How, when and where to report an incident affecting patient safety

From the Massachusetts Nurse Newsletter
January/February 2005 Edition

By Mary Crotty, RN, MBA, JD
MNA Nurse Researcher

Many nurses have found themselves in situations where patient safety has been jeopardized, where a nurse’s voiced concerns have fallen on deaf management ears, or where there is a legal obligation for a nurse to report a patient safety-related incident of which a nurse becomes aware. Hospitals also have legal reporting requirements, but it is often unclear to nurses whether hospitals have met their legal reporting requirements.

The following information is intended to help nurses understand what their legal obligations are and what resources are available to assist them to protect their patients.

The Massachusetts Department of Public Health (DPH) has regulations governing the reporting by hospitals of incidents affecting the health and safety of patients. In addition, nurses themselves may have a duty to report certain behaviors that they observe.

If you are unclear whether your hospital has fulfilled its duty to report, please file again! In fact, the Division of Healthcare Quality has recommended this to MNA.

How to report

1. Contact the Division of Healthcare Quality (DHQ), which is the DPH agency that handles quality concerns. A report form which can be used for this purpose is below; you may modify it as you see fit; or
2. Similarly, you may use the form below but report anonymously; or
3. Contact your labor representative at the MNA, who will work with Mary Crotty, RN, JD, associate director of nursing, to file a complaint with DHQ; or
4. Contact Mary Crotty to follow up with your labor representative.

Call, during normal weekday business hours, the DPH intake staff in the Division of Healthcare Quality at 617.753.8150. After hours emergency callers may contact DHQ at 617.522.3700.

Mail reports to Department of Public Health, Division of Health Care Quality, Intake Unit, 10 West Street, Fifth Floor, Boston, Massachusetts 02111.

Note: Paul Dreyer is Director of DHQ. Phone 617.753.8000.

What to report

DPH regulations require that hospitals report fire, suicide, serious criminal acts, pending or actual strike, serious physical injury resulting from accidents or unknown causes, and other incidents that seriously affect the health and safety of patients.

MDPH definitions

• "Serious injury" means injury that is life threatening, results in death, or requires a patient to undergo significant diagnostic or treatment measures.
• "Accidents" include falls, burns, electrocutions, and other misadventures not related to patient treatment.
• "Other serious incidents that seriously affect the health and safety of patients" means incidents that result in serious injury. These include, but are not limited to: poisonings occurring within the facility; reportable infectious disease outbreaks; equipment malfunction or user errors; medication errors; and other incidents resulting in serious injury not anticipated in the normal course of events.

The list below from DPH gives examples as to which incidents are reportable to them.

‘Reportable’ and ‘non-reportable’

• Medication errors including, major I.V. therapy errors such as wrong rate or route, with serious complications (e.g., resulting in death, paralysis, coma, or permanent injury)
• Burns (e.g., hot liquids, equipment, hot packs)
• Slips or falls occurring within the facility that result in serious head injury, coma or permanent injury; or requiring significant additional therapeutic intervention or extended hospitalization.
• Major biomedical device or other equipment failure resulting in serious injury or having potential for serious injury to a patient, visitor, or employee. This would include user errors, as well as those device failures that must be reported to the U.S Food and Drug Administration pursuant to the Safe Medical Device Act.
• Surgical errors involving the wrong patient, the wrong side of the body, the wrong organ or the retention of a foreign object (e.g., sponge or clamp)
• Blood transfusion errors (e.g., wrong type of blood, outdated blood, blood not given when ordered, given to wrong patient, HIV sero-positive transfusion) with potential serious complications (Does not alter requirement for reporting under 105 CMR 135.000)
• Poisonings occurring within the facility
• Infectious disease outbreaks
• Criminal acts or allegations of abuse within the facility that result in serious harm (physical or mental) to a patient
• Fire
• Pending or actual staff strikes
• Supplier strikes that may seriously affect patient services
• Any maternal death within 90 days of delivery or termination of pregnancy
• Death of a patient by suicide
• Discharge of an infant to the wrong family.
• Presentation of an infant to the wrong mother for breast-feeding.
• Serious physical injury resulting from accident or unknown cause

"Non-Reportable Incidents" are adverse outcomes directly related to the natural course of a patient’s illness or underlying condition. Other non-reportable incidents include, but are not limited to:

• Medication errors that do not result in serious complications or diminish the therapeutic value of the medication (e.g., medication given early or late, missed dose)
• Minor reaction to medication or blood transfusion where reactions are controlled with minimum amounts of medication or palliative therapy
• Minor bio-medical device failure or damage resulting in no injury to patient, visitor, or employee
• Patient refuses treatment or procedure or leaves against medical advice
• Incorrect, needle, sponge, or instrument count corrected before surgical procedure is terminated
• Dietary problems that do not affect the patient’s status (e.g., food allergy)
• Treatment or procedure error with no residual effect (e.g., routine X-ray or lab test performed without order, or results posted late)
• Surgical procedure error with no residual effect, e.g., which does not require a patient to undergo significant additional diagnostic or treatment measures
• Slips or falls resulting in minor injury
• Minor injuries of unknown origin

Nurse’s duty to report

A nurse is required to report to the Massachusetts Board of Nursing if he or she directly observes another nurse engaged in any of the following:

(a) abuse of a patient; (b) practice of nursing while impaired by substance abuse; (c) diversion of controlled substances.

Any such report, by law, must be submitted honestly and in good faith.

Other statutory requirements

The Massachusetts Code of Conduct for Nurses also contains a number of other mandatory reporting and other requirements for nurses.

244 CMR 9.03(6) Compliance with Laws and Regulations Related to Nursing.

(a) A nurse who holds a valid license shall comply with M.G.L. c. 112, §§ 74 through 81C, as well as with any other laws and regulations related to licensure and practice. Examples of such laws include, but are not limited to, the following:

• obligation to report elder abuse disabled persons
• report of death to medical examiner
• Controlled Substances Act — requirement for possessing, dispensing, administering and prescribing controlled substances.
• obligation to report abuse of patient or resident
• obligation to report infant with swollen, red, or inflamed eye(s) or with unnatural discharge within two weeks after birth
• obligation to report examination or treatment of child with Reyes syndrome
• obligation to report lead poisoning
• obligation to report child abuse

Feel free to contact Mary Crotty, associate director of nursing at the MNA, for more information about this process:

Mary Crotty, RN, MBA, JD
Associate Director of Nursing
Massachusetts Nurses Association
340 Turnpike Street
Canton, MA 02021
Phone: 781.830.5743
Email: mcrotty@mnarn.org

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