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Based on document review and interview, it was determined that for 1 of 4 (Pt. #1) clinical records reviewed for patients with ileostomy (part of small intestine connected to the abdominal wall), the hospital failed to document that the patient was fully informed regarding the nature and plan for the proposed procedure.

Findings include:

1. On 7/30/2024, the clinical record for Pt. #1 was reviewed. On 5/08/2024, Pt. #1 came to the hospital for an outpatient colonoscopy (examination of the colon) procedure. Pt. #1 diagnosis was adenocarcinoma (a type of cancer) of the sigmoid colon (portion of the large intestine). Pt. #1 presents with a diverting loop ileostomy (part of small intestine connected to the abdominal wall). The clinical record included:

- At 7:38 AM, MD #1 (Gastroenterologist) examined Pt. #1. MD #1's notes indicated, " ... (Pt. #1) ... here for GI (gastrointestinal) evaluation ... Past Medical History ... Physical Exam ... Recommendations: GI Evaluation/colonoscopy. Risk and benefits of procedure including perforation, bleeding and missed lesions was (discussed with Pt. #1)..."

- At 9:16 AM, Pt. #1 signed the Consent for Surgery/Procedure that indicated, " ... 7. Your provider is (MD #1) who has recommended the following surgery or procedure to be beneficial in the diagnosis and/or treatment of your condition ... Description of Surgery or Procedure ... Colonoscopy with possible biopsy, snare polypectomy (polyp removal) and ablation (cautery) of lesion with thermal therapy and possible stent (hollow tube) placement and possible tattooing ..." The consent was also signed by MD #1 and witnessed by E #2 (Pre-op Nurse).

- MD #1's operative report indicated, "Procedure: Colonoscopy ...After obtaining informed consent, the scope was passed under direct vision... The colonoscope was introduced through the ileostomy and advanced to the terminal ileum. The colonoscopy was performed without difficulty. The patient tolerated the procedure well. The quality of the bowel preparation was good ..."

- The consent did not indicate that the colonoscopy will be done through the ileostomy. The clinical record also did not indicate that MD #1 explained to Pt. #1 that another procedure will be performed at a later time because a full examination of the colon could not be performed because Pt. #1 did not receive appropriate bowel preparation.

2. On 7/30/2024, the hospital's policy titled, "Informed Consent" (11/2021) was reviewed and included, "... Process... The informed consent discussion and the documentation of information discussed, is the responsibility of the provider... The informed consent process includes discussion of the following elements... Nature of patient's condition... and reasons for the proposed... procedure (s)... "

3. On 7/31/2024 at approximately 10:50 AM, an interview was conducted with MD #1 (Gastroenterologist). MD #1 agreed that the colonoscopy consent should have indicated that the colonoscopy will be done through the ileostomy. MD #1 also agreed that there was no documentation that Pt. #1 was made aware of the plan that another procedure (sigmoidoscopy) will be done at another date because Pt. #1 did not receive appropriate bowel preparation.

4. On 7/31/2024 at approximately 2:35 PM, an interview was conducted with MD #2 (Gastroenterologist/Medical Director). MD #2 stated that the consent should have indicated that the procedure will be done through the ileostomy. MD #2 agreed that there should have been a documentation in the clinical record regarding the planned procedures to indicate that the patient was fully informed.

Based on document review and interview, it was determined that for 4 of 12 (Pt. #1, Pt. #6, Pt. #8, and Pt. #10) patients' clinical records reviewed who underwent procedures, the hospital failed to ensure that the operative reports included post-operative diagnosis.

Findings include:

1. On 7/30/2024, the hospital's policy titled, "Documentation for Patients with Procedures" (3/2024) was reviewed and included, "... Postoperative Documentation... The Operative Report will contain... Postoperative diagnosis..."

2. On 7/30/2024, the clinical record for Pt. #1 was reviewed. On 5/08/2024, Pt. #1 came to the hospital for an outpatient colonoscopy (examination of the colon) procedure. Pt. #1 has a diagnosis of adenocarcinoma (a type of cancer) of the sigmoid colon (portion of the large intestine). MD #1's (gastroenterologist) Operative Report indicated, "Procedure: Colonoscopy... The colonoscope was introduced through the ileostomy and advanced to the terminal ileum. The colonoscopy was performed without difficulty..." The operative report did not include a postoperative diagnosis.

3. On 7/31/2024, the clinical record for Pt. #6 was reviewed. On 7/19/2024, Pt. #6 came to the hospital for an outpatient colonscopy procedure. Pt. #6 had a pre-operative diagnosis of 'screening for colorectal malignant neoplasm (type of cancer)'. MD #1's Operative Report included, "...Procedure: ...the colonoscopy was performed without difficulty ...". The operative report did not include a postoperative diagnosis.

4. On 7/31/2024, the clinical record for Pt. #8 was reviewed. On 7/12/2024, Pt. #8 came to the hospital for an outpatient colonscopy procedure. Pt. #8 had a pre-operative diagnosis of 'abnormal CT (computed tomography/imaging technique to view internal images of the body) of GI (Gastrointestinal) tract'. MD #1's Operative Report included, "...Procedure: ...the colonoscopy was performed without difficulty ...Findings: the entire examined colon appeared normal on direct and retroflexion views ...". The operative report did not include a postoperative diagnosis.

5. On 7/31/2024, the clinical record for Pt. #10 was reviewed. On 6/28/2024, Pt. #10 came to the hospital for an outpatient colonscopy procedure. Pt. #10 had a pre-operative diagnosis of 'screening for colorectal malignant neoplasm (type of cancer)". MD #1's Operative Report included, "...Procedure: ...the colonoscopy was performed without difficulty ...Findings: ...the entire examined colon appeared normal on direct and retroflexion views ...". The operative report did not include a postoperative diagnosis.

6. On 8/1/2024 at approximately 12:00 PM, findings were discussed with E #11 (Chief Operating Officer) and E #12 (Vice President for Patient care Services). E #11 and E #12 agreed that there were no postoperative diagnosis on the clinical records.