Section 264.1000  Scope and Purpose

 

a)         The purpose of this Part is to implement the Birth Center Licensing Act, which requires birth centers to be licensed by the Department.

 

b)         This Part establishes general provisions, licensing procedures, building requirements, enforcement provisions, and operational and clinical standards for the provision and coordination of treatment and services in birth centers.

 

c)         Nothing in this Part shall be construed to prohibit a facility licensed as a birth center from offering other reproductive health care subject to any applicable laws, rules, regulations, or licensing requirements for those services.  In this subsection (c), "reproductive health care" has the same meaning as used in Section 1-10 of the Reproductive Health Act. (Section 30(b) of the Act)

 

Section 264.1050  Definitions

 

Act – Birth Center Licensing Act.

 

Adequate – enough in either quantity or quality, as determined by a reasonable person familiar with the professional standards of the subject under review, to meet the needs of the clients of a birth center under the set of circumstances in existence at the time of review.

 

Administrative Perinatal Center or APC – a referral facility intended to care for the high-risk client before, during, or after labor and delivery and characterized by sophistication and availability of personnel, equipment, laboratory, transportation techniques, consultation and other support services.  An APC is a university or university-affiliated hospital designated by the Department as a Level III hospital that receives financial support from the Department to provide leadership and oversight of the Regionalized Perinatal Healthcare Program.

 

Administrator – the person who is directly responsible for the operation and administration of the birth center, irrespective of the person's assigned title.

 

Advanced practice registered nurse or APRN – a person who has met the qualifications for a certified nurse midwife (CNM); certified nurse practitioner (CNP); certified registered nurse anesthetist (CRNA); or clinical nurse specialist (CNS) and has been licensed by the Department of Financial and Professional Regulation. (Section 50-10 of the Nurse Practice Act)

 

Antepartum – the period before labor or childbirth.

 

Applicant – any person, acting individually or with any other person, who proposes to build, own, establish or operate a birth center.

 

Birth assistant – a licensed certified professional midwife or a person licensed or certified in Illinois by the Department of Financial and Professional Regulation in a health-related field and under the supervision of a physician, a certified nurse midwife, or a licensed certified professional midwife who in attendance, has specialized training in labor and delivery techniques and care of newborns; and receives planned and ongoing training as needed to perform assigned duties effectively. (Section 25(d) of the Act)

 

Birth attendant – an obstetrician, family practitioner (family physician) physician, certified nurse midwife, or licensed certified professional midwife shall attend each person in labor from the time of admission through birth and throughout the immediate postpartum period. (Section 25(c) of the Act)

 

Birth center or center – a designated site, other than a hospital:

 

in which births are planned to occur following a normal, uncomplicated, and low risk pregnancy;

 

that is not the pregnant person’s usual place of residence;

 

that is dedicated to serving the childbirth-related needs of pregnant persons and their newborns, and has no more than 10 beds;

 

that offers prenatal care and community education services and coordinates these services with other health care services available in the community; and

 

that does not provide general anesthesia or surgery (except as allowed per Sections 264.1800(h) and (i). (Section 5 of the Act)

 

Birthing person – an individual who is pregnant or in labor.

 

Birth room – a room specifically designed and equipped for a single occupancy client to give birth under the care of birth attendant.

 

Birth unit – several birth rooms grouped or clustered around a central area/station that maintains direct supervision (electronic supervision is not permitted) of the birth rooms.

 

Certified nurse midwife or CNM – an advanced practice registered nurse licensed in Illinois under the Nurse Practice Act with full practice authority or who is delegated such authority as part of a written collaborative agreement with a physician who is associated with the birthing center or who has privileges at a nearby birthing hospital.  (Section 5 of the Act)

 

Charitable care – the intentioned provision of free or discounted birth center services to persons who cannot afford to pay for the services.

 

Client – a person who receives services provided at the birth center and the infant of that birth.

 

Clinical director – a physician who is either certified or eligible for certification by the American College of Obstetricians and Gynecologists or the American Board of Osteopathic Obstetricians and Gynecologists or has hospital obstetrical privileges; or a certified nurse midwife (CNM) (Section 25 of the Act) who provides guidance, leadership, oversight, and quality assurance to the birth center.

 

Close proximity –a distance which allows a person to be physically present in a place within 30 minutes after being called.

 

Community education services – information and education provided to the pregnant person and their family, during both early and late pregnancy, that promote healthy outcomes for the pregnant person and their infant and postpartum period. 

 

Department – the Illinois Department of Public Health. (Section 5 of the Act)

 

Governing body – a board of trustees, governing board, board of directors or other body or individual responsible for governing a birth center.

 

Gravidity and Parity or GP – the number of times a person has been pregnant (gravidity) and carried the pregnancies to a viable gestational age (parity).

 

Health-related field – either a registered nurse, certified professional midwife or licensed practical nurse, or other classifications that are licensed, registered, or certified by the Illinois Department of Financial and Professional Regulation.

 

High-risk client – a person, fetus, or newborn with an increased level of risk of harm or mortality from congenital and/or environmental factors.

 

Hospital – a facility licensed under the Hospital Licensing Act. "Hospital" does not include places where pregnant females are received, cared for, or treated during delivery if it is in a licensed birth center, nor includes any facility required to be licensed as a birth center.  (Section 5 of the Act)

 

Immediate postpartum period – the first 24 hours after childbirth.  This period refers to the time just after childbirth, during which the infant's physiology adapts and the risks to the pregnant person of postpartum hemorrhage and other significant morbidity are highest.

 

Inspection – any survey, evaluation, or investigation of the birth center's compliance with the Act and this Part by the Department or designee.

 

Intrapartum – the time from the onset of labor until the delivery of the infant and placenta.

 

Licensed certified professional midwife – a person who has successfully met the requirements under Section 45 of the Licensed Certified Professional Midwife Practice Act and holds an active license to practice as a licensed certified professional midwife in Illinois.  (Section 5 of the Act)

 

Licensee – the person or entity licensed to operate the birth center.

 

Low-risk pregnancy – a pregnancy that, based on history, application of risk criteria per subsection 264.1550(g), and adequate prenatal care, is broadly predicted to have a normal, uncomplicated outcome.

 

Medical care facility – a hospital, birthing center, and any other licensed facility that provides obstetrical and newborn nursery services. (Section 2 of the Early Hearing Detection and Intervention Act)

 

Newborn infant or newborn or infant – an infant who is delivered at the birth center or a referral hospital following transfer from the birth center.

 

Nurse – a registered nurse or licensed practical nurse as defined in the Nurse Practice Act.

 

Obstetrician – a physician who is certified or eligible for certification by the American Board of Obstetricians and Gynecologists.

 

Operator – the person responsible for the control, maintenance and governance of the birth center, its personnel and physical plant.

 

Owner – the individual, partnership, corporation, or other person who owns the birth center.

 

Physician – a physician licensed to practice medicine in all its branches in Illinois.  (Section 5 of the Act)

 

Postpartum person – an individual who gave birth at the birth center or who was transferred to a referral hospital.

 

Pregnant person – an individual with a developing embryo, fetus, or unborn child within their body.

 

Prenatal care – medical care for a pregnant person and their fetus throughout their pregnancy.

 

Program narrative – a description of the center's proposed operation, which clarifies or explains choices related to space, equipment, finishes, or other specifications in the architectural plans (See Section 264.2700). 

 

Quality assurance – an ongoing, objective, and systematic process of monitoring, evaluating, and improving the quality, appropriateness, and effectiveness of care.

 

Quality Assessment and Performance Improvement Program or QAPI – a systematic, comprehensive, and data-driven approach to maintaining and improving safety and quality in birth center services while involving all staff in practical and creative problem solving.  Quality assessment is the specification of standards for quality of service and outcomes, and is a process used throughout the organization to ensure care is maintained at acceptable levels in relation to those standards.  Performance improvement is the continuous study and improvement of processes with the intent to better services or outcomes, and to decrease the likelihood of problems, by identifying areas of opportunity.

 

Referral hospital – a hospital designated under the Regionalized Perinatal Health Care Code and intended to care for the high-risk client before, during, or after labor and delivery and characterized by sophistication and availability of personnel, equipment, laboratory, transportation techniques, consultation, and other support services.

 

Registered professional nurse or RN – a person who is licensed as a registered professional nurse under the Nurse Practice Act.

 

Risk assessment – a process by which historical, physical, and laboratory data are applied for the prediction of pregnancy outcome.

 

Sanitize – to destroy microorganisms by cleaning or disinfecting.

 

Sterilization – the use of a physical or chemical procedure to destroy all microbial life, including bacterial endospores.

 

Substantial compliance or substantially comply – meeting requirements, except for variance from the strict and literal performance that results in unimportant omissions or defects, given the circumstances involved. 

 

Supervision – authoritative procedural guidance by a qualified person for the accomplishment of a function or activity within his/her sphere of competence, with initial direction and periodic surveillance of the actual act of accomplishing the function or activity.

 

Support person – an individual who provides emotional support or help with relaxation techniques and comfort measures.

 

Survey – a detailed, complete inspection of the birth center.

 

Universal/standard precautions – as defined by the Centers for Disease Control and Prevention (CDC), recommendations designed to prevent transmission of human immunodeficiency virus (HIV), hepatitis B virus (HBV) and other blood borne pathogens when providing health care.

 

Vaginal delivery – a vaginal birth that occurs without assistance from forceps or a suction device.

 

Section 264.1100  Incorporated and Referenced Materials

 

a)         The following private and professional association standards are incorporated in this Part:

 

1)         FGI 2014 Guidelines for Design and Construction of Hospitals and Outpatient Facilities, available at:  https://shop.fgiguidelines.org/products/23 or from the American Institute of Architects (AIA) Academy of Architecture for Health, Facilities Guidelines Institute, PO Box 60628, Florence, MA  01062.

 

2)         The standards of the American Society of Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE), Handbook of Fundamentals (2009), which may be obtained from the American Society of Heating, Refrigerating, and Air-Conditioning Engineers, Inc., 180 Technology Parkway NW, Peachtree, GA  30092.

 

3)         The following standards of the National Fire Protection Association (NFPA), which may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA  02269:

 

A)        NFPA 101 (2012):  Life Safety Code and all appropriate references under Chapter 2, Referenced Publications

 

B)        NFPA 101A (2013): Guide on Alternative Approaches to Life Safety

 

4)         International Building Code (2012), which may be obtained from the International Code Council, 4051 Flossmoor Road, Country Club Hills, IL  60478.

 

5)         The American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, Guidelines for Perinatal Care, Eighth Edition (September 2017), which may be obtained from the American Academy of Pediatrics, 141 Northwest Point Boulevard, P.O. Box 927, Elk Grove Village, IL  60009-0927.

 

6)         The American Association of Birth Centers, Standards for Birth Centers (2017), available at:  https://assets.noviams.com/novi-file-uploads/aabc/downloads/AABC-STANDARDS-RV2017.pdf or from the American Association of Birth Centers, 3123 Gottschall Road, Perkiomenville, PA  18074.

 

7)         Commission for the Accreditation of Birth Centers, Indicators of Compliance with Standards for Birth Centers, Reference Edition 2.2 (April 1, 2020), available at:  https://www.birthcenteraccreditation.org/wp-content/uploads/2020/04/CABC_IndicatorsRefEd-2.2_2020-0401.pdf

 

8)         The Joint Commission, Perinatal Care Certification Review Process Guide, available at: https://www.jointcommission.org/-/media/tjc/documents/accred-and-cert/survey-process-and-survey-activity-guide/2022/2022-perinatal-care-organization-rpg.pdf (January 1, 2022)

 

9)         The Joint Committee on Infant Hearing (JCIH), Year 2019 Position Statement: Principles and Guidelines for Early Hearing Detection and Intervention Programs, available at:  https://digitalcommons.usu.edu/jehdi/vol4/iss2/1/ or from the American Speech-Language-Hearing Association (ASHA), 2200 Research Boulevard, Office 309, Rockville, MD  20850.

 

b)         The following federal guidelines from the Centers for Disease Control and Prevention are incorporated in this Part:

 

1)         Guideline for Hand Hygiene in Health-Care Settings; available at: https://www.cdc.gov/infectioncontrol/guidelines/hand-hygiene/index.html (October 25, 2002)

 

2)         Infection Control in Healthcare Personnel, available in two parts:  "Infrastructure and Routine Practices for Occupational Infection Prevention and Control Services" (October 25, 2019) and "Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients" (October 3, 2022), both available at: https://www.cdc.gov/infectioncontrol/guidelines/healthcare-personnel/index.html

 

c)         All incorporations by reference of federal guidelines and regulations and the standards of nationally recognized organizations refer to the regulations, guidelines, and standards on the date specified and do not include any later amendments or editions.

 

d)         The following federal laws are referenced in this Part:

 

1)         Title XVIII and Title XIX of the Social Security Act (42 U.S.C. 301 et seq., 1935 et seq., and 1936 et seq.)

