# 6 CCR 1011-1 Chapter 26: CHAPTER 26 - HOME CARE AGENCIES > Colorado · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_6_CCR_1011_1_Chapter_26 ## Section - **Citation:** 6 CCR 1011-1 Chapter 26 - **Heading:** CHAPTER 26 - HOME CARE AGENCIES - **Jurisdiction:** Colorado - **Kind:** Regulations - **Status:** In force - **Text as of:** August 14, 2026 - **Source:** Compiled text - **Location:** Code of Colorado Regulations / 1000 Department of Public Health and Environment / 1011 Health Facilities and Emergency Medical Services Division (1011, 1015 Series) / 6 CCR 1011-1 Chapter 26 ## Text 1 DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT Health Facilities and Emergency Medical Services Division STANDARDS FOR HOSPITALS AND HEALTH FACILITIES CHAPTER 26 - HOME CARE AGENCIES 6 CCR 1011-1 Chapter 26 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Adopted by the Board of Health on April 16, 2025. Effective July 1, 2025. INDEX Part 1 – Statutory Authority and Applicability Part 2 – Definitions Part 3 – Placement Agencies Part 4 – Department Oversight Part 5 – General Requirements for all License Categories Part 6 – Skilled Care Part 7 – Non-Medical/Personal Care PART 1. STATUTORY AUTHORITY AND APPLICABILITY 1.1 Statutory Authority The statutory authority for the promulgation of these rules is set forth in Sections 25-1.5-103 and 25-27.5- 101, et seq., C.R.S. 1.2 Applicability (A) A home care agency, as defined herein, shall comply with all applicable federal, state, and local laws and regulations, including but not limited to, the following: (1) This Chapter 26 as it applies to the type of services provided. (2) 6 CCR 1011-1, Chapter 2, General Licensure Standards, unless otherwise modified herein. (B) Contracted services performed on behalf of the home care agency shall meet the standards established herein. PART 2. DEFINITIONS 2.1 “Authorized representative” means an individual responsible for the private payment of home care services or an individual who possesses written authorization from the consumer to represent their interests regarding care, treatment, and services provided by the home care agency. The authorized representative shall not be the home care consumer’s service provider except as allowed by state Medicaid programs. Code of Colorado Regulations Secretary of State State of Colorado CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division their interests regarding care, treatment, and services provided by the home care agency. The authorized representative shall not be the home care consumer’s service provider except as allowed by state Medicaid programs. Code of Colorado Regulations Secretary of State State of Colorado CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 2 2.2 “Branch office” means a location or site from which a home care agency provides services within a portion of the total geographic area served by the parent agency. The branch office is part of the home care agency and is located close to share administration, supervision, personnel, and services in a manner that renders it unnecessary for the branch to independently meet the requirements of this chapter. 2.3 “Bylaws” means a set of rules adopted by a home care agency for governing the agency’s operation. For purposes of this Chapter 26, “governing documents” is synonymous with “bylaws”. 2.4 “Certified home care agency” means an agency that is certified by either the federal Centers for Medicare and Medicaid Services (CMS) or the state Department of Health Care Policy and Financing (HCPF) to provide skilled home health or personal care services. 2.5 “Clinical note” means a written notation of a healthcare contact with a consumer that is signed, with date and time, by personnel of the home care agency that describes signs and symptoms; treatment; education; drugs administered and the consumer’s reaction; and any changes in physical or emotional condition. 2.6 “Community Centered Board” means a community-centered board, as defined in Section 25.5-10- 202, C.R.S., that is designated pursuant to Section 25.5-10-209, C.R.S., by the Department of Health Care Policy and Financing. 2.7 “Department” means the Colorado Department of Public Health and Environment. 2.8 “Geographic area” means an area of land for which the agency shall be licensed surrounding the home care agency’s primary location community-centered board, as defined in Section 25.5-10- 202, C.R.S., that is designated pursuant to Section 25.5-10-209, C.R.S., by the Department of Health Care Policy and Financing. 2.7 “Department” means the Colorado Department of Public Health and Environment. 2.8 “Geographic area” means an area of land for which the agency shall be licensed surrounding the home care agency’s primary location. There is no restriction as to the number of agencies that may provide services in a particular geographic area. 2.9 “Governing body” means the board of trustees, directors, or other governing entity in whom the ultimate authority and responsibility for the conduct of the home care agency is vested. 2.10 “Home care agency” means any sole proprietorship, partnership, association, corporation, government, or governmental subdivision or agency subject to the restrictions in Section 25-1.5- 103(1)(a)(II), C.R.S., not-for-profit agency, or any other legal or commercial entity that manages and offers, directly or by contract, skilled home health services or personal care services to a home care consumer in the home care consumer’s temporary or permanent home or place of residence. Home care agency is also referred to in this chapter as “HCA” or “agency.” (A) A residential facility that delivers skilled home health or personal care services that the facility is not licensed to otherwise provide shall either be licensed as a home care agency or require the skilled home health or personal care services to be delivered by a licensed home care agency. (B) “Home care agency” does not include: (1) Organizations that provide only housekeeping services; (2) Community and rural health networks that furnish home visits for the purpose of public health monitoring and disease tracking; (3) An individual who is not employed by or affiliated with a home care agency and who acts alone, without employees or contractors; CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 3 ousekeeping services; (2) Community and rural health networks that furnish home visits for the purpose of public health monitoring and disease tracking; (3) An individual who is not employed by or affiliated with a home care agency and who acts alone, without employees or contractors; CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 3 (4) Outpatient rehabilitation agencies and comprehensive outpatient rehabilitation facilities certified pursuant to Title 18 or 19 of the “Social Security Act,” as amended; (5) Consumer-directed attendant programs administered by the Colorado Department of Health Care Policy and Financing; (6) Licensed dialysis centers that provide in-home dialysis services, supplies, and equipment; (7) Subject to the requirements of Section 25-27.5-103(3), C.R.S., a facility otherwise licensed by the Department; (8) A home care placement agency as defined in this part; (9) Services provided by a qualified early intervention service provider and overseen jointly by the Department of Education and the Department of Human Services; or (10) A program of all-inclusive care for the elderly (PACE), established in Section 25.5-5-412, C.R.S., and regulated by the Department of Health Care Policy and Financing and the CMS, except that PACE home care services are subject to regulation in accordance with Section 25-27.5-104(4). 2.11 “Home care consumer” means a person who receives skilled home health services or personal care services in their temporary or permanent home or place of residence from a home care agency or from a provider referred by a home care placement agency. A home care consumer is also referred to in this chapter as “consumer”. 2.12 “Home care placement agency” means an organization that, for a fee, provides only referrals of providers to home care consumers seeking services services or personal care services in their temporary or permanent home or place of residence from a home care agency or from a provider referred by a home care placement agency. A home care consumer is also referred to in this chapter as “consumer”. 2.12 “Home care placement agency” means an organization that, for a fee, provides only referrals of providers to home care consumers seeking services. A home care placement agency does not provide skilled home health services or personal care services, directly or by contract, to a home care consumer in the home care consumer’s temporary or permanent home or place of residence. Such organizations shall follow the requirements of Section 25-27.5-101, et seq., C.R.S., that pertain to home care placement agencies and Part 3 of this chapter. 2.13 “Informal caregiver” means a person who provides care to the consumer without payment and who is not an employee of the agency. 2.14 “Licensed independent practitioner” means an individual permitted by law and the HCA to independently diagnose, initiate, alter, or terminate health care treatment within the scope of their license, and includes Advanced Practice Registered Nurses (APRN) and Physician Assistants. 2.15 “Manager” or “administrator” means any person who is responsible for and supervises or offers or attempts to oversee and supervise the day-to-day operations of a home care agency or home care placement agency. 2.16 “Nurse aide” means a nurse aide certified by the Colorado Department of Regulatory Agencies (DORA) or a nurse aide who has completed the requisite training and is within four (4) months of achieving certification. 2.17 “Owner” means a shareholder in a for-profit or nonprofit corporation, a partner in a partnership or limited partnership, a member in a limited liability company, a sole proprietor, or a person with a similar interest in an entity, who has at least a fifty-percent (50%) ownership interest in the business entity. d the requisite training and is within four (4) months of achieving certification. 2.17 “Owner” means a shareholder in a for-profit or nonprofit corporation, a partner in a partnership or limited partnership, a member in a limited liability company, a sole proprietor, or a person with a similar interest in an entity, who has at least a fifty-percent (50%) ownership interest in the business entity. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 4 2.18 “PACE home care services” means skilled home health services or personal care services: (A) Offered as part of a comprehensive set of medical and nonmedical benefits, including primary care, day services, and interdisciplinary team care planning and management by PACE providers to an enrolled participant in the program of all-inclusive care for the elderly established in Section 25.5-5-412, C.R.S. and regulated by the Department of Health Care Policy and Financing and the CMS; and (B) Provided in the enrolled participant’s temporary or permanent place of residence. 2.19 “Parent agency” means the agency that develops and maintains administrative control of branch offices. 2.20 “Personal care services” means assistance with activities of daily living, including but not limited to: bathing, dressing, eating, transferring, walking or mobility, toileting, continence care, housekeeping, personal laundry, medication reminders, and companionship services, furnished to a home care consumer in the home care consumer's temporary or permanent home or place of residence, and those normal daily routines that the home care consumer could perform for themselves were they physically capable, which are intended to enable that individual to remain safely and comfortably in the home care consumer's temporary or permanent home or place of residence ip services, furnished to a home care consumer in the home care consumer's temporary or permanent home or place of residence, and those normal daily routines that the home care consumer could perform for themselves were they physically capable, which are intended to enable that individual to remain safely and comfortably in the home care consumer's temporary or permanent home or place of residence. 2.21 “Personnel” means individuals employed by and/or providing services under the direction of the HCA, including but not limited to: managers, administrators, staff, employees, contractors, students, interns, or volunteers. 2.22 “Plan of care” means a plan developed in consultation with the licensed independent practitioner and agency staff that covers all pertinent diagnoses, including mental status, types of services and equipment required, frequency of visits, prognosis, rehabilitation potential, functional limitations, activities permitted, instructions for timely discharge or referral, and any other appropriate items. 2.23 “Plan of correction” means a written plan prepared by the home care agency or home care placement agency and submitted to the Department for approval that specifies the measures the agency shall take to correct all cited deficiencies. 2.24 “Pseudo-patient” means a person trained to participate in a role-play situation or a computer- based mannequin device. A pseudo-patient must be capable of responding to and interacting with the nurse aide and must demonstrate the general characteristics of the primary consumer population served by the HCA in key areas such as age, frailty, functional status, and cognitive status. 2.25 “Qualified Early Intervention Service Provider” has the same meaning set forth in Section 27- 10.5-702, C.R.S. 2.26 “Respite care” means services provided to a consumer who is unable to care for themselves on a short term basis because of the absence or need for relief of those persons normally providing care. the HCA in key areas such as age, frailty, functional status, and cognitive status. 2.25 “Qualified Early Intervention Service Provider” has the same meaning set forth in Section 27- 10.5-702, C.R.S. 2.26 “Respite care” means services provided to a consumer who is unable to care for themselves on a short term basis because of the absence or need for relief of those persons normally providing care. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 5 2.27 “Service Agency” means a service agency, as defined in Section 25.5-10-202, C.R.S., that has received certification from the Department of Health Care Policy and Financing as a developmental disabilities service agency under rules promulgated by the medical service board and is providing services pursuant to the supported living services waiver or the children’s extensive service support waiver or the home and community-based services waivers administered by the Department of Health Care Policy and Financing under Part 4 of Article 6 of Title 25.5, C.R.S. 2.28 “Service note” means a written notation that is signed, with date and time, by personnel of the home care agency furnishing the non-medical services. 