Current through Register Vol. XLI, No. 38, September 20, 2024
10.1.
Before extensive construction or renovation of a MAT program facility begins,
the program shall submit to the Secretary for approval a complete set of the
plans for the project, which includes the drawings and specifications for the
architectural, structural and mechanical design and work.
10.2. The Secretary shall advise the program
within 60 days whether approval has been granted. In the event the plans for
the project are not approved, the Secretary shall set forth in writing the
reasons for the disapproval and provide the program the opportunity to correct
any deficiencies. Extensive construction or renovation of a facility may not
begin until the Secretary has issued final approved of the plans.
10.3. All MAT program facilities shall comply
with the current standards of the Americans with Disabilities Act of 1990,
42 U.S.C. §§
12101, et seq. (1990), as
amended.
10.4. All MAT program
facilities must meet all other requirements of applicable federal or state
regulatory or oversight agencies.
10.5. Life Safety Policies and Procedures.
10.5.a. Each MAT program shall develop,
implement and maintain policies and procedures regarding the appropriate and
safe administration of medications and other medical treatment. The policies
and procedures shall:
10.5.a.1. Ensure that
the correct dose of medication is administered and that appropriate actions are
taken if a mistake is made, including a mechanism for reporting unusual
incidents to appropriate program staff;
10.5.a.2. Establish a current plan of
emergency administration of medications in case the program must be closed
temporarily, including how patients will be informed of these emergency
arrangements;
10.5.a.3. Ensure that
there is appropriately trained staff on duty at all times who are, at a
minimum, proficient in cardiopulmonary resuscitation and reversal of opiate
overdose; and
10.5.a.4. Ensure that
each medication-assisted treatment medication used by the MAT program is
administered and dispensed, if applicable, in accordance with its approved
product labeling. Dosing, dispensing and administration decisions shall be made
by a program physician familiar with the most up-to-date product labeling.
These procedures must ensure that any significant deviations from the approved
labeling, including deviations with regard to dose frequency, or the conditions
of use described in the approved labeling, are specifically documented in the
patient's record.
10.6. Each MAT program shall develop,
implement and maintain policies and procedures regarding safe and effective
access to the facility and staff. The policies and procedures shall:
10.6.a. Provide 24-hour, seven day-per-week
access to designated program staff, as described in paragraph 9.1.b.4., so that
patient emergencies may be immediately addressed and dosage levels
verified;
10.6.b. Require the
program to display in facility offices and waiting areas the names and
telephone numbers of individuals or agencies who should be contacted in case of
an emergency;
10.6.c. Include an
up-to-date disaster plan that specifies emergency evacuation procedures, fire
drills, and maintenance of fire extinguishers; and
10.6.d. Address safety and security issues
for patients and staff, including training staff to handle physical or verbal
threats, acts of violence, inappropriate behavior, or other escalating and
potentially dangerous situations, with emphasis on when security guards or
police need to be summoned.
