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Fundamentals of Risk Management &
Patient Safety for Community Health Centers
On-site RM Training Seminar 2008
Petra S. Berger PhD RN, CPHRMHealthcare Risk and Patient Safety Consultant
pberger@rmpsi.com - Phone: 517–281-7816
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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
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RM 101
Overview, 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 Liability review Risk intervention: immediate & QI
referral Ten common (clinical) risk issues at CHCs Staff & Leadership roles
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VITAL BRIDGE OVER TROUBLED WATERS
QUALITY MANAGEMENT
Patient Safety = Q. I. Risk Management
= identify risk – respond – prevent
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CORE PURPOSE of RISK MANAGEMENT
S T O P ADVERSE OUTCOMES
Preventing patient harm Protecting the Healthcare facility from
the chaos of adverse outcomes litigation and financial loss patient and community distrust
Protecting involved Providers
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QUALITY OUTCOMES & RISK ASPECTS
on 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
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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%
FTCA CLAIMS DATA
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Liability Question: Allegation of NEGLIGENCE Duty – based on existing provider-patient relationship
“To exercise degree of care that a reasonable& competent provider would exercise undersame or similar circumstances”
Breach of DutyPlaintiff must show that defendants failed toexercise ‘reasonable’ care, and adherence toestablished clinical standard (expert testimony)
Injury proximately CAUSED by breach (foreseeable)
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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.
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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.
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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
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Alleged ‘Negligence’ = ‘Process Failures’ Duty? Breach? Injury? Damages?
A. Clinic 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]
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Purpose & Type of Risk Outcome Monitoring
Risk 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
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Procedures of Incident 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
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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
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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
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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
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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 failures without fear of censure
Capacities to detect unexpected threats AND contain them before they cause harm
Attentiveness to error prone processes facing workers at the frontline
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Risk & Quality Leadership Roles Strategic Risk & Quality planning based on
Risk identification & prioritization
Policies & Protocols, Guidelines Implementation of process re-design &
monitoring through Q. I. “Knowledge transfer” to create internal
inventory of patient safety practices
Electronic information systems: Baselines & progress made
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Why & How internal Policy compliance?
Policy = standard by which care is judged
Difficult to defend internal policy/procedure: If not congruent w/ evidence-based guidelines If local practice not congruent w/ policies If no allowance made for clinical judgment to
vary from protocol If level of detail & requirements of local policies
are difficult to follow If not adjusted & monitored w/practice change
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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
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Risk aspects #3: The Medical Record
Risk 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
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Risk aspects #5: Clinical Practice Risk 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
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Risk aspect # 7: Medication Safety Risk 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
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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
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Risk Aspects of Clinic Services & The Medical
Record RM 102
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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
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Culture of Safety – dual focus of RCA: (1 – 99%) Systems & Providers (1 – 99%)
Blunt End: Org. ‘Systems’
Sharp end: Provide
rs
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)
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Risk aspects #3:
The 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
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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
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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
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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’
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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
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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
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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
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Risk related Documentation Audit Criteria 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
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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
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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
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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
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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)
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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
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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
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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
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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
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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
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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
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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
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Preventive actions Associated with Medication Safety 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
Source: Cohen, Current Issues in Medication Safety, Institute for Safe Medication Practices, 1998. www.ismp.com
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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)
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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.
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EQUIPMENT LIABILITYHow to protect against risk
THE EQUIPMENT WAS: appropriate for procedure 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 adequately educated and trained
Procedures developed & staff trained on how to respond in case of equipment failure
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Environment of CareInfection 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
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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.
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Risk aspect #8: STAFF
PERFORMANCE Staff qualification & orientation
Clear directives/protocols & Training Staffing levels & Material resources Human factor remedies:
distraction, memory overload, fatigue, confirmation bias
Performance feedback (data based)
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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
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MEDICAL STAFF QUALITY REVIEWCredentialing & Privileging
RM 103
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Medical Staff Quality Peer Review & Credentialing
Credentialing, privileging, and
peer review of medical providers
Medical quality measures and use of clinical protocols
Clinical risk aspects of perinatal, surgical, behavioral, dental services
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Risk aspects #5: Clinical Practice 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/
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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/
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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
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Risk aspects # 6: Clinical Mis-Diagnosis Most frequent
Cancer – Myocardial infarction – Stroke – Meningitis – Acute abdomen – Fractures – Prenatal risk factors – Infections
Factors Atypical signs & symptoms Incomplete or inaccurate information
about medical history; many co-morbidities
Insufficient diagnostic work up; Delays
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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)
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Confirmation Bias
Paris in thethe 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
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Pre-natal risk assessment PRE NATAL ASSESSMENT per protocol (standardized)
Consistent documentation of ALL prenatal visits Weekly clinical update; prompt high risk referral
PRE NATAL MEDICAL RECORD TO HOSPITAL
36wk for continuity
Maternal conditions: hypertension \diabetes \drug & alcohol\ antepartum hemorrhage \ cardiac \ prior PE
http://www.rmf.harvard.edu/; AAFP standards / ACOG standards
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SURGICAL PROCEDURES
Scope of Privileges Patient assessment, pre procedure
History & Physical Past events related to procedures
Informed Consent and Refusal Patient education / Health literacy
Post procedure follow up: Complication? Infection? Pain?
