MASSACHUSETTS RADIOLOGICAL SOCIETY, iNC.
CHAPTER OF THE AMERICAN COLLEGE OF RADIOLOGY
P. O. Box 549132, Waltham, MA 02454-9132 · (781) 434-7314 · Fax: (781) 464-4896 · www.massrad.org
_________________________________________________________________________________________________
PRESIDENT
Deborah Levine, MD, FACR
Professor of Radiology
Vice Chair of Academic Affairs,
Director of Ob/Gyn Ultrasound
Department of Radiology
Beth Israel Deaconess Medical Center
330 Brookline Ave
Boston, MA 02215
617-667-8901
PRESIDENT-ELECT
Bruce G. Stewart, MD
VICE-PRESIDENT
Maryellen R.M. Sun, MD
SECRETARY
Samuel Madoff, MD
TREASURER
Rodrick Williams, MD
Leominster Hospital
60 Hospital Road
Leominster, MA 01453
(978) 466-2685
Executive Committee:
Above Officers
Jalil Afnan, MD
Giles W. Boland, MD, FACR
David J. Bindman, MD
James A. Brink, MD
Jennifer C. Broder, MD
Ilse M. Castro-Aragon, MD, BSC
Phillip M. Devlin, MD, FACR
John S. Dubrow, MD, FACR
Florian Fintelmann, MD
Martin W. Fraser, MS, FACR, FAAPM
Laurie E. Gianturco, MD
Jeffrey J. Greenberg, MD
Murray L. Janower, MD, FACR
Jonathan Kruskal, MD, FACR
Sharon J. Kuong, MD
Raymond W. Liu, MD
Neel Madan, MD
Andrea B. McKee, MD
Kaushal Mehta, MD
John E. Mignano, MD, PhD
Sishir Rao,MD
Philip A. Rogoff, MD, FACR
Max P. Rosen, MD, MPH, FACR
David A. Rosman, MD, MBA
A. Alan Semine, MD, FACR
Sanjay K. Shetty, MD, MBA
Priscilla J. Slanetz, MD, MPH, FACR
Philip E. Steeves, MD, FACR
Christoph Wald, MD, PhD, FACR
Arthur C. Waltman, MD, FACR
E. Kent Yucel, MD, FACR
Legal Counsel:
Edward J. Brennan, Jr., Esq.
80 Washington St., Suite O-53
Norwell, MA 02061
(781) 982-9143
Fax: (617) 982-7037
Chapter Administrator:
Ginny DuLong
860 Winter Street
Waltham, MA 02451
(781) 434-7314
Fax : (781) 464-4896
Rationale. The proposed deletion of language requiring a Responsible Physician be Board Certified or graduated within the past 24 months from a radiology residency is inconsistent with BORIM regulations as well as the standards that have been in place in Massachusetts from the very beginning of mammography regulations. We hope this was an oversight. For quality and safety purposes, MRS would urge that the language in the current regulations regarding Qualification of a Responsible Physician be retained.
2. Section 127.014(A). Interpreting Physician Initial Qualification. The proposed changes in section (A) are also inconsistent with BORIM regulations. The MRS strongly believes that the delineation of qualifications of an Interpreting Physician should be made by the BORIM, which regulates the practice of medicine. If the DPH regulations concerning mammography facilities addresses physician qualification, it should be consistent with BORIM regulations. The proposed Section (A) does not reflect the BORIM regulations, and if implemented as written, it would disqualify dedicated radiologists who interpret mammograms. We hope that is not the intent. It is difficult enough to recruit and retain physicians specializing in mammography.
MRS would recommend that clause (3) be re-written to be consistent with BORIM regulation 243 CMR 2.07 (24)(a) 2, 3 and 4. Therefore, DPH regulation 127.014 (A)(3) should be expanded to 2 clauses as follows:
“3. Has American Board of Radiology (ABR) or American Osteopathy Board of Radiology (AOBR) certification, or has successfully completed and graduated from an accredited radiology residency within the past 24 months; or
4. Has had at least three months of documented formal training in the interpretation of mammograms and in topics relating to mammography. The training shall include instruction in radiation physics, including radiation physics specific to mammography, radiation effects and radiation protection. The mammographic interpretation component shall be under the direct supervision of a physician who meets the requirements of 243 CMR 2.07 (24)(a).”
