N.H. Admin. Code § He-P 4047.05

Current through Register No. 45, November 7, 2024

Section He-P 4047.05 - General Technical Requirements for Facilities Using Therapeutic Radiation Machines

(a) The registrant shall ensure that radiation protection surveys of all new facilities, and existing facilities not previously surveyed, are performed with an operable radiation measurement survey instrument calibrated in accordance with He-P 4047.08.

(b) The radiation protection survey shall be performed by, or under the direction of, a radiation therapy physicist or a qualified expert.

(c) The radiation protection survey shall verify that, with the therapeutic radiation machine in a "BEAM-ON" condition, with the largest clinically available treatment field and with a scattering phantom in the useful beam of radiation, the following requirements are met:

(1) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in He-P 4020.05; and

(2) Radiation levels in unrestricted areas do not exceed the limits specified in He-P 4020.13(a) and (b) .

(d) In addition to the requirements of He-P 4047.05(a) , a radiation protection survey shall also be performed prior to any subsequent medical use; and:

(1) After making any change in the treatment room shielding;

(2) After making any change in the location of the therapeutic radiation machine within the treatment room;

(3) After relocating the therapeutic radiation machine to a different treatment room; or

(4) Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external radiation therapy treatment room.

(e) The survey record required in He-P 4047.05(d) shall include:

(1) All instances where the facility is in violation of applicable rules;

(2) The date of the measurements;

(3) The reason for the survey;

(4) The manufacturer's name;

(5) Model number of the therapeutic radiation machine;

(6) Serial number of the therapeutic radiation machine;

(7) The instrument(s) used to measure radiation levels;

(8) A diagram of the areas surrounding the treatment room that were surveyed;

(9) The measured dose rate at several points in each area expressed in microsieverts or millirems per hour;

(10) The calculated maximum level of radiation over a period of 1 week for each restricted and unrestricted area; and

(11) The signature of the individual responsible for conducting the survey.

(f) If the results of the surveys required by He-P 4047.05(a) and (d) indicate any radiation levels in excess of the respective limit specified in He-P 4020, the registrant shall lock the control in the "OFF" position and not use the unit except as may be necessary to repair, replace, or test the therapeutic radiation machine, test the therapeutic radiation machine shielding, or test the treatment room shielding.

(g) If the survey required by He-P 4047.05(a) and (d) indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by He-P 4020.13(a) and (b) , before beginning the treatment program the registrant shall:

(1) Equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with He-P 4020.13(a) and (b) ;

(2) Perform the survey required by He-P 4047.05(a) again; and

(3) Include in the record required by He-P 4047.05(e) :

a. The results of the initial survey;

b. A description of the modification made to comply with He-P 4047.05(g) (1) ; and

c. The results of the second survey.

(h) The registrant shall have a dosimetry system available for use which has been calibrated by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL) as follows:

(1) For beams with energies greater than 1 MV (1 MeV), the dosimetry system shall have been calibrated for Cobalt-60; and

(2) For beams with energies equal to or less than 1 MV (1 MeV), the dosimetry system shall have been calibrated at an energy or for an energy range appropriate for the radiation being measured.

(i) The calibration of the dosimetry system required in He-P 4047.05(h) shall have been performed within the previous 24 months, and after any servicing that may have affected system calibration.

(j) An independent survey shall be conducted by a radiation therapy physicist or qualified expert other than the person performing the original survey prior to the system being used except as described in He-P 4047.05(f) .

(k) The registrant shall have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system shall be compared with a system that has been calibrated in accordance with He-P 4047.05(h) through (j) . This comparison shall have been performed within the previous 12 months, and after each servicing that may have affected system calibration. The quality assurance check system shall be the same system used to meet the requirements in He-P 4047.05(h) through (j) .

(l) The registrant shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for each therapeutic radiation machine.

(m) For each calibration, intercomparison, or comparison, the record shall include:

(1) The date;

(2) The model numbers of the instruments that were calibrated;

(3) The serial numbers of the instruments that were calibrated, intercompared, compared, or used to meet the requirements in He-P 4047.05(h) through (k) ;

(4) The correction factors that were determined;

(5) The names of the individuals who performed the calibration, intercomparison, or comparison; and

(6) Evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a radiation therapy physicist.

(n) The registrant for any therapeutic radiation machine shall be able to furnish a copy of the records required in He-P 4047.05 to DHHS/RHS upon request, within 30 days following completion of the action that initiated the record requirement.

(o) Each registrant using radiation therapy machines shall establish and maintain a quality management program to provide high confidence that radiation will be administered as directed by the authorized user.

(p) The registrant shall make modifications to the quality management program to increase the program's efficiency.

