Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 127.000 - Licensing Of Mammography Facilities
Requirements
Section 127.020 - Clinical Quality Assurance/Recordkeeping

Universal Citation: 105 CMR 127.000 MA Code of Regs 127.020

Current through Register 1531, September 27, 2024

(A) Responsible Physician Reports: The Responsible Physician, or his or her designee, shall maintain a recordkeeping system for each patient, with a record of the mammography services the facility provides, including:

(1) The date the mammography procedure was performed;

(2) The name, address, and date of birth of the patient;

(3) A description of the procedures performed;

(4) The name and business address of the referring physician or other person to whom mammogram(s) (images) are loaned or otherwise transferred on a temporary basis; the date the mammograms are sent; and the date the mammograms are expected to be retrieved by the mammography facility.

(B) Interpreting Physician Reports: The Interpreting Physician shall:

(1) Review the patient's previous mammograms, when available, in the process of interpreting the current mammogram(s);

(2) Prepare and sign a written report on his or her interpretation of the mammogram(s);

(3) Provide a copy of the written report and the images to the patient's mammography facility for inclusion in the patient's medical record;

(4) Provide a written statement to the patient, either through a referring physician or his or her designate, or, if a referring physician is not available, directly to the patient, by mail, secure electronic submission, or secure web-based access. This statement:
(a) Shall be written in clear plain language that a lay person can understand. The facility shall use reasonable means to communicate the required information to patients who are not proficient in reading English or are blind or visually impaired.

(b) Shall describe the test results and the importance of mammography to the patient's ongoing health (including, if her results suggest other than routine mammographic follow-up, a description of the next steps), as well as the patient's responsibility to share with any new physician or facility performing her next mammography procedure the date and place of her previous mammography procedure;

(c) Shall record the following information:
1. Date of the procedure;

2. Name and address of the facility providing the procedure;

3. Name of the physician (if any) to whom the patient wants a copy to be sent; and

4. Indication that images are being provided to the mammography facility for inclusion in the patient's medical record.

(5) Communicate all reports that suggest other than routine mammographic follow-up to the patient and/or the referring physician or his or her designated representative by telephone, certified mail, or other means of communication in such a manner that receipt is assured and documented;

(6) Provide 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. This written notification shall be in terms easily understood by a lay person and include, at a minimum, the following information:
(a) That the patient's mammogram shows dense breast tissue;

(b) That the degree of density is apparent and an explanation of that degree of density;

(c) That dense breast tissue is common and not abnormal but that dense breast tissue may increase the risk of breast cancer;

(d) That dense breast tissue can make it more difficult to find cancer on a mammogram and that additional testing may be needed for reliable breast cancer screening;

(e) That additional screening may be advisable and that the patient should discuss the results of the mammogram with the patient's referring physician or primary care physician;

(f) That the patient has the right to discuss the results of the patient's mammogram with the interpreting radiologist or the referring physician;

(g) That a report of the patient's mammogram has been sent to the referring physician and will become part of the patient's medical record; and

(h) Where the patient can find additional information about dense breast tissue.

(C) Health Questionnaire. Before the initial procedure at the facility, the patient shall fill out a health questionnaire specific to breast cancer risk factors. The questionnaire shall be placed in the patient's medical record at the facility. The questionnaire shall require information on at least the following:

(1) Past history of breast cancer;

(2) Family history of breast cancer;

(3) Age of onset of menses and menopause;

(4) Hormones;

(5) Surgery;

(6) Time and place of previous mammogram; and

(7) Child bearing history.

(D) Record Management.

(1) The facility shall develop and implement policies and procedures for record management.

(2) All mammograms (images), reports and other related patient medical records are confidential and shall not be disclosed without the written authorization of the patient or his or her representative except in response to a court order.

(E) Record Retention.

(1) All records required under 105 CMR 127.020(A) and (B) must be retained in the patient's permanent medical records at the mammography facility for a period of ten years following the date of service or, for hospitals and clinics, the records retention period specifies in M.G.L. c. 111, § 70; or

(2) Until such time as the patient should request that the patient's medical records be forwarded to a medical institution or a healthcare provider designated by the patient; and,

(3) If the facility should cease to operate before the end of the ten year period, the records must be retained in a manner which provides security and which permits former patients or their healthcare provider access to them for the remainder of the ten year period.

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