PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Amendment of section 16.25; and addition of section 16.59 to Title 10 NYCRR.
Statutory authority:
Public Health Law, section 225
Subject:
Computed Tomography (CT) Quality Assurance.
Purpose:
To protect the public from the adverse effects of ionizing radiation.
Substance of proposed rule (Full text is posted at the following State website: www.health.ny.gov):
The regulatory proposal would revise Part 16 of 10 NYCRR as described in more detail below. Section 16.59 is added to cover radiation safety and quality assurance on Computed Tomography (CT) equipment. Section 16.59 (a) of the proposed regulation specifies a number of definitions used to describe CT systems and their operations. The next four sections, respectively, describe: physical and system requirements (16.59(b)); patient communication and viewing requirements (16.59(c)); CT system calibration requirements (16.59(d)); and quality assurance testing requirements (16.59(e)). Part 16.59(f) contains requirements for operations including a requirement for accreditation. One of the requirements is accreditation by a nationally recognized accrediting body that is acceptable to the Department. Currently the American College of Radiology (ACR), the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) or the Intersocietal Accreditation Commission (IAC) are considered acceptable to the Department. This is consistent with the accrediting bodies that CMS accepts. This accreditation requires the registered facility to have one of these three organizations perform a review that includes the physical layout of the facility, policy and procedures, quality assurance and image assessment. The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) required the Center for Medicare and Medicaid Services (CMS) to designate accrediting bodies for imaging centers that perform CT (as well as certain other imaging studies). Accreditation is now a requirement under CMS regulation for all non-hospital providers to receive the technical component payment, and these three organizations (ACR, JCAHO, and IAC) are approved by CMS.
Section 16.25 is that subsection of Part 16 that requires the recording or reporting of medical misadministrations. This part is amended to include an additional reporting requirement for CT misadministrations when the wrong patient is scanned, when the wrong part of the body is scanned or when there is damage to an organ or organ system including erythema and/or hair loss.
Text of proposed rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.ny.gov
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:
The Public Health and Health Planning Council is authorized by § 225(4) of the Public Health Law (PHL) to establish, amend and repeal provisions of the State Sanitary Code (SSC), subject to the approval of the Commissioner of Health. PHL §§ 225(5)(p) & (q) and 201(1)(r) authorize SSC regulations to protect the public from the adverse effects of ionizing radiation. These statutory provisions authorize the Department, pursuant to 10 NYCRR Part 16, to license or register health care providers to use radioactive materials or ionizing radiation emitting equipment on patients.
The federal Atomic Energy Act of 1954, (the Act), (codified at 42 USC §§ 2021 et. seq.) authorizes the U.S. Nuclear Regulatory Commission (NRC) to regulate the use of radioactive materials. The Act also authorizes "Agreement States" to regulate the use of radioactive materials in lieu of the NRC, provided that the "Agreement State" promulgates regulations that are comparable to or exceed NRC's regulatory standards. New York State is an "Agreement State" within the meaning of the Act. New York's regulatory standards for the use of radioactive materials in 10 NYCRR Part 16 must therefore meet or exceed comparable NRC regulatory standards. The Act governs only the use of radioactive materials: it does not apply to x-rays or radiation therapy equipment that emit only x-rays.
Legislative Objectives:
The legislative intent of PHL Sections 225(5)(p) & (q) and 201(1)(r) is to protect the public from the adverse effects of ionizing radiation. Establishing regulations to ensure safe and effective clinical uses of radiation producing equipment is consistent with this legislative objective.
Needs and Benefits:
DOH's regulations are designed to require the delivery of quality care while protecting people and the environment from the harmful effects of radiation. In recent years, technology and equipment used for diagnostic medical imaging has become significantly more complex. Computed Tomography delivers high quality imaging that is of significant benefit to patients and for this reason it represents the dominant imaging modality. However, it also represents the largest contributor to an increase in population radiation exposure based on reports from the National Council on Radiation Protection and Measurements. The usage of CT scans has more than tripled in the past decade and currently there are about 80 million CT scans in the US each year.
The problems that have been documented with CT scans in the past several years reflect a lack of quality assurance and/or a lack of administrative controls which these regulations seek to implement. These regulations seek to ensure high quality CT imaging that is appropriate with respect to professional bodies such as the American College of Radiology’s (ACR) recommendations on appropriateness criteria. These regulations will implement Quality Assurance (QA) requirements that are already being voluntarily implemented by a majority of facilities in New York State.
Currently the only provisions in the State Sanitary Code that apply are general quality assurance regulations that do not adequately describe the operations or quality assurance requirements for the use of CT equipment.
