Surgery In Certain Outpatient Settings - Medicine - Business & Professions - CA

Section § 2215

This law acknowledges that many significant surgeries are done outside of hospitals in places that may not be properly regulated, which could harm public health and safety. Although the doctors in these places are licensed, additional checks are needed to make sure they perform safe and effective surgeries. The law aims to establish new regulations to improve patient safety without imposing unnecessary or costly facility upgrades, unless they are vital for safety and cost-effective. Any changes should be the cheapest way to protect patients, as evaluated by the Medical Board's Division of Licensing.

The Legislature finds and declares that in this state, significant surgeries are being performed in unregulated out-of-hospital settings. The Legislature further finds and declares that without appropriate oversight, some of these settings may be operating in a manner which is injurious to the public health, welfare, and safety. Although the health professionals delivering health care services in these settings are licensed, further quality assurance is needed to ensure that health care services are safely and effectively performed in these settings. The Legislature further recognizes that there is a wide range of surgical procedures safely performed in a myriad of outpatient settings, and the degree of patient risk varies greatly. It is the intent of the Legislature to create regulations that directly impact patient safety. It is not the intent of the Legislature to require standards in excess of those requirements in Section 1248.15, or to require physical modifications to facilities unless the modifications or standards directly impact patient safety and are cost-effective. The cost effectiveness of any modifications shall be taken into consideration by the Division of Licensing of the Medical Board of California, and shall ensure that the least costly and effective method of achieving patient safety is required.

unregulated surgeries out-of-hospital settings public safety

Section § 2216

Starting from July 1, 1996, doctors in California cannot perform surgeries using strong anesthesia in outpatient settings that might risk a patient's critical reflexes, unless those settings meet specific criteria. However, giving mild sedation or pain relief in doses that don't put the patient at such risk is allowed. The definition of 'outpatient settings' is explained in another section of the law (Section 1248).

On or after July 1, 1996, no physician and surgeon shall perform procedures in an outpatient setting using anesthesia, except local anesthesia or peripheral nerve blocks, or both, complying with the community standard of practice, in doses that, when administered, have the probability of placing a patient at risk for loss of the patient’s life-preserving protective reflexes, unless the setting is specified in Section 1248.1. Outpatient settings where anxiolytics and analgesics are administered are excluded when administered, in compliance with the community standard of practice, in doses that do not have the probability of placing the patient at risk for loss of the patient’s life-preserving protective reflexes.

The definition of “outpatient settings” contained in subdivision (c) of Section 1248 shall apply to this section.

outpatient surgery anesthesia restrictions local anesthesia

Section § 2216.1

Since July 1, 2000, doctors performing procedures outside of a hospital must do so with at least two staff members present on-site. One of these staff must be either a licensed doctor or a healthcare professional certified in handling heart emergencies, as long as there is a patient who hasn't yet been discharged from care at the location.

On and after July 1, 2000, it is unprofessional conduct for a physician and surgeon to perform procedures in any outpatient setting except in compliance with Section 2216, unless the setting has a minimum of two staff persons on the premises, one of whom shall either be a licensed physician and surgeon or a licensed health care professional with current certification in advanced cardiac life support (ACLS), as long as a patient is present who has not been discharged from supervised care.

unprofessional conduct outpatient setting compliance

Section § 2216.2

This law states that it's considered unprofessional for doctors to perform surgeries outside of a general acute care hospital without having proper insurance coverage or being part of a trust to cover patient claims. The medical board decides what counts as 'adequate security.' However, insurance companies aren't required to offer this coverage. Acceptable types of coverage include policies from certain licensed insurers or cooperative corporations.

(a) It is unprofessional conduct for a physician and surgeon to fail to provide adequate security by liability insurance, or by participation in an interindemnity trust, for claims by patients arising out of surgical procedures performed outside of a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code.

(b) For purposes of this section, the board shall determine what constitutes adequate security.

(c) Nothing in this section shall require an insurer admitted to transact liability insurance in this state to provide coverage to a physician and surgeon.

(d) The security required by this section shall be acceptable only if provided by any one of the following:

(1) An insurer admitted pursuant to Section 700 of the Insurance Code to transact liability insurance in this state.

(2) An insurer that is eligible pursuant to Section 1765.1 of the Insurance Code.

(3) A cooperative corporation authorized by Section 1280.7 of the Insurance Code.

(4) An insurer licensed to transact liability insurance in at least one state of the United States.

unprofessional conduct physician liability surgical procedures

Section § 2216.3

This law requires outpatient medical centers to report any adverse events to the board within five days of detection or within 24 hours if it's an urgent threat to patients or others. An adverse event includes various issues such as surgery on the wrong body part, infections from contaminated products, patient deaths, medical errors, and even criminal activities like impersonation or assault. The center must also inform the affected patient or their representative about the event. Adverse events range from surgical mistakes to environmental hazards and patient-protected events like discharging a minor to the wrong person.

These events can result in serious disabilities, defined as impairments lasting over seven days that impact daily life. Lastly, surgical procedures involve any operation cutting or accessing the body, according to specific medical coding standards.

(a) An outpatient setting accredited pursuant to Section 1248.1 of the Health and Safety Code shall report an adverse event to the board no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the adverse event has been detected. Disclosure of individually identifiable patient information shall be consistent with applicable law.

