Chapter 8 - The University of Texas Medical Branch

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Nov 15, 2013 (4 years and 1 month ago)

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8
-
1

CHAPTER
8


Use of Diagnostic X
-
ray Equipment

in Healthcare


INTRODUCTION



Overview

A
Certificate of Registration for the use of diagnostic x
-
ray
equipment

and
a
Certification
of Mammography Systems

for mammography systems
have been issued to the Universi
ty
of Texas Medical Branch by the Texas Depa
rtment of State Health Services (TDSHS)

Radiation Control Program
.




The fundamental objective for the use of diagnostic x
-
ray equipment is to obtain
optimum diagnostic information with minimum exposure
to
UTMB
patients, staff and
visitors.




Regulations


Diagnostic x
-
ray equipment

are regulated by state and federal laws, i.e.

the Texas

Administrative Codes (TAC)

and the Food and Drug Administration

(FDA)

who also
administers the
Mamm
ography Quality Standards Act (MQSA)
. UTMB
shall comply
with the required regulations
.



Registration

All
diagnostic x
-
ray equipment

shall

be registered with
TDSHS with
in thirty (30) days of
the commencement of use. All mammography
equipment

shall

be cer
tified by the Texas
Department of State Health Services,
Radiation Control Program

and accredited by the
FDA

prior to patient use.

Registration of diagnostic x
-
ray equipment
shal
l be conducted
by the Radiation Safety Program
.






























Revised 7/30/06




8
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2



U
se of Diagnostic X
-
ray Equipment

in Healthcare


GENERAL INFORMATION




Radiation Safety


Surveys


Surveys
shall
be performed on diagnostic x
-
ray units within thirty (30) days of the
commencement of use. Mammography equipment
shall

be surveyed prior
to patient use.

At UTMB, radiation surveys and/or quality
shall

be performed annually

or after a major
repair of the unit or if a tube head is replaced. All radiation safety surveys
shall
be
performed
by a Licensed Medical Physicist. Radiation Safety Prog
ram
shall

review all
physicist reports for compliance.




P
urchasing
, Installing

or
Re
-
Installing X
-
ray


Equipment

Radiation Safety Program
MUST be

contacted when:




Planning to purchase and/or
install new

x
-
ray
equipment
.
The s
hielding criteria
shall

be

determined prior to the installation of new x
-
ray
equipment
.



Relocating x
-
ray
equipment
, major repairs or replacement of

the
tube head



Disposing, transferring or selling x
-
ray
equipment. Radiation Safety Program
shall
delete

the equipment
from the regist
ration list.
For equipment that is
transferred or sold, t
he name of the individual or company receiving the x
-
ray
equipment

is required for notifying
TDSHS.



Installing x
-
ray
equipment
. A copy of the FDA Form 2579 ‘REPORT OF
ASSEMBLY OF A DIAGNOSTIC X_RAY S
YSTEM” shall be provid
ed to the
Radiology Department

and
Radiation Safety Program
.





























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-
3





Use
of Diagnostic X
-
ray Equipment in Healthcare



CREDENTIALING



Introduction


All use of diagnostic x
-
ray equipment
in healthcare
shall
be made by or under the
supervision of a licensed practitioner of the healing arts.



Physician Qualifications

A
ll physicians who practice radiology at UTMB shall hold a current Texas license issued




by the Texas Board

of Medical Examiners
. They must be board eligible for certification




in the
appropriate discipline. They
shall have their credentials reviewed and approved





and shall
meet the standards for credentialing and re
-
credentialing set for
th

by t
he
ir




respective departments
.




Operator
Qualification
s

All operators
of diagnostic

x
-
ray equipment
shall meet the appropriate credentialing




requirements
issued
in accordance with the Medical Radiologic

Technologist Act, Texas




Occupation Code,

and

Chapter 601. Documentation of initial training, retraining and




current

credentials/licensure shall be provided to UTMB. Copies of the documentation




shall be

kept at

the individual’s work location.





Physicist Qualifications

The individual performing evaluation of diagnostic
x
-
ray equipment
performance shall

hold a current Texas license under the Medical Physicist Practice Act,
Occupation Code

602 in
the appropriate discipline. The physicist
shal
l
be certified by the American

Board of Radiology i
n

diagnostic radiology

to perform evaluations of
mammography


systems for MQSA

requirements
.



Student Qualifications

Students are defined as individuals enrolled in a radiologic technology program which


meets

the requirements of the Texas Department of State Health Services for Medical

Radiologic

Technologists. Students shall not
:




O
perate diagnostic x
-
ray
equipment

with out a staff technologists and/or
certified instructor present.



