Consuelo Carreto Valencia, a member of the Carreto family sex trafficking ring that operated between Mexico and Queens, N.Y., was sentenced to 121 months in prison for benefitting financially from her participation in the organization, which transported young Mexican women to the United States and forced them into prostitution.

“We must engage the broadest spectrum of community partners in order to stem youth violence, and a cornerstone of that partnership is young people themselves,” said Attorney General Holder. “The Department of Justice is committed to working with young people to develop innovative solutions to help prevent teen dating abuse.”

The plain truth is that youth violence is far-too common. There’s no single cause and no simple solution. But we know one important contributor is the absence of a responsible, loving father. Here in D.C., where half of African-American households don’t include even one grown man, the implications of this fact could not be clearer.

An indictment unsealed today in Philadelphia charged Omelyan Botsvynyuk, Stepan Botsvynyuk, Mykhaylo Botsvynyuk, Dmytro Botsvynyuk, and Yaroslav Botsvynyuk, a/k/a Yaroslav Churuk, with extortion and conspiracy to violate the Racketeer Influenced and Corrupt Organizations Act (RICO) for their alleged involvement in a human trafficking operation.

Bidemi Bello, formerly of Buford, Ga., and presently from Nigeria, was arraigned today, following an indictment returned by a federal grand jury on Sep.10, 2010.

At the direction of President Obama, the Departments of Justice and Education officially launched the National Forum on Youth Violence Prevention (the forum) along with participating localities and other federal agencies.

The Department of Justice, the Environmental Protection Agency and the United States Attorney’s Office announced today, the settlement of claims against ConocoPhillips Company and Sasol North America Inc. to resolve their liability to EPA under CERCLA for contamination in the Calcasieu Estuary of Louisiana.

Attorney General Eric Holder today commended teams from six cities across the country for developing comprehensive plans to reduce youth violence in their communities.

"This gathering marks an important step forward in what I know – and what I pledge – will be an ongoing conversation about how we can address violence among – and directed toward – our nation’s young people."

“This conference provides a critical opportunity to highlight, to celebrate, and – hopefully – to replicate, the extraordinary progress that’s been made under Minneapolis’s “Blueprint for Action” strategy. It’s also our chance to reaffirm our commitment to the goals that we share – protecting young people in need and at risk; and strengthening our approach to addressing one of the greatest public safety – and public health – epidemics of our time: children’s exposure to violence.”

Bidemi Bello, 41, a former resident of Suwanee, Ga., and a citizen of Nigeria, was convicted on eight counts by a federal jury late on Friday on charges of two counts of forced labor, two counts of trafficking for forced labor, one count of document servitude, one count of alien harboring and two counts of making false statements in an application to become a U.S. citizen.

The operator of Morning Star Center, a residential facility located in Port-au-Prince, Haiti, that provided food and shelter to minors, has been charged with offenses involving the sexual abuse of minors in Haiti.

"You are here today because you know how important it is to continue finding innovative and effective ways to fight violent crime. As someone who focuses on criminal prosecution, I am absolutely committed to doing everything I can to help make our communities safer."

One hundred and seventy five young men and women from nearly 50 tribal communities across the country have convened at the week-long 2011 National Intertribal Youth Summit in Santa Fe, N.M., which runs from July 24-28, 2011.

Bidemi Bello, 42, formerly of Suwanee, Ga., was sentenced today in Atlanta by U.S. District Judge William S. Duffey Jr. on human trafficking charges including forced labor, trafficking with respect to forced labor, document servitude, harboring for financial gain and procurement of naturalization unlawfully.

“The work we are doing is sending an unmistakable message: that, in this country, we will not give up on our children when it comes to combating youth violence,” Attorney General Eric Holder said.

Following a comprehensive investigation, the Justice Department announced today its findings that the state of Mississippi violated the constitutional rights of youth detained at the Walnut Grove Youth Correctional Facility.

Universal Health Services Inc. (UHS) and two subsidiaries have reached a settlement in a False Claims Act lawsuit with the United States and the Commonwealth of Virginia, the Justice Department announced today.

