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Based on interview and record review, the hospital failed to follow its policy and procedure for informed consent (the permission a patient gives a medical doctor (MD) to perform a test or procedure after the MD has fully explained the purpose, potential consequences, risks, and benefits) for one of 21 sampled patients (Patient 1) when the MD 1 was not notified Patient 1 was refusing a medical procedure. This failure had the potential for Patient 1 to be unaware of the reason for treatment and negative outcome of not accepting the treatment/care.

Findings:

During a review of the clinical record for Patient 1, the Palliative (serious illness) Care Additional Narrative, dated 3/1/19, at 2:32 PM, indicated "Patient was unsure if she wanted to move forward with PEG (percutaneous endoscopic gastrostomy) tube (a flexible feeding tube is placed through the abdominal wall and into the stomach, to allow nutrition, fluids and/or medications to be put directly into the stomach). . ."

During an interview with Patient 1, on 8/20/19, at 9:24 AM, she stated because she had failed the swallow evaluation (test to determine ability to safely swallow different textures and thickness of food and liquids) twice, she was told she needed a PEG tube. She stated she refused to have a PEG tube. Patient 1 stated she told the Palliative Care Nurse (PCN - specially trained nurse for people with serious illness), the Case Manager (CM), and the skilled nursing facility (SNF - provides nursing care prior to returning home) representative she did not want a PEG tube.

During an interview with PCN and review of the clinical record for Patient 1, on 8/22/19, at 12:59 PM, she stated Patient 1 had changed her mind about having a PEG tube. PCN stated she had a conversation with Patient 1, with the CM and the SNF representative. PCN stated Patient 1 was told she was improving, the PEG tube was not a forever deal, and she would starve to death without a PEG tube. It was noted there was no documentation MD 1 was notified of Patient 1's refusal for a peg tube. PCN confirmed the findings.

During an interview with Patient 1, on 10/9/19, at 12:16 PM, she stated the PCN was wrong, it (reconsideration of PEG tube) was not a second thought. Patient 1 stated she said from the very beginning that she did not want a PEG tube.

During a review of the policy and procedure titled "Consent and Informed Consent - California" dated 4/26/18, it indicated "L. Refusal of Treatment: 1. If a patient or the patient's legal representative refuses treatment, the proceduralist/practitioner shall be contacted immediately so that he or she can explain the reason for the treatment and the possible implications of not accepting the care."

Based on interview and record review, the hospital failed to follow its policy and procedure on informed consents (the permission a patient gives a medical doctor (MD) to perform a test or procedure after the MD has fully explained the purpose, potential consequences, risks, and benefits) when the MD failed to provide the required information for two of 21 sampled patients (Patient 1 and Patient 2) before the consents for surgical procedure were done. This failure had the potential for patients to receive insufficient information about the medical procedure and not fully participate in the plan of care.

Findings:

1. During a review of the clinical record for Patient 1, the Hospitalist (dedicated in-patient physician who works exclusively in a hospital) Progress Note dated 2/28/19, at 12:29 PM, indicated Patient 1's care was discussed with Family Member (FM) 1, as Patient 1 did not have the capacity to make decisions at that time.

During a review of the clinical record for Patient 1, the Gastroenterology (Digestive System) Consultation dated 2/28/19, indicated Patient 1 was admitted to the hospital following a stroke (blocked blood supply to the brain) and had failed a swallow evaluation (test to determine ability to safely swallow different textures and thickness of food and liquids) twice. The recommendation indicated to schedule Patient 1 for a Percutaneous Endoscopy Gastrostomy Tube placement [PEG tube, a flexible feeding tube is placed through the abdominal wall and into the stomach, to allow nutrition, fluids and/or medications to be put directly into the stomach].

During a review of the clinical record for Patient 1, the Physician's Order (PO) dated 2/28/19, at 7:21 PM, indicated "Esophagogastroduodenoscopy [an examination of the upper digestive tract using a camera attached to a flexible tube] with biopsy [tissue sample] and PEG tube placement. . .Nursing to witness consent after provider has explained risk/benefits."
During a review of the clinical record for Patient 1, the Authorization for Consent to Surgery or Special Procedure dated 3/1/19, at 5:15 AM, indicated "Your doctor has adequately explained to you the operation or procedure along with the risk, benefits, and alternatives, and the other information described above in this form; 3) you have had a chance to ask your doctors questions; 4) you have received all of the information you desire concerning the operation or procedure and the anesthesia. . ." The Authorization for Consent to Surgery was received from FM 1 by Registered Nurse (RN) 1 and RN 3 on the telephone.

