216-40-10 R.I. Code R. § 13.6

Current through August 19, 2024

Section 216-RICR-40-10-13.6 - Patient Care Services

13.6.1Rights of Patients

A. Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall observe the standards enumerated in R.I. Gen. Laws § 23-17-19.1 with respect to each patient admitted to its physician ambulatory surgery center/ podiatry ambulatory surgery center.

B. Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall display in a conspicuous place in the licensed physician ambulatory surgery center/ podiatry ambulatory surgery center a copy of the "Rights of Patients."

13.6.2Admission, Transfer and Discharge

A. Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall have and implement written admission, transfer and discharge policies and procedures pertaining to at least the following:

1. Types of surgical procedures and conditions acceptable for admission;

2. Requirements for pre-admission history;

3. Transfer of patients for continuity of care or emergency care accompanied by the "Rhode Island Department of Health Continuity of Care Short Form" available on-line: www.healthri.org;

4. Emergency instructions shall be posted at each telephone. The names and telephone numbers to be called in an emergency shall be posted and easily accessible (including, but not limited to, "911", physicians to be called in an emergency, nearest hospital emergency department).

5. Emergency transfer of patients to the nearest full-service emergency department of an acute care hospital. When indicated, a physician, physician assistant, or nurse shall accompany the patient.

6. Discharge of patient with responsible adult, as indicated;

7. Constraints imposed by limitations of services, physical facilities; and

8. Instruction of patients on self-care upon discharge.

13.6.3Patient Care Management

A. Each patient shall be under the continuing supervision of a physician or podiatrist on-site throughout the period of a patient's stay in the physician ambulatory surgery center/ podiatry ambulatory surgery center.

B. A physician, podiatrist, registered nurse, physician assistant, advanced practice nurse, or midwife shall care for the patient at all times while in the recovery area.

C. Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall have and implement written patient care management policies and procedures pertaining to at least the following:

1. Scope of services provided either directly or per contractual arrangements;

2. Criteria for admission, transfer and discharge;

3. Management of patients with known or suspected infectious diseases, including the exclusion of patients who are known or suspected of having airborne infectious diseases;

4. Physician services and consultation services;

5. Staffing plan that delineates the personnel required to be present in the physician ambulatory surgery center/ podiatry ambulatory surgery center in order to provide effective safe patient care and all other related services;

6. Radiology and laboratory services, including the facility's required minimum specific testing; and

7. Counseling services, if indicated.

D. All orders for medications or treatments must be in writing. An order is considered to be in writing if:

1. It is written and signed by a lawfully authorized person; or

2. It is dictated to and transcribed by a registered nurse or other appropriately licensed person onto the order form. Additionally, the registered nurse or other appropriately licensed person must:

a. Date the order and identify the verbal order by the name and title of the authorized individual who gave the order; and

b. Sign the order entry with his/her own name and title. All verbal orders must be appropriately signed within twenty-four (24) hours.

E. The physician ambulatory surgery center/ podiatry ambulatory surgery center shall, within seventy-two (72) hours of receipt of such information, notify the licensing agency of any reportable event as follows:

1. Transfer of the patient from the physician ambulatory surgery center/ podiatry ambulatory surgery center to a hospital emergency department;

2. Unscheduled hospital admission of the patient within seventy-two (72) hours of discharge from the physician ambulatory surgery center/ podiatry ambulatory surgery center;

3. Extension of the surgical procedure beyond four (4) hours;

4. Unplanned readmission to the physician ambulatory surgery center/ podiatry ambulatory surgery center within seventy-two (72) hours;

5. Death of the patient within thirty (30) days;

6. Subjecting a patient to a procedure not ordered or intended by the patient's physician, excluding: procedures not requiring a physician's order, medication errors, and collection of specimens, for laboratory study, obtained by non-invasive means or routine phlebotomy;

