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 1
Inspections Inspection Scheduling Frequency Announced versus Unannounced all reasonable times Staff Availability Duration Inspector Questions General State Mandated Certification Postings 4 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. 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. 5 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. 2
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. 3
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 X RAY 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. 4
30308 (b)(4) Gonadal Shielding 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. 5
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. 6
Fluoro monitoring equation X MUST be less than 1.25 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. 7
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 Patient shielding (if appropriate) 8
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. 9
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/ 10
First Time Violation 11
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. 12
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 X ray 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. 13
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 X ray 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: 14
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 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. 15
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. 16
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. 17
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? robert.l.mcdermott@kp.org jessica.clements@kp.org www.cdph.ca.gov/rhb 18
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