AUTHORITY: Alternative Health Care Delivery Act [210 ILCS 3].
SOURCE: Adopted at 35 Ill. Reg. 6501, effective March 31, 2011; amended at 43 Ill. Reg. 1633, effective January 18, 2019; amended at 46 Ill. Reg. 18820, effective November 4, 2022; Subchapter b recodified at 49 Ill. Reg. 1638.
SUBPART A: GENERAL REQUIREMENTS
Section 265.1000 Scope and Purpose
a) The purpose of this Part is to implement the Birth Center Demonstration Program under the Alternative Health Care Delivery Act, which allows up to 10 birth centers to be licensed by the Illinois Department of Public Health as birth center alternative health care delivery models.
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.
Section 265.1050 Definitions
Act – the Alternative Health Care Delivery Act.
Administrator – the person who is directly responsible for the operation and administration of the birth center, irrespective of the person's assigned title.
Applicant – any person, acting individually or with any other person, who proposes to build, own, establish or operate a birth center.
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 facility under the particular set of circumstances in existence at the time of review.
Advanced practice nurse or APN – 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 of time before labor or childbirth.
Birth assistant – 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 the physician or certified nurse midwife in attendance, who 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 35(6) of the Act)
Birth attendant – an obstetrician, family practitioner physician, or certified nurse midwife who attends each woman in labor from the time of admission and throughout the immediate postpartum period. (Section 35(6) of the Act)
Birth center or center – an alternative health care delivery model that is exclusively dedicated to serving the childbirth-related needs of women and their newborns and has no more than 10 beds. A birth center is a designated site that is away from the mother's usual place of residence in which births are planned to occur following a normal, uncomplicated, and low-risk pregnancy.
Birth room – a room specifically designed and equipped for a single occupancy client to give birth under the care of professionals in that health care specialty.
Birth unit – a number of 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 – a registered nurse who meets the requirements for licensure as an advanced practice nurse under the category of certified nurse midwife under Section 15 of the Nurse Practice 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 woman who gives birth at a center and the infant of that birth.
Community education services – information and education provided to the pregnant woman and her family, during both early and late pregnancy, that promote healthy outcomes for the woman and her infant.
Demonstration Program or Program – a program to license and study alternative health care models authorized under the Act. (Section 10 of the Act)
Department – the Illinois Department of Public Health. (Section 10 of the Act)
Federally qualified health center – a community health center funded under Section 330 of the federal Public Health Service Act (42 USC 254b).
Governing body – a board of trustees, governing board, board of directors or other body or individual responsible for governing a birth center.
Health-related field – either a registered nurse or licensed practical nurse, physician, physician assistant, or other classifications that are licensed, registered or certified by the Illinois Department of Financial and Professional Regulation.
Hospital – any institution, place, building or agency licensed pursuant to the Hospital Licensing Act. (Section 3 of the Hospital Licensing Act)
Immediate postpartum period – a minimum of two hours following the delivery of the placenta and until the client is clinically stable.
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 true labor until the delivery of the infant and placenta.
Licensee – the person or entity licensed to operate the birth center.
Low-risk pregnancy – a pregnancy that, based on history, application of risk criteria, 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)
Medical director – a physician, licensed to practice medicine in all of its branches, who is certified or eligible for certification by the American Board of Obstetricians and Gynecologists, who provides guidance, leadership, oversight and quality assurance to the birth center.
Newborn infant or newborn – an infant who is less than 72 hours old.
Nurse – a registered nurse or licensed practical nurse as defined in the Nurse Practice Act.
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.
Perinatal center – a referral facility designated under the Regionalized Perinatal Health Care Code and intended to care for the high risk patient before, during, or after labor and delivery and characterized by sophistication and availability of personnel, equipment, laboratory, transportation techniques, consultation and other support services.
Person – any individual, partnership, corporation, association, municipality, political subdivision, trust, estate or other legal entity.
Physician – any person licensed to practice medicine in all of its branches under the Medical Practice Act of 1987.
Prenatal care – medical care for a pregnant woman and her fetus throughout her pregnancy.
Program narrative – a description of the center's proposed operation, which clarifies or explains choices related to such items as space, equipment, finishes or other specifications in the architectural plans. The program narrative shall include, but is not limited to, the:
Number of beds;
Medical needs of proposed clients;
Proposed food service operation;
Proposed laundry operation; and
Interrelation of the functions of the birth center.
