ParadigmHTM Podcast: Recent Episodes
ParadigmHTM Podcast
The key to building a strong HTM industry is building a strong HTM community. We encourage you to share, interact, and network through local, regional, and national groups. We strive to enhance academic offerings, create a pipeline for the next generation of HTM professionals, and provide opportunities for those already rooted in the industry to grow.
Medical imaging is a crucial component of healthcare, encompassing various techniques that provide essential insights into the body's internal structures and functions for accurate diagnosis and treatment. Government agencies like the FDA and NRC, along with accreditation bodies such as The Joint Commission and ACR, rigorously regulate medical imaging practices to ensure patient safety and high-quality care. These regulations encompass equipment safety, quality control, radiation protection, and staff training, with certified medical physicists and technologists playing key roles. Continuous quality assessment, adherence to safety principles, and swift response to safety alerts are integral in maintaining compliance. Medical imaging's stringent oversight guarantees patient welfare and optimal healthcare outcomes, all while upholding the principles of radiation safety through the expertise of health physicists and the vigilance of Radiation Safety Officers.
HIPAA, the Health Insurance Portability and Accountability Act, enacted in 1996, safeguards sensitive health data through the Privacy and Security Rules. The Privacy Rule establishes national standards for protecting health information, while the Security Rule ensures the security of electronic protected health information (ePHI). Compliance with HIPAA is essential for healthcare entities, encompassing providers, plans, and associates, to prevent penalties. Patient privacy, data security, and staff training are imperative to safeguard personal and medical data. Leveraging healthcare IT (HIT) optimizes operations and patient care, adhering to standards like ITIL and IEC 80001 for risk management in IT networks incorporating medical devices. Seamless integration of medical devices into hospital networks enhances clinical decisions and patient care, utilizing methods such as vendor-specific interfaces, HIE platforms, and IoT integration. Cybersecurity is paramount in healthcare, addressing patient data protection and regulatory compliance. NIST guidelines and Manufacturer Disclosure Statement for Medical Device Security (MDS2) forms aid secure device integration, promoting patient confidentiality and data integrity.
A Quality Management System (QMS) is a structured framework organizations use to manage and improve the quality of their products, services, and processes, ensuring customer satisfaction, continuous improvement, and regulatory compliance. Key elements encompass policies, procedures, risk-based approaches, documentation, resource management, monitoring, measurement, and continuous improvement. ISO 9001 and ISO 13485 are prominent QMS standards, with ISO 9001 focusing on overall organizational processes and customer satisfaction, while ISO 13485 tailors requirements for the medical device industry. ANSI/AAMI EQ56:2020 provides guidance for comprehensive medical equipment management plans, aligning with quality principles and regulatory standards, enhancing patient safety, and meeting ISO 9001 compliance requirements.
The National Fire Protection Association (NFPA) is a nonprofit organization established in 1896, committed to promoting fire safety through comprehensive codes, standards, research, and educational programs. In healthcare, the NFPA establishes guidelines for fire protection and life safety in various settings, including hospitals. They also provide specific requirements for medical equipment electrical safety inspections, ensuring safe operation and preventing hazards. Relocatable Power Taps (RPTs) are permitted on patient care medical equipment when permanently attached, meeting UL requirements. Compliance with NFPA standards is essential for healthcare facilities to ensure patient and staff safety.
The Medical Equipment Management Plan (MEMP) is a comprehensive strategy designed to ensure the safe and effective management of medical equipment in healthcare facilities. It includes processes for equipment acquisition, maintenance, testing, and disposal to meet quality and safety standards. The MEMP can vary between accreditation organizations like The Joint Commission and DNV GL Healthcare due to their unique standards and survey processes. Implementing a successful AEM program involves grounding it in data, continuous monitoring, documented procedures, limitations on exclusions, collaboration, and embracing evidence-based maintenance. ANSI/AAMI EQ56:2020 is a standard that provides guidance for creating a comprehensive medical equipment management plan, emphasizing a risk-based approach and assisting in various management aspects. A Computerized Maintenance Management System (CMMS) is crucial in clinical settings, acting as a powerful platform for equipment management, workflow automation, regulatory compliance, data analysis, and improved patient care and safety.
