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MQSA Facility Satisfaction Survey - Second Segment

Archived Document - Not for Official Use

Table of Contents


MQSA Information Resources
    Internet Access and Mammography Web Site
    Aware That Information is Published Only on the Mammography Web Site
  Access to the Internet
  Have Visited the Mammography Web Site
  Publications
    "Preparing for MQSA Inspections"
  Mammography Matters
  "Mammography Facility Survey, Equipment Evaluation, and Medical Physicist Qualification Requirements Under MQSA"
  Federal Register
  Other Information Resources
    FDA's Mammography Web Site
  FDA's MQSA Hotline (1-800-838-7715)
  Information Provided by Inspector
  Policy Guidance Help System (PGHS)
  E-mail Notification of New MQSA-related Information
  Suggestions and/or Comments About MQSA Resources
    Value of the Current Resources
  Manuals and/or Forms and "Layman's" Language Would be Helpful
  Additional Resources
  Concerns

Pre-Inspection Process
  Notice of Inspection and Rescheduling of Patients
  Preparing for the Inspection
  Suggestions and/or Comments about the Pre-Inspection Process
    Preparation Time
  Suggestions for Additional Materials

Inspection Process
  Equipment and Activity
    Number of Units
  Number of Mammograms Performed Daily
  Number of Mammograms Performed on Inspection Day
  Inspection Time
  Recent and Past Inspections
  Suggestions and Comments About the Inspection Process
    Inspection should take less time and be more efficient
  Consistency
  Less Strict and Critical
  Suggestions for Improving the Process

Professionalism of the Inspector
  Inspector Attributes
  Using MQSA Hotline for Inspector Feedback

Inspection Results as Provided in the Exit Interview
  Exit Interview and Citations
  Report
  Future Inspections
  Comments and/or Suggestions
    Receive information on updates/guidelines changes
  Inspection Report
  Inspection Informative and Inspector Doing Good Job
  Cost of Inspection
  General Comments

Conclusions
  MQSA Information Resources
    Internet Access and Mammography Web Site
  Publications
  Other Resources
  Summary
  Pre-Inspection and Inspection Process
    Time Spent Preparing for MQSA Inspection
  Facility Size and Inspection Process
  Professionalism of the Inspector
  Inspection Results

Recommendations
  Communications
  Scheduling of Inspection
  Additional Resources
  Streamlining the Inspection Process
  General
  Summary

 MQSA Information Resources

At the beginning of the MQSA program, FDA/DMQRP established communication with mammography facilities as a priority. The Federal Register containing the Interim Regulations was mailed to every mammography facility. The quarterly publication, Mammography Matters, and the Facility Hotline, a 1-800 number to respond to accreditation and certification questions, were in place by 1994.

"What a Mammography Facility Should Do to Prepare for the MQSA Inspection" was distributed to all facilities in June of 1995. An addendum to this document was distributed in July 1996. "Medical Physicist’s Annual Survey Requirements" was circulated in April 1996.

By 1996, FDA was posting MQSA information on the Internet. Documents published on the web site included:

  • Federal Register notices
  • Mammography Matters
  • "What a Mammography Facility Should Do to Prepare for the MQSA Inspection" with its amendment
  • "Medical Physicist’s Annual Survey Requirements"
  • MQSA Policy Statements in a Question and Answer Format, also known as "The Policy Notebook," which is the predecessor of today's Policy Guidance Help System (PGHS).

In the 1997 customer satisfaction survey, facilities were asked to evaluate these resources on a scale of 1-7 with "7" representing "Most useful" and "1" representing "Not useful at all." In addition, respondents were given the option of selecting "Unknown" and "No access." In the 2001 customer satisfaction survey, facilities were asked to evaluate these same resources.

Between 1997 and 2001, major changes in the way FDA communicated with the mammography facilities took place. In 2000, in keeping with FDA's policy of making information available primarily on the Internet, FDA stopped mailing MQSA information to facilities and other interested parties and began publishing it exclusively on its Mammography web site.

In 1999, the PGHS was developed, replacing "The Policy Notebook." The PGHS presents FDA-approved guidance organized by Final Regulation citation. Most information is presented in a question and answer format. It is available on the Mammography web site as both an on-line system and a file that can be downloaded to run on systems using Windows 95/98/NT/2000. In addition, FDA established a ListServ e-mail notification system to alert subscribers to the publication of new and updated information on the web site.

As a result of these events, questions regarding respondents’ access to the Internet, including e-mail notification and the PGHS, were included in the 2001 survey.

As in the 1997 survey, facilities were asked to evaluate these resources on a scale of 1–7 with "7" representing "Very useful" and "1" being "Not useful." Respondents were also given the option of selecting "No access" or "Have access, but didn't use."

The 1997 Survey Report focused only on the rated (1–7) responses regarding usefulness of each resource and did not include the "No access" and "Unknown" responses in the analysis. For the 2001 Survey Report, SciComm elected to include all responses and incorporated the 1997 data for the excluded responses in this analysis. Charts that show the comparisons between the 1997 and 2001 surveys as presented in the 1997 Survey Report with the "No access" and "Unknown" data excluded may be found in Appendix D.

Internet Access and Mammography Web Site

In 2000, FDA ceased all mailing of MQSA documents and publications and began publishing MQSA-related information only on the Mammography web site. Because this is the only access facilities currently have to MQSA information, FDA wanted to know if the respondents were aware that the information was being published exclusively on the web site, where (and if) respondents have access to the Internet, and whether they have visited the Mammography web site.

Only 49% of the RTs who responded to the survey knew that information is published only on the web site, while 65% of the Administrators knew. The RTs were also less likely to have access to the Internet at work (54%) than the Administrators (86%). This is significant in that RTs made up 81% of the 737 respondents and, therefore, were most often the facility representative for the inspection.

 

Radiologic Technologist
599 (81%)

Administrator

74 (10%)

Other (MD, DO, Physicist, Other)
64 (9%)

Aware that information is published only on the Mammography web site

49%

65%

67%

Have Internet access at work

54%

86%

72%

Have visited web site from work

34%

65%

47%

Have Internet access at home/elsewhere

78%

91%

84%

Have visited web site from home/elsewhere

38%

27%

39%

Although 78% of the RTs have Internet access at home/elsewhere, only 38% have visited the web site. Those Administrators who are aware that information is published only on the web site (65%) have also visited the web site from home/elsewhere.

Aware That Information is Published Only on the Mammography Web Site

Slightly more than half (52.3%) of the respondents were aware that MQSA information and guidance is published only on the Mammography Web Site.

Graph - Aware that MQSA Information and guidance is published only on the web site - data in paragraph above

They tended to be from larger facilities and spent more time preparing for their inspections. They were also more apt to have visited the Mammography web site.

  • Those from facilities that had 3+ mammography units were more aware (61%) than those from facilities with 2 units (48%);
  • Those who had visited the Mammography web site from work (67%) and from home/elsewhere (68%) were more aware than those who had not (43% in both cases);
  • Respondents who had spent 10+ hours preparing for the inspection were more aware (60%) than those who had spent 0–4 hours preparing (49%).

Access to the Internet

More respondents had access to the Internet at home/elsewhere (80.3%) than at work (59.5%).

Of the 436 respondents who said they had access to the Internet at work, only 63% (276) of them had actually visited the Mammography web site from work. This means that less than 40% of all respondents had visited the web site from work, a statistic which will be examined in the next section.

Graph - Have Access to Internet at Work and Home or Elsewhere - Data in text below

Respondents who had access to the Internet at work tended to be from larger facilities, had not visited the web site from home/elsewhere, and had spent more time preparing for the inspection.

  • Respondents from facilities with 3+ mammography units were more likely to have access (74%) than those from facilities with 2 units (61%) or 1 unit (56%);
  • They were less likely to have visited the Mammography web site from home/elsewhere (62%) than those who had (54%);
  • They were more likely to spend 10+ hours preparing for the inspection (69%) than 0–4 hours preparing (54%).

Of the 591 respondents who had access to the Internet from home/elsewhere, only 261 (35% of all respondents) had visited the Mammography web site from home/elsewhere.

Have Visited the Mammography Web Site

Less than 40% of the respondents have visited the Mammography web site from either work or home/elsewhere.

 

Respondents who had visited the web site from work tended to be from larger facilities and knew that MQSA information is available only on the web site. They had also visited the web site from home/elsewhere and spent more time preparing for the inspection.

Graph - Have Accessed the Mammography Web Site from Work and From Home or Elsewhere - Data follows graphic

  • They were more likely to be from facilities with 3+ mammography units (54%) than from facilities with 2 units (39%) or with 1 unit (36%);
  • They were more likely to be aware that MQSA information is published only on the Mammography web site (50%) than those who were not (26%);
  • They were more likely to have visited the web site from home/elsewhere (47%) than those who had not (34%);
  • They were more likely to have spent 10+ hours preparing for the inspection (48%) than 0–4 hours (35%).

Those who had visited the Mammography web site from home/elsewhere tended to be from facilities that performed 10 or more mammograms on a daily basis. They were more aware that MQSA information is published only on the web site, did not have access to the Internet at work, and spent less time preparing for the inspection.

  • They were more likely to be from facilities that performed 10–19 (42%) and 20+ mammograms on a daily basis (38%) than from facilities that performed 0–9 (28%);
  • They were more likely to be aware that MQSA information is published only on the Mammography web site (48%) than those who were not (25%);
  • They were less likely to have access to the Internet at work (41%) than those who did (34%) — however, those with access were more likely to have visited the web site from work (44%) than those who had not (32%);
  • They were more likely to have spent 0–4 hours preparing for the inspection (40%) than 5–9 hours preparing (30%).

When asked to offer suggestions and/or comments about the MQSA information resources, more comments were made about Internet access than any other resource.

  • 12% indicated that they had limited access to the Internet/web site;
  • 9% indicated that they had limited time for the Internet/web site;
  • 4% had just recently acquired Internet access.

Below are examples of comments that respondents provided. Additional comments may be found in Appendix C.

"If information is only on the web site it would be nice if workplaces were required to give access to the QA tech so we could use it at work. Making it a requirement is the only way I would get it."

"We have no access to web site at work. The mailings helped — we used them at work because they come directly to work. As a full-time working mother — my home time is extremely busy — my time on web sites at home is limited. Policies for small facilities who don't have these resources are left out!"

"Some of us don't have access to a computer for web site/Internet access. Making it hard to get all MQSA changes and updates. So publications are nice since we are a small facility."

"Prefer printed mailings. Internet address [sic] is available at work, but computer not often available for use by mammographer."

"I have only recently gone on-line — just in time to have the web site be new info. only. Pretty presumptuous to assume everyone has Internet access."

"We have just acquired Internet access at our facility — before this I had to go to the local library to access!"

"I was just given Internet access at work in May and I don’t have access at home, so I am not real familiar with the system yet. We used Mammography Matters to help us through inspections."

Publications

Both the 1997 and 2001 surveys asked respondents to rate four publications: Mammography Matters, Federal Register, "Preparing for MQSA Inspections" and "Mammography Facility Survey, Equipment Evaluation, and Medical Physicist Qualification Requirements Under MQSA." (Note that the last two documents carried different titles in 1997 and both were revised to reflect the Final Regulations.) "Preparing for MQSA Inspections" was the top rated publication in both surveys. In the 2001 survey, the "Mammography Facility Survey, Equipment Evaluation, and Medical Physicist Qualification Requirements Under MQSA" document was more highly rated than in the 1997 survey.

Percent of Respondents Rating Publications "Very useful"

Publication

1997

2001

Change

"Preparing for MQSA Inspections"

61.8%

60.8%

-1.0

Mammography Matters

57.1%

53.3%

-3.8

"Mammography Facility Survey, Equipment Evaluation, and Medical Physicist Qualification Requirements Under MQSA"

39.4%

45.4%

+6.0

Federal Register

27.6%

30.3%

+2.7

There has been a dramatic increase in those who reported that they have "No access" to these publications.

Percent of Respondents Who Have "No access" to Publications

Publication

1997

2001

Change

"Preparing for MQSA Inspections"

4.3%

11.5%

+7.2

Mammography Matters

3.2%

10.6%

+7.4

"Mammography Facility Survey, Equipment Evaluation, and Medical Physicist Qualification Requirements Under MQSA"

6.8%

18.9%

+12.1

Federal Register

9.0%

18.6%

+9.6

"Preparing for MQSA Inspections"

There has been no significant change in the "Very useful" rating for this publication between the 1997 and 2001 surveys. The greatest change is in the "No access" category, moving to 11.5% from 4.3%.

Respondents who found this publication "Very useful" (60.8%) were evenly distributed across the sample in terms of facility size1 and time spent preparing for the inspection. However, they did tend to be aware that MQSA information is published only on the Mammography web site, have access to the Internet at work, and have visited the Mammography web site from both work and home/elsewhere.

Graphic - Preparing for MQSA Inspections - Data follows in Text

  • Those who were aware that MQSA information is published only on the web site rated it higher (66%) than those who were not (55%);
  • Those who had access to the Internet at work rated it higher (65%) than those that did not (54%);
  • Those who had visited the Mammography web site both at work and from home/elsewhere rated it higher (69% in both instances) than those who did not (56% in both instances).

Although not statistically significant, there is a pattern that suggests that those who spent more time preparing for the inspection found this document more useful than those who spent less time.

