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 RegulationsFebruary 2014

Table of Contents Previous Next

Authenticated PDF Version

On October 1, 2013 (Volume 17, Issue 4), 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 October 31, 2013, 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. The Agency disagrees that the reporting of adverse events will improperly intermingle facility specifications and practitioner conduct. The reporting of adverse events will facilitate the monitoring of the safe and sanitary environment within facilities that perform invasive medical procedures. The regulations do not regulate physician licenses or practice; only the safety of the care provided in the facilities that perform invasive medical procedures. Issues related to physician licensure will continue under the oversight of the Division of Professional Regulation.
Agency Response: The Agency appreciates and acknowledges these comments. Upon consideration of the comment and review of current literature, the Agency will further clarify the definition of anesthesia to exclude (1) the administration of less than 50% nitrous oxide in oxygen with no other sedative or analgesic medications by any route or (2) a single, oral sedative or analgesic medication administration in doses appropriate for the unsupervised treatment of insomnia, anxiety, or pain.
Agency Response: The Agency appreciates and acknowledges these comments. The language referencing the post-anesthesia care experience and certification in advanced cardiac life support requirement in 3.8 is specific to the registered nurse. The regulation wording will be re-ordered to clearly reflect this requirement.
Agency Response: The Agency appreciates and acknowledges these comments. The standards of practice require the practitioner that performed that invasive medical procedure be onsite and immediately available until the patient is discharged from the facility; therefore, the regulation will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will not have a template to complete investigative reports. However, in the event of an adverse event, the facility will be expected to complete a root cause analysis of the incident and provide the Department with a thorough investigative report including details of the incident, the root cause analysis, follow-up that was completed as a result of the incident/investigation and any other pertinent information.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency agrees and will revise the regulation to state, “The facility shall maintain policies and procedures based upon accepted standards of practice.”
Agency Response: The Agency appreciates and acknowledges these comments. The Agency disagrees and the regulation will remain as written. The intent of this regulation is to ensure patients receive safe care in the event that a facility chooses to voluntarily surrender accreditation and stop performing invasive medical procedures.
Agency Response: The Agency appreciates and acknowledges these comments. The goal of the Department is to ensure the safety of those Delawareans receiving services in facilities that perform invasive medical procedures. Because of the broad range of invasive medical procedures that are performed in these facilities, this regulation, as written, provides the appropriate latitude to determine compliance with a multitude of standards. The Department agrees with the Medical Society and the goal will be to re-open these facilities as quickly as possible, not only to ensure their viability as small businesses, but to make sure Delawareans continue to receive necessary care.
Agency Response: The Agency appreciates and acknowledges these comments. The timeframes included within these regulations are in compliance within the Administrative Procedures Act within Delaware Code.
Agency Response: The Agency appreciates and acknowledges these comments. The Department will review the plan of correction immediately upon receipt and a revisit will be conducted expeditiously upon the receipt of an acceptable plan of correction.
Agency Response: The Agency appreciates and acknowledges these comments. The mechanism for a facility to resume practice already exists through the submission and implementation of an acceptable plan of correction as outlined in the regulations.
State Council for Persons with Disabilities, Denise McMullin-Powell, Chairperson:
The State Council for Persons with Disabilities (SCPD) has reviewed the Department of Health and Social Services/Division of Public Health’s (DPH’s) proposal to adopt a new regulation regarding facilities that perform invasive procedures using anesthesia. The proposed regulation was published as 17 DE Reg. 397 in the October 1, 2013 issue of the Register of Regulations. SCPD provided commentary on the initial set of proposed regulations in April 2013 and has the following observations on the revised version.
Governor’s Advisory Council for Exceptional Citizens, Terri A. Hancharick, Chairperson:
The State Council for Persons with Disabilities and The Governor’s Advisory Council for Exceptional Citizens submitted the following comments:
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will insert the word “the” between “from” and “facility”.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency acknowledges the lack of a preposition and will change the definition of “accrediting organization” to “...organization requires facilities to complete self-assessments and expert surveyors to conduct thorough reviews.”
3. In §2.0, the definition of “certified registered nurse anesthetist” is simply “an individual currently licensed under 24 Del.C. Ch. 19.” This definition is problematic since it would literally mean anyone licensed under that chapter (LPN; RN; APN) qualifies as a nurse anesthetist under the regulations. There is no separate license or certification of a nurse anesthetist mentioned in Chapter 19, only a passing reference in §1902(b)(1).
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will clarify the definition of “certified registered nurse anesthetist” to read, “an individual currently licensed as an advanced practice nurse currently licensed under 24 Del.C. Ch. 19.”
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will not capitalize “(t)he” in Par. (2) and insert “and” before “(4)”.
