Sonoma County patients left in limbo as testing problems hamper response to coronavirus outbreak

Santa Rosa resident Kelly Cramer had been sick for three weeks, hospitalized for half that time and already was back at home for three days, in an empty house, before she learned the result of her COVID-19 test.

It was negative, but it hardly mattered at that point.

She'd been kept apart from her three teenage kids for two weeks and had been held in isolation at Santa Rosa Memorial Hospital while everyone awaited her test results. She checked herself out at the end of 10 days when waiting was all that was left to do.

The hospital staff had used scarce protective gear every time they entered her room, and though they were gracious and kind in every way, it was clear they were frustrated as well over the lengthy wait, she said.

But Cramer, 42, who wasn't even approved for testing until she developed pancreatitis on top of the worst respiratory illness of her life, said the emotional toll of confinement and separation from her children in the midst of a terrifying global pandemic was as severe as the physical discomfort she endured. Thirteen days had elapsed when she got the report on her results.

“Not knowing that I possibly had it and could have infected my children - that weighs heavily on a mother's heart,” she said.

Cramer is among thousands of Californians, including many in Sonoma County, who have been trapped in the same waiting game amid what's already a brutally uncertain time in the age of the new coronavirus.

The nationwide problems with testing, including a shortage of kits, delays in results and concerns about accuracy, have hampered health officials' ability to more precisely gauge the shape of the outbreak and order more targeted interventions.

At a Saturday news conference, Gov. Gavin Newsom vowed to increase the number of tests conducted in the state “by fivefold” and said far too few Californians have been tested for the virus.

As of Saturday, more than 126,700 people had been tested for COVID-19 across the state, a volume of testing the governor said “may sound high to some, it is low to many others, and certainly to me.”

“The testing space has been a challenging one for us, and I own that, I have a responsibility as governor to do more testing in California,” Newsom said.

Newsom said Californians would soon be able to have blood-based tests with quick turnaround of between 5 and 15 minutes. He also said the University of California campuses at Davis and San Diego are helping the state develop high-output testing hubs.

A better, quicker and more reliable testing regimen, also would help return those who prove not to have the disease to their families and to work - a key step to help keep households and essential services up and running during a prolonged pandemic.

Dr. Sundari Mase, Sonoma County's health officer, said closing the testing time lag would help to better track the outbreak locally and hone in on clusters of cases that could halt the virus' spread.

“I really would like to see a turnaround time of 24 to 48 hours, which is what we would expect, and what our public health lab and Kaiser are able to do,” Mase said.

The county lab and Kaiser Permanente each handle about a third of the testing in Sonoma County, with Quest Diagnostics, the large commercial lab that ran Cramer's test, picking up the other third, a county spokeswoman said. Sutter Health also is sending some high-priority specimens to its Sutter Shared Laboratory, while St. Joseph Health facilities send some tests to Providence Oregon Regional Laboratory, representatives said.

Sonoma County reported 107 positive COVID-19 cases by Saturday night and one death. The county lab has conducted about 2,200 tests, but since it only receives positive tests from the other labs, it's not clear how many COVID-19 tests overall have been run for Sonoma County residents.

The return time is also highly variable, with the fastest time occurring at Kaiser's in-house lab, which has a turnaround time of about 12 hours, a spokesman said. The public health lab usually reports results within about 24 hours.

Many patients in Sonoma County and elsewhere, however, have waited a week, 10 days, even 13, like Cramer, to hear back from Quest

Across the state, results remained unknown Friday for nearly two-thirds of the patient specimens collected for testing since the outbreak began at the end of January. While more than 35,000 results had been reported to the California Department of Public Health as of Friday, 59,500 were still pending, the agency reported. On Saturday, that number of pending tests had dropped to 13,000, a sharp reduction that could not immediately be explained.

Many of those tests, and perhaps most, were being handled by Quest Diagnostics, which launched private nationwide testing from a single lab March 9 and was quickly overwhelmed by demand.

