DEPARTMENT OF HEALTH AND SOCIAL SERVICES
Division of Public Health
4408 Facilities that Perform Invasive Medical Procedures
On April 1, 2013 (Volume 16, Issue 10), the Department of Health and Social Services (DHSS) published in the Delaware Register of Regulations its notice of proposed regulations governing medical facilities and held them out for public comment per Delaware law. The public comments resulted in significant changes, which necessitated the submission of a new set of regulations for public review and comment.
On October 1, 2013, the Office of Health Facilities Licensing and Certification, Health Systems Protection Section, Division of Public Health, Department of Health and Social Services, is again proposing regulations for facilities that perform invasive medical procedures using anesthesia. 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, patient legal representative or current facility employee complaints involving the unsafe and/or unsanitary conditions in such facilities.
Copies of the proposed regulations are available for review in the October 1, 2013 edition of the Delaware Register of Regulations, accessible online at: or by calling the Office of Health Facilities Licensing and Certification at (302) 283-7220.
Any person who wishes to make written suggestions, testimony, briefs or other written materials concerning the proposed regulations must submit same to Deborah Harvey by Thursday, October 31, 2013 at:
Division of Public Health
417 Federal Street
Dover, DE 19901
Phone: (302) 744-4913
4408 Facilities that Perform Invasive Medical Procedures
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.
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 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 complete self-assessments and expert surveyors 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. Local anesthesia is not included in this definition.
"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 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 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, (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, (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 under 24 Del.C. Ch. 17.
"Physician Assistant" means an individual currently licensed 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 under 24 Del.C. Ch. 5.
"Procedure" means invasive medical procedure.
"Registered Nurse" means an individual currently licensed 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.
3.1 The physician/dentist/podiatrist must determine that the facility is an appropriate forum for the particular procedure(s) to be performed on the particular patient.
3.2 The physician/dentist/podiatrist and/or when involved, the certified registered nurse anesthetist must determine whether the patient is an appropriate candidate for the anesthesia to be provided in the facility using the ASA classification system.
3.2.1 The physician/dentist/podiatrist or certified registered nurse anesthetist must examine the patient immediately before the procedure to evaluate the risk of anesthesia and of the procedure to be performed.
3.3 The facility must maintain written protocols for the timely and safe transfer of a patient to a hospital for emergency care or hospitalization if necessary.
3.4 At least one attending clinical team member must be certified in Advanced Cardiac Life Support.
3.5 The facility must maintain equipment and supplies, unless precluded or invalidated by the nature of the patient, procedure, or equipment, including but not limited to:
3.5.1 Age-appropriate and size-appropriate monitors, resuscitative equipment, supplies and medication in accordance with the scope of the procedures and the anesthesia services provided, including, but not limited to:
220.127.116.11 Electrocardiographic monitor;
18.104.22.168 Blood pressure monitor;
22.214.171.124 Pulse oximeter;
126.96.36.199 Continuous suction device;
188.8.131.52 Positive pressure ventilation device;
184.108.40.206 Emergency intubation equipment;
220.127.116.11 IV solutions and IV tubing;
18.104.22.168 Sufficient ampoules of dantrolene sodium or similar FDA approved drug, if the facility utilizes anesthetic agents that trigger malignant hyperthermia;
22.214.171.124 Esophageal or precordial stethoscope;
126.96.36.199 Temperature monitoring device; and
188.8.131.52 End tidal CO2 monitor.
184.108.40.206 Crash cart shall include:
220.127.116.11.1 Appropriate resuscitative equipment; and
18.104.22.168.2 Medications for surgical, procedural or anesthetic complications.
3.5.2 Appropriate sterilization equipment.
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.
3.7 The facility must maintain a policy/procedure for a time-out to ensure the risk of medical error is minimized.
3.8 A physician/dentist/podiatrist/physician assistant/certified registered nurse anesthetist or registered nurse with post-anesthesia care experience and certification in Advanced Cardiac Life Support must monitor the patient until the patient has met the facility's criteria for discharge.
3.9 A physician/dentist/podiatrist must be available onsite during patient treatment and until the patients are medically discharged.