Respondents who reported "No access" (11.5%) to the "Preparing for MQSA Inspections" document were from facilities that performed 10-19 mammograms on a daily basis and were not aware that MQSA information is published only on the Mammography web site. They also tended to have no access to the Internet at work and had not visited the Mammography web site either at work or home/elsewhere:

  • Those at facilities that performed 10–19 mammograms on a daily basis were less likely to have access (15%) than those at facilities that performed 20+ mammograms daily (9%);
  • They were not as aware that MQSA information is published only on the mammography web site (17%) as those that were (6%);
  • They were less likely to have access to the Internet at work (17%) than those who did (8%);
  • They were less likely to have visited the Mammography web site either at work (15%) or at home/elsewhere (13%) than those who had (6% and 8% respectively).

Few comments directly referenced this document.

"‘Preparing for the MQSA Inspection’ [sic] was an excellent resource that was easy to read and use."

"‘The Preparing for MQSA Inspections’ document was more informative in 1997 than the one we received this year."

____________________
1 Determination of facility size was reached by looking at the number of mammography units at a facility along with the number of mammograms performed both on a daily basis and on inspection day.

Mammography Matters

From 1994 through the Winter 2000 issue, the Mammography Matters quarterly newsletter was mailed to all certified mammography facilities, FDA-designated groups, and individuals who had asked to be put on the mailing list. Beginning with the Spring 2000 issue, the newsletter was published only on the Mammography web site.2   Publication of Mammography Matters was suspended after the Fall 2000 issue and the Mammography web site became the sole vehicle for publication and distribution of MQSA-related information.

As shown in the chart below, the greatest change in the usefulness of Mammography Matters is in the category "No access," which moved up to 10.6% from 3.2%.

Graphic - Mammography Matters - Data in text above

Respondents who indicated that they had "No access" to Mammography Matters tended to be unaware that MQSA information is published only on the Mammography web site and did not have access to the Internet at work.

  • They were not as aware that MQSA information is being published only on the web site (15%) as those who were (7%);
  • They were less likely to have access to the Internet at work (15%) than those who did (7%).

Respondents who rated Mammography Matters as "Very useful" (53.3%) were, for the most part, evenly distributed across the sample. They tended to be aware that MQSA information is published only on the Mammography web site and had visited the Mammography web site from both work and home/elsewhere.

  • Those respondents who were aware that MQSA information is published only on the web site rated it higher (62%) than those who were not (44%);
  • Those who had visited the Mammography web site from both work home/elsewhere rated Mammography Matters higher (60% and 63% respectively) than those who had not (49% and 48%).

Respondents’ comments about Mammography Matters reflect both the prestige that the publication enjoyed and the degree to which it is missed. It is also apparent from the comments that many of the respondents were unaware that publication of the newsletter had been suspended, which could account for some of the "No access" responses.

Of all the comments respondents provided about MQSA Information Resources, there were no negative comments about Mammography Matters. On the positive side:

  • 11% wanted Mammography Matters/newsletters sent to facilities;
  • 9% stated that Mammography Matters was useful.

Below is a sample of those comments:

"I was very disappointed that Mammography Matters is no longer in circulation. Access to the Internet is difficult since I must borrow someone else’s computer."

"I liked having Mammography Matters coming to my work site. I don’t have on-line access at work and don’t find the time, or take the time, to work on work at home."

"Mammography Matters was excellent. It was interesting and gave useful information (especially since I do not have access to the Internet)."

"What happened to Mammography Matters? Haven’t seen publication in several months."

"Please bring back Mammography Matters for those of us who cannot access the website at all!"

"Mammography Matters was excellent! I had just gotten permission to subscribe when they canceled. I had been getting them second-hand. Web site is a little cumbersome — plus I have to use it off-hours."

"I would recommend to continue to have copies made of Mammography Matters, etc. for the facilities that do not have Internet access."

____________________
2 The circulation of Mammography Matters was 22,500 when FDA ceased printing and mailing it.

"Mammography Facility Survey, Equipment Evaluation, and Medical Physicist Qualification Requirements Under MQSA"

There has been more change in the rating of this document than in the other publications. In 2001, 45% of the respondents rated it "Very useful" compared to 39% in 1997. And while "No access" jumped from 7% to 19%, there was a significant drop from "Unknown" (15%) to "Didn’t use" (6%). For purposes of this discussion this document will be referred to as the "Mammography Facility Survey."

Facility Survey, Equipment Evaluations adn MP Qulificiations - Data in text above

Respondents who rated the "Mammography Facility Survey" document "Very useful" tended to be from facilities that performed 20 or more mammograms on a daily basis. They also tended to be aware that MQSA information is published only on the Mammography web site, had access to the Internet at work, had visited the Mammography web site from both work and home/elsewhere, and spent 5–9 hours preparing for the inspection.

  • Those respondents from facilities that performed 20+ mammograms on a daily basis rated it higher (51%) than those from facilities performing 10–19 mammograms daily (42%);
  • Those who were aware that MQSA information is published only on the web site rated it higher (50%) than those who were not (40%);
  • Those who had Internet access at work and had visited the Mammography web site from work rated it higher (49% and 50% respectively) than those who did not (40% and 42%);
  • Those who had visited the Mammography web site at home/elsewhere rated it higher (53%) than those who had not (41%);
  • Those who had spent 5–9 hours preparing for the inspection rated it higher (52%) than those who had spent 0–4 hours (41%).

Respondents who reported they had "No access" (18.9%) to the "Mammography Facility Survey" document tended to be from facilities that performed 0–9 mammograms daily, were unaware that MQSA information is published only on the Mammography web site, did not have access to the Internet at work, and had spent 0–4 hours preparing for the inspection.

  • Those at facilities performing 0–9 mammograms on a daily basis were less likely to have access (23%) than those at facilities performing 20+ (15%);
  • They were less likely to know that MQSA information is published only on the mammography web site (27%) than those who did (12%);
  • They were less likely to have access to the Internet at work (28%) than those who did (13%);
  • They were more likely to have spent 0–4 hours preparing for the inspection (23%) than 5–9 hours (13%).

There were no comments specifically addressing the "Mammography Facility Survey" document.

Federal Register

Only 30% of the respondents rated the Federal Register as "Very useful." In 2001, twice as many respondents (19%) reported "No access" as those surveyed in 1997 (9%). The Federal Register was mailed out to all facilities in October 1997 along with The Small Entity Compliance Guide. The regulations were subsequently modified, in part to comply with provisions of the Mammography Quality Standards Reauthorization Act of 1998 (MQSRA). These modifications were announced in the Federal Register and published both in Mammography Matters and on the Mammography web site.

Respondents who found the Federal Register "Very useful" tended to be from large facilities and had visited the Mammography web site from home/elsewhere.

  • Those from facilities with 3+ mammography units rated it higher (39%) than those from facilities with 2 units (26%);
  • Those who had visited the Mammography web site from home/elsewhere rated it higher (37%) than those who had not (26%).

Graph - Federal Register - Data in Text Below

Respondents who indicated that they had "No access" to the Federal Register (18.6%) tended to be from smaller facilities, were not aware that MQSA information is published only on the Mammography web site, and did not have access to the Internet at work.

  • Those from facilities with one mammography unit were less likely to have access (22%) than those from facilities with 3+ units (12%);
  • Those respondents who were not aware that MQSA information is published only on the Mammography web site were less likely to have access (26%) than those who were aware (12%);
  • Those who did not have access to the Internet at work were less likely (25%) than those who did (14%) to have access to the Federal Register.

There were no positive comments about the usefulness of the Federal Register, while 8% of the comments indicated that it is confusing and/or difficult to interpret.

  • "The Federal Register is very difficult to read and it's hard to find the area you are looking for!"
  • "The Federal Register is not very user friendly. Clearer delineation between areas would be helpful. An index with page numbers would also be helpful."
  • "The Federal Registry [sic] needs an index that would allow you to reference specific topics without an endless search throughout the entire book."

Other Information Resources

FDA’s Mammography Web Site

The most dramatic change in usefulness of MQSA information resources occurred with the web site. In 1997, 68% of the respondents did not have access to the web site. By 2001, that figure had dropped to 24% — a 44 point change. Concurrently, there was a 26 point increase (3% to 29%) in the "Very useful" rating and a 16 point increase (4% to 20%) in the "Somewhat useful" rating.

It is important to note, however, that nearly half (48%) of the respondents either had no access or didn't use the web site.

Graph - FDA Mammography Web Site - Data in Text Above

Respondents who found the web site "Very useful" tended to be aware that MQSA information is published only on the web site, had Internet access at both work and home/elsewhere, and had visited the web site from both work and home/elsewhere.

  • Those respondents who were aware that MQSA information is published only on the Mammography web site rated it higher (40%) than those who were not (17%);
  • Those respondents who had access to the Internet at work and had visited the Mammography web site from work rated it higher (38% and 50% respectively) than those who did not (16% in both instances);
  • Those who had Internet at home/elsewhere and had visited the web site from home/elsewhere rated it higher (32% and 47% respectively) than those who did not (16% and 18%).

Respondents who reported that they have "No access" (23.6%) to the Mammography web site tended to be from smaller facilities that performed 0–9 mammograms on a daily basis, not know that MQSA information is published only on the web site, and spent 0–4 hours preparing for the inspection.

  • Those from facilities with one unit were less likely to have access to the web site (25%) than those from facilities with 3+ units (13%);
  • Those from facilities that performed 0–9 mammograms on a daily basis were less likely to have access to the web site (31%) than those from facilities performing 20+ mammograms (19%);
  • Those who were not aware that MQSA information is published only on the web site were less likely to have access (28%) than those who were (20%);
  • Those respondents who spent 0–4 hours preparing for the inspection were less likely to have access (28%) than those who had spent 10+ hours preparing (19%).

Respondents who said that they "Have access, but didn't use" (24.3%) indicated that they received enough notice of the upcoming inspection, were not aware that MQSA information is published only on the web site, and spent 5–9 hours preparing for the inspection.

  • They were more apt to have received enough notice (25%) than those who did not (7%);
  • They were less likely to know that MQSA information is published only on the web site (31%) than those who did (19%);
  • They were more likely to have spent 5–9 hours preparing for the inspection (29%) than 10+ hours (20%);

There was a mix of positive and negative comments about the Mammography web site with 9% indicating that the web site was beneficial and 6% saying that it was confusing and/or not user friendly.

Below is a sampling of the comments received.

"Web site is the best!"

"I would not have done as well without the web site and Hotline."

"The web site is great. I have downloaded the PGHS and refer to it often. I find the site easy to use and comprehensive. I wish I had Internet access at work, but I have printed out much of it to keep in the office and print relevant Mammography Matters for the techs to read."

"I am very pleased to be able to access this web site. It always answers any questions I may have."

"Did not find the web site to be user friendly. We were looking for information regarding processor and had to go thru [sic] many links to find info."

"Access to the information on the web site should not have to be downloaded to a disc. Several are Web TV systems and cannot access. We knew nothing about the 1-800 Hotline before this."

"The web site is too lengthy and to download information is extremely difficult without access to Internet at work."

FDA's MQSA Hotline (1-800-838-7715)

Respondents indicated that this resource has become more useful since the 1997 survey with a nine point increase (26% from 17%) in those who found it "Very useful." In 2001, only 4% found it "Not useful," compared to 8% in 1997. The "No access" responses experienced a similar decline, from 9% in 1997 to 5% in 2001. However, it should be noted that in both surveys 40% of the respondents either did not know about or had not used the Hotline.

Graph - FDA MQSA Hotline - Data in text above

Those who found the Hotline "Very useful" were evenly distributed across the sample.

When asked if they had contacted the Hotline, only half of the respondents (49.3% of 718) respondents indicated that they had. They tended to be from facilities with at least 2 units, were aware that MQSA information is available only on the web site, and had visited the web site from home/elsewhere.

  • They were more likely to be from facilities that have 2 units (57%) than from facilities with 1 unit (46%);.
  • They were more likely to be aware that MQSA information is being published only on the Mammography web site (53%) than those who were not (45%);
  • They were more likely to have visited the web site from home/elsewhere (56%) than those who had not (45%).

The 2001 survey indicated that there has been a positive shift in how those respondents who used the Hotline rate it.

Graph - Rate Hotline Responsiveness to Questions and Comments - Data in Text Above

The respondents who rated it "Excellent" tended to be from facilities with 2 units and had not visited the web site from work. They were likely to have spent 0–4 hours preparing for the inspection and found it both educational and beneficial.

  • Those from facilities with 2 mammography units rated it higher (59%) than those from facilities with 3+ units (41%);
  • Those who had not visited the web site from work rated it higher (59%) than those who had (46%);
  • Those who spent 0–4 hours preparing for the inspection rated it higher (63%) than those who spent 10+ hours (49%);
  • Those who rated the inspection "Very" educational and "Very" beneficial rated it higher (62% in both instances) than those who found it "Somewhat" educational and beneficial (46% and 42% respectively).

Of the comments received, 4% found the Hotline beneficial, 4% indicated that either the phones were not answered or the Hotline was not helpful/didn't answer question, and 3% said that they received inconsistent answers to questions.

"The 1-800 Hotline has been so very helpful; more so then the website."

"If I had utilized the Hotline, I could have avoided a citation. If I had understood that it was OK to document that a technologist was deficient, instead we insisted that the technologist earn and receive her CME certificates for the inspection. This task was not completed until 24 hours after the inspection. This was not the best solution, obviously."

"Couldn't get anyone to answer phone. Then when I actually got a human, when I asked my question, she said she didn't know and didn't seem to want to help me find out."

"Could not get thru [sic] on Hotline. Found it difficult to find specific answers or specific questions for that matter on website but that could be computer challenged on user's part!!"

