Use of Registries in Product Safety Assessments

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Once a drug or device is approved for use by a regulatory authority, the product is generally use by larger and more divers populations than are typically studied in the clinical trials leading up to approval.

Medical devices in the United States have differeent surveillance programs from those for drugs.  The MEDICAL DEVICE QUALITY SYSTEMS MANUAL which was published by The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), develops and implements national programs to protect the public health in the fields of medical devices and radiological health.

These programs are intended to assure the safety, effectiveness, and proper labeling of medical devices, to control unnecessary human exposure to potentially hazardous ionizing and non-ionizing radiation, and to assure the safe, efficacious use of such radiation.

The Safe Medical Devices Act of 1990 requires that high risk medical devices be tracked after marketing and that product corrections and removals be reported to FDA if actions were taken to reduce health risks. 

Most medicl device safety tracking is accomplished through reports sumitted to FDA from medical facilites when devices are implanted or explanted.  In additon, hospitals, nursing homes ambulatory surgery centers and outpatient treatment facilites are requried to report to FDA whenever they believe that a device caused or contributed to the death of a patient.

The role of registries as one of the available tools for enhanced understanding of product safety through advers event detection and evaluation.  The legal obligations of regulated companies is spelled out in the CDHR's MEDICAL DEVICE QUALITY SYSTEMS MANUAL.

In a blog written by Business Intelligence Solutions the obligatons of regulated companies are spelled out in a recent blog article. 

The reporting process starts with a complaint. All FDA regulated manufacturers are responsible for documenting complaints against the product and evaluating them for reports. Technically, a communication would be considered as “complaint” only if alleged some “deficiencies in the product identity, quality, durability, consistency, security, efficiency, or performance of a product or device after it is released for distribution” (21 CFR Part 820).

Practicle and operational issues with reporting adverse events from registries involves the systematic collection of data from a diffused and diverse sources such as patients, potential events, diseases and medicines. 

Registries and other prospective dat collection approaches have the advantage of incorporating both health care provider and patient reproted data. 

Outcomes Information for Decision making

For clinicians and patients, outcomes research provides evidence about benefits, risks, and results of treatments so they can make more informed decisions. One group of researchers, for example, studied the outcomes of patients with pneumonia, a common cause of hospitalization in elderly people.

They developed a way for clinicians to determine which patients with pneumonia can be treated safely at home, an option that not only reduces Medicare costs but is preferred by many patients. In areas such as cancer, where outright cure is often not the only goal, outcomes research has provided the information to help patients make choices that will improve their quality of life.

Perscription for Change

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Doctors, patients, and other decision makers need access to the best available clinical evidence, which can come from systematic reviews, experimental trials, and observational research.

A new information value chain—built on evidence-based insights—is emerging that could reconcile the divergent interests within the US healthcare industry. The ultimate beneficiary: the patient.

Currently, the US healthcare industry consists of producers (for example, pharmaceutical companies and medical device makers), payers (insurance companies, HMOs), providers (hospitals, pharmacies and physicians) and government— all working across the system in an uneasy, inefficient and often ineffective alliance.

To realize business value, each party relies on a limited, highly specific set of data and analyses. Few take a systematic, holistic view of all of the evidence within a standardized framework.  In fact, while some stakeholders might see the potential uses of an expanded data set as an opportunity to collaborate, others view it as a threat to their business interests.

Courtesy of Accenture - Perscription for Change

We are entering an era where advancement of technology combined with the maturity of organizational mind set will enable healthcare organizations to improve patient care at a reduced cost.  Healthcare organizations as well as medical device and pharmaceutical companies will be able to use data to evaluate the total cost of treating patients. 

With today’s technology, applications are coming to market that provide hospitals with a wide spectrum of capabilities, combined with amazing ease of use, and very affordable prices.

So what has changed recently that is making this a reality? The answer is technology and mind set. To start off, the delivery of on-demand software-as-a-service (SaaS) or cloud-based applications has become a de facto standard in many application types, and a competitive advantage to healthcare organizations. It’s fast, it’s cheap, and it’s secure. The most exciting part about on-demand applications is that they are becoming very specialized.

For instance, there are applications that empower healthcare providers to deliver the highest quality of care by helping them collect, analyze and act on their data.

