1. (a) Scope. The provisions of this section apply to all licensees who use sealed sources in the healing arts and are in addition to, and not in substitution for, other applicable provisions of this chapter.

2. (b) Interstitial, intracavitary, and superficial applications.

   1. (1) Accountability, storage and transit.

      1. (A) Except as otherwise specifically authorized by the agency, each licensee shall provide accountability of sealed sources and shall keep a record of the issue and return of all sealed sources. A physical inventory shall be made at least every six months and a written record of the inventory maintained.
      2. (B) When not in use, sealed sources and applicators containing sealed sources shall be kept in a protective enclosure of such material and wall thickness as may be necessary to assure compliance with the provisions of 21.201, 21.207, and 21.301 of Texas Regulations for Control of Radiation (TRCR) Part 21 as adopted by reference in §289.113 of this title (relating to Standards for Protection Against Radiation).
   2. (2) Testing sealed sources for leakage and contamination. Sealed sources of radioactive material shall be tested for leakage and contamination in accordance with §289.201(g) of this title (relating to General Provisions).

   3. (3) Radiation surveys.

      1. (A) The maximum radiation level at a distance of one meter from the patient in whom brachytherapy sources have been inserted shall be determined by measurement or calculation and preferably by both. This radiation level shall be entered on the patient's chart and other signs as required under paragraph (4) of this subsection.
      2. (B) The radiation levels in the patient's room and the surrounding area shall be determined, recorded, and maintained for inspection by the agency.

   4. (4) Signs and records.

      1. (A) In addition to the requirements of 21.901, 21.902, and 21.904 of TRCR Part 21 as adopted by reference in §289.113 of this title, the bed, cubicle, or room of the hospital brachytherapy patient shall be marked with a sign indicating the presence of brachytherapy sources. This sign shall incorporate the radiation symbol and specify the radionuclide, the activity, date, and the individual(s) to contact for radiation safety instructions. The sign is not required provided the exception in 21.903 is met.

      2. (B) The following information shall be included in or on the patient's chart:

         1. (i) the radionuclide administered, number of sources, activity in millicuries and time and date of administration;
         2. (ii) the exposure rate at one meter, the time the determination was made, and by whom;
         3. (iii) the radiation symbol; and
         4. (iv) the precautionary instructions necessary to assure that the exposure of individuals other than the patient does not exceed that permitted under 21.201 of TRCR Part 21 as adopted by reference in §289.113 of this title.

   5. (5) Release of patients containing temporary implants or permanent implants.

      1. (A) Immediately after removing the last temporary implant source or retraction of a source(s) from a remote control brachytherapy device at the conclusion of treatment, and before the patient is released from the therapy room, the licensee shall perform a radiation survey of the patient with an appropriate survey instrument. The licensee shall not release from confinement for medical care a patient treated by temporary implant or remote control brachytherapy device until all sources have been removed, except as provided in subparagraph (C) of this paragraph.
      2. (B) Any individual containing permanent implant sources shall remain hospitalized and shall not be released from confinement until the maximum exposure rate from the patient is less than five milliroentgens per hour at a distance of one meter from the implant location.

      3. (C) Upon prior approval by the agency of the licensee's written procedures, patients treated with temporary eye plaques may be released from the hospital provided that the procedures ensure that:

         1. (i) the exposure rate from the patient is less than five milliroentgens per hour at a distance of one meter from the eye plaque location;
         2. (ii) the patient is provided with written instructions and radiation safety guidance on how to maintain exposures to other individuals as low as reasonably achievable (ALARA); and
         3. (iii) after removal of the eye plaque and prior to release of the patient, a radiation survey of the patient is made with an appropriate survey instrument to verify that all sources have been removed.
      4. (D) A physical inventory of the sources shall be conducted by the licensee to confirm that all sources have been removed from the patient and the inventory records shall be maintained for inspection by the agency.
      5. (E) Records of surveys required by subparagraph (C)(iii) of this paragraph shall be maintained for inspection by the agency.

3. (c) Teletherapy.

   1. (1) Equipment.

      1. (A) The housing shall be so constructed that, at one meter from the source, the maximum exposure rate does not exceed ten milliroentgens per hour when the beam control mechanism is in the "off" position. The average exposure rate measured at a representative number of points about the housing, each one meter from the source, shall not exceed two milliroentgens per hour.
      2. (B) For teletherapy equipment installed after January 1, 1970, the leakage radiation measured at one meter from the source when the beam control mechanism is in the "on" position shall not exceed one roentgen per hour or 0.1% of the useful beam exposure rate.
      3. (C) Adjustable or removable beam-defining diaphragms shall allow transmission of not more than 5.0% of the useful beam exposure rate.
      4. (D) The beam control mechanism shall be of a positive design capable of acting in any orientation of the housing for which it is designed to be used. In addition to an automatic closing device, the mechanism shall be designed so that it can be manually returned to the "off" position with a minimum risk of exposure.
      5. (E) The closing device shall be so designed as to return automatically to the "off" position in the event of any breakdown or interruption of the activating force and shall stay in the "off" position until re-activated from the control panel.
      6. (F) When any door to the treatment room is opened, the beam control mechanism shall automatically and rapidly restore the unit to the "off" position and cause it to remain there until the door is secured and the unit is reactivated from the control panel.
      7. (G) There shall be at the housing and at the control panel a warning device that plainly indicates whether the beam is on or off.
      8. (H) The equipment shall be provided with a locking device to prevent unauthorized use and shall be locked in the "off" position when not attended.
      9. (I) The control panel shall be provided with a timer that automatically terminates the exposure after a pre-set time.
      10. (J) Provision shall be made to permit continuous observation of and two-way aural communication with patients during irradiation.

   2. (2) Shielding.

      1. (A) Primary protective barriers shall be provided for any area that the useful beam may strike when using the largest possible diaphragm opening. Such barriers should extend at least one foot beyond the useful beam for any possible orientation.
      2. (B) Secondary protective barriers shall be provided for all occupied areas exposed to leakage and scattered radiation.
   3. (3) Operation. No individual who is occupationally exposed to radiation shall be in the treatment room during irradiation unless that individual is the patient. No other individual shall be there except when it is clinically necessary.
   4. (4) Testing for leakage and contamination. Teletherapy sources shall be tested for leakage and contamination in accordance with the procedures described in §289.201(g) of this title (relating to General Provisions). Tests of leakage may be made by wiping accessible surfaces of the housing port or collimator while the source is in the "off" position and measuring these wipes for transferred contamination.

Source Note:The provisions of this §289.256 adopted to be effective November 1, 1995, 20 TexReg 7978.