Part 7: Quality Control and Regulatory Issues

1.  Which pair of the following systems is suitable for chromatographic determination of radiochemical impurities in Tc-99m MDP?

a.      Silica gel/saline for free Tc, paper/acetone for HR Tc

b.      Silica gel/saline for HR Tc, paper/acetone for free Tc

c.      20% saline for free Tc, water for HR Tc

d.      20% saline for HR Tc, water for free Tc

2.  There are four mandatory dose calibrator tests. The geometry test is performed at installation. What is the required frequency for performing the other three tests?

a.      Accuracy test daily, linearity test weekly, constancy test monthly

b.      Accuracy test annually, linearity test weekly, constancy test quarterly

c.      Accuracy test daily, linearity test quarterly, constancy test annually

d.      Accuracy test annually, linearity test quarterly, constancy test daily

3.  When performing the Mo-breakthrough test, the technologist first determines the reading of the unshielded vial containing the eluate in the plastic sleeve routinely used to measure Tc-99m doses. The Tc-99m setting is used. With long-handled tongs, he then carefully transfers the eluate vial into the special lead vial shield accompanying his dose calibrator, covers the shield with a lead cover and, using the Mo-99 setting, determines the amount of Mo-99 present. Which one of the following is true?

a.               The individual steps were performed correctly and in correct order

b.               The individual steps were performed correctly but in incorrect order

c.               The individual steps were performed incorrectly but in correct order

d.               The individual steps were performed incorrectly and in incorrect order

4.     Which of the following is a radionuclide impurity?

a.      Mo-99 in the Tc-99m eluate

b.      HR Tc in the Tc-99m eluate

c.      Free Tc in the Tc-99m eluate

d.      Unbound I-123 in I-123 mIBG

5.      Which two of the following are NOT radiochemical impurities?

a.      Aluminum ion in the Tc-99m eluate

b.      HR Tc in the Tc-99m eluate

c.      Free Tc in Tc-99m MDP

d.      Mo-99 in the Tc-99m eluate

1.      a and b

2.      b and d

3.      a and c

4.      a and d  

6.   The upper limit of Mo-99 breakthrough for a fission Mo-99 generator is

a.      0.15 mCi Mo-99/mCi Tc-99m at time of elution.

b.      0.15 mCi Mo-99/mCi Tc-99m at time of administration

c.      1.5 mCi Mo-99/mCi Tc-99m at time of elution.

d.      1.5 mCi Mo-99/mCi Tc-99m at time of administration       

7.   The amount of Hydrolyzed Reduced Tc-99m found in preparations of Tc-MAA is ...?

a.      Typically <1%

b.      Typically between 1-3 %

c.      Typically between 5-10%

d.      Hydrolyzed Reduced Tc-99m in Tc-MAA cannot be determined

8.    Radiochemical impurities are quantitated by

a.      Dose calibration

b.       Gamma ray spectral analysis

c.       Chromatography

d.       Colorimetry

9.    A technologist performed the Aluminum ion breakthrough test by placing a drop of an aluminum standard solution on one end of the special test paper and a sample of the Tc-99m eluate on the other end of the test strip. The eluate spot turned a medium red color and the standard solution turned the paper a faint pink color. Which of the following is correct:

a.      The test was performed incorrectly and therefore results are invalid

b.       The test was positive for aluminum ion breakthrough

c.       The test was negative for aluminum ion breakthrough

d.       The test should have been performed using a dose calibrator

10.  For radioisotope dose calibrator quality control tests,

a.      Measured values must be within 5% of the expected values

b.      Measured values must be within 10% of the expected values

c.      Measured values must be within 15% of the expected values

d.      The value is set independently by each laboratory

11. Regular room monitoring by Nuclear Medicine Technologists is mandatory. What is the required frequency of performance of this monitoring?

a.   GM Counter daily, wipe test daily

b.   GM Counter daily, wipe test weekly

c.   GM Counter weekly, wipe test daily

d.   GM Counter weekly, wipe test weekly

12. Regular hand monitoring by Nuclear Medicine Technologists is mandatory. What is the required frequency of performance of this monitoring?

a.   Hourly

b.   After each study

c.   Before lunch and before leaving at end of the day

d.   Daily

e.   Weekly

 13. Which one of the following statements regarding licensure for use of radioisotopes is true?

a.  The director of Nuclear Medicine is licensed

b.  The director of Radiology is licensed

c.  Each individual user of isotopes is licensed

d.  The institution is licensed

14. Treadmill monitoring by Nuclear Medicine Technologists is mandatory. What is the required frequency of performance of this monitoring?

a.  Hourly

b.  After each study

c.  Before lunch and before leaving at end of the day

d.  Daily

e.  Weekly

15. Radiation readings are received on a monthly basis from the film badge monitoring service. By law, how frequently must your department chairman notify you of your radiation exposure levels?

a.  Weekly

b.  Monthly

c.  Annually

d.  Notification is not mandatory

16.   Mark the following True or False:

a.      By law, the dose calibrator must be checked to ensure proper function every day that radioisotope studies are performed, including holidays and weekends.

b.      It is illegal to discard a 100 mCi Tc-99m standard in the toilet, but permissible to discard radioactive human excreta in the toilet, even if their radioactivity levels are high

c.      The institutional limit for isotopes discarded in the Hot Sink is 1 Ci per year for all users for all isotopes

d.      JCAHO requires daily monitoring and recording of the internal temperature of every laboratory refrigerator and freezer in the Nuclear Medicine Department

17.   You assisted in the administration of a 10 mCi therapy dose of I-131 NaI.  True/False:

a.  You must have your thyroid monitored 24 hours after dose administration

b.  The RSO must collect a urine and blood sample from everyone participating in the therapy dose administration to ensure absence of uptake of volatile iodine

c.  You must take 200 mg of Saturated Solution of KI p.o. prior to dose administration

d.   None of the above is required