Skip to main content

Error Management: Legal and Regulatory Responsibilities

  • Chapter
  • First Online:
Error Reduction and Prevention in Surgical Pathology
  • 547 Accesses

Abstract

Laws, governmental and nongovernmental regulations, and accreditation standards that control the laboratory environment affect safety and strongly influence surgical pathology error prevention and reduction. The Centers for Medicare and Medicaid Services is the primary governmental entity involved with surgical pathology, and the College of American Pathologists is a key accrediting agency. Surgical pathology laboratories have instituted or strengthened several error reduction programs to meet increasingly stringent accrediting agency requirements and regulatory requirements regarding surgical pathology error. Medical malpractice risk reduction efforts focus on misdiagnosis, delayed diagnosis, and failure to diagnose. With the “loss of chance” doctrine, the legal system is adapting to consider the standard of cares’ increasing requirement for early, accurate, and specific diagnoses. It is likely that checklists, a relatively recent addition to the health quality armamentarium, will in the future not only provide increasing cost savings but also assist in decreasing medical error. Apology for medical error, not long ago considered to be a popular mechanism for reducing medical malpractice risk, has recently received heavy criticism, and despite its popularity, its future use is problematic. Ultimately, a no-fault system of compensation for medical injuries might allow for more surgical pathology error transparency and yield increased patient safety. Successful advancement of medical error reduction, including surgical pathology error reduction, will require physicians to work closely with other stakeholders.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

eBook
USD 16.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 16.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 129.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Oyebode F. Clinical errors and medical negligence. Med Princ Pract. 2013;22(4):323–33.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Rodziewicz TL, Hipskind JE. Medical error prevention. StatPearls. 03/30/2018. https://www.ncbi.nlm.nih.gov/books/NBK499956/. Accessed 10/12/2018.

  3. Delacroix R. Exploring the experience of nurse practitioners who have committed medical errors: a phenomenological approach. J Am Assoc Nurse Pract. 2017;29(7):403–9.

    PubMed  Google Scholar 

  4. Bowden C. Regulating patient safety: the end of professional dominance? Med Law Rev. 2018;26(2):361.

    Article  Google Scholar 

  5. Allen TC, Stafford M, Liang BA. Pathology and medical malpractice. Academic and trainee empirical review of cases by State of Texas physicians. Am J Clin Pathol. 2014;141(4):501–9.

    Article  PubMed  Google Scholar 

  6. Allen TC, Liang BA. Pathologists and liability: an old medical story needing a new ending. Am J Clin Pathol. 2015;144(6):828–9.

    Article  PubMed  Google Scholar 

  7. Robertson JJ, Long B. Suffering in silence: medical error and its impact on health care providers. J Emerg Med. 2018;54(4):402–9.

    Article  PubMed  Google Scholar 

  8. Battard J. Nonpunitive response to errors fosters a just culture. Nurs Manag. 2017;48(1):53–5.

    Article  Google Scholar 

  9. Walker JM, Carayon P, Leveson N, et al. EHR safety: the way forward to safe and effective systems. J Am Med Inform Assoc. 2008;15(3):272–7.

    Article  PubMed  PubMed Central  Google Scholar 

  10. Arbel YA, Kaplan Y. Tort reform through the back door: a critique of law and apologies. 90 S. Cal L. Rev. 1199 (2017).

    Google Scholar 

  11. Kionka EJ. Things to do (or not) to address the medical malpractice insurance problem. 2006; 26 N. Ill. U. L. Rev. 469, 519.

    Google Scholar 

  12. Davenport AA. Forgive and forget: recognition of error and use of apology as preemptive steps to ADR or litigation in medical malpractice cases. 2006; 6 Pepp. Disp. Resol. L. J. 81.

    Google Scholar 

  13. van Dijck G. The ordered apology. Oxf J Leg Stud. 2017;37(3):562.

    Article  Google Scholar 

  14. Raper SE. No role for apology: remedial work and the problem of medical injury. 2011; 11 Yale J. Health Pol’y L & Ethics 267, 316–317.