M
anipulate the tec
hnique factors. This is the responsibility of the staff
technologist. Students may work the controls for energizing the x
-
ray tube, set
the factors established and posted by the staff technologists and/or
R
adiology
department.
















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-
4



Use of Diagnos
tic X
-
ray Equipment in Healthcare


PERSONNEL
PROTECTIVE E
QUIPMENT



Purpose

Protective devices
shall

be used to reduce exposures and are

keeping with the principle

of



As Low as Reasonably
Achievable (
ALARA). Protective devices shall be used:





When it

is necessary for an individual other than the patient to remain in the
room or an individual to hold a patie
n
t



When it is necessary to protect a patient who cannot be removed from the room
or positioned at a six (6) feet distance from the tube head and/or

edge of the
image receptor.



When
the gonads

are in or within
five (
5
)

cm of the x
-
ray beam
UNLESS

the
use of the shield interferes with the diagnostic procedure.



When fluoroscopic procedures are being performed, protective devices such as
lead drapes, hin
ged sliding panels and lead aprons shall be in place.



L
ead Thickness

The
required thickness of the protective devices is as follows:



Gonadal shielding shall be at least 0.5 millimeters lead equivalent material
.




Protective devices shall be at least 0.25

millimeters lead equivalent material to
protect against primary scatter radiation from the interaction of the useful beam
with the patient and/or
x
-
ray
equipment.



For fluoroscopic areas without lead drapes, 0.5 mm lead equivalent
shall
be
used.


Inspect
ion
of Protective

Devices

Protective devices

such as l
ead aprons, vests, skirts, gloves, gonadal shields shall be

i
nspected annually for defects such as holes, tears or cracks. This inspection
shall
be

conducted visually and/or by x
-
raying the device.

A record of the inspection listing the

device, the results
, and the
name of
the inspector
shall

be maintained
.

Any device found

to be

defective
shall

be removed from the service or repaired.
























8
-
5


Use of
Diagnostic

X
-
ray
E
quipment

in H
ealthcare


RADIATION EXPOSURES



Staff



Reduction of radiation exposure to an individual from external sources of radiation
shall


be achieved by any one or any combination of the following measures:


1.

Increasing the distance of the individual from the
source (useful beam)


2.

Reducing the duration of exposure (time)


3.

Using protective barriers between the individual and the source (shielding)



For d
iagnostic
x
-
ray
equipment
, shielding and distance are the factors most

r
eadily

controlled.

Protective shie
lding includes that incorporated into the equipment, mobile or

temporary

devices i.e. portable screens,
or lead impregnated
aprons and gloves;

or
permanent

barriers and structural shielding i.e. walls containing lead and or concrete.



Patients


Individu
als (p
atients
)

shall not be exposed to the useful beam except for healing arts
purposes, unless such exposure has been authorized by a licensed practitioner of the
healing arts. This provision specifically prohibits deliberate exposure for the following
pu
rposes:


1.

Exposure of an individual for training, demonstration, or other non
-
healing arts
purposes.


2.

Exposure of an individual for the purpose of healing arts screening except as
authorized by the Texas Department of State Health Services,
Radiation Contro
l
Program

to UTMB from a specific requested procedure.


3.

Exposure of a research subject unless approved by the Institutional
Review
Board
.



Techniques employed in radiography and radiation therapy sh
all

be those which
achieve
the
desired objective
with a m
inimum dose to the patient. Persons performing the x
-
ray
procedures

sh
all

follow the guides listed below to reduce and/or minimize the patient
exposure:




The useful beam sh
all

be limited to the smallest clinical area as
practical,

and
consistent with the o
bjectives of the radiological examination or treatment.




The source to skin distance
(SSD) employed in medical radiological
examinations sh
all

be practical and consistent as not to exceed the entrance
exposure limits in keeping with the diagnostic objectiv
es of the study.




Protection of the embryo/fetus during radiological examination or treatment of
women known to be pregnant sh
all

be given special consideration.

NOTE: Ideally
,

abdominal radiological examination of a wom
a
n of childbearing
age sh
all

be per
formed during the first ten (10) days following a menstrual
period to minimize the possibility of irradiation of an embryo. In practice,
medical needs sh
all

be the primary factors in deciding the timing of the
examination.





