Introduction

In order to best understand the context of healthcare information and management systems, it is necessary to first understand the concept of health. The World Health Organization (WHO) asserts that “health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”1 The WHO has not amended this definition since 1948.

Why is it important that we more fully understand this more holistic concept of health? If we do not present for care until we are in an advanced stage of disease or arrive with injuries from unsafe working or living practices, the cost of providing that care is likely to be high and the health outcomes often less than desired. The practice of healthcare, and thus the systems and management processes supporting it, is increasingly focused on those activities that have the greatest impact on the overall health of the community and patient populations. A state of health is not best achieved by limiting our engagement to patients’ visits to the doctor's office and admissions to hospitals, but is increasingly extended to wellness encounters with nonphysician healthcare providers, virtual encounters through telehealth or mobile health technologies and safety and preventive care outreach programs. The increasing strain of healthcare costs on national economies is forcing us to continually reevaluate our healthcare delivery paradigm to optimize health outcomes at an affordable cost. This is the macroeconomic context in which health information professionals and technologists will be performing their art.

The healthcare environment is an exceptionally complex one in which multiple players compete for placement on center stage. The four pillars of quality, access, cost and value require dynamic trade-offs in which healthcare professionals are under constant pressure to deliver the highest quality of care to the greatest portion of their supported population within tight cost constraints, while having to demonstrate the value of health information technology (IT). Placed upon this already complex four-legged stool are demands from multiple stakeholders, including governments, consumer groups, professional associations, regulatory organizations, payers/insurers and suppliers.

The Organisation for Economic Cooperation and Development (OECD) provides a solid basis for comparing international approaches with organizing and resourcing national healthcare with several key indicators on health system performance across countries. Figure 1.1 illustrates the substantial variance in spending by country and the proportion of public to private contribution to overall national health expenditures.

These investments have seen great reductions in cardiovascular and infant mortality rates, but lifestyle and risk factors show that more than 18% of adults continue to smoke daily,2 while almost one-third of children 5–9 years are overweight, with the rate of overweight children increasing from 20.5% to 31.4% from 1990 to 2016.2

Therefore, it is not hard to develop a sense of the complexities of the healthcare environment in which we toil. The breadth of stakeholders, the balance of public versus private funding and the active engagement to improve the health of populations, one individual at a time, produce a daunting task. This is the arena the health information professional and technologist enter to ensure that the best possible information management and systems support are available to improve the quality of life for the greatest number of our world's citizens.

Healthcare Organizations

The number and types of organizations involved in the provision of care, supporting the provision of care and paying for the care provided is large, complex and constantly evolving. The simplest way to categorize these is through the eyes of the patient. When speaking of accessing care, often a patient will say, “I went to see my doctor at her office” or “I was in the hospital last week to have my appendix out.” So, in a broad sense, we have the constructs of hospital-based care—often referred to as inpatient care—and care from doctors’ offices—referred to as outpatient or ambulatory care. Additionally, given the diverse types of diagnostic services and pharmaceuticals needed to support the healthcare process, providers of ancillary services are included as well. Lastly, regulators and payers of care are discussed. The interrelationships among these diverse players will be expanded upon in the next section. The following is an overview of many of these structures, which vary not only by country but also often by geographic location within countries.

Hospitals

While hospitals may be categorized in any number of ways, a single hospital may also be classified in more than one way. For example, a hospital may be a private, not-for-profit and specialty hospital, thus falling into three categories. Notable systems for classifying hospitals include classification by the following:

Ownership. Public (government-managed) versus private hospitals.

In public hospitals, governments (at the national, provincial, state or other level) own and are responsible for the operations. The healthcare providers in such hospitals are generally private practitioners, although in some countries the providers may be government employees as well (e.g., in the National Health Service [NHS] of the United Kingdom or the U.S. Veterans Health Administration hospitals).

In private hospitals, staffing arrangements span a broad spectrum of private practitioners or groups of healthcare providers. Private hospitals in some countries are further classified as for profit versus nonprofit.

For-profit private hospitals, also referred to as investor-owned hospitals, often exist as part of a multihospital system with varying degrees of interrelationship among the system's hospitals. Examples of large, investor-owned hospital systems include the Hospital Corporation of America (http://hcahealthcare.com/) and BMI Healthcare in the United Kingdom (http://www.bmihealthcare.co.uk/).

Nonprofit private hospitals are not investor owned, but rather exist under laws at national and state levels allowing them to organize as nonprofit corporations, generally providing them the advantage of avoiding federal and property taxes. Canada's hospitals, although publicly financed, are almost exclusively private, nonprofit organizations,3 albeit funded through the provincial/territorial governments. Just more than half of the hospitals in the United States operate as private, nonprofit organizations.4

Types of service provided. Hospitals are often classified by the types of service they provide. While the majority of hospitals will be general hospitals supporting the most common types of medical and surgical care requirements, hospitals specializing in more focused areas of care are becoming more prevalent. Such hospitals include psychiatric hospitals, which focus on mental healthcare; rehabilitation hospitals, which generally focus on restoring neurological and musculoskeletal functions following treatment in an acute care facility; and children's hospitals, which focus on the care and treatment of children.

Teaching status. In addition to providing inpatient clinical services, teaching hospitals train future physicians and other healthcare providers. Often associated with academic institutions, teaching hospitals may be further classified as academic medical centers or university hospitals. Many such institutions also contribute substantially to medical research and publish much of the knowledge that advances the science of medicine.

Geographic location. Hospitals may be further classified as urban hospitals when located in large cities or as rural hospitals when substantially distant from major urban areas with greater resources. While such classifications appear mundane, the challenges of operating in urban and rural environments are different enough to require programs of specialization. Meeting government standards for classification as urban or rural may provide such hospitals access to special government funding programs.

Outpatient or Ambulatory Care—A Shift in the Care Setting

When a patient's care does not require the intensive management of a hospital setting that care is generally received in an outpatient or ambulatory care setting—most frequently in a doctor's office. Most primary care—the care practiced by primary care providers (PCPs) or general practitioners (GPs)—is provided in the ambulatory setting. Similarly, most PCP/GP referrals to clinical specialists for evaluation are completed in the ambulatory setting as well. The past decade has seen a dramatic shift from the acute care setting to less-expensive, more patient-friendly care settings. In the last few years, many less complicated surgical procedures that previously required an overnight hospital stay have been moved to the outpatient setting as well. Even major surgeries such as total joint replacement are now routinely performed in an ambulatory surgery center (ASC) with the patient going home the same day. Patients are demanding more flexible hours, and urgent care or injury clinics are opening up at a tremendous rate. Nontraditional care settings are springing up, with drugstores offering “minute clinics” and other walk-in options. Today's patient is accustomed to an always-on, always available experience and demands that from healthcare. There is a proliferation of direct appointment booking and “virtual” visits using video calling apps. These patients are no longer content to call a physician office and wait to be called back, or to wait weeks to see a specialist. Practices that are responsive to this new model will be the ones who thrive. There are multiple models of outpatient care, including single independent provider offices, larger multi-provider group practices in which a broader range of specialists may be available, and—while not a preferred approach from an expense perspective—hospital emergency departments.

Community Health Organizations

In the healthcare environment, a “community” generally refers to the specific geographic location in which healthcare is delivered. Thus, healthcare organizations serving the population of local areas tend to be broadly referred to as community health organizations. Community-centered hospitals and clinics in most nations provide most of the care available to their local populations. Some nations provide more formal designations of community healthcare organizations that impose both legally constrained definitions and operational characteristics. In Canada, a community health center (CHC) is a key provider of local health services and aspires to support access and comprehensive care, including health promotion and illness prevention, through a publicly administered process.5 In the United States, CHCs are generally associated with medically underserved areas as defined by the Health Resources and Services Administration (HRSA). These health centers strive to provide comprehensive, culturally competent, quality primary healthcare services to medically underserved communities and vulnerable populations.6 Small community hospitals located in rural areas of the United States may apply for designation as critical access hospitals (CAHs), allowing them to receive higher reimbursement rates.

Diagnostic and Pharmaceutical Services

The most effective healthcare treatment quite frequently requires the aid of diagnostic services and pharmaceutical treatments, commonly referred to as ancillary services. While larger hospitals will generally have these capabilities, smaller hospitals and outpatient care centers will usually rely on external providers of such services to support comprehensive care to their patients. Key services provided in this area include laboratory and anatomic/anatomical pathology services, diagnostic imaging/radiology services and pharmacies. Close associations with these service providers are formed with provider offices and hospitals to ensure effective and comprehensive healthcare delivery.

Healthcare Payers

From the perspective of the healthcare delivery organization, payments generally come from three types of entities: government-financed and managed programs, insurance programs administered by private entities and personal funds.

Government-financed and managed programs are generally funded through countries’ general taxes. These programs may pay for the healthcare system directly, as does the single-payer system of the NHS of the United Kingdom, which finances hospitals and salaries of most NHS providers. Alternatively, government programs may provide funding for a national health insurance program, such as that in Canada, where the program is administered through provincial health plans. These plans fund hospitals through community trusts and pay providers through the government's insurance program. Multipayer systems, such as that of the United States, are more complex to administer. The U.S. system includes the federally managed program for Medicare, through which citizens 65 years of age and older have most of their healthcare needs provided for; the shared-cost federal/state program Medicaid, which supports care for low-income families; another federal/state program called the Children's Health Insurance Program (CHIP), which provides care to children of uninsured families that do not qualify for Medicaid; and several others for smaller groups of special populations. These three programs provide coverage for roughly one-third7 of the U.S. population.

Insurance programs administered by private entities are generally funded by employers, citizens themselves or by a combination of both. Germany mandates shared health insurance contributions from employers and employees, but these funds are administered by about 1100 private, nonprofit sickness funds that cover more than 90% of the population by making payments to hospitals and providers. In the United States, roughly 55% of citizens have employer-based insurance and an additional 11% purchase insurance directly.8 Even in many countries that have universal healthcare programs, people who can afford to purchase private health insurance are usually allowed to do so. The purchase of private health insurance generally allows the purchaser to receive services that may not be covered under a national benefit structure and may also improve access to care. When healthcare organizations treat patients insured through a private entity, they bill the private health insurance entity rather than a government organization.

Healthcare services are often personally funded by individuals who have government or employer-supported health plans, as well as by the uninsured. While patient co-payments were not required by many universal coverage programs in years past, an increasing number of countries are adding this requirement to offset growing healthcare costs. In the United States, co-payments are required under most healthcare programs, whether government or privately managed. Persons with higher incomes may choose to avoid the constraints of insurance programs and, as they can tolerate the financial risk, are cash payers. Lastly, and perhaps most perversely, those who fail to qualify for government-supported programs such as Medicaid in the United States but still cannot afford to purchase health insurance find themselves at the mercy of a healthcare system that charges premium, nonnegotiated rates to those least able to afford such costs. A 2019 study on bankruptcies in the United States found that 66.5% of all bankruptcies from 2013 to 2016 were tied to medical issues, with 58.5% caused specifically by medical bills. The rest met criteria for medical bankruptcy due to income loss related to illness.9 Although politically divided, the Patient Protection and Affordable Care Act signed into law on March 23, 2010, was intended to help reduce some of these financial risks for patients in the United States and make healthcare more affordable and accessible. Despite gains in coverage and access to care from the ACA, findings suggest that it did not change the proportion of bankruptcies with medical causes.9

In summary, from the perspective of the healthcare delivery organization, three basic types of payers are at play: government-financed and managed programs, insurance programs administered by private entities and patients who pay with personal funds. Add to that the number of potential insurance companies in the market and the differences in payers’ health benefits coverage, and the management of accounts receivable can become an incredibly complex task requiring sophisticated administration and automation support.

Interrelations Within and Across Healthcare Organizations

The purposes of interrelationships among healthcare organizations are numerous. Some of the key requirements include enabling comprehensive care, assuring effective transfers of care, ensuring the general portability of information in support of care, reporting public and population health information, obtaining appropriate reimbursement for care and supporting particular organizational models of care.

Enabling Access to Comprehensive Care Services

As noted in the section above, healthcare organizations are reliant upon a number of partners within or outside of their organization to enable the delivery of comprehensive care. Providers in the outpatient setting often rely on external laboratory and radiology services to ensure accurate diagnoses and on the availability of pharmacies to provide prescribed medications to complete the provider's care plan for the patient. Absent effective communications—increasingly electronic today—the care process will break down and patient outcomes could suffer as a result. This is the area in which technology is having the greatest impact. Various public and private initiatives are in place to facilitate the seamless, transparent interchange of patient clinical data. “Interoperability” is the keyword here, as the transferred data must be consumable by the receiving system in order to eliminate duplicate data entry and make the data instantly available to the treating provider.

Assuring Effective Transfers of Care

When a provider determines that the scope of care required for a patient's treatment is outside of his or her capability, care is generally transferred to another provider or healthcare organization. Effectively communicating health information during the transfer of care is exceptionally important to the patient's welfare. When a complete set of information is transferred with the patient regarding the history of the present illness, along with subjective and objective findings that include the results of diagnostic tests performed and medications prescribed and administered, the receiving organization can advance the patient's treatment in a substantially more efficient and effective manner. When such information does not accompany a patient during transfer, precious time is often lost, as that information is re-created through repetitive evaluations and repeat administration of diagnostic tests that are sometimes of an invasive nature. To facilitate the provision of essential health information during transfer of care between providers or facilities, an initiative in the United States encourages the use of Health Level Seven International's (HL7) Consolidated-Clinical Document Architecture (C-CDA), which is a standard for electronically transmitting continuity of care information.10

Both the loss of time in treating an acute patient and the need to repeat invasive tests can have adverse consequences for a patient. Not having a clear awareness of the pharmaceutical products a patient may be taking or has been administered in the present course of care can be life threatening and has led to attempts in some countries to ensure that medication reconciliation has taken place. In the United States, medication reconciliation is defined as the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage, frequency and route, by comparing the medical record to an external list of medications obtained from a patient, hospital or other provider.11

Ensuring the General Portability of Care

Even when patients are enrolled to a specific clinical organization or provider for care, there are times when they will need care from other providers. This occurs not only under the two scenarios covered above, but also when patients travel away from their routine places of care. If a patient who is several hundred miles away from home becomes ill or is injured in an automobile accident, having the correct health information available can have a powerful influence on the patient's health outcomes from the clinical intervention. The most common example is that of the new provider who does not know a patient's medication allergies. To overcome these challenges, some nations are implementing national health information exchanges (HIEs) that endeavor to provide virtual, real-time access to patients’ health information. One such initiative is Canada's Health Infoway, a nonprofit organization made up of the 14 federal, provincial and territorial deputy ministers of health. Infoway's vision is “healthier Canadians through innovative digital health solutions.”12 In the United States, much work is under way to define standards to facilitate ease of sharing health information both through HIEs at the state level and nationally via the Nationwide Health Information Network (NHIN) and, more recently, through the Nationwide Interoperability Roadmap. The United Kingdom has also invested heavily in its NHS Digital (formerly Health and Social Care Information Centre (HSCIC)) through its national health system, which connects England's healthcare organizations to facilitate the availability of clinical information that can be shared to support the continuity of care and safety of patients in the healthcare process.

Roles and Responsibilities of Healthcare Information and Management Systems Professions

The number of position titles in the health information management (HIM) and health information technology (HIT or IT) space is quite large. In a single-provider office, the person who performs the broad range of HIM/IT tasks may work less than full-time or double as the office manager. In a large academic medical center or IDS, the IT department could include more than 100 personnel. The top IT position in healthcare organizations is usually referred to as the chief information officer (CIO). The CIO is generally accountable for a broad range of IT activities, including many that are not directly related to healthcare. Among these would be such things as maintaining organizational computing rooms, individual desktop computers, telephone communications (including an increasing variety of mobile and BYOD (Bring Your Own Device) and IOT (Internet of Things) equipment, secure Internet access, local and wide area networks and the organization's website.

In larger organizations, the complexity of HIM and IT functions leads to specialization. The chief security officer (CSO) endeavors to secure the healthcare organization's computing and communications assets from either intentional or unintentional security breaches from inside or outside the organization. Lead IT security personnel may carry the Certified Information Systems Security Professional (CISSP®) credential from the Information Systems Security Certification Consortium, Inc. (ISC2®).15 Similarly, the privacy officer is responsible for ensuring that personally identifiable data, including protected health information, is accessed exclusively by those authorized to do so under a broad range of laws—in the United States, the Privacy Act and the Health Insurance Portability and Accountability Act (HIPAA), among others. A credential leveraged in supporting this role is that of Certified in Healthcare Privacy and Security (CHPS®).16

The chief technology officer (CTO) is generally responsible for the technical architecture of the IT systems supporting the organization and often looks toward the developing market in HIM and IT to try and keep the organization competitive from a technology perspective. This could range across the full spectrum of such things as mobile computing platforms, cloud-based computing and state-of-the-art clinical applications.

