1. “Never Events”: Will They (N)Ever Go Away? Maryland Association for Healthcare Quality October 29, 2009 Health Science Institute Larry L. Smith Vice President, Risk Management, MedStar Health, Inc. President, MD-DC Society for Healthcare Risk Management

2. MHA’s Payment Guidelines on Serious Adverse Events Maryland Hospitals agreed that whenever one of these events result in death or serious disability to a patient the hospital would waive payment for any of the stay: –Surgery on wrong body part –Surgery on wrong patient –Wrong surgical procedure –Unintended retention of a foreign object –An air embolism that occurs while being treated –A medication error resulting in death, paralysis, coma or other major permanent loss of function. –A hemolytic transfusion reaction due to administration of incompatible blood or blood products

3. MHA’s Payment Guidelines on Serious Adverse Events In addition, Maryland Hospitals agreed to evaluate on a case-by-case basis whether full or partial payment should be waived for other event that resulted in patient death or serious disability based on: Was the error or event preventable? Was the error or event within the control of the hospital? Was the injury to the patient the result of a mistake made in the hospital?

4. MedStar’s Adverse Event Reporting System What is reported Serious Safety Harm Report –Any event resulting in death or serious harm –Surgery on wrong body part –Surgery on wrong patient –Wrong surgical procedure –Unintended retention of a foreign object –An air embolism that occurs while being treated –A medication error resulting in death, paralysis, coma or other major permanent loss of function. –A hemolytic transfusion reaction due to administration of incompatible blood or blood products

5. Source: Duke University Medical Center Patient Safety – Quality Improvement

7. Preventable Errors I Have Known Wrong: Limb Side of head (neurosurgery) Level spine surgery Patient (cath’ed) Procedure-right patient (bunioinectomy v. foot release) Blood Type Patient Circumcised Test results given to patient (AIDS) Solution used to clean site (100% acetic acid) Drug: – dose –Administration-route Organ(s) transplanted Organ removed Retained: Sponge Kelly Clamp Needle Retractor (14” by 3”) Tip of glove

8. How should we respond when a patient is injured due to error? Disclosure – What? When? Why? Who? Apology or Expression of Regret? To Bill or not to Bill? Discipline or Blamelessness?

9. Disclosure Why? –Right thing to do –Reinforces for staff that transparency is a core value of the organization and its leadership –Risk management issues are secondary, not primary……... “the patient may not sue” What? –The facts as we know them to be When? –As soon as the patient/family is psychologically and physically ready

10. Disclosure Who: –Requires a situational analysis – often best done by – or at least in the presence of - someone with a pre-existing relationship with the patient/family

11. Apology or Expression of Regret? Expressions of regret are appropriate for all unanticipated outcomes Apology is appropriate when the unanticipated outcome was clearly caused by unambiguous error or system failure