CHAPTER 22 - BIRTH CENTERS

1

DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT

Health Facilities and Emergency Medical Services Division

STANDARDS FOR HOSPITALS AND HEALTH FACILITIES: CHAPTER 22 - BIRTH CENTERS

6 CCR 1011-1 Chapter 22

[Editor’s Notes follow the text of the rules at the end of this CCR Document.]

_________________________________________________________________________

Adopted by the Board of Health on June 18, 2025. Effective August 14, 2025.

INDEX

Part 1 – Statutory Authority and Applicability

Part 2 – Definitions

Part 3 – Governing Body

Part 4 – Administrator

Part 5 – Clinical Director

Part 6 – Staffing and Personnel

Part 7 – Client Rights

Part 8 – Client Care

Part 9 – Emergency Care and Transfers

Part 10 – Registration, Admission, and Discharge

Part 11 – Health Information Management

Part 12 – Laboratory Services

Part 13 – Pharmacy Services

Part 14 – Equipment and Supplies

Part 15 – Food Services

Part 16 – Housekeeping Services

Part 17 – Laundry and Linens

Part 18 – Physical Plant Standards

Part 19 – Interior and Exterior Environment

Part 20 – Waste Storage and Disposal

PART 1 – STATUTORY AUTHORITY AND APPLICABILITY

1.1

The statutory authority for the promulgation of these rules is set forth in section 25-1.5-103 and

25-3-100.5, et seq., C.R.S.

1.2

A birth center, as defined herein, shall comply with all applicable federal and state statutes and

regulations, including, but not limited to:

(A)

This Chapter 22, and

(B)

6 CCR, 1011-1, Chapter 2, General Licensure Standards, unless otherwise modified

herein.

PART 2 – DEFINITIONS

2.1

“Admission” means the acceptance of a registered client experiencing physiologic birth for labor

and childbirth at the birth center.

Code of Colorado Regulations

Secretary of State

State of Colorado

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

, General Licensure Standards, unless otherwise modified

herein.

PART 2 – DEFINITIONS

2.1

“Admission” means the acceptance of a registered client experiencing physiologic birth for labor

and childbirth at the birth center.

Code of Colorado Regulations

Secretary of State

State of Colorado

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

2

2.2

“Auxiliary Staff” means licensed or unlicensed individuals with adult and neonatal resuscitation

skills providing client care support to clinical providers. Auxiliary staff may include, but is not

limited to; individuals regulated by Title 12 of the Colorado Revised Statutes who do not have

midwifery in their facility-specific clinical privileges, regardless of their professional scope of

practice, or birth assistants.

2.3

“Birth Assistant” means an individual not licensed or otherwise regulated under Title 12 of the

Colorado Revised Statutes who has completed a structured course of study in providing support

to clinical providers in non-hospital birth settings, and whose training includes hands-on

competency testing and adult and neonatal resuscitation skills.

2.4

“Birth Center” means a freestanding facility licensed by the department that:

(A)

Is not a hospital, attached to a hospital, or in a hospital;

(B)

Provides prenatal, labor, delivery, and postpartum care to low-risk pregnant persons and

their newborns; and

(C)

Provides Care during delivery and immediately after delivery that is generally less than

twenty-four hours.

2.5

“Client” means a person receiving prenatal, intrapartum, and postpartum services. Unless the

context dictates otherwise, client also means an infant receiving newborn care services from the

facility.

2.6

“Clinical Privileges” means the clinical, nursing, and other client care procedures, activities, and

responsibilities the governing body approves an individual clinical provider, or auxiliary or

contracted staff member, to perform while providing services at the birth center

s. Unless the

context dictates otherwise, client also means an infant receiving newborn care services from the

facility.

2.6

“Clinical Privileges” means the clinical, nursing, and other client care procedures, activities, and

responsibilities the governing body approves an individual clinical provider, or auxiliary or

contracted staff member, to perform while providing services at the birth center.

2.7

“Clinical Provider” means a member of the birth center’s staff who is licensed or otherwise

regulated under Title 12 of the Colorado Revised statutes to practice medicine or midwifery, and

for whom the practice of medicine or midwifery is included in their clinical privileges.

2.8

“Doula” means a person who provides physical, emotional, and informational support to a

pregnant person before, during, and after pregnancy.

2.9

“Facility” means a birth center.

2.10

“Intrapartum” means pertaining to the period of labor and birth.

2.11

“Low Risk Pregnancy” means expected normal, uncomplicated prenatal and intrapartum course

assisted by adequate prenatal care and prospects for a normal uncomplicated birth based on

continual screening for prenatal high-risk factors.

2.12

“Medical waste” means waste that may contain disease causing organisms such as discarded

surgical gloves, sharps, blood, human tissue, products of conception; or waste that may contain

chemicals that present potential health hazards such as pharmaceutical waste and laboratory

waste.

2.13

“Physiologic birth” means labor and birth powered by the innate human capacity of a pregnant

person and the pregnant person's fetus, which includes endogenous hormone systems.

2.14

“Physiologic postpartum process” means the biologic process that happens to both the newborn

and birthing person after delivery due to endogenous hormone systems.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

e innate human capacity of a pregnant

person and the pregnant person's fetus, which includes endogenous hormone systems.

2.14

“Physiologic postpartum process” means the biologic process that happens to both the newborn

and birthing person after delivery due to endogenous hormone systems.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

3

2.15

“Registration” means acceptance of a pregnant person as a client of the facility for perinatal

services prior to admission.

PART 3 – GOVERNING BODY

3.1

The birth center shall have an organized governing body.

3.2

The governing body shall be responsible for:

(A)

Overseeing the overall operation and management of the facility.

(B)

Ensuring that adequate facilities, personnel, and services necessary for the welfare and

safety of the clients are provided.

(C)

Delineating the structure, membership, and operation of the governing body in written

policy, including, but not limited to, requirements that the governing body:

(1)

Meets at least annually and maintains accurate records of such meetings; and

(2)

Adopts administrative and operational by-laws in accordance with legal

requirements that include the facility’s organizational structure with lines of

authority and responsibility.

3.3

In order to provide for the overall operation and management of the facility as set forth in Part

3.2(A), the governing body shall:

(A)

Define the scope of the services provided by the facility.

(B)

Ensure the development of and approve job descriptions that delineate functional

responsibilities and authority for each employee position. Administrator and clinical

director job descriptions shall include, but not be limited to policy development,

recommendation, and implementation responsibilities.

(C)

Appoint an individual or individuals, in writing, as follows:

(1)

An administrator responsible for the day-to-day operation of the facility and

fulfilling the administrator requirements in Part 4.

uthority for each employee position. Administrator and clinical

director job descriptions shall include, but not be limited to policy development,

recommendation, and implementation responsibilities.

(C)

Appoint an individual or individuals, in writing, as follows:

(1)

An administrator responsible for the day-to-day operation of the facility and

fulfilling the administrator requirements in Part 4.

