Risk Management: Best Practices to Optimize

Prevention

All-Grantee Meeting, Washington D.C.June 24, 2008

Petra S. Berger PhD RN, CPHRMHealthcare 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 GOALS on 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 & PREVENT HARM = Patient Advocacy

• PROTECT the Healthcare facility from – litigation and financial loss – patient and community distrust

• PROTECT involved Providers & Staff

6

Health Center Trends and Issues

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%

7

Liability Analysis: Allegation of NEGLIGENCE

Duty – based on existing provider-patient relationship;To exercise degree of care that a reasonable &competent provider would exercise under sameor similar circumstances

Breach of DutyPlaintiff must show that defendant failed to exercise‘reasonable’ care, and adherence toestablished clinical standards (expert testimony)

Injury proximately 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. Standard of Care - prelude to Q. measuresMonitoring 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 CONTROL Risk 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 IE08/13/07

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 to patient • 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-provider team 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 frequentCancer – 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

the Spring 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 confrontations incl. ill-intended trespassers

• Security audits needed to reveal problems• Address potential risk of violenceSource: ECRI, HRC Risk Analysis – Overview: Managing Risks in Physician Practices, July

2003.

27

EQUIPMENT LIABILITYMonitoring to protect against risk

• THE EQUIPMENT WAS: appropriate for procedureused in reasonable manner (vs. ‘user error’) inspected for obvious defects prior to useon regular preventative maintenance

schedule• All staff using the equipment were

adequately EDUCATED AND TRAINED• Procedures developed & staff trained on

how to respond in case of equipment 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 from hazardous 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 factor remedies: 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 Focus Initial vs. Re-credentialing

• INITIAL: Licensure verification, References re: privileges Qualifying education & experience, NPDB ck Provisional credentialing and Proctoring

• RE-CREDENTIALING: need Quality & Risk data– Which measures 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 data trends

Guideline adherence; MR Documentation

– Sect. B - Risk data: events & practice patternP.C.E. = Potentially compensable eventPt. 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