    Google Scholar 

  15. Teniinbaum GH. How medical apology programs harm patients. 2011; 15 Chap. L. Rev. 307, 341–342.

    Google Scholar 

  16. Liang BA, Ren LL. Medical liability insurance and damage caps: getting beyond band aids to substantive systems treatment to improve quality and safety in healthcare. 2004; 30 Am. J. L. and Med. 501, 535.

    Google Scholar 

  17. Raper SE. Announcing remedies for medical injury: a proposal for medical liability reform based on the Patient Protection and Affordable Care Act. 2013; 16 J. Health Care L. & Pol’y 309, 349.

    Google Scholar 

  18. Studdert DM, Brennan TA. Toward a workable model of “no-fault” compensation for medical injury in the United States. 2001; 27 Am. J. L. and Med. 225, 227–228.

    Google Scholar 

  19. Kapp MB. Medical error versus malpractice. 1997; 1 DePaul J. Health Care L. 751, 772.

    Google Scholar 

  20. Safety Laws and Standards Pertinent to Laboratory. Prudent practices in the laboratory: handling and management of chemical hazards: Updated Version. National Research Council (US) Committee on Prudent Practices in the Laboratory. Washington, DC: National Academies Press (US); 2011. http://www.ncbi.nlm.nih.gov/books/NBK55862/. Accessed 10/28/13.

    Google Scholar 

  21. Mascioli S, Carrico CB. Spotlight on the 2016 National Patient Safety Goals for hospitals. Nursing. 2016;46(5):52–5.

    Article  PubMed  Google Scholar 

  22. Clinical Laboratory Improvement Amendments (CLIA). Centers for Medicare & Medicaid Services. CMS.gov. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/. Accessed 11/2/13.

  23. Nakhleh RE, Souers R, Brown RW. Significant and unexpected, and critical diagnoses in surgical pathology: a College of American Pathologists’ survey of 1130 laboratories. Arch Pathol Lab Med. 2009;133(9):1375–8.

    PubMed  Google Scholar 

  24. Rivers PA, Dobalian A, Germinario FA. A review and analysis of the clinical laboratory improvement amendment of 1988: compliance plans and enforcement policy. Health Care Manag Rev. 2005;30(2):93–102.

    Article  Google Scholar 

  25. CLIA program; approval of the College of American Pathologists--HCFA. Notice. Fed Regist. 1995;60(27):7774–80.

    Google Scholar 

  26. Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)--HCFA. Final rule with comment period. Fed Regist. 1992;57(40):7002–186.

    Google Scholar 

  27. Ehrmeyer SS. Satisfying regulatory and accreditation requirements for quality control. Clin Lab Med. 2013;33(1):27–40.

    Article  PubMed  Google Scholar 

  28. Bennett J, Cervantes C, Pacheco S. Point-of-care testing: inspection preparedness. Perfusion. 2000;15(2):137–42.

    Article  CAS  PubMed  Google Scholar 

  29. Raab SS. Improving patient safety by examining pathology errors. Clin Lab Med. 2004;24(4):849–63.

    Article  PubMed  Google Scholar 

  30. Nakhleh RE. Patient safety and error reduction in surgical pathology. Arch Pathol Lab Med. 2008;132(2):181–5.

    PubMed  Google Scholar 

  31. Renshaw AA, Gould EW. Reducing false-negative and false-positive diagnoses in anatomic pathology consultation material. Arch Pathol Lab Med. 2013;137(12):1770–3.

    Article  PubMed  Google Scholar 

  32. Allen TC. Second opinions: pathologists’ preventive medicine. Arch Pathol Lab Med. 2013;137(3):310–1.

    Article  PubMed  Google Scholar 

  33. Silverman JF. Recent trends in quality, patient safety, and error reduction in nongyn cytology. Adv Anat Pathol. 2010;17(6):437–44.