(2)

A clinical director with authority, responsibility, and accountability for clinical

services provided at the facility and for fulfilling the clinical director

responsibilities in Part 5. The appointed clinical director shall be a clinical

provider, as defined in Part 2.7 of these rules, and have the necessary

professional scope of practice, as regulated under Title 12 of the Colorado

Revised Statutes, to supervise the facility’s clinical providers.

(3)

The governing body may appoint a single individual to the roles in this Part

3.3(C) or may appoint separate individuals, as appropriate for the size, structure,

and operation of the birth center.

(D)

Review and approve written policies and procedures for the operation of the facility at

least annually to ensure they are consistent with current professional standards and

statutory and regulatory requirements.

(E)

Review and approve written personnel policies developed in accordance with Part 6.2(A).

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

ove written policies and procedures for the operation of the facility at

least annually to ensure they are consistent with current professional standards and

statutory and regulatory requirements.

(E)

Review and approve written personnel policies developed in accordance with Part 6.2(A).

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

4

(F)

Maintain an effective quality management program in accordance with 6 CCR 1011-1,

Chapter 2, Part 4.

3.4

In order to ensure the provision of adequate facilities, personnel, and services necessary for the

welfare and safety of the clients as set forth in Part 3.2(B), the governing body shall:

(A)

Ensure the facility and its equipment comply with the requirements of this chapter and are

available 24 hours per day, 7 days per week.

(B)

Review and approve the facility’s clinical policies and procedures, as recommended by

the clinical director in accordance with Part 5.2.

(C)

Ensure the development and maintenance of a written emergency preparedness plan for

the emergency care or relocation of clients based on emergencies identified through an

annual evaluation of all hazards relevant to the facility. The evaluation of hazards shall

include, but is not limited to, the following natural and human-caused crises: fire(s); gas

leaks or explosions; power or other utility outages; equipment malfunction; tornado(s);

flooding; threatened or actual acts of violence; and bioterror, pandemic, or disease

outbreak events.

(D)

Ensure a written plan is developed, approved, and implemented for emergent and non-

emergent transport of clients to a hospital. At a minimum, such plan shall meet the

requirements at Part 9.1 of these rules and be reviewed annually.

(E)

Ensure that staff perform the following drills:

(1)

Emergency evacuation drills per the emergency preparedness plan developed in

3.4(C), at least semiannually; and

nsure a written plan is developed, approved, and implemented for emergent and non-

emergent transport of clients to a hospital. At a minimum, such plan shall meet the

requirements at Part 9.1 of these rules and be reviewed annually.

(E)

Ensure that staff perform the following drills:

(1)

Emergency evacuation drills per the emergency preparedness plan developed in

3.4(C), at least semiannually; and

(2)

Emergency medical drills at least quarterly.

(F)

Approve infection control policies and procedures developed by the clinical director or

delegated committee of clinical providers in accordance with Part 5.2 to ensure the

adequate investigation, control, and prevention of infections. The policies and procedures

shall reflect a nationally recognized standard and reflect the scope and complexity of

services provided by the facility.

(G)

Appoint and delineate, in writing, clinical privileges for each individual clinical provider

and auxiliary or contracted staff member based upon recommendations by the clinical

director or delegated committee of clinical providers in accordance with Part 5.2(B) of

these rules and commensurate with the individual’s qualifications, experience, and

present capabilities.

(1)

Approved clinical privileges for any clinical provider, auxiliary staff member, or

contracted clinical staff member who is licensed, certified, or registered under

Title 12 of the Colorado Revised Statutes shall not exceed the individual’s

regulated professional scope of practice.

(2)

Approved clinical privileges for birth assistants shall ensure the birth assistant

serves in a support role to a clinical provider and that they not have the authority

to act as an independent practitioner within the facility.

ber who is licensed, certified, or registered under

Title 12 of the Colorado Revised Statutes shall not exceed the individual’s

regulated professional scope of practice.

(2)

Approved clinical privileges for birth assistants shall ensure the birth assistant

serves in a support role to a clinical provider and that they not have the authority

to act as an independent practitioner within the facility.

(3)

Approved clinical privileges shall not exceed the scope of services provided by

the facility, regardless of an individual’s regulated scope of practice.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

5

(H)

Ensure that all contracts are reviewed, revised as necessary, and approved annually.

PART 4 – ADMINISTRATOR

4.1

The administrator shall be responsible for the day to day operation of the facility, including, but

not limited to:

(A)

Ensuring the development of operational (non-clinical) policies as included in the

administrator’s position description determined by the governing body in accordance with

Part 3.3(B) of these rules.

(B)

Ensuring all facility personnel are aware of and trained on the facility’s emergency

preparedness plan developed in accordance with Part 3.4(C) of these rules.

(C)

Ensuring all facility personnel adhere to the infection control policies and procedures

developed in accordance with Part 3.4(F) of these rules.

(D)

Ensuring emergency drills are performed in accordance with the timelines at 3.4(E).

(E)

Ensuring contracted services that are non-clinical in nature are performed in accordance

with the facility’s applicable policies and procedures.

(F)

Ensuring facility staff have access to an up to date roster of the facility’s clinical providers,

and auxiliary and contracted staff, that specifies each individual’s clinical privileges, as

approved by the governing body in Part 3.4(G).

(G)

Ensuring that personnel files for all employees and contracted staff are maintained in

accordance with Part 6.3

lity’s applicable policies and procedures.

(F)

Ensuring facility staff have access to an up to date roster of the facility’s clinical providers,

and auxiliary and contracted staff, that specifies each individual’s clinical privileges, as

approved by the governing body in Part 3.4(G).

(G)

Ensuring that personnel files for all employees and contracted staff are maintained in

accordance with Part 6.3.

4.2

The administrator shall designate in writing a qualified employee to act as administrator in the

temporary absence of the administrator.

PART 5 – CLINICAL DIRECTOR

5.1

The clinical director, as appointed by the governing body in accordance with Part 3.3(C)(2), shall

have authority, responsibility, and accountability for clinical services provided by the facility, and

shall:

(A)

Be one of the facility’s clinical providers.

(B)

Supervise the facility’s clinical services, whether provided by clinical providers, or

auxiliary or contracted staff.

(C)

Be the formal clinical liaison with the governing body.

(D)

Implement, coordinate, and assure the quality of client care services provided by the

facility.

(E)

Ensure the coordination of professional medical consultant services and referrals

provided within the facility.

(F)

Ensure contracted clinical services are performed in accordance with the facility’s

applicable policies and procedures.

5.2

The clinical director, individually or with a committee of the facility’s clinical providers, shall:

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

6

(A)

Recommend and enforce rules, regulations, and policies for the proper organization and

conduct of the facility’s clinical providers.

