Current through Register Vol. 50, No. 9, September 20, 2024
A.
Administrative Staff. The following administrative staff is required for all
ASCs:
1. a qualified administrator at each
licensed geographic location who shall meet the qualifications as established
in these provisions;
2. other
administrative staff as necessary to operate the ASC and to properly safeguard
the health, safety and welfare of the patients receiving services;
and
3. an administrative staff
person on-call after routine daytime or office hours for the length of any
patient stay in the ASC.
B. Administrator/Director
1. Each ASC shall have a qualified
administrator/director who is an on-site employee responsible for the
day-to-day management, supervision and operation of the ASC.
2. Any current administrator employed by a
licensed and certified ASC, at the time these licensing provisions are adopted
and become effective, shall be deemed to meet the qualifications of the
position of administrator as long as the individual holds his/her current
position. If the individual leaves his/her current position, he/she shall be
required to meet the qualifications stated in these licensing provisions to be
re-employed into such a position.
3. The administrator shall meet the following
qualifications:
a. possess a college degree
from an accredited university; and
b. have one year of previous work experience
involving administrative duties in a healthcare facility.
4. An RN shall meet the following
qualifications to hold the position of administrator:
a. maintain a current and unrestricted RN
license; and
b. have at least one
year of management experience in a healthcare facility.
5. Changes in administrator shall be reported
to the department within 10 days.
C. Medical Staff
1. The ASC shall have an organized medical
staff, including any licensed medical practitioners who practice under a use
agreement with the ASC.
2. All
medical staff shall be accountable to the governing body for the quality of all
medical and surgical care provided to patients and for the ethical and
professional practices of its members.
3. Members of the medical staff shall be
legally and professionally qualified for the positions to which they are
appointed and for the performance of privileges granted.
4. The medical staff shall develop, adopt,
implement and monitor bylaws and rules for self-governing of the professional
activity of its members. The medical staff bylaws shall be maintained within
the ASC. The bylaws and rules shall contain provisions for at least the
following:
a. developing the structure of the
medical staff, including allied health professionals and categories of
membership;
b. developing,
implementing and monitoring to review credentials, at least every two years,
and to delineate and recommend approval for individual privileges;
c. developing, implementing and monitoring to
ensure that all medical staff possess current and unrestricted Louisiana
licenses and that each member of the medical staff is in good standing with
his/her respective licensing board;
d. recommendations to the governing body for
membership to the medical staff with initial appointments and reappointments
not to exceed two years;
e.
developing, implementing and monitoring for suspension and/or termination of
membership to the medical staff;
f.
developing, implementing and monitoring criteria and frequency for review and
evaluation of past performance of its individual members. This process shall
include monitoring and evaluation of the quality of patient care provided by
each individual;
g. the election of
officers for the ensuing year;
h.
the appointment of committees as deemed appropriate; and
i. reviewing and making recommendations for
revisions to all policy and procedures at least annually.
5. Medical staff shall meet at least
semi-annually. One of these meetings shall be designated as the official annual
meeting. A record of attendance and minutes of all medical staff meetings shall
be maintained within the ASC.
6. A
physician shall remain within the ASC until all patients have reacted and are
assessed as stable.
7. The patients
attending physician, or designated on-call physician, shall be available by
phone for consultation and evaluation of the patient, and available to be
onsite if needed, until the patient is discharged from the ASC.
8. Each patient admitted to the ASC shall be
under the professional supervision of a member of the ASCs medical staff who
shall assess, supervise and evaluate the care of the patient.
9. Credentialing files for each staff
physician shall be kept current and maintained within the ASC at all
times.
D. Nursing Staff.
A staffing pattern shall be developed for each nursing care unit (preoperative
unit, operating/procedure rooms, post anesthesia recovery area). The staffing
pattern shall provide for sufficient nursing personnel and for adequate
supervision and direction by registered nurses consistent with the size and
complexity of the procedure(s) performed and throughout the length of any
patient stay in the ASC.
1. Nursing services
shall be under the direction of an RN that includes a plan of administrative
authority with written delineation of responsibilities and duties for each
category of nursing personnel.
2.
The ASC shall ensure that the nursing service is directed under the leadership
of a qualified RN. The ASC shall have documentation that it has designated an
RN to direct nursing services.
3.
The director of nursing (DON) shall:
a. have a
current, unrestricted Louisiana RN license;
b. be in good standing with the State Board
of Nursing; and
c. shall have a
minimum of one year administrative experience in a health care setting and the
knowledge, skills and experience consistent with the complexity and scope of
surgical services provided by the ASC.
4. The RN holding dual administrative/nursing
director roles shall meet the qualifications of each role.
5. Changes in the director of nursing
position shall be reported in writing to the department within 10 days of the
change on the appropriate form designated by the department.
6. Nursing care policies and procedures shall
be in writing, formally approved, reviewed annually and revised as needed, and
consistent with accepted nursing standards of practice. Policies and procedures
shall be developed, implemented and monitored for all nursing service
procedures.
7. There shall be a
sufficient number of duly licensed registered nurses on duty at all times to
plan, assign, supervise and evaluate nursing care, as well as to give patients
the high quality nursing care that requires the judgment and specialized skills
of a registered nurse.
a. There shall be
sufficient nursing staff with the appropriate qualifications to assure ongoing
assessment of patients' needs for nursing care and that these identified needs
are addressed. The number and types of nursing staff is determined by the
volume and types of surgery the ASC performs.
