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Medical Legal Aspects of Quality Improvement

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Colorectal Cancer Screening

Abstract

The use of quality improvement tools such as clinical practice guidelines and quality measures can improve patients’ clinical outcomes and reduce the incidence of adverse events. In addition to improving patient care, properly structured quality improvement policies can also reduce physician liability. If a physician is sued for malpractice, proof that the physician complied with a guideline or quality measure will help prove lack of fault for a negative outcome. However, guidelines and quality measures are double-edged swords. As quality measures and guidelines become established, courts may adopt them as de facto standards of care, and physician noncompliance may lead to liability during a malpractice trial. The careful gastroenterologist will need to keep up with quality measures both to provide good patient care and to manage risk.

This chapter reviews potential legal risk areas associated with quality improvement measures for colonoscopy. The first part introduces the basic legal concepts used in malpractice cases. The second part examines clinical practice guidelines and quality measures and their use by courts to define the standard of care. The third part discusses the confidentiality protection afforded by peer review to data gathered for health-care quality improvement. The fourth part discusses specific aspects of CRC screening where physicians may face liability for noncompliance with practices defined in guidelines, quality measures, or other quality-improvement-related recommendations. Part five addresses liability risks and other potential problems associated with the use of financial incentives to encourage physicians to meet specified quality measures and benchmarks. Finally, part six presents the concept of risk management programs and their use in limiting a physician’s malpractice risk.

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Notes

  1. 1.

    Hood v. Phillips, 554 S.W.2d 160, 165 (Texas 1977).

  2. 2.

    Salgo v Leland Stanford Jr. University Board of Trustees 317 P.2d 170 (California 1957).

  3. 3.

    Committee to Advise the Public Health Service on Clinical Practice Guidelines, Institute of Medicine, Clinical Practice Guidelines: Directions for a New Program, at 8 (Marilyn J. Field and Kathleen N. Lohr eds., 1990)

  4. 4.

    I.e., the ACG in its guidelines are developed under the auspices of the American College of Gastroenterology and its Practice Parameters Committee, using expert opinion and data available at the time. The ACG then seeks the approval of the governing boards of the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and the American Association for the Study of Liver Diseases. See id.

  5. 5.

    See May v. Moore 424 So 2d 596 (Ala 1982) (“there is no tenable policy reason why a physician should not be required to keep abreast of the advancements of his profession.”).

  6. 6.

    Some states, including Maine, Florida, Kentucky, and Minnesota have created statutes to permit physicians to use adherence to CPGs as an affirmative defense in malpractice actions.

  7. 7.

    See Hood v Phillips, 554 S.W.2d 160, 165 (TX, 1977) (“A physician is not guilty of malpractice where the method of treatment used is supported by a respectable minority of physicians, as long as the physician has adhered to the acceptable procedures of administering the treatment as espoused by the minority”).

  8. 8.

    See Helling v. Carey (519 P.2d 981 Wash. 1974).

  9. 9.

    See, e.g., Frakes v. Cardiology Consultants, PC, 1997 Tenn App 597 (Tenn Ct App 1997) (holding that the guidelines at issue, which were promulgated by the American College of Cardiology and American Heart Association, were recognized by a majority of experts as the standard of care for the profession and therefore were relevant and had authoritative power as substantive evidence in malpractice litigation).

  10. 10.

    American Gastroenterological Association, Guidelines, available at http://www.gastro.org/practice/medical-position-statements.

  11. 11.

    See Virmani v. Novant Health, Inc., 259 F.3d 284, 290 (4th Cir. 2001) (“[A]ll fifty states and the District of Columbia have recognized the [peer review] privilege.”); Health Care Quality Improvement Act of 1986 (HCQIA), 42 U.S.C. § 11101 et seq.

  12. 12.

    See also generally Bredice v. Doctors Hosp., Inc., 50 F.R.D. 249–50 (D.D.C. 1970); Claypool v. Mladineo, 724 So. 2d 373, 388 (Miss. 1998); Cruger v. Love, 599 So. 2d 111, 114–15 (Fla. 1992); Trinity Med. Ctr., Inc. v. Holum, 544 N.W.2d 148, 155 (N.D. 1996); Young v. Saldanha, 431 S.E.2d 669 (W. Va. 1993); Moretti v. Lowe, 592 A.2d 855, 857 (R.I. 1991); HCA Health Servs. of Virginia, Inc. v. Levin, 530 S.E.2d 417, 420 (Va. 2000); Glover v. Griffin Health Servs., No. X06CV055001692S, 2007 WL 3173658 at *4 (Conn. Super. Oct. 11, 2007).

  13. 13.

    Orgavanyi v. Henry County Health Center, 2010 WL 5394785 (Iowa Ct. App. Dec. 22, 2010); Legg v Hallet, No. 07AP-170 (Ohio Ct. App. Dec. 11, 2007); Columbia/HCA Health Care Corporation v. Eighth Judicial District Court, 936 P.2d 844 (Nev. 1997).

  14. 14.

    Schleondorff v Society of New York Hospital, 211 N.Y.125, 105 N.E. 92 (1914), New York.

  15. 15.

    Salgo v. Leland Stanford Jr. University Board of Trustees 317 P.2d 170, California.

  16. 16.

    Canterbury v. Spence 464 F.2d 772(D.C. Cir. 1972).

  17. 17.

    One possible example: “The information you received noted that no test is perfect, including this endoscopy, and our staff have reviewed the risks of colonoscopy, including bleeding, perforation, infection, heart or respiratory complications, missed diagnosis, incomplete procedure, and sedation risks. Do you have any questions for me?”

  18. 18.

    Mitchell v. United States, 141 F3d 8; 49 (1st Cir 1998).

  19. 19.

    OA is financially rewarding for practices.

  20. 20.

    i.e., accomplishing screening colonoscopy in a single visit.

  21. 21.

    See, e.g., ASGE Practice Guidelines on Open Access Endoscopy, available at http://www.asge.org/assets/0/71542/71544/04fc88121fec40b6b99883384beb5cf6.pdf.

  22. 22.

    Informed consent is particularly important and the patient must be given sufficient time before the procedure to ask questions or inform the physician of additional concerns or complications the patient might have. The informed consent process as it relates to OA will be detailed in section c., infra.

  23. 23.

    Safer v. Pack, 677 A2d 1188, cert. Den’d, 683 A2d1163 (New Jersey 1996).

  24. 24.

    (see the article by Greenwood elsewhere in this issue).

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Author information

Authors and Affiliations

  1. Seattle, WA, USA

    Kayla Allison Feld & Sarah Faye Blankstein

  2. Department of Gastroenterology, University of Washington, Group Health Cooperative, 125 16th Ave East CSB-2, 98112, Seattle, WA, USA

    Andrew D. Feld

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  1. Kayla Allison Feld
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  2. Sarah Faye Blankstein
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  3. Andrew D. Feld
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Correspondence to Andrew D. Feld .

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Editors and Affiliations

  1. Department of Gastroenterology, Minneapolis VA Medical Center, Minneapolis, Minnesota, USA

    Aasma Shaukat

  2. Department of Medicine, Yale University, New Haven, Connecticut, USA

    John I. Allen

Additional information

Disclaimer: This chapter is written for educational purposes, and should not be construed to provide specific legal advice; for that the reader will need to consult his/her own health-care attorney

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Feld, K., Blankstein, S., Feld, A. (2015). Medical Legal Aspects of Quality Improvement. In: Shaukat, A., Allen, J. (eds) Colorectal Cancer Screening. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-2333-5_12

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