HospitalInspections.org

Based on review of facility policies, medical records (MR), and interview with staff (EMP), it was determined the medical staff failed to follow its bylaws by failing to abide by facility policies for obtaining informed consent and performing timeout prior to bedside procedures for two of twenty medical records reviewed (MR1, MR2).

Findings include:


Review of facility policy entitled "Universal Protocol: Pre-procedure Verification, Site Marking, and Time-Out ... POL-6953392", last revised 10/31/2023, revealed: " ... Allegheny Health Network will protect patient safety by correctly identifying the patient, the procedure, and the site prior to operative and invasive procedures, including procedures done for both diagnostic and treatment-related purposes. This policy applies not only to procedures being performed in the operating room but to other procedural rooms or at the beside. ... ".


Review of facility policy "General and Informed Consent ... POL-6241648 ...", last approved 5/19/2023, revealed: " ... Except in emergency situations, Informed Consent must be obtained from the patient or appropriate Legally Authorized Representative prior to the performance/administration of surgery; anesthesia; radiation; ... insertion of a surgical device or appliance ... It is the responsibility of the Physician who will perform, order or supervise the treatment or procedure to obtain the patient's Informed Consent. ...".


Review of MR1 revealed that on February 13, 2024 at 8:44 AM, the patient signed an informed consent for a right side thoracentesis. On February 13, 2024, at 9:34 AM, a left side thoracentesis was performed. Further review of MR1 revealed no time out was performed prior to the procedure.

Review of MR2 revealed the patient signed a informed consent on February 25, 2024 at 10:15 AM, for a "TALC Pleurodesis". On February 25, 2024 at 12:35 PM, a "Pleurodesis" was performed on the patient of MR2, but the site was not marked during the pre-procedure time out per facility policy.


Further review of MR2 revealed the patient consented to and underwent a left sided thoracentesis on March 1, 2024, at 4:44 PM. Further review of MR2 revealed the site was not marked during pre-procedure time out per facility policy.


The above was confirmed with EMP1 during medical records review on March 11, 2024, between approximately 11:00 AM and 1:00 PM.