After-hours staffing shortages at Tulare Regional Medical Center (TRMC) contributed to the death of two patients in the hospital’s care, a January report from the Centers for Medicaid and Medicare Services (CMS) found.
The report, originally received by the Visalia Times-Delta and dated January 26, stemmed from a November 2016 survey. It stated that “one surgeon performed high risk […] and lengthy […] surgical cases without a surgical assistant after hours; despite existing policy and procedure criteria.”
“The hospital had only one Operating Room on-call team to cover all emergency surgeries and emergent Caesarian-section deliveries between 5PM and 7AM,” the report continued.
Out of six files that inspectors pulled, two involved deaths and a third involved a surgical implant being left inside the patient. The Voice has identified one of the patients, who has since filed suit against the hospital.
“[Healthcare Conglomerate Associates]/Tulare Regional Medical Center does not agree with the survey report,” a statement from the hospital read. “However, the hospital did offer a plan of correction to that report, because it is always seeking to improve its procedures and practices, and that plan has been fully accepted by the state.”
“It is ridiculous and wholly inconsistent with what Tulare’s hospital has done to date to suggest that administration would ever delay implementation of a safety or quality measure (personnel, equipment, or otherwise), especially if there was any concern by any staff member,” the statement continued. “In fact, the contrary is true. Since HCCA has come on board, Tulare’s hospital has made leaps and bounds in quality improvements and patient safety.”
HCCA is the company that the hospital’s board of directors has outsourced management of the hospital to.
The hospital claims that it has been subjected to an unusually high amount of inspections in the last 18 months, and stated that these are due to “frivolous complaints” by Citizens for Hospital Accountability, a group that is working to change the hospital’s leadership and is spearheading a recall effort against Dr. Parmod Kumar, a hospital board member.
In a separate statement, hospital officials stated that the inspection is the “latest episode of the vicious attempts by a few disgruntled doctors set to vilify and destroy Tulare’s hospital.”
Surgery, Delayed Nine Hours
The CMS report revealed that two patients died in the hospital’s care in August and September of 2016, and a surgical implant was left in the third, requiring additional surgery.
Those patients are anonymized in the report as Patients A, B, and C.
Patient B has been identified by the Voice as Christine Griesbach. Her family has filed suit against the hospital and Dr. Rebecca Zulim, the surgeon scheduled to operate on her the day she died.
The lawsuit states she arrived at TRMC on September 16 at 10:30am, and was diagnosed with an incarcerated strangulated ventral hernia.
At 2pm on September 16, Zulim “documented an impression of SBO [small bowel obstruction] with incarcerated [where the intestine is pinched off, thereby stopping blood flow, and a medical emergency] ventral incision hernia [a hernia near the site of a previous hernia], possible strangulated [stoppage of blood flow, and a medical emergency] hernia.”
The report also noted severe dehydration, sepsis and hypovolemic shock, which the report describes as “an emergency condition in which severe blood or fluid loss makes the heart unable to pump enough to the blood to the body, and can cause many organs to stop working.”
Griesbach was not taken to the operating room until 11pm; when she was given anesthetic medications shortly thereafter, and before surgery began, hospital staff were forced to begin performing CPR on her.
“She was survivable, had she done the surgery when she came in, or later in the evening,” said Richard C. Watters, the attorney representing the Griesbach family.
Griesbach was pronounced dead at 12:47am on September 17.
“They put her off,” Watters said. “Why not transfer her to Kaweah Delta, or even Community Regional Medical Center [in Fresno]?”
Indeed, the CMS report notes, Griesbach was assessed at 1pm, and a physician in the emergency department noted “discussed with surgeon” and “admit to surgery” — but Griesbach stayed in the emergency department throughout the afternoon and evening.
The primary cause of death listed on her death certificate is cardiac arrest, followed by sepsis and an incarcerated ventral hernia.
Watters declined to make the Griesbach family available for comment.
Patients A and C were both rolled out mid-surgery so that staff could make way for other cases.
Patient A was admitted to TRMC on August 9, 2016, for rectal bleeding, but did not accept the proposed treatments of blood transfusions and removal of hemorrhoids until August 21. While surgery was decided for Patient A at 8:45am, it was not performed until 8pm.
Notes in the patient’s medical record stated that the patient had “refused urgent hemorrhoidectomy” until August 22, but that Zulim, the patient’s surgeon, was “already tied up with another emergency case;” Zulim was called by a nurse stating that “large, copious” amounts of blood were coming out of the patient’s rectum.
Patient A’s surgery plan called for a gastroenterologist to perform a colonoscopy to search for the source of bleeding and operate to control the bleeding.
But the operating room and staff were needed for an emergency C-section, and Patient A was moved into the hospital’s ICU at 9:37pm, where an unsuccessful colonoscopy was attempted, before being brought back in to the hospital’s operating room at 10:53pm. Although she was given blood transfusions, she later died.
Patient C, a 62-year old woman, came to TRMC for the treatment of a chemical burn to her skin and around an ostomy port — an opening between the intestines and the stomach. It was planned that she would have surgery to reverse the ostomy and reconnect her small intestine.
During the course of surgery, Zulim lacked a surgical assistant to keep track of instruments. A SurgiFish device slid inside one of the patient’s open wounds, and a competing emergency case “distracted members of [the patient’s] surgical team during the counting of instruments.”
