oversight

Screening Mammography: Low-Cost Services Do Not Compromise Quality

Published by the Government Accountability Office on 1990-01-10.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

.J;Ilrrl~lrv . I!)!)()
                         SCREENING
                         MAMMOGRAPHY
                         Low-Cost Services
                         Do Not Compromise
                         Quality
L*   1
         United States
G/f%!0   General Accounting Office
         Washington, DE. 20548
     ,
         Human Resources Division



         *January 10, 1990

         The Honorable Lloyd Bentsen
         Chairman, Committee on Finance
         United States Senate

         The IIonorable John D. Dingell
         Chairman Committee on Energy and Commerce
         I Iouse of Representatives

         The Iionorable Dan Rostenkowski
         Chairman, Committee on Ways and Means
         IIouse of Representatives

         The Honorable Barbara B. Kennelly
         Ilouse of Representatives

         This report responds to a provision of the Medicare Catastrophic Coverage Act of 1988
         (P.L. 100-360) that required the Comptroller General to review the quality of screening
         mammography provided in a variety of settings. The report also responds to a request from
         Representative Barbara Kennelly to provide additional information on screening
         mammography, including the services constituting a complete mammography examination
         and the procedural differences between screening and diagnostic mammography.

         We are sending copies of this report to certain other House and Senate committees and
         subcommittees, the Secretary of Health and Human Services, the Director of the Office of
         Management and Budget, state health departments, and other interested parties, We also will
         make copies available to others on request.

         Please call me on (202) 275-6195 if you or your staff have any questions about this report.
         Other major contributors are listed in appendix VI,




         Mark V. Nadel
         Associate Director for
           National and Public
           Health Issues
E&ecutiveSummary


             The Medicare Catastrophic Coverage Act of 1988 (P.L. 100-360) intro-
Purpose      duced screening mammography for symptom-free women as a new bene-
             fit for Medicare-eligible women, to become effective in 1990. The act
  /          limited the charge for Medicare-funded screening to approximately $50.
             Some members of Congress were concerned that this limit could compro-
             mise women’s ability to obtain quality services. To help assure that
  I          quality services would be provided, the act required (1) the Secretary of
             Health and Human Services (HHS) to establish standards to assure the
             safety and accuracy of this test and (2) the Comptroller General to
             report on the quality of screening mammography performed in a variety
             of settings. Representative Barbara Kennelly also asked GAOto provide
             additional information on screening mammography, including what con-
             stitutes a complete screening examination.

             In November 1989, the Congress repealed most provisions of the Medi-
             care Catastrophic Coverage Act of 1988, including the mammography
             benefit. However, legislation to restore the mammography benefit has
             been introduced.


             Breast cancer causes over 40,000 deaths per year in the United States.
Background   The best method for improving a woman’s chance of survival is early
             detection, and the most effective tool for early detection is mam-
             mography, an X-ray that can find cancers too small for the woman or
             her physician to feel. Leading medical organizations recommend that
             women begin periodic mammographic screening at the age of 40; regular
             screening can reduce mortality rates by 30 percent. Screening mam-
             mography, which is performed on women without symptoms to detect
             unsuspected abnormalities, can be provided more economically than
             diagnostic mammography. The latter is used to provide more detailed
             information about abnormalities that have been discovered. (See
             pp. lo-12-j

             Despite the recommendations for regular screening mammography,
             studies indicate that over half of women over 40 have never had the
             test. A new Medicare benefit could greatly increase the number of
             women receiving such screening. (See pp. 12-13.)

             GAOinterviewed mammography experts to identify quality standards
             that contribute to optimal screening mammography and sent a question-
             naire to 1,485 facilities providing mammography in four states-cali-
             fornia, Florida, Idaho, and Michigan. The facilities were asked to



             Page 2                          GAO/HRD-90-32 Quality of Screening Mammography
                            Executive Summary




                           categorize their type of setting and supply information on services pro-
                           vided, equipment, personnel performing and interpreting mammograms,
                           quality assurance activities, reporting and record-keeping, volume, and
                           charges for screening mammography services. In addition to obtaining
                           information on federal oversight of mammography and laws and regula-
                           tory programs in the four states reviewed, GAOvisited 15 screening
                           mammography providers to supplement the survey data. (See
                           pp. 14-16.)


                           Many providers lack adequate quality assurance programs. This may
Re:zlts in Brief           contribute to the wide range of image quality and patient radiation dose
                           that occurs in current mammography practice. GAOfound no relation-
                           ship between the price charged for screening mammography and adher-
                           ence to quality standards. Providers with higher mammography volume
                           were more likely to comply with many quality standards than were
                           those with lower volume. There is evidence that high volume permits
                           economies of scale and does not compromise quality.

                           Federal and state oversight programs have been limited by the absence
                           of legally binding quality standards. In September 1989, however, 1111s
                           published proposed regulations for Medicare-funded screening mam-
                           mography that parallel professional quality standards. Such regulations
                           would help federal and state regulators in assuring that mammography
                           providers deliver quality services. Because the Medicare Catastrophic
                           Coverage Act of 1988 was repealed, HHSwill withdraw its proposed
                           regulations.



GAO’s Analysis

Quality Standards Exist,   The quality of screening mammography depends on providers comply-
bug Image Quality and      ing with a wide range of quality standards. The primary goal is a mam-
                           mographic image of good quality, obtained with low radiation dose to
Patient Dose Vary          the patient and followed by accurate interpretation of the image.
                           Although professional groups have established quality standards to
                           guide facilities, these standards are not uniformly followed, and image
                           quality and dose vary widely in current mammography practice. (See
             Y             pps 23-25.)




                           Page 3                          GAO/HRD-90-32 Quality   of Screening Mammography
                           Executive Summnry




Qublity Assurance          To maintain a consistent level of quality, providers should perform qual-
Stdndards Met Less Often   ity assurance activities, such as periodic inspections of equipment per-
                           formance. Many providers that GAOsurveyed, however, were not
Thbn Other Standards       complying with standards for quality assurance programs. Inadequate
  /
  !                        quality assurance programs may be a cause of the variation in image
                           quality and dose. Primary care physicians and multispecialty clinics
                           were the providers reporting the lowest rates of compliance with stan-
  ,                        dards for quality assurance activities. (See pp. 26-32.)


M re High-Volume           High-volume providers were more likely to comply with many quality
Pr4 viders Comply W‘ith    standards than were low-volume providers. However, providers charg-
                           ing higher fees were no more likely to adhere to quality standards than
Qu(ality Standards         were those charging lower fees. Several providers that GAOvisited
                           reported that they met many quality standards while charging $50 or
                           less for screening mammograms; all were high-volume facilities. (See
                           pp. 32-34).


E&nomies Possible With     Compared with diagnostic mammography, screening mammography is a
Screening Mammography      less complex process, which permits certain economies of scale that
                           make it less costly to provide. The radiologist need not be present during
Not Always Realized        the examination to read the films, but can read a large batch of films at
                           once, resulting in a more efficient use of the radiologist’s time. In addi-
                           tion, increasing patient volume results in more efficient use of expensive
                           equipment. (See pp. 12 and 20-21.)

                           Most providers operate at relatively low volume-fewer  than 50 mam-
                           mograms per week. Survey respondents reported charging a wide range
                           of fees for screening mammography, with the average about $100. One
                           reason most charges are higher than $50 may be that providers base
                           these charges on the more complex and expensive diagnostic procedure.
                           (See pp. 21-22.)


Limits of Current          State oversight of mammography is limited. Three of the four states GAO
Regulation Make HHS        reviewed have no legally binding standards for image quality or radia-
                           tion dose; nor do they require the use of equipment specifically designed
Standards Important        for mammography. The federal government currently does not regulate
                           the quality of mammography. The Food and Drug Administration (FDA)
            *              is responsible for ensuring the correct manufacture and installation of
                           X-ray equipment, but not for overseeing its subsequent use. FDAinspects
                           a relatively small number of mammography machines. (See pp. 35-40.)


                           Page 4                           GAO/HRD-90-32 Quality of Screening Mammography
                                                    -
                   Executive Summary




                   The limitations of existing oversight and evidence of problems with
                   image quality and radiation dose underscore the importance of quality
                   standards the Medicare Catastrophic Coverage Act of 1988 required the
                   Secretary of HHSto issue for Medicare-funded screening mammography.
                   Proposed standards published by HHSbefore repeal of the screening
                   mammography benefit paralleled professional quality standards. Such
                   standards would have filled existing regulatory gaps, (See pp. 41 and
                   43.)

-
                   GAOmakes no recommendations in this report.
Rethommendations




                   Page 5                        GAO/HRpBO-82 Quality of Screening Mammography
contents


Exbcutive Summary                                                                                       2

Chbpter 1                                                                                           10
Inqroduction            Screening Mammography Can Reduce Breast Cancer                              10
  I                          Mortality
                        Purposes of Screening and Diagnostic Mammography                            12
  /
                             Differ
                        Efforts Made to Increase Use of Screening Mammography                       12
  /                     Medicare Benefit for Screening Mammography Proposed                         13
                        Objectives, Scope, and Methodology                                          14

Chapter 2                                                                                           17
V+iation in Screening   Hospitals and Radiology Offices Predominate Among                           18
                            Mammography Settings
Mtimmography            Lack of Distinction Between Screening and Diagnostic                        19
Ch.arges May Be             Mammography Contributes to Fee Variations
                        Mammography Volume Linked to Charges                                       21
Litiked to Volume
Ctiapter 3                                                                                         23
High-Volume             Compliance With Professional Standards Important to                        23
                            Quality
Providers Most Likely   Problems in Meeting Image Quality, Radiation Dose                          25
to Adhere to Quality        Standards Revealed
                        Many Providers Do Not Meet Standards for Quality                           26
Standards for               Assurance Programs
Screening               High-Volume Providers More Often Adhere to Quality                         32
                            Standards
                        Compliance With Quality Standards Not Related to                           32
                            Charge

Chapter 4                                                                                          35
Federal and State       State Oversight of Mammography
                        FDA Regulates Manufacture, Assembly of Mammography
                                                                                                   35
                                                                                                   39
Regulation                    Equipment
of Screening            IIIIS Proposed Standards for Screening Mammography                         41
Mammography
Is Limited y


                        Page 6                         GAO/HRD-90-32 Quality of Screening Mammography
             Content43




Ch’apter 5                                                                              42
C+clusions
Aqpendixes   Appendix I: GAO’s Survey Methodology                                       44
             Appendix II: GAO Questionnaire on Mammography                              46
             Appendix III: Selected Quality Standards for                               65
                 Mammography and Related Survey Results
             Appendix IV: State Oversight of Screening Mammography                      69
             Appendix V: Additional Results From GAO’s Screening                        71
                 Mammography Survey
             Appendix VI: Major Contributors to This Report                             77

Tables       Table 2.1: Distribution of Survey Respondents and                          18
  I               Mammography Volume, by Setting
  I          Table 2.2: Survey Respondents’ Charges for Screening                       19
                 Mammography
             Table 2.3: Survey Respondents’ Weekly Mammography                          22
                 Volume
             Table 3.1: Survey Respondents’ Compliance With Key                         27
                 Quality Standards for Screening Mammography
             Table 3.2: Relationship Between Volume and Providers’                      34
                 Compliance With Quality Standards
             Table 4.1: Michigan Mammography Equipment With                             38
                 Image Quality and/or Radiation Problems, by Facility
                 Type (,Jan.-Nov. 1988)
             Table 4.2: Florida Mammography Equipment Not in                            38
                 Compliance (Fiscal Year 1988)
             Table 4.3: FDA Inspections of Newly Installed                              40
                 Mammography Equipment in Four States (1986-
                  1988)
             Table 4.4: Noncompliances Identified by FDA in Four                        40
                 States (1982-1989)
             Table I. 1: Response to GAO Questionnaire, by State                        45
             Table V. 1: Settings of Respondents Performing Screening                   71
                 Mammography, by State
             Table V-2: Respondents’ Charges for Screening                              72
                 Mammogram, by Locale and Setting
             Table V-3: Volume of Mammograms Performed, by Setting                      74
             Table V-4: Survey Respondents Accredited by ACR                            74
                 Mammography Accreditation Program, by Setting
                 and State (As of April 1989)


             Page 7                         GAO/HRD-90-32 Quality of Screening Mammography
          Contents




          Table V,5: Survey Respondents Reporting Annual                              75
               Inspection by Radiological Physicist, by Setting and
              State
          Table V.6: Survey Respondents Reporting Annual                              75
               Physicist Inspection of Beam Quality (HVL), Average
              Glandular Dose, and Phantom Image Quality, by
              Setting and State
          Table V.7: Survey Respondents Reporting Compliance                          76
              With Selected Quality Assurance Standards, by
              Setting
          Table V.8: Survey Respondents’ Retention of Original                        76
              Mammographic Images, by Setting

Figures   Figure 3.1: Annual Inspection Performed by Radiological                     28
               Physicist, by Setting
          Figure 3.2: Annual Inspection of Selected Features by                       29
               Radiological Physicist, by Setting
          Figure 3.3: Daily Processor Sensitometry, by Setting                        30
          Figure 3.4: Semiannual Phantom Image Checks, by Setting                     31
          Figure 3.5: Selected Quality Assurance Activities, by                       33
               Setting




          Page 8                          GAO/HRD-90-32 Quality of Screening Mammography
----
       Contents




       Abbreviations

       ACIZ       American College of Radiology
       ACS        American Cancer Society
       AWN1       American Registry of Clinical Radiographic Technologists
       AHIlT      American Registry of Radiologic Technologists
       HCDDI      Breast Cancer Detection Demonstration Project
       I3SE       breast self-examination
       CC         craniocaudal
       CDRII      Center for Devices and Radiological Health
       CIICPD     Conference of Radiation Control Program Directors
       DHS        Department of Health Services
       DHH        Division of Radiological Health
       FDA        Food and Drug Administration
       HCFA       Health Care Financing Administration
       HHS        Department of Health and Human Services
       IIII'      Health Insurance Plan
       HMO        health maintenance organization
       HVI,       half value layer
       ICS        Investigation and Compliance Section
       MAP        Mammography Accreditation Program
       NC1        National Cancer Institute
       NCRP       National Council on Radiation Protection and Measurements
       CWA        Office of Technology Assessment
       PPRC       Physician Payment Review Commission
       XMRC       X-ray Machine Registration and Control


       Page 9                          GAO/HRD-90-32 Quality of Screening Mammography
Chabter
   /    1

Iritroduction


                       Breast cancer is a leading cause of death and illness in the United States;
                       over 40,000 breast cancer deaths are expected to occur in 1989. No pre-
                       ventive strategies are known, but early detection through periodic
                       screening mammography can lower a woman’s risk of dying from breast
                       cancer by 30 percent. The Medicare Catastrophic Coverage Act of 1988
                       (P.L. 100-360) created a new benefit for periodic screening mam-
                       mography for Medicare-eligible women that was to go into effect in Jan-
                       uary 1990. However, on November 22, 1989, the Congress repealed most
                       provisions of the act, including the mammography benefit. Legislation
                       that would restore a Medicare screening mammography benefit has been
                       introduced in the House of Representatives. If such a benefit is enacted,
                       millions of women would become eligible for low-cost screening, which
                       could have a significant impact on breast cancer morbidity and mortal-
                       ity in the United States.

                       To help contain costs, the act generally limited the fee providers could
                       charge for a screening mammogram to $50. Some members of Congress
                       expressed concern that the charge limit could compromise the quality of
                       Medicare-funded screening mammography. To help assure that quality
                       services would be provided, the Congress required the Secretary of
                       Health and Human Services (HHS) to establish quality standards for
                       facilities providing screening mammography to Medicare beneficiaries.
                       To provide the Congress with information on the quality of current
                       screening mammography services, the act also required GAOto assess
                       quality of care in a variety of settings. In response to this requirement
                       and a request from Representative Barbara Kennelly, we developed
                       information on which settings currently provide screening mam-
                       mography, what they charge, whether quality of care varies by setting
                       or charge, and government regulation of screening mammography.


                       Breast cancer is the most common cancer and second leading cause of
Screening              cancer deaths in women in the United States, and its incidence is
Mammography Can        increasing. One in 10 women will develop breast cancer during her life-
Reduce Breast Cancer   time; only 4 years ago, the rate was 1 in 13. The American Cancer Soci-
                       ety (ACS)estimates that during 1989, nearly 143,000 women in the
Mortality              United States will develop breast cancer and 43,000 will die from it.
                       Increasing age is the most important risk factor for developing breast
                       cancer. There is a dramatic increase in risk after age 40, and over one-
                       third of the cases diagnosed occur in women over 65.
            ”
                       At present, the best method known to reduce breast cancer mortality is
                       early detection, which permits treatment that greatly increases the


                       Page 10                          GAO/HRD-90-32 Quality of Screening Mammography
-

    --l-----       Chapter 1
                   Introduction




-
                   chance for survival. Detection of breast cancer is accomplished through
                   mammography, clinical breast examination, and monthly breast self-
                   examination. Of these methods, mammography, an X-ray of the breast,
                   is the most effective for detection of early stage breast cancer.

