216-40-10 R.I. Code R. § 13.5

Current through August 19, 2024

Section 216-RICR-40-10-13.5 - Organization and Management

13.5.1Control and Management

A. Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall be responsible for:

1. The management and control of the operation;

2. The assurance of the quality of care and services;

3. The conformity of the physician ambulatory surgery center/ podiatry ambulatory surgery center with all federal, state and local laws and regulations relating to fire, safety, sanitation, infection control; and

4. Other relevant health and safety requirements and with all the rules and regulations herein.

B. The physician ambulatory surgery center/ podiatry ambulatory surgery center shall provide appropriate personnel, physical resources, and equipment based on the scope of services provided.

C. The physician ambulatory surgery center/ podiatry ambulatory surgery center shall designate:

1. an administrator who shall be responsible for the management and operation of the physician ambulatory surgery center/ podiatry ambulatory surgery center; and

2. a medical director to assure achievement and maintenance of quality standards of professional practice.

3. The administrator and the medical director may be the same individual.

D. The physician ambulatory surgery center/ podiatry ambulatory surgery center shall adopt and maintain policies/procedures defining responsibilities for the operation and performance of the physician ambulatory surgery center/ podiatry ambulatory surgery center, identifying purposes and means of fulfilling such, and in addition the policies/procedures shall include but not be limited to:

1. A statement of qualifications and responsibilities of the medical director and administrator;

2. A statement of the physician ambulatory surgery center/ podiatry ambulatory surgery center's responsibility for the quality of care and services;

3. A statement of physician ambulatory surgery center/ podiatry ambulatory surgery center's policy establishing the criteria for the selection and admission of patients;

4. Such other matters as may be relevant to the organization of the physician ambulatory surgery center/ podiatry ambulatory surgery center.

E. All policies and procedures adopted by the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be reviewed annually.

13.5.2Personnel Requirements

A. The appointment of all personnel shall be documented in writing. The job description of each member of the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be documented in writing and shall include directives related to responsibilities and discipline.

B. A timely written performance evaluation shall be required for all employees.

C. The number and type of registered nurses and ancillary personnel shall be based on the scope of services provided and staff capabilities, to ensure direct patient care as needed throughout the period of the patient's stay. All personnel, such as nurses, shall be licensed as required by the R.I. Gen. Laws.

D. The physician ambulatory surgery center/ podiatry ambulatory surgery center shall make initial appointments, and assignment or curtailment of surgical privileges, based on the education, training, experience and evidence of competence of the licensed professional staff person providing surgical services, consistent with state law. (See also §13.6.5(B) of this Part).

E. The physician ambulatory surgery center/ podiatry ambulatory surgery center shall clearly define in writing the responsibilities and supervision of any student personnel utilized in the physician ambulatory surgery center/ podiatry ambulatory surgery center.

F. The physician ambulatory surgery center/ podiatry ambulatory surgery center shall adhere to a written procedure for granting and renewing privileges for anesthesiologists or certified registered nurse anesthetists that specifies the required training, experience, board certification, and/or other factors that indicate acceptable proficiency.

G. A physician ambulatory surgery center/ podiatry ambulatory surgery center shall require all persons, including students, who examine, observe, or treat a patient of such office operatory to wear photo identification badge which states, in a reasonably legible manner, the first name, licensure/registration status, if any, and staff position of such person.

H. All surgical personnel, pre-operative, and recovery personnel shall be trained in basic life support (CPR) at least every two (2) years.

I. All surgical personnel shall be trained in basic aseptic techniques.

J. All surgical personnel shall wear suitable attire.

K. Administrator. The physician ambulatory surgery center/ podiatry ambulatory surgery center shall appoint a qualified administrator who may be the medical director, who shall be responsible for:

1. The management and operation of the physician ambulatory surgery center/ podiatry ambulatory surgery center;

2. The enforcement of policies, rules and regulations and statutory provisions pertaining to the health and safety of patients;

3. Serving as liaison between the physician ambulatory surgery center/ podiatry ambulatory surgery center and the staff; and

4. The planning, organizing and directing of such other activities as may be delegated by the physician ambulatory surgery center/ podiatry ambulatory surgery center.

