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Based on interview, record and policy review, the facility failed to provide evidence of an informed consent for the return to surgery of 1 (SP#1) of 3 sample patients (SP).

Findings include:

Review of sample patient (SP) #1 Consent for Operation/Procedure dated 11/11/2020 at 9:14AM documented: Description of operation/procedure: Lung Transplant; Anatomical Location: Right.

Interview with Medical Director Transplant Services on 01/11/2021 at 1:48PM revealed the consent for SP#1 return to surgery is included on the surgical consent as an addendum.

Review of SP#1 Consent for Operation/Procedure dated 11/11/2020 at 9:14AM documented: Addendum/Further Specifications: Multiple Bronchoscopies and Samples. Possible Open Chest Delayed Chest Closure with Multiple Washouts.

Review of SP#1 Final Operative Report dated 11/21/2020 at 10:31AM documented Date of Operation: 11/12/2020. Diagnosis: Status post single lung transplant under right leakage of the bronchial anastomosis. Procedure: Revision of the bronchial anastomosis.

Interview with Transplant Services Risk Manager on 01/11/2021 at 12:44PM revealed that returns to the operating room are covered on SP#1 Consent for Operation/Procedure dated 11/11/2020. Staff unable to identify. Return to the operating room was not listed on SP#1 Consent for Operation/Procedure as a specified risk. Acknowledged facility does not have documentation evidence of the surgical consent for the return to surgery for SP#1.

Review of Policy No. 150A, Subject: Informed Consent Process, Last Revised:12/10/2020, documented E. Completing the Consent for Treatment Forms, 2. Informed Consent for Specific Treatment, i. A new consent for specific treatment must be executed if the planned treatment or procedure is materially different from the originally proposed treatment or procedure.

Facility failed to provide evidence of informed consent for Procedure: Revision of the bronchial anastomosis.