    Article  PubMed  Google Scholar 

  34. Raab SS, Grzybicki DM, Mahood LK, Parwani AV, Kuan SF, Rao UN. Effectiveness of random and focused review in detecting surgical pathology error. Am J Clin Pathol. 2008;130(6):905–12.

    Article  PubMed  Google Scholar 

  35. Zarbo RJ, Meier FA, Raab SS. Error detection in anatomic pathology. Arch Pathol Lab Med. 2005;129(10):1237–45.

    PubMed  Google Scholar 

  36. Coffin CM. Pediatric surgical pathology: pitfalls and strategies for error prevention. Arch Pathol Lab Med. 2006;130(5):610–2.

    PubMed  Google Scholar 

  37. Raab SS, Vrbin CM, Grzybicki DM, et al. Errors in thyroid gland fine-needle aspiration. Am J Clin Pathol. 2006;125(6):873–82.

    Article  PubMed  Google Scholar 

  38. Becich MJ, Gilbertson JR, Gupta D, Patel A, Grzybicki DM, Raab SS. Pathology and patient safety: the critical role of pathology informatics in error reduction and quality initiatives. Clin Lab Med. 2004;24(4):913–43, vi.

    Article  PubMed  Google Scholar 

  39. Kang HP, Sirintrapun SJ, Nestler RJ, Parwani AV. Experience with voice recognition in surgical pathology at a large academic multi-institutional center. Am J Clin Pathol. 2010;133(1):156–9.

    Article  PubMed  Google Scholar 

  40. Nakhleh RE, Myers JL, Allen TC, et al. Consensus statement on effective communication of urgent diagnoses and significant, unexpected diagnoses in surgical pathology and cytopathology from the College of American Pathologists and Association of Directors of Anatomic and Surgical Pathology. Arch Pathol Lab Med. 2012;136(2):148–54.

    Article  PubMed  Google Scholar 

  41. Allen TC. Medicolegal issues in pathology. Arch Pathol Lab Med. 2008;132(2):186–91.

    PubMed  Google Scholar 

  42. Allen TC. Loss of chance doctrine: an emerging theory of medical malpractice liability. Pathol Case Rev. 2012;17(4):172–4.

    Article  Google Scholar 

  43. Kern KA. The delayed diagnosis of breast cancer: medicolegal implications and risk prevention for surgeons. Breast Dis. 2001;12:145–58.

    Article  CAS  PubMed  Google Scholar 

  44. Epstein JB, Sciubba JJ, Banasek TE, Hay LJ. Failure to diagnose and delayed diagnosis of cancer: medicolegal issues. J Am Dent Assoc. 2009;140(12):1494–503.

    Article  PubMed  Google Scholar 

  45. Black’s Law Dictionary, 6th Ed., St. Paul: West; 1991.

    Google Scholar 

  46. Havighurst CC, Hutt PB, McNeil BJ, Miller W. Evidence: its meanings in health care and in law. (Summary of the 10 April 2000 IOM and AHRQ Workshop, “Evidence”: its meanings and uses in law, medicine, and health care). J Health Polit Policy Law. 2001;26(2):195–215.

    Article  CAS  PubMed  Google Scholar 

  47. Allen TC. Accurate diagnosis of mesothelioma: more important than ever. Arch Pathol Lab Med. 2013;137(5):601–2.

    Article  PubMed  Google Scholar 

  48. Allen TC. Targeted molecular therapy for lung cancer: exuberance reestablished. Arch Pathol Lab Med. 2013;137(6):747.

    Article  PubMed  Google Scholar 

  49. Cagle PT, Allen TC, Olsen RJ. Lung cancer biomarkers: present status and future developments. Arch Pathol Lab Med. 2013;137(9):1191–8.

    Article  CAS  PubMed  Google Scholar 

  50. Cagle PT, Allen TC. Lung cancer genotype-based therapy and predictive biomarkers: present and future. Arch Pathol Lab Med. 2012;136(12):1482–91.

