BILL ANALYSIS                                                                                                                                                                                                    



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          Date of Hearing:  April 28, 2015


                   ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS


                                Susan Bonilla, Chair


          AB 1092  
          (Mullin) - As Amended April 20, 2015


          SUBJECT:  Magnetic resonance imaging technologists.


          SUMMARY:  Establishes a registration program for Magnetic  
          Resonance Imaging (MRI) technologists under the California  
          Department of Public Health (CDPH).


          EXISTING STATE LAW:


          1)Establishes standards of education, training, and experience  
            for persons who use X-rays on human beings and prescribes  
            means for assuring that these standards are met.  (Health and  
            Safety Code (HSC)  114840-114896)
          2)Defines a radiologic technologist (RT) as a person, other than  
            a licentiate of the healing arts, applying X-rays to human  
            beings for diagnostic or therapeutic purposes. (HSC  114850)


          3)Makes it unlawful to perform radiological imaging procedures  
            on humans without a license, certification, and supervision.   
            (HCS  116955-107111)


          4)Requires general acute care hospitals, acute psychiatric  








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            hospitals, and dentistry and maternity hospitals to report  
            "adverse events" to the CDPH no later than five days after the  
            adverse event has been detected, or, if that event is an  
            ongoing urgent or emergent threat to the welfare, health, or  
            safety of patients, personnel, or visitors, not later than 24  
            hours after the adverse event has been detected. (HSC   
            1279.1)


          5)Defines an "adverse event" as, among other things, 1) patient  
            death or serious disability associated with the use or  
            function of a device in patient care in which the device is  
            used or functions other than as intended, and 2) an event or  
            series of events that cause the death or serious disability of  
            a patient, personnel, or visitor. (HSC  1279.1)


          6)Defines "serious disability" as a physical or mental  
            impairment that substantially limits one or more of the major  
            life activities of an individual, or the loss of bodily  
            function, if the impairment or loss lasts more than seven days  
            or is still present at the time of discharge from an inpatient  
            health care facility, or the loss of a body part. (HSC   
            1279.1(d))


          7)Requires the CDPH to provide information regarding reports of  
            substantiated adverse events and the outcomes of inspections  
            and investigations conducted on its website and in written  
            form, including each substantiated adverse event, including  
            compliance information history. (HSC  1279.3)


          EXISTING FEDERAL LAW:


          8)Establishes mandatory requirements for manufacturers,  
            importers, and device user facilities to report certain  
            device-related adverse events and product problems to the  








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            federal Food and Drug Administration (FDA): (Title 21 Code of  
            Federal Regulations (CFR)  803)


             a)   Requires manufacturers to report to the FDA when they  
               learn that any of their devices may have caused or  
               contributed to a death or serious injury.  Manufacturers  
               must also report to the FDA when they become aware that  
               their device has malfunctioned and would be likely to cause  
               or contribute to a death or serious injury if the  
               malfunction were to recur.  (21 CFR  803.50-803.58)
             b)   Requires importers to report to the FDA and the  
               manufacturer when they learn that one of their devices may  
               have caused or contributed to a death or serious injury.   
               The importer must report only to the manufacturer if their  
               imported devices have malfunctioned and would be likely to  
               cause or contribute to a death or serious injury if the  
               malfunction were to recur.  (21 CFR  803.40-803.42)


             c)   Requires user facilities to report a suspected medical  
               device-related death to both the FDA and the manufacturer.   
               User facilities must report a medical device-related  
               serious injury to the manufacturer, or to the FDA if the  
               medical device manufacturer is unknown. Defines a "device  
               user facility" as a hospital, ambulatory surgical facility,  
               nursing home, outpatient diagnostic facility, or outpatient  
               treatment facility, which is not a physician's office.   
               User facilities must also submit annual reports to the FDA  
               by January 1.  (21 CFR  803.30-803.33)


          THIS BILL: 


          9)Defines an "MRI technologist" as a person who operates MRI  
            equipment to produce cross-sectional images of a patient's  
            body for diagnostic purposes.
          10)Requires MRI technologists to register with the CDPH.








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          11)Requires the CDPH to maintain an official roster of  
            registered MRI technologists, and record:


             a)   The location, employer, and supervisor of each MRI  
               technologist;
             b)   A description of the practice of each MRI technologist,  
               including the services provided; and,


             c)   Any certification possessed by the MRI technologist, if  
               applicable.


