The Department of Justice filed a lawsuit today against Con-Way Freight Inc. alleging that the company violated the Uniformed Services Employment and Reemployment Rights Act.

The Justice Department filed a lawsuit today against Sairam Enterprises Inc. LLC alleging that it discriminated against Jeffrey Crockett and his family on the basis of disability in violation of Title III of the Americans with Disabilities Act.

A Cleveland federal grand jury returned an indictment against one current executive and two former executives of Bridgestone Corp. for their roles in an international conspiracy to fix prices of automotive anti-vibration rubber parts sold in the United States and elsewhere.

A former Bridgestone Corp. executive has agreed to plead guilty and to serve 18 months in a U.S. prison for his role in an international conspiracy to fix prices and rig bids of automotive anti-vibration rubber parts sold in the United States and elsewhere.

Showa Corp., an automotive parts manufacturer based in Saitama, Japan, has agreed to plead guilty and to pay a $19.9 million criminal fine for its role in a conspiracy to fix prices and rig bids for pinion-assist type electric powered steering assemblies installed in cars sold in the United States and elsewhere.

Robert C. Sathre was sentenced today to serve 36 months in federal prison for tax evasion by U.S. District Judge Alan B. Johnson in Cheyenne, Wyoming, the Justice Department and Internal Revenue Service (IRS) announced.

A former trader for ConvergEx Global Markets Limited (CGM Limited) — a former securities broker-dealer registered in Bermuda — has been charged in the District of New Jersey with conspiracy to commit wire fraud.

Attorney General Eric Holder announced today that the Obama administration, as part of successfully concluding negotiations on the E.U.-U.S. Data Protection and Privacy Agreement (DPPA), would seek to work with Congress to enact legislation that would provide E.U. citizens with the right to seek redress in U.S. courts if personal data shared with U.S. authorities by their home countries for law enforcement purposes under the proposed agreement is subsequently intentionally or willfully disclosed, to the same extent that U.S. citizens could seek judicial redress in U.S. courts for such disclosures of their own law enforcement information under the Privacy Act

On the one-year anniversary of the Supreme Court decision that struck down a key part of the Voting Rights Act, Attorney General Eric Holder pledged Wednesday that the Justice Department would remain aggressive in using Section 2 of the law—which was left intact by the Court’s decision—to guard against unjust voting restrictions

An executive of Japan-based Denso Corp. has agreed to plead guilty and to serve one year and one day in a U.S. prison in connection with the Antitrust Division’s investigation into a conspiracy to fix the prices of instrument panel clusters, also known as meters, installed in cars sold in the United States and elsewhere, the Department of Justice announced today

An executive of Japanese auto parts maker G.S. Electech Inc. pleaded guilty and was sentenced today to serve 13 months in a U.S. prison for his role in an international conspiracy to rig bids and fix prices on auto parts used on antilock brake systems installed in U.S. cars, the Department of Justice announced

The Justice Department announced today that the owners and operators of the Alger Meadows Apartments in Grand Rapids, Michigan, have agreed to pay $550,000 in damages and civil penalties and to terminate property manager Dale VanderVennen’s role in managing the complex to settle a lawsuit alleging that VanderVennen sexually harassed female tenants in violation of the Fair Housing Act (FHA).

NGK Spark Plug Co. Ltd., an automotive parts manufacturer based in Nagoya, Japan, has agreed to plead guilty and to pay a $52.1 million criminal fine for its role in a conspiracy to fix prices and rig bids for spark plugs, standard oxygen sensors, and air fuel ratio sensors installed in cars sold to automobile manufacturers in the United States and elsewhere, the Department of Justice announced today

Life Care Services LLC, a manager of skilled nursing facilities based in Des Moines, Iowa, and CoreCare V LLP, doing business as ParkVista, a skilled nursing facility in Fullerton, California, have agreed to pay a total of $3.75 million to the government for causing the submission of false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.

Episcopal Ministries to the Aging Inc., a Maryland not-for-profit corporation that owns skilled nursing facilities, has agreed to pay $1.3 million to the government for submitting false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.

Communities and policymakers working to meet the challenges of a global pandemic may need to take a range of targeted actions, such as building awareness, launching preventive measures, boosting health care infrastructure, or allocating emergency funding. These decisions, which can influence health outcomes significantly, highlight the importance of having the information needed to evaluate...

True or False:

(1) eSource in clinical trials means eliminating the possibility for transcription errors.

(2) Data collected in Electronic Data Capture (EDC) systems is eSource.

