PDF Laboratories with approved Electronic Custody and Control ...

Date: December 2017

Laboratories with approved Electronic Custody and Control Form (ECCF) systems

Before an HHS-certified test facility can use a Federal ECCF for regulated specimens, the test facility must submit a detailed plan and proposed standard operating procedures (SOPs) for the ECCF system for HHS review and approval (through the National Laboratory Certification Program - NLCP). Proposed systems must be reviewed on-site by the NLCP prior to implementation.

The following list of laboratories with HHS approval to implement an ECCF system for use with regulated testing has been compiled by the NLCP. This list does not constitute an endorsement of the ECCF system. It reflects the approval for the listed laboratory to use the reviewed ECCF system for regulated specimens.

Alere Toxicology Services Gretna, LA Alere eScreen Type of eCCF system: Combination Electronic/Paper (Type 2) Approval date: October 9, 2015

Alere Toxicology Services Richmond, VA Alere eScreen Type of eCCF system: Combination Electronic/Paper (Type 2) Approval date: May 5, 2016

Clinical Reference Laboratory, Inc. Lenexa, KS FormFox, Inc. Type of ECCF system: Combination Electronic/Paper (Type 2) Approval date: August 2, 2016

Clinical Reference Laboratory, Inc. Lenexa, KS eScreen Type of ECCF system: Combination Electronic/Paper (Type 2) Approval date: January 19, 2017

LabOne, Inc. d/b/a Quest Diagnostics Lenexa, KS FormFox Type of ECCF system: Combination Electronic/Paper (Type 2) Approval date: August 3, 2016

LabOne, Inc. d/b/a Quest Diagnostics Lenexa, KS eScreen Type of ECCF system: Combination Electronic/Paper CCF (Type 2) Approval date: September 20, 2017

Laboratory Corporation of America Holdings Research Triangle Park, NC Laboratory Corporation of America Type of ECCF System: Combination Electronic/Paper (Type 1) Approval date: August 8, 2016

Laboratory Corporation of America Holdings Houston, TX Laboratory Corporation of America Type of ECCF System: Combination Electronic/Paper (Type 1) Approval date: August 8, 2016

Laboratory Corporation of America Holdings Southaven, MS Laboratory Corporation of America Type of ECCF System: Combination Electronic/Paper (Type 1) Approval date: August 8, 2016

Laboratory Corporation of America Holdings Raritan, NJ Laboratory Corporation of America Type of ECCF System: Combination Electronic/Paper (Type 1) Approval date: August 10, 2016

Quest Diagnostics Incorporated West Hills, CA FormFox Type of ECCF system: Combination Electronic/Paper (Type 2) Approval date: August 5, 2016

Quest Diagnostics Incorporated West Hills, CA eScreen Type of ECCF system: Combination Electronic/Paper (Type 2) Approval date: December 15, 2017

Quest Diagnostics Incorporated Tucker, GA FormFox

Type of ECCF system: Combination Electronic/Paper (Type 2) Approval date: August 5, 2016

Quest Diagnostics Incorporated Tucker, GA eScreen Type of ECCF system: Combination Electronic/Paper (Type 2) Approval date: December 7, 2017

Quest Diagnostics Incorporated Norristown, PA FormFox Type of ECCF system: Combination Electronic/Paper (Type 2) Approval date: August 5, 2016

Quest Diagnostics Incorporated Norristown, PA eScreen Type of ECCF system: Combination Electronic/Paper (Type 2) Approval date: November 22, 2017

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