Current through Register Vol. 47, No. 17, September 10, 2024
Basis and Purpose - 8035
The statutory authority for this rule includes but is not
limited to sections
44-50-202(1)(b),
44-50-203(1)(b),
44-50-203(1)(g),
44-50-203(1)(j),
44-50-203(2)(i),
44-50-203(2)(k),
and 44-50-203(2)(p),
C.R.S. The purpose of this rule is to establish specific records a Healing
Center must maintain on the Licensed Premises and the requirement for a Healing
Center to maintain the confidentiality of personally identifying information
and medical data in records.
A. A
Healing Center must maintain records required by this Rule and Rule
3010.
B. A Healing Center must
maintain copies of:
1. All Facilitator
licenses, issued by the Department of Regulatory Agencies, for Facilitators
providing Natural Medicine Services at the Healing Center.
2. All Natural Medicine Handler License(s) or
Owner License(s), issued by the State Licensing Authority for Facilitators
providing Natural Medicine Services at the Healing Center.
3. Any Adverse Health Events required to be
reported in Rule 3015.
C.
A Healing Center must maintain a log of Administration Sessions. The Healing
Center must submit all prior year Administration Session logs required in this
Rule in accordance with Rule 2130. Administration Session logs must include at
least the following information:
1. The date
and duration of each Administration Session;
2. The number of Participants in each
Administration Session;
3. The
License numbers for Facilitators participating in each Administration
Session;
4. The package number,
dose, and type of Regulated Natural Medicine or Regulated Natural Medicine
Product the Participant(s) consumed;
5. Deidentified information regarding the
intention or desired outcome for the Administration Session, including whether
the Administration Session is intended to treat physical or behavioral
conditions, or is for wellness services;
6. Any other food or beverages that were
consumed during the Administration Session; and
7. Any amount of Regulated Natural Medicine
that is disposed of as Regulated Natural Medicine Waste following each
Administration Session.
D.
Standard Operating
Procedures. A Healing Center must maintain the following standard
operating procedures on the Licensed Premises and provide copies of these
standard operating procedures to all employees, Natural Medicine Handler
Licensees, and Owner Licensees. The standard operating procedures required by
this Rule may be contained in a single document maintained by the Healing
Center.
1.
Administration Session
Preparedness Plan. The Administration Session preparedness plan
must address how Healing Center employees, Natural Medicine Handler Licensees,
and Owner Licensees will monitor a Participant's access to the Licensed
Premises after consuming Regulated Natural Medicine or Regulated Natural
Medicine Product when the Participant needs to temporarily leave the
Administration Area.
a. The plan should
include procedures for:
i. Escorting or
monitoring a Participant who needs to use a restroom during the Administration
Session;
ii. Ensuring the Licensed
Premises is maintained to prevent safety hazards;
iii. Monitoring and limiting Participant
interaction with vendors, contractors, other Participants, or other persons who
may be present at the Healing Center; and
iv. Emergency response when a Participant
experiences a medical or other emergency during an Administration Session,
including but not limited to, instructions for using an on-site medical
kit.
b. A Healing Center
may defer implementing the Administration Session preparedness plan if the
Facilitator and Participant have agreed, through written informed consent, to
other procedures for the Administration Session if the Healing Center maintains
a copy of the informed consent on the Licensed Premises.
2.
Emergency Plan. A
Healing Center must have an emergency plan that includes the following:
a. Documented procedures for evacuating and
relocating Participants to a safe and confidential location when the
Administration Areas become unsafe due to unforeseen circumstances, including
but not limited to fire or a power outage. Licensees should take all reasonable
steps to maintain Participant confidentiality should evacuation and relocation
become necessary.
3.
Certificates of Analysis. All certificates of analysis
provided to the Healing Center by a Natural Medicine Testing Facility of any
Samples submitted for testing shall be maintained on the Licensed Premises in
accordance with Rule 3010.
E.
Confidentiality of Patient
Records. A Healing Center must maintain the confidentiality of any
personally identifying information disclosed in Participant records possessed
or stored at the Healing Center's Licensed Premises.