(B)

Recommend clinical privileges to the governing body for each individual clinical provider

and auxiliary or contracted staff member for approval in accordance with Part 3.4(G) of

these rules.

pter 22

Health Facilities and Emergency Medical Services Division

6

(A)

Recommend and enforce rules, regulations, and policies for the proper organization and

conduct of the facility’s clinical providers.

(B)

Recommend clinical privileges to the governing body for each individual clinical provider

and auxiliary or contracted staff member for approval in accordance with Part 3.4(G) of

these rules.

(1)

Recommended clinical privileges for any clinical provider, auxiliary staff member,

or contracted clinical staff member who is licensed, certified, or registered under

Title 12 of the Colorado Revised Statutes shall not exceed the individual’s

regulated professional scope of practice.

(2)

Recommended clinical privileges for birth assistants shall ensure the birth

assistant serves in a support role to a clinical provider, and that they not have the

authority to act as an independent practitioner within the facility.

(3)

Recommended clinical privileges shall not exceed the scope of services provided

by the facility, regardless of an individual’s regulated scope of practice.

(C)

Participate in the facility’s quality management program.

(D)

Ensure the development of the facility’s clinical policies and procedures for

recommendation to the governing body for its consideration and approval in accordance

with Part 3.4(B). Such clinical policies and procedures shall be in accordance with

national standards for midwifery care, respect cultural diversity, and include, but not be

limited to the following:

(1)

Client care, as required by Part 8.2;

(2)

Emergency care and emergent and non-emergent transport, as required by Part

9.1;

(3)

Registration, admission, and discharge, as required by Part 10.1,

(4)

Storage, dispensing, and administration of medications and intravenous fluids, as

required by Part 13.2;

(5)

Infection control, as required by Part 3.4(F); and

e, but not be

limited to the following:

(1)

Client care, as required by Part 8.2;

(2)

Emergency care and emergent and non-emergent transport, as required by Part

9.1;

(3)

Registration, admission, and discharge, as required by Part 10.1,

(4)

Storage, dispensing, and administration of medications and intravenous fluids, as

required by Part 13.2;

(5)

Infection control, as required by Part 3.4(F); and

(6)

Client records, as required by Part 11.1.

(E)

Develop policies and procedures for non-facility practitioner consultation, collaboration,

and referrals to meet the needs of facility clients.

(1)

Such policies and procedures shall be available to the facility’s clinical providers

and auxiliary or contracted staff at all times.

(F)

If the clinical director works with a committee of the facility’s clinical providers to fulfill the

responsibilities in (A)-(E) of this part, the committee shall meet at least annually and

maintain accurate records of such meetings.

5.3

The clinical director shall designate in writing one of the facility’s other clinical providers to act as

the clinical director when the appointed clinical director is temporarily absent. The designated

clinical provider shall have the appropriate clinical privileges to carry out the responsibilities of the

clinical director.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

7

PART 6 – STAFFING AND PERSONNEL

6.1

Staffing

(A)

Each facility shall be staffed with an appropriate number clinical providers and auxiliary

staff with the appropriate clinical privileges to assure client safety at all times.

(B)

There shall be sufficient clinical providers and auxiliary staff on duty to:

(1)

Meet the demands for services routinely provided.

(2)

Ensure adequate coverage during periods of high demand or emergency.

6.1

Staffing

(A)

Each facility shall be staffed with an appropriate number clinical providers and auxiliary

staff with the appropriate clinical privileges to assure client safety at all times.

(B)

There shall be sufficient clinical providers and auxiliary staff on duty to:

(1)

Meet the demands for services routinely provided.

(2)

Ensure adequate coverage during periods of high demand or emergency.

(3)

Meet the total clinical, nursing, and other care needs of each client present at the

facility at all times.

(C)

A clinical provider or auxiliary staff member with the appropriate clinical privileges shall

be present at the facility at all times when a birthing client or newborn is present

postpartum through discharge.

(D)

The following staff shall be present at each birth and until the client and newborn are

stable postpartum:

(1)

One of the facility’s clinical providers, and a second person as follows:

(a)

For clinical providers with clinical privileges that include the authority to

determine the need for and administer intravenous fluids or medications,

the second staff member may be another clinical provider, or a member

of the auxiliary staff.

(b)

For clinical providers with clinical privileges that do not include the

authority to determine the need for and administer intravenous fluids or

medications, the second staff member shall be a clinical provider or

auxiliary staff member with clinical privileges that include the authority to

determine the need for and administer intravenous fluids or medications.

(E)

Clinical providers and auxiliary staff shall perform their duties in accordance with their

individual professional scope of practice, not to exceed their governing body-approved

clinical privileges.

6.2

Personnel policies and procedures

(A)

The administrator shall ensure the development and implementation of written personnel

policies and procedures including but not limited to the following:

(1)

Conditions of employment.

xiliary staff shall perform their duties in accordance with their

individual professional scope of practice, not to exceed their governing body-approved

clinical privileges.

6.2

Personnel policies and procedures

(A)

The administrator shall ensure the development and implementation of written personnel

policies and procedures including but not limited to the following:

(1)

Conditions of employment.

(2)

Orientation and training requirements, including the following topics, at a

minimum:

(a)

The facility’s emergency preparedness plan.

(b)

Infection control policies and procedures, as applicable to the position

and responsibilities.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

8

(c)

Emergency care and emergent and non-emergent transport policies and

procedures, as applicable to the position and responsibilities.

(d)

The facility’s scope of services.

(e)

The facility’s operational, clinical, and personnel policies and procedures,

as applicable to the individual’s position.

(f)

Client rights and informed consent requirements.

(g)

The facility’s policies protecting the rights of a birthing person during the

perinatal period, in accordance with part 7.3 of these rules.

(3)

Supervision and management of employees.

(4)

A requirement that all clinical providers and auxiliary or contracted staff have

adult and neonatal resuscitation skills.

(5)

Skill evaluation for auxiliary staff who are not regulated under Title 12 of the

Colorado Revised Statutes.

s protecting the rights of a birthing person during the

perinatal period, in accordance with part 7.3 of these rules.

(3)

Supervision and management of employees.

(4)

A requirement that all clinical providers and auxiliary or contracted staff have

adult and neonatal resuscitation skills.

(5)

Skill evaluation for auxiliary staff who are not regulated under Title 12 of the

Colorado Revised Statutes.

(6)

Protection of clients from exposure to communicable disease. The policy shall:

(A)

Address pre-employment health requirements, if any.

(B)

Identify which communicable diseases render an employee ineligible for

duty and the process for restoring eligibility for duty.

(C)

Require documentation that clinical providers and auxiliary staff are fully

immunized against hepatitis B unless they refuse. If the employee

refuses, the refusal shall be documented in the employee’s personnel

file, and the facility shall ensure the client is protected from exposure to

hepatitis B.

(7)

A requirement that all persons, including students, who examine, observe, or

treat clients to wear identification stating, at minimum, the person’s name and

credentials.

