Overview
Risk Management:
Challenges in the Ambulatory
Care Setting
Patricia Breen, RN,BSN,FCN
Bureau of Primary Health Care/HRSA
Learning Objectives
• Identify elements in ambulatory care that may
influence claims
• Identify claims trends in the ambulatory care
setting including FTCA related claims
• Recall risk assessment practices .
• Recognize key strategies for improving patient
safety and mitigating risk in the ambulatory care
setting.
Clinical Landscape
Health Center Impact
• 21.7 Million Patients
• 93% Below 200% Poverty
Program Grantees Served
All Ages
• 35% Uninsured
• 62% Racial/Ethnic
Minorities
• 1,131,414 Homeless
Individuals
• 861,120 Farmworkers
• 227,665 Residents of Public
Housing
• 1,202 Grantees with 9,208
Service Sites
• 86 Million Patient Visits
Source: Uniform Data System, 2013,
Service Sites:
HRSA Electronic Handbooks
The Clinical Landscape
Healthcare in the primary care setting increasingly
complex:
• Patients with Multiple morbidities and
polypharmacy (5 or more meds)
• Short consultation times
• Fragmentation of care
• Increased patient awareness
• Lack of information on patient safety in ambulatory
setting
(Wallace et al ,2013)
Challenges
In 2009, an estimated 326 million physician office
visits, were made by adults aged 18 years or older
with Multiple Chronic Conditions (MCC) representing
37.6% of all medical office visits by adults.
The number of visits by patients with MCC increased
with age and was greater for men than for women
and for adults with public rather than private
insurance.
(Ashman, Jacobson and Beresovsky, 2013)
Errors:
Ambulatory Care Setting
1 out of every 7
outpatient care visit
includes a medical error
of some type.
Of those errors, 24%
result in harm and
another 70% have the
potential to cause harm.
(O’Reilly K.B, 2006)
Major Causes of Error
5 major causes of medical errors in primary care:
• ordering medications
• implementing lab tests
• filing systems errors
• dispensing medications
• responding to abnormal lab test results.
(Runy, L.A. 2006)
Common Themes
A systematic review of malpractice claims in primary
care ( 34 studies /5 countries) noted:
• failure to or delay in diagnosis was the most
common medical misadventure.
• Commonly missed or delayed diagnoses were
cancer and myocardial infarction in adults and
meningitis in children.
• Medication error represented the second most
common domain.
• Most common recorded patient outcome was
death.
(Wallace,et al, 2013)
• “Delayed or missed diagnoses constitute the most
common (and costly) reasons for a malpractice
claim, especially in the outpatient setting”
( Sarkar and Shojania, 2014)
• An estimated 5% (more than 12 million) of adults in
the United States experience a serious diagnostic
error in the outpatient setting every year.
(Singh, Meyer, & Thomas, 2014)
Medication Errors
IOM report (2006) stated approximately 530,000
Medicare beneficiaries in ambulatory care clinics
experienced a medication-related error in the year.
(Runy, L.A. 2006)
General Event Trends
• 2013 Joint Commission
report found that of 901
sentinel events in 2012,
62% were related to poor
leadership.
• Poor communication
contributed to 59% of the
sentinel events.
(outcomes can have
multiple causes)
(TJC,2013)
Allegations of team failures
include:
• Failure to supervise
• Vicarious liability
• Administrative
negligence
Claims
Settlements
59% of all settled malpractice claims in
ambulatory care involve diagnostic errors
that caused patient harm.
(Kairys,J.A., 2007)
Recommendation: ECRI Risk and Safety News
FY 14 Incidents by Type
3, 1%
4, 2%
1, 0%
17, 8%
Diagnosis Related
Obstetrics Related
75, 34%
25, 11%
Treatment Related
Medication Related
Surgery Related
37, 17%
Monitoring Related
Equipment/Product Related
Anesthesia Related
61, 27%
• Duty Owed
– Established relationship
– Applicable standard of care (SOC)
• Breach
– Failure to provide applicable SOC
• Harm
• Causation of Injury
– Action/ inaction led to a damage
Litigation resulting in
payment
Child Born with Cerebral Palsy and Permanent
Disability after Labor Induction, $12.1M Award
ECRI Risk and Safety News (7/26/13)
Failure to Timely Treat Ill Child, Death from
Bacterial Meningitis, $1M Settlement
ECRI Risk and Safety News (8/9/13)
Failure to Perform Follow-Up Testing after
Prescribing Medication, $2M Awarded
ECRI Risk and Safety News (3/8/13)
Potential Consequences
of a Lawsuit
• Payment of damages
• License action
• Reporting to the National Practitioner Data Bank
• Reporting to state databases
• Emotional damage
• Damage to entity's reputation
A Valuable Asset
19
Celebrate
Patients receive roughly the same quality of care in
private physician practices as in safety net
community health clinics, regardless of whether
they have private insurance, are uninsured or
insured through Medicaid.
