“Never Events”: Will They (N)Ever Go Away?

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

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

7. 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 Preventable Errors I Have Known • 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