2.29 “Skilled home health services” means health and medical services furnished in the consumer's temporary or permanent home or place of residence that include: wound care services; use of medical supplies including drugs and biologicals prescribed by a physician; in-home infusion services; nursing services; certified nurse aide services that require the supervision of a licensed or certified health care professional acting within the scope of their license or certificate; occupational therapy; physical therapy; respiratory care services; dietetics and nutrition counseling services; medication administration; medical social services; and speech-language pathology services. “Skilled home health services” does not include the delivery of either durable medical equipment or medical supplies alth care professional acting within the scope of their license or certificate; occupational therapy; physical therapy; respiratory care services; dietetics and nutrition counseling services; medication administration; medical social services; and speech-language pathology services. “Skilled home health services” does not include the delivery of either durable medical equipment or medical supplies. 2.30 “Subdivision” means a component of a multi-function health agency, such as the home care department of a hospital or the nursing division of a health department, which independently meets the licensure requirements for HCAs. A subdivision that has branch offices is considered a parent agency. 2.31 “Summary report” means the compilation of the pertinent factors of a home care consumer's clinical notes that is submitted to the consumer's physician by the skilled home healthcare agency. 2.32 “Supervision” means authoritative procedural guidance by a qualified person for the accomplishment of a function or activity. 2.33 “Workstation” means a location separate from the parent agency that operates solely for the convenience of direct care staff. Any non-medical, medical, state, or federally certified agency may establish a workstation within the agency’s geographic service area. The site may provide a place to work so that direct care staff can decrease travel. Consumer charts are not to be kept at a workstation, but the site may contain phones, faxes, office supplies, wound care supplies, policies, procedures, forms, etc. The workstation shall not be used to accept referrals; conduct marketing, administrative activities, or personnel training; or store consumer records. The workstation shall not be staffed to serve the public and signage at the workstation shall not be posted to invite the public inside to conduct business. PART 3 hones, faxes, office supplies, wound care supplies, policies, procedures, forms, etc. The workstation shall not be used to accept referrals; conduct marketing, administrative activities, or personnel training; or store consumer records. The workstation shall not be staffed to serve the public and signage at the workstation shall not be posted to invite the public inside to conduct business. PART 3. PLACEMENT AGENCIES 3.1 Registration (A) It is unlawful for a person to conduct or maintain a home care placement agency without a valid, current home care placement agency registration issued by the Department. (B) A person who violates any part of this section is: (1) Guilty of a misdemeanor and, upon conviction thereof, shall be punished by a fine of not less than $50, nor more than $500; and CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 6 (2) May be subject to a civil penalty assessed by the Department of up to $10,000 for each violation. The penalty shall be assessed, enforced, and collected in accordance with Article 4 of Title 24, C.R.S., and any penalties collected by the Department shall be transferred to the state treasurer for deposit in the general fund. 3.2 Criminal History Record Check (A) The home care placement agency shall require any provider seeking placement to submit to a criminal history record check to ascertain whether the provider applying has been convicted of a felony or misdemeanor, which felony or misdemeanor involves conduct that the agency determines could pose a risk to the health, safety, or welfare of home care consumers. (B) The criminal history record check shall, at a minimum, include a search of criminal history in the State of Colorado and be conducted not more than ninety (90) days prior to placement of the provider. (C) The cost of such inquiry shall be paid by either the home care placement agency or the individual seeking placement could pose a risk to the health, safety, or welfare of home care consumers. (B) The criminal history record check shall, at a minimum, include a search of criminal history in the State of Colorado and be conducted not more than ninety (90) days prior to placement of the provider. (C) The cost of such inquiry shall be paid by either the home care placement agency or the individual seeking placement. (D) In assessing whether to refer a provider with a felony or misdemeanor conviction, the home care placement agency shall consider the following factors: (1) The history of convictions or pleas of guilty or no contest; (2) The nature and seriousness of the crimes; (3) The time that has elapsed since the conviction(s); (4) Whether there are any mitigating circumstances; and (5) The nature of the position for which the provider would be referred. (E) The home care placement agency shall develop and implement policies and procedures regarding the referral of any provider who is convicted of a felony or misdemeanor to ensure that the provider being referred does not pose a risk to the health, safety, and welfare of the home care consumer. 3.3 Disclosures (A) The home care placement agency shall provide a written disclosure notice to the home care consumer concerning the duties and employment status of the individual(s) providing services. (B) The disclosure notice, in the form and manner prescribed by the Department, shall be signed by the consumer or authorized representative before the start of services and shall include, at a minimum, the following information: (1) That the home care placement agency is not the employer of any provider it refers to a home care consumer; and loyment status of the individual(s) providing services. (B) The disclosure notice, in the form and manner prescribed by the Department, shall be signed by the consumer or authorized representative before the start of services and shall include, at a minimum, the following information: (1) That the home care placement agency is not the employer of any provider it refers to a home care consumer; and (2) That the home care placement agency does not direct, control, schedule, or train any provider it refers. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 7 (C) The home care placement agency shall maintain proof that disclosures have been provided before referring a provider to a home care consumer. 3.4 Inspections (A) The Department may inspect, as it deems necessary, a home care placement agency’s records on weekdays between 9 a.m. and 5 p.m. to ensure that the home care placement agency is in compliance with the criminal history record check, general liability insurance, and disclosure requirements. (1) The home care placement agency shall retain its records for a period of seven (7) years and those records shall be readily available to the Department during inspections. (B) The Department shall make inspections as it deems necessary to ensure that the health, safety, and welfare of a home care placement agency’s home care consumers are being protected. Inspections of a home care consumer’s home are subject to the consent of the consumer to access the property. 3.5 Plan of Correction For purposes of this chapter, a plan of correction against a registered home care placement agency shall be completed in accordance with 6 CCR 1011-1, Chapter 2, Part 2.10.4(B). 3.6 Intermediate Restrictions or Conditions (A) The Department may impose intermediate restrictions or conditions on a home care placement agency that may include at least one of the following: (1) Retaining a consultant to address corrective measures; a plan of correction against a registered home care placement agency shall be completed in accordance with 6 CCR 1011-1, Chapter 2, Part 2.10.4(B). 3.6 Intermediate Restrictions or Conditions (A) The Department may impose intermediate restrictions or conditions on a home care placement agency that may include at least one of the following: (1) Retaining a consultant to address corrective measures; (2) Monitoring by the Department for a specific period; (3) Providing additional training to personnel, owners, or operators of the home care placement agency; (4) Complying with a directed written plan to correct the violation; or (5) Paying a civil fine not to exceed $10,000 per calendar year for all violations. (B) If the Department imposes an intermediate restriction or condition that is not the result of a serious and immediate threat to health, safety, or welfare, the Department shall provide the home care placement agency with written notice of the restriction or condition. No later than ten (10) calendar days after receipt of the notice, the home care placement agency shall submit a written plan that includes the time frame for completing the directed plan that addresses the restriction or condition specified. (C) If the Department imposes an intermediate restriction or condition that is the result of a serious and immediate threat to health, safety, or welfare, the Department shall notify the home care placement agency in writing, by telephone, or in person during an on-site visit. (1) The home care placement agency shall remedy the circumstances creating the harm or potential harm immediately upon receiving notice of the restriction or condition. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 8 partment shall notify the home care placement agency in writing, by telephone, or in person during an on-site visit. (1) The home care placement agency shall remedy the circumstances creating the harm or potential harm immediately upon receiving notice of the restriction or condition. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 8 (2) If the Department provides notice of a restriction or condition by telephone or in person, the Department shall send written confirmation of the restriction or condition to the home care placement agency within two (2) business days. (D) After submission of an approved written plan, the home care placement agency may appeal any intermediate restriction or condition to the Department through an informal review process as specified by the Department. (E) If the Department imposes an intermediate restriction or condition that requires payment of a civil fine, the home care placement agency may request and the Department shall grant a stay in payment of the fine until final disposition of the restriction or condition. (F) If a home care placement agency is not satisfied with the result of the informal review or chooses not to seek informal review, no intermediate restriction or condition shall be imposed until after the opportunity for a hearing has been afforded the home care placement agency pursuant to Section 24-4-105, C.R.S. 3.7 Enforcement and Disciplinary Sanctions (A) For purposes of this chapter, enforcement activities against a registered home care placement agency shall comply with 6 CCR 1011-1, Chapter 2, Part 2.11. (B) If the Department suspends, revokes, or refuses to renew a home care placement agency registration, the home care placement agency shall be removed from the registry maintained by the Department pursuant to Section 25-27.5-103(2)(a)(I), C.R.S or purposes of this chapter, enforcement activities against a registered home care placement agency shall comply with 6 CCR 1011-1, Chapter 2, Part 2.11. (B) If the Department suspends, revokes, or refuses to renew a home care placement agency registration, the home care placement agency shall be removed from the registry maintained by the Department pursuant to Section 25-27.5-103(2)(a)(I), C.R.S. 3.8 Registration Procedure (A) An applicant for an initial or renewal home care placement agency registration shall provide the Department with a complete application including all information and attachments specified in the application form and any additional information requested by the Department. Each application shall include, at a minimum, the following: (1) A non-refundable annual registration fee as published in accordance with 6 CCR 1011-1, Chapter 2, Part 2.12. Registrations will be valid for one year from the date of issue. (2) Evidence of general liability insurance coverage that covers the home care placement agency and the providers it refers to home care consumers. Such coverage shall be maintained for the duration of the license period. The minimum amount of coverage is $100,000 per occurrence and $300,000 aggregate. (3) The legal name of the entity and all other names used by it to provide home care placement services. The applicant has a continuing duty to notify the Department of all name changes at least thirty (30) calendar days prior to the effective date of the change. (4) Contact information for the entity including mailing address, telephone and facsimile numbers, e-mail address, and website address, as applicable. name of the entity and all other names used by it to provide home care placement services. The applicant has a continuing duty to notify the Department of all name changes at least thirty (30) calendar days prior to the effective date of the change. (4) Contact information for the entity including mailing address, telephone and facsimile numbers, e-mail address, and website address, as applicable. (5) The identity of all persons and business entities with a controlling interest in the home care placement agency, including administrators, directors, and managers. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 9 (B) With the submission of an application for registration or within ten (10) calendar days after a change in the owner, manager, or administrator, each owner, manager or administrator of a home care placement agency shall submit a complete set of their fingerprints to the Colorado Bureau of Investigation for the purpose of conducting a state and national fingerprint-based criminal history record check. (1) Each owner, manager, or administrator is responsible for paying the fee established by the Colorado Bureau of Investigation for conducting the criminal history record check. (2) If the owner, manager, or administrator of the home care placement agency has been convicted of a felony or of a misdemeanor which felony or misdemeanor involves conduct that the Department determines could pose a risk to the health, safety, or welfare of the home care placement agency’s consumers, the Department will not approve the application for registration. PART 4. DEPARTMENT OVERSIGHT 4.1 License Classification (A) An HCA shall be issued a license consistent with the type and extent of services provided. Unless otherwise specified, each licensed HCA shall meet the requirements in Part 5 of this chapter as well as Parts 6 and/or 7 depending upon the services provided. ency’s consumers, the Department will not approve the application for registration. PART 4. DEPARTMENT OVERSIGHT 4.1 License Classification (A) An HCA shall be issued a license consistent with the type and extent of services provided. Unless otherwise specified, each licensed HCA shall meet the requirements in Part 5 of this chapter as well as Parts 6 and/or 7 depending upon the services provided. (1) Class A – a home care agency that provides any skilled healthcare service. Agencies with a Class A license may also provide personal care services. (2) Class B – a home care agency that provides only personal care services. An agency with a Class B license shall not provide any skilled healthcare service. (B) An HCA providing home care services that are regulated by the Colorado Department of Health Care Policy and Financing (HCPF), excluding certified agencies defined in Part 2.4 of this chapter, shall be licensed as a Class B agency unless otherwise specified below. (1) Any HCA providing services regulated by HCPF that also provides skilled care or services delivered by a licensed professional shall be licensed as a Class A HCA. (a) In reviewing compliance with the requirements of this chapter by the Program of All-Inclusive Care for the Elderly (PACE) established in Section 25.5-5-412, C.R.S., the Department shall coordinate with HCPF in regulatory interpretation of both license and certification requirements to ensure the intent of similar regulations is congruently met. professional shall be licensed as a Class A HCA. (a) In reviewing compliance with the requirements of this chapter by the Program of All-Inclusive Care for the Elderly (PACE) established in Section 25.5-5-412, C.R.S., the Department shall coordinate with HCPF in regulatory interpretation of both license and certification requirements to ensure the intent of similar regulations is congruently met. (b) Any HCA participating in the In-Home Support Service program may be licensed as a Class A or B HCA and shall comply with both HCPF’s regulations concerning those programs and the applicable portions of this chapter. The Department shall coordinate with HCPF in regulatory interpretation of both license and certification requirements to ensure the intent of similar regulations is congruently met. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 10 (C) Residential facilities (1) Any residential facility that delivers skilled home health or personal care services that the facility is not otherwise licensed or certified to provide, shall either become licensed as a home care agency or require the skilled home health or personal care services to be delivered by a licensed home care agency. (a) Consumer services shall be provided only upon individual service contracts. The resident or consumer requiring services not covered under the primary license shall be given the opportunity to contract with the home care agency of choice and shall not be restricted to the use of the residential facility home care agency. (b) A residential facility may not contract for nor provide skilled home health or personal care services on a facility-wide basis under this license. Each residential facility providing facility-wide services shall be licensed according to the appropriate provider type. ontract with the home care agency of choice and shall not be restricted to the use of the residential facility home care agency. (b) A residential facility may not contract for nor provide skilled home health or personal care services on a facility-wide basis under this license. Each residential facility providing facility-wide services shall be licensed according to the appropriate provider type. (c) The home care records shall be easily identifiable and separated in the consumer record from the residential care records. (2) The requirements contained in Parts 5 through 7 of this chapter shall apply only to processes, policies, and procedures that address those consumers receiving skilled home health or personal care services in their temporary or permanent home or place of residence. (a) The requirements apply to all residential facilities providing skilled home health services not covered under the primary residential care license or certification. (b) The requirements for governing body, professional advisory committee, complaints, occurrences, and quality assurance activities may be met, in whole or in part, in conjunction with like activities of the primary license. However, there shall be documented oversight of the home care portion of the services provided distinct from that of the primary license. (D) Pursuant to Section 25.5-10-202(22), C.R.S., Independent Residential Support Services do not require licensure by the Department. (E) Nothing in this section relieves an entity that contracts or arranges with a community centered board or service agency, and that meets the definition of a “home care agency” under Section 25-27.5-102, C.R.S., from the entity’s obligation to apply for, and operate under, a license in accordance with these regulations. 4.2 License Procedure (A) The HCA shall comply with the requirements of 6 CCR 1011-1, Chapter 2, regarding license application procedures, the process for change of ownership, and the continuing obligations of a licensee definition of a “home care agency” under Section 25-27.5-102, C.R.S., from the entity’s obligation to apply for, and operate under, a license in accordance with these regulations. 4.2 License Procedure (A) The HCA shall comply with the requirements of 6 CCR 1011-1, Chapter 2, regarding license application procedures, the process for change of ownership, and the continuing obligations of a licensee. (B) When submitting an application for an initial or renewal license, the HCA shall include evidence of either liability insurance coverage or a surety bond in lieu of liability insurance coverage. Such coverage shall be maintained for the duration of the license period. The minimum amount of coverage is: CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 11 (1) Class A – $500,000 per occurrence and $3,000,000 aggregate. (2) Class B – $100,000 per occurrence and $300,000 aggregate. (C) The agency shall submit to the Department a list of the contiguous counties that it plans to serve and assure adequate staffing, supervision, consumer care, and services are provided within the declared geographical area. (D) With the submission of an application for licensure or within ten (10) calendar days after a change in the owner, manager, or administrator, each owner and each manager or administrator of a home care agency shall submit a complete set of their fingerprints to the Colorado Bureau of Investigation for the purpose of conducting a state and national fingerprint-based criminal history record check. Each owner, manager, or administrator is responsible for paying the fee established by the Colorado Bureau of Investigation for conducting the criminal history record check. (1) The Department may acquire a name-based criminal history record check for an applicant who has twice submitted to a finger-print based criminal history record check and whose fingerprints are unclassifiable. record check. Each owner, manager, or administrator is responsible for paying the fee established by the Colorado Bureau of Investigation for conducting the criminal history record check. (1) The Department may acquire a name-based criminal history record check for an applicant who has twice submitted to a finger-print based criminal history record check and whose fingerprints are unclassifiable. (2) When the results of a finger-print based criminal history record check of an applicant reveal a record of arrest without a disposition, the Department shall require that person to submit to a name-based criminal history record check. (3) No license shall be issued or renewed by the Department if the owner, applicant, or licensee of the home care agency has been convicted of a felony or a misdemeanor, which felony or misdemeanor involves conduct that the Department determines could pose a risk to the health, safety, or welfare of HCA consumers. (4) Each HCA owner, applicant, or licensee is under an affirmative obligation to inform the Department if they are convicted of a felony or of a misdemeanor that involves moral turpitude or conduct that the Department determines could pose a risk to the health, safety, or welfare of HCA consumers. Failure to advise the Department of a conviction may result in non-renewal or other appropriate sanctions, as set forth in Parts 4.7 and 4.8 of this chapter. (E) No license shall be transferred from one location to another without prior notice to the Department as provided in this subsection. If an agency is considering moving or changing the licensed physical address, the agency shall notify the Department thirty (30) days prior to the intended relocation. (1) To retain the current license, the new physical location shall be relocated within the existing geographic service area and retain the same governing body and administrator. tice to the Department as provided in this subsection. If an agency is considering moving or changing the licensed physical address, the agency shall notify the Department thirty (30) days prior to the intended relocation. (1) To retain the current license, the new physical location shall be relocated within the existing geographic service area and retain the same governing body and administrator. (2) If the change in physical address does not meet the requirements listed above, the HCA shall submit an application for a new license. (F) An HCA shall notify the Department thirty (30) days prior to making any changes to the branch office physical address or organization. (G) An HCA seeking a waiver of these regulations, or any other Department regulations, shall comply with the requirements of 6 CCR 1011-1, Chapter 2, Part 5. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 12 4.3 Provisional Licenses (A) The HCA shall comply with the requirements of 6 CCR 1011-1, Chapter 2, Part 2.4 regarding provisional licenses, with the following additions: (1) If requested by HCPF, the Department may issue a provisional license for a period of ninety (90) days to an agency that has applied to be a certified home care agency. (2) No provisional license shall be granted before completion of a criminal background check and finding in accordance with Part 4.2 of this chapter. 4.4 License fees HCA license applicants and licensees shall pay and submit license and license-related fees as published in accordance with 6 CCR 1011-1, Chapter 2, Part 2.12. (A) Applicable fees may include, but are not limited to: (1) Initial, renewal, provisional, or conditional licenses; (2) Change of ownership of an existing license; (2) Branch and workstation fees; (3) Additional volume fees based on the previous year’s reported annual admissions; (4) Revisit fees; or ense and license-related fees as published in accordance with 6 CCR 1011-1, Chapter 2, Part 2.12. (A) Applicable fees may include, but are not limited to: (1) Initial, renewal, provisional, or conditional licenses; (2) Change of ownership of an existing license; (2) Branch and workstation fees; (3) Additional volume fees based on the previous year’s reported annual admissions; (4) Revisit fees; or (5) Change of name and change of address. (B) Fees in (A), above, may vary based on factors such as the HCA, its Class, and its Medicare or Medicaid certification status. 4.5 License process (A) Initial licensure (1) Each HCA license applicant shall specify the type and extent of services to be provided and request the appropriate license category based upon the criteria set forth in Part 4.1 of this chapter. (2) Any currently licensed Class B HCA that desires to change its license category to a Class A HCA shall submit an initial license application and initial license fee for a Class A license. (B) Renewal licensure (1) Each HCA shall report its annual admissions for the previous year on its license renewal application. (2) Each HCA that is currently certified to provide Medicaid or Medicare services shall be eligible for a deduction from its base fee. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 13 (3) A license applicant that is accredited by an accrediting organization recognized by CMS as having deeming authority may be eligible for discount off the base renewal license fee. In order to be eligible for this discount, the license applicant shall submit copies of its most recent recertification survey(s), and any plan(s) of correction with the most recent letter of accreditation showing the license applicant has full accreditation status in addition to a completed renewal application. (C) Branch and workstation fees (1) For existing branches, the fee shall be submitted with the license application. his discount, the license applicant shall submit copies of its most recent recertification survey(s), and any plan(s) of correction with the most recent letter of accreditation showing the license applicant has full accreditation status in addition to a completed renewal application. (C) Branch and workstation fees (1) For existing branches, the fee shall be submitted with the license application. (2) For new branches, the fee shall accompany the notice of the HCA's intent to open a branch office pursuant to Part 5.2 of this chapter. (3) An HCA that operates one or more work stations solely for the convenience of direct care staff shall pay a fee per workstation. (E) Revisit fee (1) An HCA’s annual license fee may be increased as the result of a licensure inspection or substantiated complaint investigation where a deficient practice is cited that has either caused harm or has the potential to cause harm to a consumer and which the HCA has failed to demonstrate appropriate correction of the cited deficiencies at the first on-site revisit. (2) The fee shall be assessed for the second on-site inspection and each subsequent on-site inspection pertaining to the same deficiency. 