4.1 All records maintained by the facility shall be open to inspection by the authorized representatives of the Department.
4.2 The facility must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations or accepted standards of practice. The Department shall keep patient information confidential in accordance with state and federal laws.
4.3 Report of adverse events:
4.3.1 The facility must report all adverse events to the Department within forty-eight (48) business hours of the occurrence.
4.3.2 The facility must conduct an investigation of all adverse events.
4.3.3 The facility must forward a complete investigative report to the Department within 30 calendar days of the event.
4.4 The facility must keep reports of adverse events, accidents and medical emergencies on file at the facility for a minimum of five years.
4.5 Facility procedures shall not:
4.5.1 Generally result in blood loss of more than ten percent of estimated blood volume in a patient with a normal hemoglobin;
4.5.2 Include major or prolonged intracranial, intrathoracic, abdominal or major joint replacement procedures;
4.5.3 Directly involve major blood vessels; or
4.5.4 Be generally emergent or life-threatening in nature.
4.6 All personnel who provide clinical care in a facility must be qualified to perform services commensurate with appropriate levels of education, training and experience and in keeping with practice standards. Nothing in these regulations shall prohibit a licensed individual from performing procedures within their scope of practice.
4.7 All services shall be provided in a safe and effective manner in accordance with accepted standards of practice.
4.7.1 The facility shall develop and maintain policies and procedures based upon accepted standards of practice.
4.8 Back-up power sufficient to ensure patient protection in the event of an emergency shall be immediately available.
4.9 There must be sufficient space in the room in which the procedure is being performed.
4.9.1 The room shall accommodate all necessary equipment and personnel allowing for expeditious access to the patient and all resuscitation and monitoring equipment.
4.10 All equipment shall be maintained and functional to ensure patient safety.
4.11 A facility that chooses to stop performing invasive medical procedures and voluntarily surrenders accreditation, must notify the Department in writing, 30 days prior to the voluntary surrender of accreditation or cessation of invasive medical procedures.
5.1 The facility must provide and maintain a functional and sanitary environment, to avoid sources and transmission of infections and communicable diseases.
5.2 The facility shall establish and implement an ongoing infection prevention and control program which shall be based upon nationally-recognized infection control guidelines/standards (i.e. CDC, AORN, etc.) to prevent, control and investigate infections and communicable diseases.
5.2.1. The ongoing infection prevention and control program must:
22.214.171.124 Include an active surveillance component that covers both patients and personnel working in the facility.
126.96.36.199.1 Surveillance includes infection detection through ongoing data collection and analysis.
188.8.131.52 Include mechanisms that result in immediate action to take preventive or corrective measures that improve the facility's infection control outcomes.
184.108.40.206 Target its plan to be specific to each particular area of the facility, including, but not limited to, the waiting room(s), the recovery room(s) and the procedure areas.
6.1 A legible, comprehensive and accurate medical record must be maintained for each patient evaluated or treated.
6.2 The medical record must include:
6.2.1 Patient identifying information;
6.2.2 Patient's medical history and a physical examination:
220.127.116.11 Inclusive of the cardiorespiratory system and other systems related to the diagnosis;
18.104.22.168 Completed within 30 days prior to the procedure;
6.2.3 Diagnosis and plan of care;
6.2.4 Appropriate diagnostic reports;
6.2.5 Informed consent;
6.2.6 Documentation of the time-out;
6.2.7 Operative/procedure report
6.2.8 Pathology reports, if applicable; and
6.2.9 Outcome and follow-up plans
6.2.10 Documentation of anesthesia used:
22.214.171.124 A separate anesthesia record must be kept for all anesthesia/sedation;
126.96.36.199 Documentation must include:
188.8.131.52.1 Type of anesthesia;
184.108.40.206.2 Drug type, dose and route;
220.127.116.11.3 Time of administration;
18.104.22.168.4 Fluids administered;
22.214.171.124.5 Patient weight;
126.96.36.199.6 Vital signs monitoring;
188.8.131.52.7 Estimated blood loss;
184.108.40.206.8 Duration of procedure; and
220.127.116.11.9 Any complication or unusual event related to the procedure or anesthesia.
6.2.11 Intra-procedure and post-procedure monitoring.
6.3 The facility must ensure the security and confidentiality of the medical record in accordance with state and federal laws.
