A major Bay Area hospital now under investigation in the deaths of four children overstated its patient counts six years ago to win state certification for its fledgling pediatric intensive care unit and performed complex surgeries on newborns despite being barred from doing so, state records show.

The California Department of Health Care Services, known as DHCS, is charged with ensuring high-quality medical care across the state. But it certified John Muir Health’s pediatric intensive care unit, or PICU, to participate in the state’s program to treat medically fragile children after ignoring evidence that the Walnut Creek facility hadn’t met the required minimum patient volume of 350 a year, documents show.

Fifth & Mission podcast: Scant California Oversight Preceded Child Patient Deaths

The coveted 2017 certification for the California Children’s Services program, or CCS, allowed John Muir’s PICU to boost profits and admit some of the state’s sickest patients. But in the years that followed, reporters found, the state maintained scant oversight over the unit and more than two dozen other state-certified PICUs, overlooking subpar patient caseloads.

Instituted decades ago, the state’s minimum admissions requirement is meant to ensure that PICU doctors and nurses are treating enough children to maintain lifesaving skills and provide top-notch care.

New documents reviewed by The Chronicle show that when John Muir first made its bid for certification in 2017, it gave a presentation to DHCS officials claiming that its PICU had admitted 352 children the previous year — just enough to vault it over the threshold for certification. But around the same time, John Muir also submitted an official report of its figures, stating that it had admitted 282 patients in 2016.

Last October, John Muir told The Chronicle that its PICU admitted about 280 patients in 2016. However, last month, when reporters asked John Muir officials why they had in the 2017 presentation shared a significantly larger number with the state, a spokesperson said for the first time that the 352 figure was accurate. John Muir, he said, had mistakenly undercounted the unit’s patient volumes when filing the critical, official data that the state uses to evaluate its approved PICUs.

Hospital officials declined to share supporting documents with The Chronicle, or to meet with reporters to review the data. DHCS said its records indicate John Muir’s PICU had 282 admissions in 2016 and that the agency considers that to be the correct count.

This past December, a Chronicle report detailed four children’s potentially preventable deaths at John Muir after the community hospital partnered with Stanford Medicine Children’s Health to open the PICU in 2015. Top medical experts told reporters that the deaths appeared to reflect John Muir’s low patient volumes and inexperience treating exceptionally ill children.

Vikki Plumlee, whose 13-year-old daughter died in the John Muir PICU in 2016 after doctors failed in multiple intubation attempts, said that California had betrayed the families who rely on its oversight.

“The state failed us,” Plumlee said in a recent interview. “It is really important for the state to keep track of these things because people’s lives are at stake. The future of my family has been devastated.”

The John Muir spokesperson, Ben Drew, said in a statement that “there were never any attempts to mislead CCS or any other regulatory agency.” He said that hospital officials excluded dozens of patients who came to the unit for cancer-related inpatient procedures in the official 2016 admissions count, but had since received verbal guidance that they should have been included. Drew declined to elaborate on those cases.

He said that when the state flagged John Muir’s unauthorized neonatal surgeries during the 2017 on-site visit, “we stopped doing the surgeries they identified immediately.”

“There were no adverse events or otherwise negative outcomes with any of these procedures,” Drew said. While the operations in question were more complex than the state allowed John Muir to perform, he said these surgeries were not considered “high-risk procedures.”

In a statement, DHCS spokesperson Anthony Cava said that “admission volumes are not the sole criteria for approval, as there are other factors that are indicators of quality of care.”

When approving John Muir’s PICU in 2017, Cava said the state considered “the clinical assessment, compliance with various CCS PICU standards, and the need to increase access to PICU services in the Bay Area.” 

Cava said the state takes its supervision of the CCS program seriously and “disagrees with characterizations implying that DHCS had little to no oversight over John Muir Health’s PICU or other CCS-approved PICUs.”

In response to The Chronicle’s investigation last year, the state announced that it would review 13 PICUs that had recently fallen below the annual admission threshold, starting with John Muir. Cava said the reassessment of the unit, which included an on-site visit in February, is expected to be completed this month.

The Medical Board of California, which has the authority to discipline doctors, also announced in December that it was investigating the four John Muir pediatric deaths, and has since contacted the families of two of the children.

