10-144 C.M.R. ch. 263, § 10 - PROFICIENCY TESTING REQUIREMENTS

A. Obtaining proficiency test samples

A laboratory must obtain proficiency test samples from an approved provider meeting the criteria below:

1. Approved providers of proficiency test samples

a. The National Environmental Laboratory Accreditation Program (NELAP) Institute, also known as The NELAP Institute (TNI);

b. EPA; or

c. Other proficiency test providers that are also accreditation bodies.

2. Criteria for approval

The accreditation officer must approve a proficiency testing provider, if the proficiency testing provider:

a. Is compliant with a national or international standard and is a recognized proficiency testing provider acceptable for use by TNI;

b. Clearly defines the scope of each proficiency testing study;

c. Evaluates results from all proficiency testing studies using the acceptance criteria described in national or international standards or those specified by the accreditation officer;

d. Scores each result as either "acceptable," "not acceptable," "satisfactory," "unsatisfactory," "pass," "fail," "no evaluation" or "not reported;"

e. Provides to participant laboratories reports that include:

(i) The provider name in the header;

(ii) The laboratory name, laboratory address (physical location), EPA laboratory ID number in the header, and the name, title and telephone number of the laboratory point of contact in the header or cover letter;

(iii) The study number and study type in the header;

(iv) The shipment date and closing date of the study in the header;

(v) The date of any amended report, if applicable, in the header;

(vi) Analyte name for each analyte included in the sample;

(vii) Method description;

(viii) Laboratory value as reported;

(ix) Assigned values and acceptance values reported to three significant figures, except for tests requiring reports of presence or absence of the analyte;

(x) The acceptable/not acceptable status;

(xi) A "no evaluation" score for reported values containing alpha characters;

(xii) An indication of the length of the report presented by either "page X of Y" or the total number of pages with each page numbered consecutively; and

(xiii) For amended reports, an indication of the amended results, including a brief description of the reason for the amendment.

f. Sends reports of results no later than 21 calendar days after the study closing date;

g. Maintains the overall effectiveness of the provider's quality system to indicate that samples provided for testing are verifiable, homogeneous and stable;

h. Makes available to the accreditation officer and any participating laboratory, upon request, a complete report of the provider's analytical data and documentation of the provider's quality system, which relates to the assigned values, homogeneity and stability of a particular proficiency testing study;

i. Makes available to the accreditation officer, upon request, a report listing the total number of participating laboratories and the number of laboratories scoring "not acceptable" for each analyte;

j. Supplies reports to the accreditation officer in an electronic format acceptable to the accreditation officer; and

k. Supplies the laboratory with a proficiency test sample formulated from a lot that has not been previously sent to the laboratory. If the lot was previously used in a proficiency test sample or its assigned values sent to any laboratory, the original proficiency test sample tracking ID must be obliterated, and the new sample tracking ID must be unique.

B. Availability of proficiency test samples

1. The accreditation officer must determine that a proficiency test sample for a particular field of testing is not available if:

a. None of the approved providers list the proficiency test sample through published catalogs, websites or other widely distributed literature; or

b. None of the approved providers make the proficiency test sample available in a form similar to routine samples. For example, proficiency test samples may be considered unavailable if the preparation instructions require the laboratory to perform pretreatment steps not normally associated with the requirements of the approved methods. In this context, dilution of the proficiency test sample is not considered pretreatment.

2. If the accreditation officer determines that no approved provider has proficiency test samples for a field of testing, the accreditation officer must request written documentation from the laboratory of QC data, meeting the minimum requirements under this rule to evaluate the capability of the laboratory to perform testing.

C. Proficiency testing requirements to obtain or maintain accreditation

1. A laboratory seeking to obtain accreditation must successfully complete at least one proficiency test sample, unless a proficiency test is not available, for each requested field of testing, no more than six months before the date the laboratory submits its application.

2. When a laboratory is granted accreditation status, it must continue to complete proficiency testing studies for each field of testing each calendar year and maintain a history of at least one acceptable evaluation for each field of testing out of the most recent two proficiency test sample results submitted to the proficiency test provider.

3. When a laboratory has attained accreditation and requests to add a field of testing to its scope of accreditation, the laboratory must submit acceptable proficiency testing results for that field of testing, analyzed no more than six months before the date that the laboratory submits its application.

4. To maintain accreditation, a laboratory must complete the annual study, and any corrective action study required, by October 31.

5. If the laboratory is accredited by the MLAP through equivalency, and maintains accreditation or certification by another approving body, proficiency test sample results for all analytes and programs must be sent at the request of the accreditation officer.

D. Proficiency test sample analysis requirements

1. A laboratory must analyze proficiency test samples in the same manner as used for routine environmental samples, using the same staff, sample tracking, sample preparation and analysis methods, SOPs, calibration techniques, QC procedures and acceptance criteria. The laboratory must follow sample preparation steps for the proficiency test sample as instructed by the approved proficiency test provider for which the proficiency test sample was obtained.

2. Laboratories under the same ownership are not to participate in the same study by the same approved proficiency test provider for the same fields of testing, except when a study is not again available for that field of testing by any approved proficiency test provider within the calendar year.

3. Prior to the closing date of a study, laboratory personnel, including corporate personnel, may not:

a. Communicate with any individual at another laboratory concerning the analysis of the proficiency test sample prior to the closing date of the study;

b. Subcontract the analysis of any proficiency test sample or a portion of a proficiency test sample to another laboratory for any analysis;

c. Knowingly receive and analyze any proficiency test sample or portion of a proficiency test sample from another laboratory for which the results of the proficiency test sample are intended for use for initial or continued accreditation; or

d. Attempt to obtain the assigned value of any proficiency test sample.