Quality assurance – an ongoing, objective and systematic process of monitoring, evaluating and improving the quality, appropriateness and effectiveness of care.
Quality improvement or performance improvement – an organized, structured process that selectively identifies projects to achieve improvement in products or services.
Registered nurse – 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 particular 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 inspection of the actual act of accomplishing the function or activity.
Support person – an individual who provides emotional support and 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 – spontaneous labor and delivery.
(Source: Amended at 43 Ill. Reg. 1633, effective January 18, 2019)
Section 265.1100 Incorporated and Referenced Materials
a) The following private and professional association standards are incorporated in this Part:
1) FGI Guidelines (2010 edition), Guidelines for Design and Construction of Health Care Facilities, which may be obtained from the American Institute of Architects (AIA) Academy of Architecture for Health, Facilities Guidelines Institute, 1919 McKinney Ave., Dallas, Texas 75201.
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., 1791 Tullie Circle, N.E., Atlanta, Georgia 30329.
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, Massachusetts 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, Illinois 60477-5795.
5) The American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, Guidelines for Perinatal Care, seventh edition (2012), which may be obtained from the American Academy of Pediatrics, 141 Northwest Point Boulevard, P.O. Box 927, Elk Grove Village, Illinois 60009-0927.
6) The American Association of Birth Centers, Standards for Birth Centers (2016), which may be obtained from the American Association of Birth Centers, 3123 Gottschall Road, Perkiomenville, Pennsylvania 18074
b) The following federal guidelines are incorporated in this Part:
1) Center for Infectious Diseases, Centers for Disease Control and Prevention, United States Public Health Service, Department of Health and Human Services. The guidelines may be obtained from the National Technical Information Service (NTIS), U.S. Department of Commerce, 5285 Port Royal Road, Springfield, Virginia 22161.
A) Guideline for Hand Hygiene in Health-Care Settings (October 2002)
B) Guidelines for Infection Control in Health Care Personnel (1998)
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 USC 301 et seq., 1395 et seq., and 1396 et seq.)
2) Clinical Laboratory Improvement Amendments (42 USC 1861 and 1902)
3) Public Health Service Act (42 USC 254b)
e) The following State laws and administrative rules are referenced in this Part:
1) State of Illinois laws:
A) Nurse Practice Act [225 ILCS 65]
B) Medical Practice Act of 1987 [225 ILCS 60]
C) Hospital Licensing Act [210 ILCS 85]
D) Illinois Health Facilities Planning Act [20 ILCS 3960]
E) Pharmacy Practice Act [225 ILCS 85]
F) Illinois Administrative Procedure Act [5 ILCS 100]
G) Health Care Worker Background Check Act [225 ILCS 46]
H) Alternative Health Care Delivery Act [210 ILCS 3]
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]
2) State of Illinois 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) Rules of 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 Service Sanitation Code, Illinois Department of Public Health (77 Ill. Adm. Code 750)
G) Health Care Worker Background Check Code, Illinois Department of Public Health (77 Ill. Adm. Code 955)
H) Regionalized Perinatal Health Care Code, Illinois Department of Public Health (77 Ill. Adm. Code 640)
I) Illinois Vital Records Code, Illinois Department of Public Health (77 Ill. Adm. Code 500)
J) Perinatal HIV Prevention Code, Illinois Department of Public Health (77 Ill. Adm. Code 699)
K) Nonhazardous Special Waste Handling and the Uniform Program, Illinois Pollution Control Board (35 Ill. Adm. Code 809)
(Source: Amended at 43 Ill. Reg. 1633, effective January 18, 2019)
Section 265.1150 Demonstration Program Elements
a) A birth center shall be exclusively dedicated to serving the childbirth-related needs of women and their newborns and shall have no more than 10 beds. (Section 35 of the Act)
b) A birth center shall be licensed pursuant to this Part to be considered a participant in the Program.
c) Applications for participation in the Program shall be considered only when a vacancy exists in one of the allocated Program slots for the relevant geographic area, as set forth in Section 30(a-25) of the Act.
d) The Department shall deposit all application fees, renewal fees and fines collected under the Act and this Part into the Regulatory Evaluation and Basic Enforcement Fund in the State Treasury. (Section 25(d) of the Act)
e) Birth centers shall, within 30 days after licensure, seek certification under Titles XVIII and XIX of the Federal Social Security Act. (Section 30(d) of the Act)
f) Birth centers shall provide charitable care consistent with that provided by comparable health care providers in the geographic area. (Section 30(d) of the Act)
g) A licensed birth center that continues to be in substantial compliance after the conclusion of the demonstration program shall be eligible for annual license renewals unless and until a different licensure program for that type of health care model is established by legislation. (Section 30(c) of the Act)
h) No place or person shall hold itself out to the public as a "birth center" unless it is licensed as a birth center under the Act and this Part.
