nuclear Medicine Laboratory The use of by broverya72

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									                       Guidelines for starting Nuclear Medicine Laboratory

The use of radioisotopes for the purpose of diagnosis and therapy using nuclear medicine should be
done in a laboratory approved as per guidelines specified by the Atomic Energy Regulatory Board
(AERB). These laboratories should also have a minimum trained and qualified staff that is approved by
AERB for this particular application. The AERB Safety Code on Nuclear Medicine Facilities
(AERB/SC/MED-4 Rev-1, 2001) gives the mandatory regulatory requirements to be met by the
nuclear medicine centres. This Code and various application forms pertaining to nuclear medicine are
available on www.aerb.gov.in

Following are the general guidelines to be adopted in this matter:

1. Planning and approval of Nuclear Medicine laboratory:

    Planning and approval of the laboratory is done by the Radiological Physics and Advisory
Division, BARC, CT&CRS, Mumbai-400094. Two copies of the layout of the nuclear medicine
laboratory (drawn to scale 1:50) indicating the various rooms alongwith their dimensions, positions of
doors, windows, exhausts, alongwith fumehoods, workbenches, sinks and other details should be sent
to RP&AD, BARC. A site plan (drawn to scale 1:500) indicating the location of the nuclear medicine
laboratory and the occupancies around it including those above the ceiling and below the floor, if any.
2. Staff requirement:
   Following staff with the specified qualifications should be made available prior to commissioning
   of the laboratory:

   Laboratories undertaking diagnostic procedures and low dose therapy

   (a) Nuclear Medicine Physician:

   Qualifications: A bachelor’s degree in Medicine recognised by the Medical Council of India and
   A qualification in Nuclear Medicine recognised by the Medical Council of India, (i.e either MD –
   Nuclear Medicine, DRM, DNB)
   Certificate from AERB for the use radioisotopes on Humans for diagnostic purposes
   (b) Nuclear Medicine Technologist:

   Qualifications: A Bachelor’s Degree in Science subjects from a recognised University and
   A Diploma in Medical Radioisotope Technology from an AERB approved institution
   (c) Radiological Safety Officer (RSO) Level – II

   - Either a Nuclear Medicine Physician or a Technologist with above qualifications,
   - Certificate from Head, RP&AD, BARC to perform duties of RSO after passing the RSO
     Certification Exam conducted by RP&AD, BARC and
   - Approval from AERB
     Laboratories undertaking High Dose cancer therapy
     (a) Nuclear Medicine Physician:
     -       Nuclear medicine physician with above mentioned qualification and training for therapeutic use
             of radioisotopes on humans from approved AERB nuclear medicine centres and
     -       Certificate from AERB for the use radioisotopes on Humans for therapeutic purposes.


     (b) Nuclear Medicine Technologist:

     - Nuclear medicine technologist with above qualifications
     (c) Radiological Safety Officer Level – III:

     - M.Sc. and Dip. RP or M.Sc. (Med. Physics) from a recognised University and
     - Approval from AERB

3.       Issuance of NOC/authorisation for procurement of radioisotopes

     (i)        Construction of laboratory as per the approved plan
     (ii)       Installation of imaging/non imaging devices, fumehood(s)
     (iii)      Procurement of isotope calibrator, l-benches and laboratory accessories
     (iv)       Appointment of staff as per above qualification
     (v)        Personnel monitoring services provided to radiation workers
     (vi)       Procurement of radiation protection instruments such as contamination monitor, survey
                monitor
     (vii)      Submission of Application for Regulatory Consent to RSD, AERB
     (viii)     Written request to AERB, with a list of radioisotopes to be imported for obtaining NOC
     (ix)       Placement of order with BRIT for procurement of indigenously made radiopharmaceuticals.

4.       Issuance of NOC/authorisation for procurement of radioisotopes to existing laboratories

     (i)        Receipt of Annual Status Report for the calendar year and
     (ii)       Validity of the RSO certificate issued by AERB

Forms pertaining to nuclear medicine available at www.aerb.gov.in:
(http://www.aerb.gov.in/T/forms/regforms/Nuclear_Medicine/Nuclear_Medicine_Forms.html,
http://www.aerb.gov.in/t/forms/regform.html)

1. AERB/NM/Radiation Safety/02: Annual Report on Status of Radiation safety in Nuclear Medicine
   Institutions/Departments. This form is to be submitted to Head, RSD, AERB, before the end of
   January every year.
2. AERB/444-NM/RC-FORM: Regulatory Consent Application for Nuclear Medicine
3. AERB-RSOM-II/III: Form for Application for Approval of RSO for NM

								
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