Health information managers have held roles in medical records departments for decades, but prior to the common availability of electronic health records (EHRs), there was not a strong relationship between HIM and IT departments. As medical records functions have become increasingly automated over the past few years, culminating in EHRs of advanced capabilities, HIM departments are finding themselves at the center of the IT activities in healthcare organizations. In the HIM area, you will find professionals with the Registered Health Information Administrator (RHIA) or Registered Health Information Technologist (RHIT®)17 credential in the United States or with the Certification in Health Information Management (CHIM) credential in Canada.18 Healthcare organizations may also rely on the Certified Professional in Healthcare Information and Management Systems (CPHIMSTM)19 credential to ensure that staff members in the IT department have a broad base of knowledge and experience in healthcare information and management systems.

The role of clinical informatics professionals is also expanding as the practice of medicine is increasingly supported by EHRs and other health information systems. The role of clinical informatics is discussed in depth in Chapter 3.

The American Medical Informatics Association (AMIA) advocates advanced training for clinicians to develop a clinical informatics subspecialty in the practice of medicine.20 A frequently used title for staff with such backgrounds in the health information space is that of chief medical information officer (CMIO). Popular variants are chief medical informatics officer and chief health information officer (CHIO), and in the area of nursing, chief nursing informatics officer (CNIO). With the increasing use of IT in healthcare processes, effective integration of clinical insights into systems solutions is of great importance.

While the great variety of organizational structures in IT departments is driven by such factors as organization size, geographical distribution and line of business, a sample organization structure a CIO may oversee could include:

Application development and support

Data center operations

Database administration

Desktop support

Information security

Network operations

Similarly, the specific roles an IT organization may expect to fill would vary based on the functions the organization supports. These roles could be filled by staff, consultants or contractors. Examples of the more common types of positions one might expect to see include

Desktop support technician

Database administrator

Programmer/application developer

Web developer

Network engineer/analyst

Systems analyst/administrator

Project manager

Security analyst

In summary, there is great variation in the size and structure of IT departments within healthcare organizations, which drives the number and specialization of jobs within the IT organization.

Roles of Government, Regulatory, Professional and Accreditation Agencies in Healthcare

Given the importance of healthcare in our lives—including our quality of life, our longevity and even our ability to continue living following life-threatening encounters with disease or accidents—and the incredible expense of delivering high-quality healthcare to very large populations, it is not surprising that a tremendous amount of government oversight and a great number of regulatory bodies are involved in healthcare processes. An overview of these organizations and their associated activities is provided below.

Government

The role of governments in healthcare is quite pronounced, as discussed in the previous section on healthcare organizations. Because most countries continue to experience increases in the proportion of their gross domestic product (GDP) consumed by healthcare activities, they are concerned that these trends will weaken their national economies if not slowed—or even stopped and reversed. Stopping the growth in healthcare costs as a percentage of GDP requires exceptionally difficult decisions for governments in industrialized countries, as citizens have grown accustomed to the existing health benefits programs.

According to the Peterson Kaiser Health System tracker:

Over the past four decades, the difference between health spending as a share of the economy in the U.S. and comparable OECD countries has widened. In 1970 the U.S. spent about 6% of its GDP on health, similar to spending by several comparable countries (the average of comparably wealthy countries was 5% of GDP in 1970). The U.S. was relatively on pace with other countries until the 1980s, when its health spending grew at a significantly faster rate relative to its GDP. In 2017, the U.S. spent 17% of its GDP on health consumption, whereas the next highest comparable country (Switzerland) devoted 12% of its GDP

It is easy to see that healthcare is consuming our national economies at an unsustainable rate, making governmental engagement in these factors essential.

To address the growth in healthcare costs, many nations’ governments are considering changes to their health programs. Among these are enhancements to the primary care delivery system to manage chronic diseases more effectively in Australia, experimentation with privatization in Canada, global budgeting and competition among sickness funds in Germany, requiring long-term care residents to pay for room and board in Japan and consideration of pro-market reforms in the United Kingdom.22 Similarly, the development of ACOs in the United States is being encouraged with a goal of producing better health outcomes at lower cost. Such trends will continue as we collectively grapple with the best ways to balance quality, access, cost and safety for the greatest proportion of our populations.

Healthcare Regulators

Healthcare regulatory agencies serve a broad range of functions in the healthcare environment, generally by implementing the provisions of a nation's health laws through a more explicit system of regulations. In the United Kingdom, the Health and Care Professions Council (HCPC) is the statutory regulator for 15 professions with nearly 290,000 health and care professionals in the country.23 The HCPC maintains standards of proficiency and conduct for the professions it regulates. In the United States, the dominating regulatory entity is the CMS. The CMS drafts the rules and finalizes the regulations for the management of multiple federally subsidized healthcare programs for the nation through a complex process of rulemaking involving public engagement. The Food and Drug Administration (FDA) in the United States evaluates and approves medical devices and new drugs used in the treatment of patients. Similarly, medical devices in Canada are regulated by Health Canada's Therapeutic Products Directorate.

While it may be a common belief that regulatory organizations are always government entities, it is not uncommon to find that private-sector organizations, commissions and associations may perform in a regulatory capacity as well. These are addressed in the following sections.

Professional Associations

According to the Merriam-Webster Dictionary, a profession is “a calling requiring specialized knowledge and often long and intensive academic preparation.”24 Professional associations in the healthcare environment have proliferated greatly, many serving in a semi-regulatory role. The College of Kinesiologists of Ontario25 provides a good description of the roles and functions of professional associations, stating that their primary role is to advocate on behalf of its members and promote the profession and may

Advocate with policy makers in the interest of members

Table 1.1 Professional Associations Related to Healthcare and Healthcare IT

Clinical

Administrative and IT

American Academy of Pediatrics

American College of Healthcare Executives

International Confederation of Midwives

American Health Information Management Association

International Council of Midwives

American Medical Informatics Association

Royal College of General Practitioners

Healthcare Information and Management Systems Society

World Dental Federation

Information Systems Security Association International

World Medical Association

International Medical Informatics Association

Accreditation Organizations

Accreditation organizations (AOs) have substantial interactions with healthcare organizations and generally play a semi-regulatory role in that they often serve on behalf of federal organizations to ensure specific standards or conditions of participation (CoP) are met. The Joint Commission and Joint Commission International (JCI)26 are perhaps the most recognized AOs utilized for the certification of hospitals in the United States and internationally. The JCI currently operates in more than 100 countries around the globe. In the United States, the AOs under CMS are very visible examples of accreditation agencies. CMS AOs determine compliance with Medicare CoP. When a healthcare organization is certified by a CMS AO for compliance with CMS requirements, the organization is deemed to have met the requirements and may then bill CMS for covered services. For participation in Medicare programs, a number of other organizations are authorized to act as AOs, as shown in the Table 1.2.

Table 1.2 CMS-Approved Accreditation Organizations

Organization

Program Type

Accreditation Association for Ambulatory Health Care (AAAHC)

Ambulatory surgical centers (ASCs)

Accreditation Commission for Health

Home health agencies (HHAs)

Care, Inc. (ACHC)

Hospices

American Association for Accreditation of

ASCs

Ambulatory Surgery Facilities (AAAASF)

Outpatient physical therapy (OPT) providers

Rural health clinics (RHCs)

American Osteopathic Association/

ASCs

Healthcare Facilities Accreditation Program (AOA/HFAP)

Critical access hospitals (CAHs)

Hospitals

Center for Improvement in Healthcare Quality (CIHQ)

Hospitals

Community Health Accreditation Program

HHAs

(CHAP)

Hospice

DNV GL-Healthcare (DNVGL)

Hospitals

CAHs

Institute for Medical Quality (IMQ)

ASCs

National Dialysis Accreditation Commission (NDAC)

ESRD Facilities

The Compliance Team (TCT)

RHC

Joint Commission

ASCs

CAHs

HHAs

Hospices

Hospitals

Psychiatric hospitals

Source: Centers for Medicare & Medicaid Services, https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-.pdf.27

The interrelationships among government agencies, regulators, professional associations and AOs can be surprisingly complex. For example, in the United States. Figure 1.3 shows the many organizations that play a role in the life of a physician assistant moving through training and into medical practice.

Figure 1.3Steps and organizations involved in becoming a practicing physician assistant. (Adapted from AAPA, becoming a PA, Alexandria, VA: AAPA, http://www.Aapa.org/your_pa_career/becoming_a_pa.Aspx.28).

Provide continuing professional development opportunities

Represent members interests by monitoring development which may impact scope of practice, employment opportunities and enhancing relationships with related professionals

Regulatory bodies on the other hand have a purpose of protecting the public by regulating the profession. They may

Set requirements for entry to the profession

Maintain a list of individual eligible to practice

Develop standards of practice

Receive and investigate complaints about professional practice and administer appropriate disciplinary action when necessary

Require professionals to participate in continuing professional development

Summary

We have covered the breadth of organizational structures in the public and private domains, defined the nature of their interactions, identified roles of healthcare information and management systems professionals and described the great number of governmental, regulatory, professional and AOs affecting our healthcare delivery systems today. The complexity of the processes can be overwhelming. Fortunately, advances in automation, including inexpensive data storage, increasing network capacities and simplified software programming tools, will allow professionals in healthcare information and management systems to make life simpler for those who deliver care by transferring much of the information processing requirements to automated tools.

Market and promote the profession

Introduction

The world now is steered by technology and computers—from social networks to IoT (Internet of Things) devices, everything we interact with has a computer in the process. Healthcare may have been a little bit slower than other industries to adopt information technology (IT), but now the electronic health record (EHR) is an essential part of every facility that provides care to patients—from population health to the intensive care unit. Patients are no longer surprised when the provider pulls out a tablet computer instead of a paper chart and pen.

Most hospitals and outpatient sites provide wireless networks for staff to use in caring for patients and a different network for family and visitors to access. It is common to see patients updating their status on Facebook, reviewing their care plan from their hospital beds or checking in for their outpatient visit using their smartphone. Where hospitals used to have policies forbidding employees from accessing social networks during working hours, many institutions now employ staff to monitor and update social media sites. Many patients have personal health records (PHRs) they manage online, as well as access to a patient portal through the facility's EHR system. Healthcare IT is changing the way that healthcare does business, as well as the way that clinicians care for patients. An understanding of the attributes of healthcare IT, as well as knowledge of the applications and hardware required for their use, is essential in helping to improve the care and the safety of the care provided to patients.

There are three components of the technology environment:

Applications—the software used by administrative, clinical and support staff to process and store data, manage patients’ records, provide information and knowledge

Hardware—the actual servers (virtual, cloud and physical), network connections and devices used to access and generate information

Networks—the wired or wireless connections that link the infrastructure together and enable accessibility of the applications and patient data

A healthcare facility requires these three components to function. While this may seem a very simplistic listing, these are essential to providing IT to a healthcare institution. And, while essential, with the rapid changes in technology and improvements in software, the sections of these components change frequently. Decreased access time and increased processor and hard drive speed enables the application to return processed data to the requesting clinician much more quickly. Technology changes are supporting—and changing the applications and the functions of the applications. The illustrations here are not intended to be a complete listing but to provide an overview.

Software in Healthcare IT

Software provides the face of healthcare IT. Hardware is not typically visible to the end users, but the applications that run on that hardware are. Use of the various software applications, along with changes in workflow and processes, can benefit the organization. The software is what the end user interacts with, using interfaces ranging from mobile devices to voice enabled assistants. There are a large number of applications, so we will discuss the major groups of applications and examine some of the newer ideas that are in the pipeline.

Clinical Applications

As with most specialties, healthcare IT has developed its own terminology and acronyms. Some of the terms seem interchangeable when, in fact, they do have different meanings. The EHR, the electronic medical record (EMR) and the PHR are examples of this. The EMR is the continuous, longitudinal electronic record in one specific setting—a provider's office, a hospital or a home healthcare service. The EHR is a longitudinal record covering multiple settings over time.1–3 The PHR is a medical record often created, edited, maintained and controlled by the patient, and possibly includes importation of clinical data from other sources. Often created online, it is accessible by providers when the patient invites providers to review information in the PHR using secure access.

Clinical applications support patient care wherever it is being delivered. The most apparent clinical application is the EHR. In some institutions, this is a one-vendor application; in others, it is a best of breed, with many different vendor applications performing different functions. The EHR is used by clinicians to document patient care, from medication administration to order entry, as well as to retrieve patient data from the lab or from radiology. The provider's office can send electronic prescriptions to the patient's pharmacy, as well as import and export data from an inpatient stay or outpatient testing from a health information exchange (HIE) system.

EHR systems can also execute algorithms for stratifying various clinical and operational activities. The data points that drive these prediction models can range from vital signs, lab results, to the number of no shows for outpatient visits. Enterprise EHR's can also include population health capabilities, clinical specialty modules and integration with outside regulatory and public health systems. The list of capabilities keeps growing as these systems mature.

The EHR interfaces with specialized systems in different departments. As an example, in the United States, radiology and pathology labs have specific requirements, with formatting and data display governed by different accrediting agencies, such as Clinical Laboratory Improvement Amendments (CLIA), the College of American Pathologists (CAP) and the American College of Radiology.4,5 In Europe, the European Cooperation for Accreditation6 covers laboratory certifications. Professional dietitians, case managers and social workers all have specific needs in software functionality, often dictated by professional or regulatory standards.

Some clinical areas, such as the perinatal areas (labor and delivery, nursery, neonatal intensive care and postpartum), the perioperative areas (preoperative unit, operating rooms and post anesthesia care unit), the critical care units, the outpatient centers for primary care and special functions like renal dialysis, have specialized documentation and information needs. The picture archiving and communication system (PACS) stores and displays images from ultrasounds to computed tomography (CT) scans and magnetic resonance imaging (MRIs). These systems require fine-resolution monitors, large storage drives, good bandwidth and large amounts of random access memory (RAM) for image display. Some of the major EHR vendors are able to support all the specialty areas; others do not and require the purchase and interface of a niche system specific to each specialty. The goal of all these systems is to communicate and exchange this patient health information, also known as interoperability. Interoperability is one of the most important attributes of clinical systems, since data should not be entered into systems more than one time. It is essential that these systems exchange data with each other.

The availability of clinical data at the point of care has transformed how clinicians care for patients. They no longer need to go to the radiology department to look at MRIs or CT scans; those images can now be made available in the EHR application, saving time for clinicians, as well as money for the institution, since there are no films to create, store, or retrieve. Perinatal systems archive the fetal monitor strips electronically, saving thousands of dollars in charges for storage of paper fetal strips.

Administrative Applications

Administrative applications provide support for clinicians, as well as the administrative staff in an institution. These applications run the gamut from electronic time cards, intranet, payroll, staff competency record keeping and educational applications, to scheduling both staff for work shifts and patients for procedures and office visits. Bed management systems, which include staff from housekeeping and patient transportation, as well as clinicians, are very helpful in getting patients into a room as soon as possible. Popular applications in the last few years include equipment-tracking applications that use radio frequency identification (RFID) technology, thus saving staff time spent in hunting for needed equipment. Web-based applications that permit staff to bid for understaffed shifts are being implemented, reducing overtime labor costs and increasing staff satisfaction, as do systems that permit self-scheduling.

Financial Applications

Financial applications in healthcare IT cover all the features of any organization's financial needs, but possibly with more variables than most businesses have to entertain. From the solo provider's office to the multihospital, multi-provider health system, there is a need for financial systems. Multiple regulations govern how billing can be done, how bills are submitted and the details that have to be included with a bill, such as diagnosis codes and providers’ licenses and billing numbers—the list is incredibly long. Systems have to handle charge posting via both orders and manual charge entry, payment posting and billing based on the providers. Insurance, coinsurance and deductibles have to be part of the calculations, as do revenue codes, supplies, tests and medications. Items that require a provider's order and cannot be billed to patients without an order must be distinguished from items that do not require an order and can be billed to patients. Statements need to be provided to patients and claims to insurance companies. These billing systems are commonly referred to as practice management systems.

A general ledger must accurately track charges, bills and payments. Payroll systems need to accept data from the electronic time card system and convert it to salary costs, correctly matching hours worked, both regular and overtime, and calculate any overtime pay, holiday bonuses, shift differentials, or additional wages earned from professional certifications. It also has to track earnings for paid time off, usually based on the number of hours worked by the employee. The accounts payable portion of the software must also be in sync with all the other systems; financial systems have to communicate in real time. The supply chain mission and support has to include all methods of supply purchasing, as well as invoice payment, and ensure that they are linked correctly.

