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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsNovember 2014

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16 DE Admin. Code 4405
On July 1, 2014 (Volume 18, Issue 1), DHSS published in the Delaware Register of Regulations its notice of proposed regulations, pursuant to 29 Delaware Code Section 10115. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by July 31, 2014, after which time the DHSS would review information, factual evidence and public comment to the said proposed regulations.
In accordance with Delaware Law, public notices regarding proposed Department of Health and Social Services (DHSS) Regulations governing Free Standing Surgical Centers were published in the Delaware State News, the News Journal and the Delaware Register of Regulations. Written comments were received on the proposed regulations during the public comment period (July 1, 2014 through July 31, 2014). Entities offering written comments included:
Section 3.2.1.11 states: “Applicants wanting to open a FSSC to accommodate patient stays of 23 hours and 59 minutes must have written approval from the local government having jurisdiction prior to applying for licensure to the Department.”
Agency Response: The Agency appreciates and acknowledges these comments. Local governments are best positioned to address quality of life issues within their communities. The Agency will revise the regulation to read “3.2.1.11 Applicants wanting to open a FSSC to accommodate patient stays of 23 hours and 59 minutes must have written approval from the local government having jurisdiction certifying that the proposed use will not conflict with any zoning restrictions, deed restrictions and local noise ordinances prior to applying for licensure to the Department”.
2. Section 6.7.7 refers to licensed independent practitioners but does not define this term. We would suggest that a definition of this term be added to the definitions section of the regulation as follows:
6.7.7 If the FSSC assigns patient care responsibilities to licensed independent practitioners (needs to be defined) other than physicians, it must have:
Agency Response: The Agency appreciates and acknowledges these comments. Based upon review of current national standards, the Agency will revise 6.7.2 to read “One (1) or more physicians should be in attendance in the FSSC, or in the case of overnight care, immediately available via electronic communication, at all times during patient treatment and recovery and until patients are medically discharged.” In addition, the Agency will define “Licensed Independent Practitioner” as “a person currently licensed as an advanced practice nurse pursuant to Title 24 Chapter 17 of the Delaware Code, or a person currently licensed as a physician’s assistant pursuant to Title 24 Chapter 19 of the Delaware Code.”
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will revise the definition to read “…1) a Baccalaureate Degree; 2) five (5) years healthcare experience; and 3) one (1) year supervisory experience in a surgical setting.”
3.1.5 suggest a clarification as a surgery center routinely schedule more patients during the day than the total number of licensed beds. Suggested language in the second sentence “…The number of admitted patients shall not exceed…” to avoid the unintended consequence of not distinguishing between a scheduled patient and an admitted patient.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will revise the second sentence of 3.1.5 to read “The number of admitted patients shall not exceed the total number of licensed beds.”
Agency Response: The Agency appreciates and acknowledges these comments. As stated in regulation 3.1.3, free standing surgical center (FSSC) licenses are non-transferable from person to person, entity to entity or from one location to another. Therefore, to ensure the provision of quality care in a safe surgical setting, regulation 3.1.7 will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The license for a free standing surgical center (FSSC) will be issued for specific hours of operation. If the FSSC choses to operate beyond the hours specified on the license, the FSSC must notify the Agency and obtain the necessary approvals. The regulation will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The local government written approval is required by any free standing surgical center (FSSC) wishing to accommodate patient stays of 23 hours and 59 minutes. To clarify, regulation 3.2.1.11 is specific to new FSSC applicants and regulation 3.2.2 is specific to currently licensed (existing) FSSCs; therefore, the regulations will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The intent of the free standing surgical center (FSSC) regulations is not to restrict the natural cycle of business, but to ensure the provision of quality care in a safe environment. As stated in regulation 3.1.3, FSSC licenses are non-transferable from person to person, entity to entity or from one location to another. The Agency will delete regulations 3.4.5.8 and 3.4.5.9.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency follows a protocol which requires a thirty (30) calendar day notice to ensure the continuity of operations during a modification of ownership and control. Therefore, the regulations will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. As stated in regulation 3.1.3, free standing surgical center (FSSC) licenses are non-transferable from person to person, entity to entity or from one location to another. The Agency follows a protocol to ensure the continuity of operations during the transition. Therefore, the regulations will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will revise the regulations to delete 6.8.5 and add “7.7 There must be healthcare professionals with specialized training or experience in emergency care including current Advance Cardiac Life Support certification, available in the FSSC to provide emergency treatment at all times when patients are present.” In addition, the definition of healthcare professionals will be added to 2.0 Definitions.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will revise 7.6.6 to read “All employees/contractors involved in direct patient care shall be trained on basic and special nutritional needs and proper food handling techniques. Training shall be part of the initial orientation and shall be conducted annually thereafter.”
