CHAPTER 26 - HOME CARE AGENCIES

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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

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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

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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

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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;

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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;

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(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.

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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.

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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

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(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.

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(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.

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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.

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(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.

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(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.

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(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:

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(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.

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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.

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(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.

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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.

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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.

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(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.

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(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.

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(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.

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(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

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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

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(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.

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(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.

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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);

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(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);

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(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

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(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.

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(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.

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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.

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(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.

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(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.

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(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.

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(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;

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(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

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(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.

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(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;

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(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;

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(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:

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(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;

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(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.

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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

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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

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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

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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 (60) days or more frequently when there

is a significant change in condition.

nal 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 (60) days or more frequently when there

is a significant change in condition.

(1)

For consumers receiving intermittent respite and waiver services that are not

provided within a continuous sixty (60) day period, the time frame for review

begins upon the re-initiation of care.

(F)

Licensed HCA personnel shall promptly alert the physician or licensed independent

practitioner to any changes that suggest a need to alter the plan of care.

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(G)

If person-to-person contact with the physician or licensed independent practitioner or

their designated representative was not completed or if awaiting a return response, all

contacts and interactions shall be documented. The HCA shall have a written policy

regarding how the HCA will intervene if the attending physician or licensed independent

practitioner cannot be contacted or does not respond in a timely manner.

(H)

All orders shall contain sufficient information to carry out the order, name of the physician

or licensed independent practitioner, and, if appropriate, representative conferring the

order to the HCA.

(I)

Any program or service offered by the HCA, directly or under arrangement, shall be

provided in accordance with the plan of care and HCA policy and procedure.

6.9

Medication Management

(A)

If the plan of care includes medication administration, medication management, or

medication set-up, there shall be documentation in the consumer record as to who is

responsible to monitor the medication supply, order refills, and ensure the timely delivery

of medications

arrangement, shall be

provided in accordance with the plan of care and HCA policy and procedure.

6.9

Medication Management

(A)

If the plan of care includes medication administration, medication management, or

medication set-up, there shall be documentation in the consumer record as to who is

responsible to monitor the medication supply, order refills, and ensure the timely delivery

of medications. There shall be evidence that the plan has been developed with input from

the consumer or authorized representative.

(1)

Medication review shall be documented when new medications are prescribed.

(2)

Medication review shall be documented periodically throughout the episode of

care to determine if the consumer has added or eliminated medications or herbal

products from the medication regime.

(B)

Drugs and treatments shall be administered by HCA personnel only as ordered by the

physician or licensed independent practitioner and in accordance with professional

standards of practice.

(1)

Vaccines may be administered per HCA policy, developed in consultation with a

physician and after an assessment for contraindications.

(2)

For consumers receiving medication administration services, a current

medication administration record shall be maintained as part of the consumer

record.

(3)

The personnel administering medication(s) shall monitor for effectiveness,

interactions, and adverse effects.

(C)

If controlled drugs are being administered by the HCA, there shall be a policy regarding

how the drugs will be administered and monitored.

rs receiving medication administration services, a current

medication administration record shall be maintained as part of the consumer

record.

(3)

The personnel administering medication(s) shall monitor for effectiveness,

interactions, and adverse effects.

(C)

If controlled drugs are being administered by the HCA, there shall be a policy regarding

how the drugs will be administered and monitored.

(1)

HCAs shall have a written policy stating how controlled drugs will be monitored if

HCA personnel transport the drugs from the pharmacy to the consumer.

6.10

Care Coordination

(A)

Care coordination shall be demonstrated for each consumer at least every sixty (60) days

for cases where there is more than one (1) agency sharing the provision of the same

home health services. The minutes of these case conferences shall reflect discussion

and input by all the disciplines providing care to the consumer.

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(B)

The HCA shall be responsible for the coordination of consumer services both with

internal personnel and known external services providing care and services to the same

consumer.

(C)

All personnel providing care on behalf of the HCA shall maintain communication to

ensure that their efforts are coordinated effectively and support the objectives outlined in

the plan of care and as delineated through outside home care services.

(D)

The clinical record, care coordination notes, or minutes of case conferences establish

that effective interchange, reporting, and coordination of consumer care do occur.