Consumer Applications

Consumers are becoming more and more involved in electronic records and their patient health information. Not infrequently, patients request electronic versions of their charts from providers. The importance of the consumer's relationship to the record and the information in that record is more apparent. While there used to be discussions about who owned the medical record, this seems to have been decided in the patient's favor. Most EHRs have a patient portal that permits the patient to view test results and clinical notes, ask for prescription refills and send the provider or the office staff a secure e-mail, as well as schedule an appointment. Some portals permit patients to add comments or request amendments to their EHR.7,8

Some PHRs are stand-alone and are not connected with an institution's EHR. These applications may be web based, or an application installed on the user's computer or mobile app. In the United States, the Centers for Medicare & Medicaid Services (CMS) encourages the use of PHRs9,10 and provides a link to Blue Button®, a PHR initiative which originated through the Veteran's Administration and is now being offered through other healthcare organization patient portals. The National Committee on Vital and Health Statistics also provides detailed information on the advantages of a PHR.10 Convenient guides are helpful to patients around the world.11 Web-based PHRs give the patient full control of the record's contents, and often offer the opportunity to import prescription medication history from national drug store chains or results from laboratories. According to Gherardi et al., PHRs are becoming very popular in Europe, the United Kingdom and Scandinavia.12 Vendors are increasing their promotion about the PHR across Europe, the United Kingdom and China.13

Some healthcare organizations have partnered with web-based PHR vendors and uploaded records into patients’ PHR applications from those healthcare institutions. Some healthcare insurers also provide the ability to create a PHR from their websites.14 In the United States, a national survey conducted by the California Health Care Foundation (CHCF) provides evidence that PHRs actually support patients in improving their own health.15 According to the survey, caregivers did note that PHRs were almost a necessity in maintaining knowledge and continuity of care for family members with multiple chronic conditions.

The numbers of patients using PHRs is growing rapidly, with the CHCF survey reporting that most patients want to use PHRs that their physician or insurer provides. The survey also identified security as the major stumbling block to PHR adoption, with patients looking for evidence that any information they enter into the PHR is completely secure. Most websites clearly provide information on how security and privacy of the patients’ records is maintained. Most allow the patients to decide who can view their information, often by providing a secure URL or separate login and password for the healthcare provider. Patients have found that after establishing a PHR through their insurance company or other third-party vendor, information could not be easily transferred to a different PHR, resulting in the patients having to reenter the data in their new systems. PHR use has increased with the medical home and accountable care platforms, as they provide incentives for keeping patients healthy.16 In addition, the use of in-home health monitoring systems and wearable devices has also intensified the need for PHRs. In the United Kingdom, the NHS Summary Care Record (SCR) is an electronic summary of key clinical information (including medicines, allergies and adverse reactions) about a patient, sourced from the general practitioner (GP) record. It is used by authorized healthcare professionals, with the patient's consent, to support their care and treatment. If you are registered with a GP practice in England, your SCR is created automatically, unless you have opted out. 98% of practices are now using the system. The SCR is created automatically through clinical systems in GP practices and uploaded to the Spine. The Spine is a set of national services used by the NHS Care Record Service. In addition to the SCR, these include: The Personal Demographics Service (PDS), which stores demographic information about each patient and their NHS number. Patients cannot opt-out from this component of the spine and the secondary uses service (SUS), which uses data from patient records to provide anonymized and pseudonymised business reports and statistics for research, planning and public health delivery.17

Patients are also very interested in communicating electronically with their providers. According to the Wall Street Journal,18 doctors are far behind the rest of the world in using electronic communications, and either patient portals or secure messaging applications can provide security for this increasingly popular communication. Most patient issues can actually be addressed in e-mail by office staff, leaving only a few e-mails that the physician or nurse practitioner needs to address. Patients want the convenience of electronic communication with their providers, but at the same time, both sides of the communication have to be secure. While providers may not have the skill to set up secure communications, there are web-based and application-driven tools that will provide both security and convenience.

The requirement to be able to provide “human-readable” medical records in electronic format is something very new to healthcare. In the past, patients had to go to the health information management department, complete paperwork to request their own records and often pay a per-page fee for a copy of the paper record. As an example, in the United States, Stage 1 of the CMS Meaningful Use requires that a copy of the medical record be available to the patient within 24 hours of the request.19 While it is not always easy to retrieve data from EHR systems, this requirement has to be fulfilled. Ensuring the EHR can provide this information, whether on a flash drive, or pushed out through an existing patient portal, is essential. In addition, regardless of the regulations, informed patients want copies of their records. Patients want to see their records, as determined by a group of researchers in the United States and Canada.20

Clinical Business Intelligence (CBI) and Analytics

According to the HIMSS Clinical and Business Intelligence (CBI) Committee, CBI consists of “technologies, applications and practices for the collection, integration, analysis and presentation of clinical information, for the purpose of better clinical decision-making. In recent times, quality in healthcare is being shaped by evidence-based medicine and the proper utilization of data.”21 Tools of clinical and business intelligence can provide support to clinicians to improve patient safety and patient care, as well as analyzing operating room use and staff overtime patterns. Collecting—and reporting in a meaningful way—supports not only direct patient care, but also all aspects of healthcare, including predictive analytics. Hospitals want to show that they are providing high-quality, low-cost care for their patients; providers want to show that they are doing the same. Data and data analysis are the only keys to providing that information. More and more organizations around the world are implementing clinical and business intelligence, whether by using specific applications or by constructing data warehouses, to document the care they provide, as well as to show trends in patients’ conditions and document improvements in patients’ status and population health outcomes based on the care that they were given.

Hardware in Healthcare IT

Technology Infrastructure

The basis of any technology has to be the hardware systems that store data, run applications and connect those applications and tools together. The physical routers, switches and virtual and physical servers are some of the integral parts needed to connect clinicians, administrators, providers and patients to essential clinical systems, information and support. Firewalls, both physical and software based, along with virus scanning systems, protect the network from unauthorized access as well as maintain security of the information in the system.

Servers

While the vision that many people have of IT is a data center full of servers, this is no longer completely accurate. Most healthcare IT departments have virtual, physical and cloud servers. What application is installed on which type of server is determined by the vendors’ recommendations, as well as the capabilities of the organization to support this technology. Servers are part of the most expensive equipment in a healthcare IT shop and must be managed well and appropriately. Cloud computing provides alternative cost-effective options for those organizations that may not have the appropriate space, resources, or desire to house and maintain their data in-house.

Data Storage

There are, depending on the type of patient, regulations on how long patient data must be maintained. Many healthcare organizations are simply resigned to keeping charts forever.

With paper records, that translates to a large amount of money to store stacks of paper that will probably never be looked at again. Health information management departments have looked for a less expensive and more reliable storage method. Historically, most organizations were forced to store paper charts off-site and have to order them when or if they are needed, thus adding transportation costs to and from the storage area to the record-keeping costs. Some health systems have a practice of scanning paper charts, and then appropriately disposing the paper chart. EHRs have reduced or eliminated the need for paper chart storage. Current practice, where data is stored, backed up and archived, is changing—often to the cloud. The cloud can provide room for storage, even when those storage needs may double every few years.

Mobile Devices

Hardware needs to be designed to support clinical workflow, and increasingly that means portable devices and wireless connectivity. Healthcare institutions are using workstations on wheels (WOWs) with wireless access, as well as smaller handheld devices. These workstations can be configured to meet end users’ needs, from drawers for storage to holders for barcode medication scanners and locked drawers for security of medications. Workstations can also be designed for outpatient clinics and other clinical areas that have no need for drawers or scanners, while other workstations can have medical devices mounted on them. It is important to remember that while standardization may be a goal, one documentation device will likely not meet every area or end user needs.

The popularity of smartphones, and their increased functionality, is prompting end users to ask for similar devices for use in healthcare units. Smartphones are one of the most popular handheld devices. Most EHR vendors have updated their applications for use on handheld devices. Devices with touchscreens are being configured for healthcare, with attention to the concern about maintaining good infection control practices while using equipment that is touched by gloved hands. Several devices, such as MRI scanners, employ touchscreens to program the examinations and review the images.

A major concern with any handheld device that connects to the institution's network is security, especially when end users actually bring their own devices (BYOD) to work. Prior to permitting staff's use of their personal devices in the clinical areas, it is important to establish a policy to ensure that protected health information (PHI) is safe, that the institution can wipe a device clean if it is compromised and that passwords are required to access the device. The decision to permit data storage on a personal device must be dependent on maintenance of the data's security.22,23

Medical Devices

Many physiologic devices, such cardiac monitors, ventilators, some IV fluid pumps, medication pumps and vital sign monitors, have the ability to send out the data they obtain, often in Health Level Seven (HL7®) format. This integration with the EHR helps staff by decreasing data entry and transcription errors, as well as saving time. Depending on the EHR, this data could be sent directly to preconfigured fields, or a third-party device can be used to translate the data into EHR-acceptable format. It is important to require validation of the information by the clinician prior to permanently storing data in the EHR.

Laboratory devices can conduct tests and export the information to the EHR. Typically, radiologic images are stored in a PACS and viewed via a link from the EHR to the image in PACS or enterprise imaging system. Both areas have specific regulatory agencies that supervise the use of those devices and regulate them. As an example, in the United States, the Food and Drug Administration (FDA) regulates medical devices. Since so many of those devices have incorporated advanced technology, IT must be aware of the laws and regulations from the FDA that apply to hardware and software that is IT supported. In addition to radiologic images, any display of physiologic data, such as heart rhythms, fetal monitor tracings, ventilator or heart waveforms and any implantable device, such as an automatic cardiac defibrillator, are covered by the FDA. In addition, the FDA regulates mobile medical apps. Examples of these are applications that display fetal heart tracings or cardiac waveforms on physicians’ cell phones.24 The institution's biomedical engineering department must work closely with IT to maintain these important systems.

In Europe, the Parliament and the Council of the European Union have developed directives for medical devices and in vitro diagnostics. Canada has medical device regulations, as does Japan.25 In Russia, the Ministry of Public Health and Social Development of the Russian Federation control medical devices.26 The World Health Organization (WHO) has published a large amount of information about medical device requirements on its web page.27 According to the WHO, “65% of 145 countries have an authority responsible for implementing and enforcing medical device specific product information.”28 There is discussion that the European Commission's regulations for devices are not strong enough to really protect patients.

Networks in Healthcare IT

Network Infrastructure

The network, while still dependent on network cables, is increasingly connected using wireless points. Putting the information for clinicians at the point of care requires wireless access points, not hard or physical wires. Clinicians want data at their fingertips and do not accept the model of going to the patient's room and then back to the nurse's station to log in to the clinical system and retrieve results. Providers can now take the electronic chart with them to the patient's room, where they can review lab results, x-ray reports and other tests with the patient. Wireless access points can support this workflow, permitting clinicians to work with the information they need when and where they need it. This wireless and cabled access supports more than just documentation stations. Virtual private networks (VPNs), voice over Internet protocol (VoIP) using fiber-optic cables and coaxial cables and supporting protocols, govern the connection of routers and switches. Local area networks (LANs) using Ethernet and a token ring, and wide area networks (WANs) using multiprotocol label switching (MPLS) or asynchronous transfer mode (ATM) are all in use, supporting the hardwired and wireless networks. VPN technology is a safer, more secure method of providing remote access to an organization's network and servers. VPNs, using tunneling protocols and encryption, require authentication to block out unauthorized users.

There are guidelines and rules from regulatory bodies and professional organizations, and standards that require documentation about patients and the care given to those patients, as well as documentation of procedures. One of the major requirements of an EHR is that it must be able to support the documentation, order entry and lab results reporting required by regulations, professional standards and patient need. Ideally, that care is documented when and where it is provided, thereby reducing errors.30

There are many areas in an organization that have cabled access to the organization's intranet (internal) and Internet (external). Cabled access is more reliable and faster. Many institutions already have cable that was installed before wireless was within the price range and speed requirements of most IT departments. Clinical departments, as well as administrative and support services, usually have hardwired desktop computers. Some healthcare providers, especially in outpatient settings, have installed a desktop or fixed device in each patient exam room. Specific clinical areas, such as radiology examination rooms, need special hardware, such as larger, high-resolution monitors and high-speed graphic cards that will support detailed images. In addition, hardware devices in patient care areas have to be cleaned with appropriate cleansing agents.

Communications

There are many different types of data communication protocols and media available in healthcare IT today, from the standard telephone landline with conferencing and video capabilities to various devices that use VoIP and broadband access. Data communication protocols allow information to transmit from one point or media to another. One of the most common examples would be the telephone. Some of the devices look like the same cell phones that are used outside the hospital, while some are clip-on, hands-free phones worn by staff members. As with other devices in use in clinical areas, such as tablets and medical devices, infection control is a major concern. Materials for these devices need to be antibacterial and cleanable. While some of these devices can send and receive text messages, there are concerns about the security of using text messages for patient orders and not all providers want to use text messages for orders. Bifurcated workflows such as these can result in missed patient care. Other examples of communication protocols would include broadband access, Ethernet and Wi-Fi for transmitting data across computer networks or accessing the Internet.

Interoperability and Standards

An important facet of all healthcare IT applications is the use of standards. Interoperability is essential to smooth functioning of healthcare IT, and systems that support standards ensure that functionality. Health Level Seven (HL7) is an international standard interface language used in healthcare,31 HL7 Fast Healthcare Interoperability Resources (FHIR®) is a next-generation standards framework that leverages the latest web standards, Digital Imaging and Communications in Medicine (DICOM®) is used as a standard for images32 and the Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT®) is the most comprehensive multilingual clinical healthcare terminology in the world,33 while the International Statistical Classification of Diseases and Related Health Problems (ICD) provides diagnosis codes for most disease conditions.34 In the United States, these codes, along with current procedural terminology (CPT®) codes, classify patients’ diagnoses and the procedures they had and provide a link between each procedure and the diagnosis that required it.35 In France, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has developed charge codes for providers, including the correct prices that can be charged for a specific procedure.36 These codes can be entered into the system by clerical staff as well as providers, and in most cases, these codes have a large part in determining if an institution or provider will receive the maximum amount of reimbursement for performing a procedure or the minimum amount.

Interoperability is “the extent to which systems and devices can exchange data and interpret that shared data” and the “uniform movement of healthcare data from one system to another such that the clinical or operational purpose and meaning of the data is preserved and unaltered.”1 With the current movement to exchanging patient data, regardless of the physical location of the patient and the patient's home data, those standards, especially data formats, have become increasingly important and necessary.

Without standards, interoperability is impossible; without standards, healthcare IT would most resemble the Tower of Babel, with no system or device speaking the same language and resulting in duplicative effort and work from clinical and administrative staff as well as patient safety concerns. In the United States, governing standards are included in the Final Rule, published by CMS in August 2012, as well as the Advisory Board for Health Standards in Europe.37

Included in the discussion of standards are nursing and other disciplines’ terminologies. These terms can be used by nurses, as well as other providers, including physicians, to document patient care. The need to standardize terms affects all parts of healthcare and especially impacts quality reporting. The use of standard words for documentation improves data, research and natural language processing (NLP), since it is clear what the standardized terms mean.

There are challenges to EHR interoperability throughout the world. The integration effort currently in place in Europe is improving the chances of adoption. This integration needs to move quickly, as the number of specialty systems is increasing. The specialty systems are often intended for use by only one discipline, moving away from an integrated EHR.

Data Integration

Data integration and the use of interface engines are essential in healthcare IT. Interface engines permit systems to be connected correctly. It is not enough to simply send data from one application to another—there are many rules that must be followed. If data does not go to the right patient's chart, errors in the patient's care, bill and final report could result. Interface engines in a healthcare IT environment really drive the systems, matching data and patients correctly in near real time. Without data integration and interface engines, a national health information network, connections to EHR's with best of breed systems and EHR app integration using FHIR would not be possible.

Data Warehouses

Data warehouses are highly prevalent in today's healthcare IT landscape. The value of being able to store and mine data from multiple sources, such as the EHR and ancillary systems, is clearly recognized. Storing data in one place—the warehouse—from multiple sources allows it to be queried at the same time. Healthcare institutions have multiple requirements for submission of their data to different organizations, from the Bureau of Vital Statistics to the American Heart Association in the United States or the European Society of Cardiology. Often, these organizations require submission of the same quality improvement data elements, but just want it in a different format. The warehouse can support this type of quality reporting, as well as clinical research and analytics. Data mining can be used to identify populations at risk, search for patterns of illness and identify potential study candidates or those patient populations that are doing well.39 Defining a data model, deciding if a data mart would be more helpful than a warehouse and determining how to search the warehouse are all decisions that should be made by an experienced database manager.

Privacy and Security

Maintaining patients’ information, ensuring that it is kept private and secure, is the first charge for EHR administration. As an example, while patients’ data has to be shared through HIEs and Regional Health Information Organizations (RHIOs), it must remain confidential. Increasingly, data regulations are including strong language about privacy and security, emphasizing that the EHR can and must be developed without compromising a patient's privacy. Systems, as part of their design, have to be able to provide the patient an accounting of disclosures. The system must be able to maintain levels of confidentiality. For example, a nurse or physician must be able to see the patient's laboratory results, but a nurse's aide using that same EHR should not be able to see that information.

While disclosures of information can be made to appropriate agencies, such as the patient's insurance provider, those agencies cannot be given complete access to the patient's record, but must be given the minimum amount of information necessary.

