HLT-36-08-00023-P Practice of Radiologic Technology
9/3/08 N.Y. St. Reg. HLT-36-08-00023-P
NEW YORK STATE REGISTER
VOLUME XXX, ISSUE 36
September 03, 2008
RULE MAKING ACTIVITIES
DEPARTMENT OF HEALTH
PROPOSED RULE MAKING
NO HEARING(S) SCHEDULED
I.D No. HLT-36-08-00023-P
Practice of Radiologic Technology
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Repeal of Part 89 and addition of new Part 89 to Title 10 NYCRR.
Statutory authority:
Public Health Law, section 3504
Subject:
Practice of Radiologic Technology.
Purpose:
Amendment updates the regulation to reflect the current practice of radiologic technology and the administration of the program by Department of Health.
Substance of proposed rule (Full text is posted at the following State website: www.health.state.ny.us):
Part 89 of Title 10 of the New York Codes Rules and Regulations (NYCRR) governs the practice of x-ray technology and delineates how radiologic technologists are to be trained, examined and licensed. Much of the existing Part 89 was promulgated pursuant to the enactment of Article 35 of the Public Health Law in 1965. In 2006, a law was passed that repealed Article 35 and replaced it with a new Article 35 that now governs the practice of radiologic technology. As a result, the language in the existing regulation is outdated and does not accurately reflect how the technologists are currently examined and licensed by the department. Therefore, a new Part 89 is proposed to implement the 2006 law. The proposed regulation contains the following provisions:
Section 89.0 states that the purpose of Part 89 is to define legal requirements relating to the practice of radiologic technology.
Section 89.1 covers the definitions of terms used in this Part. Several new definitions have been added including accrediting organization, authorized person, direct supervision, personal supervision, sponsoring institution, supervision and authorized user. The definitions of applicable regulations, negligence and/or incompetence and unethical conduct have been updated.
Section 89.2 updates the scope of practice of radiographers and radiation therapists and defines the scope of practice of nuclear medicine technologists. After December 31, 2008 only licensed persons can practice nuclear medicine technology.
Section 89.3 describes the registration process for educational programs in radiologic technology.
Section 89.4 covers the standards that an educational program must follow.
Section 89.5 itemizes the regulations that relate to students enrolled in a course of study in radiologic technology. Students in the last six months of training may be assigned up to a total of 80 hours of clinical practice on evenings, weekends or holidays.
Section 89.10 describes the radiologic technologist licensing process. The new fee for a lifetime license is $120. This section also addresses individuals practicing nuclear medicine technology prior to July 26, 2006.
Section 89.11 provides information on the recourse for individuals who have been disqualified for a license by the department.
Section 89.20 describes the registration process for radiologic technology licensure and continuing education requirements beginning January 1, 2010. The Section also contains a registration fee increase from $15 per year to $20 per year and an extension of the registration period from two years to four years.
Section 89.21 covers the issuance of temporary permits to practice radiologic technology.
Section 89.30 describes exemptions to Article 35 for dental assistants and persons authorized to provide supporting service to a licensed podiatrist.
Section 89.40 describes the qualifications and certification process required for radiologic technologists to administer intravascular contrast media.
Text of proposed rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.state.ny.us
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
Regulatory Impact Statement
Statutory Authority
Sections 3504 and 3507(2) of the Public Health Law (PHL) authorizes the Commissioner of Health to make rules and regulations to carry out the provisions of Article 35 of the Public Health Law that govern the practice of radiologic technology. Section 3504 also requires that the Commissioner, when promulgating regulations, act on the advice of the Radiologic Technology Advisory Board mandated in Section 3503. Subdivision 4 of section 3502 of the PHL authorizes the department to promulgate regulations relating to the administration of intravenous contrast media by radiographers. PHL section 3508 requires institutions offering a course of study in radiologic technology to register with Department of Health. PHL section 3510(1)(g) authorizes the Commissioner to promulgate regulations that define "unethical conduct." PHL section 3507(7) also authorizes the Commissioner to promulgate regulations relating to continuing education. These amended regulations include the Board's advice, which was obtained through a meeting of a quorum of the Board and through written correspondence with all the Board members.
