Lab Quality Assessment

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Background

The goal of a lab quality program is to assure that the results for the samples received are accurate, precise within the limitation of the methodology employed, and that the results that are reported match the samples that were delivered. Three factors control the ability of a laboratory to accomplish these goals: the employees, the instrumentation and the lab management systems.

Laboratory employees fall into two categories: quality management and technicians. In very small laboratories, these are the same people. Effective laboratories have quality management staff that have at least a masters degree in one of the analytical sciences relevant to the analyses being performed, and their knowledge continues to be updated through attendance at conferences and other professional development opportunities. Effective technicians have internal training programs that include review of standard operating procedures, supervised performance of the method, and finally testing of performance on the method using standardized material. Only technicians who have demonstrated competence with the methods by producing precise and accurate results with standard materials should be permitted to analyze customer samples.

Laboratory instrumentation must be adequate to provide the precision and accuracy needed, and the instrumentation must be adequately maintained. Usually instrumentation is specified by one or more government methods. Maintenance of the instrumentation should conform to the owners’ manual and in addition, regular testing of instrument response and detection limits are needed.

Management systems assure that laboratory quality is maintained. They include instructions on maintaining internal chain of custody, systems for developing and maintaining standard operating procedures, systems for employee training and records management, internal audit methods and others.

How labs were selected and assessed

The goal of this evaluation was to identify laboratories to recommend for residents of Vashon-Maury Island to use for measurement of heavy metals in soil, particularly lead, arsenic and cadmium.

We obtained the list of laboratories certified by the Washington State Department of Ecology. From that list we deleted any laboratories that were not certified for inorganic analyses, any that were not commercial labs, and any that were not located in the Puget Sound region. The remaining list contained 30 labs. All of these laboratories were contacted by letter, requesting a laboratory quality package. All responsive laboratories were reviewed and a good laboratory practice audit performed for those meeting the audit criteria.

This audit evaluated the personnel, instrumentation and management systems of the laboratories in as much as they related to the measurement of heavy metals in soils. Laboratory information about other measurements, e.g. water measurements or measurement of organic contaminants, was not evaluated. These results cannot therefore be used for evaluating the competence of laboratories for anything other than heavy metals in soils.

The Rating System

Personnel, instrumentation and management systems were evaluated separately, using the scoring system described below. Any laboratory getting a zero in any of the three areas was disqualified. Those laboratories were not listed on the website. The score for each area was calculated by calculating a percent of possible for each area. An overall percentage score was calculated by weighting each of the three areas equally. The percentage score for each of the three quality areas and the overall percentage score were disclosed to the public via the website.

In addition to quality information we requested the laboratories provide information about price, turnaround and any pickup service they may provide.

Personnel (Maximum score: 6)

Management Education: No employees with advanced degrees = 0; at least 1 employees with an advanced degree = 1 Multiple employees with advanced degrees = 2

Management professional development: no system = 0; Employees permitted to educate self = 1; active program for professional development paid for by company = 2

Technician training: No training system = 0; complete training system in place = 1; training system in place, fully documented and up to date = 2

Instrumentation (Highest score dependent on the number of analyses evaluated; 3 per instrument)

For each analysis:

Instrumentation meets the requirement of the relevant government standard
yes = 1, no = 0

The instrument is properly maintained per the owners manual
not maintained = 0; maintained and documented in instrument log or lab manual = 1

Instrument undergoes annual detection limit study
no = 0, yes = 1

Management system (Total Possible 20) (Y=1; N=0)

Internal chain of custody

Reception clean and neat (Y/N)
SOP’s in place and followed (Y/N)
Samples secured (Y/N)
Internal check in/sign out adequate and followed (Y/N)
Within sample labeling adequate & followed (Y/N)
Proper temperature maintained and documented (Y/N)

Glassware, etc.

Adequate supplies of glass/plastic ware (Y/N)
Cleaning SOP in place and followed (Y/N)
Reagent grade water available (Y/N)

Soil digestion

Samples digested using 3050 or equivalent (Y/N)
Thermometers calibrated and NIST traceable (Y/N)
SOP’s in place and followed (Y/N)

Heavy metals analysis

SOP’s in place and followed (Y/N)
Standards up to date and documented (Y/N)
Standard curves run with each batch (Y/N)
Spike, Blanks, Duplicates run at least every batch (Y/N)
Spike standards kept separate from method standards (Y/N)
Adequate troubleshooting in place (Y/N)

Lab data review

Percentage review: < 100% = 0; 100 - 200% = 1; >200% = 2

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Disclosure Example

Xyz Laboratory
123 Main St
Somewhere, WA
Attn: Jane Doe

Overall Score: 89%
Personnel 80%
Instrumentation 95%
Management Systems 92%

Average turnaround time 2 weeks
Fee for 3 day service: Double charges
Cost per sample (three metals) $45
Discount for multiple samples: 10% for 10 or more samples
Sample courier service: NO