CMS SOM App. A, Tag A-1000

If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or

osteopathy. The service is responsible for all anesthesia administered in the

hospital.

Interpretive Guidelines §482.52

The provision of anesthesia services is an optional hospital service. However, if a

hospital provides any degree of anesthesia service to its patients, the hospital must

comply with all the requirements of this Condition of Participation (CoP).

“Anesthesia” involves the administration of a medication to produce a blunting or loss of:

• pain perception (analgesia);

• voluntary and involuntary movements;

• autonomic function; and

• memory and/or consciousness,

depending on where along the central neuraxial (brain and spinal cord) the medication is

delivered.

In contrast, “analgesia” involves the use of a medication to provide relief of pain through

the blocking of pain receptors in the peripheral and/or central nervous system. The patient

does not lose consciousness, but does not perceive pain to the extent that may otherwise

prevail.

Anesthesia exists along a continuum. For some medications there is no bright line that

distinguishes when their pharmacological properties bring about the physiologic

transition from the analgesic to the anesthetic effects. Furthermore, each individual

patient may respond differently to different types of medications. The additional

definitions below illustrate distinctions among the various types of “anesthesia services”

that may be offered by a hospital. These definitions are generally based on American

Society of Anesthesiologists definitions found in its most recent set of practice guidelines

(Anesthesiology 2002; 96:1004-17).

• General anesthesia: a drug-induced loss of consciousness during which patients are

not arousable, even by painful stimulation. The ability to independently maintain

ventilatory support is often impaired. Patients often require assistance in maintaining

a patent airway, and positive pressure ventilation may be required because of

depressed spontaneous ventilation or drug-induced depression of neuromuscular

function. Cardiovascular function may be impaired. For example, a patient

undergoing major abdominal surgery involving the removal of a portion or all of an

organ would require general anesthesia in order to tolerate such and extensive

surgical procedure. General anesthesia is used for those procedures when loss of

consciousness is required for the sage and effective delivery of surgical services;

• Regional anesthesia: the delivery of anesthetic medication at a specific level of the

spinal cord and/or to peripheral nerves, including epidurals and spinals and other

central neuraxial nerve blocks, is used when loss of consciousness is not desired but

sufficient analgesia and loss of voluntary and involuntary movement is required.

Given the potential for the conversion and extension of regional to general anesthesia

in certain procedures, it is necessary that the administration of regional and general

anesthesia be delivered or supervised by a practitioner as specified in 42 CFR

482.52(a).

• Monitored anesthesia care (MAC): anesthesia care that includes the monitoring of

the patient by a practitioner who is qualified to administer anesthesia as defined by

the regulations at §482.52(a). Indications for MAC depend on the nature of the

procedure, the patient’s clinical condition, and/or the potential need to convert to a

general or regional anesthetic. Deep sedation/analgesia is included in MAC.

- Deep sedation/analgesia: a drug-induced depression of consciousness during

which patients cannot be easily aroused but respond purposefully following

repeated or painful stimulation. The ability to independently maintain

ventilatory function may be impaired. Patients may require assistance in

maintaining a patent airway, and spontaneous ventilation may be inadequate.

Cardiovascular function is usually maintained. Because of the potential for the

inadvertent progression to general anesthesia in certain procedures, it is

necessary that the administration of deep sedation/analgesia be delivered or

supervised by a practitioner as specified in 42 CFR 482.52(a).

• Moderate sedation/analgesia: (“Conscious Sedation”): a drug-induced depression

of consciousness during which patients respond purposefully to verbal commands,

either alone or accompanied by light tactile stimulation. No interventions are

required to maintain a patent airway, and spontaneous ventilation is adequate.

Cardiovascular function is usually maintained. CMS, consistent with ASA

guidelines, does not define moderate or conscious sedation as anesthesia (71 FR

68690-1).

• Minimal sedation: a drug-induced state during which patients respond normally to

verbal commands. Although cognitive function and coordination may be impaired,

ventilator and cardiovascular functions are unaffected. This is also not anesthesia.

• Topical or local anesthesia; the application or injection of a drug or combination of

drugs to stop or prevent a painful sensation to a circumscribed area of the body where

a painful procedure is to be performed. There are generally no systemic effects of

these medications, which also are not anesthesia, despite the name.

Rescue Capacity: As stated above, because the level of sedation of a patient receiving

anesthesia services is a continuum, it is not always possible to predict how an individual

patient will respond. Further, no clear boundary exists between some of these services.

Hence, hospitals must ensure that procedures are in place to rescue patients whose level

of sedation becomes deeper than initially intended, for example, patients who

inadvertently enter a state of Deep Sedation/Analgesia when Moderate Sedation was

intended. “Rescue” from a deeper level of sedation than intended requires an

intervention by a practitioner with expertise in airway management and advanced life

support. The qualified practitioner corrects adverse physiologic consequences of the

deeper-than-intended level of sedation and returns the patient to the originally intended

level of sedation. (Rescue capacity is not only required as an essential component of

anesthesia services, but is also consistent with the requirements under the Patients’ Rights

standard at §482.13(c)(2), guaranteeing patients care in a safe setting.)

Anesthesia services throughout the hospital (including all departments in all campuses

and off-site locations where anesthesia services are provided) must be organized into one

anesthesia service.

Areas where anesthesia services are furnished may include (but are not limited to):

• Operating room suite(s), both inpatient and outpatient;

• Obstetrical suite(s);

• Radiology department;

• Clinics;

• Emergency department;

• Psychiatry department;

• Outpatient surgery areas;

• Special procedures areas (e.g., endoscopy suite, pain management clinic, etc.)