(Bruen, Ku, Lu,Shin
2013)
Community health center patients were more likely
than other patients to report having received
counseling on topics such as smoking, exercise,
nutrition, and alcohol or drug use. (Shi,
Steven,2007)
Risk Management Perspective
Risk Management Objectives
• Improve Patient Safety
• Prevent errors, system breakdowns, and patient
harm
• Minimize clinical risks and liability losses
• Support regulatory, accreditation compliance
• Protect organizational resources
Developing a Risk Management Plan: A Step by Step Approach
ECRI- March 2010 archived audio conference
Reason’s Swiss Cheese Model of a
System
Clinical Risk Management
• Approach to improve quality and safety of healthcare
Identify what places
patients at risk
Assess the risk
Manage the risk
Vulnerabilities
• Inadequate Policies, Protocols and Procedures
• Inadequate Rx Protocols, Policies and Procedures
• Lack of Adherence to Evidence-Based Medicine
• Inadequate Continuing Education or Training
• Inadequate Supervision of Trainees and Mid-level
Providers
• Inadequate Clinical Record Documentation
• Inadequate Medical Materials Monitoring
• Inadequate Care Coordination/ Referral
• Inadequate Collaboration and Communication
Address Vulnerabilities
With goal to provide:
• Safe (No harm)
• Effective (evidence based)
• Patient centered
• Timely
• Efficient (use resources wisely – do it right)
• Equitable (fair)
Care
Processes for
identification of risk
• Patient and employee satisfaction surveys
• Patient and employee complaints
• Internal reporting system trends
• Proactive process assessment via Failure Mode
Effects Analysis (FMEA) and Cause and Effects
Diagrams/ Fishbone Charts (Ishikawa diagrams)
• Reactive (post event)internal analysis via Root
Cause Analysis
• Patient safety alerts
Indiana Trends
Risk Management Strategies
Culture
Credential
Competence
Communicate
Consent
Chart
Coordinate
Conduct
Culture
The single greatest impediment to error prevention
in the medical industry is “that we punish
people for making mistakes.”
Dr. Lucian Leape
Professor, Harvard School of Public Health
Testimony before Congress on Health Care Quality Improvement
Culture of Safety
• Everyone feels comfortable voicing a concern
• CUS ( concerned, uncomfortable, safety issue,
STOP!)
• Internal reporting mechanism for errors , near
misses and adverse events
• High degree of confidence that concerns will be
acted upon
• Environment of respect
• Flattening of the hierarchy
Evolution of Safety Cultures
Situational Awareness
Develop situational awareness (SA)
“A person’s perception of the elements in the
environment within a volume of space and time, the
comprehension of their meaning, and the projection
of their status in the near future. In essence, SA is a
shared understanding of ‘what’s going on’ and ‘what
is likely to happen next’”.
(Singh, Petersen, Thomas, 2006, p. 159)
34
Individual Responsibilities
•
Looking for the risks around me
• Reporting errors and hazards
• Helping to design safe systems
• Making safe choices
• Following procedure
• Making choices that align with organizational
values
• Never signing for something that was not done
(Marx, D., 2007)
Credential/ Privilege
• Apply credentialing policy to all health center
practitioners, employed or contracted, volunteers or
locum tenens, at all health center sites.
• Exercise due care in selecting providers, supervising
them, and reviewing the competency of their clinical
activities to avoid potential liability for negligent hiring
or retention of a provider, health centers.
• Evaluate a practitioner’s eligibility to provide clinical
services and evaluate the provider’s competency for
specific clinical privileges.
Sample Credentialing and Privileging Policy found in Credentialing Toolkit
on the ECRI Clinical Risk Management Program website
PIN 2002-22 :Clarification of Bureau of Primary
Health Care Credentialing & Privileging Policy
http://bphc.hrsa.gov/ftca/about/ftcapolicies.html
Competence
Cognitive Abilities
Biomedical and clinical knowledge and the ability to
apply it to concrete situations
Diagnostic Problem Solving and Clinical Judgment
Obtains sufficient information from clinical history and
patient notes
Arrive via reasonable differential diagnoses at a final
diagnosis incorporating details noted in focused
physical examination and through the correct utilization
and application of laboratory tests and medical
procedures
(Wimmers, P, 2006)
Competence
Interpersonal Skills
Effective communication with patients and colleagues
Professional Qualities
Respectful and professional relationships with patients and
in the provision of health care
(Wimmers, P, 2006)
Regular assessment
of care
appropriateness
Evidence Based Practice
Limiting Radiation Exposure during Dental
Radiographic Examinations
Comprehensive Behavioral Health
Screening in Primary Care
ECRI Institute, on behalf of HRSA presents
Optimal Outcomes, a FREE 9-hour fetal
heart monitoring interpretation and
intrapartum management course
For course access, e-mail
Clinical_RM_Program@ecri.org or call (610) 8256000 ext. 5200. Please include your name, license
number, title or position, e-mail address, and the
name and address of your health center/free clinic
Communicate- Team
• Effective communication among caregivers has
remained on the annual National Patient Safety
Goals list since its inception in 2002.