(q) The quality management program required by He-P 4047.05(o) shall include written policies and procedures to meet the following specific objectives:

(1) Prior to administration, a written directive shall be prepared for any external beam radiation therapy dose;

(2) Notwithstanding He-P 4047.05(q) (1) above, a written revision to an existing written directive shall be acceptable provided that the revision is dated and signed by an authorized user prior to administration of the external beam radiation therapy dose or the next external beam radiation therapy fractional dose;

(3) If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive shall be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by an authorized user within 48 hours of the oral revision;

(4) The written directive shall contain the patient or human research subject's name, the type and energy of the beam, the total dose, dose per fraction, treatment site and number of fractions;

(5) A written revision to an existing written directive shall be made provided that the revision is dated and signed by an authorized user prior to the administration of the therapeutic radiation machine dose, or the next fractional dose; and

(6) The registrant shall retain a copy of each written directive for 3 years.

(r) The registrant shall develop, implement and maintain written procedures to provide high confidence that:

(1) Prior to the administration of each course of radiation treatment, the patient's identity is verified, by more than one method, as the individual named in the written directive;

(2) Each administration is in accordance with the written directive;

(3) The therapeutic radiation machine final treatment plans and related calculations are in accordance with the respective written directives by:

a. Checking both manual and computer generated dose calculations to verify they are correct and in accordance with the written directive; and

b. Verifying that any computer generated calculations are correctly transferred into consoles of authorized therapeutic medical units;

(4) Any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken; and

(5) The registrant retains a copy of the procedures for administrations for the duration of the registration.

(s) Each registrant using radiation therapy equipment shall have a quality management program that specifies staff, staff duties and responsibilities, equipment, and procedures.

(t) Each existing registrant shall submit to DHHS/RHS a copy of the written quality management program that has been implemented.

(u) The registrant shall include as a part of the quality management program the following:

(1) An evaluation of a representative sample of patient administrations and a review of all recordable events, and all misadministrations, if any, to verify compliance with all aspects of the quality management program;

(2) Reviews conducted at intervals not to exceed 12 months;

(3) An evaluation of each review to determine the effectiveness of the quality management program and, if necessary to make modifications to meet the requirements of these rules; and

(4) Records of each review, including the evaluations and findings of the review, which shall be retained for 3 years.

(v) Each registrant shall report any event resulting from intervention of a patient or human research subject in which the administration of therapeutic radiation machine results, or will result in, unintended permanent functional damage to an organ or a physiological system as determined by a physician.

(w) Other than events that result from intervention by a patient or human research subject each registrant shall report any event in which the administration of a therapeutic radiation machine therapy dose:

(1) Involved the wrong patient, wrong treatment modality or wrong treatment site; or

(2) The calculated weekly administered dose differing from the weekly prescribed dose by more than 30 percent; or

(3) The calculated total administered dose differing from the total prescribed dose by more than 20 percent of the total prescribed dose.

(x) The registrant shall evaluate and respond, within 30 days after discovery of a recordable event, by:

(1) Assembling the relevant facts including the cause;

(2) Identifying what, if any, corrective action is required to prevent recurrence; and

(3) Retaining a record, for 3 years, of the relevant facts, and the corrective action, if any, which was taken.

(y) The registrant shall evaluate each misadministration.

(z) The registrant shall take the following actions in response to a misadministration:

(1) Notify DHHS/RHS by telephone no later than the next business day after discovery of the misadministration;

(2) Submit a written report to DHHS/RHS within 15 days after discovery of the misadministration including:

a. The registrant's name;

b. The prescribing physician's name;

c. A brief description of the event;

d. Why the event occurred;

e. The effect on the patient;

f. What improvements are needed to prevent recurrence;

g. Actions taken to prevent recurrence;

h. Whether the registrant notified the patient or the patient's responsible relative or guardian; and

i. What information was provided to the patient; but

j. Shall not include the patient's name or other information that could lead to identification of the patient;

(3) Notify the referring physician;

(4) Notify the patient of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the registrant either that he/she will inform the patient or that, based on medical judgment, telling the patient would be harmful;

(5) Notify the patient as soon as possible thereafter if the referring physician or patient cannot be reached within 24 hours;

(6) Not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the misadministration, because of any delay in notification;

(7) If a verbal notification is made, the registrant shall inform the patient, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant shall provide such a written description if requested; and

(8) Retain a record of each misadministration for 3 years, including:

a. The names of all individuals involved;

b. The patient's Social Security number or other identification number;

c. A brief description of the event;

d. Why it occurred and the effect on the patient;

e. What improvements are needed to prevent recurrence;

f. The actions taken to prevent recurrence; and

g. Whether the patient was notified or not.

(aa) Aside from the notification requirements in (z) above, nothing in this section shall affect any rights or duties of registrants and physicians in relation to each other, to the patient affected by the event, or to that patient's responsible relative or guardian.

N.H. Admin. Code § He-P 4047.05

#6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07

Amended byVolume XXXV Number 06, Filed February 12, 2015, Proposed by #10764, Effective 1/23/2015, Expires7/22/2015.

Amended by Volume XXXV Number 32, Filed August 13, 2015, Proposed by #10894, Effective 7/21/2015, Expires 7/21/2025.