Section 406.260  Quality Assurance

a)         A written description of the current laboratory quality assurance program shall be maintained and made available to analysts in an area of the laboratory where analytical work takes place.  A record of analytical quality assurance tests and quality assurance checks on materials and equipment shall be prepared and retained for at least 3 years.

b)         A laboratory manual containing complete written instructions for each parameter or method for which the laboratory is certified shall be maintained and made available to analysts in an area of the laboratory where analytical work takes place.

c)         The laboratory shall participate at least twice per year in those U.S. Environmental Protection Agency Performance Evaluation Studies that include parameters and methods for which the laboratory is or desires to be certified. Analytical results shall be within 1.73 times the standard deviation of the specific analysis as described in "Environmental Radioactivity Laboratory Intercomparison Studies Program, Fiscal Year 1981-1982," EPA-600/4-81-004, Table 3, U.S. Environmental Protection Agency (1982).  Results shall be provided to the Department within 90 days after receipt of the performance evaluation sample.

d)         The laboratory shall participate at least once per year in the blind Performance Evaluation Study administered by the U.S. Environmental Protection Agency.  Analytical results shall be within 1.73 times the standard deviation of the specific analysis as described in "Environmental Radioactivity Laboratory Intercomparison Studies Program, Fiscal Year 1981-1982," EPA-600/4-81-004, Table 3, U.S. Environmental Protection Agency (1982), for each parameter or method for which the laboratory is or desires to be certified.  Results shall be provided to the Department within 90 days after receipt of the blind performance evaluation sample.

e)         Operating manuals and calibration protocols for counting instruments shall be available to laboratory personnel.

f)          Calibration data and maintenance records on all radiation instruments shall be maintained in a permanently bound record.

g)         The following quality control procedures shall be utilized by the laboratory on a daily basis:

1)         To verify internal laboratory precision for a specific analysis, 10 percent or more duplicate analyses shall be performed.  If the difference between duplicate analyses exceeds two times the standard deviation of the specific analysis as described in "Environmental Radioactivity Laboratory Intercomparison Studies Program, Fiscal Year 1981-1982," EPA-600/4-81-004, Table 3, U.S. Environmental Protection Agency (1982), prior measurements are suspect, calculations and procedures shall be examined and samples shall be re-analyzed when necessary.

2)         When 20 or more specific analyses are performed each day, a performance standard and a background sample shall be measured with each 20 samples.  If less than 20 specific analyses are performed each day, a performance standard and a background sample shall be measured along with the samples, except for low level gamma counting.

3)         Quality control performance charts or records shall be maintained for each instrument.

h)         Weights certified by the manufacturer as meeting the requirements established by the American Society for Testing and Materials (ASTM) for Class "1" weights shall be available at the laboratory and used to make periodic checks on balances.

i)          Chemicals shall be dated upon receipt of shipment and replaced before shelf life has been exceeded.

j)          The laboratory should prepare and follow a written quality assurance (QA) plan.  The following items should be addressed in each QA plan:

1)         Sampling procedures;

2)         Sample handling procedures, which specify the methods used to maintain the integrity of all samples (i.e., tracking samples from receipt by laboratory through analysis to final disposition), and provide for maintaining and documenting the chain of custody of samples identified to the laboratory as likely to be the basis for enforcement actions;

3)         Instrument or equipment calibration procedures and frequency of their use;

4)         Analytical procedures;

5)         Data reduction, validation and reporting, including conversion of raw data to final reported results, insuring accuracy of data transcription and calculations, and procedures and format for reporting data to water supply operators, the Department, and other state and federal agencies;

6)         Types of quality control checks and frequency of their use, which may include preparation of calibration curves, instrument calibrations, replicate analyses, use of quality control samples or calibration standards, and use of quality control charts;

7)         Preventive maintenance procedures and schedules;

8)         Specific routine procedures used to determine data precision and accuracy for each contaminant measured.  Precision is determined based on the results of replicate analyses.  Accuracy is normally determined by comparison of results with known concentrations in reagent water standards and by analyses of water matrix samples before and after adding a known contaminant spike;

9)         Corrective action contingencies, specifying the laboratory's response to obtaining unacceptable results from analysis of performance evaluation samples and from internal quality control checks;

10)         Laboratory organization and responsibility, including a chart or table showing the laboratory organization and line of authority, and listing the key individuals who are responsible for ensuring the production of valid measurements and for the routine assessment of measurement systems for precision and accuracy (e.g., who is responsible for internal audits and reviews of the implementation of the plan and its requirements).

k)         The quality assurance plan may be a separately prepared quality assurance document or may incorporate by reference already available standard operation procedures (SOPs) that are approved by the laboratory director and that address the items listed in subsection (j) of this Section.  If a particular listed item is not relevant, the quality assurance plan should state this and provide a brief explanation (e.g., some laboratories do not collect samples and thus are not required to describe sampling procedures).  A laboratory quality assurance plan should be concise but responsive to the items listed in subsection (j) of this Section.  Minimizing paperwork while improving the dependability and quality of data are the intended goals.