E. Proficiency test sample reporting requirements

The laboratory must evaluate and report the analytical result for accreditation as follows:

1. For instrument technology that employs a multi-point calibration, the working range of the calibration under which the proficiency test sample is analyzed must be the same range as used for routine samples.

a. A result for any proficiency test at a concentration above or equal to the lowest calibration standard must be reported as the resultant value.

b. A result for any proficiency test at a concentration less than the lowest calibration standard must be reported as less than the value of the lowest calibration standard.

c. A result for any proficiency test greater than the highest calibration standard must be diluted to fall within the range of the calibration curve.

2. For instrument technology (e.g., ICP-AES or ICP-MS) that employs standardization with a zero point and a single point calibration standard, the laboratory must evaluate the analytical result in the same range as used for routine samples.

a. A result for any proficiency test at a concentration above or equal to the RL must be reported as the resultant value.

b. A result for any proficiency test at a concentration less than the RL must be reported as less than the value of the RL.

c. A result for any proficiency test greater than the high calibration standard must be diluted to be within the working range.

3. A laboratory must ensure that the proficiency test results include the correct physical address of the laboratory.

4. The laboratory must report the analytical results for accreditation to the proficiency test provider on or before the closing date of the study using the reporting format specified by the proficiency test provider.

5. On or before the closing date of the study, the laboratory must authorize the proficiency test provider to release the laboratory's final evaluation report directly to the laboratory's primary approving body. The MLAP will evaluate only results received directly from the proficiency test provider.

6. A laboratory must supply results by authorizing the approved proficiency test provider to release all accreditation and corrective action results to the accreditation officer by an electronic format specified by the accreditation officer.

7. For programs other than the Drinking Water Program, a laboratory may use one proficiency test sample to analyze and report results for multiple methods by the same technology, provided the sample is analyzed under analytical conditions which satisfy all technologies reported and the most stringent method QC requirements are fulfilled.

8. Errors in reporting the proper matrix, the method used or the tested analytes in the proficiency test study by the laboratory must be graded as "not acceptable" by the MLAP.

9. A laboratory may not request a revised report from the proficiency test provider when the revisions to the report are due to any error on the part of the laboratory.

10. Laboratories also accredited under NELAP must designate one of the two annual proficiency test studies performed to be sent to the MLAP. Additional proficiency test studies received will be evaluated and subject to the same corrective action requirements found in SubSection I of this Section.

F. Proficiency test sample study record retention

1. The laboratory must maintain copies of all written, printed and electronic records pertaining to proficiency test sample analyses for five years or for as long as is required by the applicable regulatory program, whichever is greater.

2. Proficiency test records must include, but not be limited to:

a. Bench sheets;

b. Instrument strip charts or printouts;

c. Data calculations;

d. Data reports; and

e. Proficiency test study report forms used by the laboratory to record proficiency test results.

3. The laboratory must make all retained records available to assessors during on-site assessments of the laboratory.

G. Evaluation of results

1. All study data released from the proficiency test provider will be scored for compliance with this rule.

2. A laboratory must demonstrate acceptable performance, as determined by the approved provider, for each field of testing reported.

3. For the purpose of initial or continuing accreditation, the accreditation officer will deem unacceptable any reported results not meeting the criteria under this Section.

4. Proficiency test samples analyzed or reported after the study closing date are not valid for compliance with the proficiency testing requirements under this Section.

H. Questionable proficiency test samples

Upon notice from a laboratory and verification by the approved provider that a proficiency test sample did not meet the requirements in this Section, the accreditation officer may determine that the affected laboratory must analyze another proficiency test sample for that field of testing.

I. Corrective actions for unacceptable results

1. When an approved provider notifies a laboratory that a proficiency test sample result for any reported field of testing is unacceptable, the laboratory must:

a. Review each "not acceptable" result to determine:

(i) Cause of the error; and

(ii) Corrective action(s) the laboratory need(s) to take to correct the problem.

b. Document the cause(s) and corrective action(s) the laboratory has taken to correct each problem that caused or contributed to the "not acceptable" result;

c. Submit the corrective action report to the MLAP within 30 days of receiving the notification of unacceptable results from the approved provider;

d. Request a supplemental proficiency test study within 30 days of closing the corrective action report;

e. Ensure that results of all proficiency test samples are received by the accreditation officer and submitted directly by the proficiency test provider; and

f. Notify the MLAP if the laboratory fails a second proficiency test (PT) for an accredited parameter.

J. Grounds for suspension of accreditation

The following constitute grounds for suspension of accreditation:

1. Failure to produce acceptable results in two consecutive proficiency testing studies for the same field of testing; or

2. Failure to submit an acceptable corrective action report in response to an unacceptable proficiency testing result.

K. Requirements for reinstatement of accreditation after suspension

1. The following requirements must be met for reinstatement of accreditation following a proficiency test related suspension:

a. The laboratory must complete a corrective action report within 30 days of the suspension;

b. The laboratory must pass two unique, successive proficiency test studies, analyzed at least one day apart; and

c. The proficiency tests must be completed within 180 days of the suspension or before the expiration of the current certificate, whichever is sooner, to restore accreditation.

2. To reinstate accreditation after suspension for failure to submit corrective action, refer to Section 7(E).

L. Additional samples for compliance

The accreditation officer may require Maine accredited laboratories to test additional proficiency test samples at any time to determine compliance with this rule.

Notes

10-144 C.M.R. ch. 263, § 10