Strictly speaking, both statements are false. If that surprises you, it’s probably because many casual uses of the term “eSource” actually differ from the formal definition laid out by FDA. If the participants in any discussion share the same interpretation of “eSource”, or if it’s clear from context how “eSource” is being used, then no harm, no foul. (Contemporary translation: “Meh.”) BUT…and you know where we’re going with this…when a term can be interpreted in multiple ways, there’s always a possibility for miscommunication and cross talk.



FDA Guidance on eSource in Clinical Investigations
FDA defines eSource as *any* data initially recorded in electronic format. That’s a broad definition, one that includes:
     a) equipment-generated data, such as digital imaging and labs
     b) electronic Patient Reported Outcome (ePRO) transmissions
     c) data streams from mobile health devices, such as Apple ResearchKit
     d) data entered directly into an EDC, known as Direct-Data-Entry (DDE) solutions
     e) data entered into an Electronic Health Record (EHR) or electronic Medical Record (EMR) system


Discussion of Direct-Data-Entry (DDE)
DDE systems allow research staff members to use portable devices to enter study data directly into an EDC system. DDEs have been garnering a lot of industry attention of late, and a number of companies offer solutions that offer a DDE data flow. As independent 3rd party auditors, we don’t want to play favorites by mentioning specific systems as examples, but if your company sells or uses a DDE system that you want to highlight, feel free to add a comment below to give it a shout out.

Discussion of EMR/EDC Integration
Not long after finalizing its e-Source guidance, FDA hosted a webinar that encouraged companies to explore direct EMR/EDC integration. While a few industry players have taken up the effort, movement has been slow. One difficulty: generally EMRs are built with healthcare in mind, not clinical research. Secondly, with so many EMR and EDC vendors, ensuring that EMR data from one system is mapped to appropriate EDC fields in another system relies heavily on data standards that are still being defined and need to be implemented on both sides. 

Source Data Verification (SDV)
If data is transmitted directly from the source system to an Electronic Data Collection (EDC) system, SDV is not required, since the source data isn’t being transcribed manually. (Note: other types of Source Data Review (SDR) activities are still necessary, even if SDV isn’t. SDR must be conducted to verify ALCOA-C data principles such as attribution, originality, accuracy, completeness, etc.) Direct transmission from source system to EDC system is the typical pathway for items (a) – (d) above, and so SDV is not required for these types of eSource.


Common Confusions
SDV. Unless there is EMR/EDC integration – Item (e) above – source data from an EMR system needs to be manually transcribed. This is what makes T/F question #1 false. Just because source data originates in an EMR, it does *not* suggest SDV checks are superfluous. You could argue, as many have, that SDV is not a high-value activity and uncovers only a small percent of data error. That argument may well influence how much SDV is conducted, but whenever data is transcribed from original source into an EDC system, SDV is a relevant discussion.

EDC Data. It’s not unusual for someone to refer to data stored in EDCs as eSource. Data stored in EDCs are electronic, and may be source, but only if the EDC is the first place the data is recorded. This is what makes T/F question #2 false.

In Summary
If you’re ever in a discussion about eSource and things start going sideways, it may be time to haul out the formal definition of eSource -- in all its tedious detail -- to make sure everyone is using the term the same way. 

_____________________________________________________

Image Credit: Paradox by Brett Jordan

by Wendi C. Thomas, MLK50: Justice Through Journalism

MEMPHIS, Tenn. — On her first day at her new warehouse job, Daria Meeks assumed the business would provide face coverings. It didn’t.

She assumed her fellow workers would be spread out to account for the new coronavirus. They weren’t.

There wasn’t even soap in the bathroom.

Instead, on March 28, her first day at PFS, which packages and ships makeup and jewelry, Meeks found herself standing alongside four other new workers at a station the size of a card table as a trainer showed them how to properly tuck tissue paper into gift boxes.

The following day, Meeks, 29, was just two hours into her shift when she heard that a worker had thrown up.

“They said her blood pressure had went up and she was just nauseated, but when we turned around, everybody who was permanent that worked for PFS had on gloves and masks,” Meeks said.

Temporary workers like her weren’t offered either.

Since then, workers have been told twice that coworkers have tested positive for the coronavirus. The first time was April 10 at a warehouse just across the state line in Southaven, Mississippi. The next was April 16 at the warehouse in southeast Memphis where Meeks worked, several temporary and permanent workers told MLK50: Justice Through Journalism and ProPublica.