4.6 Inspections (A) The HCA shall comply with the requirements of 6 CCR 1011-1, Chapter 2, Parts 2.9.4, 2.10.1, and 2.10.2 regarding inspections, with the following additions: (1) The Department shall make such inspections as it deems necessary to ensure that the health, safety, and welfare of home care consumers are protected. In addition to licensure inspections, the Department may conduct supplemental inspections at any time in response to complaints alleging noncompliance with the regulations contained in this chapter. ding inspections, with the following additions: (1) The Department shall make such inspections as it deems necessary to ensure that the health, safety, and welfare of home care consumers are protected. In addition to licensure inspections, the Department may conduct supplemental inspections at any time in response to complaints alleging noncompliance with the regulations contained in this chapter. (a) Consumer records kept in the home or individual consumer documents not included in the HCA’s permanent record shall be made available to the Department within two (2) hours of request if the last visit occurred fourteen (14) or more days prior to the request. The time for production may be extended at the Department’s discretion. (b) The consumer file and administrative records, including but not limited to, census and demographic information, complaint and incident reports, meeting minutes, quality assurance, and annual program review documents shall be provided to the inspector commencing within thirty (30) minutes of request. The time for production may be extended at the Department’s discretion. (2) Inspections shall not be conducted in a home care consumer’s home without the consumer’s consent. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 14 4.7 Plan of Correction The HCA shall comply with the requirements of 6 CCR 1011-1, Chapter 2, Part 2.10.4(B) regarding a plan of correction. 4.8 Intermediate Restrictions or Conditions (A) The Department may impose intermediate restrictions or conditions on a license, which may include at least one of the following: (1) Retaining a consultant to address corrective measures; (2) Monitoring by the Department for a specific period; (3) Providing additional training to personnel, owners, or operators of the home care agency; (4) Complying with a directed written plan to correct the violation; or tment may impose intermediate restrictions or conditions on a license, which may include at least one of the following: (1) Retaining a consultant to address corrective measures; (2) Monitoring by the Department for a specific period; (3) Providing additional training to personnel, owners, or operators of the home care agency; (4) Complying with a directed written plan to correct the violation; or (5) Paying a civil fine not to exceed $10,000 per calendar year for all violations. (B) If the Department imposes an intermediate restriction or condition that is not the result of a serious and immediate threat to health or welfare, the Department shall provide the agency with written notice of the restriction or condition. No later than ten (10) days after receipt of the notice, the agency shall submit a written plan that includes the time frame for completing the directed plan that addresses the restriction or condition specified. (C) If the Department imposes an intermediate restriction or condition that is the result of a serious and immediate threat to health, safety, or welfare, the Department shall notify the agency in writing, by telephone, or in person during an on-site visit. (1) The agency shall remedy the circumstances creating the harm or potential harm immediately upon receiving notice of the restriction or condition. (2) If the Department provides notice of a restriction or condition by telephone or in person, the Department shall send written confirmation of the restriction or condition to the agency within two (2) business days. (D) After submission of an approved written plan, the agency may appeal any intermediate restriction or condition to the Department through an informal review process as specified by the Department. (E) If the Department imposes an intermediate restriction or condition that requires payment of a civil fine, the agency may request, and the Department shall grant, a stay in payment of the fine until final disposition of the restriction or condition the agency may appeal any intermediate restriction or condition to the Department through an informal review process as specified by the Department. (E) If the Department imposes an intermediate restriction or condition that requires payment of a civil fine, the agency may request, and the Department shall grant, a stay in payment of the fine until final disposition of the restriction or condition. (F) If an agency is not satisfied with the result of the informal review, or chooses not to seek informal review, no intermediate restriction or condition shall be imposed until after the opportunity for a hearing has been afforded the licensee pursuant to Section 24-4-105, C.R.S. 4.9 Enforcement and Disciplinary Sanctions The provisions of 6 CCR 1011-1, Chapter 2, Part 2.11 regarding enforcement and disciplinary sanctions shall apply to all HCAs and home care placement agencies. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 15 4.10 Civil Fines If the Department assesses a civil fine pursuant to Part 4.7 of this chapter, the money received by the Department shall be transmitted to the state treasurer who shall credit the same to the general fund. PART 5. GENERAL REQUIREMENTS FOR ALL LICENSE CATEGORIES 5.1 Out of State Entities Every HCA providing services within the state shall have a physical business office capable of conducting day-to-day business as an HCA within Colorado and shall be licensed according to the services rendered. 5.2 Branch Offices (A) An HCA shall notify the Department in advance of its plan to establish a branch office. Notification shall include, at a minimum: (1) A description of the services to be provided; (2) The geographic area to be served by the branch office that is within a portion of the total geographic area served by the parent agency; and hall be licensed according to the services rendered. 5.2 Branch Offices (A) An HCA shall notify the Department in advance of its plan to establish a branch office. Notification shall include, at a minimum: (1) A description of the services to be provided; (2) The geographic area to be served by the branch office that is within a portion of the total geographic area served by the parent agency; and (3) A description of how the parent agency will supervise the branch office on a daily basis. (B) A branch office, as an extension of the parent agency, may not offer services that are different than those offered by the parent agency. (C) The location of the branch, in relation to the parent agency, shall be such that the parent agency is able to ensure adequate supervision at all times. (1) The parent agency shall be physically located so that sharing of administration, supervision, personnel, and services with the branch can occur on a daily basis, and to ensure that the branch office has back-up coverage ready and available to serve all consumers when they are scheduled to receive services. (2) In the event the branch office is unable to meet the consumer’s needs, the parent agency shall ensure all consumers continue to receive services when scheduled, in accordance with the consumer’s care plan. (D) The parent agency administrator, manager, or supervisor shall conduct an on-site visit of the branch office in accordance with agency policy. (E) One or more health professionals who possess the experience, education, and qualifications to oversee all care and services provided by the branch shall be available during all operating hours. scheduled, in accordance with the consumer’s care plan. (D) The parent agency administrator, manager, or supervisor shall conduct an on-site visit of the branch office in accordance with agency policy. (E) One or more health professionals who possess the experience, education, and qualifications to oversee all care and services provided by the branch shall be available during all operating hours. (1) If only personal care services are provided, personnel that meet the qualifications of a supervisor shall be available during all operating hours. (F) The branch office shall have a copy of all agency policies available and readily accessible to staff. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 16 (G) The parent agency shall ensure that consumer records are readily accessible to all staff providing care and services. (H) The parent agency shall be aware of the staffing, census, and any issues/matters affecting the operation of the branch office at all times. 5.3 Consumer Rights (A) The provisions of 6 CCR 1011-1, Chapter 2, Part 7, shall apply, with the following additions: (1) Assurance of rights (a) A complete statement of consumer rights, including the right to file a complaint with the Department, shall be distributed to all personnel upon hire. (b) At a minimum, the HCA’s policies and procedures shall specify that: (i) The consumer or authorized representative has the right to be informed of the consumer’s rights through an effective means of communication. (ii) The consumer has the right to be assured that the HCA shall not condition the provision of care, or otherwise discriminate against a consumer, based upon personal, cultural, or ethnic preference, disabilities, or whether the consumer has an advance directive. (iii) The HCA shall protect and promote the exercise of these rights. (2) Exercise of rights and respect for property and person ation. (ii) The consumer has the right to be assured that the HCA shall not condition the provision of care, or otherwise discriminate against a consumer, based upon personal, cultural, or ethnic preference, disabilities, or whether the consumer has an advance directive. (iii) The HCA shall protect and promote the exercise of these rights. (2) Exercise of rights and respect for property and person (a) The rights of the consumer may be exercised by the consumer or authorized representative without fear of retribution or retaliation. (b) The consumer has the right to have their person and property treated with respect. (c) The consumer has the right to be free from neglect; financial exploitation; and verbal, physical, and psychological abuse, including humiliation, intimidation, or punishment. (d) The consumer or authorized representative, upon request to the HCA, has the right to be informed of the full name, licensure status, staff position, and employer of all persons with whom the consumer has contact and who is supplying, staffing, or supervising care or services. (e) The consumer has the right to be served by agency staff who are properly trained and competent to perform their duties. (f) The consumer has the right to live free from involuntary confinement, and to be free from physical or chemical restraints as defined in 6 CCR 1011-1, Chapter 2, Part 8. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 17 (g) The consumer or authorized representative has the right to express complaints verbally, or in writing, about services or care that are or are not furnished or about the lack of respect for the consumer’s person or property by anyone who is furnishing services on behalf of the HCA. (h) The consumer has the right to confidentiality of all records, communications, and personal information. on 17 (g) The consumer or authorized representative has the right to express complaints verbally, or in writing, about services or care that are or are not furnished or about the lack of respect for the consumer’s person or property by anyone who is furnishing services on behalf of the HCA. (h) The consumer has the right to confidentiality of all records, communications, and personal information. (i) The HCA shall advise the consumer of the agency's policies and procedures regarding disclosure of clinical information and records. (3) Right to be informed and to participate in planning care and services (a) The HCA shall inform the consumer or authorized representative, in advance, about the care, method of delivery, and services to be furnished, and of any changes in the care, method of delivery, and services to be furnished, to enable the consumer to give informed consent. (i) The consumer has the right to refuse treatment, within the confines of the law, to be informed of the consequences of such action, and to be involved in experimental research only upon the consumer’s voluntary written consent. (ii) The consumer has the right to be told, in advance of receiving care, about the services that will be provided, the disciplines that will be utilized to furnish care, the frequency of visits proposed to be furnished, the method of delivery of services and any changes in the method of delivery of services, and the consequences of refusing care or services. (iii) The consumer has the right to refuse to change from an in- person method of delivery of services to a telehealth method of delivery. If the consumer refuses telehealth, their services shall continue in person. (b) The HCA shall offer the consumer or authorized representative the right to participate in developing the plan of care, and receive instruction and education regarding the plan. es. (iii) The consumer has the right to refuse to change from an in- person method of delivery of services to a telehealth method of delivery. If the consumer refuses telehealth, their services shall continue in person. (b) The HCA shall offer the consumer or authorized representative the right to participate in developing the plan of care, and receive instruction and education regarding the plan. (i) The HCA shall advise the consumer, in advance, of the right to participate in planning the care or treatment, and in planning changes in the care or treatment. (4) The consumer has the right to receive prompt care in accordance with the care plan. (5) The consumer or authorized representative has the right to be advised of any changes in billing or payment procedures before implementation. (a) If an HCA is implementing a scheduled rate increase to all consumers, the HCA shall provide a written notice to each affected consumer at least thirty (30) days before implementation. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 18 (b) The HCA shall advise the consumer of any individual changes, orally and in writing, as soon as possible, but no later than five (5) business days from the date that the HCA becomes aware of a change. (c) An HCA shall not assume power of attorney or guardianship over a consumer utilizing the services of the HCA, require a consumer to endorse checks over to the HCA, or require a consumer to execute or assign a loan, advance, financial interest, mortgage, or other property in exchange for future services. (6) The consumer or authorized representative has the right to be advised of the availability of the state’s toll-free HCA hotline. torney or guardianship over a consumer utilizing the services of the HCA, require a consumer to endorse checks over to the HCA, or require a consumer to execute or assign a loan, advance, financial interest, mortgage, or other property in exchange for future services. (6) The consumer or authorized representative has the right to be advised of the availability of the state’s toll-free HCA hotline. (a) The consumer also has the right to use this hotline to lodge complaints regarding care received or not received, including implementation of the advance directives requirements. (7) The HCA shall make available to the consumer or authorized representative, upon request, a written notice listing all individuals or other legal entities having ownership or controlling interest in the agency. (a) When a change of ownership occurs, the new owner shall send a written notice to all of the HCA’s consumers listing all of the new owners and give the consumer the opportunity to continue services with the HCA or receive assistance in transferring care and services to a different HCA. (8) The HCA shall maintain documentation showing that it has complied with the requirements of this section. 5.4 Admissions (A) Agencies shall only accept consumers for care or services on the basis of a reasonable assurance that the needs of the consumer can be met adequately by the agency in the individual’s temporary or permanent home or place of residence. (1) There shall be initial documentation of the agreed upon days and times of services to be provided, based upon the consumer’s needs, that is updated at least annually. (B) If an agency receives a referral of a consumer who requires care or services that are not available at the time of referral, the agency shall advise the consumer’s primary care provider, if applicable, and the consumer or authorized representative of that fact. tion of the agreed upon days and times of services to be provided, based upon the consumer’s needs, that is updated at least annually. (B) If an agency receives a referral of a consumer who requires care or services that are not available at the time of referral, the agency shall advise the consumer’s primary care provider, if applicable, and the consumer or authorized representative of that fact. (1) The agency shall only admit the consumer if the primary care provider and the consumer or consumer’s representative agree the ordered services can be delayed or discontinued. 5.5 Discharge Planning (A) There shall be a specific plan for discharge in the consumer record, and there shall be ongoing discharge planning with the consumer. (B) If no improvement or no discharge is expected, the agency shall document this finding in the consumer record. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 19 (C) The HCA shall assist each consumer or authorized representative to find an appropriate placement with another agency if the consumer continues to require care and/or services upon discharge. The HCA shall document due diligence in ensuring continuity of care upon discharge, as necessary, to protect the consumer’s safety and welfare. (D) Once admitted, an HCA shall not discontinue or refuse services to a consumer unless documented efforts have been made to resolve the situation that triggered such discontinuation or refusal to provide services. (1) The consumer or authorized representative shall be notified, verbally and in writing, of the agency’s intent to discharge and the reasons for the discharge. (E) An HCA shall notify the Department before it initiates discharge of any consumer who requires and desires continuing paid care or services where there are no known transfer arrangements to protect the consumer’s health, safety, or welfare. The consumer or authorized representative shall be notified, verbally and in writing, of the agency’s intent to discharge and the reasons for the discharge. (E) An HCA shall notify the Department before it initiates discharge of any consumer who requires and desires continuing paid care or services where there are no known transfer arrangements to protect the consumer’s health, safety, or welfare. (1) Emergency discharges necessary to protect the safety and welfare of staff shall be reported to the Department within forty-eight (48) hours of the occurrence. 5.6 Disclosure Notices (A) Agency Disclosure Notice (1) Within one (1) business day of the start of services, the HCA shall provide a written disclosure notice to the consumer or authorized representative that specifies the service provided by the HCA and the consumer’s obligation regarding the home care worker. (2) The disclosure notice, in the form and manner prescribed by the Department, shall be signed by the consumer or authorized representative and shall include information as to who is responsible for the following items: (a) Employment of the home care worker; (b) Liability for the home care worker while in the consumer’s home; (c) Payment of wages to the home care worker; (d) Payment of employment and social security taxes; (e) Payment of unemployment, worker’s compensation, general liability insurance, and, if provided, bond insurance; (f) Supervision of the home care worker; (g) Scheduling of the home care worker; (h) Assignment of duties to the home care worker; (i) Hiring, firing, and discipline of the home care worker; (j) Provision of materials or supplies for the home care worker's use in providing services to the consumer; and CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 20 the home care worker; (g) Scheduling of the home care worker; (h) Assignment of duties to the home care worker; (i) Hiring, firing, and discipline of the home care worker; (j) Provision of materials or supplies for the home care worker's use in providing services to the consumer; and CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 20 (k) Training and ensuring qualifications that meet the needs of the consumer. (3) Within one (1) business day of the start of services, the HCA shall ensure that the consumer or authorized representative acknowledges the disclosure notice. (a) In the event the consumer refuses to acknowledge the disclosure notice in writing, the HCA will document the conveyance of information verbally to the consumer or authorized representative. (B) Notice of Consumer Rights (1) Within one (1) business day of the start of services, the HCA shall provide the consumer or authorized representative with a notice of the consumer’s rights, in the form and manner prescribed by the Department and in a manner that the consumer understands. (2) The notice shall include information about the consumer’s options if rights are violated, including how to contact an individual employed with the HCA who is responsible for the complaint intake and problem resolution process. (C) Within one (1) business day of the start of services, the HCA shall inform the consumer concerning the agency’s policies on advance directives, including a description of applicable state law. The HCA may furnish advance directives information to a consumer at the time of the first home visit, as long as the information is furnished before care is provided. (D) Within one (1) business day of the start of services, the HCA shall inform the consumer or authorized representative, orally and in writing, of the extent to which payment for the HCA services may be expected from insurance or other sources and the extent to which payment may be required from the consumer of the first home visit, as long as the information is furnished before care is provided. (D) Within one (1) business day of the start of services, the HCA shall inform the consumer or authorized representative, orally and in writing, of the extent to which payment for the HCA services may be expected from insurance or other sources and the extent to which payment may be required from the consumer. (E) When the HCA accepts the consumer for treatment or care, the HCA shall inform the consumer, in writing, of the telephone number of the home health hotline established by the state, the hours of its operation, and that the purpose of the hotline is to receive complaints or questions about local HCAs. (F) The HCA shall maintain documentation showing that it has complied with the requirements of this section. 5.7 Complaint Processing (A) The HCA shall develop and implement policies to include the following items: (1) Investigation of complaints made by a consumer or others about services or care that are or are not furnished or about the lack of respect for the consumer's person or property by anyone furnishing services on behalf of the HCA. (2) Documentation of the existence, the investigation, and the resolution of the complaint. (a) The agency shall notify the complainant of the results of the investigation and the agency’s plan to resolve any issue identified. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 21 (3) Incorporation of the substantiated findings into the HCA’s quality assurance program in order to evaluate and implement systemic changes, where needed. (4) An explicit statement that the HCA does not discriminate or retaliate against consumers for expressing a complaint or multiple complaints. (5) Maintenance of a separate written or electronic record/log/file detailing all activity regarding complaints received and their investigation and resolution thereof. ity assurance program in order to evaluate and implement systemic changes, where needed. (4) An explicit statement that the HCA does not discriminate or retaliate against consumers for expressing a complaint or multiple complaints. (5) Maintenance of a separate written or electronic record/log/file detailing all activity regarding complaints received and their investigation and resolution thereof. (a) The record shall be maintained for at least a two (2) year period of time and shall be available for audit and inspection purposes. 5.8 Agency Reporting Requirements (A) The provisions of 6 CCR 1011-1, Chapter 2, Part 4.2, regarding occurrence reporting requirements shall apply to all HCAs and home care placement agencies. (B) The HCA shall develop and implement policies and procedures regarding the investigation of reportable occurrences and any alleged incidents involving neglect, abuse, or personnel misconduct, including but not limited to: (1) The timely investigation of all alleged incidents involving neglect, abuse, or personnel misconduct. (2) The investigation of each reportable occurrence and appropriate measures instituted to prevent similar future occurrences. (a) A report with the investigation findings shall be available for review by the Department within five (5) working days of the occurrence. (3) Administrative procedures to be implemented to protect the HCA's consumers during the investigation process. (4) Documentation regarding the investigation, including the appropriate measures to be instituted, that shall be made available to the Department, upon request. (C) Nothing in this Part 5.8 shall be construed to limit or modify any statutory or common-law right, privilege, confidentiality, or immunity. (D) Mandatory Reporting (1) HCA personnel engaged in the care or treatment of at-risk persons shall report suspected physical or sexual abuse, exploitation, and/or caretaker neglect to law enforcement within twenty-four (24) hours of observation or discovery pursuant to Section 18-6.5-108, C.R.S. nstrued to limit or modify any statutory or common-law right, privilege, confidentiality, or immunity. (D) Mandatory Reporting (1) HCA personnel engaged in the care or treatment of at-risk persons shall report suspected physical or sexual abuse, exploitation, and/or caretaker neglect to law enforcement within twenty-four (24) hours of observation or discovery pursuant to Section 18-6.5-108, C.R.S. (2) HCA personnel engaged in the care or treatment of children shall report suspected abuse or neglect to the county department, local law enforcement, or to the child abuse reporting hotline pursuant to Section 19-3-304 and 307, C.R.S. (3) The HCA shall ensure all personnel have knowledge of these requirements. (4) The HCA shall report the incident to the Department as an occurrence, if applicable. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 22 5.9 Personnel (A) Policies (1) The HCA shall define the required competence, qualifications, and experience of personnel in each program or service it provides. (2) The HCA shall ensure that all personnel have access to and are knowledgeable about the HCA’s policies and procedures. (B) Records (1) Personnel records shall include references, dates of employment and separation from the HCA, and the reason for separation. (2) Personnel records shall include, at a minimum: (a) Qualifications and licensure that are kept current; (i) Qualifications include confirmation of type and depth of experience, advanced skills, training, and education; appropriate, detailed, and observed competency evaluation; and written testing overseen by a person with the same or higher validated qualifications; (b) Orientation to the agency; (c) Job descriptions for all positions assigned by the agency; and and licensure that are kept current; (i) Qualifications include confirmation of type and depth of experience, advanced skills, training, and education; appropriate, detailed, and observed competency evaluation; and written testing overseen by a person with the same or higher validated qualifications; (b) Orientation to the agency; (c) Job descriptions for all positions assigned by the agency; and (d) Annual performance evaluation for each employee. (C) Criminal History Record checks (1) The HCA shall require any individual seeking employment with the agency to submit to a criminal history record check to ascertain whether the individual seeking employment has been convicted of a felony or misdemeanor, which felony or misdemeanor involves conduct that the agency determines could pose a risk to the health, safety, or welfare of home care consumers. (2) The criminal history record check shall, at a minimum, include a search of criminal history in the State of Colorado and be conducted not more than ninety (90) days prior to employment of the individual. (3) The cost of such inquiry shall be paid by either the HCA or the individual seeking employment. (4) In assessing whether to employ an applicant with a felony or misdemeanor conviction, the HCA shall consider the following factors: (a) The history of convictions or pleas of guilty or no contest; (b) The nature and seriousness of the crimes; (c) The time that has elapsed since the conviction(s); CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 23 (d) Whether there are any mitigating circumstances; and anor conviction, the