Costs:
The Department estimates that many regulated parties that use Computed Tomography will not incur any additional costs to comply with the proposed addition of 10 NYCRR § 16.59. There are approximately 440 facilities that are registered with the DOH that operate one or more CT scanners for diagnostic purposes on human beings. Approximately 75% of these sites already have been accredited by bodies currently accepted by Centers for Medicare and Medicaid Services (CMS), (American College of Radiology, Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and IAC). The initial costs of this accreditation vary based on which of the three organizations are used, however the ACR is the most popular and in general the least expensive for a facility that only has a single CT scanner. The costs of a three year accreditation from the ACR will average $7550, which includes: (i) the typical fees for a consulting physicist (average of $1750); (ii) a $2500 accreditation fee from the ACR; and (iii) $3300 for the purchase of an ACR phantom if the facility does not already have one. Facilities that already have the ACR phantom (or for reaccreditation) will not need to purchase another phantom.
The other proposed additions in 10 NYCRR § 16.59 will impose little or no cost to regulated parties because existing facility staff can comply with the new quality assurance requirements.
Local Government Mandates:
There are fourteen hospitals that fall under this category, including three State University hospitals, a Department operated hospital and ten hospitals operated by public benefit corporations. Of these fourteen hospitals, ten are already accredited in CT scanning. The remaining four hospitals would incur additional costs to comply with the new regulatory requirement to be certified in CT (approximately $9,500 for each three year period). No other additional costs are associated with implementation of these requirements. Registrants and licensees, including the hospitals operated by state and local governments, are currently required to retain all quality assurance documents for review by the Department. The additional records and filing is estimated to be a small incremental amount. Affected parties will need to complete an application for accreditation initially and every three years thereafter.
Paperwork:
DOH regulations (10 NYCRR Part 16) require registrants and licensees to maintain a variety of records relating to the use of ionizing radiation for review by the Department. The Department estimates that licensees and registrants may have a small amount of additional documentation to create, maintain or file. Affected parties will have to complete an application for CT accreditation. The accrediting bodies are transitioning to an online application process to minimize time and effort for regulated parties seeking accreditation.
The proposed regulations will not affect registration documents issued by the Department to current registrants. The Department plans to provide updated QA guidance when these regulations are adopted.
Duplication:
There is no duplication of the proposed regulatory requirements by any federal, state or local agency for licensees, registrants or authorized users subject to 10 NYCRR Part 16. New York State entered into an agreement with the federal government on October 15, 1962 by which the federal government discontinued its regulatory authority over the use of radioactive materials and New York assumed such authority. The Atomic Energy Act does not govern use of x-ray emitting equipment.
Alternatives:
One alternative to adopting these regulations is to take no action and maintain the existing structure that relies on DOH guidance and voluntary compliance. However, while rapid advances in CT technology have produced better healthcare outcomes in many cases, there has been a downside to this increased use – particularly, patients experiencing radiation burns as a result of the improper use of CT scans. The New York Times and the Los Angeles Times have both reported on CT-related medical problems that were caused by the failures of both regulators and medical personnel. The scientific press also has numerous articles documenting overutilization of CT and quality assurance failures. The general population and the scientific community are aware that New York State currently lacks adequate quality assurance regulations and monitoring. The development of these proposed regulations, after consultation with radiologists, physicists and several professional organizations including the Hospital Association of New York State and the New York State Radiological Society, is intended to minimize future CT-related medical events in New York State. New York is not the only state to strengthen its regulation of this area: Texas and California have adopted regulations governing CT quality assurance (California) and reporting of events and monitoring of patient dose (Texas).
As a result, there are no suitable alternatives to the proposed addition of 10 NYCRR § 16.59. There are no alternative requirements that would meet the objectives of implementing appropriate Quality Assurance on CT scanners.
Federal Standards:
These proposed revisions to 10 NYCRR § 16.59 do not conflict with any federal regulations. Existing federal regulations relate only to the manufacture and distribution of radiation producing equipment and not to its operations.
Compliance Schedule:
The proposed regulatory amendments will be effective upon publication of the Notice of Adoption in the State Register, except for the requirements in proposed 10 NYCRR § 16.59(f)(5) relating to accreditation in computed tomography. Proposed 10 NYCRR § 16.59(f)(5) requires that registrants apply for accreditation by one of the previously mentioned organizations and that such accreditation becomes effective within one year of the effective date of the proposed regulation.
Regulatory Flexibility Analysis
Effect on Small Business:
The Department has issued registrations to approximately 440 facilities for the use of Computed Tomography equipment of which an estimated 230 are small business. Specifically these are private practice or group practice physicians who own and operate their own CT scanner. Some of these registrants would be affected by the proposed revisions to 10 NYCRR § 16.59, in particular the requirement for accreditation may affect some businesses. However, as of January 1, 2012, the Centers for Medicare and Medicaid Services (CMS) required that all non-hospital providers of the technical component of CT imaging must meet the accreditation requirements in Section 135 (a) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). Therefore the majority of small business, private practice physicians have or are in the process of obtaining accreditation for CT.