8
-
6



Use of Diagnostic X
-
ray Equip
me
n
t in Healthcare


RADIATION EXPOSURES

(
cont
inued)






Suitable protective devices to shield the gonads
of patients

who are procreative
shall

be used when the examination or method of treatment may include the
gonads in the useful beam or be within 5 cent
imeters of the useful beam unless it
will interfere with the diagnostic procedures.




Fluoroscopy

sh
all

not be used as a substitute of radiography, but sh
all

be
reserved for the study of dynamics or spatial relationships or for guidance in
spot film record
ing of clinical details.




X
-
Ray film, intensifying screens, and other image recording devices sh
all

be as
sensitive as is necessary with the requirement of the examination.




Film

processing materials and techniques sh
all

be those recommended by the x
-
ray f
ilm manufacturer




Individuals Other

Than

the Patient




Except for other patients who can

not be moved out of the room (such as in critical care



areas and trauma c
e
nter) or
when
a person
is
holding, on
ly the staff and ancillary




personnel are

required for the radiologic procedure shall be in the room during radiation




exposure.

Training staff for students shall be allowed in the room as needed for training




purposes

or demonstration. All indivi
duals, other than the patient being examined, shall




be posi
t
ioned such that no part of the bo
dy will be struck by the useful

beam unless




p
rotective

devices are used having at least 0.25 millimeter lead equivalent material

.



Holding Patient or

F
ilm

When a patient or image receptor must be supported during an x
-
ray exposure
, use

a







mechanical supporting or restraining device.

Patients sh
all

be held ONLY after every






available resource has been exhausted or the mechanical devices were inadequate.





The following circumstances may require a patient to be held
:





Trauma cas
es




Small children or infants




Restrained and combative patients




Operating Room patients


Any individual holding a patient
shall

be provided appropriate protective devices and/or
garments and positioned so as not to intercept the useful beam. To assist i
n minimizing
exposure, it is important for the radiologic technologist to collimate carefully to the area
of clinical interest
.
For small children, and/or infants

the individual holding sh
all

be the
parent. Pregnant women or potentially pregnant women or i
ndividuals under 18 years old
S
HALL NOT hold patients or films, and

x
-
ray technologists SHALL NOT hold patients
or films.




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7



Use of Diagnostic X
-
ray Equipment in Healthcare


POSTING
,

N
OTICE TO EMPLOYEES & INSTRUCTIONS TO WORKERS







Areas where diagnosti
c x
-
ray equipment
is

used
shall

be posted in accordance to Texas




Administrative Codes. The following signs
shall

be conspicuously posted and replaced




if
defaced
:




“Caution
-

X
-
ray”
sign shall be posted in
on all doors to rooms with a fixed



x
-
ra
y unit.



“Notice to Employees “
B
RC Form 2
03
-
1




Regulation Card

indicating where copies of the TAC
and

pertinent documents
can be reviewed.




The rooms in which fixed x
-
ray
equipment

is

located and operated are
“Radiation Areas” and are restricted. The ra
diation area is designated by
the”
CAUTION RADIATION AREA” sign.



A
ll

x
-
ray equipment
shall

have a label that cautions individuals that radiation is
produced when it is energized.
This label shall be affixed in a clearly visible
location on the face of the
control unit.



Exceptions to Posting
s

Requirements



Pos
ting of caution
sign

in areas or rooms containing x
-
ray equipment for
periods





of less than
8 hours

is not required
, if all of the following conditions
are

met:




The x
-
ray equipment

is constantly attended during these periods by an
individual who takes precautions necessary to prevent the exposure of
individuals to radiation in excess of the limits established in TAC
.



The area or room is subject to the user’s control




Restricted A
reas

All diagnostic radiographic rooms and areas containing x
-
ray
equipment
s are considered

to be “restricted areas”.

These are areas into which access is controlled by the registrant
for purposes of protection of individual(s).from exposure to radiatio
n. The restricted area
shall

be maintained during radiographic exposures by the operator of the x
-
ray
equipment

posted in accordance with the requirement
s

listed above.





8
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8

U
se of Diagnostic X
-
ray

E
quipment in

H
ealthcare


X
-
RAY MACHINE OPERATION AND FILM
PROCESSING



General Guidelines




Ordering of X
-
ray examinations


N
o x
-
ray exams shall be taken unless ordered by a licensed practitioner
.




Operator Position

The operator
shall
be able to continuously view and communicate with the patient during th
e
exposure.

T
he operator
shall
be positioned using the concept of ALARA, i.e. at least six feet
distance, wear protective devices and avoid the useful beam




Technique Chart

The use of a technique
chart aides in reducing the exposure to the patient, and ope
rator. The
chart sh
all
be used for all exposure, except in exam cases where the patient doesn’t fit the
normal profile and adjustment

shall
be made. If automatic exposure control (AEC) is
available do not override the system.