7.1 The facility must post written notice of patient rights in a conspicuous place, at or near, the entrance in a manner which is plainly visible and easily read by the patients (or their representatives, if applicable) waiting for treatment.
7.1.1 The facility's notice of rights must include the names, addresses, and telephone numbers of the State agencies and accrediting organization to whom patients can report complaints.
18.104.22.168 Complaints received by the Department will be investigated as appropriate.
22.214.171.124 Complainants (unless anonymous) will be notified of the outcome of any investigation.
7.2 The patient has the right to:
7.2.1 High-quality care delivered in a safe, timely, efficient and cost-effective manner and assurance the expected results can be reasonably anticipated.
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:
126.96.36.199 Informed consent must be obtained after discussion of the risks, benefits and alternatives for the procedure.
188.8.131.52 The patient must be given information about the current diagnosis, treatment and prognosis.
7.2.5 Refuse any procedure or treatment and to be advised of the likely medical consequences of such refusal.
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;
8.1.3 Failed to correct deficiencies in accordance with a timetable submitted by the facility and agreed upon by the Department;
8.1.4 Engaged in any conduct or practices detrimental to the welfare of the patients; or
8.1.5 Refused to allow the Department access to the facility or records for the purpose of conducting inspections/surveys/investigations as deemed necessary by the Department based on the receipt of a complaint or report of an adverse event.
8.2 Disciplinary sanctions:
8.2.1 The Department may make and enforce such emergency orders as it deems necessary to protect the health and safety of the public.
184.108.40.206 If the Department determines during the course of any investigation or inspection that any facility poses an immediate and substantial risk to the health or safety of any person, the Department may order that such facility be closed until such time as it no longer poses a substantial risk.
220.127.116.11.1 An order of closure under this section shall remain in effect for a period not longer than 90 calendar days from the date of the issuance of said order, unless the facility requests a continuance of the date for the final hearing before the Department.
18.104.22.168 If the Department determines during the course of any investigation or inspection that any facility poses a possible risk to the health or safety of any person, the Department may:
22.214.171.124.1 Issue of a letter of reprimand and/or
126.96.36.199.2 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.
188.8.131.52 An order to close may apply to the performance of invasive medical procedures.
184.108.40.206 An order to close may apply to the facility as a whole.
8.3.2 The facility shall be notified forthwith in writing. The order to close shall be personally served upon the facility or sent by mail, return receipt requested, to the facility's last address of record.
220.127.116.11 A statement of deficiencies (identified during the investigation/inspection) will be forwarded to the facility within 48 hours of completion of the investigation/inspection.
8.3.3 In response to the order to close, the facility may:
18.104.22.168 Take no action, in which case the order to close shall remain in effect.
22.214.171.124 Take action to correct the unsafe and unsanitary practices identified during the survey.
126.96.36.199.1 The facility may submit evidence through a written plan of correction showing that the deficient practices, identified during the investigation, have been addressed and corrected.
188.8.131.52.1.1 A change of location for the facility does not nullify an order to close and an acceptable plan of correction must still be submitted.
184.108.40.206.2 The Department shall determine if the plan of correction is acceptable.
220.127.116.11.3 Once accepted, the Department shall schedule a revisit as soon as possible.
18.104.22.168 Request, in writing, an administrative hearing with the Secretary of the Department to contest the order to close.
22.214.171.124.1 Such request must be received within 20 calendar days from the date on which the order to close was issued.
126.96.36.199.1.1 As soon as possible, but in no event later than 60 calendar days after the issuance of the closure order, the Department shall convene a hearing on the reasons for closure.
188.8.131.52.1.2 The Department shall make a determination based upon the evidence presented.
184.108.40.206.1.3 A written copy of the determination and the reasons upon which it is based shall be sent to the facility within 30 calendar days.