Ethically, healthcare providers have an obligation to keep any patient's information private and confidential. The healthcare professions have codes of ethics that clearly detail the nurse's and physician's obligation to protect the patient's information.40

Summary

Understanding the basic foundations of healthcare technologies, applications and other tools used in connecting them together provides healthcare professionals and others allied to the field the ability to create, support and maintain healthcare information. Knowledge of these fundamental areas, as well as key issues and especially trends, is the basis of building and designing healthcare IT and supporting healthcare providers in their work of caring for patients in a safe, accurate and timely manner.

Introduction

Clinical informatics is a vast and diverse study of information technology (IT) and how it can be applied to the healthcare field. HIMSS defines clinical informatics as the promotion of “understanding, integration and application of information technology in healthcare settings to ensure adequate and qualified support of clinician objectives and industry best practices.”1 The field includes2:

Methods to collect, store and analyze healthcare data

The study of information needs and cognitive processes and optimal ways to meet those needs

Methods to support clinical decisions, including summarization, visualization, provision of evidence and active decision support

Optimizing the flow of information and coordinating it with care providers’ and patients’ workflows to maximize patient safety and care quality

Methods and policies for information infrastructure, including privacy and security

Globally, clinical informatics has been increasingly impactful to the healthcare world. Diana Nole, the Chief Executive Officer (CEO) of Wolters Kluwer Health, states that in 2018 there was more than US$ 8 billion in digital health deals made.3 Clinical decision support (CDS) continues to be a powerful tool in providing guidance to today's clinicians. Drug usage and cost is being looked at with new eyes through data, and artificial intelligence (AI) and machine learning adoption are on the rise. With the increased focus on social determinants of health and patient-driven care, AI will development and usage will continue well into the future.3 And clinical informaticists will be needed to maintain their role as translators in the interprofessional team, as a professional that speaks both informatics and healthcare.

As discussed in Chapter 1, “Healthcare Environment,” often considered a hybrid of many different informatics models and theories, clinical informaticists can consist of physicians, nurses, pharmacy, laboratory, radiology and other clinical professions. Physicians and nurses make up the largest group of healthcare professionals, “who have actively contributed to and advanced the theory and practice of clinical informatics.”4 Nurses established an early role as clinical informaticists, with certifications starting in 1992.4 Physicians later followed with their own certifications through the American Medical Informatics Association (AMIA) in 2013.5 HIMSS, Certified Associate in Healthcare Information and Management Systems (CAHIMSSM) and Certified Professional in Healthcare Information and Management Systems (CPHIMSSM) are listed among the highest recommended informatics certifications for clinicians, as well as board certifications. Acquiring a certification is recognized as a “highly-visible quality indicator and a tool to improve recognition among peers.”4 Table 3.1 takes a look at the differences between nursing and physician certification processes.

Table 3.1 Comparison of Informatics Certification Processes for Nurses and Physicians4

Nursing Informatics Certification Informatics Skills/Competencies References

Clinical Informatics Board Certification for Physician* Informatics Skills/Content Outline References

Skills and Competencies

Scope of nursing informatics practice: foundational knowledge of metastructures, concepts and tools, functional areas of nursing informatics; evolution of informatics competencies, ethics, the future of nursing informatics including trends in practice roles, technology, regulatory changes and quality standards, care delivery models and innovation. Standards of nursing informatics practice: assessment, diagnosis, problems and issues, outcomes identification, planning, implementation, evaluation standards of professional performance for nursing informatics: ethics, education, evidence-based practice and research, quality of practice, communication, leadership, collaboration, professional practice evaluation, resource utilization, environmental health

Informatics competencies as listed on the outline for board certification: leading and managing change, health information systems, fundamentals of informatics, clinical decision-making and care process improvement, legal, ethical and regulatory issues

Global Aspects of Clinical Informatics

Although many items referenced in this chapter are centered around the United States, clinical informatics is very global. Global clinical informatics is a fast-growing, interdisciplinary field. From privacy and security issues to global population health, clinical informatics professionals have a great impact on the management of patient health data.

Health information data can be stored across borders, which allows for the impact of international law with both the data usage as well as patient's rights.6 This requires not only a strong healthcare system and regulatory knowledge for the country of origin but any foreign locations as well.

Several global initiatives share the mission of increasing clinical informatics education and best-practices. The AMIA leads a global health informatics working group (GHIWG) designed to work with resource-constrained countries. They work to increase overall informatics usage and facilitate collaborative efforts between clinical informatics workers. Their connection forum helps to facilitate the exchange of both informatics experiences, as well as expertise, across the global spectrum.7

HIMSS has always had its North American roots. Within that scope, it includes the digital health support of Canada, including its own HIMSS certification (CPHIMS-CASM). Digital health is a term for clinical informatics more commonly used outside the United States. Through HIMSS, “international insights, resources, and audiences” are provided at the ready for the Canadian clinical informatics professionals.8 The Canadian/HIMSS collaboration currently concentrates in three areas8:

Strengthening the HIMSS Ontario Chapter (ON Chapter) through increasing the Canadian health association presence in HIMSS activities, volunteer opportunities and project that will aid both Ontario's, as well as HIMSS, global digital health influence.

Support existing associations and Canadian digital health initiative by including (and sponsoring) local informatics groups such as the British Columbia Health Information Management Professionals Society (BCHIMPS) and the Canadian Trade commission.

And by filling the void. HIMSS has the unique ability to bridge the clinical informatics gap and aid in increasing the knowledge and expertise of Canadian stakeholders. This is evidenced by its recent expansion efforts, including the formation of the Canadian Prairies Chapter of HIMSS to support other areas of Canada in a more local fashion.

Furthermore, since the publication of this chapter, HIMSS has also worked with local constituents to form the Canadian Prairies Chapter and with the BCHIMPS to form the HIMSS British Columbia Chapter.

Finally, there is the EU–US eHealth Work Project, which culminated its project work in May 2018. As a Horizon 2020 project, its goal was to “map skills and competencies, provide access to knowledge tools and platforms and strengthen, disseminate and exploit success outcomes for a skilled transatlantic eHealth workforce.”9 The 21-month project began in September 2016 with funding from the European Commission's Horizon 2020 research and innovation grant program and came to a close in May 2018. Their challenge was to develop something that would expand the foundations already in place for digital skills and push the global boundaries of innovation and resource development. This included making sure that clinical informaticists were engaged and brought into the extensive stakeholder community. They achieved this through the development of the Consortium, which consisted of a network of partners in academia, healthcare associations, as well as healthcare providers, and industry workers. The Consortium included: Omni Miro Systems/Med Solutions (Germany) who served as the project coordinator, European Health Telematics Association (EHTEL) (Belgium), University of Applied Sciences Osnabrück (Germany), Tampere University of Technology (Finland), Steinbeis 2i GmbH (Germany),9 and the HIMSS Foundation with project fulfillment by the HIMSS Technology Informatics Guiding Education Reform (TIGERTM) Initiative. To meet their goals, they conducted a survey (Survey of Current State and Needs of the eHealth Workforce) to identify the “real world” challenges and gaps in informatics. The study, which served as the flagship of the project, considered demographics with over 1,000 respondents globally, primarily from the United States (72%) and Europe (19%). One of the most significant results of the survey was the need for increased clinical informatics education, specifically with nurses, physicians and educators rounding out the top three. They released this as GAP1: eHealth knowledge and skills of healthcare professionals, with there being ten significant gaps identified in total. Other deficiencies consisted of gaps in teacher/trainer knowledge, acceptance and usage of systems, availability of course or programmes for education and the quality of current training materials for any clinical informaticist.9

The project also included an update of the Health Information Technology Competencies (HITCOMP) Tool to a 2.0 version. Seen as an innovative solution, this tool is available to the global clinical informatics community and concentrates on eHealth, digital skills research, education development, skills assessment, and career progression. It contains over 1000 competencies, over 250 healthcare roles, in five major European languages.

The HIMSS TIGER Initiative continues its partnership with the project through support in several platforms such as the Foundational Curriculum and the Interactive Web Platform TRIE (tools, resource, information, education) (includes HIMSS TIGER Virtual Learning Environment (VLE)). Also, the skills and knowledge assessment and development (SKAD) framework promotes certification programs such as the HIMSS CAHIMS/CPHIMS.9

Domains of Clinical Informatics

With patient safety always paramount, “clinical informaticians transform healthcare by analyzing, designing, implementing and evaluating information and communication systems that enhance individual and population health outcomes, improve patient care, and strengthen the clinician-patient relationship.”10

According to AMIA (Figure 3.1), “clinical informaticians use their knowledge of patient care combined with their understanding of informatics concepts, methods, and tools to:

Figure 3.1Domains of clinical informatics.10

Assess information and knowledge needs of healthcare professionals and patients;

Characterize, evaluate and refine clinical processes;

Develop, implement and refine clinical decision-support systems; and

Lead or participate in the procurement, customization, development, implementation, management, evaluation and continuous improvement of clinical information systems.”10

In this chapter, we will take a deeper dive into the world for clinical informatics. Starting with the basics, we will review the language and definitions commonly used in healthcare. We will also examine clinical metrics frequently represented in informatics such as average daily census, turnaround time, adherence and barcode medication administration. To evaluate these metrics, often informaticists will need to use various analytical tools. It is essential to have a good understanding of clinical and operational outcomes through the use of tools such as reports, tables, graphs, charts and predictive models. Finally, in this chapter, we will review one of the most often used tools, and often debated, clinical content and decision-support tools.

Figure 3.1Domains of clinical informatics.10

Assess information and knowledge needs of healthcare professionals and patients;

Characterize, evaluate and refine clinical processes;

Develop, implement and refine clinical decision-support systems; and

Lead or participate in the procurement, customization, development, implementation, management, evaluation and continuous improvement of clinical information systems.”10

In this chapter, we will take a deeper dive into the world for clinical informatics. Starting with the basics, we will review the language and definitions commonly used in healthcare. We will also examine clinical metrics frequently represented in informatics such as average daily census, turnaround time, adherence and barcode medication administration. To evaluate these metrics, often informaticists will need to use various analytical tools. It is essential to have a good understanding of clinical and operational outcomes through the use of tools such as reports, tables, graphs, charts and predictive models. Finally, in this chapter, we will review one of the most often used tools, and often debated, clinical content and decision-support tools.

Table 3.2 Frequently Used Clinical Terminology Prefixes11, 12

Brachi/o

Arm

Lapar/o

Abdomen, loin or flank

Cardi/o

Heart

My/o

Muscle

Cyt/o

Cell

Neur/o

Nerve

Derm/a, derm/o, dermat/o

Skin

Ocul/o

Eye

Encephal/o

Brain

Ophthalm/o

Eyes

Gastr/o

Stomach

Or/o

Mouth

Hemat/o

Blood

Ot/o

Ear

Intestin/o

Intestine

Pulmon/o

Lungs

Table 3.3 Common Drug Routes and Abbreviations13

Classification

Drug Routes

Common Abbreviations

Enteral

Oral

PO

Sublingual

SL

Per rectum

PR

Parenteral

Injections

SQ, IM, IV, IA, IT, IO, ID

Inhalation

Lungs

Aerosols, steam

Topical

Skin

Enepidermic, epidermic, insufflation, instillation, irrigation, swabbing

Table 3.4 Medical Specialties14

Allergy and Immunology

Allergies

A provider that specialized in diagnosis and treatment of allergies, including allergy testing, medications

Anesthesiology

Sedation/anesthesia

Specializes in anesthesia, sedation and airway management. Typically seen in the operating room working with the patient during their surgery

Cardiology

Cardiovascular system

The provider treats heart and blood vessel issues and disease processes

Dermatology

Integumentary system

The provider delivers care from aesthetics (e.g., laser treatments) to rashes, skin cancers and other skin issues

Endocrinology

Endocrine system

Diseases such as diabetes and thyroid issues

Family Physician

Primary care provider

Providers deliver basic care (typically nonspecialized) for patients across all spectrums (genders and ages)

Gastroenterology

Digestive system

Providers works around the esophagus, stomach, intestinal issues including reflux, gallbladder, colitis, etc.

Infectious Disease

Infections

Difficult to diagnose or treat, such as tuberculosis, Zika, or Dengue

Internal Medicine

Primary care provider

Specialized providers that encompass sub-specialties such as cardiology or endocrinology

Neurology

Neurologic system

Works with spinal issues, brain, nerves. Some examples include Parkinson's and neuropathies

Pediatrics

Pediatric care

The care is given to younger patients, typically infancy through age 18. This includes well-checks, immunizations, physicals, etc.

Oncology

Cancer management

Providers care for cancer, side-effects of treatment, clinical trials and end-of-life care

Obstetrics/Gynecology

Women's health

Reproductive care, preventive care (annual pap exams, mammograms), pregnancy, menopause, contraception and infertility

Otolaryngology

Ears, nose and throat

Most often, ENTs are also surgeons that cover areas from sinus issues, neck cancers, etc.

Psychiatry

Mental and behavioral healthcare

Providers work with patient counseling, psychotherapy, analysis, hospitalization and medications

Radiology

Imaging

A physician trained at interpreting diagnostic exams/testing

Surgery

Surgical care

General or specialized surgical providers. Responsible for planning pre-operative needs, the surgery, post-operative needs, as well as any complications that may arise (e.g., orthopedics, general, bariatrics, etc.)

able 3.5 Frequently Used Clinical Abbreviations13

Abbreviation

Definition

Abbreviation

Definition

AM

Morning

L

Liter

AC

Before meals

LMP

Last menstrual period

AD

Right ear

MCG

microgram

Ad lib

Freely

mEq/L

Milliequivalent per liter

Amp

Ampule

mL

Milliliter

Ante

Before

Mm

Millimeter

AS

Left ear

N/V

Nausea and vomiting

ASA

Aspirin

NKDA

No known drug allergies

AU

Both ears

NPO

Nothing by mouth

BID

Twice a day

OD

Right eye

BMI

Body mass index

OS

Left eye

BP

Blood pressure

OU

Both eyes

BS

Blood sugar

oz

Ounce

CC

Chief complaint

PRN

As needed

Cap

Capsule

PM

Evening

CM

Centimeter

PMH

Past medical history

CXR

Chest x-ray

Q

Every

DC

Discontinue

Q2h

Every two hours

Disp

Dispense

Q6h

Every six hours

ER/EC/ED

Emergency room

Qam

Every morning

G

Gram

Qpm

Every night

Gr

Grain

QID

Four times a day

HR

Hour

QOD

Every other day

H/O

History of

Rx

Prescription

HR

Heart rate

SL

Sublingual

HS

At bedtime

SQ

Subcutaneous

HX

History

STAT

Immediately

ID

Intradermal

Supp

Suppository

IM

Intramuscular

T

Temperature

IN

Intranasal

TID

Three times a day

INJ

Injection

w/o

Without

IV

Intravenous

WNL

Within normal limits

able 3.6 Frequently Used Healthcare Information Technology Vocabulary15–19

Affordable Care Act (ACA)

The comprehensive healthcare reform law in the United States enacted in March 2010, also known as “Obamacare”

Accountable Care Organization (ACO)

A group of healthcare providers who give coordinated care, chronic disease management and thereby improve the quality of care patients receive

Current Procedural Terminology (CPT®)

These codes are used for the billing of medical procedures

Digital Imaging and Communication in Medicine (DICOM®)

The Digital Imaging and Communications in Medicine (DICOM) Standard was developed for the transmission of images and is used internationally for Picture Archiving and Communication Systems (PACS)

Federally Qualified Health Center (FQHC)

Federally funded nonprofit health centers or clinics that serve medically underserved areas and populations

Health Information Portability and Accountability Act (HIPAA)

U.S. law designed to provide privacy standards to protect patients’ medical records and other health information provided to health plans, doctors, hospitals and other healthcare providers

Health Level Seven (HL7)

ANSI-accredited, a nonprofit, standard-developing organization that creates methods for interoperability of healthcare data interchange. It focuses on clinical and administrative data

Tenth revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10)

ICD-10 is a system used by physicians and other healthcare providers to classify and code all diagnoses, symptoms and procedures recorded in conjunction with hospital care in the United States

Logical Observation Identifiers Names and Codes (LOINC®)

Coding system for the electronic exchange of laboratory test results and other observations. LOINC development involved a public-private partnership comprised of several federal agencies, academia and the vendor community. This model can be applied to other standards setting domains

Merit-Based Incentive Payment System (MIPS) (U.S. based)

MIPS was designed to tie payments to quality and cost-efficient care, drive improvement in care processes and health outcomes, increase the use of healthcare information and reduce the cost of care

Natural Language Processing (NLP)

Natural language processing (NLP) is a branch of artificial intelligence that helps computers understand, interpret and manipulate human language. NLP draws from many disciplines, including computer science and computational linguistics, in its pursuit to fill the gap between human communication and computer understanding

Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT®)

SNOMED-CT (Clinical Terminology) has been created from the combination of SNOMED-RT (Reference Terminology) and Read codes

Unified Medical Language System (UMLS®)

Developed by the National Library of Medicine in an attempt to unify disparate medical vocabularies and facilitate sharing medical knowledge across information systems

Basic Information Technology Vocabulary and Terms

Common Clinical Metrics in Informatics

Most clinical informatics professionals will credit the birth of clinical metrics with the 1999 publication by the Institute of Medicine (IOM), “To Err is Human.” This landmark report brought to light issues within the healthcare system that not only was responsible for significant financial loss but also loss of life.20 With the field of clinical informatics being vast in scope, certain areas set it apart from other types of IT. One is the focus of healthcare informaticists on the need for identification and adoption of clinical metrics. Since the IOM report, there has been a significant surge in the development of methods to help keep down cost, provide accessible healthcare, as well as significantly improve patient safety.

