| (vi) name and registration number of the entity contracted
for "provider of equipment," registered in accordance with §289.226
of this title; or
(vii) an increase in the number of radiation machines
authorized by the certificate of registration in any radiation machine
type or type of use category.
(H) The registrant, or the parent company, shall notify
the agency, in writing, immediately following the filing of a voluntary
or involuntary petition for bankruptcy. This notification shall include:
(i) the bankruptcy court in which the petition for
bankruptcy was filed; and
(ii) the case name, number, and date of filing the
petition.
(I) The registrant shall inventory all radiation machines
in the registrant's possession at an interval not to exceed 12 months.
(i) The inventory shall include:
(I) manufacturer's name;
(II) model and serial number of the control panel;
and
(III) location of radiation machine, for example, room
number.
(ii) Records of the inventory shall be made and maintained
in accordance with subsection (k)(2) of this section for inspection
by the agency.
(J) The registrant shall make and maintain records
of receipt, transfer, and disposal of radiation machines.
(i) The records shall include the following:
(I) manufacturer's name, model, and serial number from
the control panel;
(II) date of the receipt, transfer, and disposal;
(III) name and address of person the radiation machine
received from, transferred to, or disposed of; and
(IV) name of the individual recording the information.
(ii) Records of receipt, transfer, and disposal of
radiation machines shall be made and maintained in accordance with
subsection (k)(2) of this section for inspection by the agency.
(K) The following criteria applies to loaner or demonstration
radiation machines.
(i) For persons having a valid certificate of registration,
radiation machines used for loaner or demonstration radiation machines
may be used for up to 30 days. After 30 days, the registrant shall:
(I) notify the agency of an increase in the number
of radiation machine authorized by the certificate of registration
in any radiation machine type or type of use category; and
(II) perform an equipment performance evaluation on
the radiation machine in accordance with subsection (j)(5)(N) of this
section.
(ii) For persons who do not hold a valid certificate
of registration, a loaner radiation machine may be used up to 30 days,
by or under the direction of a veterinarian licensed by the Texas
Board of Veterinary Medical Examiners in accordance with this section.
(6) Termination of certificates of registration. When
a registrant decides to terminate all activities involving radiation
machines authorized under the certificate of registration, the registrant
shall notify the agency immediately and do the following:
(A) request termination of the certificate of registration
in writing to be signed by the RSO, owner, or an individual authorized
to act on behalf of the registrant;
(B) submit to the agency a record of the disposition
of the radiation machines and if transferred, to whom transferred;
and
(C) pay any outstanding fees in accordance with §289.204
of this title, as amended.
(7) The agency shall take actions for modification,
suspension, and revocation of certificates of registration, shall
be taken in accordance with §289.205 of this title.
(j) Use of radiation machines for veterinary medicine.
(1) ALARA. Persons shall use, to the extent practical,
procedures and engineering controls based upon sound radiation protection
principles to achieve occupational doses and public doses that are
ALARA.
(2) Operating and safety procedures. Each registrant
shall have and implement written operating and safety procedures.
These procedures shall be made available to each individual operating
a radiation machine, including any restrictions of the operating technique
required for the safe operation of the particular radiation machine.
(A) The registrant shall document that each individual
operating a radiation machine has read the operating and safety procedures
annually not to exceed 12 months. This documentation shall be maintained
in accordance with subsection (k)(2) of this section for inspection
by the agency. The documentation shall include the following:
(i) name and signature of individual;
(ii) date individual read the operating and safety
procedures; and
(iii) initials of the RSO.
(B) The operating and safety procedures shall include
the following procedures as applicable:
(i) posting notices to workers in accordance with paragraph
(4)(B) of this subsection;
(ii) instructions to workers in accordance with paragraph
(3)(G) of this subsection;
(iii) notifications and reports to individuals in accordance
with paragraph (4)(B) and (C) of this subsection and subsection (k)(3)(B)
- (D) of this section;
(iv) ordering x-ray exams in accordance with subsection
(b)(1) of this section;
(v) occupational dose requirements in accordance with
paragraph (3)(A) of this subsection;
(vi) personnel monitoring requirements in accordance
with paragraphs (3)(B), (D), and (E) of this subsection;
(vii) controlling a radiation area in accordance with
paragraph (4)(C) and (D) of this subsection;
(viii) use of a technique chart in accordance with
paragraph (5)(A) of this subsection;
(ix) use of protective devices in accordance with paragraph
(3)(H) of this subsection;
(x) exposure of individuals in accordance with paragraph
(3)(I) of this subsection;
(xi) holding of animals or image receptors in accordance
with the following:
(I) a list of circumstances in which mechanical holding
devices cannot be routinely utilized; and
(II) a procedure used for selecting an individual to
hold or support the animal or image receptor;
(xii) control of scattered radiation in accordance
with paragraph (6)(C) of this subsection; and
(xiii) film processing program or digital image processing
in accordance with paragraphs (10) - (12) of this subsection.
(3) Personnel requirements.
(A) Occupational dose limits. Except as otherwise exempted,
all individuals who are associated with the operation of a radiation
machine are subject to the occupational dose limits of this subparagraph
regarding dose limits to individuals, and the personnel monitoring
requirements of subparagraph (B) of this paragraph.
(i) The registrant shall control the occupational dose
to individuals to the following dose limits.
(I) An annual limit shall be the total effective dose
equivalent (TEDE) being equal to 5 rems (0.05 Sv).
(II) The annual limits to the lens of the eye, to the
skin of the whole body, and to the skin of the extremities shall be:
(-a-) a lens dose equivalent (LDE) of 15 rems (0.15
Sv); and
(-b-) a shallow dose equivalent (SDE) of 50 rems (0.5
Sv) to the skin of the whole body or to the skin of any extremity.
(III) The annual limits for a minor shall be 10 percent
of the annual occupational dose limits specified in subclauses (I)
and (II) of this clause.
(IV) If a woman declares her pregnancy, the registrant
shall ensure that the dose equivalent to an embryo/fetus during the
entire pregnancy, due to occupational exposure of a declared pregnant
woman, does not exceed 0.5 rem (5 mSv). If a woman chooses not to
declare pregnancy, the occupational dose limits specified in subclauses
(I) and (II) of this clause are applicable to the woman.
(-a-) The registrant shall make efforts to avoid substantial
variation above a uniform monthly air kerma to a declared pregnant
woman so as to satisfy the limit in clause (i) of this subparagraph.
The National Council on Radiation Protection and Measurements recommended
in NCRP Report No. 91 "Recommendations on Limits for Exposure to Ionizing
Radiation" (June 1, 1987) that no more than 0.05 rem (0.5 mSv) to
the embryo/fetus be received in any one month.
(-b-) If by the time the woman declares pregnancy to
the registrant, the dose equivalent to the embryo/fetus has exceeded
0.45 rem (4.5 mSv), the registrant shall be deemed to be in compliance
with clause (i) of this subparagraph, if the additional dose equivalent
to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the
remainder of the pregnancy.
Cont'd... |
