ACI's Obstetric Malpractice Claims Presentation 1
•
1 gefällt mir•801 views
Genetic and Epigenetic Disorders: Emerging Trends and Strategies
Empfohlen
Empfohlen
Weitere ähnliche Inhalte
Was ist angesagt?
Was ist angesagt? (20)
Ähnlich wie ACI's Obstetric Malpractice Claims Presentation 1
Ähnlich wie ACI's Obstetric Malpractice Claims Presentation 1 (20)
Kürzlich hochgeladen
Kürzlich hochgeladen (20)
ACI's Obstetric Malpractice Claims Presentation 1
- 3. #ACIObstetricMal ACI’s14TH AnnualAdvancedForumon ObstetricMalpracticeClaims David A. Clark, MD Chair, Dept. of Pediatrics Albany Medical College Genetic and Epigenetic Disorders: Emerging Trends and Strategies Andrew S. Kaufman Partner Kaufman Borgeest & Ryan LLP Victoria L. Vance Chair of HealthCare Practice Group Tucker Ellis LLP June 23-24, 2015 Tweeting about this conference?
- 4. #ACIObstetricMal Managing Patient Expectations and Risk in Today’s Genetic Environment
- 6. #ACIObstetricMal What Patients Hear: “Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes — and to give all of us access to the personalized information we need to keep ourselves and our families healthier.” —President Barack Obama, State of the Union Address, January 20, 2015
- 7. #ACIObstetricMal What Patients Read: •“Accurate, Affordable Detection – Gains in Genetic Tests in Breast Cancer” • NY Times, April 21, 2015 (p. B1) •“Project Sheds Light on What Drives Genes” • NY Times, Feb. 19, 2015 (p. A16)
- 8. #ACIObstetricMal What Hospitals Claim: • “. . . Comprehensive clinical genetic services including diagnosis, testing, management and counseling . . . For both patients and their families.” • “. . . Specialize in evaluation, treatment, diagnosis and genetic counseling for individuals of all ages and their family members.” • “. . . [our] genetic experts will work with your PCP to assess your potential risks . . . This information will be incorporated into the overall care you receive.”
- 9. #ACIObstetricMal Leads to . . . Hope Demands Beliefs Expectations RISK
- 11. #ACIObstetricMal 1. Timely Recognition of Patient Risk Case: $7.5M verdict – failure to recognize newborn’s declining neurologic status and order metabolic testing. Infant had Maple Syrup Urine Disease (MSUD) Lessons: • Maintain competency and awareness of complex genetic developments • Recognize patients at risk (through information, not appearance) • Cultural Sensitivity
- 12. #ACIObstetricMal 2. Timely Referral for Genetic Testing/Counseling Case: $1.75M settlement – Failure to properly obtain Expanded AFP test (California, Dec. 2011) Lessons: • Know the indications for referral • Request a timely consult • Know where to refer – • Regional Comprehensive Genetic Centers
- 13. #ACIObstetricMal 3. Order Follow Up and Interpretation of Genetic Tests Challenge: • Knowing who to test (for breast cancer, all women over 30?) • Studies show a general lack of training among doctors ordering genetic tests: 1.Test request not complete 2.Ordering wrong test 3.Not familiar with recommended screenings for patients with positive results • Result: Get it, Read it, Know it • Provide accurate guidance and interpretation of results
- 14. #ACIObstetricMal 4. Lab Medicine Risks Case: $50M verdict – Failure of lab to clarify genetic test order (Washington, Nov. 2013) Lessons: • ARUP studies show frequent errors in gene test orders: 1. Requesting the wrong gene test 2. Mixing up rare diseases with similar names; and 3. Ordering a gene test for one cancer mutation even though family history suggests a different gene test is more clinically appropriate
- 15. #ACIObstetricMal 4. Lab Medicine Risks • New U.S. National Institute of Standards and Technology (NIST) offers DNA Standard to better calibrate equipment and ensure accuracy and reliability of genetic tests (May 18, 2015) • March 2015: ACMG, Assoc. for Molecular Pathology and College of American Pathologists announce a variant classification system and standard terminology to classify genomic variants
- 16. #ACIObstetricMal 5. The Informed Consent Process • Provide accurate explanations of risks, limitations, testing options and counseling resources • Implications of Testing: Does Patient Want to Know the Results? • Provide tailored informational literature and websites • Offer genetic counseling: Pre- and Post- test
- 17. #ACIObstetricMal 6. Documentation •Accurately document risk discussions, counseling recommendations, testing options, handouts •Document Patient (family) refusals, delays
- 18. #ACIObstetricMal 7. Electronic Medical Record • Technology to integrate family health history (multi-generations) • CAUTION when including living relatives’ PHI into another patient’s EMR; or accessing relative’s record w/out consent • Risk of reliance on decision support tools • Timely upgrades? • Customizable to patient and workflow?
- 19. #ACIObstetricMal 7. Electronic Medical Record • System Security • The eMerge Network • An NIH funded consortium researching genomics, statistics, ethics and informatics • Examining best use of EMR to incorporate genetic variants to improve genetic risk assessments, diagnosis, algorithms, and treatment
- 20. #ACIObstetricMal 8. Privacy & GINA Genetic Information Nondiscrimination Act (GINA) •Title I: Health Insurers cannot use genetic information to: • Establish premiums • Determine eligibility • Request person undergo genetic testing
- 21. #ACIObstetricMal 8. Privacy & GINA •Title II: Employers cannot use genetic information to: • Make decisions to hire, fire, promote, reassign person • Request, require, or purchase genetic information about employee or family member
- 22. #ACIObstetricMal 8. Privacy & GINA •HIPAA Final Rule (78 Fed Reg. 5566, 5660) expands on GINA: • All health plans that are covered entities prohibited from using genetic information for underwriting purposes (except LTC)
- 23. #ACIObstetricMal 9. Patient Counseling & Education •Set reasonable expectations •New Advances: Gene altering in human embryos (“The Gene Editor” NY Times, May 12, 2015) •Be cognizant of insurance and coverage issues
- 24. #ACIObstetricMal 10. Marketing & Promotion Say what you mean AND Mean what you say!
- 25. #ACIObstetricMal Best Practices: The ACOG Committee on Ethics and Genetics recommend the following guidelines: 1. Clinicians should be able to identify patients within their practices who are candidates for genetic testing and should maintain competence in the face of increasing genetic knowledge
- 26. #ACIObstetricMal Best Practices: 2. Obstetrician-gynecologists should recognize that geneticists and genetic counselors are an important part of the health care team and should consult with them and refer as needed 3. Discussions with patients about the importance of genetic information for their kindred, as well as a recommendation that information be shared with potentially affected family members as appropriate, should be a standard part of genetic counseling
- 27. #ACIObstetricMal Best Practices 4. Obstetrician-gynecologists should recognize that genetic information has the potential to lead to discrimination in the workplace and to affect an individual’s insurability adversely. In addition to including this information in counseling materials, physicians should recognize that their obligation to professionalism includes a mandate to prevent discrimination.
- 28. #ACIObstetricMal Best Practices: Steps that physicians can take to fulfill this obligation could include, among others, advocacy for legislation to ban genetic discrimination. - ACOG Committee Opinion: “Ethical Issues in Genetic Testing” (Number 410 – June 2008 (Reaffirmed 2014))