The December Chronicle investigation found that John Muir partnered with Stanford — one of the most prestigious national names in pediatric medicine — with an expectation that its new PICU would treat thousands of children each year. But the unit struggled to draw patients and top doctors, even as John Muir and Stanford used the state approval to market the unit to local families, reporters found.

Stanford Medicine Children’s Health spokesperson Elizabeth Valente declined to comment for this story, but said that Stanford would fully cooperate with any “potential or active investigations.”

To better understand why John Muir was allowed to treat some of the state’s sickest children despite official patient admission counts that fell below the state’s certification criteria, The Chronicle examined hundreds of pages of documents related to John Muir’s PICU approval process, including site review reports, medical consultant notes and emails and letters from 2014 to 2022 between state and county health officials and John Muir and Stanford medical leaders. Reporters also interviewed more than a dozen medical professionals familiar with the CCS program.

They found that, at the 2017 site review of the PICU, DHCS inspectors appeared to accept the higher numbers presented by John Muir even as they unearthed other troubling information that should have thrown the certification into further question, according to medical experts familiar with the CCS program.

This included the discovery that John Muir doctors were performing the unapproved surgeries on babies in the hospital’s neonatal intensive care unit, or NICU, as well as details apparently related to the death of Plumlee’s daughter, Katrina Daly.

Additionally, The Chronicle found that, from 2015 through 2021, the state’s CCS program administrators neglected to reassess 10 of the 13 PICUs across the state that dropped below 350 patients per year. Three of these hospitals, including John Muir, never met the threshold during this time, according to the state’s annual PICU quality reports.

“It is concerning and very troubling — not only that these deaths occurred, but also that this facility was essentially operating out of compliance,” said Dr. Bela Matyas, director of Solano County’s public health department, which oversees the local CCS program that has referred young patients to John Muir. “We rely on the state to maintain an active list of patient referral sites and there has to be regular state oversight to make sure these facilities are meeting the criteria and maintaining their quality.”

As of December, state health officials had failed to perform reviews that they are required to complete every three years for all 30 of California’s certified PICUs, according to DHCS’ statements to The Chronicle.

State health officials blamed the overdue PICU evaluations across the state on the COVID-19 pandemic, which restricted access to hospitals. They said they have continued to monitor the PICU data and discuss any concerns with their advisory committee.

At John Muir, however, emails and other records reviewed by The Chronicle show that the hospital has continued to push against, and in some cases break, rules set by the state program’s regulators.

Despite the state warnings in 2017, The Chronicle found that John Muir continued to perform certain banned neonatal operations as recently as last fall, emails show.

Drew said that John Muir doctors stopped performing those additional neonatal procedures immediately in September 2022 after learning the hospital was relying on outdated state guidelines from 1988.

John Muir also moved forward with a high-risk spinal surgery on 15-year-old Isaiah Lofton, who came to the hospital in 2018 through the Solano County CCS program, despite state guidance in 2017 that the hospital “should refer any orthopedic surgeries that require a higher level of care and complexity” to more equipped centers like Stanford or UCSF.

Isaiah, who had severe cerebral palsy and an extreme spinal curvature of about 105 degrees, died in 2019 after doctors waited a week to clean out a deep infection that had developed in his surgical site.

Asked about John Muir’s decision to perform Isaiah’s surgery, Drew said that “the decision as to where to perform a surgical procedure is a medical decision made by the surgeon, family, PICU medical director, and nurse manager. If the surgeon and the family feel a procedure is better performed at a different facility, it will be done at that facility.”
 
Isaiah’s mother, Michelle Brantley, said she was never told about the state’s advice on orthopedic surgeries. She said the CCS program should be more transparent with families about the level of care they can expect at hospitals.

“I would hate for any other family to have to go through nearly as much pain as I am going through,” she said.

The Department of Health Care Services describes itself as “the backbone of California’s health care safety net.”

The agency’s oldest public health program is California Children’s Services, a publicly funded program akin to Medicaid for roughly 200,000 mostly low-income children in California with serious chronic or life-threatening medical conditions such as heart disease and cancer.

