Section 144-256-ONE-7 - PERSONNEL7.1Personnel. 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.7.2Laboratory Director. Each medical laboratory must have a director who is a legal resident of the State of Maine. See 22 M.R.S.A. §20297.2.1Compliance. The laboratory director is responsible for the medical laboratory's compliance with these rules. See 22 M.R.S.A. §2014(3).7.2.2Accessible. The director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed.7.2.3On-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.7.2.4Limitation. 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.7.2.5Absence. 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.7.2.6Director 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: 7.2.6.1Certification. 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; or7.2.6.2Special qualifications. The individual is a physician licensed to practice medicine with special qualifications acceptable to the department; or7.2.6.3Qualified 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).7.2.7Continued 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.7.3Laboratory personnel. Laboratory personnel must meet state personnel requirements and federal CLIA personnel requirements for medical laboratories. See Section 1.12 of these rules.10-144 C.M.R. ch. 256, § ONE-7