Opinion Column: Which Way for Laboratory Accreditation in California?


Coverage of new ELAP regulations supported by LabWorks, waterLIMS™

Dropper placing liquid into test tubes

By David Kimbrough
Pasadena Water & Power

Dr. David Kimbrough

A hundred years ago, there had been a major revolution in public health. Fatalities from waterborne diseases such as typhoid and cholera were plummeting. Chlorinated water was being delivered via pressurized pipes to houses with in-door plumbing at very low prices.

People could drink, cook, and wash with safe water inexpensively and life expectancy increased. However it was quickly determined that it was difficult to adequately chlorinate water if the density of bacteria was not known.

The State of California decided it needed to encourage as many laboratories to form as possible to ensure that even the most remote and underserved communities had access to laboratory services. In 1923 the Bureau of Sanitary Engineering (under the direction W. F. Langelier, the state’s chief Chemist and Bacteriologist) prepared a short laboratory guidance manual for creating and operating “A Small Bacteriological Laboratory.”

Why the emphasis on small laboratories? Many communities that practiced the new science of chlorination could not afford to operate a larger laboratory and it was essential to get samples to a laboratory as quickly as possible to get the most accurate results.

Dr. Langelier wrote: “With this in mind we have installed in a number of small cities in California, small laboratories which we believe fulfill the requirements. In these laboratories simple bacterial counts of the raw and treated water are made in the cases daily…” 

Having a large network of smaller laboratories able to serve the broadest possible geographical area to analyze water quickly was seen as a crucial tool to protect public health. The last century has proven him correct.

TNI Standards

Proposed changes threaten to roll back that protection. The Environmental Laboratory Accreditation Program (ELAP) is proposing a new set of regulations which would incorporate by reference The NELAC Institute (TNI) 2016 Standard. This standard would add 180 pages of new regulations, resulting in hundreds, if not thousands, of new requirements.

If you were to look at any one requirement, it would consist of additional bookkeeping, adding nothing of analytical value, and largely harmless in and of itself. However the cumulative impact of hundreds of additional record keeping tasks has proven crippling where it has been applied.

In both Florida and New York in the year 2000, all laboratories were required to become TNI compliant. Most laboratories were able to do this but then afterwards many dropped their accreditation. The vast burden of paperwork proved excessive and laboratories chose to stop being accredited altogether or scale back significantly their scope of accreditation.

While laboratories of all sizes and types were impacted, it was felt most strongly by smaller laboratories in more underserved areas.

Those who support this effort argue that adding the TNI requirements on top of existing requirements will improve data quality. However it is important to note that data quality is determined by the application of approved methods and TNI does not actually change those methods, they are spelled out in the Code of Federal Regulations.

A laboratory using MMO-MUG to test for the presence of coliform bacteria will do nothing different at the bench using TNI requirements as opposed to without.  Moreover, no one has shown that laboratories accredited by ELAP are producing results of sub-standard quality nor does anyone have any evidence that if such sub-standard data is being produced, that requiring additional paperwork would solve those problems.

Additional Staffing

Almost every laboratory will need to add about one full time equivalent of staff time to maintain the flow of required paperwork under this system. For example, the Drinking Water and Radiation Laboratory, part of the Department of Public Health, is planning on becoming TNI compliant. To do that, they submitted a Budget Change Proposal to the Department of Finance to authorize additional funds to support a full-time equivalent.

The SWRCB is preparing to adopt these new regulations within the next 12 months. If this comes to pass, it is likely that many laboratories in California, public and private, large and small, will have to either drop their accreditation, shorten their list of tests for which they are certified, or spend more money to hire more staff.

This does not provide the same public health protections that California has enjoyed over the last 100 years.