          12)Authorizes the CDPH to impose a fee for the registration of  
            an MRI technologist in an amount that is no greater than the  
            amount reasonably sufficient to cover the administrative costs  
            of the registration program.
          13)Requires a registered MRI technologist to report to the CDPH  
            any accident, within 30 days of its occurrence, resulting in  
            injury or death to a patient, damage to the property of a  
            patient, or damage to the MRI equipment.


          14)Authorizes the CDPH to issue a citation to a person, if  
            acting in the capacity of, or engaging in the practice of, an  
            MRI technologist, not registered with the department. 


          15)Requires the citation to contain an order of abatement and a  
            minimum civil penalty of two hundred dollars ($200) up to a  
            maximum of one thousand dollars ($1,000).


          16)States that MRI technologist are not authorized to practice  
            medicine, surgery, or any other form of healing.









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          FISCAL EFFECT:  Unknown. This bill is keyed fiscal by the  
          Legislative Counsel.


          COMMENTS:


          17)Purpose.  This bill is author sponsored.  According to the  
            author, "Currently, California law is silent on MRI  
            technologists. AB 1092 will provide for a registry of all  
            persons in the state of California operating MRI.  This bill  
            will allow the Department of Public Health to collect more  
            data on specifically who is performing MRI; this language  
            would also require reporting of accidents within 30 days of  
            occurrence. Registration of MRI technologists is the least  
            burdensome option for providers, and will permit collection of  
            information relevant to the regulatory strategy. This bill is  
            a good step towards better MRI safety and practices."
          18)Background.  According to the FDA, MRI is a medical imaging  
            procedure that uses strong magnetic fields and radio waves to  
            produce cross-sectional images of organs and internal  
            structures in the body.  MRI devices run an electric current  
            through coiled wires to create a temporary magnetic field  
            around a patient's body. Radio waves are sent from and  
            received by a transmitter/receiver in the machine, and the  
            signals are used to produce digital images of the area of  
            interest.


          The individuals that operate the medical imaging devices include  
            technologists and technicians.  Technologists and technicians  
            that operate MRI scanners may, among other things: 1) provide  
            instructions for patients, 2) assist patients on and off the  
            scanning table, 3) monitor vital signs, 4) keep the MRI suite  
            clear of ferrous magnetic objects, and 5) adjust the scanner  
            to fix image quality issues.  While technologists often  
            interact with patients when operating the equipment, they do  
            not interpret the images produced and must be supervised by a  








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            qualified healing arts licensee (HCS  106960).


          State Regulation of Medical Imaging.  In California, MRI  
            technologists are industry regulated-there are no licensing or  
            certification requirements for technologists or technicians  
            that operate MRI scanners.  While an employer may hire any  
            individual to serve as an MRI technologist, the employer is  
            unlikely to hire or keep the technologist if the technologist  
            is poorly trained, consistently produces poor quality images,  
            or negligently operates the machine.  


          Even if there are no mandatory educational requirements for MRI  
            technologists, there are several voluntary MRI certifications  
            available, such as the American Registry of Radiologic  
            Technologists (AART) MRI certification and the American  
            Registry of Magnetic Resonance Imaging Technologists (ARMRIT)  
            certification.  Job searches for MRI Technologist using  
            websites such as Glassdoor and Indeed show that many employers  
            in California require or prefer candidates with MRI AART or  
            ARMRIT certifications.  There also voluntary MRI safety  
            guidelines published by the American College of Radiology  
            (ACR), which the FDA recommends (discussed below). 


          Under current law, the only medical imaging devices that require  
            a license to operate are those that use ionizing radiation,  
            such as devices used for computed tomography (CT),  
            fluoroscopy, and radiography (X-ray).  Ionizing radiation is  
            regulated is because it can be dangerous, even when used  
            correctly.  According to the FDA, ionizing radiation is  
            high-energy radiation that can potentially cause damage to  
            DNA, elevating a person's lifetime risk of developing cancer.   
            Further, poorly produced images and retests unnecessarily  
            increase this risk.


