Current through Register Vol. 43, No. 02, November 27, 2024
(1)
Generally. Inspections
of licensees shall be carried out by the Commission in accordance with §
20-2A-52(a)(3),
Code of Ala. 1975, (as amended). Immediately prior to
commencing operations and, thereafter, no less often than annually (and more
often, depending on the type of license provided), a licensee shall undergo at
least one announced inspection by the Commission or its representatives; the
licensee may also be subject to one or more unannounced inspections.
(2) Announced Inspections.
(a) Pre-Commencement Inspection. When a
licensee is set to commence operations at any facility, the licensee shall
contact the Commission to set a date for inspection under the procedures for an
announced inspection set forth in this Chapter, except that the
Pre-Commencement Inspection may be set at any mutually acceptable time. No
licensee's operations may commence at any facility until the facility has
passed a pre-commencement inspection with no critical violations and all minor
infractions having been corrected. Reinspection following a failed
pre-commencement inspection shall occur within 30 days, after which, if the
licensee passes the inspection it may commence operations; a licensee having
failed a second pre-commencement inspection must petition the Commission for
permission for a further precommencement inspection; if the Commission denies a
third pre-commencement inspection or the licensee fails the third inspection,
the licensee is precluded from commencing operations and its license shall be
revoked.
(b) Announced Inspections
Generally.
1. Timing. Not less than 14 days
prior to any announced inspection, the Commission, acting by and through its
representative, will notify the licensee of its intention to conduct an
announced inspection of the licensee's facilities, operations, and
documentation, advising the licensee of a specific date and time for the
inspector's anticipated arrival as well as the individuals who are anticipated
to be part of the inspection team.
2. Scope. At the time of the announced
inspection, licensees shall make their facilities, personnel, operations, and
documentation available for review and auditing at the request of the
inspector. Areas of inspection shall include, but are not limited to: all areas
of all facilities that have been in operation at any time since the last
announced inspection; all facilities not in operation that the licensee is
planning to put in operation at any time during the next two years; proper
credentialling, licensing, qualifications, education, suitability and
experience, as applicable, for all personnel, including owners, officers,
administrators, managers, employees (full-time or part-time) and volunteers;
all operations and processes being conducted by the licensee, including but not
limited to, all machinery, equipment and supplies; all security monitoring and
video surveillance files and log book data maintained by the licensee; all IT
files maintained by the licensee, including but not limited to the licensee's
test results, any third-party inventory control and tracking systems, and the
Statewide Seed-to-Sale Tracking System; background check certificates and/ or
personnel files of all owners, officers, administrators, managers, employees
(full-time or parttime), and volunteers; and all documents provided to the
Commission at the time of licensing, including all updates to such documents
made at any time since the last announced inspection, with or without the
permission of the Commission. (See
538-X-4-.07 of this
Chapter.)
3. Compliance liaison.
Throughout the announced inspection, the licensee shall have a designated
compliance liaison who is knowledgeable about the licensee's facilities,
personnel, operations, and documentation, and who will be on hand to answer
questions or coordinate with additional persons to provide answers or
information in response to questions by the inspection team.
4. Duty of Cooperation. The licensee is
expected to comply with all inspections with the highest level of integrity and
transparency. Failure to cooperate with an inspection by the Commission may
lead to sanctions, within the Commission's discretion, up to and including
revocation of license.
(c) Unannounced Inspections.
1. Timing. Unannounced Inspections may be
conducted without prior notice at any time, without respect to whether the
licensee has or has not undergone an announced inspection.
2. Scope. An unannounced inspection may cover
any and all areas described above with respect to announced
inspections.
3. Procedures. The
licensee shall, at the time of licensing, receive confidential instructions
relating to procedures that will be implemented immediately before the
unannounced inspection begins. The licensee shall follow these instructions and
can therefore be secure in the knowledge that the inspection is authentic and
is being carried out at the instance of the Commission and not
otherwise.
