(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, composited 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-LAP, LLC has a Memorandum of Understanding (MOU) with the Environmental Protection Agency (EPA), which recognizes AIHA-LAP as an approved laboratory accrediting organization working in cooperation with the EPA National Lead Laboratory Accreditation Program (NLLAP). Laboratories which are accredited by AIHA-LAP 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 or composited wipes as additional matrices. 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-LAP 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-LAP 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 PAT, LLC ELPAT Program.
What are the program requirements?
The ELLAP Program contains six main program area requirements:
1) Proficiency Testing
Laboratories seeking AIHA-LAP ELLAP accreditation must participate in the AIHA PAT Programs, LLC ELPAT program for each lead matrix analyzed by the laboratory, with the exception of Composited Wipes which is a Demonstration of Competency. 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 statistics. 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. Please note that for Composited Wipes, a separate validation may have to be performed for each method that involves compositing a different number of wipes, i.e. one validation for compositing two wipes and another validation for compositing four wipes. Alternatively, the lab may, as per the memorandum of 13 Oct 2006, analyze composited wipes under its single wipe FoT accreditation as long as each wipe in a composited sample is split into single wipe sub-samples, digested separately as per the lab’s single wipe SOPs, and the results combined to produce a total for the sample.
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 Assessors
Site assessments of laboratories are conducted by trained, experienced assesors contracted by AIHA-LAP, LLC . These assessments will generally take place once every two years, unless additional site assessments are deemed necessary by the AAB .
For more information on the ELLAP Program, contact AIHA-LAP, LLC at (703) 846-0736.
Updated: 09/07/2011