Staff say UCD student health center failed to inform patients about contaminated STI testing

2022-10-11 01:51:13 By : Mr. Shangguo Ma

In September 2019, a UC Davis student tested positive for the sexually transmitted infection chlamydia at the campus’ Student Health and Wellness Center. There was just one problem, medical staff recalled: she hadn’t had sex. At the patient’s insistence, a doctor agreed to retest her before prescribing treatment. This time, the result was negative.

To test for chlamydia, Student Health and Counseling Services, which runs the health center, used a nucleic acid amplification test, an advanced technology that is typically highly accurate. The false result worried clinicians and medical staff.

On Oct. 15, SHCS leaders discussed the issue at a meeting. “3 weeks ago a provider had a patient with a positive result for chlamydia (swab test). Patient did not agree so test was rerun with a urine test and it was negative,” the meeting minutes state. Later that day, the laboratory discovered a positive chlamydia result for a second patient was false.

Chlamydia is one of the most common STIs in the world. Testing for it is fast and easy, and the disease can be effectively treated with antibiotics. If left untreated it can cause lasting damage that increases the risk of infertility and ectopic pregnancy. 

Because the disease only spreads through sex, a chlamydia diagnosis can also have dramatic social consequences, especially for people in relationships they presumed were monogamous. “If the patient did not have sex with somebody else, then the assumption is that their partner cheated on them,” said Ina Park, an STI researcher and professor at the UC San Francisco School of Medicine. “Psychologically, it can be devastating.”

For nearly a month, SHCS paused its in-house chlamydia testing to investigate the errant results. The health center concluded deficiencies in its infection control protocol led to contamination, which “created some false positives,” SHCS Director Margaret Trout told The Enterprise, though it was impossible to know when the problems began or how many results were tainted.

In the preceding months, from July through September, 44 students tested positive for chlamydia at the student health center, according to an internal report. But three years later, medical staff feared many of those patients were never informed that their diagnoses were based on questionable results. “It seems like they tried to keep this as quiet as possible,” a staff member said.

At the student health center, patient test samples for chlamydia were collected upstairs in exam rooms by clinical staff, stored in the clinic for up to a few days, and taken downstairs to the laboratory to be processed, typically on Tuesdays and Thursdays.

On Oct. 16, the day after SHCS discovered the second false positive, the health center halted its chlamydia testing. Over the next several days, specialists from Hologic, the manufacturer of the diagnostic machine SHCS used to process chlamydia tests, visited the health center multiple times. After confirming the machine’s mechanics functioned properly, they found infection control problems at both ends of the testing process.

In August 2019, following a technical update published by Hologic, laboratory staff scaled back cleaning a rack that held patient samples within the machine from after each use to once per week. The new protocol was supported by studies, Hologic said, but when SHCS told the company about the false positives, a Hologic specialist advised the laboratory to disinfect the sample racks “more often than recommended,” according to an internal email. “The suspected cause [of the false positives] was contamination of the rack that holds samples within the diagnostic machine,” SHCS leaders said.  

Internal records show there were also problems during sample collection. After swabbing patients and placing the swabs in collection tubes, medical staff would put all the tubes in a single container, usually a blue paper cup, instead of storing each patient’s samples in their own biohazard bag, an industry standard. “We reviewed the collections process and found the actual collection container is flawed and can allow cross contamination,” Tanya Mcmanus, associate director of clinical services, said in an internal email. If chlamydia got on the outside of a collection tube, or if it was on a health care worker’s glove, a staff member explained, it could spread to other tubes and contaminate the samples when the machine’s needle punctured the tube’s septum to test the specimen.

“There were multiple places where contamination could have happened,” a staff member said. After discovering the false positives, SHCS Laboratory Supervisor Marsha Lucio swabbed surfaces in the laboratory and the exam rooms for traces of chlamydia. The cover of one of the machine’s sample racks tested positive. A couple months later, so did a benchtop in an exam room.

Scores of internal emails, meeting minutes and other documents, which The Enterprise obtained through public records requests, provide a detailed picture of the student health center’s day-to-day response to the contaminated testing. They indicate SHCS worked diligently to identify and correct its disinfection problems before resuming chlamydia testing in mid-November 2019. It is less clear what SHCS, which is supported by student fees and serves many of UC Davis’ roughly 40,000 students, did to notify patients who tested positive for chlamydia while those problems were present.