220.127.116.11.2 A facility may request an expedited hearing.
18.104.22.168.2.1 The Department shall schedule the hearing on an expedited basis provided that the Department receives the facility's written request for an expedited hearing within five (5) calendar days from the date on which the facility received notification of the Department's decision to close the facility.
22.214.171.124.2.2 The Department shall convene an expedited hearing within 15 calendar days of the receipt by the Department of such a request.
126.96.36.199.2.3 The Department shall make a determination based upon the evidence presented.
188.8.131.52.2.4 A written copy of the determination and the reasons upon which it is based shall be sent to the facility within 30 calendar days.
8.3.4 During an administrative hearing:
184.108.40.206 The facility has the right to be represented by counsel.
220.127.116.11 All statements made shall be under oath.
18.104.22.168 The facility has the right to examine and cross-examine witnesses.
22.214.171.124 A stenographic recording will be made by a qualified court reporter. At the request and expense of any party, such record shall be transcribed with a copy to the other party.
126.96.36.199 The decision of the Department shall be based upon sufficient legal evidence. If the charges are supported by such evidence, the Department may continue, modify or revoke the closure order.
8.3.5 Upon reaching its conclusion of law and determining an appropriate disciplinary action, the Department shall issue a written decision and order in accordance with § 10128 of Title 29.
8.3.6 All decisions of the Department shall be final and conclusive. Where the facility is in disagreement with the action of the Department, the facility may appeal the Department's decision to the Superior Court within 30 days of service or of the postmarked date of the copy of the decision mailed to the facility. The appeal shall be on the record to the Superior Court and shall be as provided in §§ 10142 - 10145 of Title 29.
9.1 General requirements
9.1.1 All facilities must register with the Department using a form created by the Department. It will include:
188.8.131.52 The facility name;
184.108.40.206 Facility address;
220.127.116.11 Facility phone number;
18.104.22.168 A contact person; and
22.214.171.124 Acknowledgment that invasive medical procedures are performed in the facility.
9.1.2 No person shall establish, conduct or maintain in this State any facility without obtaining accreditation from an accrediting organization that is approved by the Department.
126.96.36.199 The Department shall maintain a list of approved accrediting organizations.
9.1.3 All facilities must provide proof of accreditation to the Department within 12 months of the first day of operation of such facility.
9.1.4 The accreditation certificate shall be posted in a conspicuous place on the facility premises, at or near the entrance, in a manner which is plainly visible and easily read by the public.
9.1.5 The facility must submit an accreditation certificate to the Department within 30 days of each accrediting organization survey.
188.8.131.52 The Department may request and the facility must submit a copy of the entire accreditation report.
184.108.40.206 Facilities required to submit a plan of correction to an accrediting organization will also be required to submit a copy of the plan of correction to the Department.
9.2 Accreditation termination
9.2.1 Termination of accreditation may occur secondary to:
220.127.116.11 Voluntary surrender of accreditation by the facility.
18.104.22.168 Revocation of accreditation by the accrediting organization.
9.2.2 Any facility that fails to maintain accreditation shall immediately cease to operate.
22.214.171.124 The facility may be required to remain open for administrative purposes for a period of time to be determined by the Department.
9.3.1 Unannounced inspections of any facility by authorized representatives of the Department may occur:
126.96.36.199 Anytime upon receipt of a complaint by a current facility employee or patient or upon the occurrence of any adverse event.
188.8.131.52 Anytime upon receipt of a referral from the Division of Professional Regulation.
9.3.2 Facilities certified by the Centers for Medicare and Medicaid Services (CMS) will be inspected pursuant to the process required by CMS rather than otherwise stated in these regulations.
9.4 Notice to patients
9.4.1 The facility shall notify each patient (or the patient's authorized representative) scheduled for an upcoming invasive medical procedure of an accreditation termination, or as directed under an order issued by the Department.
9.4.2 The facility shall include in the notification information regarding alternative healthcare providers.
9.5 Exclusions from accreditation
9.5.1 The following persons, associations or organizations are not required to obtain accreditation as facilities:
184.108.40.206 Those facilities required to be licensed under Title16 of the Delaware Code.
In the event any particular clause or section of these regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.