Anesthesia Specific Risk Management

1. 2nd Annual Ellison Pierce Symposium Positioning Your ORs For The Future Anesthesia Specific Risk Management Mary Ellen Erlandson, Esq May 18, 2006 3:00-3:30pm

2. In reference to the patients dental state prior to surgery, which is true for your practice? QUESTION: • Thoroughly document dental conditions pre- and post- surgery • Not consistently documented pre- and post- surgery • Only document in patients with poor dentition • Sporadic and varies between practitioners 0 / 10

3. Does your department have an active risk management program in place? QUESTION: • Yes • No • Currently developing • Present, but minimally active 0 / 10

4. Contents • Development of a Risk Management Plan with Attention to Evidentiary Protections • Review of Claims and Other Data to Identify Reporting Events • Develop Reporting Program • Develop Program for Response to an Adverse Event

5. Disclosure and Apology • Documentation – Why Necessary • Anesthesia Risk Strategies 101

6. Development of Risk Management Program • Program should be developed as a component of the hospital’s peer review protected process • Be cognizant of your state’s peer review laws and where the protections lie in designing your program • Patient Safety and Quality Improvement Act of 2005 allows for establishment of patient safety organizations and confidential review of data -not operational until final regulations enacted – ASA will probably be a PSO - -could help with legal protections for anesthesia groups that want to aggregate data from multiple facilities

7. Reporting • Crucial for risk and quality reasons – allows for tracking and trending, identification of where to put your efforts, benchmarking • Crucial for development of proactive strategies to decrease risk • Crucial to know when to do a root cause analysis • Crucial for claims management, especially if captive, and for notification to commercial insurers • Crucial to implement real-time risk strategies when there is an adverse event – can result in prevention of law suit or mitigation of damages

8. Problems with Reporting • Under reporting • Concern will make practitioner look bad • Risk adjustments not usually done in anesthesia reporting so limitations in comparison use • Difficulty if multiple forms are used • Very difficult for a group practice that rotates to multiple facilities

9. Reporting Process • On-line becoming more standard • If on paper, keep uniform across facilities • Make part of culture • Train clinicians when to do real time call to counsel or risk manager for immediate implementation of risk management strategies - don’t wait for written communication --- requires much training on this expectation

10. Reporting Process • Develop reporting guidelines and list of events • ASA is great resource, in addition to ASA Closed Claims Project data • If group uses one system for reporting of potentially compensable events and quality occurrences, risk management and performance improvement staff can identify proper categorization of event and required response

11. Reporting Process • Design process so can complete right in OR area • Provide for all applicable confidentiality protections and legal privileges • Aim for 24/7 - back up systems • AAM requires first report to chief or call team coordinator and then to risk manager when indicated • AAM recognized need for web based reporting – one of our anesthesiologists has worked with company in which AAM has an interest and developed program

12. Response to an Adverse Event • While patient safety is driving force, want to reduce risk on the spot • Develop guidelines and train staff • Require incident supervisor – ASA has good guidelines • Team approach is a must • Regardless of clinician’s experience bring in assistance from anesthesiologist known at facility to enhance trust

13. Response to an Adverse Event • Incident supervisor should designate a record keeper • Incident supervisor should oversee calling other specialists when indicated • Incident supervisor should review anesthesia record and anesthesia note for completeness and accuracy • Incident supervisor should provide support to staff

14. Response to an Adverse Event • Incident supervisor should make sure equipment is sequestered in accordance with hospital policy, when indicated • Incident supervisor should make sure data is printed before any computers are turned off • Counsel or risk manager should be notified before note placed in record, when indicated • Report event in real time when indicated and/or through reporting system

15. Response to an Adverse Event Clinician involved in event should establish relationship with the patient and make arrangements to be at that facility and personally follow the patient throughout the admission or via phone contact when day surgery

16. Disclosure • To patient (and family when applicable and in compliance with HIPAA) • Right thing to do – some believe prevents law suits • Disclosure note is crucial –be specific in documenting what was disclosed and to whom, with date and time • Apologize when indicated without admitting liability – when error is committed and needs to be disclosed, seek advice from legal or risk manager on how to do

17. Disclosure • Just the facts – avoid speculation • Etiology may not be yours to conclude – leave to others when applicable • Let patient know what will be done to care for him • Don’t promise investigation results unless sure that will be shared – others make that decision

18. Disclosure • Avoid finger pointing • If appropriate, do with the surgeon • Answer questions and provide opportunities to discuss in future • If initial disclosure is to family you need to go back and disclose to patient when patient is awake • Focus is not on you, but on the patient

19. Deficient Documentation & Record Maintenance POTENTIAL ADVERSE CONSEQUENCES • Primary one is the potential to alter patient safety and care • Failed Medicare audit with penalties • Non-compliance with JCAHO standards can adversely affect certification, with potential serious financial loss to the institution • Failure to comply with hospital policies, procedures and guidelines can result in alteration of privileges, with resultant reporting to Board of Registration in Medicine and National Practitioner Data Bank

