Here’s why you should attend clinical compliance trainings

No doubt, the OIG recommends guidelines and doesn’t mandate implementation of any of them.

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Wondering if you should attend clinical compliance trainings? The following paragraphs will explain to you the criticality of clinical compliance trainings. We hope this article will help you understand why you should attend clinical compliance trainings.

First, let us start with an understanding of clinical compliance, after which we will lead to into an understanding of why you should attend clinical trainings: Clinical compliance, as different from laboratory compliance, is mainly about adhering to the guidelines relating to areas of healthcare such as billing, coding, medical claims, insurance and related ones, although it is common to come across terms that use the two words, “clinical” and “laboratory” together, somewhat loosely and interchangeably.

The Office of the Inspector General (OIG), which comes under the US Department of Health and Human Services (HHS), set out these guidelines for clinical compliance in August 1998. This guideline, formally termed the Compliance Program Guidance for Clinical Laboratories, which replaced the model compliance plan of March 1997, is considered more accurate and consistent with the current clinical practices.

It sets out guidelines for clinical compliance by suggesting seven areas to which a clinical setting must comply. The OIG suggests that a clinical practice must have these systems in place to show compliance with its guideline of 1998:

  • It must have written policies, procedures and standards in place, which will set out its rules of conduct
  • The clinical practice must have a compliance officer and a compliance committee
  • It should impart effective training and education
  • It should keep effective lines of communication open
  • It should enforce compliance standards through well-publicized disciplinary guidelines
  • It should implement a mechanism for internal monitoring and auditing
  • It should put in place resources that help it to respond promptly to any error or offense it could detect. It should develop corrective action.

Now, here’s why you should attend clinical compliance trainings

No doubt, the OIG recommends guidelines and doesn’t mandate implementation of any of them. But this is no comfort because a look at the guidelines makes it clear that effective training and education is a must. Noncompliance with this, or for that matter, any of these guidelines is taken seriously. What happens if an organization fails to meet these requirements?

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A cursory look at some of the random cases in which the OIG, under its Project Lab Scam has imposed penalties on clinical practices that have not complied with the regulations will shed light on the need for clinical compliance trainings:

  • Laboratory Corporation of America (LabCorp) had to pay nearly $200 million to resolve civil penalties under the False Claim Act (FCA). The reason: it allegedly submitted claims for medically unnecessary tests
  • As far back as in the mid-1990’s, Damon Clinical Laboratories entered into a settlement agreement with the Department of Justice (DOJ) of close to $120 million in civil and criminal penalties. Its crime: submitting false claims to the Medicare and Medicaid programs
  • By far, the biggest catch has been of the highly reputable SmithKline Beecham Clinical Laboratories. It was made to pay astronomical settlement charges of $325 million because the OIG detected violations in the company’s Medicare, Medicaid, CHAMPUS, and Railroad Retirement Board health care programs.

Seemingly simple reasons for penalizing

While these are some of the high-profile cases that have made the headlines, as recently as July 18, 2018, eClinical Works, LLC was made to cough up $132,500 in penalties. The nature of its offence: noncompliance in reporting Patient Safety Issues as Reportable Events in a timely manner as required by the OIG!

If this is the extent to which a clinical practice can be penalized, aren’t these enough reasons for why should attend clinical compliance trainings? Here’s why you should attend clinical compliance trainings:

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The HHS considers a clinical practice to be compliant when it has satisfactorily met all the guidelines it has set out. According to it, a practice is considered compliant when it carries these out among other things:

  • It charges, bills and documents rightly
  • Its facility is approved
  • Reimburses accurately

Another reason for why you should attend clinical compliance trainings: A clinical setting cannot take chances with any of these guidelines. It is only through the right clinical compliance trainings that it will be able to do this. There are those who complain about the upper cost of clinical compliance trainings. Now, this is cynical at best and poor low-level thinking at worst. Any clinical practice that thinks on these lines has to decide which of these is more prudent: spending a few hundred dollars on compliance training or save them to cough up millions!

https://oig.hhs.gov/authorities/docs/cpglab.pdf

https://academic.oup.com/labmed/article/40/7/428/2504865

https://www.hcca-info.org/Portals/0/PDFs/Resources/Conference_Handouts/Compliance_Institute/2017/P13print2.pdf

https://www.uclahealth.org/compliance/workfiles/PDF2/ComplianceTraining-Staff.pdf

https://pdfs.semanticscholar.org/presentation/6f36/94dae4a56c396754f0db36baeb34c6aebaa5.pdf

https://www.hcca-info.org/Portals/0/PDFs/Resources/Conference_Handouts/Compliance_Institute/2013/POST/POSTAM10print2.pdf

http://www.msm.edu/Administration/Compliance/hipaa/clinical.php

https://oig.hhs.gov/fraud/enforcement/ciae/stipulated-penalties.asp

What Makes FDA Guidelines So Addictive That You Never Want to Miss?

