Skip to Page Content
Delaware.gov  |  Text OnlyGovernor | General Assembly | Courts | Elected Officials | State Agencies
 Photo: Featured Delaware Photo
 
 
 Phone Numbers Mobile Help Size Print Email

Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsMay 2015

Table of Contents Previous Next

Authenticated PDF Version

16 DE Admin. Code 4408
On February 1, 2015 (Volume 18, Issue 8), DHSS published in the Delaware Register of Regulations its notice of proposed regulations, pursuant to 29 Del.C. §10115. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by March 3, 2015, after which time the DHSS would review information, factual evidence and public comment to the said proposed regulations.
Agency Response: The Agency appreciates and acknowledges these comments. To ensure that patients undergoing a surgical abortion receive care in a safe and sanitary setting, as was the clear intent of the General Assembly, the regulations will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. To ensure that patients undergoing a surgical abortion receive care in a safe and sanitary setting, as was the clear intent of the General Assembly, the regulations will remain as written.
THEREFORE, IT IS ORDERED, that the proposed State of Delaware Regulations Governing Facilities that Perform Invasive Medical Procedures are adopted and shall become effective May 11, 2015, after publication of the final regulation in the Delaware Register of Regulations.
Delaware Department of Health and Social Services adopts these regulations pursuant to the authority vested by 16 Del.C. §122(3)(y and z). These regulations establish standards with respect to the safe and sanitary conditions, and require the accreditation of any facility that performs invasive medical procedures in which the accepted standard of care requires anesthesia, major conduction anesthesia, or sedation. These regulations also provide for the investigation of any patient or current facility employee complaints involving the unsafe and/or unsanitary conditions in such facilities.
"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 invasive medical procedures other than surgical abortions, the following shall be excluded from the definition of anesthesia: This definition excludes: (1) local anesthesia, (2) the administration of less than 50% nitrous oxide in oxygen with no other sedative or analgesic medications by any route, or (3) a single, oral sedative or analgesic medication administration in doses appropriate for the unsupervised treatment of insomnia, anxiety, or pain.
"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 invasive medical procedure is performed, but shall not include any hospital, as defined in 16 Del.C. §1001(2), or any freestanding birthing center, freestanding surgical center or freestanding emergency center as such terms are defined in 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.
"Invasive Medical Procedure" means any medical procedure, including dental and podiatric procedures, in which the accepted standard of care requires anesthesia, major conduction anesthesia or sedation.
"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. Local anesthesia 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 (i.e. systemic sedation such as spinal, epidural, axillary, stellate ganglion block, regional blocks, supraclavicular, intraclavicular and intravenous regional anesthesia) where significant cardiovascular or respiratory complications may result.
"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.
"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 invasive medical procedure.
"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.
Last Updated: December 31 1969 19:00:00.
site map   |   about this site   |    contact us   |    translate   |    delaware.gov