 

2)         Clinical Laboratory Improvement Amendments (42 U.S.C. 1861 and 1902)

 

3)         Public Health Service Act (42 U.S.C. 254b)

 

e)         The following State laws and administrative rules are referenced in this Part:

 

1)         State of Illinois Statutes

 

A)        Birth Center Licensing Act [210 ILCS 170]

 

B)        Nurse Practice Act [225 ILCS 65]

 

C)        Medical Practice Act of 1987 [225 ILCS 60]

 

D)        Hospital Licensing Act [210 ILCS 85]

 

E)        Illinois Health Facilities Planning Act [20 ILCS 3960]

 

F)         Pharmacy Practice Act [225 ILCS 85]

 

G)        Illinois Administrative Procedure Act [5 ILCS 100]

 

H)        Medical Patient Rights Act [410 ILCS 50]

 

I)         Ambulatory Surgical Treatment Center Act [210 ILCS 5]

 

J)         Vital Records Act [410 ILCS 535]

 

K)        Infant Eye Disease Act [410 ILCS 215]

 

L)        Illinois Insurance Code [215 ILCS 5]

 

M)       Early Hearing Detection and Intervention Act [410 ILCS 213]

 

N)        Prenatal Syphilis Act [410 ILCS 320]

 

O)        Licensed Certified Professional Midwife Practice Act [225 ILCS 64]

 

P)         Newborn Metabolic Screening Act [410 ILCS 240]

 

Q)        Reproductive Health Act [775 ILCS 55]

 

2)         State of Illinois Administrative Rules

 

A)        Control of Communicable Diseases Code, Illinois Department of Public Health (77 Ill. Adm. Code 690)

 

B)        Control of Tuberculosis Code, Illinois Department of Public Health (77 Ill. Adm. Code 696)

 

C)        Practice and Procedure in Administrative Hearings, Illinois Department of Public Health (77 Ill. Adm. Code 100)

 

D)        Illinois Plumbing Code, Illinois Department of Public Health (77 Ill. Adm. Code 890)

 

E)        Illinois Accessibility Code, Illinois Capital Development Board (71 Ill. Adm. Code 400)

 

F)         Food Code, Illinois Department of Public Health (77 Ill. Adm. Code 750)

 

G)        Regionalized Perinatal Health Care Code, Illinois Department of Public Health (77 Ill. Adm. Code 640)

 

H)        Illinois Vital Records Code, Illinois Department of Public Health (77 Ill. Adm. Code 500)

 

I)         Perinatal HIV Prevention Code, Illinois Department of Public Health (77 Ill. Adm. Code 699)

 

J)         Special Waste Hauling, Illinois Pollution Control Board (35 Ill. Adm. Code 809)

 

K)        Newborn and Infant Screening and Treatment Code (77 Ill. Adm. Code 661)

 

L)        Universal Newborn Hearing Screening Program (89 Ill. Adm. Code 504)

 

f)         Illinois Department of Public Health (IDPH), Newborn Screening Practitioner's Manual (September 2015), available at:  https://dph.illinois.gov/content/dam/soi/en/web/idph/files/publications/publications-ohpm-practitioners-manual-2015-042116.pdf

 

Section 264.1200  Information Available for Public Inspection

 

a)         A birth center shall post the following information in plain view of the public:

 

1)         Its current license or a photocopy of the current license;

 

2)         A description of the birth center complaint procedures;

 

3)         The name, address and telephone number of a person authorized by the Department to receive complaints; 

 

4)         Client rights;

 

5)         Emergency exit routes;

 

6)         Rights relating to women, pregnancy, and childbirth per the Medical Patient Rights Act; and

 

7)         Information about domestic violence and human trafficking resources.

 

b)         A birth center shall make the following information or documents available upon request for public inspection:

 

1)         A copy of any order pertaining to the birth center issued by the Department or a court during the past five years;

 

2)         A complete copy of every inspection report that the birth center received from the Department during the past five years. This information shall not disclose the name of any health care professionals, employees, or clients at the center;

 

3)         A description of the services provided by the birth center and the rates charged for those services;

 

4)         A copy of the statement of ownership; and

 

5)         A complete copy of the report of the Department's most recent inspection of the birth center.  This information shall not disclose the name of any health care professionals, employees, or clients at the center.

 

Section 264.1250  General Requirements for Licensure

 

a)         No person shall open, manage, conduct, offer, maintain, or advertise as a birth center without a valid license issued by the Department.  All birth centers in existence as of September 1, 2023 shall obtain a valid license to operate by September 1, 2025.  (Section 10 of the Act)

 

b)         A birth center shall obtain a certificate of need from the Health Facilities and Services Review Board under the Health Facilities Planning Act before receiving a license by the Department under the Act.  (Section 17(a) of the Act)

 

c)         A birth center shall have no more than 10 beds.

 

d)         Each license shall specify the licensed bed capacity of the birth center. If, after obtaining an initial certificate of need under subsection (a), a birth center seeks to increase the bed capacity of the birth center, the birth center must obtain a certificate of need from the Health Facilities and Services Review Board before increasing bed capacity and obtain approval from the Department before operating expanded beds.  (Section 17(b) of the Act)

 

e)         Proposed changes in birth center licensed bed capacity shall be submitted in writing to the Department and shall be subject to the approval of the Department based upon need and compliance with Subpart B of this Part.

 

f)         A birth center shall be a designated site that is away from the pregnant person’s usual place of residence and in which births are planned to occur following a normal, uncomplicated, and low-risk pregnancy. 

 

g)         A birth center shall offer prenatal care and community education services and shall coordinate these services with other health care services available in the community.  (Section 5 of the Act)

 

h)         A birth center shall seek certification under Titles XVIII and XIX of the federal Social Security Act.  (Section 40(a) of the Act)

 

i)          Each birth center must become accredited by either the Commission for the Accreditation of Freestanding Birth Centers or the Joint Commission within two years after becoming licensed.  (Section 35 of the Act)

 

j)          Each birth center shall have all agreements as required in Section 264.2250.

 

k)         No person or place shall represent itself as a "birth center" or use the term "birth center" in its title, advertising, publications, or other form of communication unless licensed as a birth center in accordance with this Part.

 

l)          Procedures performed at birth centers shall be limited to those normally accomplished in uncomplicated childbirth, including repairs of obstetric lacerations performed in accordance with the birth attendant's or birth assistant's scope of practice (See Section 264.1550).  Surgical procedures such as tubal ligation are prohibited at birth centers.

 

m)        A birth center may not discriminate against any client requiring treatment because of the source of payment for services, including Medicare and Medicaid recipients.  (Section 40(d) of the Act)

 

n)         The clinical director, or their designee, shall be available on the premises or within close proximity.

 

o)         The birth center license shall be prominently displayed in an area visible to the public.

 

p)         A change of ownership will require a new application.

 

q)         The Department will issue a license under the Act and this Part if, after application, inspection, and investigation, it finds the applicant meets the requirements of the Act and this Part.  (Section 15(c) of the Act)

 

1)         The license shall not be transferable; it is issued to the licensee and for the specific location and number of beds identified in the license.

 

2)         The license shall become automatically void and shall be returned to the Department if the birth center's license is revoked, nonrenewed or relinquished, denied, forfeited, or suspended.

 

r)          The birth center shall provide oral and written information for all languages spoken by the significant population(s) being served by the facility as per the recommendations of the Commission for the Accreditation of Birth Centers.

 

Section 264.1300  Application for Initial and Renewal License

 

a)         An applicant for a license to establish or operate a birth center under the Act shall submit an application on forms prescribed by the Department.  (Section 15(a) of the Act).

 

b)         The application shall be accompanied by a copy of the Certificate of Need to establish and operate a birth center issued by the Health Facilities and Services Review Board under the Illinois Health Facilities Planning Act.

 

c)         Application forms and other required information shall be submitted and approved pursuant to Subpart B of this Part, prior to surveys of the physical plant or review of building plans and specifications, and prior to submission of the license application.

 

d)         Each application shall be accompanied by a non-refundable license application fee of $500 plus $100 for each licensed birthing bed. (Section 15(a) of the Act)

 

e)         The application shall contain, at a minimum, the following information:

 

1)         The name, address, and telephone number of the applicant, if the applicant is an individual; in the case of a firm, partnership, or association, the name, address, and telephone number of every member thereof; in the case of a corporation, the name, address, and phone number thereof and the name of its officers and its registered agent; and in the case of a unit of local government, the name, address, and telephone number of its chief executive officer.

 

2)         The name of the person or persons who will manage or operate the birth center.

 

3)         The location of the birth center, including the name, address, and number of beds (not to exceed 10).

 

4)         Information regarding any felony conviction, or conviction of any misdemeanor involving moral turpitude in the last five years, of the applicant; or, if the applicant is a firm, partnership, or association, of any of its members; or, if the applicant is a corporation, of any of its officers or directors; or of the person designated to manage or operate the birth center.

 

5)         The name, address, telephone number, experience, credentials and any professional licensure or certification of the clinical director.

 

6)         A list of all clinical staff, including name and license number.

 

7)         A list of the number and type of proposed staff.

 

8)         A detailed description of the services to be provided by the birth center, including the admission criteria (see Section 264.1550).

 

9)         Letter demonstrating compliance with requirements in Subpart B.

 

10)         A copy of the contract between the birth center and referral hospital, including a transfer agreement pursuant to Section 264.2250.

 

11)         A written narrative on the prenatal care and community education services offered by the birth center and how these services are being coordinated with other health services in the community.

 

12)         An admission protocol specifying the criteria for admitting a client to the birth center shall be included in the application as provided in this Section.

 

f)        Each application shall contain documentation demonstrating compliance with Section 25 of the Act and Section 264.1750 of this Part relating to personnel.

 

g)       Copies of the policies referenced in Section 264.1525 shall be submitted as specified in the license application. 

 

h)       Upon receipt and review of a complete application for licensure, the Department will conduct an inspection to determine compliance with the Act and this Part.

 

i)          A license is renewable every year upon submission of a renewal application and fee and a report on a form prescribed by the Department that includes information related to the quality of care at the birth center.  The report must be in the form and documented by evidence as required by the Department.  (Section 15(d) of the Act) 

 

j)          A birth center's annual renewal application shall be filed with the Department within 90 days prior to the expiration of the license. 

 

k)         The renewal application shall comply with the requirements of subsections (a), (d), (e)(1) through (e)(8), and (e)(10) through (e)(12) of this Section and shall include the following data:

 

1)         Utilization data involving client length of stay;

 

2)         Number of admissions and discharges;

 

3)         Number of complications for both pregnant/postpartum person and newborn (See Sections 264.1800(f) and 264.2450(f));

 

4)         Number of transfers for both pregnant and postpartum persons and newborns to higher level of care;

 

5)         Number of deaths (maternal, fetal, and neonatal), including deaths at the birth center or post transfer;

 

6)         Any other publicly reported data required under the consumer Guide to Health Care; and

 

7)         Post-discharge client status data where clients are followed for 14 days after discharge from the birth center to determine whether the postpartum person or baby developed a complication or infection.  (Section 45 of the Act) 

 

l)          The Department may grant a temporary initial license to any birth center that does not substantially comply with the provisions of the Act and this Part if the Department finds that the health and safety of the clients and staff of the birth center will be protected during the period for which the temporary license is issued.  A temporary initial license expires on the earlier of the date the Department denies the license or the date 6 months after the temporary initial license was issued (Section 15(b) of the Act):

 

m)        The Department will advise the applicant or licensee of the conditions under which the temporary initial license is issued, including:

 

1)         The manner in which the birth center fails to comply with the provisions of the Act and this Part;

 

2)         The changes and corrections required;

 

3)         The time within which the changes and corrections necessary for the birth center to substantially comply with the Act and this Part shall be completed; and

 

4)         The interim actions that are necessary to protect the health and safety of the clients in compliance with requirements for the temporary initial license.

 

Section 264.1400  Inspections and Investigations

 

a)         The Department, whenever it determines necessary, may conduct a special inspection, survey, or evaluation of a birth center to assess compliance with licensure requirements and standards or a plan of correction submitted as a result of deficiencies cited by the Department or an accrediting body to ensure compliance with the Act and this Part. (Section 55(a) of the Act)

 

b)         Representatives of the Department shall have access to and may reproduce or photocopy any books, records, and other documents maintained by the birth center or the licensee to the extent necessary to carry out the Act and this Part.  Failure to provide access to any records requested by the Department or failure to respond to a request for records is a violation of this Part.

 

c)         The Department may investigate an applicant or licensee on its own motion or based upon complaints received by mail, electronic means, telephone, or in person. 

 

1)         Complaints regarding birth centers licensed under the Act and this Part may be submitted either in writing, by telephone or by other electronic means to the Department's Central Complaint Registry.

 

2)         The Department will investigate all complaints received.  An appropriate investigation may include, but is not limited to, record reviews, telephone interviews, on-site surveys, or a combination of methods.

 

d)         Upon the Department’s completion of any special inspection, survey or evaluation, the appropriate Department personnel who conducted the special inspection, survey, or evaluation shall submit a copy of his or her report to the licensee upon exiting the birth center, and shall submit the actual report to the appropriate regional office.  (Section 55(b) of the Act)

 

Section 264.1450  Notice of Violation and Plan of Correction

 

a)         The Department will determine whether a birth center is in violation of this Section no later than 60 days after completion of each special inspection, survey, evaluation, or plan of correction. (Section 55(e) of the Act)

 

b)         Upon determination that the licensee or applicant is in violation of the Act or this Part, the Department shall issue a written Notice of Violation and request a plan of correction.  The notice shall specify the violations in a Statement of Deficiencies and instruct the licensee or applicant to submit a plan of correction to the Department’s central office.  A birth center has 10 days after the date of service of the Notice of Violation to submit a plan of correction. 

 

c)         Within the 10-day period, a licensee or applicant may request additional time for submission of the plan of correction.  The Department may extend the period for submission of the plan of correction for up to an additional 30 days if the Department finds that corrective action by the birth center to abate or eliminate the violations will require substantial capital improvement.  The Department will consider the extent and complexity of necessary physical plant repairs and improvements and any impact on the health, safety, or welfare of the clients of the birth center in determining whether to grant a requested extension.

