Is Your Healthcare Facility Prepared for a Compliance Audit?

Is Your Healthcare Facility Prepared for a Compliance Audit?
Posted in: Healthcare

Being caught unprepared for a compliance audit can put your facility’s reputation – and accreditations – in jeopardy. In this article, learn how to leverage technology solutions to always stay compliant and ready for a healthcare audit.

Understanding the different types of healthcare audits and demonstrating compliance can be a challenge for any facility. Creating a safe working environment while delivering high-level patient care requires well-defined policies and procedures, clear communication and training, and precision facility monitoring. Fortunately, Primex OneVue is a valuable resource that can help you to monitor, document and report on your facility performance to ensure you’re meeting the standards and are prepared for any compliance review.

In this article we’ll discuss how to use the OneVue system, along with other tools and best practices, to ensure your facility is always ready to demonstrate compliance.

What is the Purpose of Auditing?

Healthcare audits play a role in patient care, claims and billing, and worker safety. They provide assurance that facilities are meeting legal and regulatory requirements set by both mandatory and voluntary certification standards. While they can be complex, compliance audits can help improve patient experience and outcomes, reveal opportunities for cost savings and identify areas for corrections in safety protocols.

For example, according to the CDC, about 8 million U.S. healthcare workers are potentially exposed to hazardous drugs every year. This includes pharmacy and nursing personnel, physicians, operating room personnel, environmental services workers, workers in research laboratories, veterinary care workers, and shipping and receiving personnel. The long-term effects of exposure can result in abnormal reproductive issues, infertility and even cancer. Every step in the handling of hazardous drugs (HDs) is a potential point of exposure. As a response, the USP <800> standard was developed to provide guidance on the management of HDs and incorporate these practices into a healthcare facility’s occupational safety plan.

Learn more about USP 800 Compliance

Many standards require that organizations maintain a list of HDs, provide proper settings and engineering controls for infection containment, have competent personnel, safe work practices, proper use of PPE and protocol for waste and disposal. Facility conditions that promote patient safety, worker safety, and environmental protection can be achieved through environmental controls and precision monitoring. The Primex OneVue suite of software, sensors and timekeeping solutions provides assurance that variables such as differential pressure, access, time tracking and communication are managed within safety guidelines.

How to be Prepared for a Compliance Audit

The first focus is comprehension of the standards and regulations that define the requirements for your facility operations. Having a designated team leader who can demonstrate thorough understanding of the different guidelines as well as the purpose, intent and protocols is fundamental to compliance.

Secondly, a full scope list of practices and protocols that fall under regulatory review will serve as a basis for your facility’s operational plan. This can include documentation, record keeping, list of hazardous drugs used, hospital claims and even measures for healthcare of specific conditions such as diabetes monitoring.

Once your facility has a solid grasp on all the relevant requirements, you can establish the facility operations needed, such as engineering controls. Lastly a review of the work practices — including training, communication, signage, etc. — will ensure all areas and components of the facility meet healthcare compliance.

Meeting Compliance Challenges with Primex OneVue

Regulatory requirements for a facility can include creating areas with negative or positive pressure, proper air exchange and venting. They can also include a provision for prominent signage and restricted access for authorized personnel. From designated areas for HDs including receipt and unpacking, storage, non-sterile compounding and sterile compounding, to time tracking to storage, below are a few of the compliance solutions OneVue can provide.

Monitoring Medications at Receiving, Storage and Compounding

Certain standards set environmental requirements for handling of medications. For example, hazardous drugs must be received in a neutral or negative pressure room and stored in a negative pressure room to meet the requirements of the USP <800> standard. Similar restrictions apply to rooms where the drugs are prepared and distributed. Once the design and HVAC engineering of these designated areas is complete, the task of monitoring environmental conditions, as well as documenting access to restricted areas, are necessary to maintain parameters and meet the requirements of a compliance review. Primex OneVue provides a solution that can monitor, document and report on the conditions of areas that are designated for medication handling and control.

Within the OneVue Sense environmental monitoring system Differential Pressure Monitoring sensors work to detect ultra-low changes in air pressure that could affect the integrity of climate controlled spaces. Even with minimal airflow, these easy-to-install sensors are able to detect changes in air pressure and alert the responsible staff through notifications sent by text, phone or email. The system captures pressure-reading data and allows the information to be accessed anywhere through the web-enabled OneVue Monitor.

Visual Displays and Time-Tracking Events

Time tracking and visual signage are also crucial elements to patient care and staff safety. Synchronized time tracking provides the capacity to document the time of receipt, duration of medication storage or compounding, and also the time of administering medications to patients. Providing verified time sources within the areas designated for medication handling or highly-visible elapsed timers for code blue response tracking is a simple, effective way to support compliance. As a connected device within OneVue Monitor system, Sync solutions can provide the synchronized time tracking needed to accurately document coded events, medication delivery, vaccine administration or other activities that are subject to regulatory oversight.

Visual displays that are connected to a centralized OneVue monitoring system can also be utilized to label restricted areas or alert staff to a critical event, such as a spill or a patient emergency. OneVue Notify InfoBoard can provide visual notification to communicate the protocols associated with regulatory standards.

Documenting Personnel Traffic in Restricted Access Areas

Personnel protocols and limiting traffic within restricted areas to authorized personnel only is paramount to maintaining safety guidelines. Monitoring access to restricted storage, handling or procedure areas can be achieved with OneVue Sense Contact Closure Sensors. These small, reliable devices use magnetic strips connected to a monitor that can measure and record the opening and closing of the contacts. They are easy to install at doors, cabinets and refrigeration units. When used as part of the OneVue Monitor software the sensors act as a line of defense that can confirm the integrity of controlled areas by verifying access against event and treatment logs.

Managing Vaccine Protocols for Children

The guidelines for pediatric immunization set strict protocols for availability, access, education, schedule, storage and record keeping. For a healthcare facility, this demands a comprehensive monitoring system that can assist caregivers and, when needed, provide easily retrievable reports and records that verify storage conditions, like temperature, personnel access and time tracking of when vaccines are administered. Primex OneVue Sense provides the tools needed to maintain compliance with vaccine management as set by the US Department of Heath and Human Services (HHS).

Take Control of Compliance Reviews with OneVue

With Primex OneVue implemented, the team leaders charged with maintaining healthcare compliance can accurately monitor and improve protocols or conditions throughout day-to-day operations. The differential pressure sensors, InfoBoard displays, contact closure sensors and temperature sensors for vaccines paired with the OneVue Monitor software provide easily accessible records on performance that can be used to remedy problems and support continual improvements.

This capability becomes invaluable at the time of a compliance audit, allowing the designated team member to verify the facility’s adherence by utilizing accurate records and reports. This data summary may either be prepared in advance or readily accessible through the OneVue Monitor dashboard. With OneVue Sense, your team can be confident in the level of compliance not just as a measure of performance but also for their everyday workplace effectiveness and safety.


Hazardous Exposures in Health Care (CDC)

USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings (USP)

The Standards for Pediatric Immunization Practice (HHS)

September 11, 2020
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