Agency Response: The Agency appreciates and acknowledges these comments. The definition of “invasive medical procedure” reflects the statutory definition and will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will insert the word “and” before “(2)”.
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.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will clarify the definitions of “physician” and “physician assistant” to read “Physician means an individual currently licensed as a physician under 24 Del.C. Ch. 17” and “Physician Assistant means an individual currently licensed as a physician assistant under 24 Del.C. Ch. 17”.
Agency Response: The Agency appreciates and acknowledges these comments. The standard requirements of a “time-out” include correctly identifying the patient, the procedure and the site; therefore, the definition of “time-out” will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will insert a comma after “anesthetist”.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will delete “and” at the end of §3.5.1.11.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will substitute a semicolon for the period after the word “monitor” in §3.5.1.12.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will insert the word “which” between “cart” and “include” in §3.5.1.13.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will substitute a semicolon for the period in §3.5.1.13.2.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will substitute “; and” for the period at the end of §3.5.2.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will replace the word “their” with “his/her” to resolve conflict between a plural pronoun and a singular noun.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will delete the comma after the word “accreditation” in §4.11.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will delete the comma after the word “environment” in §5.1.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will add a semicolon at the end of §6.2.7.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will delete the word “and” at the end of §6.2.8.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will insert a semicolon at the end of §6.2.9.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency recognizes the similarity of the requirements and will amend §6.2.10 to read “A separate anesthesia record for each administration of anesthesia which must include:” Therefore, §§6.2.10.1 and 6.2.10.2 will be deleted as the requirements will be contained in §6.2.10.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will renumber §§6.2.10.2.1 through 6.2.10.2.9 as 6.2.10.1 through 6.2.10.9; however, the period after the renumbered 6.2.10.9 will remain.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will delete the comma after “near” in §7.1.
A. Under §§8.3.3.3.1 and 8.3.3.3.1.1, a hearing could routinely occur on the 80th day after issuance of the closure order and §8.3.3.3.1.3 suggests that the hearing decision could be issued on the 110th day. During days 91-109, the closure order would no longer be in effect and the facility could reopen. If a continuance were granted per 8.2.1.1.1, this time period would be extended and the facility could reopen for an even longer period.
Agency Response: The Agency appreciates and acknowledges these comments. If a facility requests a hearing, the request must be received by the Department within 20 calendar days from the date on which the order to close was issued and the hearing must be held within 60 days from the date on which the order to close was issued; therefore, completing the entire process within the 90 day timeframe. The 90 day timeframe is to ensure the timely resolution for those facilities requesting an administrative hearing and those facilities choosing to address and correct the issues leading to an order to close. If a facility takes no action to correct the issues that led to the order to close, the facility must remain closed. The regulation will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The regulation will remain as written.
26. The exclusion in §9.5.1.1 is contrary to the statutory definition of “facility”. See Title 16 Del.C. §122(3)y.3.C. If the Stockley Center, Mary Campbell Center, or other long-term care facility engaged in invasive procedures (including dental and podiatry procedures), they should be required to comply with the regulation.
Agency Response: The Agency appreciates and acknowledges these comments. The Stockley Center, Mary Campbell Center and other long-term care facilities, and the healthcare services provided within these facilities, are regulated by Title 16 Chapter 11.
Agency Response: The Agency appreciates and acknowledges these comments. Upon consideration of the comment and review of current literature, the Agency will further clarify the definition of anesthesia to exclude (1) the administration of less than 50% nitrous oxide in oxygen with no other sedative or analgesic medications by any route or (2) a single, oral sedative or analgesic medication administration in doses appropriate for the unsupervised treatment of insomnia, anxiety, or pain.
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. [Local anesthesia is not included in this definition 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) [Tt]he 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.
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.
3.5.1.13 Crash cart [which] shall include:
3.8 A [registered nurse with post-anesthesia care experience and certification in Advanced Cardiac Life Support or 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.
4.7.1 The facility shall [develop and] maintain policies and procedures based upon accepted standards of practice.
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.
6.2.10 [Documentation of anesthesia used: A separate anesthesia record for each administration of anesthesia which must include:]
[6.2.10.1 A separate anesthesia record must be kept for all anesthesia/sedation;
6.2.10.[2.]1 Type of anesthesia;
6.2.10.[2.]2 Drug type, dose and route;
6.2.10.[2.]3 Time of administration;
6.2.10.[2.]4 Fluids administered;
6.2.10.[2.]5 Patient weight;
6.2.10.[2.]6 Vital signs monitoring;
6.2.10.[2.]7 Estimated blood loss;
6.2.10.[2.]8 Duration of procedure; and
6.2.10.[2.]9 Any complication or unusual event related to the procedure or anesthesia.
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.
Last Updated: December 31 1969 19:00:00.
site map   |   about this site   |    contact us   |    translate   |    delaware.gov