Compliance Requirements:
Licensees and applicants will need to become familiar with the new requirements and modify their quality assurance policies and procedures accordingly. Those who are not currently accredited will need to do so within 12 months of the effective date of the rule.
Professional Services:
The majority of large facilities have in-house staff who will conduct the required QA and small facilities either contract with the manufacturer of the equipment or professional medical physicists that perform quality assurance testing for CT. The average cost for professional service for the accreditation component of these regulations ranges from $1550 to $1950 per CT, depending on location. This service would be required every three years.
Compliance Costs:
The amortized annual cost is estimated to be approximately $2500 per year for accreditation (based on a three-year accreditation cost of $7550). However, approximately 75% of the facilities are currently accredited; therefore this regulation will not impose an additional cost. There are no capital costs mandated by this regulation directly, however, one of the three accrediting bodies requires the use of their own phantom at a cost of $3300.
Economic and Technological Feasibility:
There are no capital costs or new technology required to comply with the proposed rule. Facilities that use the ACR as the accrediting body must have or purchase an ACR CT phantom. The use of some type of phantom is the industry standard for CT testing and evaluation.
Minimizing Adverse Impact:
Facilities will have 12 months to become accredited. This will allow a facility adequate time to select the accreditation body of their choice, complete an application and budget funds for the accreditation fee.
Small Business and Local Government Participation:
A copy of the draft proposed rule was sent via email to individuals representing the Healthcare Association of New York State (HANYS), the New York state chapter of the ACR, physicists throughout the state, the NYS Society of Radiological Sciences and other interested parties including private practice physicians. The majority of the comments were technical clarifications that have been incorporated in the currently proposed regulations. The Department is developing guidance to assist the affected facilities in implementing and complying with the new requirements.
Rural Area Flexibility Analysis
Types and Estimated Numbers of Rural Areas:
There are 106 affected facilities with approximately 120 CT units located in 40 of the 43 rural counties in New York State. Including the total from 11 other counties that have a population of 200,000 or greater, and towns with population densities of 150 persons or fewer per square mile, brings the total to 309 registrants and 426 CT scanners. The statewide totals were 436 registrants and 596 CT scanners for facilities outside of New York City.
Reporting, Recordkeeping and Other Compliance Requirements; and Professional Services:
A misadministration involving a CT-scan must be reported to the Department in writing within 15 days of occurrence. CT misadministrations are distinguished from events involving other diagnostic imaging modalities because of the greater risk associated with the radiation dose and contrast agents used in CTs. No additional professional service costs are anticipated for already accredited facilities. Facilities will be required to maintain records of quality assurance test results and accreditation documents for review by the Department’s inspectors. Compliance with the recordkeeping requirements will require only a minor incremental amount of time and effort for affected facilities.
Costs:
The cost to comply with the accreditation requirement will be an initial $7550 every three years. This will be a new cost to approximately 25% of the facilities that will be subject to the proposed 10 NYCRR § 16.59, because 75% of the facilities are either currently accredited or have an application for accreditation pending. Facilities that are currently accredited or have an application pending have done so for a number of reasons. However the main reason facilities have pursued accreditation is to meet the 2012 CMS requirements for Medicare Part B payments.
Minimizing Adverse Impact:
Facilities will have 12 months to become accredited. This will allow a facility adequate time to select the accreditation body of their choice, complete an application and budget funds for the accreditation fee.
Rural Area Participation:
A copy of the proposed regulations was sent via e-mail to members of the New York State chapter of the American College of Radiology and to members of the American Association of Physicists in Medicine for review. The only comments received back were of a technical nature requiring clarification of the proposal. No comments were received objecting to the cost of accreditation.
Job Impact Statement
Nature of Impact:
It is anticipated that no jobs will be adversely affected by this rule. Diagnostic imaging providers in New York will need to become familiar with, and implement the new regulatory requirements set forth in the proposed 10 NYCRR § 16.59. The Department does not expect that the new regulatory requirements would significantly change the training or experience requirements of radiological technologists or physicians. The Department anticipates that few if any persons will be adversely affected. Facility staff, specifically those designated as the radiation safety officer, medical physicist, radiological technologist especially CT technologists will need to become familiar with the new requirements.
Categories and Numbers Affected:
There are approximately 440 facilities with a total of about 600 CT units that would be subject to the rule. The registered facilities include 150 hospitals or their satellite facilities with approximately 300 of the CT units. The other 300 registrants (typically with only 1 CT at each site) represent individual or group practice physicians.
Regions of Adverse Impact:
No areas will be adversely affected.
Minimizing Adverse Impact:
There are no alternatives to the proposed regulations. The Department will revise guidance to assist all licensees, including those in rural areas, with implementation of the proposed regulations.
Self-Employment Opportunities:
The rule is expected to have minimal impact on self-employment opportunities since the majority of providers that will be affected by the rule are not sole proprietorships.
