Kaweah Health under regulators’ microscope after drug control negligence, deaths

Editors’ note: This article was corrected to state that a doctor who inspectors said stole federally controlled drugs was an anesthesiologist, not an emergency department physician.

It was also corrected to clarify that the statements confirming the report’s version of events were in the inspectors’ report and in the response to it.

Failure to monitor and prevent theft and abuse of federally-controlled drugs by a contracted employee who worked in the emergency department and the former Department Chair of Anesthesia at Kaweah Health Medical Center led health authorities to threaten sanctions that could have resulted in the Kaweah Delta Health Care District losing a substantial portion of its federal funding.

According to an inspection report by the California Department of Public Health (CDPH), an ongoing pattern of negligence on the part of the district’s governing board, administrators and care providers in securing the hospital’s supply of dangerous controlled pharmaceuticals against theft and mishandling led to the overdose death of a contracted employed in a public restroom at its main facility. The report also uncovered what appears to be a drug-abuse problem among staff at the health district’s main campus.

Statements from hospital officials quoted in the inspectors’ report and in the hospital’s plan of correction confirm the report’s version of the events.

Feds Get Involved, Threaten Funding

After the worker’s death from an apparent overdose of the anesthetic propofol, the hospital reported the incident–as well as incidents of an anesthesiologist stealing hospital drugs for personal use over a period of at least six months beginning in May 2020–to the CDPH. When federal authorities at the Centers for Medicare & Medicaid Services (CMS) learned of the report, that agency requested a detailed investigation by regulators from the CDPH.

The CDPH inspection–running from March 22 to April 1, and including statements from dozens of witnesses, as well as review of emails, security video and documents–resulted in a 285-page report outlining their findings.

The report made clear the health district could have lost its Medicare and Medicaid funding if it failed to come into and maintain compliance.

According to the California’s Office of Statewide Health Planning and Development, the Kaweah Delta Health Care District received Medicare and Medicaid payments totalling nearly $648 million for patient services during fiscal year 2019-20, a sum equal to more than a quarter of the district’s average total patient-generated income. The American Hospital Directory reports the district’s patient revenue exceeds $2.22 billion annually.

CEO Says Problems Solved

Kaweah Health CEO Gary Herbst publicly disclosed the death of the contractor–a medical scribe who acted as an assistant to physicians and documented patient visits–and the report in a July 9 post on the Kaweah Health website. The death of the scribe took place December 22, 2020, and the CDPH’s report was released by the CMS on April 29.

The report details four “conditions of participation” that must be maintained in order to receive Medicare and Medicaid payments and which Kaweah Health violated repeatedly.

“This report is deeply disappointing because it describes activities and behaviors that do not meet our performance standards or expectations for patient safety,” Herbst wrote on July 9. “While we do have robust systems in place to prevent and detect drug diversion, the surveyors found that we did not consistently follow our established practices and policies. It is our responsibility to learn from these mistakes and make sure they do not happen again.”

In the same July 9 announcement, Herbst wrote the CMS had accepted the hospital’s plan of correction, a document outlining how the hospital would cure the failings in the inspection report.

A hospital spokesperson confirmed to the Valley Voice that CMS accepted the third revision of the plan of correction on July 8, and a team from the CDPH visited the hospital on July 20, finding the hospital was in “substantial compliance” with the plan. Further improvements are still needed, Herbst said.

In a subsequent statement, Herbst said the district does not expect the CDPH to return to the hospital for another survey.

Kaweah Health’s Failures

According to the facts as reported by CDPH following its investigation, staff and leadership at Kaweah Health failed systematically to comply with federal, state and local laws. The report also details violations of policy by the governing board, the medical staff and the hospital’s pharmacy. Those failures, the CDPH said, resulted in the death of a Kaweah Health staff member on December 22, 2020, as well as the death of a second patient the same day.

“The hospital failed to ensure it has a process and safety measures that prevented the diversion and abuse of propofol for one of one contracted staff … in the emergency department,” the CDPH survey said. “This failure apparently resulted in the death of the (staff member).”

The report identifies six distinct areas in which the hospital did not follow its own policies, health regulations or laws.

