10-144-263 Me. Code R. § 7

Current through 2024-51, December 18, 2024

Section 144-263-7 - ACCREDITATION

A.Levels of laboratory/method accreditation

1. An accredited laboratory has met the regulatory performance criteria as explained in this rule and as specified by the 40 CFR Part(s) 141, as amended up to July 1, 2022, and/or 40 CFR Part 136 , as updated in the Annual Edition of July 1, 2022, and all other applicable regulatory requirements.

2. A provisionally accredited laboratory has deficiencies but demonstrates its ability to consistently produce valid data within the acceptance limits specified by the 40 CFR Part(s) 141, as amended up to July 1, 2022, and/or 40 CFR Part 136 , as updated in the Annual Edition of July 1, 2022, and within the policies required by this rule. A provisionally accredited laboratory may analyze samples for compliance purposes, if clients are notified in writing of its provisional status and affected methods/analytes are notated on reports as "provisionally accredited." The accreditation officer may not grant provisional accreditation if the accreditation officer determines that the laboratory cannot perform an analysis within the acceptance limits specified by this rule and applicable regulations.

3. A laboratory may not possess accreditation for a method under this rule if, in the opinion of the accreditation officer, the lab is determined to be deficient in performance and cannot consistently produce valid data for that specific method.

B.Awarding accreditation

1. Documentation of a laboratory's accreditation must include:

a. A certificate acknowledging the laboratory's compliance with base accreditation requirements; and

b. The scope of accreditation for the laboratory.

2. The certificate and scope of accreditation must include the:

a. Seal of the State of Maine (certificate only);

b. Name of the laboratory;

c. Physical address of the laboratory;

d. Laboratory identification number issued by the EPA or the program in the absence of an EPA ID;

e. Effective date of the accreditation certificate; and

f. Expiration date of the accreditation certificate.

3. If a laboratory's scope of accreditation changes, the accreditation officer will issue a new scope of accreditation.

4. A laboratory's accreditation is valid for one or two years from the date of awarding base accreditation or renewal of base accreditation, unless conditions warrant initiation of suspension or revocation by proceedings pursuant to 5 MRS §10051 or as otherwise provided for by law.

5. A laboratory must return its certificate and scope of accreditation to the accreditation officer upon revocation of accreditation.

6. An accredited laboratory must not misrepresent its accreditation on any document, including laboratory reports, catalogs, advertising, business solicitations, proposals, quotations or other materials.

7. A laboratory must make available its current certificate and corresponding scope of accreditation, upon the request of a client, accreditation authority or regulatory agency. The laboratory must not supply a copy of its current certificate without the accompanying copy of its scope of accreditation.

C.Denial of accreditation

1. The MLAP may deny a laboratory's request for accreditation, including a request for renewed accreditation, if:

a. The application does not meet the requirements of Section 4;

b. The laboratory's current or prior accreditation has been downgraded or revoked; or

c. The laboratory or one of its owners or employees is currently in violation of this rule.

2. A laboratory which has been denied a request for accreditation may reapply after deficiencies are corrected and/or violations resolved. The application and all required documentation must be accompanied with the applicable fees.

3. The accreditation officer will not refund a base accreditation fee if an application is denied.

D.Downgrading of accreditation to provisional status

1. For deficiencies not affecting the laboratory's ability to produce valid data, the MLAP may downgrade a laboratory's accreditation status to provisional, in total or in part, for a period not to exceed 90 calendar days. If the MLAP determines that there are grounds for downgrading, the MLAP will notify the laboratory in writing by certified mail.

2. If the laboratory does not correct the deficiencies related to the accreditation status downgrade within 90 calendar days, accreditation, in full or in part, will be revoked.

3. A laboratory that has had its accreditation downgraded to provisional status may request reinstatement once deficiencies have been corrected, as long as corrections are completed within the time period prescribed in the notification of downgrading and are done in accordance with the requirements of Section 4.

E.Suspension and reinstatement of accreditation after suspension

1. Grounds for suspension of accreditation are:

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

b. Failure to submit an acceptable corrective action report in response to an inspection or unacceptable proficiency testing results.

