06-096-263 Me. Code R. § 8

Current through 2024-44, October 30, 2024

Section 096-263-8 - QUALITY SYSTEMS

A.Laboratory organization

The laboratory must:

1. Be an entity that can be held legally responsible;

2. Carry out its testing activities in such a way as to meet the requirements of this rule and to satisfy the needs of clients and the regulatory authorities;

3. Have technical management and personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties and to identify the occurrence of departures from the quality system and to initiate actions to prevent or minimize such departures;

4. Use personnel employed by, or under contract to, the laboratory. Where contracted and additional technical and key support personnel are used, the laboratory must ensure that such personnel are supervised and competent and that they work in accordance with the laboratory's quality system;

5. Have a written policy that, as indicated by signature, ensures management and personnel are free from any undue internal and external commercial, financial and other pressures, and influences that may adversely affect the quality of their work or diminish confidence in its competence, impartiality, judgement or operational integrity;

6. Define the organization and management structure of the laboratory, its place in any parent organization and the relationships between quality management, technical operations and support services;

7. Define the responsibilities of key personnel in the organization that have an involvement or influence on the testing, if the laboratory is part of an organization performing activities other than testing, in order to identify potential conflicts of interest;

8. Have policies and procedures to ensure the protection of its clients' confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results;

9. Maintain records of the relevant authorization(s), demonstration(s) of capability, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel. This information must be readily available and include the date on which authorization and/or competence is confirmed; and

10. Maintain initials and signatures of anyone analyzing or reviewing data so that the records can be traced back to the individual approving the data.

B.Duty to notify

1. A laboratory must notify the accreditation officer in writing within 30 days of a change in the:

a. Name of the laboratory;

b. Physical location, postal mailing address or electronic mailing address of the laboratory;

c. Owner of the laboratory;

d. Names and telephone numbers of a designated contact person(s); including the laboratory technical director and quality assurance officer;

e. Name of at least one managing agent with signature;

f. Names of supervisory professional staff responsible for the analyses; or

g. Major analytical equipment.

2. When there is a change in location or instrumentation, a laboratory must provide results of proficiency testing samples or a demonstration of capability, analyzed in the new laboratory location or analyzed under a change in instrumentation.

C.Personnel requirements - Laboratory Technical Director

Each laboratory must appoint a laboratory technical director. The laboratory technical director is responsible for the technical and scientific oversight of all laboratory activities. The laboratory technical director must certify that personnel with appropriate education and technical background perform all tests for which the laboratory is accredited. Each laboratory will be accredited only after presentation of documentation to the MLAP regarding education and work experience.

1. Qualifications for laboratory technical director of a chemistry laboratory are as follows:

a. A bachelor's degree in chemistry, environmental science, biological sciences, physical sciences or engineering, with a minimum of two years' experience in environmental analysis.

b. For laboratories engaged in inorganic analysis only, excluding metals analysis, the laboratory technical director may hold an associate's degree in chemistry or environmental science or equivalent with a minimum of two years' experience performing inorganic environmental analysis.

2. Qualifications for laboratory technical director of a bacteriology laboratory are as follows:

a. A bachelor's degree in microbiology, biology, chemistry or environmental science, with a minimum of two years' experience in environmental analysis.

b. For laboratories engaged in microbiological analysis limited to coliform and heterotrophic plate count testing, the laboratory technical director may hold an associate's degree in science or the equivalent, with at least four semester credit hours in microbiology and one year of experience in environmental analysis.

3. Qualifications for laboratory technical director of a radiochemistry laboratory are a bachelor's degree in chemistry or physics with two years' experience, one year of which must be in the supervision of environmental radiochemistry.

4. A valid treatment plant operator's certificate or license may be substituted for the above qualifications for a laboratory technical director of a drinking water or wastewater treatment facility engaged in the analysis of bacteriology samples or chemistry, other than radiochemistry, collected within the State. The certificate or license must meet or exceed the classification for the drinking water or wastewater treatment facility in which the laboratory is located.

5. When the laboratory engages in more than one analytical category (chemistry, bacteriology and/or radiochemistry), one or more persons may complement the laboratory technical director, provided that each meets the applicable qualifications for the analytical category as specified in paragraphs (1), (2) and (3) above.

6. An individual is not permitted to be laboratory technical director of more than one Maine accredited laboratory without authorization from the MLAP. Circumstances to be considered for authorization include, but will not be limited to:

a. Operating hours of the laboratories;

b. Adequacy of supervision; and

c. Availability of environmental laboratory services in the area.

D.Personnel requirements - Quality Assurance Officer (QAO)

1. Each laboratory must appoint a QAO, however named. The QAO is the person responsible for the laboratory's quality assurance program and its implementation.

2. The QAO must review laboratory quality control data, conduct annual internal laboratory audits and notify laboratory management of deficiencies found in the laboratory's quality system. The QAO must be free from internal and external influences when evaluating data and conducting audits.

3. The QAO must have documented training and/or experience in QA and QC procedures and must have knowledge of the approved analytical methods and quality system requirements. The QAO must maintain the laboratory's QA documents up to date.

