Ensuring compliance, quality and service

Singulex views quality as one of the most essential elements of our company. We are committed to excellence and have implemented policies, processes, and procedures to ensure that quality standards are achieved and exceeded. Quality improvement processes recommended by legislative agencies and professional organizations are used at Singulex Clinical Laboratory to maintain and improve the standard of patient care and to address unique client needs. Through constant monitoring and a focus upon continual improvement, Singulex Clinical Laboratory ensures that clients are satisfied with the service they receive.

Compliance Statement
The Singulex Clinical Laboratory has developed SMCTM and other lab developed tests and determined their performance characteristics. The U.S. Food and Drug Administration (FDA) has not approved or cleared these tests. Test results are not intended as the sole means for clinical diagnosis or patient management decisions.

Health Insurance Portability and Accountability Act (HIPAA) and Singulex Clinical Laboratory
Singulex Clinical Laboratory is committed to complying with the Health Insurance Portability and Accountability Act (HIPAA) regulations. Singulex Clinical Laboratory has implemented policies, processes, and procedures designed to ensure compliance with these standards.

Compliance to the standards are monitored continuously and audited for effectiveness. Singulex Clinical Laboratory complies with the Security standards by insuring that its systems, policies, and procedures meet or exceed all required and addressable implementation specifications. Electronic and physical access to systems and information is limited to only authorized individuals.

Singulex Clinical Laboratory Licenses & Certifications

State or Accrediting Agency Certificate/Permit #
CLIA/CMS CLIA #: 05D2050618
CAP LAP #: 7229934
AU-ID #: 1561066
California Lab ID #: CLF 00343341
Pennsylvania Lab ID #: 032472
Florida License #: 800026656
Maryland License #: 2025
Rhode Island License #: LCO00763

Singulex Clinical Laboratory Management
Dean J. Nickles, M.D., Laboratory Director

Singulex Clinical Laboratory Privacy Officer
1701 Harbor Bay Parkway
Alameda, CA 94502-3012, USA
Privacy Officer Tel: 800-400-4344
Email: Compliance.Officer@singulex.com

*This test was developed and its performance characteristic determined by the Singulex Clinical Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.