6.3

Personnel files shall be maintained on the premises for all employees and contracted personnel.

Such files shall contain, at a minimum, the following:

(A)

The individual’s job description, responsibilities, and governing body-approved clinical

privileges.

(B)

Evidence of current licensure, certification, registration, and training, as applicable to the

individual’s responsibilities and clinical privileges.

(C)

Documentation of adult and neonatal resuscitation competency.

(D)

Signed contracts for contracted personnel.

(E)

Documentation that the individual has received orientation and training in accordance

with the facility’s personnel policies and procedures. At a minimum, the personnel file

shall include documentation that the individual is familiar with and understands the

following:

l privileges.

(C)

Documentation of adult and neonatal resuscitation competency.

(D)

Signed contracts for contracted personnel.

(E)

Documentation that the individual has received orientation and training in accordance

with the facility’s personnel policies and procedures. At a minimum, the personnel file

shall include documentation that the individual is familiar with and understands the

following:

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

9

(1)

The facility’s emergency preparedness plan, including the individual’s roles and

responsibilities under the plan.

(2)

The facility’s infection control policies and procedures.

(3)

The facility’s policies and procedures regarding the emergency care and

emergent and non-emergent transport of clients to a hospital, if applicable to the

individual’s position and clinical privileges.

(4)

The facility’s written emergent and non-emergent transport plan, as applicable to

the individual’s position and clinical privileges.

PART 7 – CLIENT RIGHTS

7.1

The facility shall comply with 6 CCR 1011-1, Chapter 2, Part 7 - Client Rights.

7.2

The facility shall provide a written, accessible (printed or electronic) copy of its client rights

policies to clients as part of the disclosures required in Part 10.2(D) of these rules.

7.3

The birth center shall have a policy protecting the rights of birthing persons during the perinatal

period in compliance with Section 25-3-126, C.R.S., and the client rights included in 6 CCR 1011-

1, Chapter 2, Part 7. The policy shall, at a minimum:

(A)

Ensure any person experiencing physiologic birth is not excluded from receiving care that

is within the birth center’s scope of services as identified in Part 3.3(A) of these rules, and

consistent with the birth center’s policies. The following do not constitute exclusion from

care:

(1)

Transferring the person experiencing physiologic birth in accordance with Part 9

of these rules.

a minimum:

(A)

Ensure any person experiencing physiologic birth is not excluded from receiving care that

is within the birth center’s scope of services as identified in Part 3.3(A) of these rules, and

consistent with the birth center’s policies. The following do not constitute exclusion from

care:

(1)

Transferring the person experiencing physiologic birth in accordance with Part 9

of these rules.

(2)

Immediate referral or transfer to another facility of persons experiencing

physiologic birth who are not registered as clients of the birth center prior to their

arrival at the facility.

(3)

The birth center’s lack of capacity or capability to perform or support treatment or

care outside of its identified scope of services.

(B)

Ensure that the process of physiologic birth is not interrupted without the informed

consent of the birthing person.

(1)

Such informed consent shall be specific to the process of interrupting physiologic

birth.

(2)

Obtaining Informed consent, as defined at 6 CCR Chapter 2, Part 1.33, shall be

the responsibility of licensed independent practitioners and other service

providers in accordance with 6 CCR 1011-1, Chapter 2, Part 7.

(3)

All information and explanations required as part of informed consent shall

include information and explanations related to both the birthing person and the

fetus or newborn, as applicable.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

10

(C)

Prioritize a newborn’s bonding with their family in order to facilitate the physiologic

postpartum process, including efforts to promote bonding in cases where a newborn or

the birthing person requires emergency or ongoing medical services, within the birth

center’s capacity and capability.

(1)

If the facility provides services for clients in custody, the facility shall prioritize

such client’s newborn’s bonding with their family in order to facilitate the

physiologic postpartum process, unless:

rocess, including efforts to promote bonding in cases where a newborn or

the birthing person requires emergency or ongoing medical services, within the birth

center’s capacity and capability.

(1)

If the facility provides services for clients in custody, the facility shall prioritize

such client’s newborn’s bonding with their family in order to facilitate the

physiologic postpartum process, unless:

(a)

The parent or legal guardian of the newborn consents to medical

treatment,

(b)

The newborn is released to a legal guardian, or

(c)

The birthing person is discharged from the facility.

(D)

For all clients other than those in custody, the facility shall:

(1)

Allow the client to have a companion or doula with them during labor and birth in

addition to a partner or spouse.

(a)

The facility shall ensure the client’s choice of doula is not restricted by

requirements for specified training, credentials, or approval by the facility.

(b)

The client shall be allowed to have the companion or doula with them in

all situations and locations where a partner or spouse would be allowed.

(c)

The companion or doula and partner or spouse shall be subject to the

facility’s restrictions, if any, put in place during periods of heightened risk

of transmission of a communicable disease in accordance with Section

25-3-125(3)(b)(I), C.R.S.

(2)

Specify the facility’s process related to receiving the client's medical information

from any provider regulated under Title 12 of the Colorado Revised Statutes who

has provided the client with care.

(3)

Establish processes to transfer and receive pregnant persons across levels of

care of licensed facilities, within the facility’s capacity and capability.

with Section

25-3-125(3)(b)(I), C.R.S.

(2)

Specify the facility’s process related to receiving the client's medical information

from any provider regulated under Title 12 of the Colorado Revised Statutes who

has provided the client with care.

(3)

Establish processes to transfer and receive pregnant persons across levels of

care of licensed facilities, within the facility’s capacity and capability.

(4)

Establish a process to receive individuals who are pregnant, undergoing

physiologic birth, or in the physiologic postpartum process from locations other

than licensed facilities, including a process to receive verbal and written

information from individuals with relevant information, including but not limited to

health-care providers regulated under Title 12 of the Colorado Revised Statutes,

doulas, or family members.

(E)

The facility shall ensure that all clinical providers and auxiliary staff who may interact with

a birthing person are aware of and comply with the policies protecting the rights of a

birthing person during the perinatal period, as set forth in these rules.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

11

PART 8 – CLIENT CARE

8.1

The facility shall have written policies and procedures regarding the provision of comprehensive

perinatal care for low-risk pregnancy, newborn care, and referral of high-risk pregnancy,

consistent with current standards of practice, as developed by the clinical director and approved

by the governing body. Policies and procedures shall respect cultural diversity, be in accordance

with national standards for midwifery care, and include, but not be limited to:

(A)

Client education, including orientation to the philosophy of care and the scope of services

of the facility.

(B)

Continuous risk screening that requires:

(1)

Screening processes with written criteria that ensure the facility registers and

admits only clients with low-risk pregnancies.

al diversity, be in accordance

with national standards for midwifery care, and include, but not be limited to:

(A)

Client education, including orientation to the philosophy of care and the scope of services

of the facility.