In addition to paying for care, the state program partners with county public health departments, which help enroll eligible children, provide case management services and refer them to qualified medical providers and hospitals that have received CCS certification to care for them.

The much-sought-after approvals require hospitals to adhere to strict quality standards, including minimum patient volume guidelines for PICUs and neonatal surgery programs for critically ill infants. Although hospitals can open PICUs without CCS certification, the approval allows them to treat more patients in the units and receive additional compensation for that care.

“CCS gives a little bit of a (reimbursement) boost over Medi-Cal, so you can understand why a hospital might want to tap into that money,” said Jennifer Rienks, a UCSF researcher who recently authored an extensive overview of the CCS program. “But the CCS standards end up benefiting all children who might seek care in these facilities.”

Rienks’ February report, as well as emails between CCS officials and interviews with several medical professionals familiar with the program, show that the program has faced a multitude of challenges over the years, including budget cuts, staffing shortages, leadership turnover and the COVID-19 pandemic, which diverted medical personnel and led to decreased hospital access for inspectors. These issues, The Chronicle found, have led to less thorough site reviews of units, or no reviews at all.

For instance, the children’s services program has a PICU Technical Advisory Committee, or TAC, which includes pediatric intensivists from hospitals around California. The committee has historically produced detailed quality reports and made certification approval or denial recommendations to DHCS based on their findings from site reviews, said Dr. James Marcin, a pediatric intensive care specialist at UC Davis and longtime member of the PICU TAC.

But in the last 10 years, Marcin said, the TAC has not been included in many of the reviews.

“These reviews are not being discussed with the TAC like they used to be,” said Marcin. “We used to discuss every site visit.”

Dr. Chester Randle Jr., who worked for DHCS as a medical consultant from roughly 2006 to 2017 and was involved in the approval of John Muir’s PICU, said that by the time he left the agency, worker shortages had created a backlog of applications for the CCS program. “It was getting to be pretty gnarly in terms of staffing,” he said.

Dr. Roy Schutzengel, who was medical director of the DHCS division that includes CCS from January 2019 through May 2021, called the program “invaluable … to the health of children in California.” But Schutzengel said in an interview that the state has also long struggled to hire doctors and other medical professionals, including into oversight jobs.

“They don’t pay well and they aren’t high-profile jobs,” Schutzengel said. “So it tends to be people who are either very committed to public service … or are late in their career and sort of wanting to slow down a bit.”

“It was getting to be pretty gnarly in terms of staffing.”

— Dr. Chester Randle Jr., who worked for DHCS as a medical consultant from roughly 2006 to 2017 and was involved in the approval of John Muir’s PICU

In his statement to The Chronicle, Cava said that it did “not appear that the PICU TAC was involved in the 2017 approval process for the John Muir PICU.” 

In 2018, Cava said, the agency moved to a new model for conducting CCS reviews. The state now contracts with universities to provide expertise and “continues to engage external experts.”

Five medical professionals familiar with the CCS program told The Chronicle that the requirement that PICUs have at least 350 patient admissions each year has been a fairly steadfast rule, with limited exceptions intended for PICUs that provide critical access to children in rural or underserved areas and that are otherwise meeting the standards.

Patient volume “is an indirect indicator of quality,” Schutzengel said. “Generally they are pretty strict about that criteria because the reason for those criteria is that having more experience caring for individuals who are that severely ill increases the skill set of those involved.”

Even before John Muir’s PICU debuted in 2015, John Muir Health executives knew that low patient volumes might hold up the approval process, emails reviewed by The Chronicle show.

In a March 26, 2014, email, Beth Lannon, the executive director of Children’s Specialty Services at John Muir Health, sent Dr. Gwendolyn Hamilton, then the CCS co-medical director for Contra Costa County, a question: “Since the PICU at John Muir will be a new unit, will we have to wait until we have 350 admissions before we can apply for CCS certification?”

The response was unequivocal.

“John Muir’s PICU will need to wait until they have 350 admissions before applying,” a member of the state’s facility review team replied to Lannon in an April 14 email that also included Hamilton and state health officials.

The following day, Hamilton emailed state officials asking if John Muir’s PICU could receive provisional approval as it worked its way to the volume standard.