In interviews, the workers complained of a crowded environment where they shared devices and weren’t provided personal protective equipment. The company has about 500 employees at its four Memphis-area locations, according to the Memphis Business Journal.

In right-to-work states such as Tennessee and Mississippi, where union membership is low, manual laborers have long said they are vulnerable, and workers’ rights advocates say the global pandemic has underscored just how few protections they have.

A spokesman for Tennessee’s Occupational Safety and Health Administration confirmed that the department received an anonymous complaint about PFS in April.

“A few of (sic) people have tested positive for Covid-19 and the company has not taken precaution to prevent employees from contracting the coronavirus,” the complainant wrote. “As of today (04/13/2020) no one have (sic) come to clean or sanitize the building.”

In response, the spokesman said TOSHA sent the company a letter “informing them of measures they may take to help prevent the spread of COVID-19.”

PFS did not answer specific questions about the number of workers infected at its facilities or about specific precautions it takes. Instead the company released a short statement that said PFS “is committed to the safety and well-being of its employees.” It also said it performs temperature checks at the door and supplies workers with masks, gloves and face shields.

But workers said none of these measures were in effect as late as the middle of April, when Shelby County, Tennessee, and DeSoto County, Mississippi, each home to two PFS facilities, were reporting more than 1,600 coronavirus infections and 30 deaths. (As of Friday, there are more than 2,750 infections and 50 deaths in the two counties.) A current employee said the company now provides gloves and masks, but they’re optional, as are the temperature checks.

When Meeks started at PFS, cases in the county were still at a trickle. But she didn’t stick around long.

On her third day at work, workers were split into two groups for lunch, but the break room was still full. “You could barely pull out a chair, that’s how crowded it was,” she said. “Everybody was shoulder to shoulder.”

Meeks said she asked the security guard at the front desk if she could eat her lunch in the empty lobby but was told no.

“I said, this is just not going to work,” said Meeks, who was paid $9 an hour. “You got different people coughing, sneezing, allergies — you never know what’s going on with a person.”

She left during her break and didn’t come back.

Economy Dominated by Low-Wage Industry, Jobs

In cities across the country, workers at Amazon facilities and other warehouses have been infected with COVID-19, as have workers at meatpacking plants nationwide.

What makes Memphis different is the outsized share of the workforce in the logistics industry, which includes warehouses and distribution centers.

The Greater Memphis Chamber of Commerce boasts on its website that the logistics industry employs 1 in 6 workers in the Memphis metro area, a higher share than anywhere else in the country.

The high concentration of these low-wage jobs is a testament to the city’s decades-old campaign to brand itself as “America’s Distribution Center.” Memphis is home to FedEx’s headquarters and its world distribution hub, which is undergoing a $1.5 billion expansion, as well as to Nike’s largest global distribution center, a sprawling 2.8 million-square-foot facility.

According to 2019 data from the U.S. Bureau of Labor Statistics, more than 58,000 workers in the Memphis metro area fill and stock orders, package materials and move materials by hand.

In Memphis, workers at distribution centers for FedEx, Nike and Kroger have tested positive for the coronavirus. The Shelby County Health Department received 64 complaints about businesses between April 1 and April 29, but could not say how many were about warehouses.

Interim guidance from the Centers for Disease Control and Prevention calls for employers to notify workers of positive cases. But it is voluntary. The federal OSHA has no such requirement, and neither does Tennessee’s OSHA.

Although Congress passed the Families First Coronavirus Response Act, which provides two weeks paid sick leave for coronavirus-affected or infected workers, it doesn’t apply to many warehouse and temporary employees, said Laura Padin, senior staff attorney at the Washington-based National Employment Law Project, which advocates for better public policy for workers, particularly low-wage workers.

“The big issue is that it exempts so many employers, especially employers with over 500 employees,” Padin said. “And the vast majority of temp workers and many warehouse workers work for employers with more than 500 employees.”

The coronavirus has disproportionately affected people of color, the very group that makes up the bulk of the warehouse and temporary workforce.

“Black workers make up 12% of the workforce but 26% of temp workers, and Latino workers make up 16% of the workforce but 25% of temp workers,” said Padin, citing Bureau of Labor Statistics data released in 2018.

Add to that the yawning racial wealth gap and low-wage workers like Meeks are in an untenable situation, Padin said.

“They either stay home and they risk their financial security,” Padin said, “or they go to work and risk their lives.”

