In the latest round of civil penalties issued for violations or deficiencies constituting an immediate jeopardy to the health and safety of a hospital patient, California hospitals were penalized for making patient care errors that led to five deaths and necessitated repeat surgery in seven patients.
The repeated surgeries were to remove surgical towels or sponges, in one case after a sponge went undetected for four years despite the patient's repeated complaints.
In one patient, surgeons had to perform a second surgery because they performed the wrong procedure the first time and at another hospital the operating room team set up the wrong equipment resulting in another patient's ruptured bladder.
The California Department of Public Health can levy fines between $25,000 and $100,000 in these so-called "immediate jeopardy" cases when it determines that the hospital failed to comply with one or more licensure requirements that resulted in the potential for or actual occurrence of harm or death to the patient, Debby Rogers, deputy director of the department's Center for Health Care Quality said during a news briefing Thursday.
Since 2009, the agency has imposed 235 administrative penalties on 135 California hospitals, with fines totaling $9.25 million, including $825,000 imposed on 14 hospitals in this round. The state has collected $6.64 million, so far and 29 cases are under appeal.
Events prior to 2009 carry a fine of $25,000 but legislation that took effect Jan. 1, 2009 raised the amount to $50,000 for the first violation, $75,000 for the second and $100,000 for the third or subsequent violation by the same licensed hospital.
In this round of penalties, two hospitals received the maximum fine of $100,000, three are fined $75,000, seven are fined $50,000 and two are ordered to pay $25,000.
According to state documents, which can be found on the CDPH website by county, the details of each incident are as follows:
1. At California Hospital Medical Center, in Los Angeles County, a combative trauma patient, subsequently sedated, apparently went into respiratory arrest unnoticed in the CT scanning room.
State investigators wrote that the hospital failed to initiate cardiopulmonary resuscitation or promptly call a Code Blue for a patient who was not breathing. The patient died.
"Employee C stated that after the scan was done, 'We got the patient, placed him on the gurney and as we were coming out the door, I looked at the patient. I said, "this patient may not be breathing" to Employee A and Employee A replied, "Let's just take him to his room." ' Employee C stated a code blue was not called in the hallway."
Employee A was terminated "due to failure to monitor and observe the patient's physical condition, signs and symptoms," documents say.
The incident is the hospital's second penalty, which carries a $75,000 fine.
2. At Kaiser Foundation Hospital, Los Angeles, in Los Angeles County, multiple failures contributed to the death of a patient who pulled out her left femoral hemodialysis catheter and bled to death.
State documents say that a non-working cardiac monitor on the patient went unnoticed, a Vocera receiver alarm didn't go off (possibly because staff weren't trained to use it), there was a low level of nurse staffing (two nurses were preoccupied with a narcotics count), and the wrist restraint the patient was ordered to have because of her previous attempts to tear out her catheter was loose.
"RN2 indicated that she had to be both the charge nurse and monitor technician and she thought the 'staffing [was] very unsafe,' " state documents say.
This is the hospital's first penalty and comes with a $50,000 fine.
3. At Kaiser Foundation Hospital, San Francisco, in San Francisco County, a patient received wrong doses of insulin and died because hospital staff did not remove the insulin pump that was attached to her body when she was admitted. Meanwhile, physicians continued to give her doses of insulin to lower her blood sugar, and failed to notice when it dropped to 7 mg/dl, far below normal of 70-105).
Her cause of death was due to "anoxic encephalopathy due to hypoglycemia, (brain injury and death due to a low blood sugar)" according to the state report.
An RN told investigators that she didn't know whether the patient's insulin pump was on. "The patient's nephrologist (kidney doctor) came by and told the patient to turn it off. I think the patient turned it off, but she still had it on her body at the end of my shift."
This is the hospital's third penalty since 2009, which comes with the maximum $100,000 fine.
4. At St. Mary's Medical Center, San Francisco, in San Francisco County, a patient who had undergone a triple coronary artery bypass graft procedure died when a portable ECMO heart-lung bypass machine designated for intra-facility transport became disconnected as the patient was being transferred in an ambulance.
