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Based on interview and documentation review, it was determined the disclosure/explanation of complications related to Patient #1's fluoroscopy-guided gastrostomy tube (g-tube) placement and exploratory laparotomy were not documented in accordance with Hospital Guidelines.

Findings included:

Medical record documentation indicated Patient #1; a 70+ year old with metastatic head and neck cancer, underwent a fluoroscopy-guided g-tube placement with moderate conscious sedation. The procedure commenced at 8:30 AM. After inflation of the stomach through the NG tube, the anterior gastric wall was fixed to the anterior abdominal wall, and a needle was directed toward the gastric antrum. Next, a guidewire was placed, and a dilator was utilized to create the g-tube tract. When the guidewire was removed, the injection of contrast material opacified a branch of the portal vein, and the dilator was pulled back and directed toward the fundus. A 12-gauge g-tube was then placed with its tip toward the fundus, and secured. The procedure ended at 9:00 AM.

Nursing documentation indicated that at some point following g-tube tract dilitation, Staff RN #1 noted blood coming from the g-tube insertion site, and notified the Attending Radiologist. Nursing documentation also indicated: the g-tube was flushed with contrast; the Attending Radiologist questioned a stomach perforation and ordered a stat hematocrit (Hct) level and; Patient #1 was comfortable and had stable vital signs at the end of the procedure.

Documentation indicated that while Staff RN #1 was attempting to draw blood for the Hct, Patient #1 became hypotensive and bradycardic. Oxygen, IV fluids and IV atropine were ordered and administered and the Medical Emergency Team (MET) was summoned to Patient #1's bedside. The MET intubated Patient #1 and ordered stat blood testing including typing and cross-matching for 2 units of packed red blood cells, stat abdominal and pelvic CT scans and a surgical consultation. Patient #1's blood pressure and heart rate increased.

Documentation indicated Patient #1 remained hemodynamically stable and at 9:30 AM; the MET took him/her to the CT scanner. Documentation also indicated: a NG tube was inserted and connected to suction; the NG tube drained light coffee-grounds colored material; oral (through the NG tube) and IV CT contrast was administered; the CT scans were performed and; the scans revealed a pooling of oral contrast outside of and adjacent to the fundus of the stomach, a small amount of oral contrast and a few bubbles of gas outside of the stomach in the region of the lesser curvature, a high-density fluid thought to be representative of blood throughout the abdomen and extending into the pelvis particularly around the liver and spleen, and a small focus of soft tissue attenuation adjacent to the main portal vein possibly representing a focal hematoma.

The surgeon who responded to the MET call (Surgeon #1; a trauma surgeon) was interviewed in person at 9:20 AM on 5/4/10. Surgeon #1 reported meeting Patient #1 for the first time when Patient #1 was on the CT table, and receiving a report regarding Patient #1 from the MET. Surgeon #1 also reported: reviewing Patient #1's CT scans; thinking Patient #1 probably had a posterior stomach perforation; discussing Patient #1's situation with Patient #1's daughter by telephone, and; obtaining consent to perform an emergent exploratory laparotomy on Patient #1 from the Daughter.

Documentation indicated Patient #1 remained hemodynamically stable and was brought into an operating room at 10:35 AM.

Surgeon #1 said (and documentation indicated) the exploratory laparotomy revealed at least 500 cubic centimeters (ccs) of fresh blood in the abdomen, a piece of omentum adherent to a right lower quadrant appendectomy incision that was stretching the stomach, and a tongue of omentum between the anterior wall of the stomach and the abdominal wall, but did not reveal the anticipated posterior stomach perforation. Surgeon #1 also said: one of his partners was summoned to perform an intraoperative gastroscopy; the gastroscopy did not reveal a stomach perforation; the source of the bleeding was not clearly evident; it appeared that the g-tube or tethering devices went through the tongue of omentum situated between the anterior wall of the stomach and the abdominal wall, and this might have been the source of the bleeding; in the course of the stomach dissection/mobilization, it appeared that the tip of the spleen overlying the stomach was avulsed; attempts to control bleeding at the avulsion site were unsuccessful; the spleen was mobilized; mobilization of the spleen revealed the splenic capsule was also avulsed; two sources of bleeding from the spleen represented a very serious situation and; based on the seriousness of the situation, he decided to perform a splenectomy.

Documentation indicated Patient #1's splenectomy was performed without difficulty, the g-tube was replaced, and the surgical incision was closed. The surgery ended at 2:10 PM. The estimated blood loss was 2000 ccs and Patient #1 received 5 units of packed red blood cells. Patient #1 tolerated the surgery well and was transferred to an ICU; in stable condition.

Documentation indicated Patient #1 was: extubated on postoperative day #1; transfused with 2 units of packed red blood cells on postoperative days #2 and #3; transferred out of the ICU on postoperative day #7 and; discharged home with discharge/follow-up instructions and visiting nurse services on postoperative day #10.

Surgeon #1 reported explaining the exploratory laparotomy findings and surgical procedure to Patient #1 and offering to answer any questions on multiple occasions; during Patient #1's hospitalization and at follow-up office appointments.

The Hospital's Guidelines for Disclosure of Adverse Patient Events indicated documentation outlining the disclosure discussion with the patient and/or family should include: time, date and place of discussion; names and relationship of those present at the discussion; documentation of the discussion event; documentation that additional information has been shared with the patient/family or legal representative, if appropriate and; documentation of any follow-up conversations.

Surgeon #1's explanations of the exploratory laparotomy findings and/or surgical procedure to Patient #1 were not documented in the medical record.