ELLAP Program Requirements
What are the 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 the 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 Qualifications
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 be 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 assessors 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.