Attorney General Eric Holder today recognized six cities for their progress in preventing youth violence at the second annual summit of the National Forum on Youth Violence Prevention held in Washington, D.C.

"I don’t need to tell anyone here what a difficult challenge youth violence is. You’re all part of the Forum because you’ve seen the consequences of juvenile crime in your own communities. You understand how complex this issue is – and you know this is not a problem any of us can solve alone – especially in this tough fiscal climate," said Acting Assistant Attorney General Leary.

"Especially in recent weeks – as the importance of protecting our children from harm has been at the forefront of our national discourse – the urgency of this challenge has been brought into stark focus. And the need to take action has never been more clear," said Attorney General Holder.

"Because the issue of preventing Youth Violence is one that Attorney General Holder and I are deeply committed to. As he often says, fighting violence in our cities and building a fair and effective justice system – a system that keeps citizens safe and maintains its legitimacy in the eyes of everyone it serves – has never been more difficult, and never more urgent," said Acting Associate Attorney General West.

"Attorney General Holder often says that fighting violence in our cities and building a fair and effective justice system – a system that keeps citizens safe and maintains its legitimacy in the eyes of everyone it serves – has never been more difficult, nor more urgent, than right now," said Acting Associate Attorney General West.

"As we work to help keep our children safe, we cannot view youth violence and violence against women as separate and distinct, but, instead, as intertwined. To realize our vision for safe and healthy communities, we must start with safe and healthy homes," said Acting Director Hanson.

More than 200 American Indian and Alaska Native youth and adult leaders from 53 tribal communities across the country have convened at the 2012 National Intertribal Youth Summit.

"You’ve already shown that leadership is a quality available in abundance in tribal communities. The future clearly is in good hands. Thank you for everything you’re doing for your communities, and keep up the good work," said Acting Assistant Attorney General Leary.

"My wish for all of you is that the experience of this week will transform your present and give momentum to your future as proud members of your tribe and proud Americans, working to bring about the best for you as an individual and for your tribal nation," said Acting Associate Attorney General West.

"The message we’re sending is that youth violence is not inevitable. When communities engage partners across disciplines and use a data-driven, balanced approach – one that emphasizes prevention, intervention, enforcement, and reentry – they can reduce violence and improve outcomes for our youth," said Acting Assistant Attorney General Leary.

"By emphasizing collaborative partnerships, evidence-based and data-driven strategies and a balanced, holistic approach, we know we can help communities to curb violence and promote the health, safety and development of our young people," said Acting Associate Attorney General West.

Attorney General Eric Holder and Acting Assistant Attorney General for the Office of Justice Programs (OJP) Mary Lou Leary today announced that four new cities will join a White House initiative to prevent youth violence.

A federal grand jury has indicted two members of the Compton 155 street gang on federal hate crime charges related to a racially motivated attack on four African-American juveniles at a residence in the city of Compton, Calif., on New Year’s Eve.

John Stuart Dowell, 47, of Santa Cruz, Calif., was sentenced late yesterday in Harrisonburg, Va., to serve 960 months in prison, followed by a lifetime of supervised release, for producing child pornography.

Clearly, the consequences of inaction in the face of such trauma would be too great to ignore. And the associated costs – in human, moral, and even economic terms – are far too much to bear. In fact, the cost of failing to intervene in the life of a young person who’s at risk of becoming delinquent could add up to more than $3 million over the course of his or her lifetime.

The impact of this violence, and of our acquiescence, is greater than it appears on the surface. We can see the immediate physical damage it does, and we know it causes emotional trauma in the kids it touches.

Two Latino men associated with the Compton 155 street gang pleaded guilty today to federal hate crime charges related to a racially motivated attack on African-American juveniles at a residence in Compton, Calif. on New Year’s Eve.

Today, the Justice Department sought a federal court order temporarily restraining the Ohio Department of Youth Services (DYS) from unlawfully secluding boys with mental health needs in its juvenile correctional facilities.

