Risk Management: Best Practices to Optimize Prevention

1. Risk Management: Best Practices to Optimize Prevention All-Grantee Meeting, Washington D.C. June 24, 2008 Petra S. Berger PhD RN, CPHRM Healthcare Quality, Risk & Patient Safety Consultant pberger@rmpsi.com - Phone: 517–281-7816

2. Learning objectives • Discuss concepts and tools of risk management,patient safety and integration with quality improvement • Describe ten clinical risk factors (process & outcome)common @ Health Centers, along with strategies of risk prevention & control

3. VITAL BRIDGE OVER TROUBLED WATERS QUALITY MANAGEMENT Patient Safety= Q. I.Risk Management = identify risk – respond – prevent

4. DIVERSE QUALITY & RISK GOALSon O N E Platform • Efficiency & Cost control • Access to care; Referral mgt • Patient Satisfaction • Clinical Effectiveness • Regulatory compliance • Patient Safety vs. error, delay, omission

5. PURPOSE x 3:RISK MANAGEMENT • STOP & PREVENTHARM = Patient Advocacy • PROTECTthe Healthcare facility from • litigation and financial loss • patient and community distrust • PROTECTinvolved Providers & Staff

6. Claims Occurrence Error in Diagnosis 30% Treatment related 21% Medication related 10% OB Related 22% Surgical Procedures 6% Claims Location Health Center 65% Hospital 35% Health Center Trends and Issues

7. Liability Analysis:Allegation of NEGLIGENCE Duty – based on existingprovider-patient relationship; To exercise degree of care that a reasonable & competent provider would exercise under same orsimilar circumstances Breachof Duty Plaintiff must show that defendant failed to exercise ‘reasonable’ care, and adherence to established clinical standards (expert testimony) Injuryproximately CAUSED by breach(foreseeable)

8. Case Example: Medication Monitoring • 58-year-old male patient is scheduled for a major diagnostic procedure at the hospital where a certified registered nurse anesthetist (CRNA) provides conscious sedation. • A required copy of the clinic medical record is sent preoperatively. No mention is made of the patient’s seizure medication.

9. Case Example:Medication Monitoring • No recent blood level had been obtained related to the patient’s seizure medication. • Patient compliance with the medication was unknown. • The patient underwent scheduled procedure • The patient experienced a grand mal seizure during the procedure and had a respiratory arrest. Intubation was delayed and the patient suffered permanent brain damage.

10. Liability Analysis Duty?Breach? Injury? Damages? A.StandardofCare - prelude to Q. measures • Monitoring patient medication & document • Test result reported to & signed off by provider • Patient notified & documented • Treatment plan updated, w/ or w/out change • Medical records accurate & comprehensive B.CRNA & hospital standards of care

11. PRIMARY STRATEGY OF RISK CONTROLRisk Identification & Analysis • Event or Claims review: Root Cause analysis • Incident reporting - adverse event (1 - 30%) • Omitted or delayed diagnostic workup • Adverse medication event • Patient or family complaint or feedback • Staff feedback & surveys • ‘Risk reporting marathons’ = snapshots • Occurrence Screens • Missed appointments; Waiting times

12. Risk process #1: Patient communication • Patient assessment & interview • Treatment planning & Goal contracting • Non compliance – Termination of care • Informed Consent / refusal • Health instruction – literacy – interpreters • Explain back / read back • Patient feedback & complaints

13. Informed Consent – or refusal • Used whenever an invasive procedure is proposed that carries a risk of harm • Medical Provider has discussion of the • Procedure and benefits (P) • Risks of the procedure ( R) • Alternatives to the procedure (A) • Questions asked (Q) • What should be documented? • Consent process, any questions answered

14. Complaints & Regulatory requirements • CMS CoP - Infraction of patient rights IF • Evidence of non responsiveness • Non-resolution of complaint or grievance • Complaint = verbal, informal, promptly resolved • Grievance = req. investigation; 7d TAT; appeal • Develop P&P w/ time frame & implement • Inform patients on how to report a concern • Use grievance committee as needed ‘Pt Complaints & Grievances–No Leeway for Lapses in Resolution’ RMPSI IE 08/13/07

15. Complaints:Preventive factors • Organizational Factors • Culture of Patient centeredness • Certain care processes that invite complaint • Medical Provider & Staff Factors • Communication skills; Clinical skills • Time pressure, fatigue, frustration • Patient Factors • Difficulty understanding; feeling abandoned • Stress of diagnosis, finance, grief, fear • Somatizing; non adherence

16. Disclosure – What and How • Known Facts – s/p investigation • Same as documentation, medical record • SUMMARY: Sequence of events • SUMMARY: Discovered Cause(s) per evidence • Clinical results & effects on patient • “Corrective actions taken” – no staff names • Empathy & concern expressed topatient • Apology if error made and harm caused

17. Risk Process #2:Organizational & Provider Communication • Flow & Availability of Organizational Information (P & P, Staff Educ., Pt. Info., MR) • Inter-providerteam relations; conflict mgmt • Communication breakdowns occur during hand-off at transition points from one provider to another --verbal & written • Communication barriers are cause of 2/3 of serious medical errors (JC reports)

18. Risk process #3: Litigation review ofMEDICAL RECORD DOCUMENTATION • ?Treatment rationale; ?Diagnostic Follow Up • Omissions \ delays in needed care • Contradictions; confusion between provider • Finger pointing; subjective statements • Corrections: Write overs & White out • Illegibility & error prone abbreviations • Altered Medical Records; “Late entries” • Do not mention‘incident report completed’

19. Risk process #4:Clinic Operations (systems) • Continuum of care(62% claims) & F. U. • vs. Fragmentation across settings • Referral management • Diagnostic test tracking • After hours coverage & Telephone triage • Access to care & No shows • Missed Appointments: • Tickler system, patient return for annual exams, FU tests, preventive screens

