HospitalInspections.org

Based on document review, observation, and interview, it was determined that for 4 of 4 Hospital Staff (MD #1/Radiologist, E #1/Registered Nurse/RN Navigator, E #2, RN Navigator, and E #3/RN Navigator) observed and interviewed regarding provision of informed consent, the Hospital failed to adhere to the process for obtaining consent to a procedure, to ensure patient's right to make an informed decision.

Findings include:

1. On 4/12/2023, the Hospital's policy titled, "Informed Consent for Treatment, Procedure or Surgery (other than for investigational devices, procedures, or drugs)" (revised 3/23/2020) was reviewed and required, " ... Policy ... C.1. Informed consent is required for any invasive procedure ... a. It is the responsibility of the ... physician performing the... procedure to obtain an informed consent from the patient ... b. It is the obligation of the (Name of the Hospital) nursing personnel ... to confirm that such informed consent has been obtained ... 4 ... b. The appropriate consent form will be signed by the patient or surrogate after the physician has obtained an informed consent for the treatment or procedure ..."

2. On 4/12/2023, the Hospital's policy titled, "Ultrasound Guided Breast Biopsy Procedure" (revised on 1/2/2023) was reviewed and required, " ...Policy ... 1. Before Biopsy ... h. Informed consent must be obtained and documented prior to breast biopsy ... B. Procedure ... A. At Time of Biopsy ... 2. Along with the MD (medical doctor), explain the procedure to the patient. 3. Obtain signed consent ..."

3. On 4/12/2023 at approximately 10:30 AM, an observational tour of the Hospital's Women's Center (Breast Program) was conducted. During the tour, there were two patients scheduled for an ultrasound guided breast biopsy. One of the two patients (Pt. #2) was waiting for her procedure:

- At approximately 10: 40 AM, E #1 called Pt. #2 from the waiting area. E #1 and Pt. #2 proceeded to a patient room where E #2 explained the scheduled procedure, name of the physician performing the procedure (MD #1), how the procedure will be done, including rationale regarding implantation of a titanium marking clip after the breast biopsy. MD #1 was not present during explanation of the procedure and when Pt. #2's signature was obtained.

4. On 4/12/2023, between approximately 1:18 PM through 1:45 PM, interviews were conducted with E #1, E #2, and E #3 (RN Navigators). E #1, E #2, and E #3 stated that the department's practice is that the RN Navigator obtains the patient's signature before the patient meets the physician performing the procedure. The three RN's also stated that the physician performing the procedure is not present during explanation of the procedure and when a patient's signature is obtained.

5. On 4/12/2023, at approximately 1:45 PM, an interview was conducted with MD #1 (Radiologist). MD #1 stated that, before the procedure starts, she is not present when the RN Navigator explains details of the procedure. MD #1 stated that for ultrasound guided breast biopsy, she does not normally repeat the explanation regarding the use of titanium marking clip given by the RN Navigator before the procedure starts.