Legislative Objectives
Enacted as Chapter 175 of the Laws of 2006, Article 35 of the PHL updates the educational and licensure requirements for radiologic technologists. In addition, the 2006 law creates a new licensed profession, nuclear medicine technology, and allows radiographers to administer contrasts media intravenously. The Department is responding to this legislative objective in revising this regulation.
Needs and Benefits
Much of the existing 10 NYCRR Part 89 was promulgated pursuant to the enactment of PHL Article 35 in 1965, which is now repealed. Since 1965, the practice of radiologic technology has changed drastically as well as educational standards for radiologic technologists. Consequently, Part 89 must be revised to implement PHL Article 35 that is currently in effect, and to more accurately reflect how these professions should be regulated.
The most significant change in the 2006 law is the addition of a new licensed profession, nuclear medicine technology. In 1979 individuals with the required education or certification were authorized to inject radiopharmaceuticals under 10 NYCRR Part 16. For many years, almost all nuclear medicine studies were performed in hospital settings where the individuals performing the studies were credentialed by the facility under the requirements of Part 405 of the State Hospital Code. This level of oversight, in addition to periodic inspections by New York State and New York City staff, provided the department with reasonable assurance that nuclear medicine studies were being performed by trained and competent individuals. More recently, many nuclear medicine studies have been performed in private imaging centers and cardiology practices with much less oversight by the department. This trend, combined with equipment safety concerns, ever-increasing complexity of nuclear medicine studies, and the appreciation that nuclear medicine technology should be acknowledged as part of radiologic technology profession made licensing nuclear medicine technologists important.
PET/CT imaging is the merger of a nuclear medicine study (positron emission tomography or PET) and another imaging study such as an x-ray study (computed tomography or CT). The information generated provides the physician with a more complete picture of the functioning (from the PET study) and structure (from the CT study) of the human body than either test alone. A PET/CT scanner is a type of nuclear medicine equipment and a PET/CT study is performed by a nuclear medicine technologist who has additional training in the use of the CT equipment. The statute, and therefore the regulations do not authorize nuclear medicine technologists to use x-rays except as an integral part of a merged imaging procedure that includes the use of a nuclear medicine study.
The 2006 law and these regulations allow radiographers with additional education and certification to administer contrast media intravenously. The department will ensure that the education, training and experience criteria are based on national standards and were established to assure that licensees are competent to perform this function.
Costs
Cost to State and Local Government:
There are no costs to State and Local Government.
Costs to the Department of Health:
Licensing for nuclear medicine technologists.
The Department's Bureau of Environmental Radiation Protection estimates that 2300 individuals may apply for a nuclear medicine technologist license statewide. The department expects that it will take 10 minutes (.167 hr.) to approve a typical application for licensure, enter the data and generate and mail the license. Using 2007/2008 salary, fringe benefit and indirect cost rates:
The department expects that approximately 150 (10%) applicants will be apply under the law's grandfather provisions. These submissions will require more extensive review (average 30 minutes) by a Radiological Health Specialist.
These costs of licensing of individuals will be offset by the $120 one time licensing fee (2300 applicants x $120 = $276,000). Once individuals are licensed, they become part of an existing program that registers radiologic technologists, investigates complaints of unprofessional conduct by technologists and disciplines technologists as necessary.
Contrast Media Injection Certification
The Department began issuing certificates to radiologic technologists on January 22, 2007. The review of credentials, data entry and certificate generation takes about 10 minutes. Recertification will occur at the time of license registration. There are currently over 16,000 registered radiographers, and it is estimated that 2000 will apply for a certificate.
The $20 certification fee will offset these costs for 2000 applicants equaling $40,000.
Cost to Private Regulated Parties:
Nuclear medicine technologist licensing. The Bureau estimates that there are about 2300 individuals currently providing nuclear medicine technology services in New York State. Most (90%) individuals are currently certified in this practice by either the Nuclear Medicine Technology Certifying Board or the American Registry of Radiologic Technology. The other 10% have varying credentials and may qualify under the grandfather provisions in the law. All must be licensed by January 1, 2009 to continue to practice nuclear medicine technology. There is a one-time $120 licensing fee and a $20 per year registration fee.
