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Based on observation, interview, and record review the hospital failed to follow its policy and procedure (P&P) titled, "Consent and Informed Consent (Consent, a process where an individual gives voluntary agreement to a procedure, treatment, or action after receiving and understanding adequate information about its potential risks, benefits, and alternatives)"-California," for seven of 24 patients (Patient 4, Patient 2, Patient 3, Patient 20, Patient 24, Patient 25 and Patient 30) when:

1. A Consent for a nephrostomy tube (a tube placed in the kidney to drain urine) placement was not completed and in the medical record for one of 24 Patients (Patient 4).

2. A Consent was incomplete when the procedure, anesthesia and doctor performing the the procedure were left blank on the consent form for one of 24 Patients (Patient 2).

3. A Consent indicated a different procedure than the procedure ordered by the medical doctor for one of 24 Patients (Patient 3).

4. Computed Tomography (CT-medical imaging technique) Consents with contrast (a substance given to a patient to improve visibility during a imaging test) were not witnessed (verifys the person signing the consent is the patient or responsible person) for 4 of 24 Patients (Patient 20, Patient 24, Patient 25 and Patient 30).

These failures resulted in inaccurate and incomplete consents and had the potential for patients to have wrong site procedures.

Findings:

1. During a review of Patient 4's "History & Physical (H&P)," dated 6/3/25 at 6:29 p.m., the "H&P" indicated, "Pt [patient] BIBA [brought in by ambulance] for c/ [complaints of] left clogged nephrostomy tube ...Assessment/Plan ...IR [Interventional Radiology - specialized field that uses medical imaging to guide instruments for diagnosis and treatment] consulted, they will place nephrostomy tube tomorrow ..."

During a review of Patient 4's "Order Requisition (OR)," dated 6/3/25, the "OR" indicated, "CT Perc [percutaneous- through the skin] Nephrostomy Tube Plmnt [placement] ...Priority: Routine. Reason for Exam ...Obstructed Kidney ..."

During a review of Patient 4's "Moderate Sedation/Deep Sedation Form (MSDSF)," dated 6/3/25, the "MSDSF" indicated, "Date: 6/3/25. Planned Procedure: Nephrostomy Tube Insert ...Informed consent documented: Yes ..."

During a review of Patient 4's "CT Perc Nephrostomy Final Report (CTPNFR)," dated 6/4/25, the "CTPNFR" indicated, "Result Title: CT Perc Nephrostomy Tube Plmnt ...Impression: CT-guided percutaneous nephrostomy catheter [a small tube inserted into the body to drain fluids] placement ..."

During a review of Patient 4's "Progress Note (PN)," dated 6/4/25, the "PN" indicated, " ...Patient had a nephrostomy tube placement 6/4 ..."

During a concurrent interview and record review on 9/9/25 at 11:29 a.m. with Information Technologist Educator Registered Nurse (ITRN), Patient 4's "Medical Record (MR)," undated was reviewed. The "MR" indicated there was no consent for the Nephrostomy Tube Placement. ITRN stated there was not a consent completed for the nephrology tube placement for Patient 4.

During an interview on 9/9/25 at 11:33 a.m. with Director of Nursing (DON), the DON stated there was no consent noted in the chart but there should be one.

During a review of the facility's process for "Nephrostomy Tube," undated: " ...4. Verification & Documentation ...Confirm the consent form is signed by the patient (or authorized representative) and witnessed by the RN ...5. MD Documentation- Must Be Completed Pre-Procedure. Ensure the physician has completed and signed: the H&P, Informed Consent ..."

2. During a review of Patient 2's "H&P," dated 6/18/25, the H&P indicated, " ...brought to ER [Emergency Room] for dizziness and ground-level fall ...Patient was transferred intensive care [specialty unit provides highest level of medical care to adults] for further monitoring and care ..."

During a review of Patient 2's General Surgery Consultation (GSC)," dated 6/19/25, the "GSC" indicated, " ...CT scan of the abdomen and pelvis showed fluid around the gallbladder ...recommend IR cholecystostomy tube [tube placed in the gallbladder to drain fluid and reduce infection] as gallbladder does appear diseased ..."

During a review of Patient 2's "OR," dated 6/19/25, the OR indicated, "Procedure: CT Drain Peritoneal Abscess [a collection of pus and infected fluid in the abdominal area] ...Reason for Exam: Abscess. Special Instructions: gall bladder drain ..."

During a concurrent interview and record review on 9/9/25 at 10:00 a.m. with DON, Patient 2's "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures (ACSSDTP)," dated 6/19/25 was reviewed. The "ACSSDTP" indicated, "1. Your physicians and surgeons have recommended the following operation or procedure" was blank. The ACSSDTP indicated, "...the following type of anesthesia [medication given before surgical operations to lessen awareness and/or pain]" was blank. The ACSSDTP indicated, "...2. Name of the practitioner who is performing the procedure or administering the medical treatment," was blank. The DON stated the consent was completely blank including procedure name, anesthesia and name of doctor performing. DON stated these should have been completed. DON stated the consent was incomplete.

During a review of the facility's Process for "CT-guided biopsy, drain," undated: "Description: CT-guided biopsy and drain placement are minimally invasive procedures performed under computed tomography (CT) imaging to precisely target areas of concern within the body ...Work Standard Summary ...5. Pre-Procedure Requirements (MD to complete) ...informed consent ..."

3. During a review of Patient 3's "H&P," dated 7/2/25, the H&P indicated, " ...presented to the emergency department on [name of hospital] for one week of diffuse abdominal pain ..."