          In California, certified radiologic technologists (CRT) that  








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            work with ionizing radiation are licensed by the Radiological  
            Health Branch (RHB) under the CDPH.  CRTs must meet  
            educational, training, and experience requirements designed to  
            prevent "excessive and improper exposure to ionizing  
            radiation" (HSC  114840).  They must also be AART certified,  
            although not in MRI specifically. 


          Further, while not specific to MRI or imaging, there are  
            mandatory reporting requirements under state law-certain  
            medical facilities are required to report adverse events.   
            Adverse events include any event, or series of events,  
            including those involving MRI, that cause the death or serious  
            disability of a patient, personnel, or visitor.  However, this  
            is limited to general acute care hospitals, acute psychiatric  
            hospitals, and dentistry and maternity hospitals.  Other  
            facilities, including facilities that only perform imaging,  
            are excluded.


          The CDPH posts the adverse event information on its website:  
            https://hfcis.cdph.ca.gov/.  


          Hazards Associated with MRI.  Unlike ionizing radiation, MRI is  
            not inherently dangerous.  According to the FDA, there are no  
            known harmful side-effects associated with temporary exposure  
            to the strong magnetic field used by MRI scanners.  However,  
            the FDA does note the following safety concerns involved with  
            the MRI environment:


             a)   The magnet can cause pacemakers, artificial limbs, and  
               other implanted medical devices containing ferrous metal to  
               malfunction or heat up;
             b)   Loose, ferrous metal objects may cause damage or injury  
               if pulled toward the magnet; and,










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             c)   Dyes from tattoos or tattooed eyeliner can cause skin or  
               eye irritation;


             d)   Medication patches with ferrous metal can cause a skin  
               burn;


             e)   The wire leads used to monitor an electrocardiogram  
               (ECG) trace or respiration during a scan must be placed  
               carefully to avoid causing a skin burn;


             f)   Prolonged exposure to radio waves during the scan could  
               lead to slight warming of the body; and, 


             g)   If a contrast agent is used, there is a slight risk of  
               an allergic reaction. MRI contrast agents can cause  
               problems in patients with significant kidney disease. In  
               California, contrast agents require a license to inject,  
               MRI technologists cannot perform this procedure (HSC   
               106985);
          FDA Workshop on MRI Safety.  In 2011, the FDA held a public  
            workshop to obtain information regarding the safety of MRI use  
            (76 Federal Register (FR) 58281).  It also held a two-month  
            public comment period, however it only received 20 comments.   
            In the public workshop notice, the FDA indicated:


          The number of MRI procedures performed each year continues to  
            rise. At the same time, MRI technology, implanted medical  
            devices and medical device accessories (non-implanted) are  
            becoming more complex.  There is increasing demand to scan  
            patients with implanted or accessory medical devices, and the  
            presence of these devices are becoming commonplace in the MRI  
            suite during imaging procedures.  While MRI procedures are  
            relatively safe, there are hazards inherent to the MRI  
            environment that must be considered to ensure the safety of  








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            patients, healthcare providers, and others who enter the MRI  
            suite.  The Agency recognizes the need to work with  
            stakeholders to identify hazard reduction strategies that  
            minimize risk in the MRI environment.


          During the stakeholder meeting, the speakers and attendees  
            discussed general MRI safety, ferromagnetic detectors,  
            scanning patients with medical implants, and the impact of  
            innovation on MRI safety concerns.  The FDA also discussed its  
            own MRI data-including the fact that its reporting database,  
            the Manufacturer and User Facility Device Experience (MAUDE),  
            was not meant to evaluate trends.  It also noted that  
            "preventing harm is likely possible if the users are aware of  
            the known hazards and follow existing [ACR] recommendations  
            pertaining to MRI safety."


          Federal Reporting Requirements.  Federal law requires  
            manufacturers, importers, and healthcare facilities to report  
            device related adverse events to MAUDE, including adverse  
            events related to MRI scanners.  Manufacturers and importers  
            must report when they learn that a device sold may have caused  
            or contributed to death or serious injury.  Facilities using  
            the device must report any suspected device related death, but  
            not device malfunction.


          Although a user facility is not required to report a device  
            malfunction, they can voluntarily inform the FDA of such  
            product problems through MedWatch, the FDA's Safety  
            Information and Adverse Event Reporting Program.  MedWatch is  
            used to report adverse events relating to medical products,  
            including serious drug side effects, product use errors,  
            product quality problems, and therapeutic failures for, among  
            other things, medical devices. 


