DHS Adverse Event Reporting Requirements

1
DHS Adverse Event Reporting Requirements

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

2
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

3
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

4
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
5
Surgical Events

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

6
Surgical Events

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

7
Surgical Events

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

8
Product or Device Events

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

9
Product or Device Events

• 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

10
Product or Device Events

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

11
Patient Protection Events

• An infant discharged to the wrong person

12
Patient Protection Events

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

13
Patient Protection Events

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

14
Care Management Events

• Death/serious disability associated with a
  medication error

15
Care Management Events

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

16
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

17
Care Management Events

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

18
Care Management Events

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

19
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)

20
Care Management Events

• Death/serious disability due to spinal
  manipulation at hospital

21
Environmental Events

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

22
Environmental Events

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

23
Environmental Events

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

24
Environmental Events

• Patient death/serious disability associated with
  a fall

25
Environmental Events

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

26
Criminal Events

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

27
Criminal Events

• Abduction of a patient of any age

28
Criminal Events

• Sexual assault of a patient

29
Criminal Events

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

30
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