"The Hotline attendee could not answer my questions and referred me to ACR [American College of Radiology] and my inspector (who initially asked me to call the Hotline with my question!). That was disappointing."

"Each time we've called the FDA we've gotten different answers to our questions. We called twice in one day, spoke with two different individuals with the same question and got two totally different answers."

"Response took too long."

"The FDA/MQSA Hotline gives conflicting information on the same issues."

Information Provided by Inspector

There was a significant jump (11 points) in the "Very useful" rating of "Information provided by the inspector" from 59% to 70%. Also, there was a corresponding decline in all of the other ratings.

Graph - Information Provided by Inspector - Data in text below

Although not statistically significant, there is a pattern that suggests that those who gave high ratings to the inspector-provided information spent less time preparing for the inspection.

Respondents who found information provided by the inspector to be "Very useful" indicated that they received enough notice of the upcoming inspection, and found the inspection to be both very educational and very beneficial.

  • Those respondents who said that they received enough notice of the inspection rated it higher (71%) than those who did not (53%);
  • Those respondents who found the inspection to be "Very" educational rated it higher (85%) than those who found it to be "Somewhat" educational (60%);
  • Those who found the inspection to be "Very" beneficial rated it higher (86%) than those who found it to be "Somewhat" beneficial (52%).

Comments were generally positive:

"If I have questions, I either call our physicist or inspector. They have both been very helpful."

"I love your web site. Also the inspector [specific reference omitted] has been helpful answering my questions in a timely manner. [specific reference omitted] is also helpful."

"I have contacted the local inspectors directly with questions. I have received prompt attention to my concerns."

Policy Guidance Help System (PGHS)

The PGHS is a resource that has been added since the 1997 survey. Use of this resource is dependent upon access to, and use of, the Mammography web site. Those who used the PGHS were divided between rating it "Very useful" and "Somewhat useful" with only 2.4% indicating that it was "Not useful." It is important to note that 62.6% of the 710 respondents reported that they either had "No access" or "Have access, but didn't use," with "didn't use" making up the largest group.

Respondents who rated the PGHS "Very useful" tended to be aware that MQSA information is published only on the Mammography web site, had access to the Internet both at work and home/elsewhere, and had visited the web site both at work and home/elsewhere. They also tended to spend 10 or more hours preparing for the inspection.

Graph - Usefulness of Resources - Policy guidance Help system on the Website - Data in text below

  • Those who were aware that MQSA information is published only on the Mammography web site rated it higher (28%) than those who were not (9%);
  • Those who had Internet access at work and at home/elsewhere rated it higher (24% and 21% respectively) than those who did not (11% and 9%);
  • Those who had visited the Mammography web site from work and from home/elsewhere rated it higher (34% and 32% respectively) than those who had not (10% and 11%);
  • Those who spent 10+ hours preparing for the inspection rated it higher (25%) than those who spent 0–4 hours preparing (14%).

Respondents who stated that they had "No access" (26.3%) to the PGHS tended to be from facilities with 1–2 mammography units that performed 0–9 mammograms on a daily basis and 1–10 mammograms on inspection day. They tended to be unaware that MQSA information is published only on the Mammography web site, have no access to the Internet at either work or home/elsewhere, and spent 0–4 hours preparing for the inspection.

  • Respondents from facilities with 1 or 2 units were less likely to have access (28% and 27% respectively) than those from facilities with 3+ units (15%);
  • Those from facilities that performed 0–9 mammograms on a daily basis were less likely to have access (32%) than those from facilities that performed 20+ (23%).
  • Those from facilities that performed 1–10 mammograms on the inspection day were less likely to have access (32%) than those from facilities that performed 11+ (20%);
  • They were less likely to be aware that MQSA information is published only on the Mammography web site (32%) than those who were (21%);
  • They were less likely to have Internet access at work (51%) or at home/elsewhere (49%) than those that did (9% and 21%);
  • Those who spent 0–4 hours preparing for the inspection were less likely to have access (30%) than those who spent 10+ hours preparing (22%).

Respondents who stated that they "Had access, but didn't use" the PGHS (36.3%) indicated that they had enough notice of the upcoming inspection. They tended to be unaware that MQSA information is published only on the Mammography web site, although they tended to have access to the Internet at both work and home/elsewhere.

  • They were more likely to have received enough notice of the upcoming inspection (38%) than those who had not (15%);
  • They were less likely to know that MQSA information is published only on the Mammography web site (44%) than those who did (30%);
  • They were more likely to have access to the Internet at work (45%) and home/elsewhere (38%) than those who did not (25% and 29% respectively).

When asked if they had used the PGHS, 22% said that they had. Of those, an overwhelming 93% reported that the PGHS was useful.

 

Yes 

No 

# Respondents

Used the PGHS?

22.3%

(163)

77.7

(568)

731

If so, was it useful?

92.9

(144)

7.1

(11)

155

Respondents who had used the PGHS tended to be from larger facilities that performed more than nine mammograms on a daily basis. They were aware that MQSA information is published only on the Mammography web site and they have access to, and have visited, the web site from both work and home/elsewhere. They also spent more time preparing for the inspection.

  • They were more likely to be from facilities with 3+ mammography units (31%) than facilities with 1 unit (20%);
  • They were more likely to be from facilities that performed 20+ mammograms and 10–19 mammograms on a daily basis (24% and 25% respectively) than from facilities that performed 0–9 (17%);
  • They were more likely to be aware that MQSA information is published only on the Mammography web site (35%) than those who were not (8%);
  • They were more likely to have Internet access at work and have visited the web site from work (26% and 39% respectively) than those who did not (17% and 12%);
  • They were more likely to have Internet access at home/elsewhere and have visited the web site from home/elsewhere (26% and 42% respectively) than those who did not (9% and 11%);
  • They were more likely to have spent 10+ hours preparing for the inspection (29%) than those who spent 0–4 hours (19%).

Comments about the PGHS include:

"I have downloaded the PGHS and refer to it often."

"Policy Guidance Help System very helpful!"

"Perhaps I used it incorrectly, but I could only get references to legislation."

"The Policy Guidance Help System is a little overwhelming. When using it I didn't always have a specific question I was trying to answer. Sometimes I just wanted to browse just to get the big picture of what it is all about and how much information is provided."

"I find the Policy Guidance Help System very helpful, but find I have to read through a lot that I am not particularly interested in, at that moment, to find a answer. Perhaps a more specific index would be helpful. What if my particular question is not in there?"

E-mail Notification of New MQSA-related Information

As with the PGHS, this is a new resource since 1997 and also requires both Internet and e-mail access. Sixty-nine percent of the respondents either had "No access" or "Had access, but didn't use." Of those who were aware of the service, 17% found it "Very useful" and 11% found it "Somewhat useful" with only 2% rating it "Not useful."

Respondents who found e-mail notification "Very useful" tended to be those who had not received enough notice of the upcoming inspection, were aware that MQSA information is published only on the web site, had Internet access at both work and home/elsewhere, and had visited the web site from both work and home/elsewhere.

Useflness of Email Notificaiton of New MQSA Related Information - Data Follows

  • Those who said they had not received enough notice of the upcoming inspection rated it higher (36%) than those who had (16%);
  • Those who were aware that MQSA information is published only on the Mammography web site rated it higher (26%) than those who were not (8%);
  • Those who had access to the Internet at work and had visited the web site from work rated it higher (21% and 28% respectively) than those who had not (11% in each instance);
  • Those who had access to the Internet at home/elsewhere and those who had visited the web site at home/elsewhere rated it higher (20% and 28% respectively) than those who had not (6% and 11%).

Respondents who said they had "No access" (43.1%) tended to be from smaller facilities, not know that MQSA information is published only on the web site, and have no access to the Internet at either work or home/elsewhere.

  • Those from facilities with one mammography unit were less likely to have e-mail access (45%) than those from facilities with 3+ units (33%);
  • Those who were not aware that MQSA information is published only on the Mammography web site were less likely to have e-mail access (50%) than those who were (37%);
  • Those who did not have access to the Internet at work were less likely to have e-mail notification (65%) than those who did (28%);
  • Those who did not have access to the Internet at home/elsewhere were less likely to have e-mail notification (66%) than those who did (38%).

Respondents who "Have access, but didn't use" (26.3%) tended to be unaware that MQSA information is published only on the web site and have access to the Internet at either work or home/elsewhere.

  • These respondents were less likely to know that MQSA information is published only on the Mammography web site (31%) than those who knew (22%);
  • They were more likely to have access to the Internet at work (33%) than those who did not (17%);
  • They were more likely to have access to the Internet at home/elsewhere (28%) than those who did not (19%).

Most of the comments addressed respondents’ unfamiliarity with the e-mail notification of the posting of MQSA-related information on the Mammography web site.

"E-mail notification is apparently available but has not been offered to me."

"I would like to receive email notification of new MQSA information but have not seen how to sign up."

Suggestions and/or Comments About MQSA Resources

To gain further insight into what additional resources might be useful to facilities and to find out how they feel about the current resources, respondents were asked to offer suggestions and comments. Below is a sampling of those comments. All the comments are included in Appendix C.

Value of the Current Resources

"Very resourceful and easily accessible."

"Resources are adequate and very useful."

"The resources are good!"

"I can usually get my questions answered by the resources that are now available."

"The resources are valuable and necessary — please do not cut them."

Manuals and/or Forms and "Layman’s" Language Would be Helpful

"I would like to see a compact technician-friendly manual for MQSA pre-preparation. I would like to have a MQSA Rule and Regulation manual written in layman's terms."

"I would like a book or catalog with specific sections that are user friendly! The internet takes too long."

"I do not find the question-and-answer style of our MQSA documents as helpful as the style ACR manuals have. I would like to see MQSA manuals done in this form, including the QC [Quality Control] forms standardized (easier and faster for inspector also). I would like this as I find it less confusing, a clearly written manual — even if it's so similar to ACR."

"A workbook similar to the ACR Quality Control Manual."

"A unified process, all forms and framework should be standard."

"Please consider keeping the language very simple and easy to understand. Many (most) of us are not computer literate and can easily get lost in "computer talk." Also, keep in mind that 90% of the users are us "lowly" techs — we do not have degrees in physics and we are not doctors."

"I find it difficult to translate some of the regulations."

"Updated version in layman’s terminology on all regulations. For some reason it’s difficult to keep up on the changing regs."

Additional Resources

"Specific phone calls by the representative and/or e-mail stating changes or upcoming changes to the guidelines."

"Possible ‘local’ seminars. We have had the inspectors talk at our mammography seminar and they are invaluable."

"Additional information regarding resources for my staff, radiologist, and technologists to obtain required CEU's [Continuing Education Units] at a minimal cost."

"1.) Send every MQSA facility a list of all the possible resources we could use.
2.) In or by 2001, we need a mammo tracking system in use — 2001 inspections — what will the inspector expect or what — lists, diagrams — etc?"

"More information on Mobile Mammography would be helpful."

Concerns

"We have trouble submitting the ‘Government [sic] Entity’ paperwork on time due to delays in the mail. It would be helpful if overseas military facilities could have permanent Government Entity status. After all, these facilities are extremely unlikely to be contracted out."

"We get a lot of conflicting information. Can't seem to get a clear answer."

"We need more money per exam. I lose $8,000 a year to do mams [sic] in a rural county. I will have to spend $80,000 in the next 6 months to keep losing this amount. I would like to quit doing mams but I am the only unit in the county."

"Lighten the paperwork."

Pre-Inspection Process

The pre-inspection process covers those activities that lead directly up to the inspection. They include:

  • facility notification of inspection;
  • amount of notice received;
  • rescheduling of appointments;
  • time spent preparing for the inspection.

Notice of Inspection and Rescheduling of Patients 

In 2001, 55% of the respondents said that they received more than 14 days notice compared to 39% in 1997 (a 16 point increase). There has been a corresponding drop in those who received 5–9 days notice from 27% to 14%.

When respondents were asked in the 1997 survey how much notice they felt they should have, the average time requested was 16 days. As seen in the chart below, FDA heeded that request.

Graph - Amount of Notice - Data in Text Below

In general, respondents from facilities that received at least 14 days notice indicated that they had enough notice. Those who received 9 days or less were more likely to say that they did not have enough notice.

Those who received more than 14 days notice tended to be from facilities with 1–2 mammography units, had received enough notice, and were from facilities that did not perform mammography on inspection day.

  • Those from facilities with 1 and 2 units were more likely to receive more than 14 days notice (58% in each instance) than those from facilities with 3+ units (39%);
  • They were more likely to have received enough notice (57%) than those who had not (15%);
  • They were more likely to be from facilities that did not perform mammography on inspection day (61%) than from facilities that performed 11+ mammograms (49%).

Those from facilities that received less than 10 days notice tended to be from larger facilities and to say that they had not received enough notice.

  • Those from facilities that received 5–9 days notice were more likely to be from facilities with 3+ mammography units (22%) than from facilities with 1 unit (14%) or 2 units (12%).
  • Those from facilities that received 2–4 days notice stated that they did not receive enough notice (31%) compared to those who had (1%).

When asked if they received enough notice, 94.6% stated that they did. While the number of respondents who said that they did not receive enough notice is small (40) and the data analysis is less meaningful than if the sample had been larger, it is interesting to note that there is a pattern that indicates that they tend to be from larger facilities that performed 20 or more mammograms daily and 11 or more on inspection day. They were also likely to have spent 10 or more hours preparing for the inspection.