Registry Data to Evaluate Patient Outcomes

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Registries have the potential to produce databases that are an important source of information regarding health care patterns, decision making and delivery. 

Registries, for example, can providie valuable insight into the safety and or effectiveness of an intervention, or the efficiency, timeliness, quality and patient centeredness of a health care system.

Improving Organizational Performance by Reducing Costs and Improving Patient Outcomes

Outcomes research seeks to understand the end results of particular health care practices and interventions. End results include effects that people experience and care about, such as change in the ability to function. In particular, for individuals with chronic conditions—where cure is not always possible—end results include quality of life as well as mortality.

By linking the care people get to the outcomes they experience, outcomes research has become the key to developing better ways to monitor and improve the quality of care.

The urgent need for outcomes research was highlighted in the early 1980s, when researchers discovered that "geography is destiny." Time and again, studies documented that medical practices as commonplace as hysterectomy and hernia repair were performed much more frequently in some areas than in others, even when there were no differences in the underlying rates of disease. Furthermore, there was often no information about the end results for the patients who received a particular procedure, and few comparative studies to show which interventions were most effective.

These findings challenged researchers, clinicians, and health systems leaders to develop new tools to assess the impact of health care services.

Click to download new white paper on Improving Organizational Performance by Reducing Costs and Improving Patient Outcomes.

Healthcare Organizations can use their Data Assets to improve Performance.

To compete effectively in today’s adverse economic environment, a healthcare organization must be able to access and manage data effectively across the enterprise; without the ability to drive insight and action, data is nothing but overhead. The more efficient an organization is at using data assets to create a clear strategy for action, the better positioned it will be to adapt swiftly to changes and prevent potential problems from escalating.

Practical Strategies to Improve Care - Measuring Outcomes

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Officials managing the skyrocketing costs of growing public health programs in all parts of the world are becoming more proactive in seeking to control costs and improve quality. Government spending on healthcare has been on the rise since at least 1990 in the G7 economies, as seen in graph below.

In the U.S., Medicare expenditures are projected to reach nearly $900 billion by 2018.8 Between 2000 and 2025, experts predict that the Medicare population will grow at four times the rate of the “employed” population between ages 18 and 64.9 The sum of all non-private hospital expenditures is likely to reach over $1 trillion by 2015.10

To cope with the growing public burden, countries like the U.K. and Australia are becoming more proactive in managing the costs of healthcare products and services, including deeper engagement with providers and more strategic contracting.

The Cen­ter for Medicare and Medicaid Services already requires that hospitals report quality information in order to receive full reimbursements, and a wave of new regulations in connection with the 2010 Affordable Care Act carry significant implications for all players in the healthcare sector.

Trends Impacting Healthcare.

• New and changing government regulations: HIPAA, Health Information Technology for Economic and Clinical Health (HITECH) Act, Security, Meaningful Use Requirements
• Fragmented document and records management
• Inefficient, paper-based manual processes and workflows
• Reporting processes can be fragmented, costly and time-consuming
• Remote access is limited and not secure
• Maintaining privacy and security of patient data is a significant concern

Practical Strategies to Improve Care - Measuring Outcomes

Historically, clinicians have relied primarily on traditional biomedical measures, such as the results of laboratory tests, to determine whether a health intervention is necessary and whether it is successful. Researchers have discovered, however, that when they use only these measures, they miss many of the outcomes that matter most to patients. Hence, outcomes research also measures how people function and their experiences with care

Healthcare Organizations use their Data Assets to improve Performance.

To compete effectively in today’s adverse economic environment, a healthcare organization must be able to access and manage data effectively across the enterprise; without the ability to drive insight and action, data is nothing but overhead. The more efficient an organization is at using data assets to create a clear strategy for action, the better positioned it will be to adapt swiftly to changes and prevent potential problems from escalating.

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Trends Impacting Healthcare and Patient Outcomes

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The healthcare industry today is sitting on oceans of untapped data that can make real differences in patient outcomes and medical costs.

How do healthcare organizations benefit if they could systematically collect, analyze, present, and then act on those oceans of data?

Trends Impacting Healthcare.  