"The facility failed to follow the oxygenator manufacturer's recommendation to connect and band all blood lines," the state report said. "This failed practice resulted in the disconnection of the blood tubing from the oxygenator venous inlet and was the direct cause of the death of Patient 1."
State documents say that after the CABG procedure, "several attempts were made to wean (switch from heart-lung machine to person's own heart and lung) Patient 1 from the cardiopulmonary bypass machine" without success.
So an attempt was made to transfer the patient to another facility's intensive care unit to be placed on a long-term left ventricular assist device.
State investigators asked the hospital's risk manager if there were any facility policies or procedures for setting up the portable ECMO bypass system for intra-facility transport. "RM-1 said, 'No, we are working on writing them up now.' "
This is the hospitals first penalty, and carries a $50,000 fine.
5. At Stanford Hospital, Stanford, in Santa Clara County, a patient admitted for aortic dissection suffered lack of oxygen resulting in brain injury, and later death, after a nurse who was not qualified to do a procedure removed sutures that anchored the patient's tracheostomy tube.
"Removal of the sutures allowed the tube to become dislodged, causing a hypoxic episode resulting in brain injury," the state report said.
The nurse told investigators she cut the sutures in order to clean the area but did not obtain a physician's order first, and did not document what she had done in the medical record.
"By failing to timely report her conduct, Nurse A caused inexcusable delay in patient treatment. These actions caused or are likely to have caused, serious injury or death for the patient and therefore constituting an immediate jeopardy within the meaning of (the) Health and Safety Code," according to the state report.
The hospital was fined $50,000. This was its first penalty.
6. At Fountain Valley Regional Hospital and Medical Center, Fountain Valley, in Orange County, a licensed vocational nurse called by a staffing service was said to not be competent to care for bariatric surgery patients.
Nevertheless, she was assigned to care for such a patient, and incorrectly removed a gastrostomy tube without a physician's order, resulting in the patient developing blood clots in his left lower leg, bleeding, a prolonged hospital stay, and necessitating a second surgery.
The incident, which occurred in 2008, is the hospital's third penalty and resulted in a $25,000 fine.
7. At John F. Kennedy Memorial Hospital, Indio, in Riverside County, a six-year-old boy had to undergo a second surgery to remove a growth after a surgeon performed the wrong surgery on his tongue.
"This failure resulted in Patient A being exposed to the risks of bleeding and infection, and unnecessary exposure to the risks associated with anesthesia that was needed to perform the right procedure," state documents say.
The surgeon told investigators that he couldn't be sure whether a time-out, which was said to have transpired according to the hospital's policies, was ever done.
"Either time-out was not done or it was done, but I could not recall what procedure was said," the surgeon told state investigators. The surgeon then said that team members, who should have known the correct procedure, should have asked why there was no specimen of tissue from the removed growth.
Asked whether he examined the patient prior to the surgery, the surgeon replied, "Usually, I don't examine anybody. In this case, there was no time to do pre-operative visit. From now on, I need to see the patient prior to surgery."
This is the hospital's fifth administrative penalty and comes with a $50,000 penalty.
8. At Kaiser Foundation Hospital, South San Francisco, in San Mateo County, a Ray-Tec or "tuck" sponge was left undetected in a patient for more than six months, even though the patient had come back into the hospital for a second surgery to debride the wound that had failed to heal.
"When this surveyor asked the surgeon if he could remember whether or not he announced (the use of) a deep tuck sponge, he replied, 'I don't remember if I did.' "
This is the hospital's second penalty and carries a $75,000 fine.
9. At Menlo Park Surgical Hospital, Menlo Park, in San Mateo County, a "hysteroscopy (visual instrumental inspection of the uterine cavity) set up was prepared and used on the patient instead of a cytoscopy (inspection of the interior of the bladder by means of a cytoscope) set up, causing Patient-A's bladder to rupture," documents show.
The error resulted in the patient, who had come to the hospital for endometrial surgery, having to use a foley catheter. The state said the hospital did not follow its own "Time-Out" policies, especially as it should apply to equipment.
