N.H. Admin. Code § He-P 808.12

Current through Register No. 45, November 7, 2024

Section He-P 808.12 - Administrative Remedies

(a) The department shall impose administrative remedies for violations of RSA 151, He-P 808, or other applicable licensing rules, including:

(1) Requiring a licensee to submit a POC in accordance with (c) below;

(2) Imposing a directed POC upon a licensee in accordance with (d) below;

(3) Imposing conditions upon a licensee; or

(4) Monitoring a licensee.

(b) When administrative remedies are imposed, the department shall provide a written notice, as applicable, which:

(1) Identifies each area in which the licensee is not in compliance with RSA 151 or a provision of He-P 808; and

(2) Identifies the specific remedy(s) that has been proposed.

(c) A POC shall be developed and enforced in the following manner:

(1) Upon receipt of a notice of the areas of non-compliance the licensee shall submit a POC detailing:

a. How the licensee intends to correct each area of non-compliance;

b. What measures will be put in place, or what system changes will be made to ensure that the non-compliance does not recur;

c. The date by which each area of non-compliance shall be corrected; and

d. The position of the employee responsible for the corrective action.

(2) The licensee shall submit a POC to the department within 21 days of the date on the letter that transmitted the statement of findings unless the licensee requests, either verbally or in writing, and the department agrees, to extend that deadline, based on the following criteria:

a. The licensee demonstrates that he or she has made a good faith effort, as verified by documentation or other means, to develop and submit the POC within the 21 day period but has been unable to do so; and

b. The department determines that the health, safety, or well-being of a patient will not be jeopardized as a result of granting the extension;

(3) The department shall review each POC and accept each POC that:

a. Achieves compliance with RSA 151 and He-P 808;

b. Addresses all areas of non-compliance as cited in the statement of findings;

c. Prevents a new violation of RSA 151 or He-P 808 as a result of the implementation of the POC; and

d. Specifies the date upon which the areas of non-compliance shall be corrected;

(4) If the POC is acceptable, the department shall issue a license certificate or provide written notification of acceptance of the POC, whichever is applicable;

(5) If the POC is not acceptable, the department shall notify the licensee, in writing, within 14 days of the reason for rejecting the POC;

(6) The licensee shall develop and submit a revised POC within 14 days of the date of the written notification from the department that states the original POC was rejected, unless within the 14 day period the licensee requests an extension, either via telephone or in writing, and the department grants the extension based on the following criteria:

a. The licensee demonstrates that he or she has made a good faith effort, as verified by documentation or other means, to develop and submit the POC within the 14 day period but has been unable to do so; and

b. The department determines that the health, safety, or well-being of a patient will not be jeopardized as a result of granting the extension;

(7) The revised POC shall comply with (c)(1) above and be reviewed in accordance with (c)(3) above;

(8) If the revised POC is not acceptable to the department or is not submitted within 14 days of the date of the written notification from the department that states the original POC was rejected, the licensee shall be subject to a directed POC in accordance with He-P 808.12(d) and a fine in accordance with He-P 808.13(c)(9);

(9) The department shall verify the implementation of any POC that has been submitted and accepted by:

a. Reviewing materials submitted by the licensee;

b. Conducting a follow-up inspection; or

c. Reviewing compliance during the next annual inspection;

(10) Verification of the implementation of any POC shall only occur after the date of completion specified by the licensee in the plan; and

(11) If the POC has not been implemented by the completion, at the time of the next inspection, the licensee shall be:

a. Notified by the department in accordance with He-P 808.12(b); and

b. Issued a directed POC in accordance with He-P 808.12(d).

(d) The department shall develop and impose a directed POC that specifies corrective actions for the applicant or licensee to implement when:

(1) As a result of an inspection, areas of non-compliance were identified that require immediate corrective action to protect the health, safety, and well-being of patients and personnel;

(2) A revised POC is not submitted within 14 days of the written notification from the department or such other date as applicable if an extension was granted by the department; or

(3) A revised POC submitted by the licensee or administrator has not been accepted.

(e) If at the time of the next inspection, the directed POC referenced in (d) above has not been implemented by the completion date stated in the directed POC, the department shall, as appropriate:

(1) Issue a warning that enforcement action will be taken if the POC is not implemented;

(2) Impose a fine;

(3) Deny the application of a license in accordance with He-P 808.13(b); or

(4) Revoke the license in accordance with He-P 808.13(b).

(f) The department shall offer an opportunity for informal dispute resolution to any applicant or licensee who disagrees with an area or areas of non-compliance cited by the department on a statement of findings, provided that the applicant or licensee submits a written request for an informal dispute resolution.

(g) The informal dispute resolution shall be requested in writing by the applicant, licensee, or program director no later than 14 days from the date the statement of findings was issued by the department.

(h) The department shall change the statement of findings if, based on the evidence presented, the statement of findings is determined to be incorrect. The department shall provide written notice to the applicant or licensee of the determination.

(i) The deadline to submit a POC, in accordance with (c) above, shall not apply until the notice of the determination in (h) above has been provided to the applicant or licensee.

(j) Any violations cited for the State Fire Code may be appealed to the New Hampshire state fire marshal and shall not be the subject of informal dispute resolutions as described in this section.

(k) An informal dispute resolution shall not be available for any applicant or licensee against whom the department has imposed a fine or initiated action to suspend, revoke, deny, or refuse to issue or renew a license.

(l) The department shall impose state monitoring under the following conditions:

(1) Repeated non-compliance on the part of the facility in areas that impact health, safety, or well-being of patients; or

(2) The presence of conditions in the laboratory that negatively impact the health, safety, or well-being of patients.

(3) Concern that the facility is not ending the pattern of citations for violations of licensing rules and coming into compliance with those rules; or

(4) Conditions exist for implementation of temporary management as described in (n) below but no temporary manager can be found.

(m) The department shall appoint a temporary manager to assume operation of a laboratory when, following an inspection, the department determines that:

(1) The licensee has repeatedly failed to manage and operate the laboratory in compliance with RSA 151 and He-P 808 and such laboratory practices have adversely impacted the health, safety, or well-being of patients;

(2) The licensee has failed to develop or implement policies and procedures for infection control, sanitation, or life safety codes, which results in imposing harm or the potential for harm to the patients; or

(3) The health, safety, and well-being of the patients are at risk and emergency action is required.

N.H. Admin. Code § He-P 808.12

#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