Rationale. The Board certification language in the proposed DPH regulations is accurate. However, radiology residents are unable to take their board certification exams until 15 months after graduating from residency. In order to allow these radiologists, trained in mammography during their residency, to interpret mammograms prior to becoming board certified, the 24 months provision has been in the current DPH regulations and is consistent with similar provisions in the BORIM regulations. We also note that it is important that the conjunction “or” be used rather than “and” which is in the proposed regulations.
MRS recommends that a new clause 4, referenced above, be inserted which would allow physicians who are not board certified, or within 24 months of graduating from a radiology residency, to interpret mammograms. We would recommend that the language, which is in the BORIM regulation 243 CMR 2.07 (24)(a) 4, be adopted as part of these regulations. This language was adopted by the BORIM to allow qualified radiologists who are not board certified or within 24 months of graduating from a residency to interpret mammograms. At the time the BORIM adopted the language, there were, and may still be, radiologists who fall
into this category and without this provision would be disqualified from interpreting mammograms. MRS supported the regulatory provision adopted by the BORIM, and we recommend that DPH include such language in its regulations. By doing so DPH regulations would be consistent with the BORIM and also with MQSA.
3. Section 127.020 (B) Interpreting Physician Reports. MRS supports the addition of clause (6) requiring written notification to a patient if an interpreting physician determines, based on standards set by the American College of Radiology, that the patient has dense
breast tissue. Mammography facilities have been doing this since the law became effective. Reference to the statute is appropriate, but for ease of understanding for anyone reading the regulations, perhaps a restatement of the statutory provisions would be helpful
4. Section 127.020 (E). Record Retention. Under current regulations mammography medical records must be retained for at least 10 years. We are concerned that the change to 5 years is too short and could raise issues relating to appropriate medical record retention for the benefit of patients and also raise medical/legal issues. The BORIM requires physicians to maintain medical records for at least 7 years. While a mammography facility is not regulated by the BORIM, MRS believes that the appropriate retention period for mammography records should be the current 10 years. This should be consistent for all mammography facilities including hospitals, clinics and physician offices. We would recommend that the current regulatory provision be retained, which requires all mammography facilities retain mammography records for at least 10 years.
II. Medical Physics
1. 127.005 Definitions:
Film Screen Mammography. Mammography images have become digital and the use of film has become obsolete. We do not know whether film is still being used in mammography facilities in Massachusetts. If there are no facilities using film, we are prepared to recommend that reference to “film” throughout these regulations be removed in favor of “images.” However, if film is still being used we would then support the use of the word “film” as used in these proposed regulations.
Half Value layer (HVL). There appears to be a typo in the definition. The number “2” in the phrase “is reduced to 2 of its original value” should be replaced with the number “1/2”.
Mammography Unit or Units. Delete in the 3rd line the word “tube” and substitute the word “X-ray source.” The phrase should read “…an X-ray housing assembly…” This would allow for future inclusion of non-tube (solid state) source.
Xeromammography. Delete the definition. This is an obsolete modality.
2. Section 127.013 Requirements of Medical Physics. The MRS believes the qualifications for a medical physicist qualified to be employed in a mammography facility should be consistent with ACR accreditation requirements, which are similar to the current provisions of Section 127.013. Therefore, we recommend that the current language requiring certification in clause (1) and the education requirements in clause (2) be retained to make clear the minimum qualifications of medical physicists performing services at mammography facilities.
3. Section 127.016 Optimum Exposure Ranges. In the 3rd line there appears to be a typo. The word “3mg” should be changed to “3mGy”
4. Section 127.020 (D)(2) Record Management. The phrase “All mammograms (films)” should be changed to an all-encompassing phrase that better defines the required provision, which is: “All mammograms (images)…”