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Based on interview and record review, the facility failed to implement, and maintain an effective, ongoing, hospital-wide data driven quality program for following adverse events when the facility failed to ensure Patient 5's planned exploratory laparotomy (surgical procedure, abdomen is opened and examined) with colostomy (colon diverted to an artificial opening in the abdominal wall) was performed correctly.

This failure resulted in Patient 5 having another surgical procedure on January 4, 2023, for an exploratory laparotomy and ostomy revision (a surgical procedure performed to modify or repair an existing colostomy).

In addition, this failure resulted in Patient 5 suffering from surgical complications such as infection, pain, delay in recovery and could have led to the deterioration of medical condition and/or the death of the patient.

Findings:

On December 11, 2023, an unannounced visit was conducted at the facility.

On December 12, 2023, a review of Patient 5's record was conducted with the Cardiac Program Manager (CPM) and the Senior Clinical Effectiveness Coordinator (SCEC). The facility document titled, "ED [Emergency Department] Physician Record," dated December 25, 2022, at 9:39 p.m., indicated, "...[name of patient 5] was brought in via EMS [Emergency medical services, ambulance service]...complaining of abdominal pain with vomiting which began suddenly..."

The facility document titled, "CT [computed tomography (an imaging test)] Abdomen/Pelvis w/o [without] Contrast [iodine base liquid]," dated December 25, 2022, at 11:30 p.m., indicated, "...Peritoneum [cavity of the abdomen]: Small ascites. Minimal pneumoperitoneum [presence of air or gas in the abdominal cavity], which may represent perforated viscus in the absence of recent intervention. Recommend clinical correlation..."

The facility document titled, "History & [and] Physical," dictated by Surgeon 1 on December 26, 2022, at 4:53 a.m., indicated, "...Assessment: Perforated viscus [the wall of the gastrointestinal tract ruptures and the enteric contents leak into the abdominal cavity], peritonitis [inflammation of the abdominal cavity]...will proceed with exploratory laparotomy..."

The facility undated document titled, "Lab View," indicated, "...December 27, 2022, at 2:26 a.m., WBC [white blood cells] 9.6...December 28, 2022, at 5:16 a.m., WBC 14.4...December 29, 2022, at 3:41 a.m. WBC 11.6...December 30, 2022, at 12:13 p.m., WBC 9.9...December 31, 2022, at 6:22 a.m., WBC 10.2...January 1, 2023, at 4:10 a.m., WBC 11.5...January 2, 2023, at 6:03 a.m., WBC 17.4...January 3, 2023, at 5:55 a.m., WBC 15.8...January 6:26 a.m., WBC 16..."

The facility document titled, "Operative Report," dictated by Surgeon 1 on December 26, 2022, at 8:07 a.m., indicated, "...the piece of the colon [part of the large intestine] with perforation was resected proximally [near the point of origin] and distally [furthers way from the center] with GIA 75, mesentry [sic] [attaches your intestines to the wall of your stomach] taken down with ligature [tying or binding]. The distal stump was over sawn [sic] with 2-0 silk and covered with omentum [a fold connecting the stomach with other abdominal organs] in an attempt to prevent stump blow out (full of hard rock stool). The proximal colon mobilized with ligatured device to obtain adequate length. Abd [abdomen] irrigated with multiple liters of fluid until clear...the descending colon delivered via the stoma [an opening]..."

The facility document titled, "Progress note-Physician," dictated by Physician 1 dated December 28, 2022, at 5:41 p.m., indicated, "...Gastrointestinal...colostomy bag on left side-minimal output, bowel sound sluggish..."

The facility document titled, "Progress note- Physician," dictated by Physician 2 dated January 2, 2023, at 9:41 a.m., indicated, "...WBC rose overnight to 17.4...colostomy bag on left side-minimal output-stool present, bowel sounds sluggish...viscus perforation with peritonitis with sepsis [microorganisms in the blood] S/P [status post] exploratory laparotomy with colostomy..."

The facility document titled, "CT Abdomen/Pelvis w/o Contrast," dated January 3, 2023, at 10:41 p.m., indicated, "...Indication...Abdominal Distention/Intestinal Obstruction [blockage]; eval [evaluation] colostomy- distal vs proximal colon...Impression...CONTRAST FROM OSTOMY LIES IN THE DESCENDING COLON AND RECTUM..."

The facility document titled, "Consult - General Surgery," dictated by Surgeon 2 dated January 4, 2023, at 9:47 a.m., indicated, "...plan for exploratory laparotomy today at 1 PM [after noon] for ostomy revision..."