• New and changing government regulations: HIPAA, Health Information Technology for Economic and Clinical Health (HITECH) Act, Security, Meaningful Use Requirements)
• Fragmented document and records management
• Inefficient, paper-based manual processes and workflows
• Reporting processes can be fragmented, costly and time-consuming
• Remote access is limited and not secure
• Maintaining privacy and security of patient data is a significant concern 

A sound system for outcome measurement will combine existing statistics and audits, new clinical registers, and patient attitudes to the results of their operation.

The following issues need to be addressed:

• What do we measure? - Deciding which operations define a surgeon’s ability and are done frequently enough by all surgeons within a specialty to get statistically meaningful data will be tougher for some areas than others.
• How do we measure? – What is considered a successful operation will very much depend on the type of procedure, the seriousness of the condition it is aiming to treat and the age/fitness/expectation of the patient.
• Timescale – How long after the operation does its true outcome become apparent? For many operations it may be some years afterwards, for others the results may be instantaneous.
• Patient reported and clinical analysis – Both are important and should be given due weight. But evidence-based, clinical analysis operates by a scientific set of measurements; whereas patient experience is far more nuanced and subjective. Any system of outcomes will need to be sophisticated enough to allow these two worlds to meet – and that will take refinement and experience.
• How do we publish? – With a lot of complex statistical data to be gathered and reconciled, careful planning must be put into how this data is published for various audiences – especially the general public for whom the information must be both easily understandable and sophisticated enough to give them valid choice.
• Risk adjustment – Statistics gathering must take account of surgeons who take on the highest risk cases or are developing new techniques. Outcome measurement must not encourage a spirit of conservatism in medical practice.
• Data quality – variation in the quality of how data is recorded exists across the NHS and improved data systems. Training for clerks and harmonization of processes must be a priority for government if the system is to produce valid results.
• Team v individual data? – Modern medical practice is increasingly focused on working across disciplines and aiming for better care by inter-reliance between specialists. While being refined, outcome measures should focus on team results to ensure their validity before drilling down to individual level.

Watch the video to see what trends are impacting healthcare organizations

Empowering Healthcare Providers To Improve Patient Outcomes

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We are entering an era where advancement of technology combined with the maturity of organizational mind set will enable healthcare organizations to improve patient care at a reduced cost. 

With today’s technology, applications are coming to market that provide hospitals with a wide spectrum of capabilities, combined with amazing ease of use, and very affordable prices.

So what has changed recently that is making this a reality? The answer is technology and mind set. To start off, the delivery of on-demand software-as-a-service (SaaS) or cloud-based applications has become a de facto standard in many application types, and a competitive advantage to healthcare organizations.  It’s fast, it’s cheap, and it’s secure. The most exciting part about on-demand applications is that they are becoming very specialized.

For instance, there are applications that empower healthcare providers to deliver the highest quality of care by helping them collect, analyze and act on their data.

Another technological advancement—rich internet applications—are now coming of age. The software, if properly constructed, can practically guide the novice user through complex tasks, ensuring proper completion, and much less human errors. This translates into improving workflow efficencies, drastic reduction in training costs and user mistakes.

Finding new revenue opportunities

When it comes to organizational mind set, healthcare organizations today understand the urgent need to move fast and stay compliant, and it is becoming clear that the only way to move fast, react fast, and win is to stay ahead of the pack in both technology and internal processes and procedures. Systems that enable flexibility and provide value to users are now welcomed inside all companies.

Imagine a case where your healthcare organization or hospital has a process or system that provides it with full visibility of not only its quality and compliance status, but also helps you with patient outcomes and registries.

All of this is delivered in an on-demand model, with an application that requires very little investment to get started, and very little organizational training. This translates into the ability to move fast and to have immediate results rather than implementing expensive cumbersome systems—something which healthcare organizations and hospitals typically shy away from.

Clinical Audit Improves Patient Care and Outcomes

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Clinical audit is a process that has been defined as "a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change".

The key component of clinical audit is that performance is reviewed (or audited) to ensure that what should be done is being done, and if not it provides a framework to enable improvements to be made. It had been formally incorporated in the healthcare systems of a number of countries.

