Requirements for Recordkeeping

(A) Records of Authority and Responsibilities for Radiation Protection Programs. (1) A licensee shall retain a record of actions taken by the licensee’s management in accordance with 105 CMR 120.515(A) for five years. The record must include a summary of the actions taken and a signature of licensee management. (2) The licensee shall retain a current copy of the authorities, duties and responsibilities of the Radiation Safety Officer as required by 105 CMR 120.515(E), and a signed copy of the Radiation Safety Officer’s agreement to be responsible for implementing the radiation safety program, as required by 105 CMR 120.515(B). The record must include the signature of the Radiation Safety Officer and licensee management. (3) For each Associate Radiation Safety Officer appointed under 105 CMR 120.515(B), the licensee shall retain, for five years after the Associate Radiation Safety Officer is removed from the license, a copy of the written document appointing the Associate Radiation Safety Officer signed by the licensee's management. (B) Records of Radiation Protection Program Safety Changes. A licensee shall retain a record of each radiation protection program change made in accordance with 105 CMR 120.517(A) for five years. The record must include a copy of the old and new procedures; the effective date of the change; and the signature of the licensee management that reviewed and approved the change. (C) Records of Written Directives. A licensee shall retain a copy of each written directive as required by 105 CMR 120.521 for three years. (D) Records of Medical Events. A licensee shall retain a record of medical events reported in accordance with 105 CMR 120.594(A) for three years. The record must contain the licensee’s name; names of the individuals involved; the social security number or other identification number if one has been assigned, of the individual who is the subject of the medical event; medical event a brief description of the event; why it occurred; the effect, if any, on the individual; the actions, if any, taken, or planned, to prevent recurrence; and, whether the licensee notified the individual (or the individual’s responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician. (E) Record of a Dose to an Embryo/Fetus or a Nursing Child. A licensee shall retain a record of a dose to an embryo/fetus or a nursing child reported in accordance with 105 CMR 120.594(B) for three years. The record must contain the licensee’s name; names of all the individuals involved; social security number or other identification number if one has been assigned of the embryo/fetus or nursing child who is the subject of the event; a brief description of the event; why it occurred; the effect, if any, on the embryo/fetus or nursing child; the actions, if any, taken, or planned, to prevent recurrence; and whether the licensee notified the pregnant individual or mother (or the mother’s or child’s responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician. (F) Records of Calibrations of Instruments Used to Measure the Activity of Unsealed Radioactive Material. A licensee shall maintain a record of instrument calibrations required by 105 CMR 120.532 for three 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. (G) Records of Survey Instrument Calibrations. A licensee shall maintain a record of instrument calibrations required by 105 CMR 120.533 for three years. The record 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. (H) Records of Dosages of Unsealed Radioactive Material for Medical Use. A licensee shall maintain a record of dosage determinations required by 105 CMR 120.534 for three years. The record must contain the radioactive drug; the patient’s or human research subject's name, or identification number if one has been assigned; prescribed dosage; the determined dosage, or a notation that the total activity is less than 1.1 MBq (30 :Ci); the date and time of the dosage determination; and the name of the individual who determined the dosage. (I) Records of Possession of Sealed Sources and Brachytherapy Sources. (1) A licensee shall retain a record of the leak test required by 105 CMR 120.536(B) for three years. The record must contain the model number, and serial number if one has been assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the results of the test, the date of the test, and the name of the individual who performed the test. (2) A licensee shall retain a record of the semi-annual physical inventory of sealed sources and brachytherapy sources required by 105 CMR 120.536(E) for three years. The inventory record must contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory. (J) Records of Surveys for Ambient Radiation Exposure Rate. A licensee shall retain a record of each survey required by 105 CMR 120.539 for three years. 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. (K) Records of the Release of Individuals Containing Radioactive Drugs or Implants Containing Radioactive Material. (1) A licensee shall retain a record, signed by the authorized user, of the basis for authorizing the release of an individual, for three years after the date of release, if the total effective dose equivalent is calculated by: (a) Using the retained activity rather than the activity administered; (b) Using an occupancy factor less than 0.25 at one meter; (c) Using the biological or effective half-life; or (d) Considering the shielding by tissue. (2) A licensee shall retain a record, for three years after the date of release, that the instructions required by 105 CMR 120.540(B) were provided to a breast-feeding woman [if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding five mSv (0.5 rem)]. (L) Records of Administrative and Technical Requirements That Apply to the Provision of Mobile Services. (1) A licensee shall retain a copy of the letter(s) that permits the use of radioactive material at a client’s address of use, as required by 105 CMR 120.541(A)(1), for three years after the last provision of service. (2) A licensee shall retain the record of each survey required by 105 CMR 120.541(A)(4) for three years. 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. (M) Records of Decay-in-storage. A licensee shall maintain records of the disposal of licensed materials, as required by 105 CMR 120.543, for three years. The record must include the date of the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey. (N) Records of Radionuclide Purity. A licensee shall maintain a record of the radionuclide contaminant concentration tests required by 105 CMR 120.548(B) and (C) for three years. The record must include, for each measured elution of radionuclide used to prepare a radioactive drug, the ratio of the measures expressed as kilobecquerel of contaminant per megabecquerel of desired radionuclide, or microcuries of contaminant per millicurie of desired radionuclide, the time and date of the measurement, and the name of the individual who made the measurement. (O) Records of Safety Procedures. A licensee shall retain a copy of the procedures required by 105 CMR 120.573(A)(4) and (D)(2)(b) until the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit. (P) Records of Safety Instruction and Training. A licensee shall maintain a record of safety instructions and training required by 105 CMR 120.553, 120.562 and the operational and safety instructions required by 120.573 for three years. The record must include a list of the topics covered, the date of the instruction or training, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction. (Q) Records of Radiation Surveys of Patients and Human Research Subjects. A licensee shall maintain a record of the surveys required by 105 CMR 120.560 and 120.571 for three years. Each record must include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.