Avoiding Liability Risks Associated with GI Endoscopic Procedures

1. Avoiding Liability Risks Associated with GI Endoscopic Procedures Marti Erwin, RN, JD October 2010

2. Hospital or Endoscopic Center Systems to Reduce Risks • Appropriate staffing levels and skills mix • Type of Staff needed for the community served and the services offered • APRN • RN • LPN • Assistive Personnel • Scope of practice for nursing for state in which individual is licensed and practicing

3. Advance Practice Registered Nurse • Role still evolving • Advanced assessment of the GI patient • Initiates and interprets diagnostic tests and endoscopy procedures per an appropriate nurse practice agreement with a supervising physician • Systematically interprets clinical and diagnostic findings within normal and abnormal variations in making differential diagnoses. • Prescribes pharmacological agents and/or treatments within his or her prescriptive authority and state law SGNA Position Statement; Role Delineation of the Advanced Practice Registered Nurse in Gastroenterology

4. RN and LPN Roles RN Role Delineation LPN Role Delineation • Systematically assesses the health status of individuals and records related health data • Establishes a nursing diagnosis • Plans and implements nursing interventions • Administers and evaluates pharmacological and other therapeutic treatment regimens • Evaluates Outcomes of nursing intervention • Contributes to the planning, implementation and evaluation of patient care • Observes, records and reports significant changes in patient condition to the nurse or physician • Documents patient data to ensure continuity in the provision and coordination of care • Assists physician and/or GI RN during diagnostic and therapeutic procedures to promote optimal patient outcomes

5. Nursing Assistive Personnel • Assists in data collection such as vital signs • Assists, under direction of the GI RN, in implementation of the plan of care • Assists physician and GI RN before, during and after diagnostic and therapeutic procedures • Provides and maintains safe environment for patient and staff

6. Risk Reduction through Adequate Staff • Consider the number of patients • Layout of unit • Patient acuity • Technology • Education and experience and competency of staff • Needs of community and patient population

7. Minimum Levels of StaffingSGNA • Pre-procedure 1 RN • Each Procedure Room 1 RN to Assess and Monitor IV sedation • 1 RN, LPN or Tech to Assist • Post Procedure 1 RN • Severe conditions and complex procedures such as ERCP, PEG insertion, Large Polyp Removal, Double Balloon Enteroscopy requiring a higher level of sedation and pediatric patients must have a minimum of 1 RN plus an additional member of the team present at all times –normally 3 people for complicated procedures

8. Credentials and Privileging to Reduce Liability Risks • Physicians • Sedation and Anesthesia Providers • APRNs • Employed RNs of Independent Physicians

9. Physicians • Professional Associations such as the American Society for Gastrointestinal Endoscopy (ASGE) and the American College of Gastroenterology (ACG)establish standards for competence and methods for assessing competence of practitioners • What is competence? • Minimal level of skill, knowledge and or experience derived through training and experience that is required to safely and proficiently perform a task or procedure

10. How is competence determined? • Training measures are set forth • Assessment of the endoscopist by his or her peers determines competence • Technical and cognitive skills required to accurately diagnose the patient and ensure that he or she receives the appropriate care • Training assures that only indicated endoscopies are performed, sedation and analgesia are given competently, patient risk factors are identified and steps are taken to minimize identified risks

11. Training Programs • Endorsed and recognized by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association

12. Threshold Number of Procedures • ACGE recommends performance of a minimum of 140 colonoscopies and 130 esophagogastroduodenoscopies (EGDs) be performed before competency can be assessed for the procedures • Short courses outside of training programs should be used as adjunctive or CME and are in no way adequate for training for Endoscopy

13. Evaluation of Competence and Training • Fellowship or training program director evaluation and observation of procedures

14. Privilege Determination • Separate for each type of endoscopic procedure • Review of credentials provided by the training program director in writing • Review of curriculum • Confirm training and experience • Require an observed level of competence • Specify level of training, threshold number of procedures and types of credentials needed

15. Endoscopy by Non-Physicians • Base decision on competence in endoscopy, availability of physician resources, volume of patients needing procedure • Non-physician will not attain extensive formal training in gastrointestinal diseases sufficient to attain cognitive expertise needed for patient care • Performance of sigmoidoscopies as part of colon cancer detection has been determined as safe for the non-physician • Sigmoidoscopies for evaluation of symptoms has not been proven safe and is not recommended • If upper endoscopy and colonoscopy is to be performed by a non-physician, a qualified physician must supervise • Never use non-physicians for therapeutic procedures

16. Advanced Training • For complex procedures, the physician needs to have completed an approved GI fellowship

17. Competence in Sedation • Must be able to recognize various levels of sedation from minimum to general anesthesia • Must understand the pharmacology of each sedative they intend to use and the reversal agent • Must be able to appropriately monitor each sedation technique • Must be able to recognize complications of sedation and to rescue the patient.

