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Based on policy and procedure review, record review, and intreview it was determined the facility failed to provide patient safety in that the facility allowed two of two Cardiologists to insert the Impella Heart Pump without being granted privileges to perform the procedure, have the required training, or consult with a cardiac surgeon per facility policy on eight of eight Patients (#1, #4, #7, #9, #10, #11, #16, and #17). The failed practice had the potential to affect all patients that receive the Impella Heart Pump and the likelihood of causing serious injury, harm, impairment or death by non-privileged practitioners without documented training. See CMS 2567 A0341.

Based on policy and procedure review and interviews, it was determined that the facility failed to assure that two of two Physician's ( #3 and #4) performing the Impella Heart Pump procedure were granted privileges to perform the procedure, have the required training, or have a consultation with a cardiac surgeon per the facility policy in six of six patients. The failed practice had the potential to affect all patients that receive the Impella Heart Pump and created the likelihood of causing serious injury, harm, impairment, or death by non-privileged practitioners due to the lack of documented training.

Findings:
A. Review of Facility's Med Staff/ Physician Privileges dated 10/28/18 on 03/23/21 revealed that Physician #3 and Physician #4 do not have privileges granted to perform Impella Heart Pump insertion.

B. Review of Facility's Policy and Procedure Titled "Impella Procedures for Cath Lab Policy" dated 02/19/20 showed the following:

1. Qualifications Physicians

a) On site didactic training utilizing the relevant Impella Course slides with documented participation by Abiomed Trainer and Physician. OR Completion of the relevant online Impella Training Program with the relevant console, on www.abiomedtraining.com. Completion - reviewed materials and passed exam.

2) Performed a minimum of two successful implants and explants of the Impella in the presence of an Abiomed representative.

B. Review of training records on 03/23/21 showed no evidence of training for two of two cardiologists inserting the Impella Heat Pump.

C. During interview with Quality Manager on 03/23/21, she verified that the only training for Physician #3 and #4 inserting the Impella Heat Pump was online training performed and there was no hands on training as stated in the facilitiy's policy.

D. Review of Facility's Med Staff/Physician Privileges on 03/23/21 dated 10/28/18 showed Physician #3 and Physician #4 with no privileges granted to perform the Impella Heart Pump insertion.

E. Review of Facility's Policy and Procedure Titled "Impella Procedures for Cath Lab Policy" and Policy and Procedure Titled "Impella Procedures for ICU Policy" both dated 02/19/20 showed the following: "The Impella is a temporary ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in an urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option"

F. On 03/23/21 in an interview with the CQO (Chief Quality Officer), she stated there is no Heart Surgeon practicing at the facility and there is no affiliation or consulting agreement with a Heart Surgeon.

G. During interview with CQO on 03/23/21and review of the query report obtained from the CQO on 03/23/21, she confirmed eight patients received the Impella Heart Pump from 09/01/20 to 03/22/21with following outcomes.

1) Patient's #1, #4, #7, #9, #16, and #17 were transferred to a higher level of care.

2) Patient #10 had the Impella pump device pulled in the Cath Lab and was discharged home.

3) Patient #11 expired. Review of the Death Note dated 01/07/21 by physician showed, "Shortly after the placement of pacemaker, Patient had a cardiac arrest. Time of death 12:16 PM."

E. The above findings A-G were verified by the CQO on 03/23/21.