When this is the rationale for which the FDA passes its guidelines, the imperative to meet these guidelines becomes clear.

What makes FDA guidelines so addictive that you never want to miss them? Well, FDA guidelines are something like the reminders for your car servicing. What happens when you buy a car? You get reminders from your dealer asking you to service it on time. The reason: your car is meant to be in fine shape when you drive it on the roads in real life conditions. What happens if you miss the service deadline? Nothing, except that you could be responsible for an accident which causes severe consequences.

Now, in this scenario, what if you had an idea of how much damage your car could cause in which type of accident? Would you still want to miss the servicing and checkup date? This is the summary of the principle of what makes FDA guidelines so addictive that you never want to miss out on them! Simple: just like how an inadequately serviced car or any other vehicle can lead to accidents and carry grave consequences for either the driver or the accident victim or both; having products in the market that don’t adhere to FDA guidelines has its costs.

Understand the reasons for which guidelines are issued

It is in everyone’s interest to ensure that products produced by companies in the regulated industries meet FDA guidelines. Their task will become a lot less tedious when they understand the importance of these FDA guidelines. After all, for whose benefit are these guidelines made? Is it for the FDA’s? No. It is for the benefit of the consumers, the organizations marketing these products, and for the general health of the public. When this is the rationale for which the FDA passes its guidelines, the imperative to meet these guidelines becomes clear.

To take the case of the example given here further, there is another very strong reason for which meeting FDA guidelines is addictive to the extent that you never want to miss them: stringent enforcement actions that follow from non-implementation. The FDA has prescribed strict penalties for different kinds of non-implementation of its guidelines. Its enforcement actions are carried out in the following four broad categories:

Warning Letters: The first and mildest of enforcement actions; a Warning Letter notes the violations the company may have committed and advises them on what action has to be taken to correct them.

Seizure: This action is about confiscating an adulterated or misbranded product and ensuring that such products do not enter the market or removing them if they already have.

FDA guidelines so addictive that you would never want to miss them!
https://goo.gl/gzUxeX

How outcome can be improved for every patient with state-of-the-art cardiac solutions

Healthcare providers and payers to quickly and securely integrate and flow data across the healthcare network.

DXC Technology , the world’s leading independent, end-to-end IT services company, announced DXC Open Health Connect, a digital health platform that enables healthcare providers to give better quality of care and patient outcomes by enabling interoperability between disparate environments to provide data when and where it’s needed across the healthcare system.

Rising costs, increased regulations and shifting consumer expectations are leading healthcare organizations to seek efficiencies through digital transformation. According to the IDC FutureScape: Worldwide Healthcare 2018 Predictions, “By 2019, more than 50 percent of life-science and healthcare companies will have dedicated resources to support accessing, sharing and analyzing real-world evidence for use across their organizations.”

Click here to know how outcome can be improved for every patient with state-of-the-art cardiac solutions.

A connected healthcare ecosystem — including integrated delivery networks, accurate patient data and increased access to information — is essential to lowering costs, improving care quality and boosting patient outcomes. DXC’s agile, cloud-based DXC Open Health Connect enterprise platform delivers the necessary tools and blueprints to healthcare providers and payers to quickly and securely integrate and flow data across the healthcare network.

“As the healthcare industry moves away from a volume-based model in favor of outcomes-based programs, interoperability and data sharing — financial, clinical and operational — will be key to achieving enhanced patient care,” said Andrea Fiumicelli, vice president and general manager, Healthcare and Life Sciences, DXC Technology.

“The future of connected healthcare will be about collaboration and care within and beyond the walls of a hospital or clinic. DXC Open Health Connect encapsulates the future of healthcare by delivering the speed, scale, flexibility and continuous innovation necessary for clients to turn their traditional healthcare systems into major digital-health enablers.”