The anesthesia services must be under the direction of one individual who is a qualified

doctor of medicine (MD) or doctor of osteopathy (DO). Consistent with the requirement

at §482.12(a)(4) for it to approve medical staff bylaws, rules and regulations, the

hospital’s governing body approves, after considering the medical staff’s

recommendations, medical staff rules and regulations establishing criteria for the

qualifications for the director of the anesthesia services. Such criteria must be consistent

with State laws and acceptable standards of practice.

As previously mentioned, there is often no bright line, i.e., no clear boundary, between

anesthesia and analgesia. This is particularly the case with moderate versus deep

sedation, but also with respect to labor epidurals. However, the anesthesia services CoP

establishes certain requirements that apply only when anesthesia is administered.

Consequently, each hospital that provides anesthesia services must establish policies and

procedures, based on nationally recognized guidelines that address whether specific

clinical situations involve anesthesia versus analgesia. (It is important to note that

anesthesia services are usually an integral part of “surgery,” as we have defined that term

in our guidance. Because the surgical services CoP at §482.51 requires provision of

surgical services in accordance with acceptable standards of practice, this provides

additional support for the expectation that anesthesia services policies and procedures

concerning anesthesia are based on nationally recognized guidelines. ) We encourage

hospitals to address whether the sedation typically provided in the emergency department

or procedure rooms involves anesthesia or analgesia. In establishing such policies, the

hospital is expected to take into account the characteristics of the patients served, the skill

set of the clinical staff in providing the services, as well as the characteristics of the

sedation medications used in the various clinical settings.

The regulation at 42 CFR 482.52(a) establishes the qualifications and, where applicable,

supervision requirements for personnel who administer anesthesia. However, hospital

anesthesia services policies and procedures are expected to also address the minimum

qualifications and supervision requirements for each category of practitioner who is

permitted to provide analgesia services, particularly moderate sedation. This expectation

is consistent not only with the requirement under this CoP to provide anesthesia services

in a well-organized manner, but also with various provisions of the Medical Staff CoP at

§482.22 and the Nursing Services CoP at §482.23 related to qualifications of personnel

providing care to patients. Taken together, these regulations require the hospital to assure

that any staff administering drugs for analgesia must be appropriately qualified, and that

the drugs are administered in accordance with accepted standards of practice.

Specifically:

• The Medical Staff CoP at §482.22(c)(6) requires the medical staff bylaws,

“Include criteria for determining the privileges to be granted to individual

practitioners and a procedure for applying the criteria to individuals requesting

privileges.”

• The Nursing Services CoP requires at:

• §482.23(b)(5) that nursing personnel be assigned to provide care based on

“the specialized qualifications and competence of the nursing staff available.”

• §482.23(c) that, “Drugs and biologicals must be prepared and administered in

accordance with Federal and State laws, …and accepted standards of

practice.” And

• §482.23(c)(3) , “… If … intravenous medications are administered by

personnel other than doctors of medicine or osteopathy, the personnel must

have special training for this duty.”

Finally, it is expected that the anesthesia services policies and procedures will undergo

periodic re-evaluation that includes analysis of adverse events, medication errors and

other quality or safety indicators related not only to anesthesia, but also to the

administration of medications in clinical applications that the hospital has determined

involve analgesia rather than anesthesia. This expectation is also supported by the

provisions of the Quality Assessment and Performance Improvement (QAPI) CoP at

§482.21, which requires the hospital to ensure its QAPI program, “…involves all hospital

departments and services…”; “…focuses on indicators related to improved health

outcomes and the prevention and reduction of medical errors....”; “…track[s] quality

indicators, including adverse patient events…”; “… use[s] the data collected to monitor

the effectiveness and safety of the services and quality of care…”; and “…take[s] actions

aimed at performance improvement…”

Hospitals are free to develop their own specific organizational arrangements in order to

deliver all anesthesia services in a well-organized manner. Although not required under

the regulation to do so, a well-organized anesthesia service would develop the hospital’s

anesthesia policies and procedures in collaboration with several other hospital disciplines

(e.g., surgery, pharmacy, nursing, safety experts, material management, etc.) that are

involved in delivering these services to patients in the various areas in the hospital.

A well-organized anesthesia service must be integrated into the hospital’s required

Quality Assessment/Performance Improvement program, in order to assure the provision

of safe care to patients.

Survey Procedures §482.52

• Request a copy of the organizational chart for anesthesia services.

• Determine that a doctor of medicine or osteopathy has the authority and

responsibility for directing all anesthesia services throughout the hospital.

• Look for evidence in the director’s file of the director’s appointment privileges

and qualifications, consistent with the criteria adopted by the hospital’s governing

body. Review the position description. Confirm that the director’s responsibilities

include at least the following:

- Planning, directing, and supervising all activities of the service;

- Evaluating the quality and appropriateness of the anesthesia services provided

to patients as part of the hospital’s QAPI program;

• Request a copy of and review the hospital’s anesthesia services policies and

procedures.

- Do they apply in all hospital locations where anesthesia services are provided?

- Do they indicate the necessary qualifications that each clinical practitioner

must possess in order to administer anesthesia as well as moderate sedation or

other forms of analgesia?

- Do they address what clinical applications are considered to involve analgesia,

in particular moderate sedation, rather than anesthesia, based on identifiable

national guidelines? What are the national guidelines that they are following

and how is that documented?

• Does the hospital have a system by which adverse events related to the

administration of anesthesia and analgesia, including moderate sedation, are

tracked and acted upon?