Transcript Digital Imaging, Inspections, and Continuing

Inspections, Digital Imaging, and Continuing
Education, oh, my!
What to expect when you are inspected
Julie Miller
Senior Health Physicist
CDPH-RHB
Mission Statement
• The mission of the Radiologic Health Branch is
to protect public health and safety throughout
California by:
– Ensuring the safe use of radiologic equipment and
materials within industry, medicine, and research
– Preventing radiological health hazards
– Educating and enforcing applicable state and
federal radiation laws and regulations
What we do
• Ensure compliance with the Radiation Control
Law and applicable federal regulations.
• Inspection and investigation of over 32,000
facilities with over 85,000 X-ray machines.
Perspective –
• About 10% of the X-ray tubes in the United States
are located in California
Inspections
• Inspection Scheduling
 Frequency
 Announced versus Unannounced
“…all reasonable times…”
 Staff Availability
 Duration
• Inspector Questions
 General
 State Mandated
 Certification
 Postings
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How much is too much?
 California law and regulations do not limit how much
radiation a patient can receive – medical necessity.
 Patient radiation from medical X-rays is still radiation exposure which
carries some risk.
 Dental x-rays ARE limited by §30311.1, and they have to cover the
patient with a full apron for every x-ray.
 Society (public awareness) and physicians determine what is
considered acceptable radiation exposure.
 Patients and their families are starting to ask how much radiation
exposure they received.
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“You Can’t Come In Here”
• California Code of Federal Regulations, title
17, Section 30254 (a) states that each user
shall afford to the Department or other official
agency specifically designated by the
Department, at all reasonable times,
opportunity to inspect materials, machines,
activities, facilities, premises, and records
pursuant to these regulations.
Notice to Employees
• You see this every day but have you really read it? The
Notice to Employees outlines what employees
(radiation and non-radiation worker) can expect from
their employers in the way of accidental exposure
reporting, monitoring, and emergency procedures to
name a few. It also informs employers that they have
to comply with requirements of the radiation control
regulations, post any notice of violation of radiologic
working conditions, and provide any employee with
information on their exposure among, other things. It
tells the employee where to report any health or safety
concern and what they can expect following such a
report.
Caution-X-Ray
• Title 17 of the California Code of Regulations
states areas or rooms that contain permanently
installed X-ray machines as the only source of
radiation shall be posted with a sign or signs
“Caution X-ray” in lieu of other signs required by
the Title 10 of the Code of Federal Regulations,
part 20, section 20.1902. 10 CFR 20 states that
each radiation area be posted with a conspicuous
sign bearing the radiation symbol and the words,
“Caution, Radiation area”,” Caution, High
Radiation area”.
Caution X-Ray (continued)
• If an X-ray machine is the only source of
radiation in a room, a CAUTION X-RAY sign
must be posted and no CAUTION RADIATION
AREA sign is allowed.
• If radioactive material is present in a room
housing an X-ray machine, signs required per
10 CFR 20.1902, CAUTION RADIATION AREA,
for example, must be posted, and CAUTION XRAY signs are not required.
“The Doctor Made Me Do It”
INSPECTION FINDING(S)/VIOLATION(S):
California Health and Safety Code, section 106965(a) mandates that it shall be unlawful
for any person to administer or use diagnostic or therapeutic X-ray on human beings in
this state unless such person has been certified or granted a permit and is acting within
the scope of such certification or permit, and is acting under the supervision of a
licentiate of the healing arts.
Contrary to the above, one individual was performing X-ray procedures outside the scope
of their permit/with an expired certificate/with no certificate.
California Health and Safety Code, section 106970 mandates that it shall be unlawful for
any person to direct, order, assist, or abet a violation of section 106965.
Contrary to the above, the supervising licentiate was directing, ordering, assisting, or
abetting a violation of section 106965.
“But The Doctor Pushes the Button”
30400.85. Radiography.
“Radiography” means the recording of static images on any suitable medium
by passing X-rays through portions of the human body, and includes one or
more of the following:
(a) Positioning the patient.
(b) Selecting exposure factors.
(c) Exposing the patient and the recording medium to X-rays.
Gonadal Shielding
• 30308 (b)(4)
Gonadal shielding of not less than .5 mm lead
equivalent shall be used for patients who have not
passed the reproductive age during radiographic
procedures in which the gonads are in the direct
beam, except for cases in which this would interfere
with the diagnostic procedure.
Proper placement is important to avoid increasing
dose based on AEC or ABC.
