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7 The External Environment Influencing Diagnosis: Reporting, Medical Liability, and Payment
Pages 307-342

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From page 307...
... In this chapter the committee emphasizes the need for safe environments for voluntary error reporting, without the threat of legal discovery or disciplinary action, where health care organizations can analyze and learn from diagnostic errors in order to improve diagnosis. The role of medical liability reform is also described as an opportunity to increase the disclosure of diagnostic errors as well as to promote improved reporting, analysis, and learning from diagnostic errors.
From page 308...
... REPORTING AND LEARNING FROM DIAGNOSTIC ERRORS The committee concluded that there need to be safe, confidential places for health care organizations and professionals to share and learn from their experiences of diagnostic errors, adverse events, and near misses. Conducting systems-based analyses of these events presents the best opportunity to learn from such experiences and to implement changes to improve the diagnostic process.
From page 309...
... Unfortunately, it is often difficult to create environments where diagnostic errors, adverse events, and near misses can be shared and discussed. Health care organizations and clinicians have been challenged by the limitations of inconsistent and individual state-enacted peer review and quality improvement processes for the protection of information relating to adverse events and medical errors, the external use of such information, and what benefits the health care organizations and clinicians receive from reporting.
From page 310...
... In the interim, smaller-scale efforts to improve voluntary reporting and learning from diagnostic errors, adverse events, and near misses may be helpful for generating and sharing the lessons learned from such efforts. For instance, at the level of health care organizations, quality and patient safety committees can incorporate the analysis of and learning from diagnostic errors, and these activities may be protected from disclosure by state statutes.
From page 311...
... When health care organizations or health care professionals join a PSO, they can then voluntarily send patient safety data to the PSO for analysis and feedback on how to improve care. Additionally, PSOs can send de-identified patient safety data to the Network of Patient Safety Databases (NPSD)
From page 312...
... . The PSO PPC works with individual PSOs that wish to submit deidentified patient safety event information.
From page 313...
... The committee recommends that AHRQ should modify the PSO Common Formats for reporting of patient safety events to include diagnostic errors and near misses. To implement Common Formats specific to diagnostic error, AHRQ could begin with high-priority areas (such as the most frequent diagnostic errors or "don't miss" health conditions that may result in significant patient harm, such as stroke, acute myocardial infarction, and pulmonary embolism)
From page 314...
... . The current tort-based judicial system for resolving medical liability claims creates barriers to improvements in quality and patient safety and stifles continuous learning.
From page 315...
... The committee recommends that states, in collaboration with other stakeholders (health care organizations, professional liability insurance carriers, state and federal policy makers, patient advocacy groups, and medical malpractice plaintiff and defense attorneys) , should promote a legal environment that facilitates the timely identification, disclosure, and learning from diagnostic errors.
From page 316...
... A number of alternative approaches to the current medical liability system were evaluated, and the committee concluded that the most promising approaches included CRPs, the use of clinical practice guidelines as safe harbors, and administrative health courts (see Box 7-1)
From page 317...
... While some of the specifics related to CRP implementation may vary based on an organization's circumstances, Box 7-1 describes the essential components of a CRP. CRPs could improve patient safety generally and reduce diagnostic errors in several ways.
From page 318...
... CRPs typically incorporate the following elements: o  Early reporting of adverse events to the health care organization or liability insurer for rapid analysis using human factorsa and other ad vanced event analysis techniques o eveloping plans for preventing recurrences and communicating these D plans to patients and their families o pen communication with patients and their families about unantici O pated care outcomes and adverse events o  Proactively seeking resolutions, including offering an explanation as to why the event occurred and an acknowledgment of responsibility and/ or an apology o  Initiating support services, both emotional and other types of support, for the patient, family, and care team o  here appropriate, offering timely reimbursement for medical expenses W not covered by insurance or compensation for economic loss or other remedies •  afe harbors for adherence to evidence-based clinical practice guide S lines are laws that provide health care professionals and organizations a defense against a malpractice claim if they can show that they followed a clinical practice guideline in providing care for a patient. Safe harbors: processing times, and reduced liability costs and settlement amounts (Boothman et al., 2009, 2012; Kachalia et al., 2010)
From page 319...
... . For example, the American College of Physicians has called for "strong, broad legal protections that ensure apologies from physicians and other health care professionals are inadmissible" in a subsequent medical malpractice action (ACP, 2014)
From page 320...
... . Other considerations will influence the implementation and effectiveness of CRPs, including the presence of organizational champions and a culture that supports the reporting of medical errors; a focus on coaching and support services to help clinicians participate in disclosures and the CRP processes; and buy-in from and coordination with health care organizations and professional liability insurance carriers (Mello et al., 2014a)
From page 321...
... Safe Harbors for Adherence to Evidence-Based Clinical Practice Guidelines Safe harbors for following evidence-based clinical guidelines have the potential to raise the quality of health care by creating an incentive -- liability protection -- for clinicians to follow evidence-based clinical practice guidelines.4 Safe harbors can create an affirmative defense for health care professionals who adhered to accepted and applicable clinical practice guidelines. Input to the committee suggested that safe harbors, unlike other approaches to improving the medical liability environment, offer direct opportunities to improve diagnosis (Kachalia, 2014)
From page 322...
