A question was brought up that was very similar to one which we have encountered in the past but with a significant difference. If a state agency requires the use of an accredited laboratory and there is only one laboratory from which to choose, what are the options?
We have encountered the issue where there were no accredited laboratories in the past, which meant the requirement was clearly moot, but with a single laboratory the issue becomes less clear. For decades now it has been common knowledge the EPA could not require the use of a sole source vendor, but I never remember seeing the regulation with the restriction. The TNI audit program also will not require an audit unless there are two sources for it. But, when you speak of the individual states it gets complex as to how things will work if there has never been any legal determination on the support for a monopoly in such a case in that state. Logically, it would seem the states would face a similar problem as the federal EPA should they require a monopoly, but some states do have legal monopolies for gambling and alcohol sales. I would suggest that anyone encountering a sole source situation ask the question of the regulatory body. The EPA guidance paper on how to choose a laboratory even states that accreditation is no guarantee of quality.
I was always a big proponent for laboratory accreditation and I even did a little badgering of the SCAQMD to accredit TES when they first started their program. That was the type of accreditation I envisioned, where the people were knowledgeable on the issue and wanted to ensure the analysis was done correctly. The later programs around the country that morphed into income generation programs really do not make that difference in my opinion. The fact that I can find accreditations which are technically impossible, such as the analysis of O2 and N2 by an FID, and others which are for the SOP of the laboratory and not the requirements for the actual method indicate to me the programs are not going to be the quality control they should be. The focus on the paperwork and documentation I saw in most of the accreditation audits are the result of not having a staff with the vast experience needed to understand the methods being accredited. Some states have a limited focus on what they will review, while others seem to review anything that will allow them to charge their fees. The fact that the bodies with which I have checked have essentially the same cost schedule for both reviewing all of the documents for a primary accreditation and confirming the certificates from another body for a secondary accreditation, indicates a focus on income generation to me. This is generally because the state requires them to generate the funds they need to operate.
I am reminded of some of the early issues with documentation as a focus. I remember the big “time travel” cases where laboratories were found to be changing the dates and times on the computers to show samples with limited hold times were analyzed within that limited window. One case in particular resulted in someone at the vice-president level getting jail time for this. Another involved a testing company which changed its name and its owner even changed his name at one time. That was unusual, but it helped hide his reputation for a while longer. I was told he would have a field notebook for every project where he would document the data for the tests. This was back when a strip-chart was the pinnacle of documentation technology and looked like a good QA/QC program. Until he was caught with two notebooks for the same project, and one was already filled with data that would show the source was in compliance while the other was yet to be completely filled. I think the regulator who was to initial the pages to “document” the data recorded noticed a stain was missing from one page and caught the scam that way. We were involved when I was asked to confirm our reports which had been submitted. Our reports were all correct, but it seems in the investigation they discovered templates for reports which could have been used to change the reported results. One of the clues to a modification is the changes in font, but when all of the font can be changed it makes it harder to detect without comparing two reports. I never knew if the cover pages were copied or whether they were the only part used, but it made me think about our ability to deal with something of that nature since ethically the report belonged to our client, who was paying for it, and releasing any information would be up to that client.
The fact that no accreditation program nor any on-site audit would be expected to uncover such issues shows the weakness in a focus on documentation alone. Of course, there were the cases where laboratories were generating data for which they had no equipment to perform such analyses. Those too resulted in serious problems, but ones which a good audit should catch, providing sufficient knowledge of equipment and analyzers.
The modifications to the method via the SOP are another point of concern. We recently were to be a back up for an accredited laboratory in a higher profile project overseen by multiple agencies. In the review of the submitted SOP for each laboratory it was found that none followed the strict method. We had additional QA/QC steps included to improve the quality of our data, but the primary laboratory could not explain why the deviations from the methods were included in their SOP. As a result of the review of the modifications made to the method, we are to be the primary laboratory for this project.
In another instance I was asked to comment on a protocol for landfill gas where the laboratory indicated the canisters would be pre-charged with an inert gas prior to shipping. That gas would be either nitrogen or helium. Given the samples would be required to have an analysis of oxygen, nitrogen, carbon dioxide, and methane, the use of a compound of interest would cause innumerable questions on the validity of those results. The fact that it was an option would raise flags in my mind since there is always a potential for a mix up in what is in the canisters. That is why ALL of our canisters have helium in them regardless of what we would expect their use to be.
To return to the initial question, now that we understand the accreditation programs will not indicate any better quality by themselves, how does a state regulatory agency reconcile the requirement for an accreditation without competition with the goal of getting the best possible data? Does the specific law take precedence over the larger need to protect the environment or people, or are there mechanisms to allow for the use of a better quality than is present in the accredited choice. I expect this might have to be ultimately decided in a court if a state were to try to maintain the monopoly stance when there is only one accredited source.
If anyone has had personal experience with a situation like this, I would love to know any details that may be shared with me.
Triangle Environmental Services, Inc.
P.O. Box 13294 122 US Hwy 70 E
Research Triangle Park, NC 27709 Hillsborough, NC 27278
(919) 361-2890 (800) 367-4862 Fax: (919) 361-3474