18. What risk is associated with credentialing and why is it important? • Negligent credentialing • High awards • Punitive damages because the health care institution did not use ordinary care in determining the competence and training of practitioners

19. Other Practitioners and Credentials • APRN • Scope of practice determined by state in which individual is licensed • Nurse practice agreement in writing with supervising physician • Appropriate DEA certification • Meets the requirements set forth by the state for advance practice in the desired area of specialty and must be the same as the supervising physician

20. Other Providers • PAs normally have the same scope of practice as the physician that they work with. Must also have a clear delineation of privileges and must not be outside of supervising physician scope • RNs who work for an independent practitioner • Privileges based upon scope of practice as an RN in the state in which licensed

21. Scenarios of Risk • Physician on staff trained in flexible sigmoidoscopy by a local physician and performing these for 12 years applies for hospital privileges for colonoscopy. He has been using a colonoscope on selected patients and has been reaching the cecum in many patients. He attended a two day seminar on colonoscopy and has a certificate and now he wants privileges. Does he meet criteria?

22. NO • He does not meet the ASGE requirements for privileges and thus should be denied. He has no formal training in gastroenterology or surgery and the requisite cognitive and procedural skills are not present to perform this procedure safely and competently. • Minimum of 140 colonoscopy procedures in training program before an assessment is made of the physician’s qualifications.

23. What are the legal ramifications? • What if he perforates a bowel and the patient subsequently dies? Whose fault? • Physician • Hospital and MEC

24. Physician Assistant Family practice has a PA to perform colonoscopies. He trained with a GI group in another state. He has done 200 supervised colonoscopies and has good references. He wants unrestricted privileges to perform colonoscopies at the hospital No family practitioner has endoscopic privileges.

25. NO • While it may be safe for a PA to perform flexible sigmoidoscopy as part of colon screening, it is not appropriate for the PA to perform unrestricted colonoscopies in an unsupervised manner.

26. FMG • Foreign Medical Graduate with training in non-US hospital completed a three year gastroenterology fellowship in US and has more than 500 EGDs and colonoscopies and a good letter of reference. She has an unrestricted medical license and is a permanent resident alien. She cannot be boarded by the ABIM because she can’t take the exam in gastroenterology. Wants privileges.

27. YES • She meets the requirements and was recommended by her program director. She does not have to be board certified to have privileges.

28. ERCP • Physician completed three years of endoscopic training. During third year he was involved with 133 ERCP procedures, but the staff physician completed most of these. His evaluations noted he was not competent to perform independent ERCPs. He wants privileges to perform the ERCP.

29. ?? • No. ERCP is complicated and advanced endoscopic procedure. Can have serious life threatening short term and long term complications. Studies indicate 180 to 200 procedures needed for the trainee to be competent. Must meet objective performance criteria because of the serious nature of this procedure. ASGE requirements not met.

30. Problem for Hospital • Liability– If hospital privileges an unqualified physician to do such a complex procedure and did not follow ASGE guidelines or recommendations from the trainee’s program, then we would have serious negligent credentialing issues to deal with.

31. Consent and Informed Consent • Considered a Pre-procedure quality indicator • Consent to Treat • Hospital responsibility • Avoids allegations of battery • More specific than general consent on the COA • Informed Consent • Requires evaluation of patient’s cognitive function • Done by treating physician • Involves detailed discussion of the procedure, the risks, benefits and alternatives to the procedure • Patient must have opportunity to get all his questions answered by his physician • Always done prior to sedation taking effect and prior to procedure

32. Policies and Procedures • Delineate the process to be used in performing GI procedures • Outlines pre, intra and post procedural care • Outlines such things as sedatives used and vial sizes • One large indicator of standard of care—a legal standard to which a physician and other health care providers are held • If your policy indicates that you will use and follow these policies and procedures and then you don’t, you must have a really defensible reason for deviating in the case

33. Quality Indicators and Measurement • ASGE and ACG have been working to define quality indicators for GI care • SGNA has been working to establish data sets for use during the pre, intra and post procedure periods of care. • Such indicators establish potential databases for decision making such as staffing levels, medication and supply needs, etc. • Also can set the hospital up for comparison among other hospitals if the quality indicators and used and published • Provides one indication that the standard of care was not followed if the quality indicators in a case situation demonstrate that the case fell below accepted standards on the indicators or that there was a pattern and the hospital consistently did not meet quality standards. • Provides a measuring stick for programs, physicians and for pay for performance