... Additionally, recent policy changes add to the resistance of using clinical practice guidelines for legal purposes. The legislation that repealed the sustainable growth rate included a provision that prevents the use of guidelines or standards used in federal programs as proof of negligence: The "development, recognition, or implementation of any guideline or other standard" under the Medicare and Medicaid programs and any provision in the Affordable Care Act "shall not be construed to establish the standard of care or duty of care owed by a health care provider to a patient in any medical malpractice or medical product liability action or claim."5 Administrative Health Courts Administrative health courts have been proposed as a way to provide injured patients with expedited compensation decisions for certain types of medical errors and to promote the disclosure of medical errors (such as diagnostic errors)
From page 323...
... . The establishment of administrative health courts could help to reduce process inefficiencies and inequities in compensation caused by shortcomings in the current system of tort liability, and adjudicated cases could be used to inform and foster the development of mechanisms to identify and mitigate medical errors (IOM, 2002; Mello et al., 2006)
From page 324...
... PIAA, the industry trade association representing companies in the medical liability insurance field, has a data sharing project that gathers and analyzes data on medical professional liability claims submitted by its members (Parikh, 2014) .6 The project's findings are used to identify opportunities to reduce risk and improve patient safety in health care organizations.
From page 325...
... . COPIC, a provider of medical liability insurance, reported that it conducts more than 2,000 practice site visits each year, in which specially trained nurses use explicit criteria to identify patient safety and risk issues, including vulnerability to systems errors, communication failures, information transfer, EHR issues, and standardized processes (Lembitz and Boyle, 2014)
From page 326...
... . Given the importance of team-based care in the diagnostic process, the lack of financial incentives in FFS payment to coordinate care may contribute to challenges in diagnosis and diagnostic errors, particularly delays in diagnosis (Rosenthal, 2014)
From page 327...
... . To improve teamwork and care coordination in the diagnostic process, the committee recommends that the Centers for Medicare & Medicaid Services (CMS)
From page 328...
... Thus, the committee recommends that CMS and other payers reorient relative value fees to more appropriately value the time spent with patients in evaluation and management activities. Realigning relative value fees to better compensate clinicians for cognitive work in the diagnostic process has the potential to improve accuracy in diagnosis while also reducing incentives that drive the inappropriate utilization of diagnostic testing.
From page 329...
... . The documentation guidelines have become an even greater concern with the broad implementation of EHRs because EHR design has focused on fulfilling documentation and legal requirements and not on facilitating the diagnostic process (Berenson et al., 2011; Schiff and Bates, 2010)
From page 330...
... Thus, the committee recommends that CMS and other payers should assess the impact of payment and care delivery models on the diagnostic process, the occurrence of diagnostic errors, and learning from these errors. Assessing the impact of payment and care delivery models, including FFS, on the diagnostic process, diagnostic errors, and learning are critical areas of focus as these models are evaluated more broadly.
From page 331...
... The use of quality measures and reporting may incentivize organizations to detect the underuse of these screening activities, to reengineer care, to invest in electronically based decision support and artificial intelligence which could improve accuracy, to engage clinicians in ongoing activities to improve diagnostic skills, and to engage in systems approaches to mitigating harm from potential diagnostic errors. • Accountable Care Organizations o efinition: "Groups of providers that voluntarily assume responsibility for D the care of a population of patients" (Schneider et al., 2011, p.
From page 332...
... many of the alternative payment models and is well suited to evaluate the impact of these models on the diagnostic process and the occurrence of diagnostic errors. While new payment models have the potential to reduce diagnostic errors, the committee also recognized that these models may also create incentives for clinicians and health care organizations that could reduce use of appropriate testing and clinician services (e.g., specialty consultations)
From page 333...
... also there is a need for better measurement tools to identify diagnostic errors in clinical practice (see Chapters 5 and 6)
From page 334...
... Recommendation 6c:  States, in collaboration with other stakehold ers (health care organizations, professional liability insurance car riers, state and federal policy makers, patient advocacy groups, and medical malpractice plaintiff and defense attorneys) , should promote a legal environment that facilitates the timely identifica tion, disclosure, and learning from diagnostic errors.
From page 335...
... Recommendation 7b:  CMS and other payers should assess the im pact of payment and care delivery models on the diagnostic process, the occurrence of diagnostic errors, and learning from these errors. REFERENCES AAFP (American Association of Family Physicians)
From page 336...
... 2015d. Medical liability reform and patient safety initiative progress report.
From page 337...
... 2012. The value of clinical practice guidelines as mal practice "safe harbors." Urban Institute.
From page 338...
... 2015. Patient safety and quality improvement act of 2005 statute and rule.
From page 339...
... 2014. Greatest impact of safe harbor rule may be to improve patient safety, not reduce liability claims paid by physi cians.
From page 340...
... 2006. "Health courts" and accountability for patient safety.
From page 341...
... Joint Commission Journal on Quality and Patient Safety/Joint Commission Resources 40(2)


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