Crucially, the report finds the hospital’s board of directors and administrators failed to provide adequate policies and procedures to monitor distribution and access to prescription narcotics and associated medical equipment, such as syringes. It also failed to adequately oversee the chain of possession of those drugs by staff or to ensure unused portions of them were tracked.

“This failure place(s) staff, visitors, and the public at risk for injury,” the report said.

The governing board also put the district’s physician training program at risk when its lack of oversight allowed an anesthesiologist with an admitted substance abuse problem to bypass the chain of possession for controlled narcotics. According to the CDPH report, three resident physician anesthesiologists were required by their attending MD to give up possession of narcotics in violation of policy.

“This failure resulted in these three anesthesia residents acting as potential proxies for the attending physician … to obtain controlled substances, in which five of 73 sampled patients … had documented larger doses of medications given for short procedures,” the report states.

‘Divertable’ Substances Mishandled

A major failure cited in the report was a lack of enforcement to sufficiently control access and chain of possession of dangerous drugs, such as propofol, and federally controlled substances, such as fentanyl, and for the disposal of unused portions of those drugs.

“This failure allowed easy access to a dangerous divertible medication, propofol,” the CMS report said.

Propofol was stolen by the contractor who later fatally overdosed by injecting the drug in the bathroom. An anesthesiologist admitted stealing fentanyl from the hospital from May 2020 through January of this year, reporting his thefts to the director of pharmacy services.

The physician–ID’d as MD 1 and the former Department Chair of Anesthesia in the CDPH report–is no longer practicing at Kaweah Delta.

“This failure allowed drug theft, loss and/or diversion to go unchecked and escape detection,” the report added.

Fentanyl is a synthetic opiate, the second strongest opiate used in medicine, and has recently been linked to a global increase in overdose deaths among opioid users. Propofol was the drug administered to pop star Michael Jackson, leading to his death.

In a March 31 interview, the director of pharmacy services stated that they “didn’t trust” that MD 1 only used fentanyl–the doctor’s self-described “drug of choice”–and that the pharmacy department “did not do a deep dive on other anesthesiologists,” and he stated that he “did not inquire about other controlled substances or propofol used and accessed by anesthesiologists.”

Search for Stolen Drugs Continues

Hospital officials stated in their response to the CDPH report that additional audits are ongoing, and significant improvements and policy changes have been made in response to the CDPH’s findings.

They also notified the State Board of Pharmacy, DEA, Visalia Police Department and hospital leadership on January 21, the date officials say MD 1 disclosed his drug theft to the hospital’s pharmacy director, according to the plan of correction. However, testimony from one of the hospital’s certified registered nurse anesthesiologists (CRNA) said hospital administrators were aware of MD 1’s drug use and thefts well before the reported January 21 disclosure and that the thefts were far more wide-spread.

“CRNA 1 stated (the hospital) ‘knew of it,’ MD 1 ‘diverting versed and fentanyl for years,’” the CDPH investigators said.

Reports relating to MD 1 were previously routed to the hospital’s chief of staff, not to hospital administration officials, according to the plan of correction. That’s changed now: reports alleging potentially illegal activities by a “hospital employee, contractor, student or practitioner” will be escalated directly to the CEO and Kaweah Delta Health Care District’s administration.

Hospital Increases Self-Policing

Future reports of suspected illicit behavior will come from the METER Committee, a group of hospital staff members who will screen and sort incident reports from the hospital’s staff. The committee will also immediately escalate incident reports of other incidents members feel could harm the hospital or its image. It will investigate events that “contributed to permanent harm to a person or hospital infrastructure,” required the need to initiate life support, resulted in the death of an individual, and any verified or unverified event that places the hospital at risk–including the risk of “adverse publicity.”

The hospital also created a Diversion Prevention Committee, charged with overseeing the hospital’s efforts to ensure that controlled substances cannot be pilfered for use or sale by employees.

Those efforts include the introduction of Bluesight, software marketed as having the ability to track drugs during the process of administering them, from initial physician orders through the updating of medical records for patients who received the drugs.