 

d)         Each plan of correction shall be based on the birth center's assessment of the conditions or occurrences that are the basis of the violations and an evaluation of the practices, policies, and procedures that have caused or contributed to the conditions or occurrences.  The birth center shall maintain documentation of such assessment and evaluation.  The plan of correction may contain related comments or documentation provided by the birth center that may refute findings in the report, explain extenuating circumstances that the birth center could not reasonably have prevented, or indicate methods and timetables for correction of deficiencies described in the report.  (Section 55(d) of the Act)  Each acceptable plan of correction shall include:

 

1)         The procedure for correcting each deficiency cited, typed in the right-hand column of the original Statement of Deficiencies, including the following:

 

A)        specific actions that the birth center will be taking to abate, eliminate, or correct the violation, and

 

B)        steps that will avoid future occurrence of the same and similar violations.

 

2)         The title of the individual responsible for implementing and monitoring the plan of correction;

 

3)         Documentation that the birth center has incorporated systemic improvement efforts into its quality assessment and performance improvement program to prevent the recurrence of the deficient practice;

 

4)         Supporting documentation of correction;

 

5)         Procedures for monitoring and tracking to ensure that the plan of correction is effective;

 

6)         A completion date for correction of each deficiency cited, along with interim dates for any phases or intermediate steps; and

 

7)         Date and signature of the authorized representative, on the bottom of page one of the original Statement of Deficiencies and plan of correction.

 

e)         Submission of a plan of correction will not be considered an admission by the birth center that the violation has occurred.

 

f)         The applicant or licensee may submit additional information in response to the Notice of Violation that it believes will clarify the condition or alleged violation.  The Department will consider the information in reviewing the applicant's or licensee's response and the plan of correction.

 

g)         The Department will review each plan of correction to ensure that it provides for the abatement, elimination, or correction of the violation.  The Department will reject a submitted plan if it fails to address any of the requirements in subsection (d).

 

h)         The Department will notify the licensee or applicant if the plan of correction is rejected, including specific reasons for the rejection of the plan.  The birth center shall submit a modified plan that addresses the requirements of subsection (d) of this Section within three days after receipt of the notice of rejection.

 

i)          If a licensee or applicant fails to submit a modified plan of correction as required in subsection (h), or if the modified plan is not acceptable to the Department, the Department will specify and impose a plan of correction.

 

j)          The Department shall maintain all special inspection, survey, or evaluation reports for at least 5 years in a manner accessible to the public. (Section 55(f) of the Act)

 

Section 264.1500  Adverse Licensure Action and Administrative Hearings

 

a)         Before denying an initial license application, refusing to renew a license, revoking a license, or assessing an administrative fine, the Department will notify the applicant or the licensee in writing.  The notice will specify the charges or reasons for the Department's contemplated action and will provide the applicant or licensee an opportunity to file a request for a hearing within 10 days after receiving the notice.

 

1)         A failure to request a hearing within 10 days shall constitute a waiver of the applicant's or licensee's right to a hearing.

 

2)         The hearing shall be conducted by the Director, or an individual designated in writing by the Director as an Administrative Law Judge, in accordance with the Department's Practice and Procedure in Administrative Hearings. 

 

b)         An initial license application may be denied, a license may be revoked, the renewal of a license may be denied, or an administrative fine may be assessed, for any of the following reasons:

 

1)         Violation of any provision of the Act or this Part.

 

2)         Conviction of the owner or operator of the birth center of a felony, a misdemeanor involving moral turpitude, or of any other crime under the laws of any state or of the United States arising out of or in connection with the operation of a health care facility.  The record of conviction or a certified copy of it shall be conclusive evidence of conviction.

 

3)         An encumbrance on a health care facility license issued in Illinois or any other state to the owner or operator of the birth center.

 

4)         Revocation of any facility license issued by the Department during the previous five years or surrender or expiration of the license during the pendency of action by the Department to revoke or suspend the license during the previous five years if the prior license was issued to the individual applicant or a controlling owner or controlling combination of owners.

 

c)         The Department may initiate an action to assess an administrative fine in conjunction with or in lieu of any other adverse licensure action.

 

d)         The Department will determine the amount of an administrative fine in consideration of the following:

 

1)         The nature and severity of the violation;

 

2)         The birth center's diligence in correcting the violation;

 

3)         Whether the birth center had previously been cited for a similar violation;

 

4)         The number of violations;

 

5)         The duration of an uncorrected violation; and

 

6)         The impact or potential impact of the violation on client health and safety.

 

e)         The administrative fine will be calculated in relation to the number of days the violation existed or continues to exist, if it has not been corrected.  The total amount of the fine assessed will fall within the following parameters:

 

1)         For a violation that occurred as a single event or incident – between $100 and $5,000 per violation.

 

2)         For a violation that was continued or is continuing beyond a single event or incident – between $100 and $500 per day per violation.

 

Section 264.1525  Policies and Procedures, Employee Training, and Best Practices Requirements

 

a)         The birth center shall have written policies and procedures governing all operations of the birth center and all services provided by the birth center. 

 

b)         The written policies and procedures shall be formulated by the clinical director and approved by the governing body. 

 

c)         The written policies shall be followed by the birth center and shall be reviewed at least annually, unless specified otherwise in this Part.

 

d)         The policies shall comply with all of the requirements in this Part, and shall address, at a minimum, the following subjects:

 

1)         Admission protocols defining the criteria to determine which pregnancies are accepted as normal, uncomplicated, and low-risk, incorporating both medical and social factors.

 

2)         Protocols for local anesthesia.

 

3)         Procedures and criteria for antepartum acceptance and transfer to a hospital, and intrapartum and postpartum transport to a referral hospital.  The criteria for acceptance and transport to hospital at any stage shall also comply with the transfer agreement between the birth center and the referral hospital in the Perinatal System, pursuant to the requirements of Section 264.2250.

 

4)         Discharge procedures for the postpartum person and infant, in accordance with requirements of Section 264.1950.

 

5)         Client rights, to ensure patient dignity, privacy, and safety, in accordance with the Medical Patient Rights Act.

 

6)         Employee health program that includes, at a minimum, the following: an assessment of the employee's health and immunization status at the time of employment; immunization requirements; and procedures for the periodic health assessment of all personnel, which specify the content of the health assessment and the interval between assessments in compliance with the Control of Tuberculosis Code.

 

7)         Identifying potential dangers to the health and safety of personnel providing services in the birth center and procedures for protecting agency personnel from identified dangers.

 

8)         Orientation program and procedures for new patients.

 

9)         Childbirth education program for new and returning patients.

 

10)       Prenatal care.

 

11)       Labor and delivery personnel requirements and clinical care.

 

12)       Emergency transfer services and procedures for the pregnant person and neonate.

 

13)       Post-delivery care of the pregnant person.

 

14)       Clinical care of the newborn, in accordance with the Guidelines for Perinatal Care and including the clinical care requirements outlined in Section 264.1800(h).

 

15)       Identification of the newborn as required in Section 264.1800(h)(2).

 

16)       Procedures performed at the birth center as identified in Section 264.1250.

 

17)       Infection control.

 

18)       Disposal of medical waste.

 

19)       Emergency services.

 

20)       Follow-up postnatal and postpartum care for the infant and postpartum person.

 

21)       Laboratory and pharmacy services.

 

22)       Clinical record requirements and retention, maintenance, and confidentiality.

 

23)       Food services.

 

24)       Quality Assurance and Improvement Program.

 

25)       Reporting requirements.

 

26)       Employee training policies that at a minimum:

 

A)        Define the acts and practices that are allowed or prohibited for birth center employees;

 

B)        Establish how training will be conducted; and

 

C)        Illustrate how initial competency will be established.  (Section 50 of the Act).

 

27)       Visitors.

 

28)       Emergency preparedness.

 

e)         Staff Training and Continuing Education Requirements

 

1)         All staff members shall be oriented to existing policies and procedures and shall be promptly notified of changes in policies or procedures.

 

2)         All staff members shall receive initial competency training and be evaluated to determine whether they meet established competency requirements consistent with the Commission for the Accreditation of Birth Centers of the Joint Commission and consistent with the scope of practice for the staff members' professional license.  All personnel records shall demonstrate proof that initial competency standards have been met.

 

3)         All staff members shall receive annual training on infection control, following the standards set forth in the guidelines for Infection Control in Health Care Personnel.

 

4)         Birth centers shall have a written policy and conduct continuing education yearly for providers and staff of obstetric medicine and other staff that may care for pregnant or postpartum women.  The written policy and continuing education shall include management of severe maternal hypertension and obstetric hemorrhage, addressing airway emergencies experienced during childbirth, and management of other leading causes of maternal mortality for units that care for pregnant or postpartum women. (Section 2310-222(b) of the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois)

 

f)         Birth centers shall utilize best practices made available by the Department in consultation with the Illinois Perinatal Quality Collaborative for timely identification and assessment of all pregnant and postpartum persons for common pregnancy or postpartum complications and for care provided by the birth center throughout the pregnancy and postpartum period.  These standards must be incorporated into the policy referenced in subsection (e).

 

Section 264.1550  Admission Protocols for Acceptance of Birth Center Clients

 

a)         Only clients whose births are planned to occur following a normal, uncomplicated, and low-risk pregnancy may be allowed to receive services at the birth center.  Clients must meet the criteria for birth center admission that are consistent with accreditation standards and the certified nurse midwife's or physician's scope of practice and with requirements of this Section.

 

b)         No general, spinal/epidural, or regional anesthesia may be administered at the birth center.

 

c)         Any pregnant person walk-in who is beyond 32 weeks of gestation and is in labor, and who has not previously been approved for admission, shall be immediately transported to a hospital.

 

d)         An obstetrician, family practitioner (family physician) or physician, certified nurse midwife, or licensed certified professional midwife shall attend each person in labor from the time of admission through birth and throughout the immediate postpartum period. Attendance may be delegated only to another physician a certified nurse midwife, or a licensed certified professional midwife. (Section 25(c) of the Act)

 

e)         Criteria for approval for admission shall be in writing.

 

f)         Each birth center shall establish a written risk assessment that shall be completed prior to admission for each client and included in the client's clinical record.  The assessment must include a detailed medical history, a physical examination, family circumstances, and other social and psychological factors.

 

g)         A physician, certified nurse midwife, or a licensed certified professional midwife shall determine the general health and complete a risk assessment of the client per requirements in subsection (f), using the following criteria for exclusion as a birth center client.  These criteria shall be considered for all clients prior to acceptance for birth center services and throughout the pregnancy for continuation of services.  The clinical director shall use professional judgment consistent with recommendations in the Guidelines for Perinatal Care, Standards for Birth Centers, and Indicators of Compliance with Standards for Birth Centers to make determinations of the criteria for exclusion for delivery at the birth center.

 

1)         Pre-pregnancy body mass index of less than 18 or greater than 40.

 

2)         Medical risk factors, including, but not limited to:

 

A)        Chronic hypertension not controlled by medication;

 

B)        Elevated blood glucose levels unresponsive to dietary management;

 

C)        Positive HIV antibody test; or

 

D)        Current drug or alcohol substance use disorder.

 

3)         Obstetrical risk factors, including but not limited to:

 

A)        Two or more prior cesarean sections (a client with a single prior cesarean may be admitted subject to conditions in subsection (h));

 

B)        History of gynecologic uterine wall surgery in which the uterine cavity was entered; or

 

C)        History of manual removal of a placenta.

 

4)         Prenatal/delivery risk factors, including but not limited to:

 

A)        Documented low-lying placenta in an individual with a history of previous cesarean delivery;

 

B)        Anemia resistant to supplemental therapy;

 

C)        Documented placental anomaly;

 

D)        Lie other than vertex at term;

 

E)        Pre-eclampsia/gestational hypertension (as defined by current ACOG standards);

 

F)         Multiple gestation;

 

G)        Premature labor at less than 36 weeks (client may return to the birth center if not delivered at 37 weeks);

 

H)        Rupture of membranes prior to the 37^th week gestation;

 

I)         Gestation beyond 42 weeks by reliable confirmed dates;

 

J)         Isoimmunization, Rh-negative sensitized, positive titers, or any other positive antibody titer, which may have a detrimental effect on the childbearing individual or fetus;

 

K)        Suspected deep vein thrombosis;

 

L)        Placental abruption or previa;

 

M)       Dead fetus;

 

N)        Known fetal anomalies that may be affected by the site of birth; or

 

O)        Primary genital herpes infection in pregnancy.

 

h)         Trial of labor after cesarean/vaginal birth after cesarean (TOLAC/VBAC)

 

1)         A birth center may admit a client with a previous cesarean section for a TOLAC/VBAC if the client meets the following criteria:

 

A)        The client has an operative report documenting one prior low transverse cesarean section, or if the surgical details of the previous cesarean incision are not known, the client gives informed consent based on information provided under subsection (h)(3)(C);

 

B)        The client's BMI prior to the current pregnancy was less than 40;

 

C)        A documented ultrasound of the client's placental location, performed by a radiologist or maternal-fetal medicine physician, shows no abnormalities (previa, low-lying/suspected accreta, percreta, increta, etc.); and 

 

D)        The Department additionally recommends that the interval since the client's previous birth be at least 19 months and that the estimated weight of the fetus at delivery be less than 4000 grams (8.8 pounds).

 

2)         A birth center that accepts clients for TOLAC/VBAC shall have a transfer agreement with a Level 1 or higher perinatal center that agrees to receive TOLAC patients from birth centers, within a ground travel time distance that allows for an emergency cesarean section to be started within 30 minutes after the decision that a cesarean section is necessary.

 

A)        The transfer agreement must address communication between the receiving hospital and birth center when a TOLAC client is admitted to the birth center and during the progression of the client's labor. The agreement must also address the hospital's and birth center's response in situations where progression of labor is delayed.

