Improving Patient Safety Background

1
Improving Patient SafetyBackground Legislation

• Impact of IOM report To Err is Human (1999)
• The National Quality Forum
• NQF Safe Practices for Better Health Care (2003)
• The Quality Choir-Joint Commission, Institute for
  Healthcare Improvement, Agency for Health
  Research Quality, National Quality Forum, the
  LeapFrog Group Centers for Medicare Medicaid
  (CMS)

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Reportable Adverse Events (Never Events)

• SITUATION
• Treatment for some hospital acquired conditions
  will not be paid by CMS and some private payors.
  These conditions are generally known as
  reportable adverse events or never events.
• BACKGROUND
• REPORTABLE ADVERSE EVENTS (NEVER EVENTS)
• In May of 2006, CMS (Center for Medicare and
  Medicaid Services) issued a list of non-
• covered events scheduled for a gradual phase
  in with the initial eight being scheduled
• for 2008 implementation.
• In January 2008, following a request from
  Governor Gregoire, all hospitals which are
• members of the Washington State Hospital
  Association, adopted a voluntary
• agreement which states that when an adverse
  event occurs, no patient will be
• required to pay for care related to the event
  by the physician or facility directly involved
• in care. This is effective now and includes
  all the adverse events listed on the next
• pages.

3
Adverse Health Events

• Surgery performed on the wrong body part.
• Surgery performed on the wrong patient.
• Wrong surgical procedure performed on a patient.
• Unintended retention of a foreign object in a
  patient after surgery or other procedure.
• Intraoperative or immediately post-operative
  death in an ASA Class 1 patient.
• Patient death or serious disability associated
  with the use of contaminated drugs, devices, or
  biologics provided by the healthcare facility.
• Patient death or serious disability associated
  with the use or function of a device in patient
  care in which the device is used or functions
  other than as intended.
• Patient death or serious disability associated
  with intravascular air embolism that occurs while
  being cared for in a healthcare facility.
• Infant discharged to wrong person.
• Patient death or serious disability associated
  with patient elopement (disappearance).
• Patient suicide or attempted suicide resulting in
  serious disability, while being cared for in a
  healthcare facility.
• Patient death or serious disability associated
  with a medication error (e.g. errors involving
  the wrong drug, wrong dose, wrong patient, wrong
  time, wrong rate, wrong preparation or wrong
  route of administration.
• Patient death or serious disability associated
  with a hemolytic reaction due to administration
  of BO/HLA-incompatible blood or blood products.
• Maternal death or serious disability associated
  with labor or delivery in a low risk pregnancy
  while being cared for in a healthcare facility.
  Includes events that occur within 42 days
  post-delivery.

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Adverse Health Events (continued)

• Patient death or serious disability associated
  with hypoglycemia, the onset of which occurs
  while the patient is being cared for in a
  healthcare facility.
• Death or serious disability (kernicterus)
  associated with failure to identify and treat
  hyperbilirubinemia neonates.
• Stage 3 or 4 pressure ulcers acquired after
  admission to a healthcare facility.
• Patient death or serious disability due to spinal
  manipulative therapy.
• Patient death or serious disability associated
  with electric shock or elective cardioversion
  while being cared for in a healthcare facility.
• Any incident in which a line designed for oxygen
  or other gas to be delivered to a patient
  contains the wrong gas or is contaminated by
  toxic substances.
• Patient death or serious disability associated
  with a burn incurred from any source while being
  cared for in a healthcare facility.
• Patient death or serious disability associated
  with a fall while being cared for in a healthcare
  facility.
• Patient death or serious disability associated
  with the use of restraints or bedrails while
  being cared for in a healthcare facility.
• Any instance of care ordered by or provided by
  someone impersonating a physician, nurse,
  pharmacist, or other licensed healthcare
  provider.
• Abduction of a patient of any age.
• Sexual assault on a patient within or on the
  grounds of a healthcare facility.
• Death or significant injury of a patient or staff
  member resulting from a physical assault (i.e.
  battery) that occurs within or on the grounds of
  a healthcare facility.
• Artificial insemination with the wrong donor
  sperm or egg.

5
Reportable Adverse Events (Never Events)
Some commercial insurers (WellPoint and Cigna)
have announced that they will cease payment for
the CMS Never Events, including those listed
above.
6
Reportable Adverse Events (Never Events)

• ASSESSMENT
• Reportable Adverse of Never events reporting
  will require that processes be established to
  identify whether these events were present on
  admission. Critical Access Hospitals (CAHs) are
  currently exempt from present on admission
  reporting. However, due to the adoption by the
  State of Washington of the 28 never events list
  and the anticipated impact of the Recovery Audit
  Contactor (RAC) surveys, critical access
  hospitals should be updating their systems to
  capture this data (conditions present on
  admission).
• PRESENT ON ADMISSION INFORMATION
• Beginning in 2007, prospective payment system
  hospitals were required to submit a present on
  admission indicator for every inpatient
  diagnosis. Present on Admission is defined as
• Any condition present at the time of the
  physician order for inpatient admission
• Any condition that develops during an
  outpatient encounter (including Emergency
  Department,
• observation or outpatient surgery) and still
  present at time of inpatient admission.
• Present on Admission applies to all inpatient
  diagnosis codes, both principal and all secondary
  diagnoses.

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Improving Patient SafetyBackground Legislation

• Why Adverse Event Reporting
• An important goal--the reporting law drives
  quality improvement in facilities as part of a
  broader statewide vision of creating patient
  safety
• Adverse event reporting systems enhance both
  accountability and transparency
• The true strength of the adverse event reporting
  system is the focus on learning, sharing
  information about root causes and best practices
  for prevention and increased awareness of about
  adverse events.

8
Improving Patient SafetyBackground Legislation

• 27 States receive adverse event reports-26
  mandatory 1 voluntary
• 12 States and District of Columbia use NQF list
  of adverse events, or modified version
• 14 States use a state defined list
• Source National Academy for State Health
  Policy, 2007 Guide to State Adverse Event
  Reporting Systems/Download this publication at
  www.nashp.org/Files/shpsurveyreport_adverse2007.pd
  f

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Improving Patient SafetyBackground Legislation

• 70.56 RCW Adverse Event Reporting
• Became law on June 5, 2006 amended in 2008
• Quality Improvement Focus not Regulatory
• Definitions from NQF Serious Reportable Events
• Adverse Event Notification within 48 hours of
  confirmation and may include contextual
  information
• Root Cause Analysis with Action Plan to DOH
  within 45 days.
• DOH provides review and consultation for RCAs
• Public disclosure of adverse event notifications
  permitted
• Report/RCAs not subject to public disclosure

10
Improving Patient SafetyBackground Legislation

• 70.56 RCW Adverse Event ReportingDepartment of
  Health Role
• Receive Investigate, where necessary, adverse
  event notifications, root cause analyses, and
  corrective action plans and communicate the
  departments conclusions to facilities
• Consultation Visits initiated through RCA review
  or by request

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Improving Patient SafetyBackground Legislation

• 70.56 RCW Adverse Event ReportingDepartment of
  Health Role
• Developed the Root Cause Analysis Evaluation Tool
  1
• PSAE ProgramReview of 300 RCAs utilizing Root
  Cause Analysis Evaluation Tool 1
• Reference
• 1. Adapted from Joint Commission Sentinel Event
  Methodology and Maryland Department of Health
  Mental Hygiene, Office of Health Care Quality

12
Improving Patient Safety General Findings from
RCA Reviews

• Definition for Root Cause Analysis An analytic
  tool that can be used to perform a comprehensive,
  system based review of critical incidents and
  adverse health events.

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Improving Patient Safety General Findings from
RCA Reviews

• Goals of an RCA
• What happened?
• Why did it happen?
• What can be done to reduce the likelihood of
  recurrence?

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Improving Patient Safety General Findings from
RCA Reviews

• RCA Models
• US Veteran Affairs National Center for Patient
  Safety
• Joint Commission Sentinel Events
• Canadian Root Cause Analysis Framework
• Other Models OK with DOH Permission

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Improving Patient Safety General Findings from
RCA Reviews

• Root Cause Analysis Evaluation Tool 1
• RCA Elements
• Determine that an adverse event occurred
• Composition of RCA Team
• Conduct of RCA
• Develop an Action Plan
• Measure Effectiveness of Plan
• Relevant Literature

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Improving Patient Safety General Findings from
RCA Reviews

• Findings
• Composition of RCA Team
• Team often developed by Nursing Department
• Lack representation from physicians, biomedical,
  pharmacy, operations
• RCA teams provide an opportunity to create a
  culture of safety
• Organization endorsements for RCA team
  inconsistent

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Improving Patient Safety General Findings from
RCA Reviews

• Findings
• Conducting an RCA
• Plans for what to review are inconsistent
• Review of medical records, policies, procedures,
  maintenance logs, site inspections, staff
  interviews strengthen data collection
• Short training session about how to conduct RCA
  for members can be helpful
• Development of team member roles
• RCAs can be accomplished in 3 meetings with good
  planning
• Review proximate factors at meeting
• Formulate specific causal statements

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Improving Patient Safety General Findings from
RCA Reviews

• Findings
• Outcome Measures
• Improvements changes are successful when
  processes become routine or habit or new
  employees demonstrate proper procedure after
  orientation
• Communication plans are not always developed for
  internal and external release
• Data analysis plan often unspecified
• Plans to include these findings in administrative
  rounds or 24 hour reports reinforces culture of
  safety

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Thank You!

• Randy Benson, PhD
• Executive Director
• Rural Healthcare Quality Network
• 206-577-1821
• randyb_at_wsha.org