Environmental Lead Laboratory Accreditation Program (ELLAP)
(ISO/IEC 17025 Accreditation)
The Environmental Lead Laboratory Accreditation Program (ELLAP), recognized by the EPA National Lead Laboratory Accreditation Program (NLLAP), accredits laboratories performing analysis of lead in environmental samples including paint, soil, dust wipes and air.
The Environmental Lead Laboratory Accreditation Program is for laboratories involved with the analysis of lead in environmental samples. The EPA estimates that somewhere between 300 and 3,000 accredited laboratories will be needed to perform analyses related to lead-based paint and matrices contaminated with lead-based paint. ELLAP meets the EPA requirements for recognition of laboratories as capable of analysis of paint film, soil, and/or dust wipes.
What is the ELLAP Program?
The Environmental Lead Laboratory Accreditation Program (ELLAP) is an approved lead laboratory accreditation program under the Environmental Protection Agency's (EPA) National Lead Laboratory Accreditation Program (NLLAP).
What should laboratories applying for ELLAP know?
AIHA has a Memorandum of Understanding (MOU) with the Environmental Protection Agency (EPA), which recognizes AIHA as an approved laboratory accrediting organization working in cooperation with the EPA National Lead Laboratory Accreditation Program (NLLAP). Laboratories which are accredited by AIHA for the analysis of lead in the matrices of paint chips, dust and soil will be recognized by the NLLAP as being capable of performing adequate analysis for lead in the matrix or matrices for which it has been accredited. In addition, accreditation as part of the AIHA program may include lead in air as an additional matrix. To obtain copies of either the NLLAP Laboratory Quality Requirements or the NLLAP approved listing of laboratories, please call the EPA Lead Clearinghouse at (800) 424 - LEAD. If you have not already done so, your laboratory should be enrolled in the appropriate proficiency testing program.
What is the relation between ELLAP and NLLAP?
AIHA has been formally recognized as an approved lead laboratory accrediting organization by the EPA NLLAP. A memorandum of understanding with the EPA declares that all laboratories accredited by AIHA for the analysis of lead in paint chips, dust wipes, and/or soil will be recognized by the NLLAP as capable of performing acceptable lead analyses. To obtain EPA NLLAP recognition, a laboratory must also participate in the AIHA ELPAT Program.
What are the program requirements?
The ELLAP Program contains six main program area requirements:
1) Proficiency Testing
Laboratories seeking AIHA ELLAP accreditation must participate in the ELPAT program for each lead matrix analyzed by the laboratory. These proficiency samples will be of varying concentrations and as real-world as possible. Proficiency for award of accreditation allows no outliers reported in the last two consecutive rounds or 25 percent or less cumulative outliers reported in the last four rounds. Proficiency is evaluated for each matrix (i.e., paint, soil, dust wipes) and accreditation may be granted for any combination of matrices.
2) Personnel Qualification Review
The laboratory will identify those who function as technical manager, quality assurance coordinator, and analyst(s), however titled within the laboratory organization. The technical manager must have a college degree in chemistry or related science, a minimum of three years nonacademic analytical chemistry experience, and a minimum of two years nonacademic metals analysis experience (times may run concurrently). The quality assurance coordinator must fulfill one of two equivalent criteria: 1) earned a college degree in a basic science, have one year of nonacademic analytical chemistry experience, and training in statistics; or 2) four years of nonacademic analytical chemistry experience and training in statisitics. Each analyst must provide documentation of completion of a training course in metals analysis.
3) Quality Assurance Program Review
A written quality assurance plan is required and must be submitted for review. This plan must include a statistical quality control plan and documentation that statistically-based measures for accuracy and precision of data from analysis are used. In addition, matrix-spiked samples of paint and soil will be analyzed at a frequency of one per batch or at 5 percent per sample batch, whichever is larger. Method spike/method duplicates made from blank wipe collection media are used for wipe sample quality control spike preparation. One method blank must be analyzed per sample batch or at 5 percent per sample, whichever is larger. At least one external reference standard must be analyzed with each batch. There are specific requirements for sample log-in, analysis data documentation, and reporting of results. Information on these procedures with instrument calibration and calculation and report review procedures must documented and presented as part of the application.
4) Analytical Method Documentation Review
No specific method is required for accreditation, but analyses shall be conducted using recognized methods, methods mandated by legal requirements, or methods developed and validated by the laboratory. Laboratories must have established performance criteria for analytical methods and must have documentation demonstrating that the criteria are met.
5) Facility Review
The program accredits the laboratory facility, not an individual or an organization. A description of the facility, including a floor plan, must be submitted as part of the application. Specific instruments or types of instruments are not mandated, but information on, and identification of, all instruments used must be submitted. Instrument performance checks and documentation of maintenance activities are required elements of the ELLAP. Mobile laboratories are permitted.
6) Site Visits
A trained site visitor will perform an on-site assessment of the laboratory as a representative of AIHA prior to accreditation. This prearranged, announced visit is conducted using a checklist to ensure examination of lead analysis issues. Site visits are conducted every two years.
Click here to view a flowchart that outlines the process of accreditation.
For more information on the ELLAP Program, contact the Laboratory Accreditation Department at AIHA; (703) 849-8888