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| Volume 7, Issue 2                                                                                                                                                                                                                                                                                                                                                                                                                                                           |   | Spring 2000 |
| In This Issue...Adding the FFDM System to Your MQSA CertificateMammography Today Update!From the DirectorNew Mammography Program WebsiteEnsuring High-Quality Mammography:  Spotlight on InspectorsInspection Fee Payment ReminderRecognizing Inspectors' ServiceFDA Addresses Consumer IssuesQ&AAccreditation, Certification, and Commercial Products                                                                                                                  | Ensuring High-Quality Mammography:  Spotlight on Inspectors

With the five-year anniversary of the MQSA Inspection Program last fall, FDA began honoring inspectors who have provided five years of service in making high-quality mammography a reality. Given this milestone, now is an appropriate moment to highlight two of our program's dedicated inspectors. Tom Garvin, a seasoned FDA inspector from Milwaukee, Wisconsin, was one of the first to go through the Agency's training program in 1994. Mary James hails from Columbia, South Carolina, where she has served as a State inspector for less than one year.

**Tom Garvin**Working with the MQSA Inspection Program from Day One 

"My career with FDA began in the late 1970s — a time before specialization of inspectors was widespread," Tom Garvin recalled. Originally conducting food inspections, Garvin was tapped to receive training in Diagnostic X-ray Surveys in 1979. This career turn allowed him to perform x-ray field tests on a variety of equipment, serve as the principal inspector performing medical device inspections at the many General Electric facilities in his native Wisconsin, and conduct radiological inspections/ injury investigations before becoming an x-ray auditor in 1988. 

Based on his extensive experience with FDA's radiological health programs, Garvin was asked in 1993 to serve as an advisor to FDA as it implemented MQSA. His years of experience qualified him to provide the "field perspective" in the planning and implementation of FDA and State inspector training. "My fellow x-ray auditors and four select State personnel became the first guinea pigs for MQSA training courses," Garvin joked. Among the first group of MQSA Auditors FDA selected in 1994, he works closely with 12 State inspectors in four states in this role.

Beyond his professional experience, Garvin has a B.S. in Zoology, including more than 100 semester hours in the biological and physical sciences. To maintain his inspection proficiency, he conducts independent and joint audit inspections and attends professional meetings, such as those sponsored by the Radiological Society of North America and the Conference of Radiation Control Program Directors.

Drawing on his professional experience and education, Garvin works to ensure that the inspection experience is positive for the facilities he inspects. He cited the MQSA Inspection Program as a role model that fosters a positive attitude by distributing educational materials to the facilities — unparalleled in Garvin's experience within FDA. MQSA also has created a cooperative environment through its policy of pre-announcing inspections, allowing facilities to adjust patient schedules and review their inspection documentation, which reduces onsite inspection time.

**Mary James**Building on a Registered Mammographer Background

Certified as an MQSA inspector in July 1999, Mary James has worked in mammography since 1993, when she obtained her Associates Degree in Allied Health. James is a registered technologist and holds advanced certifications in mammography and quality management. Before becoming an inspector, she worked in a hospital for two years and then in a private practice outpatient radiology office, where she served as the quality control (QC) technologist for five years. In addition to performing mammograms in that practice, James performed sterotactic breast biopsies, DEXA bone density scans, ultrasound procedures, fluoroscopy exams, and plain films.

"I worked with a wonderful group of radiologists, who taught me about mammography and always expected me to perform at my personal best," James said. In addition to these radiologists, she credits the technologists, medical physicists, inspectors, service technicians, film representatives, and especially her patients for building her knowledge base.

That base never stops expanding, as James works to maintain her certification as an MQSA inspector. Similar to her past efforts to keep current as a registered mammographer, she reported, "I attend mammography seminars and take advantage of my affiliation with the American Society of Radiologic Technologists by using the directed readings in mammography."

Like Garvin, James goes the extra mile to make the inspection process a positive experience. Commenting on the anxiety some facility staff feel when she calls to schedule an inspection, James tries to ease their fears by letting them know what to expect during the inspection and informing them that they will receive a faxed confirmation that details the inspection process. "If facilities know you share their goal of ensuring the quality of their mammography program to provide the best patient care, the inspection will be a positive experience," she explained.

**An Educational Experience**

Garvin and James agree that setting a positive tone includes making the inspection educational — one of FDA's goals. In fact, Garvin noted, inspectors "go out of their way to educate facilities on compliance issues." This information exchange occurs when inspectors act as resources via the phone or during the inspection or by some States distributing policy documents and technical data to sites within their jurisdiction. In sum, Garvin said, "The philosophy of the FDA field staff and State inspectors has been to guide facilities so they can voluntarily achieve compliance."

James believes that the goal of making an inspection educational has been largely achieved. Having been on both sides of an inspection allows her to project an attitude that the inspection provides an educational benefit to a facility's QC program. "I don't want technologists to feel I am looking for something to be wrong so that I can cite them. I want to be sure their program is working at its best to provide the highest quality images to their patients," she explained. James imparts educational information by helping facilities understand the reasons behind the QC program and regulations. "If I were to just cite them for a violation, I would be doing an injustice to the reason behind an inspection. I tell the facilities about websites that help clarify the final regulations, updates, and Mammography Matters," she noted.