Agency Response: The Agency appreciates and acknowledges these comments. The regulation will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The “Clinical Director” is responsible for the supervision and direction of services, which includes nursing services, offered by the free standing surgical center. Similar to the Centers for Medicare and Medicaid Services regulations for ambulatory surgical centers, nursing services must be under the leadership of a registered nurse; therefore, the definition of “Clinical Director” will remain as written. The Agency will revise the definition of “Director” to read “…1) a Baccalaureate Degree; 2) five (5) years healthcare experience; and 3) one (1) year supervisory experience in a surgical setting.”
3.1.5 should be tweaked for clarification purposes. Suggested language in the second sentence “…The number of admitted patients shall not exceed…” to avoid the unintended consequence of not distinguishing between a scheduled patient and those currently in care.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will revise the second sentence of 3.1.5 to read “The number of admitted patients shall not exceed the total number of licensed beds.”
Agency Response: The Agency appreciates and acknowledges these comments. As stated in regulation 3.1.3, free standing surgical center (FSSC) licenses are non-transferable from person to person, entity to entity or from one location to another; therefore, regulation 3.1.7 will remain as written. The Agency will delete regulations 3.4.5.8 and 3.4.5.9.
Agency Response: The Agency appreciates and acknowledges these comments. As stated in regulation 3.1.3, free standing surgical center (FSSC) licenses are non-transferable from person to person, entity to entity or from one location to another. The Agency follows a protocol which requires a thirty (30) calendar day notice to ensure the continuity of operations during a modification of ownership and control. Therefore, to ensure the provision of quality care in a safe surgical setting, the regulations will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The local government written approval is required by any free standing surgical center (FSSC) wishing to accommodate patient stays of 23 hours and 59 minutes. To clarify, regulation 3.2.1.11 is specific to new FSSC applicants and regulation 3.2.2 is specific to currently licensed (existing) FSSCs; therefore, the regulations will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will revise the regulations to delete 6.8.5 and add “7.7 There must be healthcare professionals with specialized training or experience in emergency care including current Advance Cardiac Life Support certification, available in the FSSC to provide emergency treatment at all times when patients are present.” In addition, the definition of healthcare professionals will be added to 2.0 Definitions.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will revise 7.6.6 to read “All employees/contractors shall be trained on basic and special nutritional needs and proper food handling techniques. Training shall be part of the initial orientation and shall be conducted annually thereafter.”
1. Add clarifying language at the end of Section 2.0.
In section 2.0 following the definition of "Surgery", DANA proposes adding the phrase: "Nothing in this definition is intended to restrict the practice of qualified licensed healthcare professionals practicing in accordance with Delaware law."
DANA suggests adding this language to avoid unintended confusion about the appropriate role of qualified licensed healthcare professionals in Free Standing Surgical Centers. The statute that authorizes this regulation, 16 Del.C. §122(3)p, makes it clear that Regulation 4405 shall not expand or limit the scope of practice afforded to professionals under other provisions of Delaware law.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will revise 6.6.4 by adding the following sentence, "Nothing in these regulations is intended to restrict the practice of qualified licensed healthcare professionals practicing in accordance with Delaware law."
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will revise 6.7.7, 7.2 and 7.3 to consistently use “licensed independent practitioner”. In addition, “licensed independent practitioner” has been added to regulation 2.0 Definitions.