                   The value of mammography for breast cancer screening is that it can
                   detect cancers that are too small to be felt through physical examination
                   (palpation), and these early stage cancers can be 90 to almost 100 per-
                   cent curable. When detected at a later stage, they are much more likely
                   to have spread to the axillary lymph nodes or distant sites, and the
                   5-year survival rate can drop as low as 18 percent.’ Not only is treat-
                   ment then more debilitating, it also is much less effective.

                   The National Cancer Institute (NCI) and ACS believe that a breast physi-
                   cal examination is also an essential element of breast cancer screening,
                   as a small percentage of cancers is identified by palpation but cannot be
                   seen on a mammogram. However, this examination need not necessarily
                   occur at the same time as the mammogram.

                   Through technological refinement of mammography equipment, the
                   effectiveness of mammography has increased, while the amount of radi-
                   ation exposure has dropped dramatically. Current levels are one-tenth
                   of those produced during the 1960s. They are considered safe enough so
                   that the value of the mammographic examination for women eligible for
                   screening far outweighs any risk from the exposure.

                   Studies indicate a significant decrease in breast cancer mortality for
                   women who have screening mammograms at recommended intervals.
                   Among the studies are those of the Health Insurance Plan (IIIP) of
                   Greater New York Screening Project and the Breast Cancer Detection
                   Demonstration Project (RCDDP),a collaborative effort of NCI and ACS.
                   Leading medical organizations, including NCI, ACS,and the American Col-
                   lege of Radiology (ACR),~ have endorsed the following breast cancer
                   screening guidelines:

               . An annual or biennial mammogram for women 40-49 and
               l An annual mammogram for women age 50 and older.



                   ‘Survival rate in white women.
                   “AC12is a professional and educational association of 20,000 board-certified rddiok)gists and radiolog-
                   ical physicists.



                   Page 11                                      GAO/HRD-90-32 Quality of Screening Mammography
                             Chapter 1
                             Introduction




                             Mammography     is performed for two different purposes, screening and
Ptirposes of Screening       diagnosis,
anfl Diagnostic
M&nmo&aphy Differ        l
                           Screening mammography is an examination of a woman without breast
                           symptoms to detect breast cancer before a lesion can be felt by her or
                           her physician. It is done simply to detect unknown abnormalities in
                           women who appear to be disease-free.
                         0 Diagnostic mammography is an examination of a woman who exhibits a
  ,I                       symptom, such as a lump, that indicates the possible presence of breast
                           cancer. It is performed to fully characterize lesions, providing as much
  I                        information as possible.

                             The process of performing the mammograms is the same for both. A
                             diagnostic procedure, however, may require additional breast views and
                             other tests, such as ultrasound, to provide more information about a
                             suspicious lesion. Because of its more limited purpose, screening mam-
                             mography can take advantage of certain economies not possible during
                             diagnostic mammography. For example, a radiologist need not be on the
                             premises for immediate interpretation of screening mammograms.
                             Instead, the day’s films can be read all at one time, allowing greater effi-
                             ciency in the costly use of a radiologist’s time.


                             Despite the recommendations for regular screening mammography,
Efforts Made to              studies indicate that around 60 percent of women age 40 and over have
Increase Use of              never had a screening mammogram. The most common reasons women
Screening                    give for not being screened are that they do not think they need screen-
                             ing mammograms and that their physicians did not recommend them.
Mammography                  Other reasons include fear of excess radiation and high fees. Fear of
                             detecting breast cancer also may act as a deterrent, because until
                             recently, such a diagnosis meant the likelihood of death or at least loss
                             of a breast.

                             In an effort to increase the number of women who are screened, ACShas
                             been supporting numerous local campaigns since 1987 to establish pro-
                             grams that promote and provide low-cost screening mammography.
                             Common features of these programs include low charges for screening
                             ranging from $36 to $50 and criteria for participating facilities to assure
                             provision of high-quality services. Some states also sponsor programs to
           Y
                             increase the use and awareness of mammography, and some mandate
                             health insurance coverage of screening mammography.




                             Page 12                          GAO/HRD-90-32 Quality of Screening Mammography
                       Chapter 1
                       Introduction




                       Currently, Medicare covers diagnostic mammography only, as it gener-
Medicare Benefit for   ally pays only for treatment, not preventive services. The only excep-
Sc ‘eening             tions have been immunizations for pneumococcal pneumonia and
M f mmography          hepatitis B. During 1987, Medicare spent approximately $75 million on
                       diagnostic mammograms.
Prbposed
                       The Medicare Catastrophic Coverage Act of 1988 (P.L. 100-360) intro-
                       duced a new Medicare benefit for screening mammography, effective in
                       1990. This would have represented the first mass screening procedure
                       supported by Medicare. The population eligible for this benefit includes
                       nearly 18 million women age 65 and over and a portion of the more than
                       1 million disabled women under age 65. The Health Care Financing
                       Administration (HCFA) estimated that the cost of providing this benefit
                       would be $150 million in fiscal year 1990 and $275 million in fiscal year
                       1991.

                       Because of the potential cost of the benefit, the law established an
                       indexed limit on the amount providers could have charged. Participating
                       physicians (those who agree to accept Medicare-approved charges as
                       payment in full for services) could have charged a maximum of $50 for
                       screening mammography performed in 1990, including both examina-
                       tion and interpretation, of which Medicare would have reimbursed 80
                       percent. In years subsequent to 1990, the charge limit would have been
                       the preceding year’s limit increased by the percentage increase in the
                       Medicare Economic Index.” Nonparticipating physicians could have
                       charged 125 percent of the $50 limit ($62.50) in 1990, and their maxi-
                       mum charge would have decreased to 115 percent of the indexed limit
                       by 1992.

                       The Congress specified that the Secretary of HHSwas to establish stan-
                       dards to assure the safety and accuracy of Medicare-funded screening
                       mammography. The law also set limits on the individual’s use of the
                       screening mammography benefit. These frequency limitations generally
                       coincided with NCI’S guidelines for screening mammography, with the
                       following exception. For women over age 64, Medicare would have pro-
                       vided reimbursement for a screening mammogram every 2 years instead
                       of every year.




                       “After 1991, the Secretary of HHS could have reduced the limit to the amount required to assure the
                       availability of convenient screening mammography of good quality.



                       Page 13                                     GAO/HRD-90-32 Quality of Screening Mammography
                              Chapter 1
                              Introduction




                              The Medicare Catastrophic Coverage Act of 1988 required the Comp-
Okjjectives, Scope, and       troller General to report to the House Committees on Ways and Means
Methodology                   and Energy and Commerce and the Senate Committee on Finance on the
                              quality of care of screening mammography provided in a variety of set-
                              tings. Congressional conferees indicated that these settings include hos-
                              pital outpatient departments, clinics, radiology practices, physicians’
                              offices, and other facilities where Medicare beneficiaries could obtain
                              screening mammography.’ In addition, Representative Barbara Ken-
                              nelly, in a letter of June 28, 1988, asked GAOto provide additional infor-
                              mation on mammography.

                              In response to the statutory requirement and the request from Repre-
                              sentative Kennelly, and as agreed with congressional staff, our objec-
                              tives were to collect and analyze data across settings on the provision of
                              screening mammography, charges for services, and quality assurance
                              mechanisms. We developed information to answer the following
                              questions:

                          l What provider settings currently offer screening mammography pro-
                            grams, and where do Medicare patients currently obtain
                            mammography?
                          . What do different settings that provide screening mammography charge
                            for their services?
                          . What are the factors necessary for screening mammography of accept-
                            able quality, and do quality factors vary by setting or by charge?
                          l What governmental and professional regulations and oversight pro-
                            grams are in place to assure the quality of screening mammography?

                              We conducted our work in four states: California, Florida, Idaho, and
                              Michigan. The criteria used to select these states were availability of
                              information on facilities with mammography equipment, geographic
                              diversity, size of the Medicare population, population density, and inclu-
                              sion of a variety of mammography settings.

                              Our principal source of information on the first three questions was a
                              mail survey WCconducted of 1,485 facilities (757 in California, 313 in
                              Florida, 35 in Idaho, and 380 in Michigan) providing mammography in
                              the four states. These were all the facilities identified by the state radio-
                              logical health departments as having mammography equipment. Our


                              ‘l’hc~ law also required the Physician Payment Review Commission to report on the cost of providing
                              screening mammography in a variety of settings and at different volume levels.



                              Page 14                                     GAO/HRD-90-32 Quality of Screening Mammography
: ,


          Chapter 1
          Introduction




          questionnaire requested information on providers’ screening mam-
          mography practices, focusing on equipment, personnel, services pro-
          vided, quality assurance mechanisms, reporting and record-keeping,
          volume, and charges. (Our survey methodology is described in more
          detail in app. I, and a copy of the questionnaire is presented in app. II.)
          The response rate was 82 percent overall, and, for each state, at least 80
          percent.

          Questionnaire items were based on the standards and recommendations
          developed by the ACR for use in granting accreditation to screening mam-
          mography programs (see p. 24 for more detailed information on ACR
          accreditation), the requirements of Public Law 100-360, and factors
          identified by other experts as associated with quality in screening mam-
          mography. The questionnaire was reviewed by officials from ACRand
          NCI.

          When analyzing the questionnaire responses, we used the following set-
          ting categories:

      .   Primary care physician: Office of a primary care physician such as a
          gynecologist, internist, or surgeon;
      .   Radiology private practice: Individual or group radiology practice;
      .   Hospital: Hospital radiology department, outpatient clinic, or ambula-
          tory care center;
      .   Hospital breast clinic: Breast screening clinic located in a hospital;
      .   Breast clinic: Freestanding facility for screening and/or treatment of
          breast disease;
          HMO:Health maintenance organization;
          Multispecialty clinic: Multispecialty group practice or outpatient clinic;
          Mobile van: Mobile van fitted with mammography equipment that may
          or may not be affiliated with a hospital, clinic, or physician’s practice;
          and
      .   Other: Includes freestanding imaging centers not owned by radiologists,
          military primary care clinics, and other outpatient facilities.

          Our survey results are based completely on self-reporting in the ques-
          tionnaire, pertain only to the four states, and cannot be projected
          nationwide. The data from the questionnaire are reported in the aggre-
          gate, but any marked differences between the states are pointed out.

          To gather information about topics not addressed in the questionnaire,
          we conducted site visits in each state at some facilities participating in
          the survey. We visited 15 facilities-5 in California, 4 each in Florida


          Page 16                           GAO/HRD-90-32 Quality of Screening Mammography
-&-..----                                                                                I

            Chapter 1
            Introduction




            and Michigan, and 2 in Idaho. The types of setting visited included pri-
            mary care physician, radiology practice, hospital, breast clinic, multi-
            specialty clinic, mobile van, and “other.” (The latter was a practice in
            which portable mammography equipment was transported among sev-
            eral rural hospitals and physicians’ offices.)

            In the four states studied, we identified state laws and regulations per-
            taining to mammography, interviewed officials responsible for oversight
            of mammography facilities, and analyzed data on state inspections. To
            analyze the federal role in oversight of screening mammography and
            promoting quality assurance, we interviewed Food and Drug Adminis-
            tration (FDA) and HCFAofficials and obtained data on FDAinspections. For
            information on quality standards and on the role of screening mam-
            mography in early detection of breast cancer, we reviewed the literature
            and interviewed many health care practitioners and experts from a wide
            range of organizations.

            Our work was performed from September 1988 to July 1989 in accord-
            ance with generally accepted government auditing standards.




            Page 16                         GAO/HRD-90-32 Quality of Screening Mammography
Variation in ScreeningMammography Charges
May l3eLinked to Volume

              The majority of screening and diagnostic mammograms currently are
              done in hospitals and radiology offices, where most Medicare-funded
              diagnostic mammography also occurs. The fees charged for screening
              mammography vary widely, from $50 or less to over $150, our survey
              showed. More than two-thirds of our respondents reported charges in
              the $51-125 range, with an average charge of $104.

              One reason for the wide range of charges for screening mammography is
              providers’ lack of distinction between screening and diagnostic services.
              Most of our respondents began providing screening within the past 5
              years, and many did not distinguish between screening and diagnostic
              purposes. Screening programs can operate at a higher patient volume
              and take advantage of certain economies of scale that allow them to pro-
              vide services at a lower fee. Mobile vans typically concentrate on screen-
              ing mammography. Of the mobile vans in our survey, 60 percent
              charged $50 or less, and none charged more than $125. The Physician
              Payment Review Commission found that, at facilities that did not differ-
              entiate between screening and diagnostic mammography, the average
              charge was $103. However, at providers that did make a distinction, the
              average charges for screening and diagnostic mammography were $53
              and $113 respectively.

              Most survey respondents perform fewer than 50 mammograms per
              week, a relatively low volume. Practitioners and studies have indicated
              a relationship between high volume and the ability to lower the price of
              screening, and our survey data showed a similar trend.




      w




              Page 17                         GAO/HRD-9032 Quality of Screening Mammography
                                    Chapter 2
                                    Variation in Screening Mammography
                                    Charges May Be Linked to Volume




                                    The majority of our respondents (65 percent) were hospitals and radiol-
HoGpitals and                       ogy private practices, and the majority of screening and diagnostic
Radiology Offices                   mammograms (57 percent) were performed in those settings, as table 2.1
                                    shows.i (For information on setting distribution by state, see table V. 1.)
Prddominate Among
M      WiwPhY
Set
  y ings
     1
     I

Tablei2.1: Distribution of Survey
Respffndents and Mammography                                                                            Distribution (percent)
Volun~e, by Setting                 Setting                                                         Respondentsa            Volumeb
     I                              Hospital        -...--                                                        40                  33
                                    Radiology private___-practice                                                 25                  25
                                    Multispecialty  clinic                                                        10                   8
                                    .--.____---             -. ~--.~
                                    Primary   care physician                                                       9                   4
                                    -..  -______
     I                              Breast clinic                                                                  8                  13
                                    HMO                                                                            4                  IO
     /                              Hospital breast clinic -.___--                                                 2                   4
                                    Mobile van                                                                     1                   2
                                    Other                                                                          1                   1
                                    Totals                                                                       100                 100
                                    aA total of 1,026 respondents reported doing screening mammography and reported where it was done.

                                    “Based on reported weekly volume of screening and diagnostic mammography.


                                    The distribution of settings our respondents reported is similar to the
                                    distribution of settings where Medicare beneficiaries currently receive
                                    diagnostic mammography services. Most mammograms reimbursed by
                                    Medicare in 1987 took place in an outpatient hospital setting or a radiol-
                                    ogist’s office, according to data provided by HCFA.

                                    About 83 percent of respondents that did screening mammography
                                    reported an urban or suburban location and 17 percent a rural location.
                                    Of the four states we focused on, only Idaho reported that a majority of
                                    its facilities were in rural areas (66 percent).




                                    ‘Respondents were asked to name the principal setting from the list we provided (see ch. 1 and app.
                                    II).



                                    Page 18                                     GAO/HRD-90-32 Quality of Screening Mammography
                                          Chapter 2
                                          Variation in Screening Mammography
                                          Charges May Be Linked to Volume




                                         Our survey respondents reported charging a wide range of fees for
Labk of Distinction                      screening mammography. Since many providers do not differentiate
Bebween Screening                        between screening and diagnostic mammography, they may not take
an@Diagnostic                            advantage of the economies of scale possible with screening mam-
                                         mography. This may explain why most respondents currently charge
M+nwpwhy                                 more than the $60 Medicare generally would have allowed under the
Co//tributes to Fee                      screening benefit.
Vdriations

ScqeeningCharges Vary                    Questionnaire recipients’ reported charges for a screening mammogram,
Widely                                   including both performance and interpretation of the mammogram,
                                         ranged from $50 or less2to $275, with an average of $104. The median
                                         charge was $100.

                                         About 7 percent of the charges were in the lowest ($1-50) of five charge
                                         ranges that we established (see table 2.2). This range coincides with the
                                         reimbursement limit set for screening mammograms that would have
                                         been funded by Medicare. Overall, about 48 percent of respondents
                                         reported charging less than $100, and 52 percent charged $100 or more.

Table 2.2: Survey Respondents’ Charges
for Screening Mammography                                                                                          No. of      Percent of
                                         Charge range                                                        respondents    respondent@
                                         $1 - 50                                         ___.I__         ---__         71   __-              7
                                                                                                                                     ---._~ ~~
                                                                __. -__      .---
                                         $51. -~.-
                                               99_._.
                                                   - ~~_.-.-_--  ___.-__                                ---           395                  41
                                                                                   --.
                                         $100 - 125                        ______                                 .___264                  28
                                         $126- 150                       -_.-..-.-       __--      -.                 145   _---..~----~ 15 ~
                                         Over$150                                                                      81                    9
                                         Totals                                                                      956                100
                                         Qespondents   reporting a charge of $0 are excluded


                                         In comparing charges by state, we found that almost all Idaho facilities
                                         (97 percent) charged less than $100. This was a substantially higher
                                         percentage than in California (44 percent), Florida (54 percent), and
                                         Michigan (47 percent).



                                         ‘About 2 percent of respondents, most of them HMOs, reported charging either nothing or only a
                                         nominal amount for screening mammography, presumably because it is a covered service for which
                                         there is no charge or a small copayment. We exclude no-charge cases from the remainder of this
                                         analysis.