But how do Garvin and James avoid "crossing the line" — educating facilities without acting as a consultant? Garvin explained that he offers independent suggestions without steering facilities toward a specific commercial product or service. For James, maintaining the distinction between the two roles means not telling a facility how its QC program should be run, particularly because "what works best for one facility does not always work for another. I simply help the facilities understand the regulations and the reasons behind them."

**Inspection Findings**

To ensure accuracy in measurements among facility inspections, FDA calibrates mammography test equipment annually. We asked our two inspectors if facilities were interested in this information. Probably not, said Garvin, although "I think they presume we are using calibrated equipment. As regulators, it is critical that our equipment be traceable to a national standard." James, in contrast, thinks facilities are interested in this information, "especially when there is a violation that involves testing with our equipment." However, she usually discusses equipment calibration with facilities "only if they question my results or ask about my equipment."

Occasionally, a facility disagrees with the inspection findings. Garvin and James were asked to comment on what recourse a facility has in this situation. Garvin first noted that of the more than 2,000 inspections in his district since the first MQSA inspections in January 1995, only about six have had disputed items. However, he explained, when a site does disagree with findings, it should voice its concerns during the exit interview. If the inspector erred, he or she can revise the Post-Inspection Report at that time. "The inspector's supervisor should be informed of any significant concerns. Should concerns persist, the FDA auditor or FDA Facility Hotline are suitable conduits for voicing these issues," Garvin concluded.

James concurred that a facility should discuss its disagreement with the findings with the inspector. And, she continued, "the facility can contact my supervisor, who can review my records and inspection report." Like Garvin, James advised, "If the issue cannot be resolved at that level, the facility can contact the FDA to question the findings."

**Impact of Final Regulations**

With the passage of the final MQSA regulations in April 1999, what effect, if any, have Garvin and James seen in inspection findings? Garvin commented that he has seen an increase in the Level-1 and Level-2 noncompliance findings. "The most common Level-1 finding has been from failure to perform a weekly phantom test." For Level-2 citations, the most common have involved the Complaint File and Infection Control Policies. "Many sites didn't realize they had a regulatory obligation to report serious unresolved complaints to their accreditation body," he explained. 

James also has seen an increase in infection control and phantom image findings, noting as well increased findings in the assessment category and consumer complaint areas. "Most of these increases have resulted from misinterpretation of the wording of the final regulations," she explained. "Some facilities are unaware of the MQSA Guidance documents, which can clarify misinterpretation. I give these facilities the website address for the Policy Guidance Help System [PGHS] or, if they do not have Internet access, copies of these documents or the Facts-on-Demand number," James concluded.

**Effect of New Software and Laptops**

Garvin and James also discussed the impact of FDA's new inspection software, implemented in July 1999. Garvin doesn't believe the new software has impacted the facilities "to any great degree," although James noted the "overall positive impact on the inspection process." Garvin explained that as the compliance contact for the Inspection Program with the Minneapolis District, he finds that changes to the Compliance-Tracking software have been far more significant. "Once an inspection is uploaded from the inspector's laptop, I have access not only to the Post-Inspection Report, but to all of the inspector's comments and other data entry items. This advance has resulted in improved customer service in responding to facilities that submit corrective action plans." 

James noted that because the new software provides previous dates and information, inspectors spend less time looking for information that wouldn't have changed from year to year. She added that although the software lacks flexibility in some finding areas, inspectors can use the inspector remark areas for additional comments. 

Both inspectors concluded their remarks on the new software by citing the benefits of another software tool, the MQSA Final Regulations PGHS. Garvin praised this system as a "superb resource that greatly simplifies finding help on all MQSA topics by correlating the regulations to FDA policies." He encourages sites to access this search engine online or download it for offline browsing. James added that the search engine is "very useful when trying to locate information during an inspection."

To help facilitate reporting of inspection data and access to the PGHS, FDA began providing inspectors with laptops in 1994. Have laptops made the inspection process more efficient? "Very much so," said Garvin, pointing to FDA's Minneapolis District's completion of 500+ inspections each year with only 12 inspectors, most of whom are State employees with duties beyond MQSA. James noted that "the laptop is a tremendous help in inspection efficiency, allowing me to follow the software and see areas that are complete and missing information. With the missing data report, I can be sure all inspection areas are covered." |
| ***Facility Hotline***Call the facility telephone hotline (1-800-838-7715) or fax (410-290-6351) for more information about FDA certification or inspections.                                                                                                                                                                                                                                                                                                               |
| *Mammography Matters*is a quarterly publication of the Division of Mammography Quality and Radiation Programs (DMQRP), Center for Devices and Radiological Health (CDRH), Food and Drug Administration. Its purpose is to help mammography facilities comply with the requirements of the Mammography Quality Standards Act of 1992. Comments should be addressed to: *Mammography Matters* | FDA/CDRH (HFZ-240) | 1350 Piccard Drive | Rockville, MD 20850Fax 301-594-3306 |