6 Colo. Code Regs. § 1011-1-20-2

Current through Register Vol. 47, No. 22, November 25, 2024

Section 6 CCR 1011-1-20-2 - DEFINITIONS

2.1 "Administrator" means an individual who has authority over the daily operations of an ambulatory surgical center or ambulatory surgical center with convalescent center or an individual who is designated by the governing body of an ambulatory surgical center. Such individual shall have sufficient authority to interpret and implement all policies of the owner or proprietor and must be sufficiently qualified to perform those tasks.

2.2 "Ambulatory Surgical Center" means a health care entity established for the primary purpose of providing medically necessary surgery, elective surgery, or preventive diagnostic procedures that do not require hospitalization but do require post surgical or post procedural observation and monitoring that generally will not exceed 24 hours from admission to discharge. For convenience in this Chapter 20 only, an ambulatory surgical center is also referred to as a "center."

(A) Offering multiple health services in the same building does not preclude or exempt a center from meeting the requirements of Chapter 20. The other health services being offered in the same building must be physically separated from the ambulatory surgical center.

(B) A licensed ambulatory surgical center may sublease space to another licensed ambulatory surgical center for use if all of the criteria set forth below are met. If the Department finds deficient practice by either licensee, it has the discretion to assign those deficiencies to both licensees.

(1) The licensed centers shall not operate at the same time or on the same days of the week;

(2) There shall be clear public signage stating the days and times each licensed center is in operation.

(3) There shall be a written agreement between the licensed centers that establishes the responsibilities of each party regarding services, supplies and equipment use, quality assurance and infection control. All agreements must comply with this chapter and any other applicable local, state and federal law;

(4) Each licensed center shall meet all license requirements either directly or by contract; and

(5) Each licensed center shall ensure that all information regarding its patients is kept confidential and safeguarded from access by the other center.

(C) The term "ambulatory surgical center" includes a clinic or practitioner's office if:

(1) It is certified as an ambulatory surgical center by the Centers for Medicaid and Medicare Services,

(2) It is operated or used by a practitioner or entity other than the primary practitioner(s), or

(3) It holds itself out to the public or other health care providers as an ambulatory surgical center, surgical center, surgicenter or similar facility using a similar name or variation thereof.

(D) The term "ambulatory surgical center" does not include:

(1) A practitioner's private office or treatment rooms where the practitioner primarily consults with and treats patients including, but not limited to, practitioners organized as professional corporations, professional associations, professional limited liabilities companies, partnerships and sole proprietorships; or

(2) An outpatient surgery unit that is licensed as part of a hospital and located on a hospital campus as defined in 6 CCR 1011-1, Chapter 4; or

(3) An outpatient surgery center that is owned and operated by a hospital; licensed as an off campus location of the hospital; and has signage that clearly indicates the surgery center's connection with the hospital.

(a) A licensed hospital provider of ambulatory surgical services may use the term "ambulatory surgery" or a similar term to indicate that ambulatory surgical services or an ambulatory surgery or surgical department is available or housed within the hospital as part of the facility's services. Such hospital shall not indicate to the public nor hold itself out to the public as an ambulatory surgical center (free standing or otherwise) unless the hospital entity actually possesses such a license.

2.3 "Convalescent Center" means a health care entity that provides post surgical, post procedural and/or post diagnostic medical and nursing services to patients for whom an uncomplicated recovery is anticipated and for whom acute hospitalization is not required. A convalescent center shall be licensed and operated only in conjunction with a licensed ambulatory surgical center.

2.4 "Department" means the Colorado Department of Public Health and Environment.

2.5 "Medical Director" means the physician responsible for planning, organizing, conducting and directing the medical affairs of the ambulatory surgical center. The medical director shall meet one of the following requirements in order to be considered qualified:

(A) Is board eligible or board certified in at least one of the services provided at the ambulatory surgical center and has had at least 12 months of experience or training in the care of patients in a surgical environment, or

(B) Has served for at least 12 months in a leadership role at a health facility during the prior five year period.

(1) In geographical areas where a medical director meeting the above criteria is not available, another licensed and credentialed physician may fill that role if approved to do so by the Department prior to initial appointment.

2.6 "Medical Staff" means a formal organization of physicians, dentists, podiatrists or other health professionals, who are appointed by the governing body to attend to patients within the ambulatory surgical center.

2.7 "Medical Waste" means any infectious, pharmaceutical or trace chemotherapy waste generated in a health care setting in the diagnosis, treatment, immunization, or care of humans or animals; generated in autopsy or necropsy; generated during preparation of a body for final disposition such as cremation or interment, generated in research pertaining to the production or testing of microbiologicals; generated in research using human or animal pathogens; or related to accident, suicide, or other physical trauma. Medical waste does not include fluids, tissues or body parts removed from the whole body for the purposes of donation, research or other use, or those returned to the person from whom they were removed, or their authorized representative, as long as the material is rendered safe for handling.

6 CCR 1011-1-20-2