Petra S. Berger PhD RN, CPHRM Healthcare Risk and Patient Safety Consultant

1. Fundamentals of Risk Management & Patient Safety for Community Health CentersOn-site RM Training Seminar 2008 Petra S. Berger PhD RN, CPHRM Healthcare Risk and Patient Safety Consultant pberger@rmpsi.com - Phone: 517–281-7816

2. Learning Objectives, 4 Modules • Demonstrate understanding of risk issues inherent in providing community health center services • Explain leadership tools & methods related to: • Proactively identifying risk concerns, and • Responding from the risk control, quality, and patient safety perspective • Recognize the critical role played by patients and families regarding high risk aspects of patient care • Evaluate own learning gain regarding principles and practice of proactive risk management

3. RM 101Overview, Risk & Quality Management • What is “Risk management” @ CHCs • D & O (Fin., Reg., Contracting)\Property\Gen. • Employment Practice \Workers’ Comp • Professional Liability (=Clinical RM)& FTCA • Concepts in Professional Liability • Risk identification & reporting • Clinical Liabilityreview • Risk intervention: immediate & QI referral • Ten common (clinical) risk issues at CHCs • Staff & Leadership roles

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

5. CORE PURPOSEof RISK MANAGEMENT S T O PADVERSE OUTCOMES • Preventing patient harm • ProtectingtheHealthcare facilityfrom • the chaos of adverse outcomes • litigation and financial loss • patient and community distrust • ProtectinginvolvedProviders

6. QUALITYOUTCOMES & RISK ASPECTSon O N E Quality Management Platform • Patient Satisfaction • complaint management • Clinical Effectiveness • missed pediatric meningitis • Policies & Protocols • informed consent\after hours coverage • Regulatory compliance • NPSG Implementation expectations • Efficiency, UR, Cost control • omitted care elements

7. 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 FTCA CLAIMS DATA

8. Liability Question: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 defendants failed to exercise ‘reasonable’ care, and adherence to established clinical standard (expert testimony) InjuryproximatelyCAUSED by breach(foreseeable)

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

10. Case: Seizure & Respiratory arrest • 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 • Patient experienced a grand mal seizure during the procedure and had a respiratory arrest. Intubation was delayed and the patient suffered permanent brain damage.

11. Immediate RISK INTERVENTION PATIENT status? • Incident management >> mitigate liability & loss • Skilled, fact-based investigation • No premature conclusions • Timelines and event analysis (RCA) • Sequestering evidence • Privileged & protected information • MEDICAL RECORD AS CORE EVIDENCE

12. Alleged ‘Negligence’ = ‘Process Failures’Duty?Breach? Injury? Damages? A.Clinicstandardsof care = ‘duty’ • Monitoring, patient medication & document • Test result reported & signed off by provider • Treatment plan updated, w/ or w/out change • Reliablemedical record system @ hand off with external medical providers and hospital B.[CRNA & hospital standards of care]

13. Purpose & Type of Risk OutcomeMonitoringRisk identification – Evidence – RCA – Q.I • Event \Claims review:Root Cause analysis • Incident reporting - adverse single event (1 - 30%) • Omitted or delayed diagnostic workup • Adverse medication event – outcome or process • Patient or family complaint; Feedback • Staff feedback & surveys • ‘Risk reporting marathons’ = snapshots • Occurrence Screens –global events • Missed appointments; Waiting times • Optimum Electronic information system

14. Procedures ofIncident reporting - How • H o w to report in writing (incident report) • Fact based, objective, concise, w/ timeline • not: “gave wrong med” • No speculation, opinion, blaming • Persons notified: RM, provider, family • No copy, no staples, no MR placement\mention • Medical record documentation • Date\time, pt.’s clinical status, provider actions • Only patient-pertinent information; using quotes • NO PERSONAL NOTE KEEPING

15. Type of Risk Process Monitoring • Monitoring results – Quality audits per criteria • Adherence to Anticoagulant guidelines • Misfiled and non initialed test results • Medical records documentation • Regulatory & Professional standards • National Pt Safety Goals:Patient identification; Verbal orders – Hand off @ transition – Infection control – Medication safeguards: reconciliation, high alert meds – Critical lab value reporting – Patient involvement in care – Suicide assessment

16. Risk vs. Quality measures: need both? Sample RISK MEASURES • Patient complaints re: non response to adverse effects of new medication & patient harm • Insulin medication error and patient harm • Missed diagnosis: meningitis, age 2 Sample QUALITY MEASURES • Patient satisfaction trends • Diabetic HgbA1C baseline & improvement • Pediatric Immunization rates

17. Culture of Patient safety • Transparency • Errors are discussed openly between colleagues incl. lessons learned (under protection of confidentiality) • Non – punitive reporting • Medical provider who missed diagnosis does not automatically get blamed; instead, • Objective RCA takes place; corrective action plans are jointly developed

