Mammography Inspections

"Widespread mammographic screening has the potential to significantly reduce mortality from breast cancer. However, the effectiveness and success of such screening depend on consistent production of high-resolution, high-contrast, low-dose mammographic images. Poor quality mammograms will lower the detection rate of early breast cancer and undermine the public's confidence in the value of mammography. Furthermore, substandard mammography will generate many equivocal examinations leading to patient anxiety and the time, trouble and cost of additional tests including unnecessary biopsies. Achieving high quality at low levels of tissue irradiation requires vigilant attention to quality control. High standards must be maintained at every step of the imaging process."

State rules and federal regulations have been enacted to ensure that mammography facilities provide high quality mammograms in a safe manner to patients. State rules governing mammography can be found in division 106 of the Oregon Administrative Rules for the Control of Radiation. (Please search for 106-0700)

Mammography Federal Standards Act

At present, there are approximately 101 facilities in the state of Oregon who provide mammography service. The state of Oregon employs "health physicists" to inspect mammography facilities through the Oregon Health Services's Radiation Protection Services Section (RPS). These health physicists are experienced in evaluating all types of x-ray facilities and have, in addition, undergone rigorous training by the Food and Drug Administration (FDA) in order to obtain certification to inspect federally-certified mammography facilities.

RPS is contracted by the FDA to inspect mammography facilities for compliance with the federal regulations. Thus, RPS performs two inspections simultaneously, one for the FDA and one for the State of Oregon. The federal regulations are found in the "Mammography Quality Standards Act" (MQSA).


Based on our inspection data and experience, and the philosophy of keeping radiation exposure 'as low as reasonably achievable' (ALARA), Oregon rules supports a mammography dose limit that is lower than the current federal standard. The federal standard dictates that the dose for one cranio-caudal view be no higher than 300 millirads; Oregon dictates that the dose be no more than 200 millirads. Oregon enjoys a good reputation nationally in regards to its progressive attitudes toward radiation protection. Our inspection procedure is conducted toward educating users in good radiation safety practices. State Inspectors may, time permitting, inspect other types of x-ray equipment while they are on-site for the mammography inspection.

The mammography inspection covers the following areas:

• Equipment performance (including image quality and dose)
  
  
• The technologist's and medical physicist's quality control/quality assurance tests and tasks
  
  
• Medical audit and outcome analysis records
  
  
• Medical records (mammography reports and films)
  
  
• Personnel qualification records

The inspector will also review facility records. During the inspection facility staff may conduct their usual duties, although staff will need to be available during the records review for questions or other assistance.


Mammography Inspection Documentation Guide
(MQSA Final Rules)

(Please note: This is only a guide and does not constitute all records that may be required.) Other information could be needed depending upon what may or may not be noted at the time of inspection. The State of Oregon Radiation Protection Services provides the ADDITIONAL information listed below, to help facilities through this process. It is, however, the facility's responsibility to be informed concerning regulatory requirements and to be prepared for this inspection.


If more comprehensive information is required, please refer to the FDA document entitled "What a Mammography Facility Should Do to Prepare for the MQSA Inspection" and its addendum, as well as the FDA final regulations and the FDA "Small Entity Compliance Guide." Should you need additional clarification, please feel free to contact your inspector.

At the time of inspection you will be asked to provide the following:

• The name, title, telephone and fax numbers of the facility contact person, the responsible person that you supplied to ACR, and the person to whom the FDA should send the inspection fee notice.

• After April 28, 1999, reports must contain a final assessment of findings, i.e., negative, benign, probably benign, suspicious, highly suggestive of malignancy, incomplete. Although the final assessment findings must not vary from these categories and must be stated as written above, limited flexibility is allowed as long as the original meaning is retained.

• After April 28, 1999, all patients must receive a lay summary of their mammography results.

• Policies/procedures describing your system for:

  a. communicating mammography examination results;

  b. communicating serious findings ASAP;

  c. providing timely reports and lay summaries (within 30 days);

  d. providing a consumer complaint mechanism;

  e. providing for infection control.

• Your facility's Employer Identification Number (EIN), i.e., 94-00000.

• The room number, x-ray control serial number, manufacturer, manufacture date, and model of each mammography machine control panel.

• The radiologist's most current state license.

• The technologist's current general radiographic state license or certification from ARRT or ARCT.

• Personnel qualification records such as continuing education and experience, etc.

• A copy of the previous year's MQSA inspection report.

• Mammography patient logs for the previous 12-month period.

• Test film/s from your most current fog, film/screen contact, and phantom image tests.

• QC records for the previous twelve-month period.

• For QC tests that the technologist found to be failing at times throughout the year, documentation is required to show that corrective action was taken and occurred within the following time frames:

  QC Test	Corrective action is required within this time frame:
  Processor out of 0.15 limit - M.D.&D.D	Before further films are processed
  Processor out of + 0.03 limit - Base + fog	Before further films are processed
  Fixer retention	30 days
  Phantom image score	Before further films are processed
  Compression paddles	Before further films are processed
  Repeat analysis change >2%	30 days
  Screen/film contact	Before further examinations with errant screens
  Darkroom fog >0.05 DD	Before further films are processed

• Your facility's most current medical physicist's mammography survey report and date of the previous survey (must be no more than 14 months between surveys).

  If mammography equipment was moved or had a major repair done, a medical physics mammography equipment evaluation report must also be available for review. It is now a requirement that your physicist send reports to you within 30 days.
  
  

• Documentation demonstrating correction and response to failures, and recommendations noted in your physicist's survey report.
  Documentation regarding equipment failures must include service records and repeat test data. Correction must have occurred within the following time-frames:

  Item surveyed by Medical Physicist:	When correction/response is required:
  Phantom image score	Before further examinations are performed
  Dose	Before further examinations are performed
  All other items failed	Within 30 days
  Recommendations	Within 30 days

   

• Responsibilities of the radiologist in charge of mammography (Lead Radiologist), the QC Technologist, and the Medical Physicist.
  The responsible persons must be identified by name and at a minimum, by their general area of responsibility. It is wise (but not required) to identify the specific duties of these individuals. And, if some of these duties have been delegated to others, the individual(s) as well as their delegated duties should be indicated.

  Note: You will also be required to identify by name, the Interpreting Physician designated to review the medical audit and outcomes analysis.
  
  
  The Food and Drug Administration (FDA) site describes the documentation necessary to establish the credentials for:
  1) interpreting physicians;
  2) radiologic technologists, and
  3) medical physicists.
  Note: Once in the document, please scroll down to the tables.
  
  More Documentation for the State of Oregon Inspection
  
  The name and title of the facility administrator, CEO, president, or owner.

• Current State Radiologic Technologist's license for all mammographers.
• Certificate or card indicating ARRT Mammography Certification for all mammographers.
• The most current Oregon registration certificate/s for your mammography machine/s.
• Personnel monitoring records for the previous 12-month period.
• Repeat tests for equipment-related corrective actions taken in response to the physicist's report are required. The tests must be performed by your physicist.
• A representative from your facility's administration must be present at the inspection exit interview. A mutually acceptable time for the exit interview will be discussed at the start of the inspection. Newsletter
  
  Newsletters are periodically published and sent to registrants (x-ray facilities registered with the State of Oregon), as well as vendors who provide services to these facilities. The newsletters are intended to provide news about pertinent rules and regulations.
  
  
  Note: The Mammography Newsletter of the Radiation Protection Services is being revised.