7. Or any other incident reported to the malpractice insurance carrier.

13.6.4Anesthesia Service

A. Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall have and implement written anesthesia service policies and procedures pertaining to at least the following:

1. Staff privileges for anesthesia services established in accordance with §§13.5.2(D) and (F) of this Part;

2. Emergency coverage;

3. Administration of anesthetics;

4. The maintenance of safety controls, including, but not limited to, inspection, maintenance, and calibration of equipment;

5. Qualifications and supervision of non-physician anesthetists;

6. Qualifications of the supervising physician;

7. Anesthesia monitoring standards of § 13.2(C) of this Part.

B. In addition, the policies shall include provisions for at least the following:

1. Pre-anesthesia evaluation by a physician;

2. Safety of the patient during the anesthesia period;

3. Review of patient's condition prior to induction of anesthesia and post-anesthetic evaluation in accordance with the standards cited in § 13.2(C) of this Part; and

4. Recording of all events related to each phase of anesthesia care.

C. A board-certified anesthesiologist or a board-certified anesthesiologist, in conjunction with a certified registered nurse anesthetist, if the facility utilizes certified registered nurse anesthetists to administer anesthesia shall be responsible for developing the policies and procedures cited in §§13.6.4(A) and (B) of this Part.

D. General anesthesia shall be permitted only in those licensed physician ambulatory surgery centers/ podiatry ambulatory surgery centers that meet the requirements of §§13.6.4(E), (G), and 13.6.7(D) of this Part. If any type of anesthesia is administered that may fail mid-procedure necessitating the use of general anesthesia, the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be in compliance with §§13.6.4(E), (G), and 13.6.7(D) of this Part at all times.

E. No explosive anesthetics shall be utilized in any physician ambulatory surgery center/ podiatry ambulatory surgery center.

F. The administration of anesthesia, with or without sedation or a dissociative drug, shall be under the direct supervision of a qualified physician.

G. In a licensed physician ambulatory surgery center/ podiatry ambulatory surgery center administering general anesthesia, an anesthesiologist or a certified registered nurse anesthetist shall administer the anesthesia.

H. In a licensed physician ambulatory surgery center/ podiatry ambulatory surgery center administering all types of anesthesia, other than general anesthesia, an anesthesiologist, a certified registered nurse anesthetist, or a physician shall administer anesthesia.

I. The person administering anesthesia shall not function in any other capacity during the surgical procedure.

13.6.5Surgical Service

A. Written staff rules and regulations and policies shall be established and implemented to govern surgical services that shall include surgical staff privileges, supporting services of professional and paramedical personnel, provisions for emergency coverage and operating suite procedures.

B. Surgical procedures shall be performed only by physicians or podiatrists who have current surgical privileges for the same or a similar class of procedures at a nearby hospital.

C. Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall schedule elective surgery only.

D. Discharge of the patient shall be the responsibility of the operating physician or podiatrist and shall take place only after direct evaluation by the physician or podiatrist, determining the patient is adequately recovered to function independently (i.e., vital signs stable, full responsiveness and orientation, ability to move voluntarily). If sedation, regional block, or general anesthesia has been utilized, a responsible adult shall accompany the patient and be instructed about the patient's care.

E. Surgical procedures performed in the physician ambulatory surgery center/ podiatry ambulatory surgery center shall:

1. Be performed only on patients determined in writing by the operating physician or podiatrist prior to surgery to be classified as ASA Class 1, ASA Class 2, or ASA Class 3 under the American Society of Anesthesiology "Physical Status Classification". For ASA Class 3 patients, surgical procedures utilizing planned general anesthesia, or planned epidurals, spinals, or brachial plexus blocks, may be performed only when the operating physician or podiatrist and a board-certified anesthesiologist concur (in writing prior to the surgery) that the patient is an acceptable candidate for a surgical procedure in the physician ambulatory surgery center/ podiatry ambulatory surgery center setting;

2. Not exceed an expected duration of two (2) hours, as documented in writing prior to the initiation of the procedure by the operating physician or podiatrist; Surgical procedures exceeding two (2) hours in duration shall be peer-reviewed and documented in accordance with the requirements set forth in §13.5.4(A) of this Part.

