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eScreen Quality Watch

eScreen Drugs of Abuse System Indications for Use
Instrumented Point-of-Collection drug testing.

The eScreen Employment Screening system is made up of the eCup and the eReader and is intended for use by professionals in prescription workplace settings for the rapid, qualitative detection of target drugs and/or metabolites including Cocaine, Cannabinoids, Methamphetamine, Opiates, and Phencyclidine in urine. The eScreen system is a ‘screen only’ device. All inconclusive samples are sent to SAMHSA certified laboratories for further testing. The eScreen system is intended for use by professionals for the automated screening of drugs of abuse in human urine and is not intended for over the counter sales to lay persons.

HIPAA Compliance
Health Information Portability and Accountability Act

eScreen has implemented a Privacy Policy to ensure proper access, uses, and disclosures of Individually Identifiable Health Information (IIHI) and/or Protected Health Information (PHI), and serves as an extension of the Proprietary Information Policy for eScreen, Inc. The guidelines set forth in this policy represent the covenants and restrictions imposed through our role as a Business Associate to a Covered Entity as defined in the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

eScreen is not considered to be a diagnostic entity that is generating, storing or transmitting medical healthcare related data. We recognize our responsibilities to ensure that this information is secure from unauthorized access, and have implemented a security model that incorporates the highest level of authentication, encryption, & transmission standards available. These standard security practices meet and exceed current HIPAA requirements.

s For more information about the Health Information Portability and Accountability Act please contact www.hipaa.org.

CLIA Regulations
Clinical Laboratory Improvement Amendments

Employment related drug screening is not currently subject to CLIA Federal Regulations, provided the screening is unrelated to drug treatment. eScreen Corporate retains information indicating CLIA is not applicable to our employment-related drug testing device.

For more information about CLIA please contact www.fda.gov/cdrh/CLIA/.