(B)

Continuous risk screening that requires:

(1)

Screening processes with written criteria that ensure the facility registers and

admits only clients with low-risk pregnancies.

(2)

Routine evaluation of clients by clinical providers throughout pregnancy to ensure

that their pregnancy remains low risk and appropriate for facility services.

(3)

Protocols for referring high-risk clients and newborns with conditions outside of

the facility’s scope of care to appropriate providers, consistent with the facility’s

policies and procedures developed in accordance with Part 5.2(E) of these rules.

(C)

Lactation and infant feeding supportive practices.

(D)

The availability of clinical providers 24 hours per day, 7 days per week.

8.2

Provision of Care

(A)

All persons registered as clients of the facility shall be under the care of clinical providers.

(B)

Prenatal Care

(1)

Clients shall be educated on the following, at a minimum:

(a)

Anticipated changes during pregnancy.

(b)

The signs of preterm labor.

(c)

Preparation for labor and delivery, including pain management and

potential obstetrical complications and procedures.

(d)

Feeding options and care of the newborn, including infant safe sleep

practices.

(e)

Signs of depression during pregnancy and after childbirth.

Clients shall be educated on the following, at a minimum:

(a)

Anticipated changes during pregnancy.

(b)

The signs of preterm labor.

(c)

Preparation for labor and delivery, including pain management and

potential obstetrical complications and procedures.

(d)

Feeding options and care of the newborn, including infant safe sleep

practices.

(e)

Signs of depression during pregnancy and after childbirth.

(f)

Preparation needed prior to discharging the client and the newborn

following delivery, including referrals associated with ensuring the

continuity of care.

(2)

Each client shall have a plan of care developed by their team of clinical

providers. The plan shall identify the care to be provided and the need for

postpartum services. The client shall be involved in reassessments and revisions

of the plan that may be required.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

12

(3)

Each client shall undergo prenatal testing in accordance with professional

standards of care and all applicable state laws and regulations.

(C)

Care During Labor and Delivery

(1)

The facility shall ensure compliance with informed consent requirements in 6

CCR 1011-1, Chapter 2, for each client upon their arrival to the facility.

(2)

The facility shall ensure regular and appropriate assessment of the client and

fetus is provided throughout labor by staff with appropriate clinical privileges, in

accordance with national standards.

(3)

Anesthesia shall be limited to local anesthesia for episiotomies and repair of

lacerations. Such anesthesia shall only be administered by a clinical provider or

auxiliary staff member whose clinical privileges include such administration.

(4)

The facility may provide nitrous oxide for client use as an analgesic, in

compliance with national standards.

(D)

Postpartum Care. Care during the postpartum period shall include, but not be limited to:

(1)

Postpartum Client

(a)

Postpartum physical assessments and follow up care.

dministered by a clinical provider or

auxiliary staff member whose clinical privileges include such administration.

(4)

The facility may provide nitrous oxide for client use as an analgesic, in

compliance with national standards.

(D)

Postpartum Care. Care during the postpartum period shall include, but not be limited to:

(1)

Postpartum Client

(a)

Postpartum physical assessments and follow up care.

(b)

Screening and referral for postpartum depression.

(2)

Newborn Client

(a)

Newborn assessments and follow up care.

(b)

Eye prophylaxis in accordance with Section 25-4-301, C.R.S.

(c)

Newborn screenings in accordance with current standards of practice,

Section 25-4-1001, et seq., C.R.S., and state regulations.

(i)

If the facility does not provide newborn hearing screening, it shall

provide information regarding where parents may have their

infants’ hearing screened and the importance of such screening.

(ii)

For the purposes of compliance with Section 25-4-1004.3,

C.R.S., critical congenital heart defect screening performed by

the facility between 24 and 48 hours post-birth shall be

considered to have been performed prior to the newborn’s

release from the birth center.

(iii)

For the purposes of compliance with 5 CCR 1004-4, Part 2.2.1.2,

blood specimens collected between 24 and 48 hours post-birth

shall be considered to have been collected prior to the newborn’s

discharge from the birth center.

(d)

Any newborn identified with abnormalities shall be referred for

appropriate follow up, in accordance with facility policy. The facility shall

transfer birth and newborn records to the care provider(s) upon request.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

een collected prior to the newborn’s

discharge from the birth center.

(d)

Any newborn identified with abnormalities shall be referred for

appropriate follow up, in accordance with facility policy. The facility shall

transfer birth and newborn records to the care provider(s) upon request.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

13

8.3

If client care deviates from the facility’s policies and procedures, the facility shall document the

reason for the deviation in the client’s record.

PART 9 – EMERGENCY CARE AND TRANSFERS

9.1

The facility shall have policies and procedures regarding emergency care and emergent and non-

emergent transfers. The policies and procedures shall be developed by the clinical director and

approved by the governing body and include, but not be limited to, the following:

(A)

Emergency care provided by the facility within its scope of services.

(B)

Equipment, pharmaceuticals, and other supplies to provide emergency care for at least

two simultaneous emergency events, in accordance with national birth center standards.

(C)

Storage of equipment, pharmaceuticals, and other supplies needed for emergency care

to ensure they are readily accessible by all clinical providers and auxiliary staff with the

appropriate clinical privileges at all times.

(D)

The facility’s written plan for emergent and non-emergent transport of clients to a

hospital. The plan shall:

(1)

Include specific examples denoting emergency and non-emergent conditions

consistent with national standards for birth centers, and their applicable transport

methods.

(2)

Require clients with emergency conditions be transported by emergency medical

services (EMS) to the nearest hospital capable of providing the appropriate level

of care.

(3)

Address the transfer of information required for proper care and treatment of the

individual(s) transferred, including client health records.

ith national standards for birth centers, and their applicable transport

methods.

(2)

Require clients with emergency conditions be transported by emergency medical

services (EMS) to the nearest hospital capable of providing the appropriate level

of care.

(3)

Address the transfer of information required for proper care and treatment of the

individual(s) transferred, including client health records.

(4)

Include processes to ensure the security and accountability of the personal

effects of the individual(s) being transferred.

(5)

Include procedures for communication with the receiving hospital.

9.2

The facility shall transfer an intrapartum, postpartum, or newborn client who requests transfer

from the facility to a hospital in accordance with the facility’s written emergent and non-emergent

transport plan.

9.3

The facility shall transfer an intrapartum, postpartum, or newborn client to a hospital in

accordance with the facility’s written emergent and non-emergent transport plan if:

(A)

The client is admitted with any conditions that preclude birth center delivery by the clinical

providers available to be physically present at the facility;

(B)

The client develops or displays any condition that national birth center standards indicate

as necessitating transfer; or

(C)

The client develops or displays any complication beyond the facility’s scope of services

determined by the governing body in accordance with Part 3.3(A).