As part of his My Brother’s Keeper initiative, President Obama announced new AmeriCorps partnerships with federal agencies and the private sector to connect young people to mentoring, support networks and job skills to help them reach their full potential

Today, the Justice Department asked a federal court to dismiss its case involving Oakley Training School in Raymond, Mississippi, because the state of Mississippi and the Division of Youth Services have significantly improved conditions for confined youth at Oakley. The reforms, implemented under a consent decree, resulted in increased protections to prevent harm to youth, improved suicide prevention practices, improved medical, dental and mental healthcare, increased rehabilitative services and improved special educational services

The following are some of the stocks in the healthcare sector that touched a high yesterday. Will the rally continue?

Q: If Notes to File can be regulatory red flags, should we quit using them?
A: No, and here's why...

Regulatory inspections are often conducted long after the conclusion of the study. When an FDA investigator asks you a question about an anomaly five years after it’s happened, will anyone recall the circumstances well enough to satisfy the regulator’s concerns? You’ll be doing yourself a huge favor if you write NTFs that answer the questions regulators might one day be asking you.



NTFs can be used to effectively explain an irregularity, locate a document, or note a change in procedures. While there are no regulations or guidances that govern NTFs per se, ICH E6(R2) 2.10 states “All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.” A well-written NTF will not only describe an event, but will document who made the notation and when, why the problem occurred, what was done to fix it, and what changes were made to keep it from happening in the future. That’s a lot, so it’s a good idea to develop an NTF template to remind authors to include these elements.

Example of a poorly written NTF:
Informed Consent for study BH-90210 was revised by the IRB 01/7/2017. Subject 867-5309 was not re-consented at her next study visit, as per IRB instructions.

This NTF does nothing more than document the deficiency.

Improved NTF:
Informed Consent for study BH-90210 was revised by the IRB 01/07/2017 to include lab procedures on Visit 5. IRB instructions required a re-consent for all enrolled subjects at next study visit. Subject 867-5309 was not re-consented at her next (2nd) study visit, but was re-consented at her 3rd visit.

This version of the NTF gives us a little more context and lets us know that the subject was re-consented before the new lab procedures were performed. The oversight was corrected in time to preserve Jenny’s* rights, but we still don’t know why it happened; there’s not enough information to satisfy a regulator that failure to re-consent was not a pervasive problem. What were the site’s re-consenting procedures at the time of this study? Were they being followed? Who do we ask?


Complete NTF Using Template



Since the subject was consented before the additional lab procedures were performed, there was no violation of informed consent regulations. This was an oversight with no ill-effects, not a significant break with procedures. Discussing it at the departmental meeting is an appropriate, proportional response. (Note that if the subject had not been re-consented before the new lab procedures were performed, the site would have been in violation of consent regulations and an NTF would not have been sufficient. Both the IRB and the sponsor would have needed to be informed of the failure to consent.)

A poorly written NTF – one that doesn’t provide enough information, one that identifies a problem but no solution, one that is inadequately standing in for proper record keeping – won’t satisfy a regulator’s concerns. These are the sorts of NTFs that can actually do more harm than good. A well-written NTF, on the other hand, is something your future self will thank you for.

In case you missed it, our last post was about how GMP activities affect GCP study procedures.
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* If you know why Subject 867-5309 goes by “Jenny," one of your friends wore a pink tux with shoulder pads to prom.

A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

You know you need a computer systems audit, but that’s literally the extent of what you know.
Has this ever been you?

Yes, you use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply. Terms like “cloud computing” make you feel slightly queasy. You’d rather get a root canal than discuss “distributed processing.” Your expertise is in manufacturing. Or clinical research. Or non-clinical lab operations. And somehow it’s your job to make sure an effective and properly-sized system audit is conducted. Great.



Yet your Quality Assurance colleagues -- whether they’re from your internal QA department or an external compliance company -- need your input. They need to understand what software is being purchased, what services are being contracted, how and where components of the system are being implemented, and how the system will be used.

