New Hampshire Code of Administrative Rules
He - Department of Health and Human Services
Subtitle He-P - Former Division of Public Health Services
Chapter He-P 800 - RESIDENTIAL CARE AND HEALTH FACILITY RULES
Part He-P 808 - LABORATORIES AND LABORATORY SERVICES RULES
Section He-P 808.08 - Laboratory Requirements for Organizational Changes
Current through Register No. 40, October 3, 2024
(a) The licensee shall provide the department with written notice at least 30 days prior to changes in any of the following:
(b) The laboratory shall complete and submit a new application form, required by He-P 808.04(a)(1), and obtain a new or revised license, license certificate, or both, as applicable, prior to operating, for:
(c) When there is to be a change of address without a change in location, the laboratory shall provide the department with a copy of the notification from the local, state, or federal agency that requires the address change.
(d) When there is a change in the name, the laboratory shall submit to the department a copy of the certificate of amendment from the New Hampshire secretary of state, if applicable.
(e) An inspection by the department shall be conducted prior to operation for:
(f) A new license and license certificate shall be issued for a change in ownership, classification, or physical location.
(g) A revised license and license certificate shall be issued for changes in the laboratory name.
(h) A revised license certificate shall be issued for any of the following:
(i) The laboratory shall inform the department, in writing, when there is a change in administrator or laboratory director no later than 5 days prior to a change, or as soon as practicable in the event of a death or other extenuating circumstances requiring an administrator or laboratory director change, and provide the department with the following:
(j) Upon review of the materials submitted in accordance with (i) above, the department shall make a determination as to whether the administrator or laboratory director meets the qualifications for the position as specified in He-P 808.14(e)(6) and He-P 808.14(e)(6).
(k) If the department determines that the new administrator or laboratory director does not meet the qualifications, it shall so notify the program in writing so that a waiver can be sought or the licensee can search for a qualified candidate.
(l) When there is to be a change in the testing provided, the licensee shall provide the department with:
(m) The department shall review the information submitted under (l) above and determine if the added services shall be provided under the licensee's current license.
(n) The laboratory shall inform the department, in writing via email, fax, or mail, of any change in the e-mail address no later than 10 days of the change. The department shall use email as the primary method of contacting the facility in the event of an emergency.
(o) A restructuring of an established laboratory that does not result in a transfer of the controlling interest of the facility, but which might result in a change in the name of the facility or corporation, shall not constitute a change in ownership and a new license shall not be required.
(p) If a licensee chooses to cease operation of a laboratory, the licensee shall submit written notification to the department at least 60 days in advance which shall include a written closure plan.
#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