6 Colo. Code Regs. § 1011-1 Chapter 26, pt. 5

Current through Register Vol. 47, No. 16, August 25, 2024

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

(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.

(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.

(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

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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

(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.

(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.

(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.

(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.

(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.

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

(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);

(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

(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

(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.

(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

(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.

(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:

(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.

(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) 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.

(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

(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.

6 CCR 1011-1 Chapter 26, pt. 5