Collimation

and Alignment

T
h
e useful beam shall be restricted to the area of clinical interest. Use the centering and
collimator

p
rovided on the x
-
ray equipment




Film Processing

Unexposed
x
-
ray film is stored in light

leak

tight bins which are shielded from exposure to
radiation (x
-
r
ays) and generally in the dark room. Loaded cassettes in the x
-
ray room
shall

be
stored in an area free of scatter

rays to prevent fogging.


Digital imaging is the preferred method
and most widely utilized form
of
image

development
at UTMB
;

however
,

for th
e areas which have not been converted they shall use the following
procedure:


Films developed by the time and temperature method
shall use the procedure
recommended
by the manufacturer. The time and temperature of the automatic processor
shall
be posted o
n
the processor. Do not process film unless the develo
per temperature is posted. Run blank
films through the processor at the beginning of the work day.


Expiration dates on film and chemicals sh
all
be checked periodically. Do
not use film or
chemicals tha
t

a
re past their expiration date. Use older film and chemicals first.


Light leak tests
shall

be performed every
twelve (12)

months and recorded.


























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9

Use of
Diagnostic

X
-
ray

E
quipment

in Healthcare



RADIATION SAFETY PRECAUTIONS FOR PE
RSONNEL OPERATING X
-
RAY
EQUIPMENT



General Precautions
:



Always we
ar

your assigned personnel dosimeter during work hours, and
store
the dosimeter at UTMB after hours in an area free of radiation.




Check to insure that you’re performing x
-
rays on the corre
ct patient, and
that you have written orders

from a licensed practitioner
.




Collimate to the area of clinical interest for the ordered procedure.




Use protective devices
when necessary.



Routine Radiographic

Procedures



Close and lock all doors to the x
-
ray room prior to exposures which cannot
be physically monitored by the technologist(s).




Technologist(s) shall position themselves behind the control booth or
portable shield prior to making exposures.




Ensure that no individual(s) other than the patient
is

in the x
-
ray room.




Utilize the technique chart to set machine parameters for ordered exams,
unless physical limitations prevent a quality examination from being
achieved
.



Flouroscopic

and Sterile

Field Special Procedures



Only necessary personnel sha
ll be in the x
-
ray room and wearing protective
devices of 0.25 mm lead equivalent material with the personnel dosimeter
to be worn outside the device at the collar.




Protective devices i.e., lead drapes shall be in place on the fluoroscopic
tower unless it
’s a sterile field procedure and protective barriers or drapes
cannot be utilized.




Ensure the fluoroscopic run down timer is zeroed.




Start the fluoroscopic procedure with shutters closed, opening only to the
area of clinical interest.






.













8
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10


Use of Diagnost
ic X
-
ray Equipment in Healthcare


RADIATION
SAF
E
TY PRECAUTI
O
NS FOR PERSONNEL OPERATING X
-
RAY
EQUIPMENT

(
cont
inued)



Mobile X
-
ray

Procedures



Always wear a protective device of 0.25 mm lead equivalent material and
provide devices to i
ndividuals unable to be removed from the area




Remove other patients and personnel from the area to the greatest practical
extent. A distance of six (6) feet from the tube and/or edge of the image
receptor is required.




Prior to making exposures, verbally
warn all individuals in the general
vicinity of x
-
ray exposure.



Dental X
-
Ray

Procedures



Operators shall stand at least six (6
)

feet from the tub
e head and
perpendicular to the
useful beam during exposures.




The operator
shall
position the film holder
;

however
,

do not hold the film
holder during exposures.




Provide the patient with a protective device.




Check to insure no individuals are within six (6) feet prior to making
exposures.



Bone Densitometry

Requirements



Bone densitometers
shall
only be ope
rated by credentialed personnel listed
on the hardship exemption received from the Texas Department of State
Health Services.


o

Hardship exemptions
shall

be renewed annually

o

Operators
shall

have documented training on the specific bone
densitometer in posse
s
s
ion




The operators shall use t
he
manufacturer’s

recommendations

and
procedures for d
e
nsitometer

operation.




Personnel monitoring is not required and operators shall maintain a
minimum six (6) feet from the densitometer during operation, ALARA
shall

alway
s be practiced.




Interlocks shall not be defected and quality assurance calibrations
shall be

conducted
by

the
manufacturer’s

recommendations.