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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsApril 2013

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Copies of the proposed regulations are available for review in the April 1, 2013 edition of the Delaware Register of Regulations, accessible online at: http://regulations.delaware.gov or by calling the Office of Health Facilities Licensing and Certification at (302) 283-7220.
Email: Deborah.Harvey@state.de.us
Accredited Medical Facility” means a medical facility which has received required accreditation from a nationally recognized accrediting organization approved by the Department.
Adverse Event” means the death or serious injury of any patient at a facility; or 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.
Anxiolysis” means minimal sedation.
ASA Classification” means the American Society of Anesthesiologists physical classification status of patients used in determining if a medical facility procedure is appropriate.
Conscious Sedation” means moderate sedation.
Deep Sedation” means 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.
Dentist” means an individual currently licensed as such by 24 Del.C. Ch. 11.
Department” means the Delaware Department of Health and Social Services or its designee.
General Anesthesia” means a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function 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.
Invasive Medical Procedure” means a procedure performed for the purpose of structurally altering the human body by the incision or destruction of tissues (including induced expulsion of a human fetus) and is part of the practice of medicine, dentistry or podiatry. It is also the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes and needles. The tissue can be cut, burned, vaporized, frozen, sutured, probed, or manipulated by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic or chemical means. Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system, is also considered to be an invasive medical procedure (this does not include the administration by nursing personnel of some injections, subcutaneous, intramuscular, and intravenous, when ordered by a physician/dentist/podiatrist). All of these procedures are invasive, including those that are performed with lasers, and the risks of any procedure are not eliminated by using a light knife or laser in place of a metal knife, or scalpel.
Local Anesthesia” means the injection or application of an anesthetic drug to a specific area of the body. Local anesthetics are used to prevent patients from feeling pain during medical, surgical, or dental procedures. Local anesthesia involves the injection into the skin or muscle or application to the skin of an anesthetic directly where pain will occur. Local anesthesia can be divided into four groups: injectable, topical, dental (non-injectable) and ophthalmic. It does include infiltration block anesthesia but would not include procedures in which local anesthesia is injected into areas of the body other than skin or muscle (systemic sedation such as spinal, epidural, axillary, stellate ganglion block, regional blocks (i.e. interscalene), supraclavicular, infraclavicular and intravenous regional anesthesia) where significant cardiovascular or respiratory complications may result.
Medical Facility” means the office of a physician or physician practice, dentist or podiatrist or a clinic where invasive medical procedures utilizing any level of anesthesia are performed. Medical facilities may be classified as Level I, Level II or Level III. Those facilities required to be licensed under Title 16 of the Delaware Code are excluded from this definition.
Minimal Sedation” means a drug-induced state during which patients respond normally to verbal commands. 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 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.
Nationally Recognized Accrediting Organization” means an organization through which a medical facility is able to measure the quality of its services and performance against nationally recognized and evidenced based standards that focus on: ensuring quality health care and provider competence; reducing risks; monitoring standards of practice; promoting continuous quality improvement; and, demonstrating accountability. The organization requires self-assessment by the medical facility, as well as a thorough review by the organization’s expert surveyors. Such organizations must be approved by the Department.
Nitrous Oxide Inhalation” means a sedative agent that is mixed with oxygen and inhaled through a small mask that fits over a patient’s nose to help the patient relax for a procedure. Nitrous oxide is not intended to put a patient to sleep and the patient should be able to hear and respond to any requests or directions.
Patient” means a person who receives a health care service from a medical facility.
Physician” means an individual currently licensed as such by 24 Del.C. Ch. 17.
“Plan of Correction” means a medical facility’s written response to findings of regulatory non-compliance. Plans must adhere to the format specified by the Department, must include acceptable timeframes in which deficiencies will be corrected and must be approved by the Department.
Podiatrist” means an individual currently licensed as such by 24 Del.C. Ch. 5.
Procedure” means invasive medical procedure.
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 unlawful 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 involves the entire operative team, including the patient, uses active communication and includes correctly identifying: the patient, the procedure, and the site.

 

3.3.7 Equipment and supplies, unless precluded or invalidated by the nature of the patient, procedure, or equipment, including but not limited to:
Last Updated: December 31 1969 19:00:00.
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