18. High Reliability Organizations (HROs)Reason J. Human error: models & management. BMJ. 2000;320:768-770 • Acknowledgment of high-risk, error-prone nature of organization’s activities, AND commitment to safety • A culture of safety in which individuals can draw attention to potential or real hazards, barriers, gaps, or failureswithout fear of censure • Capacities to detect unexpected threatsAND contain thembefore they cause harm • Attentiveness to error prone processes facing workers at the frontline

19. Risk & Quality Leadership Roles • Strategic Risk & Quality planning based on Risk identification & prioritization • Policies & Protocols, Guidelines • Implementation of processre-design & monitoring through Q. I. • “Knowledge transfer” to create internal inventory of patient safety practices • Electronic information systems: • Baselines & progress made

20. Why & How internal Policy compliance? • Policy = standard by which care is judged • Difficult todefend internal policy/procedure: • Ifnot congruent w/ evidence-based guidelines • If local practice not congruent w/ policies • If no allowance made for clinical judgment to vary from protocol • Iflevel of detail & requirements of local policies are difficult to follow • Ifnot adjusted & monitoredw/practice change

21. Risk aspect #1: Patient communicationRisk aspect #2: Provider Team Communication • PATIENT COMMUNICATION • Patient interview & Treatment planning • Health instruction – literacy – interpreters • Patient feedback & complaints • PROVIDER TEAM COMMUNICATION • Hand off @ transition points • Inter-provider relations & teamwork

22. Risk aspects #3: The Medical RecordRisk aspects #4: Clinic Operation & Flow The Medical Record • Content & What To Document • Legal aspects: alterations, legibility, etc. • Confidentiality & Release of information Clinic Operation & Flow • Continuum of care (62% claims)vs. fragmentation • Diagnostic test tracking • After hours coverage; telephone triage

23. Risk aspects #5: Clinical PracticeRisk aspects # 6:Medical Mis-Diagnosis • Medical evaluation & Treatment • Use of Practice Guidelines • Complications, preventable • OB,Surgical procedures, Emergency Most frequent Mis-Diagnosis • Cancer – Myocardial infarction – Stroke – Meningitis – Acute abdomen – Fractures – Prenatal risk factors – Infections

24. Risk aspect # 7:Medication SafetyRisk aspect #9:Medical Provider Quality Adverse Medication events related to phases: • Product labeling, packaging, nomenclature • Prescribing:Indications, interaction, off label • Dispensing: compounding,distribution error • Administration: wrong drug/ dose/ route • Medical Provider Quality & Peer review • Review mechanism - who and how • Data sources: 1) Quality 2) Risk

25. Risk aspect #8: Clinic Staff performanceRisk aspect #10:EQUIPMENT – EOC – EMERGENCY • Staff qualification & orientation • Clear directives/protocols & Training • Staffing levels & Material resources • Emergency Preparedness • Crash cart (incl. pediatrics) & checks • Behavioral • Building /weather

26. Risk Aspects of Clinic Services & The Medical RecordRM 102

27. Risk Aspects of Clinic Services • MEDICAL RECORD DOCUMENTATION • Confidentiality and release of information • DIAGNOSTIC tracking, follow up, referrals • MEDICAL EMERGENCY response • Safe MEDICATION management • STAFF QUALIFICATION • PROVIDER COMMUNICATION

28. Blunt End: Org. ‘Systems’ Sharp end:Providers Culture of Safety – dual focus of RCA:(1 – 99%)Systems & Providers(1 – 99%) Organizational Factors: Clinical protocol; Resources (Staff, Edu);established flow, Clinic Operation Communication Factors: Patient & Family relations; Inter-Provider teamwork Human Factors: Knowledge & Skills requirement; Cognitive limits (memory, fatigue, distraction, confirmation bias)

29. Risk aspects #3:The Medical Record - Content • Medical history, comprehensive & in ink • Diagnosis & Currentmedical problem list • Double check @ each visit before chart returned • Lab work, other diagnostic results • Allresults initialed by medical provider: QC • Patient notification documented: QC • Current medication log in ink(herbals, OTC) • Double check @ each visit before chart returned • Cross off old info w/single line, explain i. e. D/C

30. What To Document – Concurrent • Notification: Referrals & consultations • Patient’s response to intervention • Instruction to patient /family,in writing • Questions addressed • Correspondence to & from pt / family • Informed consent / refusal DISCUSSION • Patient's failure to keep appointments • All entries are dated & signed /initialed

31. Guess that Prescription • Handwritten prescriptions are often misread • In the prescription above, the drug name “Avandia” • was incorrectly interpreted as Coumadin. • http://www.medscape.com/viewarticle/557740?src=mp • From American Journal of Health-System Pharmacy

32. Risk & litigation aspectsMEDICAL 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’

33. Alteration of Medical Records • A recent case in Ohio involved a physician who “whited out” the following phrase: “I do not feel that a biopsy is necessary at this time” • And replaced it with: “The patient does not want a biopsy at this time” • Jury returned a verdict for $3 Million in an otherwise defensible case ! • Destruction of records is equally detrimental