• Use structured communication ( SBAR) for care
transitions
• Respect patient privacy and maintain
confidentiality
• Supervision of Trainees and Mid-level Providers
( know state regulations)
Communicate – Patient
• Consider barriers to communication ( language,
competence, emotional state, educational levels)
• Give evidence-based advice and explain rationales
• Advise of consequences of not following the advice
• Give the patient a time frame to comply
• Document the advice given and the patient's
response
• Have patient/ family repeat – back to ensure
comprehension
Communicate – Patient
Noncompliance? find out why
• urge compliance
• repeat explanation of the necessity for compliance
• continue to teach the patient
• enlist other healthcare providers to reinforce the
advice.
• Consider barriers like transportation, finances,
work demands, caregiver status
Effective Health Communication
• Health Literacy
– Using Clear/Understandable Language
• Linguistic Competency
– Meeting the Needs of Limited English Proficient Patients
• Cultural Competency
– Honoring Diverse Patient Worldviews
Effective Communication Tools for Healthcare
Professionals free, on-line, go-at-your-own-pace 5 hour,
5 module training offered at
http://www.hrsa.gov/publichealth/healthliteracy/
Consent
Patient Education is Essential to Informed Consent
Obtaining a patient’s informed consent involves an exchange of information between a
provider and the patient that results in the patient’s decision to accept or decline a specific
medical treatment. Informed consent is not simply a form that a patient must sign; it is an
educational process by which the provider carries out his or her legal duty to provide
information that the patient needs to understand the proposed treatment in order to make
an informed decision. State requirements on informed consent vary, but all states impose
a legal duty for patients to be informed of the risks of their care.
 Document all education and information provided to patients during the informed consent
discussion, the patient’s understanding of the information, and any language or
communication assistance provided to patients or their surrogate decision makers.
Consent
• Guiding principle - “Nothing about me, without me”
• Don’t give informed consent, you get informed consent
• Competent informed adult has right to refuse
• Document witnessed refusal and efforts to inform regarding
recommended intervention /benefits/ risks
Chart
Meticulous Clinical Record Documentation is Crucial
• Documentation must be legible and complete
• Up to date patient problem list and medication list
• Document conversations with patients & specialists
• Document after hours calls
• Document noncompliance/missed appointments
• Document follow up efforts
• Document informed consent and refusal
• Records should be signed and available
• Do not alter the records
Coordinate
• Implement comprehensive tracking management
system for test results/referrals and
hospitalizations
• Provide effective communication of all diagnostic
test results to patient
• Support coordination of care through well designed
policies, protocols and procedures
• Standardization of processes
• Create independent checks – build in redundancy
• Learn when things go wrong
Coordinate
Improve Processes for Tracking Patient Referrals
Claims related to missed or delayed diagnosis have consistently been one of the most
frequent allegations against FTCA-covered health centers and free clinics. Breakdowns in the
process of referring patients to specialty consultants can cause a delay in appropriate medical
follow up. Taking steps to ensure patients attend referral appointments in a timely manner
can help prevent cases of missed or delayed diagnoses, improve overall patient care, and
ensure continuity of care.
 Communicate to patients the importance of keeping referral appointments and the
inherent risks of lack of follow-up (e.g., diagnosis may be missed or delayed).
 Follow-up with patients who miss referral appointments and encourage them to
reschedule. Reemphasize the risks of missing referral appointments.
Conduct
• Medical Materials Monitoring
• Environment of Care surveys
• Proper Sterile Processing of equipment
Resources
• Bi-weekly eNews
• Quality In Action
• Quarterly Webinars
• Annual Virtual Conference
• CME courses
Technical Assistance and Resources
FTCA WEBSITE
Resources
General Contact Information
FTCA/BPHC Help Line
Phone: 1-877-974-BPHC (877-974-2742)
9:00 AM to 5:30 PM (ET)
Email: BPHChelpline@hrsa.gov
FTCA Website: http://www.bphc.hrsa.gov/ftca/
Questions ?
Contact Information
Patricia M. Breen
Public Health Analyst
Bureau of Primary Health Care
Office of Quality Improvement
5600 Fishers Lane,16W61C
Rockville, Maryland 20857
Phone: 301- 443-6349
Email: pbreen@hrsa.gov