10-144-256 Me. Code R. § ONE-1

Current through 2024-51, December 18, 2024

Section 144-256-ONE-1 - DEFINITIONS

As used in these rules the following terms have the following meanings, unless the context indicates otherwise.

1.1Approved accreditation organization for laboratories. "Approved accreditation organization for laboratories" means a private, nonprofit accreditation organization that has formally applied for and received approval from the federal Centers for Medicare and Medicaid Services (CMS) based on the organization's compliance with federal CLIA regulations. See 42 Code of Federal Regulations (CFR) Part 493.

1.2Category of testing by complexity. "Category of testing by complexity" means laboratory tests are categorized by complexity as one of the following:

(1) waived tests;

(2) tests of moderate complexity, including provider-performed microscopy (PPM) procedures; or

(3) tests of high complexity. See 42 C.F.R. Part 493.

1.3CMS. "CMS" means the Centers for Medicare and Medicaid Services, U. S. Department of Health and Human Services.

1.4CLIA. "CLIA" means the federal Clinical Laboratory Improvement Amendments of 1988, as amended. Federal CLIA regulations apply to all laboratories that perform testing on human specimens. See 42 C.F.R. Part 493.

1.5CLIA Certificate. "CLIA Certificate" means any of the following types of certificates issued by CMS or its agent:

1.5.1Certificate of Compliance. A "Certificate of Compliance" means a certificate issued to a laboratory after a CLIA inspection that finds the laboratory to be in compliance with all applicable condition level requirements.

1.5.2Certificate for Provider-Performed Microscopy (PPM) Procedures. A "Certificate for Provider-Performed Microscopy (PPM) Procedures" means a certificate issued to a laboratory in which a physician, midlevel practitioner or dentist performs no tests other than PPM procedures and, if desired, waived tests.

1.5.3Certificate of Accreditation. A "Certificate of Accreditation" means a certificate issued based on the laboratory's accreditation by an accreditation organization approved by CMS, indicating that the laboratory is held to have met applicable CLIA requirements.

1.5.4Certificate of Registration. A "Certificate of Registration" or "registration certificate" means an issued certificate that enables the entity to conduct moderate or high complexity laboratory testing or both prior to a survey by CMS or its agent, or accreditation by an approved accreditation organization.

1.5.5Certificate of Waiver. A "Certificate of Waiver" means a certificate issued by CMS to a laboratory to perform only the list of waived tests approved by federal law. See 42 CFR Part 493.

1.6Department. Unless otherwise indicated, "department" means the Maine Department of Health and Human Services or DHHS.

1.7Directed plan of correction. "Directed plan of correction" is an enforcement measure that directs a medical laboratory or a Health Screening Laboratory (HSL)to take specific corrective action within specific periods in order to achieve regulatory compliance.

1.8Director of medical laboratory. "Director of medical laboratory" means an individual who is responsible for the professional, technical and scientific operation of a medical laboratory, including the reporting of the findings of medical laboratory tests. The director of a medical laboratory may not be merely nominal, but must be responsible for its operation to such extent as may be necessary to assure compliance with these rules. See 22 M.R.S.A. §2014(3).

1.9Exempt laboratory. "Exempt laboratory" means a medical laboratory that does not have to secure a state license to operate a medical laboratory. Exempt medical laboratories must be CLIA certified. See 22 M.R.S.A. §2013-A(1).

1.10Final agency action. "Final agency action" means a decision by DHHS that affects the legal rights, duties or privileges of specific persons, which is dispositive of all issues, legal and factual, and for which no further recourse, appeal or review is provided within DHHS. See 5 M.R.S.A. §8002(4).

1.11Health screening laboratory (HSL). "Health screening laboratory" (HSL) means a testing site that is not at a fixed location that performs only approved health screening tests for the public. A permit is required to operate a HSL.HSL testing is for screening purposes only and not for diagnostic purposes. HSLs include but are not limited to screening laboratories that move from testing site to testing site such as mobile units providing laboratory screening tests at health fairs, or other temporary screening test locations. See 22 M.R.S.A. §2013-A(1)(G).

1.11.1 A HSL does not include a workplace health screening event for employees only.

1.12Laboratory personnel. "Laboratory personnel" means personnel that meet state personnel requirements and federal CLIA personnel requirements for medical laboratories. CLIA personnel requirements include qualifications for laboratory directors, technical supervisors, general supervisors, technical consultants, clinical consultants and testing personnel. See 42 CFR Part 493, Subpart B (waived testing) and Subpart M (non-waived testing).

1.13Licensee. "Licensee" means an individual, corporation, partnership, association or similar entity that has beenissued a Maine medical laboratory license.

1.14Medical Laboratory. "Medical Laboratory" or "laboratory" means any institution, building or place that provides through its ownership or operation an entity for the examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. See 42 CFR Part 493, Subpart A and 22 M.R.S.A. §2014(4).

1.15Midlevel practitioner. "Midlevel practitioner" means a licensed nurse midwife, nurse practitioner or physician assistant. See 42 C.F.R. Part 493, Subpart A.

1.16Nonexempt laboratory. "Nonexempt laboratory' means a medical laboratory that must secure a state license to operate a medical laboratory. Nonexempt medical laboratories must be CLIA certified. See 22 M.R.S.A. §2013-A.

1.17Owner. "Owner" means a person, corporation, partnership, association or similar entity that owns any interest in the laboratory.

1.17.1Exception. A person with an interest in a laboratory whose stock or securities are publicly traded is not an "owner" for the purposes of these rules. See 42 C.F.R. Part 493, Subpart A.

1.18Permit. For the purposes of these rules, "permit" means a department-issued document authorizing a laboratory to perform health screening tests as set out in PART TWO of these rules.

1.19Person. "Person" means any individual, corporation, partnership, association or similar entity.

1.20Reference laboratory. "Reference laboratory" means a medical laboratory that accepts referrals from other entities to perform laboratory testing on the other entity's patients.

1.21Resident of Maine. "Resident of Maine" means an individual living in the state with the intention of making a home in Maine. Proof of residency includes but is not limited to a Maine driver's license or a non-driver photo identification card issued by Maine.

1.22Waived Test. "Waived test" means a test system, assay or examination that meets the federal CLIA statutory waiver criteria and is listed as a waived test approved by federal law.

10-144 C.M.R. ch. 256, § ONE-1