(E)

The HCA shall prepare a written summary report which shall be sent to the attending

primary care provider every sixty (60) days. This report is only required for consumers

who experienced a change in status or needs that necessitated a change in the plan of

care during the sixty (60)-day period

erences establish

that effective interchange, reporting, and coordination of consumer care do occur.

(E)

The HCA shall prepare a written summary report which shall be sent to the attending

primary care provider every sixty (60) days. This report is only required for consumers

who experienced a change in status or needs that necessitated a change in the plan of

care during the sixty (60)-day period.

6.11

Extended Care

(A)

Extended care is defined as a total of six (6) or more hours of home health services

provided in a twenty-four (24)-hour period by a licensed agency that provides skilled

health services on a continuous basis.

(B)

The HCA shall have a contingency plan regarding how the care is managed if the

scheduled personnel cannot provide care.

(C)

A communication record shall also be available in the home if a consumer is receiving

extended care.

(1)

The record shall contain:

(a)

The current plan of care;

(b)

Notes containing consumer status and continuing needs;

(c)

The medication administration record; and

(d)

Any other information deemed necessary by the HCA.

(2)

If nurse aide service is the only service providing extended care, a home

communication record is not required.

(a)

Written instructions shall be maintained in the home and in the

permanent record.

(D)

The HCA shall have an orientation plan for the personnel providing care to the

consumers. Since extended care cases may involve highly technical services, this plan

shall reflect how the HCA ensures that the individuals providing the extended care are

qualified to provide these types of services.

(E)

Contracting for extended care services

(1)

A licensed HCA may contract with another entity to provide extended care in the

licensed HCA’s service area provided that administration, care, and supervision

down to the consumer care level are ultimately the responsibility of the primary

HCA.

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racting for extended care services

(1)

A licensed HCA may contract with another entity to provide extended care in the

licensed HCA’s service area provided that administration, care, and supervision

down to the consumer care level are ultimately the responsibility of the primary

HCA.

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(2)

The contract shall be in conformance with Part 5.9(F) of this chapter.

(3)

The contracted personnel shall have completed the HCA orientation and

competency evaluation for provisions of care and services for the extended care

consumer.

(a)

Documentation of personnel qualifications, orientation, and competency

evaluation shall be kept at the primary HCA.

(F)

Prior to withdrawing skilled nursing or nurse aide services for an extended care

consumer, the HCA shall:

(1)

Show continuing and documented efforts to resolve conflicts unless the safety of

personnel is placed at immediate risk;

(2)

Provide evidence that ongoing efforts were made to recruit personnel or place

the consumer with another HCA; and

(3)

Give the consumer or authorized representative fifteen (15)-business days' notice

of the intent to discharge the consumer unless staff or consumer safety is at

immediate risk.

(a)

The HCA shall maintain evidence that such notice was delivered in

person or by certified mail.

6.12

Skilled Nursing Services

(A)

The registered nurse shall be responsible for the following:

(1)

Conducting the initial assessment and comprehensive assessment visit;

(2)

Regularly reevaluating the consumer's nursing needs;

(3)

Initiating the plan of care and necessary revisions;

(4)

Furnishing those services requiring substantial and specialized nursing skill;

(5)

Initiating appropriate preventive and rehabilitative nursing procedures;

(6)

Preparing clinical notes, coordinating services, and informing the physician and

other personnel of changes in the consumer's condition and needs;

ng the consumer's nursing needs;

(3)

Initiating the plan of care and necessary revisions;

(4)

Furnishing those services requiring substantial and specialized nursing skill;

(5)

Initiating appropriate preventive and rehabilitative nursing procedures;

(6)

Preparing clinical notes, coordinating services, and informing the physician and

other personnel of changes in the consumer's condition and needs;

(7)

Counseling the consumer and family in meeting nursing and related needs; and

(8)

Participating in in-service programs, supervising, and teaching other nursing

personnel.

(B)

The licensed practical nurse shall be responsible for the following:

(1)

Performing nursing services in accordance with their scope of practice and as

assigned by the physician, licensed independent practitioner, and/or registered

nurse;

(2)

Furnishing services in accordance with HCA policies;

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(3)

Preparing clinical notes; and

(4)

Assisting the consumer in learning appropriate self-care techniques.

6.13

Nurse Aide Services

(A)

The HCA shall select nurse aides on the basis of such factors as the ability to read, write,

carry out directions, effectively communicate to demonstrate competency in the safe and

effective provision of care and services, and treat consumers with dignity and respect to

person and property.