Hospital accreditation is vital to ensuring safe and high-quality care. In the U.S., the "big three" accrediting organizations are The Joint Commission, DNV, and HFAP (now part of ACHC). They conduct comprehensive surveys to assess compliance with standards. Deemed organizations are accredited by CMS-approved entities, allowing them to meet Medicare and Medicaid requirements without direct CMS surveys. The Joint Commission, formerly JCAHO, conducts voluntary surveys to evaluate compliance in various settings. The Program Specific Tracer evaluates equipment and supply management, and the Environment of Care and Emergency Management assessment assess compliance with relevant standards. DNV GL is a global quality assurance company with a healthcare arm pioneering the NIAHO® program, focusing on continuous improvement and patient safety. They offer program certifications for specialty care areas, emphasizing compliance with standards. The merger between ACHC and HFAP aims to offer complete accreditation and certification services to healthcare providers globally.
The United States has two federal health insurance programs, Medicare and Medicaid, which cater to specific groups like the elderly, individuals with disabilities, and those in need of renal dialysis or transplantation. Compliance with minimum health and safety standards mandated by the Social Security Act is necessary for providers and suppliers to participate in these programs. CMS (Centers for Medicare & Medicaid Services) develops Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) to set standards for healthcare organizations in Medicare and Medicaid, ensuring quality and patient safety. State health agencies enforce CMS requirements, promoting a unified approach to healthcare delivery. The HTM department's role is vital in meeting CMS standards, as non-compliance could lead to financial consequences and reputational damage. Regular inspections and continuous training ensure consistent evaluations and improvements in healthcare quality. CLIA oversees laboratory testing, and preventative maintenance and AEM programs for medical devices are essential for patient safety and continuous care. State regulations are crucial in ensuring public safety and quality healthcare services in hospitals, and state departments of health collaborate with CMS to implement federal healthcare programs and monitor compliance with regulations through inspections.
The FDA's oversight is crucial as it covers various aspects of the medical device industry, including the path to market, post-market surveillance, device recalls, and key definitions. Medical devices are categorized into Class I, II, and III, with each class subject to different levels of regulation. HTM professionals in healthcare organizations play an essential role in ensuring compliance with FDA guidelines to manage medical devices safely and efficiently, benefiting patient care outcomes.
Understanding the total cost of ownership is necessary in evaluating technology but the expenses are just one piece of the return on investment equation. You need to look at the revenue and expenses, and be clear on you financial assumptions.
If you are assessing healthcare technology for purchase or investment you not only have to consider the technical aspects but also the financial aspects of the technology. Total cost of ownership is not just a purchase price. You can't buy a car and never put gas in it. (I know... unless you have an electric vehicle, but don't mess with my metaphor)
Learn how to to review clinical research with a critical eye and also find out more about my habit of drinking too much soda.
Continuation of the determination and validating of "real science", we now take a deeper dive into clinical research methodologies.
Last episode we covered gold standard comparisons of measurements devices. Now lets talk about gold standard comparisons of screening devices. We will touch on the ever-confusion terms of sensitivity and specificity through an illustration about... what else... fishing!
To properly assess clinical technology it is often required to evaluate the technology against a know gold standard. This must be done in a thoughtful and systematic way. This episode touches on gold standard comparisons of measurement devices and briefly introduces concepts in validate you data and draw proper conclusions.
When evaluating or assessing healthcare technology you have to first validate that the science behind the technology is "real". Does it solve a real clinical problem? Is it based on real scientific principles?
Having a comprehensive life cycle plan for your healthcare technology is a good start. But you also need a systematic process to implement that plan and guide your decisions. New investments and growth are important but don't forget about your routine replacements before its too late. You need to have method to this madness we call life cycle planning.
Support, maintenance, and utilizations of healthcare technology is only part of the overall HTM financial picture. The overall life cycle plan takes into consideration to ongoing expenses of you technology as well as the potential impact of future capital purchases. We can't just look at individual equipment decisions. We have to look at the full picture as these financial decisions are competing for the same pot of gold.
Contract terms can get complicated and messy. Many of us have not gone through law school so we rely on those with legal training to ponder the language but we still have a responsibility to understand enough to assure the contract language reflects our intended deliverables and supports our current and future service strategies.