4. Point of Contact. At
the time of any unannounced inspection, the licensee shall identify to the
inspectors an acceptable point-of-contact for the inspection, usually one of
the leaders of the company then on duty, who will fill the role of compliance
liaison (as set forth in subparagraph 2.b.(3) of this rule) in all respects
possible for the unannounced inspection.
5. Duty of Cooperation. To the extent the
Commission follows the confidential procedures set forth at the time of
licensing, the licensee, during an unannounced inspection, has the same
obligations of cooperation as with an announced inspection, and the same
consequences for failing to cooperate.
(3) Use of Third-Party Inspectors. The
Commission may, in its discretion, utilize qualified independent third parties
and may cooperate with State and Local Agencies in conducting inspections, both
announced and unannounced.
(4)
Inspection Report. As a result of all inspections, the Commission, acting by
and through its inspectors, shall issue a written report within 14 days,
covering all areas inspected, addressing any noted infractions and, in addition
to the notation described below, any critical violations.
(a) Noted Infractions
1. Definition. An infraction is a minor
violation of the Act or these Rules, or a benign difference between the
documentation previously provided to the Commission and the reality of the
licensee's operations. Those infractions which cannot be corrected to the
satisfaction of the inspector immediately or, in any event, prior to the
inspector's report, or which represent a repeated issue the licensee has been
orally warned of previously, shall be noted on the report and then constitute a
"noted infraction."
2. Remediation.
Noted Infractions must be set forth in the written report and addressed to the
satisfaction of the Commission within 30 days and either demonstrated as
compliant by the licensee or re-inspected and deemed compliant. A licensee's
remediation of a noted infraction within 30 days is usually, but not always,
sufficient for the licensee to avoid sanctions. A licensee's failure to address
and correct a noted infraction to the Commission's satisfaction within 30 days,
or any repeat noncompliance of the same noted infraction within a period of
five (5) years, shall be deemed sanctionable conduct by the licensee.
(b) Critical violations.
1. Definition. A critical violation is an
intentional or substantial violation of the Act or these Rules, or a material
difference between the documentation previously provided to the Commission and
the reality of the licensee's operations, when that difference poses a clear
and present danger to the safety of the licensee's employees, patients,
caregivers, or the public.
2.
Notice. In addition to being included in the report filed by the inspector,
critical violations shall be noted in writing to the licensee and the
Commission at the time of the inspection and in no event more than 48 hours
after the inspection in which the critical violation was noted.
3. Shutdown. A critical violation may warrant
an immediate shutdown of the facility in question, pending remediation of the
violation by the licensee; a shutdown is considered a matter of health and
safety and does not comprise a sanction, which may also be warranted and may
result in license suspension, revocation, or nonrenewal.
4. Correction. A licensee must address and
remedy a critical violation immediately and in no event, more than the time
allowed for re-inspection of a critical violation pursuant to this
rule.
(5)
Consequences. A critical violation shall result in sanctions as may be imposed
by the Commission, and failure to address a critical violation or a repeat of
the same critical violation within five (5) years, or more than three critical
violations within five (5) years, may result in an escalation of sanctions
imposed as a result of the original critical violation. In determining the
sanction to be imposed on the licensee for a critical violation, the Commission
may consider whether the conduct that gave rise to the sanction was knowing,
willful, reckless or negligent, the prior conduct of the licensee, the
licensee's compliance history, and the swiftness with which the licensee
addressed and remedied the critical violation.
(6) Re-inspection. If necessary, a
re-inspection may be performed to determine whether a noted infraction or
critical violation has been properly corrected or remedied. Reinspections shall
be performed no less than 30 and no more than 45 days from the date of the
notice, or, alternatively, at a mutually agreeable time and date after the
licensee announces ready.
Author: William H. Webster; Justin C.
Aday
Statutory Authority:
Code of Ala.
1975, §§
20-2A-22, as amended.
