N.H. Admin. Code § He-P 4047.04

Current through Register No. 45, November 7, 2024

Section He-P 4047.04 - General Administrative Requirements for Facilities Using Therapeutic Radiation Machines

(a) The use of therapeutic radiation machines shall be by, or under the supervision of, a licensed practitioner of the healing arts.

(b) The registrant shall be responsible for directing the operation of the therapeutic radiation machines which have been registered with DHHS/RHS.

(c) The registrant shall ensure that the requirements of Part He-P 4047 are met in the operation of the therapeutic radiation machine(s) .

(d) A therapeutic radiation machine which does not meet the provisions of these rules shall not be used for irradiation of patients.

(e) The registrant for any therapeutic radiation machine subject to He-P 4047 shall require the authorized user to be a physician who:

(1) Is certified in:

a. Radiation oncology or therapeutic radiology by the American Board of Radiology; or

b. Radiation oncology by the American Osteopathic Board of Radiology; or

c. Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or

d. Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

(2) Is in the active practice of therapeutic radiology, and has:

a. Completed 200 hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit;

b. Completed 500 hours of supervised work experience; and

c. A minimum of 3 years supervised clinical experience.

(f) To satisfy the requirement for instruction in He-P 4047.04(e) (2) a., the classroom and laboratory training shall include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of ionization radiation; and

(4) Radiation biology.

(g) To satisfy the requirement for supervised work experience in He-P 4047.04(e) (2) b., training shall:

(1) Be under the supervision of an authorized user; and

(2) Include:

a. Review of the full calibration measurements and periodic quality assurance checks;

b. Evaluation of prepared treatment plans;

c. Calculation of treatment times and patient treatment settings;

d. Use of administrative controls to prevent misadministrations;

e. Implementation of emergency procedures to be followed in the event of the abnormal operation of a external beam radiation therapy unit or console; and

f. The checking and use of radiation survey meters.

(h) To satisfy the requirement for a period of supervised clinical experience in He-P 4047.04(e) (2) c., training shall include:

(1) One year in a formal training program approved by:

a. The Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education; or

b. The Committee on Postdoctoral Training of the American Osteopathic Association; and

(2) An additional 2 years of clinical experience in therapeutic radiology under the supervision of an authorized user; and

(3) The following training:

a. Examining individuals;

b. Reviewing individuals' case histories to determine their suitability for external beam radiation therapy treatment, and any limitations and contraindications;

c. Selecting proper dose;

d. Selecting how the dose is to be administered;

e. Calculating the external beam radiation therapy doses;

f. Collaborating with the authorized user in the review of patients' progress;

g. Considering of the need to modify originally prescribed doses and/or treatment plans as warranted by patients' reaction to radiation;

h. Post-administration follow-up; and

i. Post-administration review of case histories.

(i) Notwithstanding the requirements of He-P 4047.04(e) (1) and He-P 4047.04(e) (2) , the registrant for any therapeutic radiation machine subject to He-P 4047 shall also submit the training of the prospective authorized user physician for DHHS/RHS review.

(j) A physician shall not act as an authorized user for any therapeutic radiation machine until such time as said physician's training has been reviewed and approved by DHHS/RHS.

(k) The registrant for any therapeutic radiation machine subject to He-P 4047 shall require the radiation therapy physicist to be registered with DHHS/RHS, under the provisions of He-P 4040, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units, and either:

(1) Be certified by:

a. The American Board of Radiology in:

1. Therapeutic radiological physics;

2. Roentgen-ray and gamma-ray physics;

3. X-ray and radium physics; or

4. Radiological physics; or

b. The American Board of Medical Physics in Radiation Oncology Physics; or

c. The Canadian College of Medical Physics; or

(2) Alternately, the radiation therapy physicist shall meet the following requirements:

a. Hold a master's or doctor's degree in physics, medical physics, engineering, applied mathematics, biophysics, radiological physics, or health physics from an accredited college or university;

b. Have completed one year of full time training in therapeutic radiological physics;

c. Have completed one year full-time work experience under the supervision of a radiation therapy physicist at a medical institution; and

d. The training and work experience as required in He-P 4047.04(2) above, shall be conducted in a clinical radiation facility that provides high-energy external beam radiation therapy.