Contracts are governing documents that not only define service strategies, organizational liabilities, response guarantees, but are also the source document for many of the financial and business arrangements in HTM. This episode gets you started and the next episode picks up from there.
Financial management for HTM is highly dependent of an understanding of the technical, operational, and regulatory considerations for the medical devices and systems. Therefore, a basic introduction on HTM Service Management options and strategies is essential.
Medical equipment management, whether it is viewed from the perspective of a healthcare delivery organization, medical device manufacturer, or independent service organizations, is grounded in a complex framework of regulations, standards, and best practices. It is important to understand these foundational rules in order to grasp a deep understanding of why the medical device industry operates the way it does.
Healthcare Technology Management budgets have some distinct characteristics however the basic finance, accounting, and budget principles are they same. We will look at the HTM budget from two perspectives. The first is the basic budget outline for an HTM department and the second is the basic budget outline for an HTM services program. You will see later that these have significant overlap and interdependencies, but we will start off simple for the sake of explanation.
The general ledger is the “log book” for all financial transactions in a business. In Healthcare Technology Management (HTM), many of these transactions are a result of purchasing activities associate with the HTM supply chain. The basic financial statements, such as income and cashflow statements, can summarize and describe these transactions in a way that helps the business assess the effectiveness of their strategies and show the status of their accounts. However, the basic financial statements do not detail the business plans, projected performance, or validation of current performance against that plan. That is the purpose of the operational budget.
A familiarity with basic financial and accounting concepts will help build an understanding of how Healthcare Technology Management (HTM) operations contribute to business decisions or how business decisions drive HTM operations. In order to contribute to the short term or long term financial goals for a healthcare technology business (ie hospital or service provider) it is necessary to link HTM operations to that financial plan through structured documentation and budgets. However, before we discuss budgets we need to review a key concept in the HTM financial ecosystem. This topic is supply chain management (SCM).
Let's make lemonade and financial statements! In this episode we will review the primary types of financial statement. These are standard formats for how to represent a summary of accounting information for an organization. Understanding the basic concepts and terminology of these statements will help to deepen your understanding of HTM departments budgets, equipment services budgets, and capital equipment planning.
The cost of healthcare is a mystery for two reasons. First, the average consumer does not understand the essential costs of providing care such as clinical cost, facility costs, and ancillary support costs. Second, the methods for pricing, billing, and collecting payments is extraordinarily complex. Understanding both the total cost of care and the reimbursement for that care is important for an HTM professional as these factors can drive each other. In other words, the more it costs to treat patients (including equipment service operations) the more we must charge for the care. And conversely, the less the insurance companies are willing to pay, the more expense we need to cut out of our costs. It’s a push and pull relationship.
We are beginning our discussion from the very basic fundamentals of finance and accounting related to HTM. In this episode, we will cover some basic accounting practices and terminology that lay the foundation for our journey through HTM financial management. It is important for us to start from the ground up and you will find that you will be able to play the game, without knowledge barriers, and you will ultimately be able to function as part of the greater multidisciplinary team that drives HTM finances.
If you believe for a moment that the technology you support is separate from yourself, you are mistaken. It is you. Just as your arms, your legs, and your heart are fully you. It is your eyes watching over someone who deserves the attention, and your eyes looking for things that need to be noticed. It is your ears listening to a symphony of life, or a desperate cry for help, or a quiet whisper of hope. It is your hands on someone who is very, very afraid, or is finally relieved of their worries, or so full of joy they can’t hold it inside any longer. You are there during the greatest of human miracles, and the deepest of personal tragedies, and you are there when lives change in a blink of an eye. If a patient where to ask you, “what is your role in all of this?” You reply with conviction, “All of these blinking lights and beeping noises, and all of these dangling cables and dancing screens, are my eyes, my ears, and my hands. We are watching over you. We are finding you answers. We are caring for you with every part of ourselves.”
This ParadigmHTM Podcast Series covers key apsects of financial management related to healthcare technology. This introduction will provide an overview of why this topic is important and how it applies to the work you do. The subsequent episodes will describe basic accounting and financial concepts, budgeting, life cycle planning, and other topics that tie in to HTM financial management.