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Prior to the passage of the Mammography Quality Standards Act (MQSA), there were many inconsistencies in mammography practices throughout the country, including mammographic equipment testing, quality control (QC) procedures and frequencies, and training of mammography personnel. Some of these inconsistencies led to the performance of suboptimal mammography. The key to a successful prognosis for breast cancer is early detection. Early detection of areas in the breast containing tiny microcalcifications requires excellence in image resolution. Equipment, QC, and personnel have a direct impact on image resolution. Poorly operating equipment, processors out of limits, or improperly positioned mammographic images can all lead to missed breast cancers. Missed breast cancers negatively impact patients and their families as well as facilities and staff.
For this reason, it is imperative to do everything possible to ensure that patients receive the best mammography possible. Accreditation through the American College of Radiology (ACR) as well as successful results in the annual MQSA inspections can reassure patients and referring physicians that this is the case. It is proof to everyone that a facility performs quality mammography, on quality equipment, by qualified, competent staff.
Obtaining perfection year after year in a mammography facility on an annual MQSA inspection is no easy task. It does not just happen, but rather requires good communication, excellent documentation, and much hard work and dedication by an entire breast imaging team. During the past 5 years, the author has undergone 12 MQSA inspections at various sites, all ending with a “No Findings Rating”-a perfect score. What follows are the 25 reasons for this success: hopefully, these suggestions will prove valuable to those who are planning for an MQSA inspection.
1. ACR accreditation and an MQSA inspection are not one and the same.
Many administrators not directly involved with mammography often confuse accreditation with the MQSA inspection. Accreditation by an accrediting body, of which the ACR is one, is required by the FDA in order to meet MQSA guidelines, but that is only one small piece of the puzzle. ACR accreditation, which occurs on a triennial basis, involves QC tasks and frequencies, personnel requirements (radiologist, technologist, and physicist), and image evaluation. The MQSA inspection, on the other hand, occurs on an annual basis and involves not only many of the ACR tasks, but also development of an infection control policy, a medical outcomes audit, a consumer complaint mechanism, as well as timely communication of results and recommendations to referring physicians and to the patients themselves. The MQSA requirements either meet or in many cases exceed those of the ACR. In states where the state is not an accrediting body, ACR accreditation is a prerequisite for FDA certification.
2. The administrators of the department or facility must have a good overall understanding of the law.
Frequently, administrators or managers delegate responsibility for compliance to a QC technologist or an office staff member who handles QC tasks, documentation, and reports. Even though an administrator does not perform the QC tasks on a regular basis, they should be fully informed as to what must be done, when it must be done, and what the results must be if a facility is to continue processing clinical images. Talk regularly with the QC technologist and review QC logs together. It is important to spend time reviewing MQSA guidelines and talking with the MQSA inspector; the film, processor, and equipment vendors; as well as the physicist. Staff credentials and continuing education unit (CEU) documentation need to be reviewed. It also is advisable to check the state and American Registry of Radiologic Technologists (ARRT) Web sites to be certain that technologists are in fact properly credentialed and that their credentials are up to date. One should never assume anything. The manager must be an active part of the MQSA process. And if there is a failed MQSA inspection, it is not because the QC technician forgot to run “the strip” in the morning. The manager ultimately must assume responsibility for the failure.
3. The MQSA interim regulations of 1994 and the final regulations of 1999 are not the same. If you are following the interim regulations, then you are in violation of the MQSA.
In 1994, the MQSA and interim regulations came into existence. At the time, many of the regulations were based on those required for ACR accreditation as those guidelines had been in existence for quite a period of time and were widely accepted by mammography facilities throughout the country. In 1999, when the final MQSA regulations were released, many changes were made. These changes affected the requirements for initial and continuing experience of personnel, the QC task frequencies, the number of cases that needed to be read/performed by qualified personnel (radiologists, technologists, physicists), and mammography equipment specifications. The final regulations also included a consumer complaint mechanism, communication of results to referring physicians and patients, and an infection control policy, to name just a few. In general, the final regulations toughened many of the interim standards for equipment, QA/QC, personnel, and requirements for accrediting bodies.
4. Initial and continuing requirements for technologists, radiologists, and physicists are not the same and new personnel standards vary from those established for personnel during the interim regulation time period.
Just as an example, a radiologist initially must be licensed by the state to practice medicine and be certified by the American Board of Radiology (ABR), the American Osteopathic Board of Radiology (AOBR), or have 3 months of documented training in mammography interpretation as well as have interpreted 240 cases within 6 months. Continuing requirements include 15 CME in mammography and interpretation of 960 examinations in 24 months. Technologists initially must be licensed by their state or certified by the ARRT and have 40 hours of documented training specific to mammography, breast anatomy, pathology, etc and have performed 25 mammograms under direct supervision of a qualified technologist. Continuing experience requirements include 15 CEU credits specific to mammography in 36 months as well as the performance of 200 mammograms in 24 months. Physicists must initially be licensed by the state and have an MS degree in physical science with 20 hours in physics plus 20 hours of documented training in conducting mammography surveys, plus have performed 10 surveys, plus have completed 8 hours of training per modality. Continuing experience requirements are that 15 CEU be obtained in 36 months plus that six surveys be conducted in at least two facilities in 24 months. Because interim regulations were not as stringent for all categories of personnel, it is important to remember that new staff, be it radiologist, technologist, or physicist coming on board in mammography today, will be held to the higher standard of the final regulations.