The good news is that the QA auditors can help you. They know that FDA favors a risk-based approach to validation and Part 11 implementation, and they even know what that means. They love to talk about configuration management and change procedures. They love gathering evidence that demonstrates your system works correctly and is in a state of control, and they know what rocks they should look under to find and fix vulnerabilities.

What follows are examples of the types of information you need to convey to QA – and that they should be asking you about – to properly size and scope an audit.

How do You Plan to Use the System?

Suppose you need to audit the supplier of a new Document Management System. The first thing an auditor would need to understand is how you plan to use the system. How mission critical are the documents you’re looking to store?  Are they covered under regulatory scope?  Maybe you plan to use the system as a collaboration environment for developing new SOPs. That would require a relatively low level of scrutiny, especially if you only plan to print out the finalized documents for wet ink signature. (As a point of comparison, if you plan to use the system to finalize SOP approval, the auditor would need to check that Part 11 requirements for electronic signatures are properly implemented.) What if the Document Management System will be housing critical GxP documents, such as Trial Master Files, Master Schedule Sheets, or Master Batch Records? In these cases, the validation would have to be far more thorough, and Part 11 electronic record features, such as audit trails and archiving functionality, would have to be implemented and verified.

Here’s another “use” example. Similar to the term “Document Management System,” the term “Analytics System” does not tell the whole story. From a business perspective, study start up (SSU) metrics may be vital for sponsors and CROs to collect and analyze. But since they have no regulatory impact, the FDA would not require an SSU analytics system to be validated. (That doesn’t necessarily mean you might not want to, though.) On the other hand, a system that performs statistical analysis on study data for regulatory submission is about as critical as it gets, and would require thorough validation and Part 11 implementation. Other analytics systems, such as dashboards that pull data from critical systems, might fall somewhere between these two extremes.

What is the Vendor Providing? And How? And Where?

If you need to audit a complex system, the questions QA will ask you will go beyond system use. The auditors will need to understand the combination of software and services the vendor is providing, and where the software and data reside.

• Does the software and data reside internally at your company or does the vendor provide a hosting service?
  If the vendor is hosting, the auditor needs to tour the facilities and review SOPs and records to evaluate physical security, staff training, environmental controls, backup procedures, disaster recovery plans, data retention, computer infrastructure, and change control.
  
  
• Does the hosting vendor own its own servers or does it, in turn, outsource that function to a 3rd party hosting company, (possibly even in the cloud)?
  If the hosting is outsourced, ideally an auditor would be able to visit the hosting site. Failing that, the auditor would ask questions about the vendor’s qualification processes and review SOPs that govern vendor selection/management procedures. If the vendor outsources other services beyond hosting, those services might need to be considered, as well.
  
  
• Is the vendor providing any other services?
  Many EDC vendors will provide study-specific services such as screen development and data entry validation edits. Auditors would need to review SOPs for providing these services and understand how the vendor tests and manages modifications to these components as the study proceeds.
  Sometimes computer systems vendors provide ancillary services, such as help desk functions and user account management. That would mean additional SOPs and training records for the auditor to look through.

Other Considerations

There are many. For example, where are you in the product life cycle? You ask different questions about a new system than you would about one that has been operating for a few years. Is the product Commercial off-the-shelf (COTS) or highly customized? COTS systems vendors often have their own validation package which auditors would review, and then ensure proper operation in the sponsor/CRO’s specific environment. A highly customized or custom-built system would require a more extensive validation process.


The Take Away

CSV/Part 11 audits will never be standardized, cookie cutter type activities; there are simply too many factors -- in too many combinations -- to consider. You want your QA efforts to be worth the money you spend and be able to answer the questions FDA says you need to be asking. If you’re unsure how to do that, that’s ok. Other people know, as long as you can help them understand how you plan to use the system, what software and services are being supplied, and how components of the system are being implemented.

In case you missed it, our previous post was Notes 2 Fix Your Notes 2 File.
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Many thinks to Lisa Olson for sharing her insights with me.