As concepts of clinical audit have developed, so too have the definitions which sought to encapsulate and explain the idea. These changes generally reflect the movement away from the medico-centric views of the mid-Twentieth Century to the more multidisciplinary approach used in modern healthcare. It also reflects the change in focus from a professionally-centred view of health provision to the view of the patient-centred approach. These changes can be seen from comparison of the following definitions.

In 1989, the White Paper, Working for patients, saw the first move in the UK to standardise clinical audit as part of professional healthcare. The paper defined medical audit (as it was called then) as "the systematic critical analysis of the quality of medical care including the procedures used for diagnosis and treatment, the use of resources and the resulting outcome and quality of life for the patient."

Medical audit later evolved into clinical audit and a revised definition was announced by the NHS Executive:

"Clinical audit is the systematic analysis of the quality of healthcare, including the procedures used for diagnosis, treatment and care, the use of resources and the resulting outcome and quality of life for the patient."

The National Institute for Health and Clinical Excellence (NICE) published the paper Principles for Best Practice in Clinical Audit, which defines clinical audit as "a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes, and outcomes of care are selected and systematically evaluated against explicit criteria.

Where indicated, changes are implemented at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery.

Clinical Audit - The Process

Stage 1: Identify the problem or issue

This stage involves the selection of a topic or issue to be audited, and is likely to involve measuring adherence to healthcare processes that have been shown to produce best outcomes for patients. Selection of an audit topic is influenced by factors including:

• where national standards and guidelines exist; where there is conclusive evidence about effective clinical practice (i.e. evidence based medicine).

• areas where problems have been encountered in practice.

• what patients & public have recommended that be looked at.

• where there is a clear potential for improving service delivery.

• areas of high volume, high risk or high cost, in which improvements can be made.

In our next blog article we will outline the next 4 processes of clinical audits that improve patient care.  Subscribers to our blog will receive the updates. 

Challenges that Limit Meaningful Use

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Health information technology (HIT) is perceived as an essential component for addressing inefficiencies in healthcare. Without understanding the challenges that limit meaningful use of HIT, there is a high chance that institutions will convert complex paper-based systems to expensive digital chaos.

RECENT FINDINGS:

Clinical information systems do not communicate with each other automatically because integration of existing data standards is lacking. Data standards for medical specialties need further development. Database architectures are often designed to support single clinical applications and are not easily modified to meet the enterprise-wide needs desired by all end-users.

Despite the improvements in charge capture and better access to health information the realized savings and impact on patient throughput is not enough to cover the cost of the technology, maintenance, and support. HIT is necessary for improved quality of care but it increases the cost of doing business. Poor user interface and system design hinders clinical workflow and can result in wasted time, poor data collection, misleading data analysis, and potentially negative clinical outcomes.

Government incentives to increase HIT will likely result in a more computerized clinical environment. Understanding the challenges can help avoid costly mistakes. The future looks promising but caution is warranted, as achievement of full benefits of HIT requires addressing significant challenges.

The Health Information Technology for Economic and Clinical Health (HITECH) Act provides HHS with the authority to establish programs to improve health care quality, safety, and efficiency through the promotion of health information technology (HIT), including electronic health records and private and secure electronic health information exchange.

Under HITECH, eligible health care professionals and hospitals can qualify for Medicare and Medicaid incentive payments when they adopt certified EHR technology and use it to achieve specified objectives. 

Two regulations have been released, one of which defines the “meaningful use” objectives that providers must meet to qualify for the bonus payments, and the other which identifies the technical capabilities required for certified EHR technology.

• Incentive Program for Electronic Health Records: Issued by the Centers for Medicare & Medicaid Services (CMS), this final rule defines the minimum requirements that providers must meet through their use of certified EHR technology in order to qualify for the payments.
• Standards and Certification Criteria for Electronic Health Records: Issued by the Office of the National Coordinator for Health Information Technology, this rule identifies the standards and certification criteria for the certification of EHR technology, so eligible professionals and hospitals may be assured that the systems they adopt are capable of performing the required functions.

To gain a true understanding of the quality of their care and resultant outcomes, healthcare providers have to mine their primary-source clinical data, not their administrative databases.

The challenges and barriers to capturing, analyzing and acting on this data may seem insurmountable, but at QCMetrix we know that they're not.