          Other Regulation of MRI.  MRI technologists require licenses in  








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            two other states, Oregon and West Virginia.  At the federal  
            level, health plans may only receive Medicare reimbursement  
            for medical imaging, including MRI, if the facilities are  
            accredited by the ACR, Intersocietal Accreditation Commission,  
            RadSite, or the The Joint Commission.  The four accreditation  
            bodies each require MRI technologists to either be certified  
            or be licensed to practice MRI, but the certification does not  
            necessarily have to be MRI specific (ACR, for instance,  
            requires a general ARRT certification).  


          ARGUMENTS IN SUPPORT: 


          The  American Registry of Magnetic Resonance Imaging  
          Technologists  writes in support, "MRI is an exceptionally safe  
          imaging modality, with no inherent adverse biological affects  
          when performed correctly and safely. MRI is the preferred  
          modality, especially for pediatric patients, due to the need to  
          avoid CT Scans and X-Ray (ionizing radiation). CT Scans and  
          X-Ray have been directly related to cancer. As stated by  
          Speakers at our 2014 Annual Meeting in San Diego, CA, the  
          current and future applications of MRI are infinitesimal.


          MRI is however not without unique safety issues. Ferrous objects  
          can fly into the magnet bore causing severe injury or death,  
          radio-frequency burns could occur on the patient's skin,  
          high-decibel acoustic noise can damage hearing, and  
          gadolinium-based IV-contrast agents, while much safer than  
          iodine based contrast agents, can be harmful in patients with  
          compromised kidney function.


          MRI accidents reported to the FDA, it is estimated, amount to  
          only 30-40 percent of the total number that have occurred The  
          MRI Technologist must be trained in preventing, and responding  
          to, all possible MRI hazards. The most horrific injuries that  
          have occurred were due to ferrous oxygen tanks and other ferrous  








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          items allowed near the MRI machine which were drawn into the  
          magnet bore with incredible levels of force. There have been a  
          number of MRI related fatalities, which occurred when a  
          technologist failed to protect his/her patients. Lack of proper  
          MRI safety training is the cause."


          ARGUMENTS IN OPPOSITION:


          None on file.


          AMENDMENTS:


          At this time, there is no clear data suggesting the industry is  
          unable to properly regulate MRI technologists.  Further, there  
          are licensed CRTs that currently perform MRI that are already  
          required to pay a fee.  Therefore, the author should make the  
          amendments below to narrow the scope of the registration  
          requirement.


          Exempt RTs to prevent double registration:


          19)On page 3, between lines 12 and 13, insert:


           (b) A radiological technologist certified under subdivision (b)  
            or (c) of Section 114870 of the Health and Safety Code may  
            provide the information described in subdivision (a) of this  
            section:


          (1) In the technologist's initial Radiologic Technology  
            Certificate Application;









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          (2) In the technologist's Renewal Application forms; or


          (3) Using a method established by the department under this  
            section. 


           20)On page 3, line 13, strike:  (b)  and before "The" insert:


           (c) 


           21)On page 3, between lines 16 and 17, insert:


           (b) A radiological technologist certified under subdivision (b)  
            or (c) of Section 114870 of the Health and Safety Code is not  
            required to pay a registration fee under this chapter.


           Switch the reporting from the individual to the facility:


          22)On page 3, line 17, strike:  A  and before "registered" insert:


           Each employer of a 


           Narrow the reportable accidents:


          23)On page 2, after line 12, insert:


           (d) "Serious disability" means a physical or mental impairment  
            as defined Section 1279.1(d) of the Health and Safety Code.  








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            "Serious disability" may result from following MRI-specific  
            issues the following MRI-specific issues:


          (1) Thermal-related issues.


          (2) Medical device incompatibility. 


          (3) Faulty or lack of hearing protection.


          (4) The presence of ferrous objects. 


          (5) Contrast media issues.


           24)On page 3, line 18, strike:  any accident  , and after  
            "department" insert:


           an accident resulting from the use or malfunction of MRI  
            equipment, 


           25)On page 3, line 19, strike:  injury  and after "in" insert:


           serious disability


           REGISTERED SUPPORT:  


          American Registry of Magnetic Resonance Imaging Technologists










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          REGISTERED OPPOSITION:  
          None on file. 




          Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301