(b) For the purposes of this section, “adverse event” includes any of the following:

(1) Surgical or other invasive procedures, including the following:

(A) Surgical or other invasive procedure performed on a wrong body part that is inconsistent with the documented informed consent for that patient. A reportable event under this subparagraph does not include a situation requiring prompt action that occurs in the course of surgery or a situation that is so urgent as to preclude obtaining informed consent.

(B) Surgical or other invasive procedure performed on the wrong patient.

(C) The wrong surgical or other invasive procedure performed on a patient, which is a procedure performed on a patient that is inconsistent with the documented informed consent for that patient. A reportable event under this subparagraph does not include a situation requiring prompt action that occurs in the course of surgery, or a situation that is so urgent as to preclude the obtaining of informed consent.

(D) Retention of a foreign object in a patient after surgery or other procedure, excluding objects intentionally implanted as part of a planned intervention and objects present prior to surgery that are intentionally retained.

(E) Death of a patient during or up to 24 hours after admittance of a patient to an outpatient setting that follows induction of anesthesia after surgery of a normal, healthy patient who has no organic, physiologic, biochemical, or psychiatric disturbance and for whom the pathologic processes for which the operation is to be performed are localized and do not entail a systemic disturbance.

(F) Transfer of a patient to a hospital or emergency center for medical treatment for a period exceeding 24 hours following a scheduled procedure outside of a general acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code.

(2) Product or device events, including the following:

(A) Patient death or serious disability associated with the use of a contaminated drug, device, or biologic provided by the outpatient setting when the contamination is the result of generally detectable contaminants in the drug, device, or biologic, regardless of the source of the contamination or the product.

(B) Patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended. For purposes of this subparagraph, “device” includes, but is not limited to, a catheter, drain, or other specialized tube, infusion pump, or ventilator.

(C) Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in an outpatient setting, excluding deaths associated with neurosurgical procedures known to present a high risk of intravascular air embolism.

(3) Patient protection events, including the following:

(A) A minor discharged to the wrong person.

(B) A patient suicide or attempted suicide resulting in serious disability while being cared for in an outpatient setting due to patient actions after admission to the outpatient setting.

(4) Care management events, including the following:

(A) A patient death or serious disability associated with a medication error, including, but not limited to, an error involving the wrong drug, the wrong dose, the wrong patient, the wrong time, the wrong rate, the wrong preparation, or the wrong route of administration, excluding reasonable differences in clinical judgment on drug selection and dose.

(B) A patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products.

(C) Patient death or serious disability directly related to hypoglycemia, the onset of which occurs while the patient is being cared for in an outpatient setting.

(D) A patient death or serious disability due to spinal manipulative therapy performed at the outpatient setting.

(5) Environmental events, including the following:

(A) A patient death or serious disability associated with an electric shock while being cared for in an outpatient setting, excluding events involving planned treatments, such as electric countershock.

(B) Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by a toxic substance.

(C) A patient death or serious disability associated with a burn incurred from any source while being cared for in an outpatient setting.

(D) A patient death associated with a fall while being cared for in an outpatient setting.

(E) A patient death or serious disability associated with the use of restraints or bed rails while being cared for in an outpatient setting.

(6) Criminal events, including the following:

(A) Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider.

(B) The abduction of a patient of any age.

(D) The death or significant injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of an outpatient setting.

(7) An adverse event or series of adverse events that cause the death or serious disability of a patient, personnel, or visitor.

(c) The outpatient setting shall inform the patient or the party responsible for the patient of the adverse event by the time the report is made.

(d) “Serious disability” means a physical or mental impairment that substantially limits one or more of the major life activities of an individual, or the loss of bodily function, if the impairment or loss lasts more than seven days or is still present at the time of discharge from an inpatient health care facility, or the loss of a body part.

(e) “Surgical or other invasive procedures” are defined for the purposes of this section as operative procedures in which skin or mucous membranes and connective tissue are incised or an instrument is introduced through a natural body orifice. They include all procedures described by the codes in the surgery section of the Current Procedural Terminology.

outpatient setting adverse events urgent threat

Section § 2216.4

If an outpatient facility doesn't report a serious incident as required, they can be fined up to $100 for each day it's late, after a certain grace period. If the facility disagrees with the fine, they have 10 days to ask for a hearing to contest it. The fine has to be paid after all appeals are done.

If an accredited outpatient setting fails to report an adverse event pursuant to Section 2216.3, the board may assess the accredited outpatient setting a civil penalty in an amount not to exceed one hundred dollars ($100) for each day that the adverse event is not reported following the initial five-day period or 24-hour period, as applicable. If the accredited outpatient setting disputes a determination by the board regarding an alleged failure to report an adverse event, the accredited outpatient setting may, within 10 days of notification of the board’s determination, request a hearing, which shall be conducted pursuant to the administrative adjudication provisions of Chapter 4.5 (commencing with Section 11400) and Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. Penalties shall be paid when appeals pursuant to those provisions have been exhausted.

accredited outpatient setting adverse event civil penalty

Section § 2217

This section lets the Division of Licensing within the Medical Board of California create rules to put into effect this article and a specific part of the Health and Safety Code. Basically, it's about giving them the power to make detailed regulations to enforce certain healthcare laws.

The Division of Licensing of the Medical Board of California may adopt regulations to implement this article and Chapter 1.3 (commencing with Section 1248) of Division 2 of the Health and Safety Code.

Division of Licensing Medical Board regulations