Digital transformation has become a top priority for most organizations with efforts currently underway regardless of industry. Paper-based approaches giving way to digitized solutions, the automation of manual processes to improve efficiency, and tech-enabled systems provide intelligent applications leading to ‘success through data’.

While the flurry of digital activity has become business as usual for many organizations, the clinical laboratory remains challenged by two crucial requirements to realize the value gained from migration to a truly digital world: managing patient data in proprietary formats and tracking the chain of custody while maintaining the integrity of specimens throughout its lifecycle. The outdated workflows present in today’s clinical laboratories prevent the progress of digitization and their ability to deliver secure, timely, accurate, and cost-effective pathology services.

Compliance Considerations for Clinical Digital Transformation

Anatomical pathology (AP) labs are largely run on a multiplexed universe of manual process. Tracking specimens in a secure and compliant framework while maintaining chain of custody records is as arduous task for most laboratories and in clinical settings, with significant consequences for errors occurring throughout the process.

The AP industry is heavily regulated, requiring strict adherence to extensive compliance measures under CLIA, CAP, FDA and HIPAA guidelines. Each year, the quantity and frequency of regulations governing clinical testing is increasing, with a new regulation or modifications to existing regulations occurring nearly every week. Furthermore, under federal law, AP is classified as “high complexity” testing. CLIA (Clinical Laboratory Improvement Amendments) and CAP (College of American Pathologists) regulations governing these labs require that certain educational and training qualifications for laboratory personnel have been met and properly documented along with scientifically endorsed accreditations to ensure that laboratory standards meet or exceed CLIA requirements.

Conversely, while regulation is increasing by leaps and bounds, reimbursements for professional AP services are decreasing by an even higher margin: 35% decrease in 2018, leading up to an additional 8% average decrease in 2021. This creates additional burden on pathology practices to obtain and manage additional repayment options through hospitals and clinics, ultimately driving up operational costs.

The management of records, documentation, and reporting that is critical to support compliance standards and facilitate audit requirements within an AP practice far exceeds their ability to cost effectively manage the process within a setting of manual operating procedures, necessitating a new business model to remain competitive in the marketplace.

Perfect the Workflow, Perfect the Business

The demands of the current regulatory landscape have created a huge opportunity for improving operational efficiency and, therefore, profitability for AP practices through better integration and digitally automated workflows. Cerebrum, a leader in Laboratory Information Management Systems (LIMS), offers intelligent lab workflow software solutions for medical and life sciences pathology labs, focusing on improving patient safety, regulatory compliance, and lab efficiencies. Their mission is to enable pathology lab professionals to perfect their businesses by perfecting their workflows for all types of patient specimens at busy, growing practices.

Cerebrum’s LABdivus^® software platform provides a cloud-based digitized workflow solution for AP labs and CRO’s to automate their operations to increase productivity and avoid the risk of error by accurately tracking specimens from accessioning through reporting. The core application features that will allow you to achieve and maintain your CLIA/CAP/FDA compliancy while effectively managing the workflow of your growing lab include:

• Specimen Tracking: Comprehensive and accurate specimen tracking is of utmost importance in a highly regulated environment. Knowing what specimens are in the work queue, where they are and who handled them provides valuable real-time information as well as an imperative historical perspective.
• Compliance Integration: With LABdivus SOP, workflow tracking and reporting, your operation will avoid compliance issues and shutdowns. Password protection, two-factor authentication and administrative-designated user restrictions provide a level of security that is fully CLIA, CAP and FDA compliant.
• Pathologist Diagnosis Reporting: Quick access to patient data, both past and present, allows for greater efficiency in reporting out a case. Pathologists have complete control over diagnosis and CPT codes, microscopic descriptions and additional commentary needed for the technical components.
• Lab Insights: See your lab operation’s work volume at every workflow step. Report on lab tech throughput, turn-around-time, completed diagnosis reports and specialized reports such as cancer reports and high-profile diagnosis reports.
• EMR Connectivity: Connect your lab data workflow to electronic medical record (EMR) and other systems. LABdivus includes HL7 and other customizable interface protocols to integrate with your practice management, billing, and insurance systems. Eliminate redundant data entry, human error, and efficiently automate inbound and outbound information.

Summary

Automating your AP workflow with LABdivus will alleviate bottlenecks in accessioning and specimen tracking and provide a higher level of confidence in the data associated with your specimens to avoid compliance issues and potential regulatory shutdowns. By transforming outdated manual workflows to digitized seamless processes, pathologists can realize 4X efficiency gains to allow your lab to remain competitive in the marketplace, even in the face of ever-changing regulatory and cost reduction measures, while positioning your business for future growth.

Why it Matters for You

While digital transformation has become a top priority for most organizations, the clinical laboratory remains challenged by two crucial requirements to realize the value gained from migration to a truly digital world: managing patient data in proprietary formats and tracking the chain of custody while maintaining the integrity of specimens throughout its lifecycle. Implementing the following solutions will allow you to seamlessly digitize your clinical laboratory to achieve gains in operational efficiency:

• Knowing what specimens are in the work queue, where they are and who handled them provides valuable real-time information as well as an imperative historical perspective, critical for chain of custody tracking in a highly regulated AP environment.
• Having quick access to past and present patient data, diagnosis and CPT codes, and microscopic descriptions, increases pathologist’s efficiency in reporting out a case and detailing its technical components.
• Connecting your lab data workflow to EMRs and other systems through HL7 or API interface protocols will integrate with your practice management, billing and insurance systems to eliminate redundant data entry, and human error that can occur during data transfer.
• Using Cerebrum’s LABdivus^® cloud-based software platform in your AP lab will automate your operations and increase productivity while providing a level of security that is fully CLIA, CAP and FDA compliant.
• Perfecting your workflows will enable you to perfect your business!

About Astrix

Astrix partners with many of the industry leaders in the informatics space to offer state of the art solutions for all of your laboratory informatics needs. With over 25 years of industry proven experience, Astrix has the informatics specialists and business process analysis tools required to develop and implement the solution that works best for your enterprise. Our domain experts have helped hundreds of companies globally effectively navigate their digital transformation journey, connecting people, processes, and systems to accelerate the advancement of science and medicine.