The facility document titled, "Operative Reports," dictated by Surgeon 2 on January 4, 2023, at 3:12 p.m., indicated, "...CT of the abdomen pelvis with contrast through the ostomy was in the descending colon extending down to the rectum suggestive that the distal colon was brought up as the ostomy. Patient requires an exploratory laparotomy, possible bowel resection, with new ostomy creation...Findings...Previous colostomy was distal transverse colon stump resected, new colostomy brought up to right abdomen..."

An interview and record review were conducted on December 12, 2023, at 1:40 p.m. with Surgeon 2. Surgeon 2 stated feces was getting backed up in the patients gut for two days. Surgeon 2 further stated, the proximal part of the colon should have been brought up to the ostomy, but the distal end was brought up instead.

An interview and record review were conducted on December 12, 2023, at 3:15 p.m. with the DMS and the SCEC. The DMS and the SCEC both stated the event was not discussed in the Quality Improvement Committee in January or February meetings due to California Code, 1157, this is confidential and protected.

An interview and record review were conducted on Decemeber 13, 2023, at 9:36 a.m. with Physician 3. Physician 3 stated, "...The surgeon did not follow his normal routine, and there was a little bit of a rush, because the patient was sick...Instead of the proximal portion of the bowel that should have been diverted and brought out the rectal portion of the bowel, he brought out the wrong side..."

A review of the facility document titled, "QI (Quality Improvement) Plan," was conducted with Physician 3 and the SCEC. Physician 3 and the SCEC both stated that the policy included sentinel events to be discussed in Quality Improvement Plan and this incident was not.

There is no documented evidence that this sentinel event was discussed at the Quality Improvement Committee's January and February 2023 meetings.

A review of the facility's policy and procedure (P&P) titled, "QI (Quality Improvement) Plan," dated August 8, 2022, was conducted. The P&P indicated, "...Initiatives are intended to attain optimal patient outcomes and patient family experience, enhance appropriate utilization and minimize risks and hazards of care...IDENTIFICATION & PRIORITIZATION OF OPPORTUNITIES AND INITIATIVES...Balancing the ongoing desire for improvement in multiple areas with the reality of limited resources requires criteria for determining which initiatives to prioritize...Quality Improvement Committee uses the following criteria to identify and prioritize quality initiatives in the organization:...b. Sentinel Events..."

A review of the facility's P&P titled, "Event Reporting," dated August 8, 2022, was conducted. The P&P indicated, "...The following severity classification shall be used...H- Event occurred that required intervention necessary to sustained life (Sentinel event)...I- Event contributed or cause death (Sentinel event)...The results of this activity shall be reported to appropriate peer review and Performance Improvement Committees..."

Based on interview and record review the facility failed to provide surgical services in accordance with acceptable standards of practice when Patient 5's planned exploratory laparotomy (surgical procedure, abdomen is opened and examined) with colostomy (colon diverted to an artificial opening in the abdominal wall) was performed incorrectly.

This failure resulted in Patient 5 having another surgical procedure on January 4, 2023, for an exploratory laparotomy and ostomy revision (a surgical procedure performed to modify or repair an existing colostomy).

In addition, this failure resulted in Patient 5 suffering from surgical complications such as infection, pain, delay in recovery and could have led to the deterioration of medical condition and/or the death of the patient.

Findings:

On December 11, 2023, an unannounced visit was conducted at the facility.

On December 12, 2023, a review of Patient 5's record was conducted with the Cardiac Program Manager (CPM) and the Senior Clinical Effectiveness Coordinator (SCEC). The facility document titled, "ED [Emergency Department] Physician Record," dated December 25, 2022, at 9:39 p.m., indicated, "...Patient 5 was brought in via EMS [Emergency medical services, ambulance service]...complaining of abdominal pain with vomiting which began suddenly..."

The facility document titled, "CT [computed tomography (an imaging test)] Abdomen/Pelvis w/o [without] Contrast [iodine base liquid]," dated December 25, 2022, at 11:30 p.m., indicated, "...Peritoneum [cavity of the abdomen]: Small ascites. Minimal pneumoperitoneum [presence of air or gas in the abdominal cavity], which may represent perforated viscus in the absence of recent intervention. Recommend clinical correlation..."

The facility document titled, "History & [and] Physical," dictated by Surgeon 1 on December 26, 2022, at 4:53 a.m., indicated, "...Assessment: Perforated viscus [the wall of the gastrointestinal tract ruptures and the enteric contents leak into the abdominal cavity], peritonitis [inflammation of the abdominal cavity]...will proceed with exploratory laparotomy..."