34. Policy developmentConfidentiality & Release of information Release of information • verify request authenticity • Incapacitated adults; Minors • Families of deceased patients • Law enforcement officials /agencies • Employers and other third parties Protecting Confidentiality • Leaving message on answering machine /at work • Sign in sheet at front desk & privacy • Privacy re: staff conversation /phone calls, reception area • Faxing protocols

35. Faxing documents & Confidentiality • What not to fax: HIV results, mental health records • Avoid sending to general locations, e.g. mailrooms • Request that the recipient acknowledge receipt • Include confidentiality statement on fax cover sheet • If intended recipient does not receive fax because of incorrect dialing, fax request using incorrect fax number & request return or destruction of material

36. Legibility Omissions Treatment Rationale Diagnostic Follow Up Abbreviations Corrections No White out No Write over Late entries Correct patient’s chart Accurate content Timely notations Objective and factual Continuity No finger pointing Avoid adjectives; instead, quote directly Signature verifiable Risk relatedDocumentation Audit Criteria

37. Risk aspects #4:Clinic Operation & Flow • Continuum of care (62% claims) • 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

38. Monitor for action steps of test tracking: • Test ordered by med. provider & log • Request form created - copy retained • Test completed - patient compliance? • Results received & logged in / ck log • Results reported to provider (same day for abnormal /critical results) • Patient notification documented

39. Risk aspect #2:Provider Team Communication • Half of communication breakdowns occurred as patients were HANDED OFF @ TRANSITION POINTS between providers (verbal & written) • 2/3 of serious medical errors occur @ transition points (TJC reports) • Inter-provider relations& teamwork

40. PROVIDER COMMUNICATION & MEDS PHARMACIST function • Legible prescriptions for Pharmacist • Including indications / purpose and/or diagnosis • Explicit directions: “stop Lipitor, start Zocor” • Include all of the following components in order: dose – strength – units/metric – route – frequency • Guarding against LASA drugs: • Restoril ordered, Remoran dispensed(Antidepressant) • Patient also taking another anti-depressant • Contact pharmacist about error & join in RCA task (26)

41. PROVIDER COMMUNICATION & MEDSNURSES and Verbal Orders • Restricting Verbal Orders – Limit to Emergencies • Speaking slowly & deliberately • Specific indications /purpose provided for all medication, including for “as needed” P.R.N. • “Read back” verification, with spelling of drug name as necessary • Caution w/ sound alike and high alert drugs • Nurses to ask for clarification of illegible or unclear orders; eliminating second guessing

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

43. Clinical Protocols Documenting MEDICATION MONITORING • Cholesterol – liver panel, lipids • Anticonvulsants – drug levels, liver, CBC • Chronic anti-inflammatory /arthritis meds • kidney function, esp. geriatric patients • Anticoagulant • Warfarin / Coumadin – INR, PT, PTT

44. Anti Coagulant Monitoringheparin – warfarin – other anticoagulants • Warfarin dispensed by pharmacy per Patient • Clinical pharmacist resource support • Education about anticoagulants for prescribers, nurses and pharmacists • Patient /caregiver education includes • reasons and benefits of therapy • follow-up monitoring /compliance • dietary restriction; potential drug interaction

45. ABBREVIATIONS “Do Not Use” list • - NOT: U (unit) or IU (international unit) • - NOT: Q.D., Q.O.D. • - NOT: MS, MSO4, MgSO4 • - NOT: Trailing zero (X.0 mg)- write X mg • -DO use leading zero (NOT .X mg) instead • Do write 0.X mg

46. Medication security • Manage controlled substances • Manage sample drugs • Storing & securing (authorized access; log in & out) • No prescription pads in exam rooms • Monitoring expiration dates • Dispensing function • log in & out; lot # • Recall function

47. Protocol: Prescription refills • Medical records reviewed prior to renewals for • Needed labs, • Most recent & next appointment (missed appt?) • Medication renewals limited to patients previously seen by medical provider in clinic • Pain med renewal ONLY by Medical provider • Document: • Medication name, dose, amount, date of last appointment, completed labs as applicable

48. Patient knowledge: Hx, liver / kidney disease, multi prescribers, OTC Knowledge of proper dose, interaction, contraindications Similar drug names High risk drugs & inadequate warning labels / unclear labels Verbal orders Including purpose on med order & PRN Educating patients Monitor use by patient & response Prescriber Access to Drug Information Pharmacy Resources Preventive actions Associated with Medication Safety Source: Cohen, Current Issues in Medication Safety, Institute for Safe Medication Practices, 1998. www.ismp.com

49. Risk aspect #10: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 • Building /weather (power outage; fire)

50. Pediatric office emergencies • “…occur more commonly than perceived by family physicians; most offices not well prepared • Obtaining training in pediatric emergencies, performing mock ‘codes’ to assure office readiness can improve actual handling of pediatric emergencies • Common airway emergencies include foreign-body aspiration and croup.” Source: Wheeler, Kiefer and Poss. American Family Physician, Pediatric Emergency Preparedness in the Office, June 1, 2000.