                                         Page 19                                      GAO/HRD90-32 Quality of Screening Mammography
                           Chapter 2
                           Variation in Screening Mammography
                           Charges May Be Linked to Volume




                           Screening mammography charges were lower in mobile vans than in
                           other settings. Sixty percent of the mobile vans reported charging $50 or
                           less and none over $125. Typically, mobile vans concentrate on screen-
                           ing services, which allow them to take advantage of such procedural
                           economies as batch reading of films (see p. 21). In contrast, no primary
                           care physicians reported charging $50 or less, and a large percentage of
                           hospitals and hospital breast clinics (31 and 37 percent respectively)
                           charged more than $125. For additional information on charges by set-
                           ting and by state, see table V.2.

                           In regard to location, rural facilities tended to charge somewhat less
                           than facilities in urban/suburban locations, which may contribute to the
                           lower charges in Idaho. Forty-seven percent of the urban/suburban
                           facilities and 56 percent of the rural facilities charged less than $100.
                           Conversely, 25 percent of the urban/suburban and 15 percent of the
                           rural facilities charged over $125.


Limited Use of Economies   The medical community is at an early stage in distinguishing between
of Scale in Screening      screening mammography, a relatively new service, and diagnostic mam-
                           mography. Almost two-thirds of the respondents to our survey reported
Mammography Affects        that they began providing screening services after 1984 and almost half
Charges                    after 1985.

                           Over half of the 15 facilities we visited did not distinguish between the
                           two kinds of mammography or differ in the way they provided these
                           services or in their fees. This may account for the wide range of charges
                           reported. In a 1989 report to Congress” on the cost of providing screen-
                           ing mammography, the Physician Payment Review Commission (PPRC)
                           noted a similar relationship. In surveying 125 randomly selected mam-
                           mography providers, PPRC found that at facilities that did not differenti-
                           ate between screening and diagnostic mammography the average charge
                           was $103. However, at providers that did make a distinction, the aver-
                           age charge for screening was $53 and for diagnostic mammography,
                           $113.

                           The higher fees for screening mammography where providers do not
                           distinguish between the two types of service may result from limited use
                           of procedural efficiencies permitted by screening mammography. These
                           include:


                           “PI’RC, The Costs of Providing Screening Mammography, June 30, 1989.



                           Page 20                                   GAO/HRD-90-32 Quality of Screening Mammography
                               Chapter 2
                               Variation in Screening Mammography
                               Charges May Be Linked to Volume




                          l   Batch reading of films. A major factor driving up the price of diagnostic
                              mammography is the need for a radiologist to read the films while the
                              patient is present. This does not apply to a screening situation.
                          l   Maintaining a large volume of patients. This generates additional reve-
                              nue without requiring additional investment in equipment.
                          l   Requiring payment at time of service. This eliminates costs associated
                              with billing and bad debt.


                              Mammography experts have indicated that high volume is essential for
Mhography                     providing screening mammography at lower fees. Many of our survey
V@rne Linked to               respondents reported a relatively low weekly mammography volume,
Charges                       and our analysis showed some association between higher volume and
                              lower charges.


Generally Low Volume of       The majority of facilities responding to our survey performed a rela-
Mammography Reported          tively low volume of mammography.4 The weekly volume ranged from 2
                              to 500 mammograms, but the average was 52 and the median 35, indi-
                              cating a concentration at the lower end of the range. About one-third of
                              respondents providing data on volume performed fewer than 25 mam-
                              mograms per week, while only 21 percent did 75 or more weekly (see
                              table 2.3).

                              Analysis by setting reveals great variation in mammography volume. At
                              the lower end, 70 percent of the primary care physicians reported
                              weekly volume under 25, and none performed more than 100 mam-
                              mograms per week. Seventy-one percent of the hospitals reported a
                              weekly volume under 50, with 7 percent doing over 100. In contrast,
                              over half (58 percent) of the hospital breast clinics do at least 75 mam-
                              mograms per week, with 37 percent doing over 100. (For additional
                              information, see table V.3.)




                              4The volume data reported represent total mammography volume, including both screening and diag-
                              nostic mammography. Although we asked for separate data, some respondents provided only com-
           Y                  bined volume data and others used a definition of screening different from the one we provided. Our
                              definitions of screening mammography and diagnostic mammography (that conducted on asymptom-
                              atic patients versus symptomatic patients) coincided with those of mammography experts, but some
                              respondents evinced difficulty with these concepts. For example, one respondent stated that although
                              many of the facility’s patients were asymptomatic, it did not perform screening mammography.



                              Page 21                                     GAO/HID-90-32 Quality of Screening Mammography
                                       Chapter 2
                                       Variation in Screening Mammography
                                       Charges May Be Linked to Volume




Table .3: Survey Respondents’ Weekly
Mam nr, ography Volume                 No. of mammograms                                                   Percent of              No. of
                                       performed weekly                                                 respondents                cases
     I
                                       l-24                                                                         34                   336
     /
                                       25-49                                                                        28                   269
                                       50-74                                                                        17                   167
                                       75-
                                       --- 100                                                                      10                   100
                                       Over100                                                                      11                   104
                                       Totals                                                                     100                    976



Higher Volume Associated               Lower charges tended to be linked with a higher volume of mam-
With Lower Charges                     mography in our survey. The proportion of facilities charging $50 or
                                       less was almost three times greater among those performing over 100
                                       mammograms weekly (15 percent) than among those doing fewer than
                                       25 a week (6 percent). Another indication of this relationship is the fact
                                       that of the facilities performing more than 100 mammograms per week,
                                       over twice as many charged $50 or less (15 percent) as those that
                                       charged over $150 (7 percent). The relationship is reversed for facilities
                                       performing fewer than 25 mammograms per week. In that group, 6 per-
                                       cent charged $50 or less and 10 percent, over $150.

                                       Experts on screening mammography emphasize that a key factor that
                                       makes screening for a lower fee possible is increased volume of service.
                                       To offer inexpensive mammography, one expert practitioner has stated,
                                       a provider must take advantage of certain economies of scale that
                                       require at least 15 patients daily. This minimizes periods when expen-
                                       sive equipment is idle. A break-even price for 16 patients a day of about
                                       $64, for 20 patients about $54, and for 25 patients about $46 was
                                       reported by a Florida physician who gave us information on the costs of
                                       a mobile van providing screening mammography.

                                       At a stationary setting with average costs, the cost for providing one
                                       screening mammograms ranges from about $34 at a volume level of 50
                                       exams per day to $107 at a volume of 5 exams daily, PPRC said in its
                                       report. The unit cost at between 15 and 20 exams per day is around $50.
                                       Thus, WHCconcluded, $50 is sufficient payment for screening mam-
                                       mography if volume levels are high enough.(;


                                       “lncludcs nonphysician cost per exam and physician fee.

                                       “I’PHC also recommended increasing the Medicare payment to $60 in rural areas of low population
                                       density where it is not possible to generate sufficient volume to support a $50 payment.



                                       Page 22                                    GAO/HRD-90-32 Quality of Screening Mammography
Chgpter 3

@gh-VolumeProviders Most Likely to Adhere
t$ Quality Standaxis for Screening

                      Professional groups have developed quality standards for providers of
                      screening mammography to follow. They include using dedicated equip-
                      ment (i.e., equipment designed specifically for mammography instead of
                      general purpose X-ray equipment), employing staff with proper creden-
                      tials to perform and interpret mammograms, reporting and retaining
                      records of mammographic results, and having an adequate quality
                      assurance program. The primary goal of these standards is to produce a
                      mammogram with good image quality, while limiting the patient’s radia-
                      tion dose, and to provide an accurate interpretation of the image. How-
                      ever, these standards are not uniformly followed, and there is great
                      variation in image quality and radiation dose in current mammography
                      practice.

                      Compliance with many of the professional quality standards, such as
                      using equipment specifically designed for mammography, was wide-
                      spread among the providers we surveyed. However, many did not com-
                      ply with standards for quality assurance activities, such as annual
                      inspection by a radiological physicist. Primary care physicians and
                      multispecialty clinics reported the lowest rates of compliance with stan-
                      dards for quality assurance programs; in general, hospital breast clinics,
                      HMOS,and mobile vans reported the highest.

                      Providers reporting higher levels of mammography volume showed a
                      greater degree of compliance with quality standards than those per-
                      forming fewer mammograms. Higher charges, however, did not necessa-
                      rily buy higher quality. We found no consistent relationship between
                      charge and adherence to quality standards.


                      Mammography is a complex process that requires providers’ adherence
Compliance With       to numerous quality standards to produce good results. Professional
Professional          groups have established widely recognized quality standards to guide
Standards Important   providers. Because of the complexity of the process, failure to comply
                      with any of the standards can compromise the quality of the results.
tb Quality            Some of the standards, such as using dedicated equipment and employ-
                      ing qualified personnel, relate directly to provision of mammography
                      services. Others, such as daily inspection of the film processor, relate to
                      the facility’s quality assurance program. Adhering to quality assurance
                      standards allows facilities to test their systems to ensure that they are
            Y
                      providing high-quality mammograms and interpretations.

                      Most of the features considered necessary for quality screening mam-
                      mography contribute to the goal of obtaining good image quality with


                      Page 23                          GAO/HRD-9052 Quality of Screening Mammography
Chapter 3
High-Volume Providers Most Likely to Adhere
to Quality Standards for Screening




minimal risk to the patient. Because a mammogram is among the radio-
graphic images most difficult to read, it must have optimal clarity. If
image quality is poor or the interpretation faulty, the interpreter may
miss cancerous lesions. This could delay treatment and result in an
avoidable death or mastectomy. Problems with images or interpretation
also can lead to unnecessary testing and biopsies if normal tissue is mis-
read as abnormal.

The American College of Radiology has made a comprehensive effort to
establish quality standards for screening mammography through its vol-
untary Mammography Accreditation Program (MAP). Started in 1987, it
offers peer review and evaluation of a facility’s equipment, staff qualifi-
cations, examination procedures, reporting practices, recordkeeping,
and quality control and assurance programs. ACR also obtains informa-
tion on image quality and radiation dose, which are evaluated through
the USCof a breast phantom’ and dosimeter. A set of the facility’s own
mammographic images is also evaluated for image quality.’

A relatively small number of facilities have applied for and received
accreditation. As of April 1989,8 percent of facilities that responded to
our questionnaire were accredited, according to data ACR supplied.:’ The
setting with the highest proportion of accredited facilities was breast
clinics (13 percent), followed by radiology practices (11 percent). Table
V.4 provides additional information on respondents’ ACRaccreditation
by setting and state. Other groups also have issued mammography
guidelines. They include the National Council on Radiation Protection
and Measurements (NCRP),~ some of whose standards ACRincorporated




 ’ Phantoms arc objects designed to simulate breast tissue when exposed. The ACR phantom is a block
with a wax insert cont,aining fibers, specks, and masses that simulate growths that could be cancer-
ous. Tht: facility exposes the phantom with its equipment, and the visibility and clarity of the objects
imbcddcd in the phantom are evaluated.
‘When facilities submit clinical images to ACR as part of its MAP, the features that are assessed
include proper patient positioning, acceptable image contrast, compression, and adequate visualiza-
tion of structures within the breast.
“No Idaho facility was accredited, but 3 percent of the California, 6 percent of the Florida, and 19
percent of the Michigan respondents were. An ACR official said that participation in the accreditation
program has been high in states where ACS chapters have required accreditation for participation in
KS screening programs. Michigan ACS and state officials have encouraged participation.
‘NCRI’, Mammography-A User’s Guide, Report No. 85, Mar 1, 1986. The NCRP is a nonprofit corpo-
ration chartered by the Congress to make recommendations on radiation protection and related
matters.



Page 24                                       GAO/HRD-90-32 Quality of Screening Mammography
.
                          Chapter 3
                          High-Volume Providers Most Likely to Adhere
                          to Quality Standard6 for Screening




                          into its accreditation program, and the Conference of Radiation Control
                          Program Directors (CRCPD).~

    I
                          Despite the existence of professional standards intended to result in
Pqoblems in Meeting       optimal levels of image quality and radiation dose, ACRand state regula-
In;lage Quality,          tory agencies have identified significant problems in current mam-
Rbdiation Dose            mography practice. An analysis” of data collected from the ACR
                          accreditation process revealed wide ranges of image quality and dose.
Sdandards Revealed        The author of the analysis concluded that the underlying reason for
                          these variations is the lack of universal compliance with quality assur-
                          ante standards by mammography facilities.

                          The analysis was based on data collected from 647 providers that had
                          completed the ACKaccreditation process as of February 1, 1989. Twenty-
                          nine percent of the applicants did not meet ACR’S criteria and were not
                          granted accreditation. Of these, about 36 percent failed because of poor
                          clinical images, 38 percent because of poor phantom image quality, and
                          15 percent for both reasons. An additional 3 percent failed because of
                          excessive radiation dose, and 8 percent failed to meet both dose and
                          clinical image criteria. These findings were echoed in Michigan’s inspec-
                          tion program, which also found significant problems when it evaluated
                          equipment using ACRstandards. (See pp. 37-38 for more detailed
                          information.)

                          For the states we reviewed, the following applicants who had completed
                          the ACR process as of May 1989 had received accreditation, according to
                          ACH:

                      l   Michigan and Florida, about two-thirds of the 109 and 32 applicants,
                          respectively;
                      l   California, 82 percent of the 34 applicants; and
                      l   Idaho, neither of 2 applicants.




                          “CHCPD, Mammography Screening Guide, Conference Publication 87-4, Feb. 1987 (prepared in coop-
                          eration with the Ccntcr for Devices and Radiological Health (CDRH) of the Food and Drug Adminis-
                          tration; it also uses NCRP standards). The CRCPD is an association of state radiation control officials
                          that has worked to improve the quality of mammography.
                          “H. Edward Hendrick, Ph.D., “Quality Control in Mammography: The American College of Radiology’s
                          Mammography Screening Accreditation Program,” Current Opinion in Radiology, Vol. I, 1989, p. 203.



                          Page 25                                       GAO/HRD-90-32 Quality of Screening Mammography
                         Chapter 3
                         High-Volume Providers Most Likely to Adhere
                         to Quality Standards for Screening




                         We found widespread compliance with many quality standards, particu-
MaGy Providers Do        larly those directly related to providing mammographic services, such as
Not! Meet Standards      employing certified or licensed technologists to perform the mam-
for Quality Assurance    mograms. But many facilities did not comply with standards for quality
                         assurance programs, our survey showed. A comprehensive quality
Pro@ams                  assurance program is essential to evaluate both equipment and staff
                         performance, as problems in image quality and radiation dose have been
                         attributed to the lack of such programs. Primary care physicians and
                         multispecialty clinics reported the lowest levels of compliance with
                         quality assurance standards; hospitals, hospital breast clinics, HMOS, and
                         mobile vans generally reported the highest levels.

                         Almost all of our respondents reported adhering to a number of key
                         quality standards (see table 3.1). Additional information about the
                         importance of these practices and the results of our survey appears in
                         appendix II. However, smaller percentages of providers reported com-
                         plying with professional standards for quality assurance activities, as
                         we discuss in more detail below.

-’

An&al Inspection by      ACRpolicy states that a mammography system should be inspected by a
Radiological Physicist   radiological physicist at least once a year. About two-thirds (69 per-
                         cent)’ of the facilities responding to our survey reported that either a
Varies by Setting        staff or consultant radiological physicist conducts this annual inspec-
                         tion. Compliance with this standard varies greatly by setting, ranging
                         from 43 percent of primary care physicians to 91 percent of mobile vans
                         (see fig. 3.1). For a more detailed analysis by setting and state, see table
                         v.5.




                         71’ercentagesby state were: California, 73; Florida, 62; Idaho, 62; and Michigan, 68.



                         Page 26                                       GAO/HRD-90-32 Quality      of Screening Mammography
                                         Chanter 3
                                         l&&-Volume Providers Most Likely to Adhere
                                         to Quality Standards for Screening




 ib(e 3.1: Survey Respondents’
    pliance With Key Quality Standards                                                                                 Percent of respondents
    creening Mammography                 Quality standard                                                                reporting compliance
                                         Service delivery standards: ___-
                                         ._---                                                                                                   -_-
                                         Takina medical history                                                                                     100
                                         Using
                                         ..-...__.-dedicated mammography
                                                                     ---.     __--equipment                                                           97
                                         Taking     2
                                         __.-_..----. or more   breast  views                                                                         99
                                         Certified    or licensed
                                             _..-- .-..- -~ .._.__ mammography operator                                               ---~.-      .~- 97
                                         Interpretation of mammograms by radiologist                                   ____---.--.                    99
                                                                                                                                             .-. _- -~~
                                         Reporting results of abnormal mammograms to patient and/
                                             or physician:
                                             When patient has designated physician                                                                   99
                                             When patient has not designated physician            -                                                  99
                                         Retention of original mammographic images:
                                             5 years or more                                                                                         98
                                             Over 10 years                                                                                           49
                                         Instructing patients
                                         -_               --       on breast self-examination
                                                                                         .._______. ____-..                                          90

                                         Quality assurance standards:
                                                              ..~___                  ___~___-.                    _.I-_--..---...~          -~~.-
                                         Annual inspection .-~by-__.__-.
                                                                   radiological physicist                                                            69
                                         Annual physicist inspection of beam quality, average
                                            glandular dose, and phantom image ._________
                                                                                      quality       ___.-                                            55
                                         Daily processor sensitometry                                                                                35
                                         Semiannual phantom image check by facility                                                                  46
                                         Monitoring repeat mammograms and doing one other quality
                                            assurance activitya                                                                                      44
                                         Performing       second reading of mammograms within facility
                                                                                                    -____.                                           29
                                          _-.----...--.-.-----__-
                                         Following up on patient biopsies                                                                            76
                                         aOther activities include second reading of mammogram within facility, peer review of readings, and
                                         follow-up on patient biopsies.




