How to Evaluate HIPAA and CLIA Compliant Cytogenetic Services

Proper certifications and compliance ensure the accuracy, reliability, and timeliness of clinical laboratories’ test results.Any laboratory conducting cytogenetic testing is dealing with personal and confidential patient information and must treat it withthe highest quality standards.

The most pertinent certification to cytogenetics is the Clinical Laboratory Improvement Amendments certificate (CLIA). Per CLIA Statue and Regulations, CLIA establishes three categories of testing based on complexity level. In increasing order of complexity, these categories are waived, moderate complexity, which includes the subcategory of provider-performed microscopy (PPM), and high complexity. Laboratories must hold a CLIA certificate for the most complex form of CLIA-regulated testing that they perform. It is also vital to ensure all employed cytogentic technologists are fully certified.

When a laboratory conducts electronic transactions of cytogenetic services results, such as transmitting lab results, that organization is required to follow Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliance regulations. These regulations were designed to secure electronic personal health information (ePHI) and are heavily enforced across the healthcare industry. Any organization that becomes part of the chain of transmission of data is included and faces stiff fines for non-compliance. In fact, November 2016, saw Quest Diagnostics fall victim to a cyber attack that affected 34,000 patients. The cybercriminals accessed names, dates of birth, lab results and some telephone numbers. Large healthcare organizations are often targets for these type of cyber-security breaches.

Virtual Scientific is a privately held cytogenetic testing laboratory that is HIPAA compliant and has all testing locations appropriately licensed/certified under CLIA and through required State laboratory licensure programs. We hire only ASCP certified technologists who produce high-quality cytogenetic services. We invest in top-notch security and offer the fastest turnaround time (TAT) in the business. For digital images, our TAT is as short as 24 hours.Complex, abnormal cases may require more time but are still very fast.

As you review your options for cytogenetic testing laboratories for your send outs, include comparisons regarding certifications, licensing, and compliance and be sure to request a copy of laboratory certification documents.

To learn more about selecting the best cytogenetic services for your business, download our executive guide: “Top Considerations for Cytogenetic Lab Send Outs,” or contact us for a complimentary consultation.