6 Colo. Code Regs. § 1011-1 Chapter 02 Part 1

Current through Register Vol. 47, No. 11, June 10, 2024

Part 1 - DEFINITIONS

1.1 "Abuse" means the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish.

1.2 "Addition" means the addition of more space that was previously not part of the licensed facility. The addition may be new construction or existing structures that are being repurposed for client use.

1.3 "Administrative Officer" means the person appointed by the governing body of the facility or agency who is responsible for the day-to-day management of the facility or agency.

1.4 "Admission" means the acceptance of a person as a client of the facility or agency.

1.5 "Advance Directive" means a written instruction concerning medical treatment decisions to be made on behalf of the adult who provided the instruction in the event that they become incapacitated.

1.6 "Board" means the State Board of Health.

1.7 "Building Permit" means an official document issued by the local building department or other local jurisdiction which authorizes erection, alteration, demolition, and/or moving of buildings and structures.

1.8 "Business Entity" means any organization or enterprise and includes, but is not limited to, a sole proprietor, association, corporation, business trust, joint venture, limited liability company, limited liability partnership, partnership, or syndicate.

1.9 "Campus" means the physical area immediately adjacent to the facility's or agency's main building(s), other areas and structures that are not strictly contiguous to the main building(s) but are located within 250 yards of the main building(s) and any other areas determined by the Department, on an individual case basis, to be part of the facility's or agency's campus.

1.10 "Capacity" means the number of clients to whom a facility or agency is able to provide services. "capacity" is synonymous with the term "bed" as used in this Chapter and elsewhere in 6 CCR 1011-1.

1.11 "Chemical Restraint" means giving an individual medication involuntarily for the purpose of restraining that individual; except that "chemical restraint" does not include the involuntary administration of medication pursuant to section 27-65-111(5), C.R.S., or administration of medication for voluntary or life-saving medical procedures.

1.12 "Client" means any person receiving services from a facility or agency that is subject to licensing pursuant to section 25-3-101, C.R.S. The term "client" is synonymous with the terms "patient", "resident", or "consumer" as used elsewhere in 6 CCR 1011-1.

1.13 "Client Care Advocate" means the person or persons designated by a facility or agency to function as the primary contact to receive complaints from clients regarding services.

1.14 "Client Record" is the documentation of services that are performed for the client by the facility or agency. Client records include such diagnostic documentation as X-rays and EKG's. Client records do not include health care provider office notes, which are the notes of observations about the client made while the client is in a non-hospital setting and maintained in the health care provider's office.

1.15 "Controlling Interest" means the operational direction or management of a facility or agency including but not limited to, the authority, express or reserved, to change the corporate identity of the applicant; the authority to appoint members of the board of directors, board of trustees, or other applicable governing body of the facility or agency; the ability to control any of the assets or other property of the facility or agency or to dissolve or sell the facility or agency.

1.16 "Cost sharing" means the share of cost covered by a client's insurance that the client pays out of pocket. This term includes, but is not limited to deductibles, coinsurance, copayments, or other similar charges.

1.17 "Deficiency" means a failure to fully comply with any statutory and/or regulatory requirements applicable to a licensee.

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

1.19 "Design Documents" means current construction plans, specifications, and any other information as requested by the Department for a guideline compliance review. Design documents should be completed in a manner consistent with the practice of architecture as found at section 12-25-301, C,R.S., et seq. and 4 CCR 730-1, Bylaws and Rules of the State Board of Licensure for Architects, Professional Engineers, and Professional Land Surveyors.

1.20 "Designated Representative" means a designated representative of a client or service provider who is a person so authorized in writing or by court order to act on behalf of the client or service provider. In the case of a deceased client, the personal representative, as defined at section 15-10-201(39), C.R.S., or, if none has been appointed, heirs shall be deemed to be designated representatives of the client.

1.21 "Direct Ownership" means the possession of stock, equity in capital, or any interest greater than 5 percent of the facility or agency.