HCA shall consider the following factors: (a) The history of convictions or pleas of guilty or no contest; (b) The nature and seriousness of the crimes; (c) The time that has elapsed since the conviction(s); CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 23 (d) Whether there are any mitigating circumstances; and (e) The nature of the position for which the applicant would be employed. (5) The HCA shall develop and implement policies and procedures regarding the employment of any individual who is convicted of a felony or misdemeanor to ensure that the individual does not pose a risk to the health, safety, and welfare of the consumer. (D) Before employing any individual to provide direct consumer care or services, the HCA must show compliance with the Colorado Adult Protective Services Data System (CAPS Check) requirements as set forth in Section 26-3.1-111, C.R.S., and 6 CCR 1011-1, Chapter 2, Part 2.3.6. (E) Before employing any individual to provide direct consumer care or services, the agency shall contact the DORA to verify whether a license, registration, or certification exists and is in good standing. A copy of the inquiry shall be placed in the individual’s personnel file. (F) Contracted Personnel (1) If contracted personnel are used by the HCA, the HCA shall have a written contract with such personnel that specifies the following: (a) That consumers are accepted for care only by the primary HCA; (b) The specific services to be furnished; (c) The necessity to conform to all applicable agency policies, including personnel qualifications; (d) The responsibility for participating in developing plans of care or service; (e) The manner in which services will be controlled, coordinated, and evaluated by the primary HCA; (f) The procedures for submitting clinical/service notes, scheduling of visits, and periodic consumer evaluation; and ; (c) The necessity to conform to all applicable agency policies, including personnel qualifications; (d) The responsibility for participating in developing plans of care or service; (e) The manner in which services will be controlled, coordinated, and evaluated by the primary HCA; (f) The procedures for submitting clinical/service notes, scheduling of visits, and periodic consumer evaluation; and (g) The procedures for payment for services furnished under the contract. (2) Personnel policies shall be available to all contracted personnel. 5.10 Emergency Preparedness (A) The HCA shall conduct a risk assessment of the hazards or potential emergency situations the HCA could encounter. (1) This assessment shall address, but not be limited to, the following considerations: (a) Geographical location of the HCA, any branch offices and workstations, and its consumers; (b) Needs of the HCA’s consumer population; and CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 24 (c) Potential natural and human-made crises that impact the HCA’s ability to operate, including but not limited to: extreme weather, fire, power or internet/communication outages, threatened or actual acts of violence, and pandemic or disease outbreak events. (2) The assessment shall be documented. (3) The assessment shall be reviewed at least annually and updated as necessary. (B) The HCA shall develop a written emergency preparedness plan, based on the results of the assessment required in Part 5.10(A), that is designed to manage consumers’ care and services. The HCA shall implement the plan in response to the consequences of natural disasters or other emergencies that disrupt the HCA’s ability to provide care and services or threaten the lives or safety of its consumers. (C) The emergency preparedness plan shall be reviewed at least annually or after any emergency response and shall be updated as necessary igned to manage consumers’ care and services. The HCA shall implement the plan in response to the consequences of natural disasters or other emergencies that disrupt the HCA’s ability to provide care and services or threaten the lives or safety of its consumers. (C) The emergency preparedness plan shall be reviewed at least annually or after any emergency response and shall be updated as necessary. (D) Personnel shall be trained on the emergency preparedness plan upon hire and at least annually or when any changes in the emergency preparedness process, procedures, or responsibilities are made. (E) At a minimum, the emergency preparedness plan shall include the following: (1) Strategies for addressing emergency situations identified by the risk assessment; (2) Identification of personnel responsible for responding to emergency situations and implementing the plan; (3) Procedures to contact personnel and consumers impacted by an emergency; (4) A mechanism for assessing and triaging the needs of its consumers to ensure continuation of necessary care for all consumers during an emergency. The HCA shall continually assess the status of its consumers to ensure they are triaged appropriately based on needs; (5) Strategies for continuing to provide consumer services when there are interruptions in the supply of essentials, including but not limited to: water, pharmaceuticals, and personal protective equipment (PPE); (6) Education for consumers, caregivers, and families on how to handle care and treatment, safety, and/or well-being during and following instances of natural and other disasters, including strategies and resources for ensuring access to life sustaining supplies, appropriate to the needs of the consumer; (7) Strategies to protect and transfer consumer records, if necessary; and ve equipment (PPE); (6) Education for consumers, caregivers, and families on how to handle care and treatment, safety, and/or well-being during and following instances of natural and other disasters, including strategies and resources for ensuring access to life sustaining supplies, appropriate to the needs of the consumer; (7) Strategies to protect and transfer consumer records, if necessary; and (8) Strategies for continuing consumer care in the event the HCA is unable to access consumer records. 5.11 Coordination with External Home Care Agencies (A) Each HCA shall be responsible for the coordination of consumer services with known external HCAs providing care and services to the same consumer. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 25 (1) No HCA shall refuse to share consumer care information unless the consumer has chosen to refuse coordination with external HCAs. (2) The consumer’s refusal of such coordination shall be documented in the consumer’s record. 5.12 Quality Management Program Every HCA shall establish a quality management program appropriate to the size and type of agency that evaluates the quality of consumer services, care, and safety, and that complies with the requirements set forth in 6 CCR 1011, Chapter 2, Part 4.1. 5.13 Infection Prevention and Control (A) The HCA shall provide training for its personnel regarding the agency’s written infection prevention and control policies and procedures at the time of hire and at least annually. (B) The HCA shall evaluate the adequacy of its infection prevention and control policies and procedures at least annually, make any necessary substantive changes, and document such changes in writing or electronically. (C) Personnel Health – Communicable Disease Prevention (1) It shall be the responsibility of the HCA to establish written policies concerning pre-employment physical evaluations and personnel health. Those policies shall include, but not be limited to: control policies and procedures at least annually, make any necessary substantive changes, and document such changes in writing or electronically. (C) Personnel Health – Communicable Disease Prevention (1) It shall be the responsibility of the HCA to establish written policies concerning pre-employment physical evaluations and personnel health. Those policies shall include, but not be limited to: (a) Work restrictions to be placed on direct care personnel who are known to be affected with any illness in a communicable stage or to be a carrier of a communicable illness or disease. 5.14 Missed Visits (A) The HCA shall have a mechanism for informing the consumer about scheduled visits in accordance with HCA policy. Documentation shall be maintained and alterations in the schedule shall be provided to the consumer in advance of any changes to the schedule, where possible. (1) The HCA’s policy shall address processes for HCA planning for coverage of personnel illness, vacation, holidays, and unexpected voluntary or involuntary termination of employment. (2) If the consumer does not respond to let personnel in the home for the scheduled visit, the HCA’s attempts to ensure the safety of the consumer and the outcome of each attempt shall be documented. (3) If there is a missed visit, services missed shall be provided as agreed upon by the consumer and the HCA. (4) If the HCA admits consumers with needs that require care or services to be delivered at specific times or parts of day, the HCA shall ensure qualified personnel in sufficient quantity are employed by the agency or have other effective back-up plans to ensure the needs of the consumer are met. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 26 A admits consumers with needs that require care or services to be delivered at specific times or parts of day, the HCA shall ensure qualified personnel in sufficient quantity are employed by the agency or have other effective back-up plans to ensure the needs of the consumer are met. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 26 (5) The back-up plan for scheduled services that cannot be delivered shall not include calling for an ambulance or other emergency services unless emergency services would have been warranted even if the scheduled personnel had been in the home and had delivered services. 5.15 Information Management System (A) Each HCA shall implement a policy and procedure for an effective information management system that is either paper-based or electronic. Processes shall include effective management for capturing, reporting, processing, storing, and retrieving clinical/service data and information in accordance with standards of practice. The system shall provide for: (1) Privacy and confidentiality of protected health information from unauthorized use or manipulation; and (2) Organization of the consumer record utilizing standardized formats for documenting all care, treatment, and services provided to consumers according to HCA policy. Standardization shall not include pre-filled documentation of future care and services. (B) In addition, for electronic consumer records, policies and procedures shall be developed and implemented to ensure: (1) A method for validating data entry access and changes to previously entered data; and (2) Recovery of records, including contingency plans for operational interruptions (hardware, software, or other systems failures), an emergency service plan, and a back-up system for retrieval of data from storage and information in the operating system. (C) Content of Consumer Records (1) All HCAs shall have a complete and accurate record for each consumer assessed, cared for, treated, or served. 2) Recovery of records, including contingency plans for operational interruptions (hardware, software, or other systems failures), an emergency service plan, and a back-up system for retrieval of data from storage and information in the operating system. (C) Content of Consumer Records (1) All HCAs shall have a complete and accurate record for each consumer assessed, cared for, treated, or served. (2) The record shall contain sufficient information to identify the consumer; support the diagnosis or condition; justify the care, treatment, and/or services delivered; and promote continuity of care internally and externally, where applicable. (3) Records shall contain consumer-specific information as appropriate to the care, treatment, or services provided, including but not limited to: (a) Records of communications with the consumer or authorized representative regarding care, treatment, and services, including documentation of phone calls and e-mails; and (b) Referrals to and names of known home care agencies, individuals, and organizations involved in the consumer’s care. (4) The record shall indicate if the service or visit was provided in person or via telehealth. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 27 (5) Clinical records for HCAs providing skilled home health services shall contain, where applicable: (a) Hospital and emergency room records for known episodes or documentation of efforts to obtain the information; (b) Medical equipment provided by the HCA or related to the care, treatment, and services provided, including assessment of consumer and family comprehension of appropriate use and maintenance; (c) Consumer and family education and training on services or treatments, and the use of equipment at the time of delivery to the home; (d) Safety measures taken to protect the consumer from harm, including fall risk assessments, and documentation why any identified or planned safety measures were not implemented or continued; and nsumer and family comprehension of appropriate use and maintenance; (c) Consumer and family education and training on services or treatments, and the use of equipment at the time of delivery to the home; (d) Safety measures taken to protect the consumer from harm, including fall risk assessments, and documentation why any identified or planned safety measures were not implemented or continued; and (e) Diagnostic and therapeutic procedures, treatments, tests, and their results. (D) Consumer records must be retained for five (5) years after the discharge of the consumer, unless state law requires a longer period of time. (1) The HCA’s policies shall provide for retention of consumer records even if it discontinues operation. (a) When an HCA permanently discontinues operation, it shall comply with the requirements of 6 CCR 1011-1, Chapter 2, Part 2.14.4. (b) When an HCA discontinues operation, it shall inform the state agency of where clinical records will be maintained. (2) A change of ownership does not constitute discontinuing operation. (3) When an HCA has a change of ownership, the existing owner shall provide the new owner with all consumer records. PART 6. SKILLED CARE 6.1 Governing Body (A) An HCA shall have an organized governing body consisting of members who singularly or collectively have business and healthcare experience sufficient to oversee the services provided by the HCA. (B) The governing body shall assume responsibility for: (1) Compliance with all federal, state, and local laws and regulations. (2) Quality consumer care, including annual review and approval of the HCA's Quality Management Plan. (3) Development of policies and procedures which describe and direct functions or services of the HCA and protect consumer rights. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 28 (4) Development of bylaws or governing document that shall include, at a minimum: luding annual review and approval of the HCA's Quality Management Plan. (3) Development of policies and procedures which describe and direct functions or services of the HCA and protect consumer rights. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 28 (4) Development of bylaws or governing document that shall include, at a minimum: (a) A description of functions and duties of the governing body, officers, and committees, including a process for review of agency operations at least annually; (b) A statement of the authority and responsibility delegated to the administrator; and (c) A requirement to meet at least annually. (5) Development of a policy and procedure for determining the qualifications of the administrator. Appointment of a qualified administrator, responsible for the HCA’s overall functions, shall be documented in writing. (6) Review of the written agency evaluation report and other communications from the administrator or group of professional personnel with evidence of written response. (7) Establishing and ensuring the maintenance of a system of financial management and accountability. (8) Organizing services furnished, administrative control, and lines of authority for the delegation of responsibility down to the consumer care level, that are clearly set forth in writing and are readily identifiable. (9) Documentation of governing body meetings and activities. 6.2 Administration (A) The HCA, under the direction of the governing body, shall be responsible for preparation of an overall plan and a budget that includes an annual operating budget and capital expenditure plan, as applicable. sibility down to the consumer care level, that are clearly set forth in writing and are readily identifiable. (9) Documentation of governing body meetings and activities. 6.2 Administration (A) The HCA, under the direction of the governing body, shall be responsible for preparation of an overall plan and a budget that includes an annual operating budget and capital expenditure plan, as applicable. (1) The governing body shall review and update the overall plan and budget at least annually. (B) Any HCA that performs procedures in the consumer’s residence that are considered waivered clinical laboratory procedures under the Clinical Laboratory Improvement Act of 1988 shall possess a certificate of waiver from the Centers for Medicare and Medicaid Services or its designated agency. (C) Any HCA that provides equipment to consumers shall develop and implement policies and procedures for the management of medical equipment provided for use in consumer homes, including: selection, acquisition, delivery, and maintenance of the equipment. (1) The HCA shall make full disclosure of the policies and procedures to all consumers before the equipment is provided. (2) The policies and procedures shall include the following: (a) A process to provide an appropriate back-up system, including emergency services twenty-four (24) hours per day where the malfunction may threaten the consumer’s life; CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 29 (b) Monitoring and acting upon equipment hazard notices and recalls; (c) Checking equipment upon delivery to the consumer to ensure it is sanitary, undamaged, and operating properly; (d) Basic safety and operational checks on infusion pumps that include a volumetric test of accuracy of infusion rate between each consumer use; and ter 26 Health Facilities and Emergency Medical Services Division 29 (b) Monitoring and acting upon equipment hazard notices and recalls; (c) Checking equipment upon delivery to the consumer to ensure it is sanitary, undamaged, and operating properly; (d) Basic safety and operational checks on infusion pumps that include a volumetric test of accuracy of infusion rate between each consumer use; and (e) Performance of routine and preventive maintenance conducted at defined intervals per manufacturer’s guidelines. (D) Availability After Business Hours (1) The HCA shall have a registered nurse or other appropriate health professional available after business hours. (2) The HCA shall have a policy describing, at a minimum, the following: (a) How consumers will contact the agency after hours; and (b) How the agency will ensure the health professional on call has access to all current consumer information. 6.3 Agency Evaluation (A) The HCA's governing body or its designee shall conduct a comprehensive evaluation of the HCA's total operation at least annually. (B) The evaluation shall assure the appropriateness and quality of the HCA’s services with findings used to verify policy implementation, to identify problems, and to establish problem resolution and policy revision as necessary. (C) The evaluation shall consist of an overall policy and administration review, including the scope of services offered, arrangements for services with other agencies or individuals, admission and discharge policies, supervision and plan of care, emergency care, service records, and personnel qualifications. (1) The HCA shall implement an on-going mechanism for consumer involvement to provide input and comment regarding services provided by the HCA in accordance with HCA policy. Consumer input and commentary shall be provided to the governing body at least annually to identify trends or issues requiring consideration. (D) In evaluating each aspect of its total program, the HCA shall consider four (4) main criteria: all implement an on-going mechanism for consumer involvement to provide input and comment regarding services provided by the HCA in accordance with HCA policy. Consumer input and commentary shall be provided to the governing body at least annually to identify trends or issues requiring consideration. (D) In evaluating each aspect of its total program, the HCA shall consider four (4) main criteria: (1) Appropriateness - assurance that the area being evaluated addresses existing and/or potential problems. (2) Adequacy - a determination as to whether the HCA has the capacity to overcome or minimize existing or potential problems. (3) Effectiveness - the services offered accomplish the objectives of the HCA and anticipated consumer outcomes. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 30 (4) Efficiency - whether there is a minimal expenditure of resources by the HCA to achieve desired goals and anticipated consumer outcomes. (E) Documentation of the annual evaluation shall include the names and titles of the persons carrying out the evaluation, the criteria and methods used to accomplish it, and any action taken by the HCA as a result of its findings. (F) Appropriate professionals representing the scope of the HCA’s program shall evaluate the HCA's consumer records at least quarterly. (1) The evaluation shall include a review of sample active and closed consumer records to ensure that HCA policies are followed in providing services, both directly and under arrangement, and to assure that the quality of service is satisfactory and appropriate. The review shall consist of a representative sample of all home care services provided by the HCA. 6.4 Administrator (A) The administrator shall assume authority for the operation of the HCA’s skilled health services, including but not limited to: (1) Organizing and directing the HCA’s ongoing functions; under arrangement, and to assure that the quality of service is satisfactory and appropriate. The review shall consist of a representative sample of all home care services provided by the HCA. 6.4 Administrator (A) The administrator shall assume authority for the operation of the HCA’s skilled health services, including but not limited to: (1) Organizing and directing the HCA’s ongoing functions; (2) Employing qualified personnel and ensuring appropriate ongoing education and supervision of all personnel; (3) Ensuring the accuracy of public information materials and activities; (4) Implementing a budgeting and accounting system; and (5) Designating in writing a qualified alternate administrator to act in the administrator’s absence. (B) The administrator shall: (1) Be at least twenty-one (21) years of age; (2) Be a licensed physician, registered nurse, or other licensed healthcare professional, or have experience and education in health service administration; (3) Be qualified by education, knowledge, and experience to oversee the services provided; and (4) Have at least two (2) years healthcare or health service administration experience with at least one (1) year of supervisory experience in home care or a closely related health program. (C) The administrator shall have the overall responsibility to ensure the following: (1) The HCA’s skilled health services are in compliance with all applicable federal, state, and local laws; (2) The completion, maintenance, and submission of such reports and records as required by the Department; CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 31 (3) Ongoing liaison with the governing body, personnel, and the community; (4) Maintenance of a current organizational chart to show lines of authority down to the consumer level; (5) The management of the business affairs and the overall operation of the HCA; ired by the Department; CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 31 (3) Ongoing liaison with the governing body, personnel, and the community; (4) Maintenance of a current organizational chart to show lines of authority down to the consumer level; (5) The management of the business affairs and the overall operation of the HCA; (6) Maintenance of appropriate personnel, financial, and administrative records and all policies and procedures of the agency; (7) Employment of qualified personnel in accordance with written job descriptions; (8) Orientation of new personnel, and regularly scheduled in-service education programs and opportunities for continuing education are provided for the personnel; (9) Availability of the administrator or designee at all hours personnel are providing services, at minimum, any eight (8) hour period between 7 a.m. and 7 p.m. Monday through Friday; (10) Marketing, advertising, and promotional information accurately represents the HCA and addresses the care, treatment, and services that the HCA can provide directly or through contractual arrangement; and (11) Maintenance of a coordinated HCA-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HCA’s quality management program. (D) Curriculum for administrator training (1) A first-time administrator or alternate administrator shall complete a total of twenty-four (24) clock hours of training in the administration of an HCA before the end of the first twelve (12) months after designation to the position. (2) A first-time administrator or alternate administrator shall complete eight (8) clock hours of educational training in the administration of an HCA within the first month of employment. The eight (8) clock hours shall include, at a minimum, the following topics: (a) Home care overview; (b) Information on the licensing standards for the HCA; and lve (12) months after designation to the position. (2) A first-time administrator or alternate administrator shall complete eight (8) clock hours of educational training in the administration of an HCA within the first month of employment. The eight (8) clock hours shall include, at a minimum, the following topics: (a) Home care overview; (b) Information on the licensing standards for the HCA; and (c) Information on state and local laws applicable to the HCA. (3) A first-time administrator or alternate administrator shall complete an additional sixteen (16) clock hours of educational training before the end of the first twelve (12) months after designation to the position. Any of the sixteen (16) clock hours may be completed prior to designation if completed during the twelve (12) months immediately preceding the date of designation to the position. The additional sixteen (16) clock hours shall include the following subjects and may include other topics related to the duties of an administrator: CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 32 (a) Consumer rights, governing body and administrator responsibilities, quality management plans, occurrence reporting, and complaint investigation and resolution process; (b) Personnel qualifications, experience, competency, and evaluations; (c) Financial management; (d) Ethics in healthcare; (e) Needs of the fragile, ill, and physically and cognitively disabled in the community setting with special training and staffing considerations; (f) Behavior management techniques; (g) Staffing methodologies and oversight of scheduling; (h) Staff training and supervision; and b) Personnel qualifications, experience, competency, and evaluations; (c) Financial management; (d) Ethics in healthcare; (e) Needs of the fragile, ill, and physically and cognitively disabled in the community setting with special training and staffing considerations; (f) Behavior management techniques; (g) Staffing methodologies and oversight of scheduling; (h) Staff training and supervision; and (i) Limitations of personal care versus health care services. (4) The twenty-four (24) clock hour education requirement shall be met through structured, formalized classes, correspondence courses, competency-based computer courses, training videos, distance learning programs, or other training courses. Subject matter that deals with the internal affairs of an organization does not qualify for credit. The training shall be provided or produced by an academic institution, a recognized state or national organization or association, an independent contractor, or an HCA. (a) If an HCA or independent contractor provides or produces training, the training shall first be approved by the Department or recognized by a national organization or association. The HCA shall maintain documentation of this approval for review by inspectors. (5) Documentation of administrator or alternate administrator training must be on file at the HCA and contain the name of the class or workshop, the course content or curriculum, the hours and dates of the training, and the name and contact information of the entity and trainer who provided the training. (6) After completion of the twenty-four (24) clock hours of educational training within the first twelve (12) months after designation as a first-time administrator or alternate administrator, each must then complete the continuing education requirements in each subsequent twelve (12)-month period after designation. name and contact information of the entity and trainer who provided the training. (6) After completion of the twenty-four (24) clock hours of educational training within the first twelve (12) months after designation as a first-time administrator or alternate administrator, each must then complete the continuing education requirements in each subsequent twelve (12)-month period after designation. (7) An administrator shall complete twelve (12) clock hours of continuing education within each twelve (12)-month period beginning with the date of designation. The education shall include at least two (2) of the following topics and may include other topics related to the duties of the administrator. (a) Any of the topics listed under the initial training requirements; (b) Development and implementation of agency policies; (c) Healthcare management; CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 33 (d) Ethics; (e) Quality improvement; (f) Risk assessment and management; (g) Financial management; (h) Skills for working with consumers, families, and other professional service providers, including considerations for special populations served by the HCA; (i) Community resources; and (j) Marketing. (8) For an administrator or alternate administrator who has not served as an administrator for 180 days or more immediately preceding the date of designation, at least eight (8) of the twelve (12) clock hours within the first twelve rs, families, and other professional service providers, including considerations for special populations served by the HCA; (i) Community resources; and (j) Marketing. (8) For an administrator or alternate administrator who has not served as an administrator for 180 days or more immediately preceding the date of designation, at least eight (8) of the twelve (12) clock hours within the first twelve (12) months after designation shall include the topics listed for first time administrators. The remaining four (4) clock hours shall include topics related to the duties of the administrator and include at least two (2) of the topics listed under continuing education. If a previous administrator has not been employed as such for two (2) years or more, the requirements for a first time administrator apply. 