4. The QAO duties and responsibilities may also be carried out by the laboratory technical director.

5. The QAO must have direct access to laboratory management.

6. The QAO should (when possible) have functions independent from laboratory operations for which they have quality assurance oversight.

E.Responsibilities of laboratory management

1. Personnel documentation

Laboratory management must:

a. Ensure the laboratory has sufficient personnel with the necessary education, training, technical knowledge and experience for their assigned functions;

b. Specify and document the responsibility, authority and interrelationships of all personnel, who manage, perform or verify work affecting the quality of the tests;

c. Establish job descriptions to include the minimum level of qualifications, experience and basic laboratory skills necessary for all positions in the laboratory;

d. Appoint a member of staff as QAO (however named) who, irrespective of other duties and responsibilities, will have defined responsibility and authority for ensuring that the management system related to quality is implemented and followed at all times;

e. Appoint a deputy when the laboratory technical director is absent from the laboratory for more than 15 consecutive calendar days. The appointed deputy must meet the qualifications for laboratory technical director. The laboratory management must notify the MLAP in writing when the absence of the laboratory technical director exceeds 65 consecutive calendar days; and

f. Authorize specific personnel to perform particular types of sampling and environmental testing, issue test reports, give opinions and interpretations and operate particular types of equipment.

2. Personnel training and supervision

The laboratory management must:

a. Provide adequate supervision of testing staff, including trainees, by persons familiar with methods and procedures;

b. Formulate goals with respect to the education and training skills of the laboratory personnel. The laboratory must have policies and procedures for identifying training needs and providing training of personnel. The training program must be relevant to the present and anticipated tasks of the laboratory staff;

c. Ensure all technical laboratory staff has demonstrated capability in the activities for which they are responsible; and

d. Ensure that the training of the laboratory personnel is kept up to date (on-going) by providing the following:

(i) Documentation that each employee has read, understands and uses the latest version of the laboratory's quality documents;

(ii) Training documentation on equipment, techniques and/or procedures;

(iii) Training in ethical and legal responsibilities, as stated in Section 8; and

(iv) Documentation of each analyst's continued performance at least once per year according to Section 8.

3. Quality control

The laboratory management must:

a. Be responsible for documenting the quality of all data reported;

b. Ensure that all personnel are responsible for complying with all QA and QC requirements that pertain to their organizational and technical function; and

c. Ensure that all sample acceptance criteria are verified and samples are logged into the sample tracking system and are properly labeled and stored.

4. Communication

Laboratory management must:

a. Ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the laboratory management system; and

b. Ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the laboratory management system.

F.Internal audits

1. The laboratory must, at least annually and in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the laboratory management system and this rule. The laboratory's internal audit program must address all elements of the laboratory management system, including testing and/or calibration activities.

2. It is the responsibility of the QAO to plan and organize audits as required by the schedule and requested by management. Such audits must be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited.

3. When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory's test or calibration results, the laboratory must take timely corrective action and must notify clients in writing if investigations show that the laboratory results may have been affected. The laboratory must:

a. Have a policy that specifies the time frame for notifying clients of events that cast doubt on the validity of the results; and

b. Ensure that these actions are discharged within the agreed-upon time frame.

4. Audit reports must document the focus of the audit, the audit findings and corrective actions that arise from them.

5. Follow-up audit activities must verify and record the implementation and effectiveness of the corrective action taken.

G.Management reviews

1. In accordance with a predetermined schedule and procedure, the laboratory's senior management must conduct an annual review of the laboratory's management system and laboratory testing to ensure their continuing suitability and effectiveness and to introduce necessary changes or improvements. Findings from management reviews and the actions that arise from them must be recorded. The management must ensure that those actions are carried out within an appropriate and agreed time frame. The written management review and management team meeting must be completed within the first quarter of each calendar year.

2. The review must take account of:

a. The suitability of policies and procedures;

b. Reports from managerial and supervisory personnel;

c. The outcome of recent internal audits;

d. Corrective actions;

e. Assessments by external bodies;

f. The results of interlaboratory comparisons or proficiency tests;

g. Changes in the volume and type of the work;

h. Client feedback;

i. Complaints;

j. Recommendations for improvement; and

k. Other relevant factors, such as QC activities, resources and staff training.

H.Data integrity training

1. The data integrity training must:

a. Be provided as a formal part of new employee orientation;

b. Be provided on an annual basis for all current employees;

c. Be provided in writing and available to all trainees; and

d. Have a signature attendance sheet or other form of documentation that demonstrates that each staff person has received the training and understands their obligations related to data integrity.