In the United States, the development of the American Reinvestment and Recovery Act (ARRA), the accompanying Health Information Technology for Economic and Clinical Health (HITECH) Act,21 and the Patient Protection and Affordable Care Act22 reinforced the shift in focus even more towards the goal of decreasing government spending on healthcare while also improving patient safety. These public laws, as well as the Centers for Medicare and Medicaid Services (CMS) introduction of Meaningful Use (MU), created a rapidly changing landscape for clinical informatics. Before the introduction of these laws, adoption was slow at best. But with the incentives provided by the HITECH Act, a landslide of implementation of certified electronic health records (CEHRTs) was kick-started.

CMS has had many variations since 2009, of the expectations of meeting their electronic clinical quality measures (eCQMs). These tools were designed to specifically aid in measuring and tracking several aspects of healthcare. The reporting of these measures revolved around working the eligible providers (EPs), eligible hospitals, dual-eligible hospitals and critical access hospitals (CAHs). Per CMS (2019), their current version of meeting the guidelines includes using the 2015 version of CEHRT to meet the requirements of the promoting interoperability program (PIP) (Tables 3.7, 3.8). Each year, CMS provides updates to the eCQMs. These consist of updates regarding evidence-based medicine, code sets and measure logic.23 The current measurement goals of eCQMs for both Medicare and Medicaid for 2019 include23:

Patient and Family Engagement

Patient Safety

Care Coordination

Population/Public Health

Efficient Use of Healthcare Resources

Clinical Process/Effectiveness

With these new standards of cost-saving and healthcare safety, there have been many organizations developed to aid in quality improvement. These groups accomplished this by setting forth guidelines and metrics for facilities and providers to integrate into their care of patients. The tools they provide aid clinical informaticists to develop and implement system functionality to optimize clinical effectiveness and efficiencies. There are many, but two of the more significant ones include the National Quality Forum (NQF) and the Agency for Healthcare Research and Quality (AHRQ).

The NQF is an agency that supports improving overall national health by several methods: setting national standards, recommendation of measure for use in payment and public reporting programs, identification of quality improvement (QI) priorities, advancement of electronic measurement and providing information and tools to help healthcare decision-makers.25 The tools provided by the NQF are especially helpful to healthcare providers when aiming to meet metrics and achieve both facility and personal goals. Table 3.9 provides a brief explanation of the tools provided.

able 3.9 National Quality Forum Tools26

NQF Graphics Library

Collection of downloadable graphics that can be used in your work

Alignment Tool

Helps you align, expand, or start your measurement and reporting efforts in ways that fit with key national programs

Health IT Knowledge Base

Provides answers to some of the most technical questions surrounding NQFs health IT and eMeasures initiatives

My Dashboard

Helps track what is happening at the NQF and lets you personalize your experience on the web

NQFs Action Registry

Online collaboration space designed to help people on the frontlines of making care sage connect with others, find new resources and help distribute proven ideas

Field Guide to NQF Resources

Dynamic, online resource designed to help those involved with measurement and public reporting more easily access basic information and NQF resources related to quality measurement

The AHRQ is a U.S. government agency that functions as part of the Department of Health & Human Services (DHHS). Its primary mission is to support research and produce evidence for the improvement of quality healthcare. To achieve this, they developed quality indicators to determine the standards of healthcare and if certain providers are meeting those standards.27 Examples of their goals are keeping patients safe, helping physicians and other healthcare providers improve quality, and develop data to track changes in the healthcare system (Table 3.10).

Table 3.10 Agency for Healthcare Research and Quality Areas of Focus27

Project ECHO (Extension for Community Healthcare Outcomes)

AHRQ funded an innovative model, Project ECHO, for training and supporting primary care clinicians in rural communities to provide specialized care for their patients. This model has flourished and expanded from its initial focus on hepatitis C into new clinical areas, including mental health and substance abuse and HIV. It has also been adopted by the Veterans Health Administration as a tool for expanding access to high-quality care for veterans across the country.

Re-Engineered Discharge (RED)

RED is a structured protocol and suite of implementation tools that help hospitals rework their discharge processes to reduce readmissions by determining patients’ needs and carefully designing and communicating discharge plans. Hospitals using these tools have seen a 30% reduction in hospital readmissions and emergency rooms visits.

Centers of Excellence

Three Centers of Excellence were funded to study how high-performing healthcare systems promote evidence-based practices in delivering care. The AHRQ project will help close this research gap and produce information that can be used by health systems throughout the United States to improve patient outcomes.

These metrics, such as average daily census, cervical cancer screening and diabetic eye exams, require a thorough investigation of the requirements as well as current and future state workflow assessments to ascertain how the metrics can be met within a CEHRT. The subsequent reporting on to government agencies for either reimbursement incentives or avoidance of penalties often becomes the primary goal. But workflow and ease of usability are factors that also need to be considered when asking providers and other healthcare professionals to aid in meeting these metrics. To accomplish this, often times the use of CDS systems will be brought into play.

Clinical Content and Decision Support Tools

Clinical informaticists and clinicians in general, have been making a significant impact in HIT since the late 1950s. Since then, there has been the development of mathematical models used to aid providers in diagnosing various medical conditions28 to the present-day use of AI, application programming interfaces (APIs), substitutable medical applications reusable technologies (SMART), the fast healthcare interoperability resources (FHIR®), or a combination of several of these such as SMART on FHIR.

CDS is defined as “a category of concepts and methods designed to provide patient-specific clinical information to a healthcare provider at the point of care.”29 The ultimate goal in the use of CDS is, of course, patient safety and improved patient experience. But, it can also serve other purposes. Establishing a robust and reliable process for developing best-practice maintenance of a CDS is paramount. Good build design and implementation can not only provide better patient outcomes but improved overall quality, reduced cost, improved documentation consistency and reliability, as well as an enhanced clinician experience. This is where clinical informaticists are paramount. They have the skills to translate workflow into the CDS design and build. Clinical informaticists have the ability to better communicate and understand all the challenges that clinicians face and that come along with new CDS, new implementation of any kind, within an electronic health record, “acceptance and adoption of CDS is critical for successful implementation.”4 CDS is typically implemented within an EHR, in the form of order sets, condition-specific clinical alerts, access to reference information (also known as info buttons) and passive/active generalized alerts. But, it can also be seen in use with patient portals, health information exchanges (HIEs), mobile applications and other HIT systems.

Considering it takes up to 17 years for translational research to make its way into clinical practice, maintaining current, evidence-based clinical content can be a challenge but is required for any successful use of CDS in the healthcare setting.30 To maintain this rapidly changing use of not only technology, but medicine as well, skilled workflow assessments, governance and maintenance is a must. According to Butterfield, “medical knowledge doubles approximately every eight years, so a physician's knowledge base is outdated very quickly after graduation from medical school. Keeping up with current knowledge by reading journal articles is impractical due to the volume of material and lack of time for reading it.”31

To quote Dr. W. Edwards Deming of The Deming Institute, “a bad system will beat a good person every time.” No matter the amount of governance management, or expert opinion of the project informaticist, if the design and build are “bad,” the implementation will fail. Here, we look as some of the advantages and disadvantages of CDS

able 3.11 Advantages and Disadvantages of Computerized Provider Order Entry33

Advantages

Disadvantages

Averting handwriting issues

Perceived as more work for clinicians

Drug/drug, drug/food, drug/allergy alerts

Provider coding requirements

Formulary recommendations

Bad use of CDS; design, maintenance

Safer or lower cost

Duplicate alert drop-down issue

Economic savings

Never-ending system demands

Better billing turn around

Hybridized paper/electronic workflows

Faster order transmission to lab/pharmacy/radiology

Constantly changing evidence and technology

Overdependence on CDS

Advantages of CDS:

Increased quality of care and enhanced health outcomes

Avoidance of error and adverse events

Improved efficiency, cost–benefit and provider and patient satisfaction

Computerized practitioner order entry

Disadvantages of CDS:

Alarm/alert fatigue

Clinical burnout, documentation burden

Delegation of order entry to other clinicians

Data integrity

Auto-population

Design and implementation issues

Lack of maintenance and governance

According to Bresnick, “CDS tools are designed to help sift through enormous amounts of digital data to suggest next steps for treatments, alert providers to available information they may not have seen, or catch potential problems…. ”34

Osheroff et al. recommends a five-rights framework for CDS that has been adopted and promoted as best practice by the AHRQ35 (Figure 3.2). There is also a need for increased usability. This relates directly to CPOE. The less a physician or advanced practice provider (APP) uses the order systems as designed, the less impactful CDS is. It will be alerting in the face of the incorrect people. So, our providers have to be well trained, well informed and satisfied with the usability of the system.

The five rights include (Table 3.12)37:

Table 3.12 Explanation of the Five Rights of CDS36

Right Information

Right Person

Right Format

Right Channel

Right Time

Have the right decision-makers involved

Include the end-users and the healthcare team

Alerts; passive or actionable?

EHRs

When should the CDS be presented in the workflow?

Evidence-based, recognized guidelines

Determine who needs to actually see the CDS

Order sets, HIEs, patient portals

CPOE

Workflow analysis

Actionable, not too much information

Is the person seeing it qualified to use it?

Infobuttons

Forms, etc.

Close the loop

The right information

To the right person

In the right intervention format

Through the right channel

At the right time in the workflow

Ultimately, CDS is not going anywhere, anytime soon, “CDS tools are increasingly leveraging machine learning and artificial intelligence to sophisticated power analytics. Machine learning algorithms can ingest large quantities of data, identify patterns, and return detailed results to users.”34

Clinical Data Analytics Tools

To put all of this together, clinical informatics is all about the clinical data; how do we enter it, where do we store it, what can we do with it? Whether it is a retrospective look at the data or more towards the future with predictive analytics, clinical informatics plays a vital role in healthcare. Considering what has been discussed related to data, CDS and quality measures, outcomes are a top goal and are necessary in order to meet the goals you have set for providers and facilities, including lowering cost and improving the patient experience. This consists of defining and understanding both clinical outcomes as well as the operational outcomes. Later chapters discuss the systems life cycle and data management in more detail. With all the regulatory and accreditation requirements (e.g., Joint Commission, DNV GL), the ability to develop and maintain a functional system of data management is challenging. According to McBride & Tietze, “data management, measures, and analytics are the foundations of improvement.”6 Data warehouses, retrospective storage of data, can include clinical and operational data.38 See Chapter 2 for more discussion surrounding data warehouses.

Clinical Outcomes

Clinical outcomes are somewhat different from typical outcomes measures. The clinical measurements are related to specific changes in health or health quality, as it relates to the healthcare a patient has received. They are measurable and can be evaluated through activity metrics such as hospital re-admission rates, or catheter-associated urinary tract infections (CAUTIs), as well as many other metrics.39 Often times, facilities will benchmark or compare themselves to other comparable facilities based on a shared standard. This ranking is usually available to the public. It is easy to see why keeping up with data, and clinical outcomes would be considered vitally important.

Operational Outcomes

Operational outcomes are defined as outcomes that are specific and measurable statements about improvements a facility would like to make to its processes or services, “each outcome should flow directly from a more general goal of the unit.” For example, if an academic department has a goal of increasing diversity, then the department might have separate outcomes addressing the recruitment of more diverse students and recruitment of more diverse faculty.40

In the development of outcomes, the use of the acronym SMART is often recommended to assure a measurable outcome is designed.

Outcomes should be SMART:

Specific

Measurable

Attainable

Realistic

Timely

Common Data Analytics Tools

Now that you have all this data, how do you go about making it work for you? The process starts with learning about your data, manipulating it, creating information from it and then distributing that knowledge and wisdom to others. By determining what kind of data you have (nominal, ordinal, interval, ratio), you can examine or explore the data set. There are many tools available for data analysis, including Microsoft Excel, IBM SPSS, Tableau, business intelligence software and many more. When you have identified and opened your data file, you can start with a visual inspection6:

What rows and columns do the data set reflect?

How are the data structured?

Are there visibly missing data apparent in the file?

Do they appear to be sorted in some order?

What variables in the data set represent dependent, independent and grouping variables?

In healthcare, it is not uncommon for there to be data integrity issues or problems with the accuracy or validity of the data over its lifecycle.41 This can often occur for various reason. Some of the more common ones are listed here:

Wrong patient data

Height/Weight inaccuracies impacting drug calculations

Allergies and medications documentation inaccuracies or omissions

“Fat finger” errors, physical typing/entering the wrong data

Overall missing data; forgetting, time constraints, fraudulent documentation

Not documenting real time (e.g., sepsis alert dependent on vital signs data entry)

Based on these examples, it is not hard to understand the value of inspecting your data prior to presenting it. With that, the ability to recognize clinical and operational outcomes through the use of various data analytics tools (e.g., reports, tables, graphs, charts, predictive models) is a necessary skill set for any clinical or healthcare informatics specialist. Here are some examples of the more common data analytics tools and terminology

Table 3.13 Common Data Analytics Tools and Terminology38

Tool

Purpose/Definition

Example

Fields

Vertical column in a database that contains data with common characteristics for the entire record

“First Name”

“Last Name”

“Date of Birth”

Records

Horizontal rows in a database containing different pieces of data belonging to a given entity

All of the fields related to the row of “Billy”

Tables

Consists of all records; combinations of all fields and records together

All horizontal and vertical rows together

Reports

Alternate view of data; typically assembled from a query

Generally generated on paper, can also be electronic for distribution of data

Query

Process of selecting desired records; pulling the data

Pulling data related to all female patients older than 50 with a history of colon polyps

Graphs and Charts

Tool for examining and presenting data

Scatter plot, pie charts, bar charts, flowcharts

Control Charts

Tool for looking at a process over time

Common and special-cause variation, upper and lower control limits

Predictive Modeling

Instead of retrospective data analytics, the data is used to predict future outcomes

Pulling last five years of financial data to predict next years’ budget needs

Summary

Introduction

Different industries have adopted the use of information technology (IT) in their various operations in order to enhance growth, conform to emerging standards, attract new customers, maximize profitability and acquire business intelligence. Different sectors, however, have adopted IT use in different capacities. The health sector, like all others, is striving to enhance the acceptance of better and easier techniques available through an IT implementation, yet the average use of IT in healthcare has lagged behind other industry sectors for the better part of the last decade. According to Deloitte's 2018 Global CIO Survey, only about 4.26% of revenues were spent on technology in the healthcare services industry. This is up three quarters of a percent since the previous survey in 2017.1 In early 2019, Forrester Research and Gartner both released predictions that spending on healthcare would increase to nearly 9%. Gartner's report though further broke down the spending, which continues to show that, although spending is up, monies are allocated mainly on supporting and maintaining the current infrastructure, not on growing and transforming the business through IT.2 Healthcare has many potential benefits from IT implementation in both managerial operations and patient-related operations. These benefits may be realized through systems implementation. A common methodology that may be followed during this pursuit is the systems development life cycle (SDLC). The SDLC is a process used to develop an information system, including requirements, validation, training and user ownership through investigation/planning, analysis, design, implementation and maintenance.3 During the planning phase of the SDLC, the phase prior to the analysis phase, the initial idea for an health information system project is first developed. The feasibility, objectives and scope are examined, current problems with the existing situation are considered and a recommended solution is proposed. If the project appears to be worth pursuing the project then moves to the analysis phase. The purpose of the systems analysis phase is to understand the business requirements and to build a logical model of the new system. Requirements modeling is going to be completed, business processes are going to be described and defined, data, process and object modeling will take place, and ultimately a systems requirements document describing the management and user requirements, alternative plans and costs and an analysis of the recommendation will be produced. During the systems analysis phase, the following objectives should be met:4

Gather, analyze and validate technical, functional and nonfunctional requirements.

Evaluate the alternatives and prioritize the requirements.

Examine the information needs of end users and establish the systems goals.

Create software, hardware and network requirements documentation.

Requirements gathering in this phase is key. Lack of end user input can mean a weak analysis. A weak analysis leads to poor design, which can lead to failed projects.

