Section 844IAC5-5-21. Approval of accreditation agencies; requirements

   In approving accreditation agencies to perform accreditation of office-based settings, the board shall ensure that the certification program, at a minimum, includes standards for the following aspects of an office-based setting's operations:

(1) Anesthesia, as follows:

(A) The level of anesthesia administered shall be appropriate for the:

(i) patient;

(ii) procedure;

(iii) clinical setting;

(iv) education and training of the personnel; and

(v) equipment available.

Practitioners shall select patients for procedures in office-based settings using anesthesia by criteria, including the American Society of Anesthesiologists (ASA) Physical Status Classification System, and so document.

(B) The choice of specific anesthetic agents and techniques shall focus on providing anesthesia that will:

(i) be safe, effective, and appropriate; and

(ii) respond to the specific needs of patients while also ensuring rapid recovery to normal function with appropriate efforts to control postoperative pain, nausea, or other side effects.

(C) A health care provider administering anesthesia shall be licensed, qualified, and working within the provider's scope of practice. In those cases in which a nonphysician provider administers the anesthesia, the provider must be:

(i) under the direction and supervision of a practitioner as required by IC 25-22.5-1-2(a)(20); or

(ii) under the direction of and in the immediate presence of a practitioner as required by IC 25-22.5-1-2(a)(13), if the provider is a certified registered nurse anesthetist.

(D) A:

(i) health care provider who administers anesthesia; and

(ii) practitioner who:

(AA) performs a procedure that requires anesthesia; or

(BB) directs or supervises the administration of anesthesia;

in an office-based setting shall maintain current training in advanced resuscitation techniques, such as advanced cardiac life support (ACLS) or pediatric advanced life support (PALS), as applicable. At least one (1) person with ACLS or PALS training should be immediately available until the patient is discharged.

(E) In addition to the health care provider performing the procedure, sufficient numbers of qualified health care providers, each working within the individual provider's scope of practice, must be present to:

(i) evaluate the patient;

(ii) assist with the procedure;

(iii) administer and monitor the anesthesia; and

(iv) recover the patient.

Other health care providers involved in the delivery of procedures in an office-based setting that require anesthesia, at a minimum, shall maintain training in basic cardiopulmonary resuscitation.

(F) Patients who have preexisting medical or other conditions who may be at particular risk for complications shall be referred to:

(i) a hospital;

(ii) an ambulatory surgical center; or

(iii) another office-based setting appropriate for the procedure and the administration of anesthesia.

(G) The practitioner administering the anesthesia, or supervising or directing the administration of anesthesia as required by clause (C), shall do the following:

(i) Perform a preanesthetic examination and evaluation or ensure that it has been appropriately performed by a qualified health care provider.

(ii) Develop the anesthesia plan or personally review and concur with the anesthesia plan if the plan has been developed by a certified registered nurse anesthetist (CRNA).

(iii) Remain physically present during the operative period and be immediately available until the patient is discharged from anesthesia care for diagnosis, treatment, and management of complications or emergencies.

(iv) Assure provision of appropriate postanesthesia care.

(H) Patient assessment shall occur throughout the preprocedure, periprocedure, and postprocedure phases. The assessment shall:

(i) address not only physical and functional status, but also physiological and cognitive status; and

(ii) be documented in the medical record.

The procedure and anesthesia shall be properly documented in the medical record.

(I) Physiologic monitoring of patients shall be appropriate for the type of anesthesia and individual patient needs, including continuous monitoring or assessment of the following:

(i) Ventilation.

(ii) Cardiovascular status.

(iii) Body temperature.

(iv) Neuromuscular function and status.

(v) Patient positioning.

(vi) Oxygenation using a quantitative technique such as pulse oximetry.

When general anesthesia is used, equipment to assess exhaled carbon dioxide must also be available.

(J) Provisions shall be made for a reliable source of the following:

(i) Oxygen.

(ii) Suction.

(iii) Resuscitation equipment.

(iv) Emergency drugs.

(2) Procedures, as follows:

(A) Procedures shall be provided by qualified health care providers in an environment that promotes patient safety.

(B) Procedures to be undertaken shall be within the:

(i) scope of practice, training, and expertise of the health care providers; and

(ii) capabilities of the facilities.

(C) The procedure shall be of a duration and degree of complexity that will permit patients to recover and be discharged from the office-based setting in less than twenty-four (24) hours.

(D) Provisions shall be made for appropriate ancillary services on site or in another predetermined location. Ancillary services shall be provided in a safe and effective manner in accordance with accepted ethical professional practice and statutory requirements. These services include, but are not limited to:

(i) pharmacy;

(ii) laboratory;

(iii) pathology;

(iv) radiology;

(v) occupational health; and

(vi) other associated;

services.

(3) Facilities and equipment, as follows:

(A) The office-based setting shall:

(i) be clean and properly maintained and have adequate lighting and ventilation;

(ii) be equipped with the appropriate medical equipment, supplies, and pharmacological agents that are required in order to provide:

(AA) anesthesia;

(BB) recovery services;

(CC) cardiopulmonary resuscitation; and

(DD) other emergency services;

(iii) have:

(AA) appropriate firefighting equipment;

(BB) signage;

(CC) emergency power capabilities and lighting; and

(DD) an evacuation plan;

(iv) have the necessary:

(AA) personnel;

(BB) equipment; and

(CC) procedures;

to handle medical and other emergencies that may arise in connection with services provided; and

(v) comply with:

(AA) applicable federal, state, and local laws and codes and regulations, and provisions must be made to accommodate disabled individuals in compliance with the Americans with Disabilities Act of 1990 (42 U.S.C. 12101 et seq.); and

(BB) federal and state laws and regulations regarding protection of the health and safety of employees.

(B) The space allocated for a particular function or service shall be adequate for the activities performed.

(C) In locations where anesthesia is administered, there shall be appropriate anesthesia apparatus and equipment to allow appropriate monitoring of patients. All equipment shall be maintained, tested, and inspected according to the manufacturer's specifications. Backup power sufficient to ensure patient protection in the event of an emergency shall be available. There shall be sufficient space to:

(i) accommodate all necessary equipment and personnel; and

(ii) allow for expeditious access to patients and all monitoring equipment.

(D) When anesthesia services are provided to infants and children, the required:

(i) equipment;

(ii) medications; and

(iii) resuscitative capabilities;

shall be appropriately sized for children.

(E) All equipment used in patient care, testing, or emergency situations shall be inspected, maintained, and tested:

(i) on a regular basis; and

(ii) according to manufacturers' specifications.

(F) Appropriate emergency equipment and supplies shall be readily accessible to all patient service areas.

(G) Efforts shall be made to eliminate hazards that might lead to:

(i) slipping;

(ii) falling;

(iii) electrical shock;

(iv) burns;

(v) poisoning; or

(vi) other trauma.

(H) Procedures shall be implemented to:

(i) minimize the sources and transmission of infections; and

(ii) maintain a sanitary environment.

(I) A system shall be in place to:

(i) identify;

(ii) manage;

(iii) handle;

(iv) transport;

(v) treat; and

(vi) dispose of;

hazardous materials and wastes, whether solid, liquid, or gas.

(J) Smoking must be prohibited in all patient care areas.

(Medical Licensing Board of Indiana; 844 IAC 5-5-21; filed Apr 24, 2008, 1:41 p.m.: 20080521-IR-844070842FRA; readopted filed Dec 2, 2014, 10:09 a.m.: 20141231-IR-844140391RFA)