During an interview with Risk Management (RM) and review of the clinical record for Patient 1, on 9/13/19, at 3:05 PM, the History and Physical-Gastroenterology dated 3/1/19, at 4:09 PM, indicated there was a check mark on the box "Informed Consent Documented." She was unable to find documentation of an informed consent with risks and benefits provided by MD 1 prior to FM 1 signing the Authorization for Consent for Surgery. She confirmed the Gastroenterology Consultation, dated 2/28/19, did not indicate a discussion with Patient 1 and Responsible Party regarding the risks, benefits, alternative treatments, and likelihood of success for the procedure had occurred. RM also confirmed the check mark on the box "Informed Consent Documented" in the History and Physical-Gastroenterology, was completed 11 hours after the authorization for consent for surgery was obtained.

During an interview with the Director of Surgical Services (DSS), on 9/13/19, at 2:04 PM, she reviewed the clinical file for Patient 1, and confirmed the surgical consent had been received from FM 1, by telephone, on 3/1/19, at 5:15 AM. DSS confirmed MD 1 documented the informed consent information had been provided to Patient 1 on 3/1/19, at 4:09 PM. DSS stated the nurse should confirm the patient had spoken to the MD and had been given the alternatives, risks and benefits before the patient's signature was witnessed on the authorization for surgery. DSS stated prior to the procedure, the MD would speak to the patient, answer any questions, and check the informed consent documented box on the history and physical-gastroenterology.

During an interview with RN 1, on 10/24/19, at 12:06 PM, she reviewed the clinical record for Patient 1 and confirmed she was one of the RNs who had received the Authorization for Surgery Consent by telephone. She stated it was facility practice for the night shift RNs to make telephone calls to the responsible party between 5 AM and 6 AM to receive verbal consents for surgical procedures that would occur that morning. She stated the night shift RNs would call to help reduce the day shift RNs work load. RN 1 stated the patient would sign the authorization for surgery if they were awake and aware. She stated the responsible party would be called if the patient was physically unable to sign, or if the patient was confused. RN 1 stated she asked if FM 1 was aware Patient 1 was scheduled for a procedure to have a tube placed into her stomach for nutrition. She stated he said he had heard something like that. RN 1 asked if FM 1 was aware of the risks and benefits of the procedure. She stated they spoke about five minutes until FM 1 consented to the authorization for surgery. RN 1 stated the MD may have documentation in the progress notes the informed consent information had been provided. She stated the Authorization for Surgery could be signed if the hospitalist had provided the risk and benefit information. RN 1 reviewed the PO, dated 2/28/19, at 7:21 PM, and confirmed it indicated "Nursing to witness consent after provider has explained risk/benefits."



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2. During a review of the clinical record for Patient 2, the Physicians Phone Order by MD 1 dated 10/21/19, at 12:22 PM, indicated "Esophagogastroduodenoscopy . . . Nursing to witness consent after provider has explained risk/benefits." The Authorization for Consent to Surgery or Special Procedure, dated 10/21/19, at 1 PM, indicated "your doctor had adequately explained to you the operation or procedure along with the risk, benefits, and alternatives, and the other information described above in this form; 3) you have had a chance to ask your doctors questions; 4) you have received all of the information you desire concerning the operation or procedure and the anesthesia..." The Authorization for Consent to Surgery was received from Patient 2 and witnessed by RN 2, on 10/21/19, at 1 PM. The History and Physical-Gastroenterology, dated 10/21/19, at 6:26 PM (5.25 hours after the authorization for surgery was signed), had a check mark on the box "Informed Consent Documented."

During an interview and review of the clinical record with RN 2 and RM, on 10/22/19, at 2:50 PM, RN 2 stated she recalled Patient 2 was admitted to the hospital by MD 3, on the previous Sunday, (10/20/19). She stated the MD 3 had told Patient 2 and his family, he would need a procedure for his gastrointestinal bleeding. RN 2 stated the next day (10/21/19), the telephone order from MD 1 for the procedure was in the computer. She stated Patient 2 signed his surgical consent. RN 2 stated the doctor doing the procedure should have explained the risk and benefits before Patient 2 signed the consent. She stated she had not confirmed MD 1 had provided the necessary information to make an informed consent to Patient 2 before the Consent to Surgery was signed.

During a review of the facility policy and procedure titled, "Consent and Informed Consent," dated 5/8/19, it indicated "a. The practitioner who ordered the procedure is responsible for providing the patient or patient's legal representative with the information that is necessary to allow an "informed decision" to be made and obtaining the informed consent or refusal. The informed consent or refusal must be obtained and documented prior to performance of the procedure. d. The practitioner who will perform the important part of the procedure (i.e., the surgeon (s), the anesthesiologist, radiologist, or other specialist) shall describe the nature of the services he or she will provide and any specific risks and possible complications associated with such service. The practitioner shall document in the patient's medical record that this discussion occurred and when consent was given or confirmed."