10-144 C.M.R. ch. 263, § 5 - LABORATORY INSPECTION

A. Laboratory inspection

1. The accreditation officer must conduct a comprehensive on-site inspection of each laboratory located within the State of Maine, prior to granting accreditation. In addition, an on-site inspection of each Maine accredited laboratory may be completed every two years.

2. The accreditation officer may notify the laboratory prior to arrival at the facility or may conduct an inspection without prior notice at any time during normal business hours to verify compliance with this rule.

3. When the accreditation officer determines, after inspection that a Maine accredited laboratory does not comply with applicable provisions of this rule, the accreditation officer must notify the laboratory of the deficiencies in writing within 30 days of inspection by issuing a notice referred to as the initial on-site assessment report.

4. Additional on-site inspections, scheduled or unannounced, may be conducted to resolve problems indicated by deficiencies found during prior on-site inspections or when there is a change of location, key personnel or equipment, or to resolve a complaint. If the deficiencies listed in a previous on-site inspection report are substantial or numerous, an additional onsite inspection may be conducted before a final decision for accreditation is made.

5. A laboratory must remedy any deficiencies and provide documentation of the correction to the accreditation officer.

a. Within 30 days of receiving the initial on-site assessment report of deficiencies, the laboratory must submit responses and documentation of corrective actions implemented and planned.

i. If the laboratory does not provide responses and documentation of corrective action within 30 days, the accreditation officer must notify the laboratory that its accreditation may be suspended in total or in part.

ii. If the laboratory does not provide any documentation of deficiency corrections within 30 days following the notification of possible suspension, the accreditation officer will notify the laboratory that its accreditation is revoked in total.

b. When the accreditation officer determines, after review of the laboratory responses to the initial on-site assessment report and review of documentation of corrective actions, that the corrective actions do not comply with applicable provisions of this rule, the accreditation officer will notify the laboratory, in writing, of the deficiencies within 30 days of the receipt of laboratory responses and documentation. This notice issued by the accreditation officer is referred to as the follow-up report.

c. Within 30 days of receiving the follow-up report from the accreditation officer, the laboratory must submit responses and documentation of corrective actions addressing the deficiencies noted in the follow-up report. If the laboratory does not provide acceptable documentation of corrective actions within 30 days of receiving the follow-up report, the accreditation officer will notify the laboratory that its accreditation may be suspended in total or in part pursuant to the Maine Administrative Procedure Act at 5 MRS §10051 or as otherwise provided for by law.

If the laboratory does not provide any documentation within 30 days of notification of possible suspension, the accreditation officer may institute suspension or revocation proceedings, in total or in part, pursuant to 5 MRS §10051 or as otherwise provided for by law.

d. When all deficiencies indicated in the initial on-site assessment report have been addressed satisfactorily, the MLAP will acknowledge the closing of the assessment in writing with an Acceptable Corrective Action Plan (ACAP) letter.

6. A laboratory may not reapply for accreditation after suspension or revocation until it has corrected all deficiencies. After all deficiencies are corrected, the laboratory may apply for accreditation according to Section 4. With its new application, the laboratory must submit written documentation of the steps employed to correct the deficiencies.

7. At the discretion of the accreditation officer, third-party assessors may be used for inspection purposes by the MLAP.

B. Equivalency of laboratories in other states

1. A laboratory in another state may request accreditation in Maine. This request is performed through an equivalency determination of the program of the state in which the laboratory is located or through equivalency determination of the federal agency which accredits or certifies the laboratory. A laboratory in another state must submit the resident state or federal agency's accreditation or certification program requirements for review prior to the accreditation request.

a. If the resident state does not offer the specific program for which the laboratory is requesting accreditation, the accreditation officer may consider equivalency through another accreditation or certification which the laboratory holds. This accreditation program must be with a state or federal entity.

2. The accreditation officer will determine if the accrediting or certifying program of federal agencies and agencies of other states are substantially equivalent. Equivalency will be based on a comparison between this rule and the laboratory's resident state or federal agency's accreditation or certification program requirements. For a program to be determined equivalent, the program's criteria must be at least as stringent as stated in this rule.

3. An accreditation or certification program is not considered equivalent if:

a. Inspections of accredited or certified laboratories are performed at intervals exceeding three years; or

b. The accrediting or certifying agency does not require an acceptable corrective action response with supporting documentation from the laboratory as required under Section 8; or

c. The accrediting or certifying agency is not the primary authority to initiate necessary enforcement actions, such as suspension or revocation of the laboratory's accreditation/certification.

4. When a program is deemed equivalent, the accreditation officer will accredit an out-of-state laboratory that:

a. Submits an application meeting the requirements of Section 4;

b. Submits the appropriate fees;

c. Provides a copy of current accreditation or certification from the resident state or federal agency;

d. Provides a copy of the accrediting or certifying authority's most recent inspection report and complete responses; and

e. Fulfills proficiency testing requirements of Section 10.

5. When a program is not deemed equivalent, the accreditation officer may accredit an out-of state laboratory that meets the requirements of this rule as determined by:

a. A review of an application meeting the requirements of Section 4;

b. Submission of the appropriate fees, including an on-site inspection fee for out-of state laboratories;

c. Inspection under the requirements of Section 5(A); and

d. Fulfillment by the laboratory of proficiency testing requirements.

6. A laboratory accredited under this sub-section must notify the accreditation officer within 14 days after any enforcement action is assessed by the laboratory's primary accrediting or certifying authority.

7. A laboratory accredited under this sub-section must notify the accreditation officer within 14 days after any adverse change in accreditation or certification status is assessed by the laboratory's primary accrediting or certifying authority. The notification from the laboratory must contain an indication of the changes to the list of analytes.

8. Laboratories accredited under equivalency must comply with the applicable requirements of this rule. Mobile laboratories may not apply for equivalency.

9. Out-of-state laboratory inspection. If a laboratory located in another state is accredited by MLAP and is not scheduled for inspection by the laboratory's primary accrediting or certifying authority of that state prior to the period specified in that state's rules, MLAP must be notified 60 days prior to the two-year anniversary of the last complete inspection of the laboratory.

Notes

10-144 C.M.R. ch. 263, § 5