Updated Treatment plan
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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
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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
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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
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Risk aspect #9: Medical Provider Quality Review Quality measures defined PER SCOPE Review mechanism - who and how Electronic information systems
Data sources Quality:
service volume; guideline adherence Risk:
adverse outcomes, high risk processes
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Human Factor: Knowledge & Skill Communication skills: providers, patients
Documentation skills
Understanding Patient needs: assessment & clinical monitoring
Clinical /technical judgment & knowledge
Diagnostic skill and experience
Medication knowledge – indications, interaction, off label use, etc.
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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
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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
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Credentialing process: Initial and bi-annually
Responsibility of medical staff and board Include all mid level providers & residents Documented process to grant privileges
Reference letters address privileges sought Qualifying education and experience - criteria
NPDB query, all states w/ previous practice Initial criminal background check Check all staff & volunteers, all pertinent states
Results of Quality & peer review s/p 2 y.
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Initial Credentialing Scope - Resources
http://www.aafp.org/online/en/home/practicemgt/privileges/positionpapers.html
Procedural Position Papers Cesarean Delivery in Family Medicine
Diagnostic OB-GYN Ultrasonography by Family Physicians
Colposcopy by Family Physicians
Family Physician Interpretation of Outpatient Radiographs
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Re-credentialing – Risk Outcomes
Diagnostic and treatment concerns (51%) Omissions, delays, errors, lost results Referral issues
Adverse Medication outcomes (10%) Prescribing, dispensing, administering
Complications – OB, Surgical (28%) Patient & family complaints (clinical focus)
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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
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Re-credentialing – Risk Process Guideline adherence: e.g. Anticoagulant
Tx
Patient assessment & monitoring (MR) Diagnostic test tracking & follow up
Unclear /inconsistent documentation Medication errors made (no harm) Communication – hand-off; after hrs; verbal
Disruptive practitioner
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PATIENT RELATIONS & COMMUNICATION
RM 104
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Risk aspect #1: Patient communication Patient assessment & interview Treatment planning & consent
Conflict resolution; Non compliance Behavioral incidents Termination of care
Health instruction – literacy – interpreters Explain back / read back
Patient feedback & satisfaction Complaint management Disclosure
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Nat. Patient Safety Goals - JCAHO
PATIENT PARTICIPATION -- GUIDELINES Goal 13 - Encourage patients’ active involvement in
their own care as a patient safety strategy 13A: Define & communicate the means for patients
and their families to report concerns about safety and encourage them to do so
When patients know what to expect, they are more aware of possible errors and choices. Patients can be an important source of information about potential adverse events and hazardous conditions.
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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
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Informed Refusal - signed Should be obtained whenever refusal to
have a test or procedure done may have
adverse results
Examples Mammograms Chest or other x-rays Cardiac work-ups Lumbar punctures Other
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Informed Refusal – sample text
This is to certify that I, __ a patient @ CHC, am refusing to permit the following procedure___ against advice of my medical provider __ (name) because ___ .
My present diagnosis and condition, specific medical risks of my refusal, and alternative treatment have been fully explained to me.
I was given the opportunity to ask questions which have been answered.
I hereby release __ CHC and its medical providers from liability for any consequences of my treatment refusal.
Signed ______ Date____ Time ___ Witness ____
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Medication safety &PATIENT COMMUNICATION
50% non-adherence to prescribed meds
10% hospital admission (older adults)
8.4 mio not taking hypertension meds
Continuity vs. episodic care; missed appt
Medical literacy & English proficiency
Lay language & validated understanding
Hearing, vision, cognitive limitations ?
Eliciting information & closing loop at next visit
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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
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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
Family medical history Special diet and other health measures Health insurance information Living will
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Telephone triage & Documentation
Using protocols adopted by medical staff,or direct consultation w/ med. provider
Name of Call recipient & purpose of call Advice & orders given (prescription refills) Follow-up instructions & comprehension Legible, full sentences, no abbreviations. Date, time, AND initial of medical provider Review through Q.I. process: assure
competency Based on criteria of clinical protocols
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Telephone communication w/ Patients
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 disagreement about medical
treatment prescriptions provided
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Missed scheduled appointments Tracking high-risk patients who miss
scheduled appointment
Diagnostic results? Specialist referral?
Written correspondence with patient include medical implication of missing appointments
Documenting all notification attempts
If worsened outcome possible, a certified letter is sent, with copy & receipt in medical record
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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.
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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
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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
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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
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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
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• Collect data
• Analyze data
• Determine the effectiveness of the change
• Data collection
• Data analysis
• Implement the change /pilot
• Select problem process
• Understand the process
• Decide on process steps to improve
• Make change permanent (standardize) or
• Continue the PDCA cycle