The company has increased its capacity to field lab samples substantially since then. It now processes about 30,000 a day, meeting and even surpassing demand on some days, it said.

At Healdsburg District Hospital, test results were coming back from Quest more quickly over the past week than they had been, in closer to three or four days, said Gina Fabiano, a spokeswoman for the North Sonoma County Health District, which operates the hospital. It was possible that a new feature allowing hospital personnel to log into the Quest system and retrieve the results had facilitated the improvement, she said.

But last week, Quest still had a backlog of 115,000 tests, according to a company news release.

Quest nonetheless is touting an average turnaround time of four to five days from the point of specimen pickup. It said top-priority cases - individuals who are either hospitalized patients or symptomatic health care workers - could be tested through a special program in an average time of two to three days and sometimes in less than 24 hours.

“We appreciate the frustration of waiting for a test result, and our laboratories are performing COVID-19 tests 24/7 to provide testing as quickly as possible,” the company said in a statement.

Chris Denny, founder of The Engine is Red, a Santa Rosa branding, advertising and web development company, endured an eight-day wait for his negative test that meant adding the agony of extended anxiety to an already heavy load of family isolation, physical illness and “economic catastrophe that's happening simultaneously.”

Julie Hull, a retired public defender who moved from Chicago to Rohnert Park last year, described the not knowing as living in some kind of “netherland.”

On Friday, she was waiting to find out about a test she had nine days earlier in the emergency room at Petaluma Valley Hospital.

Hull, 66, had gone to the hospital late one night because she couldn't stop coughing and couldn't fill her lungs

“I was just hoping I'd get to breathe and maybe find out if I was a danger to others,” she said.

She was treated for acute bronchitis and tested for the highly infectious new virus. She was told to expect the results in three to five days, which suggested she would have known by the beginning of last week.

“We're just caught in that netherland, that thin space between knowing and not knowing,” Hull said.

In terms of patient care and treatment, it probably doesn't matter a great deal, clinicians said. There is no cure for COVID-19, and medical practitioners are providing the same supportive care for the symptoms that they would whether or not the virus were present, in most cases. And individuals who are not hospitalized, which is most, should be resting, sheltering in place and generally avoiding contact with others if they are sick, whether or not they test positive for coronavirus.

“We acknowledge that it is hard for our patients and caregivers to not have immediate results,” said Christina Harris, communication manager for St. Joseph Health, Northern California, which runs Memorial and Petaluma Valley hospitals, among others. “That being said, the result of a laboratory test is only part of what we do for the care of the patient and our caregivers. We continue to provide appropriate, medically indicated care regardless of diagnosis.”

Local testing protocols are designed to provide for the fastest turnaround in cases that are considered highest risk, either because the patient is particularly vulnerable due to age or underlying medical problems, or because their interaction with other vulnerable people or work in an essential community role puts them at high risk of spreading the virus.

Quest accepts tests from the broadest range of patients, including those considered low priority by the Centers for Disease Control and who would be declined testing in most cases by Kaiser and county health.

Kaiser Permanente runs its members' tests in-house, returning results within about 12 hours, spokesman David Ebright said. But it tests only those in high-priority categories, including hospitalized patients with signs and symptoms of the disease; symptomatic older adults and individuals with chronic medical conditions or compromised immune systems that put them at risk for poor outcomes; and health care personnel with exposure to a suspected or confirmed case within 14 days before the onset of symptoms or who have a history of travel from affected geographic areas within 14 days of their symptom onset.

The county health lab, meanwhile, can conduct up to 100 tests a day with a turnaround time of 24 hours or less, and is running well below its capacity, averaging about 40 per day, county spokeswoman Jennifer Larocque said.

But its tests are reserved for the highest-priority patients: individuals with signs and symptoms compatible with COVID-19 who also are hospitalized and significantly ill; or who are health care personnel or first responders with direct patient contact; law enforcement or firefighters; people who live or work in long-term care facilities; chronically homeless people; or jail inmates and employees. Nearly 2,000 tests have been run at the county lab so far.