 

B)        The birth center shall notify the receiving hospital immediately if an emergency transfer becomes necessary.

 

3)         The birth center shall obtain informed consent from a prospective client for a TOLAC/VBAC.

 

A)        The consent forms must include up to date information, from peer reviewed publications or expert consensus such as that of the American College of Obstetricians and Gynecologists (ACOG) or the American Academy of Pediatrics (AAP), concerning the incidence of uterine rupture during TOLAC/VBAC and the incidence of neonatal ICU admissions and neonatal deaths when uterine rupture occurs.

 

B)        The consent form shall use language that is easily understood from a health literacy perspective and is translated into the language of the birthing person.

 

C)        In a case where the surgical details of the previous cesarean incision are not known, the birth center shall notify the client that the quoted risk of rupture is based on their history only, and may be higher than the risk for a client with a documented low transverse cesarean section.

 

4)         A birth center that accepts TOLAC/VBAC clients shall have a letter of agreement with an Administrative Perinatal Center and share the renewal data submitted to DPH OCHR with the APC on an annual basis, including the addition of TOLAC/VBAC patient numbers. The birth center shall also participate in the APC's morbidity and mortality reviews.

 

i)          Pregnant persons who fail to register for acceptance with the birth center before 32 weeks gestation and who have not received prenatal care shall be reviewed and approved by the clinical director prior to admission.  The person shall otherwise meet the criteria for the risk assessment that are set forth in this Section, the birth center shall have documentation of prenatal care, and the birth center shall comply with the transfer agreement between the birth center and the referral hospital.

 

j)          The acceptance and admission policies of the birth center shall not discriminate against clients based on disability, race, religion, source of payment, sexual orientation or any other basis recognized by applicable State and federal laws.

 

k)         Before acceptance and admission to services, a client shall be informed of:

 

1)         The qualifications of the birth center clinical staff;

 

2)         The risks related to out-of-hospital childbirth;

 

3)         The benefits of out-of-hospital childbirth; and

 

4)         The possibility of referral or transfer if complications arise during pregnancy or labor, with additional costs for services rendered.

 

l)          The birth center shall obtain the client's written consent for birth center services, and a copy of the signed consent shall be included in the client's individual clinical record.

 

m)        The number of pregnant persons in active labor who have been admitted to the birth center at any given point in time shall be no greater than the number of birth rooms in the birth center.

 

Section 264.1600  Governing Body

 

a)         Each birth center shall have an organized governing body that is responsible for:

 

1)         The management and control of the birth center;

 

2)         The assurance of quality care and services;

 

3)         Compliance with all federal, State, and local laws; and

 

4)         Protection of personal and property rights of clients, newborn infants, and support persons.

 

b)         The governing body shall be responsible for providing a sufficient number of appropriately qualified personnel, physical resources, and equipment, supplies and services for safe, effective, and efficient delivery of care services for normal, uncomplicated and low risk pregnancies as defined in this Part.

 

c)         The governing body shall appoint an administrator responsible for the operation and administration of the birth center.  The qualifications, authority, responsibilities, and duties of the administrator shall be defined in a written statement adopted by the governing body.

 

d)         The governing body shall appoint a clinical director.

 

e)         The governing body shall adopt effective policies and bylaws governing operation of the birth center.  The policies and bylaws shall be in writing, dated and available for public review.

 

f)         The governing body shall annually review, revise, and approve client rights policies and procedures (see Section 264.1700).

 

Section 264.1650  Length of Stay

 

The maximum length of stay in a birth center shall be consistent with existing State laws related to health insurance (see 215 ILCS 5/356s) allowing a 48-hour stay or appropriate post-delivery care.  If the postpartum person and infant are discharged earlier than 48 hours, the birth center must ensure arrangements are made to meet all newborn screening requirements pursuant to Section 264.1800(h).

 

Section 264.1700  Client Rights

 

a)         A client shall not be deprived of any rights, benefits, or privileges guaranteed by law based solely on the client's status as a client of the birth center.

 

b)         Every client shall be permitted to refuse medical treatment and to know the consequences of such action.

 

c)         It is the right of every pregnant person, and support person, to expect and receive services as per the Medical Patient Rights Act and as listed below:

 

1)         Good quality care and high professional standards that are continually maintained and reviewed.

 

2)         Answers to questions regarding services and treatment, and the names and functions of the staff person providing services.

 

3)         Confidentiality of client records.  Information from or copies of records may be released only to authorized individuals, and the birth center shall ensure that unauthorized individuals cannot gain access to or alter client records.  The birth center shall release original medical records only in accordance with federal or State laws, court orders, or subpoenas.

 

4)         Unimpeded, private, and uncensored communication by mail and telephone.  The birth center shall ensure that correspondence is promptly received and mailed, and that telephones are reasonably accessible.

 

5)         Respectful and dignified treatment at all times.

 

6)         Information regarding cost and counseling on the availability of known financial resources to the service being rendered.

 

7)         Disclosure and discussion of the nature, purposes, expected effects, and results of the medical treatment under consideration, prior to signing an informed consent.

 

8)         Access to an obstetrician, family practitioner (family physician), physician, certified nurse midwife, or licensed certified professional midwife, pursuant to Section 264.1250(n).

 

9)         A copy of the birth center's rules that apply to conduct as a pregnant person, spouse, support person, and other family member or visitor.

 

10)       A written copy of the rights guaranteed by this Section and by the birth center.

 

11)       Treatment without discrimination based upon race, color, religion, sexual preference, national origin, or source of payment.

 

12)       The right to expect emergency procedures to be implemented without unnecessary delay.

 

Section 264.1750  Personnel

 

a)         Clinical Director. A birth center shall have a clinical director who shall be appointed by and responsible to the governing body and may also be designated as the individual responsible for the administrative operation of the birth center.  The clinical director shall be responsible for:

 

1)         The development of policies and procedures for services required by this Part;

 

2)         Coordinating the clinical staff and overall provision of client care;

 

3)         Developing and approving policies defining the criteria to determine which pregnancies are accepted as normal, uncomplicated, and low risk;

 

4)         Developing and approving policies regarding anesthesia services available at the center.  (Section 25(b) of the Act)

 

5)         Advising and consulting with the staff of the birth center on all matters related to medical management of pregnancy; birth; postpartum, newborn, and gynecologic health care; and infection control;

 

6)         Coordinating all professional medical consultants to the birth center (e.g., consulting obstetrical physicians, pediatricians, family physicians); and

 

7)         Such other functions as may be deemed appropriate.

 

b)         The clinical director shall also be responsible for determining whether a person or fetus found to have clinically significant risk factors (See Section 264.1550(g)) should be admitted to the birth center, or whether the birth center should continue to provide care to pregnant person and/or newborn during the puerperium period.

 

c)         Administrator.  The birth center shall have an administrator, who is an individual designated by the governing body to be responsible for the administrative operation of the birth center.  One person may function in more than one capacity, provided that the person meets all the minimum qualifications and can perform all the prescribed duties.

 

1)         The duties of the administrator include, but are not limited to:

 

A)        Administratively supervising the provision of services at the birth center;

 

B)        Organizing and directing the birth center's ongoing functions;

 

C)        Employing qualified staff;

 

D)        Ensuring education and evaluations of staff; and

 

E)        Supervising non-professional staff.

 

2)         The administrator shall implement a budgeting and accounting system, which shall include an auditing system for monitoring State or federal funds.  The administrator shall ensure that all billings or insurance claims (e.g., Medicaid) submitted are accurate.

 

3)         The administrator shall ensure that issues and complaints relating to the conduct or actions of licensed health care professionals are addressed and, if warranted, referred and reported to the appropriate licensing board, and that such review and action taken are documented.

 

4)         The administrator shall administratively conduct or supervise the resolution of complaints received from clients concerning the delivery of their care or services at the birth center.

 

d)         A birth center shall have a birth attendant and a birth assistant assigned to each client.

 

e)         Professional and support staff shall be on duty or on call to meet the demands for services provided to assure client safety and satisfaction.

 

f)         At each birth there shall be two staff on duty that are currently certified in:

 

1)         Adult CPR equivalent to American Heart Association Class C life support; and

 

2)         Neonatal Resuscitation Program equivalent to American Academy of Pediatrics/American Heart Association requirements.

 

g)         Prior to employing any individual in a position that requires a State license, the birth center shall contact the Illinois Department of Financial and Professional Regulation to verify that the individual's license is active and in good standing.  A copy of the verification shall be placed in the individual's personnel file.

 

h)         All birth center employees who are exposed to blood shall have full immunization against hepatitis B or documented refusal.

 

Section 264.1800  Clinical Care and Service Requirements

 

a)         Clients shall meet all the requirements of Section 264.1550 before being admitted and receiving services at the birth center.

 

b)         Each birth center shall assure that each pregnant person and their family registering for admission for care at the birth center shall be given an orientation to the birth center, which includes, but is not limited to:

 

1)         The philosophy and goals of the birth center;

 

2)         Services directly available at the birth center;

 

3)         Services provided through consultation and referrals;

 

4)         Policies and procedures;

 

5)         The requirement for signed consent for care and services, attesting to full awareness of care and services to be provided;

 

6)         The involvement of the pregnant person (and support person whenever possible) in the development and assessment of a protocol of care in accordance with this Section;

 

7)         Charges for required care and potential additional charges; and

 

8)         The risk assessment process and risk factors that might preclude admission for care at the birth center.

 

c)         Each birth center shall provide a childbirth education program or make a program available to the center's clients.

 

1)         The childbirth education program shall consist of a course of instruction to the pregnant person and support persons pertaining to prenatal care and its benefits, preparation for participation in the childbirth process, labor and delivery, care of the newborn, and self-care.

 

2)         The education program shall be coordinated with other health care services available in the community.

 

3)         The birth center shall encourage all pregnant persons who have not previously attended a childbirth education program to attend such a program, preferably with a support person.

 

4)         Childbirth education can be provided at any location in the community or through telehealth.  The location should meet the needs of the participant by encouraging and supporting attendance.

 

d)         The birth center shall ensure that pregnant persons have adequate prenatal care in accordance with the birth center's written policies and procedures and acceptable standards of practice.  The birth center shall comply with the following requirements: 

 

1)         Every pregnant person shall be involved in the development and assessment of a plan of care.

 

2)         Every pregnant person shall be evaluated within four weeks after the initial request for admission for care.  If the pregnant person is at 32 weeks gestation at the time of their initial request for admission, the birth center shall evaluate the pregnant person as soon as possible, pursuant to Section 264.1550.  To establish a database of risk assessment, identify problems and needs, and develop a plan of care, the evaluation shall include:

 

A)        Data from history and physical examination, including documented infectious disease (e.g. HIV, syphilis);

 

B)        Laboratory findings;

 

C)        Social, nutritional and health assessments; and

 

D)        Frequency of prenatal visits.

 

3)         Every pregnant person accepted for care at the birth center shall be evaluated on a regular basis for the presence of any risk factor listed in Section 264.1550(g). If a pregnant person develops problems or conditions considered to be high risk, the clinical director shall review the case to determine whether the birth center can continue to provide care to the pregnant person. Findings shall be entered in the clinical record and signed by the clinical director.

 

e)         Labor and Delivery. 

 

1)         A birth attendant shall be present for each pregnant person in labor from admission through the immediate postpartum period.

 

2)         The birth assistant, trained in the common duties associated with birth and postpartum, and emergency policies, procedures, and equipment, shall be present at each birth.

 

3)         The birth attendant shall perform the following minimum duties:

 

A)        Monitor the fetal heartbeat;

 

B)        Monitor the pregnant person's blood pressure, pulse, respirations, and temperature;

 

C)        Perform adult and infant cardiopulmonary resuscitation, if needed;

 

D)        Monitor the infant's heartbeat, respirations, and temperature; and

 

E)        Assess the client's fundus and blood loss.

 

4)         Interventions during labor and delivery shall be limited to those required to accomplish a vaginal delivery in accordance with the birth attendant's or birth assistant's scope of practice.

 

5)         The birth center may not use pharmacologic agents to induce or enhance labor.

 

f)         Consultation and Transfer to Referral Hospital.  If a clinical complication occurs during labor or delivery or postpartum, the obstetrician, family physician, certified nurse midwife, or licensed certified professional midwife shall consult with the referral hospital to provide clinical information regarding the potential reason for transfer.  If transfer is warranted, the birth center shall have the pregnant or postpartum person and newborn transported immediately.  The clinical director shall be notified of all transfers.  Records necessary to explain the situation fully shall accompany a pregnant or postpartum person and newborn upon transport to the referral hospital.

 

g)         Post Delivery Care.

 

1)         If a pregnant or postpartum person or newborn is not in satisfactory condition for discharge within 48 hours following birth, the birth center shall transfer the pregnant person or newborn to a hospital that has obstetrical and nursery services.

 

2)         The birth center's clinical director, obstetrician, family physician, certified nurse midwife, or licensed certified professional midwife shall be accessible by telephone, 24 hours per day, to assist postpartum persons as needed during the postpartum period.

 

3)         The birth center's postpartum clinical services shall include the following:

 

A)        assessment of the postpartum person and infant, including healthcare provider examination, laboratory screening tests, newborn genetic, metabolic, and critical congenital heart disease screenings at appropriate times, and birthing person’s postpartum status;

 

B)        guidance relating to care of the infant, including immunizations and referrals to sources of pediatric care;

 

C)        newborn hearing screening in accordance with subsection (h)(1)(J);

 

D)        assessment of postpartum person-child relationship, including breastfeeding and ongoing lactation support or referral to lactation support services;

 

E)        information and referrals for family planning services; and

 

F)         follow-up consultation with the postpartum person 14 days after discharge from the birth center to determine whether the mother or baby has developed a complication or infection.

