SUMMARY: Whistleblowers at the State of California’s brand-new COVID-19 Valencia Branch Laboratory are telling reporters about staff sleeping on the job, unlicensed staff handling specimens, and other significant issues. Given the reports of several news outlets, one relevant question for the clinical laboratory profession is whether state lab inspectors, federal CLIA officials, and the College of American Pathologists will hold this government-owned lab fully accountable to all regulations.
SERIOUS DEFICIENCIES IN COVID-19 LAB TESTING AND SLACK MANAGEMENT OF EMPLOYEES are some of the latest problems associated with the Valencia Branch Laboratory (VBL) at California’s brand-new clinical lab facility located in Valencia.
This is the start-up lab facility that the State of California is funding, after the California Department of Public Health (CDPH) awarded a no-bid contract last August to PerkinElmer of Waltham, Mass., that may be worth as much as $1.7 billion. The plan is for the diagnostic test developer and life science company to build and operate that lab. One goal is for the laboratory to perform 150,000 molecular SARS-CoV-2 tests per day in early March and report those results within 48 hours of testing. (See “California Builds Its Own COVID Lab: $25 Million or $1.7 Billion?” TDR Nov. 16, 2020.)
Once news surfaced last fall that the the state government would spend up to $1.7 billion to build and operate a laboratory for COVID-19 testing, news outlets throughout the state began to cover the story.
As pathologists and clinical laboratory managers know, building a new clinical laboratory, validating instruments and assays, and launching operations is one of the most complex tasks in laboratory medicine—primarily because of the risk that the new and untried systems could produce inaccurate results that would harm patients. News reporters are learning about these risks and multiple whistleblowers within VBL are talking to reporters.
Multiple Lab Whistleblowers
In one news story broadcast on Feb. 8, news reporter Julie Watts of CBS13 in Sacramento, said “CBS13 has interviewed more than half a dozen whistleblowers and obtained dozens of internal records and quality control reports. The documents detail problems ranging from contamination causing inconclusive results to swapped samples and inaccurate results sent to patients. Records indicate that employees handling patient specimens had not been signed off for competency on crucial skills,” she added in her report.
The COVID-19 Valencia Branch Laboratory started operations on Nov. 1, 2020. During a routine inspection, on Dec. 8, staff from CDPH’s Laboratory Field Services (LFS) found significant numerous deficiencies, according to reporting from the Associated Press on Feb. 22. CDPH inspectors and state officials attributed those deficiencies to the rapid increase in testing that CDPH required under its contract with PerkinElmer, the AP added.
PerkinElmer Provided Data
The lab continues to operate, and PerkinElmer said some of the information it provided to CDPH since the inspection was not included in the inspection report and that the company believes the deficiencies have been resolved.
LFS inspectors said the lab was unable to test about 250 samples (0.017%) due to lab errors, and that the lab issued corrected reports for about 60 (0.0039%) samples, the AP reported. “A fraction of 1% of the more than 1.5 million tests processed at the VBL had problems,” the state said in a preliminary report. But California Health and Human Services Secretary Mark Ghaly, MD, MPH, said, “one incorrect test result is one too many,” the AP reported.
“California takes these findings seriously” and continues working with the contractor “to ensure Californians have accurate, timely, high-quality test results,” Ghaly added.
In addition, CDPH also is investigating the whistleblower allegations of incompetence and mismanagement, including reports of workers sleeping on the job, CBS13 TV reported.
Last week, PerkinElmer was reported to be suing a whistleblower who spoke to CBS13 and indicated that the company may sue others. (See sidebar below.)
CBS13 also found that in addition to swapped samples, contamination caused inconclusive test results and inaccurate results were sent to patients. CDPH acknowledged that at least “38 samples were reported incorrectly” because of mix-ups in samples, but added that patients were notified quickly.
The station said documents showed some employees handling patient specimens were unlicensed and inadequately trained. State officials said then that “a handful of individuals” were retrained or moved to assignments that fit their credentials.
