Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 256 - MAINE MEDICAL LABORATORY RULES › Part ONE - CLIA CERTIFICATION AND STATE-ISSUED LICENSE › Section 144-256-ONE-7 - PERSONNEL

Current through 2024-29, July 17, 2024
7.1
Personnel.
Laboratory
				  personnel must meet state personnel requirements and federal CLIA personnel
				  requirements for medical laboratories including qualifications for laboratory
				  directors, general supervisors, technical supervisors, technical consultants,
				  clinical consultants, and testing personnel.
7.2
Laboratory Director
. Each
				  medical laboratory must have a director who is a legal resident of the State of
				  Maine. See
				  22 M.R.S.A.
				  §2029
7.2.1
Compliance.
The laboratory
				  director is responsible for the medical laboratory's compliance with these
				  rules. See
				   22 M.R.S.A.
				  §2014(3).
7.2.2
Accessible.
The director
				  must be accessible to the laboratory to provide onsite, telephone or electronic
				  consultation as needed.
7.2.3
On-site.
The director, if not a full time employee, must make and
				  document a minimum of monthly visits to the laboratory. Up to one-half of the
				  monthly visits in a six month period may be made by a qualified supervisor on
				  the director's staff.
7.2.4
Limitation.
No individual shall be director of more than 5
				  laboratories that perform CLIA non-waived tests. This limitation applies
				  whether the medical laboratory is licensed or exempt from state
				  licensure.
7.2.5
Absence.
If the director is to be absent for a period exceeding one month, then
				  the director must arrange for another person, qualified to be a laboratory
				  director, to be accessible to laboratory personnel.
7.2.6
Director qualifications.
The laboratory director must comply with state personnel requirements in
				  these rules and with federal CLIA personnel qualifications and requirements.
				  The laboratory director must possess one of the following qualifications:
7.2.6.1
Certification.
The
				  individual is a physician licensed to practice medicine in the State of Maine
				  who is certified by the American Board of Pathology or the American Osteopathic
				  Board of Pathology, or an individual who is a physician who possesses
				  qualifications acceptable to the department that are equivalent to such
				  certification; or
7.2.6.2
Special qualifications.
The individual is a physician licensed to
				  practice medicine with special qualifications acceptable to the department;
				  or
7.2.6.3
Qualified persons
				  other than physicians.
The individual has an earned doctorate degree in
				  a chemical, physical or biological science from an accredited institution and
				  either is certified in at least one laboratory specialty by the American Board
				  of Clinical Chemistry, American Board of Medical Microbiology or other national
				  accrediting board acceptable to the department.
7.2.6.3.1 Medical laboratories directed by
				  persons qualified under 7.2.6.3 must only perform those examinations within the
				  scientific area in which members of the staff are trained and certified. See
				   22 M.R.S.A.
				  §2029(3).
7.2.7
Continued employment.
Individuals qualified and employed as a laboratory director of state
				  licensed medical laboratories prior to the effective date of these rules shall
				  be permitted to continue to function in that capacity as long as they maintain
				  employment at that specific laboratory where they are currently
				  employed.