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National Laboratory Certification Program - NLCP

04 Jun 2015

... Who will approve laboratories for electronic custody and control forms (eCCF) - 

NLCP:  Identified and Defined

NLCP is an acronym that stands for National Laboratory Certification Program. Exactly what does this program do and what are the functions and responsibilities of NLCP?  This article will explain some of the roles and functions of NLCP.

The primary role is to oversee that the laboratories that are accredited by Substance Abuse and Mental Health Services Administration (SAMHSA) are doing their tasks correctly and in a manner that will meet the forensic standards as required by Federal workplace drug testing and testing as required by Federal agencies of private or local government employers.

NLCP had its start with the advent of the SAMHSA Mandatory Guidelines in year 1988.  At that time it was decided to follow the military example and have a drug testing laboratory inspection program.  The Federal Workplace testing program was at that time, managed by National Institute of Drug Abuse (NIDA/HHS).

NIDA put into place a contract for an entity to manage the laboratory inspection program.  The winner of that contract was Research Triangle Institute (RTI) located in Raleigh, NC.  The contract has remained with RTI since that time.

What does the RTI do in the performance of their contracted duties?  They are responsible to SAMHSA to ensure that the labs are meeting forensic standards through a very thorough oversight program that includes inspections and performance testing. Some of the key aspects of this the NLCP program are as outlined below:

  • Inspection of the laboratories at least twice a year by a team of qualified forensic toxicologists. Failure to meet program requirements results in mandatory corrective actions 
  • Blind performance specimens submitted to each lab each quarter with the results being returned to RTI for comparison with expected target values. Unacceptable results are remediated by the NLCP.
  • Review of the laboratory Standard Operating Procedure (SOP) manual.  This manual is generally regarded as very important and is the protocol for all specimen handling, analysis, review and reporting procedures.
  • Certify that all the laboratory analytical procedures are being conducted in accordance with the requirements of the Mandatory Guidelines, program guidance and good forensic laboratory practices.
  • Investigation of erroneous laboratory reporting, i.e., reporting a negative specimen as positive.
  • Review of any new proposed analytical procedures to ensure that the laboratories are qualified to test for the new analyte.  It should be noted that all the accredited laboratories have to be approved before those new drugs will be put on the testing panel.
  • Review of all specimen validity testing procedures.
  • Review of all blind specimens test results submitted as required by a Federal Agency or employers regulated by DOT or NRC. This is performed when the target values have not been met by the testing laboratory and a report has been made to NLCP by NRC or DOT.
  • Attendance at meetings of the Drug Testing Advisory Board (DTAB) to make presentations as needed or required by SAMHSA.
  • Review of the E-CCF as proposed to be used by each laboratory. This review will be ensure accuracy of data transmission and data security by all parties using the E-CCF.
  • As each new specimen type (oral fluid and hair) is proposed and allowed, SAMHSA and the NLCP will ensure that standards are in place and equivalent to those established for urine laboratory based testing.  

The above list is not complete but should give the reader some idea of what NLCP is and what the standards are required of SAMHSA accredited laboratories. In the opinion of this writer, this is a very rigorous oversight program but it should be as the stakes are high and no mistakes can be allowed.

This testing is to meet the requirements of the Fourth Amendment and public safety in all Federal arenas of testing hence the prescriptive nature of the Mandatory Guidelines and other regulations, i.e., 49 CFR part 40 and 10 CFR part 26.

This is why the Federal Program is the gold standard.

For further information please contact the writer.  The article submitted by Robert C. Schoening.