Serious Reportable Events

What are we measuring and why?

The term Serious Reportable Events (SRE) was coined by the National Quality Forum (NQF). NQF is a national not-for-profit membership organization created to develop and implement a comprehensive approach for health care quality measurement, reporting, and improvement. Representing a diverse group of members as a public-private partnership, the NQF is committed to developing common methods of measuring health care quality, with the explicit purpose of making health care better and safer. To learn more about the National Quality Forum Serious Reportable Events Report and Safe Practices, visit www.qualityforum.org.

Beginning in January 2008, all Massachusetts hospitals were mandated to collect and report any Serious Reportable Event to the state Department of Public Health. Mass General has been collecting and reporting the NQF-endorsed SREs since 2007.

NQF has defined six categories of SREs that include 28 specific event types that they recommend we track and report. These categories are:

Surgical:  Any instance of surgery performed on the wrong body part, wrong patient, or when the wrong surgical procedure is performed. All events of this type are reported, even if there is no serious disability or death. This category also includes an instance when a foreign object is unintentionally left inside a patient, and any instance of death of an otherwise very healthy patient either during surgery or in the recovery room.

Product or Device:  Any patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility. Also, in this category is any 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. Any patient death or serious disability associated with an intravascular air embolism that occurs while being cared for in a healthcare facility is also considered a product-or-device-related SRE.

Patient Protection:  This category includes an infant discharged to the wrong person, patient suicide or attempted suicide resulting in serious disability while being cared for in a healthcare facility. Finally, patient death or serious disability associated with a patient leaving the facility without permission is also in this category.

Care Management:  This category includes patient death or serious disability associated with the following: medication error, hemolytic reaction (abnormal breakdown of red blood cells) due to the administration of incompatible blood or blood products, maternal death associated with labor or delivery in a low-risk pregnancy while being cared for in a healthcare facility, and the onset of hypoglycemia (low blood sugar) while the patient is being cared for in a healthcare facility. This category also includes very serious pressure ulcers (bed sores) acquired after admission to a healthcare facility, artificial insemination with the wrong donor sperm or wrong egg, death or serious disability due to spinal manipulative therapy, or failure to identify and treat high blood bilirubin in newborns.

Environment:  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 toxic substances is an environment-related SRE. Also, any instance of patient death or serious disability associated with electric shock, a burn, a fall, or the use of restraints or bedrails while being cared for in a healthcare facility are all considered in this category.

Criminal:  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, or death or significant injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of a healthcare facility.

How are we doing?

MGH patients experienced 16 Serious Reportable Events (SREs) during 2008, in three of the six categories. Five events were in the surgical category. Three occurred in outpatient areas and were minor procedures involving injections. The other two surgical procedures were performed in the day-surgery unit. One event was an incorrect minor surgical procedure, and the second event was reported when a small piece broke off of an instrument and was retained in a dental cavity. This small piece was then successfully removed. No permanent harm, disability, or death occurred with any of these events, and all of the patients involved were fully informed about the events.

MGH patients experienced ten falls that were reported under the environment category. Most of the patients who fell were getting up to go to the bathroom or fell while getting up off an exam table. One patient fell while using a walking device for assistance. Of the ten, nine required surgery to correct a fracture that resulted from the fall.

MGH reported one event in the product or device category. A very sick patient with a serious brain abnormality had a procedure to control the associated bleeding. A coil used to control the bleeding during the surgical case malfunctioned and prematurely released. Only part of the coil could be removed. The patient died several days later, as a result of the original bleeding and a stroke associated with the coil. The Food and Drug Administration and the manufacturer were notified, alerting them that a new device is needed.

SURGICAL EVENTS
Wrong Body Part 3
MGH had three events of this type in 2008.
Wrong Patient 0
MGH had no events of this type in 2008.
Wrong Procedure 1
MGH had one event of this type in 2008.
Retention of Foreign Object 1
MGH had one event of this type in 2008.
Death of ASA Class 1 Patient 0
MGH had no events of this type in 2008.

PRODUCT OR DEVICE EVENTS
Use of Contaminated Drugs, Biologics or Device 0
MGH had no events of this type in 2008.
Misuse/Malfunction of a Device 1
MGH had one event of this type in 2008.
Air Embolism 0
MGH had no events of this type in 2008.

PATIENT PROTECTION EVENTS
Infant Discharged to the Wrong Person 0
MGH had no events of this type in 2008.
Patient Elopement [Disappearance] 0
MGH had no events of this type in 2008.
Patient Suicide 0
MGH had no events of this type in 2008.