3. Be permitted only when at least one (1) physician, podiatrist, or a certified registered nurse anesthetist currently trained in Advanced Cardiac Life Support (ACLS) is available and will continue to be available in the recovery area until the patient is discharged from the physician ambulatory surgery center/ podiatry ambulatory surgery center.

F. No overnight stays shall be permitted in the physician ambulatory surgery center/ podiatry ambulatory surgery center under any circumstances.

G. If termination of pregnancy procedures are performed in a physician ambulatory surgery center, the requirements of the rules and regulations for the Termination of Pregnancy (Part 20-10-6 of this Title) shall also apply.

H. Each operating/procedure room suite shall have policies and procedures pertaining to safety controls prominently posted.

I. All tissues/specimens removed at surgery shall be submitted for pathological examination except those exempted in writing by the operating physician or podiatrist.

J. The patient's medical record shall be available in the operating/procedure room at the time of surgery.

K. An accurate and complete description of operative procedure shall be recorded by the operating physician or podiatrist within a timely fashion following completion of surgery.

L. Areas for the processing of clean and dirty supplies and equipment shall be separated by physical barriers.

M. Written procedures shall be adhered to for all sterilization and for the appropriate disposal of wastes and contaminated supplies.

N. Reports of bacteriological tests and inspection records shall be maintained on the premises.

13.6.6Infection Control

A. A mechanism shall be established by the medical director for the development of infection control policies that shall pertain to no less than:

1. Infection surveillance activities;

2. Sanitation and asepsis;

3. Handling and disposal of waste and contaminants;

4. Sterilization, disinfection, and laundry;

5. Reporting, recording and evaluation of occurrences of infections; and

6. Documentation of infection rate.

B. The physician ambulatory surgery center/ podiatry ambulatory surgery center shall report promptly to the licensing agency infectious diseases that may present a potential hazard to patients, personnel, and the public. Included are the reportable diseases cited in the rules and regulations regarding "Rules and Regulations Pertaining to Reporting of Infectious, Environmental and Occupational Diseases [R 23-10 -DIS]" and the occurrences of other diseases in outbreak form.

13.6.7Supplies and Equipment

A. Supplies of appropriate sterile linens, gloves, dressings and so forth, shall be maintained in sufficient quantities for routine and emergency use.

B. Such surgical instruments, accessory and operating/procedure room lights, and resuscitation equipment as are appropriate for the types of surgery and surgical risks that may be encountered in a physician ambulatory surgery center/ podiatry ambulatory surgery center shall be provided and maintained in clean, safe, and sterile condition.

1. An adequately-stocked cardiopulmonary resuscitative cart shall be available for emergencies and shall include, at a minimum, an Ambu Bag, a laryngoscope, airway management equipment, and a medication kit. The medication kit shall include appropriate medications for the treatment of anaphylaxis, cardiac arrhythmias, cardiac arrest, and malignant hyperthermia.

C. When anesthesia is utilized, appropriate monitoring equipment shall be available, shall be maintained in proper working condition, shall meet the requirements of the guidelines of § 13.2(D) of this Part incorporated above in this Part, and shall include monitors for pulse oximeter, non-invasive blood pressure, and EKG.

D. In those physician ambulatory surgery centers/ podiatry ambulatory surgery centers administering general anesthesia, the following monitoring equipment shall be present in the facility: blood pressure apparatus, EKG oscilloscope, defibrillator, pulse oximeter with alarm, oxygen analyzer with alarm, and CO2 monitor.

E. Defibrillating equipment shall be available.

F. Supplies of appropriate drugs, medications, fluids, electrolyte solutions, etc. shall be maintained in sufficient quantities for routine and emergency use.

