Transcript Document
Fundamentals of Risk Management & Patient Safety for Community Health Centers
On-site RM Training Seminar – November 2008
Petra S. Berger PhD RN, CPHRM
Healthcare Risk, Quality, and Patient Safety Consultant [email protected]
Phone: 517 –281-7816 1
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
2
Definitions
Risk 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 Liability review Risk intervention:
immediate & QI referral
3
VITAL BRIDGE OVER TROUBLED WATERS QUALITY MANAGEMENT Patient Safety = Q. I.
Risk Management
= identify risk – respond – prevent
4
CORE PURPOSE
of
RISK MANAGEMENT
S T O P ADVERSE OUTCOMES
Preventing Patient harm
Protecting Healthcare facility
from litigation and financial loss patient and community distrust
Protecting
involved
Providers 5
QUALITY OUTCOMES & RISK ASPECTS on 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 6
Risk & Quality Leadership Roles
A
culture of safety
in which individuals can draw attention to potential or real
hazards, barriers, gaps, or failures without 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 7
Health Center Trends and Issues
FTCA CLAIMS DATA
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% 8
Liability Question: Allegation of NEGLIGENCE
Duty –
based on
existing provider-patient relationship
To exercise
degree of care
that a
reasonable & competent provider
would exercise under
same or similar circumstances Breach
of Duty Plaintiff must show that defendants failed to exercise
‘reasonable’ care,
and
adherence to
established
clinical standard
(expert testimony)
Injury
proximately
CAUSED
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
medication
.
seizure 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?
Medical Record As Core Evidence
Privileged & protected information
Fact-based investigation
No premature conclusions Timelines and event analysis (RCA) Sequestering evidence 12
Alleged Negligence: Duty? Breach?
A.
Clinical standards of care
= ‘duty’
Monitoring, patient medication & document
Test result reported & signed off by provider
Treatment plan updated, w/
or
w/out change
Reliable medical record system @ hand off with external medical providers and hospital B.
[CRNA &
hospital
standards of care]
13
P o l i c y & P r o c e d u r e s: Standards by which Care is judged
Difficult to defend
policy & procedure: If not based on
evidence-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 14
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 15
Procedures of
Incident 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
NO PERSONAL NOTE KEEPING
adjectives 16
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 17
TJC: National Pt Safety Goals
P atient identification Verbal orders Hand off @ transition Medication reconciliation Critical lab value reporting Patient involvement in care Suicide assessment
18
Risk aspect #1 : Risk aspect #2:
Patient communication 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 19
Risk aspects #3:
The Medical Record
Risk aspects #4:
Clinic Operation & Flow
The Medical Record
Chart c
ontent &
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 20
Risk aspects #5 : Risk aspects # 6
:
Clinical Practice 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
21
Risk aspect # 7: Risk aspect # 8
:
Medication Safety
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 22
Risk aspect #9
: Risk aspect #10:
Clinic Staff performance
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 23
Risk Aspects of Clinic Services I
24
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
25
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 26
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
27
Medication compliance
PATIENT 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
28
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
patient and/or family of
29
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
30
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
31
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 32
Telephone communication
Document phone calls incl.
AFTER HOURS
calls,
in the medical record
if the following was discussed:
medical symptoms, new or continued abnormal test results reported medical advice offered
questions about medical treatment prescriptions provided 33
Missed appointments
–
No Shows
Tracking high-risk patients scheduled appointment who miss
Pending diagnostic results?
Documenting all notification attempts
Include medical implication appointments of missing
If worsened outcome possible record , a certified letter is sent, with copy & receipt in medical 34
Risk ID through Patient Complaint
Categorize
types
of complaints Prioritize by
severity & risk level
Establish
who is responsible for responding
to the complaints
Log and trend
complaints & resolution
Address systems issues
through
P.I.
35
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
36
Termination of Care
Solution of
‘last resort’
Patient given notice of termination Evidence of certified letter in chart Patient given reasonable amount of time which to obtain alternative care Usually thirty days in Patient given assistance in obtaining alternative care e.g., a list of appropriate potential providers
37
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
38
Risk Aspects of Clinic Services II
39
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
40
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 41
Risk aspect #9:
STAFF PERFORMANCE
Staff qualification & orientation
Clear directives/protocols & Training Staffing levels & Material resources Human factor remedies
:
distraction, memory overload, fatigue, confirmation bias Provide Performance feedback
42
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
43
Quality & Peer review:
Clinical Practice Pattern
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/
44
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/
45
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) 46
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 47
Pre-natal risk assessment
PRE NATAL ASSESSMENT per 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
48
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?
49
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 50
Suicide assessment
-
Document
Concurrent Dx :
depression \bi-polar \psychosis Family history
Previous patient attempts Lack of social support
Recent significant loss Alcohol /drug intoxication Terminal or chronic debilitating disease Abrupt withdrawal from normal routine
John Hopkins Health Information, 1998.
