Maintaining compliance with an ever-evolving list of regulatory requirements is a hot-button issue for the healthcare industry. Forward-thinking healthcare organizations are leveraging monitoring technologies, IQ OQ PQ, and other tactics to ensure compliance.
Healthcare expenditure in the US has continued its steady upward trend for nearly six consecutive decades. According to recent Centers for Medicare and Medicaid Services (CMS) estimates, health spending in the US is anticipated to grow at a CAGR of 5.3%, to hit $6.2 trillion by 2028, up from $3.8 trillion in 2019.
However, with public safety and health on the line, the healthcare sector needs checks and balances. Healthcare practitioners, businesses, and institutions are regularly subjected to validation and review by federal regulatory agencies, including CDC and FDA, not to mention private entities, such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).
Navigating the global Covid-19 pandemic has already presented the healthcare industry with a set of once-in-a-lifetime challenges. In addition, the healthcare field is also facing a raft of regulatory challenges that include:
● Recovery audit contractors gaining more and more traction
● Labor and employment-related problems
● Fluctuating reimbursement rates
● Issues with co-management arrangements
● Increasing incidences of data breaches targeting the healthcare sector, compounded by varying HIPAA guidelines and fines associated with data leaks
● Soaring cases of frivolous whistleblower and false claim lawsuits
● Hospital-physician relationship regulatory issues linked to the Anti-Kick Statute and the Stark Law
While a complete list of regulatory challenges is much longer, what’s clear is that healthcare is a lucrative market, but only if it’s approached with compliance in mind. And that’s what we’re going to discuss today – how healthcare companies can stay on top of regulatory compliance.
As the healthcare field has expanded in the last several decades, so has the list of regulatory bodies governing it. The following are the key industry regulators most healthcare organizations must comply with:
FDA: The FDA is the primary federal governing body for the industry. It’s tasked with protecting public health through the prioritization of security, efficacy, and safety of biopharmaceuticals and medical devices.
FDA regulations are categorized into the 50 titles contained within its Code for Federal Regulations (CFR). Title 21 is perhaps the most comprehensive set of rules surrounding healthcare-related products like medical devices, drugs, and vaccines.
CDC: The Centers for Disease Control and Prevention (CDC) employs various regulations and rules to help protect Americans from safety and health threats. Categories of CDC regulations include public health consultation, biological preparation, occupational safety, select toxins and agents, clinical laboratory standards, controlling infectious diseases, and biological standards.
JCAHO: Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) is a standalone nonprofit institution that provides certifications and accreditations to thousands of healthcare programs and organizations in the United States. The organization has put together several patient safety goals that every member healthcare facility must uphold to maintain accreditation.
CAMH: CAMH stands for CMS’ Alliance to Modernize Healthcare and is a federally-financed institution whose mission is to strengthen the healthcare system in the US. The other regulatory body that governs the healthcare industry is PHARMACOPEIA.
Putting the right set of environmental monitoring technologies and equipment in place isn’t a good-to-have strategy for healthcare organizations. It’s essential to ensuring consistency in conditions and meeting regulatory requirements.
Healthcare companies must ensure they have the right tools for monitoring vaccines, medications, operating rooms, and other sensitive assets. Those tools are essential to creating an effective healthcare monitoring system.
Remember, vaccines, medications, and medical devices are exposed to a wide variety of environments throughout the supply chain, from production and packaging to transportation and on-site storage. Industry players must measure, record, and document environmental variables, such as temperature, at all points in this chain.
Cloud-based integration and remote monitoring capability can take things to a whole new level. With remote and real-time access to monitoring data, appropriate personnel can quickly determine any harmful fluctuations in conditions and take corrective actions immediately.
Once vaccines and medications are in hospital storage, staff can monitor data loggers remotely using a web-based interface. This provides even greater visibility of any excursion that may cause harm to healthcare assets.
The monitoring system also automates the collection, storage, and documentation of environmental data, which can be used as evidence of consistency and of how excursions were tackled. In this way, healthcare organizations can reduce the odds of failing regulatory audits and comply with FDA and industry standards.
IQ OQ PQ is a series of activities that healthcare organizations can conduct to validate their medical equipment, facilities, and utilities. IQ is short for installation qualification, OQ for operational qualification, and PQ for performance qualification. The primary objective of validation is to establish and document evidence that the equipment is:
● Installed properly
● Operates as requires
● Performs reliably and safely within a pre-approved set of conditions
The quality assurance and validation process are also designed to demonstrate that the equipment operation under actual working conditions will yield compliant results. Of more importance to regulatory compliances is that documentation is created and compiled with detailed results of all tests carried out at each phase of the quality assurance process. Specifically:
● IQ phase validates that the medical equipment or facility has been properly installed
● OQ phase validates that the system operates as designed and intended
● PQ phase validates equipment operating stability over an extended period
Healthcare organizations must carry out all three steps according to the ISO and FDA standards. In doing so, they can prove that their medical devices, equipment, and utilities meet all pre-approved requirements for safety, functionality, and quality, as well as regulatory requirements.
Hospitals, clinics, and even large healthcare systems are faced with increased claims of age discrimination linked to employee dismissals. In addition, they must also address more requests to accommodate staff members with a disability. To overcome this challenge and ensure compliance, healthcare organizations must implement well-documented policies for employee termination. They must also provide precise job descriptions to minimize chances of confusion.
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