In a recent interview, Hamilton, who is now retired, said her thinking at the time had been that it would be “a tremendous boon for the children of Contra Costa County to have that kind of resource.”

“That was the goal, to see if we could accomplish that for our community,” Hamilton said.

But two hours after Hamilton sent her email, Dr. Robert Dimand, then the state’s CCS chief medical officer, reinforced in another email to the county and state health officials that the 350-patient admission requirement had existed for decades and that every PICU had to achieve the benchmark before approval.

“Is there something completely unique to this situation??” Dimand asked in the April 15 email. “Otherwise the same rules would apply to all.”

Fifteen minutes later, Dimand sent a second email to the health officials raising concerns about John Muir. “It increasingly appears that a meeting with them is necessary, as these questions appear to indicate either a lack of understanding or interest in following the standards,” he wrote.

A year later, in April 2015, John Muir and Stanford opened the eight-bed PICU, promoting it as the first unit of its kind in Contra Costa County and suggesting that it would draw thousands of sick children every year.

By the end of 2015, Lannon sent an email to the state expressing optimism that the unit would reach the state’s “350 admission mark” the following year.

But on Dec. 13, 2016, when John Muir applied for CCS certification, it indicated that the PICU had just 238 patient admissions through that point in the year and 209 admissions in 2015, records reviewed by The Chronicle show.

The hospital also reported to the state that it had two children die in the PICU in that time period.

John Muir’s PICU data and the children’s death certificates show that the first death was an 11-year-old girl admitted for a severe infection in June 2015; the second was Katrina Daly in 2016. While the 11-year-old had a high risk of dying based on the severity of her condition on admission, Katrina had a low “probability of death,” records reviewed by The Chronicle indicate.

Yet the records don’t appear to detail additional information about the quality of care Katrina received. That documentation has typically been included in unit reviews, according to records reviewed by The Chronicle and medical professionals familiar with the CCS program.

“It strikes me that there were two wrongs here,” said Dr. Matthew Scanlon, a pediatric critical care specialist at Children’s Wisconsin in Milwaukee who reviewed Katrina’s medical record on behalf of The Chronicle. “Katrina dying when she arguably could have been saved, and the state not ensuring that safe care was being provided there.”

Following the December 2016 application, a DHCS team, including three nurse consultants and Randle, conducted an initial desk review of the documents John Muir had submitted to the state by filling out a checklist and noting whether John Muir had met or not met certain standards.

On the checklist form, which The Chronicle obtained through a California Public Records Act request, many of the boxes were blank: The state reviewers repeatedly did not mark whether certain standards were met or not met, and they often did not leave additional comments.

Medical professionals familiar with CCS who reviewed the checklist on behalf of The Chronicle said the document appeared to reflect a lack of comprehensiveness by the state.

Notably, the reviewers recorded the sub-350 yearly admission numbers that John Muir had entered on its application. But there were two separate boxes for documenting whether the standard had, or had not, been met. They were left empty.

Cava, the state spokesperson, said that DHCS has since “created a more thorough CCS approval protocol process for its staff, including ensuring that the PICU checklists are fully completed.”

It’s unclear how John Muir’s application moved to the next step — an April 2017 site review — after reporting just 238 admissions in 2016.

Dimand, who had repeatedly warned that John Muir would need to reach a caseload of 350 before applying, retired from the state effective April 1, 2017. He now works as a consultant for Kern County’s CCS program and declined to comment.

At the two-day site review on April 18 and 19, Randle was tasked with determining whether the PICU had met state standards, including the volume requirement, Randle said in a recent interview with The Chronicle.

“That number was important because the assumption is that the more cases you see the better equipped a unit is to take care of critically ill children,” said Randle, adding that he didn’t recall whether low volumes were an issue for John Muir.

Told that John Muir had submitted 238 on its application, Randle said the state normally wouldn’t allow a PICU with such low numbers to progress through the process. He said he could not recall how John Muir managed to move forward.

There are different ways to count PICU admissions that can lead to variations in recorded volumes, medical experts told The Chronicle. However, the state uses a standardized approach for assessing yearly patient volumes in the annual PICU quality reports that are submitted to DHCS by Virtual Pediatric Systems, or VPS, a national pediatric critical care database.