(l) To meet the requirement in He-P 4047.04(k) (2) c. above, the individual shall have performed the tasks listed in He-P 4047.05(a) through (f) , and He-P 4047.06(r) and (s) , and He-P 4047.07(u) and (v) , under the supervision of a radiation therapy physicist during the year of work experience.

(m) Notwithstanding the provisions of He-P 4047.04(k) (2) and (l) , certification pursuant to He-P 4047.04(k) (1) shall be required on or before December 31, 1999 for all persons currently qualifying as a radiation therapy physicist pursuant to He-P 4047.04(k) .

(n) Each individual who operates a therapeutic radiation machine for medical use shall:

(1) Be a registered radiation therapy technologist with the American Registry of Radiologic Technologists (ARRT); or

(2) Submit evidence that he or she has satisfactorily completed a radiation therapy technologist training program that complies with the requirements of the Joint Review Committee on Education in Radiologic Technology; or

(3) Be a student working under the direct supervision and in the physical presence of a registered radiation therapy technologist.

(o) The names and training of all personnel currently operating a therapeutic radiation machine shall be kept on file at the facility.

(p) Information about former operators shall be retained for a period of at least 2 years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.

(q) Written safety procedures and rules shall be developed by a radiation therapy physicist.

(r) Written safety procedures and rules shall be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine.

(s) The operator shall be able to demonstrate familiarity with the procedures and rules required in He-P 4047.04(q) and (r) .

(t) Individuals shall not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by an authorized user.

(u) The provision in He-P 4047.04(t) shall specifically prohibit deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes.

(v) Notwithstanding the provisions of He-P 4047.04(e) (1) and (e) (2), a registrant may permit any physician to act as a visiting authorized user under the term of the registrant's Certificate of Registration for up to 60 days per calendar year under the following conditions:

(1) The visiting authorized user has the prior written permission of the registrant's management;

(2) The use occurs on behalf of an institution, or the institution's Radiation Safety Committee;

(3) The visiting authorized user meets the requirements established for authorized user(s) in He-P 4047.04(e) (1) and He-P 4047.04(e) (2) ; and

(4) The registrant maintains copies of all records specified by He-P 4047.04(v) for 5 years after the records are made.

(w) All individuals associated with the operation of a therapeutic radiation machine shall be instructed in the provisions of the registrant's quality management program.

(x) All individuals associated with the operation of a therapeutic radiation machine shall comply with the provisions of the registrant's quality management program.

(y) All individuals associated with the operation of a therapeutic radiation machine shall be subject to the requirements of He-P 4020 through He-P 4022.

(z) The registrant shall maintain for inspection by DHHS/RHS the following information in a separate file or package for each therapeutic radiation machine:

(1) Report of acceptance testing;

(2) Records of all:

a. Surveys with date(s) performed;

b. Calibrations with date(s) performed;

c. Periodic, dated, quality assurance checks of the therapeutic radiation machine required by He-P 4047; and

d. The name(s) of person(s) who performed such activities;

(3) Records of:

a. Maintenance, with the date(s) it was performed;

b. Any modifications, with the date(s) the modifications were performed on the therapeutic radiation machine; and

c. The name(s) of person(s) who performed such services; and

(4) The signature of the person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.

(aa) All records required by He-P 4047 shall be retained until disposal is authorized by DHHS/RHS unless another retention period is specifically authorized in He-P 4047.

(ab) All required records shall be retained in an active file from at least the time of generation until the next DHHS/RHS inspection.

(ac) Any required record generated prior to the last DHHS/RHS inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until such time as DHHS/RHS authorizes final disposal.

N.H. Admin. Code § He-P 4047.04

#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.