The Interface Between Quality Improvement and Law



A solid legal footing provides the framework and benchmarks for credible, persuasive, accountable quality management activities. Medical quality management (MQM) should reflect prevailing societal preferences, establishing a balance between the interests of patients, practitioners, institutional providers, health plans, regulatory agencies, and the general public. Legal standards help to ensure that these preferences are honored and bring clarity and accountability to the process. The quality of care delivered in a facility or health plan is directly influenced by the organization’s quality improvement (QI) activities, including regulatory and accreditation compliance, provider credentialing, risk management, and clinical peer review.


  1. 1.
    Dynasty of Ur (2019) Mesopotamian history.
  2. 2.
    King LW (2004) The code of Hammurabi. Kessinger Publishing, WhitefishGoogle Scholar
  3. 3.
  4. 4.
    Sarma PJ (1931) Hindu medicine and its antiquity. Ann Med Hist 3:318Google Scholar
  5. 5.
    Furrow BR, Greaney TL, Johnson SH, Jost T (2000) Health law, 2nd edn. West Group, St. PaulGoogle Scholar
  6. 6.
    Kohn LT, Corrigan JM, Donaldson MS (eds) (1999) Institute of Medicine. To err is human: building a safer health system. National Academies Press, Washington DCGoogle Scholar
  7. 7.
    Institute of Medicine (2001) Crossing the quality chasm: a new health system for the 21st century. National Academies Press, Washington DCGoogle Scholar
  8. 8.
    National Quality Strategy Fact Sheets (2017) Agency for Healthcare Research and Quality, Rockville.
  9. 9.
    2015 National Healthcare Quality and Disparities Report and 5th Anniversary Update on the National Quality Strategy (2016) Content last reviewed May 2016. Agency for Healthcare Research and Quality, Rockville.
  10. 10.
    U.S. Government Accountability Office (2004) Report to congressional requestors: GAO-04-850: centers for medicare and medicaid services needs additional authority to adequately oversee patient safety in hospitals.
  11. 11.
    Bryant, M (2017) Hospitals often retain accreditation despite safety violations. Wall Street Journal. Healthcare Dive. Accessed 12 Sept 2017
  12. 12.
  13. 13.
    Castellucci M (2017) New data from CMS’ hospital-acquired condition program have analysts questioning value. Modern Healthcare.
  14. 14.
    Agency for Healthcare Research and Quality (2016) How PSOs help health care organizations improve patient safety culture. Accessed Apr 2016
  15. 15.
    PSO Privacy Protection Center (2019) Overview common formats.
  16. 16.
    Agency for Healthcare Research and Quality (n.d.) Common formats—scope and reporting.
  17. 17.
    Wagner C, Cecchettini D, Fletcher J (2011) The safe table collaborative: a statewide experience. Jt Comm J Qual Patient Saf 37(5):206–210PubMedGoogle Scholar
  18. 18.
    Jaffe R, Manneh C (2015) CHPSO safe table. In: Patient safety first materials. National Health Foundation.[1].pdf
  19. 19.
    Edwards MT, Benjamin EM (2009) The process of peer review in U.S. hospitals. J Clinical Outcomes Manage 16(10):461–467Google Scholar
  20. 20.
    Edwards MT (2013) A longitudinal study of clinical peer review’s impact on quality and safety in U.S. hospitals. J Healthcare Manage 58(5):369–384CrossRefGoogle Scholar
  21. 21.
    U.S. Department of Health & Human Services (1986) Title IV of Public Law 99–660: The Health Care Quality Improvement Act of 1986.
  22. 22.
    Langford C (2012) Bitter feud between surgeon and hospital. Courthouse News. Accessed 20 Sept 2012
  23. 23.
    Supreme Court of Texas (2015) Memorial hermann hospital system physician network; Michael Macris, MD; Michael Macris MD, PA; and Keith Alexander, Relators. NO> 14–01701. Accessed 22 May 2015
  24. 24.
    Rappleye E (2017) Jury sides with heart surgeon in $6.4M defamation lawsuit against Memorial Hermann: 5 things to know. Becker’s Hospital Review. Accessed 30 Mar 2017
  25. 25.
    Sixel LM (2017) Heart surgeon wins $6.4 million verdict in defamation case against Memorial Hermann. In Houston Chronicle. Accessed 20 Mar 2017
  26. 26.
    Langford C (2019) Texas Doctor Keeps $6M Award in Bitter Feud With Hospital. In Courthouse News Service. Accessed
  27. 27.
    101st Congress (1990) Omnibus Budget Reconciliation Act of 1990, Pub. L. No. 101–508, 4401, 104 Stat. 1388–143Google Scholar
  28. 28.
    Health Resources and Services Administration, U.S. Department of Health and Human Services (2019) National Practitioner Data Bank Guidebook.
  29. 29.
    104th Congress (1996) Health Insurance Portability and Accountability Act of 1996 (HIPAA).
  30. 30.
    U.S. Department of Health & Human Services. HIPAA for Professionals (2019) Other administrative simplification rules.
  31. 31.