Industry guidelines advise health care providers to disclose errors that could potentially have impacted patients. “Withholding information without the patient’s knowledge or consent is ethically unacceptable,” the American Medical Association’s Code of Medical Ethics states. If a medical facility discovered its STI testing was unreliable, it would have an “ethical duty to notify people they may have gotten false results,” said Park, the UCSF professor, who co-authored the Centers for Disease Control and Prevention’s STI treatment guidelines.

In November 2021, multiple SHCS employees, who were directly involved in testing patients for chlamydia, approached The Enterprise with a nagging concern. They suspected SHCS never told more than a few patients about the contaminated testing. “This could have broken up patients’ marriages or long-term relationships,” one employee said. “I’m still upset about it.”

SHCS Medical Director Cindy Schorzman, Associate Medical Director Amanjit Sekhon-Atwal, and Trout, the SHCS director, all played a role in responding to the contaminated testing. They declined to be interviewed for this story. In collaboration with UC Davis’ communications office, the SHCS leaders provided collective written responses to questions from The Enterprise, which a campus spokesperson said should be attributed to UC Davis. They said they stood by the way the student health center handled patient outreach about the contaminated testing.

SHCS had software it could have used to generate a list of patients who tested positive for chlamydia during a chosen timeframe. Then, typically, the health center would have sent those patients a “batch message” through their confidential patient portal. But when they discovered the contaminated testing, SHCS leaders “favored the more sensitive doctor-to-patient communication,” they said, and never sent any batch messages about it.

“Providers were advised to discuss the situation with their patients, even though the opportunity for retesting may have passed due to treatment, in acknowledgement that a positive diagnosis could have caused stress for students or their partners,” the leaders said. However, internal documents, interviews with medical staff, and SHCS leaders’ responses to follow-up questions indicated the only providers who received that instruction were the few whose patients tested positive during a single week in mid-October, nearly two months after SHCS said it stopped cleaning its testing machine adequately and at least three weeks after it identified the first false positive.

Because there was no evidence of a substantial patient outreach plan in the hundreds of pages of emails and other records The Enterprise obtained, the newspaper asked SHCS to provide documentation showing doctors were told to contact patients about the unreliable testing. In response, SHCS leaders cited a single document they said confirmed “this approach,” an email Schorzman sent Sekhon-Atwal, then the medical staff supervisor, on Oct. 18, 2019. “Providers whose students had positive results this week should reach out directly to their students,” the email says. According to meeting minutes, three patients tested positive — one falsely — for chlamydia that week.

In the weeks and months prior, dozens of others tested positive. When The Enterprise asked SHCS leadership who, if anyone, told those patients about the contamination, the leaders appeared to contradict their statement that they informed patients who were already treated, “in acknowledgement that a positive diagnosis could have caused stress for students or their partners,” and suggest that contacting those patients was not a priority. “Since any repeat tests would be negative for individuals after treatment, the main effort was to encourage outreach to those that potentially had not yet been treated,” they said. According SHCS staff and medical experts, it generally takes a few days at most to diagnose chlamydia and prescribe treatment.

Medical ethics guidelines make it clear that clinical errors should be disclosed irrespective of their implications for treatment. “It’s important for people to know the truth,” Park said.  

The Enterprise spent months investigating whether SHCS providers did, in fact, discuss the situation with more than a few patients, and found no evidence of it. On the chance that an outreach plan was made without leaving a paper trail, the newspaper asked SHCS to arrange an interview with any provider who told patients about the contaminated testing. SHCS declined to do so. When The Enterprise reached out directly to dozens of medical staff, including several providers, Trout emailed staff a “refresher” on a UC Davis Student Affairs media policy, which tells employees they “should decline to comment” if approached by a journalist.

Despite that policy, multiple providers spoke to The Enterprise. They regularly tested and treated patients for chlamydia, and remembered the contamination in 2019, but they didn’t discuss it with their patients because they thought that type of outreach would have been taken care of by administration. “The situation is familiar to me, but I don’t know how it was handled,” one provider said. “It would have been a lab or administrative thing.”

Asking doctors to notify patients about an error that wasn’t theirs would have been both unpopular and unusual, medical staff and providers said, adding that “there was no reason not to send a batch message.” As far as they knew, there wasn’t a coordinated effort by doctors to contact their patients. “That did not happen,” a provider said.

In total, The Enterprise interviewed eight SHCS employees who were familiar with the contaminated testing, all of whom requested confidentiality because they were not authorized to speak to the newspaper. When medical staff learned during interviews that SHCS leaders told The Enterprise that “no batch (bulk) messages were sent” to patients about the contamination, they concluded many were simply never informed. “It’s a huge issue from a patient care perspective,” a high-level employee said. “If a patient had to talk to a partner, that conversation could have gone really badly.”

