16 Del. Admin. Code § 3335-2.0

Current through Register Vol. 28, No. 3, September 1, 2024

Section 3335-2.0 - Definitions

The following words and terms, when used in this regulation, should have the following meaning unless the context clearly indicates otherwise:

"Accredited Facility" means a facility that is accredited by an accrediting organization approved by the Department. Approval requires an accrediting organization to be independent from the facility.

"Accrediting Organization" means an organization able to measure the quality of facility's services and performance against nationally-recognized and evidenced-based standards that focus on (1) ensuring quality health care and provider competence, (2) reducing risks, (3) monitoring standards of practice (4) promoting continuous quality improvement, and (5) demonstrating accountability. The organization requires facilities to complete self-assessments and expert surveyors to conduct thorough reviews.

"Adverse Event" means the death or serious injury of any patient at a facility; a reasonable determination by the Department that death or serious injury may result from any unsafe or unsanitary condition at a facility; or the initiation of any criminal investigation arising out of or relating to any diagnosis, treatment or other medical care at a facility.

"Anesthesia" means anxiolysis, conscious sedation, deep sedation, major conduction anesthesia, minimal sedation, moderate sedation or general anesthesia and all anesthesia, including local anesthesia, used for surgical abortions. For office-based surgery other than surgical abortions, the following shall be excluded from the definition of anesthesia:

(1) local anesthesia,

(2) the administration of less than 50% nitrous oxide in oxygen with or without local anesthesia but with no other sedative or analgesic medications by any route, or

(3) the administration of a single, oral sedative or analgesic medication in doses appropriate for the unsupervised treatment of insomnia, anxiety, or pain with or without local anesthesia.

"Anxiolysis" means minimal sedation.

"ASA Classification" means the American Society of Anesthesiologists's physical status classification of preoperative patients for anesthetic risk assessment.

"Certified Registered Nurse Anesthetist" means an individual currently licensed as an advanced practice nurse under 24 Del.C. Ch.19.

"Complaint" means a complaint filed by a patient or current facility employee in writing, in such format as the Department requires.

"Conscious Sedation" means moderate sedation.

"Deep Sedation" means a drug-induced depression of consciousness during which:

(1) patients cannot be easily aroused but respond purposefully following repeated or painful stimulation,

(2) the ability to independently maintain ventilatory function may be impaired,

(3) patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate, and

(4) cardiovascular function is usually maintained.

"Dentist" means an individual currently licensed as a dentist under 24 Del.C. Ch. 11.

"Department" means the Delaware Department of Health and Social Services or its designee.

"Facility" means a location at which any office-based surgery is performed, but does not include any hospital, as defined in 16 Del.C. § 1001, or any freestanding birthing center, freestanding surgical center or freestanding emergency department as such terms are defined in 16 Del.C. § 122(3) p.

"General Anesthesia" means a drug-induced loss of consciousness during which:

(1) patients are not arousable, even by painful stimulation,

(2) the ability to independently maintain ventilatory function is often impaired,

(3) 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, and

(4) cardiovascular function may be impaired.

"Local Anesthesia" means the injection of the skin or muscle, or application of an anesthetic drug to a specific area of the body, to prevent patients from feeling pain directly where the pain will occur during a medical, surgical or dental procedure. Local anesthesia can be divided into four groups: injectable, topical, dental (non-injectable) and ophthalmic.

"Major Conduction Anesthesia" means the administration of a drug, or a combination of drugs, to interrupt nerve impulses without loss of consciousness, e.g. epidural, caudal, or spinal anesthesia, lumbar or brachial plexus blocks, and intravenous regional anesthesia. However, isolated blockade of small peripheral nerves, such as digital nerves are not included.

"Minimal Sedation" means a drug-induced state during which:

(1) patients respond normally to verbal commands, and

(2) cognitive and physical coordination may be impaired but airway reflexes and ventilatory and cardiovascular functions are unaffected.

"Moderate Sedation" means a drug-induced depression of consciousness during which:

(1) patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation,

(2) no interventions are required to maintain a patent airway,

(3) spontaneous ventilation is adequate, and

(4) cardiovascular function is usually maintained.

"Musculoskeletal Injection" means a trigger point injection, lumbar puncture, or injection that targets a joint, including shoulder, hip, knee, elbow, hand, wrist, foot, ankle, and sacroiliac joint. Musculoskeletal injections do not include any other injection in which the spine is the target of the injection.

"Office-Based Surgery" means any medical procedure, including dental and podiatric procedures, which include any of the following:

(1) Surgical abortions,

(2) Procedures in which the facility utilizes anesthesia, major conduction anesthesia or sedation,

(3) Procedures in which the spine (i.e. epidural, facet joint) is the target of an injection, or

(4) Procedures in which the accepted standard of care requires anesthesia, major conduction anesthesia or sedation. Office-based surgery does not include musculoskeletal injections.

"Patient" means a person, person's spouse, parent, legal guardian, or legal custodian of a person under 18 or any legal guardian or legal custodian of a person who is an adult, who has received diagnosis, treatment or other medical care at a facility.

"Physician" means an individual currently licensed as a physician under 24 Del.C. Ch. 17.

"Physician Assistant" means an individual currently licensed as a physician assistant under 24 Del.C. Ch. 17.

"Plan of Correction" means a facility's written response to findings of regulatory non-compliance. Plans must adhere to the format specified by the Department, include acceptable timeframes in which deficiencies will be corrected and must be approved by the Department.

"Podiatrist" means an individual currently licensed as a podiatrist under 24 Del.C. Ch. 5.

"Procedure" means office-based surgery.

"Registered Nurse" means an individual currently licensed as a registered nurse under 24 Del.C. Ch.19.

"Serious Injury" means physical injury that creates a substantial risk of death, or that causes serious disfigurement, prolonged impairment of health or prolonged loss or impairment of the function of any bodily organ or which causes the termination of a pregnancy without the consent of the pregnant female.

"Time-out" means a pause in action conducted in the procedure room immediately before the procedure is to begin. The time-out (1) involves the entire operative team, including the patient, (2) uses active communication, and (3) includes correctly identifying: the patient, the procedure, and the site.

16 Del. Admin. Code § 3335-2.0

18 DE Reg. 862(5/1/2015)
23 DE Reg. 125( 8/1/2019) (Final)