Intravenous Contrast Administration Certificate. There are about 850 facilities in New York State (243 hospitals and about 600 imaging centers and private practices) that perform diagnostic x-ray studies requiring contrast media. Using certified radiologic technologists to perform this function is voluntary and facilities may choose to continue to use other qualified individuals to perform injections.
To qualify for intravenous contrast administration certification a radiographer must complete training in the injection procedure and recognition of adverse reactions, and cardiopulmonary resuscitation. Many hospitals currently require radiologic technologists to be certified in cardiopulmonary resuscitation.
Training in the injection procedure and related information should require about eight (8) hours of didactic and practical preparation. Radiologic technologists who specialize in computed tomography (CT) procedures earn about $29/hr and could earn approximately $232 to teach the course. The cost to radiographers who take the course ranges from free to $75. Some employers may offer such education free of charge. Cardiopulmonary resuscitation training is approximately eight (8) hours. Periodic recertification is four (4) hours in duration. The cost of the cardiopulmonary resuscitation course from the American Red Cross is $90.
Beginning in 2010 radiologic technologists will need to earn 12 continuing education (CE) credits for each year of their registration period in order to renew the registration of their license. The CE credits earned must be Category A credits as designated by the American Society of Radiologic Technologists. The cost of obtaining the CE credits will depend on the number credits offered by the course. There are on-line courses that offer one or two CE credits at no cost. Other on-line courses cost from $25 to $100. Seminars consisting of two to seven days of lectures and demonstrations will cost $200 to $1000.
Local Government Mandates
This regulation does not mandate any new programs, services, duties or responsibilities upon any county, city, town, village, school district, fire district or any other special district.
Paperwork
Individuals interested in being licensed in nuclear medicine technology must present their credentials to the department for approval. Radiologic technologists who want to be authorized to inject intravenous contrast material must apply and obtain a certificate from the department. Once the licensee has received his/her first intravenous contrast administration certificate, subsequent certificate applications will be linked to the registration process. All radiologic technologists must register their licenses every four years.
Duplication
This regulation does not duplicate any other State or Federal law or regulation.
Alternatives
There are no other acceptable alternatives to this proposal. The PHL requires a licensing and registration program for radiologic technologists. The PHL authorizes the commissioner of health to make any regulations necessary to conduct the licensing program.
Federal Requirements
This regulatory amendment does not exceed any minimum standards of the Federal government.
Compliance Schedule
The proposed rule change will become effective upon publication of a Notice of Adoption in the State Register. The requirement for a license to practice nuclear medicine technology is effective January 1, 2009. Individuals have until that date to submit their credentials for licensing.
Regulatory Flexibility Analysis
Effect on Small Business
There are about 750 hospitals, imaging centers and private medical practices licensed to use radiopharmaceuticals in New York State. These facilities use nuclear medicine technologists to perform diagnostic medical tests. From past inspection experience, it is believed that the vast majority of individuals performing these functions are certified in this practice by the Nuclear Medicine Technology Certification Board or the American Registry of Radiologic Technologists in Nuclear Medicine Technology. Any individual who does not have one of these credentials has until January 1, 2009 to obtain the national certification or to apply to the department under the grandfather provisions in the law. After that date, only persons licensed by the department may practice nuclear medicine technology in this state.
There are about 545 hospitals, imaging centers and private practices that perform diagnostic x-ray studies requiring contrast media. These health care providers may employ radiologic technologists certified to administer contrast media or may choose to continue to use other qualified individuals to administer contrast media. Radiologic technologists seeking to be certified to administer contract media intravenously must complete training covering the injection procedure and recognition of adverse reactions and training in cardiopulmonary resuscitation.
It is expected that training in the injection procedure and related information will require eight (8) hours of didactic and practical preparation. Radiologic technologists who specialize in computed tomography (CT) procedures make on average $58,000 a year or about $29/hr. The cost of staff salaries for training each technologist is about $232.
For those licensed radiologic technologists that are not certified in cardiopulmonary resuscitation, initial training is approximately eight (8) hours or $232 in salary costs per individual. Periodic recertification is four (4) hours in duration and $116 in salary cost.
Facilities may experience a cost and efficiency saving following radiologic technologist certification due to improved patient flow.
