HospitalInspections.org

Citation Text for Tag 0131, Regulation FA19

Buchanan, Tina
Based on interview and record review, the hospital failed, for one of five patients who underwent cardiac catheterization (injecting contrast through a catheter into the coronary arteries and heart chambers) (Patient 602) to ensure the physician documented a discussion with the patient (or the patient's representative) regarding information required to make an informed decision prior to the procedure. This failure resulted in the potential for patients to undergo procedures without the necessary information needed to give a truly informed consent.

Findings:

The record for patient 602 was reviewed on June 12, 2012, at 1 p.m. Patient 602, a 75 year old female, underwent cardiac catheterization by physician D on May 22, 2012.

The record contained a standard procedural consent form signed by the patient and witnessed by a nurse, but no documentation by the physician of a discussion between himself and the patient regarding the risks, benefits, alternatives, and likelihood of success for the procedure. The Vice President of Quality reviewed the chart and agreed the record lacked evidence of informed consent by the physician.

Citation Text for Tag 0955, Regulation FA19

Buchanan, Tina
Based on interview and record review, the hospital failed, for one of five patients who underwent cardiac catheterization (injecting contrast through a catheter into the coronary arteries and heart chambers) (Patient 602) to ensure the physician documented a discussion with the patient (or the patient's representative) regarding information required to make an informed decision prior to the procedure. This failure resulted in the potential for patients to undergo procedures without the necessary information needed to give a truly informed consent.

Findings:

The record for patient 602 was reviewed on June 12, 2012, at 1 p.m. Patient 602, a 75 year old female, underwent cardiac catheterization by physician D on May 22, 2012.

The record contained a standard procedural consent form signed by the patient and witnessed by a nurse, but no documentation by the physician of a discussion between himself and the patient regarding the risks, benefits, alternatives, and likelihood of success for the procedure. The Vice President of Quality reviewed the chart and agreed the record lacked evidence of informed consent by the physician.