 

h)         Newborn Infant Care.

 

1)         Clinical care provided to the newborn shall include the following:

 

A)        Resuscitation of the newborn, as necessary;

 

B)        Within two hours after delivery, ophthalmic ointment, or drops containing tetracycline or erythromycin, shall be instilled into the eyes of the newborn infant as a preventive against ophthalmia neonatorum in accordance with the Infant Eye Disease Act;

 

C)        A single parenteral dose of vitamin K-1, water soluble 0.5 milligrams, shall be given to the infant soon after birth as a prophylaxis against hemorrhagic disorder in the first days of life;

 

D)        Conduct and document the physical examination of the newborn performed before discharge;

 

E)        Provide referrals for any abnormalities or problems;

 

F)         Complete newborn heart and blood spot screening and collect blood for newborn screening in accordance with the Newborn Metabolic Screening and Treatment Code;

 

G)        Implement procedures for the detection of Rh and ABO isoimmunization;

 

H)        Conduct HIV testing pursuant to the Perinatal HIV Prevention Code;

 

I)         Prepare and submit birth certificates; and

 

J)         Complete newborn hearing screening in accordance with the Universal Newborn Hearing Screening Program, the Early Hearing Detection and Intervention Act, and Year 2019 Position Statement: Principles and Guidelines for Early Hearing Detection and Intervention Programs.

 

i)          Mandatory Newborn Hearing Screening.  Each birth center shall conduct the initial bilateral hearing screening of each newborn infant prior to discharge unless medically contraindicated or the infant is transferred to a hospital before the hearing screening can be completed. (Section 5(a) of the Early Hearing Detection and Intervention Act)

 

ii)         If an infant does not pass the initial inpatient newborn hearing screening prior to discharge, then a second inpatient bilateral newborn hearing screening shall be completed prior to 48 hours of age.

 

iii)        If an infant does not pass either inpatient hearing screening in both ears at the same time the center shall complete an outpatient bilateral newborn hearing screening prior to 30 days of age. 

 

iv)        If an infant does not pass the inpatient or outpatient hearing screening(s) in both ears at the same time the center shall refer the infant's parents or guardians to a pediatric audiologist and health care practitioner for follow-up.

 

v)         The facility performing the hearing screening(s) shall report all screenings and document the referral, including the name of the health care practitioner and pediatric audiologist, to the Department’s Office of Health Promotion- Division of Health Assessment & Screening -Newborn Screening Program within 7 days after screening, status change, or care coordination activity.

 

vi)        If the hearing screening is conducted at the birth center, the birth center shall ensure the infant’s postnatal primary care provider receives the final inpatient and outpatient screening results referencing the date of screening, ear-specific screening results, type of screening completed, risk factors for hearing loss, and recommendations for follow-up.

 

2)         Identification of Newborns.  The procedures for identification of newborns shall include the following:

 

A)        While the newborn is still in the birth room, the birth assistant, certified nurse midwife, or licensed certified professional midwife in the birth room shall prepare identical identification bands for both the postpartum person and the newborn.  Wrist bands alone may be used; however, it is recommended that both wrist and ankle bands be used on the newborn. 

 

B)        The birth center shall not use foot printing and fingerprinting alone as methods of client identification. 

 

C)        The wrist and ankle bands shall indicate the postpartum person’s admission number, the newborn's gender, the date and time of birth, and any other information required by birth center policy. 

 

D)        Birth room personnel shall review the bands prior to securing them on the postpartum person and the newborn to ensure that the information on the bands is identical. 

 

E)        The birth attendant or birth assistant in the birth room shall securely fasten the bands on the newborn and the postpartum person without delay as soon as they have verified the information on the identification bands.

 

F)         The birth records and identification bands shall be checked again before the newborn leaves the birth room.

 

G)        If the condition of the newborn does not allow the placement of identification bands, the identification bands shall accompany the newborn and shall be attached as soon as possible. 

 

H)        When the newborn is taken to the postpartum person, the birth center staff shall examine the postpartum person’s and the neonate's identification bands to verify the gender of the neonate and to verify that the information on the bands is identical.

 

I)         The umbilical cord shall be identified according to birth center policy.  All umbilical cord blood samples shall be labeled correctly with an indication that these are a sample of the newborn's umbilical cord blood and not the blood of the birthing person.

 

3)         Discharge of newborn infants shall be in accordance with the birth center policies (see Section 264.1950).

 

4)         The birth center shall communicate with the pediatric care provider and shall transfer birth and newborn records to the pediatric care provider.

 

5)         In breastfeeding and in the storage and handling of infant formula, the birth center shall comply with the provisions of the Guidelines for Perinatal Care.

 

i)          No general anesthesia, which includes spinal/epidural or regional anesthesia and analgesia, may be administered at the birth center.  Local anesthesia for repair of obstetric lacerations may be administered in accordance with written policies and procedures established by the clinical director.

 

j)          Surgical procedures shall be limited to procedures that do not require general anesthesia, including immediate postpartum IUD insertion or contraceptive arm implant and repair of obstetric lacerations performed in accordance with the birth attendant's or birth assistant's scope of practice.

 

Section 264.1950  Discharge Policies and Procedures

 

a)         The maximum length of stay in a birth center shall be consistent with existing State laws (See 215 ILCS 5/356s) allowing a 48-hour stay or appropriate post-delivery care if the postpartum person and infant are discharged earlier than 48 hours. 

 

b)         The birth center shall develop a discharge plan of care for all postpartum persons and infants.

 

c)         The discharge plan shall be based on the assessment of the postpartum person's and infant's needs by the various disciplines responsible for their care.

 

d)         The postpartum person and infant shall be discharged from the birth center when both are clinically stable and have met the discharge criteria established by the birth center.

 

e)         The postpartum person and infant shall not be discharged prior to four hours after the time of birth.

 

f)         The birth center shall provide the postpartum person with written discharge instructions.  The discharge instructions shall include written guidelines detailing how the mother may obtain emergency assistance for themselves and their infant and completion of newborn screening(s) as required per Section 264.1800.

 

g)         The birth center shall develop and implement written policies to provide follow-up postnatal and postpartum care to the infant and the postpartum person, either directly or by referral.  Follow-up care may be provided in the birth center, at the postpartum person's preferred location, by telehealth, or by a combination of these methods.

 

Section 264.2000 Infection Control

 

a)         Each birth center shall provide a sanitary environment to avoid sources and transmission of infections and communicable diseases.

 

b)         The birth center shall have an active program for the prevention, control and investigation of infectious and communicable diseases that includes, but is not limited to:

 

1)         Hand-washing techniques for adequate protection of the pregnant or postpartum person and newborn infant from infection and other contamination;

 

2)         Contagious disease control measures for birth center personnel, carrier or suspected carrier, spouse, or support persons;

 

3)         Sterilization methods and procedures; and

 

4)         Infection control measures, including birth room cleaning policies and birth room waste disposal policies and procedures.

 

c)         The birth center shall implement universal/standard precautions, including:

 

1)         Ensuring that all staff comply with universal/standard precautions;

 

2)         Establishing procedures for monitoring compliance with universal/standard precautions; and

 

3)         Requiring birth center employees to complete educational course work or training in infection control and barrier precautions, including basic concepts of disease transmission, scientifically accepted principles and practices for infection control, and engineering and work practice controls.

 

d)         A person or persons shall be designated as infection control officer or officers to develop and implement policies governing control of infectious and communicable diseases.  The means of qualification (e.g. education, training, and experience; or certification) shall be documented.  Policies and procedures shall be developed to address the following:

 

1)         Medical, nursing and non-professional staff behaviors to prevent and control the transmission of infections or communicable diseases;

 

2)         Measures to handle infectious cases that develop in the birth center;

 

3)         Reporting and care of cases of communicable diseases in accordance with the Control of Communicable Diseases Code; and

 

4)         A systematic plan of checking and recording cases of infection, known, or suspected, that develop in the birth center.

 

e)         The birth center shall maintain a sanitary environment with all equipment in good working order.  Written procedures shall include:

 

1)         Garbage, refuse and medical waste removal in such a manner that will not permit the transmission of a contagious disease, create a nuisance or fire hazard, or provide a breeding place for vermin or rodents;

 

2)         Insect and rodent control;

 

3)         Maintenance of water, heat, ventilation, and air conditioning, and electrical service;

 

4)         The use, cleaning, sterilization, and care of equipment and supplies; and

 

5)         Housekeeping and cleaning measures and schedule.

 

f)         Laundry shall be processed in accordance with Section 264.2350(i).

 

g)         The birth center shall comply with the Guideline for Hand Hygiene in Health-Care Settings and the Infection Control in Healthcare Personnel: Infrastructure and Routine Practices for Occupational Infection Prevention and Control Services.

 

Section 264.2050  Disposal of Medical Waste

 

a)         All pathological and bacteriological waste, including blood, body fluids, placentas, sharps, and biological indicators, shall be disposed of by a waste hauler with a permit from the Illinois Environmental Protection Agency as required by the Pollution Control Board's Special Waste Hauling administrative rules.

 

b)         These materials shall be sealed, transported, and stored in biohazard containers.  These containers shall be marked "Biohazard", bear the universal biohazard symbol, and be orange, orange and black, or red.  The containers shall be rigid and puncture resistant, such as a secondary metal or plastic can with a lid that can be opened by a step-on pedal.  These containers shall be lined with one or two high-density polyethylene or polypropylene plastic bags with a total thickness of at least 2.5 mil or equivalent material. 

 

c)         Containers that are marked "Biohazard" shall be sealed before being removed from the birth center.

 

Section 264.2100  Emergency Services

 

a)         The birth center shall have communication with their local emergency medical transport provider/EMS ambulance providers to be aware of their hours and possible need for emergency transportation of the pregnant or postpartum person and/or newborn infant to a referral hospital.

 

b)         The birth center shall provide emergency equipment and emergency medications as follows:

 

1)         Oxygen;

 

2)         Airway and manual infant breathing bags;

 

3)         Suction equipment;

 

4)         A neutral thermal environment for resuscitation; and

 

5)         Other medications and equipment as approved by the clinical director.

 

c)         The birth center shall provide the EMS ambulance provider clinical information regarding the postpartum person and/or infant including, but not limited to:

 

1)         Demographics: name, date of birth, age, birth attendant, and gestational age;

 

2)         Individual(s) who will accompany the postpartum person/newborn;

 

3)         Prenatal history: ultrasound findings, laboratory results/pertinent findings, prior pregnancy outcomes, current medications, allergies, history of medical problems;

 

4)         Reason for transport details as related to postpartum person and or newborn (e.g., antepartum, labor, birth and immediate postpartum history, newborn assessment); and

 

5)         Copies of pertinent records for the postpartum person/newborn.

 

Section 264.2150  Laboratory and Pharmacy Services

 

a)         Each birth center shall meet the following requirements:

 

1)         Possess a valid Clinical Laboratory Improvement Amendments (CLIA) certificate for those tests performed by the birth center; and

 

2)         Have a written agreement with a laboratory that possesses a valid CLIA certificate to perform any required laboratory procedures that are not performed in the birth center.

 

b)         Pharmacy services shall be provided directly by the birth center or by an off-site pharmacy licensed pursuant to the Pharmacy Practice Act.

 

c)         Pharmacy services provided directly by the birth center shall be under the direction of a registered pharmacist.

 

d)         All drugs and medicines shall be stored and dispensed in accordance with applicable State and federal laws.

 

Section 264.2200  Clinical Records

 

a)         Each birth center shall adopt, implement, enforce, and maintain a clinical record system to assure that the care and services provided to each client are completely and accurately documented and systematically organized to facilitate the compilation and retrieval of information.

 

b)         Each birth center shall maintain accurate and complete clinical records for each client, and all entries in the clinical record shall be made at the time when care, treatment, medications, consultations, or other medical services are given.  The record shall include, but not be limited to, the following:

 

1)         Client-identifying information;

 

2)         Name of the client's birth attendants, and the name of all other birth assistants;

 

3)         Initial risk assessment in accordance with Section 264.1550(f);

 

4)         A disclosure statement and informed consent that is signed by the client that explains the benefits, limitations, and risks of the services available at the center, and that describes the collaborative arrangements that the center has with physicians and with referral hospitals;

 

5)         Record of antepartum (prenatal) care;

 

6)         History and physical examination of the client;

 

7)         Laboratory tests, ultrasounds, procedures and results;

 

8)         Written progress notes, signed and dated by the person rendering the service, and incorporated into the client record within 24 hours after services;

 

9)         Medication list and medication administration record, if applicable;

 

10)       Intrapartum care;

 

11)       Newborn assessment and care, including, but not limited to:

 

A)        Apgar scores;

 

B)        Maternal-newborn interaction;

 

C)        Prophylactic procedures;

 

D)        Accommodation to extra-uterine life;

 

E)        Blood glucose when clinically indicated;

 

F)         Supplemental oxygen;

 

G)        Newborn screening required per the Hearing Screening and Vision Screening administrative codes and the Newborn Metabolic Screening and Treatment Code.

 

12)       Postpartum care;

 

13)       Allergies and medication reactions;

 

14)       Documentation of consultation;

 

15)       Refusal of the client to comply with advice or treatment;

 

16)       Discharge summary, to include postpartum person and infant;

 

17)       Discharge plan and instructions to the client;

 

18)       Arrangements for newborn follow-up screening and testing it the newborn is discharged prior to the 48 hours;

 

19)       Authentication of entries by the physician or physicians, birth attendants and birth assistants who treated or cared for the client and newborn;

 

20)       A copy of the transport form if the client or newborn was transferred to the referral hospital; and

 

21)       Documentation that a birth certificate was filed or, if applicable, a death certificate was filed.