2. Key topics covered during training must include:

a. The organizational mission and its relationship to the critical need for honesty and full disclosure in all analytical reporting, as well as how and when to report data integrity issues and record keeping;

b. Proper procedures to ensure data integrity, recognition and prevention of improper laboratory practices, the promotion of objectivity and impartiality in the generation and reporting of analytical data;

c. Discussion regarding all data integrity procedures and documentation, data integrity training documentation and in-depth data monitoring;

d. Specific examples of breaches of ethical behavior, referencing current events in the media, including improper data manipulations, adjustments of instrument time clocks and inappropriate changes in concentrations of standards; and

e. An emphasis on the importance of proper written narration on the part of the analyst with respect to those cases where analytical data may be useful, but are in one sense or another partially deficient. The data integrity procedures may also include written ethics agreements, examples of improper practices (e.g., improper chromatographic manipulations) and requirements for external ethics program training. Procedures may also include external resources available to employees.

3. Senior managers must acknowledge their support of these procedures by upholding the spirit and intent of the organization's data integrity procedures and effectively implementing the specific requirements of the procedures.

4. Employees are required to understand that any infractions of the laboratory data integrity procedures will result in a detailed investigation that could lead to severe consequences, including immediate termination, debarment or civil or criminal prosecution.

I.Data integrity investigations

All investigations resulting from data integrity issues are to be conducted in a confidential manner until they have been completed. These investigations must be documented, as well as any notifications in writing made to clients receiving any affected data, within 30 calendar days of investigation completion. This written notification must include a time frame for re-issuing affected laboratory reports and associated electronic database deliverables (EDDs), if applicable. A copy of each written notification must be provided to the accreditation officer within seven calendar days of submission to affected clients.

J.Corrective action

The laboratory must establish a corrective action policy and procedure and must designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical operations have been identified.

1. Selection and implementation of corrective actions

a. Where corrective action is needed, the laboratory must identify potential corrective actions in a timely manner. It must select and implement the action(s) most likely to eliminate the problem and to prevent recurrence.

b. Corrective actions must be to a degree appropriate to the magnitude and the risk of the problem.

c. The laboratory must document and implement any required changes resulting from corrective action investigations.

d. Corrective action reports must be closed when corrective action has been completed.

2. Monitoring of corrective actions

The laboratory must monitor the results to ensure that the corrective actions taken have been effective.

3. Additional audits

Where the identification of nonconformities or departures casts doubt on the laboratory's compliance with its own policies and procedures, or on its compliance with this rule, the laboratory must ensure that the appropriate areas of activity are audited. Such additional audits often follow the implementation of the corrective actions to confirm their effectiveness. An additional audit is necessary when a serious issue or risk to the business is identified.

K.Demonstration of capability

1. Initial demonstration of capability

a. The laboratory must demonstrate that it can properly perform all methods before conducting tests. An initial demonstration of capability must be completed each time there is a change in instrument, personnel or method.

b. The demonstration of capability must be performed by spiking a known standard into a clean matrix which duplicates that used for routine analysis (e.g., drinking water, soil). For analytes which do not lend themselves to spiking, the demonstration of capability may be performed using QC samples.

c. All demonstrations must be documented. All data applicable to the demonstration must be retained for a minimum of five years and available for inspection. The laboratory must set reasonable criteria for acceptability of the demonstration of capability.

d. Prior to adding an analyte to their scope of accreditation that is not currently found on the laboratory's list of accredited analytes, the laboratory must perform an initial evaluation.

2. Procedure for initial demonstration of capability

a. A QC sample must be prepared by the laboratory using stock standards that are not used in instrument calibration (e.g., calibration verification standard).

b. The analyte(s) must be diluted in a volume of clean matrix sufficient to prepare four aliquots at the concentration specified, or if unspecified, to a concentration of the mid-level standard.

c. At least four aliquots must be prepared and analyzed according to the test method either concurrently or over a period of days.

d. Using all of the results, the laboratory must calculate the mean recovery in the appropriate reporting units and the sample standard deviations for each parameter of interest must be calculated. Recovery for each analyte in each aliquot and the calculated standard deviation must be within the limits specified by the applicable approved method or by the applicable permit, program or rule. When it is not possible to determine mean and standard deviations, such as for presence or absence and logarithmic values, the laboratory must assess performance against established and documented criteria.

e. It is the responsibility of the laboratory to document that any other approaches to the demonstration of capability are adequate. The documentation must be provided within the laboratory's Quality Manual (e.g., for Bacteriology).

3. Continuing demonstration of capability

After the initial demonstration of capability has been completed, the laboratory is required to continue demonstrating method performance through one of the following:

a. Acceptable performance of a blind sample;

b. Another demonstration of capability as described in Section 8(K)(2)(a) -(e);

c. Successful analysis of a blind performance sample on a similar method using the same technology;

d. Analysis of at least four consecutive laboratory control samples with acceptable levels of precision and accuracy; or

e. If one of the above cannot be performed, the analysis of environmental samples that have been analyzed by another trained analyst with statistically indistinguishable results.

f. Results of all continuing demonstration of capability determinations must be documented in writing.