Section 265.1200 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; and
5) Emergency exit routes.
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 required by Section 35(6) of the Act; 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 265.1250 General Requirements for Licensure
a) Birth centers shall obtain a permit from the Illinois Health Facilities and Services Review Board and shall obtain a license from the Illinois Department of Public Health. No person may engage in the business of providing birth center services, or represent to the public that the person is a provider of such services for pay or other consideration, without a license.
b) A birth center shall be exclusively dedicated to serving the childbirth-related needs of women and their newborns and shall have no more than 10 beds. (Section 35(6) of the Act)
c) A birth center is a designated site that is away from the mother’s usual place of residence and in which births are planned to occur following a normal, uncomplicated, and low-risk pregnancy. (Section 35(6) of the Act)
d) 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 35(6) of the Act)
e) A birth center license shall be required if the birth center is operated as:
1) A part of the operation of a federally qualified health center as designated by the United States Department of Health and Human Services; or
2) A facility other than one described in Section 35(6)(A)(1) or (A)(2) of the Act or subsection (e)(1) of this Section whose costs are reimbursable under Title XIX of the federal Social Security Act. (Section 35(6)(B)(2) of the Act)
f) Each birth center must become accredited by either the Commission for the Accreditation of Freestanding Birth Centers or the Joint Commission on Accreditation of Health Care Organizations within two years after becoming licensed. (Section 35(6) of the Act)
g) A birth center shall be certified to participate in the Medicare and Medicaid Programs under Titles 18 and 19, respectively, of the federal Social Security Act if allowable. (Section 35(6) of the Act)
h) A birth center shall be located within a ground travel time distance from the general acute care hospital with which the birth center maintains a contractual relationship, including a transfer agreement that allows for an emergency caesarian delivery to be started within 30 minutes after the decision a caesarian delivery is necessary. (Section 35(6) of the Act)
i) 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.
j) Each license shall specify the licensed bed capacity of the birth center.
k) Procedures performed at birth centers shall be limited to those normally accomplished in uncomplicated childbirth, including simple episiotomies and repairs of lacerations. Surgical procedures such as tubal ligation or termination of pregnancy are prohibited at birth centers.
l) 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.
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 35(6) of the Act)
n) The medical director or his or her physician designee shall be available on the premises or within a close proximity. Close proximity means being able to be physically present in the facility within 30 minutes after being called. (Section 35(6) of the Act)
o) The birth center license shall be prominently displayed in the area accessible to the public.
p) Staff Continuing Education Policies and Requirements.
1) 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 educational modules regarding management of severe maternal hypertension and obstetric hemorrhage and other leading causes of maternal mortality for units that care for pregnant or postpartum women. Birthing facilities must demonstrate compliance with these written policy, education, and training requirements. (Section 2310-222(b) of the Department of Public Health Powers and Duties Law)
2) Birth centers shall annually submit documentation demonstrating compliance with the requirements in subsection (p)(1) to their respective Administrative Perinatal Center.
q) Birth centers shall incorporate the 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 women for common pregnancy or postpartum complications and for care provided by the birth center throughout the pregnancy and postpartum period. The best practices shall be incorporated into the written policy required in subsection (p). (Section 2310-222(d) of the Department of Public Health Powers and Duties Law)
r) A birth center licensed under the Act shall make reasonable efforts to have activated at all times the closed captioning feature on a television in a common area provided for use by the general public or in a patient's room, or enable the closed captioning feature when requested to do so by a member of the general public or a patient, if the television includes a closed captioning feature. As used in this subsection (r), "closed captioning" means a text display of spoken words presented on a television that allows a deaf or hard of hearing viewer to follow the dialogue and the action of a program simultaneously.