  • They were more likely to be from facilities with 3+ units (8%) than from facilities with 1 unit (5%);
  • They were more likely to be from facilities that performed 20+ mammograms daily and 11+ mammograms on inspection day (7% in both instances) than from facilities that performed 0–9 daily and 1–10 on inspection day (3% in both instances);
  • They were more likely to have spent 10+ hours preparing (8%) than 5–9 hours (4%).

When asked if they had to reschedule patients 52% said that they did. They tended to be from facilities with 1–2 units that performed 10–19 mammograms daily, had not received enough notice, and performed 1–10 mammograms on inspection day.

  • Those from facilities with 1 unit and 2 units were more likely to have rescheduled patients (55% and 52% respectively) than those from facilities with 3+ units (37%);
  • They were more likely to be from facilities that performed 10–19 mammograms on a daily basis (58%) than from facilities that performed 20+ (48%);
  • They were less likely to have received enough notice (77%) than those who did (50%);
  • They were more likely to be from facilities that performed 1–10 mammograms on inspection day (61%) than from facilities that performed 11+ mammograms (44%) or no mammograms (49%).

Of the comments received regarding notice, 21% wanted more notice. One of the main reasons cited for requesting more notice is the need to reschedule patients. Others indicated that they had adequate notice and were prepared because they keep their records up-to-date throughout the year (24%) or that pre-inspection preparation takes minimal time (12%). Six percent indicated that flexibility in scheduling is needed, including four respondents who said that their inspector was inflexible about accommodating their scheduled vacations. See Appendix C for a complete list of all comments.

"More notice would be nice. Some patients are scheduled months in advance and don't appreciate being re-scheduled 5–10 days prior to scheduled appointment."

"As our facility gets busier (and we have only 1 unit) I think we should have at least 2–3 weeks notice for the inspection to block our schedule."

"I think we are given adequate notice to prepare. If you are adhering to MQSA guidelines you shouldn't have anything too drastic for the inspection to prepare, you should already be doing it on a daily, monthly or quarterly basis."

"Two weeks notice would be adequate time for large hospital with a large mammogram patient load. If we knew that the inspector was coming we would not schedule patients on that day."

"A 2-week notice would be nice. Keeping the paper work up to date is very difficult to maintain."

"I had to reschedule patients. This is a small town where some patients still do not have telephone facilities and some of them were rescheduled after they arrived. Two days in advance is not sufficient, when some patients are awaiting for more than 2 weeks for an appointment."

"It is wonderful to be contacted directly by the inspector to schedule our inspection. This gives us ample time to clear our schedule and plan for this day."

"I had my plane tickets for vacation already. The inspector called to say when he was coming – so I had to have everything absolutely "marked and ready" because my "2nd in command" wasn't exactly sure about everything. I just thought that he maybe could've come another week so I could have been there. Just a thought!"

Preparing for the Inspection

After being notified of the upcoming inspection, 41% of the respondents spent 0–4 hours preparing for it. The next largest group of respondents (32%) spent 10 or more hours preparing for the inspection.

Graph - After Notification, Time Spent Preparing for Inspection - See Data in Text Above

Those respondents who spent 0–4 hours preparing tended to be from smaller facilities that performed 1–10 mammograms on inspection day, were not cited, and do not have Internet access at work.

  • They were more likely to be from facilities with 1 unit (46%) than from facilities with 2 units (34%) or 3+ units (30%);
  • They were more likely to be from facilities that performed 1–10 mammograms on inspection day (49%) than from facilities that performed none (35%) or 11+ (36%);
  • They were less likely to have received any citations (45%) than those that did (35%);
  • They were less likely to have Internet access at work (48%) than those who did (37%).

Those who had spent 10 or more hours preparing tended to be from facilities with 2 or more mammography units that performed 11 or more mammograms on inspection day. They had Internet access at work and had visited the Mammography web site from work.

  • They were more likely to be from facilities with 2 units (41%) or 3+ units (39%) than from facilities with 1 unit (28%);
  • They were likely to be from facilities that performed 11+ mammograms on inspection day (38%) than from those that performed 1–10 (26%);
  • They were more likely to have Internet access work (36%) than those who did not (27%);
  • They were more likely to have visited the Mammography web site from work (38%) than those who had not (28%).

Respondents in the 2001 survey (operating under the Final Regulations) indicated that it took them longer by 1.6 hours to prepare for the inspection than it did in 1997 (under the Interim Regulations).

Time Spent Preparing for the MQSA Inspection

Hours Spent

1997

2001

Change

Minimum

0

0

---

Maximum

150

160

+ 10

Median

5

6

+ 1

Average

8.69

10.3

+ 1.61

This increase in time spent could account, in part, for the significant shift in how respondents characterized the time spent preparing for inspections (see chart below). In the 2001 survey, the average rating on the 1–7 scale was 4.2, solidly in the "Neutral" range.

Graph - Characterize time spent preparing - data in text below

In 1997, respondents indicated that 64% found the preparation time to be "Minimal" compared to only 21% in 2001 — a drop of 43 points. In 2001, more respondents were "Neutral" (69%) than in 1997 (35%) — an increase of 34 points. However, it should be noted that there was a 10 point increase in those respondents who found the time to be "Excessive" — 11% in 2001 compared to 1% in 1997.

Those who characterized the time spent preparing for the inspection as "Minimal" (20.6%) were more likely to have spent 0–4 hours preparing (43%) than those who had spent 5–9 hours (9%) or 10 or more hours (3%).

Those who characterized the time spent as "Excessive" (10.8%) tended to have spent 10 or more hours preparing, were from facilities with 2 units that performed 20 or more mammograms daily, and said that they had not received enough notice.

  • They were more likely to have spent 10+ hours preparing (23%) than 0–4 (3%) or 5-9 hours (6%);
  • They were more likely to be from facilities with 2 units (15%) than from facilities with 1 unit (9%);
  • They were more likely to be from facilities that performed 20+ mammograms daily (15%) than 10–19 (8%);
  • They were less likely to say that they had received enough notice (25%) than those who had (10%).

Suggestions and/or Comments about the Pre-Inspection Process

Preparation Time

Of those that commented on the pre-inspection process, 12% indicated that preparation time is minimal and 10% indicated that it is time-consuming.

"Preparation is an on-going process. The '2' hours represents final review of all required materials prior to inspection."

"The info provided in the pre-inspection materials were clear. We operate in a very small department, so prep for the inspection consisted mainly of putting strips phantom images, film screen contact films in easy access for the inspector to review."

"No, I felt that because I keep my records current other then rescheduling patients, no actual prep time is needed."

"My time is excessive because I am responsible for 4 facilities in a 40-mile radius. 3 satellites with 1 medical center. Time consuming to review books for each facility!"

"Less than one hour on preparation — already prepared. If by pre-inspection process you mean the entire year before the inspection getting ready for the inspection then that amount is more extensive than time given in any books. Example — it does not take 15 minutes to do a phantom image in two rooms."

"I was prepared to the point of having everything completed, except for revising the policy and procedures, which is time consuming!"

"Our inspection includes 11 mamm [sic] units at one time, even though I only have 3 on-site. That's why it takes longer to prepare."

"Cannot provide number of hours. This is a large facility with over 35 techs and to give a number to the time spent preparing is impossible."

"Getting ready for the inspection takes a lot of time, but I do not know how to improve the process. We keep up to date, it's just getting everything together and worrying if the inspector will throw something new at you."

"I knew when (approx) my inspection was, therefore I was ready by the time it was actually scheduled. It is very consuming each day. I can't even begin to mentally tally up how many hours total. Too much."

Suggestions for Additional Materials

"It would be very helpful to receive a "basic" list of everything needed for the inspection date. To receive this prior to the inspection would be very helpful."

"A list of items, in order as they appear on the inspector's computer screen, would allow the inspection to go smoother, notify the participant of any "new" requirements. I.e., infection control policy — require a log be kept (never saw that info on website)."

"What they’re looking for in the audit is not as clearly defined or explained as well as it should be — i.e. what format they want."

"Provide file type packet with notice so all info. can be put into proper order and pre-sorted for inspection and also as a reminder to gather all info that will be needed."

Inspection Process

Equipment and Activity

Between the 1997 survey and the 2001 survey there has been a 21.4% increase in the number of mammography units at the surveyed facilities as well as increases in the average number of mammograms performed daily (27.8%) and on inspection day (37.9%) at those facilities. There has been less of an increase in the amount of time needed to complete the inspection (5.3%) and in the number of hours spent preparing for the inspection (18.4%).

It is interesting that while the percent increase in the number of mammograms performed daily is just 6 percentage points more than the percent increase in number of units, the increase in the number of mammograms performed on inspection day is 16.5 percentage points more. This is indicative that both inspectors and facilities have learned how to manage the inspection process so that the impact of the inspection does not affect women’s access to mammography as much as it did four years ago.

Equipment and Activity

 

1997

2001

% increase

Average number of mammography units

1.4

1.7

21.4%

Average number of mammograms performed daily

16.2

20.7

27.8%

Average number of mammograms performed inspection day

8.7

12.0

37.9%

Average number of hours to complete inspection

5.7

6.0

5.3%

Average number of hours to prepare for inspection

8.7

10.3

18.4%

The average time required to complete the full inspection has risen only 5.3% since 1997, in spite of an increase in the number of units inspectors are required to evaluate. While more respondents rated the time spent preparing for the inspection as "Excessive" than in 1997 (see page 44), the time spent preparing for the inspection has not increased as much on a percentage basis as either the number of units or the number of mammograms performed both daily and on inspection day.

Number of Units

Most of the surveyed facilities (67%) have one unit, 19% have 2 units and 14% have 3 or more units.

Graph - Number of Mammography Units at Facility - See data in text above

As would be expected, those from facilities with one mammography unit reported that their facilities performed fewer mammograms on both a daily basis and inspection day than those from larger facilities. Also, they spent less time preparing for the inspection, and they were less likely to have access to the Internet at work.

  • Facilities with 1 mammography unit were more likely to have performed 0–9 (97%) or 10–19 (91%) mammograms on a daily basis than 20+ (20%);
  • They were more likely to have performed no (95%) or 1–10 (89%) mammograms on inspection day than 11+ (19%);
  • They were more likely to have spent 0–4 hours preparing for the inspection (74%) than 10+ hours (58%);
  • Those from facilities with one unit were less likely to have Internet access at work (72%) than those who did (63%).

Those from facilities with 3 or more units performed 20 or more mammograms on a daily basis and 11 or more mammograms on inspection day. They were more apt to have spent 10 or more hours preparing for the inspection and have access to the Internet at work.

  • Their facilities were more likely to have performed 20+ mammograms on a daily basis (37%) than 0–9 or 10–19 (1% in each instance);
  • Their facilities were more likely to have performed 11+ mammograms on inspection day (39%) than none or 1–10 (1% in each instance);
  • They were more likely to have spent 5–9 hours (17%) or 10+ hours (18%) preparing for the inspection than 0–4 hours (10%);
  • They were more likely to have Internet access at work (17%) than those who did not (9%).

Number of Mammograms Performed Daily

Twenty-nine percent of the facilities perform 0–9 mammograms on a daily basis, 35% perform 10–19 and 36% perform 20 or more.

Graph - Average Number of Mammographys Per Day - See Data in Text above

Those at facilities that perform 0–9 mammograms on a daily basis tend to be smaller and perform no mammograms on inspection day.

  • Those at facilities with 1 unit were more likely to perform 0–9 daily mammograms (42%) than those from facilities with 2 units (4%) or 3+ units (1%);
  • They were more likely to perform no mammograms on inspection day (53%) than 1–10 (35%) or 11+ (1%).

Those at facilities that perform 10–19 mammograms on a daily basis also tend to be smaller.

  • Those at facilities with 1 unit were more likely to perform 10–19 mammograms on a daily basis (48%) than those at facilities with 2 units (15%) or 3+ (2%);
  • They were more likely to perform 1–10 mammograms on inspection day (53%) than none (37%) or 11+ (12%).

Those at facilities that perform 20 or more mammograms on a daily basis tend to be from larger facilities that performed 11 or more mammograms on inspection day and spent 10 or more hours preparing for the inspection.

  • Those at facilities with 2 units (81%) or 3+ units (97%) were more likely to perform 20+ mammograms on a daily basis than those from facilities with 1 unit (11%);
  • They were more likely to have performed 11+ mammograms on inspection day (88%) than none (10%) or 1–10 (12%);
  • They were more likely to have spent 10+ hours preparing for the inspection (42%) than 0–4 hours (31%) or 5–9 hours (36%).

Number of Mammograms Performed on Inspection Day

Twenty-nine percent of the respondents reported that their facilities performed no mammograms on inspection day, 39% said that their facilities performed 1–10 mammograms, and 33% said that their facilities performed 11 or more mammograms.

Average Number of Mammograms Performed on Day of Inspection - see data in text above

Those that performed no mammograms on inspection day tended to be from smaller facilities.

  • Respondents were more likely to be from facilities with 1 unit (40%) than from facilities with 2 units (7%) or 3+ units (2%);
  • They were more likely to be from facilities that performed 0–9 mammograms on a daily basis (52%) than from facilities that performed 10–19 (30%) or 20+ (8%).

Respondents from facilities that performed 1–10 mammograms on inspection day tended to be from smaller facilities that performed less than 20 mammograms on a daily basis. They had received enough notice of the upcoming inspection, did not receive any citations, had spent 0–4 hours preparing for the inspection, and did not have Internet access at work.