20. Risk process #5:Clinical Practice • Medical evaluation & Treatment • Complex medical conditions: Cancer, Co-morb. • Medication therapy; Pre-natal risk factors • Pre- and post-surgical patient evaluation • Use of Practice Guidelines: decr. variability • Asthma, Anticoagulants, Stroke, Pediatric Fever • Guarding against Complications (preventable) • OB,Surgical procedures, Emergency Sample protocols can be accessed at http://www.guideline.gov/

21. Risk Outcome # 6:Diagnostic Error, Delay, Oversight Most frequent • Cancer – Myocardial infarction – Stroke – Meningitis – Acute abdomen – Fractures – Prenatal risk factors – Infections post surgical Factors • Atypical signs & symptoms • Incomplete or inaccurate information about medical history; many co-morbidities • Insufficient diagnostic work up; Delays

22. Confirmation Bias Paris in the theSpring Once we decide that we “know” what something is, we tend to exclude or neglect information that may be contrary to our original perceptions

23. Diagnostic Test tracking per Flowchart & Checklist • Test ordered by med. provider & log • Request form created - copy retained • Test completed - patient compliance? • Results received and logged in / ck log • Results reported to provider (same day for abnormal /critical value results) • Patient notification documented

24. Risk process # 7:Medication Safety Adverse Medication events related to phases: • Product labeling, packaging, nomenclature • Prescribing: Indications, interaction, off label • Antibiotics, anticoagulants, narcotics, cardiovascular, steroids • Dispensing: compounding,distribution error • Administration: wrong drug/ dose/ route Source: National Coordinating Council on Medication Error Reporting and Prevention –www.nccmerp.org

25. Risk process #8:EQUIPMENT – EOC – EMERGENCY RESPONSE Emergency protocols implemented and monitored for • Medical emergency • 1 BLS trained staff on-site at all times • Crash cart (incl. pediatrics) & checks • Behavioral emergency • Building /weather (power outage; fire)

26. Behavioral Emergencies • OSHA cites healthcare facilities under general duty clause for failure to prevent patient violence against healthcare workers • Medical providers & staff exposed to potentially dangerous confrontationsincl. ill-intended trespassers • Security audits needed to reveal problems • Address potential risk of violence Source: ECRI, HRC Risk Analysis – Overview: Managing Risks in Physician Practices, July 2003.

27. EQUIPMENT LIABILITYMonitoring to protect against risk • THE EQUIPMENT WAS: • appropriate for procedure • used in reasonable manner (vs. ‘user error’) • inspected for obvious defects prior to use • on regular preventative maintenance schedule • All staff using the equipment were adequately EDUCATED AND TRAINED • Procedures developed & staff trained onhow torespond in case ofequipment failure

28. Environment of CareInfection control & Hazardous Material • Develop, implement & monitor an Infection control (I.C.) plan pertinent to pt population • Involve I.C. professional • Protect staff, providers, patients, and visitors fromhazardous material – BBP • Trend I.C. events & take corrective action

29. Risk process #9:Clinic Staff performance • Staff qualification & orientation • Qualified staff • Clear, written directives • Job-tailored Training, initial & ongoing • Human factorremedies: distraction, memory overload, fatigue, confirmation bias • Performance feedback (data based) • Staffing levels & Material resources

30. Accountability & Just Culture • Imperfect behaviors, lapses, oversight • Inadequate realization of risk, inadequate diligence – systems barriers & gaps? • At-risk behaviors -- e.g. shortcuts • Intentional conduct that unintentionally increases risk: non compliance: double check • Reckless behavior • Recognition of high risk but risk is disregarded • Intentionally hazardous acts

31. Credentialing FocusInitial vs. Re-credentialing • INITIAL: Licensure verification, Referencesre: privileges Qualifying education & experience, NPDB ck Provisional credentialingandProctoring • RE-CREDENTIALING: need Quality & Risk data • Whichmeasures to select & how to obtain • What to do with quality & risk information

32. Risk process #10:Provider performance, MS • Quality measures = trending • Service Volume – Guideline adherence • Documentation – Prescription review • Peer Review = Risk events • Adverse outcomes;Inadequate processes • Complaints; Disruptive behavior • Proctoring & Provisional Credentialing

33. Credentialing Files:Risk & Quality section • Credentialing files organized into 2 sections • Top Confidential, keep secured • Separate Quality file per practitioner • Sect. A - Quality datatrends Guideline adherence; MR Documentation • Sect. B - Risk data: events & practice pattern P.C.E. = Potentially compensable event Pt. c/o; RCA results; Peer review reports

34. Medical Record “Pertinence” Review • Adequate health history & physical exam as pertinent to pt. presentation & complaint • Clinical risk factors ID’d on Tx plan • Conclusions & Dx supported by findings • Diagnostic & therapeutic orders supported • Patient /family involved in Tx plan • Progress notes indicate continuity of care • Consulting providers support Tx plan • Abnormal findings addressed

35. California Dept. Managed Health Care (DMHC) Fines Kaiser Health Plan for Lack of Quality Oversight (7/07) DMHC observed that of 228 peer-review files, one-third were deficient, such as • Not handling quality concerns promptly • Not fully considering a physician’s complaint history in evaluating peer-review matters • Not carrying out corrective actions HRC Alerts at http://www.ecri.org

36. External Peer Review • Purpose • Baseline data \proctor role \SE case review • Contract w/ external qualified physician • Designate external MD as official member of peer review committee of requesting facility • A contract protects MD reviewer under HCQIA • MD reviewer stays anonymous & unidentified • MD may clarify questions re: findings, BUT: • External reviewer is adjunct to internal peer review decision; NOT involved w/ investigation