The VBL has 600 employees and the capacity to run 100,000 tests per day and eventually to run as many as 150,000 molecular COVID-19 tests per day starting in March. But testing volume in California is lower than it was during the last few weeks of 2020. Still, the state is expected to send the lab 502,000 specimens each week, or about 72,000 tests per day.
Even after the latest reporting on the state inspection, several of the whistleblowers told CBS13 that they continue to be concerned by the official narrative that the lab deficiencies have been addressed. The whistleblowers, who work in the lab, have said that lab managers have ignored their concerns.
“It is still just as disorganized as it was three months ago when I first started,” one whistleblower told CBS13 in a report broadcast on Feb. 22.
In the report, CBS13 said whistleblowers have continued to see unlicensed lab techs sleeping on the job and incorrect results being released to patients and physicians without a procedure to notify patients who received incorrect results. The whistleblowers also said unsupervised staff have been processing patient samples before completing training or before being rated as competent for the job they will do, as required by law, CBS13 reported.
“The staff are very untrained and unsupervised,” one whistleblower told the TV station. And lab management has not been forthcoming about the training of its workers, the whistleblower added.
In response to the concerns broadcast on Feb. 22, state officials said all individuals working at the laboratory and handling specimens “are credentialed and trained.”
CBS13 also reported that one day after its initial report, state officials started their own investigation at the lab. “Investigators are now inside the California Department of Public Health-PerkinElmer COVID testing lab following concerning allegations from more than a half-dozen whistleblowers,” CBS13 reported on Feb. 8. “However, the state’s initial response to the allegations is raising more questions.”
Will the allegations reported in these news accounts put pressure on the state lab inspectors, federal CLIA officials, and the CAP to act decisively in formally noting the deficiencies in this lab and putting them on record? A government-owned lab should be held to the same standards as the nation’s other clinical labs.
PerkinElmer Is Suing Lab Whistleblower
ON FEB. 24, CBS13 TV IN SACRAMENTO reported that PerkinElmer, the lab company running California’s COVID Valencia Branch Laboratory, filed a lawsuit against one named whistleblower and 25 other unnamed whistleblowers who may be named later.
The TV station’s investigation began with one whistleblower and then other workers at the lab made allegations about management practices at the state’s new COVID testing lab, saying those practices pose a significant risk to public health, CBS13 reported.
“CBS13 obtained documents that back up the allegations, which whistleblowers reported to us and, in some cases, to regulators,” the news station added. “They say their prior complaints to management were ignored.
“Most of the whistleblowers asked that we conceal their identities out of fear of retaliation, but former lab manager, Dr. Mahnaz Salem agreed to show her face. She reached out after seeing our initial reports and, like many, confirmed the allegations,” the station noted.
CBS13 also said “… after seeing our reports, former Laboratory Manager Mahnaz Salem, PhD, reached out and offered to speak on the record. ‘I really want (the) public to know that this lab should not continue operating like this,’ explained Dr. Salem, who recently resigned from the lab. She was previously a state laboratory inspector.”
In the lawsuit filed Feb. 22, CBS13 reported that the lab company alleged that Salem emailed herself proprietary information in violation of a confidentiality agreement, and that Salem had used such information “to PerkinElmer’s competitive disadvantage.”
PerkinElmer Response on California Lab Issues
PERKINELMER, THE LAB COMPANY RUNNING THE COVID-19 VALENCIA BRANCH LABORATORY (VBL) said in a statement issued on Feb. 22 that it received the routine lab inspection report on Feb. 19 and was preparing a response that is due to state officials on March 1.
“During the months of December and January, the VBL supplied additional information at LFS’ request. Upon review, it appears that LFS had not yet incorporated this extensive information into its routine inspection report. PerkinElmer believes that the deficiencies identified by LFS have long since been resolved,” the company said.
In addition, inspectors from the College of American Pathologists (CAP) visited the VBL on Feb. 19 as the first step in the process to accredit the lab, PerkinElmer added.
“The VBL is seeking accreditation from the CAP so that Californians have no doubt about the quality of the services at the laboratory,” the company said. “Once accredited, the VBL will join PerkinElmer’s labs in Pennsylvania, India, and China that already have the CAP accreditation.”