  • They were more likely to be from facilities with 1 unit (51%) or 2 units (21%) than from facilities with 3+ units (2%);
  • There were more likely to be from facilities that performed 0–9 or 10–19 mammograms on a daily basis (48% and 59% respectively) than from facilities that performed 20+ (13%);
  • They were more likely to have received enough notice of the inspection (40%) than those who had not (23%);
  • They were less likely to have received a citation (45%) than those who did (29%);
  • They were more likely to have spent 0–4 hours preparing for the inspection (46%) than 5–9 hours (36%) or 10+ hours (30%);
  • They were less likely to have Internet access (43%) than those who did (36%).

Those from facilities that performed 11 or more mammograms on inspection day tended to be from larger facilities that performed 20 or more mammograms on a daily basis and spend ten hours or more preparing for the inspection.

  • They were more likely to be from facilities with 3+ units (96%) or 2 units (72%) than from facilities with 1 unit (9%);
  • They were more likely to have performed 20+ mammograms on a daily basis (79%) than 10–19 (11%) or 0–9 (1%);
  • They were more likely to have spent 10+ hours preparing for the inspection (39%) than 0–4 hours (29%).

Inspection Time

In the 2001 survey respondents were asked if they were told how long the inspection of each mammography unit would take — this question was not asked in 1997. In both surveys respondents were asked if they were told how long the complete inspection would take. There was no change in the response level from 1997 to 2001; 92% of the respondents in both surveys were told how long the complete inspection process would take.

When asked if the inspection was completed in the expected time, 91% of the respondents in both surveys said that it was.

Inspection Completed in Expected Time

 

1997

2001

Yes

91.0%

90.5%

No

4.9%

4.5%

Not told

4.0%

5.0%

Number of respondents

670

726

The 2001 respondents reported that, on average, it took 2.1 hours to complete the inspection of each mammography unit.

Graph - Average Time to Inspect Each Mammography Unit - See data in text above and below graph

Those who reported that it took less than 1.5 hours to inspect each unit tended to be from larger facilities that performed 20 or more mammograms on a daily basis and 11 or more mammograms on inspection day.

  • They were more likely to be from facilities with 2 units (43%) or 3+ units (56%) than from facilities with 1 unit (33%);
  • They were more likely to be from facilities that performed 20+ mammograms on a daily basis (47%) than from those that performed 0–9 (31%) or 10–19 (36%);
  • They were more likely to be from facilities that performed 11+ mammograms on inspection day (51%) than from those that performed none (26%) or 1–10 (37%).

Correspondingly, those who reported that it took more than 2.5 hours were more likely to be from facilities with 1 unit that performed fewer than 20 mammograms on a daily basis and fewer than 11 on inspection day.

  • They were more likely to be from facilities with 1 unit (34%) than from facilities with 3+ units (13%);
  • They were more likely to be from facilities that performed 0–9 (35%) or 10–19 (33%) mammograms on a daily basis than 20+ (20%);
  • They were more likely to be from facilities that performed no (40%) or 1–10 (31%) mammograms on inspection day than 11+ (17%).

Those respondents at facilities where the average inspection time for each mammography unit took 1.5–2.5 hours were less likely to have received enough notice of the inspection (48%) than those that did (32%).

From 1997 to 2001, there was a shift from "Minimal" (69% to 45%) to "Neutral" (27% to 50%) in how respondents characterized the amount of time that their equipment was not available for use.

Graph - Characterize Time Equipment Not Available for Use - Data in text

Those who indicated that the time was "Minimal" tended to be those who said they had enough notice and had spent 0–4 hours preparing for the inspection.

  • They were more likely to have received enough notice of the inspection (46%) than those who did not (26%);
  • They were more likely to have spent 0–4 hours preparing for the inspection (50%) than 10+ hours preparing (40%).

Those who said that the time was "Excessive" were less likely to have received enough notice of the upcoming inspection (26%) than those who had (5%).

Several respondents said that their inspection was scheduled for a day on which no mammograms were performed. Others suggested that the equipment inspection time should be minimal and raised the issue that the inspector duplicates many of the tests that the physicist performs.

"We scheduled an inspection on a day when I do no patients."

"Stop performing equipment inspections and use records maintained by the facility to determine equipment performance. That is why we do annual and interim physicist surveys as well as other QA/QC testing. That would reduce the length and cost of the inspection and would not result in a loss of revenue for that day."

"Downtime for the mammography unit should be minimal. The inspector duplicates many tests the physicist has already performed. More emphasis should be placed on the facilities' compliance with patient notification and follow-up, as well as Quality Control performance and the overall mammography program."

"Make less measurements — use physicist report and only check for compliance and spot check output."

On average, the time to perform the complete inspection was six hours.

Graph - Average Time of Facility's Complete Inspection - Data in Text

As might be expected, facilities where the inspection took less than 4.5 hours tended to be smaller facilities that performed fewer than 20 mammograms on a daily basis and 1–10 on inspection day, received enough notice of the inspection, and did not receive any citations. The respondents tended to spend 0–4 hours preparing for the inspection.

  • They were more likely to be from facilities with one unit (51%) than from facilities with 2 or 3+ units (22% and 11% respectively);
  • They were more likely to be from facilities that performed 0–9 or 10–19 mammograms on a daily basis (49% in each instance) than to be from facilities that performed 20+ (24%);
  • Their facilities were more likely to have performed 1–10 mammograms on inspection day (55%) or none (38%) than 11+ (24%);
  • They were more likely to have received enough notice (41%) than not (23%);
  • They were less likely to receive a citation (46%) than those that did (29%);
  • They were more likely to have spent 0–4 hours preparing (56%) than 10+ hours (25%).

Those at facilities where the inspection took 5.0–6.5 hours tended to be from facilities with 2 units and have spent 10 or more hours preparing for the inspection.

  • Their facilities were more likely to have 2 units (39%) than 3+ units (26%);
  • They were more likely to have spent 10+ hours preparing for the inspection (37%) than 0-4 hours (28%).

Those from facilities where the inspection took 7 or more hours tended to be from facilities with 2 or more units that performed 20+ mammograms on a daily basis and none or 11 or more mammograms on inspection day, received a citation, and spent 5 or more hours preparing for the inspection.

  • Their facilities were more likely to have 2 units or 3+ units (39% and 63% respectively) than 1 unit (15%);
  • Their facilities were more likely to have performed 20+ mammograms on a daily basis (44%) than 0–9 or 10–19 (13% and 19% respectively);
  • They were more likely to have received a citation (37%) than those that did not (21%);
  • They were more likely to have spent 5–9 hours or 10+ hours preparing for the inspection (31% and 38% respectively) than 0–4 hours (16%);
  • Their facilities were more likely to have performed either no mammograms or 11+ on inspection day (23% and 44% respectively) than those who performed 1–10 (13%).

Recent and Past Inspections

Although there was a drop in those who rated the inspection process for the most recent inspection as "Excellent" from 1997 to 2001, there was a corresponding increase in those who rated it "Fair."

Those who rated the inspection process "Excellent" tended to be from facilities that received no citations and performed 1–10 mammograms on inspection day. They spent 0–4 hours preparing for the inspection and found it to be both educational and beneficial.

Rate Inspection Process for Most Recent Inspection - data in text

  • Those whose facilities received no citations rated it higher (71%) than those from facilities that received citations (54%);
  • Those who had spent 0–4 hours preparing for the inspection rated it higher (75%) than those who had spent 10+ hours (54%);
  • Those whose facilities had performed 1–10 mammograms on inspection day rated it higher (71%) than those who had performed either no mammograms (62%) or 11+ (61%);
  • Those who found the inspection "Very" educational rated it higher (80%) than those who found it "Somewhat" educational (51%);
  • Those who found the inspection "Very" beneficial rated it higher (83%) than those who found it "Somewhat" beneficial (42%).

Respondents’ comments about their most recent inspection were both favorable and unfavorable with some concerns about consistency.

"Each time during the inspection process went extremely well. All of our inspectors have been very helpful and were very pleasant."

"I felt our inspector's attitude was rather abrupt initially, later she warmed up and was fine. Very helpful especially on understanding the regulations."

"An excellent job was done. Very pleased."

"Inspectors shouldn't be such hard-nosed people. This inspector was the first in my 38 years in this field that was so extremely unfriendly and impersonal about her visit. Made a tech feel so inferior. This is not necessary."

"Be consistent! If the rules don't change, why change the way things are done from one year to the next. If a rule was the same last inspection and the policy at the facility was okay then, why isn't the policy okay this inspection??"

While there is not a direct comparison3 between the data from the 1997 and 2001 surveys relating to the "previous" inspection, it is interesting to note that in 2001 the majority of respondents (67%) indicated that it was the "Same," an increase in this rating of 20 percentage points.

Graph - Rate Inspection Process for Previous Inspection - Note In 1997 respondents were asked to rate recent inspection against their first MQA inspection - data in text

Those who rated the inspection process better tended find the inspection both educational and beneficial and be from facilities that performed 1–10 mammograms on inspection day.

  • They were more likely to be from facilities that performed 1–10 mammograms on inspection day (33%) than from facilities that performed 11+ (25%);
  • They were more likely to find the inspection "Very" educational (36%) than "Somewhat" educational (23%);
  • They were more likely to find the inspection "Very" beneficial (34%) than "Somewhat" beneficial (23%).

Most of the comments received indicate that the respondents find the inspection process to be stable from year to year.

"I have been involved in ten inspections over the years, and I find them to be well organized and the inspectors to be very helpful and informative. They inform you up front what they will need and what to expect. No surprises. Keep up the good work."

"I've been through multiple inspections with at least four different inspectors. They were all very good, professional, and treated our facility fairly."

"It goes smoother if the same inspector comes every year. Different inspectors seem to want different information."

"We had an inspector from [specific reference omitted] inspect our facility last time. He appeared confused on many issues. In past years an inspector from [specific reference omitted] did our inspections — they always went smoothly. She was well versed and explained all upcoming regulations."

____________________
3 In 1997, respondents were asked to compare the most recent inspection to their first inspection, while in 2001 they were asked to compare it to their previous inspection.

Suggestions and Comments About the Inspection Process

Of the comments received, 30% indicated that the inspection should take less time and be more efficient, 14% said that inspectors should be more consistent, 13% said that inspections should be less strict and critical, and 10% reported no problems. There were a number of suggestions for improving the process. See Appendix C for a complete listing of the comments.

Inspection should take less time and be more efficient

"If they could send you an outline prior to the inspection of everything they want to see and in what order, we could arrange things accordingly and it would take less time. The inspectors spend a fair amount of time just looking for the information in the books."

"Databank of radiologists and technologists showing current CE and other pertinent material. Not needing to show all this paperwork would take hours off the inspection process."

"The inspectors and physicist do a lot of the same tests and check a lot of the same records; this seems repetitive."

"When multiple sites (under the same ownership) are inspected, sometimes within hours or days of one another, must the same policies, radiologist data, physicist data, etc. be dragged out and inspected? I realize each facility stands alone, but when all the same physicians, physicists, and policies are used from a central facility, it seems ridiculously time consuming to look at the same data over and over within hours or days of the last inspection."

"Many redundancies between what we are required to do and then what the inspection covers. I.e., we are required to have a physicist review of the mammo unit but the inspector must redo many of the tests. Also, why must all staff and radiologist records be kept at all facilities when the radiologists and staff are the same ones who rotate through the facilities. Seems one check of these records at the main facility would be adequate. We also keep the same information for ACR. This is another duplicity."

"It is a very slow process and uses a lot of staff time. Inspectors don't always work independently. Some need to be spoon-fed the info. It was difficult to get a straight answer from him with regards to audit info. He could have directed me to website or other resource perhaps."

"The inspectors are very "entrenched" in the wording or phraseology of our policies. There appears to be no citations for how things are worded in the law; however, the inspector spent a lot of time focusing on phraseology and how he wanted it worded. I believe the inspection should be more focused on the actual law."

Consistency

"The inspectors are not consistent. One of them wants things one way and the next will tell you to do some other way. It is very confusing and frustrating. A facility only gets one inspection a year and it is very expensive. It should not be so non-consistent."

"All inspectors should have a standard set of rules and regulations to follow with the correct interpretation so one inspector does not differ from another."

"Inspectors give different answers at different sites to the same question. Ex: Daily documentation per patient of equip cleaning. We were told we must document on every patient. Our sister site was told by the same inspector ‘only have to document if it says you do in your policy.'"

"Yes, I feel Inspectors look at things differently from one another, for instance at our 1999 Inspection the inspector [specific reference omitted] told me we did not need the Dr.'s Attestation sheets any more and he then pulled them out and threw them away! Then at our 2000 Inspection the inspector, a different inspector, said we needed those attestations and we were out of compliance till I got them to her! … So I feel the Inspectors should not pull things out of our books and they should all be sure of what’s needed and what's not!"

Less Strict and Critical

"I think the inspection process should be approached as a help rather than a strict, follow the regulation to the smallest detail. In the past, I have had inspectors that interpreted the standards to the strictest detail and left no room for other interpretation. The inspector that was here the last two years was great, through. He was here to help us comply and did not waste time on small, trivial items."

"Inspector seemed as though he wanted to catch me in a lie and when I didn't, he admitted to other facilities being caught in lies. I don't like to be on the defense and I felt as though I was through most of the inspection. I was so drained after the inspection I literally cried and this was my fourth year doing it. It was by far the hardest and worst yet."

Suggestions for Improving the Process

"A standard format (order) in which facility presents info. to inspector. For example, a printout is sent prior to inspection but that order is not followed. If facility could arrange notebook in a specific order, it would save time."

"I feel that if a radiologist has passed MQSA with his or her credentials then it (the name) should go on an approved list for that. Have an approved list or archive of all approved radiologists of their initial MQSA, (CE, license, #'s read not included)."

