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

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

2. Learning Objectives • 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

3. DefinitionsRisk Management & Liability Coverage • What is “Risk management” @ CHCs • Dir. & Officers: Financial, Contracting • Employment Practice, Workers’ Comp • General Liability: Property etc. Concepts in Professional Liability • Risk identification & reporting • Clinical Liabilityreview • Risk intervention: immediate & QI referral

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 • ProtectingHealthcare facilityfrom • 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 diagnosis • Policies & Protocols • after hours coverage • Regulatory compliance • informed consent • Efficiency, UR, Cost control

7. Risk & Quality Leadership Roles • A culture of safety in which individuals can draw attention to potential or real hazards, barriers, gaps, or failureswithout fear • Non – punitive reporting • Strategic Risk & Quality planning based on Prioritization • Implementation of practice guidelines and procedures through Monitoring and Q. I. • “Knowledge transfer” of patient safety practices

8. 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

9. 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)

10. 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.

11. 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.

12. Immediate RISK INTERVENTION • PATIENT STATUS? • Medical Record As Core Evidence • Privileged & protected information • Fact-based investigation • No premature conclusions • Timelines and event analysis (RCA) • Sequestering evidence

13. Alleged Negligence:Duty? Breach? A.Clinicalstandardsof 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]

14. P o l i c y & P r o c e d u r e s: Standards by which Care is judged • Difficult todefend policy & procedure: • Ifnot based onevidence-based guidelines • If no allowance is made for clinical judgment to vary from protocol • If local practice not the same as policies • If not monitored for adherence

15. RISK IDENTIFICATION • Generic screens: waiting times, no show rate • Incident (or occurrence) reporting(1 - 30%) • Omitted or delayed diagnostic reporting • Adverse medication event –outcome /process • Patient or family complaint; Feedback • Staff feedback & surveys • Risk reporting marathons • Electronic information system

16. Procedures ofIncident reporting • H o w to complete incident report • Fact based, objective, w/ timeline • No speculation, opinion, blaming • not: “gave wrong med” • Persons notified: RM, provider, family • No copy – no staples – no mention, MR placement • Medical record documentation • Date & time, provider actions • Patient’s clinical status; quotes not adjectives • NO PERSONAL NOTE KEEPING

17. Risk vs. Quality measures: need both Sample RISK MEASURES • Patient complaints • Misfiled and non initialed test results • Missed diagnosis: Cancer • Insulin medication error and patient harm • Adherence to Anticoagulation guidelines Sample QUALITY MEASURES • Medical record documentation audits /criteria • Diabetic HgbA1C baseline & improvement • Pediatric Immunization rates

18. TJC: National Pt Safety Goals • Patient identification • Verbal orders • Hand off @ transition • Medication reconciliation • Critical lab value reporting • Patient involvement in care • Suicide assessment

19. 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

20. Risk aspects #3: The Medical RecordRisk aspects #4: Clinic Operation & Flow The Medical Record • Chart 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

21. Risk aspects #5:Clinical PracticeRisk aspects # 6:Medical Mis-Diagnosis • Patient assessment & monitoring • Treatment & Use of Practice Guidelines • Medication prescription practice • Complications, preventable • OB,Surgical procedures, Emergency visit Most frequent Mis-Diagnosis • Inadequate medical history & physical exam • Insufficient diagnostic work-up • Incorrect interpretation of diagnostic tests • Incomplete follow-up

22. Risk aspect # 7:Medication SafetyRisk aspect # 8:EQUIPMENT – EOC – EMERGENCY Adverse Medication events related to phases: • Product labeling, packaging, nomenclature • Prescribing:Indications, interaction, off label • Dispensing: compounding,distribution error • Administration: wrong drug/ dose/ route • Emergency Preparedness • Crash cart (incl. pediatrics) & checks • Behavioral • Building /weather

23. Risk aspect #9: Clinic Staff performanceRisk aspect #10:Medical Provider Quality • Staff qualification & orientation • Clear directives & protocols • Orientation and Training • Staffing levels • Material resources • Medical Provider Quality & Peer review • Review mechanism – why, who and how • Data sources and Measures • Quality indicators • Risk indicators and events

24. Risk Aspects of Clinic Services I

25. High Risk Clinic Service Aspects – I • Diagnostic ordering and test tracking • Patient & Family Communication • Informed consent and refusal • Telephone triage, After hours, No shows • Patient satisfaction & complaints • Health Literacy • Non compliance • Termination of Care

26. Risk aspect #4:Diagnostic test tracking & QC audits • 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

27. Risk aspect #1: Patient communication • Patient assessment & interview • Treatment planning & consent • Conflict resolution; Non compliance • Termination of care • Health instruction – literacy – interpreters • Explain back / read back • Patient feedback & satisfaction • Complaint management

28. Medication compliancePATIENT COMMUNICATION • Medical literacy & English proficiency • Lay language • Validated understanding • Hearing, vision limitations ? • 50% non-adherence to prescribed meds • 8.4 mio not taking hypertension meds

29. Why Do People Sue? • Study of law suits against a large medical center indicated Problematic Relationships: • Perceived desertion of the patient • Devaluing patient and/or family views • Poorly delivering health information • Failing to understand the perspective of patient and/or family

30. Informed Consent • Used whenever an invasive procedure is proposed that carries a material risk of harm • Need to have a 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

31. Informed Refusal - signed • Should be obtained whenever refusal to have a test or procedure done may have adverse results – related to index of suspicion • Examples • Mammograms • Chest or other x-rays • Cardiac work-ups • Lumbar punctures