    Article  CAS  PubMed  Google Scholar 

  51. Lindeman NI, Cagle PT, Beasley MB, et al. Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. Arch Pathol Lab Med. 2013;137(6):828–60.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  52. Picken MM. New insights into systemic amyloidosis: the importance of diagnosis of specific type. Curr Opin Nephrol Hypertens. 2007;16(3):196–203.

    Article  PubMed  Google Scholar 

  53. Price WN. Regulating black-box medicine. 116 Mich. L. Rev. 421 (2017).

    Google Scholar 

  54. Buckler S. Loss of chance: recovery for the lost opportunity of survival – Matsuyama v. Birnbaum, 890 N.E.2d 817 (Mass. 2008), 2009, 5 J. Health & Biomed. L. 117, 117.

    Google Scholar 

  55. Renehan JF. A new frontier: the loss of chance Doctrine in Medical Malpractice Cases. 2009, 53 B.B.J. 14, 15.

    Google Scholar 

  56. Wurdeman M. Loss-of-chance doctrine in Washington: from Herskovits to Mohr and the need for clarification. 89 Wash. L. Rev. 603 (2014).

    Google Scholar 

  57. Casaceli B. Losing a chance to survive: an examination of the loss of chance doctrine within the context of a wrongful death action. 9. J. Health & Biomed. L. 521 (2014).

    Google Scholar 

  58. Negligence--failure to carry out physical examination and biopsy--damages for loss of chance of extended lifespan. Brown v Willington [2001] ACTSC 100 J. Law Med. 2002:397–398.

    Google Scholar 

  59. Warzecha CM. The loss of Chance Doctrine in Arkansas and the door left open: revisiting hold ex rel. Holt v Wagner. 2010, 63 Ark. L. Rev. 785, 803.

    Google Scholar 

  60. Koch SR. Whose loss is it anyway? Effects of the “Lost-Chance” Doctrine on Civil Litigation and Medical Malpractice Insurance. 2010, 88 N.C.L. Rev. 595, 598–599.

    Google Scholar 

  61. Frasca R. Loss of chance rules and the valuation of loss of chance damages. 2009, 15 J. Legal Econ. 91.

    Google Scholar 

  62. Brahams D. Loss of chance of survival. Lancet. 1996;348(9042):1604.

    Article  CAS  PubMed  Google Scholar 

  63. Guest L, Schap D, Tran T. The “loss of chance” rule as a special category of damages in medical malpractice: a state-by-state analysis. 21 J. Legal Econ. 53 (2015).

    Google Scholar 

  64. Chicago Brain Hemorrhage Misdiagnosis Lawyers. http://www.cirignani.com/Brain-Injries/Missed-Brain-Hemorrhage.shtml. Accessed 04/09/11.

  65. Brass C. A proposed evidentiary privilege for medical checklists. 2010; Colum Bus. L. Rev. 835, 836.

    Google Scholar 

  66. Mehlman MJ. Professional power and the standard of care in medicine. 2012; 44 Ariz. St. L. J. 1165, 1230.

    Google Scholar 

  67. Brass C. A proposed evidentiary privilege for medical checklists. 2010; Colum. Bus. L. Rev. 835, 893–894.

    Google Scholar 

  68. Liang BA. Dr. Arthur Grayson Distinguished Lecture in Law & Medicine: promoting patient safety through reducing medical error: a paradigm of cooperation between patient, physician, and attorney. 2000; 24 S. Ill. U. L. J. 541, 556.

    Google Scholar 

  69. Furrow BR. Patient safety and the fiduciary hospital: sharpening judicial remedies. 2009; 1 Drexel L. Rev. 439, 483.

    Google Scholar 

  70. Nussbaum L. Trial and error: legislating ADR for medical malpractice reform. 76 Md. L. Rev. 247 (2017).

    Google Scholar 

  71. Parasideis E. Clinical decision support: elements of a sensible legal framework. 20 J Health Care L. & Pol’y 183 (2018).