(B)

The HCA shall ensure that each nurse aide it employs is certified by DORA within four (4)

months of starting employment and that certification remains current. Each aide that

provides care and services prior to certification shall be supervised in the home by direct

observation at least weekly for the first month of employment and every two (2) weeks

thereafter until certification is obtained.

(B)

The HCA shall ensure that each nurse aide it employs is certified by DORA within four (4)

months of starting employment and that certification remains current. Each aide that

provides care and services prior to certification shall be supervised in the home by direct

observation at least weekly for the first month of employment and every two (2) weeks

thereafter until certification is obtained.

(1)

HCAs that employ nurse aides awaiting certification shall do so in accordance

with Section 12-255-214, C.R.S.

(C)

The HCA shall complete a competency assessment with direct observation of each nurse

aide before assignment, in accordance with Part 6.13(E) of this chapter.

(D)

For all consumers who are receiving skilled care and need nurse aide services, the

supervising healthcare professional shall, during supervisory visits, accomplish the

following:

(1)

Obtain the consumer’s input, or that of the consumer’s authorized representative,

regarding the nurse aide assignment form, including all tasks to be performed

during each scheduled time period.

(a)

Details such as, but not limited to, housekeeping duties and standby

assistance shall be negotiated and included on the nurse aide

assignment form so that all obligations and expectations are clear.

(b)

The nurse aide assignment form shall contain information regarding

special functional limitations and needs, safety considerations, special

diets, special equipment, and any other information that is pertinent to

the care that will be given by the nurse aide.

(c)

The HCA shall ensure that the consumer or the consumer’s authorized

representative approves and signs the form and is provided a copy at the

beginning of services, and at least annually.

(d)

Provide each consumer and/or the consumer’s authorized representative

with a new copy of the consumer rights form and explain those rights at

least annually.

the care that will be given by the nurse aide.

(c)

The HCA shall ensure that the consumer or the consumer’s authorized

representative approves and signs the form and is provided a copy at the

beginning of services, and at least annually.

(d)

Provide each consumer and/or the consumer’s authorized representative

with a new copy of the consumer rights form and explain those rights at

least annually.

(e)

If nurse aide services are provided to a consumer who is receiving in-

home care by a health professional, the supervising health care

professional, in accordance with the professional’s scope of practice and

state and federal law, shall make a supervisory visit no less than every

two (2) weeks to supervise the nurse aide services. The visit shall be

conducted either in the consumer’s home or via telehealth, in

accordance with the requirements in Part 6.17(A)(1).

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(i)

Direct observation of care being provided by the nurse aide shall

occur at least every sixty (60) days in the consumer’s home.

(ii)

More frequent direct supervision shall occur if there are adverse

changes in the consumer’s condition, complaints received

associated with the provision of care by a nurse aide,

supervision requested by the nurse aide or consumer for specific

issues, or other matters concerning the provisions of care by the

nurse aide.

(f)

If nurse aide services are provided to a consumer who is not receiving in-

home care by a health professional, a supervisory visit with the nurse

aide present at the consumer’s home shall occur no less frequently than

every sixty (60) days.

nurse aide,

supervision requested by the nurse aide or consumer for specific

issues, or other matters concerning the provisions of care by the

nurse aide.

(f)

If nurse aide services are provided to a consumer who is not receiving in-

home care by a health professional, a supervisory visit with the nurse

aide present at the consumer’s home shall occur no less frequently than

every sixty (60) days.

(i)

More frequent direct supervision shall occur if there are adverse

changes in the consumer’s condition, complaints received

associated with the provision of care by a nurse aide,

supervision requested by the nurse aide or consumer for specific

issues, or other matters concerning the provisions of care by the

nurse aide.

(E)

Nurse aide training and orientation

(1)

The HCA shall ensure that skills learned or tested elsewhere can be transferred

successfully to the care of the consumer in their place of residence. This review

of skills may be performed when the nurse installs an aide into a new consumer

care situation, during a supervisory visit, or as part of the annual performance

review. A pseudo-patient may be used for this evaluation.

(2)

If the HCA’s admission policies and the case-mix of HCA consumers demand

that the nurse aide care for individuals whose personal care and basic nursing or

therapy needs require more complex training than the minimum required in the

regulation, the HCA shall document how these additional skills are taught and

validated.