5. Temporary, casual status, or per diem staff will be held to the same standards as all other mammography staff.
The FDA has granted no leniency for part- time, casual, temporary, or per diem staff, be they technologists, radiologists, or physicists. All personnel performing or interpreting mammography or testing mammography equipment will be held to the same standards as all regular staff. There are no exceptions. At the time these personnel are hired, require that they show you their state licenses, ABR, or ARRT certificates, evidence of CEU or CME, as well as documentation of continuing experience. This documentation will be required for future MQSA inspections even if the employee worked only 1 day or 1 hour at a facility.
6. General radiographic viewbox lighting and mammographic viewbox lighting are not the same.
Standard viewboxes for image review have a luminance level of 1,000 nit; however, mammographic viewbox luminance levels are required to be at 3,000 nit. Under no circumstances should mammography images be reviewed on standard viewboxes in daylight conditions. Mammography films are read in darkened reading areas on high luminance viewboxes using magnifying glasses. Microcalcifications, often the beginning stages of a ductal carcinoma in situ (DCIS), will not be seen under standard viewing conditions. It is also important to remember that when one viewbox bulb is replaced, all mammography viewbox bulbs must be replaced at that time as viewbox luminance must be consistent on all viewbox panels.
7. Film processing solutions must meet film manufacturers’ minimum developing specifications.
Processing solutions were designed to allow a specific type/brand film to exhibit optimal contrast and density. It does little good nor is it now acceptable to use processing? solutions designed for one type/brand of film on another type/brand of film.
8. Written communication of results is now required both to the referring physician as well as to the patient in a timely manner.
In the past, sending a formal report to a patient’s referring physician was enough. Did those results ever get conveyed to the patient, and, if they did, was it done in a timely manner? To be certain that patients are always kept informed and that no results or recommendations for follow-up get lost in the cracks, the FDA requires that results be sent both to the referring physician as well as to the patient. With the final regulations, it specifies that the patient’s results and follow-up recommendations must be written in simple layman’s terms, which they can understand. It also specifies that the written report must include the patient’s name and identifier, the physician’s name, an overall assessment of findings, as well as recommendations for additional action if necessary. A timely manner generally means that the report must be provided within 30 days of the examination, unless it is highly suggestive for malignancy, which means it should then be provided within 1 week of the examination.
9. Original mammograms must be transferred upon request.
In the past, many facilities not wishing to part with their original films sent copies to the patients to use for comparison. Unfortunately, the resolution of the original films surpasses that of copy films, which could impact the outcome. The FDA now requires that the original films must be transferred to a referring physician, medical institution, or the patient upon request or on behalf of the patient.
10. Mammography reports and films must be maintained minimally for 5 years, unless they represent the only mammogram a patient ever had, then it is 10 years, unless state law specifies otherwise.
Many institutions routinely purge radiology film files every 5 years; if your facility does so, it is imperative that mammograms be treated differently if you are to abide by the FDA final regulations.
11. Annual equipment tests are not an option.
According to the MQSA, specific equipment tests such as AEC reproducibility, kV(p) accuracy, focal spot condition, half-value layer measurement (HVL), mean glandular dose, and x-ray field vs light field must be performed on all mammography equipment on an annual basis. The physicist performs many of these tests. Facilities that rely on the services of private physicists should be certain to plan well in advance to get their equipment tested in a timely manner, as physicists are in great demand. Also remember that a written report of the equipment testing from the physicist is required. It does no good to get a report and not bother reading the results.
12. Complete image identification is imperative.
According to the final regulations, all mammography images must include a permanent legible identification that does not obscure anatomic structures. The information noted must include the patient’s name and identifier, the date of the examination, the view and laterality, the facility’s name and location, the technologist and mammography unit ID, as well as the cassette screen number. In the past, many facilities received comparison mammograms, which did not even have a patient’s name; now, during your annual inspection, the inspector will review actual films to be certain they contain this specific information.
13. You must identify an interpreting physician as well as qualified personnel responsible for equipment testing and QC tasks.