 

c)         The birth center shall maintain all original medical records, either paper or electronic, for a period of not less than 10 years.  If the birth center has been notified in writing by an attorney before the expiration of the 10 year retention period that there is litigation pending in court involving the record of a particular client as possible evidence and that the client is their client or is the person who has instituted such litigation against their client, then the birth center shall retain the record of that client until notified in writing by the plaintiff's attorney, with the approval of the defendant's attorney of record, that the case in court involving such record has been concluded or for a period of 12 years from the date that the record was produced, whichever occurs first in time.

 

d)         Records shall be stored in a manner that will assure safety from water, fire or other sources of damage and will safeguard the records from unauthorized access.

 

e)         The birth center shall develop a policy for maintenance and confidentiality of all original records or copies of those records, in accordance with State and federal laws.

 

f)         If a birth center closes, inactive records shall be preserved to ensure compliance with this Section.  The birth center shall send the Department written notification of the reason for closure, the location of the client records, and the name and address of the client record custodian.  If a birth center closes with an active client roster, a copy of the active client record shall be transferred with the client to the receiving birth center or other health care facility to assure continuity of care and services to the client.

 

Section 264.2250  Transfer Agreement

 

a)         A birth center shall link and integrate its services with at least one birthing hospital (referral hospital) with a minimum of level 1 perinatal designation, as defined in the Regionalized Perinatal Health Code.  (Section 20(a) of the Act)

 

b)         The birth center shall have an established agreement (transfer agreement) with a nearby receiving birthing hospital (referral hospital) with policies and procedures for timely transfer of maternal and neonatal clients (within 30 minutes for rural and nonrural hospitals). The agreement shall include a determination of maternal and neonatal conditions necessitating consultation and referral.  This should include plans for communication with the receiving hospital (referral hospital) before and after transfer and cases requiring review during the Morbidity and Mortality review with the referral hospital.  (Section 20(b) of the Act).

 

c)         The birth center's transfer agreement with the referral hospital shall include the staff required to transfer clients, the staff responsible for initiating transport, the mode of emergency transportation between facilities, and information regarding the referral hospital's coordinated procedures with an APC in the event of a need to transfer a high-risk newborn pursuant to Section 264.1800(f).

 

Section 264.2300  Equipment

 

The birth center shall have sufficient client care equipment and space to assure the safe, effective, and timely provision of the available services to clients, which include, but are not limited to, the following:

 

a)         A heat source for infant examination or resuscitation;

 

b)         Transfer incubator or isolette (if not provided by local emergency medical transport provider/EMS ambulance providers in birth center service area);

 

c)         Blood pressure equipment;

 

d)         Thermometers;

 

e)         Fetoscope/doppler;

 

f)         Intravenous equipment;

 

g)         Sterilizer/autoclave;

 

h)         Resuscitation equipment (for neonate and pregnant person);

 

i)          Oxygen equipment for maternal and neonate uses;

 

j)          Newborn hearing screening equipment;

 

k)         Neonatal pulse oximeter;

 

l)          Instruments for delivery, and repair of obstetric lacerations;

 

m)        Other supplies and equipment specified by the clinical director; and

 

n)         Newborn blood spot screening collection cards.

 

Section 264.2350  Environmental Management

 

a)         The birth center shall maintain birth rooms that meet the requirements for emergency procedures, pursuant to Section 264.2100.  All birth rooms shall allow, for the physical and emotional care of a client, their support person and the newborn during labor, birth, and the recovery period.

 

b)         The birth center shall be designed to provide for the following:

 

1)         Birth rooms shall be located to provide unimpeded, rapid access to an exit of the building that will accommodate emergency transportation vehicles;

 

2)         The birth center shall be located on the same level as ambulance delivery and pickup;

 

3)         Fixed and portable work surface areas shall be maintained for use in the birth room;

 

4)         A separate space for a clean area and a contaminated area shall be provided.  Sanitary waste containers, soiled linen containers, storage cabinets, and sterilizing equipment shall be available;

 

5)         Space shall be provided for prenatal and postpartum examinations, which will include privacy for the client, hand-washing facilities, and the appropriate equipment for staff;

 

6)         Space shall be provided for medical record storage; and

 

7)         Client interview, instruction and waiting rooms shall be provided.

 

c)         Toilet and Bathing Facilities

 

1)         A toilet and lavatory shall be maintained in or adjacent to the birth room.

 

2)         Hand-washing facilities shall be in or immediately adjacent to the birth room entry door.

 

3)         A bathtub or shower shall be available for client use and may include a large tub used for hydrotherapy for labor.

 

4)         All floor surfaces, wall surfaces, water closets, lavatories, tubs, and showers shall be kept clean, and all appurtenances of the structures shall be of sound construction, properly maintained, in good repair and free from safety hazards.

 

d)         The birth center shall provide facilities for secure storage of personal belongings and valuables of clients.

 

e)         Visual privacy shall be provided for each pregnant person and their support person.

 

f)         Hallways and doors providing access and entry into the birth center and birth room shall be able to accommodate maneuvering of ambulance stretchers and wheelchairs.

 

g)         All areas of the birth center shall be well-lighted and shall have light fixtures capable of providing at least 20-foot candles of illumination at 30 inches from the floor to permit observation, cleaning, and maintenance.  Light fixtures shall be maintained and kept clean.

 

h)         Heating and cooling systems shall be provided to maintain a minimum temperature of 68 degrees Fahrenheit and a maximum temperature of 78 degrees Fahrenheit.

 

i)          Laundry

 

1)         Clean clothing, bed linens, and towels shall be available to the clients.  Where laundry facilities are provided, space shall be provided, and areas shall be designated for separating clean and soiled clothing, linen, and towels.

 

2)         Written procedures shall be developed and maintained pertaining to the handling, storage, transportation, and process of linens in a manner that will prevent spread of infection and will assure the maintenance of clean linens.

 

3)         Laundry rooms (if provided) shall be well lighted and properly ventilated.  Clothes dryers shall be vented to the exterior.  Carts used for transporting dirty clothes, linen and towels shall not be used for transporting clean articles.

 

A)        All linens shall be cleaned and disinfected as follows:

 

1)         Mechanically wash and dry following the instructions for sanitizing from the washer/dryer manufacturer; and

 

2)         Use hot water (158-176 degrees Fahrenheit) and laundry detergent.

 

B)        If laundry facilities are not provided, soiled laundry items shall be cleaned per contractual agreement with a commercial laundry.

 

j)          Beds and bedding shall be kept in repair and shall be cleaned and sanitized whenever soiled.  Mattresses and pillows shall have cleanable covers, which shall be cleaned and sanitized between use by different clients.  Clean sheets shall be used for each client.  Blankets shall be washed or dry cleaned between clients and whenever soiled.  Sheets, blankets, and clean clothing shall be stored in a clean, dry place between laundering and use.

 

k)         The grounds and building shall be maintained in a safe and sanitary condition.

 

l)          The birth center shall be kept free of all insects and rodents.  All outside openings shall be effectively sealed or screened to prevent entry of insects or rodents.

 

m)        Poisonous or toxic compounds shall be labeled, locked, and stored apart from food and other areas where storage would constitute a hazard to the clients.

 

n)         Drinking water shall be available to all clients.

 

o)         Hot and cold running water under pressure and at a safe temperature, not to exceed 110 degrees Fahrenheit to prevent scalding, shall be provided to all restrooms, lavatories, and bathing areas.

 

p)         Refuse, biohazards, infectious waste and garbage shall be collected, transported, sorted, and disposed of by methods that will minimize nuisances or hazards in compliance with federal, State, and local laws.

 

Section 264.2400  Food Services

 

a)         Each birth center shall have the capacity to provide postpartum persons and families with appropriate nourishment and light snacks.  The minimum equipment shall include a refrigerator (capable of maintaining a temperature of 45 degrees Fahrenheit or lower), microwave, sink, cupboard, and counter space or equivalent.

 

b)         If food service is provided by the birth center or by contract with a food service provider, the following requirements shall be met:

 

1)         Food services shall comply with the Food Code and any applicable local requirements.

 

2)         Meals shall be nutritionally balanced.  The birth center shall work with clients to accommodate clients' preferences.

 

3)         Menus shall be planned and made available in advance of being served.

 

4)         A sufficient number of personnel shall be on duty to meet the dietary needs of the clients.

 

c)         Therapeutic or modified diets shall be followed if ordered by the birth attendant.

 

Section 264.2450  Quality Assurance and Improvement

 

a)         A birth center shall implement a quality improvement program consistent with the requirements of the accrediting body and is encouraged to participate in quality improvement projects implemented by the Department's Administrative Perinatal Centers and other Department-supported perinatal quality improvement projects. (Section 35 of the Act)

 

b)         The birth center shall adopt, implement, and enforce a written quality assurance and improvement program that includes all health and safety aspects of client care for both pregnant or postpartum persons and infant.

 

c)         The ongoing monitoring and evaluation of the quality and accessibility of care and services provided by the birth center or under contract shall include, but not be limited to:

 

1)         Admission of clients appropriate to the capabilities of the birth center;

 

2)         Client satisfaction, complaints, and grievances;

 

3)         Review of the clinical records;

 

4)         Incidences of morbidity and mortality of postpartum person and infant;

 

5)         Postpartum infections;

 

6)         All transfers to a referring hospital for delivery, care of infant, or postpartum care of birthing person;

 

7)         Incidents, problems, and potential problems identified by staff of the birth center, including infection control;

 

8)         Any issues of unprofessional conduct by any member of the birth center's staff (including contractual staff);

 

9)         The integrity of surgical instruments, medical equipment, and client supplies;

 

10)       Client referrals and consultations;

 

11)       Appropriateness of medications prescribed, dispensed, or administered in the birth center;

 

12)       Problems with compliance with any federal or State laws;

 

13)       At least an annual review of protocols, policies and procedures relating to maternal and newborn care;

 

14)       Appropriateness of the risk criteria for determining eligibility for admission to and continuation in the birth center program of care;

 

15)       Appropriateness of diagnostic and screening procedures;

 

16)       Quarterly meetings of clinical practitioners to review the management of care of individual clients and to make recommendations for improving the plan of care;

 

17)       Regular review and evaluation of all problems or complications of pregnancy, labor and postpartum and the appropriateness of the clinical judgment of the clinical practitioner in obtaining consultation and attending to the problem; and

 

18)       Evaluation of staff on ability to manage emergency situations by unannounced periodic drills for fire, maternal/newborn emergencies, power failure, etc.

 

d)         The birth center shall identify and address quality assurance issues and implement corrective action plans as necessary.  The outcome of any corrective action plans shall be documented.  The outcome of the remedial action shall be documented.

 

e)         The QAPI shall include, but not be limited to:

 

1)         Routine testing of the efficiency and effectiveness of all equipment (e.g., sphygmomanometer, dopplers, sterilizers, resuscitation equipment, transport equipment, oxygen equipment, communication equipment, heat source for newborn, smoke alarms, and fire extinguishers);

 

2)         Routine review of housekeeping procedures and infection control; and

 

3)         Evaluation of maintenance policies and procedures for heat, ventilation, emergency lighting, waste disposal, water supply and laundry and kitchen equipment.

 

f)         The QAPI program shall monitor and promote quality of care to clients and the community through an effective system for collection and analysis of data, which includes, but is not limited to:

 

1)         Outcomes of care provided:

 

A)        Spontaneous abortions;

 

B)        Neonatal morbidity;

 

C)        Maternal morbidity;

 

D)        Persons registered for admission for care;

 

E)        Antepartum transfers;

 

F)         Persons admitted to birth center for intrapartum care;

 

G)        Intrapartum transfers;

 

H)        Number of births in the birth center;

 

I)         Percentage of breastfeeding persons;

 

J)         Births occurring en route to the birth center;

 

K)        Postpartum transfers;

 

L)        Newborns transferred;

 

M)       Type of delivery; normal spontaneous vaginal delivery or other;

 

N)        Third and fourth degree lacerations;

 

O)        Infants with birth weight less than 2500 grams or greater than 4500 grams;

 

P)         Apgar scores less than 7 at five minutes;

 

Q)        Neonatal mortality; and

 

R)        Maternal mortality.

 

2)         Reasons for transfer:

 

A)        Antepartum;

 

B)        Intrapartum;

 

C)        Postpartum; and

 

D)        Newborn.

 

g)         Clinicians, or their clinical representative, attending persons in labor at the birth center shall attend morbidity and mortality reviews that occur at the receiving birthing hospital on their clients, when invited, at a mutually agreeable time.  This includes, but is not limited to, maternal and neonatal clients transferred to the receiving birthing hospital. (Section 35 of the Act)

 

Section 264.2500  Reporting Requirements

 

a)         The birth center shall comply with the requirements of the Control of Communicable Diseases Code for reporting communicable diseases.

 

b)         The birth center shall comply with the reporting requirements of the Early Hearing Detection and Intervention Act [410 ILCS 213] for reporting of newborn hearing screening and follow-up.

 

c)         The following incidents shall be reported to the Department in writing, by fax or email within 24 hours after the occurrence, to the Division of Health Care Facilities and Programs via fax to 217-782-0382, or email to: DPH.BirthingCenter@illinois.gov.

 

1)         A death of a postpartum person, infant, or fetus during labor occurring in the birth center; and

 

2)         A death of a pregnant or postpartum person or infant within 24 hours after discharge from the birth center or transfer to a referral hospital.

 

d)         The birth center shall comply with the laws of the State, the Vital Records Act, and the Vital Records Code in preparing and filing birth, stillbirth, and death certificates.

