1. Setting the Stage for Managing Risk in Reproductive Medicine: An Ounce of Prevention is Worth a Pound of Cure Marybeth Gerrity, Ph.D., HCLD Reproductive Biology Resources, Inc. Auxogyn, Inc.

2. Reproductive Biology Resources, Inc. Setting the Stage for Managing Risk Management in Reproductive Medicine Learning Objectives At the conclusion of this lecture, participants will be able to Discuss the role of the informed consent process in risk management and identify resources for informed consent in the IVF setting. Understand the difference between standard of care and legal requirements and how this affects fertility practices. Enumerate tissue banking risks that affect the IVF practice and may require remedial action. Integrate basic risk management strategies into practice operations.

3. Planning Ahead, Managing Risk, Identifying Liability Risk Management is the gathering of information to reduce uncertainty, and making a decision based on information. Reproductive Biology Resources, Inc.

4. What is Risk? Risk is the possibility of suffering a loss: Loss of quality outcome Loss of professional reputation/credibility Loss of patient or staff safety, health (life?) Loss of profitability Loss of success Reproductive Biology Resources, Inc.

5. Managing Risk Identify sources of risk (What can go wrong?) Evaluate processes that lead to high impact risks Devise systems to monitor high risk activities Use data from this monitoring to improve functions Develop response plan for the system failures Reproductive Biology Resources, Inc.

6. Sources of Risk in Reproductive Medicine Informed Consent process Patient Identification and Specimen Labeling Tissue Banking and use of stored cells/tissues Inadequate or inappropriate resources: Staff, equipment, etc. Lack of leadership, professional responsibility Inadequate SOPs or “changes” in methods without authorization or knowledge (DRIFT) Preparation of solutions/reagents Change in payor mix, insurance coverage or self pay patients (Financial) Reproductive Biology Resources, Inc.

7. Standard of Practice Standard of Care Industry Standards Reproductive Biology Resources, Inc. Defining and Benchmarking Best Practices

8. The Standard of Care What would another reasonable and comparable practice have done? Standard of care may be established de facto as a result of litigation. ASRM Guidelines establish some standards of care. New SART Consents Geography does not usually affect ART! AVOID ISOLATION! Reproductive Biology Resources, Inc.

9. Standards Developed, reviewed and amended by a consensus process. Identifies specific, essential requirements for materials, methods, or practices. Must be used in an unmodified form. Any discretionary components clearly indicated. Recognized as a means of demonstrating conformance. May become mandatory when adopted by outside organizations in regulations. Reproductive Biology Resources, Inc.

10. Role of Industry Standards in Insulating Against Liability Up to Date Regularly Reviewed Accurate You cannot insulate yourself against negligence! Reproductive Biology Resources, Inc.

11. Examples of Standards Applicable in Reproductive Medicine AATB Tissue Banking Standards Some ASRM/SART Policies and Guidelines KEY POINT: They are not mandatory and have no enforcement component Reproductive Biology Resources, Inc.

12. Standard of Care Versus Regulatory Requirements Reproductive Biology Resources, Inc.

13. Regulations Developed by government agency under legislative mandate May arise from: –Need for good practices –Societal, political or other considerations Opportunity for public comment Enforcement by responsible agency Reproductive Biology Resources, Inc.

14. Examples of Regulations Applicable in Reproductive Medicine CLIA 1988 Fertility Clinic Success Rate and Certification Act (Wyden Law) FDA Regulations on Tissue Banking KEY POINT: They ARE mandatory and have SIGNIFICANT enforcement components Reproductive Biology Resources, Inc.

15. Minimizing and Managing Risk is a Team Responsibility You must identify risk in order to manage it well! Reproductive Biology Resources, Inc.

16. The Informed Consent Process: Because You’ve Never Enjoyed Walking On Egg Shells: Scenarios

17. Patient Identification At least two methods to identify patients. Clear identification of first and last name as sex of patient. Beware of Cultural contexts in Patient ID Patient should give name; don’t prompt! Process not a signature Golden Moments! Double witnessing invites failure! Reproductive Biology Resources, Inc.

18. Informed Consent Process: A Nursing Challenge Contracts and Consents Involved Parties Ownership of Gametes Execution Process Reproductive Biology Resources, Inc.

19. New SART Consent Forms www.sart.org (Members) www.sart.org Introduction to ART In-Vitro Fertilization Document Recipients of Donor Eggs Document Disposition of Embryos Declaration Information for Gestational Carriers and Intended Parents Information for Gestational Carriers and Intended Parents Egg Donation Document Egg Cryopreservation Information Disposition of Eggs Declaration Reproductive Biology Resources, Inc.

20. New SART Consents: Purpose Redraft the consents in lay person’s terms Remove gender specific and dated terms in an era of same sex marriage Provide a method to change disposition of gametes and embryos after storage Address changing state laws re: donor gametes Freezing of eggs is no longer experimental Formalize the method of signing (notary) Reproductive Biology Resources, Inc.

21. Consents and Contracts are ONE Focus of Risk Management They establish the terms and conditions of the relationship. They define the parties to the agreement. They bring attention to the risks and benefits of the procedures. They outline the process and define the expected and reasonable outcomes. They set the stage for expectations. They provide a pathway for withdrawing consent. They do no excuse negligence! Don’t eliminate risk or need to defend again error. Reproductive Biology Resources, Inc.