32. Telephone triage & Legible Documentation Using protocols adopted by medical staff, or direct consultation w/ med. provider • Name of Caller & purpose of call • Advice & orders given (prescription refills) • Follow-up instructions • Date, time, AND initial of provider • Review through Q.I. process • Based on criteria of clinical protocols

33. Telephone communication • Document phone calls incl. AFTER HOURScalls, in the medical recordif the following was discussed: • medical symptoms, new or continued • abnormal test results reported • medical advice offered • questions about medical treatment • prescriptions provided

34. Missed appointments – No Shows • Tracking high-risk patients who miss scheduled appointment • Pending diagnostic results? • Documenting all notification attempts • Include medical implication of missing appointments • If worsened outcome possible, a certified letter is sent, with copy & receipt in medical record

35. Risk ID through Patient Complaint • Categorize types of complaints • Prioritize by severity & risk level • Establish who isresponsible for responding to the complaints • Log and trend complaints & resolution • Address systems issues through P.I.

36. Risk-related Inventory Reasons for Care Termination • Group A • 1. Repeatedly missing appointments w/out prior notification • 2. Disagreement over treatment recommendations • 3. Non-adherence /non-cooperation w/ treatment plan • Group B • 1. Verbally disruptive and hostile behavior toward medical provider and/or staff [by patient or family /caregiver] • 2. Threatening behavior toward medical provider / staff • Group C • 1. Noncompliance with office policy re: prescriptions • Group D • 1. Delinquency on bill payments

37. Termination of Care Solution of ‘last resort’ • Patient given notice of termination • Evidence of certified letter in chart • Patient given reasonable amount of time in which to obtain alternative care • Usually thirty days • Patient given assistance in obtaining alternative care • e.g., a list of appropriate potential providers

38. Perhaps not now -- Termination of Care • During treatment for an imminent or unstable medical condition • Mental health disability if yet untreated • in process of medical workup for diagnosis • Pregnant patient, approx. last trimester • Pregnant patient approx. last 2 trimesters if high risk • Patient in immediate postoperative stage • Precaution w/discrimination issues, e.g. HIV • Remote area and lack of alternate providers

39. Risk Aspects of Clinic Services II

40. High Risk Clinic Service Aspects – II • Staff communication & Human Factors • Credentialing, Privileging, Peer review • Clinical risk factors in Perinatal, Surgical, Behavioral Health, and Dental Services • Emergency Response

41. 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

42. Risk aspect #9:STAFF PERFORMANCE • Staff qualification & orientation • Clear directives/protocols & Training • Staffing levels & Material resources • Human factorremedies: distraction, memory overload, fatigue, confirmation bias • Provide Performance feedback

43. Human Factor:Patient safety Ownership & Just Culture • Imperfect behaviors, lapses, oversight • Inadequate realization of risk, poor risk awareness, inadequate diligence – systems barriers & gaps? • At-risk behaviors -- e.g. shortcuts • Intentional conduct that unintentionally increases risk of harm: policy non compliance re:double checks • Reckless behavior /questionable moral judgment • Recognition of high risk, BUT risk is disregarded;commission of intentionally hazardous acts -- cause violation of trust; e.g. alteration of medical records

44. Quality & Peer review:Clinical PracticePattern • Medical evaluation & Treatment • Complex medical condition:Cancer, Co-morbidities • Medication therapy • Pre-natal risk factors • Pre-, intra- & post-surgical Tx & evaluation • Use of Practice Guidelines: decrease variability • Asthma, Anticoagulants, Stroke, Pediatric Fever • Complications, preventable • OB,Surgical procedures, Emergency Sample protocols can be accessed at http://www.guideline.gov/

45. Clinical Protocols w/ Risk Focus • Pre natal risk assessment & OB practice • Fever in Children (ACEP) • Stroke • Chest pain • Abdominal pain • Anticoagulant Management • Sample protocols can be accessed at http://www.guideline.gov/

46. Pain assessment: a diagnostic Key • Assessment(Pain & Headache) & DOCUMENT • Location and Radiation (All locations) • Onset – Duration - Frequency • Severity (per scale 1 – 10) • Pain Quality or Type (pressure, cramps etc.) • Last dose of Pain medication / frequency • Recent Health history, events, procedures • Other S & S: weakness, numbness, neck pain, stiffness, photophobia, diaphoresis, N-V, SOB (LMP)

47. 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

48. Pre-natal risk assessment • PRE NATAL ASSESSMENTper protocol (standardized) • Consistent documentation, prenatal visits • Prompt high risk referral • PRE NATAL MED. RECORD TO HOSPITAL @ 36 wks • Maternal conditions: hypertension – prior PE – diabetes – drug & alcohol – antepartum hemorrhage – cardiac risk factors http://www.rmf.harvard.edu/; AAFP standards / ACOG standards

49. SURGICAL PROCEDURES • Scope of Privileges • Patient assessment, pre procedure • History & Physical • Prev. complications related to procedures • Informed Consent and Refusal • Patient education / Health literacy • Post procedure follow up: • Complication? Infection? Pain?

50. BEHAVIORAL HEALTHCARE • Initial Assessment & Treatment Plan • Suicide assessment and Safety precautions • Case management • Medication therapy (?informed consent) • Monitoring of effects and compliance • Patient /family education: purpose /side effects • On-going acuity assessment & referrals • Documentation standards & confidentiality