3. Add language in section 7.4 to reflect the current standard of care in evaluating a patient for proper recovery from anesthesia.
In accordance with the Centers for Medicare and Medicaid Services 1 and the Delaware law, DANA suggests adding the phrase "or certified registered nurse anesthetist" after the word "physician" to reflect the appropriate standard of care and current practice of evaluating patients for proper recovery from anesthesia.
1 The Federal Regulations direct that a physician or anesthetist must evaluate a patient for proper anesthesia recovery prior to discharge from an ambulatory surgery center. See 42 CFR 416.42(a) - Standard: Anesthetic Risk and Evaluation (2) Before discharge from the ASC, each patient must be evaluated by a physician or by an anesthetist as defined at §410.69(b) of this chapter, in accordance with applicable State health and safety laws, standards of practice, and ASC policy, for proper anesthesia recovery.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will add "or certified registered nurse anesthetist" to 7.4. In addition, “Certified Registered Nurse Anesthetist” was added to regulation 2.0 Definitions.
The Departments proposal for Section 3.2.1.11 Applicants wanting to open a FSSC to accommodate patient stays of 23 hours and 59 minutes must have written approval from local government having jurisdiction prior to applying for licensure to the Department, is very vague, and has no guidelines or standards to follow for approval.
In addition to Karen's proposal I would also like amend Section 3.2.1.11 to read: Section 3.2.1.11 Applicants wanting to open a FSSC to accommodate patient stays of 23 hours and 59 minutes must have written approval from local government having jurisdiction prior to applying for licensure to the Department. The local government shall certify that the proposed use will not conflict with any zoning restrictions, deed restrictions, and will not adversely affect the quality of life in adjacent communities. All members residing in communities within 1000 feet of the FSSC shall be notified by the facility of their intent and the facility shall conduct a meeting with the community or communities at a convenient and neutral location. 50% of community's approval shall be required prior to applying for government approval.
Agency Response: The Agency appreciates and acknowledges these comments. Local governments are best positioned to address quality of life issues within their communities. The Agency will revise the regulation to read “3.2.1.11 Applicants wanting to open a FSSC to accommodate patient stays of 23 hours and 59 minutes must have written approval from the local government having jurisdiction certifying that the proposed use will not conflict with any zoning restrictions, deed restrictions and local noise ordinances prior to applying for licensure to the Department”.
Agency Response: The Agency appreciates and acknowledges these comments. The intent of the free standing surgical center (FSSC) regulations is to ensure the FSSC is utilizing current accepted standards of practice. Grandfathering all existing FSSCs for ten (10) full years could potentially delay the FSSC implementation of current accepted standards of practice and would be inconsistent with the Agency’s mission.
Agency Response: The Agency appreciates and acknowledges these comments. The existing law does not exempt free standing diagnostic endoscopy facilities and pain management centers from state licensure. A Delaware Attorney General’s interpretation, issued on January 12, 1995, exempted single specialty diagnostic endoscopy and pain management centers from licensure as a free standing surgical center. Therefore, the regulations will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency has revised the definition of “Director” to read “…1) a Baccalaureate Degree; 2) five (5) years healthcare experience; and 3) one (1) year supervisory experience in a surgical setting.” The Agency will not apply this regulation to directors appointed prior to the effective date of this regulation. Directors appointed on or after the effective date of this regulation must comply with the new standards.
Agency Response: The Agency appreciates and acknowledges these comments. As stated in regulation 3.1.3, free standing surgical center (FSSC) licenses are non-transferable from person to person, entity to entity or from one location to another. Therefore, to ensure the provision of quality care in a safe surgical setting, regulation 3.1.7 will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. As stated in regulation 3.1.3, free standing surgical center (FSSC) licenses are non-transferable from person to person, entity to entity or from one location to another. Therefore, the regulations will remain as written.