"If a site receives no citations 2 years in a row, then change the next inspection to 2–3 years later."

"If an inspector can't find something — I think they should ask for it instead of just writing you up for it — they should also have to explain what it is they want. We should not have to guess as to how to correct a deficiency and wait till next year to find out we did not correct the problem adequately."

"Not really a suggestion but a concern: It has been my experience that the inspectors are not necessarily of one mind on any of the items for inspection. We have been cited (in the past) for something another facility also did that did not receive a citation. One inspector may cite — the next give a ‘recommendation.’"

Professionalism of the Inspector

Inspector Attributes

As in 1997, the 2001 survey asked respondents to rate the responsiveness of the inspectors. In both surveys the inspectors received similarly high ratings.

Inspector Responsiveness

 

Yes

No

1997

2001

1997

2001

Inspector provided phone number when making appointment

97.6%

96.7%

2.4%

3.3%

Inspector arrived at appointed time

94.7%

95.1%

5.3%

4.9%

Respondent had questions for the inspector

---

87.8%

---

12.2%

Inspector answered questions

99%

97.6%

1%

2.4%

Respondents in both surveys reported that inspectors almost always provided a contact phone number when making the appointment. They also reported that the inspectors were prompt, arriving at the scheduled time in 95% of the inspections. Although 98% of the respondents said that the inspectors answered their questions, at least one respondent felt that the questions were not adequately answered. Others stated that the inspectors got back to them with the answers to their questions.

"Inspector was very helpful and answered all questions I asked."

"The inspectors that didn't answer questions called back with the information I requested."

"I think the inspector could assume the role to help the faculty instead of just catching our errors. Be more straightforward about answers to questions — seemed like he was worried about giving "by the book" answers."

"The questions that I had for the inspectors (every year) were not answered to my satisfaction. Either they talked around the issue — changed the subject or just plainly admitted that they "didn't know." I feel that they should know. If it means my facility not passing its next inspection — they should know — it is their job. If they "don't know" — who does?"

The 2001 evaluations of inspectors’ attributes closely paralleled those from the 1997 survey. Overall, inspectors received the same high ratings in both surveys. The exceptions were "Polite/courteous/respectful" where the "Very" rating dropped from 91% to 86%, and "Helpful" where it dropped from 87.5% to 80.7%. In each instance the drop was reflected by the increase of the "Somewhat" rating.

Inspector Attributes

 

Very*

Somewhat*

Not at all*

Average rating**

1997

2001

1997

2001

1997

2001

2001

Polite/courteous/respectful

91.0%

86.0%

8.6%

13.3%

0.4%

0.7%

6.2

Helpful

87.5%

80.7%

11.3%

18.3%

1.2%

1.0%

6.1

Knowledgeable about mammography

80.7%

80.6%

18.2%

19.0%

1.1%

0.4%

6.1

Knowledgeable about inspection process

88.0%

87.6%

11.7%

12.4%

0.3%

0%

6.3

Accommodating with respect to patient scheduling

86.6%

84.3%

12.0%

14.3%

1.4%

1.4%

6.2

Prepared with equipment needed for inspection

93.5%

94.0%

6.1%

6.0%

0.4%

0%

6.5

* Scale of 1–7, with 1–2 = "Not at all" and 6–7 = "Very"
** This information is not available for the 1997 survey.

It is important to note that the average rating for all inspector attributes was high in 2001, as it was in 1997. On a scale of 1–7 it was above 6.0, ranging from 6.1 for "Helpful" and "Knowledgeable about mammography" to 6.5 for "Prepared with equipment needed."

Rate Inspector Polite/Courteous/Respectful - see table
Rate Inspector Helpful - See Table
   
graph - rate Inspector knowledgeable about mammography - see table
Graph - Rate inspector knowledgeable about inspection process - see table
   
Graph - Rate inspector accommodate patient scheduling - see table
graph - rate inspector prepared with equipment needed - see table

 

There was no change in how respondents rated the inspectors’ knowledge about mammography from 1997 to 2001. Respondents in both surveys indicated that this is an important issue for them.

"My personal opinion is the MQSA inspectors serve the facility best if they themselves have worked as a clinical mammographer."

"I think the inspector should be mammo. tech."

"We had a gentleman inspector and though he was courteous, respectful, and for the most part knowledgeable about the inspection process, I felt he lacked the overall knowledge of mammography itself; the procedures themselves, the anxiety levels of the patients; the holistic picture of what it takes to achieve a Class A breast center."

"I also find it frustrating that our inspector has never performed a mammogram himself. Inspectors should have experience in mammography!"

"It appears sometimes that the inspector, at least the one who comes here, thinks she is all powerful and it would be different if she had ever done a mammogram or dealt with all the regulations, but she hasn't. All she knows is what she reads in the regs and to her they are black or white with no "gray" areas. Inspectors need to realize that those of us in the trenches have more to do than write a new policy to cover something that was okay last time but not okay this time. Consistency is a good word to learn!!"

As in 1997, 85% of 2001 survey respondents indicated that they would be very "Comfortable" having the same inspector for the next inspection. Another 12% were "Neutral" and 3% were "Uneasy."

Graph - Feel About Same Inspector Evaluating Facility Next Year - See text above for data

Those who were "Comfortable" having the same inspector next year tended to have received enough notice of the inspection, had received no citations, and found the inspection both educational and beneficial.

  • They were more likely to have had enough notice (87%) than those who had not (58%);
  • Their facilities were more likely to have received no citations (89%) than those that had (79%);
  • They were more likely to have found the inspection "Very" educational (94%) than "Somewhat" educational (79%);
  • They were more likely to have found the inspection "Very" beneficial (97%) than "Somewhat" beneficial (72%).

On the whole the comments favored having the same inspector next year, which coincides with the responses, although there was some question as to whether this was an option.

"We have a super inspector. He is always helpful and very comfortable to work with."

"I think having the same inspector helps the relationship. Though I think a facility should be able to request a different one if desired. I am very happy with our inspector. He has greatly helped us to improve the quality of our work and I feel he is genuinely supportive of our facility. He is constructive with his advice and I appreciate his genteel manner."

"The choice isn't mine in having the same inspector again."

Using MQSA Hotline for Inspector Feedback

When asked if the MQSA Hotline was a good way to provide inspector feedback, 90% said it was. In the 2001 survey, respondents were given the option of responding only "Yes" or "No," thereby forcing them to make a choice. However, in 1997 respondents also had the option of saying that they were "Not sure" and 63% selected that option. Because this was not offered in 2001, we cannot determine if there has been any real change in how respondents perceive the Hotline as an avenue for providing feedback.

The tables and graphs below demonstrate the impact that including and/or excluding these "Not sure" responses have in comparing the effectiveness of the Hotline as an inspector feedback resource in 1997 and 2001.

Hotline Good Way to Provide Inspector Feedback

 

1997

2001

Yes

34.8%

89.9%

No

1.9%

10.1%

Not sure

63.0%

(not an option)

Number Respondents

640

646

(Total Sample)

When the "Not sure" responses are excluded, the 1997 sample size drops to 235 respondents and there is only a 5% difference between the "Yes" and "No" responses between the two surveys.

Hotline Good Way to Provide Inspector Feedback

 

1997

2001

Yes

94.9%

89.9%

No

5.1%

10.1%

Number Respondents

235

646

(Sample Excluding 1997 "Not sure" Responses)

Graph - Hotline Good Way to Provide Feedback About Inspectors - Total Sample - see text for data
Graph - Hotline Good Way to Provide Feedback About Inspectors - Sample excluding 1997 not sure responses - see text for data
(Total Sample)
(Sample Excluding 1997 "Not sure" Responses)

 

There were no comments from respondents indicating that they had used the Hotline for this purpose, even though 90% of the 2001 respondents indicated that it is a good way to provide feedback. Some respondents were not aware of the Hotline and others indicated problems in trying to contact it.

"I think that process should be more confidential. All types of people answer that line and refer you to people who sometimes cannot help."

"I have not used this number, but would be very wary of giving a non-favorable feedback over the phone."

"We are from a western state and the Hotline is open during earlier business hours. It would be good to staff the Hotline until Pacific time closings."

"Unaware of availability." [There were a number of comments to this effect.]

"Did not know at the time of inspection, there was a phone number."

"Don't know if Hotline is good way to provide feedback about inspectors."

"The inspector/facility relationship is good. However, 1-800 Hotline has never returned any phone messages left on the recorder. I have contacted the Hotline several times during the hours stated open for business, I have never been able to speak to anyone."

In addition to the Hotline, respondents were asked to suggest other ways of providing inspector feedback. Six percent of the comments suggested that comment cards be available and 6% suggested surveys.

"Comment cards left at the facility to be completed and mailed to FDA or telephone survey."

"Maybe a self-addressed stamped envelope — made out to the inspector’s boss with a comment card would be a way."

"The inspector could leave a comment card or survey that could be sent back if needed."

"How about the Inspector leaving a critique form at the end of inspection session with Insp. I.D. and an immediate evaluation could be done, as well as questions posed before forgotten!"

"I did a lot of research getting ready for this inspection. He expected things that were not required anywhere and changed what was required so it was almost impossible to get. Let me fill out a survey after the inspection to mail in."

"I would prefer to complete a questionnaire similar to this one, specific to the inspector. I have spoken to FDA in the past about an inspector and it was not kept confidential. The inspector was fully aware that I questioned something that he told me."

Some respondents indicated that they feared reprisals if they complained.

"I don't ever use it because I'm afraid if I complained it would be held against me in further inspections."

"Since state is contracted to inspect our facility for MQSA, any complaint against inspector may result into difficulty in other areas and inspections."

"I think the facility would fear some sort of retaliation if they complained about the inspector if they had the same inspector the next year."

"I have not used this Hotline so I don't know whether I would use it or not. I would be inclined not to complain about an inspector — I would not want to make him mad at me!"

As requested by the survey, several respondents commented on the the inspector/facility relationship.

"Give us an organized checklist to prepare."

"Just instill in the technologist that the inspectors are there for our learning and documenting correctly — that they are beneficial."

Graph - Exit Interview Conducted and useful? - See Text

Ninety-seven percent of the respondents reported that the exit interview was useful.

When asked if their facility was cited, only 37.5% of the respondents said that they were. This question did not appear on the 1997 survey, so there is no comparable data.

Graph - Received Citations? - see text for data

Those who received citations tended to be those who had spent more time preparing for the inspection and were from facilities that performed either no or 11 or more mammograms on inspection day. Although not statistically significant, there appears to be a pattern that those facilities with 3 or more units are more likely to be cited than those with 1–2 units.

  • They were more likely to have spent 10+ hours preparing for the inspection (42%) than those who spent 0–4 hours (31%);
  • They were more likely to be from facilities that performed no (49%) or 11+ (39%) mammograms on inspection day than from those that performed 1–10 (28%).

Of those facilities that received citations, 97% of the respondents understood the reasons for their citations and 95% knew how to respond to them. Of the few comments received about citations, most indicated that the respondents did not believe that the citations were appropriate.

Graph - Understood Citations and told How to Respond to them - see text for data

"We didn't receive any citations this time, but we have in the past. It was easy to respond and correct the problem."

"The inspector asked for additional credentials for one of our radiologists. The request did not apply. The radiologist was in residency at the time. This inspector had recently inspected two other facilities where this radiologist reads films. We tried to call her and e-mail her and she never replied, but we received the nasty form letter."

"Our inspector was wonderful. I learned a lot from her. I did not agree with 2 areas were cited and felt we had no recourse. (We were cited on 2 points I believe were not deserved, ie: if a tech does not have enough CEU's — we pull her from mammo's — we document it — I don't know how to "not" get cited for this problem. I can only warn them when their credits are low, I cannot make them get CEU's. I only have control if they work or get a day's pay in mammography.)"

"Inspectors are inconsistent. Each has a different method/focus on specific regulations. We are cited for something by this inspector that the previous passed."

One comment reflected the frustration of not having control over all elements to ensure that the facility is in compliance.

"When the radiologists do not comply with CEU's or other info, what can the techs do to ensure cooperation for the facility's behalf. How can they, as the radiologists, be accountable for their noncompliance rather than the facility?"

Report

The majority of the 2001 respondents (92%) said that they received an initial report at the conclusion of the inspection and 36% (down from 61%) said that they received the final report "Immediately."

Fifty percent of the 2001 respondents received the final report within a month compared to 30% in 1997.

Graph - Received Initial Report at Conclusion of Inspection - See text for data Graph - when was final detailed copy of inspection rport received - see text for data

 

The majority of those who selected "Other" tended to stipulate a more specific time frame than the choices offered (i.e., "a few days," "one week," "two weeks"). The rest had not yet received their report.

"Faxed copy of inspection report within two days but not final."

"Received report within a few days."

"Didn't receive initial inspection report due to computer problems. Received report in one week."

"We still haven't received an inspection report!! I have faxed the inspector and left many messages for him. Nothing returned. … The inspection was 12-11-2000."

"Can't respond. Have not yet received inspection report — inspection done 3/30/01."

As shown in the table below, there was no significant change in how respondents rated the usefulness of the test results in identifying areas for improvement and validity of the tests between 1997 and 2001. The question regarding correct evaluation of records was not included in the 1997 survey.