 

e)         The birth center shall notify the Department of any incident, including reports of abuse, that had a significant effect on the health, safety or welfare of a client or clients.

 

f)         Incidents or accidents that affect the health, safety, or welfare of a group of clients or all clients in the birth center and that require a response by the fire department, police department or local emergency services agency shall be reported to the Department.  These include, but are not limited to, fire, power outage, loss of water supply or building damage resulting from severe weather.

 

g)         Notification shall be made to the Division of Health Care Facilities and Programs at DPH.HospitalReports@illinois.gov within 24 hours after each reportable incident or accident, as described in subsections (e) and (f).  The birth center shall send a narrative summary of each accident or incident occurrence that has a significant effect on the health, safety or welfare of a resident or group of clients or all clients to the Department within seven days after the occurrence.

 

h)         A descriptive summary of each reportable incident or accident shall be recorded in the progress notes or nurse's notes for each client affected.

 

i)          The birth center shall maintain a file of all written reports of reportable incidents or accidents affecting clients.  A birth center is not required to report an incident or accident that causes no harm to a client.

SUBPART B: CONSTRUCTION STANDARDS

 

Section 264.2550  Applicability of This Subpart

 

This Subpart shall apply to all birth centers and major alterations and additions to birth centers.  (Major alterations are those that are not defined as minor alterations in Section 264.2600(b).)

 

Section 264.2600  Submission of Plans for New Construction, Alterations or Additions to Birth Centers

 

a)         New Construction, Addition, or Major Alteration to Existing Construction

 

1)         Design Drawing

When construction is contemplated, design development drawings and outline specifications shall be submitted to the Department for review.  Approval of design development drawings and specifications shall be obtained from the Department prior to starting final working drawings and specifications. The Department will provide comments or approval within 30 days after receipt.

 

2)         Final Drawings

 

A)        The final working drawings and specifications shall be submitted to the Department for review and approval prior to the beginning of construction.  Alternative methods of design development and construction may be acceptable, subject to the approval of the Department.  Department approval is null and void if construction contracts are not executed and construction is not started within one year after the plan approval date.  The Department will provide approval or comments within 60 days after the day on which the submission is deemed complete. 

 

B)        The Department shall be notified, in writing, of the award of construction contracts.

 

3)         Any contract modifications that affect or change the function, design, fire/life safety, or purpose of a birth center shall be submitted to the Department for approval prior to authorizing the modifications. The Department will provide comments or approval within 30 days after receipt.

 

4)         The Department shall be notified when construction has been completed and before any area is occupied.

 

5)         The birth center shall maintain as-built drawings on site.

 

b)         Minor Alterations and Remodeling. Minor alterations or remodeling changes that do not affect the structural integrity of the building, that do not change functional operation, that do not affect fire/life safety, and that do not add beds more than the number for which the center is licensed need not be submitted for approval.

 

c)         Codes and Standards

 

1)         Construction shall be in accordance with the requirements of the National Fire Protection Association Standard No. 101, Life Safety Code, Chapter 38, New Business Occupancies and Subpart B of this Part.

 

2)         Nothing stated in this Part shall relieve the birth center from compliance with building codes, ordinances, and regulations that are enforced by city, county jurisdictions or other authorities having jurisdiction.

 

3)         The recommendations of the International Building Code shall apply insofar as such recommendations are not in conflict with the standards set forth in this Part or with the National Fire Protection Association (NFPA) Standard No. 101, Life Safety Code.  The International Building Code is intended as a model code for municipalities with no building code of their own.  In any case, the most stringent rule would be applicable.

 

4)         The codes and standards referenced in this Part can be ordered from the various agencies at the addresses listed in Section 264.1100 and are effective on the dates cited in that Section.

 

5)         The birthing center shall comply with the Illinois Accessibility Code.

 

Section 264.2650  Preparation of Drawings and Specifications − Submission Requirements

 

a)         Drawings and specifications shall be executed by or be under the immediate supervision of an architect licensed in the State of Illinois. 

 

1)         Structural drawings and specifications for these systems may be executed by or be under the immediate supervision of a Structural Engineer licensed in the State of Illinois. 

 

2)         Mechanical and electrical drawings and specifications for these systems may be executed by or be under the immediate supervision of a Professional Engineer licensed in the State of Illinois. 

 

b)         Drawings and specifications shall be submitted for review and approval to determine compliance with Subpart B by the Department.  The drawings and specifications shall be adequate to convey a clear understanding of the birth center and mechanical life safety systems serving the birth center.

 

Section 264.2700  General Requirements

 

a)         Program Narrative

The program narrative shall include the number of beds, medical needs of proposed clients, proposed food service and laundry operations, the interrelation of the functions of the birth center, and the following:

 

1)         Size and Layout

 

A)        Birth center departments' sizes and clear floor areas depend on program requirements and organization of services within the birth center.

 

B)        As required by community needs, combination or sharing of some functions shall be permitted, provided the layout does not compromise safety standards and medical or nursing practices and receives approval from the Department.

 

2)         Transfer Agreements

 

A)        A transfer agreement with the referral hospital shall be in place prior to initiating the planning and construction of these facilities. 

 

B)        These agreements shall be submitted to the Department for approval at the time of project submission.

 

3)         Birth Center Location

A birth center shall be located within a ground travel time distance from the referral hospital with which the birth center maintains a contractual relationship, pursuant to Section 264.2250.

 

b)         Site

The birth center shall be sited to avoid placement in a flood plain, seismic fault line, or another natural impediment to maintaining a stable operational environment.

 

1)         Transport Support Features

 

A)        A birth center's transfer agreements shall include ambulance services to ensure the timely transfer of clients presenting to the birth center and requiring surgical or other hospital-based interventions.

 

B)        There shall be emergency parking available for an ambulance close to the emergency entrance and the designated client rooms holding clients requiring transfer to a referral hospital or APC.

 

C)        Where appropriate, features such as garages, approaches, lighting, and fencing to meet State, federal and/or local regulations that govern the placement, safety features, and elements required to accommodate ambulance service shall be provided.

 

2)         Accessibility to Public Transportation

The birth center shall be sited to provide easy and convenient access to public transportation, if locally available.

 

3)         Parking

 

A)        Each new birth center, major addition, or major change in function shall be provided with parking spaces to satisfy the needs of the client population, personnel, and public.

 

B)        Additional parking may be required to accommodate other services.

 

C)        The birth center shall provide accommodations for loading and off-loading clients from vehicles in an area sheltered from the weather.

 

Section 264.2750  Birth Unit Requirements

 

a)         Size

A minimum of one centrally-located nurses’ station shall be provided for the birth unit. The number of birth rooms shall be provided as determined by the program narrative but shall not exceed 10 beds.

 

b)         Client Rooms

 

1)         Birth rooms.  Delivery procedures shall be performed in the birth rooms. The maximum number of beds per room is one, exclusive of bassinet. This room may also serve as a prenatal/antepartum testing room. Rooming-in care of newborn infants is permissible under this Part.

 

A)        Location

The birth rooms shall be clustered in groups, shall be located out of the path of unrelated traffic, and shall be under direct supervision of the clinical staff. The birth room will serve as labor, delivery and recovery room. The birth rooms should also be located in an area adjacent to the respite nursery (if provided).

 

B)        Space Requirements

Birth rooms shall be adequate and appropriate to provide for equipment, staff, supplies, and emergency procedures required for the physical and emotional care of a maternal client, their support person and the newborn during labor, birth, and the recovery period.

 

C)        Windows

Birth rooms shall have an outside window.  The window is not required to be operable.

 

D)        Hand-washing Sinks

Each birth room shall be equipped with a hand-washing sink with hands-free operation acceptable for scrubbing.  Hand-washing sinks should include accessibility standards (See Section 264.2600(c)(5)) for knee clearance and countertop height. Hand-washing sinks shall be large and deep enough for infant bathing when not in use for hand washing. 

 

E)        Bathrooms

 

i)          Each birth room shall have direct access or be adjacent to a toilet room containing a toilet and lavatory. These bathrooms shall meet the accessibility codes per Section 264.2600(c)(5).

 

ii)         A bathtub or shower shall be available for client use and may include a large tub used for hydrotherapy for labor.

 

F)         Floor, Wall, and Ceiling Finishes

All finishes shall be kept clean and shall be of the type that is appropriate for the cleaning methods and solutions required to maintain a clean and safe environment.

 

G)        Lighting

Lighting shall be provided to accommodate the needs of the client and delivery team during labor, delivery, and postpartum, and to permit the examination and treatment of the infant in the infant resuscitation area.

 

2)         If the birth room in subsection (b)(1) is not utilized as an antepartum testing room, the birth center shall provide a separate antepartum testing room for pregnant persons presenting with false or suspected false labor and requiring monitoring.  These shall be provided based on the program narrative and located as close to the nurses’ station as possible.

 

A)        Antepartum testing rooms must be a single client room and must have a minimum area of 120 square feet (11.15 square meters).

 

B)        Each antepartum testing room must be equipped with a hand-washing station.

 

3)         Respite Nurseries (if provided)

A respite nursery may be provided to allow for the rest of the pregnant or postpartum person when requested. The nursery must be located near and accessible from the nurse station and shall meet the criteria established for newborn nurseries contained in Section 2.1.3.6.6 of the AIA Guidelines for Design and Construction of Health Care Facilities.

 

4)         Family Overnight Stay Rooms (if provided)

Family overnight stay rooms must be located in an area outside of the birth unit and clustered around a common living/dining/nourishment preparation room.  They must include the following:

 

A)        An outside window.

 

B)        A toilet room for the exclusive use of the overnight stay room, equipped with a toilet, closet, hand-washing station, and shower.

 

C)        A storage room for clean linens and supplies within the overnight stay room area.

 

D)        A storage room for holding soiled supplies within the overnight stay room area.

 

E)        A janitor closet with slop sink and storage for cleaning supplies and cart within the overnight stay room area.

 

c)         Support Areas – General

The size and location of each support area shall depend on its use. The following support areas shall be available in each birth center when included in the program narrative.  Identifiable spaces are required for each of the indicated functions.

 

d)         Support Areas for Birth Rooms

 

1)         Nurse Station

 

A)        The area shall have direct visual access to the entrance to the birth unit, the antepartum testing rooms, and the nursery (if provided).

 

B)        Nurse Stations

 

i)          Nurse stations must have adequate space for counters and storage and be located near the hand-washing station.

 

ii)         Nurse stations may be combined with reception areas. 

 

2)         Documentation Area

Charting facilities shall have a linear surface space to ensure that staff and physicians can chart and have simultaneous access to information and communication systems.

 

3)         Hand-washing Stations

 

A)        Hand-washing stations shall be easily accessible to the nurse station, medication station, and nourishment area.

 

B)        One hand-washing station shall be permitted to serve several areas.

 

4)         Medication Station

Appropriate provisions shall be made for the distribution of medications.

 

5)         Nourishment Area

 

A)        A nourishment area must have a sink, work counter, refrigerator, microwave, storage cabinets, and equipment for hot and cold nourishment. This area shall include space for trays and dishes used for nonscheduled meal service.

 

B)        Hand-washing stations shall be in or immediately accessible to the nourishment area.

 

6)         Ice Dispenser

Each birth center shall provide ice for treatments and nourishment.  A refrigerator with  self-dispensing ice is acceptable.

 

7)         Clean Workroom or Clean Supply Room

Such rooms must be separate from and have no direct connection with soiled workrooms or soiled holding rooms and contain storage space for clean and sterile supplies. If the clean workroom is used for preparing client care items, it shall also contain a work counter and a hand-washing station.

 

8)         Soiled Workroom or Soiled Holding Room

Such rooms shall be separate from and have no direct connection with clean work rooms or clean supply rooms and shall contain the following:

 

A)        A clinical sink (that is either a deep bowel free-standing wash basin sink or equivalent flushing rim fixture) and a hand-washing sink. Both fixtures shall have a hot and cold mixing faucet; and

 

B)        A work counter and space for separate covered containers for soiled linen and a variety of waste types.

 

9)         Housekeeping Rooms

A housekeeping room must be provided and meet the following requirements:

 

A)        Contain a service sink;

 

B)        Include storage space for supplies, housekeeping equipment, and housekeeping carts; and

 

C)        Be well-ventilated and have a negative air pressure relationship to adjacent areas.

 

e)         Support Areas for Staff

 

1)         Staff Toilet Rooms

Toilet rooms designated for staff and visitors only must be conveniently located in the birth unit.

 

2)         Staff Storage Locations

Securable lockers, closets, and cabinet compartments for the personal articles of staff shall be located in or near the nurse station.

 

f)         Support Areas for Clients

 

1)         Client and Family Research Library and Consultation Room (if provided)

 

A)        This room must be in the public access areas but also accessible to the client areas.

 

B)        The room must be equipped with tables, computer terminal and access ports, and library stacks for family and client research, and study carrels.  Spaces for group seating for family and staff consultation shall also be provided. This room may be equipped with a private consultation room for client and family privacy.

 

2)         Training/Conference Room (if provided)

This room is to be used for meetings, conferences, and childbirth educational training classes.

 

g)         Linen Services

Each birth center shall provide for storing and processing of clean and soiled linen for appropriate client care. Processing may be done within the center, in a separate building on or off site, or in a commercial or shared laundry.

 

h)         Waste Management

 

1)         Space and facilities shall be provided for the sanitary storage and collection of waste.

 

2)         Waste disposal shall be separated from the clean supplies and receiving.

 

i)          Engineering Services and Maintenance

All mechanical and electrical equipment rooms must include sufficient space for proper maintenance, removal, and replacement of equipment. The following shall be provided:

 

1)         Equipment Locations.