The facility document titled, "Operative Report," dictated by Surgeon 1 on December 26, 2022, at 8:07 a.m., indicated, "...the piece of the colon [part of the large intestine] with perforation was resected proximally [near the point of origin] and distally [furthers way from the center] with GIA 75, mesentry [sic] [attaches your intestines to the wall of your stomach] taken down with ligature [tying or binding]. The distal stump was over sawn [sic] with 2-0 silk and covered with omentum [a fold connecting stomach with other abdominal organs] in an attempt to prevent stump blow out (full of hard rock stool). The proximal colon mobilized with ligatured device to obtain adequate length. Abd [abdomen] irrigated with multiple liters of fluid until clear...the descending colon delivered via the stoma [an opening]..."

The facility document titled, "Progress note-Physician," dictated by Physician 1 dated December 28, 2022, at 5:41 p.m., indicated, "...Gastrointestinal...colostomy bag on left side-minimal output, bowel sound sluggish..."

The facility document titled, "Progress note- Physician," dictated by Physician 2 dated January 2, 2023, at 9:41 a.m., indicated, "...WBC rose overnight to 17.4...colostomy bag on left side-minimal output-stool present, bowel sounds sluggish...viscus perforation with peritonitis with sepsis [microorganisms in the blood] S/P [status post] exploratory laparotomy with colostomy..."

The undated facility document titled, "Lab View," indicated, "...December 27, 2022, at 2:26 a.m., WBC [white blood cells] 9.6...December 28, 2022, at 5:16 a.m., WBC 14.4...December 29, 2022, at 3:41 a.m. WBC 11.6...December 30, 2022, at 12:13 p.m., WBC 9.9...December 31, 2022, at 6:22 a.m., WBC 10.2...January 1, 2023, at 4:10 a.m., WBC 11.5...January 2, 2023, at 6:03 a.m., WBC 17.4...January 3, 2023, at 5:55 a.m., WBC 15.8...January 3, 6:26 a.m., WBC 16..."

The facility document titled, "CT Abdomen/Pelvis w/o Contrast," dated January 3, 2023, at 10:41 p.m., indicated, "...Indication...Abdominal Distention/Intestinal Obstruction [blockage]; eval [evaluation] colostomy- distal vs proximal colon...Impression...CONTRAST FROM OSTOMY LIES IN THE DESCENDING COLON AND RECTUM..."

The facility document titled, "Consult - General Surgery," dictated by Surgeon 2 dated January 4, 2023, at 9:47 a.m., indicated, "...plan for exploratory laparotomy today at 1 PM [after noon] for ostomy revision..."

The facility document titled, "Operative Reports," dictated by Surgeon 2 on January 4, 2023, at 3:12 p.m., indicated, "...CT of the abdomen pelvis with contrast through the ostomy was in the descending colon extending down to the rectum suggestive that the distal colon was brought up as the ostomy. Patient requires an exploratory laparotomy, possible bowel resection, with new ostomy creation...Findings...Previous colostomy was distal transverse colon stump resected, new colostomy brought up to right abdomen..."

An interview and record review were conducted on December 12, 2023, at 1:40 p.m. with Surgeon 2. Surgeon 2 stated feces was getting backed up in the patients gut for two days. Surgeon 2 further stated, the proximal part of the colon should have been brought up to the ostomy, but the distal end was brought up instead.

An interview and record review were conducted on December 13, 2023, at 9:36 a.m. with Physician 3. Physician 3 stated, " ...The surgeon did not follow his normal routine, and there was a little bit of a rush, because the patient was sick ...Instead of the proximal portion of the bowel, that should have been diverted, brought out the rectal portion of the bowel, he brought out the wrong side ..." Physician 3 further stated, " ...this is an unusual occurrence, that when you do an open colectomy (exploratory laparotomy) you can automatically see what is going on. You can see the intestine vs [versus] when you do a laparoscopic surgery where you can't clearly see where everything is. When done laparoscopic a lot of surgeons will put little tabs on different parts of the intestine to orient themselves. In this case it was open, he had a full view of the anatomy of the abdomen, so this becomes a very rare event when it is an open surgery..."

During a review of the facility's policy and procedure (P&P) titled, "Universal Protocol," dated April 24, 2023, the P&P indicated, "...Universal protocol is the process used to identify the correct patient, the correct procedure, the correct [sic] and the correct site...The team members providing care for the patient are accountable for patient safety..."