L.Sample handling, receipt and acceptance

1. Handling samples

a. A laboratory must have procedures for the collection, transportation (if a function of the laboratory), receipt, handling, protection, storage, retention and disposal of samples. The procedures must include provisions necessary to protect the integrity of the sample and to protect the interests of the laboratory and the client.

b. A laboratory must have a system for identifying samples. The sample's identification must be retained throughout the life of the sample in the laboratory. The identification system must be designed and operated so as to ensure that samples cannot be confused physically or when referred to in laboratory documentation. The identification of samples must accommodate a subdivision of groups of samples and the transfer of samples between laboratories.

c. Upon receipt of samples, the condition, including any abnormalities or departures from specified conditions as described in the laboratory's QA manual, must be recorded. When there is doubt as to the suitability of a sample for environmental testing, when a sample does not conform to the description provided, when an insufficient amount of sample is received or when the environmental test required is not specified in sufficient detail, the laboratory must consult the client for further instructions before proceeding and must maintain a record of the discussion.

d. A laboratory must have procedures and appropriate facilities for avoiding deterioration, contamination, and loss or damage to the sample during storage, handling, preparation and testing.

e. When samples require storage under specified environmental conditions, the conditions must be maintained, monitored and recorded. When a sample or a portion of a sample is to be held secure, a laboratory must have arrangements for storage and security that protect the condition and integrity of the secured samples and/or sample portions.

f. Samples, sample fractions, extracts, leachates and other products of sample preparation must be kept in storage units, such as cabinets, refrigerators or freezers, which are separate from the storage units for all standards, reagents, food and other potentially contaminating sources. Samples must be stored in such a manner as to prevent contamination between samples.

2. Sample receipt protocols

The following information must be verified and the results documented:

a. Samples received for analysis under the Drinking Water Program must be verified and documented per the following:

i. All samples that require thermal preservation are considered acceptable if the arrival temperature is verified and within the range required by either the approved method or by the applicable permit, program or rule.

ii. Samples that do not arrive at the proper temperature may be analyzed without client notification, or qualifying the report for temperature, if the sample is received within a reasonable timeframe after collection and there is evidence of an attempt to thermally preserve.

iii. Samples that are not received shortly after collection (e.g., received through the mail), that do not arrive at the proper temperature may be analyzed, at the client's discretion, if the following criteria are met:

(1) The sample arrived with evidence of an attempt to thermally preserve;

(2) The client is notified that the sample did not arrive at the proper temperature and the outcome of the conversation is documented; and

(3) The report is annotated to indicate that the sample arrived outside of the acceptable range and was run at the client's request.

b. Samples received for any programs other than the Drinking Water Program must be verified and documented per the following:

ii. Sample temperature must be recorded at the time of sample receipt.

iii. Samples that do not arrive at the proper temperature may be analyzed at the client's discretion, if the following criteria are met:

(1) The sample arrived with sufficient coolant to indicate adequate support for the thermal cooling process;

(2) The client is notified that the sample did not arrive at the proper temperature and the outcome of the conversation is documented; and

(3) The report is annotated to indicate the temperature of the sample at the time of sample receipt, that the sample arrived outside the acceptable range and was run at the client's request.

c. All samples that require chemical preservation are considered acceptable if the laboratory verifies that the preservation meets the requirements of the approved method. A laboratory must implement procedures for checking chemical preservation before sample preparation or analysis, except for methods where postanalysis preservation checks are required, to ensure that sample integrity is not compromised. When specified in permit, program or rule, chemical preservation must be verified upon receipt.

d. A laboratory must maintain chronological records, either paper-based or electronic, such as a logbook or database, to document receipt of all samples, including the number and types of containers received for each field of testing. The records must include the following:

(i) The client and project name, if applicable;

(ii) The date and time of laboratory receipt;

(iii) A unique laboratory-assigned identification code;

(iv) The signature, initials or equivalent electronic identification of the person receiving the samples and making the entries;

(v) The field identification code, which identifies each container, linked to the laboratory-assigned identification code in the sample receipt log;

(vi) The date and time of sample collection linked to the sample container and to the date and time of receipt in the laboratory;

(vii) The requested field of testing linked to the laboratory-assigned identification code; and

(viii) Any comments resulting from inspection for sample rejection, linked to the laboratory-assigned identification code.

3. Sample Acceptance Policy

a. A laboratory must have a written sample acceptance policy that clearly outlines the circumstances under which samples will be accepted or rejected by the laboratory. Data from samples that do not meet the laboratory's criteria must be recorded in an unambiguous manner clearly defining the nature and substance of the deviation from acceptable procedures.

b. A laboratory's sample acceptance policy must be made available to sample collection personnel and must address, at a minimum:

(i) Documentation on the chain of custody must include sample identification; location, date and time of collection; collector's name; preservation type; sample type; and any special remarks concerning the sample;

(ii) Sample labeling, to include unique identification and a labeling system for the samples with requirements concerning the durability of the labels (water resistant) and the use of indelible ink;

(iii) The use of appropriate sample containers;

(iv) Adherence to specified holding times;

(v) Adequate sample volume to perform the requested tests and relevant QC determinations; and

(vi) Procedures to be used when samples show signs of damage, contamination, inadequate preservation or loss of integrity.

c. If the sample does not meet the sample receipt acceptance criteria listed in the laboratory's QA manual, the laboratory must retain correspondence and records of conversations concerning the final disposition of rejected samples or fully document any decision to proceed with the analysis of samples not meeting acceptance criteria.

d. The report of samples analyzed without meeting the sample acceptance criteria must indicate, at a minimum, the condition of the samples on the chain of custody and the transmittal form or the laboratory receipt documents in addition to appropriately qualifying the analysis data on the final report.

e. Additional requirements - legal chain of custody protocols

Legal chain of custody protocols are used for evidentiary or legal purposes. A laboratory must have a written SOP that describes the protocols for carrying out legal chain of custody if a client specifies that the sample is to be used for evidentiary purposes.

M.Standards, reagents and bacteriological media

1. Reference standards that are used in the laboratory must be obtained, when available, from an accredited third party or a National Metrology Institute (e.g., NIST) and be traceable to the SI, International System of Units.

2. A laboratory must retain records for all standards, reagents and bacteriological media. The records must include:

a. Identification of the manufacturer or vendor;

b. Certificate of analysis or purity, if supplied;

c. Lot number;

d. Date of receipt or preparation;

e. Preparer's initials, if applicable;

f. Method of preparation, when prepared in the laboratory;

g. Recommended storage conditions; and

h. Expiration date after which the material must not be used unless its reliability is verified by the laboratory.

3. All containers of reagents, standards and bacteriological media must be assigned a unique identification linked to records containing the documentation required in this section.

4. All reagents, standards and bacteriological media must be laboratory verified before use.

a. Reagents are to be analyzed by use of a method blank before use.

b. Standards are to be verified against a lot number previously determined fit for use by the laboratory.

c. Bacteriological media must be verified by positive and negative controls before use.

5. All water must be appropriate for use.

a. Reagent water for chemical analysis:

(i) May be American Society for Testing Materials (ASTM) Type I, Type II or Type III based on the appropriateness for the analysis; or

(ii) May be Standard Methods for the Examination of Water and Wastewater, American Water Works Association, 23rd Edition, 2017 medium-quality or high-quality water based on the appropriateness for the analysis.

b. Results of these analyses must meet the specifications of the required method and records of analyses must be maintained for five years.

c. Reagent water used for bacteriological analysis must meet the following requirements:

Test	Monitoring Frequency	Maximum Acceptable Limit
Chemical Tests:
Conductivity	Monthly*	<2 µmhos/cm (µmsiemens/cm) at 25^oC
Total organic carbon	Monthly	<1.0 mg/L
Heavy metals, single (Cd, Cr, Cu, Ni, Pb, and Zn)	Annually [DAGGER]	<0.05 mg/L
Heavy metals, total	Annually [DAGGER	<0.10 mg/L
Total chlorine residual	Monthly or with each use	<0.10 mg/L
Bacteriological Tests:
Heterotrophic plate count	Monthly	<500 CFU/mL
Use test (see SM 9020B.5f2)	For a new source	Student's t [LESS THAN EQUAL TO] 2.78
Water quality test (see SM 9020B.5f1) [DOUBLE DAGGER]	Annually	0.8-3.0 ratio

*Monthly, if meter is in-line or has a resistivity indicator light; otherwise with each new batch of reagent water.

[DOUBLE] Or more frequently if nonconformance is identified.

[DOUBLE DAGGER] This bacteriological quality test is not needed for Type II water or better, as defined in Standard Methods (18th and 19th Editions), Section 1080 C, or medium-quality water or better, as defined in Standard Methods (20^th, 21^st, 22^nd and Online Editions), Section 1080 C.

N.Calibration of support equipment

1. Scope

This section applies to all devices that may not be the actual test instrument, but that are necessary to support laboratory operations, if quantitative results are dependent on their accuracy. Such devices include, but are not limited to, the following: balances; ovens; refrigerators; freezers; incubators; water baths; temperature-measuring devices, including thermometers and thermistors; thermal/pressure sample preparation devices; autoclaves; and volumetric dispensing devices, such as Eppendorf or automatic diluter/dispensing devices.

2. Requirements

a. Equipment must be operated by trained personnel. Up-to-date instructions on the use and maintenance of equipment, including any relevant manuals provided by the manufacturer of the equipment, must be readily available for use by the appropriate laboratory personnel.

b. All equipment must be properly maintained, including inspection, calibration and cleaning. Maintenance procedures must be documented. Calibration of balances, weights, temperature recording devices, light sources and detectors must be appropriate to the required precision and accuracy of the method.

c. Records must be maintained for each major component of equipment, including software. The records must include:

(i) The identity of the component of equipment, including software;

(ii) The manufacturer's name, type, identification and serial number or other unique identification;

(iii) Documentation that equipment complies with the manufacturer's specification;

(iv) The current location within the laboratory;

(v) The manufacturer's instructions, if available;

(vi) Dates, results and copies of reports and certificates of all calibrations, adjustments and acceptance criteria and the due date of the next calibration;

(vii) The maintenance plan and maintenance carried out to date, documentation on all routine and non-routine maintenance activities and reference material verifications;

(viii) Any damage, malfunction, modification or repair to the equipment;

(ix) Date received, and date placed in service or the date on which its first use or repair was recorded; and

(x) If available, condition when received, such as new, used or reconditioned.

3. Frequency of calibration

a. All support equipment must be calibrated at least annually, using references from an accredited third party or a National Metrology Institute (e.g., NIST) which are traceable to the SI.

b. On each working day, balances, ovens, water baths, refrigerators and freezers must be checked in the expected use range with thermometers from an accredited third party or a National Metrology Institute (e.g., NIST) which are traceable to the SI.

c. Mechanical volumetric dispensing devices including burettes, except Class A glassware, must be checked for accuracy at least quarterly. All glassware, including glass microliter syringes used for calibration, must be checked for accuracy and documented before its first use in the laboratory if the glassware does not come with a certificate attesting to established accuracy.

d. For chemical and biological tests using an autoclave, the temperature, cycle time and pressure of each run must be documented by the use of appropriate chemical indicators, temperature recorders and pressure gauges.

e. Volumetric equipment must be calibrated as follows:

(i) Equipment with movable parts, such as automatic dispensers, dispensers/diluters and mechanical hand pipettes, must be calibrated quarterly.

(ii) Equipment such as filter funnels, bottles, non-Class A glassware and other marked containers must be calibrated once per lot prior to first use.

(iii) The volume of the disposable volumetric equipment such as sample bottles, disposable pipettes and micropipette tips must be checked once per lot prior to first use.

f. The accuracy of all temperature measurement devices must be verified by comparing the reading of each device with that of a certified reference thermometer (e.g., NIST) which is traceable to the SI.

(i) The thermometer must be graduated in degree increments no larger than those of the device whose accuracy is being verified;

(ii) If a thermometer graduated in 0.5 °C increments or less differs from the certified reference thermometer by more than 1°C, its use must be discontinued;

(iii) The accuracy of thermometers must be verified as follows:

(1) Glass and electronic thermometers must be verified annually;

(2) Metal thermometers must be verified quarterly;

(3) Infrared detection devices must be verified every six months; and

(4) Certified reference thermometers must be verified at least once every five years.

(iv) The correction factor and date of verification of accuracy must be indicated on the thermometers. The laboratory must maintain a record that includes:

(1) Identification number of each thermometer;

(2) Temperatures displayed on both the certified reference thermometer and the thermometer being verified;

(3) Any applicable correction factor;

(4) Date each check was performed; and

(5) Signature of the analyst who performed each check.

4. Acceptance criteria

a. The results of calibrations must be within the specifications required of the application for which the equipment is used.

b. The acceptability for use or continued use must be according to the needs of the analysis or application for which the equipment is being used.

c. When the results of calibration of support equipment are not within the required specifications, the laboratory must remove the equipment from service until repaired.

d. Records must be retained to document equipment performance.

O.Calibration of analytical instruments

1. Scope This section applies to all devices that are the actual test instrument used to quantify the test results.

2. Requirements

b. All equipment must be properly maintained, including inspection, calibration and cleaning. Maintenance procedures must be documented. Calibration of instruments must be appropriate to the required precision and accuracy of the method. Calibrations must be performed at least annually and must be traceable to appropriate standards.

c. Records must be maintained for each major component of equipment, including software. The records must include the following:

(i) The identity of the component of equipment, including software;

(ii) The manufacturer's name, type, identification and serial number or other unique identification;

(iii) Documentation that equipment complies with the manufacturer's specification;

(iv) Date received and date placed in service or the date on which its first use or repair was recorded;

(v) If available, condition when received, such as new, used or reconditioned;

(vi) The current location within the laboratory;

(vii) The manufacturer's instructions;

(viii) Dates, results and copies of reports and certificates of all calibrations, adjustments and acceptance criteria and the due date of the next calibration;

(ix) The maintenance plan and maintenance carried out to date, documentation on all routine and non-routine maintenance activities and reference material verifications; and

(x) Any damage, malfunction, modification or repair to the equipment.

3. Initial calibration

a. Sufficient records must be retained to permit reconstruction of the instrument calibration, such as calibration date, approved method identification, instrument, analysis date, each analyte name, the manual or electronic identification of the analyst performing the test, concentration and response, calibration curve or response factor or unique equation or coefficient used to reduce instrument responses to concentration.

b. Sample results must be quantitated from the most recent instrument calibration and may not be quantitated from any earlier instrument calibration verification.

c. All instrument calibrations must be verified with a standard obtained from a second source such as a different manufacturer, when available. Traceability must be to a national standard, when available.

d. Criteria for the acceptance of an instrument calibration must be established, such as correlation coefficient or relative standard deviation. The criteria used must be appropriate to the calibration technique employed and must be documented in the laboratory's SOP.

e. If allowed in the permit, program or rule, results of samples outside of the concentration range established by the calibration must be reported with defined qualifiers, flags or explanations estimating the quantitative error.

f. The following must occur for methods employing standardization with a zero point and a single point calibration standard:

(i) Before the analysis of samples, the linear range of the instrument must be established by analyzing a series of standards, one of which must encompass the single point quantitation level;

(ii) A zero point and a single point calibration standard must be analyzed with each analytical batch;

(iii) A standard corresponding to the RL must be analyzed with each analytical batch and must meet established acceptance criteria;

(iv) The linearity must be verified at a frequency established by the method or the manufacturer; and

(v) If allowed in the permit, program or rule, a sample result within an analytical batch, higher than its associated single point standard, can be reported if the following conditions are met:

(1) A standard with a concentration at or above the analyte concentration in a sample must be analyzed and must meet established acceptance criteria for validating the linearity;

(2) The sample must be diluted such that the result falls below the single point calibration concentration; or

(3) The data must be reported with an appropriate data qualifier or an explanation in the narrative of the test report.

g. If the instrument calibration results are outside established acceptance criteria, corrective actions must be performed and all associated samples reanalyzed. If reanalysis of the samples is not possible, data associated with an unacceptable instrument calibration must be appropriately qualified on the test report.

h. Calibration standards must include concentrations at or below the limit specified in the permit, program or rule.

i. If an approved method does not specify the number of calibration standards, the minimum number is three, one of which must be at the RL, not including blanks or a zero standard, with the exception of instrument technology for which it has been established by methodologies and procedures that a zero and a single point standard are appropriate for calibrations. The laboratory must have an SOP that documents the protocol for determining the number of points required for the instrument calibration employed and the acceptance criteria for calibration.

j. It is prohibited to remove data points from within a calibration range while still retaining the extreme ends of the calibration range.

4. Calibration verification

a. When an instrument calibration is not performed on the day of analysis, the instrument calibration must be verified before analysis of samples by analyzing a calibration standard with each batch.

b. If calibration verification is not described in the approved method, calibration verification must be repeated at the beginning of each batch, after every tenth sample, excluding QC samples, and at the end of each batch.

c. Sufficient raw data records must be retained to permit reconstruction of the calibration verification, such as: test method; instrument; analysis date; each analyte name, concentration and response; calibration curve or response factor; or unique equations or coefficients used to convert instrument responses into concentrations. Calibration verification records must explicitly connect the verification data to the instrument calibration.

d. Criteria for the acceptance of calibration verifications must be established and evaluated using the same technique used to evaluate the instrument calibration.

e. If the calibration verification results obtained are outside established acceptance criteria, corrective actions must be performed. If routine corrective action procedures fail to produce a second consecutive (immediate) calibration verification within acceptance criteria, then the laboratory must either demonstrate performance after corrective action by performing one successful calibration verification or perform a new instrument calibration. If the laboratory has not demonstrated acceptable performance after the corrective action, sample analyses must not occur until a new instrument calibration is established and verified. Sample data associated with unacceptable calibration verification may be reported as qualified data under the following special conditions if allowed in the permit, program or rule:

(i) When the acceptance criteria for the calibration verification are exceeded high (high bias) and all associated samples contain analytes below the RL, those sample results may be reported.

(ii) When the acceptance criteria for the calibration verification are exceeded low (low bias), the sample results may be reported if the concentration exceeds a maximum regulatory limit as defined by the permit, program or rule.

f. When allowed by permit, program or rule, verification procedures may result in a set of correction factors. If correction factors are employed, the laboratory must have procedures to ensure that copies of all data records, such as in computer software, are correctly updated.

g. Test equipment, including both hardware and software, must be safeguarded from adjustments that would invalidate the test results.

P.Reporting

1. No accredited or provisionally accredited laboratory may report analytical results as a MLAP-Accredited laboratory unless:

a. The laboratory conducted the analytical measurements at the laboratory's address as stated in its current certificate;

b. The laboratory clearly distinguishes in the report between those analyses for which it is accredited, provisionally accredited or not accredited; and

c. For those analyses for which it is accredited or provisionally accredited, the laboratory clearly distinguishes in the report between those analyses that it conducted in accordance with the MLAP accreditation standards and those that it did not conduct in accordance with the MLAP accreditation standards.

2. For non-compliance analysis (e.g., private wells), no accredited or provisionally accredited laboratory may report analytical results as such, if the criteria required for program accreditation are not followed (e.g., use of an accredited method, proper sample handling, acceptable quality control). Analytical results for non-compliance samples that are generated using non-accredited procedures must be annotated as such on reports.

3. Analytical results must be reported accurately, legibly, objectively and according to any specific instructions in the laboratory's standard operating procedures or quality assurance manual.

4. The test report must include the following:

a. A title (e.g., "Test Report" or "Laboratory Results");

b. The name and address of the laboratory and the location where the tests were carried out, if different from the address of the laboratory;

c. The laboratory's EPA identification number;

d. The name and telephone number of a contact person;

e. The information in paragraph b above for the subcontracted laboratory and the phrase, "This report contains data that were produced by a subcontracted Maine accredited laboratory accredited for the fields of testing performed," if data were produced by a laboratory other than the laboratory reporting the results;

f. A unique identification of the test report, such as a serial number, an identification on each page to ensure that the page is recognized as a part of the test report and a clear identification of the end of the test report;

g. The name of the client and project name, if applicable;

h. Identification of the approved method used;

i. A description, the condition and unambiguous identification of the sample, including the client's identification code;

j. Date and time of sample collection;

k. The date and time of receipt of the sample(s) when critical to the validity and application of the results;

l. Time of sample preparation and time of sample analysis when critical to the validity of the sample result;

m. Date of analysis of the environmental test;

n. The test results with the units of measurement, when appropriate; whether data are calculated on a dry weight or an "as received" basis; the reporting or detection limit for each analyte with appropriate units of measurement; and the counting error for each radiochemistry sample;

o. The name, function and signature or equivalent electronic identification of the person authorizing the test report and the date of issue;

p. A statement to the effect that the results relate only to the samples;

q. A statement that the report must not be reproduced, except in full, without the written approval of the laboratory;

r. Deviations from the SOP, such as failed QC, additions to or exclusions from the test method and information on specific test conditions, such as environmental conditions and any nonstandard conditions that may have affected the quality of results, including the use and definitions of data qualifiers;

s. Test results that do not meet the requirement or for which the laboratory is not accredited, documentation explaining why the result does not meet the requirements and justification as to why the result was reported; and

t. QC information required by the applicable permit, program or rule.

5. When the laboratory analyzes samples by a procedure other than as written, the laboratory records and reports must include:

a. The sample identification traceable to the client;

b. The modification to the procedure;

c. The reason for the modification; and

d. The client's authorization or acknowledgment of the modification.

6. When opinions and interpretations are included, the laboratory must document the basis upon which the opinions and interpretations have been made. Opinions and interpretations must be clearly marked as such in test reports.

7. Electronic reporting of data

a. If electronic reporting is required by the MLAP or this rule, sample results must be reported in the electronic format acceptable to the MLAP.

b. If electronic reporting is required, sample results must be reported in the electronic format acceptable to the associated program. This includes the reporting of all required laboratory quality control information and associated acceptance limits.

Q.Documents and records

1. Document approval and issuance

a. All documents issued to personnel in the laboratory as part of the quality system must be reviewed and approved for use by authorized personnel prior to issuance. A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the quality system must be established and be readily available to preclude the use of invalid and/or obsolete documents.

b. The procedure(s) adopted must ensure that:

(i) Authorized editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed;

(ii) Documents are periodically reviewed and where necessary, revised to ensure continuing suitability and compliance with applicable requirements;

(iii) Invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use; and

(iv) Obsolete documents retained for either legal or knowledge preservation purposes are suitably marked.

c. Quality system documents generated by the laboratory must be uniquely identified. Such identification must include the date of issue and/or revision identification, page numbering, total number of pages or a mark to signify the end of the document and the issuing authority(ies).

2. Document changes

a. Changes to documents must be reviewed and approved by the same function that performed the original review, unless specifically designated otherwise. The designated personnel must have access to pertinent background information upon which to base their review and approval.

b. Where practical, the altered or new text must be identified in the document or the appropriate attachments.

c. If the laboratory's documentation control system allows for the amendment of documents by hand, pending the reissuance of the documents, the procedures and authorities for such amendments must be defined. Amendments must be clearly marked, initialed and dated. A revised document must be formally reissued as soon as practical.

d. Procedures must be established to describe how changes in documents maintained in computerized systems are made and controlled.

e. The record-keeping system must allow historical reconstruction of all laboratory activities that produced the analytical data. This requirement also applies to interlaboratory transfers of samples or extracts and the data resulting from the analysis of the samples or extracts.

f. Unless otherwise required by permit, program or rule, all records must be retained for a minimum of five years after generation of the last entry in the record. All information required for the historical reconstruction of the data must be maintained by the laboratory. If records are retained only in electronic form, the hardware and software required for the retrieval of electronic records must be retained for the same time period as the records to be retrieved.

g. The records must include the identity of personnel designated by the laboratory as responsible for the task performed, as described in the person's job description. The laboratory must retain records of the signatures and initials of designated personnel.

h. All information relating to the laboratory facilities, equipment, analytical test methods and related laboratory activities, such as sample receipt, sample preparation or data verification, must be documented.

i. The record-keeping system must allow for the retrieval of all working files and archived records for inspection and verification purposes, including, but not limited to, the systematic naming of electronic files.

j. All records must be signed or initialed by personnel designated by the laboratory as responsible for the task performed. All changes must be clearly indicated in the records. The laboratory must have procedures for recording changes and identifying the personnel making the change.

k. All observations used to calculate the final result must be recorded immediately. If the record is handwritten, the record must be legible and in permanent ink.

l. Entries in records must not be obliterated by methods such as erasures, overwritten files or markings. All corrections to records on paper must be made by one line marked through the error. The individual making the correction must sign or initial and date the handwritten or electronic correction.

m. A laboratory must maintain a record-keeping system that includes procedures for protecting the integrity and security of the data.

n. A laboratory must supply any documentation or data within seven calendar days of the date that the accreditation officer requests the information.

06-096 C.M.R. ch. 263, § 8