Sites frequently want to know how they can stand out to Sponsors and CROs to win more studies.
Our advice: Implement internal QC procedures.

Sponsors and CROs we work with consider a tight quality control program to be evidence that a site can be counted on to produce reliable data. It shows that managing quality at your site is a continual process, and doesn’t wait for monitors to arrive. In a risk-based monitoring environment, this is an increasingly compelling attribute.

Where to Start: The Usual Suspects
It makes sense for you to focus your QC efforts on those areas where you’ve historically had the most problems. If the phrase “trend analysis” makes you want to jump through a window -- it's okay -- you can climb back inside. You don't have to do a trend analysis. We've identified 3 areas in which audit findings are common and how you can avoid them.



Adverse Events (AEs) and Concomitant Medications (ConMeds). Often two sides of the same coin, AE and ConMed documentation needs to tell a consistent story. If source documents indicate a study participant had a sinus infection, it must be documented on an AE page, and any associated medications documented on the ConMeds page. A medication noted on the AE page must have a corresponding notation on the ConMed page. And all start and end dates must match across the source, AE, and ConMeds pages.

Drug Accountability Records. Calculating compliance percentages and counting pills are positively uninteresting tasks, easy to mess up, and involve math (which for some people triggers terrifying flashbacks of word problems about trains leaving stations). Is it any wonder that drug accountability records are frequent sources of error? Do some spot-checking: verify that the number of returned tablets matches the tallies recorded for them and recheck compliance calculations.

Essential Documents. Maintaining a complete, organized, uniform set of essential documents is an important, yet decidedly unsexy task. That’s why it’s a good indicator of your commitment to quality; a site that is disciplined enough to keep tight control over its essential documents is likely to carry that control into all aspects of trial execution. Make sure to file all documents associated with protocol amendments, such as IRB approvals and revised informed consent forms -- our auditors find these are the items most frequently missing from the essential document set. 

Write It All Down
Document your QC procedures in an SOP. It will serve as training material for site staff and a repository for worksheets and checklists.

There’s no magic organization for this QC SOP. A general set of instructions could outline how reviewers can verify that all documents follow ALCOA principles. For example, on (paper) source documents, are all pages and required signatures present? Are entries legible? Are corrections initialed, dated, and explained? Does the data make sense and lie within expected ranges? Have all data elements been populated? (Tip: turn the paper upside down to catch missing data.)

Checklists that are focused on particular types of documents should be as specific as possible. For example, QC reviews of source documents for screening visits would verify that the correct informed consent form was used, administration of consent was documented, medical release forms were sent if required, demographics were correct, all labs were received, reviewed and signed, all protocol assessments were completed, and all inclusion/exclusion criteria were met and documented.

A Virtuous Cycle
While designed to control quality, performing QC over time may actually improve quality. Results of QC reviews often suggest revisions you should make to your tools and operations to reduce error in the future.

Okay, you can climb back through the window again -- no one said CAPA. (But wouldn't that be impressive?)


Showcasing Site QC Processes
Does implementing a QC program require resources and time? Yes, and that’s the point. It’s evidence to Sponsors and CROs of your commitment to running a quality study. Not only that, but it demonstrates a proper respect for your study participants by ensuring their data can be used.

Oh, and make sure you highlight your QC program on feasibility questionnaires. It’s something to brag about.

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A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites

Guest Blogger: Greg Weilersbacher
Founder & President, Eastlake Quality Consulting

All companies outsource. It’s a humbling fact that you simply can’t do it all yourself. This often has to do with resource allocation; your company may allocate dollars to build and sustain some activities in-house while choosing to contract higher-cost operations to qualified suppliers who already have the expertise and equipment. 

You may outsource the manufacturing of tablets, sterile injectable, or topical dosage form, or the GMP release and stability testing of your product. Once the production and testing is complete, the product may need to be stored under controlled temperature and humidity conditions and then distributed to locations around the globe. The Contract Development and Management Organizations (CDMOs) who execute these critical operations are of paramount importance to your company’s success. Choosing the right suppliers will also help to minimize stress-induced headaches throughout your organization. Here are the top five ways to get the most out of a supplier audit.



