Current through Register No. 40, October 3, 2024
(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.
#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