34. Infection Control • ASGE Updated Control Guidelines • Documented cases of infection complications are rare –1 in 1.8 million procedures • Stringent reprocessing required after each scope use to prepare and disinfect for use • General infection control principles required • Aseptic technique and safe injection practices • Single use vials • Utilization of gloves and infection control standards to reduce clostridium difficile associated diarrhea

35. Examples • Desert Shadow Endoscopy • This case really involved the use of 50 ml vials of propofol, a sedative utilized for endoscopy • Henry Chanin, plaintiff, was infected with Hepatitis C during the 2006 colonoscopy he had. He sued Teva, the Parenteral Medication provider and Baxter Healthcare. • CRNAs had used the same syringes on multiple patients rather than using a new syringe each time the propofol was used • Large vials temp the CRNAs to reuse the syringes

36. Endoscopy Center of Southern Nevada • Class Action suit with 5000 potential claimants against Dr. Desai for potential infection of Hepatitis C in patients • 9 of the cases were genetically linked • 106 were likely linked to the Clinic • Reusing syringes and single unit medication vials • Only $30 million in insurance

37. Department of Veterans Affairs • 3174 veterans in Georgia, Tennessee and Florida • Allegations of improperly processed endoscopy equipment causing Hepatitis B, C and HIV

38. Risk Reduction • Institutional program for processing equipment • Cleaning according to accepted protocols • Disinfecting according to policy • Written procedures for monitoring adherence to the cleaning and sterilization regimen • Appropriate employee training • Retraining • Utilization of manufacturers guidelines • Cleansing and disinfection use two different processes • Utilization of AER or Sterilizer that is compatible with the particular scopes that are being used for the procedures

39. Ethical Considerations • Patient Satisfaction • Happy patients usually do not sue • Technical Quality of the procedure • Comfort and tolerability • Art of caring • Adequate explanations and information by physician • Reductions in wait time • Happy patients rarely sue

40. False Claims • Submission of a claim to the Federal government when it is known to be false • Includes claims for payment from Medicare and Medicaid (ex. UB-92) • Requires certification that the claims are consistent with the law. • If the claim is for services ordered by a physician with whom the hospital has a prohibited financial relationship, it is not consistent with the law. • Any original source can alert the government when a false claim has been made (“whistle blower lawsuit”) • Original source may receive a monetary percentage of the damages. • This is how most cases start • Many states also have state-specific false claims acts. • New laws have made it possible for Medicare and Medicaid to suspend payments pending an investigation

41. Licensure • How critical is licensure anyway? • All individuals working in endoscopy that are required to be licensed should hold a license • If not, what are the ramifications? • Physician • If his license has lapsed, then every procedure he has performed since the lapse would have to be reviewed and potentially rebilled to avoid False Claims liability

42. RNs and LPNs • Law requires licensed personnel. • If unlicensed, compliance issues and possible issues with billing for services provided by unlicensed personnel

43. Patient Protection and Affordable Care Act (PPACA) • Changes occurring that we are really not sure about to date • Emphasis on Quality and payment for quality care • Payment adjustments for conditions acquired in hospitals –hospitals in top 25th percentile of all for certain hospital acquired conditions will be subject to 1% reduction in payments

44. Data Mining • Data mining and health informatics used to identify patients at high risk for readmission • More transparency on health and risk data will increase information available not only to insurers, federal government, etc., but also to attorneys

45. Restrictions on Physician Investment in Healthcare Entities • Reduces Physician owned hospitals by not allowing more to start • Restricts physician investment in health care entities and requires disclosure of that interest to patients. • Physician ownership in manufacturers or GPOs regulated— • Must disclose the investment and terms • Must make the information public • Must let patients know physician’s ownership • Manufacturers have to report electronically to Secretary of HHS, those gifts made to physicians and teaching hospitals and physician ownership in the organization

46. Increased Primary Care Services • PPACA will provide for an increase in primary care services such as those focused on screenings and preventive health services. • General removal of barriers for Medicare beneficiaries to obtain preventive services

47. Electronic Medical Records • Part of new health care law • Been in works for years • Incentives to hospitals and physicians to get electronic medical records for patients in a form that promotes exchange of information, immediate availability of records and information, and theoretically promotes the improvement of individual health care for patients • Financial incentives, bonus from Medicare, target date 2015