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Ambulatory Surgery Center
Infection

Below are detailed descriptions of reportable adverse events, grouped by state or federal agency. Answer the question that appears beneath EACH description. When you're finished, click View Reporting Instructions to move to the next page.

Department of Public Health (through the National Healthcare Safety Network)

Health Care Associated Infections (HAI)

ASCs performing herniorrhaphies must report any herniorrhaphy-related surgical site infection in a patient at your facility that was not present on admission.

Please note that this question only refers to DPH requirements to report HAIs through the National Healthcare Safety Network (NHSN). DPH may modify these requirements from time to time.

Reference: M.G.L. c.111, §51H; 105 CMR § 140.309; Circular Letter #10-01-527 - 1/25/2010

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Department of Public Health

Serious Incident

DPH requires you to report, directly to the agency, any incident that seriously affected the health and safety of a patient or that caused serious physical injury to the patient. (If the infection you are reporting meets this criteria, it will involve a separate reporting mechanism than that used to report HAIs through NHSN.)

DPH uses the term “serious incident” to cover several broad categories of reportable events. In addition to the above, it also includes any of the following:

  • A patient death that is
    • Unanticipated
    • Unrelated to the natural course of the patient’s illness or underlying condition, or
    • The result of an error
  • Full or partial evacuation of the facility for any reason
  • Fire
  • Suicide
  • A serious criminal act
  • Pending or actual strike action by its employees, and contingency plans for operation of the facility
  • A surgery or anesthesia-related complication that result in serious morbidity or death of a patient
  • These events are reportable if they occurred on premises covered by your facility's license.

Reference: 105 CMR § 140.307. (Note that DPH has the regulatory authority to add to this list of serious incidents through guidance.)

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Quality and Patient Safety Division, Board of Registration in Medicine

Major Incident

QPSD requires you to report any major or permanent impairment of bodily functions or death of a patient not ordinarily expected as a result of the patient's condition on presentation. This is a Type 4 major incident.

QPSD defines major impairment as a significant change in the patient’s functional status either physically or mentally.

For your information, there are 3 other types of major incidents, which are reportable to QPSD regardless of the patient’s underlying condition.

  • Type 1. Maternal death related to delivery,
  • Type 2. Death in the course of, or resulting from, elective ambulatory procedures,
  • Type 3. Any invasive diagnostic procedure or surgical intervention performed on the wrong organ, extremity or body part.

Reference: 243 CMR § 3.08(2)

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Glossary
The Patient Safety Navigator is provided by the Betsy Lehman Center for informational purposes. You cannot submit adverse event reports or other data through the Navigator. Your use of the Navigator will not be monitored, and no data will be collected beyond what is explicitly noted in the Website Privacy Statement. Although the Betsy Lehman Center intends to maintain the Navigator’s contents, we cannot guarantee that the information will be accurate, complete, or up-to-date at all times. You should be aware that regulations and reporting systems are subject to change without our knowledge or could be interpreted differently by the agencies that oversee them. By using the Navigator, you agree that you are solely responsible for determining any reporting obligations applicable to you or your organization. For further terms and conditions, see the Terms of Use.
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