(3)

The HCA shall establish a process for standardized, step-by-step observation

and evaluation of nurse aide competency in the following subject areas prior to

the assignment of tasks requiring direct observation of items (c), (i), (j), and (k) of

this paragraph (3).

(a)

Communications skills;

(b)

Observation, reporting, and documentation of consumer status and the

care or service furnished;

(c)

Reading and recording temperature, pulse, and respiration;

(d)

Basic infection control procedures;

nurse aide competency in the following subject areas prior to

the assignment of tasks requiring direct observation of items (c), (i), (j), and (k) of

this paragraph (3).

(a)

Communications skills;

(b)

Observation, reporting, and documentation of consumer status and the

care or service furnished;

(c)

Reading and recording temperature, pulse, and respiration;

(d)

Basic infection control procedures;

(e)

Basic elements of body functioning and changes in body function that

shall be reported to a nurse aide’s supervisor;

(f)

Maintenance of a clean, safe, and healthy environment;

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(g)

Recognizing emergencies and knowledge of emergency procedures;

(h)

The physical, emotional, and developmental needs of, and methods to

work with, the populations served by the HCA including the need for

respect of the consumer, their privacy, and property;

(i)

Appropriate and safe techniques in personal hygiene and grooming that

include: bathing, including bed/sponge, tub, and shower; shampoo,

including sink, tub, and bed; nail and skin care; oral hygiene; and

toileting and elimination;

(j)

Safe transfer techniques and ambulation;

(k)

Normal range of motion and positioning; and

(l)

Adequate nutrition and fluid intake.

(4)

Written assignment and instructions for the nurse aide shall be prepared by the

registered nurse or other appropriate professional who is responsible for the

supervision of the nurse aide.

(a)

The nurse aide shall be assigned and instructed to provide only those

services the aide is permitted to perform under state law and deemed

competent to perform.

(b)

The written assignment reflects the consumer’s plan of care orders.

(c)

The written instructions of the assignment shall consider the skills of the

nurse aide, the amount and kind of supervision needed, and the specific

nursing or therapy needs of the consumer.

signed and instructed to provide only those

services the aide is permitted to perform under state law and deemed

competent to perform.

(b)

The written assignment reflects the consumer’s plan of care orders.

(c)

The written instructions of the assignment shall consider the skills of the

nurse aide, the amount and kind of supervision needed, and the specific

nursing or therapy needs of the consumer.

(i)

The written instructions shall detail the procedures for the

consumer’s unique care needs.

(ii)

The written instructions shall identify when the nurse aide should

report to the supervising professional.

(d)

The written assignment and instructions shall be reviewed every sixty

(60) days or more frequently as changes in the consumer’s status and

needs occur.

6.14

Therapy Services

(A)

Any therapy services offered by the HCA, directly or under arrangement, shall be

provided by a qualified therapist or by a qualified therapy assistant under the supervision

of a qualified therapist and in accordance with the plan of care.

(B)

The qualified therapist shall assist the physician or licensed independent practitioner in

evaluating level of function, help develop the plan of care (revising it as necessary),

prepare clinical notes, advise and consult with the family and other agency personnel,

and participate in in-service programs.

(C)

Supervision of therapy assistants

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sed independent practitioner in

evaluating level of function, help develop the plan of care (revising it as necessary),

prepare clinical notes, advise and consult with the family and other agency personnel,

and participate in in-service programs.

(C)

Supervision of therapy assistants

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(1)

A physical therapist assistant, occupational therapy assistant, or respiratory

therapy assistant performs services directed from a written plan of care,

delegated and supervised by a qualified therapist, assists in preparing clinical

notes and progress reports, participates in educating the consumer and family,

and participates in in-service programs.

6.15

Medical Social Services

(A)

Any medical social services offered by the HCA, directly or under arrangement, shall be

provided by a qualified social worker in accordance with the plan of care.

(B)

The social worker shall be responsible for the following:

(1)

Assisting the physician or licensed independent practitioner and other team

members in understanding the significant social and emotional factors related to

the health problems;

(2)

Participating in the development of the plan of care;

(3)

Preparing clinical notes;

(4)

Working with the family;

(5)

Connecting the consumer with appropriate community resources;

(6)

Participating in discharge planning and in-service programs; and

censed independent practitioner and other team

members in understanding the significant social and emotional factors related to

the health problems;

(2)

Participating in the development of the plan of care;

(3)

Preparing clinical notes;

(4)

Working with the family;

(5)

Connecting the consumer with appropriate community resources;

(6)

Participating in discharge planning and in-service programs; and

(7)

Acting as a consultant to other HCA personnel.

