HospitalInspections.org

Based on record review and interview, the hospital failed to ensure the medical staff were accountable to the governing body for the quality of medical care provided to patients. This deficient practice was evidenced by failing to implement options and recommendations timely to ensure patient care is protected for a physician (S4MD) involved in quality related event for 1 (#1) of 3 (#1-#3) sampled patients.
Findings:

Review of Patient #1's medical record revealed the patient was a 90 year old admitted to the hospital on 04/19/2024 with diagnosis of bradycardia. Further review revealed the patient went for a permanent pacemaker procedure on 04/22/2024 and expired.

Review of the hospital Medical Executive Committee (MEC) meeting minutes presented by S3Regulatory Director from meeting dated 05/21/2024 revealed, in part: Mortality Review - Old Business: 90 year old (Patient #1) pacemaker insertion (04/22/2024). The committee was informed that a review by the Cardiology Chair has taken place. The Committee Chair provided the results of additional review, which informed the committee of the following: During the procedure, a pacemaker lead became stuck in the ventricle, which resulted in a rupture. Pericardiocentesis was performed. The record indicates that the nursing staff expressed concerns with the patient's quickly deteriorating condition, stating that the physician refused to call a code and begin CPR. Subsequently, a code was called and a second cardiologist presented who essentially ran the code, with the cardiologist, originally involved in the procedure leaving the room. All efforts were made to resuscitate the patient, including assistance from the product representative who was present during the procedure. Committee members acknowledged the fact that the physician performing the procedure has been involved in other quality-related events and is, in fact, the physician involved in the ongoing review, as documented earlier in these minutes. To that end, the Committee considered options to ensure patient care is protected, as follows:
Handled through the Ochsner employment process.
Suspension of Interventional Cardiology Privileges until the physician agrees to undergo a full competency assessment at an outside facility.
Upon discussion conclusion, the Committee recommended the following:
1. The Committee Chair will address the issue with (Chief Medical Officer) prior to next week's MEC;
2. The item is to be presented at next week's MEC for their review and recommendation.

Review of the hospital Cardiology Department procedures revealed, in part, S4MD performed pacemaker insertions on 05/06/2024, 05/10/2024, and 06/03/2024.

In an interview on 06/17/2024 at 12:31 p.m., S3Regulatory Director was asked if the hospital had implemented any of the MEC options and/or recommendations. S3Regulatory Director confirmed that the hospital had not and will be discussed and reviewed at next MEC meeting.

Based on record review and interview, the hospital failed to ensure medical records included properly executed informed consent forms for procedures. This deficient practice was evidenced by informed consents that were not dated and timed by the physician performing the procedure for 2 (#1, #3) of 3 (#1-#3) sampled patients.
Findings:

1. Review of Patient #3's medical record revealed the patient was admitted to the hospital on 04/13/2024 with diagnosis of symptomatic bradycardia.

Review of Patient #3's medical record revealed a consent for Permanent Pacemaker Placement that was not dated and timed when signed by the performing physician.

2. Review of Patient #1's medical record revealed the patient was admitted to the hospital on 04/19/2024 with diagnosis of bradycardia.

Review of Patient #1's medical record revealed a consent for Cardiac Catheterization that was not timed when signed by the performing physician.

In an interview on 06/17/2024 at 12:33 p.m., S3Regulatory Director confirmed that informed consent for procedures should be dated and timed by the performing physician when consent obtained. S3Regulatory Director confirmed the consents for Patient #1 and Patient #3 were not dated and timed by the performing physician.