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

ity;

(B)

The client develops or displays any condition that national birth center standards indicate

as necessitating transfer; or

(C)

The client develops or displays any complication beyond the facility’s scope of services

determined by the governing body in accordance with Part 3.3(A).

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

14

9.4

If emergency care or emergent or non-emergent transfers or communications deviate from the

facility’s policies and procedures, the facility shall document the reason for the deviation in the

client’s record.

PART 10 – REGISTRATION, ADMISSION, AND DISCHARGE

10.1

The facility shall have policies and procedures for client registration, admission, and discharge

consistent with this Part 10, developed by the clinical director and approved by the governing

body.

10.2

Registration and Continuing Services

(A)

Eligibility for registration and continued services at the facility shall be determined by a

clinical provider, who has evaluated the client and determined they meet the facility’s

criteria as set forth in policies as required in Part 10.2(B).

(B)

Registration as a client of the facility and eligibility for continued services and admission

shall be limited to pregnant persons who meet all of the following:

(1)

Have a low-risk pregnancy according to the facility’s policies and procedures for

evaluating risk. Such policies and procedures shall be consistent with national

birth center standards of care for evaluating risk, and include, at a minimum;

(a)

Clearly delineated prenatal high-risk factors that preclude eligibility for

registration and admission as well as continued services at the facility;

and

(b)

Social, medical, obstetric, fetal, and/or neonatal risk factors which

exclude persons from the low-risk intrapartum group.

(2)

Are expected to have a normal, uncomplicated course of pregnancy and labor,

as indicated by the following:

(a)

Prenatal and intrapartum history,

(b)

Physical examination, and

eligibility for

registration and admission as well as continued services at the facility;

and

(b)

Social, medical, obstetric, fetal, and/or neonatal risk factors which

exclude persons from the low-risk intrapartum group.

(2)

Are expected to have a normal, uncomplicated course of pregnancy and labor,

as indicated by the following:

(a)

Prenatal and intrapartum history,

(b)

Physical examination, and

(c)

Laboratory screening procedures.

(3)

Agree to remain at the facility postpartum until the facility’s discharge criteria are

met or transfer is required in accordance with the facility’s policies required by

Part 9 of these rules.

(C)

Registered clients must meet registration criteria as set forth in subpart (B), above, to be

admitted to the facility during labor.

(1)

Registered clients whose risk factors or other assessments render them

potentially ineligible for continued care at and/or admission to the facility shall be

referred to other providers for further assessment or care as indicated by national

birth center standards.

(A)

The client may remain a registered client at the facility until the

determination is made that the client is not appropriate for admission to

the facility during labor.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

15

(B)

To ensure continuity of care, if it is determined that the client is not

appropriate for admission to the facility during labor, the client may

remain a registered client until care can be transferred to an appropriate

provider. In such cases, the facility shall:

ty during labor.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

15

(B)

To ensure continuity of care, if it is determined that the client is not

appropriate for admission to the facility during labor, the client may

remain a registered client until care can be transferred to an appropriate

provider. In such cases, the facility shall:

(i)

Document the plan for transferring care to another provider,

(ii)

Document the client’s understanding that they cannot be

admitted to the facility during labor,

(iii)

Continue providing care as needed until the transfer of care is

complete.

(D)

The facility shall document disclosure of the following to registered clients prior to

admission:

(1)

An explanation of the facility’s scope of services, including pharmaceutical,

diagnostic, and newborn screening capabilities.

(2)

An explanation of the services outside the facility’s scope of services, including

types of anesthesia, pharmaceutical or diagnostic services, and newborn

screening.

(3)

The facility’s consultation, collaboration, and referral policies and procedures for

client’s needs beyond the services provided by the facility.

(4)

The risks, benefits, and eligibility requirements for care at the facility.

(5)

The facility’s plan for provision of emergency and non-emergency care in the

event of complications with client or newborn, the facility’s emergent and non-

emergent transport plan, and a statement of the estimated time to and location of

the nearest hospital for care of the client and newborn.

(6)

A written statement of fees for services and responsibilities for payment.

care at the facility.

(5)

The facility’s plan for provision of emergency and non-emergency care in the

event of complications with client or newborn, the facility’s emergent and non-

emergent transport plan, and a statement of the estimated time to and location of

the nearest hospital for care of the client and newborn.

(6)

A written statement of fees for services and responsibilities for payment.

(7)

The facility’s client rights policies required by Part 7 of these rules.

10.3

Admission

(A)

Admission shall be limited to registered clients who have previously signed disclosure

documents in accordance with Part 10.2(D) and have received prenatal care in

accordance with facility policies.

(B)

A registered client experiencing physiologic birth shall only be admitted to the facility by a

clinical provider.

(1)

Any client admitted with a condition that is beyond the clinical privileges of the

clinical providers available to be physically present at the facility shall be

transferred to a hospital in accordance with Part 9.

10.4

Discharge

(A)

The facility shall have discharge policies and procedures, including criteria that must be

met by the client and newborn in order to be eligible for discharge, based on national

birth center standards of care.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

16

(B)

Clients and newborns shall not be discharged from the facility until they meet the facility’s

discharge criteria, as determined by a clinical provider.

(C)

The facility shall both review verbally and provide the client with an individualized,

discharge plan collaboratively developed by the facility’s providers, staff, and the client,

including, at a minimum:

(1)

Information about follow up visits, including a scheduled follow-up visit within 24-

48 hours post-discharge in order to complete critical congenital heart defect

screening as required by Section 25-4-1004.3, C.R.S., and collect a blood

specimen in compliance with 5 CCR 1004-4, Part 2.2.1.2.

collaboratively developed by the facility’s providers, staff, and the client,

including, at a minimum:

(1)

Information about follow up visits, including a scheduled follow-up visit within 24-

48 hours post-discharge in order to complete critical congenital heart defect

screening as required by Section 25-4-1004.3, C.R.S., and collect a blood

specimen in compliance with 5 CCR 1004-4, Part 2.2.1.2.

(2)

Referrals for continuing care for both the client and the newborn.

(3)

Relevant portions of the newborn’s records.

(4)

Instructions on requesting copies of newborn records for pediatric care providers.

(D)

The facility shall file birth certificates with the state registrar in accordance with Section

25-2-112, C.R.S.

(E)

The facility shall make a list of counselors and counseling services available to each

client known to be considering relinquishing or terminating parental rights, and to any

other family or support person designated by the client prior to discharge.

PART 11 – CLIENT RECORDS

11.1

The facility shall develop and follow client health records policies and procedures. Such policies

and procedures shall be approved by the governing body and ensure such records are:

(A)

Legible, uniform, complete, and accurate for every client from registration through

conclusion of postpartum appointments and include information in accordance with

national birth center standards and this Part 11.

(B)

Readily accessible to clinical providers, auxiliary staff, and clients.

(C)

Maintained in a system that provides for safe storage, retrieval, privacy, and security in

accordance with national birth center standards and all applicable state and federal laws

and regulations.