-Fewer  Pmvi (lers
  _.._- --_.-    Have                    Three items that a radiological physicist should inspect annually are: (1)
Annual Inspection of                     beam quality,H (2) average glandular dose,” and (3) phantom image qual-
                                         ity. (Beam quality is related to both image quality and dose.1o) About 55
Selected Features                        percent of our respondents reported annual inspection of these three



                                         ‘Ream quality is measured in terms of half value layer (HVL), which is the amount of filtration
                                         necessary to reduce the intensity of the beam to half of the original value.

                                         “The measurement of radiation absorbed by the breast that best characterizes radiation risk from
                                         mammography, according to the NCRP.

                                         “‘If the energy of the beam is too low, the radiation dose will be excessive; if too high, the contrast
                                         will be too low, resulting in poor image quality.



                                         Page 27                                        GAO/HRD-90-32 Quality of Screening Mammography
                                          Chapter a
                                          IUgh-Volume Providers Most Likely to Adhere
                                          to Quality Standarda for Screening




Figure 3.1: Annual Inspection Performed
byRa?iological Physicist, by Setting
     /                                    loo   Pomni

                                           00
                                           00

                                           70
                                           80

                                           50

                                           40

                                           a0

                                           20

                                           10

                                            0




                                          Note: Total 1,026 respondents.



                                          factors by a radiological physicist. As with overall inspection by a radio-
                                          logical physicist, primary care physicians and multispecialty clinics
                                          reported the lowest rates of compliance. Hospital breast clinics showed
                                          the highest rate of compliance (see fig. 3.2). There was considerable
                                          variation across states.ll Table V.6 presents more detailed information.


Daily Processor                           Some quality control procedures should be performed regularly by the
                                          screening mammography staff. There is a growing consensus that facili-
Ser@itometry Advised                      ties doing screen-film mammography12 need to do daily sensitometry of
                                          the film processor, a procedure that checks whether the processor that
                                          develops the film is operating properly. Of respondents using the screen-



                    *                     I ‘Percentages by state were: California, 69; Florida, 46; Idaho, 21; and Michigan, 59.
                                          “The two principal techniques for performing mammography are the screen-film and xeroradi-
                                          ography methods. Of the facilities responding to our survey, 84 percent used only the screen-film
                                          method, 11 percent used xeroradiography, and 6 percent used both.



                                          Page 28                                       GAO/HRD-90-32 Quality of Screening Mammography
                                    Chapter 3
                                    High-Volume Providers Most Likely to Adhere
                                    to Quality Standards for Screening




   1
Fig re 3.2: Annual lnrpection of
Sel cted Features by Radiological
                                    100
Phyt iclst, by Setting
                                     90

                                     80

                                     70
                                     80

                                     60
                                     40
                                     30

                                     20
                                     10




                                    Note: These selected features include beam quality (HVL), average glandular dose, and phantom
                                    image quality. Total 1,026 respondents.




                                    film method, 35 percent’:’ reported doing daily processor sensitometry;
                                    an additional 17 percent did it at least weekly. By setting, there was
                                    wide variation in compliance with the daily sensitometry standard,
                                    ranging from 10 percent of primary care physicians to 59 percent of
                                    IIMOs, as shown in figure 3.3.


Semiannual Phantom                  Although evaluating a phantom image is one component of the physi-
                                    cist’s inspection, this procedure also may be done by trained personnel
Image Checks Done by                at the facility. As discussed on page 24, exposing a phantom shows the
Half of Respondents                 quality of image the system is producing and can indicate the existence
                                    of specific problems. Recommendations for frequency of this practice
                                    vary. Overall, 46 percent of the facilities responding to our survey
                                    reported doing a phantom image check at least every 6 months. By set-
                 Y                  ting, the percentages ranged from 28 at primary care physicians to 70 at

                                    “‘Percentages by state were: California, 40; Florida, 33; Idaho, 37; and Michigan, 26.



                                    Page 29                                       GAO/HRD-SO-32 Quality of Screening Mammography
                              Chapter 3
                              High-Volume Provldem Most Likely to Adhere
                              to Quality Standards for Screening




Senaifometry, by Setting
                             loo   Poment
     I




                             Note: Only repondents who perform screen-film mammography have been included in this analysis.
                             Total 910 respondents.




                             hospital breast clinics and 73 at mobile vans, as shown in figure 3.4. We
                             also analyzed the extent to which facilities that did not report annual
                             inspection by a radiological physicist performed semiannual phantom
                             image tests, Although the need for such tests is probably greater at
                             those facilities, the proportion performing them (30 percent) was
                             smaller than for all facilities (46 percent).


SelectedQuality              Significant findings on compliance with several other quality assurance
Asbrance Activities          activities emerged from our survey:
Analyzed                   . Monitoring repeat mammograms. Monitoring the number of repeat mam-
                             mograms and analyzing the reasons the original images had to be dis-
                             carded provides information about possible problems with either the
                    *        equipment or the work of the technologist, such as improper positioning.




                             Page 30                                    GAO/HRD-90-32 Quality of Screening Mammography
                                      Chapter 3
                                      High-Volume Providers Most Likely to Adhere
                                      to Quality Standards for Screening




8 3.4: Semiannual Phantom Image
ks, by Setting




                                      Note: Total 1,026 respondents.



                                    Just over half of our respondents (62 percent) reported doing such mon-
                                    itoring, ranging from 44 percent at primary care physicians to 67 per-
                                    cent at HMOS.
                                  l Performing a second reading of mammograms within the facility, This
                                    provides a check on the radiologist’s interpretation. About 29 percent of
                                    respondents reported doing second readings; responses varied by state.14
                                  . Submitting mammograms to peer review panels for second readings.
                                    This practice provides feedback on the entire mammography process,
                                    both production and interpretation of the image. Eleven percent of
                                    respondents said they submit images for peer review.
                                  l Following up on patient biopsies. This also provides feedback on the
                                    entire mammography process and was the most common quality assur-
                                    ance activity reported by respondents. Three-fourths indicated adhering
                                    to this standard. (See table V.7 for additional data on selected quality
                                    assurance activities by setting.)



                                      14Percentagesby state were: California, 34; Florida, 32; Idaho, 10; and Michigan, 21.



                                      Page 31                                      GAO/HRD-90-32 Quality of Screening Mammography
                                                                                                                      .
                        Chapter 3
                        High-Volume Providers Meet LLkely to Adhere
                        to Quality Standards for Screening




---I   T---.-^------

                        We analyzed the proportion’ of facilities that monitored repeat mam-
                        mograms and did at least one of the other quality assurance activities
                        discussed above. About 44 percent of respondents did this, ranging from
                        35 percent of primary care physicians to 64 percent of HMOS, as shown
                        in figure 3.5.


                        A strong relationship existed between the volume of mammography per-
Hig$-Volume             formed and the rate of compliance with many quality standards. Exam-
     iders More Often   ples of quality practices where the facilities with the lowest rate of
                        compliance were in the lowest volume range and those with the highest
                        rate of compliance were in the highest volume range appear in table 3.2.

                        This association between high volume and adherence to quality stan-
                        dards is significant, because, as discussed on page 22, high volume is a
                        critical factor in reducing the price of screening mammography. A
                        recent report in the Journal of the Florida Medical AssociationI” noted
                        that not only is high volume necessary to lower costs, but it also contrib-
                        utes to quality by giving radiologists sufficient work to increase the pro-
                        ficiency of their interpretations.


                        For several quality standards, we found no direct relationship between
Compliance With         the charge for screening mammography and the degree of compliance
Quality Standards Not   with professional standards. For other standards, there was a relation-
Related to Charge       ship, but its direction was not consistent. That is, in some cases provid-
                        ers charging the lowest fees had the highest rate of compliance with a
                        quality standard, while in other cases those with the highest fees had
                        the highest rate of compliance.

                        For example, 44 percent of respondents charging over $150 reported
                        doing semiannual phantom image checks, while 56 percent of those
                        charging $50 or less said they did so. Similarly, 27 percent of the facili-
                        ties charging $50 or less reported following the practice of both sending
                        positive mammogram reports to the patient and/or physician and then
                        reminding the patient to contact her physician. This proportion was at
                        least twice as high as any other charge category. However, the charge
                        category with the highest proportion of facilities inspected annually by
                        a radiological physicist was those charging over $150 (79 percent). For

                        “Hobcrt A Clark, M.D., et al., “Screening Mammography in the Tampa Bay Area: Current Status and
                        Implications for the Next Decade,” Journal of the Florida Medical Association, May 19S9,
                        pp. 449-453.



                        Page 32                                   GAO/HRD-90-32 Quality of Screening Mammography
                                          Chapter 3
                                          High-Volume Providers Most Likely to Adhere
                                          to Quality Standards for Screening




Figbre 3.5: Selected Quality Assurance
Acthlties, by Setting
                                         100

                                          80

                                          a0

                                          70
                                          60

                                          50
                                          40                 I
                                                                                     I       n                           \

                                          30
                                          20

                                          10

                                           0




                                         Note: Activities are monitoring rate of repeat mammograms plus at least one of the following: (1)
                                         second reading of mammograms within facility, (2) peer review of interpretation, and (3) follow-up of
                                         patient biopsies. Total 1,026 respondents.




                                         daily processor sensitometry, the highest rates were in the lowest (45
                                         percent) and highest (44 percent) charge ranges.




                                         Page 33                                         GAO/HRD-90-32 Quality of Screening Mammography
                                             Chapter 3
                                             High-Volume Providera Most Likely to Adhere
                                             to Quality Standards for Screening




Table 3:2: Relationship Between Volume
and Pr+Aders’ Compliance With Quality                                                                    Percent of respondents reporting
StandaIds                                                                                                            compliance
                                                                                                         Low-volume              High-volume
                                                                                                            providers                providers
                                             Quality standarda.-.~--
                                             __.-.-__                                                     (<25/week)             (>lOO/week)
                                             Annual inspection           by radiological physicist
                                                                   ---.-____                                         58                             87
                                             -.-..~~
                                             Annual physicist inspection of beam quality,
                                                 average glandular dose, and phantom
                                                 image                                                              44                              74
                                                   ..-.._---quality ___-                                                               ____.__-.-
                                             Daily     processor sensitometry
                                                                           -- ------.--                             24                  -_____      50
                                             -.-...-.-_______
                                             Semiannual        phantom       image check by facility                33                              73
                                             ------_____
                                             Monitoring repeat mammograms and doing
                                                 one other quality assurance activityb                              40                        __-   60
                                             Performing second reading of mammogram
                                                 within facility           --                                       25                              45
                                             . .-..---        _.---
                                             Following
                                             -..- --__~_--__ up on patient biopsies                                 70                              89
                                             instructing patients on breast self-
                                                 examination                                                        84                              97
                                             aWe did not include in this table the standards shown in table 3.1 with which almost all respondents
                                             reported complying.

                                             bOther activities include second reading of mammogram within facility, peer review of readings, and
                                             follow-up on patient biopsies.


                                             Our site visits also tended to dispel the concern that quality would be
                                             compromised at facilities charging lower fees for screening mam-
                                             mography. We visited three facilities that reported complying with
                                             many quality standards and that charged $50 or less for screening mam-
                                             mograms. All reported volume levels of at least 200 mammograms per
                                             week. One used a significant amount of volunteer labor to lower operat-
                                             ing costs, but the other two did not. The quality standards and recom-
                                             mended practices present at these facilities include

                                         . trained, experienced radiologists and certified radiologic technologists;
                                         l inspection by a radiological physicist at least annually;
                                         . daily processor sensitometry;
                                         . phantom image checks at least semiannually;
                                         l monitoring of repeat mammograms and following patients with abnor-
                                           mal findings;
                                         . proper record retention and reporting practices; and
                                         . extensive instruction on breast self-examination.




                                             Page 34                                            GAO/HRINO-32 Quality of Screening Mammography
Chapter 4

Federal and State Regulationof Screening
Qbmmography Is Limited

                        Currently, both the Food and Drug Administration and the states have
                        responsibility for regulating mammography equipment and services.
                        FDA'Srole is to ensure the proper manufacture and installation of equip-
                        ment, so it has no standards for mammographic image quality or patient
                        radiation dose. Of the states we reviewed, only Michigan has a law
                        requiring the use of dedicated mammography equipment and the setting
                        of image quality and radiation dose standards. The lack of such stan-
                        dards in the other three states limits their ability to regulate screening
                        mammography services. Even with limited oversight of mammography,
                        both FDAand state inspections have found noncompliance with perform-
                        ance standards.

                        The limited scope of FDA and state regulation and the problems found by
                        inspectors underscore the importance of the quality standards that Con-
                        gress required the Secretary of HHSto issue for Medicare-funded screen-
                        ing mammography. On September 1, 1989, HHSpublished proposed
                        regulations that closely parallel the professional quality standards we
                        discussed in chapter 3. However, HHSplans to withdraw the regulations
                        due to the repeal of the Medicare Catastrophic Coverage Act of 1988.


                        State regulation of mammography equipment in the four states we vis-
State Oversight of      ited is limited. Only Michigan requires use of dedicated equipment and
Mammography             has established standards for image quality and radiation dose. Idaho
                        does not regulate operators of mammography equipment, and the other
                        three states we visited vary in the qualifications required for persons
                        interpreting mammograms. State inspections have found image quality
                        problems at mammography providers, but narrow legal authority often
                        limits state enforcement efforts.


1leeulation of
--v--   ---   -   -
                        In three of the four states we reviewed, state regulation applies to use of
Mammography Equipment   all X-ray equipment, and emphasizes protecting the equipment operator
                        and bystanders. These states have no separate standards for mam-
and Personnel Limited   mography services. In June 1989, Michigan enacted legislation adopting
                        ACRstandards for mammographic image quality and radiation dose,
                        becoming the only one of the states we reviewed to require the use of
                        equipment specifically designed for mammography.

                        Each of the states we reviewed has an office responsible for the over-
                        sight of all types of X-ray equipment. The states require registration of
                        X-ray equipment at the time of installation, as well as periodic
                        reregistration.


                        Page 38                          GAO/HRD-90.32 Quality of Screening Mammography
                                                                                                                          .
                           Chapter 4
                           Federal and State Regulation   of Screening
                           Mammography Is Limited                                                      ,




                           The competence of the person operating the mammography equipment
                           is critical to producing a useful image. Both California and Florida have
                           requirements for and license operators of X-ray equipment, including
                           mammography equipment. Idaho neither licenses the people who take
                           mammograms nor sets minimum qualifications they must meet. The leg-
                           islation enacted by Michigan in June 1989 requires state regulators to
                           set standards for mammography operators. (For additional information
                           on licensing requirements in these states, see app. IV.)

                           The four states also differ in their regulation of persons who interpret
                           mammograms, another critical component of the screening process.
                           Michigan has no law governing who may interpret mammograms.
                           According to state officials, Florida and Idaho permit any licensed phy-
                           sician to interpret mammograms. California requires interpreters to
                           have a state license in the healing arts.


Frequency and Content of   Each state we visited has an inspection program for all X-ray equip-
                           ment, including mammography machines, The programs vary with
Inspections Vary           regard to frequency of inspection, staffing, and contents of the inspec-
                           tions, although some equipment features are examined in all four states.

                           The criteria of the Conference of Radiation Control Program Directors
                           call for state inspections of new facilities within the first year of opera-
                           tion In Florida and Idaho, newly registered equipment is inspected
                           within 1 year, and Michigan will begin inspecting new equipment within
                           60 days. Subsequent periodic inspections occur annually in Florida and
                           every 3 years in California. Michigan’s new law will increase subsequent
                           inspections there from every 3 years to at least annually.

                           Idaho bases inspection priorities on the setting in which the X-ray equip-
                           ment is used. After the initial inspection during the first year, the sched-
                           ule calls for inspection of mammography equipment in hospitals once
                           every year and in physicians’ offices once every 2 to 3 years. Hospitals
                           are given priority, state officials told us, because most X-ray examina-
                           tions are performed in that setting. Because of a staffing shortage, how-
                           ever, Idaho is not completely adhering to this inspection schedule. Of
                           Idaho’s three state inspector positions, two have been vacant for over 1
                           year. Consequently, equipment in hospitals is being checked about once
                           every 2 years and in physicians’ offices, about once every 3 years.

                           The inspection procedures of the four states include a number of com-
                           mon elements. For example, all measure the beam quality (WI,) and


                           Page 36                                       GAO/HRD-90-32 Quality of Screening Mammography
                         ChnDter 4
                         Federal and State Regulation of screen&
                         Mammv@aphy     Ia Limited




                         average glandular dose. California, Idaho, and Michigan use a phantom
                         (see footnote 1, p. 24) to inspect image quality, and Florida plans to
                         begin this procedure in early 1990. Both California and Michigan use the
                         phantom ACRuses in its accreditation program. Except for Michigan, the
                         states lack legally binding standards regarding use of dedicated mam-
                         mography equipment, limitations on the radiation dose received by
                         patients, and minimum image quality. Although California uses the
                         same phantom to evaluate image quality that ACRuses in its accredita-
                         tion program, it does not have image quality standards.