1) It is not a violation of this subsection (r) if the closed captioning feature is deactivated by a member of the birth center's staff after such feature is enabled in a common area or in a patient's room unless the deactivation of the closed captioning feature is knowing and intentional. It is not a violation of this subsection (r) if the closed captioning feature is deactivated by a member of the general public, a patient, or a member of the birth center's staff at the request of a patient of the birth center.
2) If the birth center does not have a television that includes a closed captioning feature, then the birth center shall ensure that all televisions subsequently obtained for common areas and patient rooms include a closed captioning feature. This subsection (r) does not affect any other provision of law relating to disability discrimination or providing reasonable accommodations or diminish the rights of a person with a disability under any other law. (Section 35.5 of the Act)
3) A birth center shall post information regarding the availability of closed captioning on televisions in the facility and shall provide clients with information on how to activate the closed caption feature.
(Source: Amended at 46 Ill. Reg. 18820, effective November 4, 2022)
Section 265.1300 Application for Initial License
a) An application for a license to establish or operate a birth center shall be made in writing on forms provided by the Department.
b) A change of ownership will require a new application.
c) The application shall include proof of a Certificate of Need to establish and operate a Birth Center Model issued by the Health Facilities and Services Review Board under the Illinois Health Facilities Planning Act.
d) 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.
e) Each application shall be accompanied by a non-refundable license application fee of $500 plus $100 for each licensed birthing bed.
f) 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, of every member thereof; in the case of a corporation, the name, address and phone number thereof and 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 conviction 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, of a felony, or of two or more misdemeanors involving moral turpitude in the last five years.
5) The name, address, telephone number, experience, credentials and any professional licensure or certification of the following persons:
A) Administrator;
B) Medical director; and
C) Director of Nursing and Midwifery Services.
6) A list of the medical 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 265.1550).
9) Schematic architectural plans.
10) A copy of the contract between the birth center and hospital, including a transfer agreement pursuant to Section 265.1250(h).
11) The letter of agreement with a perinatal center for referral of high risk infants based upon the Regionalized Perinatal Health Care Code.
12) 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.
g) Each application shall contain documentation that the services of a medical director physician, licensed to practice medicine in all its branches, who is 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 are available to be provided in the birth center. (Section 35(6) of the Act)
h) Upon receipt and review of a complete application for licensure, the Department shall conduct an inspection to determine compliance with the Act and this Part.
i) If the birth center is found to be in substantial compliance with the Act and this Part, the Department shall issue a license for a period of one year. (Section 30 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.
j) An application for an annual license renewal shall be filed with the Department 90 to 120 days prior to the expiration of the license, on forms provided by the Department.
1) The renewal application shall comply with the requirements of subsections (a), (b), (c), (d), (e) and (f) of this Section; and
2) Upon receipt and review of a complete application for license renewal, the Department may conduct a survey, dependent upon workload priorities, time from last survey, and other factors such as complaints or reports. The Department will renew the license in accordance with subsection (i) of this Section.
k) The Department may issue a provisional license to any birth center model that does not substantially comply with the provisions of the Act and this Part:
1) A provisional license will be issued only if the Department finds that:
A) The birth center has undertaken changes and corrections which upon completion will render the birth center in substantial compliance with the Act and this Part;
B) The health and safety of the clients of the birth center will be protected during the period for which the provisional license is issued (Section 30(c) of the Act); and
C) The health and safety of the employees of the birth center will be protected during the period for which the provisional license is issued.
2) The Department shall advise the applicant or licensee of the conditions under which the provisional license is issued, including:
A) The manner in which the birth center fails to comply with the provisions of the Act and this Part;
B) The changes and corrections that shall be completed;
C) 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 (Section 30(c) of the Act); and
D) The interim actions that are necessary to protect the health and safety of the clients.
Section 265.1400 Inspections and Investigations
a) The Department shall perform licensure inspections of birth centers, as deemed necessary, to ensure compliance with the Act and this Part. (Section 25(c) of the Act)
b) Birth centers shall be subject to and shall be deemed to have given consent to all inspections by properly identified personnel of the Department, or by other such properly identified persons as the Department might designate. In addition, 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.
