1. (a) The licensee shall provide the department with written notice at least 30 days prior to changes in any of the following:

   1. (1) Ownership;
   2. (2) Physical location;
   3. (3) Address;
   4. (4) Name;
   5. (5) Number of categories authorized under the current license or revisions to the current list of tests performed; or
   6. (6) Services.

2. (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:

   1. (1) A change in ownership;
   2. (2) A change in the physical location;
   3. (3) An increase in the number of categories authorized under the current license; or
   4. (4) A change in services.
3. (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.
4. (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.

5. (e) An inspection by the department shall be conducted prior to operation for:

   1. (1) Ownership, unless the current licensee is in full compliance, in which case an inspection shall be conducted as soon as practicable by department;
   2. (2) The physical location;
   3. (3) A change in the number of categories authorized under the current license;
   4. (4) A change in licensing classification; or
   5. (5) A change that places the facility under a different life safe code occupancy chapter.
6. (f) A new license and license certificate shall be issued for a change in ownership, classification, or physical location.
7. (g) A revised license and license certificate shall be issued for changes in the laboratory name.

8. (h) A revised license certificate shall be issued for any of the following:

   1. (1) A change of administrator;
   2. (2) A change in categories authorized to test;
   3. (3) A change in address without a change in physical location;
   4. (4) A change in the scope of services provided; or
   5. (5) When a waiver has been granted in accordance with He-P 808.10.

9. (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:

   1. (1) A resume identifying the name and qualifications of the new administrator or laboratory director;
   2. (2) Copies of applicable licenses for the new administrator or laboratory director;
   3. (3) The results of a criminal records check to include results for the state of New Hampshire for the new administrator or laboratory director; and
   4. (4) A copy of the signed criminal attestation, as described in He-P 808.17(j), for the new administrator or laboratory director.
10. (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).
11. (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.

12. (l) When there is to be a change in the testing provided, the licensee shall provide the department with:

    1. (1) A description of the testing change(s);
    2. (2) Identification of what additional personnel shall be hired and their qualifications, if applicable;
    3. (3) How the new services shall be incorporated into the infection control and quality improvement programs; and
    4. (4) A description of what changes, if any, shall be made to the physical environment.
13. (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.
14. (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.
15. (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.
16. (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.

Source. #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; ss by #13710, eff 8-2-23