DXC co-created DXC Open Health Connect with a large academic and research hospital system in metropolitan New York. The solution went into production in 2017, enabling better access to all of the data and technology across the network to discover new insights that are helping to enhance patient engagement, improve operational efficiencies and boost flexibility. Ultimately, DXC Open Health Connect is enabling a shift in focus away from acute care only to concentrating more on promoting lifelong wellness.

Combining partner, product and composite application programming interfaces (APIs) with cloud services and common protocols, DXC Open Health Connect delivers faster time to value by automating deployment, personalizing the user experience and accelerating service development to seamlessly move information between disparate environments.

DXC Open Health Connect, available globally, is offered as either a technology platform or in three easy-to-consume modules:

  1. The DXC Open Health Connect interoperability module helps integrate disparate data from across the healthcare ecosystem to support the creation of an integrated care record;
  2. DXC Open Health Connect analytics provide evidence-based insights about populations and individual health to improve care; and
  3. DXC Open Health Connect’s API Director supports the ability to rapidly create new, information-rich applications while governing and controlling access to patient data. It provides enterprise security, metering, billing and policy enforcement.

The digital platform allows for the deployment of DXC Technology’s mobile applications, such as PatientAide, NurseAideand ClinicalAide, which drive appropriate behavioral changes in the healthcare ecosystem and support changes in the patient journey.

http://bit.ly/2Kv5H4W Click here to read more

National health targets lead to perverse outcomes

Those health targets were such a miserable failure that we have to find something that works and that’s better.

National has warned that there will be more preventable deaths in the health system now that the Government has dropped national health targets.

The performance targets for district health boards, which the former government introduced in 2009, have been stopped by the Coalition Government, and no data has been published since August 2017.

“Over time dropping the targets, losing the accountability, will mean more illnesses and more fatalities in our health system that could have been avoided,” National leader Simon Bridges told reporters today.

But Ian Powell, executive director of the Association of Salaried Medical Specialists, said that was not true.

“That’s crap. The obsessional nature of certain targets has contributed to some patients going blind,” he said.

Powell said the targets had not worked and they needed to be outcomes–based.

“They have led to superficial assessments of how the system has performed, they grossly mislead the public and they have had, especially in the context of underfunding, very perverse outcomes.

“The [Health] Minister, and we would agree with him, is looking more towards things that focus more on improved health outcomes,” he said.

Acting Prime Minister Winston Peters said the targets had been a “miserable failure”.

“It’s not correct to say we’ve dropped health targets. I just think those health targets were such a miserable failure that we have to find something that works and that’s better,” Peters told reporters this morning.

Health Minister David Clark said the Ministry of Health had stopped publishing data based on the previous government’s targets while other measures were developed.

“The previous government’s targets produced perverse incentives leading to what were traditionally cheaper surgeries being performed in more expensive environments. That meant the health dollar was not being spent as wisely as it could be,” Clark said.

“I want a health system that has honest and transparent measures, unlike the previous Government, which was pumping up its numbers by counting Avastin injections [used to treat eye disease] and skin lesion removals as surgeries when many could have been done in primary care.”

http://bit.ly/2Kbi2iP

What does the medical device/biotechnology auditor look for and why?

How to maintain cleanliness in these areas and keep them presentable for the auditor.

Audits -both internal and external -are a vital tool for ensuring that a medical device or biotechnology product and its manufacturing operations meet prescribed regulatory requirements. Medical device and biotechnology auditors have guidelines on how to establish that the manufacturer has met standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820.

Apart from going by these guidelines; the auditor also uses her intuition and observation gained from personal experiences to ensure that the facility she has visited is putting in place the right mechanisms to ensure what a state of control looks like. Given that a medical device audit can happen at just about any time; it is imperative for an organization in the medical device industry to be prepared for an audit any time, all the time.

What are the points that the manufacturer has to bear in mind to ensure compliance, so that the medical device audit goes on smoothly without events? What processes and methods should it follow to pass a medical device audit? These are critical questions that the manufacturer needs to have answers for.

Thorough learning on how to think like the auditor

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will equip participants with the knowledge needed to clear a medical device audit. José Mora, a Principal Consultant specializing in Manufacturing Engineering and Quality Systems, will be the speaker at this very important webinar. Over the more than 30 years that José worked in the medical device industry, he specialized in manufacturing, process development, tooling, and Quality Systems; he introduced process performance, problem solving, and Quality System methodologies.

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His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.