1.22 "Emergency medical condition" means a medical condition that manifests itself by acute symptoms of sufficient severity, including severe pain, that a prudent layperson with an average knowledge of health and medicine could reasonably expect, in the absence of immediate medical attention, to result in: serious jeopardy to the health of the individual or, with respect to a pregnant woman, the health of the woman or her unborn child; or serious impairment to bodily functions; or serious dysfunction of any bodily organ or part.

1.23 "Emergency services," with respect to an emergency medical condition, means: a medical screening examination that is within the capability of the emergency department of a hospital, including ancillary services routinely available to the emergency department to evaluate the emergency medical condition; and within the capabilities of the staff and facilities available at the hospital, further medical examination and treatment as required to stabilize the patient to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from a facility.

1.24 "Enforcement Activity" means the imposition of remedies such as civil money penalties; appointment of a receiver or temporary manager; conditional licensure; suspension or revocation of a license; a directed plan of correction; intermediate restrictions or conditions, including retaining a consultant, Department monitoring, or providing additional training to employees, owners, or operators; or any other remedy provided by state or federal law or authorized by federal survey, certification, and enforcement regulations and agreements for violations of federal or state law.

1.25 "FGI Guidelines" means the Guidelines for Design and Construction of Hospitals, Guidelines for Design and Construction of Outpatient Facilities, and Guidelines for Design and Construction of Residential Health, Care, and Support Facilities, published by the Facilities Guidelines Institute.

1.26 "Grievance" means a written or verbal complaint that is made by a client or the client's designated representative to a facility or agency that cannot be resolved at the time by a staff person. If the complaint involves occurrences specified in section 25-1-124(2), C.R.S., the facility or agency shall report it to the Department, as required by Part 4.2 of these rules.

1.27 "Grievance mechanism" means the process whereby complaints by a client or the client's designated representative may be initiated and resolved by the facility or agency.

1.28 "Guideline compliance review" means the review of design documents submitted to the department, in the format required by the Department, for determination of compliance with FGI Guidelines.

1.29 "Guideline compliance review representative" means a person designated by the licensee or applicant to submit design documents to the Department on behalf of the licensee or applicant.

1.30 "Indirect Ownership" means any ownership interest in a business entity that has an ownership interest in the applicant or licensee, including an ownership interest in any business entity that has an indirect ownership interest in the applicant or licensee.

1.31 "Influenza Season" means November 1 through March 31 of the following year, or as otherwise defined by the Division of Disease Control and Public Health Response within the Department.

1.32 "Influenza Vaccine" means a currently licensed United States Food and Drug Administration approved vaccine product.

1.33 "Informed consent" means:

(a) An explanation of the nature and purpose of the recommended treatment or procedure in layman's terms and in a form of communication understood by the client or the client's designated representative;

(b) An explanation of the risks and benefits of a treatment or procedure, the probability of success, mortality risks, and serious side effects;

(c) An explanation of the alternatives with the risks and benefits of these alternatives;

(d) An explanation of the risks and benefits if no treatment is pursued;

(e) An explanation of the recuperative period which includes a discussion of anticipated problems; and

(f) An explanation that the client, or the client's designated representative, is free to withdraw consent and to discontinue participation in the treatment regimen at any time.

1.34 "In-network" means a facility or agency that is a participating provider, as defined at section 10-16-102(46), C.R.S., in an individual's health insurance plan.

1.35 "Initial license" means the licensing of a facility or agency that is not currently licensed, as well as a licensure change from one type to another.

1.36 "Letter of Intent" means the notification provided to the Department related to an application for a license, to make changes to an existing license, to make changes in services provided by the entity, or for any other business reason the Department requests.

1.37 "Licensed independent practitioner" means an individual permitted by law and the facility or agency to independently diagnose, initiate, alter, or terminate health care treatment within the scope of their license.

1.38 "Licensee" means a facility or agency that is required to obtain a license, or a certificate of compliance for governmental entities, from the Department pursuant to section 25-3-101, C.R.S.