Usefulness and Validity of Test Results and Records Evaluation

 

Very

Somewhat

Not at all

1997

2001

1997

2001

1997

2001

Results useful in identifying areas for improvement

71.5%

69.8%

27.0%

27.2%

1.5%

3.1%

Believe results of tests were valid

80.9%

80.0%

18.5%

18.4%

0.6%

1.6%

Believe records correctly evaluated

---

82.3%

---

16.4%

---

1.3%

In both surveys respondents rated the results as "Very" useful (72% and 70%) in identifying areas for improvement. Four-fifths of the respondents rated the test results as "Very" valid in both 1997 and 2001 (81% and 80% ). In 2001, 82% of the respondents gave the highest rating ("Very") to the evaluation of records.

Those respondents who found the results useful in identifying areas for improvement tended to have received enough notification of the inspection, spent 5–9 hours preparing for it, and found it both educational and beneficial.

  • They were more likely to have received enough notification (71%) than those who had not (45%);
  • They were more likely to have spent 5–9 hours preparing for the inspection (75%) than 10+ hours (64%);
  • They were more likely to have found the inspection "Very" educational and beneficial (84% in each instance) than "Somewhat" (58% and 51% respectively).

Those respondents who rated the test results as "Very" valid tended to be from facilities that received enough notice and received no citations. They tended to have spent 0–4 hours preparing for the inspection and found it both educational and beneficial.

  • They were more likely to have received enough notification (81%) than those who had not (58%);
  • Their facilities were more likely to have received no citations (87%) than those that did (68%);
  • They were more likely to have spent 0–4 hours preparing (85%) than 10+ hours (72%);
  • They were more likely to have found the inspection "Very" educational and beneficial (90% and 92% respectively) than "Somewhat" (70% and 63%).

Those who gave the highest rating to the record evaluation tended to be from facilities with less than 3 units, received no citations, spent less than 10 hours preparing for the inspection, and found the inspection both educational and beneficial.

  • They were more likely to be from facilities with 1 or 2 units (83% and 88% respectively) than from facilities with 3+ units (73%);
  • They were more likely to be from facilities that received no citations (88%) than from facilities that did (72%);
  • They were more likely to have spent 0–4 hours or 5–9 hours preparing for the inspection (87% and 84% respectively) than 10+ hours (74%);
  • They were more likely to have found the inspection "Very" educational and beneficial (92% and 94% respectively) than "Somewhat" educational and beneficial (74% and 67%).

There has been a shift (21 points) from "Very" to "Somewhat" in the respondents rating of the cover letter that explains how to respond to inspection findings, with a mean average shift of 0.4 (from 6.2 to 5.8). While this shift is not dramatic, it is indicative that the letter addressing citations under the Final Regulations is not as well understood as the one under the Interim Regulations.

Graph - Report Cover Letter Explains How to Respond to finding - See Text for Data

Future Inspections

There has also been a shift from "Very" to "Somewhat" in how respondents rate the usefulness of inspector-provided information to future inspections, and how educational and/or beneficial the inspection was.

Graph - Inspector Provided INformation Will Assist in Future Inspections - See text for data

Those who believed that information provided by the inspector will assist them in their next inspection tended to be from facilities with less than 3 units, had received enough notice of the inspection, and found the inspection both educational and beneficial.

  • Those from facilities with 1 or 2 units were more likely to find the information useful (65% and 67% respectively) than those from facilities with 3+ units (54%);
  • They were more likely to have received enough notification (64%) than those who did not (48%);
  • They were more likely to find the inspection "Very" educational and beneficial (90% and 89% respectively) than "Somewhat" (40% and 32%).
Graph - Inspection Was Educational - see text for data Graph - Inspection was beneficial to facility - see text for data

Those who believed that the inspection was "Very" educational were more likely to have received enough notice of the upcoming inspection (51%) than not (28%). They were also more likely to have found the inspection "Very" beneficial (78%) than "Somewhat" (12%).

Those who believed that the inspection was "Very" beneficial tended to be from smaller facilities, had received enough notice, had not been cited, and had spent less than 10 hours preparing. They also found the inspection educational.

  • They were more likely to be from facilities with 1 unit (59%) than from facilities with 3+ units (46%);
  • They were more likely to have received enough notice of the upcoming inspection (59%) than those who did not (30%);
  • They were less likely to have been cited (61%) than those who were (52%);
  • They were more likely to have spent 0–4 hours preparing (60%) than 10+ hours (50%);
  • They were more likely to have found the inspection "Very" educational (90%) than "Somewhat" (26%).

In light of problems that have occurred with closure of some facilities, FDA wanted to know if respondents would find it useful for the inspectors to review steps that a facility must take to fulfill its MQSA responsibilities in the event it should close. Sixty-nine percent of the respondents said that inspectors should present this information.

Graph - Should Inspection Include Review of Steps to Take if Facility Closes? - see text for data

Those respondents who thought this information should be included in the inspection tended to be those who were not aware that MQSA information is published only on the Mammography web site, and did not have Internet access either at work or at home/elsewhere.

  • They were less likely to be aware that MQSA information is published only on the web site (76%) than those who were (63%);
  • They were less likely to have access to the Internet at work or at home/elsewhere (74% and 73% respectively) than those that did (66% and 62%).

Few comments were received from respondents about this issue. Some indicated that they did not understand the question or why it was asked.

"Steps to take concerning films from other facilities that have closed."

"That would depend on if the facility thinks it would possibly close before the next inspection."

"Yes, but only if the facility is closed."

"Don't understand question 45."

Comments and/or Suggestions

This section provided the final opportunity for respondents to provide comments and/or suggestions in this survey. Of the comments received, 21% addressed respondents needs to receive information on updates and guideline changes, 18% commented on their inspection report, 10% found their inspector informative and said that their inspector was doing a good job, and 9% were concerned about the high costs of the inspection. Some of the comments addressed issues that were raised in previous sections. See Appendix C for a complete listing of all the comments received.

Receive information on updates/guidelines changes

"New regulations, if any, from previous inspection." [Multiple comments to this effect]

"Upcoming changes in rules, OHSHA, etc. brief note re: change and where, how to look up for detailed info."

"Whatever will be new or changing in the upcoming year prior to another inspection."

"Having the inspector provide copies of acceptable policy statements or procedures would be nice. For example, our accrediting body cannot show us any examples of what the new "medical outcome audit" should look like. It is a waste of precious time to have to "re-invent the wheel" time after time after time."

"How and where to access forms. Searched several web sites, which were difficult to navigate and with no clear clues as to content."

"It would help if an outline would be provided to have your information in order so the inspection could progress in a timely fashion."

Inspection Report

"Currently two months — have not received inspection report."

"Awaiting inspection report."

"An initial report would be nice but the inspectors are already transporting a lot of equipment."

"A plain — conclusion on report. A little fuzzy if it was o.k. on certain areas they mentioned. Nervous that it doesn't sound like we need it to be fixed and may get a greater citation next time, because of it."

Inspection Informative and Inspector Doing Good Job

"Our inspector is very knowledgeable about the MQSA inspection and very helpful. He makes the whole experience a very pleasurable and educational one."

"[specific reference omitted] MQSA inspectors [specific reference omitted] and [specific reference omitted] are excellent. If I call and they don't have the answer - they get the answer from their resources and call me back. They provide value-added service."

"Nothing. I feel very comfortable calling my inspector."

"Over the years I have met three different MQSA inspectors. All of them were professional, well-trained in their field. I think FDA is doing a good job. Only thing I feel is inspection should be done every other year so smaller places won't feel the financial burden so much."

Cost of Inspection

"The fee charged for this inspection seems to be excessive, over fifteen hundred dollars. Coupled with the annual fee for the physicist and for the ACR fee for inspection, it just seems that this small facility is being charged too much for inspections, which may be overlapping and redundant, what with the low Medicare reimbursements for mammography."

"Cost of inspection too high!!!"

General Comments

"Facility responsibilities directed to Administration in more defined terms. As it is currently, all responsibilities lie on my shoulders and Administration continues to create obstructions to my meeting my responsibilities as QC Tech as well et. al. limited hours for QC/QA completion."

"What are the plans for inspecting digital mammography units?"

"Knowing that radiologists cover many facilities and their credentials are or have been reviewed if they could be brought up via the computer some way, it would save time instead of re-reviewing if the timing allows (license, board cert., attestation)."

"CE credits for participation in inspection."

"A seminar sponsored by FDA regarding MQSA Guidelines would be most helpful."

"I wish the MQSA and ACR would get together and make the regulations universal. I also wish the regs were easier to understand and straight forward (esp. some of the personal qual.)."

Conclusions

MQSA Information Resources

Internet Access and Mammography Web Site

The key questions concerning information resources are: (1) did the respondents know that information is published only on the Mammography web site, (2) did they have access to the Internet, and (3) had they accessed the web site.

Less than half (49%) of the RTs, who make up 81% of the respondents, knew that information is published only on the Mammography web site, while 65% of the Administrators (10% of the respondents) knew. In addition, RTs were less likely than Administrators to have Internet access either at work or at home/elsewhere. Only 54% of the RTs had access to the Internet at work, although 86% of the Administrators did.

In all three of these areas, the RTs, who are the ones primarily responsible for ensuring that their facilities meet MQSA regulations, are less likely to have access to the information resources than the Administrators and other professional staff.

Respondents from larger facilities with 3 or more mammography units were more likely to have access to the Internet at work, and those from facilities with 2 units were more likely to have access than those from facilities with 1 unit.

Publications

Although "Preparing for MQSA Inspections" and Mammography Matters continued to be highly rated by the respondents and "Mammography Facility Survey, Equipment Evaluation, and Medical Physicist Qualification Requirements Under MQSA" was more highly rated than in 1997, it is significant that for all four publications, the number of respondents who said they had "No access" increased by 2–3 times over 1997.

There was no statistically significant indication that these resources impacted whether or not a facility was cited among those who rated them highest in usefulness.

Other Resources

It is significant that 40% of the respondents in both surveys either did not know about or use the Hotline. Since the suspension of Mammography Matters, facility personnel can find the Hotline 1-800 phone number only on the Mammography web site or in old issues of the newsletter, unless their inspector provides them with the number.

Information provided by the inspector was more highly rated in the 2001 survey than in 1997.

Use of both the PGHS and e-mail notification of new and updated MQSA information is dependent upon access to the Internet. Only 22% of the respondents reported that they had used the PGHS and only 30% rated the usefulness of e-mail notification.

Summary

The largest issue facing FDA in communicating with mammography facilities is the lack of access to both the Internet and web site by facility staff, particularly at the smaller facilities. In addition, staff at facilities with heavy patient loads that are short-staffed often do not have time to visit the web site, even if they have access. While the decision to publish MQSA information only on the web site is based on both agency policy and monetary issues, it leaves a substantial portion of the mammography community without access to it. More than ever, facilities (particularly the smaller ones) are dependent on the information provided by their inspectors.

As in 1997, the 2001 survey respondents asked for manuals and/or checklists to use in maintaining their records and preparing for the inspection. They also asked for standardized forms to use in keeping records and developing tracking systems, such as the medical audit.

Pre-Inspection and Inspection Process

Time Spent Preparing for MQSA Inspection

FDA also wanted to examine the correlation between the time spent preparing for the inspection and (1) how respondents characterized the time spent preparing, (2) how much notice the facility received, (3) how much time the inspection took, and (4) whether the facility received a citation.

  • Those who spent 0–4 hours preparing for the inspection tended to characterize the time spent as "Minimal," while those who spent 10+ hours preparing were more likely to characterize it as "Excessive." Those who spent 5–9 hours felt "Neutral" about the time spent.
    There was a marked increase in those who rated the preparation time as "Excessive" — from 1.1% in 1997 to 10.8% in 2001. It is possible that with the increased activity, facility staff found the time spent preparing to be more intrusive than when the facilities were less busy.
  • The amount of notice that facilities received of the upcoming inspection had no effect on the amount of time the respondents spent preparing for the inspection.
  • Respondents were more likely to have spent 0–4 hours preparing at facilities where the inspection took less than 4.5 hours, and more than 5 hours at facilities where the inspection took more than 7 hours to complete. However, it is important to note that those who spent 0–4 hours preparing were also more likely to be from smaller facilities, while those who spent 10+ hours tended to be from larger facilities.
  • Those who spent 0–4 hours preparing for the inspection were less likely to be cited. There is nothing in the data to indicate that spending more than 5 hours preparing had any impact on whether or not the facility was received a citation.

Facility Size and Inspection Process

The key factor in determining facility size is the number of mammography units. FDA wanted to examine the effect of facility size against a number of factors, including number of mammograms performed, time to inspect each unit, time to complete inspection, time that equipment was not available for use, and citations.

In the table below, the percentage breakouts for each factor is shown by number of mammography units at the 737 responding facilities.

Facility and Inspection Activity by Number of Units at Facility

Percentage of Respondents

 

 

Number of Mammography Units

1 (67%)*

2 (19%)

3+ (14%)

Number of mammograms performed on a daily basis
0–9 mammograms

42%

4%

1%

10–19 mammograms

48%

15%

2%

20+ mammograms

10%

81%

98%

Number of mammograms performed on inspection day
0 mammograms

40%

7%

2%

1–10 mammograms

51%

21%

2%

11+ mammograms

9%

72%

96%

Inspection time per mammography unit
1 – 1.49 hours

33%

43%

56%

1.5 – 2.49 hours

33%

34%

31%

2.5+ hours

34%

23%

13%

Time to complete full inspection
1 – 4.5 hours

51%

22%

11%

5 – 6.5 hours

34%

39%

26%

7+ hours

15%

39%

63%

Characterize time equipment could not be used
Minimal

44%

48%

45%

Neutral

50%

48%

51%

Excessive

6%

4%

4%

Received citation(s)
Yes

37%

36%

42%

* It appears that facilities with 1 unit can be further divided between those that are less active and those that are more active. The less active facilities were more likely to perform 0–9 mammograms on a daily basis and no mammograms on inspection day. The more active 1-unit facilities tended to perform 10–19 mammograms daily and 1–10 on inspection day.