1.  Come to the Audit Prepared
This seems obvious. However, more often than not, quality auditors step into the supplier’s lobby without doing their homework. Ask yourself the following questions: Why am I auditing this supplier? Is this supplier new to my company or one that we have used before? If used previously, have I read over the audit observations as well as the supplier’s responses and do I understand them? Which audit observations do I suspect would be the most challenging for the supplier to address and which are most important to my company’s requirements for this product? Have I reviewed previously executed production batch records and testing data and are there issues that need to be resolved? Are their deviations and CAPAs to follow up on?

Your understanding the supplier’s work proposal is of great value in refining the scope of the audit. Ask yourself:  Which of our products may be manufactured and tested here and which strengths (e.g., potency) will be produced? Which equipment is likely to be used? For a tablet production, the equipment train could include balances, blenders, roller compactor, spray dryer, solvent-rated oven, comils, tablet press and tooling, gravity feeder, coating systems, de-duster, weight sorter, metal detector, tablet counter, etc. This list of equipment will assist you in requesting equipment records during the audit. 

2.  Stay On Point
Proper audit planning will help to keep the audit organized and adhere to the audit timeline. In advance of the audit, provide the audit host with a list of the technical, lab, and manufacturing staff you wish to speak with and the records you need to review. A well-organized host will have this available for your review. Stick to your audit agenda. This is critical. The best way to derail your progress is to spend precious time chasing down minor issues while glaring problems get little to no attention. Continually refer back to the audit agenda and remember to keep the content of your audit report in mind while executing the audit.


3.  Know Your Technical Expertise and Limitations
Many auditors have led previous lives in the laboratory or in manufacturing while others started their careers in quality assurance and may have little technical background with regard to equipment, manufacturing processes, GMP utilities and laboratory testing. Know your limitations and if necessary strengthen them by hiring an expert consultant to assist you during the audit.

A common problem area that is at best glossed over and at worst completely ignored during an audit is the CDMO’s compliance with GMP utilities requirements. All too often, this is due to the auditor’s lack of understanding of the operation, inputs and outputs, validation parameters, and periodic testing and maintenance requirements for utilities such as HVAC, clean or pure steam, purified water and WFI systems, autoclaves, clean compressed air, nitrogen and other gases used for operating equipment or used during processing activities in manufacturing. Typically, these areas are also less well understood by the CDMO’s employees and as a result noncompliance abound. 

Some GMP utilities may be connected to the facility’s building management system, while others may be stand-alone equipment. In either case, the CDMO should have records of alarms (e.g., out of specification or out of range conditions), an acknowledgement of each alarm by designated staff members, and documentation of corrective actions. The last item is key. This is where the execution of quality systems tends to fail. Make a point to request documentation of corrective actions for each utility alarm. 

Additionally, purified and WFI water systems along with gases, such as clean compressed air and nitrogen, require periodical sampling/testing at each point-of-use. Verify that the timelines (monthly, quarterly, or annual) for sampling and testing were performed as directed by the CDMO’s procedures. These timelines are typically not well adhered to. A clear understanding of all the operations of the supplier’s GMP utility management process will keep your thoughts clear during the audit and help identify areas that are in need of improvement. 

4.  The Auditor’s Job is to Identify the Good and the Bad (Not to Win the Debate)
An important goal of a supplier audit is to identify the supplier’s strengths and weaknesses and come away from the audit with a compliance assessment that your company can use to make important decisions. It is of no value to your company if the goal of the auditor is to show the supplier how much he or she knows by debating the fine points of compliance. GMP auditors with decades of experience generally avoid this competitive exchange as it is unproductive. Rather, it is more important to the spend the necessary time identifying compliance issues, making them known to the audit host in a professional manner, and taking detailed notes that assist in writing the audit report. Your company’s senior managers need to know the supplier’s good and not-so-good points; detailing all of these provides the greatest value. 

