PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
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.
Text or summary was published
in the May 6, 2015 issue of the Register, I.D. No. HLT-18-15-00008-P.
Final rule as compared with last published rule:
No changes.
Text of 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
Assessment of Public Comment
Public comments were submitted to the NYS Department of Health (DOH) in response to the regulation. The public comment period for this regulation ended on June 22, 2015. The Department received a total of 6 comments from 5 different individuals representing the medical physics community as well as comments from the Public Health and Health Planning Council members during the May 21, 2015 meeting.
The majority of the comments were from licensed medical physicists requesting clarification on specific wording or expressions used in the regulations.
COMMENT: A licensed medical physicist asked what types of CT equipment (diagnostic, simulator, dental cone beam, etc.) are covered by the annual audit requirement and what type of equipment is included in the accreditation requirement.
RESPONSE: The accreditation requirement applies to medical equipment used for diagnostic imaging. Therapy simulator, biopsy only and attenuation correction computed tomography units would not be covered by the accreditation requirement. Most of the other provisions would apply to all medical use equipment, but dental CBCT would not be required to meet the provisions of these regulations.
COMMENT: Several physicists asked where they could find the written definition of “under the direction of” used in section 16.59(d)(1).
RESPONSE: There is no formal definition for this term. The Department will issue updated guidance on CT QA requirements and will include additional clarifications at that time.
COMMENT: A licensed medical physicist asked if personnel who fit the ACR’s criteria (but who are not licensed as a medical physicist in NYS) would be able to test the CT unit during annual evaluations.
RESPONSE: New York State has licensed the practice of medical physics for about 15 years and has determined that certain activities described in these regulations must be performed by a licensed medical physicist. Where the regulations state that an activity must be performed “by a licensed medical physicist”, the individual performing the activity must actually be a licensed medical physicist. Other sections use the phrase “by or under the supervision of”, which allows non-licensed medical physicist to perform functions.
COMMENT: A licensed medical physicist asked if every misadministration (CT of a wrong patient, CT of a wrong body part) must be reported to the Department in writing. For those facilities other than Article 28 locations that are required to report to NYPORTS, the physicist further suggested that the regulations require that the facility record misadministrations and demonstrate corrective action, but that the facility need only report the misadministration if there is a high dose to the recipient (such as 5 rem whole body) or adverse effects are observed (such as hair loss or erythema).
RESPONSE: With respect to the reporting of all CT errors, this is required to ensure that the Department can improve its understanding of the frequency and nature of such errors. Article 28 facilities report all events in NYPORTS, while other facilities can make direct reports to BERP by fax, email, or letter.
COMMENT: A licensed medical physicist (LMP) asked what the term “evaluated” meant in section 16.59(e)(2)—specifically, whether it means performed or something else. The LMP also asked whether the section should state “only a licensed and qualified Medical Physicist (ACR) should be allowed to perform these annual QA tests and dose calibrations.”
RESPONSE: An LMP must evaluate the QA testing to determine if it is acceptable, but another individual may have actually made the measurements. The regulations do not reference specific accrediting body requirements since these vary and may change over time. NYS Education Law (Article 166) defines the requirements to practice as a physicist in NYS. Any questions of scope of practice should be directed to the State Education Department.
COMMENT: A licensed medical physicist asked if the NY State CT QA Guidelines should be an acceptable method for establishing a CT QA program. The commenter asked whether this rule now obviates the need to adhere to the Department of Health’s CT QA Guidelines.
RESPONSE: The requirements of 16.23(a) are still in place as referenced in 16.59(e)(1). The CT QA Guidelines will be updated to reflect changes that are in regulations, but the quality assurance program described in that guidelines are still required. These regulations are in addition to the requirements of 16.23.
COMMENT: A licensed medical physicist asked whether a radiologist is competent to write a quality assurance program.
RESPONSE: The radiologist has the final responsibility for patient imaging and is allowed to develop the quality assurance program if they are competent to do so.
COMMENT: A licensed medical physicist commented on 16.59(f)(5): “The dose received by a patient shall be recorded as organ dose.” The commenter asked how patient doses will be recorded because no scanners to date record patient dose, and because patient dose can only be estimated from dose to a phantom and utilization of very broad scaling factors.
RESPONSE: The wording of that section indicates that “reference dose delivered to a phantom or the dose received by a patient” must be recorded. The “dose delivered” that is being referred to in the following sentence can be either reference dose or actual dose.
COMMENT: A licensed medical physicist commented that with regards to the requirement of CT accreditation, that general hospital accreditation by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) does not meet the amendment’s requirement that the accrediting organization perform a review that includes the physical layout of the facility, policy and procedures, quality assurance and image assessment as it is related to CT. The commenter stated that there is a specific JCAHO accreditation that would mimic, for example, the American College of Radiology’s criteria.
RESPONSE: This is reflected in the language of the regulation 16.59(f)(7), which states that the accreditation must be in CT scanning or an equivalent as determined by the Department.
COMMENT: A licensed medical physicist commented that the proposed regulation states that CT specific misadministration does not use a dose threshold for CT errors, which is inconsistent with other diagnostic imaging error reporting.
RESPONSE: With respect to the reporting of CT errors without regard to patient dose, this is required to ensure that the Department can make a determination as to the frequency and nature of CT errors. Article 28 facilities report all events in NYPORTS, while other facilities can make direct reports to BERP either by fax, email, or letter.
COMMENT: A member of the Public Health and Health Planning Council commented that there have been discussions in the past about how difficult it is to come up with a cumulative radiation exposure dose because all the CT scans operate in slightly different ways. The member asked whether it would be possible within the context of these regulations to use the SHIN-NY or some other mechanism to keep track of patient dose.
RESPONSE: Currently CT scanners are not capable of tracking patient dose but rather use a reference dose. Reference dose can vary significantly from the actual patient dose due to patient size/weight. It is our understanding that the CT manufacturers are developing scanners that can input these variables to derive a patient dose. We plan to look at this issue when this capability becomes available.
COMMENT: A commenter asked if dose information is accessible to the ordering clinician or patient when they receive the results.
RESPONSE: The reference dose will be accessible, but a patient specific dose is not available. The actual dose can vary significantly from the reference dose.
