NOTICES
DEPARTMENT OF HEALTH
Notice of List of Preventable Serious Adverse Events
[39 Pa.B. 4955]
[Saturday, August 15, 2009]Under the Preventable Serious Adverse Events Act, P. L. ,No. 1, the Department of Health (Department) is publishing the list of reportable serious adverse events adopted by the National Quality Forum (NQF). Any updates to this list will be published by the Department within 30 days of the issuance of the update by the NQF.
Serious Reportable Events in Healthcare
1. Surgical Events
A. Surgery performed on the wrong body part.
B. Surgery performed on the wrong patient.
C. Wrong surgical procedure performed on a patient.
D. Unintended retention of a foreign object in a patient after surgery or other procedure.
E. Intraoperative or immediately postoperative death in an ASA Class I patient.
2. Product or Device Events
A. Patient death or serious disability associated with the use of contaminated drugs, devices or biologics provided by the healthcare facility.
B. 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.
C. Patient death or serious disability associated with intravascular air embolism that occurs while being care for in a healthcare facility.
3. Patient Protection Events
A. Infant discharged to the wrong person.
B. Patient death or serious disability associated with patient elopement (disappearance).
C. Patient suicide or attempted suicide, resulting in serious disability while being cared for in a healthcare facility.
4. Care Management Events
A. Patient death or serious disability associated with a medication error (such as, errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration).
B. Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO/HLA-incompatible blood or blood products.
C. Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a healthcare facility.
D. Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a healthcare facility.
E. Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates.
F. Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility.
G. Patient death or serious disability due to spinal manipulative therapy.
H. Artificial insemination with the wrong donor sperm or wrong egg.
5. Environmental Events
A. Patient death or serious disability associated with an electric shock while being cared for in a healthcare facility.
B. 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.
C. Patient death or serious disability associated with a burn incurred from any source while being cared for in a healthcare facility.
D. Patient death or serious disability associated with a fall while being cared for in a healthcare facility.
E. Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a healthcare facility.
6. Criminal Events
A. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider.
B. Abduction of a patient of any age.
C. Sexual assault on a patient within or on the grounds of a healthcare facility.
D. Death or significant injury of a patient or staff member from a physical assault (that is, battery) that occurs within or on the grounds of a healthcare facility.
Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) should contact Department of Health, Bureau of Facility Licensure and Certification, Room 932, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120, (717) 787-8015 or for speech and/or hearing impaired persons at V/TT (717) 783-6154 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).
EVERETTE JAMES,
Secretary
[Pa.B. Doc. No. 09-1474. Filed for public inspection August 14, 2009, 9:00 a.m.]
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