1.39 "Management Company" means the person, business entity, or agency that is paid by the licensee and has a contractual agreement with the licensee to manage the day-to-day operation of the facility or agency on behalf of the licensee.

1.40 "Mechanical restraint" means a physical device used to involuntarily restrict the movement of an individual or the movement or normal function of a portion of his or her body. Physical restraints used for fall prevention, including but not limited to raised bed rails, are considered mechanical restraints.

1.41 "Medical device" means an instrument, apparatus, implement, machine, contrivance, implant, or similar or related article that is required to be labeled pursuant to 21 CFR Part 801.

1.42 "Medical supply" means a consumable supply item that is disposable and not intended for reuse.

1.43 "Minor alterations" means building construction projects which are not additions, which do not affect the structural integrity of the building, which do not change functional operation, and/or which do not add beds or capacity above what the facility is limited to under the existing license.

1.44 "Neglect" means the failure to provide goods and services necessary to attain and maintain physical and mental well-being.

1.45 "Out-of-network" means a facility or agency that is not a participating provider, as defined at Section 10-16-102(46), C.R.S.

1.46 "New construction" means the construction of new buildings or newly constructed additions.

1.47 "Palliative Care" means specialized medical care for people with serious illnesses. This type of care is focused on providing clients with relief from the symptoms, pain, and stress of serious illness, whatever the diagnosis. The goal is to improve quality of life for both the client and the individuals who are identified as the client's personal support system. Palliative care is provided by a team of physicians, nurses, and other specialists who work with a client's other health care providers to provide an extra layer of support. Palliative care is appropriate at any age and at any stage in a serious illness and can be provided together with curative treatment. Unless otherwise indicated, the term "palliative care" is synonymous with the terms "comfort care," "supportive care," and similar designations.

1.48 "Pharmacist" means a pharmacist licensed in the State of Colorado.

1.49 "Phased submittal" means the submittal of a subset of the design documents as related to work tasks that are to begin prior to the time that all building details are finalized, in order to allow initial work to start on projects that are complex and long-term in nature.

1.50 "Physical restraint" means the use of bodily, physical force to involuntarily limit an individual's freedom of movement; except that "physical restraint" does not include the holding of a child by one adult for the purposes of calming or comforting the child.

1.51 "Proof of Immunization" means an electronic entry in the Colorado Immunization Information System (CIIS) or an immunization record from a licensed healthcare provider who has administered an influenza vaccine to an individual who provides services for the facility or agency, specifying the vaccine administered, name and title of the person who administered the vaccine, address of the location where the vaccine was administered, and the date it was administered.

1.52 "Renovation" means the moving of walls and reconfiguring of existing floor plans. It includes the rebuilding or upgrading of major systems, including but not limited to: heating, ventilation, and electrical systems. It also means the changing of the functional operation of the space. Renovations do not include "minor alterations," as defined herein.

1.53 "Responsible design professional" means a registered architect, licensed professional, or other individual who prepares and signs the design documents submitted to the Department for the guideline compliance review.

1.54 "Restraint" means any method or device used to involuntarily limit freedom of movement, including but not limited to bodily physical force, mechanical devices, or chemicals. "Restraint" includes a chemical restraint, a mechanical restraint, a physical restraint, and/or seclusion.

1.55 "Review" means any type of administrative oversight by the Department including but not limited to, examination of documents, desk audit, complaint investigation, or on-site inspection.

1.56 "Revisit" means a follow-up survey conducted after deficiencies have been cited. The purpose is to determine if the licensee is now in compliance with the applicable state regulations or federal conditions of participation.

1.57 "Seclusion" means the involuntary placement of a person alone in a room from which egress is involuntarily prevented.

1.58 "Service Provider" means an individual who is responsible for a client's care in a facility or agency.

1.59 "Survey" means an inspection of a facility or agency for compliance with applicable state regulations or federal conditions of participation.

1.60 "Tiered Inspection" means an on-site re-licensure survey that has a reduced scope and reviews fewer items for compliance with applicable state regulations than a full re-licensure survey.

6 CCR 1011-1 Chapter 02 Part 1