Section He-P 808.03 - Definitions(a) "Administrator" means the licensee or an individual appointed by the licensee who has responsibility for all aspects of the daily operations of the laboratory.(b) "Applicant" means an individual, agency, partnership, corporation, government entity, association, or other legal entity seeking a license for a laboratory pursuant to RSA 151:2, I(c).(c) "Area of non-compliance" means any action, failure to act, or other set of circumstances that cause a licensee to be out of compliance with RSA 151, He-P 808, or other federal or state requirements.(d) "Change of ownership" means the transfer in the controlling interest of an established laboratory to any individual, agency, partnership, corporation, government entity, association, or other legal entity.(e) "Clinical laboratory improvement amendments (CLIA)" means the requirements outlined at 42 CFR Part 493 which set forth the conditions that all laboratories need to meet to be certified to perform testing on human specimens.(f) "Patient" means any person receiving services from a laboratory licensed in accordance with RSA 151 and He-P 808.(g) "Patient record" means a separate file maintained for each patient, which includes all documentation required by RSA 151 and He-P 808, and as required by federal and state law.(h) "Commissioner" means the commissioner of the department of health and human services or the commissioner's designee.(i) "Days" means calendar days unless otherwise specified in the rule.(j) "Department" means the New Hampshire department of health and human services.(k) "Directed plan of correction" means a plan developed and written by the department that specifies the necessary actions the licensee must take to correct identified deficiencies.(l) "Emergency" means an unexpected occurrence or set of circumstances, which requires immediate, remedial attention.(m) "Emergency plan" means a document outlining the responsibilities of personnel in an emergency.(n) "Enforcement action" means the imposition of an administrative fine, the denial of an application, or the revocation or suspension of a license in response to non-compliance with RSA 151 or He-P 808.(o) "Facility" means "facility" as defined in RSA 151:19, II.(p) "Incident command system (ICS)" means a standardized on-scene emergency management system specifically designed to provide for the adoption of an integrated organizational structure that reflects the complexity and demands of single or multiple incidents, without being hindered by jurisdictional boundaries. ICS is the combination of facilities, equipment, personnel, procedures, and communications operating within a common organizational structure, designed to aid in the management of resources during incidents.(q) "Independent contractor" means an individual or business entity working under the supervision of the licensee but not employed by the licensee.(r) "Infectious waste" means those items specified by Env-Sw 904.(s) "Inspection" means the process followed by the department to determine an applicant or a licensee's compliance with RSA 151 and He-P 808 or to respond to allegations, pursuant to RSA 151:6, of non-compliance with RSA 151 and He-P 808.(t) "Laboratory" means any building, place, or mobile laboratory van, for the biological, microbiological, serological, chemical, immunohematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.(u) "Laboratory director" means the person who shall provide overall management and direction for all laboratory testing procedures.(v) "License" means the document issued to an applicant or licensee of a laboratory which authorizes operation, in accordance with RSA 151 and He-P 808, and includes the name of the licensee, the name of the business, the physical address, the license category, the effective date, and the license number.(w) "License certificate" means the document issued by the department to an applicant or licensee that, in addition to the information contained on a license, includes the name of the administrator and the type(s) of services authorized that the laboratory is licensed for.(x) "Licensed premises" means the building(s), other structure(s), or mobile laboratory vans, that comprises the physical location the department has approved for the licensee to conduct operations in accordance with its license. It does not include the private residence of a patient receiving services from an agency licensed under the authority of RSA 151.(y) "Licensee" means any individual, agency, partnership, corporation, federal, state, county or local government entity, association, or other legal entity to which a license has been issued pursuant to RSA 151.(z) "Licensing classification" means the specific category of services authorized by a license.(aa) "Life safety code" means the adoption by reference of the life safety code, as published by the National Fire Protection Association and as amended by the state board of fire control and ratified by the general court pursuant to RSA 153:5.(ab) "Mobile laboratory van" means a vehicle capable of traveling under its own power or being towed from site to site and fully equipped to meet all the requirements specified in section He-P 808.21.(ac) "Modification" means the reconfiguration of any space, the addition, relocation, or elimination of any door or window, the addition or elimination of load-bearing elements, the reconfiguration or extension of any system, or the installation of any additional equipment. The term does not include "repair" or "replacement" of interior finishes.(ad) "Owner" means any person, corporation, association, or any other legal entity, whether organized for profit or not, holding or claiming ownership of, or title to, a license.(ae) "Patient rights" means the privileges and responsibilities possessed by each patient provided by RSA 151:21.(af) "Personnel" means an individual who is employed by the licensee, a volunteer, or an independent contractor.(ag) "Plan of correction (POC)" means a plan developed and written by the licensee, which specifies the actions that will be taken to correct areas of non-compliance with applicable rules or codes identified at the time of the clinical or life safety inspection conducted pursuant to RSA 151:6-a or during the course of complaint investigation conducted pursuant to RSA 151:6.(ah) "Procedure" means a licensee's written, standardized method of performing duties and providing services.(ai) "Qualification" means education, experience, and skill requirements specified by the federal government, state government, an accredited professional review agency, or by policy of the licensee.(aj) "State building code" means "state building code" as defined in RSA 155-A:1, IV.(ak) "State fire code" means "state fire code" as defined in RSA 153:1.(al) "State monitoring" means the placement of individuals by the department at a laboratory to monitor the operation and conditions of the facility.(am) "Specimen" means a portion of tissue, body fluid, or material from a human body.(an) "Technical consultant" means an individual qualified as a technical consultant by 42 CFR § 493.1411.(ao) "Volunteer" means an unpaid person who assists with the provision of laboratory services, and who does not provide direct care or services to patients.(ap) "Waived testing" means all laboratory tests categorized as waived by 42 CFR § 493.(aq) "Waiver" means a request for an alternative means of satisfying a rule requirement in He-P 808.N.H. Admin. Code § He-P 808.03
#2192, eff 11-25-82; ss by #3193, eff 1-28-86; ss by #5317, EMERGENCY, eff 1-29-92, EXPIRED: 5-28-92
New. #5758, eff 12-20-93, EXPIRED: 12-20-99
New. #8409, eff 8-19-05; ss by #8852, eff 3-24-07; ss by #10267, eff 2-2-13
Amended by Number 37, Filed September 14, 2023, Proposed by #13710, Effective 8/2/2023, Expires 8/2/2033