G. Any physician ambulatory surgery center/ podiatry ambulatory surgery center that utilizes latex gloves shall do so in accordance with the provisions of the Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title) promulgated by the Department of Health.

13.6.8Laboratory, Radiology, and Pharmaceutical Services

A. Each physician ambulatory surgery center/ podiatry ambulatory surgery center may perform on the premises limited procedures such as urinalysis and CBC, provided that personnel are qualified by training and are under the supervision of a physician.

B. The requirements of the "Rules and Regulations for the Control of Radiation" pertaining to radiology shall apply to those office operatory providing such services.

C. Each physician ambulatory surgery center/ podiatry ambulatory surgery center performing laboratory testing shall be in compliance with the requirements of 42 C.F.R. Part 493.

D. Pharmaceutical services, if provided by the physician ambulatory surgery center/ podiatry ambulatory surgery center, shall be provided in accordance with prevailing standards of professional practice and shall be supervised by a pharmacist licensed in Rhode Island, by an operating physician, or by a podiatrist who is qualified to assume professional, organization, and administrative responsibility for the quality of services rendered.

E. Record-keeping and security measures shall be maintained to assure the control and safe dispensing of drugs in compliance with all state and federal laws.

F. Provisions for secure storage and proper record-keeping of all controlled substances shall be in accordance with R.I. Gen. Laws Chapter 21-28.

G. Dispensing and labeling of all pharmaceuticals shall be in accordance with R.I. Gen. Laws Chapter 21-31.

H. The quality and appropriateness of medication usage shall be monitored and evaluated as part of the quality assurance program required herein.

13.6.9Medical Records

A. An individual shall be designated to supervise the medical records and to ensure proper documentation, completion, indexing, filing, retrieval, and safe storage.

B. A medical record shall be established and maintained for every patient cared for in the physician ambulatory surgery center/ podiatry ambulatory surgery center. Said medical record may be the same patient record maintained in the physician's/podiatrist's office, provided that the information stipulated in §13.6.9(C) of this Part is included.

C. Each medical record shall contain sufficient information and data to support the diagnosis, plan of treatment, and shall contain no less than the following:

1. Patient identification, (name, address, birth date, etc.);

2. Medical history and physical examination;

3. Pre-operative and final diagnosis;

4. Results of all appropriate, minimum specific tests for the procedure(s) to be performed;

5. A signed consent form for surgical procedure;

6. A signed consent form for anesthesia;

7. The expected duration of the surgical procedure(s);

8. The type(s) of anesthesia to be used and the expected duration of each;

9. The patient's pre-operative ASA classification(s) as determined by:

a. the operating physician;

b. any consulting physician(s);

c. physician assistant(s) in collaboration with a physician; and

d. the anesthesiologist or certified registered nurse anesthetist;

e. For ASA Class 3 patients who are undergoing surgical procedures utilizing planned general anesthesia, or planned epidurals, spinals, or brachial plexus blocks, a written statement from a board-certified anesthesiologist concurring that the patient is an acceptable candidate for a surgical procedure in the physician ambulatory surgery center/ podiatry ambulatory surgery center setting shall also be required. (See §13.6.5(E)(1) of this Part).

10. Nurses' notes;

11. Anesthesiologist's and/or certified registered nurse anesthetist's reports, including pre- anesthesia evaluation, intra-operative anesthesia record, and post-anesthesia evaluation;

12. Medical consultation, and counseling (if any);

13. Operating physician's/podiatrist's operative notes, progress reports, and discharge notes;

14. Instructions given patient upon discharge; and

15. Other related reports.

D. Medical Consultation

1. Consultation and assistance in specialty fields shall be readily available and used as indicated prior to and/or following a surgical procedure. A physician ambulatory surgery center/ podiatry ambulatory surgery center shall maintain a current list of consultants available.

216 R.I. Code R. § 216-RICR-40-10-13.6