While the more active 1-unit facilities were more likely to have performed 1–10 mammograms on inspection day, facilities with 2 and 3 or more units tended to perform 11 or more mammograms on inspection day.

The time to inspect each mammography unit shortened when there were multiple units to be inspected. Of those facilities with 3 or more units, 56% reported that inspection of each unit was completed in less than 1.5 hours. In facilities with 1 unit, only 33% reported that the unit inspection was completed in less than 1.5 hours. Concurrently, at facilities with 3 or more units, only 13% reported that it took more than 2.5 hours to inspect each unit.

Fifty-one percent of the facilities with one unit reported that their inspection was completed in less than 5 hours, while 63% of the facilities with 3 or more units reported that it took more than 7 hours to complete the inspection.

Regardless of the number of mammography units, nearly half of the respondents characterized the time that the equipment could not be used as "Minimal." While one might expect that those with only 1 unit would find that the time the equipment was out of service a problem, it should be noted that 40% of these facilities performed no mammograms on the day of their inspection.

In general, facilities with more units tended to receive more citations than those with fewer units, with 42% of those with 3 or more receiving citations and 37% of those with 1 unit receiving citations. This result is not unexpected as those facilities with more units, and presumably more personnel, have more opportunities for citations.

Professionalism of the Inspector

In general, respondents gave high ratings to the inspectors and 85% reported that they would be comfortable having the same inspector next year.

As in 1997, "Knowledgeable about mammography" received the lowest rating among the inspector attributes.

Inspection Results

The majority of the respondents (85%) indicated that they would be "Comfortable" (rated 6–7 on a scale of 1–7) with having the same inspector again.

As shown in the table below, citations had no impact on whether respondents would be comfortable with having the same inspector again. The percentage breakout parallels that of all respondents, with 35% of those who received citations indicating that they would feel "Comfortable" with the same inspector. Although the number of respondents who indicated that they would be uneasy with having the same inspector is very small, 64% of those who said they would be "Uneasy" received citations.

Received Citation

 

Yes

No

Number Respondents

All respondents

37.5%

62.5%

726

"Comfortable" with having the same inspector again

34.6%

65.4%

615

"Neutral" about having the same inspector again

50%

50%

82

"Uneasy" with having the same inspector again

64%

36%

25

Of those who said that they would be "Comfortable" with the same inspector again, 55% found the inspection to be "Very" educational, while only 8% of those who said they were "Uneasy" found it so.

Inspection Educational

 

Very

Neutral

Not at all

Number Respondents

All respondents

49.7%

46.3%

4.0%

726

"Comfortable" with having the same inspector again

55.0%

42.7%

2.3%

613

"Neutral" about having the same inspector again

7.2%

68.7%

24.1%

83

"Uneasy" with having the same inspector again

8.0%

56.0%

36.0%

25

Sixty-five percent of those who found the inspection to be "Very" beneficial indicated that they would be "Comfortable" with having the same inspector again, while only 4% of those who indicated that they were "Uneasy" about having the same inspector found the inspection to be "Very" beneficial.

Inspection Beneficial

 

 

 

Very

Neutral

Not at all

Number Respondents

All respondents

57.0%

39.8%

3.2%

723

"Comfortable" with having the same inspector again

65.1%

33.9%

1.0%

610

"Neutral" about having the same inspector again

7.2%

79.5%

13.3%

83

"Uneasy" with having the same inspector again

4.0%

52.0%

44.0%

25

Respondents were asked to rate the validity of the inspection test results on a scale of 1–7. Eighty percent of the respondents (515) rated them "Very" valid. Of these respondents, 32% received citations, 58% found the inspection to be "Very" educational, and 69% found it to be "Very" beneficial.

Validity of Inspection Test Results

 

Rated Tests "Very" Valid

Number Respondents

Received citation

32%

510

"Very" educational

58%

511

"Very" beneficial

69%

508

Respondents were then asked to rate whether they believed that the records had been correctly evaluated. Eighty-two percent of the respondents (525) rated them "Very" correctly evaluated. Of these respondents, 33% received citations, 58% found the inspection to be "Very" educational, and 69% found it to be "Very" beneficial.

Records Correctly Evaluated

 

Rated Records "Very" Correctly Evaluated

Number Respondents

Received citation

33%

520

"Very" educational

58%

520

"Very" beneficial

69%

518

Overall, respondents indicated that the inspection process has "stayed the course" between 1997 and 2001. Many of the changes can be attributed to the two key factors: (1) facilities are now being inspected under the Final Regulations, and (2) FDA has changed how it communicates with the facilities.

Recommendations

Overall, facilities are generally satisfied with the inspectors and the inspection process itself. However, based on the analysis of the data and on comments received from respondents, there are opportunities for improvement as well as issues to be addressed, particularly in the communications area.

As a side note, the survey generated a large number of responses to the five open-end questions, all of which are included in Appendix C. Many of the respondents offered thoughtful responses and were comfortable expressing their thoughts. They looked upon the survey as an opportunity to share their ideas with FDA. Taken as a whole these responses offer valuable insight.

Communications

It is clear from the results that the most important issue facing FDA is communicating new and updated information to facility personnel. Only 49% of the responding RTs were aware that MQSA-related information is available only on the Internet, and just 54% of them had access to the Internet at work. Since RTs are often the facility representative for inspections, this represents a substantial gap in the dissemination of MQSA information.

   
  • Following the analysis of the initial survey results (and prior to the delivery of this report), FDA conducted a one-time mailing of several key documents to all facilities to ensure that they had access to the information. The purpose of this mailing was twofold: (1) to get information to facilities, and (2) to let facilities know that the only resource for FDA-published MQSA information is the Mammography web site. The cover letter also emphasized that this was a one-time only mailing and that facilities will have to visit the Mammography web site to get MQSA-related information in the future. FDA sent the mailing to the designated contact at each facility.

    Documents sent to facilities included:
       


    -   Equipment standards phase-in reminder

     Warning Letters: Roadmap to Corrective Action

     When Facilities No Longer Perform Mammography

     Mammography Facility Satisfaction Survey Highlights

    -   MQSA Inspection Fee Reminder

     Preparing for an MQSA Inspection

       
    In addition to the documents, FDA included two business card-size Rolodex inserts containing MQSA contact information. This information consisted of the Facility Hotline telephone number, the Mammography web site address, and instructions for subscribing to the Mammography ListServ to receive broadcast e-mail notification of new and updated MQSA-related information. It was also suggested that each facility designate someone to subscribe to the ListServ and alert mammography personnel whenever new or updated information is published. A flush of new subscribers followed the mailing, resulting in the addition of approximately 150 e-mail addresses. However, there are still fewer than 5,800 subscribers.
 
  • Other avenues that FDA might consider pursuing, if it is not already doing so, include:

        -    Sending press releases to radiology and/or mammography organizations and asking them to announce the availability of new information in their communication materials.
        Placing ads in radiology publications encouraging mammography stakeholders to subscribe to the ListServ and visit the web site;
        Encouraging inspectors and State mammography programs to make all new and updated information available to their mammography facilities.
 
  • While FDA does not plan to revive Mammography Matters at this time, it is definitely missed. Along with the information, respondents indicated that they also missed the convenience of the printed newsletter format. Although it would not replace the publication of information in a newsletter format, FDA should consider creating a quarterly or semi-annual summary of recent information published on the web site. These summaries could then serve as a printed reference index of information available on the web site for facility personnel. It could include links to that information and allow mammography personnel have a printed record of published information.

    Since the announcement of all new additions and modifications to the web site is posted on the Mammography ListServ, the ListServ archives could be used as a resource for quickly capturing this information.

    The Newsletter page of the Mammography web site presents itself as the most appropriate place to post these summaries.
 
  • While the MQSA Hotline was more highly rated in 2001 than in 1997, comments received from respondents indicate areas of concern that should be investigated. One respondent indicated that she had called several times with the same question on the same day and received different advice each time. Several others stated that the Hotline had either never returned their calls or had not been helpful.

    Another area for FDA to explore is the extent to which facilities are aware of the Hotline and how to access it. Forty percent of the respondents in both surveys reported that they either did know about or use the Hotline. Since the suspension of Mammography Matters the 1-800 phone number is only published on the Facility page of the Mammography web site. Since 40% of the respondents do not have access to the web site from work and all facilities are inspected annually, this number should be included with the materials that the inspector provides to facilities when the inspection is scheduled, along with a description of the Hotline’s mission.

Scheduling of Inspection

   
  • Another opportunity for improvement is the amount of notice that facilities receive of the upcoming inspection. There has been a marked improvement in this area since 1997, but respondents from those facilities receiving less than 10 days notice indicated that they would like more. These facilities tend to have 1–2 mammography units and found it necessary to reschedule patients to accommodate the inspection. Recognizing that many facilities are booking patients at least two weeks in advance (and sometimes more), FDA should consider encouraging inspectors to give facilities a minimum of 14 days notice.
  • By scheduling the inspections further in advance, it would be easier for inspectors to accommodate facilities’ schedules — another issue mentioned by the respondents. For example, the inspection could occur on a day when no mammograms are scheduled. If that isn’t possible, the facilities will have ample time to reschedule patients. Advance notice also presents greater flexibility in accommodating the personal schedules of key personnel. 

Additional Resources

   
  • When asked what additional resources would be helpful, recurrent themes included standardized QC forms; clearly written manuals, workbooks, and checklists; and examples of acceptable procedures. To date, FDA has refrained from providing examples of materials that facilities could modify for their own use. Recognizing that each facility has different requirements, FDA adopted this policy to avoid the impression that facilities must use FDA forms. However, given that many facilities are short-staffed and claim that they don’t have the time to create their own systems, FDA might want to revisit this policy. 
  • Another solution would be to publish a list of "suggested" resources on the web site that facility staff can use to find examples of forms, manuals, and standard operating procedures. Of course, any such list would have to include a disclaimer that examples provided by these resources are not endorsed and/or required by FDA; facilities should use them strictly as guidelines and modify them to meet their specific needs and requirements.

Streamlining the Inspection Process

   
  • While each facility stands alone in its inspection, several respondents suggested that personnel requirements — particularly the initial qualifications — be kept in a centralized database for the inspectors to reference. The inspectors would then only have to check the continuing experience, education, and licensing records of facility staff. To streamline the personnel section of the inspection, FDA could consider setting up a process similar to that for the medical physicists. Once an individual's initial qualifications have been accepted, a document could be placed in their files at each facility. Perhaps the MPRIS database could function as a resource for this process.

    A different approach would be to allow inspectors to make a note to the file after examining the initial qualifications for each individual indicating that he/she meets the requirements, thereby eliminating the need to re-evaluate the initial requirements at every inspection.
 
  • Another recommendation for simplifying the inspection process concerns the inspection of sister facilities when the same personnel are used at each site, particularly when these facilities are inspected within a short time frame. FDA should consider allowing inspectors to examine personnel records at the first facility and then use those results as the basis for evaluating personnel qualifications at the sister facilities, thereby eliminating the need to duplicate the personnel evaluations at each site.
 
  • A number of respondents commented that the amount of time the equipment was out of service for testing could be reduced by having the inspector use the medical physicist survey results instead of duplicating the same tests. To shorten the time that equipment is not available for use, FDA might want to consider reducing the number of tests that inspectors conduct, especially if the medical physicist survey was recently conducted.

    Using the MRPIS database, past inspections could be reviewed to determine if there is a history or pattern of frequently encountered problems. Inspectors could then check all units for those problems along with several randomly selected tests.
 
  • Some respondents were concerned about the amount of time their inspector spent searching for information. Offering standardized forms or checklists for facilities to use in preparing for the inspection could shorten the inspection process by making it easier for inspectors to find the required information. The materials also would be organized to track the inspector’s software, particularly with regard to the order of the evaluation of records and procedures documents. This pre-inspection organization would also make it easier for inspectors to complete an inspection without having to rely as much on facility staff to find information they need.

General

   
  • To provide feedback about the inspection, a number of respondents suggested that the inspector provide a standard form or survey for them to complete at the conclusion of their inspection. FDA might want to consider developing a standardized form that could be used for feedback about the entire inspection process, including space for written comments. The goal should be to improve the inspection process. The results could be incorporated into future inspector training sessions and/or in modifications to the inspection process and/or the inspection software.
  • To reduce the paperwork involved with Governmental Entity status, FDA should consider automatically granting this status to all federally-owned facilities, as was suggested by a respondent from an overseas military facility.

Summary

While the inspection process is working very well, the survey results offered insights into ways that FDA can improve it. Based on respondents’ comments and the analysis of data, SciComm developed the above recommendations, which are summarized below.

   
  • Communications remains a key issue, as so many of the RTs do not have access to the Internet at work. There is no easy or direct solution to this problem. Suggestions include utilizing existing professional publications and/or newsletters to publish availability of information. Inspectors and State mammography programs might be additional outlets for the distribution of new and updated MQSA information.
  • Facilities need more advance notice of the upcoming inspections.
  • Respondents asked for standardized forms and guidance in developing procedures for meeting MQSA requirements.
  • Respondents suggested that the time their equipment is out of service could be reduced if inspectors would evaluate the medical physicist report and documentation instead of repeating the same tests.
  • Facility staff indicated that they would like to provide inspector feedback on a standard form or survey.
  • FDA should consider automatically granting Governmental Entity status to government-owned facilities.