    National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners (2008) 45 C.F.R. PART 60. Accessed 31 July 2008
  32. 32.
    National Practitioner Data Bank (2008) healthcare integrity and protection data bank.
  33. 33.
    DeVille KA (1990) Medical malpractice in nineteenth-century America: origins and legacy. New York University Press, New YorkGoogle Scholar
  34. 34.
    Migden D (2000) The past and future of medical malpractice litigation. JAMA 284(7):827–829PubMedGoogle Scholar
  35. 35.
    Bishop TF, Ryan AM, Casalino LP (2011) Paid malpractice claims for adverse events in inpatient and outpatient settings. JAMA 305(23):2427–2431CrossRefGoogle Scholar
  36. 36.
    Hickson GB, Pichert JW (2008) Disclosure and apology. In: National Patient Safety Foundation Stand Up for Patient Safety Resource Guide. National Patient Safety Foundation, North AdamsGoogle Scholar
  37. 37.
    Hickson GB, Clayton EW, Githens PB, Sloan FA (1992) Factors that prompted families to file medical malpractice claims following perinatal injuries. JAMA 267:1359–1363CrossRefGoogle Scholar
  38. 38.
    Greenberg MD, Haviland AM, Ashwood JS, Main R (2010) is better patient safety associated with less malpractice activity? Rand Institute for Civil Justice. Technical Report.
  39. 39.
    Wu AW (1999) Handling hospital errors: is disclosure the best defense? Ann Intern Med 21:970–97246CrossRefGoogle Scholar
  40. 40.
    Public Health Law Center (2019) Master settlement agreement. In: Tobacco Control. Public Health Law Center at Mitchell Hamline School of Law.
  41. 41.
    Congressional Budget Office (2009) Letter to Senator Orrin J. Hatch regarding the request for an updated analysis of the effects of proposals to limit costs related to medical malpractice (“tort reform”).
  42. 42.
    National Quality Forum (2019) Serious reportable events. In: Patient Safety.
  43. 43.
    Geier P (2006) Emerging med-mal strategy: “I’m sorry.” Early apology concept spreads. NLJ. Accessed 31 July 2008
  44. 44.
    Gallagher T, Studdert D, Levinson W (2007) Disclosing harmful medical errors to patients. N Engl J Med 356:2713–2719CrossRefGoogle Scholar
  45. 45.
    Tanner L (2004) Apology a tool to avoid malpractice suits: Doctors shown financial benefits. Boston Globe: National News, 12 November 2004Google Scholar
  46. 46.
    Kraman SS, Hamm G (1999) Risk management: extreme honesty may be the best policy. Annals Internal Medicine 131:963–967CrossRefGoogle Scholar
  47. 47.
    McDonald T (2012) The “Seven Pillars” Approach: crossing the patient safety–medical liability chasm. Advancing healthcare and research. Published 2012. Accessed 28 Jan 2014
  48. 48.
    Clancy CM (2012) More hospitals begin to apply lessons from Seven Pillars Process. Agency for Healthcare Research and Quality. Accessed 22 July 2014
  49. 49.
    Mayer D (2013) Educate the young…emerging trends in quality and safety. Paper presented at ACMQ National Conference Medical Quality 2013: Transforming quality and safety in the era of change, Phoenix, AZ, 20–23 February 2013Google Scholar
  50. 50.
    Boothman RC, Imhoff SH, Campbell DA (2012) Nurturing a culture of patient safety and achieving lower malpractice risk through disclosure: lessons learned and future directions. Front Health Serv Manag 28:13–28CrossRefGoogle Scholar
  51. 51.
    Roberts RG (2007) The art of apology: when and how to seek forgiveness. Fam Pract Manag 14(7):44–49PubMedGoogle Scholar
  52. 52.
    Studdert DM, Mello MM, Gawande AA, Brennan TA, Wang YC (2007) Disclosure of medical injury to patients: an improbable risk management strategy. Health Aff 26(1):215–226CrossRefGoogle Scholar
  53. 53.
    Morton H (2018) Medical professional apologies statutes. National Conference of State Legislatures.
  54. 54.
    Saitta N, Hodge S (2012) Efficacy of a physician’s words of empathy: an overview of state apology laws. J Am Osteopath Assoc 112:302–306CrossRefGoogle Scholar
  55. 55.
    Centers for Medicare and Medicaid Services (CMS) Changes in the Quality Improvement Organization (QIO) Beneficiary Complaint and General Quality of Care Review Process (2014) IPRO.
  56. 56.
    U.S. Centers for Medicare and Medicaid Services (n.d.) Mediation: a new option for medicare beneficiaries.
  57. 57.
    Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services (2008) Pay-for-Performance: a decision guide for purchasers. Accessed 26 Aug 2008
  58. 58.
    Federal Trade Commission and the U.S. Department of Justice (2000) Antitrust guidelines for collaborations among competitors. Accessed 17 Oct 2008

Copyright information

© American College of Medical Quality (ACMQ) 2021

Authors and Affiliations

  1. 1.University of Utah School of MedicineSalt Lake CityUSA
  2. 2.University of North Carolina School of MedicineChapel HillUSA

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