Healthcare Problems and Opportunities for IT Implementation

Healthcare globally is going through dynamic changes in several ways. Improvements to healthcare information systems emerge from a need for change. Either the existing system does not meet the evolving needs of the program or there is an understanding that emerging technologies allow for radically better systems. In response, a small group, or a project champion, identifies this need and then tries to mobilize a larger group of stakeholders. During this phase, systems analysis, the perceived gaps and opportunities are documented, with a strong focus on describing the desired benefits and why. It may include the development of a high-level business case that compares the benefit with estimated costs. To begin, let's look generally at problems plaguing traditional healthcare systems and then potential opportunities to address these issues.

Problems with Traditional Healthcare Systems

Overall, there are some general problems with the traditional healthcare systems. These may include:

Poor quality of health information including redundancy and inconsistent standards for the collection and sharing information.

Inability to obtain health information at the time and place where it is needed.

The data collected in health records is limited.

Some registers in health exist only in paper form, which limits quick access to them.

Inadequate procedures for the implementation of information systems not related to the relevant organizational changes.

Existing solutions do not ensure interoperability and the lack of co-operation between systems makes management of information impossible and adversely affects the accuracy, integrity, comparability and completeness of data.

To this point, systems have been developed primarily to support the work of the administrative unit, while to a small extent adjusted to the needs of patients, doctors and other users.

Lack of computerized practitioner order information and histories for drugs and other substances, medical supplies, catalogs and lab test results.

Lack an integrated, interoperable electronic health record, image and film archiving and associated communication systems, the result analysis mechanism for ordinary patient processes such as lab tests and drug prescriptions, prescription error alert systems and electronic monitoring of high care patients.

Opportunities with Advanced Healthcare Systems

As we look toward advanced healthcare systems, there are many opportunities. Hospital information system (HIS), healthcare information system and patient data management system (PDMS), all these terms refer to the integrated information systems in the healthcare sector. They are complete solutions for managing medical, administrative, financial and legal data. The overall aim of a HIS is to provide support for patient care, achieve optimal financial performance and streamline administration. These systems include the integration of clinical systems, financial systems and administrative systems. Benefits of integrated healthcare systems include:

Operational

Increases productivity, reduces cost, improves data quality, improves data sharing/flow, provides better access to data, provides easier exchange of data, improves data presentation, reduces medical errors and helps achieve satisfaction.

Managerial

Improves managerial control, provides more understanding and control of processes, supports decision-making, improves allocation of resources, improves quality of care provided, improves work efficiency, increases performance and increases return on investment.

Strategic

Supports more effective planning, increases synchronous-asynchronous collaboration among actors (actor refers to all human and non-human users that interact with the healthcare system), improves relationships with suppliers, improves knowledge sharing, improves population's health and increases survival rates and quality of life.

IT Infrastructure

Promotes reusability of objects, reduces development risk, supports the use of e-healthcare and telemedicine-based patient support models, achieves non-invasive solutions, achieves process integration, provides object/components integration, provides data integration, provides real-time integration, integrates custom systems and integrates packaged systems and integrated e-business solutions.

Organizational

Reduces need for hospitalization or length of stay, reduces waiting times, reduces cancelled operations, achieves effective clinical and administrative management, increases business efficiency, supports clinical decision-making, results in reliable data, increases data analysis and reduces paper work processes.

The major avenues of opportunities for change are spread across clinical, administrative and financial functions as well as infrastructure.

Clinical Functions

A significant percentage of modern healthcare facilities are using IT systems in clinical operations. However, the majority of units are still dependent on traditionally used systems, such as physical patients’ document keeping, lab reports, drug administration history and other functions. While much progress has been made in these areas over the past couple of decades, we still have a long way to go before we achieve a global, interoperable healthcare system in all types of healthcare settings.

Applications for Clinical Functions

Electronic health records (EHRs) involve standardizing the way in which patients’ records are entered, stored and retrieved, not just within an organization, but across different hospitals, caregivers, government-controlled organizations and other interested parties. The biggest challenge regarding EHRs has been the establishment of an industry standard so that an efficient workflow can be realized that would allow for seamless retrieval and use of records for patients, even when patients are moved to units or facilities other than where they were initially treated.

This kind of data pool would imply a dedicated system with necessary checks and balances to prevent unauthorized access to and manipulation of patient records, while, at the same time, enabling data entry by different care providers when patients make additional visits to any facility. This concept is delicate due to the potential of malicious addition or manipulation of patient data by different staff in different facilities. Moreover, a lack of universal standards in proper coding and categorization of prescriptions and procedures has hindered the implementation of interoperable EHR systems in the last two decades. This problem can now be sufficiently handled by high-end software applications that are being developed by individual and corporate research entities.

An example of one type of system being pursued is computerized practitioner order entry (CPOE). CPOE may replace conventional order cataloging and fulfillment in a manner that will enhance tracking, logistic synchronization and cost-effectiveness. Another example of a system is a clinical decision-support system (CDSS), which, in its basic form, will give informative guidelines to practitioners regarding medication and procedures, including warning systems relating to high-risk medications and processes. In addition, the picture archiving and communication system (PACS) integrates inputs from multiple radiological and diagnostic tools to allow easy, consistent and accurate treatment of different conditions, while radio frequency identification (RFID) may help to track patients within a medical unit without the need to restrict them to a particular location or allocate a nurse to them. There are also monitoring systems that may collect vital signs which may include pulse rate, temperature level, blood pressure and other metabolic/respiratory signals. Benefits of such a system, if properly collected, stored and secured, when integrated with other dedicated software applications, may shorten treatment time, allow more freedom and lead to cost efficiency and better resource utilization within a hospital or other healthcare facility. Automated dispensing machines (ADMs) will aid in drug dispensing, while electronic materials management (EMM) systems will operate like the resource planning systems used in other sectors to manage information processing regarding pharmaceuticals, new drug development and coding, among other functions. Such a system could reduce medication errors, which, per a report from 2016 found that adverse drug events (ADEs) account for more than 3.5 million physician office visits and 1 million emergency department visits each year. This same report also stated that it is believed that preventable medication errors impact more than 7 million patients and cost almost $21 billion annually across all care settings..

Administrative and Financial Services

Functions that could be enhanced through investment in IT in the administrative category include general ledger operations, such as revenue and cash flow, expenses, purchases and other day-to-day transactions. Other functions are billing, cost accounting systems, payroll, personnel management and integrated human resource functions, patient registration and booking and electronic management of materials, among others.

Applications for Administration and Finance

IT may find many basic as well as advanced applications in administrative and financial services. Human resource management has experienced radical changes in operational methods as a result of IT implementations. Systems for employee management, role definition, reward and recognition support and performance development have been successfully automated thanks to dedicated software such as enterprise relational database management systems (RDBMSs). Such systems allow easy, timely and accurate workflow management in human resource mobilization and development, saving time and costs that would otherwise be allocated for additional staff. Other functions, such as payroll, budgeting, internal audits and strategic planning, have also been made easier, more precise and tailor-made for specific analytical objectives without incurring additional monthly or yearly charges due to the use of IT systems. Patient registration and tracking can become more enhanced and efficient, and access to the online statistics of every facility within an area may be useful in referrals and in discharge notification, enabling time saving and better emergency handling.

Infrastructure

Infrastructure is a broad category that incorporates various equipment with diverse applications, both general and specific. Current security standards have shifted toward biometric sensors for movement and access control in many major private and public buildings and premises. These security standards enhance accountability in system access and support user logging, which enhances safety and responsibility among authorized personnel. The healthcare sector could, perhaps, benefit the most from such systems, given the delicate nature of confidentiality requirements involved in patient records access and dissemination. Biometric sensors typically used include fingerprint or palm scanners, voice recognition systems and eye scanners, among others. Other more dedicated systems include bar coding systems for medication grouping, ordering, cataloging and stock control. Security infrastructure may also include closed-circuit TV cameras and night infrared cameras.

Security-Related Applications

Since IT relates to healthcare security, it may find many uses, some of which may not be achieved in other ways. Patient information access logging is important in ensuring confidentiality and professionalism in the way patients are treated. It increases patients’ confidence in their practitioners and boosts their trust levels. In addition, the use of biometric systems will eliminate to a large extent, ambiguity in accountability in delicate cases due to their high precision levels and extremely low chances of identity theft or manipulation, unlike conventional security protocols when any person with forced access to pass codes may steal information. In addition, healthcare research facilities may hold expensive machinery that, if it falls into wrong hands, may be used in ways detrimental to society. For instance, ultra-modern DNA synthesis machines, if used by experts, may find applications in the terrorist underworld. Other chemicals and drugs in healthcare facilities may also be abused or sold to unsuspecting people as legitimate prescriptions and lead to catastrophic consequences. Such security measures cannot be overlooked, and government control is restricting the use of certain machinery and equipment to high-security facilities, limiting the range of services that healthcare units with lower security may offer.

Another broad category of infrastructure has to do with network development and all associated controls. Medicare processes large amounts of information internally, not to mention the external linkage requirements associated with referrals and national accountability reports that must be processed and sent to government control and data collection agencies and other industry regulatory bodies. The baseline network infrastructure includes servers, end user computer stations, switches, network access points, all associated cabling and external access infrastructure. While very elaborate high-level applications have been incorporated into network infrastructures in a significant number of healthcare facilities, the majority of care units are using their network support equipment for only slightly more than baseline uses, such as record keeping and document sharing.

Needs Analysis in Healthcare Facilities

In order to develop a proper proposal for sustainable IT supplementation in the core processes of the healthcare sector, it is important to identify the main challenges in the sector and specifically those needs that can be sufficiently met by the implementation of sustainable, secure and cost-efficient IT practices. This section will give a detailed needs analysis to lay the foundation for the chapter. The analysis focuses on requirements that may be categorized as operational, administrative, or industry related. During the needs analysis, the problem will be further characterized, a cost–benefit feasibility study will be performed, the scope and value will be defined and the framework for what the system will do is established. The needs analysis may also be referred to as a gap analysis. A gap analysis is a method of assessing the differences in performance between an organizations systems to determine whether business requirements are being met and, if not, what steps should be taken to ensure they are met successfully.6 These gaps help inform the overall needs assessment. The following text will also describe a number of processes and tools that will aide in establishing the gaps and informing the new system requirements.

Operational Needs

Healthcare facilities need to streamline their core administrative and financial operations with the current global standards in order to foster interoperability in record keeping and analysis with other stakeholders, investors and business partners. Currently, healthcare as an industry is behind average industry standards in IT acceptance. Such processes as payment processing, e-bill systems, human resource systems, stock intake, auditing and other similar functions can be sufficiently integrated with the use of developing software.7 In order for a system to be sustainable and standard, it is necessary to select a universally accepted platform for data storage and analysis in which organizations may pool data relating to logistics and facilities. Financial as well as private human resource information does not need to be pooled in a central storage facility, but adopting software dedicated to easing these functions on a private level is necessary in order to reduce costs, enhance operational efficiency and increase profitability. Operational needs may be broken down into several areas.

Staff Productivity and Satisfaction

The use of IT may reduce time wasted by operational staff performing administrative work and enhance patient attendance time, which is the key need for patients. It will also reduce unnecessary routines in patient care and reduce work of clinical staff due to rigorous, non-work-related duties. Additionally, it will improve employee satisfaction and reduce fatigue due to extensive overtime schedules. Better productivity will invariably lead to increased patient volumes.

Increased Revenue and Cost Optimization

Increased visitor capacity per unit may boost revenues for a care unit due to a larger number of admissions and discharges per month following shortened lengths of stay, reduced unit costs for bulk purchases and improved capability to meet overhead expenses. Cost optimization needs to be realized through bulk purchases, efficient stock control and reduced cost per day for each patient. In this regard, IT practices will save costs for the unit as well as daily treatment and accommodation charges to the customer.

Patient Safety

A significant number of deaths and serious medical malpractice cases are reported each year due to errors in treatment, procedures or prescriptions. The major cases involve ADEs due to wrong prescriptions that affect patients negatively, admissions following adverse drug events, errors in surgical procedures, blood transfusions and malpractice expenses such as corrective procedures, court litigations and compensations. There is an urgent need to reduce such occurrences, many of which can be satisfactorily handled by the application of proper IT processes.

Quality of Care

Patient quality of care deals with the satisfaction that patients get from care providers’ efforts to resolve their problems. It may involve time of delay, time of treatment, appropriateness of procedures used and drugs administered and the levels of professionalism, confidentiality and courtesy of the staff. Moreover, it may involve specific professional services, such as recognition and accreditations, complication management, physician or nurse time with patients and reduced length of stay.7

Patient Access to Services

Apart from the length of stay, patients are concerned with delay time for such processes as lab reports, billing, online services such as viewing and scheduling, preventive care management and outpatient care appointment bookings. There is a need to upgrade systems that can be automated to handle most of the routine work not requiring case-specific diagnosis, such as remote patient appointment bookings and all associated alerts on scheduling, integrated lab linkage with other hospital systems that eliminates the need for extended physical queues at facilities, and electronic procedures for alternative bill settlement by customers. If proper systems are established to meet the outlined objectives, other needs relating to healthcare that cannot be quantified but lie at the core of healthcare provision will also be realized. This will lead to nonmonetary benefits such as good patient–physician relationships and improved community health

Tools for Accomplishing the Needs Analysis

Needs analysis can be conducted through a variety of tools. The most common include observation, interviews, review of documentation, surveys and data analysis.

Needs Summary

The foregoing discussion highlights the need for all-around IT supplementation to help healthcare catch up with other sectors in terms of modernization and integration. In essence, what is required is sufficient planning to implement safe, sustainable and cost-effective IT practices to help healthcare in (1) administrative, (2) operational, (3) patient-related and (4) industry-related functions. There is a need for a seamless backbone IT platform that integrates these four needs, as well as sustainable controls for the IT implementation to ensure it remains secure, serves the maximum purpose possible and is practical for universal adaptability in order to satisfy the core concern within various healthcare institutions, which is the integration of policy implementation.

Needs Prioritization

While all the needs listed above are urgent and important, there are certain ones that must be prioritized in order for IT acceptance in healthcare to stand. These processes are the backbone of healthcare, and all other requirements are built on them. For instance, patient security and safety are core driving factors for any practitioner, and they surpass the need for good bookkeeping or profit optimization. Without proper observance of fundamental safety concerns, healthcare units are likely to face legal implications that could cause them to lose their license, rendering futile any advancement they may have in their other operations. This section will therefore seek to address the need for prioritization of IT acceptance in healthcare facilities based on the hierarchy of the needs model. The needs prioritization process helps drive the likelihood of project acceptance. The primary priority from an individual facility's perspective is patient safety, followed by profitability, then ease of processes and lastly, industry standardization. From the healthcare industry's perspective, the priorities are likely to be patient safety and security, professionalism, standardization, profitability and ease of processes. Obviously, the ease of processes is in most cases tied with profitability.8 The project must therefore address IT implementation issues from both perspectives and attempt to strike a balance. Figure 4.1 illustrates the differing priorities of individual facilities and the healthcare industry.

Workflow and Process Mapping

Workflow and process mapping serve as mechanisms by which to understand current processes and how work is performed to begin the change management process and serve to support the functional data and technical strategies.9 These two methods can also help identify broken processes and provide an opportunity to address them before a system automates them. This also helps recognize the need for process improvement through automation. Process mapping guides functional specifications where a product may not address all functionality an organization may need or want. It helps visualize the need for standard data structures.9 This can also be termed process redesign or process reengineering. Workflow aids system configuration during implementation, provides scenarios to create test cases from and guides new users of the system regarding how the process with change with the new system. Workflow and process mapping identify how work is currently performed and the sequence of steps involved. There are a variety of forms these diagrams. Some tools include activity diagrams, swim lane charts, data flow diagrams, system flowcharts, entity relationship diagrams, class diagrams and uses cases.

Current Clinical Processes

Operations and processes in the healthcare sector can be analyzed in four broad categories: administrative and financial, operational, process flow and standardization.

Figures 4.2 and 4.3 present typical process flow diagrams that aid in identifying areas of two healthcare processes that are manageable using IT.10 Process diagrams and flowcharts are a visual representation of a process that show the boundaries of the process, the steps and the sequence in which the steps take place. These visual representation will use standard symbols, but different approaches and different symbol sets may be used, e.g. ISO 5807 and Unified Modeling Language (UML).

Figure 4.3Process 2: Referral-patient booking process.

Figure 4.2 shows the process flow for a typical client briefing about lab reports. A nurse will usually try to reach a patient more than four times in stated durations, usually from a few hours to a day. This process takes time, delays other functions and consequently leads to fewer patients served per day. The proper IT implementation, even on the internal level, may allow convenient patient briefing and follow-up using trusted e-mail services, among other channels. Patients can usually be given the option to choose their preferred channel of communication before leaving the hospital or other care facility.