(D)

Standardized with regard to the methodology for recording information.

(E)

Retained as follows:

ards and this Part 11.

(B)

Readily accessible to clinical providers, auxiliary staff, and clients.

(C)

Maintained in a system that provides for safe storage, retrieval, privacy, and security in

accordance with national birth center standards and all applicable state and federal laws

and regulations.

(D)

Standardized with regard to the methodology for recording information.

(E)

Retained as follows:

(1)

For persons age 18 years or older before registration as a client of the facility,

health information records shall be preserved as original records, on microfilm, or

as electronic records for no less than seven years after the most recent client

care encounter, after which time records may be destroyed at the discretion of

the facility.

(2)

For persons under 18 years of age at registration as a client of the facility, health

information shall be preserved until 10 years after the client’s 18th birthday.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

17

11.2

Each client’s record, including each newborn’s client record, shall be available separately and

include complete health information from the time of registration through conclusion of

postpartum appointments.

(A)

All entries into the record shall be dated, timed, and signed by the appropriate personnel.

(B)

All orders for diagnostic procedures, treatments, and medications shall be signed by the

clinical provider or other authorized licensed practitioner submitting them.

(C)

The record shall contain accurate documentation of significant clinical information

pertaining to the client and newborn sufficiently detailed and organized in such a manner

to enable:

(1)

Another practitioner to assume care of the client or newborn at any time.

(2)

Evaluation of the quality of client care as part of the facility’s quality management

program.

(3)

Clinical providers and auxiliary staff with the appropriate clinical privileges to

utilize the record to instruct the client and family members.

nd newborn sufficiently detailed and organized in such a manner

to enable:

(1)

Another practitioner to assume care of the client or newborn at any time.

(2)

Evaluation of the quality of client care as part of the facility’s quality management

program.

(3)

Clinical providers and auxiliary staff with the appropriate clinical privileges to

utilize the record to instruct the client and family members.

(4)

Clinical providers and auxiliary staff with the appropriate clinical privileges to

determine risk factors throughout the pregnancy, labor, delivery, and postpartum

period.

(D)

Identify the family member or support person, as designated by the registered client, who

will care for the newborn in the event that the birthing client and newborn are separated,

if available.

(E)

Newborn records shall include, at a minimum:

(1)

Date and time of birth, birth weight and length, period of gestation, sex, and

condition of infant on delivery (including Apgar and any resuscitative measures

taken).

(2)

Record of administered medications and immunizations.

(3)

Physical examination at birth and at discharge.

(4)

Results of newborn screening in accordance with national birth center standards

and state laws and regulations, or documentation of the newborn’s parent or

guardian declining such tests.

(5)

Newborn monitoring record.

(6)

Copy of birth certificate worksheet.

(7)

Any complications, referrals, and transfers.

(8)

Discharge summary.

11.3

Central Log. The facility shall maintain a log for registering client admissions and births, with

information about the birthing client and the newborn. The log shall include the following, as

applicable:

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

18

(A)

Admitted Client.

(1)

Name.

(2)

Date of delivery.

(3)

Time of delivery.

(4)

Type of delivery.

(5)

Transfer information, if applicable:

(a)

Mode of transfer, i.e, EMS or other.

(b)

Reason for transfer.

hing client and the newborn. The log shall include the following, as

applicable:

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

18

(A)

Admitted Client.

(1)

Name.

(2)

Date of delivery.

(3)

Time of delivery.

(4)

Type of delivery.

(5)

Transfer information, if applicable:

(a)

Mode of transfer, i.e, EMS or other.

(b)

Reason for transfer.

(c)

Outcome after transfer.

(B)

Newborn Client.

(1)

Name, if available.

(2)

Sex.

(3)

Weight.

(4)

Gestational age.

(5)

Apgar score.

(6)

Transfer information, if applicable:

(a)

Mode of transfer, i.e, EMS or other.

(b)

Reason for transfer.

(c)

Outcome after transfer.

11.4

Access to Records

(A)

The facility shall:

(1)

Provide a copy of the newborn’s records to a pediatric care provider upon

request by the client or the provider.

(2)

Comply with the provisions of 6 CCR 1011-1, Chapter 2, Part 6, Access to Client

Records, for all records.

PART 12 – LABORATORY SERVICES

12.1

Clinical laboratory services shall be available to meet client needs.

(A)

Clinical laboratory services may be provided by the facility on-site or through contract

with a laboratory at another location.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

19

(B)

All laboratories providing services to clients, whether on-site or contracted, shall meet the

requirements of the “Clinical Laboratory Improvement Amendments of 1988,” 42 USC §

263a, and the corresponding regulations at 42 CFR Part 493.

PART 13 – PHARMACEUTICAL SERVICES

13.1

The facility shall maintain an inventory of medications and intravenous fluids sufficient to care for

the pregnant/birthing clients and newborns registered for care.

13.2

The facility shall have and follow policies and procedures for the storage, dispensing, and

administration, and disposal of medications and intravenous fluids, as developed by the clinical

director at Part 5.2(D) and approved by the governing body in accordance with part 3.4(B)

ations and intravenous fluids sufficient to care for

the pregnant/birthing clients and newborns registered for care.

13.2

The facility shall have and follow policies and procedures for the storage, dispensing, and

administration, and disposal of medications and intravenous fluids, as developed by the clinical

director at Part 5.2(D) and approved by the governing body in accordance with part 3.4(B). Such

policies and procedures shall:

(A)

Comply with professional standards of practice and applicable state and federal laws and

regulations, including but not limited to, 21 CFR Section 1300, et seq., pertaining to

federal drug enforcement administration requirements for controlled substances.

(B)

Require that medications and intravenous fluids be administered only by a clinical

provider or auxiliary or contracted staff member with such administration included in their

clinical privileges.

(C)

Include procedures for monitoring the expiration date of all medications.

(D)

Ensure medications and intravenous fluids maintained in the facility are appropriately

stored and safeguarded against diversion or access by unauthorized persons.

(E)

Require all medications and intravenous fluids be disposed of in accordance with federal

and state laws and regulations and that appropriate records be kept regarding the

disposal.

(F)

Include the following requirements regarding controlled substances:

(1)

Controlled substances shall be maintained in double-locked, secured cabinets.

There shall be a written procedure for maintaining accountability and monitoring

for diversion.

travenous fluids be disposed of in accordance with federal

and state laws and regulations and that appropriate records be kept regarding the

disposal.

(F)

Include the following requirements regarding controlled substances:

(1)

Controlled substances shall be maintained in double-locked, secured cabinets.

There shall be a written procedure for maintaining accountability and monitoring

for diversion.

(2)

On-site destruction of controlled substances shall be witnessed and documented

in writing by two clinical providers and destroyed in a manner that renders the

controlled substances totally irretrievable.

