Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 263 - MAINE COMPREHENSIVE AND LIMITED ENVIRONMENTAL LABORATORY ACCREDITATION RULE › Section 144-263-5 - LABORATORY INSPECTION

Current through 2024-29, July 17, 2024
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.