Compliance Requirements and Recordkeeping
Beginning January 1, 2009, each facility must assure that only licensed individuals perform functions defined under the practice of nuclear medicine technology. As of January 22, 2007, facilities must document and may use registered radiographers to inject contrast media if the radiographers have received an intravenous contrast administration certificate.
Professional Services
Facilities will not require any additional professional services as a result of this amendment.
Capital Costs and Annual Costs of Compliance
There are no capital costs associated with this regulation. The licensing of nuclear medicine technologists and the certification of radiographers in injection of contrast media are responsibilities of the licensed persons. Facilities may or may not choose to provide financial assistance to these employees.
Economic/Technological Feasibility
This regulation poses no economic or technological burden to the regulated parties except documentation of appropriate licensing/certification.
Minimizing Adverse Impact
The law requires that an individual practicing as a nuclear medicine technologist be licensed to do so by January 1, 2009. The law also provides an alternative pathway to license individuals who are experienced and competent in this field.
The department is encouraging schools of radiologic technology and professional societies to provide training to radiographers in the injection of contrast media.
Small Business and Local Government Participation
The Department solicited comments from the Department's Radiologic Technology Advisory Board, the New York State Society of Radiological Sciences, the Association of Educators of Radiologic Technology in New York State, the New York State Radiological Society, and the New York State Nurses Association (NYSNA) with regard to these regulations. These organizations have members that represent small businesses. All of the organizations were in support of the licensing of nuclear medicine technologists. All of the organizations that submitted written comments indicated their support for the revised regulations, in general, except NYSNA. NYSNA was concerned about intravenous contrast administration by radiographers. This proposed regulation includes amendments/revisions that reflect the comments received. NYSNA offered three suggestions for clarification of code provisions related to the injection of contrast media. A revision was made to address one of the three comments by directly adopting the language from Article 35 of the Public Health Law for the definition of the direct supervision of radiologic technologists during contrast injections as was suggested by the NYSNA. A comment about the limitations placed on radiologic technologists during contrast injections is substantially addressed in Part 89 without using language identical to that in Article 35 as suggested by NYSNA. A NYSNA concern about assessing the status of the patient prior to a contrast injection has been substantially addressed in Part 89 without adopting the Article 35 language as suggested by NYSNA.
Rural Area Flexibility Analysis
Effect on Rural Area
There are about 100 facilities located in rural areas that are licensed to use radiopharmaceuticals. From past inspection experience, it is believed that the vast majority of individuals performing nuclear medicine technology functions are certified in this practice by the Nuclear Medicine Technology Certification Board or the American Registry of Radiologic Technologists. Any individual who does not have one of these credentials has until January 1, 2009 to obtain the national certification or to apply to the department under the grandfather provisions in the law. After that date, only licensed persons may practice nuclear medicine technology.
There are also approximately 150 facilities in rural areas that provide diagnostic x-ray studies that include contrast media injections. The passage of this amendment will improve their ability to provide service to their patients. Adding radiologic technologists to the classes of health care providers who can inject contrast media will help reduce patient waiting times, delays in test interpretations and free up nurses and physicians for other duties. However, using certified radiologic technologists for this function is voluntary and facilities may choose to continue to use other qualified individuals to perform injections.
Compliance Requirements
Beginning January 1, 2009, each facility must assure that only licensed individuals perform the functions defined under the practice of nuclear medicine technology. As of January 22, 2007, facilities may use registered radiographers to inject contrast media if the radiographers have received an intravenous contrast administration certificate.
Professional Services
Facilities will not require additional professional services as a result of this amendment.
Capital Costs and Annual Costs of Compliance
There are no capital costs associated with this regulation. The licensing of nuclear medicine technologists and the certification of radiographers in intravenous contrast administration are the responsibilities of the licensed persons. Facilities may or may not choose to provide financial assistance to these employees.
Minimizing Adverse Impact
The law requires that an individual practicing as a nuclear medicine technologist be licensed to do so by January 1, 2009. The Department is encouraging schools of radiologic technology and professional societies to provide training in the administration of contrast media at a reasonable cost.