“You Can Always Go Back”

With 1.45 million square feet of warehouse space among its four area locations, PFS is the ninth-largest third-party distribution operation in the metro area, according to the Memphis Business Journal’s 2020 Book of Lists. PFS doesn’t sell products under its own name but rather fulfills orders for better-known companies.

Pandora, which is perhaps best known for its charm bracelets, is one of PFS’s clients. “Each item shipped for PANDORA is wrapped in customized, branded, and sometimes seasonal packing materials, making every purchase a gift,” PFS’s website says.

Meeks’ favorite part of her job was taking each customer’s personal message, tucking it into a tiny envelope and then into the gift package.

“When we were sending out these Pandora bracelets and these Chanel gifts, I sat there and read all my cards,” said Meeks, who like all of the workers interviewed for this story, is black. “They were so cute.”

One Pandora customer sent a note to “beloved mother,” Meeks said, and another seemed to be from someone in a long-distance relationship.

“He was like: Even though I’m miles and miles away, I always think about you,” Meeks said. He wrote that he hoped the jewelry would “glitter in your eyes, or something like that.”

The day Meeks quit PFS, she said she called Prestigious Placement, the temporary agency that sent her there, asking for another job.

The temporary agency representative “was like, ‘Well, you can always go back to PFS until we get something else,’ and I was like, ‘No.’”

“She said, ‘Well, we haven’t had anyone to get sick,’” Meeks recalled.

Meeks said she tried to explain that regardless of whether some workers had tested positive, the company wasn’t taking enough steps, in her opinion, to keep current workers safe.

The representative said she’d ask the agency’s on-site manager about Meeks’ concerns, but Meeks said that there was no on-site manager present on her second or third day.

Prestigious Placement did not respond to multiple requests for comment for this story.

A local labor leader said Meeks’ experience illustrates the tough situation for temporary workers at warehouses.

“They tend not to have benefits, sick time and insurance and all the things that allow us to keep our whole community safe during a pandemic,” said Jeffrey Lichtenstein, executive secretary of the Memphis Labor Council, a federation of around 40 union locals.

Unlike companies such as Nike and FedEx, which have reputations to protect, the general public doesn’t know who PFS is or what it does, he said. “They have no brand vulnerability,” he said.

With little leverage to exert on businesses, these workers are up against a regional business model that mires them in dead-end, low-wage jobs, Lichtenstein said.

The city’s power brokers, he said, “have a couple of main tenets of their economic philosophy. One, logistics is really, really important, and two, cheap labor is very, very important.”

“Nothing Essential About It”

Memphis Mayor Jim Strickland issued a “Safer At Home” executive order on March 23, mirroring those put in place elsewhere. But the order specifically exempted warehouses and distribution centers from COVID-19 restrictions.

PFS gave workers a letter that cited Strickland’s order and the U.S. Department of Homeland Security’s guidance that “transportation and logistics are deemed a critical infrastructure that must be maintained during the COVID-19 crisis,” according to a copy reviewed by MLK50.

If they were stopped by authorities on the way to work, employees were told, this letter would ease their passage.

Some workers questioned whether the distribution center should be open at all.

“I don’t see nothing essential about it,” said one employee who asked to remain anonymous for fear she’d be fired for talking to a journalist. “It don’t got nothing to do with nurses or health.”

When a worker tested positive at a PFS distribution center in southeast Memphis, the employee, who worked at a Southaven, Mississippi, location about eight miles away, worried that the virus could spread if workers were shuffled between sites.

A manager assured her that workers would stay put, the employee said. But on April 16, a supervisor told workers that two Memphis workers, who had been brought in to the employee’s Southaven facility, had tested positive for the coronavirus.

“I said, ‘Well, since y’all got everybody in here messed up, can’t you call and get everyone in there a COVID-19 test?’” she remembered. “They said if you don’t feel safe, you can go home.”

She can’t risk taking the virus home to a relative, who has chronic illnesses, and she can’t afford not to work. “I’m concerned for my health,” she said. “I don’t want to die.”

Padin, who works with workers’ rights centers across the country, said she’s not aware of much being done by advocates to narrow the list of businesses considered essential. “I do think some of these essential worker orders are quite broad,” she said. “Our sense is that it’s a little arbitrary and just seems to be a result of lobbying.”

She pointed to the success of meat processing plants, which were declared “critical infrastructure” by President Donald Trump despite coronavirus outbreaks that sickened thousands and killed dozens.