                         Florida and Michigan focus on whether the facility is using equipment
                         specifically designed for mammography. Until recently, neither state
                         prohibited the use of nondedicated equipment, although both
                         encouraged facilities to use only dedicated equipment. As a result of
                         Michigan’s efforts, the number of facilities using general purpose
                         machines for screen-film mammography dropped from 25 to 3 between
                         May 1987 and November 1988. Now, as indicated earlier, Michigan law
                         requires use of dedicated equipment. (For additional information on
                         inspection personnel, see app. IV.)


State Inspections Find   Of the states we visited, only Michigan had analyzed inspection data on
Problems                 mammographic image quality and radiation exposure, basing its evalua-
                         tions on ACRstandards. Between January and November 1988, Michigan
                         inspected 95 mammography machines, over 20 percent of those in the
                         state. As shown in table 4.1,35 percent of the 95 machines produced
                         poor image quality and 11 percent registered excessive radiation dose.

                         To determine if there were differences in adherence to certain quality
                         standards in different settings, the Michigan inspection program catego-
                         rized the inspection data by facility type. Mammography machines
                         located in medical offices were more than twice as likely to produce
                         poor image quality than machines located in hospitals and had more
                         problems than those located in radiology offices.




          Y




                         Page 37                                   GAO/HRD-90-32 Quality of Screening Mammography
                                            Chapter 4
                                            Federal and State Regulation of Screening
                                            Mammography Is Limited                                                                  ,




Table i4.1: Michigan Mammography
Equipbent With Image Quality and/or                                                            Percent experiencing problem
       ion Problems, by Facility Type                                                                             By facility0
        ov. 1988)
                                                                                 All equipment                     Rad’,“;g                       Medical
                                            Equipment problem                         inspected       Hospital                                     office
                                            Poor image quality                                  35                23                    36             57
                                            High radiation exposure                             11                 9                    10             14
                                            aMichigan’s principal facility categories are hospital, radiology office, and medical office. A clinic could
                                            be included as either a radiology or medical office.

                                            In compiling data on compliance with state law and regulations concern-
                                            ing mammography (see table 4.2), Florida officials did not distinguish
                                            between minor and serious violations, even though some of the types of
                                            noncompliance cited could affect patient dose. California and Idaho offi-
                                            cials were unable to provide summary data from their inspections.

Table~4.2: Florida Mammography
Equipjment Not in Compliance (Fiscal Year                                                                                No.   of            Percent of
1988)                                       Facility                                                             inspections            noncompliance
                                            _-------      --..--___
                                            Hospital                                                                        173                         9
                                            Medical doctora                                                                 216              ~-        11
                                            Osteopath                                                                         3                         0
                                            Mobile lab                                                                       15                         0
                                            aThis category includes both physicians and clinics



Absence of Legal                            Officials from all four states told us that when they find violations of
Authority Hinders                           state standards, facilities usually respond readily to efforts to bring
                                            about compliance. Steps such as court action are rarely necessary. How-
Enforcement Efforts                         ever, because there are few state regulations pertaining to mam-
                                            mography, state officials have limited authority to require providers to
                                            correct problems. When there is no legal requirement in effect, such as
                                            for use of dedicated equipment or limiting radiation dose to the patient,
                                            state officials must depend on persuasion to correct the problem. Offi-
                                            cials told us they are often successful in these compliance efforts, even
                                            without the force of law. However, if a provider chooses not to comply
                                            with a recommendation, state radiation control officials have no author-
                                            ity to apply sanctions.

                                            The problems this situation can create are illustrated by our site visit to
                                            a California mobile van. A June 1988 inspection report by Los Angeles
                                            County noted several deficiencies, including unacceptable temperature
                                            of the developing solution in the film processor and poor phantom image



                                            Page 38                                         GAO/HRD-90-32 Quality of Screening Mammography
                             Chapter 4
                             Federal and State Regulation of Screening
                             Mammography Is Limited




                             quality, No follow-up actions occurred, and since there is no legal stand-
                             ard for image quality, the state could not require the facility to upgrade
                             its technique. The facility has to repeat 10 percent of its mammograms,
                             a facility official told us; this rate is five times that considered accepta-
                             ble by the Conference of Radiation Control Program Directors. (See
                             pp. 30-31 for a discussion of the quality assurance purpose of monitor-
                             ing repeat mammograms.)

 1


                              FDAregulates the manufacture and initial assembly of mammography
IDA Regulates                equipment. Its standards, which govern all types of X-ray machines, not
Manufacture,                 just mammography equipment, apply to manufacture and installation.
Pissembly of ’               Although FDAinspects only a small percentage of mammography equip-
                             ment, it has found noncompliance with its standards.
@--nmography
$quipment

FDA’s Performance            FDA'Srole is to ensure that diagnostic X-ray equipment (including mam-
SZandardsApply to            mography equipment) is correctly manufactured and installed. Conse-
                             quently, its standards apply only to the manufacturer and assembler of
Manufacturer, Not User       the equipment, not to the user, such as the mammography provider.

                             FDAperformance standards cover such factors as equipment alignment
                             and measurement of radiation leakage. There is no standard for the
                             radiation dose received by the patient, as FDAconsiders that to be a
                             practice of medicine issue not within its purview. FDAevaluates compli-
                             ance with the standards during inspections of newly installed radio-
                             graphic equipment.


Relatively Few Inspections   Partially through contracts with 34 state radiological health agencies,
Performed                    including those of California and Florida, FDAarranges for field testing
                             of newly installed diagnostic X-ray equipment. In states without con-
                             tracts, FDAstaff do the inspections. Inspectors test to determine whether
                             the equipment complies with FDA'Sperformance standards, focusing on
                             equipment installed within the past 12 months. Only within this time
                             frame does FDAtake regulatory action, and few inspections occur beyond
                             the first year.
           *                 States decide which X-ray facilities to inspect, with some guidance from
                             FDA as to the percentages of each type of equipment to check. The FDA



                             Page 39                                     GAO/HRD-90-32 Quality of Screening Mammography




                                                                                                                .
                                                                                                                                        ,
                                            Chapter 4
                                            Federal and State Regulation of Screening
                                            Mammography Is Limited




                                            goal is to inspect up to 30 percent of new X-ray equipment within 1 year
                                            of installation, but the proportion of mammography machines inspected
           1                                in the four states we visited was much lower (see table 4.3). This is
                                            because FDAgives priority to general purpose equipment, the type most
           I,                               frequently used.
--

Table 4.3: FDA Inspections of Newly Installed Mammography Equipment in Four States (1986-l 988)
         /
         /                                  1986                           1987                                    1988
                             Installed         Inspected       installed      Inspected        Installed              Inspected
State ’                        .. ...!“O.)      No.    Percent       (no.)     No.    Percent        (no.)             No.    Percent
Califorr 1la                           207       11          5         193      16          8           79             35          44
Florida~                           100           12              12        113          4        4        41            8          20
Idaho /                              5    -_--.-- 0               0 ___-     7          0        0         6            0            0
Michi&                              84            5               6         88          0        0        33            0          -6


--.L_



Subkantial Noncompliance                    FDA'Sinspections in the four states we visited have found a substantial
With Standards Found                       amount of noncompliance with its performance standards (see table
                                           4.4). If noncompliance is found within 1 year of equipment installation,
                                           FDA assumes it is due to improper installation. The assembler is responsi-
                                           ble for correcting the problem unless obvious misuse is apparent. FDA
                                           sends a notice of noncompliance to the assembler instructing repair
                                           within 30 days. The assembler must then notify the FDAdistrict office
                                           when the problem has been corrected.
Table 4.4: Noncompliances Identified by
FDA in Four States (1982-I 989)                                                           No. of           No. of      Percent of
                                           State .-__...---_-..---
                                           _..-...--..                     II-     inspections”  noncompliances   noncompliances
                                           California                                       86                 9                   16
                                           Florida                                          35                 8                   23
                                           Idaho
                                           ..-_ .--.---   .._--_-..                          1                 1                  100
                                           Michiaan                                          8                 1                   13
                                           “Between Jan. 1982 and Feb. 1989

                                           Problems with image receptor alignment are the most frequent type of
                                           noncompliance found. If the beam and image receptor are not properly
                                           aligned, part of the body that should not be exposed to radiation is
                                           exposed, and part that should be included in the image is not.




                                           Page 40                                  GAO/HRD-90-32 Quality of Screening Mammography
                Chapter 4
                Federal and State Regulation of Screening
                Mammography Ie Limited




                The 1988 Medicare Act required the Secretary of HHSto develop regula-
H/HS Proposed   tions to ensure that screening mammography reimbursed by Medicare
Standards for   would meet safety and accuracy standards. The law specifically called
                for requirements on equipment, personnel, and film retention. On Sep-
                tember 1, 1989, HHSpublished its proposed regulations. These included
                standards closely paralleling those developed by professional organiza-
                tions, such as ACR. Such standards, along with an adequate enforcement
                mechanism, would help to assure the provision of high quality screening
                mammography. However, since the Medicare Catastrophic Coverage Act
                of 1988 was repealed, HHSplans to withdraw its proposed regulations.




                Page 41                                     GAO/HRD-90-32 Quality of Screening Mammography
Cha&!r   fi

C&wlusions


                  Breast cancer is increasing in American women, and mammography is
                  the best method of detecting breast cancer at its earliest, most curable
                  stage. Symptom-free women who follow recommended guidelines for
                  periodic screening mammography can lower their risk of dying from
                  breast cancer by 30 percent. Despite broad agreement in the medical
                  community on the importance of regular screening, relatively few
                  women participate in screening mammography programs.

                  A Medicare screening benefit such as that provided in the Medicare Cat-
                  astrophic Coverage Act of 1988 would make millions of high-risk women
                  eligible for low-cost screening mammography. However, some members
                  of Congress were concerned that the act’s $50 limit on what providers
                  could charge might reduce the availability of high-quality services.

                  We found facilities that charged $50 for screening mammography and
                  reported complying with quality standards. Providers can better do so if
                  they distinguish between screening and diagnostic mammography and
                  operate high-volume screening practices. This enables them to use such
                  procedures as batch reading of films and make more efficient use of
                  equipment to lower the cost of providing screening services. The Physi-
                  cian Payment Review Commission, which found that providers that
                  make a distinction between screening and diagnostic services charge less
                  for screening, concluded that $50 is an appropriate charge if volume is
                  sufficiently high.

                  High volume also was associated with high quality in our survey. The
                  facilities that reported the highest rates of compliance with many qual-
                  ity standards were those providing the highest volume of mam-
                  mography services. However, we found no consistent relationship
                  between charge and compliance with quality standards.

                  Quality standards are not always adhered to in current mammography
                  practice, our survey and other studies have found. Oversight of mam-
                  mography services by the states and FDAis limited. Of particular con-
                  cern, there is little regulation of mammographic image quality and the
                  radiation dose patients may receive.

                  In conclusion, Medicare coverage for screening mammography would
                  bring a valuable life-saving tool to a large population of women at risk
                  of developing breast cancer. The evidence we found suggests that limit-
              J   ing charges to $50 should not jeopardize the quality of care available to
                  Medicare beneficiaries. To the contrary, the charge limit would



                  Page 42                          GAO/IBID-90-32 Quality of Screening Mammography
     Chapter 6
     Conclusions




-’

     encourage provision of screening mammography in high-volume set-
     tings, which we found were most likely to comply with quality stan-
     dards. By reinforcing the trend to high-volume settings, which can best
     provide high quality at lower prices, such a charge limit also could
     increase the accessibility of screening mammography for younger
     women eligible for screening.

     At the same time, we found a need for strong federal standards to
     assure the quality of screening mammography. Although there are pro-
     fessional standards for acceptable image quality and radiation dose,
     there have been few legal mechanisms to enforce them. The result is a
     wide range of image quality and patient dose in current mammography
     practice. The regulations that were proposed by HHSwould have helped
     to fill this regulatory gap.




     Page 43                         GAO/HRD90-32 Quality of Screening Mammography
Apr>e/ndix I

GAO’sSurvey Methodology


                       In January 1989, we mailed a questionnaire to all facilities identified by
                       state radiological health departments in California, Florida, Idaho, and
                       Michigan as having mammography equipment. We assumed that these
                       facilities were currently in business in the respective states. This appen-
                       dix contains a technical description of our questionnaire design, pretest
                       procedures, and response rate.

                       The questionnaire was designed to obtain information concerning the
                       practices and procedures of facilities performing screening mam-
                       mography. It was reviewed by officials from the National Cancer Insti-
                       tute and American College of Radiology.

     /
                       Before distributing the questionnaire, we pretested it in person with
Qu&tionnaire           officials at nine facilities in the Washington, D.C., metropolitan area and
Pretested in Two       two facilities in Providence, Rhode Island. These facilities represented
Arehs                  the types of settings likely to be found among the facilities to be sur-
                       veyed. Pretesting the questionnaire assured us that the questions were
                       generally understandable and free of confusion and error. During the
                       pretest, the officials completed the questionnaire as if they had received
                       it in the mail. Our staff noted the time it took to complete each question
                       and any difficulties the respondents experienced. Once the question-
                       naire was completed, we used a standardized approach to elicit descrip-
                       tions of difficulties and issues encountered with each item.

                       Using the pretest results, we revised the questionnaires to ensure that
                       (1) the potential respondents could and would provide the information
                       requested and (2) all questions were fair, relevant, easy to answer, and
                       relatively free of design flaws that could introduce bias or error into the
                       study results. In addition, we tested the questionnaire to ensure that the
                       task of completing it would not place too great a burden on the
                       respondent.


                       Of a total of 1,485 questionnaires mailed to facilities in four states,
IuJ
3 .’v.r3bculbesponse   1,242 were returned. We adjusted our universe to 1,369 to exclude ques-
       1 *? Percent    tionnaires that (1) were mailed to facilities no longer in operation, (2)
                       were duplicates,’ or (3) were returned as nondeliverable.” This resulted

                       ‘The list the state provided indicated a different address or contact person, but the recipients
                       informed us the facilities were identical.

                       “After making several unsuccessful attempts to contact these facilities by telephone and mail, we
                       assumed they were not currently in business.



                       Page 44                                       GAO/HRD90-32 Quality of Screening Mammography
                                              Appendix I
                                              GAO’e Survey Methodology




                                              in an overall response rate of 82 percent. The initial and adjusted uni-
                                              verse and the number of responses are shown by state in table 1.1.


ladle 1.1: Response to CIAO Questionnaire, by State
                                                                       No longer in
                                                     Initial             operation,                                                    No. of
                                              universe of            undeliverable             Duplicate        Adjusted              usable
State                                            facilities         questionnaires              facilities      universe __--.-   responses
                                                                                                                                      - ~-~.
Cal I fornia                                             757                         10                 70            677                553
Flo Ida                                                  313
                                                          35.________--               06                 91           298
                                                                                                                       34 _-..__. .-~~~- 239
                                                                                                                                         o
Idaho                           . . __--.--- __.-...
                                                 ---_-----__         -.-. -.~
MICc lgan                                                 380                   ___-- 3                 17            360                304
Totbls                                                1.485                          19                 97          1.389              1.126




                                              Page 45                                      GAO/HRD-90-32 Quality of Screening Mammography
   /ppc&dix II

k(l.0 Questionnaireon Mammography

-




                                                          United    States General Accounting Office
                                                                   Screening Mammography Survey
                     ‘Ihe United States General Accounting Office (GAO), an agency of the U.S. Congress, is
                     conducting a survey of facilities          identified    by state offices  of radiologic   health or
                     radiation     control   as having equipment used to perform mammgraphy.           The purpose of this
                     questionnaire       is to obtain information       about mammography conducted on asymptcmatic
                     patients.      In this questionnaire,     we refer to such mannnography as screening mamnography.
                     This questionnaire    should take about 20 minutes to ccmplete.    Your responses will be
                     kept confidential.     We will report your responses only in sum~ry with those of other
                     facilities   that respond to this questionnaire.    Your responses will not be made knm
                     to anyone outside of the GAO.
                     This questionnaire      should bs axnpleted   by the person(s) most familiar      with your
                     facility’s   screening mammography practices.        Before you begin, because of the variety
                     of information     requested,  you may want to briefly     review the questionnaire    to determine
                     the necessary sources of information        you will need and whan you may want to consult.
                     In the event you receive more than one questionnaire,              please ccanplete only one
                     questionnaire      for each facility      where mamncgraphy is performed, mark the addTiona1
                     questionnaire(s)       “duplicate”,     and return all questionnaires      in the same lusiness    reply
                     envelope provided.         It is possible      that your state records both individual     avnership     as
                     well as facility       location.     Iherefore,     since we sent a questionnaire   to each address
                      rovidd,     we may have included in our survey the owner of the equipnent as well as the
                     Pacility.        In order for us to report accurate information          to the Congress, it is very
                     imbrtant      that all questionnaires        be returned.




                                                                          LABEL




                     Please provide the name, title,    and telephone number of the primary               person we may contact
                     if additional  information  is required concerning your responses.

