Event Reporting and Patient Safety

Lapses in patient safety are a major health care quality problem, and the occurrence of patient harm due to such lapses is remarkably common. In 1999, the Institute of Medicine (IOM) identified that between 44,000 and 98,000 deaths occur each year due to medical errors and recommended that health care errors be reported in an efficient manner. The Federal Government has concurred with the IOM’s recommendation for greater health care error and adverse event reporting. This led to the National Quality Forum (NQF) being asked to identify a standardized a list of preventable, serious adverse events that would promote reporting of such occurrences. The NQF now lists 29 adverse events as reportable errors. The events may result in patient death or serious disability. The NQF encouraged adoption of this list of serious reportable events by all states in order to enable systematic learning across healthcare organizations. The many efforts of the IOM and the NQF have established a solid foundation for recognizing and reporting systems of adverse events. Due to this groundwork, UCLA Health System has a long-standing commitment to reporting and holding ourselves accountable for serious reportable adverse events. Reporting events drives systematic national improvements in patient safety based on what is learned – both about the events and about how to prevent their recurrence.  Staff are encouraged to report all actual and near miss cases to allow for the opportunity to identify systems needing improvement.  The California Department of Public Health (CDPH) and Medi-Cal both mandate the reporting of events within 5 Days of the event's discovery.

CDPH Reportable Events

Effective July 2007, CDPH issued AFL 07-10 requiring all General Acute Care Hospitals, Acute Psychiatric Hospitals and Special Hospitals to report the occurrence of defined adverse events to CDPH.  In addition to reporting the event to the CDPH, the hospital must also inform the patient or the party responsible for the patient of the adverse event by the time the report is made.  If the hospital fails to report the adverse event, the department may assess a civil penalty in an amount not to exceed one hundred dollars for each day that the adverse event was not reported following the initial five day or twenty-four hour period. 

The defined CDPH adverse events are as follows:

Surgical Events

1. Surgery performed on a wrong body part that is inconsistent with the documented informed consent for that patient (excluding urgent surgery for which an informed consent cannot be obtained).
2. Surgery performed on the wrong patient.
3. The wrong surgical procedure performed on a patient, which is a surgical procedure performed on a patient that is inconsistent with the documented informed consent (excluding urgent surgery for which an informed consent cannot be obtained).
4. Retention of a foreign object in a patient after surgery or other procedure (excluding objects intentionally implanted or retained).
5. Death during or up to 24 hours after induction of anesthesia of a healthy patient.

Product or Device Events

6. Patient death or serious disability associated with the use of a contaminated drug, device, or biologic provided by the health facility.
7. 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.  "Device" includes but is not limited to a catheter, drain, specialized tube, infusion pump, or ventilator.
8. Patient death or disability associated with intravascular air embolism that occurs while being cared for in a facility (excluding certain neurosurgical procedures).

Patient Protection Events

9. Infant discharged to the wrong person.
10. Patient death or serious disability associated with patient disappearance for more than four hours (excluding competent adult patients).
11. Suicide or attempted suicide resulting in serious disability while being cared for in a health facility due to patient actions after admission.

Care Management Events

12. 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).
13. Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products.
14. Maternal death or serious disability associated with labor or delivery in low-risk pregnancy while being cared for in a facility, including events that occur within 42 days post-delivery (excluding deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy, or cardiomyopathy).
15. Patient death or serious disability directly related to hypoglycemia, the onset of which occurs while the patient is being cared for in a health facility.
16. Patient death or serious disability associated with failure to identify and treat hyperbilirubinemia (bilirubin levels >30 mg/dl) in neonates during the first 28 days of life.
17. Stage 3, Stage 4, and Unstageable ulcers acquired after admission to a health facility (excluding progression from Stage 2 to Stage 3 if Stage 2 was recognized upon admission).
18. Patient death or serious disability due to spinal manipulative therapy performed at the heath facility.

Environmental Events

19. Patient death or serious disability associated with an electric shock while being cared for in a health facility (excluding events involving planned treatments, such as electric countershock).
20. Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by a toxic substance.
21. Patient death or serious disability associated with a burn incurred from any source while being cared for in a health facility.
22. Patient death associated with a fall while being cared for in a health facility.
23. Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health facility.

Criminal Events

24. Any instance of care ordered or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider.
25. Abduction of a patient at any age.
26. Sexual assault on a patient within or on the grounds of a health facility.
27. Death or significant injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of a facility.
28. Any adverse event or series of adverse events that cause the death or serious disability of a patient, personnel, or visitor.

Medi-Cal Guidance on Reporting Provider-Preventable Conditions:

Effective July 1, 2012 all providers are required to report provider-preventable conditions (PPCs) that occur during treatment of Medi-Cal patients. Providers need to report all PPCs that are associated with claims for Medi-Cal payment or with courses of treatment prescribed to a Medi-Cal patient for which payment would otherwise be available. Providers do not need to report PPCs that existed prior to the initiation of treatment of the beneficiary.

Providers caring for patients with either Fee-For-Service (FFS) or Managed Care Plain (MCP) Medi-Cal must report to the Department of Health Care Services the discovery of a PPC after confirmation that the patient is a Medi-Cal beneficiary. Providers are to use the one page PPC reporting from (DHCS 7107), which includes a description of the PPCs. In addition, MCP network providers must also report the PPC to the beneficiary’s plan.

Please note that reporting PPCs for Medi-Cal beneficiaries to DHCS does not remove the reporting requirement of adverse events and health-care associated infections (HAI) to the California Department of Public Health pursuant to Health and Safety Code sections 1279.1 and 1288.55.

The defined PPC are as follows:

OPPCs are defined as:

• Wrong surgical or other invasive procedure performed on a patient
• Surgical or other invasive procedure performed on the wrong body part
• Surgical or other invasive procedure performed on the wrong patient

HCACs are defined as:

• Air embolism
• Blood incompatibility
• Catheter-associated urinary tract infection (UTI)
• Falls and trauma that result in fractures, dislocations, intracranial injuries, crushing injuries, burns and electric shock
• Foreign object retained after surgery
• Iatrogenic pneumothorax with venous catheterization
• Manifestations of poor glycemic control
  • Diabetic ketoacidosis
  • Nonketotic hyperosmolar coma
  • Hypoglycemic coma
  • Secondary diabetes with ketoacidosis
  • Secondary diabetes with hyperosmolarity
• Stage III and IV pressure ulcers
• Surgical site infection following:
  • Mediastinitis following coronary artery bypass graft (CABG)
  • Bariatric surgery, including laparoscopic gastric bypass, gastroenterostomy, and laparoscopic gastric restrictive surgery
  • Orthopedic procedures for spine, neck, shoulder, and elbow
  • Cardiac implantable electronic device (CIED) procedures
• Vascular catheter-associated infection
• For non-pediatric/obstetric population, deep vein thrombosis (DVT)/pulmonary embolism (PE) resulting from:
  • Total knee replacement
  • Hip replacement

Frequently Asked Questions about PPCs can be found on this website:
http://www.dhcs.ca.gov/individuals/Pages/PPCFAQ.aspx