Collimation
• 30308 (b)(3)
The radiographic field shall be restricted to the
area of clinical interest.
Observing the Patient
California Building Code, Title 24,
Part 2, section 103C.2 states:
• Provision shall be made for the operator to
observe and communicate with the patient
without leaving the shielded position at the
control panel. When an observation window is
used, it must provide radiation attenuation equal
to that required in the surrounding barrier.”
Mobile X-Ray
• 30309(b)(3) Personnel monitoring shall be
required for all individuals operating mobile x-ray
equipment.
• 30307(b)(1) Protective aprons of at least 0.25 mm
lead equivalent shall be worn in the fluoroscopy
room when exposures are likely to be 5mR/hr or
more.
• 30447(a)(2) Limited permits issued pursuant to
section 30444 exclude authorization to operate
portable or mobile x-ray equipment.
Fluoroscopy
• 30307(b)(3) Measurement of the patient
exposure rate shall be made at least once
each year, and immediately following
alteration or replacement of a major
component. (i.e., power supply or tube)
• This is part of what the medical physicist does
for the annual audit of the department.
Fluoro (continued)
• 30307(b)(2) states that the operator shall
monitor the tube current and potential at least
once each week to ascertain that they are in their
usual ranges for a given set of operating
parameters (Baseline).
• Whenever the monitored tube current or
potential vary in a way which could increase the
patient exposure rate by more than 25% over the
last exposure rate measurement required by
30307(b)(3) (Baseline Measurement!), the cause
for the change shall be determined promptly.
Fluoro monitoring equation
𝑚𝐴𝑚𝑒𝑎𝑠𝑢𝑟𝑒𝑑 𝑘𝑉𝑚𝑒𝑎𝑠𝑢𝑟𝑒𝑑
𝑚𝐴𝑏𝑎𝑠𝑒𝑙𝑖𝑛𝑒
𝑘𝑉𝑏𝑎𝑠𝑒𝑙𝑖𝑛𝑒
X MUST be less than 1.25
2
=𝑋
Fluoro (still continued)
• Whenever the monitored tube current (mA)
or potential (kV) vary in a way which could
increase the patient exposure rate by more
than 25% over the last exposure rate
measurement required by 30307(b)(3), the
cause for the change shall be determined
promptly.
• This is a good time to speak with your medical
physicist to determine if a repair is needed.
Reportable Events
• California Code of Regulations, title 17, section 30253
(a) incorporates certain sections of title 10, Code of
Federal Regulations, part 20 by reference. More
specifically, 10 CFR 20.1101 (a) requires each licensee
to develop, document, and implement a radiation
protection program commensurate with the scope
and extent of licensed activities and sufficient to
ensure compliance with the provisions of this part.
• The radiation protection program must include a CT
reportable event policy to be commensurate with the
scope of practice at the facility when a CT unit is
present.
Venipuncture
• Senate Bill 1199 went into effect January 1,
2013.
• H&S 106985: In part, a radiologic technologist
may, under the direct supervision of a licensed
physician and surgeon, perform venipuncture
in an upper extremity to administer contrast
material.
Venipuncture (continued)
• Only after completion of a minimum of 10
venipunctures may the supervising individual
evaluate whether the technologist is
competent to perform venipuncture under
direct supervision. The supervising individual
must be a licensed physician and surgeon, a
registered nurse, or a person the physician or
nurse has previously deemed qualified to
provide personal supervision.
Technique Chart
• Title 17, section 30305.1 (a)(3) states, “For each
X-ray machine, a technique chart is provided
which establishes for each view commonly
performed the following:
•
Patient size versus selectable exposure factors
•
Source-to-image distance
•
Grid data
•
Film/Screen combinations (if applicable)
•
And
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Patient shielding (if appropriate)
Certification
• Or, I went to school for three years (or more)
and all I got was this lousy piece of paper…
RT Act
• California Health & Safety Code, Section 106965
states that it shall be unlawful for any person to
administer or use diagnostic or therapeutic x-ray on
human beings in this state after July 1, 1971, unless
that person has been certified or granted a permit
pursuant to subdivision (b) or (c) of Section 114870
or pursuant to Section 114885, is acting within the
scope of that certificate or permit, and is acting
under supervision of a licentiate of the healing arts.
But…
• Section 106975 states that Section 106965
shall not apply to students in an approved
school for radiologic technologists (or limited
permit x-ray technicians) when the students
are operating x-ray machines under the
supervision of an instructor who is a certified
radiologic technologist or a certified
supervisor or operator.
