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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, CPHRM
     Healthcare Risk and Patient Safety Consultant
      pberger@rmpsi.com       -   Phone: 517–281-7816
                                                        1
    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

                             2
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

                             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 the Healthcare facility from
        the chaos of adverse outcomes
        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 pediatric meningitis
   Policies & Protocols
     informed consent \ after hours coverage
   Regulatory compliance
     NPSG Implementation expectations
   Efficiency, UR, Cost control
     omitted care elements


                        6
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%


                            7
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)


                            8
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.


                           9
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.

                           10
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


                           11
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]



                           12
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


                             13
                  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

                              14
        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


                              15
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


                           16
      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

                         17
   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

                                  18
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


                           19
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



                          20
Risk aspect #1:   Patient communication
Risk 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



                            21
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


                           22
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

                           23
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


                            24
Risk aspect #8:   Clinic Staff performance
Risk 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


                          25
Risk Aspects of Clinic Services &
      The Medical Record
              RM 102



                                    26
    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


                          27
Culture of Safety – dual focus of RCA:
   (1 – 99%) Systems & Providers (1 – 99%)


     Blunt End:               Organizational Factors: Clinical
                              protocol; Resources (Staff, Edu);
     Org. „Systems‟           established flow, Clinic Operation



                      Communication Factors:
       Sharp end:     Patient & Family relations;
       Providers      Inter-Provider teamwork


                            Human Factors:          Knowledge
                            & Skills requirement; Cognitive
                            limits (memory, fatigue, distraction,
                            confirmation bias)



                       28
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


                              29
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


                           30
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




                                 31
Risk & litigation aspects
MEDICAL 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‟

                            32
    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

                           33
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

                                34
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

                              35
Risk related
Documentation Audit Criteria
   Legibility                     Correct patient‟s chart
   Omissions                      Accurate content
   Treatment Rationale            Timely notations
   Diagnostic Follow Up           Objective and factual
   Abbreviations                  Continuity
   Corrections                    No finger pointing
   No White out                   Avoid adjectives;
   No Write over                   instead, quote directly
   Late entries                   Signature verifiable



                               36
              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

                           37
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

                      38
                 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


                         39
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)




                               40
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



                             41
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



                                         42
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


                            43
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


                             44
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




                          45
             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


                              46
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


                            47
   Preventive actions
   Associated with Medication Safety
        Patient knowledge: Hx,                                  Verbal orders
         liver / kidney disease,                                 Including purpose on
         multi prescribers, OTC                                   med order & PRN
        Knowledge of proper                                     Educating patients
         dose, interaction,
         contraindications                                       Monitor use by patient
                                                                  & response
        Similar drug names
                                                                 Prescriber Access to
        High risk drugs &
                                                                  Drug Information
         inadequate warning
         labels / unclear labels                                 Pharmacy Resources
Source: Cohen, Current Issues in Medication Safety, Institute for Safe Medication Practices, 1998. www.ismp.com



                                                           48
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)



                             49
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.



                                            50
            EQUIPMENT LIABILITY
           How 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

                         51
             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


                           52
                 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.



                                              53
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)


                         54
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


                                55
MEDICAL STAFF QUALITY REVIEW
   Credentialing & Privileging
             RM 103


                                 56
          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

                      57
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/



                                   58
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/



                               59
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



                                            60
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


                         61
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)


                           62
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

                      63
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




                                       64
           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

                             65
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


                              66
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



                                          67
              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


                               68
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

                             69
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.

                         70
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


                           71
        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

                           72
             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.

                                73
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

                                        74
    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)


                           75
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



                                    76
     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

                          77
PATIENT RELATIONS &
  COMMUNICATION

       RM 104


                      78
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

                             79
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.

                           80
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

                           81
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


                                82
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 ____


                                83
              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



                            84
            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


                                 85
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


                               86
        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


                            87
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




                          88
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

                            89
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.



                          90
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



                           91
              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

                                 92
                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


                                  93
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

                                   94
• Make change             • Select problem
  permanent                 process
  (standardize) or        • Understand
• Continue the              the process
  PDCA cycle              • Decide on
                            process steps
                            to improve




• Collect data
                          • Data collection
• Analyze data
                          • Data analysis
• Determine the
  effectiveness           • Implement the
  of the change             change /pilot




                     95

				
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