6. Existing Regulation 4405 provides for the appointment of a CEO, a Medical Director and a Director of Nursing. Proposed Regulation 4405 requires the appointment of a Director (Section 6.1.1), a Clinical Director (Section 6.2.1) and a Medical Director (Section 6.7.3). Presumably, the term Clinical Director in Section 6.2.1 of proposed Regulation 4405 is designed to replace the position of the Director of Nursing in existing Regulation 4405. In Section 6.2.3.1, the Clinical Director must be a registered nurse with at least one year of surgical and administrative/supervisory experience. Section 7.1 in existing Regulation 4405 provides that the Director of Nursing must currently be licensed by the State of Delaware as a professional registered nurse. The requirement that the Clinical Director have at least one year of surgical and administrative/supervisory experience may mean that a number of Directors of Nursing may not qualify for the position of Clinical Director under proposed Regulation 4405. In many FSSCs, the position of Director and Clinical Director under proposed Regulation 4405 and the position of CEO and Director of Nursing under existing Regulation 4405 would be held by the same individual, i.e. a registered nurse. In those circumstances under proposed Regulation 4405, it is doubtful that the same person could be both the Director and the Clinical Director unless proposed Section 6.2.3 is modified to make it clear that a nurse licensed in Delaware as a professional registered nurse meets the requirement that the Director have a baccalaureate degree in health (Definition of Director). In addition, the requirement that the Clinical Director have at least one year of surgical experience may exclude endoscopy and other nurses from acting as a Clinical Director. The requirement that the Clinical Director have one year of surgical and administrative/supervisory experience may also prevent in many cases FSSCs from promoting within. We recommend that Section 6.2.3.1 be modified to delete the words “with at least one year of surgical and administrative/supervisory experience.
Agency Response: The Agency appreciates and acknowledges these comments. The Clinical Director of a FSSC must have surgical and administrative/supervisory experience to ensure the provision of quality care in a safe setting. Therefore, the regulation will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will revise 6.6.5 to read “All newly hired employees and contractors must have a written validation of competency upon orientation, prior to providing care to patients, and annually thereafter."
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will revise the regulations to delete 6.8.5 and add “7.7 There must be healthcare professionals with specialized training or experience in emergency care including current Advance Cardiac Life Support certification, available in the FSSC to provide emergency treatment at all times when patients are present.” In addition, the definition of healthcare professionals will be added to 2.0 Definitions.
Agency Response: The Agency appreciates and acknowledges these comments. In accordance with nationally recognized standards of practice, one registered nurse circulator should be dedicated to each patient undergoing an operative procedure and be present for the duration of the intraoperative experience. Therefore, the regulation will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The comprehensive medical history and physical assessment is used to determine if there is anything in the patient’s overall condition that requires additional intervention to reduce risks or to indicate that the free standing surgical center may not be the appropriate setting for the patient’s surgery. Therefore, the regulation will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The intent of the regulation is for the free standing surgical center (FSSC) to establish a procedure to notify patients of the pending destruction of medical records. The regulation does not specify the method each FSSC must utilize to comply with this regulation. Therefore, the regulation will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will remove “within 48 hours” from regulation 12.4.
Agency Response: The Agency appreciates and acknowledges these comments. The purpose of the free standing surgical center regulations is to ensure the provision of quality care in a safe surgical setting. Compliance with the specified regulations and standards is required to ensure the provision of quality care in safe surgical setting; therefore, the regulation will remain as written.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency has evaluated and responded to each comment received during the public comment period. The proposed free standing surgical center regulations incorporate updated standards and guidelines. As of the effective date of these regulations, the Delaware Attorney General’s interpretation, issued on January 12, 1995, which exempted single specialty diagnostic endoscopy and pain management centers from licensure as a free standing surgical center is still in effect. Therefore, the Agency will proceed with finalizing the regulations with the non-substantive revisions.
Agency Response: The Agency appreciates and acknowledges these comments. The existing law does not exempt free standing diagnostic endoscopy facilities and pain management centers from state licensure. A Delaware Attorney General’s interpretation, issued on January 12, 1995, exempted single specialty diagnostic endoscopy and pain management centers from licensure as a free standing surgical center. Therefore, the regulations will remain as written.
