Mandatory Licensure for Radiologic Personnel Christopher Jason Tien
Licensure Permission to perform a given occupation 3 rd party examinations State hands out licenses Occupations licensed: teachers, architects, real estate agents, and building contractors Also: Optometrists, dietitians, physical therapists, chiropractors, pharmacists, nurses
Licensure as an issue I really don t know why this hasn t been enacted. There are absolutely no disadvantages to licensure or certification. Josephine Piccone, PhD, Medical Physicist, Nuclear Regulatory Commission
Brief Outline About Radiation Radiation Exposure History Issue Quality Safety Economics Conclusion & Recommendations
A little about Radiation Radiologic Personnel perform: 1. Diagnostic Imaging procedures like Ultrasound, X-Ray, CT, MRI 2. Therapeutic procedures like Chemotherapy 3. Nuclear Medicine like Brachytherapy Other Radiologic Personnel licensed already
A little about Radiation Seven out of 10 Americans undergo some type of radiologic procedure annually X-rays 108 million x-rays / year as of 1964 130 million x-rays / year as of 1970. 350 million x-rays / year as of 1996
A little about Radiation 16 million men, women, and children per year need nuclear medicine procedures Nuclear medicine expose patients to about the same amount of radiation as they receive in a few months of normal living Source or Limit Approximate daily background dose from natural sources Approximate monthly background dose from natural sources Typical dose from a medical or dental x-ray Typical dose from medical X-rays and treatments mrem 0.3 9 10-20 70
Radiation Exposure Power plants provide <1% public exposure 90% attributable to medical procedures One patient receives more radiation from an x-ray examination of the abdomen than the entire exposed public received from the Three Mile Island incident. - American Society of Radiologic Technologists
Radiation Exposure The FDA Bureau of Radiologic Health has estimated 30% of exposures to man-made radiation are unnecessary An estimated 40% of operators administering ionizing radiation have no formal education in radiologic technology
History 1965 NY became 1st to license radiologic personnel in order to minimize the public s unnecessary exposure to potentially hazardous radiation delivered during medical imaging procedures. 1969 NJ & CA began licensing radiologic personnel. CA began idea of limited license 1979 only 9 states had enacted licensure laws
History 1970 Bill introduced to establish minimum standards 1978 Consumer-Patient Radiation Health and Safety Act (CPRHSA) heard by full Senate 1978-80 Bill underwent Congressional hearings 1981 Crucial decision: change mandatory licensure to strongly advise? 1981 CPRHSA passed 1983, 85 Secretary published draft and Final rule of licensure
The Issue Today, 11 states + D.C. have not adopted the federal standards Level of competence?
Back in the Spotlight? 1988 9 year-old child received double dose of Co-60 aimed at tumor in sinus 1989 An Ohio woman had hole burned into her chest while receiving breast cancer therapy
Licensure will help in 3 areas Quality Safety Economics
Quality The issue is the radiologic personnel s problem with maximizing information while minimizing radiation LNT model of radiation UNSCEAR s 7 Recommendations
UNSCEAR s 7 Recommendations 1. Reduce # radiographs / patient 2. Reduce time & intensity of exposure 3. When fluoroscopy is not essential, use conventional radiography 4. Use the smallest possible field size 5. Avoid inclusion of the gonads in the primary beam 6. Protect testicles with gonadal shields 7. Properly train and supervise staff engaged in these examinations
Quality Radiologic Technologists responsible for technique selection and positioning The individual also controls the intensity of the beam, the duration of the exposure, and also the shielding All of these factors contribute to whether or not an image will provide the required quality diagnostic image
Quality 7 10% x-ray procedures are performed as repeat exams Repeat dosages mean 200% overall radiation dose Reasons for Repeated Procedures Other Errors 20% Positioning Errors 30% Exposure Errors 50%
RECALL The FDA Bureau of Radiologic Health has estimated 30% of exposures to man-made radiation are unnecessary An estimated 40% of operators administering ionizing radiation have no formal education in radiologic technology
Quality Studies show that patients may receive 100 times more radiation for the same x- ray examination because of unqualified operators. Now remember that radiologic personnel are not only responsible for diagnostic procedures, but also for therapeutic procedures.
Safety A Canadian Study in the 1980 s of 30 hospitals The authors were quoted attributing the variation in dosage directly to the knowledge of and technique used by the equipment operator. Low High Difference Chest X-Ray 0.024 rem 0.15 rem 6x Gastrointestinal 1.6 rem 90 rem 56.25x Gallbladder 4 rem 48 rem 12x
Safety The National Cancer Institute estimates that the long-term effects of overexposure to radiation during diagnostic x-ray examinations alone may be responsible for more than 3,500 deaths per year.
NRC Misadministrations (1) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and (i) The total dose delivered differs from the prescribed dose by 20 percent or more; (ii) The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or (iii) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more. OR (2) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following-- (i) An administration of a wrong radioactive drug containing byproduct material; (ii) An administration of a radioactive drug containing byproduct material by the wrong route of administration; (iii) An administration of a dose or dosage to the wrong individual or human research subject; (iv) An administration of a dose or dosage delivered by the wrong mode of treatment; or (v) A leaking sealed source. OR (3) A dose to the skin or an organ or tissue other than the treatment site that exceeds by 0.5 Sv (50 rem) to an organ or tissue and 50 percent or more of the dose expected from the administration defined in the written directive (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site).