“VPS applies a set of criteria in order to ensure consistent reporting from all PICUs throughout the country,” Cava said in his statement, noting that to be counted in the data, patients must have a PICU admission order; require a greater level of care than that provided on the general pediatric floor; and be housed physically in the PICU.

“Exclusions from this definition include patients who never have PICU admission orders and come to the PICU temporarily for a procedure or intervention,” he said.

During the two-day site visit at John Muir in 2017, the team that included Randle and the DHCS nurse consultants reviewed patient medical records, toured the hospital’s facilities and interviewed hospital leaders and staff, documents reviewed by The Chronicle show.

John Muir also presented a PowerPoint pitch for the Walnut Creek pediatrics program that included specifics about the PICU and neonatal intensive care unit, or NICU, according to the documents.

The documents detailed successes and challenges the hospital experienced from 2015 through early 2017, including medication errors involving children in the PICU, the need for better coordination within the Pediatric Rapid Response Teams, and bloodstream infections acquired by babies in the NICU.

Additionally, the PowerPoint contained a curious number: John Muir and Stanford officials claimed in the presentation that, according to their “VPS data,” the PICU had admitted 352 patients from January through November 2016, eclipsing the minimum patient volume threshold.

The cover page of the PowerPoint says it was created on Dec. 7, 2016 — just six days before John Muir would submit its application to DHCS, stating that its PICU had 238 admissions through that point in the year.

In keeping with that lower figure, John Muir would ultimately report that its PICU had 282 admissions in 2016, according to the state’s official PICU quality reports from VPS. Drew separately confirmed this figure to The Chronicle in October 2022.

Yet when state reviewers visited John Muir in April 2017, John Muir presented the 352 figure as its VPS total for the first 11 months of 2016. 

In his statement to The Chronicle last month, Drew said the higher number included patients who were “admitted for inpatient hematology/oncology procedures.” Additionally, he said that VPS officials had told John Muir in 2018 that the hospital should have counted these patients in their reports. 

John Muir officials refused to provide supporting documentation that these patients met the admission criteria at the time. They also declined to explain why they hadn’t reported an admission number consistent with the 282 figure to state inspectors during the on-site review if they considered that to be the correct VPS tally at the time.

In a statement, VPS CEO Dr. Randall Wetzel said, “We only know about admissions reported to us by our members.” He declined to answer specific questions, citing “contractual reasons and covenants with our users.”

Medical experts who spoke with The Chronicle said that patients coming to the PICU for minor inpatient procedures are generally more stable, even if they have serious illnesses like cancer, than typical PICU patients, who often have acute problems like respiratory failure.

Randle also separately recorded in his notes from the April 2017 site visit that John Muir’s PICU had admitted 379 patients in 2016. 

Beneath that figure, he noted that there were about 70 “short term (not PICU) admissions” for procedures typically associated with hematology and oncology patients.

It is unclear from his notes whether the 379 figure includes these patients. In a phone interview, Randle said the figure would have come from John Muir officials and that he did not recall discussing discrepancies in patient volumes.

Drew, the John Muir spokesperson, said hospital leaders have “no way of knowing why Dr. Randle had 379 patients” written in his notes.

Cava said it was unclear which admissions number DHCS considered when evaluating John Muir’s PICU “based on passage of time, limited records, and change in personnel.”

But he said that, per state records, DHCS considers 282 to be John Muir’s official PICU admissions count for 2016.

It wasn’t just low patient volumes. Records show that the state’s review of John Muir turned up other potential problems related to the unit’s readiness to treat severely ill children.

In his notes under “PICU Activity,” Randle wrote that 50 patients were intubated, but did not specify during what period of time.

From 2016 through 2021, John Muir told state regulators that its PICU had managed an average of 22 intubated patients a year, the third-lowest of any of the state-approved PICUs in California, according to a Chronicle analysis of the annual PICU quality reports that are submitted to the state. The numbers were further supported by a Chronicle analysis of inpatient data that hospitals submit to the state.

Two of the children’s deaths examined in The Chronicle’s December investigation involved doctors failing to correctly perform intubations in the PICU. Katrina Daly, who was admitted for a condition known as diabetic ketoacidosis, or DKA, died from a brain injury due to lack of oxygen after multiple failed attempts to intubate the 13-year-old.