You can gain the benefit of his experience by registering for this webinar at http://bit.ly/2laaQ7G

The mental checklist

The important learning of this webinar is that José will provide insight into the auditor’s way of thinking. He will explain the kinds of clues an auditor might use in determining what areas to focus on. Rather that offer a heads-up on the regulations and standards relating to medical device audits; José will give knowledge of the general mental checklist.

Adhering to this checklist, an intuitive one created more out of the expert’s knowledge and experience rather than one gleaned from textbooks, will go a long way in determining how well an audit goes. He will also explain what kind of culture and environment a medical device organization’s management has to inculcate and encourage, so that the medical device auditor gains a better than normal perception of the organization.

An eye on the visual clues

An experienced auditor who knows her job does not need to look too far or deep to discover anomalies. The checklist she has in her mind is enough for her to match the facility’s requirements with those in it. At this webinar, José will bring his years of experience in helping participants understand how to frame a mental checklist of their own, so that they map it with that of the auditor.

He will emphasize the importance of housekeeping, proper maintenance, orderliness, and following safety rules. He will also highlight the importance of objects that serve as visual indicators in the facility, and will show how to follow them. Generally, in most medical device facilities, utility rooms and custodial closets are dumping places for several items. An experienced auditor is aware that what a medical facility hides in these places are a greater indicator of the facility’s orderliness than what are kept in the clean and presentable areas. The expert at this webinar will show how to maintain cleanliness in these areas and keep them presentable for the auditor.

José will cover these areas at this webinar:

  • What the auditor is looking for and why
  • The first five minutes
  • Touring the plant and manufacturing area
  • Entering and touring the warehouse
  • Entering and touring a cleanroom
  • Entering and touring lab areas
  • Reviewing documents
  • Reviewing the quality system
  • Summary

This course offers immense benefit to those in charge of handling auditors. These include Managers, Supervisors, Directors, and Vice-Presidents.

How to Comply with Both in the same Organization

A leading provider of professional trainings in all the areas of regulatory compliance.

Medical devices being a global market; it is not surprising to see many medical device companies marketing their products in both the US and the European Union (EU), two huge markets for these products. Given that these are two different markets; each has its own regulatory requirements. These requirements focus mainly on its Quality Management Systems (QMS). The QMS for the two markets are described in two documents: one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR 820).

On the surface, these two systems appear similar as they have many features in common. But as one delves a little into them, it turns out that they are not identical. A regulatory professional who markets medical devices into these two markets is likely to face crucial questions:

·        Is it possible, and is it permitted to have a QMS on the same site that complies with both requirements?

·        Should one QMS comply with both, and should that be put in place, or is it necessary to have two QMS coexist on the same site?

Thorough learning of the ISO and FDA QMS requirements

Answering questions such as these requires a thorough understanding of the background of both these documents, their legal status, what is expected by the regulatory authorities, and some basic concepts in quality and medical devices quality in specific. This is the learning that a webinar from Compliance4All, a leading provider of professional trainings in all the areas of regulatory compliance, will impart.

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At this webinar, Compliance4All brings the owner of ELC Consulting Services, Eyal Lerner, as expert. Eyal’s organization offers the pharmaceutical and medical devices industries support in all quality related issues, such as Preparation for inspections, CAPA and RCA, quality manual QSM, self-inspection (internal audits), compliance gap analysis, 3rd party audits (FDF and API’s), Management Review, GMP, GLP, MD: ISO 13485:2016 adjustments, DHF, DMR, V&V, 510k submission preparation and ISO 17025 (lab accreditation) and Validation. Eyal has preformed more than 100 audits in various facilities around the world as a lead auditor and auditor.

Please visit http://bit.ly/2JDpIWO to enroll for this webinar and have important doubts about the implementation of the QSRs of the ISO 13485 and 21 CFR 820 regulations clarified.

Offering insights into the two regulations

At this webinar, Eyal will give clarity to participants on how to understand what is required by both. It is necessary for regulatory professionals to understand semantic and substantial differences between the two documents. To give an example, while the ISO requires what it calls a Quality Manual (QM), the FDA QSR does not find mention of such a term. An in-depth look at the policies and Standard Operating Procedures facilitates the ease of handling of such terms. Eyal will focus on other issues that require more attention. He will explain the main features of these areas and describe what should be done from the perspective of a site or a manufacturer which wants to comply with both QMS.

The objective of this learning session is to offer a clear understanding to organizations in the medical devices industry that either develop or plan to market medical devices to USA and Europe of how to plan and implement a QMS that complies with both regulatory authorities. Eyal will help them ask themselves how to get the QMS right and make it work efficiently.

