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Title: Section 34-2.2 - Definitions

Effective Date


34-2.2 Definitions. Whenever used in this Subpart, the following terms shall have the following meanings:

(a) Agent means an individual who agrees, pursuant to a written agreement with another, the principal, to act on behalf of, instead of, and subject to the authority and control of, the principal with regard to acts described in the agreement and to perform such acts with individual good faith, loyalty and fidelity to the principal.

(b) Clinical laboratory means a facility for the microbiological, immunological, chemical, hematological, biophysical, cytological, pathological, genetic or other examination of materials derived from the human body, for the purpose of obtaining information for the diagnosis, prevention or treatment of disease, or the assessment of a health condition, or for identification purposes. Such examinations shall include procedures to determine, measure, or otherwise describe the presence or absence of various substances, components or organisms in the human body. Clinical laboratory does not mean any facility or activity specifically excluded by section 579 of the Public Health Law.

(c) Clinical laboratory services means examinations, tests and/or analyses performed by a clinical laboratory.

(d) Consideration means anything of value or benefit, in cash or in kind.

(e) Contract for laboratory management services means a legally enforceable written agreement between a clinical laboratory under department permit and a hospital or a health maintenance organization, whereby the contracting clinical laboratory:

(1) agrees to provide laboratory management services at fair market value at a facility of a contracting hospital; or

(2) agrees to provide laboratory management services at fair market value at a facility of a contracting health maintenance organization; or

(3) agrees to provide clinical laboratory services at the laboratory’s facility, and directly related services, all at fair market value, pursuant to a referral by the contracting hospital or health maintenance organization.

(f) Department means the New York State Department of Health.

(g) Directly related equipment and supplies means equipment and supplies provided by a clinical laboratory to a referring health services purveyor of a size, type and quantity reasonably related to the type and number of specimens being referred by the health services purveyor to the clinical laboratory, and which are used by the referring health services purveyor solely and exclusively for the collection, processing, storage, preservation, transport, or disposal of specimens, and which have no generally accepted use in health care practices other than solely for the collection, processing, storage, preservation, transport, or disposal of specimens.

(h) Directly related services means the following services, which are or can be performed by a clinical laboratory and are integral to the clinical laboratory services performed on referred specimens:

(1) the collection, processing, storage, preservation, transport, acceptance, or disposal of referred specimens;

(2) the reporting of test results to the referring health services purveyor; or

(3) the receipt, storage and transmittal of information between the clinical laboratory and the health services purveyor necessary for test ordering, requisitioning, reporting or billing.

(i) Fair market value means that value, calculated in monetary terms and not by bartering, in arms length transactions, consistent with general market value. The fair market value of clinical laboratory services is deemed to include the value of directly related equipment and supplies, and directly related services. With respect to rentals or leases of property and space, fair market value shall be:

(1) consistent with the value of rental property for general commercial purposes, not taking into account the property's intended use; and

(2) not adjusted to reflect the additional value the prospective lessee or lessor would attribute to the proximity or convenience to the lessor, where the lessor is a potential source of patient referrals to the lessee.

(j) Financial relationship means an ownership interest, investment interest or compensation arrangement, as those terms are defined or used in Public Health Law sections 238 and 238-a.

(k) Functions directly related to clinical laboratory operations means functions which are necessary and integral to, and have as their sole and exclusive purpose, the operation of a clinical laboratory, and may include clinical laboratory services and directly related services.

(l) Governmental agency means a department, board, bureau, division, office, agency, public benefit or other corporation, or any other unit, however described, of a state or of a political subdivision of a state, or the federal government.

(m) Health maintenance organization (HMO) means an organization operating in accordance with article 43 of the Insurance Law or article 44 of the Public Health Law, and includes an agent of the health maintenance organization.

(n) Health or health related services includes, but is not limited to, items and services available under the New York State Medical Assistance Program (Medicaid).

(o) Health services purveyor (HSP) means any person, firm, partnership, group, association, business corporation, not-for-profit corporation, professional corporation, limited liability company, or any agent, employee, fiduciary, employer or representative thereof, including, but not limited to, an entity that provides health related services, a physician, dentist, podiatrist, chiropractor, either in individual practice, group practice or employed in a facility owned by any person, group, association, firm, partnership, business corporation, not-for-profit corporation, professional corporation, limited liability company, hiring any one of the aforementioned practitioners who provides health or health related services.

(p) Hospital means a facility or institution defined in Public Health Law section 2801(1).

(q) Immediate family member means any of the following, whether natural or adoptive: spouse; parent; child and sibling; stepparent, stepchild and stepsibling; father-in-law, mother-in-law, brother-in-law, sister-in-law, son-in-law and daughter-in-law; or grandparent and grandchild.

(r) Industrial firm means any employer, including, but not limited to:

(1) an agent of an employer; or

(2) an employer or employers who establish(es) or maintain(s) a single-employer or multi-employer employee benefit plan under the Employee Retirement Income Security Act of 1974 as amended (ERISA); or

(3) or an agent of an employee benefit plan.

(s) Insurance carrier includes, but is not limited to:

(1) an insurance carrier used by an employer; or

(2) the agent of an insurance carrier.

(t) Laboratory management services means some or all services necessary for the operation of a clinical laboratory, including but not limited to:

(1) directly related services; or

(2) services performed by a clinical laboratory employee, provided the services are directly related to clinical laboratory operations, and, provided that phlebotomy services, if rendered, are accompanied by actual clinical laboratory services by the laboratory providing the employee.

(u) Legal relative means an individual with legal authority to act on behalf of the recipient of services.

(v) Patient service center (PSC) is synonymous with collecting station or collecting depot, and means a facility, fixed or mobile, operated by a clinical laboratory for the collection, drawing and temporary storage of materials derived from the human body until such material is forwarded to a clinical laboratory for clinical laboratory services.

(w) Purveyor, as used in section 586 of the Public Health Law, means a clinical laboratory that does not receive from any health care practitioner or private medical practice having an ownership interest in the clinical laboratory any referrals for clinical laboratory services for patients of such health care practitioner or private medical practice. Notwithstanding any provision to the contrary, the term purveyor shall include any clinical laboratory owned by a hospital licensed pursuant to Article 28 of the Public Health Law or any clinical laboratory that is owned and operated by a publicly traded corporation.

(x) Residence means the location at which a test subject resides, whether on a temporary or permanent basis, and whether or not the living arrangement is voluntary, and is not necessarily the subject’s legal residence.

(y) Trade union health facility means:

(1) a facility owned and operated by trade union to provide health or health related services to its members or their families; or

(2) an agent of a trade union health facility.


VOLUME A-1 (Title 10)