During the April 2017 site visit, Randle’s notes indicate that he and his team reviewed eight children’s charts. While the patients are not identified by name in Randle’s notes, one case matches Katrina’s: a 13-year-old patient with DKA who suffered a massive brain injury. 

Experts who reviewed Katrina’s case for The Chronicle agreed that John Muir’s pediatric intensivist likely misplaced the breathing tube and that the girl may have survived if seen at a facility with more experience treating critically ill children.

“It strikes me that there were two wrongs here. Katrina dying when she arguably could have been saved, and the state not ensuring that safe care was being provided there.”

— Dr. Matthew Scanlon, a pediatric critical care specialist at Children’s Wisconsin in Milwaukee who reviewed Katrina Daly’s medical record on behalf of The Chronicle

Randle’s notes do not mention the outcome — in Katrina’s case, death — nor do they cite any concerns over the care provided. In a recent interview, Randle said he could not remember the cases he reviewed during the 2017 visit or whether he discussed any concerns about intubations in the unit with John Muir leaders.

At the end of his three pages of notes, Randle did hint at possible problems involving patients with breathing difficulties, documenting that he had discussed the “value of clarifying the diagnosis of respiratory distress and respiratory failure.”

The site visit ended with the team flagging several relatively minor deficiencies in John Muir’s PICU, including the need to provide updated policies and procedures related to bioethical reviews and consent for treatment. The “Corrective Action Plan,” which was reviewed by The Chronicle, does not mention patient volumes or Katrina’s death.

After John Muir addressed the state’s corrective action plan, Dr. Seleda Williams, then a DHCS public health medical officer, gave the unit full approval in June 2017, per Randle’s recommendation.

Asked why he recommended approval for the unit, despite the contradictory volumes, Randle told The Chronicle the PICU had qualified staff and was “very well organized and the unit was well designed.”

Williams, who no longer works for the state, declined to comment.

In the years that followed, John Muir’s PICU remained below 350 patients a year, according to the VPS PICU quality reports. John Muir surpassed the 350-benchmark for the first time in 2022 amid a national surge in child respiratory illnesses.

State regulators did not investigate John Muir or two other hospitals with PICUs that never reached the minimum threshold from 2015 through 2021 — Santa Barbara Cottage Hospital and Northridge Hospital Medical Center in Los Angeles County.

Spokespeople for Cottage and Northridge did not respond to multiple requests seeking comment. In his statement, Cava said that DHCS received records from the hospitals last month and will be conducting site visits at Cottage and Northridge this year.

One month after Williams approved John Muir’s PICU in 2017, she responded to questions about whether CCS would cover “larger pediatric surgical hospitalizations” at John Muir, according to emails reviewed by The Chronicle.

San Francisco CCS officials had a case involving a child who was going to have an extensive spinal surgery performed by Dr. James Policy, a Stanford-affiliated pediatric orthopedic surgeon practicing at John Muir.

Williams informed the San Francisco CCS officials that John Muir should not be embarking on complex procedures. But there was a loophole.

“John Muir can have pediatric surgeries done at their facility, however, John Muir should refer any orthopedic surgeries that require a higher level of care and complexity to an approved CCS Tertiary Hospital,” Williams wrote in a July 12, 2017, email to a San Francisco CCS official and state health officials. Williams said the “exact type of surgical procedures” to transfer out would be left up to John Muir doctors.

A year later, in September 2018, Policy performed an extremely complex spinal surgery on Isaiah Lofton, the 15-year-old with cerebral palsy. Isaiah died the next year after developing a surgical site infection and sepsis, a condition in which the body’s immune system attacks its organs.

Policy did not respond to requests seeking comment.

State health officials declined to comment on Isaiah’s case.

Although state investigators appeared to ignore John Muir’s low PICU volumes during the unit’s 2017 site review, they did voice another concern.

In an April 19, 2017, email reviewed by The Chronicle, state health officials told a John Muir doctor that “a question has arisen regarding whether neonatal surgery is being conducted for patients in your NICU.”

They reminded Dr. Nick Mickas, then an NICU medical director, that John Muir was not certified by the state to perform such surgeries.