L. Medical Director

1. The surgical services of the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be under the direction of a physician licensed under the provisions of R.I. Gen. Laws Chapter 5-37, or a podiatrist licensed under the provisions of R.I. Gen. Laws Chapter 5-29, respectively, who meets the qualifications set forth by the physician ambulatory surgery center/ podiatry ambulatory surgery center in accordance with §13.5.1 of this Part, and who shall be responsible for no less than the following.

a. The coordination, supervision and functioning of services;

b. The establishment of provisions for infection control;

c. The achievement and maintenance of quality assurance of professional practices through a mechanism of peer review acceptable to the Director; and

d. The establishment of policies and procedures for surgical and anesthesia services and other related health care services.

M. Health Screening

1. Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient in the physician ambulatory surgery center/ podiatry ambulatory surgery center. Such health screening shall be conducted in accordance with the rules and regulations pertaining to Immunization, Testing, and Health Screening for Health Care Workers (Part 20-15-7 of this Title) promulgated by the Department of Health.

13.5.3Quality Assurance

The office operatory shall establish a formal mechanism for quality assurance for all surgical services provided by all physicians or podiatrists performing surgical procedures in the physician ambulatory surgery center/ podiatry ambulatory surgery center. The quality assurance mechanism shall be in accordance with the requirements established by the accreditation agency.

13.5.4Peer Review

A. An organized process of peer review shall be conducted in accordance with the requirements of the accreditation agency. At a minimum, peer review shall provide for:

1. Regular review of reportable events (see §13.6.3(E) of this Part) with formal determination of strategies to improve outcomes and assessment of change accomplished; and

2. Formal review of credentials and privileges of all surgeons, certified registered nurse anesthetists, and anesthesiologists.

B. Medical peer review shall be conducted in accordance with R.I. Gen. Laws §§ 5-37-1(10)(a) and (b) and subject to the confidentiality provisions of R.I. Gen. Laws § 5-37.3-7.

13.5.5Administrative Records

A. Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall maintain such administrative records as may be deemed necessary for the business operation of the physician ambulatory surgery center/ podiatry ambulatory surgery center, in addition to the following:

1. Monthly statistical summary of numbers of surgical procedures performed, appropriately classified;

2. Controlled substances register if such are maintained at the physician ambulatory surgery center/ podiatry ambulatory surgery center;

3. An operating/procedure room log book maintained in chronological sequence of admissions which shall include pertinent information such as patient's name, pre-op and post-op diagnosis, name of operating physician and person administering anesthesia, circulating nurse, surgical procedures performed, specimen sent for pathological examination, type of anesthesia and complications (if any); and

4. A record of all transfers to a hospital for post-surgical care.

13.5.6Disaster Preparedness

A. Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall develop and maintain a written disaster preparedness plan that shall include specific provisions and procedures for the emergency care of patients in the event of fire, loss of utilities, bomb threat, natural disaster or functional failure of equipment.

1. Such a plan shall be developed and coordinated with appropriate state and local agencies and representatives concerned with emergency safety and rescue;

2. A copy of the plan shall be submitted to the licensing agency;

3. Simulated drills testing the effectiveness of the plan shall be conducted at least semi-annually. Written reports and evaluation of all drills shall be maintained by the physician ambulatory surgery center/ podiatry ambulatory surgery center and available for review by the licensing agency.

B. Emergency action steps shall be clearly outlined and posted in conspicuous locations throughout the physician ambulatory surgery center/ podiatry ambulatory surgery center.

13.5.7Uniform Reporting System

Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall establish and maintain records and data in such a manner as to make uniform the system of periodic reporting. The manner in which the requirements of this regulation may be met shall be prescribed from time to time in directives promulgated by the Director.

216 R.I. Code R. § 216-RICR-40-10-13.5