                     N~MZ of Primary       Contact       Person:

                     Official    Title:

                     Telephone    Nuder:     (       )

                     Please return the questionnaire     in the enclosed business reply envelcpe, or if the
                     envelope is misplaced,   send it to the address shown on the back of the questionnaire.
                     If you have any questions,    please call Helene Toiv at (202) 426-0842 (or 426-0800).

                 Y




                                      Page 46                                      GAO/HRD-90-32 Quality of Screening Mammography



                                                                                                                                   ,
                                                                                                                               yl!$
                   Appendix II
                   GAO Questionnaire on Mammography




1.   Is mazmgraphy performed at your facility?                                (CHECKcm.)
     a. (      )   Yes

     b.(       1 NO ->(Stqpl  PLEASE HEIUHN‘IHIS QUESTIONNAIRE. IT IS IMKXIANl’ ‘IHAT YOU
                          HETURNTHIS QUESTIONNAIRE.1


2.   Does your facility    provide manmgraphy to -- (a) as
     to ss screening PPanmography), (b) sy;ptan$ic    pat6%%%$%%                                                    :ms:o
     mmmgra&),        or (c) both asymptanat c a   symptanatic patients?                                         (CHECKCNE.)
     a. (      )   Screening mnmgraphy               only ->(SKIP            lO -CN             5.1

     b. (      )   Diagnostic        mammgraphy only
     c. (      )   Both diagnostic            and screening         manmmgraphy ->(SKIP               Xl Quesnrcrs 5.)


3.   Using the categories provided helm, please indicate the ofm kind of setting
     where the      majority
                         of your diagnostic mammgrams are performed,   (CHECKCNE.)
     a, (      )   Primary care physician’s                office     (e&,        gynecologist,        inteY?IiStr        SUrgeOn)

     b. (      )   Radiology        private     practice

     c. (      )   Hospital     -- Radiology         Department

     d. (      )   Hospital     -- Cutpatient         clinic/        Ambulatory Care center
     e. (      )   Breast Center/ Clinic (i.e.,   freestanding                       facility        for screening         and/or
                     treatment of breast disease)
     f.    (   ) Health Maintenance Organization                      (HMO)
     g. (      )   Mu;;l.;Eyialty         clinic     (e.g.,       multispecialty        group practice,              outpatient

     h. (      )   Mobile van -- Affiliated                with     a hospital,      clinic,      or physician’s           practice

     i.    (   )   Mobile van -- Not affiliated                   with a hospital,         clinic,      or physician’s
                     practice
     j.    (   )   Other (PLEASE SPECIFY)




                   Page 47                                             GAO/HID-DO-32 Quality of Screening Mammography
                  Appendix II
                  GAO Queatiouuaire on Mammography




    4.   How would you describe     the physical         location     of your facility?             (CHECKONE.)

         a. (     Urban
         b. (     Suburban
         C.   (   Rural



    5.   Using the categories provided below, please indicate the am kind of setting
         where the majority of your screening tnamnogrm are performed.    (CHECKCNE.)

         a. (     Primary care physician's          office     (ea,       gynecologist,          internist,       surgeon)

         b. (     Radiology    private   practice
         C.   (   Hospital    -- Radiology    Department

         4.   (   Hospital    -- Outpatient    clinic/       Ambulatory Care Center
         e.   (   Hospital    -- Breast Screening          clinic     (i.e.,     screening       clinic       located   in
                  hospital,     but for outpatients         only)       -
         f.   (   Breast Center/ Clinic (i.e.,   freestanding                  facility        for screening       and/or
                    treatment of breast disease)
         4.   (   Health Maintenance Organization              (HMO)
         h.   (   Multispecialty     clinic   (ea,        multispecialty          group practice,         outpatient
                    clinic)
         i.   (   Mobile van -- Affiliated          with a hospital,           clinic,     or physician's          practice

         j.   (   Mobile van -- Not affiliated            with a hospital,           clinic,      or physician's
                    practice
         k. (     Other (PLEASE SPECIFY




w




                  Page 48                                      GAO/HRD-90-32 Quality of Screening Mammography
                         Appendix II
                         GAO Questionnaire on Mammography




6.   Ho.+would you describe                   the physical      location     of your facility?           (CHECKONE.)
     a. (         1 Urban
     b. (         )      Suburban
     c. (         )      Rural

7.   Approximately during what month and year did your facility
     screening manznography services?
                                                                                                 begin provid   ing


8.   During a normal week for each day listed below, indicate                                the total     number   of hours
     your facility  provides screening manuqraphy.
               Total      Nmber     of   Ham3    Screenirq      Memmgraphy      Is Prwided

     a.         Monday                           Hours
     b.         Tuesday                          Hours
     C.         Wednesday                        Hours
     d.         Thursday                         Hours
     e.         Friday                           Hours

3.   IXlring           a normal week, does your facility              provide    screening       marsqraphy     after
     6:00 p.m.?               (CHECKONE.)
     a.    (      1      Yes

     b.(          )      No ->(SKIP      ‘R) q.JETrlm        11.1



10. Approximately how many evening IXIULX (after 6:00 p.m.)                              during     a normal week
    does your facility provide screening mamnography?
                           Total    evening     hours screening       mammographyprovided




                        Page 49                                        GAO/HRD-90-32 Quality of Screening Mammography
                     Appendix II
                     GAO Questionnaire on Mammography




   << Answer only           with     mmect       to the cm       setting        ylou identified       in question      5 >>




1. Check below when, if at all, your facility is open to provide                                      screening
   mammographyduring the weekend. (Saturday and/or Sunday)                                                (CHECKONE.)
  a. (       )       Every weekend
  b. (       )       3 weekends a month
  c. (       )       2 weekends a month
  d. (       )       1 weekend a month
  e. (       )       Not open during          the weekend


!. During a normal week, haw many diagnostic                        and/or screening              -rams
   does your facility perform?
  a.                        Number of diagnostic             mananograms
  b.                        Number    of acmeming           mammograms



I. Listed Bela are various pieces of information  which might be collected fran a
   patient as part of the screening manmqraphy process.   Indicate the information
   you usually collect.    (CHECKALL 7xxr APPLY.)
  a.     (       ) Demographic data (e2,                    age, marital        status,    ethnic     background)
  b.     (       ) Current breast symptans (e.g.,                   breast        tenderness,       pain,   lump, or
                   nipple discharge)
  C.     (       ) Previous mammography information                      (e&,       date, where performed)
  d.     (       )     Surgical     history     -- breast      surgery
  e.     (       )     Family history         of breast cancer
  f.     (       ) Current         medication     history      (e.g.,      hormone)

  g*     (       ) Other (PLEASE SPECIFY)
  h.     (       )     Do not collect         information




                 Page SO                                           GAO/HRD-90-32 Quality of Screening Mammography
                       Append& II
                       GAO Questionnaire. on Mammography




        << -             -a     with nwpect to the Qy) wttinn             you identified   in qweticm !j >>


4. At the time a screening mamnogram is performed at your facility, is a breast
   physical examination (palpation) routinely conducted?     (CHECKONE.1
   a.          (   ) Yes
   b.          (   ) No->(sKIPmQuEsTIm17.)



5. When a breast physical examination                    is performed at your facility,      who usually   does
   the examination?    (CHECKONE.)
   a.          (   1 Radiologist        (who interprets      the films)
   b.          (   1 Radiologist        (not necessarily      interpreter)
   C.          (   1 Other physician
   d.          (   ) Technologist        who performs the mmmgram

   8.          (   )    Nurse

   f.          (   ) Other        (PLEASE SPECIFY1



6. Does your facility               charge a separate fee for the breast physical           examination?
   (CHECKONE.)

   a.          (   1    Yes ->         Please indicate      fee charged       $

   b.          (   )    No




                   Page 61                                     GAO/HRD90-32 Quality of Screening Mammography
                      Appendlv XI
                      GAO Questionnuke on Mammography




     << m              c&y      with     Lwspect   to the one settitlg   you idmtified       in qwstim       5 >>




17. Indicate       what mechanism(s) is used by your facility                  to inform the patient        about
    breast       self-examination.   (CHECKALL ‘IMAT.APPLY.)

    a.       (    ) Video

    b.       (    )     Pamphlet
    C.       (    )     Staff     person instructs        the patient
    d.       (    ) Other              (PLEASE SPECIFY)

    e.       (    )     No   information       provided




18. For screening manmwgraphy, indicate if your facility  perfO?ZiW Screening
    -rams       using (a) dedicated mammographyequipment (i.e.,   equipment manufactured
    for the sole purpose of nwmwgraphy M general radio&$&         equipnent that is
    modified for mamwgraphy only and cannot be used for general radiographic
   *purposes), (b) general purpose radiographic equipment, or (c) both dedicated
    manwqraphy and general purpose radiographic  eguipnt?        (CHECKONE.)
    a.       (    ) Dedicated rwmwgraphy equiprsent only ( i.e. , equipment manufactured
                    or rrcdified for manwqraphy only)     -
    b.       (    ) General plrpoee radiographic                 equipment
    C.       (    ) Both dedicated             wmmwgraphy and general purpose radiographic               eguipnent


19. Indicate the type of m                            manuwqraphy your facility      uses.
    (CHECKONE.)

    a.       (   )      Screen-film        mwtwgraphy
    b.       (   )     Xeranarranography
    C.       (   )      Both screen-film           and xermraphy




                  Page 62                                          GAO/HRD-90-32 Quality of Screening Mammography
.



                      Appendix II
                      GAO Questionnaire on Mammography




         << Aninrer akly with m3pect to the one 8ettirx.g yau identified                        in question 5 >>



    20. Which views does your facility               usually        do for a screening    bilateral   manmrgram?
        (CHECKALL ‘JXAT APPLY.)

        a.    (   )     Cranio-caudal        or Cephalo-caudal           (1 view per breast)
        b.    (   )     True Lateral         (1 view per breast)
        c.    (   ) Oblique--Mediolateral               (1 view per breast)
        d.    (   )     Other    (PLEASESPECIFY)




    21. Listed belaw are various categories representing  individuals who might
        screening mamnography. Indicate the ane category which represenfs the %%%a1
        at your facility who usually performs the screening marsnograms. (CHECKONE.)
        a.    (   ) AFW registered             radiologic          technologist

        b.    (   )     State licensed        radiologic       technologist
        CO    (   )     Padiologic     technician
        d.    (   ) Nurse
        e.   1 )        Radiologist
        f.   1 ) Technician            trained      to perform marsnography

        4*   (    )     Other    (PLEASE SPECIFY)



    22. Does any other       individual(s)         perform screening, marsnogramsat your facility?
        (CHECKONE.)
        a.   (    1 Yes
        b.   (    )     No ->(!xIP      ‘1[10-CN            24.)




                  Page 63                                             GAO/HRD-90-32   Quality of Screening Mammography
,,
                                                                                            -



                            Appendix II
                            GAO Questionnaire on Mammography




          <~krewercml~withre3mect                     to theone sf3ttingyar          identified   inque~tim    5 >>



     23. Indicate each category which represents                         the other   individual(s)  who performs
         screening -rams       at your facility.                           (CHmL       THAT APPLY,)
          a.        (   ) APKI registered         radiologic          technologist

          b.    (       )     State licensed     radiologic          technologist
          c.    (       )     Radiologic    technician
          d.    (       1 Nurse
          e.    (       )     Radiologist
          f.    (       )     Technician    trained      to perform manm-ography

          cl*   (       ) Other        (PLEASESPECIFY)


     24. Listed below are categories representing    individuals      who might interpret
         screenirq -rams.         Indicate the category which represents the individual
         at Your facility   who usually does the final interpretation       of the screening
         manmxjrams.      (CHECKONE.)
          a.    (       )     Radiologist
          b.    (       ) other physician
         c.     (       ) Nurse
         d.     (       ) Technologist
         e.     (       ) Other        (PLEASE SPECIFY)



     25. Is the final           interpretation of the screening               mammogramdone by any other
         individual(s)?               (CHECKONE.)

         a.     (       1 Yes
         b.     (       )     No ->(SKIP    ‘X0 UJEJ!KN       27.)




                        Page 64                                          GAO/HRD-90-32 Quality of Screening Mammography
                        Appendix II
                        GAO Questionnaire on Mammography




-+-



             << e                                     to   the    ahe     aettim      yuu identified     in qwstion       5 >>




      26. Indicate each category which represents                         the       individual(s) who inferprete
          screening mamnograms at your facility.                            (CHECKALL THAT APPLY.)

            a.      (   )   Radiologist
            b.      (   ) Other physician
            C.      (   )   Nurse
            d.      (   )   Technologist
            8.      (   )   Other      (PLEASE SPECIFY)


      21.   Does your facility             accept self-referred           patients?         (CHECKONE.)

            a.      (   1 No ->(sKIP           10 QxlEsTlm       31.)

            b.      (   )   Yes, but the patient must provide the
                            name of her personal physician of select                        a
                             hysician fran a list provided by the
                            15acility ->(sxcn   To tJlEsTIm 31.)

            C.      (   )   Yes,    even     if the patient       does not designate            a
                            personal        physician



      28. If a patient has a mtim     Dram      snd has not designated a personal                                     physician,
          what is usually done with the mamnogramreport?   (CHECKONE.)
            a.      (   )   Report sent to the patient
            b.      (   )   &port      sent to the patient              and patient       telephoned   about the results

            C.      (   )   Report not sent, but patient                  telephoned       about the results

            d.      (   )   Raport not sent, but filed                  at the facility
            e.      (   ) Other        (PLEASE SPECIFY)




                        Page 65                                             GAO/BRD-9052 Quality of Screening Mammography
                      Appendix II
                      GAO Questionnaire on Mammography




          ~<Mmwercnlywithm8pect              to theme      settirqyar       identifiedinauesticm                 5 77



    29.    If   a patient   has a positive mammcgramand has not designated a personal                       physician,
          mt      is usually done with the mamnogramreport?    (CHECKONE.)
          a.      (   )   Report sent to the patient
          b.      (   )   Report sent to the patient     and patient       telephoned      about     the   results

          C.      (   )   Report not sent, but patient      telephoned
                          about the results
          d.      (   )   Report not sent, but filed     at the facility
          8.      (   ) Other (PLEASE SPECIFY)



    30, List   in the space bslm,        any other actions your facility  takes when a patient
          has a pcdtive -ram             and has not designated a personal physician.




    31. For a patient who has a personal phvsician             and has a negative          nmmmgrm, what is
        usually done with the mammgrzanreport?                 (CHECKONE.)
          a.     (    )   Report sent to the patient
          b.     (    )   Report sent to patient's     physician
          C.     (    )   Report sent to the patient     -and patient's     physician
          d.     (    1   Report not sent, but patient      telephoned     about the results
          e.     (    )   Report not sent, but patient's      physician     telephoned       about     results

          f.     (    )   Report not sent, but patient     and patient's       physician      telephoned         about
                          the results
          9.     (    )   Report not sent, but filed     at the facility
          h.     (    ) Other     (PLEASE SPECIFY)
w




                      Page 56                                 GAO/HRD-90-32 Quality of Screening Mammography
-c
                         Appendix II
                         GAO Questionnaire on Mammography




             <:( Ansver Cnlv With LBSP3Ctto the One setting you identified                       ~J-Iquestion 5 77




     32. For a patient who has a personal physician                 and has a positive         mammogram,what is
         usually done with the -ram       report?                   (CHECKONE.)
        a.       (   )     Report sent to the patient
        b.       (   )     Report sent to patient's      personal      physician
        C.       (   )    Report sent to the patient          -and patient's     physician

        d.       (   )     Report not sent,     but patient     telephoned      about the results
        e.       (   )     Report not sent, but patient's          personal     physician      telephoned   about
                           results
        f.       (   )    Report not sent, but patient          and patient's      physician      telephoned   about
                          the results
        cl.      (   )    Report not sent, but filed          at the facility
        h.       (   ) Other       (PLEASE SPECIFY)



     33. What actions , if any, does your facility take in addition to sending or filing                            the
         mamrcqram report when a patient has a positive marreqram and has a physician?
         (CHECKALL THAT APPLY.)
        a.       (   )    No   other actions    taken
        b.       (   ) Telephone patient's         designated     or personal      physician     to discuss
                       marsnogram results
        C.      (    )    Contact patient      to remind her to contact         her physician
        d.       (   ) Other       (PLEASE SPECIFY)




                     Page67                                      GAO/HRD-9032 Quality of Screening Mammography
                                                                                                                                   .
                                            Appends II
                                            GAO Questionnaire on Mammography




-..--:-.--..--



                          <C~~ailyWithrBSpect                         tothare       settifqyw    identified     inqwsticm   5 77




                     34. For each item listed               below, check in:
                              Colum          1: Whether your facility           keeps the item as part of the patient's     record.

                              cdum2:                If yes, hew long the item is kept.            (CHECKCNE FOR EACH ITEM.)
                                                                 cduml                                        calm   2

                                                                Item kept?                         How long is the item kept?

                                            Item
                                                                 No      Yes
                         a.       Mamxgram report                                   If Yea -7
                       3 . Original                -ram
                           images                                                   If Yes-7
                        c.        Patient  infonnatlon
                                  provided at the time                              If Yea -7
                                  ofths   mamwgram
                        d. Other (Specify)
                                                                                    If Yea -7




                     35. How much does your facility generally charge for a screening bilateral manmqram?
                         The mamnogramcharge should include charges for the mamnoqramand interpretation
                         of the -ram.