During a review of Patient 3's "GSC," dated 7/2/25, the GSC indicated, "Patient c/o [complains of] increased pain and swelling to RUQ [right upper quadrant] abdomen at gallbladder drain site ...Patient has a liver abscess on CT scan of the abdomen ...Patient needs to proceed with an IR guided drain placement of the liver abscess ..."

During a review of Patient 3's "OR," dated 7/5/25, the OR indicated, "Procedure: CT Cath [catheter] Drainage Perc Peri [around]/Retro [behind] Cavity ...Reason for Exam: Abscess ..."

During a concurrent interview and record review on 9/9/25 at 2:21 p.m. with ITRN, Patient 3's "ACSSDTP" was reviewed. The ACSSDTP indicated, "1. Your physicians and surgeons have recommended the following operation or procedure: CT guided Liver drain placement ..." The ITRN stated the order and consent do not match. ITRN stated it looks like two different procedures were completed.

During a review of Patient 3's "CT Cath Drainage Perc Peri/Retro Cavity Final Report (CCDFR)," dated 7/5/25 the "CCDFR" indicated, "Reason for Exam: Abscess. Report: CT-guided abscess drainage of peritoneal abscess ...Impression: CT-guided drainage of abscess as described area ..."

During an interview on 9/9/25 at 2:35 p.m. with DON, DON stated the consent and order do not match. DON stated two different orders were put in place for one procedure and the previous order was not canceled. DON stated the nursing staff should have also seen there were two orders in place and before completing the consent should have contacted the surgeon for clarification. DON stated the consent should have matched the order. DON stated this is an incomplete consent because it has the wrong procedure listed.


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4. During an observation on 9/8/25 at 1:45 p.m. in the CT modular, Computed Tomography Technician (CT) 1 completed a CT angio (angiography - medical imaging techniques that uses contrast dye to visualize blood vessels and blood flow) of the head and neck with contrast on Patient 20.

During a concurrent interview and record review on 9/8/25 at 2:20 p.m. with Manager of Radiology (MR), Patient 20's "Consent For/And Explanation of Intravenous Contrast Study (CFICS)" undated was reviewed. The "CFICS" indicated there was no witness signature. MR stated a witness signature was only required if the consent was signed by someone other than the patient.

During a review of Patient 24's "CFICS", undated, the CFICS indicated there was no witness signature.

During a review of Patient 25's "CFICS", dated 5/31/25, the CFICS indicated there was no witness signature.

During a review of Patient 30's "CFICS", undated, the CFICS indicated there was no witness signature.

During an interview on 9/9/25 at 11:12 a.m. with DON, DON stated all consents are required to have a witness signature. DON stated the witness signature confirms who signed the consent.

During a review of the facility's P&P titled "Medical Staff Rules and Regulations," dated 6/15/2022, the P&P indicated " ...B. INFORMED CONSENT FOR TREATMENT. An informed consent must be obtained for all surgical, therapeutic, and invasive procedures and for the administration of anesthesia and blood and blood products. Therapies which require informed consent include injection of contrast media or other hazardous agents. It is the treating practitioner's exclusive responsibility to obtain and document and informed consent. Informed consent must include the name of the licensed independent practitioner and any assistants, medical information regarding the nature of the treatment, its expected benefits or effects, its possible risks and complications, and any alternatives to the proposed treatment and their possible risks and complications. The treating practitioner's must document in the patient's medical record that a discussion of the planned procedure and anesthesia was held with the patient and that informed consent was obtained. Evidence of informed consent (copy of signed surgery permit from physician's office, documented in pre-operative history & physical, or documented by handwritten note in the patient's medical record) will be required before commencing with the intervention ..."

During a review of the facility's P&P titled, "Consent and Informed Consent-California," dated 3/6/2025, the P&P indicated, " ...E. Treatments/Procedures That Require an Informed Consent: ...a. Informed consent must be obtained for treatments/procedures that are "complex" in that they involve material risks that are not commonly understood ...c. Typically informed consent must be obtained for: ...ii. Invasive radiology or cardiology procedures. Iii. Procedures involving contrast ...v. The administration of anesthesia or sedation medication designated in the formulary ...4. Responsibility: a. The practitioner who ordered the procedure is responsible for providing the patient or patient's legal representatives 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 role of the health care facility in the informed consent process is to verify that the practitioner(s) obtained the patient's informed consent before the practitioner(s) is/are permitted to perform the procedure/tests ...2. Consent to Surgery or Special Procedure Form: a. The consent for should include: i. The name of the patient, and when appropriate the patient's legal representative. ii. The medical terminology for the procedure (without abbreviation) and the type of anesthesia to be used if applicable. iii. Name or names of practitioners who will perform important parts of the procedure/treatment/service. iv. Signature of witness ...vi. Ensure where signature is applicable that it is accompanied with a date and time ...4. The nursing staff shall be responsible for verifying that the documentation has been included in the chart prior to the surgery/procedure and checking this off the surgical checklist. If these conditions are not met, the practitioner performing the procedure must be contacted to obtain the required documentation. Non-emergency procedures will be delayed or canceled until the informed consent process has been completed and fully documented ...J. Witnessing: 1. The role of the witness: a. The role of the person asked to serve as the signature witness is limited to the attestation of the signatures. The witnessing person should not answer questions relating to the informed consent the patient may have about the proposed surgery or procedure and should refer all such questions back to the practitioner ..."