10. At Saint Agnes Medical Center, Fresno, in Fresno County, surgeons failed to remove a surgical towel from a patient, which went unrecognized for four months. The lapse resulted in the patient suffering a small bowel obstruction, undergoing additional surgery, preventable pain, injury and harm, the state document said.
The towel went unrecognized even though the patient came back to the hospital ED after the surgery "complaining of nausea, vomiting, and abdominal pain."
"The hospital failed to implement their surgical count procedure for the surgery of Patient 1," the state report said. "This failure directly led to a surgical OR towel being retained in the patient for four months" which "led to an additional hospitalization," and "directly led to surgery for a small bowel obstruction.
11. At Saint Francis Memorial Hospital, San Francisco, in San Francisco County, surgeons forgot to remove a surgical sponge in a patient who underwent spine surgery. The sponge was not discovered until he returned for a routine post-op exam, and lumbar spine x-rays showed it.
The report says hospital staff performed a root cause analysis but "didn't come up with a definitive answer" and that "everyone did what they were supposed to."
Investigators asked the hospital's director of perioperative services why, if the root cause analysis showed the staff followed policy on sponge counts, a sponge was still left in a patient. The director replied that an extra sponge might have been in the room, or that " 'another person' came into the room during the case and left a sponge there."
The state report also faulted the hospital's policy because it did not include any information regarding competency validation, or "specify if the count process was part of the operating room staff annual competency or if observational audits of staff were done to ensure compliance."
This is Saint Francis' first penalty, which carries a $50,000 penalty.
12. At Simi Valley Hospital & Health Care Services, Simi Valley, in San Francisco County, surgeons neglected to remove a surgical sponge in a patient who underwent a hysterectomy in 2007. The sponge was not discovered until 2011.
Investigators looked back at the records on the case, and discovered that "all sponge, lap, and instrument (blade) counts were correct."
In 2011, the patient came in for an unrelated abdominal surgery, and surgeons discovered a small bowel mass they recommended she have removed at a later date, which she did.
"Following the resection of the mass and a portion of the small bowel that the mass was attached to, the specimen was sent to pathology. According to the pathology report the subserosal (below a serous membrane) nodule (mass) is seen to contain white gauzy material with occasional broad light blue fibers."
"The facility's failure to ensure the sponge count was correct, and that no sponge was retained in Patient A following the surgery...(in) 2007, created a situation that was likely to cause serious injury or death to the patient," the state report said.
This is the hospital's fourth penalty, but because the incident happened prior to 2009, it carries a $25,000 penalty.
13. At St. Jude Medical Center, Fullerton, in Orange County, surgeons failed to remove a sponge that went undiscovered for 2.5 months, "with delayed wound healing and the increased risk of infection," the state report said.
The patient had undergone bilateral mastetctomies and breast reconstruction. While in her doctor's office for a post-surgical visit, she "complained of irritation at a right axilla (armpit) incision site. The physician examined the area and found a sponge protruding, which the physician removed."
According to the state report, during the surgery "a Ray-Tec sponge was missing." An x-ray was ordered to determine if a foreign body was in the patient, but no foreign object was seen.
On further inquiry, investigators discovered that the physician did not review the chest x-ray. "Instead, the results were read ...over the phone. A subsequent review of the chest x-ray showed that the x-ray did not extend to the patient's axillary area."
This is the hospital's fourth administrative penalty and carries a fine of $100,000.
14. At the University of California Irvine Medical Center, Orange, in Orange County, surgeons neglected to remove a laparotomy sponge from a patient with testicular cancer who underwent two surgeries over a 12.5-hour period.
State investigators faulted the hospital's surgeons for failing to have repeat time-outs between procedures and when informed at one point that the sponge counts weren't correct, failed to conduct an x-ray to determine if the objects were still inside the patient.
Subsequently, another x-ray after surgery while the patient was in the ICU revealed a retained lap sponge on the upper right of the abdomen, and the patient had to undergo a repeat surgery.
"The Director of Perioperative Services...was unable to determine the times when the sponge counts were done and why there were no sponge count times indicated on the intraoperative record. She was unable to explain why there was no documentation of a change of shift count either."
The fine is $75,000 for the hospital's fourth penalty.