“We're having all our priority patients, the ones that are on that list of criteria, go to our public health lab,” Mase said, the county health officer. “So I feel better that people who are maybe most likely to have COVID, their samples aren't going to Quest.”

The high threshold that helps keep Kaiser's return time low creates its own problems for people like Fulton resident Grace Graylow, who was denied a test even though she became ill after her adult daughter tested positive for COVID-19, got pneumonia and had to be sent home with oxygen.

Graylow, 58, looks after her young grandson in her home and, luckily, he never appeared ill. And her own symptoms were relatively mild, though her face was extremely hot and tingly and “she just wanted to sleep every second.”

“We have a guest house, so I've been able to isolate here alone,” she said, but she was getting ready to scrub and sanitize the main house so she could welcome her grandson again.

The shortfall in testing has undercut the U.S. response to the coronavirus since it began to spread in the nation two months ago. Lab tests at that time were virtually impossible to come by, because of flaws in the initial round of technology produced at the Centers for Disease Control.

The nation's capacity for testing has gradually ramped up since then but continues to lag behind other countries and behind the ideal rate that medical officials believe is necessary to reveal the scope of the outbreak and target interventions.

Shortages of necessary materials, in particular the swabs used to collect respiratory secretions from the back of a person's nose and throat for testing, and now, the chemical reagents used to free the genetic material from specimen for the testing process, have also interfered with lab capacity.

A Utah-based lab, Associated Regional and University Pathologists, Inc., or ARUP, had been processing tests for facilities outside the state, including Healdsburg District Hospital, until mid-March, when it had to restrict its services to Utah only because of limited reagent supply.

Also, evidence is mounting that tests have a high false-negative rate, meaning individuals who suffer fever, coughing, sore throat and some of the other symptoms of COVID-19 but test negative. Many may actually have been infected with coronavirus even if the test did not show it.

“The sensitivity of the test is maybe 70%,” meaning as many as 30% of cases might be missed, said Dr. Nurit Licht, chief medical officer for the nonprofit Petaluma Health Center.

Increasingly, patients who otherwise present with symptoms of the virus are advised to presume they have it and isolate accordingly.

Thus Petaluma resident Paul LeMay, who fell ill in mid-March after attending a conference earlier in the month in Seattle, an early coronavirus hot spot, delayed bringing his son back into the house he shares with his girlfriend, who also got sick. His test result finally came back negative after nine days of waiting.

LeMay, 57, said his illness had been relatively mild, despite three or four days in which a walk from the living room to the kitchen would require him to stop and rest.

“I'd run out of breath,” he said.

But his doctor advised, and his son's mother insisted, that he behave as if he had in fact had the virus and complete 14 days of quarantine and then some, just to be sure.

“I'd feel better if I had a second test,” he said.

Licht, the Petaluma Health Center chief medical of“I think it's coming,” Licht said. “I think it's coming. It just seems like it can't come quickly enough.”ficer, pointed to a difficult convergence of factors for Americans, who are culturally inclined to look to testing for guidance and comfort and have the resources as a nation to make desired testing possible, and yet have been caught short.

Rapid, point-of-care testing capable of producing results within minutes appears to be on the horizon, though it will be prioritized for hospital settings first, she said.

But rapid testing that can be done accurately, widely and a second time, if needed, is the best way to persuade people to isolate, to know where the spread is occurring and to catch it, she said.

Staff Writer Julie Johnson contributed to this report. You can reach Staff Writer Mary Callahan at 707-521-5249 or mary.callahan@pressdemocrat.com. On Twitter @MaryCallahanB.

Editor's note: This story has been changed to correct a reference to a high rate of false-negative tests. It also clarifies how many tests have been handled by the county lab and the names and locations of partnering labs that receive tests for Sutter Health and St. Joseph Health.