THEREFORE, IT IS ORDERED, that the proposed State of Delaware Regulations governing Free Standing Surgical Centers are adopted and shall become effective November 11, 2014, after publication of the final regulation in the Delaware Register of Regulations.
“Division” means the Delaware Division of Public Health.
“Free Standing Surgical Center” (hereafter referred to as FSSC) means a facility which operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. The term does not include:
“Person” means sole proprietor, partnership, unincorporated association, corporation or any state, county, or local governmental unit.
4.0 Medical Records
Delaware Department of Health and Social Services adopts these regulations pursuant to the authority vested by 16 Del.C. §122(3)(p). These regulations establish standards with respect to the operation of free standing surgical centers.
[“Certified Registered Nurse Anesthetist” means an individual currently licensed as an advanced practice nurse pursuant to Title 24, Chapter 19 of the Delaware Code.]
Clinical Director” means a registered nurse, currently licensed to practice nursing pursuant to Title 24, Chapter 19 of the Delaware Code who is sufficiently qualified to provide general supervision and direction of the services offered by the free standing surgical center.
Department” means the Delaware Department of Health and Social Services.
Dentist” means a person currently licensed as a dentist by Title 24, Chapter 11 of the Delaware Code.
Dietitian” means a person currently licensed as a dietitian by Title 24, Chapter 38 of the Delaware Code.
Director” means the individual appointed by the governing body to act on its behalf in the overall management of the free standing surgical center. The director shall have: 1) a Baccalaureate Degree [in a health related field]; 2) five (5) years healthcare experience; and 3) one (1) year supervisory experience in a surgical setting.
Free Standing Surgical Center", abbreviated as FSSC, means a facility, other than a hospital or the office of a physician, dentist or podiatrist, or professional association thereof, which is maintained and operated for the purpose of providing surgical services and in which the expected duration of services would not exceed 23 hours 59 minutes following an admission.
Governing Body” means the individual, group or corporation appointed, elected, or otherwise designated, in which the ultimate responsibility and authority for the conduct of the FSSC is vested.
[“Healthcare Professional” means a person currently licensed as a physician, dentist, podiatrist, licensed independent practitioner or registered nurse.]
Incident” means a circumstance or occurrence that may be injurious to a patient or that may result in an adverse outcome to the patient.
[“Licensed Independent Practitioner” means a person currently licensed as an advanced practice nurse pursuant to Title 24, Chapter 17 of the Delaware Code, or a person currently licensed as a physician’s assistant pursuant to Title 24, Chapter 19 of the Delaware Code.]
Modification of Ownership and Control” means a change of ownership or transfer of responsibility for the FSSC’s operation.
Patient” means a person who receives health care services from a FSSC.
Physician” means a person currently licensed as a physician by Title 24, Chapter 17 of the Delaware Code.
Plan of Correction” means a written document that includes specific measures to correct identified problems or areas of concern; identifies strategies for implementing system improvements; and includes outcome measures to indicate the effectiveness of system improvements in reducing, controlling or eliminating identified problem areas.
Podiatrist” means a person currently licensed as a podiatrist by Title 24, Chapter 5 of the Delaware Code.
[Registered] Nurse” means a person currently licensed as a [registered] nurse pursuant to Title 24, Chapter 19 of the Delaware Code.
Serious Injury” means physical injury that creates a substantial risk of death, or that causes serious disfigurement, serious impairment of health or serious loss or impairment of the function of any bodily organ.
Surgery” means a procedure performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery also is 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 surgery. The term surgery as used in these Regulations does not include the administration by nursing personnel of some injections – subcutaneous, intramuscular, or intravenous – when ordered by a physician. All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical procedure are not eliminated by using a light knife or laser in place of a metal knife, or scalpel.
3.2.1.11 Applicants wanting to open a FSSC to accommodate patient stays of 23 hours and 59 minutes must have written approval from the local government having jurisdiction [certifying that the proposed use will not conflict with any zoning restrictions, deed restrictions and local noise ordinances] prior to applying for licensure to the Department; and
[3.4.5.8 One partnership is replaced by another through the removal, addition, or substitution of a partner;
3.4.5.[108] Merger of a FSSC owner (a corporation) into another corporation where, after the merger, the owner’s shares of capital stock are canceled; or
3.4.5.[119] The consolidation of a corporate FSSC owner with one or more corporations.