A typical referral process involves even more delay. The referral-patient booking process is diagrammed in Figure 4.3.11 The figure clearly demonstrates delays introduced in current healthcare systems due to lack of integration between the communication and decision-making systems involving care providers, referral centers and patients. In the workflow diagram, it may be noted that a referral patient may wait up to two weeks between the date of referral and the date of appointment booking solely due to communication and work arrangement delays. Referrals may not appear urgent on the reported data sheet, but patients’ situations may become aggravated during the waiting period when they are unable to obtain help. As a result, patient services may be greatly compromised due to the systems’ inefficiency. In addition, the lengthy waiting period can be greatly reduced if proper IT policies that incorporate remote meetings, such as video and audio conferencing, are implemented. The time spent between contacting a patient and receiving a response constitutes service degradation for the patient and revenue loss for the care provider.

A reduced number of patients are seen per day; therefore, customer satisfaction levels may also decline. While authentication issues may be cited as the reason for insistence on the use of official letters by care providers, the bulk of the processes requiring care provider–client correspondence involve non-vital documents, such as requests for bookings. A possible method of bypassing this hindrance through the IT-based communication implementation is to develop a web-based communication and client support system that would allow secure communication between the customer and the care provider. In this platform, customers would be able to receive e-mails and respond to booking notifications. Modern day patient portals are beginning to address this need, but the implementation and use of these systems is still lagging.

In addition, digital signing is a standard that is progressively being adopted by many industry sectors and is a concept that may be beneficial to healthcare providers when they send documents requiring authorization or authentication. As an alternative, the use of registered mailing services may greatly reduce the feedback duration for sensitive medical cases. Apart from the operational perspective, billing systems and other workflow routines in most facilities are also very inefficient. The entire process, which includes a medical history review, booking to be attended by the physician, physician duration, prescription, queuing at the pharmacy and bill settlement, involves avoidable delays. These work stages can be sufficiently improved by computer-aided work management and decision-making.

As workflows begin to be examined naturally other key factors to the analysis process will begin to take form. This really begins the requirements gathering processes as well.

Functional Needs Assessment

The functional needs assessment describes the key capabilities or application requirements for achieving the benefits of the system as the organization has envisioned it.9 This process is important because every organization begins from a different starting point, every organization has different needs and every vendor offers a different approach.

This process is best achieved through surveying users and reviewing use cases. Users should be asked to identify what functionality they need and perhaps rank/prioritize them. Although in the early stages of the project a user's understanding of what may be possible may be limited, it is still important to understand this as you may need to plan for additional functionality in later phases of the project. Knowing this helps ensure that you are selecting a product that will best meet all these needs, including current and potential future needs. You may also be able to identify users who have had exposure to different systems and will be able to provide feedback regarding their experiences. This also allows users to be more engaged in the process which is a critical component of implementation success.

The use case approach is often easier for clinicians to understand. A use case is a scenario that essentially describes a system behavior as it responds to a request that originates outside of that system. It will describe the interaction between the actor who initiated the interaction (such as a clinician) and the system itself. Clinicians can began to form these use cases as they consider patient care events. From these depictions of scenarios, additional visualizations can be created, e.g. process diagrams, but ultimately it will result in a listing of functional requirements to achieve the patient care use case. As part of this, current functional capabilities can be inventoried which will help users see the scope of current capabilities, as well as establish a foundation on which to understand what essential functional capability may be missing and is needed in support of other, more robust capabilities.

Requirements Analysis

The requirements analysis is going to be the documented record of what the system actually does. It is a critical component to keep the project aligned with the identified scope. It is essential to the testing process, as the information gathered in the requirements analysis will produce test cases that can then be used to validate that the system meetings the project requirements. These use cases will begin with a high-level description of the process and will furthermore include a detailed description of each requirement. Often use cases will also include a graphical depiction. This document will describe the future state and is the primary input document for estimating resources, cost and time needed for the project. It will also take into account the needs assessment and further inform the needs prioritization. Requirements are often categorized as follows: functional and workflow, reporting/analysis capabilities, regulatory requirement, data/database, security, system performance and response time, disaster recovery, platform compatibility, interface and interoperability, physical plant consideration, client devices and network.

Document Analysis

In addition to documenting the sequence of steps and decision points in the process, workflow and process mapping should also be accompanied by a collection of all of the associated documents and a documents analysis should be performed. This will also help define the data requirements associated with each process. When working with a vendor they will sometimes provide organizations with a tool to conduct this, while other times a spreadsheet is just as efficient and effective.

Additional Inventories

In addition to the various information-gathering techniques described previously, some additional inventories to be considered include an applications inventory and a reports inventory. In the applications inventory the organization identifies all of the applications that currently exist and how they may or may not be related to one another. This too will help identify the functional requirements of the new system as it leverages and interacts with current applications. It may also help to identify additional applications that could be replaced by the new system. The reports inventory serves as a document of all of the current reports being used/produced by current systems. Again, this too can inform the functional assessment regarding what may need to be produced from the new system.

Workflow and Process Mapping

Workflow and process mapping serve as mechanisms by which to understand current processes and how work is performed to begin the change management process and serve to support the functional data and technical strategies.9 These two methods can also help identify broken processes and provide an opportunity to address them before a system automates them. This also helps recognize the need for process improvement through automation. Process mapping guides functional specifications where a product may not address all functionality an organization may need or want. It helps visualize the need for standard data structures.9 This can also be termed process redesign or process reengineering. Workflow aids system configuration during implementation, provides scenarios to create test cases from and guides new users of the system regarding how the process with change with the new system. Workflow and process mapping identify how work is currently performed and the sequence of steps involved. There are a variety of forms these diagrams. Some tools include activity diagrams, swim lane charts, data flow diagrams, system flowcharts, entity relationship diagrams, class diagrams and uses cases.

Current Clinical Processes

Operations and processes in the healthcare sector can be analyzed in four broad categories: administrative and financial, operational, process flow and standardization.

Figures 4.2 and 4.3 present typical process flow diagrams that aid in identifying areas of two healthcare processes that are manageable using IT.10 Process diagrams and flowcharts are a visual representation of a process that show the boundaries of the process, the steps and the sequence in which the steps take place. These visual representation will use standard symbols, but different approaches and different symbol sets may be used, e.g. ISO 5807 and Unified Modeling Language (UML).

Figure 4.3Process 2: Referral-patient booking process.

Figure 4.2 shows the process flow for a typical client briefing about lab reports. A nurse will usually try to reach a patient more than four times in stated durations, usually from a few hours to a day. This process takes time, delays other functions and consequently leads to fewer patients served per day. The proper IT implementation, even on the internal level, may allow convenient patient briefing and follow-up using trusted e-mail services, among other channels. Patients can usually be given the option to choose their preferred channel of communication before leaving the hospital or other care facility.

A typical referral process involves even more delay. The referral-patient booking process is diagrammed in Figure 4.3.11 The figure clearly demonstrates delays introduced in current healthcare systems due to lack of integration between the communication and decision-making systems involving care providers, referral centers and patients. In the workflow diagram, it may be noted that a referral patient may wait up to two weeks between the date of referral and the date of appointment booking solely due to communication and work arrangement delays. Referrals may not appear urgent on the reported data sheet, but patients’ situations may become aggravated during the waiting period when they are unable to obtain help. As a result, patient services may be greatly compromised due to the systems’ inefficiency. In addition, the lengthy waiting period can be greatly reduced if proper IT policies that incorporate remote meetings, such as video and audio conferencing, are implemented. The time spent between contacting a patient and receiving a response constitutes service degradation for the patient and revenue loss for the care provider.

A reduced number of patients are seen per day; therefore, customer satisfaction levels may also decline. While authentication issues may be cited as the reason for insistence on the use of official letters by care providers, the bulk of the processes requiring care provider–client correspondence involve non-vital documents, such as requests for bookings. A possible method of bypassing this hindrance through the IT-based communication implementation is to develop a web-based communication and client support system that would allow secure communication between the customer and the care provider. In this platform, customers would be able to receive e-mails and respond to booking notifications. Modern day patient portals are beginning to address this need, but the implementation and use of these systems is still lagging.

In addition, digital signing is a standard that is progressively being adopted by many industry sectors and is a concept that may be beneficial to healthcare providers when they send documents requiring authorization or authentication. As an alternative, the use of registered mailing services may greatly reduce the feedback duration for sensitive medical cases. Apart from the operational perspective, billing systems and other workflow routines in most facilities are also very inefficient. The entire process, which includes a medical history review, booking to be attended by the physician, physician duration, prescription, queuing at the pharmacy and bill settlement, involves avoidable delays. These work stages can be sufficiently improved by computer-aided work management and decision-making.

As workflows begin to be examined naturally other key factors to the analysis process will begin to take form. This really begins the requirements gathering processes as well.

Functional Needs Assessment

The functional needs assessment describes the key capabilities or application requirements for achieving the benefits of the system as the organization has envisioned it.9 This process is important because every organization begins from a different starting point, every organization has different needs and every vendor offers a different approach.

This process is best achieved through surveying users and reviewing use cases. Users should be asked to identify what functionality they need and perhaps rank/prioritize them. Although in the early stages of the project a user's understanding of what may be possible may be limited, it is still important to understand this as you may need to plan for additional functionality in later phases of the project. Knowing this helps ensure that you are selecting a product that will best meet all these needs, including current and potential future needs. You may also be able to identify users who have had exposure to different systems and will be able to provide feedback regarding their experiences. This also allows users to be more engaged in the process which is a critical component of implementation success.

The use case approach is often easier for clinicians to understand. A use case is a scenario that essentially describes a system behavior as it responds to a request that originates outside of that system. It will describe the interaction between the actor who initiated the interaction (such as a clinician) and the system itself. Clinicians can began to form these use cases as they consider patient care events. From these depictions of scenarios, additional visualizations can be created, e.g. process diagrams, but ultimately it will result in a listing of functional requirements to achieve the patient care use case. As part of this, current functional capabilities can be inventoried which will help users see the scope of current capabilities, as well as establish a foundation on which to understand what essential functional capability may be missing and is needed in support of other, more robust capabilities.

Requirements Analysis

The requirements analysis is going to be the documented record of what the system actually does. It is a critical component to keep the project aligned with the identified scope. It is essential to the testing process, as the information gathered in the requirements analysis will produce test cases that can then be used to validate that the system meetings the project requirements. These use cases will begin with a high-level description of the process and will furthermore include a detailed description of each requirement. Often use cases will also include a graphical depiction. This document will describe the future state and is the primary input document for estimating resources, cost and time needed for the project. It will also take into account the needs assessment and further inform the needs prioritization. Requirements are often categorized as follows: functional and workflow, reporting/analysis capabilities, regulatory requirement, data/database, security, system performance and response time, disaster recovery, platform compatibility, interface and interoperability, physical plant consideration, client devices and network.

Document Analysis

In addition to documenting the sequence of steps and decision points in the process, workflow and process mapping should also be accompanied by a collection of all of the associated documents and a documents analysis should be performed. This will also help define the data requirements associated with each process. When working with a vendor they will sometimes provide organizations with a tool to conduct this, while other times a spreadsheet is just as efficient and effective.

Additional Inventories

In addition to the various information-gathering techniques described previously, some additional inventories to be considered include an applications inventory and a reports inventory. In the applications inventory the organization identifies all of the applications that currently exist and how they may or may not be related to one another. This too will help identify the functional requirements of the new system as it leverages and interacts with current applications. It may also help to identify additional applications that could be replaced by the new system. The reports inventory serves as a document of all of the current reports being used/produced by current systems. Again, this too can inform the functional assessment regarding what may need to be produced from the new system.

Process Improvement

These various steps may also lead to process improvement opportunities throughout the analysis phase, and the project as a whole. As workflows and processes are examined and evaluated any improvement opportunities that can be addressed prior to the system design may save time in the long run and produce a better system. Process improvement involves the business practice of identifying, analyzing and improving existing business processes to optimize performance, meet best practice standards, or simply improve quality and the user experience for customers and end users. Process improvement can have several different names such as business process management (BPM), business process improvement (BPI), business process re-engineering and continual improvement process (CIP).12

Everything everyone does in an organization is part of a process. To improve the organization, you must focus on the processes. Process improvement is a fundamental step in business management and here are many different accepted ways to improve process. A couple of examples are the DMAIC and PDCA models.

DMAIC

DMAIC stands for define, measure, analyze, improve and control. The DMAIC model is a data-driven quality strategy used to improve processes.

- Define the opportunity for improvement

- Measure the performance of the existing process

- Analyze the process to find any deficiencies

- Improve the process by addressing the root causes uncovered

Control the improved process and future processes performance to correct deviations before they result in defects and to prevent reverting back to the “old way”

PDCA/PDSA

There is also the PDCA/PDSA model, which stands for plan, do, check/study and act. This is a cyclical model that is also iterative, following a four-stage management method used for the control and continuous improvement of processes.

Plan

Identify and analyze the problem or opportunity

Develop hypotheses about the cause of the problem

Decide which to test

Do

Test the potential solution on a small scale

Measure results

Check/Study

Study results

Measure effectiveness

Decide whether the hypotheses are supported by the data or not

Act

If the pilot solution is successful, implement it

Deficiencies in Current IT Healthcare Practices

From the discussion provided above regarding process flows in the healthcare sector's IT policies and practices, it can be seen that there are still some obstacles to customer satisfaction, healthcare business profitability and industry integration. These obstacles, which are restricting the sector's potential growth, will be analyzed in this section based on the industry's key performance indicators (KPIs). Client satisfaction through good services and support, business growth through revenue generation, efficient service process arrangement and proper implementation integration can be attained through the corporate initiative.

Patient Support and Satisfaction

Unnecessarily high numbers of patients leave healthcare units without treatment due to long waits for service. Physicians see fewer patients per day when lengthy delays are caused by lack of proper equipment. Such slow systems also lead to extra work for the available personnel, which causes degradation in service quality. Proper patient support and safety also have a correlation with employee retention and employee satisfaction. When healthcare workers are overwhelmed, they tend to perform more poorly and have higher exit rates than workers in places where IT supports workflow management.

Reduction in Revenue Generation

Many healthcare systems are not efficient in revenue generation, and there is a possibility for improvement through IT innovation. Delays in customer service lead to low numbers of attended patients per day, which results in revenue losses. In addition, many patients leave unattended, which leads to business loss. On top of this, healthcare facilities lose potential clients who might have been referred by existing customers if they had not been annoyed by long wait times. In addition to losing business, healthcare units incur extra expenses due to overtime work by doctors and nurses when workloads are heavy. These increased operational expenses and reduced business revenue contribute to overall reduction in business profitability. Inefficient facilities also require a significantly higher number of workers to cope with the physical workflow and lack of integration, which results in extra costs.13

Prescription Errors

The current healthcare system does not fully utilize software-supported decision-making for medication orders, even though it would greatly enhance the checking of prescriptions to ensure proper diagnosis support, drug type and dosage. This has resulted in numerous prescription errors, which may lead to adverse patient reactions and deaths. Improper prescriptions have also led to an increase in drug-related claims, legal penalties, license withdrawals and other challenges that could be avoided by proper IT support.

Industry Standardization

Continued lack of healthcare IT standards has led to the loss of tremendous opportunities to improve interoperability, data sharing and transitions of care. This situation will be significantly changed when sustainable policy frameworks can be agreed upon and implemented by IT experts and enforced by government to expand the implementation of IT integration.

Alternative Approaches to Current Healthcare Processes

To increase revenue, provide a seamless link between facilities and regions and improve the patient experience in healthcare workflows, certain IT-based procedures can be implemented. The following sections explore these alternatives according to the deficiency area.

Industry Standardization

The Healthcare Information Technology Standards Panel (HITSP) and the Office of the National Coordinator (ONC) have made many positive achievements in IT integration over the last couple of decades. While there are numerous challenges in such an attempt and many success stories, we continue to work toward this accomplishment through different avenues.14 Future initiatives might include a new integrated architecture that would meet a cross section of market needs. This platform would be such as to link with all major existing software and hardware configurations in the market, such as EHRs, data management systems (DMSs) and imaging programs, among others.

Alternative Ways to Reduce Prescription Errors

Unlike the global integration challenge, prescription errors can be handled from a local perspective while awaiting the market integration standards. Many software applications are dedicated to prescription information and decision-support systems. Avoidance of ADEs is one major KPI that can be addressed by IT implementation in the healthcare sector. One such software category is a CDSS, which provides updated information regarding recommendations for prescriptions to nurses, physicians and other qualified healthcare workers. This system is typically integrated with the EHR and CPOE systems in order to perform a proper scenario analysis with appropriate patient backup before a provider writes a prescription. Many commercially available software options offer this functionality.