Rooms shall be provided for boilers, mechanical, and electrical equipment.

 

2)         Outdoor Equipment and Supply Storage (if necessary)

 

A)        Supply Storage

Storage for solvents and flammable liquids shall comply with NFPA 30.

 

B)        Outdoor Equipment Storage (if required)

Yard equipment and supply storage areas shall be provided. These must be located so that equipment may be moved directly to the exterior without interference with other work.

 

j)          Administrative and Public Areas

The birth center must provide an entrance at grade level, sheltered from inclement weather, and accessible to disabled persons (in accordance with the Illinois Accessibility Code).

 

k)         Construction Standards

 

1)         Building Codes.  Administrative and public areas in this Section shall be permitted to comply with the business occupancy provisions of the Life Safety Code (NFPA 101) if they are separated from the client care portion of the birth center by a one-hour fire rated barrier.

 

2)         Medical Gas.  All medical and/or compressed gases shall be stored in accordance with NFPA 99.

 

Section 264.2800  Plumbing

 

All plumbing systems shall be designed and installed in accordance with the Illinois Plumbing Code.

 

Section 264.2850  Heating, Ventilating and Air-Conditioning Systems (HVAC)

 

a)         General

 

1)         Mechanical System Design

 

A)        Efficiency. The mechanical system shall be designed for overall efficiency and appropriate life-cycle cost.

 

i)          Recognized engineering procedures shall be followed for the most economical and effective results.

 

ii)         Client care or safety shall not be sacrificed for conservation.

 

iii)        If possible, the birth center shall include provisions for recovery of waste cooling and heating energy (e.g., ventilation, exhaust, water and steam discharge, cooling towers, incinerators, etc.).

 

iv)        Use of recognized energy-saving mechanisms such as variable-air-volume (VAV) systems, and use of natural ventilation shall be considered, site and climatic conditions permitting.

 

v)         Birth center design considerations shall include site, building mass, orientation, configuration, fenestration, and other features relative to passive and active energy systems.

 

B)        Air-handling Systems

 

i)          These shall be designed with an economizer cycle, where appropriate to use outside air. (Use of mechanically-circulated outside air does not reduce the need for filtration.)

 

ii)         VAV Systems. The energy-saving potential of variable-air-volume systems is recognized, and the standards in this Section are intended to maximize appropriate use of those systems. Any system used for occupied areas must include provisions to avoid air stagnation in interior spaces where thermostat demands are met by temperatures of surrounding areas.

 

iii)        Noncentral air-handling systems (i.e., individual room units used for heating and cooling purposes, such as fan-coil units, heat pump units, etc.) may be used as recirculating units only. All outdoor air requirements shall be met by a separate central air-handling system with proper filtration, as noted in Section 2.1-8.2.1.2 of the AIA Guidelines.

 

C)        System Valves. Supply and return mains and risers for cooling, heating, and steam systems shall be equipped with valves to isolate the various sections of each system. Each piece of equipment shall have valves at the supply and return ends.

 

D)        Renovation. If system modifications affect greater than 10 percent of the system capacity, designers shall use pre-renovation water/air flow rate measurements to verify that sufficient capacity is available and that renovations have not adversely affected flow rates in non-renovated areas.

 

2)         Ventilation and Space Conditioning Requirements. All rooms and areas used for client care shall have provisions for ventilation.

 

A)        Ventilation Rates. The ventilation systems shall be designed and balanced, as a minimum, according to the requirements shown in Section 2.1-8.2.1.2 and the applicable notes of the AIA Guidelines. The ventilation rates shown in Section 2.1-8.2.1.2 do not preclude the use of higher rates.

 

B)        Temperature and Humidity. Space temperature and relative humidity shall be as indicated in Section 2.1-8.2.1.2 of the AIA Guidelines.

 

C)        Air Movement Direction. To maintain asepsis control, airflow supply and exhaust shall generally be controlled to ensure movement of air from "clean" to "less clean" areas, especially in critical areas.

 

D)        Mechanical Ventilation. Although natural ventilation for non-sensitive areas and client rooms (via operable windows) shall be permitted, mechanical ventilation shall be considered for all rooms and areas in the birth center.

 

3)         Testing and Documentation

 

A)        Upon completion of the equipment installation contract, the owner shall be furnished with a complete set of manufacturers' operating, maintenance, and preventive maintenance instructions, parts lists, and complete procurement information, including equipment numbers and descriptions. Required information shall include energy ratings as needed for future conservation calculations.  This information shall be always kept by and at the birth center.

 

B)        Operating staff persons shall also be provided with written instructions for proper operation of systems and equipment.

 

b)         Requirements for Specific Locations

 

1)         Birth Rooms

 

A)        Air Supply

 

i)          Air supply for birth rooms shall be from non-aspirating ceiling diffusers with a face velocity in the range of 25 to 35 fpm (0.13 to 0.18 m/s), located at the ceiling above the center of the work area. Return air shall be near the floor level, at a minimum. Return air shall be permitted high on the walls, in addition to the low returns.

 

ii)         Each birth room shall have at least two return-air inlets located as far from each other as practical.

 

iii)        Turbulence and other factors of air movement shall be considered to minimize the fall of particulates onto clean surfaces.

 

B)        Temperature. Temperature shall be individually controlled for each birth room.

 

C)        Ventilation Rates

 

i)          Birth room ventilation systems shall always operate, except during maintenance and conditions requiring shutdown by the building's fire alarm system.

 

ii)         During unoccupied hours, birth room air change rates may be reduced, provided that the positive room pressure is maintained as required in Section 2.1-8.2.1.2 of the AIA Guidelines.

 

2)         Fuel-fired Equipment Rooms. Rooms with fuel-fired equipment shall be provided with sufficient outdoor air to maintain equipment combustion rates and to limit workstation temperatures.

 

3)         Clean workrooms or clean holding rooms and soiled workrooms or soiled holding rooms shall comply with ventilation requirements per Section 2.1-8.2.1.2 of the AIA Guidelines.

 

c)         HVAC Air Distribution

 

1)         Return Air Systems. For client care areas, return air must be by means of ducted systems.

 

2)         HVAC Ductwork. See Section 1.6-2.2.2.1 of the AIA Guidelines.  Exception:  The use of lined ductwork is not permitted to serve any client area in the birth center.

 

3)         Exhaust Systems − General

 

A)        To enhance the efficiency of recovery devices required for energy conservation, combined exhaust systems shall be permitted.

 

B)        Local exhaust systems shall be used whenever possible in place of dilution ventilation to reduce exposure to hazardous gases, vapors, fumes, or mists.

 

C)        Fans serving exhaust systems shall be located at the discharge end and shall be readily serviceable.

 

4)         Air Outlets and Inlets – Fresh Air Intakes

 

A)        Fresh air intakes shall be located at least 25 feet (7.62 meters) from exhaust outlets of ventilating systems, combustion vents (including those serving rooftop air handling equipment), medical-surgical vacuum systems, plumbing vents, or areas that may collect vehicular exhaust or other noxious fumes. (Prevailing winds and/or proximity to other structures may require greater clearances.)

 

B)        Plumbing vents that terminate at a level above the top of the air intake may be located as close as 10 feet (3.05 meters).

 

C)        The bottom of outdoor air intakes serving central systems shall be as high as practical, but at least 6 feet (1.83 meters) above ground level, or, if installed above the roof, 3 feet (91.44 centimeters) above roof level.

 

d)         HVAC Filters

 

1)         Filter Efficiencies

 

A)        All central ventilation or air conditioning systems shall be equipped with filters with efficiencies equal to, or greater than, those specified Section 2.1-8.2.1.2 of the AIA Guidelines.

 

B)        Noncentral air-handling systems shall be equipped with permanent (cleanable) or replaceable filters with a minimum efficiency of Minimum Efficiency Reporting Value (MERV) 3.

 

C)        Filter efficiencies, tested in accordance with ASHRAE 52.2 (ASHRAE Handbook of Fundamentals), shall be average.

 

2)         Filter Bed Location. Where two filter beds are required, filter bed no. 1 shall be located upstream of the air conditioning equipment and filter bed no. 2 shall be downstream of any fan or blowers.

 

3)         Filter Frames. Filter frames shall be durable and proportioned to provide an airtight fit with the enclosing ductwork. All joints between filter segments and enclosing ductwork shall have gaskets or seals to provide a positive seal against air leakage.

 

4)         Filter Housing Blank-off Panels. Filter housing blank-off panels shall be permanently attached to the frame and constructed of rigid materials and shall have sealing surfaces equal to or greater than the filter media installed in the filter frame.

 

5)         Filter Manometers. A manometer shall be installed across each filter bed having a required efficiency of 75 percent or more, including hoods requiring HEPA filters. Provisions shall be made to allow access to the manometer for field testing.

 

e)         Steam and Hot Water Systems. See Section 2.1-8.2.1.2 of the AIA Guidelines.

 

Section 264.2900  Electrical Systems

 

a)         General

 

1)         Applicable Standards

 

A)        All electrical material and equipment, including conductors, controls, and signaling devices, shall be installed in compliance with applicable sections of NFPA 70 and NFPA 99.

 

B)        All electrical material and equipment shall be listed as complying with available standards of listing agencies or other similar established standards when such standards are required.

 

C)        Field labeling of equipment and materials shall be permitted only when provided by a nationally recognized testing laboratory that has been certified by the Occupational Safety and Health Administration (OSHA) for that referenced standard.

 

2)         Testing and Documentation. The electrical installations, including alarm, nurse call, and communication systems, shall be tested to demonstrate that equipment installation and operation is appropriate and functional. A written record of performance tests on special electrical systems and equipment shall show compliance with applicable codes and standards.

 

b)         Electrical Distribution and Transmission

 

1)         Switchboards

 

A)        Location

 

i)          Main switchboards shall be in an area separate from plumbing and mechanical equipment and shall be accessible to authorized persons only.

 

ii)         Switchboards shall be convenient for use, readily accessible for maintenance, and away from traffic lanes.

 

iii)        Switchboards shall be in a dry, ventilated space free of corrosive or explosive fumes, gases, or any flammable material.

 

B)        Overload Protective Devices. These shall operate properly in ambient room temperatures.

 

2)         Panelboards

 

A)        Panelboards serving critical branch, equipment system, or normal system loads shall be located on the same floor as the loads to be served.

 

B)        Location of panelboards serving life safety branch loads on the floor above or the floor below the loads to be served shall be permitted.

 

C)        New panelboards shall not be in public access corridors.

 

3)         Ground-fault Circuit Interrupters

 

A)        Ground-fault circuit interrupters (GFCIs) shall comply with NFPA 70.

 

B)        When ground-fault circuit interrupters are used in critical areas, provisions shall be made to ensure that other essential equipment is not affected by activation of one interrupter.

 

c)         Power Generating and Storing Equipment

Emergency Electrical Service.  Emergency power shall be provided for in accordance with NFPA 99, NFPA 101, and NFPA 110.

 

d)         Lighting

 

1)         General. See Section 1.6-2.3.1.1 of the AIA Guidelines.

 

2)         Lighting for Specific Locations in the Birth Center

 

A)        Birth Rooms. Birth rooms shall have general lighting and night lighting.

 

i)          A reading light shall be provided for each client.  Reading light controls shall be accessible to the client without the client having to get out of bed.  Incandescent and halogen light sources that produce heat shall be avoided to prevent burns to the client and/or bed linen. Unless specifically designed to protect the space below, the light source shall be covered by a diffuser or lens. Flexible light arms, if used, shall be mechanically controlled to prevent the lamp from contacting the bed linen.

 

ii)         At least one night light fixture in each birth room shall be controlled at the room entrance.

 

B)        Corridors shall have general illumination with provisions for reducing light levels at night.

 

3)         Emergency Lighting. See Section 1.6-2.3.1.2 of the AIA Guidelines.

 

4)         Exit Signs. See Section 1.6-2.3.1.3 of the AIA Guidelines.

 

e)         Receptacles

 

1)         Receptacles in Corridors.  Duplex-grounded receptacles for general use shall be installed approximately 50 feet (15.24 meters) apart in all corridors and within 25 feet (7.62 meters) of corridor ends.

 

2)         Birth Rooms. Each birth room shall have duplex-grounded receptacles. One receptacle shall be at each side of the head of each bed; one for television, if used; one on every other wall; and one for each motorized bed.

 

3)         Emergency System Receptacles. Electrical receptacle cover plates or electrical receptacles supplied from the emergency systems shall be distinctively colored or marked for identification. If color is used for identification purposes, the same color shall be used throughout the birth center.

 

f)         Call Systems

Each birthing room shall be equipped with a system of communicating to other parts of the birth center and to an outside telephone line. Specific locations in the Birth Center such as toilet and bathing area shall have a process by which a client can communicate with the birth center in the event of an emergency.

 

Section 264.2950  Emergency Electric Service

 

a)         An emergency source of electricity shall be provided.

 

b)         Birth centers shall be permitted to use a battery system for emergency power.  The following is required:

 

1)         Illumination of means of egress as required in the Life Safety Code (NFPA 101);

 

2)         Illumination of birth and recovery rooms;

 

3)         Illumination of exit and exit directional signs;

 

4)         Fire alarm and alarms required for nonflammable medical gas systems, if nonflammable medical gas systems are installed; and

 

5)         Type 3 emergency electrical service that meets all NFPA 99 requirements of this type of system.

 

Section 264.3000  Security Systems

 

Birth centers shall be designed for active and passive security systems at entry and exit points throughout the birth center, which shall be placed carefully and shall not interfere with the life and safety features necessary to operate and maintain a healthy and functional environment. The birth center shall perform emergency drills for fire evacuation and security infant abduction twice annually.