PART 14 – EQUIPMENT AND SUPPLIES

14.1

Each facility shall maintain an inventory of equipment and supplies sufficient to care for the

facility’s pregnant/birthing clients and their newborns.

14.2

The facility shall be equipped with those items needed to provide low-risk maternity care and shall

have readily accessible equipment and supplies to:

(A)

Perform initial and ongoing assessment of the client and fetus.

(B)

Provide care during birth, including repair of lacerations and management of uterine

atony.

(C)

Perform evaluation and, if necessary, resuscitation of the newborn.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

20

(D)

Perform screening and ongoing assessment of the newborn.

(E)

Provide oxygen supplementation for the birthing client or newborn as needed.

(F)

Establish and provide intravenous access and fluids, as needed.

14.3

The facility shall have readily accessible equipment, pharmaceuticals, and other supplies as

needed to carry out the facility’s emergency care policies and procedures in accordance with Part

9.1.

14.4

The facility shall have a system to monitor the readiness of all equipment, pharmaceuticals

(medications and intravenous fluids), and supplies, including the following:

(A)

Maintaining and testing all equipment in accordance with manufacturer’s instructions.

(B)

Written logs of maintenance and testing for all equipment

lity’s emergency care policies and procedures in accordance with Part

9.1.

14.4

The facility shall have a system to monitor the readiness of all equipment, pharmaceuticals

(medications and intravenous fluids), and supplies, including the following:

(A)

Maintaining and testing all equipment in accordance with manufacturer’s instructions.

(B)

Written logs of maintenance and testing for all equipment.

(C)

Monitoring expiration dates on supplies, as applicable.

14.5

Supplies such as needles, syringes, and prescription pads shall be appropriately stored to avoid

public access.

PART 15 – FOOD SERVICES

15.1

Safe food storage and preparation practices shall be followed, in accordance with policies and

procedures developed by the facility. Such policies and procedures shall:

(A)

Require that refrigerators used for food storage be separate from refrigerators used to

store any medications, laboratory specimens, or biohazardous waste.

(B)

Require that food brought into the facility by clients and stored in a facility’s communal

refrigerator be labeled with the client’s name and be consumed only by the client.

PART 16 – HOUSEKEEPING SERVICES

16.1

Each facility shall provide housekeeping services which ensure a safe and sanitary environment.

If the facility contracts with an outside vendor to provide housekeeping services, there shall be a

written agreement regarding the services and the facility shall be ultimately responsible for quality

control of the contractor.

16.2

Written policies and procedures shall be established and followed which ensure adequate

cleaning and/or disinfection of the facility and equipment.

16.3

All cleaning materials, solutions, cleaning compounds, and hazardous substances shall be

properly identified and stored in accordance with manufacturer’s instructions.

16.4

All waste containers in client care areas shall be waterproof, lined, and clean.

16.5

All personnel shall wash their hands immediately after handling waste

equate

cleaning and/or disinfection of the facility and equipment.

16.3

All cleaning materials, solutions, cleaning compounds, and hazardous substances shall be

properly identified and stored in accordance with manufacturer’s instructions.

16.4

All waste containers in client care areas shall be waterproof, lined, and clean.

16.5

All personnel shall wash their hands immediately after handling waste.

PART 17 – LAUNDRY AND LINENS

17.1

The facility shall make arrangements for the cleaning of linen and laundry either on the premises

or per contractual arrangement.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

21

17.2

The facility shall develop and implement written policies and procedures for the handling, storage,

and transporting of clean and soiled linen that prevents contamination.

17.3

Linen shall be cleaned in a manner that prevents contamination and laundry chemicals shall be

used in accordance with manufacturer’s instructions. Linen shall be maintained in good repair.

17.4

A facility with laundry service on the premises shall have space and equipment for the safe and

effective operation of a laundry service. There shall be distinct areas for the separate storage and

handling of clean and soiled linens.

PART 18 – PHYSICAL PLANT STANDARDS

18.1

Any construction or renovation of a birth center initiated on or after July 1, 2020, shall conform to

Part 3 of 6 CCR 1011-1, Chapter 2, unless otherwise specified in this current Chapter.

18.2

Birthing Room

(A)

Each birthing room shall be maintained in a condition which is adequate and appropriate

to provide for the equipment, staff, supplies, and emergency procedures required for the

physical and emotional care of a client, the client’s designated family member or support

person, and the newborn during birth, labor, and the recovery period

erwise specified in this current Chapter.

18.2

Birthing Room

(A)

Each birthing room shall be maintained in a condition which is adequate and appropriate

to provide for the equipment, staff, supplies, and emergency procedures required for the

physical and emotional care of a client, the client’s designated family member or support

person, and the newborn during birth, labor, and the recovery period.

(B)

Birthing rooms shall be located to provide unimpeded, rapid access to an exit of the

building that will accommodate emergency transportation vehicles and equipment.

(C)

Birth centers are exempt from the FGI requirement for an outside window in the birthing

room.

18.3

Doors

(A)

Doors providing entry/exit and access into the facility and birth room(s) shall be of

adequate width and/or configuration to accommodate maneuvering of ambulance

stretchers and wheelchairs and other emergency equipment.

(B)

The doors to the toilets in labor, delivery and postpartum care areas for client use shall

have hardware that allows staff emergency access.

PART 19 – INTERIOR AND EXTERIOR ENVIRONMENT

19.1

The facility shall develop and implement written policies and procedures for a maintenance

program to keep the facility in good repair and to provide for the safety, welfare, and comfort of

the occupants of the building.

19.2

The facility shall eliminate hazards to clients and visitors. In areas accessible to children,

elimination of hazards shall include, but not be limited to, uncovered electrical outlets.

19.3

The facility shall develop and implement written policies and procedures to provide for effective

control and eradication of vermin. All openings to the outer air shall be effectively protected

against the entrance of vermin by self-closing doors, closed windows, screens, controlled air

currents, or other effective means.

PART 20 - WASTE STORAGE AND DISPOSAL

20.1

Facilities shall manage, transport, and dispose of medical waste in accordance with the state

solid waste regulations, 6 CCR 1007-2, Part 1.

and eradication of vermin. All openings to the outer air shall be effectively protected

against the entrance of vermin by self-closing doors, closed windows, screens, controlled air

currents, or other effective means.

PART 20 - WASTE STORAGE AND DISPOSAL

20.1

Facilities shall manage, transport, and dispose of medical waste in accordance with the state

solid waste regulations, 6 CCR 1007-2, Part 1.

CODE OF COLORADO REGULATIONS

6 CCR 1101-1 Chapter 22

Health Facilities and Emergency Medical Services Division

22

20.2

Facilities that generate waste, including medical waste, shall conduct a hazardous waste

determination in accordance with Part 261 of the state hazardous waste regulations, 6 CCR

1007-3. If the facility generates hazardous waste, it shall manage, transport, and dispose of such

waste in accordance with 6 CCR 1007-3.