While NICUs can perform hernia operations on “stable” babies and other minor procedures specified in state regulations, they need state certification to perform more complex neonatal surgeries.

“CCS Standards apply to all patients in a CCS-approved facility and not only to patients whose care is paid for by CCS,” said the email from the state to John Muir. “Please let us know immediately whether neonatal surgery is indeed being performed.”

The inquiry kicked off a series of communications between the state and John Muir in which Mickas acknowledged John Muir had been performing various gastrointestinal surgeries on newborns and was unaware that it needed approval from the state.

The state ordered John Muir doctors to stop — in an email that also touched on patient volumes. The hospital complied.

While John Muir could consider applying for approval, according to the state’s email, the hospital’s annual case volume of about eight, which also included simple operations, was “well below” the approval threshold for NICUs — about 30 complex surgeries a year, at the time.

“As far as I can recall that was the only incident in which that occurred, and the only hospital in which we had that type of interaction.”

— Dr. Roy Schutzengel, former medical director of the DHCS division that includes CCS, on unauthorized neonatal surgeries performed at John Muir Health

Nevertheless, in 2018, John Muir applied for the certification despite its low volumes.

Stanford’s director of surgical quality at Lucile Packard Children’s Hospital Stanford lobbied for its ratification, emailing the state to underscore that John Muir already had the patient demand to meet the volume requirements, estimating that it could hit 30 to 40 neonatal surgical cases a year if approved.

“This is only expected to grow,” wrote Dr. Stephen Shew on Jan. 11, 2019, citing John Muir’s joint venture with Stanford, local demand and patient preference.

Unlike with the PICU, Stanford and John Muir didn’t sail through this time.

Schutzengel, the DHCS medical director, denied the application in a June 2020 letter due to “a paucity of cases” that would fail to ensure that frontline NICU staff would be getting enough experience to provide care that was “in the best interests of the babies we serve.”

In an interview, Schutzengel said he recalled being “very involved in having conversations” about “unusual” issues with neonatal surgeries at John Muir, adding that it was the first time he had encountered a hospital failing to abide by the neonatal surgery rules.

“As far as I can recall that was the only incident in which that occurred, and the only hospital in which we had that type of interaction,” Schutzengel said.

Yet records reviewed by The Chronicle show that as recently as September 2022, John Muir once again was admonished by the state for performing another kind of banned surgery on newborns.

This procedure requires a doctor to place a feeding tube, known as a gastrostomy tube or G-tube, directly into a baby’s stomach. Although NICUs without neonatal surgery approval were allowed to perform such operations under the 1988 rules, that changed with a 2020 update to the regulations. 

In a Nov. 8, 2022, email to John Muir’s chief medical officer, Dr. Russell Rodriguez, a member of the facility review team emphasized that the G-tube surgeries were “not among the procedures that may be performed” given that the state had denied the hospital’s application for neonatal surgery certification.

“Current CCS NICU Standards, including neonatal surgery standards, apply uniformly to all NICUs for their respective level of care,” the facility review team member wrote.

Drew said in his statement that John Muir “immediately” stopped performing the G-tube operations.

Schutzengel told The Chronicle it was “distressing” that a hospital or surgical unit would not follow state standards. He said repercussions could include the NICU losing its certification, depending on the circumstances.

“That seems like a reasonable next step if they aren’t continuing to follow the rules,” said Schutzengel, who retired from the state agency in 2021.

State rules specify that hospitals can lose CCS certification for “failure to abide by the laws, regulations, standards, and procedures governing the CCS program.”

In his statement, Cava said a 2022 agency review of “performance indicators” revealed that John Muir was performing G-tube surgeries on babies. He said state officials told doctors there to “cease that practice.” The last procedure was done on Sept. 15.

“DHCS will continue to follow this situation closely and will request data as warranted to ensure continued compliance,” Cava said.

Matyas of Solano County said that John Muir’s record points to “a hospital that is pushing beyond what it is permitted to do repeatedly.” State officials, he said, should now take a hard look at whether the hospital should retain its CCS certifications.

“I would expect the state to do something,” he said. “It questions the credibility of the program at the state level if they don’t maintain a trustworthy network.”