5.  Interview the CDMO's Lab Staff, Manufacturing Operators, and Shipping/Receiving Personnel
CDMO’s quality systems are generally written by managers and directors who have many years of industry experience. It is of utmost importance that staff members who execute these systems understand them if your company’s product is to be manufactured, tested, stored, and distributed in a compliant manner. Request to speak with manufacturing staff members who work on the production floor and are likely to work on your product. Ask them about the process they would follow to conduct lines clearance, charge powders to a blender, operate a spray dryer, use a comil, set-up of a tablet press, inspect tablets, use metal detectors, etc. Compare the information they provide to the CDMO’s SOPs to determine if the staff understands their jobs. Listen for phrases such as “I usually do it this way…” or “it’s a different every time but I typically set up the equipment like this…” These phrases reveal a lack of control and adherence to procedures. 

The Take Away
The audit itself lays the foundation for a relationship with the supplier and the take-away message should address the following questions: Will the supplier work to resolve the issues I’ve identified? Am I confident that the supplier will immediately notify and involve my company’s representatives when deviations occur during production or testing? Do the supplier’s quality systems and records meet my company’s requirements and those of regulatory agencies? How confident am I that the supplier will produce and/or test a quality product that my company can stand behind? Is the supplier simply a pair of hands or are they committed to be my partner in this product’s success? The answers will provide you with a comfort level in making the decision to move forward with the CDMO or to look to the their competition.  

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A version of this article was first published in Outsourced Pharma.

 About the Author
Greg Weilersbacher is the Founder and President of Eastlake Quality Consulting, a GMP consulting firm based in the Southern California area. Over the last 25 years, he has held director and vice president positions leading Quality Assurance, Quality Control, Analytical Chemistry, Materials Management, GMP Facilities, and Product Manufacturing in biotech and pharmaceutical companies. His unique experiences and technical background have led to the manufacture and release of hundreds of solid oral, sterile, and biologic investigational products to clinics in the U.S. and abroad. Email Greg at weilersbacher.greg@gmail.com.

Alexion agrees deal for Portola to gain access to its lead product, Andexxa, a treatment that counteracts anticoagulants.

by Lucas Waldron and Nadia Sussman

Many people across the country experienced COVID-19 symptoms but could not get a test to confirm if they actually had the virus. Now some are looking to a different kind of coronavirus test for answers.

Antibody tests are meant to recognize a past infection. Many of these have hit the market in recent weeks and are being offered at local clinics. Officials have touted the tests as crucial for reopening the economy and developing public health strategies to contain the virus.

But there are still questions about how accurate they are. And even with a very good test, it's possible to test positive for antibodies even when you don't actually have them. Watch our new video to learn why.

by Justin Elliott, Paul Kiel and Lydia DePillis

Through programs like the Small Business Administration’s Paycheck Protection Program and the Federal Reserve’s Main Street Lending Program, the federal government is deploying hundreds of billions of dollars in grants, loans and bond purchases to help businesses amid the coronavirus-sparked economic crisis. Each program comes with different strings, but their basic purpose is to keep workers on the payroll.

We want to know what this means for your workplace. How has your company treated its workers during the crisis? Have you or your colleagues been laid off, furloughed or otherwise affected? Have you seen money used in surprising ways? What do you think we should be reporting on?

We are the only ones reading what you submit. If you would prefer to use an encrypted app, here is what we suggest. Send questions to bailout@propublica.org.

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by Charles Ornstein and Lena V. Groeger

Nursing home residents have been among those hardest hit by the new coronavirus. In some states, more than half of the recorded deaths have been long-term care residents. Some of the homes have been cited for putting residents at “immediate jeopardy” of harm or death, our analysis showed.

And many of the affected homes have been previously written up for violating federal standards. That’s true in California, New Jersey and New York.

We’re updating Nursing Home Inspect to include more information about nursing homes across the country, including past problems with infection control practices, and which ones have had cases of COVID-19 among residents or staff.

