Section He-P 808.21 - Mobile Laboratory Vans(a) Mobile laboratory vans shall be eligible for licensure only if they are: (1) Operated by a laboratory that is located in a building or other permanent structure; and(2) The laboratory in (1) above has a valid license issued by the department in accordance with He-P 808.(b) Each applicant shall comply with He-P 808, except that:(1)He-P 808.07 shall not apply to mobile laboratory vans;(2) In lieu of He-P 808.04(a)(1)-(3) and (5)-(7), each applicant shall submit:a. A copy of the applicant's current laboratory and laboratory services license;b. A valid New Hampshire motor vehicle registration for the mobile laboratory van;c. The VIN of the mobile laboratory van; andd. A space utilization diagram for the mobile laboratory van; and(3) Patient and facility records that are stored off site shall be available for inspection upon request of licensing personnel within 30 minutes of being requested.(c) The laboratory portions of the mobile laboratory van used to collect, process, store, or transport specimens, reagents, or supplies shall have a non-porous floors and work surfaces.(d) Only such tests that are identified as waived in 42 CFR § 493 shall be performed in a mobile laboratory van.(e) Detailed written documentation of travel dates, times, and locations, including periods of non-use, shall be maintained for the mobile laboratory van.(f) Mobile laboratory vans shall record temperatures each day of laboratory use and whenever testing reagents are stored in the van to ensure compliance with manufacturers' instructions for the test system used by the laboratory.N.H. Admin. Code § He-P 808.21
#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.