Radiography Permits
• CCR, title 17, § 30464 A radiography supervisor
and operator permit issued by the
Department shall be required of any licentiate
of the healing arts who does one or more of
the following:
• Energizes radiography x-ray equipment.
• Supervises one or more persons who hold radiologic
technologist certificates pursuant to Section 30440.
• Supervises one or more persons who hold limited
permits pursuant to Section 30444.
What Do All Those Letters Mean?
The Supervisor/Operator Certificate or Permit
• RHL – Radiology (both radiography and
fluoroscopy) A Radiologist
• RHC – Radiography ONLY or Fluoroscopy ONLY
• RHD – Radiography AND Fluoroscopy
RHB Permits and Certificates on the Web
Check your expiration date before we do…
http://www.apps.cdph.ca.gov/rhbxray/
First Time Violation
Violations
• Yes, there is a Permanent Record of you in
Sacramento.
• Yes, that Record is reviewed if you misbehave.
• Yes, we do remember you…and the story you
told us last time.
• And, yes, we do expect you to “just say no”
when asked to do something outside of your
certification.
High Risk Violations
• More serious violations or multiple repeat
violations can lead to revocation, denial of
renewal, and/or penalties.
• Penalties are based on when the activity
started and how many x-rays were taken
outside of the Regulations.
• Complaints may be forwarded to DOJ with
penalties of over $100,000.
Violations and You
• You will need to write a letter explaining what happened and how
you will prevent it from happening again.
• You may be required to take an on-line ethics course (which you will
be required to pay for).
• You will have your certificate placed on hold until the matter is
resolved. This may cause delinquent penalties to be imposed.
• You will have your CE’s reviewed.
• You may be subject to other fines and penalties.
• Your employer may fire you.
Digital Imaging and You
• Digital Imaging acquisition allows for a wide
dynamic range in radiation exposure while still
being able to construct a diagnostic image.
• This brings in the dangers of dose creep and
possible chronic overexposure of patients
because the accountability of film is not
present.
Digital Imaging and you
• Each digital imaging acquisition manufacturer
sets a numerical value to indicate the amount
of radiation exposure absorbed by the digital
detector.
• These numerical values may be referred to by
different names depending on manufacturer
– Ex:
• Carestream / Kodak — “EI” (exposure index) number
• Fuji— “S” (sensitivity number)
Digital Imaging and You
• Manufactures determine an acceptable range for
optimum exposure. This range indicates if the Xray exposure that reached the plate was deemed
appropriate for optimum imaging for the exam.
• If a digital imaging acquisition system is present
at a facility, auditing of the numerical values
facility wide can help determine trends of dose
creep over time.
• There is generally no dose savings with digital.
Digital Imaging and You
• As a technologist you should be aware of:
– The optimum range for the exam being performed
with the imaging acquisition system in use.
– Whether the relationship of the exposure index to Xray exposure levels is inversely proportional or
directly proportional relationship. (this is dependent
on manufacturer)
• EX: if the image exposure index number is too high out of
range, was the X-ray over or under exposed
– Dependent on manufacturer
» kodak/carestream—direct relationship
» Fuji—inverse relationship
How are the values determined?
• Once signal is digitized,
each area in the image
has a digital numerical
value corresponding to
the x-ray striking that
area on the receptor.
• These values are
assigned a brightness
to create the image we
see
Image acquisition
• Some errors that commonly cause numerical
exposure values to be out of range:
– Over or under exposure of radiation
– Poor patient positioning (poor centering of part)
– Inadequate collimation (areas radiated containing
no anatomy or with great variation in tissue
thickness)
– Too many images obtained on same plate at same
time:
Digital Imaging and You
• CRT’s are not required to get digital
authorization (XT’s ARE required)
• Be aware of dose creep
• Photoshop is for selfies, not x-rays
• ID markers still work with digital
• You are the Gate Keeper for that patient’s
dose
Continuing Education 2016
• Starting July 1, 2016, there are some new
requirements.
CEU requirements
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This section discusses CE requirements for diagnostic and therapeutic, CRTs. Mammographic CRTs have
ADDITIONAL requirements which are discussed separately below.
CRTs need to earn twenty-four (24) approved CE credits, four (4) of which shall be in digital radiography, in the two
years immediately preceding the expiration date of their permit.