CARE MANAGEMENT EVENTS
Death or Serious Disability due to a Medical Error 0
MGH had no events of this type in 2008.
Death or Serious Disability due to a Hemolytic Reaction 0
MGH had no events of this type in 2008.
Death or Serious Disability in a Low Risk Pregnancy, Labor or Delivery 0
MGH had no events of this type in 2008.
Death or Serious Disability associated with Hypoglycemia 0
MGH had no events of this type in 2008.
Death or Serious Disability associated with Failure to Treat Hyberbilirubinemia 0
MGH had no events of this type in 2008.
Stage 3 or 4 Pressure Ulcers Acquired after Admission 0
MGH had no events of this type in 2008.
Death or Serious Disability due to Spinal Manipulative Therapy 0
MGH had no events of this type in 2008.
Artificial Insemination with the Wrong Donor Sperm or Donor Egg 0
MGH had no events of this type in 2008.

ENVIRONMENTAL EVENTS
Death or Serious Disability associated with an Electric Shock 0
MGH had no events of this type in 2008.
Wrong Gas or Contamination in Patient Gas Line 0
MGH had no events of this type in 2008.
Death or Serious Disability associated with a Burn 0
MGH had no events of this type in 2008.
Death or Serious Disability associated with a Fall 10
MGH had ten events of this type in 2008.
Death or Serious Disability associated with use of Restraints or Bedrails 0
MGH had no events of this type in 2008.

CRIMINAL EVENTS
Care Ordered by Someone Impersonating an MD, RN, or other provider 0
MGH had no events of this type in 2008.
Abduction of a Patient 0
MGH had no events of this type in 2008.
Sexual Assault of a Patient 0
MGH had no events of this type in 2008.
Death or Injury of a Patient or Staff from Physical Assault 0
MGH had no events of this type in 2008.

These events are reported to the Massachusetts Department of Public Health. Click here for details.

What are we doing to improve?

All Serious Reportable Events are extensively reviewed and analyzed as part of our ongoing and comprehensive safety reporting system. All hospital staff and employees have access to computer terminals and are encouraged to report events so that investigations can be conducted and improvements can be made.

To reduce the risk of any wrong-site surgeries or procedures, the Center for Quality and Safety has reviewed and revised our policy that specifies the correct procedures leading up to a procedure, with a special emphasis on ensuring that all of our ambulatory procedure areas are fully aware of the expectations.

This new policy, in line with guidance from the 2009 Joint Commission standards, is known as the Universal Protocol and includes what is referred to commonly as “the time out”. An improved monitoring system is also being put into place to reinforce the policy and give us better feedback on how we are doing across the institution.

The MGH staff is dedicated to preventing falls and patient injury associated with falling. Our philosophy is that one fall is too many. We have been monitoring our fall rates for years, and we have been active participants of the Patients First initiative sponsored by the Massachusetts Hospital Association.

What can you do?

Patients and their families can play a role in keeping patients as safe as possible in the hospital. We have seen situations where patients thought something was wrong and didn’t speak up. It’s our job to keep you safe, but you can play an important role too.

  • Please ask questions if you have doubts or concerns, and make sure you understand the answers.
  • Ask questions if you have doubts or concerns, and make sure you understand the answers.
  • Make sure you understand what will happen if you need surgery. Tell the surgeon, anesthesiologist, and nurses about any allergies, bad reaction to anesthesia, and any medications you are taking.
  • Before you go in for a procedure, ask to make sure the staff have the right information about you and the procedure you are having done.
  • Report anything unusual to your doctor, such as any changes in your condition.
  • Please speak up if you feel that something is not as it should be. We want your input.
  • When you are in a hospital or visiting someone in a hospital, be sure to check with the nurse to find out what kinds of precautions should be taken before getting out of bed.
  • Let your nurse or doctor know if you are concerned about falling. When patients are sick or recovering from an illness, it can be challenging to know just how much one can safely do. Check with your caregivers for help if you are unsure.

(Adapted from Patient Safety: Your Role in Making Healthcare Safer. Brochure accompanying video. National Patient Safety Foundation, 2002. Available at http://npsf.org/download/YourRoleVideoBrochure.pdf; Five Steps to Safer Health Care. Patient Fact Sheet. AHRQ Publication Number 04-M005, February 2004. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/consumer/5steps.htm.)

 

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