This session is aimed at professionals who are involved in implementing their organizations’ QMS, and includes Medical Devices Quality Personal (QA and QC), Laboratory Managers, R&D Researchers of Medical Devices and Combined Products, Quality Control Staff, and Regulatory Affairs (RA) Staff.

The speaker at this webinar will cover the following areas:

·        Introduction

·        Brief review of regulations and standard: status and history

·        ISO 13485:2016 short review

  • Principals
  • Quality management system
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement

·        FDA QSR (21CFR820) short review

  • Quality System Requirements
  • Design Controls
  • Document Controls
  • Purchasing Controls
  • Identification and Traceability
  • Production and Process Controls
  • Acceptance activities
  • Nonconforming Product
  • Corrective and Preventive Action
  • Labeling and Packaging Control
  • Handling, Storage, Distribution, and Installation
  • Records
  • Servicing
  • Statistical Techniques

·        Comparison between both QMS

  • Common features
  • Variances between both

·        Terms/ vocabulary

  • Comparison between terms

·        Summary.

 

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How to Effectively Manage CROs/Vendors used in the [Pharmaceutical Industry]

It is imperative for pharmaceutical companies that outsource to get a thorough understanding of the elements of a sound outsourcing system.

Today’s globalized and interconnected world has made outsourcing indispensable. Outsourcing works to the benefit of both parties. Those who outsource can let other, independent companies, usually those that have specialized in this function, to take over several of their secondary processes, so that they can concentrate on the more productive and business-yielding activities. At the other end, the outsourced company earns substantial revenues by carrying out outsourced activities.

In the pharmaceutical industry, it is necessary and important to employ efficient and accurate strategies for this important activity. When projects are outsourced without proper safeguards and monitoring going into them, the outsourcing company has higher chances of inviting FDA actions such as Warning Letters, 483’s, etc.

Putting a selection process in place is very important

Companies should put in place robust structures that help them select vendors successfully and avoid scenarios such as these. These systems should also ensure that other critical aspects of outsourcing activities in GXP areas such as contract design, quality monitoring and risk minimization remain compliant. It is imperative for pharmaceutical companies that outsource to get a thorough understanding of the elements of a sound outsourcing system.

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Complete learning on how to select CROs/Vendors

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will educate participants on the elements of managing and avoiding common pitfalls with CROs/Vendors.

Laura Brown, an independent Pharmaceutical Project Management and Training Consultant and is Course Director for the M. Sc. in Clinical Research at University of Cardiff’s School of Pharmacy; will be the speaker at this course.

Dr. Brown has over 20 years’ experience of managing clinical research projects in the pharmaceutical industry. She has worked in Project Management for several companies including Wellcome, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She is also co-author of two books on Project Management, including Pharmaceutical Project Management, a 2004 publication.

Please enroll for this webinar by visiting http://bit.ly/2JJHZVz

Learning on all elements of CROs/vendor outsourcing

At this webinar, Dr. Brown will combine theory and practical examples to offer a crucial overview of a sponsor’s responsibilities, which will give them the knowledge needed to ensure quality oversight.

In the course of this session, Dr. Brown will cover the following areas:

  • Understand how to Effectively Manage CROs/Vendors used in the Pharmaceutical Industry
  • Build an Understanding of your Responsibilities as the Sponsor or the Vendor: Identifying the Right Level of Management and Oversight
  • Discover Tools and Processes to Manage CROs/other Vendors
  • Gain an insight for CROs/other Vendors of what Sponsors Expect and how to Meet their Expectations
  • Measuring CRO Performance including Metrics and Key Performance Indicators
  • Managing and avoiding common pitfalls with CROs/Vendors.

Personnel who work in areas that involve one or more aspects of outsourcing CRO’s/vendors, such as Vendor Management, Global QA/Compliance, Contracts and Outsourcing, VPs, Directors, Outsourcing Department Staff, Purchasing, Finance and Contract, Management Staff, Managers and other personnel involved in selecting and managing cross, will benefit from this course.

Dr. Brown’s webinar is also aimed at helping personnel involved in vendor/CRO/CMO oversight (including those working in Clinical Research, Regulatory Affairs Pharmacovigilance, and Manufacturing) in the pharmaceutical, biotechnology, medical device and biologic industries who use Contract Research Organizations (CROs/CMO).

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