The Department will accept the following advanced credential certificates issued by ARRT for 24 CE credits if the
certificate was issued within the two years immediately preceding the expiration date of the certificate or permit:
• Mammography**
• Computerized Tomography
• Quality Management
• Bone Densitometry
• Vascular-interventional Radiography
• Cardiac-interventional Radiography
• Radiologist Assistant
• Radiation Therapy
Note: Issuance of a certificate through the State of California where a state examination was taken does not
qualify for CE credits. However, training courses taken in preparation for these exams may be approved by one of
the credentialing organizations listed above and therefore would qualify.
Activities meeting the definition of an ‘approved academic course’ as defined by the ARRT may be awarded CE
credit at the rate of 12 CE credits for each academic quarter credit or 16 CE credits for each academic semester
credit. The ‘approved academic course’ must also pertain to the application of X-ray to the human body to qualify
as a CE credit for California. For more information on acceptable classes, please visit the ARRT website at
www.arrt.org.
The ASRT is a recognized credentialing body for continuing education activities and those activities pertaining to
the application of X-ray of the human body will be acceptable to the Department.
Fluoro CE’s
• . Radiologic Technology Fluoroscopy (RTF)
Permit ADDITIONAL Requirements
• CRTs with a RTF permit are required to earn 24
approved continuing education credits; four of
which are required to be in radiation safety for
the clinical uses of fluoroscopy. [17 CCR
30403(a)(2)].
• PA with a RTF permit: For purposes of renewing
your RTF permit, you will need to earn 24
approved continuing education credits; four of
which are required to be in radiation safety for
the clinical uses of fluoroscopy.
Mammo CE’s
• . Mammographic Certified Radiologic Technologists
(CRT) – ADDITIONAL Requirements
Each person who has been issued a Mammographic
CRT certificate must, in the two years immediately
preceding the expiration date of the certificate, must
earn 10 of the 24 Approved CE credits in
mammography. [17 CCR 30403(a)(1)]
• **The advanced credential certificate for
mammography will meet the 10 CE credits specific to
mammography requirement. The other advanced
credentials will not meet this requirement, so
additional CE credits will need to be earned specific to
mammography.
XT’s and CE’s
• Limited Permit X-Ray Technicians (XTs) must earn twenty-four (24)
approved CE credits, in the two years immediately preceding the
expiration date of their permit.
• Limited Permit X-Ray Technicians (XTs) with digital authorization must earn
four (4) of the twenty-four (24) CE credits in digital radiography. [17 CCR
30403(a)]
• The Department will grant twenty-four (24) CE credits to XTs who have
enrolled in an approved Radiologic Technology program and who have
documented the completion of a minimum of six months coursework.
• Documentation must include a letter from an authorized representative of
the approved Radiologic Technology program. Additional documentation
may also be required, such as official school transcripts. Be sure to include
this information on your renewal application.
• Completion of instruction in digital radiologic technology (to obtain digital
authorization) in accordance with [17 CCR 30410(c)] is considered to be
approved for 20 CE credits for purposes of renewing your permit. It is
your responsibility to include these credits on your renewal application.
Why were changes made to the CE credit requirement?
• The changes and amendment were brought
about as the result of recommendations of
the Radiologic Technology Certification
Committee and fulfills the Department’s
mandate from the Legislature as stated in H&S
Code 114870(b)(2) and (c)(3).
• The RTCC is the advisory body for RHB.
H&S Code 114870(b)(2)
• Provide, upon recommendation of the
committee, that a radiologic technologist who
operates digital radiography equipment
devote a portion of his or her continuing
education credit hours to continuing
education in digital radiologic technology.
H&S Code 114870 (c)(3)
• Provide, upon recommendation of the
committee, that a limited permit X-Ray
technician who has completed the initial
instruction described in paragraph (2) devote
a portion of his or her required continuing
education credit hours to additional
continuing instruction in digital radiologic
technology.
Definition of “Portion”
• CRT’s and XT’s with Digital Authorization shall
have four (4) of the required twenty-four (24)
credits in digital radiography.
And lastly…
With digital radiography, you are exempt from CCR,
title 17, section 30308.1:
• No daily checks of the base plus fog
• No daily checks of the mid density
• No daily checks of the density difference
• No densitometers or sensitometers
• No crossover calculations
• No fixer retention tests
• No darkroom!
Where Can I Go with Questions?
• [email protected]
• [email protected]
• www.cdph.ca.gov/rhb
Any other questions?
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916-327-5106 (RHB Main)
213-351-7897 (LA County)
858-694-3621 (San Diego County)
714-524-4450 (Granada Hills)
714-524-5681 (Brea)
714-524-1409 (RAM Brea office)
510-620-3416 (Richmond)
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