2. When the accreditation officer determines that there are grounds for suspension, the accreditation officer must notify the laboratory in writing and may initiate suspension proceedings pursuant to 5 MRS §10051 or as otherwise provided for by law. A laboratory's accreditation may be suspended in total, or in part, for a period not to exceed 180 days or extend beyond the expiration date of the current accreditation.

3. Notice of suspension

a. The effective date of suspension is the date that the laboratory receives the suspension as a result of proceedings pursuant to 5 MRS §10051 or as otherwise provided for by law.

b. Upon receiving the suspension pursuant to 5 MRS §10051 or as otherwise provided for by law, the laboratory must return to the client or subcontract to another Maine accredited laboratory, samples for the field of testing for which the laboratory is suspended.

c. During the suspension period, notification to clients whose samples are subcontracted or returned is required for all fields of testing for which the laboratory's accreditation has been suspended. The notification from the laboratory must be in writing.

d. At the time the notification is sent to the client, the laboratory must submit to the accreditation officer a list of clients who received the notification and one copy of the form letter used for the notification. The laboratory must retain an electronic copy of each notification sent to the client that may be reviewed by the accreditation officer.

4. Reinstatement after suspension for failure to submit corrective action

A laboratory that has had its accreditation suspended may have the accreditation reinstated after acceptable corrective action has been received by the MLAP. Repayment of fees is not required for reinstatement if the laboratory corrects the deficiencies within the time-frame required by the accreditation officer, not to exceed 180 days or the expiration date of the current accreditation, whichever is sooner. If a laboratory takes corrective action before the end of the suspension period, accreditation for the suspended fields of testing or for the base accreditation and fields of testing must be restored if the corrective actions satisfactorily address the deficiencies cited in the notice of suspension. If the laboratory fails to correct the causes of suspension within the specified time frame, the accreditation officer will revoke in total, or in part, the laboratory's accreditation, as authorized.

5. Reinstatement After Proficiency Testing Failure Suspension

A laboratory with a suspended accreditation, due to unacceptable proficiency testing results must submit acceptable proficiency testing results according to Section 10.

F.Revocation of accreditation

The MLAP may initiate proceedings pursuant to 5 MRS §10051 or as otherwise provided for by law to revoke a laboratory's accreditation, in total or in part, if it determines that there are grounds for revocation. The MLAP will notify the laboratory in writing of the initiation of revocation proceedings pursuant to 5 MRS §10051 or as otherwise provided for by law.

1. Grounds for Revocation are:

a. Failure to comply with applicable standards of this rule;

b. Failure to pass an inspection;

c. Failure to respond to deficiencies;

d. Failure to correct the deficiencies cited in a notice of suspension within the time frame specified by the accreditation officer;

e. Failure to implement corrective action related to any deficiencies found during a laboratory inspection;

f. Failure to report compliance data to a public water system, the Drinking Water Program, the DEP or other responsible party in a timely manner or interfering with the reporting of such data produced by other entities;

g. Failure to complete proficiency testing studies and maintain a history of successful proficiency testing studies at the frequency specified in Section 10;

h. Failure to implement corrective action in response to an unacceptable proficiency testing result;

i. Revocation of accreditation or certification by an approving body with which the accreditation officer has deemed equivalent;

j. Careless, inaccurate or falsified reporting of analytical measurements and supporting documentation;

k. Operating the laboratory in such a manner so as to endanger public health or safety;

l. Making an intentionally false oral statement or written statement on any document issued by the laboratory or on any document associated with accreditation;

m. Failure to notify the MLAP in writing within the prescribed time frames, pursuant to Section 8(B), regarding any change in ownership, laboratory name, laboratory location, personnel, equipment or any other factor that could impair the analytical, reporting or operational capability of the laboratory;

n. Unethical conduct in the operation of the laboratory;

o. Fraudulent or deceptive practices;

p. Reporting sample results without indicating whether or not the laboratory is accredited for that analysis;

q. Failure to use an approved method or to follow the approved method for sample analysis where the report issued for the analysis indicates that the analysis was conducted in accordance with program accreditation standards;

r. Denial of entry during normal business hours for an inspection, unless circumstances endangering safety or welfare prohibit entry; or

s. Failure to pay the inspection fee for out-of-state laboratories requiring an on-site inspection.

2. Notice of Revocation

a. The effective date of revocation is the date that the laboratory receives the revocation as a result of proceedings pursuant to 5 MRS §10051 or as otherwise provided for by law.

b. Upon revocation pursuant to 5 MRS §10051 or as otherwise provided for by law, the laboratory must return to the client or subcontract to another MLAP-accredited laboratory, samples for the fields of testing of the revocation.

c. Notification to the client is required for all fields of testing for which the laboratory's accreditation has been revoked. The notification from the laboratory must be in writing.

d. The laboratory must retain an electronic copy of each notification sent to the client, for review by the accreditation officer.

e. At the time that the notification is sent to the client, the laboratory must submit a list of clients who received the notification and one copy of the form letter used for the notification to the accreditation officer.

3. A laboratory that has had its accreditation revoked must not advertise itself as accredited and when possible, must remove or replace any advertisements that indicate that the laboratory is accredited.

4. A laboratory with a revoked accreditation may not reapply for accreditation until it has corrected all written deficiencies. The laboratory must provide documentation of the steps implemented to correct the deficiencies before applying for accreditation according to Section 4.

5. A successor in interest of a laboratory with a revoked accreditation may not apply for reaccreditation until all conditions for re-application after revocation are met.

G.Appeal of administrative decision

1. The accreditation officer will notify a laboratory in writing of the reasons for the administrative decision to deny an application for accreditation or make an accreditation provisional.

2. A laboratory has 30 days from the date of receiving the decision to appeal the decision. A request for an administrative hearing to appeal the decision must:

a. Be in writing;

b. Indicate the facts that the laboratory disputes; and

c. Be signed by the laboratory technical director.

3. Adjudicatory proceedings will be conducted pursuant to 5 MRS, Ch. 375, Sub-Chapter 4.

a. Appeals by a laboratory are limited to appeals contending that a decision by the Department misapplies applicable laws, procedures or rules; or is based upon a significant factual error to the detriment of the laboratory.

b. Administrative hearing requests must state the specific issues being appealed and requests must be directed to:

Maine Center for Disease Control and Prevention

11 State House Station

Augusta, ME 04333-0011

c. Within 14 days of its receipt, the request for an administrative hearing accompanied by an administrative hearing report must be forwarded to:

Department of Health and Human Services

Chief Hearings Officer, Office of Administrative Hearings

11 State House Station

Augusta, ME 04333-0011

d. The administrative hearing is conducted by a hearing officer.

e. The hearing will be conducted pursuant to the rules of the Office of Administrative Hearings, as set forth in the Administrative Hearings Regulations (10-144 CMR Ch 1), and in conformity with 5 MRS Chapter 375, Subchapter 4.

f. A notice will inform the persons of the time, date and place of the hearing. The hearing will be held in Augusta, unless otherwise noted.

g. The hearing officer or the DHHS or DEP Commissioner, as applicable, will issue a written decision of the administrative hearing to all parties.

h. Any person or party dissatisfied with the hearing officer's or the Commissioner's decision has the right of judicial review under the Maine Rules of Civil Procedure, Rule 80 C.

H.Voluntary withdrawal of accreditation

1. If a laboratory chooses to withdraw its application for accreditation or its current accreditation in total, or in part, the laboratory must notify the accreditation officer in writing and specify the effective date of withdrawal.

2. The accreditation officer will consider that a laboratory has chosen to voluntarily withdraw its accreditation if the laboratory has not submitted a complete renewal application by the expiration date of its current accreditation. In this situation, the effective date is the expiration date of the laboratory's current accreditation.

3. By the effective date of the withdrawal of accreditation, in total or in part, the laboratory must notify current clients and regulatory agencies of its intent to withdraw its accreditation and must indicate the effective date of the withdrawal. Notification is required for all fields of testing for which the laboratory has chosen to voluntarily withdraw accreditation. The notification from the laboratory to the client(s) must be in writing. The laboratory must submit to the accreditation officer, at the time the lab is sending notice to clients, one copy of the notification and a list of clients to whom the notice was sent.

4. The accreditation officer will not refund fees if a current accreditation is voluntarily withdrawn by the laboratory.

10-144 C.M.R. ch. 263, § 7