6.16

Other Healthcare Services

(A)

Any healthcare services offered by the HCA, directly or under arrangement, are given by

a qualified healthcare professional or by a qualified healthcare professional assistant

under the supervision of a qualified healthcare professional and in accordance with the

plan of care.

(B)

The qualified healthcare professional assists the physician or licensed independent

practitioner in evaluating the needs of the consumer, helps develop the plan of care

(revising it as necessary), prepares clinical notes, advises and consults with the family

and other agency personnel, and participates in in-service programs.

(C)

Supervision of assistants

(1)

An assistant to the healthcare professional performs services directed from a

written plan of care, delegated and supervised by a qualified health professional,

assists in preparing clinical notes and progress reports, participates in educating

the consumer and family, and participates in in-service programs.

6.17

Telehealth Supervisory Visits

(A)

The HCA may conduct supervisory visits using telehealth for the following services, so

long as the HCA continues to ensure consumer care and treatment are delivered in

accordance with a plan of care that addresses the consumer’s status and needs.

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.17

Telehealth Supervisory Visits

(A)

The HCA may conduct supervisory visits using telehealth for the following services, so

long as the HCA continues to ensure consumer care and treatment are delivered in

accordance with a plan of care that addresses the consumer’s status and needs.

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(1)

For nurse aide services, the supervising healthcare professional may evaluate

the delivery of care and services required every two (2) weeks at Part

6.13(D)(1)(e) through an interactive audiovisual connection with the consumer.

The results of the supervisory visit must be documented by the supervising

healthcare professional.

(a)

An in-person supervisory visit with the nurse aide and consumer is

required at least every sixty (60) days if nurse aide services are provided

to a consumer who is receiving in-home care by a nurse aide.

(2)

For therapy services, such as physical therapy, occupational therapy, and

speech therapy, supervision of assistants required at Part 6.14(C) may be

provided through an interactive audiovisual connection and in accordance with all

applicable state laws and regulations.

(a)

An in-person supervisory visit shall occur in accordance with the HCA’s

policies and procedures, the plan of care, and professional standards of

practice.

(3)

For other healthcare services, supervision of assistants required at Part 6.16(C)

may be provided through an interactive audiovisual connection and in

accordance with all applicable state laws and regulations.

state laws and regulations.

(a)

An in-person supervisory visit shall occur in accordance with the HCA’s

policies and procedures, the plan of care, and professional standards of

practice.

(3)

For other healthcare services, supervision of assistants required at Part 6.16(C)

may be provided through an interactive audiovisual connection and in

accordance with all applicable state laws and regulations.

(a)

An in-person supervisory visit shall occur in accordance with the HCA's

policies and procedures, the plan of care, and professional standards of

practice.

(B)

An in-person supervisory visit is required to evaluate consumer complaints related to the

delivery of care when such concerns cannot be successfully addressed remotely through

an interactive audiovisual connection.

(C)

All other general requirements for supervisory visits, such as documentation and meeting

the same standard of care, must be met.

6.18

Clinical Record

(A)

In addition to the requirements in Part 5.15, an HCA providing skilled care shall comply

with the following requirements:

(1)

The initial and comprehensive assessments shall be documented in the

consumer record and shall include the consumer's current comprehensive

assessment, including all of the assessments from the most recent HCA

admission, clinical notes, plans of care, and physician or licensed independent

practitioner orders.

(2)

The record shall include all interventions, including medication administration,

treatments, and services, and responses to those interventions.

PART 7.

NON-MEDICAL/PERSONAL CARE

7.1

Governing Body

(A)

An HCA may choose to convene a governing body that shall have legal authority and

responsibility for the conduct of the HCA. If an HCA does not convene a governing body,

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PART 7.

NON-MEDICAL/PERSONAL CARE

7.1

Governing Body

(A)

An HCA may choose to convene a governing body that shall have legal authority and

responsibility for the conduct of the HCA. If an HCA does not convene a governing body,

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the HCA shall designate an individual who shall have responsibility for all tasks as set

forth in this Part 7.1.