    Google Scholar 

  72. Marchant GE, Lindor RA. Genomic malpractice: an emerging tide or gentle ripple? 2018 Food Drug L J. 1 (2018).

    Google Scholar 

  73. Lovell K. CRISPR/Cas-9 technologies: a call for a new form of tort. 19 San Diego Int’l L. J. 407 (2018).

    Google Scholar 

  74. Westbrook MJ. Transforming the physician’s standard of care in the context of whole genome sequencing technologies: finding guidance in best practice standards. 9 St. Louis U. J Health L & Pol’y 111 (2015).

    Google Scholar 

  75. Airapetian Z. Federal privilege under Patient Safety and Quality Improvement Act: the impact of Tibbs v. Bunnell. 11 J. Health & Biomed. L. 345 (2016).

    Google Scholar 

  76. Blum JD. Regulating for patient safety: the law’s response to medical errors: Article: Combating those ugly medical errors – it’s time for a hospital regulatory makeover! 2005; 12 Widener L. Rev. 53, 80.

    Google Scholar 

  77. Grout JR, Hill JW, Langvardt AW. Mistake-proofing medicine: legal considerations and healthcare quality implications. 2013; 14 Minn. J. L. Sci. & Tech. 387, 438.

    Google Scholar 

  78. Mello MM, Brennan TA. What we know and do not know about the impact of civil justice on the American economy and policy: deterrence of medical errors: theory and evidence for malpractice reform. 2002; 80 Tex. L. Rev. 1595.

    Google Scholar 

  79. Furrow BR. Medical mistakes: tiptoeing toward safety 2003; 3 Hous. J. Health L. & Pol’y 181, 216.

    Google Scholar 

  80. Furrow BR. Regulating for patient safety: the law’s response to medical errors: Article: Regulating patient safety: toward a federal model of medical error reduction. 2005; 12 Widener L. Rev. 1, 37–38.

    Google Scholar 

  81. Deutsch R. The federal role in reducing hospital-acquired conditions: are medicare reimbursement incentives enough? 2008; 42 Colum. J. L. & Soc. Probs. 1, 40.

    Google Scholar 

  82. Furrow BR. Adverse events and patient injury: coupling detection, disclosure, and compensation. 2012; 46 New Engl. L. Rev. 437, 472–473.

    Google Scholar 

  83. Williams AG. The cure for what ails: a realistic remedy for the medical malpractice “Crisis.” 2012; 23 Stanford L & Pol’y Rev 477.

    Google Scholar 

  84. Allen TC. Understanding medicolegality. Path Case Rev. 2012;17(4):143–5.

    Google Scholar 

  85. Kionka EJ. Things to do (or not) to address the medical malpractice insurance problem. 2006; 26 N. Ill. U. L. Rev. 469, 513–514.

    Google Scholar 

  86. Liang BA. The adverse event of unaddressed medical error: identifying and filling the holes in the health-care and legal systems. 2001; J. L. Med. & Ethics 346, 348.

    Google Scholar 

  87. Gostin LO, Jacobson PD, Record KL, Hardcastle LE. Restoring health to health reform: integrating medicine and public health to advance the population’s well-being. 2011; 159 U. Pa. L. Rev. 1777, 1780.

    Google Scholar 

  88. Robboy SJ, Weintraub S, Horvath AE, et al. Pathologist workforce in the United States: I. Development of a predictive model to examine factors influencing supply. Arch Pathol Lab Med. 2013;137(12):1723–32.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Timothy Craig Allen .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2019 Mayo Foundation for Medical Education and Research

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Allen, T.C. (2019). Error Management: Legal and Regulatory Responsibilities. In: Nakhleh, R., Volmar, K. (eds) Error Reduction and Prevention in Surgical Pathology. Springer, Cham. https://doi.org/10.1007/978-3-030-18464-3_2

Download citation

  • DOI: https://doi.org/10.1007/978-3-030-18464-3_2

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-18463-6

  • Online ISBN: 978-3-030-18464-3

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics