DHS Adverse Event Reporting Requirements

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DHS Adverse Event Reporting Requirements

• With Associated Revisions to the UCLA Event
  Reporting System
• Presented by the Quality Resource Department
• June 6, 2007

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Senate Bill 1301

• Added sections to the Health and Safety Code
  mandating California hospitals report Never 27
  Adverse Events to DHS
• Never 27 Adverse Events is a list of serious
  reportable events in health care that should
  never occur
• Reporting effective July 1, 2007

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Adverse Event Reporting to DHS

• Specific adverse events must be reported to DHS
  within 5 days of discovery and within 24 hours if
  the adverse event is an ongoing urgent or
  emergent threat to the safety of patients, staff,
  or visitors
• DHS will assess fines if the event is not
  reported in the defined time frame

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Process for Reporting DHS Adverse Events
2. Adverse Event Reported in Event Reporting
System
1. Adverse Event Occurs
3. Email Automatically Sent to DHS Coordinator
with Link to Event Report
4. Investigation into Adverse Event and Reported
to DHS if Appropriate
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Surgical Events

• Surgery performed on a wrong body part
• Surgery performed on the wrong patient
• Wrong surgical procedure performed

Current EVR Category/ Subcategory Revision
Surgical Issues/ Wrong Site Instructions for Subcategory Use this subcategory for wrong site, wrong side, wrong patient or wrong surgery/procedure. Revised question Was the surgery/procedure performed on the wrong site/side, on the wrong patient OR was the wrong surgery/procedure performed? Add Wrong patient as answer option
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Surgical Events
Current EVR Category/ Subcategory Revision
Surgical Issues/ Retained Material and Surgical Issues/ Counts No revision to Event Reporting System

• Unintentional retention of foreign object in a
  patient after surgery or other procedure

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Surgical Events

• Unexpected death during anesthesia or within 24
  hours after induction of anesthesia

Current EVR Category/ Subcategory Revision
Surgical Issues/ Death in OR Cardiac/ Respiratory Arrest/ Cardiac Arrest and Respiratory Arrest Revise Subcategory to Death in OR or Within 24 Hours of Anesthesia Add required question Did the patient have surgery/ anesthesia within 24 hours prior to arrest?
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Product or Device Events
Current EVR Category/ Subcategory Revision
Medication Related Events/ Medication Errors/Delays Medical Devices/ Equipment Blood Transfusion/ Recipient Reaction or Complication Add required question Did death or serious disability result from administering a contaminated drug? Add required question Did death or serious disability result from using a contaminated device or from use or function of a device in ways other than intended? Add required question Did death or serious disability result from the use of a contaminated biologic?

• Patient death/serious disability associated with
  the use of a contaminated drug/device or biologic

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Product or Device Events
Current EVR Category/ Subcategory Revision
Medical Devices/ Equipment IVs, Tubes, Catheters, Drains/Other Respiratory Care/Ventilator/ Ventilator Management Add required question Did death or serious disability result from using a contaminated device or from use or function of a device in ways other than intended? Add required question Did death or serious disability result from use or function of a catheter, drain or tube in ways other than intended? Add required question Did death or serious disability result from use or function of a ventilator in ways other than intended?

• Patient death/serious disability associated with
  the use/function of a device in ways other than
  intended catheter, drain, or other specialized
  tube, infusion pump, or ventilator

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Product or Device Events
Current EVR Category/ Subcategory Revision

• Patient death/serious disability associated with
  intravascular air embolism (excluding certain
  neurosurgical procedures)

IVs, Tubes, Catheters, Drains Dialysis Related Issues/ Treatment Complication Add Subcategory Intravascular Air Embolism Add required questions What type of device was used? and Did death/serious disability occur as an outcome of the intravascular air embolism? Add Death/serious disability due to intravascular air embolism to option list under Treatment Complications
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Patient Protection Events

• An infant discharged to the wrong person

Current EVR Category/ Subcategory Revision
Perinatal Issues/ Patient Identification Add required question Was an infant discharged to wrong person?
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Patient Protection Events

• Patient death/serious disability associated with
  patient disappearance for more than four hours
  (excluding adults with capacity)

Current EVR Category/ Subcategory Revision
Behavioral (Patient Only)/ Unauthorized Patient Absence Add required question Did patient death/serious disability occur associated with a patient disappearance for more than four hours?
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Patient Protection Events

• Patient suicide or attempted suicide while being
  cared for in a health facility resulting in
  serious disability

Current EVR Category/ Subcategory Revision
Behavioral (Patient Only) Add Subcategory Suicide or Attempted Suicide Add required question Was the result death or serious disability?
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Care Management Events

• Death/serious disability associated with a
  medication error

Current EVR Category/ Subcategory Revision
Medication Related Events/ Medication Errors/Delays No revision to Event Reporting System
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Care Management Events

• Death/serious disability associated with a
  hemolytic reaction due to the administration of
  ABO-incompatible blood or blood products

Current EVR Category/ Subcategory Revision
Blood Transfusion/ Wrong Product Transfused Add required question Did death or serious disability occur as a result of a hemolytic reaction due to the administration of ABO- incompatible blood or blood products?
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Care Management Events

• Maternal death/serious disability associated in
  low-risk pregnancy (including 42 days post
  delivery) excluding deaths from
  pulmonary/amniotic fluid embolism, acute fatty
  liver of pregnancy, cardiomyopathy

Current EVR Category/ Subcategory Revision
Perinatal Issues Add Subcategory Unanticipated Maternal Death Add required question Did a maternal death or serious disability occur associated with labor and delivery in a low-risk pregnancy including events that occur within 42 days post delivery? Revise Subcategory Unanticipated Death to Unanticipated Newborn Death
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Care Management Events

• Death/serious disability directly related to
  hypoglycemia onset in hospital

Current EVR Category/ Subcategory Revision
Diagnosis/ Treatment Issues Cardiac/ Respiratory Arrest/ Cardiac Arrest and Respiratory Arrest Add Subcategory Hypoglycemia Add required question Did death or serious disability occur related to hypoglycemia onset in hospital? Add required question Was the patient hypoglycemic prior to the arrest?
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Care Management Events

• Death/serious disability associated with failure
  to identify and treat hyperbilirubinemia in
  neonates during the first 28 days of life

Current EVR Category/ Subcategory Revision
Perinatal Issues Add Subcategory Hyperbilirubinemia (Neonates lt 29 days) Add required question Did death or serious disability result from the failure to identify and treat hyperbilirubinemia in a neonate during the first 28 days of life?
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Care Management Events

• Stage 3 or 4 ulcer acquired after admission
  (excluding progression from Stage 2 to Stage 3 if
  Stage 2 was recognized upon admission)

Current EVR Category/ Subcategory Revision
Skin Issues/ Pressure Ulcers No revision to Event Reporting System
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Care Management Events

• Death/serious disability due to spinal
  manipulation at hospital

Current EVR Category/ Subcategory Revision
Not specified in Event Reporting System No revision or triggers for this event
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Environmental Events
Current EVR Category/ Subcategory Revision

• Patient death/serious disability associated with
  an electric shock (excluding planned treatments)

Environmental Safety Medical Devices/ Equipment Add Subcategory Electrical Shock (Excluding Planned Treatment) Add required question Did death or serious disability result from electrical shock (excluding planned treatments electric countershock)? Add required question Did death or serious disability result from electrical shock (excluding planned treatments electric countershock)?
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Environmental Events

• Any incident where line designated for oxygen or
  other gas contains wrong gas or is contaminated
  by toxic substance

Current EVR Category/ Subcategory Revision
Respiratory Care/Ventilator and Anesthesia Issues Add Subcategory Medical Gases Add required question Did a line designated for oxygen or other gas deliver the wrong gas or was it contaminated by a toxic substance?
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Environmental Events

• Patient death/serious disability associated with
  a burn incurred from any source while being cared
  for in a health care facility

Current EVR Category/ Subcategory Revision
Falls/Injury other than Falls (Patient) Revise Subcategory Injury other than Fall to Other Injuries Add Subcategory Burn Add required question Did death or serious disability result from the burn?
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Environmental Events

• Patient death/serious disability associated with
  a fall

Current EVR Category/ Subcategory Revision
Falls/Injury other Than Falls/ Inpatient Fall No revision to Event Reporting System
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Environmental Events

• Patient death/serious disability associated with
  the use of restraints or bedrails

Current EVR Category/ Subcategory Revision
Falls/Injury other than Falls Add Subcategory Restraints/ Bedrails Add required question Did death or serious disability occur in association with the use of restraints or bedrails?
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Criminal Events

• Care ordered or provided by someone impersonating
  a licensed health care provider

Current EVR Category/ Subcategory Revision
Security Issues Add Subcategory Impersonation of a Licensed Health Care Provider
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Criminal Events

• Abduction of a patient of any age

Current EVR Category/ Subcategory Revision
Security Issues Add Subcategory Patient Abduction
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Criminal Events

• Sexual assault of a patient

Current EVR Category/ Subcategory Revision
Security Issues Add Subcategory Sexual Assault of a Patient
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Criminal Events
Current EVR Category/ Subcategory Revision

• Death or significant injury of a patient or staff
  member resulting from physical assault

Security Issues Employee Injuries/ Assault and/or Battery Against a Healthcare Worker Add Subcategory Physical Assault of Patient Add required question Did death or significant injury occur as a result of the physical assault? No revision to Event Reporting System
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Never Event 28

• An adverse event or series of adverse events that
  cause the death or serious disability of a
  patient, personnel, or visitor.

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Whats Next?

• Staff education provided regarding new reporting
  requirements
• Revisions to Event Reporting System go live
  June 15th
• Reporting to DHS effective July 1, 2007
• January 1, 2009 Information will be made
  readily accessible to consumers about
  substantiated adverse events and investigation
  outcomes
• January 1, 2015 Substantiated adverse events
  and investigation outcomes will be available on
  the DHS website