Spotting the Warning Signs of Suicide
51
Incidental Assessment of Abuse or Neglect
Domestic violence
: child – dep. adult – partner Mandatory reporting laws :
suspect, not
prove
How to assess:
Ask about abuse in private w/ respect, non blame Feel safe? What stress? Should I be concerned?
Emergency plans? Resources: friends, family?
Contusions, abrasions (head, chest, abd); fractures Abuse during pregnancy
DOCUMENT in detail
a n d
objectively 52
Human Performance Factor for Medical Providers
Clinical /technical
judgment & knowledge
Diagnostic
practice pattern & experience
Medication knowledge
– indications, interaction, off label use, etc.
Understanding Patient needs
: dialogue, health education & clinical monitoring
Communication skills:
providers, patients
Documentation skills 53
Credentialing Focus
Initial credentialing varies from re- credentialing
INITIAL
:
Licensure verification,
References
re:
privileges
Qualifying education &
experience
, NPDB
RE-CREDENTIALING
:
Quality & Risk data required
Which value-added measures to select How to obtain the data efficiently What to do with quality information
54
Credentialing process:
I n i t i a l Responsibility of
medical staff
and
board
Include all
mid level providers & residents
Documented process to
grant privileges
Reference letters address privileges sought
Qualifying
education
& experience - criteria
NPDB
query, all states w/ previous practice Initial criminal background check Check all staff & volunteers, pertinent states
55
Re-credentialing & Quality indicators
Patient assessment & monitoring (MR) Diagnostic services and follow up Unclear /inconsistent documentation Medication prescription pattern Guideline adherence: e.g. Anticoagulant Tx Communication – team & patient relations
56
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
57
Credentialing Files: Risk & Quality section
Credentialing files organized into 2 sections Separate
Quality file
per practitioner Sect. A: Guideline adherence; Documentation Sect. B: P.C.E. = Potentially compensable event Adverse event review Peer review result
Top Confidential,
keep secured
58
Risk aspect #8: EQUIPMENT – EOC – EMERGENCY RESPONSE
Emergency protocols implemented and monitored
Medical emergency
1 BLS trained staff on-site at all times
Crash cart (incl. pediatrics) & checks Behavioral Building /weather (power outage; fire) 59
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.
60
EQUIPMENT LIABILITY
How to protect against risk
THE EQUIPMENT WAS:
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 trained Procedures developed & staff trained on how to respond in case of equipment failure 61
Environment of Care Infection control & Hazardous Material
Develop, implement and monitor an Infection control (I.C.) plan pertinent to the facility Involve I.C. professional
Trend I.C. issues & take corrective action
Protect staff, providers, patients, and visitors from hazardous material 62
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 aspects of potential risk of violence Source: ECRI, HRC Risk Analysis – Overview: Managing Risks in Physician Practices , July 2003.
63
Risk Aspects, Clinic Services III
64
High Risk Clinic Service Aspects – III
Medical Record Documentation
Medication Management
65
Risk aspects #3:
T
he Medical Record -
Content
Medical history,
comprehensive &
in ink
Diagnosis
& Current medical problem list
Double check @ each visit before chart returned
Lab work, other diagnostic results
All results 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
66
Personal Health Record (PHR)
Manual or electronic version
Portable / Paper / web based / CD ROM
Content
Updated medication list incl. OTC Allergies & immunizations w/ dates Significant recent diagnostic test results Medical history incl. procedures Special diet and other health measures Health insurance information Living will
67
What
To Document
–
Concurrent
Referrals & consultations
Patient notification
Instruction to patient /family,
in writing
Questions addressed
Patient's failure to keep appointments Informed consent / refusal DISCUSSION
All entries
timed, dated & signed
/initialed
68
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
69
Risk & litigation aspects
MEDICAL RECORD DOCUMENTATION
?Treatment rationale; ?Diagnostic Follow Up Omissions \ delays 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’ 70
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 71
Policy development
Confidentiality & 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 72
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
73
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
74
PROVIDER COMMUNICATION
& MEDS
PHARMACIST function
Legible
prescriptions for Pharmacist Including
indications / purpose
diagnosis and/or Include all of the following components in order:
dose – strength – units/metric – route – frequency
Guarding against
LASA drugs
:
Restoril ordered, Remoran
(Antidepressant)
dispensed
Patient also taking another anti-depressant 75
PROVIDER COMMUNICATION
& MEDS
NURSES 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
76
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
77
Anti Coagulant Monitoring
heparin – 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 78
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 79
Sample drugs & 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 80
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 81
Medication Reconciliation
RN/ MA intake interview: takes time Interview skills Medication knowledge Pt. brings in all current medications & OTC Establish / update
Medication Inventory
Keep in visible location on pt. chart Patient keeps copy and updates Patient uses Medication inventory daily Update medication supply
@ each visit to reduce refill requests
between visits
82
• Make change permanent (standardize) or • Continue the PDCA cycle • Collect data • Analyze data • Determine the
effectiveness of the change 83
•
Select
problem process •
Understand
the process • Decide on
process steps to improve
• Data collection • Data analysis •
Implement the change /
pilot