We introduced this resource in 2012 as a way to search through tens of thousands of nursing home inspection reports to find problems and trends.

You can easily compare the nursing homes in your state based on how many times they have been cited for violating infection control protocols in the past three inspection cycles (roughly three years). We’ve also added data from The Washington Post on homes with COVID-19 cases. Nursing Home Inspect also allows you to sort by the number of health deficiencies cited by regulators; the number of serious deficiencies per home (that is, deficiencies in which patients were put in immediate jeopardy of harm); the amount of fines imposed; and how often the government has suspended payments to the home for new patients, another type of penalty.

Our data is from the U.S. Centers for Medicare and Medicaid Services (CMS), which has its own website called Nursing Home Compare. We’ve taken the information and organized it into an easy-to-use resource for families and residents, as well as researchers and other journalists.

Our site includes:

• State pages: Every state has its own section that allows you to compare all of the homes in a state on a variety of indicators.

• Individual nursing home pages: Every home has a section listing all of the health deficiencies identified within the past three survey cycles (roughly three years). The full text of these deficiency reports, if available, can be accessed via links from this page to CMS. Each home’s page also has ownership status — whether for-profit, government-run or nonprofit — and whether the home has been labeled by the government as a Special Focus Facility, meaning that it has many more problems than other homes. We’ve also labeled Special Focus Facility candidates, which meet the criteria to be a special focus facility but haven’t yet been designated as one. (We only include health deficiencies, not fire and safety violations, in this database.)

• State-by-state maps: The main page of the app shows how states compare in terms of the percentage of homes with at least one serious deficiency, the average fine paid by homes in the state, and the percentage of homes in each state with at least one infection-related deficiency.

• Top 20 Lists: We’ve listed the homes that have paid the most in fines in the nation and those with the highest number of serious deficiencies.

If homes violate federal standards, CMS may impose fines or suspend Medicare/Medicaid payments to the nursing home for new residents until the facility corrects the deficiency.

If problems persist or are not fixed, CMS can end its agreement with the nursing home. Additional details about CMS’ approach to enforcement can be found here.

Nursing Home Inspect continues to allow you to search through nearly 80,000 inspection reports by keywords, such as “choke” or “maggots,” to look for issues you care about. These search results can be sorted by date, city, state or severity of the deficiency.

Nursing homes are inspected on both a regular schedule and when there is a complaint. Inspectors typically work for state agencies paid by Medicare. If they find problems, known as deficiencies, they rank them on a scale of A to L, the most severe. The vast majority are either labeled D or E.

What you won’t find on these pages are self-reported quality measures for each home. Those can be found on Nursing Home Compare. We also don’t list the state sanctions imposed against homes because those are not centrally collected. For information on penalties within a given state, you should consult the state agency that regulates nursing homes. The federal government has a list of contacts available here.

When reading through inspection reports, it is a good idea to keep in mind the caveats we’ve outlined previously.

How We Combined Data Sources

To compile our app, we used different datasets: a listing of all Medicare-certified nursing homes, inspection violations and penalties, and deficiency report narratives.

We merged spreadsheets containing findings from routine inspections and those identified during complaint visits and kept only health violations, not fire safety violations.

We used each home’s unique identification code to match penalties imposed to the dates of their corresponding inspections so we could display that data together for each home. (We also noted some cases in which a penalty date did not have a corresponding inspection in the database.)

You can find the data we used on these sites:

• For a list of nursing homes: https://data.medicare.gov/Nursing-Home-Compare/Provider-Info/4pq5-n9py

• For penalties: https://data.medicare.gov/Nursing-Home-Compare/Penalties/g6vv-u9sr

• For health deficiency information: https://data.medicare.gov/Nursing-Home-Compare/Health-Deficiencies/r5ix-sfxw

• For deficiency report narratives (updated in April 2020): http://downloads.cms.gov/files/Full-Statement-of-Deficiencies-April-2020.zip

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