Alternative Processes for Revenue Generation

Financial processes are, perhaps, the easiest to simulate in IT process integration due to their general nature and resemblance to other industries’ financial processes. Revenue generation draws primarily from workflow optimization, which mainly seeks to reduce query time and thus queue time, reduce waiting time through the implementation of fast patient data retrieval and diagnostic support and reduce laboratory scheduling and patient briefing time by enhancing fast decision-relay procedures and online client information alternatives. Online support may be an easy way for patients to obtain their lab results electronically signed by their care providers without having to wait in queue. Such a system is not out of reach and may be developed by most modern web applications. In addition to saving time and encouraging more customers, an IT-based process would lead to higher levels of perceived efficiency, productivity, better customer experiences and satisfaction and therefore more referrals.

This chain of flow would, in turn, generate more revenue and lead to higher growth rates. Many software applications have support for workflow management, and most of them do not require very high initial investments in comparison to the average capital requirements of a modern healthcare facility.

Comparative Analysis of Alternatives

This section summarizes the current versus expected status of various aspects of a healthcare IT implementation.

Intended achievements attributable to the new system implementation are presented in Table 4.1 and supported by various research into IT-related healthcare practices. While the extent to which key industry players may benefit from the implementation of these new IT practices may vary, it is likely that the net results will be beneficial.15 In addition, the capital implications of implementing IT-based healthcare support systems are within investment range. Long-term investment costs should be recoverable from the benefits obtained from healthcare interoperability.

Table 4.1 Comparative Analysis of Core Processes in Healthcare

Work Plan Development

Also part of this phase is the start of the development of the work plan. A work plan is aimed at establishing a step-by-step implementation setup for a project, including materials and equipment layout, intended workflow processes, managing the time, analyzing processes and evaluating outcomes. In the healthcare IT implementation plan, a proper work plan involves putting in place procedures to realize the needs for IT acceptance by healthcare facilities, starting with the primary priorities and proceeding to other priorities.6 Sample elements of a work plan are presented below.

Executive Summary

This project is aimed at analyzing the efficiency of the current systems in healthcare and assessing the situation with the purpose of providing a working alternative that is IT enhanced and will lead to the realization of target objectives of the sector. The plan will provide the project implementation phases as well as define specific operations to be carried out during each phase.

Introduction and Background

The implementation of IT policies in healthcare has been faced with many challenges, rendering the process complex and nonstandardized.15 Establishing a comprehensive industry standardization process has been impossible due to various individual interests among care providers, drug and device manufacturers, pharmaceutical companies and regulating bodies. Thus, there has been a diverse range of new drugs and other medication practices localized in small market segments without proper administration and regulation. In addition, a wide network of healthcare facilities operating in different geographical, economic, technological and cultural settings has made it difficult for the various stakeholders to come together and develop an enhanced global EHR system that will ensure standardization of procedures, leading to a net lag in technology acceptance in the healthcare sector. The IT sector, however, has advanced and infiltrated all major sectors on the global platform, forcing all industries to confirm or become outdated. This is the case in the healthcare sector as well, prompting stakeholders to start seeking urgent and sustainable methods in preparation for standardization and alignment with emerging trends on the global IT platform.

Goals and Objectives

The goal of this work is to find a structure for IT integration in the healthcare sector's main processes, which includes cost-effectiveness, patient safety and care, ease of processes and industry standardization. To this end, specific objectives must be identified initially that include the following:

Evaluation of the current operational situation in each healthcare facility. This step will include analysis of current clinical processes such as process mapping. It will also document the current trends that can be found in healthcare procedures, including administrative and operational trends and integration of workflows.

Identification of the major problems in these processes with respect to the optimization of the IT use. This stage will involve comparing the efficiency of the current processes with the efficiency typically achievable in a similar setting with IT implementation.

Identification of alternative solutions to these problems through the implementation of IT policies. This process will involve providing alternative solutions to the current processes and include software and hardware recommendations, as well as a proposal for a working interface with existing resources.

Carrying out a comparative analysis of the alternative processes and the original routines. Flow charts, tables, process flows and other analytic tools will show relationships and deviations between the systems, thereby guiding the policy implementation decisions.

Evaluation of alternative solutions in alignment with the specific objectives set out in the plan. This stage will involve rethinking the project intentions and comparing them with realized outcomes to assess efficiency.

Evaluation of the ethical, legal, social and economic implications of the alternatives through a comprehensive cost–benefit analysis.

Developing a proposal for implementing recommendations and following up after the project to enable quality improvement.

Resources

The plan will usually involve the purchase of additional materials, as well as the hiring of support staff. The major resources should be assigned as follows:

Personnel - The category will involve all people contracted in the rollout process, including software support teams, simulation teams, project evaluation teams, engineers in various capacities, technical teams and other necessary personnel.

Partners - These may be governments, government-sponsored partners, nongovernment organizations and private investment agencies, among other stakeholders.

Equipment - This includes facilities and computers, software and related capital purchases.

Legal and regulatory infrastructure intended for the implementation of IT.

Work Plan Accountability

The resources available for the implementation of a proposal will be regulated and governed by a project management or steering committee that will be responsible for budgetary allocations, expenditure monitoring and accounts reconciliation. In addition, time management will be essential in order to complete the phases of the project implementation within the specified timeframe.

Proposal Evaluation

The organizational business plan for most healthcare facilities has four major objectives: patient satisfaction, revenue generation, efficient processes that cut costs and increase profits and conformity to industry standards. The proposed solution model should meet all those requirements. First, patient satisfaction is achieved through efficient processes that reduce delay time, enhance the customer experience and offer a good follow-up on patient issues. Second, revenue generation is enhanced through shortened staff time spent per patient, which leads to increased daily patient attendance figures. Third, efficiency in the process flows reduces work duplication and improves service quality, both of which increase revenue generation through cost cutting. Fourth, the proposal expressly seeks to establish a platform for standardization of healthcare IT processes. In summary, the proposed solution enhances the general business requirements and objectives for the average healthcare provider and ultimately the patient. Additionally, the following tools may also strengthen the proposal.

Cost–Benefit Feasibility Study

The stakeholders who stand to gain or lose due to this policy implementation are healthcare facilities, patients, medical practitioners’ representative bodies, drug and medical equipment manufacturers, state and federal governments and related authorities and computer equipment and software manufacturers and vendors. The expected cost–benefit elements include finance, service quality, control and time, among others. The important variables to be considered in the analysis are the time of implementation, cost of implementation, alternatives to the proposal, impact on stakeholders, impact on external parties, sustainability versus ongoing operating costs per year and value of time to be used in the implementation.

Table 4.2 provides a sample of a cost–benefit feasibility study for the enhanced IT project.

Table 4.2 Cost–Benefit Feasibility Study of Proposed Healthcare IT Implementation

Variables

Costs

Benefits

Financial implications

Internal equipment and software upgrade

Licensing fees

Loss of investment for users of nonstandard applications

Increased revenues of up to 50% per year

Access to the global interoperability platform

Customers

Possible compromise of privacy and safety due to malicious information access and manipulation

Improved services, care and access to records

Reduction of prescription errors and resources wasted due to ADEs

Drug and medical equipment manufacturers and related bodies

Possible losses in equipment standardization, but generally minimal negative effects

Better policy implementation due to globalization of standards

Less counterfeiting and associated losses

Possibility of forming stronger representative bodies

Governments

standards

Reduced control of medical and healthcare practices for member states

Possible realignment of the structure to include international representation

Increased diplomatic ties

Better availability of globally competitive healthcare standards for citizens

Achievement of core objective of standardization of healthcare

Hardware and software developers and manufacturers

Possible loss of business for companies whose products fail to support the new standards

Numerous opportunities for new developments and increase in sales

The anticipated outcome of the cost–benefit feasibility study predicts a continuous reduction in investment costs and a net increment in revenue generation for manufacturers of products that support or can be adapted to the new standard, healthcare facilities and drug and medical equipment manufacturers. Similarly, the net long-term outcome for the patient is better service, improved quality of care and greater satisfaction.

Proposal Sensitivity Analysis

Any proposed IT implementation may exhibit various levels of sensitivity to different stakeholders at different times and also to all stakeholders over the course of time. The project's sensitivity to these challenges or changes in the environment will rely on the establishment of a support team to ensure conformity of a project's various elements and initiatives.

Cost–Benefit Analysis

The information obtained from these processes, more so the RFP or RFQ, can also be used to inform a cost–benefit analysis (CBA). A CBA is a process that uses quantitative techniques to evaluate and measure the benefit of providing products or services compared to the cost of providing them.9 The CBA is going to evaluate both the costs (considering things such as hardware, software, installation and training, maintenance and support) and the benefits (considering things such as cost savings or avoidance that are achieved by the new functionality [e.g. charge capture, decision support, diagnostics studies, financial management, medical record operations, nursing department, referral management, etc.]). Taking into consideration the costs and achieved benefits, the net impact is determined for each year by subtracting the cost from the benefits (in Figure 4.4 below this in depth CBA factored in the present value (PV) and determined the accumulated net present value (NPV)). A typical period is established, such as five years, and the exercise is repeated for each year identifying both the costs and benefits for each year. The CBA also visually shows how costs change over time, e.g. many being front-loaded with lower ongoing costs or some being one-time costs and how and when benefits are realized. Once the costs and benefits are mapped, it becomes easier to identify how long it will take to achieve the payback period of the investment and furthermore when the organization will actually see a financial benefit from the implementation and provides that validation that the benefits of the recommended solution are equal to or greater than the costs.

Summary

RFI/RFP/RFQ

The various processes of systems planning and systems analysis including determining the strategic objectives, defining the usability requirements, completing the various aspects that contribute to the functional needs assessment and determining the buy vs. build strategy, all contribute to the acquisition strategy. If a decision is made to buy a product, a formal selection process takes place and this is discussed more in Chapter 6. However, in these earlier phases the information gathering regarding viable products and vendor selection begins with the request for information (RFI) and request for proposal (RFP) processes. Through these two processes, the organization should be seeking to understand:9

Does the vendor share the same vision for the product as the organization?

Does the product meet the key functionality needed to achieve the organizations strategic objectives?

Does the product/vendor utilize the appropriate technology?

Does the vendor qualify in regards to the organizations acquisition policies?

Can the vendor support the organizations implementation strategy?

What is the vendor's track record for operations and maintenance support?

What is the vendor's viability in the market?

Request for Information

RFIs are not utilized today as much as they used to be. With the popularity of information sharing through web services and trade shows, much of the information that has traditionally been requested through the RFI process is largely available on a company's website and through demonstrations. However, a RFI is intended to be an informal request for information that does not require commitment from either party. It is a collection of documents designed to collect information regarding prospective vendors and their ability to meet the defined need or high-level requirements. Should an organization still desire to execute the RFI process, it is generally a two or three page set of questions on the following areas:9

Company background (size, years in business, number of employees, product lines)

Product information (product name, product history, technical platform, overview of product capabilities)

Market information (major competitors and identification of key differentiators)

Installed base and clients (number of products the company has sold, how may they are currently implementing, number fully installed)

Special criteria (anything that the vendor has identified as unique or established as critical)

This information in combination with website research should result in a pool of about 10 to 20 products/vendors, with the intent to narrow this list down to only a handful to further evaluate. Tools like a vendor comparison map, which can be used to plot responses to key criteria and help narrow down the large list of vendors to the smaller list to pursue further.

Request for Proposal

Once the list has been narrowed, the organization should then complete the RFP process. The RFP is a formal request sent to vendors that ultimately leads to a contract between the organization and the selected vendor(s). This process is used to obtain more detailed information with more specificity placed on what the organization has identified as their system requirements. All vendors are asked the same questions, which helps foster a more consistent review and selection process. It would be most appropriate to send the RFP to the four of five vendors that seem to best fit the organization's overall criteria. Note here that the number of RFPs sent may also be dependent on the type of organization. Public organizations may be required to send RFPs to every eligible vendor. In general, RFPs have some fairly typical components including:9

Organizational profile (describes the organization seeking the new vendor including; basic demographics, mission and goals, vision for the product(s), current information infrastructure, any specific constraints, instructions for responding to the RFP, how many copies will be sent and how vendor questions will be directed)

Vendor information (description of its demographics (size and longevity, years in business, revenues, profitability, number of employees), product research and development history and plans, types of installations (number, size, status), corporate composition, references, user group information and contract history)

Functional specifications (description of functional capability and processes and workflows the product supports)

Operational requirements (data architecture, analytical processes supports, necessary interfaces, reliability and security features, system capacity, expansion capabilities, response time, downtime and other system maintenance issues)

Technical requirements (vendor should propose the appropriate technical architecture to meet the organization's functional specifications and operational requirements, specific hardware and networking and software requirements)

Application support (the proposed implementation schedule describing data conversion, acceptance testing, training and documentation, ongoing support and maintenance, which may include information regarding any service level agreements (SLAs) and upgrades)

Licensing and contractual details (supply the specific bid for one-time and recurring costs based on the organization's requirements, standard contract, financing arrangements, proposed relationship with hardware vendors, warranty information, any clauses that protect the organization should the vendor go out of business)

Evaluation criteria (provided to let the vendor know up front the most important elements of the evaluation and how certain factors are weighted)

Request for Quotation

Although a RFP may include pricing information (as described above in the licensing and contractual details description), it has also become more commonplace to also complete a request for quotation (RFQ) or a request for bid to obtain a price from which to negotiate.8 This approach can help minimize the influence of cost from the other critical evaluation factors obtained through the RFP process. The RFQ can be more suitable than the RFP if the organization has thoroughly studied products and concluded that a small number are very similar.

Non-Disclosure Agreement

As part of these processes, organizations should also consider sending a non-disclosure agreement (NDA) or confidentiality agreement to each vendor. The purpose of an NDA is to protect both companies from disclosing confidential information. An NDA includes legal terminology that, in effect, states that the vendor cannot disclose information about your company to anyone without your express permission. It may also be written as a two-way NDA, meaning that the organization cannot disclose information either.16 Any vendor who is being sent confidential information about your company should be sent the NDA and this should be signed and executed prior to releasing any information about your organization. In some cases, similar terms regarding confidential information that is exchanged between parties may be included in a master client agreement rendering an additional NDA unnecessary. Breaching these types of agreements can be very costly, so it is very important to understand the terms on agreement and identifying what is considered confidential.16 Your organizations legal counsel should be involved in reviewing the terms of any agreements that are signed.

Functional Needs Assessment

The functional needs assessment describes the key capabilities or application requirements for achieving the benefits of the system as the organization has envisioned it.9 This process is important because every organization begins from a different starting point, every organization has different needs and every vendor offers a different approach.

This process is best achieved through surveying users and reviewing use cases. Users should be asked to identify what functionality they need and perhaps rank/prioritize them. Although in the early stages of the project a user's understanding of what may be possible may be limited, it is still important to understand this as you may need to plan for additional functionality in later phases of the project. Knowing this helps ensure that you are selecting a product that will best meet all these needs, including current and potential future needs. You may also be able to identify users who have had exposure to different systems and will be able to provide feedback regarding their experiences. This also allows users to be more engaged in the process which is a critical component of implementation success.

The use case approach is often easier for clinicians to understand. A use case is a scenario that essentially describes a system behavior as it responds to a request that originates outside of that system. It will describe the interaction between the actor who initiated the interaction (such as a clinician) and the system itself. Clinicians can began to form these use cases as they consider patient care events. From these depictions of scenarios, additional visualizations can be created, e.g. process diagrams, but ultimately it will result in a listing of functional requirements to achieve the patient care use case. As part of this, current functional capabilities can be inventoried which will help users see the scope of current capabilities, as well as establish a foundation on which to understand what essential functional capability may be missing and is needed in support of other, more robust capabilities.

Requirements Analysis

The requirements analysis is going to be the documented record of what the system actually does. It is a critical component to keep the project aligned with the identified scope. It is essential to the testing process, as the information gathered in the requirements analysis will produce test cases that can then be used to validate that the system meetings the project requirements. These use cases will begin with a high-level description of the process and will furthermore include a detailed description of each requirement. Often use cases will also include a graphical depiction. This document will describe the future state and is the primary input document for estimating resources, cost and time needed for the project. It will also take into account the needs assessment and further inform the needs prioritization. Requirements are often categorized as follows: functional and workflow, reporting/analysis capabilities, regulatory requirement, data/database, security, system performance and response time, disaster recovery, platform compatibility, interface and interoperability, physical plant consideration, client devices and network.

Document Analysis

In addition to documenting the sequence of steps and decision points in the process, workflow and process mapping should also be accompanied by a collection of all of the associated documents and a documents analysis should be performed. This will also help define the data requirements associated with each process. When working with a vendor they will sometimes provide organizations with a tool to conduct this, while other times a spreadsheet is just as efficient and effective.

Additional Inventories

In addition to the various information-gathering techniques described previously, some additional inventories to be considered include an applications inventory and a reports inventory. In the applications inventory the organization identifies all of the applications that currently exist and how they may or may not be related to one another. This too will help identify the functional requirements of the new system as it leverages and interacts with current applications. It may also help to identify additional applications that could be replaced by the new system. The reports inventory serves as a document of all of the current reports being used/produced by current systems. Again, this too can inform the functional assessment regarding what may need to be produced from the new system.