Internal documents do not reveal an explicit effort by SHCS to conceal information about the contaminated testing. However, medical staff said little was communicated to them about it, and several described a work environment that discouraged staff from taking initiative, particularly around anything that could risk the health center’s reputation. “The worst thing that could happen is that they get a complaint from a patient,” a staff member said.

In 2020, UC Davis conducted a staff experience survey, soliciting feedback on qualities like collaboration, culture and leadership. SHCS scored below the campuswide average in 19 out of 20 categories. It received especially bad scores for action taking, decision making and communication. “The sad truth is that is the student who are paying the price most of all for the failed management here,” the minutes from a 2021 staff meeting state.   

SHCS leaders attributed the health center’s performance on the survey and complaints recorded during meetings to the pandemic, whose toll on health care workers was well-documented. But staff told The Enterprise morale was an ongoing problem, and internal records paint a troubling picture both before the pandemic and recently.

According to emails, staff voiced alarm over poor infection control prior to the contaminated testing—a June 2019 email described a speculum stored in a clean area “still having bodily fluid on it”. — but those who advocated for higher standards faced bullying and retaliation. In 2021, an employee was “suspected of leaving a rat” on the desk of a staff member who raised concerns about infection control, according to internal emails. A week later, the staff member walked out her front door to find one of her cars had been egged and the other had a slashed tire. In a formal complaint, she said she was labeled a “snitch” after pushing for better hygiene practices.  

This week, an SHCS supervisor sent medical assistants an email with the subject line, “BULLYING,” saying she requested a meeting with upper management “to discuss the concerning behavior” of a group of medical staff.

“It was incredibly toxic,” said a former employee who worked at SHCS for several years. Others described “an ongoing culture of bullying” and staff meetings where shouting broke out, leaving people in tears. SHCS leadership said they were “not aware of a situation” like that, though written records suggest a degree of hostility during some meetings. “Please leave if you are always complaining,” the minutes from a 2021 meeting state. “There are other jobs.”

In that environment, an employee said, “people do things based on whether or not they’ll get in trouble, not based on whether it’s the right thing to do for the patient.”

As of this month, SHCS employees continued to worry about sloppy infection control. After the contaminated testing, staff reverted to some of the problematic practices it exposed. “All lab specimens need to be in a lab biohazard bag, do not use a cup,” Schorzman reminded staff in an email this June. “Only one patient per bag.” As far as the health center knew, no results were affected.

Since fall 2019, SHCS conducted regular proficiency testing and did not discover anymore false positives, according to SHCS leaders. This summer, the student health center sent 10 positive and 10 negative chlamydia test samples to the UC Davis Medical Center as part of a quality assurance program, all of which proved to be accurate. “Student health and Counseling Services imposes the highest standards for hygiene and infection control,” SHCS leaders said.

The health center’s laboratory and infection control practices were found to be fully compliant during accreditation inspections, which happen every three years, in 2018 and 2021. In 2020, an independent accreditation organization also accredited SHCS, though it ranked its proficiency testing practices near the bottom of a group of more than 750 peer medical labs nationwide.

Over the past year, SHCS made efforts to improve morale and communications, its leaders said. They introduced a weekly “clinical highlights” email from Schorzman, the medical director, and monthly Zoom meetings where employees could ask questions anonymously. “UC Davis is a community that values critical feedback,” said UC Davis and SHCS leaders. They added that the campus “is committed to providing and maintaining a safe and secure environment free from all forms of bullying.”   

SHCS leaders pointed out that during the time contamination was found in its chlamydia testing, some patients, such as those who got tested because their partners had chlamydia, were almost certainly truly positive. Indeed, according to an internal report, the positivity rate in the summer and fall of 2019, even with the false positives, was not unusual for the student health center, an indication many of the results were likely accurate.

Nonetheless, medical staff said, when SHCS discovered contamination had caused inaccurate STI results, the health center had a responsibility to inform every patient who could have been impacted — in the months prior, there were a few dozen who tested positive — going back at least as far as it suspected the problem began. “The bottom line is they didn’t go back a few months and contact patients and they should have,” a medical staff member said. “They didn’t do right by our patients.”

— Reach Caleb Hampton at champton@davisenterprise.net. Follow him on Twitter at @calebmhampton.