22. Risk Management: Group Behavior All members of the group must adhere to the same standards No one member may accept risk on behalf of the rest Don’t confuse duplication of effort with managing risk Operate within your area of competence Reproductive Biology Resources, Inc.

23. “Ownership” of Gametes and Embryos Autologous Sperm under the exclusive control of the Sperm Source (Not the Spouse) Frozen Autologous Eggs under the exclusive control of the Egg Source (Not the spouse) Disposition of embryos requires the consents of both Gamete Sources or Parents Stage setting for ownership with unmarried couples.

24. Reproductive Biology Resources, Inc. Execution of Consents Both members of the couple must sign in ink. Each signature should be witnessed. Witness/patient signature date must match. Witness may be a staff member but not one who may “benefit” from the process. If notarized, each signature must be notarized.

25. Reproductive Biology Resources, Inc. Execution of Consents Were any alterations made to the consents? Was the complete consent returned (not just signature page)? Are the consents current? Verify the type of gamete covered? Did both gamete sources/parents sign? Is there any reason to doubt the accuracy or validity of the consent? Were consents received prior to treatment?

26. Updating Consents: How Often and When Once per year when patient is in active treatment Whenever there is a change in the consent form If therapy is stopped for more than a few months If frozen stored sperm samples are used after a break in therapy For each new frozen embryo transfer Ensure the identity of both partners Periodically verify continued partner consent

27. Reproductive Biology Resources, Inc. Disposition of Abandoned Embryos ASRM Ethical Statement www.asrm.org

28. Reproductive Biology Resources, Inc. “Abandoned Embryos” ASRM Definition More than 5 years have passed without contact with couple. Diligent efforts have been made to contact couple by phone, mail and registered mail. No prior written instructions concerning disposition. Terms of the consent signed by the couple should prevail.

29. Reproductive Biology Resources, Inc. ASRM Ethical Statement on Abandoned Embryos It is ethical to dispose of abandoned embryos The Center must be diligent about attempting to contact the couple The embryos should not be donated to another couple The embryos should not be used for research

30. Reproductive Biology Resources, Inc. Cryopreservation/Storage Consent Essential Components Maximum Length of Storage. Instructions in event of death, divorce, failure to pay storage fees, inability to agree on disposition or failure to notify Center of their whereabouts. These directives may be changed in writing. That the Center may dispose of embryos if embryos are “abandoned” Willingness to store does not imply storage in perpetuity.

31. Reproductive Biology Resources, Inc. Disposal Consents Contains Patient MR# or other unique ID Current Patient Information (Address and Phone Numbers) Specifies the type of gamete to be disposed Verification that signature of “original” partners have been provided Actual Disposal witnessed by another staff member Beware of Imposters and Name Errors

32. Reproductive Biology Resources, Inc. Moving Patient Samples Center to Center Individual patient consents required NO BLANKET OR GROUP CONSENT Verify the exact conditions for transfer Document the condition of the shipper and samples at shipping and receipt Document patient ID and quantities Do not accept the liabilities of another Center Use witnesses where appropriate

33. Reproductive Biology Resources, Inc. Risk Management Strategies Team effort Review processes not procedures Increasing staff is not the only or even best answer Two methods of identification (not duplicates) Continuous improvement of quality not increase in paperwork or procedures.

34. Reproductive Medicine Bermuda Triangle Reproductive Biology Resources, Inc. Lawyers Regulations POOR RISK MANAGEMENT ConsentsLabeling Inventory/Record Keeping Competitors Patient Identification Monitoring Trends Identifying and Planning for Risks

35. Risk Management in the IVF Program: Personnel Competency Based Training Use of Per Diem Staff (TRAINING) Auditing Existing staff performance “Trust” between staff members biggest liability OSHA REGS and Part Time Staff System for monitoring Reproductive Biology Resources, Inc.

36. Risk Management and Quality Improvement Quality is “fitness for use”, duty of care and best practices Plan-Act-Evaluate-Improve-Plan Leadership and Education are key Measurement and Feedback are Integral Undetected incidents and trends cannot be improved.

37. Reproduced with the permission of Cryo Med Tissue Banks: A Major Source Of Risk

38. Reproductive Biology Resources, Inc. Reproductive Laboratories The Biggest Sources of RISK The use of the wrong sample The mislabeled sample The missing sample The sample left behind The sample that could have been used… The mistaken disposal Poor records on the “mix and match”

39. Reproductive Biology Resources, Inc. Risk: SOPs, Revisions, Reagents Written not spoken word Following procedures as written (by all) Annual review and revision If a form requires a “write in” it needs revision Following the “spirit” and the “letter” of the procedures. Using the correct reagents and materials “Drift” decreases quality and increases risk SOPs do not vary with volume

40. Reproductive Medicine Bermuda Triangle Reproductive Biology Resources, Inc. Lawyers Regulations POOR RISK MANAGEMENT ConsentsLabeling Inventory/Record Keeping Competitors Patient Identification Monitoring Trends Identifying and Planning for Risks