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Two things to know when navigating New York’s diagnostic lab landscape

On Behalf of | Jan 16, 2024 | Diagnostic Testing And Reference Labs |

Starting a diagnostic lab in New York is an exciting venture that holds the promise of both financial reward and the satisfaction of contributing to the health and well-being of the community. As with any healthcare endeavor, the process requires careful navigation of the regulatory landscape to help better ensure success. Some of the more essential steps a lab owner should take to lay a solid foundation for a diagnostic lab in New York include the following.

Understand New York’s licensing requirements

Before you can even begin to order test tubes or hire staff, you need to develop a basic understanding of New York State’s specific licensing requirements. The New York State Department of Health’s Wadsworth Center oversees the issuance of licenses for clinical laboratories. A crucial first step is applying for a Clinical Laboratory Permit. This process involves demonstrating your lab’s proficiency in conducting tests accurately and safely, which is critical for patient care and confidence.

Moreover, specialty areas such as cytology, histopathology, or molecular diagnostics may require additional permits. The process requires more than going through a standard checklist, the state’s requirements are in place to ensure the highest standards of laboratory practice. As such for most entrepreneurs the process of preparing a meticulous application that addresses all the state’s concerns is the first challenge.

Complying with federal regulations

Beyond state-specific regulations, your lab will also need to comply with the federal Clinical Laboratory Improvement Amendments (CLIA). CLIA standards ensure the accuracy, reliability, and timeliness of patient test results. The process generally requires participation in proficiency testing and regular inspections.

Various additional federal regulations will also apply. Two examples that the government has recently doubled down on include the Anti-Kickback Statute (AKS) and Eliminating Kickbacks in Recovery Act (EKRA). Relationships between physician’s offices or hospitals and diagnostic labs can trigger allegations of a violation of these regulations. As such, it is wise that lab owners conduct regular internal audits to better ensure compliance.

Opening a diagnostic lab in New York requires an understanding of the regulatory environment, a clear vision for your business, and a commitment to providing high-quality healthcare services. With careful planning and dedication, your diagnostic lab can become a vital part of New York’s healthcare community, delivering essential services to a diverse and dynamic population. This blueprint is not just about getting started; it’s about setting the stage for lasting success in one of the world’s most challenging and rewarding markets.

Attorney John Rivas is responsible for this communication.

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