8. All professional nurses employed,
contracted or working under a use agreement with the ASC shall have a current,
unrestricted and valid Louisiana nursing license. Nonprofessional or unlicensed
personnel employed, contracted, or working under a use agreement and performing
nursing services shall be under the supervision of a licensed registered nurse.
9. There shall be, at minimum, one
RN with ACLS certification and, at minimum, one RN with PALS certification, if
a pediatric population is served, on duty and immediately available at any time
there is a patient in the ASC.
10.
The RN who supervises the surgical center shall have documented education and
competency in the management of surgical services.
11. A formalized program on in-service
training shall be developed and implemented for all categories of nursing
personnel, employed or contracted, and shall include contracted employees and
those working under a use agreement. Training is required on a quarterly basis
related to required job skills.
a.
Documentation of such in-service training shall be maintained on-site in the
ASCs files. Documentation shall include the:
i. training content;
ii. date and time of the training;
iii. names and signatures of personnel in
attendance; and
iv. name of the
presenter(s).
12. General staffing provisions for the
OR/procedure rooms shall be the following.
a.
Circulating duties for each surgical procedure and for any pediatric procedure
shall be performed by a licensed RN. The RN shall be assigned as the
circulating nurse for one patient at a time for the duration of any surgical
procedure performed in the center.
b. Appropriately trained licensed practical
nurses (LPNs) and operating/procedure room technicians may perform scrub
functions under the supervision of a licensed registered nurse.
c. Staffing for any nonsurgical, endoscopic
procedure shall be based upon the level of sedation being provided to the adult
patient, the complexity of the procedure, and the assessment of the patient.
The role and scope of the nurses staffing the procedure rooms shall be in
accordance with the Nurse Practice Act and nursing staff shall only perform
duties that are in accordance with the applicable requirements for such
personnel set forth in the Nurse Practice Act. A physician shall be required to
complete a pre-procedural assessment to determine the suitability of the
patient for the planned level of sedation. Depending upon the level of sedation
deemed appropriate and administered, at a minimum, the following staffing
levels shall be utilized for each nonsurgical, endoscopic procedure.
i. Patient is Unsedated. The OR/procedure
room shall be staffed with a single assistant who may be an RN, licensed
practical nurse (LPN) or unlicensed assistive personnel (UAP).
ii. Patient Receives Moderate/Conscious
Sedation. With moderate/conscious sedation, a single RN may administer the
sedation under physician supervision, and such RN may assist only with minor,
interruptible technical portions or tasks of the procedure. In accordance with
the LSBN, the RN monitoring the patient shall have no additional responsibility
that would require leaving the patient unattended or that would compromise
continuous monitoring during the procedure.
iii. Complex Endoscopy Procedure (with or
without sedation). For any complex endoscopy procedure (e.g. ERCP, EUS/FNA,
etc.), there shall be an RN in the operating/procedure room to continuously
monitor the patient, and a second RN, LPN or UAP to provide technical
assistance to the physician.
NOTE: For purposes of
§4567. D 12.c.i-iii, a
reference to RN may be substituted by a CRNA or advanced practiced registered
nurse. Said nursing staff shall have documentation of knowledge, skills,
training, ability and competency of assigned tasks.
iv. Deep Sedation. This level requires a CRNA
or anesthesiologist to administer the deep sedation and to monitor the patient.
There shall be a second staff person (RN, LPN or UAP) dedicated to provide
technical assistance for the endoscopy procedure.
NOTE: At any level of staffing for the nonsurgical,
endoscopic procedure described above, if an LPN or UAP is the assigned staff
providing assistance, in addition to such LPN or UAP assigned staff in the
operating/procedure room, an RN shall be immediately available in the ASC to
provide emergency assistance. That RN shall not be assigned to a
non-interruptible task during the duration of the procedure.
13.
Post-Surgical Care Area. There shall be an RN whose sole responsibility is the
post-surgical care of the patient. There shall be at least one other member of
the nursing staff in the post-surgical care area(s) onsite and continually
available to assist the post-surgical care RN until all patients have been
discharged from the ASC. E. General Personnel Requirements
1. All physicians and ASC employees,
including contracted personnel and personnel practicing under a use agreement,
shall meet and comply with these personnel requirements.
2. All physicians and ASC employees,
including contracted personnel and personnel practicing under a use agreement,
prior to and at the time of employment and annually thereafter, shall be
verified to be free of tuberculosis in a communicable state in accordance with
the ASCs policies and procedures and current Centers for Disease Control (CDC)
and OPH recommendations.
3. All
unlicensed staff involved in direct patient care and/or services shall be
supervised by a qualified professional employee or staff member.
4. A personnel file shall be maintained
within the ASC on every employee, including contracted employees and personnel
providing services under a use agreement. Policies and procedures shall be
developed to determine the contents of each personnel file. At a minimum, all
personnel files shall include the following:
a. an application;
b. current verification of professional
licensure;
c. health care
screenings as defined by the ASC;
d. orientation and competency
verification;
e. annual performance
evaluations;
f. criminal background
checks for UAPs, prior to offer of direct or contract employment after the
effective date of this Rule, as applicable and in accordance with state law.
The criminal background check shall be conducted by the Louisiana State Police
or its authorized agent; and
g. any
other screenings required of new applicants by state law.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
40:2131-2141.