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5 Beyond MQSA
Pages 164-188

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From page 164...
... This chapter examines broader approaches to optimizing breast cancer detection through an exploration of the context in which mammography is performed, including challenges associated with broad implementation of reminder systems, the complex issue of medicolegal liability, and the growth of breast imaging technologies that complement mammography, but for which there are no equivalent mandated quality assurance standards. REMINDER SYSTEMS Considerable research indicates that adherence to recommended screening intervals is important to maximizing the life-saving potential of screening mammography (Hunt et al., 1999; Tabar et al., 1999; Michaelson et al., 2000; Blanchard et al., 2004)
From page 165...
... . Unlike organized breast cancer screening programs in European countries, the United States has not established centralized registers or reminder systems to alert women when they are due for a mammogram.
From page 166...
... However, Vogt and colleagues argue that "to be maximally effective, reminder systems need to concentrate on the rarely screened." These researchers examined the cost-effectiveness of letter and phone outreach interventions to deliver breast and cervical cancer screening to approximately 41,000 women who had been unscreened for at least 3 years. A combination of letter plus follow-up phone call, the most cost-effective option, led to mammography screening in about half of women who received the intervention; this was more than twice the rate of compliance among women who received the letter alone, and five times the rate of compliance among women who were reminded only by routine system and environmental prompts.
From page 167...
... In order to explore the potential of one approach -- a no-fault liability system linked with high performance requirements -- to simultaneously improve the quality of breast imaging, reduce the burden of lawsuits, and ensure fair and timely compensation in the event of a misdiagnosis, the Committee recommends that the feasibility of such a system be tested within breast imaging Centers of Excellence, as described in Chapter 2. The following section provides the context and justification for rewarding and promoting highquality care with protection from claims of negligence.
From page 168...
... . An increasing number of medical malpractice cases and rising amounts of damages awarded by juries or through negotiated settlements may have helped fuel a dramatic increase in medical malpractice insurance rates (Studdert et al., 2004; Vidmar et al., 2005)
From page 169...
... . Medical Liability and Mammography The delay in diagnosing breast cancer in women leads to more malpractice claims than any other medical condition and is second only to the neurological impairment of newborns in the expense of paid claims, according to a 2002 Physician Insurers Association of America (PIAA)
From page 170...
... . Even experienced radiologists specializing in breast imaging will prospectively miss cancers that are evident in retrospect.
From page 171...
... . Nonetheless, based on the available national data and recognition that mammography is not a perfect test, the Workgroup recommended medical malpractice reform measures, including a limit on noneconomic damage awards, establishment of an expert panel to review presuit images for "probable cause" before advancing the case for further legal action, and a change in the burden of proof for alleged medical liability cases involving breast cancer, from the greater weight or preponderance-of-the-evidence standard to the clear-and-convincing standard (The Workgroup on Mammography Accessibility, 2004)
From page 172...
... Studies are beginning to reveal the effects of state tort reform measures. Most studies show that caps on damages significantly reduce payouts in medical malpractice cases, but their effect on medical malpractice insurance premiums is less clear.
From page 173...
... Administrator Mark McClellan indicated that the Bush Administration would consider a range of options to reform the medical liability system, including requirements to report medical errors, to set up expert review panels, and to establish early offer programs. He noted that there is growing evidence that a set of changes is needed to ensure justice for all parties in the medical malpractice system.
From page 174...
... OVERSIGHT OF OTHER BREAST IMAGING MODALITIES Mammography currently is the principal screening modality for breast cancer. But other imaging techniques are routinely used for diagnosing breast cancer, and researchers continue to explore new and existing imaging technologies for breast cancer screening and diagnosis, as noted in Chapter 4 (IOM, 2001, 2005)
From page 175...
... Currently there is no standardization of quality assurance for other breast imaging procedures, although accreditation programs do exist for breast ultrasound, stereotactic breast biopsy, and general MRI, as described below. These programs are offered by the American College of Radiology and the American Institute of Ultrasound in Medicine (Dershaw, 2000; ACR, 2004a)
From page 176...
... Stereotactic Breast Biopsy Accreditation Stereotactic breast biopsy, which entails removal of breast tissue with a needle under mammographic guidance for proper placement, is currently exempt from MQSA regulations. However, since 1996, the ACR has offered an accreditation program in the procedure, with quality standards that are consistent with those of MQSA.
From page 177...
... Given the small proportion of facilities undergoing voluntary accreditation, it may now be advisable to mandate accreditation of some other commonly used breast imaging methods like MRI 7Personal communication, P Butler, Senior Director, Breast Imaging Accreditation Programs, American College of Radiology, January 2005.
From page 178...
... The average proficiency of facilities that currently choose not to undergo voluntary breast ultrasound accreditation is likely to be lower, similar to the mammography experience prior to MQSA. Expansion of accreditation requirements to these breast imaging methods is likely to result in significant improvement in quality of practice, similar to what has been observed for mammography.
From page 179...
... Mandatory accreditation for other breast imaging techniques such as ultrasound could remove the incentive to provide one procedure over another, and the variability in physician recommendations and performance of these procedures might be reduced. However, another useful approach might be to include a requirement that women be given patient education materials prior to undergoing a breast biopsy.
From page 180...
... In recognition of the importance of a multidisciplinary approach to breast cancer detection, the Committee stresses the need to extend quality assurance, as embodied by MQSA, to stereotactic breast biopsy and standard presurgery wire localization procedures, breast ultrasound and ultrasound-guided biopsy, and breast MRI under the next MQSA reauthorization. This will entail a name change to the Breast Imaging Quality Standards Act (BIQSA)
From page 181...
... 2005. Stability, Not Crisis: Medical Malpractice Claim Outcomes in Texas, 1988­2002.
From page 182...
... 2004. Medical Malpractice Liability Reform: Legal Issues and Fifty-State Survey of Caps on Punitive Damages and Non-economic Damages.
From page 183...
... 2004. Breast imaging, standard of care, and the expert.
From page 184...
... 2004. Mammography screening is saving thousands of lives, but will it survive medical malpractice?
From page 185...
... 1996. Variation in expert opinion in medical malpractice review.
From page 186...
... 2004. The medical malpractice "crisis": Recent trends and the impact of state tort reforms.
From page 187...
... 2003. The safety net: A cost effective approach to improving breast and cervical cancer screening.


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