                              $                           Charge for Screening      Bilateral   Manwgram




                 Y




                                            Page 58                                   GAO/HRD-90-32 Quality of Screening Mammography
                        Appendix II
                        GAO Queetiouuaire on Mammography




          << mr            only with m             to the one settinq yau iclentified             in question 5 >>




    16. Does your facility periodically have saneone inspect                        all     or part of your
        mawcgraphy system? (CHECKONE.1
        a. (        )   Yes
        b.(        )    No ->(sxIP      TD (JwScIm       42.)




    ‘7. Listed b&w are various             individuals          who might inspect         a mamnqraphy system.
        Indicate in:
              columl:         Whether your marrmwgraphy system is inspected                 by each individual.
              colum 2:        If yes, how frequently        each individual     inspects       your system.
                              (CHECKONE.)
                                                                                    colum 2
                                                            ( How frequently    mammography system inspected.
                                                                                 (CHECKONE.)



              Individual

     a. Consultant
        Radiolcg ical
        Physicist                             If    Yes->
        (i.e.,    physicist
        noXt      facility)
    b. Federal/State/
       Local Radiation
       Control                                If Yes->
       Inspector


w




                        Page 69                                      GAO/HRD-9052 Quality of Screening Mammography
            Appendix II
            GAO Questionnaire on Mammography




    << Anam anlY with mmect to then on8 mttim               mu identified       in qusrtion   5 >>



38. For each of the item   listed   below, check in:
      Colmm It   Whether the consultant radiological  physicist  or radiation control
                 inspector you identified  in questian 37 inspects the item.
     &alum 2r    If yes, which individual(s)         inspects   the item.
                 (CHECKALL 'MAT APPLY.)

                              columl                                   colum2
                            1 Inspect   (                     Who inspects item?
                                item?                       (CHECKALL THAT APPLY) I

                                                                            Fed/State   I
                            l-T-                        Consultant          Local
                                                        Radiological        Control
                                                        Physicist           Inspector


                                        IfYes->




                                        IfYes->
                                        If Yes-->

                                        If Yes->
                                        If   Yes->


                                        If   Yes->



                                        IfYes->




            Page 60                                  GAO/HRD-90-32 Quality of Screening Mammography
            .

    *
-
        ,                        Appendix11
                                 GAOQueetionuaire on Mammography




                    << mr         a&     with resoect to the one 8etti.q                   you identified     in question 5 >>



                9. Is there a radiological              physicist       on staff     at your facility?         (CHECKONE.)
                   a. (     1 Yes
                   b. (     1 No ->(sKIP           TO qJEsMm            41.)

                0. Listed belaw are various              items a staff physicist            might inspect     as part of his/her
                   overall quality assurance               duties. Check in:
                     columl:        Whether the staff               physicist      at your facility      inspects   each item.
                     colum 2:       If yes, how frequently he/she performs the inspection.
                                    (CHECKALL THAT APPLY.)
                                           cbluml                                                     cblum 2
                                         I Inspect I                                      How trequently item inspected?
                                                item?                                        (CHECKALL THAT APPLY)


                                         I-T-
                       Item              I a I YesI
                a. Beam quality
                    (Half value
                    layer)
                b. Focal spot size                         If Yes->
                c. Average
                   glandular      dose                     If Yes->
                d . Phototimer                             If Yes->
                e. Consistency      of
                   mA station                              If Yes->
                f. KVP                                     If Yes-->
                g. Phantan image
                   quality                                 If Yes->
                h. Other (SPECIFY)




                               Page 61                                              GAO/HRD-90-32 Quality of Screening Mammography
                                                                                                                  .
                   Appendix II
                   GAO Questionnaire on Mammography




       << Anmmr anly with m3pect to the am aettim                       ya identified       in Quegtion 5 >>



41. Listed below are additional   items that might be inspected                      as part of your
    facility's  quality assurance program. Check in:
         colum1:       Whether each item is inspected                as part of your quality     assurance
                       program.
         C&mm 2:       If yes, how frequently               the item is inspected.      (CHECKCNE.)


                                columl                                         oolum    2

                               1 Inspect                         How frequently   is the item inspected?
                                   Item?                                      (CHECKONE.)
                               I

                               i-r
          Item                  No       Yes
a. Grids                                       If Yes-:b’
     . soreens                                 IfYes-: >’
C.    Processor
      Sensitanetry                             IfYea-: >
d. Phantan image
   quality                                     IfYes-: >


==--?I-                    I
                           t
                                     I
                                     1
                                               LfYes-: 1
                                                        /_
                                                                 I       I       I           I         I




                 Page 02                                         GAO/HRD-90-32 Quality of Screening Mammography
                   Appendix11
                   GAOQuestionnaireonMammography




-c




         << Anarrer cmly with      respect      t0 the one settins     you identified      in question   5 >>




     42. A facility might include sane of the follcwing procedures as part of its quality
         assurance program. Which procedures, if any, does your facility  usually perform.
         (CHECKw THp;r APPLY. 1
         a.    (   ) Review film      quality
         b.    (   1 Perform a second reading of mammogramswithin                   the facility
         C.    (   1 Submit mammogramsfor second reading                by peer review panel
                     outside the facility
        d.     (   )   Follow up on patient         biopsies
        e.     (   1 Monitor number of repeat -rams                    due to equipnent,      patient,   and/or
                     technologist problems
        f.     (   ) Other (PLEASE SPECIFY)

        9.    (    1 NO procedures performed



     13. In question 5, did you identify mobile                van, either affiliated   or not affiliated
         with a hospital,  clinic, or physician’s               practice , as the one kind of setting where
         the majority of your screening -rams                     are performed?      (CHECKCNE.1
        a.              Yes --#ZIP           'ID @JEXTMON46.)

        b.              No



     4. Ooes your facility      provide       any marranography services     using a mobile van?
        (CHECK ONE.)

        a.              Yes
        b.              No ->WIP        'ID UJBI'IcrJ    46.)



     5. Wring a normal week, how many diagnostic                 and/or screening       m%nmzqrams
        are performed in the mobile van?
        a.                  Number of diagnoetic        mammograms
        b.                  Number of screening         mammograms




                   Page63                                        GAO/HRD-9052Qualityoi'ScreeuingMammography
                 Appendix II
                 GAO Questionuaire on Mammography




-.




     46. If you have any comments regarding this questionnaire      or issues relating    to
         manxwgraphy, please write them in the space provided      below.




                              ****   +IrfmK ml   FOR YaJR COONJCON     ****




                Page 64                              GAO/HRD-90-32 Quality of Screening Mammography
        ,’




Aeocndix III

SelectedQuality Standardsfor Mammography
and RelatedSurvey Results

                        This appendix contains more detailed information about the quality
                        standards discussed in chapter 3, as well as additional survey results.

    I
                        To obtain the best mammographic image with the smallest dose of radia-
Us ’ of Dedicated       tion, it is essential to use dedicated mammography equipment-that
Eql1 ipment             specifically designed for mammography. Its features enable the operator
                        to obtain high-quality images with much lower radiation exposure than
    I                   is possible with general X-ray equipment. Use of dedicated equipment is
                        one of the standards the Congress had mandated for screening mam-
    I                   mography reimbursed by Medicare.


                        State-of-the-art screening mammography practice in this country is to
Ta$ing Two Breast       take two views of each breast. About 82 percent of responding facilities
Vie&w                   indicated they take two views, 17 percent take three views, and only 1
                        percent do one view. Although almost all respondents reported taking at
                        least two views, we did find one problem. The NCRPrecommends that
                        screen-film mammography consist of the craniocaudal (cc)-oblique com-
                        bination, and specifically advises using an oblique view instead of a true
                        lateral view.! However, about 11 percent of the respondents doing only
                        screen-film mammography reported using the cc-true lateral combina-
                        tion instead of cc-oblique. The settings in which this was more likely to
                        occur were primary care physicians’ offices and hospitals; no mobile
                        vans reported this practice.


                        The person taking the mammogram plays an essential role in providing
Performance and         quality mammography. Proper positioning of the patient and adjustment
Interpretation of       of the equipment are vital to producing a good image. ACR’S accreditation
Mammograms by           standards require, and the CRCPD recommends, that radiologic technolo-
                        gists operating mammography systems be registered with the American
Certified or Licensed   Registry of Radiologic Technologists (ARRT)”and/or state-licensed and
Personnel               have specialized training in mammography.

                        Of the 97 percent of facilities reporting that the person who usually per-
                        forms their screening mammograms is ARRT-certified, state-licensed, or
                        both, about 9 percent indicated that another type of staff member (see
                        app. II) sometimes performs screening mammography. The settings with

                        ‘In xeroradiography, the true lateral view is appropriate.

                        ‘CRCPD recommends registration with either ARRT or the American Registry of Clinical Radio-
                        graphic Technologists (ARCRT).



                        Page 65                                       GAO/HRD-90-32 Quality of Screening Mammography
                     Appendix III
                     Selected Quality Standards for
                     Mammography and Related Survey Results




                     the largest proportions reporting this were primary care physicians (17
                     percent), radiology practices (11 percent), and hospital breast clinics (10
                     percent). HMOS and multispecialty clinics had the smallest proportions (6
                     percent).

                     The CRCPD states that American Board of Radiology-certified radiologists
                     with documented training in mammographic image interpretation
                     should interpret mammograms. ACR requires a board-certified radiologist
                     to supervise accredited programs and interpret the mammograms. The
                     radiologist also must have specific training and experience.:’ About 99
                     percent of providers responding to our survey reported that the person
                     who interprets the mammogram is a radiologist, and 99.9 percent
                     reported that it is a radiologist or other physician.


                     Guidelines for screening mammography programs stress the importance
Reporting Positive   of a system for reporting test results-particularly   for “positive” mam-
Mhmogram Results     mograms, those with a finding of possible abnormality-to       the patient
arrd Following Up    and/or her physician, It is especially important for the facility or radiol-
                     ogist to ensure that women without personal physicians are referred for
                     appropriate care when their mammograms are positive.

                     When the woman has designated a personal physician, about 93 percent
                     of respondents reported that they send positive mammogram reports to
                     the physician. An additional 5 percent send the report to both the
                     patient and her physician.4 When the patient has not designated a physi-
                     cian, 99 percent of respondents take action to inform her of the results
                     and/or arrange for her to receive medical care.

                     Experts also recommend telephoning the patient’s physician to ensure
                     that the written report is not accidentally overlooked. Two-thirds of our
                     respondents reported following this practice. Radiology private prac-
                     tices (81 percent), hospital breast clinics (79 percent), and breast clinics
                     (78 percent) were among the settings most likely to take this extra step,
                     and hospitals (61 percent) among the least likely.


                     “The radiologist supervising the program and/or interpreting mammograms must have (1) completed
                     a residency program after 1982, when mammography was added to the radiology board examination;
                     or (2) 3 years’ experience reading at least 10 cases per week; or (3) 40 hours of mammographic
                     education in the past 2 years. ACR is now phasing in additional criteria regarding training and
                     experience.

                     IDue to rounding, table 3.1 shows a total of 99 percent of respondents reporting the results to the
                     patient and/or physician.



                     Page 96                                       GAO/HRD-SO-32 Quality of Screening Mammography
                       Appendix III
                       Selected Quality Standards for
                       Mammography and Related Survey Results




                       We also asked survey participants whether they contacted patients with
                       positive mammograms who have designated physicians to remind them
                       to contact their physicians. Eleven percent of all respondents reported
                       that they both send the radiologist’s report to the patient and/or physi-
                       cian and contact the patient with a reminder. The settings that most
                       often reported following this practice were mobile vans (36 percent),
                       primary care physicians (29 percent), and hospital breast clinics (26
                       percent).

                       When a patient with abnormal findings has not designated a physician,
                       many respondents said they take additional steps beyond reporting the
                       mammogram results to her. These include referring the patient to a sur-
                       geon or other physician and sometimes making the appointment for the
                       patient, calling the physician to confirm that the patient was seen, and
                       contacting the patient to ensure that she has sought medical care.


                       Retention of the original mammographic image is extremely important
Record Retention       for quality screening. Comparison with a previous film can indicate
                       whether a suspected abnormality is a benign structure in the woman’s
                       breast or confirm that a new lesion has appeared. ACRpolicy calls for
                       providers to keep mammograms and positive reports for at least 5 years,
                       and the CRCPDrecommends that images be maintained indefinitely.

                       Our survey found that 98 percent of all respondents keep original
                       images for at least 5 years, and 49 percent for over 10 years. (See table
                       V.8 for information by setting.) Almost all respondents told us they
                       retain the mammogram report, with 99 percent reporting they keep it
                       for at least 5 years.


                       Information collected about the patient’s medical history
Taking Patient’s
Medical History    . helps identify women who are not candidates for screening mam-
                     mography but instead should be considered diagnostic patients, such as
                     women with current breast symptoms, and
                   l can be used to identify patients who are at greater risk for developing
                     breast cancer, which may be a factor in determining how often they
                     should be screened.
           Y

                       With one exception, every respondent to our survey reported collecting
                       some patient information.



                       Page 67                              GAO/HRD-90-32 Quality of Screening Mammography
                        Appendix III
                        Selected Quality Standards for
                        Mammography and Related Survey Results




                        Because breast self-examination (BSE) is considered another critical ele-
Instruction on Breast   ment of breast cancer screening, there is consensus that a good screen-
Self-Examination        ing program should include information on how to perform BSE!As the
                        ACSwill provide free instructional pamphlets for distribution to patients,
                        cost should not be a barrier to facilities providing this service. At least
                        one form of BSEinstruction is available at 90 percent of the facilities
                        that gave us information on this subject. Three-fourths of responding
                        facilities (78 percent) give pamphlets to patients, 42 percent show a
                        video tape, and instruction by a staff person occurs at 41 percent.

                        When analyzed by setting, the data show that 100 percent of breast clin-
                        ics, hospital breast clinics, and mobile vans provide information on self-
                        examination, while 83 percent of hospitals and 85 percent of radiology
                        practices do so. However, when the analysis includes only facilities that
                        accept self-referred patients, where the need for such information might
                        be greatest, the overall rate of facilities that provide information
                        increases to 96 percent, and the rates for hospitals and radiology prac-
                        tices rise to 93 and 95 percent, respectively.




                        Page 68                              GAO/HRD-90-32 Quality of Screening Mammography
        .

A+ppendix IV

St@&?
    Oversight of ScreeningMammography


                         This appendix contains more detailed information about the state over-
                         sight programs described in chapter 4.

    /
                         California has 32 inspectors, including those in the Radiological Health
StaJffing of State       Branch of the Department of Health Services (DHS) and those in certain
Prc/grams                counties. The latter are counties with which DHScontracts for inspection
    ,                    and enforcement of radiation control regulations in their jurisdictions.
    ,                    Inspectors must be certified radiologic technologists with supervisory
                         experience. In addition, they must pass a competitive examination and
    I
                         complete 1 year of on-the-job training prior to becoming an inspector.

                         In Florida’s Office of Radiation Control, the Department of Health and
                         Rehabilitative Services has 35 inspectors. The X-ray Machine Registra-
                         tion and Control (XMRC) Section is responsible for inspecting the state’s
                         25,000 X-ray machines (as of July 1988) of which 463 are mam-
                         mography machines. According to the manager of XMHC,all inspectors
                         have the education and training necessary to oversee and regulate mam-
                         mography equipment. They are public health physicists, which requires
                         either

                     9 a bachelor’s degree with a major in radiologic health or radiologic sci-
                       ence, and 1 year of experience in radiologic health, a physical or natural
                       science, radiation control, X-ray technology, or health physics; or
                     l a bachelor’s degree with a major in engineering, mathematics, or one of
                       the physical or natural sciences, and 2 years of the experience described
                       above.

                         A master’s degree and/or doctorate in one of the educational areas
                         described above can substitute for 1 year of required experience. Also,
                         experience can be substituted for education. About one-fourth of the
                         inspectors have a master’s degree.

                         A background in radiology would allow a new inspector to begin work-
                         ing independently sooner than protocol would dictate. A trainee gener-
                         ally goes through 4 to 6 months of on-the-job training before being
                         allowed to conduct an inspection alone.

                         In Michigan, the Division of Radiological Health (DRH) in the Department
                         of Public IIealth has nine inspectors, who are radiological physicists
                         with a I3.S. degree in physics, According to the chief of the DRII Investi-
                         gation and Compliance Section (KS), in 1988 Michigan had about 20,000



                         Page 69                           GAO/HRD-90-32 Quality of Screening Mammography
                     Appendix IV
                     State Oversight of Screening Mammography




                     X-ray machines located in 8,655 facilities. Of these, 446 were mam-
                     mography machines located in 381 facilities. State inspectors participate
                     in FDAtraining courses, the chief of ICStold us, and have on-the-job train-
                     ing that includes observing an experienced inspector for a few months
                     and then conducting inspections under direct supervision for several
                     additional months. Usually after 6 months, new inspectors may perform
                     inspections without direct supervision. Due to a June 1989 law requiring
                     annual inspection of mammography equipment, the ICSchief estimates
                     he will need three additional inspectors on his staff.