NRC Misadministrations Administered dose differs by more than 20% or falls outside the prescribed dosage range. The personnel uses the wrong drug, usually because of contamination route of administration individual mode of treatment A leaking sealed source Dose to other site that exceeds expected dose by 50 rem & more than 50%
NRC Misadministrations Alabama vs. California, 1981-97 License Radiologic Personnel? Number of Misadministrations Avg. Misadministrations per Year Population ----- Avg. Misadministrations per Year per million residents Alabama NO 42 2.47 ----- 4 million 0.62 California YES 29 1.71 ----- 30 million 0.057
NRC Misadministrations Before & After Licensure, 1981-2004 Before Licensure Time Period Recorded Number of Misadministrations Avg. Misadministrations per Year Massachusetts 1981-90 55 5.5 Ohio 1981-95 47 3.1 After Licensure Time Period Recorded Number of Misadministrations Avg. Misadministrations per Year 1991-2004 7 0.047 1995-2004 1 0.067
Safety Nationwide Evaluation of X-Ray Trends (NEXT) program conclusion: we need trained operators and we need continuing education for radiologic technologists. Other risks for radiologic personnel
Economics Diagnostic image obtained with a minimum of technical and clerical errors should result in a lower cost per examination. - National Council on Radiation Protection and Measurements (NCRP), 1999
Economics Personnel are paid on a salary basis Additional scans means that there is more spent money per patient Opportunity cost repeated procedures = fewer patients seen
RECALL 7 10% x-ray procedures are performed as repeat exams Repeat dosages mean 200% overall radiation dose Reasons for Repeated Procedures Other Errors 20% Positioning Errors 30% Exposure Errors 50%
Economics The U.S. spends approximately $20 billion a year on diagnostic x-ray examinations So assuming the low-end 7% repeat-rate, almost $1.5 billion is wasted annually on unnecessary, repeated x-ray procedures
Economics A very small hospital in New York reported an initial savings of $27,000 (in 1976) in the first month A medium sized Miami hospital saved $5.2 million during an 18-month period California, after 10 years of licensure, reported that overall medical fees increased 92.7%, while fees for radiology services only increased 59.2%.
Conclusions Quality, Safety, Economics Analogies?
Recommendations Licensure Continuing Competency Continuing Education Inspections and Audits Institute of Medicine s To Err is Human IAEA s Management Requirements
Recommendations Agreement State Program v 2.0 And/or All medical radiation regulation by existing agencies
Questions?
Salaries Radiologic Technologist Arranges patients for radiological examinations. Produces radiographs (x-rays) to aid in the diagnosis of medical problems. Prevents patient from being exposed to unnecessary radiation. Requires an associate's degree from an accredited program and registration as a technologist by the A.R.R.T. Has knowledge of commonly used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision. A certain degree of creativity and latitude is required. Typically reports to a chief technologist or manager.
Salaries Radiation Technician Collects, tests and analyzes materials of nuclear powered electric generating plant. May require an associate's degree or its equivalent with 0-2 years of experience in the field or in a related area. Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision. Primary job functions do not typically require exercising independent judgment. Typically reports to a supervisor or manager.
Salaries Radiation Therapy Technologist (ARRT) Administers radiation therapy by exposing specific areas of the patient's body to prescribed doses of radiation. Maintain detailed records of all therapy sessions, noting on the patient's chart such information as the area treated, the radiation dosage, equipment control settings, the patient's reactions, and the total amount of radiation received to date. Typically requires graduation from an accredited radiation therapy program, American Registry of Radiologic Technologists (A.R.R.T) registry or registry eligibility in radiation therapy technology, and licensed by the State Department of Health Services. Familiar with standard concepts, practices, and procedures within a particular field. Relies on experience and judgment to plan and accomplish goals. Performs a variety of tasks. Works under general supervision. A certain degree of creativity and latitude is required. Typically reports to a physician or manager.
Salaries Nuclear Medicine Technologist Prepares, measures, and administers radiopharmaceuticals in diagnostic and therapeutic studies, utilizing a variety of equipment and following prescribed procedures. Administers therapeutic doses of radiopharmaceuticals under direction of physician. Follows radiation safety techniques when disposing radioactive materials. Requires a bachelor's degree with at least 2 years of experience in radiology. May be expected to meet certain state certifications. Familiar with standard concepts, practices, and procedures within a particular field. Relies on experience and judgment to plan and accomplish goals. Performs a variety of tasks. Typically reports to chief technologist or manager.
Funding for licensure? Existing licensure funding comes from licensure application fees and annual board fees, the same system should be applied to the future system, on a larger scale.
Licensure as an issue 90% or more of the handling of nuclear material except during fluoroscopy and interventional surgery is done by technicians and technologists
Institute of Medicine s To Err is Human Compilation of errors occurring in a variety of health care settings How? Why? Solutions Recommendations: work with certifying and credentialing organizations by implementing periodic reexaminations and relicensing to identify unsafe providers.
IAEA s Management Requirements There is a strong belief in limiting the contribution of human error to accidents and other events that could give rise to exposures. This can be achieved by ensuring that all personnel on whom protection and safety depend are appropriately trained and qualified