Rural Area Participation
The Department solicited comments from the Department's Radiologic Technology Advisory Board, the New York State Society of Radiological Sciences, the Association of Educators of Radiologic Technology in New York State, the New York State Radiological Society, and the New York State Nurses Association (NYSNA) with regard to these regulatory changes. These organizations have members that represent or are small businesses. All of the organizations were in support of the licensing of nuclear medicine technologists. In general, organizations that submitted written comments indicated their support for the revised regulations. The NYSNA had concerns about intravenous contrast administration by radiographers. NYSNA offered three suggestions for clarification of code provisions related to the injection of contrast media. The department accepted NYSNA's proposal to include in the regulation the language from Article 35 for the definition of the direct supervision of radiologic technologists during contrast injections. NYSNA's two other proposals relating to administration of intravenous contrast media were considered but rejected. The department felt that its regulatory provisions relating to contract media were adequate.
Job Impact Statement
Nature of Impact and Categories and Numbers Affected
All individuals who are performing the functions of a nuclear medicine technologist need to be licensed as of January 1, 2009. About 90% of these professionals are currently certified by a national certifying body and thereby qualify for a license. The other 10% are expected to qualify under the alternate pathway provided in the law. Individuals will need to pay a one-time license fee of $120 and an annual registration fee of $20.
PET/CT imaging is an emerging technology that combines information from a nuclear medicine study (positron emission tomography or PET) and an x-ray study (computed tomography or CT) to help diagnose patient illness. Because a PET/CT scan requires the use of radioactive materials, the department believes that the scanner is a type of nuclear medicine equipment and that a PET/CT study needs to be performed by a nuclear medicine technologist who has additional training in the use of the CT equipment. This means that only individuals licensed as nuclear medicine technologists may perform PET/CT scans. Nuclear medicine technologists may not perform CT scans in any other context.
This amendment adds the intravenous administration of contrast material as an integral part of a radiographic examination, to the definition of radiography. As such it updates New York State regulations to mirror national standards and aligns radiographers in this state with their national counterparts.
In facilities that employ radiographers who administer contrast intravenously, there will probably be a shift in responsibilities for the current staff in radiology services. The physician, physician assistant or nurse who previously performed this task will now be available to fulfill other medical and nursing duties. Considering the serious shortage of all these classes of practitioners, the efficiencies this change will provide is expected to improve patient care during diagnostic studies requiring contrast media. However, using certified radiologic technologists for this function is voluntary and facilities may choose to continue to use other qualified individuals to perform injections.
Adverse Impact
The nuclear medicine community has expressed its desire for licensing of nuclear medicine technologists for several decades. About 90% of the individuals performing nuclear medicine studies are already certified by the Nuclear Medicine Technology Certifying Board or the American Registry of Radiologic Technologists in Nuclear Medicine Technology and thereby qualify for a license. The grandfather provisions of the law were included to protect current individuals with experience and competence to qualify for a license.
The national professional organization for radiologic technologists is the American Society of Radiologic Technologists. This Society has included injection of contrast media as part of the practice of radiologic technology since 1991. This new regulation provides facilities with more options in performing studies using contrast material and aligns the profession in this state with the national radiologic technology community.
The Department solicited comments from the Department's Radiologic Technology Advisory Board, the New York State Society of Radiological Sciences, the Association of Educators of Radiologic Technology in New York State, the New York State Radiological Society, and the New York State Nurses Association (NYSNA) with regard to these regulations. These organizations have members that represent small businesses. All of the organizations were in support of the licensing of nuclear medicine technologists. All of the organizations that submitted written comments indicated their support for the revised regulations, in general, except NYSNA. NYSNA was concerned about intravenous contrast administration by radiographers. This proposed regulation includes amendments/revisions that reflect the comments received. NYSNA offered three suggestions for clarification of code provisions related to the injection of contrast media. A revision was made to address one of the three comments by directly adopting the language from Article 35 of the Public Health Law for the definition of the direct supervision of radiologic technologists during contrast injections as was suggested by the NYSNA. A comment about the limitations placed on radiologic technologists during contrast injections is substantially addressed in Part 89 without using language identical to that in Article 35 as suggested by NYSNA. A NYSNA concern about assessing the status of the patient prior to a contrast injection has been substantially addressed in Part 89 without adopting the Article 35 language as suggested by NYSNA.