20. Deficient Documentation & Record Maintenance In lawsuits: • Absent or deficient documentation has a huge impact on juries, as does proper documentation – can be dispositive of the outcome • Documentation problems can result in payment in a medical malpractice action, when there is no deviation from the standard of care • Failure to comply with legal, accrediting, and hospital requirements for documentation will all be presented as evidence by the plaintiff in attempting to prove negligence • Absent or poor documentation that resulted in another physician’s treatment decision can form the basis for a medical malpractice action against the recorder • Failures by physicians to document clear instructions for follow-up, even when the physician remembers giving them, have resulted in adverse verdicts – patient’s memories may differ

21. Deficient Documentation & Record Maintenance Alterations • Lose credibility with a jury • Can be readily ascertained by experts - easy to find such experts • Corrections and addenda that are not contemporaneous, especially after a claim or law suit has been filed, are viewed with great suspicion and may be deemed self-serving • Alterations make it extremely difficult to defend a medical malpractice action, even when there may not be negligence

22. Deficient Documentation & Record Maintenance Alterations and late additions after an event have resulted in settlements and large verdicts • 2002 MA settlement of 3.75 million for the death of a 40 year old man allegedly from failure to diagnose an MI – the parties and insurer felt the amount was influenced by admissions by the triage nurse and clinic physician that they changed the records after hearing about the decedent’s death, even though they were originally introduced as contemporaneous records • “The Verdict” • Resulted in a 1999 settlement for suicide in a matter in which there was evidence of a falsified note in the medical record after the death.

23. Deficient Documentation & Record Maintenance “Lost” Medical Records • Violation of duty to maintain • Can result in defense verdict or settlement that otherwise would not have occurred • In Keene v. Brigham and Women’s Hospital, 56 Mass App 10 (2002) the Appeals Court upheld a jury award of $4,108,311.66 against the Brigham, a charitable corporation, in a medical malpractice action alleging substandard care of the plaintiff for neonatal sepsis, which resulted in profound brain damage. Twenty hours of hospital records for the first day of the plaintiff’s life were missing and not produced by the hospital in response to numerous requests and a court order, making it impossible for the plaintiff to identify individual defendants. The hospital could not locate the applicable records and the Superior Court ruled that the plaintiff did not have to prove negligence and proceeded with a trial on damages only for the reason that the hospital was required by law to preserve the records and the plaintiff’s claim was irreparably prejudiced by the loss of the records. The jury returned the large verdict and the hospital appealed, claiming it was subject to the $20,000 charitable cap. The Court disagreed, ruling that the charitable immunity was stricken as a sanction for non-compliance with a discovery order. • Spoliation of physical evidence. A party will be precluded from using any evidence obtained from the negligent or intentional destruction or loss of physical evidence that the party knew or reasonably should have known would be needed for litigation. Kippenhan v. Chaulk Serv., Inc. , 428 Mass. 124 (1998).

24. Anesthesia Risk Strategies 101 • Most risk is from failure to monitor and/or timely respond to a situation, so be vigilant at all times • Promote realistic patient expectations – surgery and anesthesia procedures are not the equivalent of a visit to the barber • Failure to timely respond to patient complaints escalates the situation and makes a small matter become very big in the patient’s perception

25. Anesthesia Risk Strategies 101 • Pay close attention to pre-op record – hard to defend when a medication is given that is listed as an allergy • If you deviate from standard practice in light of unique circumstances, document your thought process • When an artifact is recorded in an electronic anesthesia record, document it was an artifact — otherwise it can look like a failure to respond to an event

26. Anesthesia Risk Strategies 101 • Thoroughly document dental condition pre and post surgery • Informed consent is a process-don’t do as the patient is being wheeled into the room • Recognize the risks of MAC – be vigilant, avoid over sedation and be quick to resuscitate

27. Anesthesia Risk Strategies 101 • Be vigilant for signs of spinal/epidural hematomas and inform staff and patient of need for immediate notification of related symptoms, when applicable • Pain clinics, office-based anesthesia—document your phone calls with patients in the medical record, including at night and on weekends

28. Anesthesia Risk Strategies 101 • Stay abreast of the standard of care for use of ultrasound for blocks and line insertion • Prevent nerve injury suits via meticulous attention to positioning, documentation of this, including periodic re-checks, and if there is an injury, follow-up and refer to a specialist, when indicated

29. Anesthesia Risk Strategies 101 • Document warnings not to drive in the medical record • After an event, do not talk about it to anyone other than your attorney or as part of the peer review process • There’s a reason for the time out process – it is next to impossible to defend wrong part or procedure cases

30. Anesthesia Risk Strategies 101 • It is next to impossible to defend when records have been altered • Establishing and maintaining a caring relationship with the patient assists in decreasing the chances of a law suit • Always respond to patient complaints in a timely fashion • Do not hold up a stat C-section

31. Anesthesia Risk Strategies 101 • There’s a lot to be said for the military and aviation practice of repeating oral orders • Medication administration safety – beware that most reported errors in Closed Claims Project were with succinylcholine and epinephrine • If a known risk of a treatment can be catastrophic, even if rare, include it in the consent form - ex. Death, paralysis, seizure, brain damage

32. Anesthesia Risk Strategies 101 • If you let EMT’s do intubations as part of their training, make this a part of the consent process • Review pre-op tests and develop system to indicate this was done, such as checks, recording of results