(B)

At least one (1) member of the governing body or designee shall have knowledge of HCA

operations.

(C)

For the purposes of this section, the governing body or designee shall:

(1)

Have bylaws or a governing document that shall specify the programs and

services offered by the HCA and be reviewed and revised as needed;

(2)

Designate and employ an HCA manager;

(3)

Develop and adopt policies and procedures for the operation and administration

of the HCA, to be reviewed annually and revised as needed;

(4)

Ensure any program or service offered by the HCA, directly or under

arrangement, shall be provided in accordance with the service plan and HCA

policy and procedure;

(5)

Review the operations of the HCA at least annually;

(6)

Keep minutes of all meetings;

(7)

Provide and maintain a fixed office location that provides for consumer

confidentiality and a safe working environment; and

(8)

Organize 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.

(D)

Agency Evaluation

(1)

The HCA's governing body or designee shall conduct a comprehensive

evaluation of the HCA's total operation at least annually.

a safe working environment; and

(8)

Organize 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.

(D)

Agency Evaluation

(1)

The HCA's governing body or designee shall conduct a comprehensive

evaluation of the HCA's total operation at least annually.

(2)

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, and shall

include any findings or improvement strategies identified by the HCA’s Quality

Management Program required in Part 5.12.

(3)

The HCA shall implement a method for ongoing process improvement and policy

and administrative review, which includes a review of the scope of services

offered, arrangements for services with other agencies or individuals, admission

and discharge policies, supervision and service plan, urgent consumer care,

service records, and personnel qualifications.

(a)

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.

(b)

All findings from the policy and administrative review and consumer input

and commentary shall be provided to the governing body at least

annually to identify trends or issues requiring consideration.

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(4)

In evaluating each aspect of its total program, the HCA shall consider four (4)

main criteria:

(a)

Appropriateness - assurance that the area being evaluated addresses

existing and/or potential problems.

(b)

Adequacy - a determination as to whether the HCA has the capacity to

overcome or minimize existing or potential problems.

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(4)

In evaluating each aspect of its total program, the HCA shall consider four (4)

main criteria:

(a)

Appropriateness - assurance that the area being evaluated addresses

existing and/or potential problems.

(b)

Adequacy - a determination as to whether the HCA has the capacity to

overcome or minimize existing or potential problems.

(c)

Effectiveness - the services offered accomplish the objectives of the

HCA and anticipated consumer outcomes.

(d)

Efficiency - whether there is a minimal expenditure of resources by the

HCA to achieve desired goals and anticipated consumer outcomes.

(5)

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.

(6)

Appropriate qualified individuals representing the programs and services offered

by the HCA shall evaluate the HCA's consumer records on an ongoing basis, but

no less than quarterly.

(a)

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.

7.2

HCA Manager

(A)

The HCA's governing body or designee shall appoint an HCA manager to supervise the

provision of the HCA’s services.

(B)

The HCA manager shall meet the following qualifications:

(1)

Be at least twenty-one (21) years of age, possess a high school diploma or GED,

and have at least one (1) year documented supervisory experience in the

provision of personal care services;

(a)

If the HCA manager does not have the required one (1) year of

experience supervising the delivery of personal care services, they shall

demonstrate they have the following:

the following qualifications:

(1)

Be at least twenty-one (21) years of age, possess a high school diploma or GED,

and have at least one (1) year documented supervisory experience in the

provision of personal care services;

(a)

If the HCA manager does not have the required one (1) year of

experience supervising the delivery of personal care services, they shall

demonstrate they have the following:

(i)

A college degree in healthcare services plus at least one (1) year

of work experience in health care during the previous ten (10)-

year period; or

(ii)

A college degree in any field plus two (2) years of work

experience in health care during the previous ten (10)-year

period.

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(2)

Be able to communicate and understand return communication effectively in

exchanges between the consumer, family representatives, and other providers,

including the use of appropriate translator services as needed;

(3)

Have successfully completed an eight (8) hour agency manager training course.

