Call Risk Management When the Unexpected Happens
Even with new regulations in place about reporting requirements and billing issues around serious reportable events (SREs), the responsibility of BWH physicians who may be involved with or discover an SRE has not changed.
Physicians and all clinical staff should call BWH Risk Management at 617-732-6442 or complete an online safety report whenever an unexpected adverse event occurs. "Communication is and always has been the key," said Janet N. Barnes, JD, RN, executive director of Clinical Compliance and Risk Management.
Since January 2008, hospitals and other health care facilities have been required to notify the Massachusetts Department of Public Health (DPH) of any of the 28 SREs as defined by the National Quality Forum (See list on page 10). DPH made the 2008 data public in April, and state health officials continue to refine reporting requirements and forms. SREs also must be reported to the Patient Care Assessment Division of the Board of Registration in Medicine.
"BWH supports increased transparency to improve patient care, and we have mechanisms and processes in place to support professional staff, report events to appropriate agencies and examine the circumstances around the event in order to improve our systems," said Tejal Gandhi, MD, MPH, executive director of Quality and Safety in the Center for Clinical Excellence at BWH.
In June, the DPH issued new cost-containment regulations associated with preventable SREs. According to the new state mandate, hospitals and other health care facilities may not charge or seek reimbursement from a patient or third-party payer for care services provided as a result of a preventable SRE that causes death or serious disability. Five state agencies—Medicaid, Health Safety Net, Commonwealth Connector, Group Insurance Commission and Department of Correction—also announced a uniform non-payment policy for costs associated with preventable SREs.
When alerted by a physician or other care provider of a potential adverse event or serious reportable event, BWH Risk Management staff will manage all reporting requirements and associated paperwork and work with the clinical team to examine what happened, whether it was preventable and what, if anything, can be done to make sure it does not happen again.
According to state regulations, the hospital must file a report with the DPH for all SREs within seven days of when the SRE was discovered. The hospital also must notify the patient of the event verbally and in writing. Risk Management will lead a root cause analysis of the event within 30 days and share its analysis with the DPH and work with Finance to determine whether or not the hospital plans to waive its costs.
Most SREs are not preventable, like falls, for example. In 2008, BWH reported 18 SREs to the DPH and more than half of them were patient falls that caused harm. Both Gandhi and Barnes said physicians should try and familiarize themselves with the 28 SREs as defined by the NQF although the goal is to report any events that are unexpected, and that cause harm or have the potential to cause harm to Risk Management. Events that may cause harm but would be preventable must be reported to Risk Management, too.
Some surgical cases may be more complex when it comes to determining whether or not it was preventable. Retention of a foreign object could be device related and may not cause disability or harm, but it still may require an additional procedure.
"Certain surgical issues may not seem like major events, but with some of the definitions, harm to the patient is irrelevant to reporting requirements," Barnes said. "Just let Risk Management know whenever in doubt."
More information on SREs is available online at http://qualityandsafety.partners.org/
SREs
Surgical Events
Wrong Body Part*
Wrong Patient*
Wrong Procedure*
Retention of a Foreign Object*
Death of ASA Class 1 Patient
*do not require death or serious disability
Product or Device Events
Use of Contaminated Drugs, Biologics or Device
Misuse/Malfunction of a Device
Air Embolism
Patient Protection Events
Infant Discharged to the Wrong Person
Patient Elopement
Patient Suicide
Care Management Events
Death or Serious Disability Due to a Medication Error
Death or Serious Disability Due to a Hemolytic Reaction
Death or Serious Disability In a Low-Risk Pregnancy, Labor or Delivery
Death or Serious Disability Associated with Hypoglycemia
Death or Serious Disability Associated with Failure to Treat Hyperbolirubinemia
Stage 3 Or 4 Pressure Ulcers Acquired After Admission
Death or Serious Disability Due to Spinal Manipulative Therapy
Artificial Insemination with the Wrong Donor Sperm or Donor Egg
Environmental Events
Death or Serious Disability Associated With an Electric Shock
Wrong Gas or Contamination in Patient Gas Line
Death or Serious Disability Associated With a Burn
Death or Serious Disability Associated With a Fall
Death or Serious Disability Associated With the Use of Restraints or Bedrails
Criminal Events
Care Ordered by Someone Impersonating an MD, RN, or Other Provider
Abduction of a Patient
Sexual Assault of a Patient
Death or Injury of a Patient or Staff From Physical Assault