La. Admin. Code tit. 48 § I-4567

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-4567 - Staffing Requirements

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.

La. Admin. Code tit. 48, § I-4567

Promulgated by the Department of Health, Bureau of Health Services Financing, LR 431747 (9/1/2017).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:2131-2141.