“A single high-profile diversion event can cause significant reputational damage for a hospital, put patients at risk, and incur substantial fines from the DEA,” Bluesight’s website states. “Only 100-percent audit coverage allows visibility into controlled substance inventory and movement across all care areas in the facility.”

The hospital is also adding security measures and updating operating procedures specifically to prevent the abuse of propofol. Proposed measures include potential introduction of an electronic alert to remind medical staff that an IV drug has not been administered and potentially needs to be discontinued.

Medical staff policies regarding the investigation of practitioners suspected of being under the influence were “significantly revised” as well.

When hospital practitioners are suspected of being under the influence, the revised rules make clear when those investigating them must avoid conflicts of interest, and staff members who observe signs of impairment or intoxication by a practitioner must immediately notify their supervisor–the supervisor must then notify the hospital’s CEO or his designee.

If testing is required, the practitioner must submit to a test within two hours: refusal will result in the summary suspension of their clinical privileges at the hospital, as would a positive test.

Herbst told the Voice that residents have been provided with additional training and that the hospital does not plan to scale back any of its teaching programs.

“We have certainly provided all residents with additional education and training around the management and handling of medications, particularly controlled substances, chain of custody related to narcotics, signs and symptoms of addiction and impairment and documentation of brain death and patient/family end-of-life directives,” Herbst stated.

“Contrary to what was reported by the CDPH in their deficiencies report, per ratio of attending physicians to residents was always in full compliance with the requirements of the ACGME.”

The Death of ‘Patient 1’

The CDPH also found–in a related incident of failure to follow policy that occurred the same night as the death of the ED scribe–that a resuscitation order for the patient whose propofol was stolen while he was being treated in the emergency department was altered by a resident doctor without the patient’s authorization, resulting in the 58-year-old man’s death.

Although the change was authorized by the patient’s sister, the resident doctor told inspectors that he “decided Patient 1 had a poor outcome and ‘put him on comfort care.'” No assessments were performed on the patient to determine his viability and potential outcome before placing him on comfort care, inspectors wrote.

“This failure to follow Patient 1’s life directions resulted in the withholding of the medical care and measures to preserve Patient 1’s life and pronouncement of death of Patient 1 after injection of fentanyl (a narcotic pain medication) and removal of breathing tube,” the CDPH report said.

Past failures, public health investigators say, may have put the lives of those who rely on the KDHCD for medical treatment in jeopardy.

“The cumulative effects of these systemic failures had the potential to negatively impact the safety and quality of care, treatment, and services of the patients, staff, and the public,” the CDPH report said.

The hospital defended the patient’s outcome in its plan of correction, stating that “documentation gaps do not reflect the extent of care collaboration and oversight from the emergency department attending,” and that due to the COVID-19 surge of patients in the emergency department, the attending physician did not document the discussions with the patient’s sister, including the comfort care policy.

The decision to place the patient on comfort care complied with American Medical Association guidance and the hospital’s policy, the hospital’s document stated.

The Death of the Scribe

According to testimony of dozens of witnesses, events the night the ED scribe died link his death with that of Patient 1 and reveal drug theft by ranking staff members that has been ongoing for years.

Prior to the morning Scribe 1 died, discovery of drug residue and paraphernalia by cleaning staff in the ED staff bathroom were a regular occurrence, according to testimony by the hospital’s director of environmental services and the environmental services manager. None of these previous incidents, the pair told investigators in a March 21 interview, were logged in MIDAS, the hospital’s incident reporting system.

There is, however, a detailed security report on the discovery of Scribe 1’s body at 2:14 a.m. on December 22, 2020.

“I received a call to go to the public bathroom between Zone 1 and Zone 2 in the ED. When I opened the door, (Scribe 1) was on the floor, unresponsive, pale, looked like blood near his head,” an individual identified in the HHS report as Security Officer 1 said. “I opened the door fully and the ED staff recognized it as a code (medical emergency) situation. The staff called for help and called a code in the bathroom. (Scribe 1) was taken to Room 21, being resuscitated.”

Scribe 1 was pronounced dead 19 minutes after he was found.

Deaths Intertwined

The two deaths were linked.

