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 office-based surgery. 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 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.
3.4 At least one attending clinical team member must be certified in Advanced Cardiac Life Support.
3.5.1.1 Electrocardiographic monitor;
3.5.1.2 Blood pressure monitor;
3.5.1.4 Continuous suction device;
3.5.1.5 Positive pressure ventilation device;
3.5.1.7 Emergency intubation equipment;
3.5.1.8 IV solutions and IV tubing;
3.5.1.10 Esophageal or precordial stethoscope;
3.5.1.11 Temperature monitoring device;
3.5.1.12 End tidal CO2 monitor;
3.5.1.13 Crash cart which shall include:
3.5.1.13.1 Appropriate resuscitative equipment; and
3.5.1.13.2 Medications for surgical, procedural or anesthetic complications;
3.5.2 Appropriate sterilization equipment; and
3.5.3 Adequate procedure room lighting.
3.6 Written informed consent is required prior to the procedure reflecting:
3.6.1 The patient's knowledge of the identified risks of the procedure (including anesthesia);
3.6.2 The consent to the procedure;
3.6.3 The licensed individual performing the procedure;
3.6.4 The type of anesthesia to be administered; and
3.6.5 The anesthesia provider.
4.3.2 The facility must conduct an investigation of all adverse events.
4.5 Facility procedures shall not:
4.5.2 Be generally emergent or life-threatening in nature.
4.7.1 The facility shall maintain policies and procedures based upon accepted standards of practice.
4.9 There must be sufficient space in the room in which the procedure is being performed.
4.10 All equipment shall be maintained and functional to ensure patient safety.
5.2.1. The ongoing infection prevention and control program must:
5.2.1.1.1 Surveillance includes infection detection through ongoing data collection and analysis.
5.3 Specific Requirements for COVID-19
5.4 The facility shall amend their policies and procedures to include:
5.4.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;
5.4.2 Staff refusals to participate in COVID-19 testing;
5.4.3 Staff refusals to authorize release of testing results or vaccination status to the facility;
5.4.5 Plans to address staffing shortages and facility demands should a COVID-19 outbreak occur.
6.2 The medical record must include:
6.2.1 Patient identifying information;
6.2.2 Patient's medical history and a physical examination:
6.2.2.1 Inclusive of the cardiorespiratory system and other systems related to the diagnosis;
6.2.2.2 Completed within 30 days prior to the procedure;
6.2.3 Diagnosis and plan of care;
6.2.4 Appropriate diagnostic reports;
6.2.6 Documentation of the time-out;
6.2.7 Operative/procedure report;
6.2.8 Pathology reports, if applicable;
6.2.9 Outcome and follow-up plans;
6.2.10 A separate anesthesia record for each administration of anesthesia which must include:
6.2.10.2 Drug type, dose and route;
6.2.10.3 Time of administration;
6.2.10.6 Vital signs monitoring;
6.2.10.7 Estimated blood loss;
6.2.10.8 Duration of procedure; and
6.2.10.9 Any complication or unusual event related to the procedure or anesthesia.
6.2.11 Intra-procedure and post-procedure monitoring.
7.1.1.1 Complaints received by the Department will be investigated as appropriate.
7.1.1.2 Complainants (unless anonymous) will be notified of the outcome of any investigation.
7.2 The patient has the right to:
7.2.2 Dignity, respect and consideration of legitimate concerns.
7.2.3 Privacy and confidentiality.
7.2.4 Be involved in all aspects of care:
7.2.4.2 The patient must be given information about the current diagnosis, treatment and prognosis.
7.2.6 Know who will be delivering the care and the qualifications of such individuals.
7.2.7 Exercise her/his rights without being subjected to discrimination or reprisal.
7.2.8 Voice grievances regarding treatment or care that is (or fails to be) furnished.
7.2.9 Be free from all forms of abuse, mistreatment, neglect or harassment.
7.2.10 Receive care from individuals who are properly trained and competent to perform their duties.
7.2.11 Request and receive a copy of the posted written notice of the patient rights.
8.1 The Department may impose sanctions singly or in combination when it finds a facility has:
8.1.1 Violated any of these regulations;
8.1.2 Violated standards for safe and sanitary care in a facility;
8.1.4 Engaged in any conduct or practices detrimental to the welfare of the patients; or
8.2.1.2.1 Issue of a letter of reprimand; and/or
8.2.1.2.2 Require the facility to complete a plan of correction.
8.3 Imposition of Disciplinary Action
8.3.1 The Department may issue an order to close the facility immediately.
8.3.1.1 An order to close may apply to the performance of office-based surgery.
8.3.1.2 An order to close may apply to the facility as a whole.
8.3.3 In response to the order to close, the facility may:
8.3.3.1 Take no action, in which case the order to close shall remain in effect.
8.3.3.2 Take action to correct the unsafe and unsanitary practices identified during the survey.
8.3.3.2.2 The Department shall determine if the plan of correction is acceptable.
8.3.3.2.3 Once accepted, the Department shall schedule a revisit as soon as possible.
8.3.3.3.1.2 The Department shall make a determination based upon the evidence presented.
8.3.3.3.2 A facility may request an expedited hearing.
8.3.3.3.2.3 The Department shall make a determination based upon the evidence presented.
8.3.4 During an administrative hearing:
8.3.4.1 The facility has the right to be represented by counsel.
8.3.4.2 All statements made shall be under oath.
8.3.4.3 The facility has the right to examine and cross-examine witnesses.
9.0 Accreditation Requirements and Procedures
9.1.1.3 Facility phone number;
9.1.1.5 Acknowledgment that office-based surgery is performed in the facility.
9.1.2.1 The Department shall maintain a list of approved accrediting organizations.
9.1.6.1 The findings of surveys;
9.1.6.2 The findings of complaint and incident investigations; and
9.1.6.3 Data for all facilities that perform office-based surgery.
9.2.1 Termination of accreditation may occur secondary to:
9.2.1.1 Voluntary surrender of accreditation by the facility.
9.2.1.2 Revocation of accreditation by the accrediting organization.
9.2.2 Any facility that fails to maintain accreditation shall immediately cease to operate.
9.3.1.2 Anytime upon receipt of a referral from the Division of Professional Regulation.
9.5 Exclusions from accreditation
9.5.1.1 Those facilities required to be licensed under Title16 of the Delaware Code.