The FDA wants to know who ultimately is responsible for the mammography program in your facility. Who is responsible for equipment testing? Who monitors the QC program to be certain all tasks are performed in a timely manner and by the book? Who reviews the medical outcomes audit, who records the dates of that audit, who shares the findings of that audit with the remaining physician staff, who identifies any issues regarding that audit, and who records the fact that follow-up action was taken if need be? It is no longer enough to gather the data: now, you must show that the data obtained is reviewed by the appropriate persons on a regular basis, that the results are shared with others involved, and that corrective action is taken as needed.
14. You do not need a computerized program for patient follow-up.
Many vendors are offering computerized software for patient follow-up and tracking. These systems do make the task simpler; however, computerized programs are not an MQSA requirement.
15. All mammography technologists must be ARRT certified in mammography.
This is a fallacy as your technologists need meet only the MQSA regulations. Many facilities use the fact that all their technologists performing mammography are ARRT certified in mammography as a marketing tool. According to hearsay, some third-party payors are setting more stringent guidelines on who can perform the examination. The important information to remember is that your technologists performing mammography must meet the MQSA guidelines discussed earlier in this article. An administrator, however, may choose to set those standards higher for your mammography staff.
16. Mobile units must meet all QA/QC requirements.
Just because a unit is mobile does not mean that it will not be held to the same standards as any other stationary unit. It still must meet all QA/QC guidelines without exception. The operator is also required to verify performance of the mobile unit every time it is moved and before clinical cases are performed. If a unit is moved three to five times a day, performance must be verified and documented three to five times a day without fail.
17. You must establish an infection control policy.
By law, every facility is now required to establish and comply with procedures for cleaning and disinfecting mammography equipment. Documentation must be maintained showing that these policies are being followed. In order to keep things consistent in our radiology department, we added a mammography section onto our existing departmental infection control policy. We obtained the acceptable cleaning and disinfecting methods from our equipment manufacturer to be certain we were following appropriate guidelines. It is not necessary to reinvent the wheel.
18. You must have a method to resolve consumer complaints.
Patients will complain, be it founded or unfounded, and it is imperative to provide them with directions for doing so. By law we will be required to hold on to all serious complaints for a minimum of 3 years. I have created postings that are hung on all mammography examination room doors giving patients my name and phone number as well as the name and address of our accrediting body should they wish to submit a complaint. These postings have actually led to many compliments from patients, which was a rather nice and unexpected outcome. Most facilities do perform quality mammography and many patients do not know where to send the compliments; the posting gave them the answers.
19. Remember that good, accurate documentation and follow-up must become a way of life.
QC documentation, the medical outcomes audit, and corrective action taken based on physicist equipment testing must be done carefully and in a timely manner. Setting phantom images and QC strips aside until you have time to read them can lead to serious problems down the line. Will it be done accurately? Will it even fall within limits? Accuracy and consistency of documentation are imperative if your facility is to achieve perfect results.
20. Meeting MQSA requirements takes time.
Too often a facility designates a technologist to QC detail; however, it fails to allocate enough time for the necessary tasks to be performed. QC takes time, patience, energy, dedication, and expertise. It must? not be rushed or just squeezed in between patients if it is to be done accurately, appropriately, and properly.
21. Don’t wait until the last minute.
You know that you will have an annual MQSA inspection; it is no secret, therefore, prepare for the day well in advance. Don’t wait until the last minute, as procrastination will only lead to a poor inspection.
22. MQSA must be a team effort!
Success year after year with the MQSA inspection relies on the efforts of the entire mammography team, including radiologists, technologists, physicist, film manufacturers, processor folks personnel, equipment repair services, and office staff. MQSA is not just the boss’s problem, but rather, the team’s annual event. Everyone must be involved!
23. MQSA must become a way of life.
If a facility is to be successful, MQSA must take front and center every day of every week of every month of every year. It should be a given that the darkroom is cleaned daily; that the processor is always in limits before any clinical images are run; that all mammography staff, radiologists, technologists, and physicists meet all MQSA requirements without fail; and that communication to the patient and referring physician always occurs in a timely manner. There must be no exceptions. MQSA is not a 1-day event each year, but rather an ongoing event every day a mammography service is in operation.
24. A “No Findings” rating is good!
A level I citation denotes that a deviation occurred that could seriously compromise mammographic quality. A level II citation is not as serious; however, mammographic quality may still be compromised and corrective action must be submitted to the FDA in a timely manner. A level III citation denotes a minor deviation for which a facility must institute policies and procedures to correct conditions, and a “No Findings” rating is perfect. The FDA does not issue gold stars.
25. Remember that a “No Findings” rating means everyone did their job and did it well!
A perfect inspection deserves a team celebration, as it was a team effort. Share the good results with the mammography team, enjoy the aftermath, make a big deal out of the success. Be certain to thank all involved. Remember a perfect inspection means that: You are performing Quality work, on Quality equipment, by Qualified competent staff, and your patients deserve nothing less.
Shirley L. Pinette, MS, RT, is manager, Breast Imaging, Yale-New Haven Hospital, New Haven, Conn.
