From:   Charles N. Dyer

Date:   October 15, 2002 

 Re:    Accreditation Advertising
           New Method Accreditation
           Quick-Response PTs
           Other PT Issues
           Dropping Calibration Points
           Environmental Monitoring
           Chlorine Residual Testing
           On-Site Assessments for 2003
           Secondary Issues

Over the course of time accredited laboratories may gain or loose accreditation for one or more Program-Method-Analyte combination for a variety of reasons. Laboratories need to keep close track of this information as it relates to documentation (reports, sales brochures, quotes, etc.) upon which they list their accredited analytes. An accredited laboratory shall not misrepresent its NELAP accredited fields of testing, methods, analytes, or its NELAP accreditation status on any document (4.6.1).

Laboratories may request NH ELAP to add Program-Method-Analyte (P-M-A) combinations to its Field of Testing (FOT). Prior to accreditation; a laboratory must send a written request to NH ELAP requesting that a particular Program-Method-Analyte combination be placed in the FOT. NH ELAP will submit a request to NELAP concerning this change in the FOT. NELAP will either grant or deny the request. The laboratory must, where appropriate, submit a standard operating procedure (SOP), an initial demonstration of capability/performance, MDL study and the laboratory will have to pass either one or two proficiency tests (PTs) depending on the P-M-A requested. Any relevant Standard as it pertains to the P-M-A needs to be addressed in the Quality Systems Manual (QSM). The request may be granted if all these processes are completed properly.

NH ELAP will allow laboratories, with NH as their only NELAC Primary Accrediting Authority (PAA), to go to the 2001 NELAC Standard in regards to proficiency test samples (PTs) use and processing. Refer to Chapter 2 of the Standards; more specifically sections 2.7.2, 2.7.3 and 2.7.3.1.

In general, two consecutive PT studies must be at least 15 days between the end of one study and the start of the next. They shall be no more than 7 months apart. Failure to have results submitted in this time frame is considered a failed study (NELAC 2001 2.7.2).

When submitting PT results to your PT provider, the method/technique must be accurate. We cannot change the results reported by your PT provider. If you reported the wrong method, the PT provider must prepare an amended report. You must have included the method on your application form. If you wish to add new analyses between applications, you must inform NH ELAP of your intention of adding the analysis to your field of testing. You must include a copy of your SOP, initial demonstration of Capability/Performance, and MDL study where appropriate.

Make sure that your PT provider supplies a useable reference on your report. Some PT providers truncate the reference using just the first part of what you report. We have seen "SM 18/19th ED 45" listed for a chloride method description. We cannot determine from this report what method the laboratory used. "SM 4500Cl E" or just "4500Cl E" would allow us to determine which chloride method was used.

NH ELAP will allow laboratories to incorporate into their QSM the policy of dropping a calibration point out of a curve in order for the curve to meet the acceptance criteria. This policy will have to be documented in the QSM. The lab will still have to meet any standard or method requirement concerning minimum number of standards used in a calibration curve, and QC requirements. Reports and logs will have to reflect the change of Reported Detection Level (RDL) value and any samples over a new high standard will have to be diluted so that they are within the new quantitation limits.

Colilert Only laboratories may use a Colilert Quality Control sample as a form of an environmental monitoring sample in order to meet the requirements of 5.7.1 / D.3.8 (2000). A suggested method; leave a Colilert QC sample open on a bench for 15 minutes, process the sample, review & record the results.

DW Microbiology samples may be mailed to the laboratory as long as the sample is run within the 30 hours hold time and the sample temperature, though it may be high, is noted on the sample paperwork upon receipt (40 CFR Part 121.21). The report does not have to be qualified, since temperature requirement is only a recommendation.

NH ELAP will require microbiology departments to test samples from "chlorinated water systems" as required in 5.5.8.3.1 of the 2002 Standards. The laboratory does not have to test samples from non-chlorinated private wells unless they know the sample was from a chlorinated (shocked) source. Noting whether a sample was tested or not and the results from any testing for chlorine needs to be recorded on the sample paperwork. The 2002 Standard clarifies some of the confusion of the earlier versions.

An on-site assessment is schedule for the following laboratories in 2003. Please check this now and let us know if there is a problem. It is much easier to make new arrangements now.

Date of Inspection	Name of Laboratory	Revision of Standards	Date of Inspection	Name of Laboratory	Revision of Standards
1/6-9/03	Biological Services	2000	7/21-24/03	A&L-ME	2001
1/20-23/03	Microbac	2000	8/4-6/03	North Conway WW	2001
2/3-4/03	Balsams	2000	9/8-12/03	Eastern Analytical	2001
2/17-20/03	Aquacheck	2000	9/22-24/03	Franklin WWTP	2001
3/3-6/03	Beland	2000	9/22-26/03	NH DES	2001
3/17-20/03	New England Radon	2000	10/20-24/03	Resource Lab	2001
4/7-10/03	Demers	2001	11/3-6/03	Nashua Health Lab	2001
4/21-23/03	Aquatec Biological Sci	2000	12/8-9/03	Berlin WW	2001
5/19-22/02/03	Nashua WWTP	2001	12-15-17/03	Canobie Lake	2001
6/16-18/03	Pennichuck	2001

The party responsible for laboratory accreditation is asked to specify the additions, changes, and/or corrections to their fields of testing in writing when renewing their accreditation and/or presenting updated analyte lists from your primary AA. There will be a much faster turn around if you do so. 4.3.3 requires an accredited laboratory to notify the accrediting authority of any changes in key accreditation criteria within 30 calendar days of the change.

If you have multiple AAs, you must prepare a list of analytes that each AA has primary responsibility. Do not include the analyses for which the primary AA grants secondary accreditation. Failure or errors in doing so can result in the loss of accreditation.