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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