According to the report, the hospital’s quality manager acknowledged that short-staffing and competing emergencies led to mishaps in both cases.
Inspectors called an “immediate jeopardy” situation on November 9, 2016, after finding that the hospital failed to ensure sufficient resources were available to “meet the needs of approximately 45 surgical patients per month, and approximately 500 surgical patients per year,” and that the hospital only had one on-call surgical team between 5pm and 7am with no plans on developing a second operating room team to be made available.
AHC Media, a healthcare industry publication, describes an “immediate jeopardy” finding as the worst finding from inspectors that could happen to a hospital.
“‘Immediate jeopardy’ are words you never want to see on a CMS survey report for your facility because it means you are on the brink of losing your accreditation for Medicare in a very short time,” an AHC Media report states. “Immediate jeopardy also means higher fines, less time to correct problems, and extremely bad publicity.”
Such a designation means that inspectors believe that noncompliance with Medicare standards could cause the injury or death of a patient in the hospital’s care.
As part of the hospital’s response to the immediate jeopardy designation, it was stated that Zulim took a voluntary 10-day leave of absence in November and the MEC was scheduled to meet and discuss corrective action.
Strains Previously Noted
One doctor, identified in the report as “MD 9”, stated that the hospital’s former Medical Executive Committee (MEC) had discussed strains on on-call operating room resources and delays in surgeries, but that the hospital had not enacted any solutions.
According to the same doctor, requests for a second operating room team had been denied by the hospital.
In fact, the report stated, minutes from the prior Medical Executive Committee showed that in November 2015, the group had raised concerns regarding understaffing — and had recommended that “administration assure full coverage for emergency cases after-hours and on weekends.”
“Currently, after 4:30 p.m. no cases can be scheduled and should a patient come in that needs to have emergency c-section, there can be a three or four hour wait to arrange for a back-up surgical team to be available,” the report reads. “Currently, there is only a skeleton crew for emergency cases, which puts patients at risk.”
The new Medical Executive Committee, installed by the hospital’s Board of Directors in January 2016, did not raise any concerns in its meetings until nearly a year later in its September 2016 meeting.
In the September meeting, members noted that there were discussions with hospital administrators “regarding having 2 surgeries simultaneously,” and that there was a “great safety issue with not being able to provide two surgical crews at the same time.”
However, the report notes that no formal recommendations or actions came from that discussion.
Critics of the new MEC charge that its members are too tied to the hospital to remain independent and focus on the quality of patient care.
“How strange that the previous MEC that [HCCA CEO Dr. Benny] Benzeevi and Kumar have said weren’t doing their job were highlighting this deficiency in the OR, it was ignored and they were replaced,” a recent post from Citizens for Hospital Accountability read. “Just think if the board and Benzeevi would have listened and taken action those people would be alive. Especially a strangulated hernia that should be a simple fix when addressed timely.”
The hospital’s operating room director, David MacDonald, told CMS inspectors that for two years he had concerns regarding patient safety regarding lengthy, complex surgeries backing up emergency ones, particularly when Zulim was on call.
The strained after-hours resources were frequently discussed at internal meetings, MacDonald told inspectors, but formal meetings between an operating room committee and the medical staff’s Surgery Committee “were often cancelled and [at the time of the November report] had not yet occurred,” Zulim was the chair of the Surgery Committee.
MacDonald had prepared a report showing delay causes and patterns from January to September of 2016 and presented it to the hospital’s CEO, Dr. Benny Benzeevi, in a bid to rectify the situation.
That report showed that “more than most other surgeons,” Zulim’s patients were frequently delayed by two to four hours. Comments associated with those delayed cases stated that Zulim had worked the previous night and was “too tired to start cases at several scheduled times prior to 1pm.”
The report noted that 15 cases in the report were performed after hours; three included delays over five hours, including Griesbach’s nine-hour delay and Patient A’s 12-hour delay.
Even after providing the report, he told inspectors that solutions were not implemented and “the same problems continued.”
“In some cases, errors were made and patient outcomes suffered,” the report states.
MacDonald later submitted a letter to the Times-Delta, stating that he would not hesitate for himself, or his family, to have surgery at TRMC.
“I have complete confidence in my team and I am proud to be a part of the progressive organization that is Tulare Regional Medical Center,” MacDonald wrote.
After the report was provided to the hospital, it enacted procedures to rectify the issue.
Benzeevi, the hospital’s CEO, will work with the board to ensure a budget that will allow the hospital to have appropriate levels of staffing at all times, the hospital stated in a response to the state, and the board will “provide a forum in their regular board meeting for Medical Staff to report surgical operational issues, if any.”
More reports will be given to the hospital’s board as well, including a “dashboard which shows the patient safety program metrics” and a “Performance Improvement Patient Safety” report.
Additionally, no elective surgeries will now be scheduled after 5:00 p.m. or on weekends unless back-up resources are available. If the operating room is in use and Level 1 or 2 surgeries, requiring operation within 2 hours, come to the hospital, those patients will be stabilized and transferred to another hospital.
Additionally, Zulim’s role of Chief of Surgery was transferred to another physician.
By March, CMS officials reaffirmed the hospital’s status, and stated that the hospital was in compliance with all regulations required for Medicare and Medicaid reimbursements.
Dr. Rebecca Zulim declined to comment for this article.