3.4.5.[1210]Any other transfer or action under 8 Del.C. is considered an MOC under these regulations.
4.4 The provisions of the Centers for Disease Control and Prevention Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005, are hereby adopted as the regulatory requirements for FSSCs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.
4.6 The provisions of the State of Delaware Food Code, 16 DE Admin. Code 4458 (May 2014 version), are hereby adopted as the regulatory requirements for FSSCs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.
4.7 The provisions of the State of Delaware, Department of Natural Resources and Environmental Control, Regulations Governing Solid Waste, 7 DE Admin. Code 1301 (November 2013 version), are hereby adopted as the regulatory requirements for FSSCs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.
6.6.4 It is the responsibility of the FSSC to ensure that employees/contractors are proficient to carry out the assigned care in a safe, effective and efficient manner. [Nothing in these regulations is intended to restrict the practice of licensed independent practitioners practicing in accordance with Delaware law.]
6.6.5 All newly hired employees and contractors must [pass a competency evaluation test have a written validation of competency upon orientation,] prior to providing care to patients, and annually thereafter.
6.7.2 One (1) or more physicians [must be on premises during all hours of surgical services and until all patients have been discharged or must be on call and immediately available on-site within 30 minutes should be in attendance in the FSSC, or in the case of overnight care, immediately available via electronic communication, at all times during patient treatment and recovery and until patients are medically discharged].
[6.8.5 There must be two (2) registered nurses, with specialized training or experience in emergency care, including current Advanced Cardiac Life Support certification, available in the FSSC to provide emergency treatment at all times when patients are present.]
6.8.[65] A registered nurse, qualified by education and experience in operating room nursing, shall be present as a circulating nurse in each operating room where moderate/deep/general anesthesia/sedation is administered during operative procedures.
6.8.[76] Individual patient assignments on a given day must be documented clearly on an assignment sheet which must be kept on file for one (1) year from date of procedure.
7.2 Not more than 30 calendar days before the date of the scheduled surgery, each patient must have a comprehensive medical history and physical assessment, completed by a physician or [other qualified] licensed independent [healthcare] practitioner, to determine whether there is anything in the patient's overall condition that would affect the planned surgery that requires additional interventions to reduce risk to the patient or may indicate that the FSSC is not the appropriate setting for the surgery. The medical history and physical assessment must be comprehensive in order to determine the patient's readiness for surgery and specifically indicate that the patient is cleared for surgery in the FSSC. The comprehensive medical history and physical assessment must include at a minimum:
7.3 Upon admission to the FSSC, each patient must have a pre-surgical assessment completed by the physician or [other qualified] licensed [healthcare independent] practitioner. The patient’s medical record must include documentation that the patient was examined prior to the commencement of surgery for changes since the comprehensive medical history and physical assessment.
7.4 Before discharge from the FSSC, each patient must be evaluated by a physician [or certified registered nurse anesthetist] for proper anesthesia recovery. It is expected that a patient will actually leave the FSSC within 15 – 30 minutes of the time when the physician signs the discharge order.
7.6.6 [A dietitian shall be available for consultation with staff on basic and special nutritional needs and proper food handling techniques and shall provide in-service training to staff on these topics at least annually. All employees/contractors involved in direct patient care shall be trained on basic and special nutritional needs and proper food handling techniques. Training shall be part of the initial orientation and shall be conducted annually thereafter.]
11.1 Medical records must include an advance health-care directive form that complies with 16 Del.C. Ch. 25, a statement that a copy of the advance health-care directive form has been requested, or a statement that none has been signed.
13.3.3.8 Storage of radio nuclides and radio pharmaceuticals as well as radioactive waste; and disposal of radio nuclides, unused radio pharmaceuticals, and radioactive waste; and
Last Updated: December 31 1969 19:00:00.
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