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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsJuly 2014

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16 DE Admin. Code 4405
The Office of Health Facilities Licensing and Certification, Health Systems Protection Section, Division of Public Health, Department of Health and Social Services, is proposing revisions to the State of Delaware Regulations Governing Free Standing Surgical Centers. Due to the extensive number of amendments the Division has concluded that the current regulations should be repealed and replaced in their entirety with the proposed regulations being published. The purpose of the amendments is to update the requirements so that they are in concert with current healthcare standards and to align them more closely with current federal requirements. On July 1, 2014, the Division plans to publish as proposed the amended regulations and hold them out for public comment per Delaware law.
Copies of the proposed regulations are available for review in the July 1, 2014 edition of the Delaware Register of Regulations, accessible online at: http://regulations.delaware.gov or by calling the Office of Health Facilities Licensing and Certification at (302) 283-7220.
“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.
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.
Incident” means a circumstance or occurrence that may be injurious to a patient or that may result in an adverse outcome to the patient.
Modification of Ownership and Control” means a change of ownership or transfer of responsibility for the FSSC’s operation.
Nurse” means a person currently licensed as a nurse pursuant to Title 24, Chapter 19 of the Delaware Code.
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.
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.
3.4.5.12 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.
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:
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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