Additional related annual training that equals twelve (12) hours shall be required

in the first year and annually thereafter;

(a)

Any person commencing service as an HCA manager shall meet the

minimum training requirements approved by the Department pursuant to

Part 7.2(D) of this chapter or provide documented and confirmed

previous job related experience or related education equivalent to

successful completion of such program. The Department may require

additional training to ensure that all the required components of the

training curriculum are met.

ce as an HCA manager shall meet the

minimum training requirements approved by the Department pursuant to

Part 7.2(D) of this chapter or provide documented and confirmed

previous job related experience or related education equivalent to

successful completion of such program. The Department may require

additional training to ensure that all the required components of the

training curriculum are met.

(b)

A copy of the certificate of completion shall be retained in the HCA

manager’s personnel file.

(4)

Be familiar with all applicable local, state, and federal laws and regulations

concerning the operation and provision of home care services.

(C)

The HCA manager shall be responsible for ensuring:

(1)

The HCA is in compliance with all applicable federal, state, and local laws;

(2)

The completion, maintenance, and submission of reports and records as required

by the Department;

(3)

Ongoing liaison with the governing body or designee, staff members, and the

community;

(4)

Maintenance of a current organizational chart to show lines of authority down to

the consumer level;

(5)

Maintenance of appropriate personnel, bookkeeping, and administrative records

and policies and procedures of the HCA;

(6)

Orientation of new personnel, and regularly scheduled in-service education

programs and opportunities for continuing education are provided for personnel;

(7)

Designating in writing the qualified staff member to act in the absence of the

manager;

(8)

Availability of the manager or designee for all hours that personnel are providing

services;

(9)

Marketing, advertising, and promotional information accurately represent the

HCA and address the care, treatment, and services that the HCA can provide

directly or through contractual arrangement;

(10)

Maintenance of a coordinated HCA-wide program for appropriate infection

prevention and control that is an integral part of the HCA’s quality management

program; and

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nd address the care, treatment, and services that the HCA can provide

directly or through contractual arrangement;

(10)

Maintenance of a coordinated HCA-wide program for appropriate infection

prevention and control that is an integral part of the HCA’s quality management

program; and

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(11)

The implementation and monitoring of the HCA’s training program for all

homemakers and personal care workers, including managing or delegating

employee training and development activities for the HCA.

(D)

An HCA manager training program shall be approved by the Department if:

(1)

The program or its components are conducted by an accredited college,

university, or vocational school or by an organization, association, corporation,

group, or agency with specific expertise in that area and the curriculum includes

at least eight (8) actual hours of training.

(2)

Instruction includes, at a minimum, discussion of each of the following topics:

(a)

Home care overview including other agency types providing services and

how to interact and coordinate, including limitations of personal care

versus health care services;

(b)

Regulatory responsibilities and compliance, including:

(i)

Consumer rights,

(ii)

Governing body or designee responsibilities,

(iii)

Quality management plans,

(iv)

Occurrence reporting, and

(v)

Complaint investigation and resolution process;

(c)

Personnel qualifications, experience, competency and evaluations, staff

training, and supervision;

(d)

Needs of the fragile, ill, and physically, cognitively, and/or

developmentally disabled in the community setting regarding special

training and staffing considerations; and

ties,

(iii)

Quality management plans,

(iv)

Occurrence reporting, and

(v)

Complaint investigation and resolution process;

(c)

Personnel qualifications, experience, competency and evaluations, staff

training, and supervision;

(d)

Needs of the fragile, ill, and physically, cognitively, and/or

developmentally disabled in the community setting regarding special

training and staffing considerations; and

(e)

Behavior management techniques.

7.3

Homemaker

(A)

A homemaker shall complete training, in accordance with the following requirements,

prior to providing services independently.

(B)

A homemaker must complete training as specified in Part 7.3(C) and pass a competency

evaluation that includes a visual observation and evaluation of relevant skills, prior to

providing care to a consumer.

(1)

If the HCA utilizes another entity to provide the training, the HCA must validate

that the training program meets the requirements in Part 7.3(C) below and retain

evidence of the individual’s successful completion of the training program in the

personnel record.

(C)

Homemaker training

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(1)

All homemaker staff shall complete HCA training before independently providing

services to consumers. Initial training must be interactive in nature and may be

completed through the following modes: in-person, online/virtual, or a hybrid, with

demonstration of learned concepts. Initial training shall include:

(a)

Personnel duties and responsibilities, including but not limited to incident

reporting and mandatory reporting;

(b)

Rules for non-medical care and services as described in this chapter;

(c)

The differences in homemaker and personal care;

(d)

Consumer rights, inclu

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