6.5 Nursing or Healthcare Supervisor (A) The skilled nursing services furnished shall be under the supervision and direction of a physician or registered nurse who has at least two (2) years of nursing experience including one (1) year in home care or a closely related service. (1) Other healthcare services shall be under the supervision and direction of a physician, registered nurse, or other licensed healthcare professional who has at least two (2) years of healthcare experience in the field of supervision including one (1) year of experience in home care or a closely related service. (B) The nursing or healthcare supervisor, or similarly qualified alternate, shall be available at all times during operating hours and participate in all activities relevant to the professional services furnished, including the development of qualifications and the assignment of personnel. (C) The nursing or healthcare supervisor shall ensure oversight of all consumer care services and personnel, including but not limited to: (1) Making consumer and personnel assignments; (2) Coordinating consumer care; (3) Coordinating referrals; (4) Assuring that consumer needs are continually assessed; and ces furnished, including the development of qualifications and the assignment of personnel. (C) The nursing or healthcare supervisor shall ensure oversight of all consumer care services and personnel, including but not limited to: (1) Making consumer and personnel assignments; (2) Coordinating consumer care; (3) Coordinating referrals; (4) Assuring that consumer needs are continually assessed; and (5) Assuring the development, implementation, and updates of the individualized plan of care. CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 34 6.6 Personnel (A) All personnel shall possess the education and experience to provide services in the homes of consumers in accordance with HCA policy, state practice acts, and professional standards of practice as set forth in this chapter. (B) Licensed, certified, and/or registered personnel shall have an active license, certification, or registration, issued by DORA with no restriction that would affect the ability to perform required duties, and shall provide services within their scope of practice. (C) Personnel not licensed, certified, or registered by DORA shall, at a minimum, meet the following requirements: (1) A phlebotomist shall: (a) Have successfully completed an approved phlebotomy training course or equivalent experience through previous employment; and (b) Have two (2) years of verifiable phlebotomy experience. (D) Ongoing training shall be provided to all direct care personnel. Training requirements shall be consistent with the program, services, and equipment the HCA provides and appropriate to the needs of the populations served. (1) Training shall consist of at least twelve (12) topics applicable to the HCA’s care and services every twelve (12) months after the starting date of employment or calendar year as designated by HCA policy. The training requirement shall be prorated in accordance with the number of months the individual was actively working for the agency. and appropriate to the needs of the populations served. (1) Training shall consist of at least twelve (12) topics applicable to the HCA’s care and services every twelve (12) months after the starting date of employment or calendar year as designated by HCA policy. The training requirement shall be prorated in accordance with the number of months the individual was actively working for the agency. (2) Training shall include, but not be limited to, the following items: (a) Promoting consumer dignity, independence, self-determination, privacy, choice, and rights; including abuse and neglect prevention and reporting requirements; (b) Behavior management techniques; (c) Disaster and emergency procedures; and (d) Infection prevention and control. (3) All training shall be documented by the HCA. (a) Documentation of training shall include: the date of training; length of training; entity or instructor(s) that offered or produced the training; a short description of the content; and staff member's written or electronic signature or proof of attendance. 6.7 Initial and Comprehensive Assessments (A) Initial assessment visit (1) A registered nurse shall conduct an initial assessment visit to determine the immediate care and support needs of the consumer. The initial assessment visit CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 35 shall be held either within forty-eight (48) hours of referral, or within forty-eight (48) hours of the consumer's return home, or on the ordered start-of-care date. (2) When an alternate professional healthcare service is the only service ordered, the initial assessment visit may be made by the appropriate healthcare professional. (3) The initial assessment visit and comprehensive assessment may be conducted during the same visit. (B) Comprehensive assessment of consumers ty-eight (48) hours of the consumer's return home, or on the ordered start-of-care date. (2) When an alternate professional healthcare service is the only service ordered, the initial assessment visit may be made by the appropriate healthcare professional. (3) The initial assessment visit and comprehensive assessment may be conducted during the same visit. (B) Comprehensive assessment of consumers (1) The HCA shall conduct an individualized comprehensive assessment that accurately reflects each consumer’s current health status and includes information that may be used to demonstrate the consumer’s progress toward achievement of the desired outcomes. (2) The comprehensive assessment shall identify the consumer’s need for home care and meet the consumer’s medical, nursing, rehabilitative, social, and discharge planning needs. (3) The comprehensive assessment shall be completed in a timely manner, consistent with the consumer's immediate needs, but no later than five (5) calendar days after the start of care. (4) Except as otherwise indicated in this section, a registered nurse shall complete the comprehensive assessment. (5) When healthcare services other than nursing are ordered by the physician or licensed independent practitioner, the primary professional healthcare worker shall complete the comprehensive assessment. (6) When nursing services are provided, the comprehensive assessment shall include a review of all medications the consumer is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. te the comprehensive assessment. (6) When nursing services are provided, the comprehensive assessment shall include a review of all medications the consumer is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. (a) The HCA shall report any concerns to the attending physician or licensed independent practitioner and to the nursing or healthcare supervisor, and these reports shall be acted upon. (7) For consumers receiving intermittent respite and waiver services that are not provided within a continuous sixty (60) day period, a comprehensive assessment shall be accomplished before reinitiating services rather than the minimum time frames set forth below. (8) The comprehensive assessment shall be updated and revised as frequently as the consumer's condition warrants due to a major decline or improvement in the consumer's health status. At a minimum, it shall be updated and revised: (a) Every sixty (60) days beginning with the start-of-care date; and (b) Within forty-eight (48) hours of the consumer's return to the home from a hospital admission of twenty-four (24) hours or more, for any reason CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 36 other than diagnostic tests or, for non-certified agencies, as ordered by the physician or licensed independent practitioner. (C) Provision of skilled services (48) hours of the consumer's return to the home from a hospital admission of twenty-four (24) hours or more, for any reason CODE OF COLORADO REGULATIONS 6 CCR 1011-1 Chapter 26 Health Facilities and Emergency Medical Services Division 36 other than diagnostic tests or, for non-certified agencies, as ordered by the physician or licensed independent practitioner. (C) Provision of skilled services (1) The HCA shall have written policies regarding nurse delegation. The policy shall delineate what tasks or procedures may or may not be delegated, the delegation process, documentation, and how the delegate shall be supervised in accordance with 3 CCR 716-1, Nursing Rules and Regulations. If the HCA prohibits nurse delegation, the HCA shall have a policy that specifies such prohibition. 6.8 Plan of Care (A) Consumer care follow a written plan of care established and periodically reviewed by a physician or licensed independent practitioner. For PACE participants, the interdisciplinary team shall establish, follow, and periodically review the plan of care. (B) The plan of care shall be developed in consultation with the HCA personnel and covers all pertinent diagnoses, including mental status, types of services, identification of any services furnished by other providers, and how those services are coordinated, equipment required, frequency and duration of visits, prognosis, rehabilitation potential, functional limitations, activities permitted, instructions for timely discharge or referral, and any other appropriate items. (1) The plan of care shall identify the consumer’s continuing need for home care and meet the consumer’s medical, nursing, rehabilitative, social, and discharge planning needs. nated, equipment required, frequency and duration of visits, prognosis, rehabilitation potential, functional limitations, activities permitted, instructions for timely discharge or referral, and any other appropriate items. (1) The plan of care shall identify the consumer’s continuing need for home care and meet the consumer’s medical, nursing, rehabilitative, social, and discharge planning needs. (2) The plan of care reflects the participation of the consumer to the extent possible. The HCA communicates the plan of care to the consumer or authorized representative in a comprehensible way. (C) If a physician or licensed independent practitioner refers a consumer under a plan of care that cannot be completed until after an evaluation visit, the attending physician or licensed independent practitioner shall be consulted to approve additions or modifications to the original plan. (D) Orders for therapy services shall include the specific procedures and modalities to be used and the amount, frequency, and duration. The therapist, other HCA personnel, and external home care providers, where applicable, shall participate in developing the plan of care. (E) The plan of care shall be reviewed in its entirety by the attending physician or licensed independent practitioner and HCA personnel as often as the severity of the consumer's condition requires, but at least once every sixty [Text truncated at 120,000 characters. The full text is on the page linked above.] ## Nearby sections - [6 CCR 1011-1 Chapter 22 CHAPTER 22 - BIRTH CENTERS](https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_6_CCR_1011_1_Chapter_22.md) - [6 CCR 1011-1 Chapter 24 CHAPTER 24 - MEDICATION ADMINISTRATION REGULATIONS](https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_6_CCR_1011_1_Chapter_24.md) - [6 CCR 1011-1 Chapter 25 CHAPTER 25 - RURAL PRIMARY CARE HOSPITALS [Repealed eff. 11/01/2004]](https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_6_CCR_1011_1_Chapter_25.md) - [6 CCR 1011-1 Chapter 26 CHAPTER 26 - HOME CARE AGENCIES](https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_6_CCR_1011_1_Chapter_26.md) - [6 CCR 1011-3 STANDARDS FOR COMMUNITY INTEGRATED HEALTH CARE SERVICE AGENCIES](https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_6_CCR_1011_3.md) - [6 CCR 1011-4 STANDARDS FOR SECURE TRANSPORTATION SERVICES](https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_6_CCR_1011_4.md) - [6 CCR 1015-1 EMERGENCY MEDICAL SERVICES ACCOUNT](https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_6_CCR_1015_1.md) - [6 CCR 1015-2 IMPLEMENTATION OF CARDIOPULMONARY RESUSCITATION (CPR) DIRECTIVES BY EMERGENCY MEDICAL SERVICE PROVIDERS](https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_6_CCR_1015_2.md) - [6 CCR 1015-3 EMERGENCY MEDICAL SERVICES](https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_6_CCR_1015_3.md) - [6 CCR 1015-4 STATEWIDE EMERGENCY MEDICAL AND TRAUMA CARE SYSTEM](https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_6_CCR_1015_4.md) --- Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_6_CCR_1011_1_Chapter_26. Check the current official text before relying on it. Not legal advice.