Propofol was stolen from a prescription for Patient 1, who had arrived at the hospital emergency department “critically ill … in distress” at 7:01 p.m. on December 21; by December 22 at 2:33 a.m., both he and the scribe had been pronounced dead.

Patient 1 was intubated at 10:02 p.m., and propofol was administered at 10:07, but stopped two minutes later because the patient had no blood pressure. CPR was initiated and the propofol drip was left on the IV pole; RN 1, the nurse handling Patient 1, told inspectors that they “(were) so busy (they) left the propofol drip on the IV pole. The propofol drip was discontinued and taken down on December 22, 2020 at 3:06 a.m., after (the scribe’s) demise.”

According to a review of video of the night of the deaths, Scribe 1 entered Room 19 where Patient 1 was being treated at 12:34 a.m. Scribe 1 opened a pair of drawers where syringes and needles were kept, discarded a piece of trash, then left the room after two minutes and entered the public bathroom where he would die.

An RN and members of the cleaning staff were in the room at the time Scribe 1 was in Room 19. The report did not state that the video showed Scribe 1 removing propofol from Patient 1’s supply.

‘We need to find him before he is dead’

It was not until two hours later a nurse (identified by CDPH investigators as RN1) discovered propofol was missing from Patient 1’s room. RN1 notified other staff of the theft, triggering a search for Scribe 1. According to RN1’s testimony another nurse (RN3) was sure Scribe 1 was involved.

“We need to find him (Scribe 1) before he is dead,” RN3 said, according to RN1’s testimony to the CDPH.

Two syringes containing propofol were found with Scribe 1, and another was found in the room where he was treated after he was discovered by staff. Needles were also found in Scribe 1’s pants pocket.

“… (I)t is reasonable to conclude that (Scribe 1) died due to accidental overdose,” said a Tulare County Sheriff’s Office detective interviewed by CDPH investigators.

The detective was unable to examine the syringes discovered with Scribe 1’s body, which were discarded by an emergency department nurse who said she was following the directions of an officer of the Visalia Police Department who was investigating Scribe 1’s death.

Hospital Leaders Knew About Drug Problem

During testimony given to CDPH investigators by Herbst during a meeting of the governing board on April 1, 2021, the district’s CEO said he was unaware of the repeated and frequent discoveries of drug paraphernalia in the emergency department bathrooms. At the same meeting, Chief Nursing Officer Keri Noeske stated she was aware drug paraphernalia had been found and said an internal investigation was ongoing.

Earlier, during a Case Review Committee Meeting held on March 24, Herbst reportedly said that while the doctor identified as MD1 had admitted to illicit drug use, it was a “single event” carried out by a “single provider.” Drug use on the job does “not happen often here at this [facility],” he said during that meeting, according to the CDPH report. Herbst also said there had been no fentanyl stolen, and if the district “has an additional problem, there’s not much to investigate.”

However, further testimony gathered by the CDPH shows leadership at the district was aware its care providers and employees were using illicit drugs on the job and knew drugs were being stolen. The chief of staff–called MD2 in the report–said MD1 told him about his drug habit and had entered the district’s internal drug-rehabilitation program, making the matter confidential.

The hospital’s chief of staff also said he was aware one of the hospital’s certified registered nurse anesthetists (CRNA4) was suspected of being under the influence while caring for a patient in an operating room. In that incident, the chief of staff said he was forced to take over care for the patient. CRNA4’s behavior was never investigated, he said.

“There was nothing to investigate,” he said. “She resigned.”

The chief of staff admitted knowing about MD1’s drug abuse since May of 2020. He said, “I determined no problem” and he was “satisfied.”

A second CRNA (ID’d as CRNA7) was criminally charged following an investigation of theft of drugs. A CDPH review of her employment file showed it had not been updated to reflect the charges against her and the file “does not contain any comments that preclude her from being reappointed.” A review of CRNA4’s employment file shows she was removed from clinical duties in 2017 by the Alabama Board of Nursing due to “suspicion of impairment,” the CDPH found.

Editor’s note: This article covers only portions of the Department of Health and Human Services Center for Medicare and Medicaid report on the Kaweah Health Medical Center, and is the first in an ongoing series. Tony Maldonado contributed to this report.