Days before Trump’s declaration, meatpacking giant Tyson ran a full-page ad in The New York Times saying “The food supply chain is breaking.”

In Memphis, an amended executive order, signed by the mayor April 21, clarified which distribution centers and warehouses could remain in operation, including ones that handle medical supplies, food and hygiene products.

The order would seem to exclude facilities such as PFS. “Products and services for and in industries that are not otherwise identified in this provision constitute non-essential goods and services,” reads the order, which is set to expire at midnight Tuesday. On Monday, Memphis will move into the first phase of its “Back to Business” plan, which means nonessential businesses can operate with face masks, social distancing in the workplace, and symptom checks.

“No Social Distancing”

Because the turnover in warehouses like PFS is high, the need for a steady flow of labor is paramount. And temp agencies are a major source of employees.

One Memphis mother saw a job posting on Facebook for PFS. A family member’s workplace had closed because of the coronavirus, so the woman rushed to find work to make up for the lost household income. She was hired in late March by Paramount Staffing and sent to a warehouse in Southaven, Mississippi. She wanted to remain anonymous for fear of job retaliation.

From the moment workers entered the building, she said, they were close together. A single-file line funneled workers past several time clocks, one for PFS’s permanent workers and one for each staffing agency with temporary workers there.

“Some people have masks on, some don’t,” said the worker, who earned $9 an hour. Workers weren’t provided any personal protective equipment.

She opted to be a packer, a mostly stationary job, but she had to use a shared tape dispenser to seal boxes and her co-workers were within arm’s reach.

Her other job option was as a picker, but they’re in motion most of the shift, selecting products for individual orders from totes and using a shared scan gun. Pickers send the completed orders to packers.

“It’s basically no social distancing at that warehouse,” she said. “They’re gonna have to work on that.”

About two hours before her shift ended April 10, a manager huddled workers in her area together for an announcement.

“He said, ‘Well, we’re just letting y’all know that we have an employee here who tested positive and we are asking everyone here to leave the building immediately and we will clock y’all out,’” the worker recalled.

The manager instructed them not to touch anything as they left, “just go straight out the door and we will let y’all know when to return,” she recalled.

The warehouse was closed for the next day and reopened the following day.

“It makes me nervous because my health is important to me, but at the same time, it’s like that’s the only thing I can do right now,” she said.

She’s grateful for the job but insists she won’t be there long. “I’m going to try to get in a couple more checks and then I’m going to quit.”

She left about a week ago, but hasn’t found another job yet.

Paramount Staffing, which sent the worker to PFS, relies on the client to provide personal protective equipment to workers, said company president Matthew Schubert.

“My understanding is that they’ve been taking temperatures as employees walk in,” Schubert said, plus performing more frequent cleanings and coaching the workers on social distancing, but he acknowledged he didn’t know when any of those measures began.

“What we want to make sure is that they’re doing everything in their power to follow the CDC guidelines,” said Schubert, who estimates Paramount has 75 to 80 workers at PFS’s area warehouses.

“We’re limited as to what we can and cannot do, because it’s not our facility.”

Both Lichtenstein and Padin say it’s the worksite employer’s responsibility to provide personal protective equipment.

A Perfect Combination: Higher Pay and Less Risk

Just days after Meeks quit PFS, she turned to a different agency and was sent to a Memphis warehouse that labels and ships cleaning products.

Her first day was April 17, and she was impressed by the precautions the employer takes.

Before workers enter the building, Meeks said, their temperatures are taken in a white tent outside. If they don’t have a fever, they get a wristband that is a different color each day.

The company provides masks, gloves and goggles, she said, and there are even kickstands on the bathroom doors, so they can be opened by foot.

Working the third shift means fewer people, Meeks said. “We’re not working close to each other.”

Meeks said she wouldn’t put a price on her health, but at her new job, the risks are lower and the pay higher — up from $9 to $11.50 an hour.

Wendi C. Thomas is the editor of MLK50: Justice Through Journalism. Email her at wendicthomas@mlk50.com and follow her on Twitter at @wendi_c_thomas.

Do you work at a warehouse or distribution center in the Memphis area? MLK50 and ProPublica want to hear from you.

• Call or text us: (901) 633-3638
• Email us: memphis@propublica.org

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Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

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This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.

Mar 19, 2020

This paper examines a recent, rapid, and ongoing transition of India's lighting market to light emitting diode (LED) technology, from a negligible market share to LEDs becoming the dominant lighting products within five years, despite the country's otherwise limited visibility in the global solid-state lighting industry.