MQSA for Nuc Med

Radiation Protection Program

• Requires ANNUAL review

• Required to keep records for 3 years

• Must use ALARA (as low as reasonably achievable)

• Need to monitor both occupational and public exposure

Areas

• Restricted

  • Area that receives > 2 mRem/h

  • Typically treatment rooms & pharm prep/dispense/decay rooms

• Un-restricted

  • Pretty much everywhere else (waiting room, filing room, etc.)

• Radiation area

  • An area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent > 5 mrem (0.05 mSv) in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates.

• High Radiation area is one in which a person receives no more than 100 millirem (mrem) exposure in one hour at a distance of 30 cm from the radiation source

Dose Exposure Limits

• Stochastic effects = those that increase in probability with dose

  • I.e. cataracts, risk of developing increases as you get more dose to eyes

• Pregnant women who is a radiation worker

  • Max of 50 mSv (5 rem) for the entire gestation

• The embryo dose limit is 0.5 rem (5 mSv) after a pregnancy is declared. A pregnancy must be declared in writing with the estimated date of conception to the Radiation Safety Officer (RSO).

• Limit for the total effective dose equivalent to individual members of the public from a licensed operation

  • Max of 0.1 rem/year = 100 mrem/year = (1 mSv/year) OR

  • 2 mrem in any single hour

  • NOTE: Care givers of someone receiving therapy may exceed the dose limit if deemed necessary for patient to have care, basically a gray area but they can exceed this limit if you are a caregiver

• Whole body dose limit for occupation workers

  • 50 mSv = .05 Sc = 5 rem

• The maximal permissible radioactivity ratio of Mo-99 to Tc-99m allowed in an elution from a Mo-99/Tc-99m generator is 0.15 uCi/mCi. This type of impurity is referred to as radionuclidic.

  • I have no idea what this means

Random Rules

• Unless directed by an authorized user, a licensee may not use a dosage if the dosage differs from the prescribed dosage by more than 20%

• The Nuclear Regulatory Commission (NRC) states that a record of calibrations of instruments used to measure the activity of unsealed by-product material must be kept for 3 years. The records must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

• Medical Event

  • (NRC) states that the licensee shall notify by telephone the NRC Operations Center no later than the next calendar day after discovery of the medical event.

  • (NRC) states that the licensee shall submit a written report to the appropriate NRC Regional Office within 15 days after discovery of the medical event.

• In addition to other shit, in order to apply for authorized user status you must witness 3 high dose (> 33mci) and 3 low dose (<33 mci) radioactive iodine administrations

• Package receipt includes performing a survey and wipe test within 3 hours of receipt if delivered during normal working hours. If the facility is closed when the package is delivered, it should be surveyed and wipe tested within 3 hours of the next business day.

• The (NRC) requires that the authorized user of a diagnostic sealed source for use to be a physician, dentist, or podiatrist who is certified by a specialty board whose certification process includes the requirements mentioned below and whose certification has been recognized by the Commission or an Agreement State and has completed training in the use of the device for the uses requested, or has completed 8 hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. Training must include radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity and radiation biology, and has completed training in the use of the device for the uses requested.

  • Note: Sealed source is a radioactive material that is permanently sealed in a capsule or bonded in a solid form

• A licensee shall survey with a radiation detection survey instrument at the end of each day of use. A licensee shall survey all areas where unsealed by-product material requiring a written directive was prepared for use or administered. A licensee does not need to perform the surveys where patients or human research subjects are confined when they cannot be released. A record of each survey must be kept.

• A licensee may authorize the release from its control of any individual who has been administered unsealed by-product material or implants containing by-product material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 0.5 rem (5 mSv).

• Licensing

  • Broad licensing

    • Given to hospitals to allow them to use a wide range of isotopes that are needed for medical care

    • Only given after demonstration of responsibility, not given as an initial license to a new applicant

  • Specific licensing

    • Given to allow use of a select few isotopes

• Surveys

  • The record must include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

• A written directive must be dated and signed by an authorized user before the administration of I-131 sodium iodide < 30 µCi (1.11 MBq), any therapeutic dosage of unsealed by-product material, or any therapeutic dose of radiation from by-product material. The other radiopharmaceuticals listed are not therapeutic and do not require a written directive.

Shit that needs to be checked/maintained

• Linearity is checked at time of installation and quarterly on a dose calibrator.

• After installation, accuracy on a dose calibrator is checked annually

• After installation, constancy is checked daily on a dose calibrator

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