                     In California, radiologic technologists must graduate from a state-
P rsons Performing   approved school of radiologic technology and pass state-approved exam-
M,ammography
 e                   inations in diagnostic radiation protection and safety and diagnostic
                     radiologic technology. There is no specific requirement for training in
                     mammography, although an official of the Joint Review Committee on
                     Education and Radiologic Technology said that mammography training
                     is considered a standard part of the curriculum of accredited radiologic
                     technology programs. A California official told us that the California
                     examination has no questions on mammography.

                     The Florida Office of Radiation Control issues six different licenses to
                     technologists; mammographers must have the general radiographer
                     license, which is the most advanced level, Generally, licenses must be
                     renewed every 2 years. General radiographers must graduate from a
                     radiologic technology program that meets the guidelines of the Commit-
                     tee on Allied Health, Education, and Accreditation, an arm of the Ameri-
                     can Medical Association. They also must pass either the national ARRT
                     examination or Florida’s examination. The ARRTexamination covers
                     mammography.




          Y




                     Page 70                               GAO/HRD-90-32 Quality of Screening Mammography
Additional ResultsFrom GAO’sScreening
Mammography Survey

Table
_-,    q.1: Settings of Respondents Performlng Screening Mammography, by State
        /                                                        Distribution of settings, by state
       I                                        CA                   FL                      ID                                          MI
Settin                                         %        No.”       %          NO.~          %                        N0.O               %             No.~
Hospit: I                                          38
                                               __..----_-------.- 195               36           79           55         16             45     1.3
       I!
RadioIcky practice                                 28             144               25           55            7          2      -      22         58
        I-.



       1 I                   _.. -___--...-~..---.~-------_~--~__
Multqkxlalty   clinic
PrlrnarJ care Dhvsician      .-                     11             55
                                  --.--__I-____---~-.--.._-_______--
                                                     7             35               11
                                                                                     7           23
                                                                                                 1.5          14
                                                                                                               3          41             8 --. _--~
                                                                                                                                        14         22.
                                                                                                                                                   38
                                                                                                                    _-
Breast lmlc                                            7               35   -       15
                                                                                  .--___________32              7         2 --.-..-~.    6 .-- . -~~. .- 16.~
HMO                                                    6               32             1           1     ___- 0            0              1                3
HospItz I breast clinic            .~-. ._-..-- _... ~...2.._....       9             1          3
                                                                    ~.~ -- - -- -..-______-______-_           14          4 --_.-.       2.- . -~~-..-- 4
Mobile Ivan                                             1               6             1          3_____.__-..---0         0              1                2
Other ~                                                 1               3 ~~~ ~~.-.-___-
                                                                                      3          6              0         0              2                4
All aetiings                                          50              514           21        217               3        29             26            266
                                                 %espondents that reported performlng screening mammography




                                                Page 71                                          GAO/HRD-90-32 Quality of Screen&g Mammography
                                                                                                                                                    I
    ,.   .._   ~   ,.. ._~--_-

                                             Appendix V
                                             Additional Results From GAO’s Screening
                                             Mammography Survey




Table     V.2:.__Respondents’
.._.__...I_..    ..--.        Charges for Screening Mammogram, by Locale and Setting
                                                        No. of   Distribution of amounts charged,’ by locale/setting (percent)
Loca jejsetting                                   respondents  -~~~$1-50
                                                                     .-__         $51-99     $100-125      $126-150        Over $150
All stbtes
tlosp(tal                                                  379           7            38           25               16 __-. ~.    15
                                                                                                                                  .-
Radi$oyy practice                                       255                 85                48                30
                                                         98                                   24                45        ~____ ,14                4
                                                                                                                                  g .__..._ ~~-.-~~3
Mult~(pec~elty clmic                                                                ..___-
Pm ry care physman                                       85                 0                 45                31               18                7
Rrea
HMC)“i91 clinic                                          83                17                 55                l97
                                                         14                21                 29                             ____2g6 ____~.-~~~-.~14
                                                                                                                                                   2

tiosp/tal breast clmIc                                    19               11                 37                16 -              32                   5
Mot+ van                                                 10                60                 30                IO                 0                  0
otheri                                                    11                0                 55                27                 9          .~-~~~_.--9
All stittings                                           954                 7                 41                26                15                  6

Califbrnia
tiosp;ta1                                               181                 8 ..~   --___-    34                   20__-  ___-.-- 18       ~~- 20
Had~Jloyy practice                                      142.                3                 46                   30             16               4
                                                                                                                -_________~--~-~-              ~-~~
Multispecialty clmlc                                     52~         -8                       15                   44             29               4
Pm&y care physman                                        35                 0-~~ ---~..       34----.              34             17              14
Breast clinic                                            34                24                 50                   15              9               3
HMO:                                                     10                20                 10                   IO
                                                                                                            ____. __-~..       ~  40              20
t-lo&al breast clmc                                       9                11                 44                   11             33               0
Mobk varl                                                 6                67                 17                   17
                                                                                                                __--..             0               0
Other                                                     2                 0                   0--     ----..-__-100     __~      0 .~~ ~.~ .-- 0
All settings                                           471                  6                 36                   27             16              11

Florida                                                                                                     ..__-
Hospital                                                 72                 6~.               40                28 -~- __~         14                   13
Hadloloyy practice                                       55                11                 47                25                 13                    4
MlJltlSpCClalty                  ChnlC                   22                 5                 27                55                 14                    0
Prmary care physician                                    14                 0                 57                43                  0                    0
Breast clmc                                              31                13                 58                26 ___-~            0                    3
HMO:                                                      1               100       __...      0         .~       0                 0                    0
Hospital beast clmic                           .~        3~                 0                 33                33 --___           33
                                                                                                                             -.-----~                    0
Mobk van                                                 2                 50                 50                  0                 0
                                                                                                                        ..._______---------              0
Oth&                                                     6                  0                 83                17                  0                    0
All settings                                           206                  6                 46                30                 10                    6
                                                                                                                                          (continued)




                                            Page 72                                         GAO/HRD-90-32 Quality of Screening Mammography
                                                  Appendix V
                                                  Additional Results From GAO’s Screening
                                                  Mammography Survey




        I                                                   No. of     Distribution of amounts charaed,a by locale/setting (percent)
Localei/setting                                    respondents            $1-50         $51-99    $100-125       $126-150 ---- Over
                                                                                                                                 -~-$150
                                                                                                                                     ...-~
Idaho i                   ..__.-_...__.
                                     __-_-~-         .__.__.-. -_____ _____- _
HospIt I                                                         16                  13               81
                                                                                                _______-_____-_.-~~-.- 6                  0 ~~. .~ ~~~ 0
        d
Radloloigy practice                                               2                    0             100
                                                               -.._. _...~ -... ~~-....--_-.-_- _______-               0                  0      .~.-  0
Multlsp e clalty cllnlc                                           4                    0             100               0         _.-._    0            0
Prlrnard care phywian                                             1                    0             100               0                 0             0
Breast klinlc                                                     2                100                 0               0                 0             0
HMO J’                                                            0                    0               0 ----          0                 0             0
Hosplt I breast clinic                                            3                  33               67               0                 0             0
Mobile                                                            0                    0               0               0                 0             0
Other Ian                                                         0                    0               0               0                 0             0
All set i ings                                                 26                16                79                 4                  0            0

Michigbn
Hospit&
Hadloldgy practice
Mult&ecialty    clmic
Prlmar)r care physlcian                                      35--__.-..-_ --.-~--_-..
                                .._.__.- _.___~.--._-_- ___.__                  0                  49                23                  26           3
Breast lclwxc                                                   16                0                69-------         19                  13           0
HMO :                                  .   ~~..       -_.     ~~-3---~~   .~~~...~..0 .~. -~-.-   100          ----. 0                    0           0
tlospltal breast clinic                                         4            --.-.-0 --. ____~~ 0                     25              50             25
MoblIe ‘van                                                    ~~2                50            50
                                                                                                -.-~..     -~-------~~ 0    .~~~ -~~~...-0~~          0
Other                                                           3                 0                33                  0              33             33
All settings                                                  249                 4                43                31              15               7
                                               “For mammogram and interpretation.       Facilities charging $0 were excluded from analysis




                                               Page 73                                          GAO/HRD-90-32 Quality of Screening Mammography
                                         Appendix V
                                         Additional Results From GAO’s Screening
                                         Mammography Survey




Table V.3: Volume of Mammograms Performed, by Setting
                                                                  Distribution of no. of mammogramsa performed weekly, by setting
                                                No. of                                        (percent)
Setting                                  respondentsb                     1-24         25-49        50-74     75-100      Over 100
Hospital                                               383                37                  34               13                  9                 7
Radrdlogy    practice
Multr:/pecialty  clfnrc                                251
                                                        98                31
                                                                          37                  27
                                                                                              29               23
                                                                                                               17                , 92--   ..~-. .--~~j
                                                                                                                                                    10
                                                                                                                             ___-..--.. ..-_-....
Prrmary care physician                                  86                 70                1.5                 8     .._____. 7 -~~ -~~... ~~~0
Breac’t clrnrc                          ~~~.....~~_..__ 79
                                                         ..._ -     ~~~... 15                16
                                                                                              ____-            27               15                27
HMO~ 4                                                  35                  6                20                17
                                                                                                            _--.--..-~~_-~~~    14       .-~ ~~   43
Hospital breast clrnrc                                  19                 11                16                16               21                37
Mob& van                                                IO                 20                20                10               20                30
Othe!                                                   12                 17                25                42                 0               17
All settinos                                           973                 34                28               17                10                11
                                        aScreenrng and diagnostic.
                                        ‘Total number of respondents in setting category

Table V.4: Survey Respondents
Accredited by ACR Mammography                                                               Percent of respondents accredited
Accreditation Program, by Setting and   Setting                                       CA           FL          ID         MI All 4~.states
                                                                                                                      .-~--.        .~ ...--
State (As of April 1989)                Hospital                                       2               4            0             21                8
                                        kadiology practice             ~~~--_____-.    6              11            0       -.--~~26               11
                                                                                                                                       ~~~~ .~~~~-.-
                                        Multispecialty clinic                          2              9               0           14                6
                                        Primary care physician                         0    ______    0               0            5                2
                                        Breast clinic                          ___- 6       ______ 9                  0          38                13
                                        HMO                                            0              0
                                                                                                   ----.-----         0  .~        0                0
                                        Hospital breast clinic                        11              0               0            0                5
                                        Mobile van                        ---.. .~--- 17              0               0
                                                                                                              _~_~...~~~           0
                                                                                                                                   ~~~~.. ~~~~ ~~~  9
                                        Other                                          0        .-__  0               0            0                0
                                        All settings                                   3              8             0           19                  8




                                        Page 74                                            GAO/HRD-90-32 Quality of Screening Mammography
            .


                                                        Append& V
                                                        Additional Results From GAO’s Screening
                                                        Mammography Survey




Table 4.5: Survey Respondents Reporting Annual Inspection by Radiological Physicist, by Setting and State
       I                                                             Percent and no.’ of respondents
                                                CA                FL            ID                Ml                                           All 4 states
                                              %          No.    %    No.      %       No.       %    No.                                           %__-. No.
                                             88           195   82    79      56       16       82   119                                           84--...- 409
                          ~-                 60           144
                                   ..-....-...- .._--.-.--..-_. 46    55       0        2       64    58                                           57       259
                                                      --55        55         52           23        25            4      32       22            48-         104
                         - . .-.....--. . . -..-      43          35         47           15          0           1      42       38              43         89
                         .---..-.-.---.....
                                                      83          35         53           32       100            2      94        16            74         85
HMO ~                                                 81          32          0            1             b              100         3            81         36
Hospltaj breast clinic                                89           9         67            3        75            4     100         4            85         20
MoblIe San                                           100          6 --- 67                 3             b              100         2            91         11
Other i                                            .----67        3           83           6             b               25         4            62         13
All setthxts                                           73    ~m--51~----i,iy-            217        52           29      89      288             89     1,026
                                                       aTotal number of respondents in setting category

        I                                              “No respondents in category.



Table V.6: Survey Respondents Reporting Annual Physicist Inspection of Beam Quality (HVL), Average Glandular Dose, and
Phantom Image Quality, by Settina and State
                                                                   Percent and no.Oof respondents
                                             CA               FL               ID                 Ml                All 4 states
Setting                                    %    No.         %      No.       %       No.        %         No.           %         No.
Hospital                                   73   195     _   60      79      25  ___-  16        73        119          69        409
Radiology practice                       .48    144         33 ~~-~~~~-.--o
                                                                    -____-- .-______.. 2___-._ 53 __...58              46         259
Multlspccialty clinic                      38    55     --i4        23        0        4        27         22  _- .-~ “-36.._-    104
Primary care physIcIan                    .29    35         33    focis.-     0        1        26 _._.__._38          28          89
Breast &nlc                                66    35       ~41       32        0        2-_.--~._~----.--.
                                                                                                81         16          58          85
HMO                                        66    32          0        1        b               100           3         67          36
Hospital breast clinic                     89     9         33       3      50 ___-_4          100
                                                                                                ___..        4
                                                                                                            __         75          20
Mobk Gan                                   67     6         33       3         b               100           2         64          11
Other                                     67      3         67       6         b                 0      ..~~ 4         46          13
All settings                              59    514        ~46    217       21        29        59        268          55      1,026
                                                       “Total number of respondents      in setting category

                                                       “No respondents    In category.




                                                       Page 75                                               GAO/HRD-90-32 Quality of Screening Mammography
                                                                                                                                                         0
          I - --_-

                                               Appendix V
                                               Additional Results From GAO’s Screening
                                               Mammography Survey




Table    ,V.7:
  _........    Survey
           ..___.
               .I.-_  Respondents Reporting Compliance With Selected Quality Assurance Standardb, by Setting
         I                                                                Percent and no.’ of respondents
                                                                                                        Second
                                                     Daily         Semianvual      Monitoring of      reading of                            Fora;;;;    of
                                                 processor       phan;;;$nage         repeat        mammo ram in
                                               8en8itometryb                       mammogram8           faci Bity                             biopsies
settine                                             %      No.
                                                             -__      %       No.      %       No.       %        No.                           %      No.
Hosy,&il                                            52     361       45       409     54       398       37       398                          82      398
led&y                practice                          16       226          46      259             51      257        22       257           71        257
Multlsdzclalty           cllnlc                       22          95         42 -___ 104             50      101        21       101           70        101
Fknar\/      cart       physIcIan
                                           ..~~. -.    10 ~~..-~. -~.
                                                      .-_         79     ~. .28
                                                                              - ..~ 89               44       85        20        85         695       __-
Brcas     cllnlc                                      37          76         65        85            62       84        33        84           75         84
tHMO 1
                                    .   ..-~~ -~ . ..--.59 - ~~~ 32          44
                                                                        - --.----      36            67       36        44        36           75          36
Hospi al breast            clmlc                      39          18         70        20            55       20        25        20           85          20
      :
Moh~lo van                                            46          11         73        11            64       11        27        11           82          11
Other I                                               33          12 ~~~     54
                                                                       ~._~~~~______   13            62       13        23        13           54          13
All settings                                          35        91oc        46     1,026c            53d   1,005c       29    1,005c          76       1,005c
                                               “Total number of respondents   in setting category.

                                               ‘Analysis excludes respondents   who do xeromammography         only

                                               ‘Numbers of total cases differ because of different numbers that responded to specific questions

                                               dTotal differs by 1% from percentage   in report because latter IS based on all cases, including those who
                                               did not identify setting.


Table V.9: Survey Respondents’
Retention of Original Mammographic                                                                    Percent of respondents
Images, by Setting                                                                                Images kept at      Images kept
                                               Setting                                              least 5 years    over 10 years                      No.”
                                               Hospital                                                            98                  49       ____...- 394
                                               Radioloav        practice                                           96          50-                       252
                                               Multispecialty       clinic
                                                                                          ~~~ -__...               98             34                     101
                                               Primary care physician                       -.   - ____
                                                                                                                   99
                                                                                                                 ____~
                                                                                                                                  56 .---__                86
                                               Breast clinic                                                      99 ____--..-__  63                       83
                                               HMO                                                   -.-   __-.- 100              42                    _--33
                                               Hospital~breast clinic                                            100        ____. 55                       20
                                               Mobile van                                                         91              55                       11
                                               Other                                                             100              27                       11
                                              All settings                                                         98                  49               991
                                               “Total number of respondents   in setting category.




                                              Page 76                                            GAO/HRD-90-32 Quality of Screening Mammography
Appendix
     I   VI                                                                                        -

M#jor Contributors to This Report


                          Issues, (202) 276-545 1
                        Mark V. Nadel, Associate Director for National Public Health
Wadhington, DC.           Issues
                        Edwin P. Stropko, Assistant Director
        /
                        Rodney E. Ragan, Assignment Manager
                        Helene F. Toiv, Evaluator-in-Charge
                        Susan L. Sullivan, Technical Adviser
                        Cynthia L. Booth, University Fellow


Detkoit Regional Offf
                        Sharon L. Fucinari, Computer Analyst


                        Gary W. Ulrich, Regional Assignment Manager
San’ Francisco
Regional Office




( IOHWll)               Page 77                         GAO/HRD-90-32 Quality of Screening Mammography
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