Improving Cost Management for Healthcare Organizations

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Never before have healthcare providers faced the level of change that they do today, both in how care is organized and in how it is financed.  Health systems are striving to better manage quality and risk and to extend their management of risk to new populations, including PPO patients that have traditionally been in fee‐for service models.

Click to Download Our White Paper

For experienced health systems, such as those in Michigan, the focus is on extending care management to a broader population and implementing increasingly sophisticated tools to better manage their risk contracts.

Improving cost management for healthcare organizations

According to a report written by Accenture,  Running IT like a business in the healthcare industry by Craig Mindrum, if the health industry is to achieve the goals of patient-centered health care while con­trolling costs, CIOs should borrow the fol­lowing approaches from the top performers uncovered in our high-performance IT research.

Focus on more strategic metrics

In addition to traditional IT metrics, CIOs should identify the measures that are linked more closely with the organization’s most important business objectives for short- and long-term outcomes.

Understanding which business functions influence these metrics the most can help determine how IT initia­tives can not only support but also improve these metrics. These more significant metrics may include data points such as internal and external resources aligned to business requirements and priorities; legacy systems proactively retired; and integrated business and IT changes reflected in the IT architecture.

Leverage outsourcing to control costs

The use of outsourcing providers is an impor­tant aspect of effective cost management. It’s also a way to gain access to critical IT skills, improve organizational agility and flex­ibility, increase the effectiveness of business processes and lower the total cost of owner­ship of applications and infrastructure.

Currently, many healthcare IT organizations are not making significant use of outsourc­ing strategies. Accenture found that IT high performers approach outsourcing as a partnership with service providers, which enables CIOs to extract significantly more value out of their application and infrastructure investments. High performers are also more effective at employing sophisticated metrics and processes to track the effectiveness of outsourcing service providers.

Directing spending toward more strategic initiatives

For IT departments, applications are the lifeblood of business value. Accenture's research found that compared with their lower-performing peers, high-performance IT organizations invest more heavily in application development: 70 percent of their resources are devot­ed to discretionary spending, such as deploying, test­ing, integrating, building or enhancing applications.

By comparison, other organizations spend less than 65 percent on such activities. This means lower per­formers are spending less time and fewer resources building new functionality and more time simply fixing and running existing, older applications.

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Meaningful Use

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The medical community and regulatory agencies have established clinical reporting standards that are now well defined and adding significant new demands for healthcare providers.

Compelling examples of this new environment include initiatives by The Joint
Commission (TJC) and the Centers for Medicare and Medicaid Services (CMS). Both are predicated on reporting clinical data for projects such as the Surgical Care Improvement Project (SCIP) and the Physician Quality Reporting Initiative (PQRI) which are tied to reimbursement updates and accreditation requirements.

Even more clearly, the accelerating rate of change in healthcare can be seen in the trend to capture a series of discrete data throughout the continuum of care by the rapidly emerging Department of Health & Human Services (DHHS) and CMS Meaningful Use Standards (MU) for Electronic Health Records (EHR) and modules, and the proposed payment criteria associated with these standards which have been implemented this year.

The emerging Meaningful Use (MU) Standards goals include:

» Improving quality, safety, and efficiency.
» Engaging patients.
» Improving coordination of care.
» Ensuring privacy and security of Protected Health Information (PHI).
» Improving population health and interact with public health programs.

QCM CAPTURE & ANALYTICS™ SYSTEM

The QCMetrix|Surgery ™ Capture & Analytics ™ System is a Web‐based, real‐time system that meets the specific requirements of the practice of surgery throughout the continuum of care.

The leading principle of this system is:

To collect clinical data once and use repeatedly to meet the needs of clinicians, to improve patient care, to enhance and protect revenues, to cut costs and to fulfill the emerging regulatory and payer reporting requirements.

An overview document has been developed to provide a summary of the
QCMetrix|Surgery™ System and associated services. QCMetrix welcomes the opportunity to provide you with a system demonstration and to answer your questions about our exciting new product.

All blog subscribers will receive a free copy of our overview document. If you are not one of our blog subscribers and would like to receive a copy of the overview report click here and a copy will be emailed to you.