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. (Section 50 of the Act)
1) Complaints in regard to 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 conduct an investigation of all complaints received. An appropriate investigation may include, but is not limited to, record reviews and/or telephone interview, on-site surveys or a combination of methods.
d) The Department shall investigate an applicant or licensee whenever it receives a verified complaint in writing of any person setting forth facts which if proven would constitute grounds for the denial of an application for a license, refusal to renew a license, suspension of a license or revocation of a license. (Section 50 of the Act)
Section 265.1450 Notice of Violation and Plan of Correction
a) 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 and shall instruct the licensee or applicant to submit a plan of correction to the Department within 10 days after receipt of the Notice.
b) 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 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.
c) 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. Each acceptable plan of correction shall include:
1) The procedure for implementing the plan of correction for each deficiency cited, typed in the right-hand column of the original Statement of Deficiencies;
2) The title of the individual responsible for implementing and monitoring the plan of correction;
3) Documentation that the facility has incorporated systemic improvement efforts into its quality assessment and performance improvement program in order 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.
d) Submission of a plan of correction shall not be considered an admission by the birth center that the violation has occurred.
e) 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.
f) 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 only if it finds any of the following deficiencies:
1) The plan does not address the conditions or occurrences that are the basis of the violation and does not evaluate the practices, policies, and procedures that have caused or contributed to the conditions or occurrences.
2) The plan does not indicate the specific actions that the birth center will be taking to abate, eliminate, or correct the violation.
3) The plan does not provide for measures that will abate, eliminate, or correct the violation.
4) The plan does not provide steps that will avoid future occurrence of the same and similar violations.
5) The plan does not provide for timely completion of the corrective action, considering the seriousness of the violation, any possible harm to the clients, and the extent and complexity of the corrective action.
g) 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 (c) of this Section within five days after receipt of the notice of rejection.
h) If a licensee or applicant fails to submit a modified plan of correction as required in subsection (g), or if the modified plan is not acceptable to the Department, the Department will specify and impose a plan of correction.
i) The Department will verify the completion of the corrective action required by the plan of correction within the specified time period during subsequent investigations, surveys, and evaluations of the birth center.
Section 265.1500 Adverse Licensure Action and Administrative Hearings
a) Before denying a license application, refusing to renew a license, suspending a license, revoking a license, or assessing an administrative fine, the Department shall notify the applicant or the licensee in writing. The notice shall specify the charges or reasons for the Department's contemplated action, and shall provide the applicant or licensee an opportunity to file a request for a hearing within 10 days after receiving the notice. (Section 50 of the Act)
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. (Section 50 of the Act)
2) The hearing shall be conducted by the Director or an individual designated in writing by the Director as an Administrative Law Judge, and shall be conducted in accordance with the Department's Rules of Practice and Procedure in Administrative Hearings and Section 55 of the Act. (Section 55 of the Act)
b) A license may be denied, suspended, or revoked, and 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 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 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:
A) the prior license was issued to the individual applicant or a controlling owner or controlling combination of owners of the applicant; or
B) any affiliate of the individual applicant or controlling owner of the applicant or affiliate of the applicant was a controlling owner of the prior license. (Section 45 of the Act)
c) An action to assess an administrative fine may be initiated in conjunction with or in lieu of other adverse licensure action.
d) The amount of an administrative fine shall be determined based on 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 shall 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 shall 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 265.1550 Admission Protocols for Acceptance for Birth Center Clients
a) An admission protocol specifying the criteria for admitting a client to the birth center shall be included in the application as provided in Section 265.1300.
b) Only clients whose births are planned to occur following a normal, uncomplicated, and low-risk pregnancy shall be allowed to receive services at the birth center. The medical director and the Director of Nursing and Midwifery Services shall jointly develop and approve policies defining the criteria to determine which pregnancies are accepted as normal, uncomplicated and low-risk, and the anesthesia services and other services available at the birth center. (Section 35(6) of the Act)
c) No general anesthesia, which includes spinal/epidural, or regional, may be administered at the birth center. (Section 35(6) of the Act)
d) Any pregnant walk-in person who is beyond 32 weeks of gestation or is ready to deliver her baby, and who has not previously been approved for admission, shall be immediately transferred to a hospital.
e) An obstetrician, family practitioner/physician, or certified nurse midwife shall attend each woman in labor from the time of admission through birth and throughout the immediate postpartum period. (Section 35(6) of the Act)
f) Criteria for acceptance for admission shall be in writing.
g) No pharmacologic agents are permitted to induce or enhance labor.
h) The birth center shall have a contractual relationship/transfer agreement with a hospital capable of performing obstetric deliveries.
i) The birth center shall have a letter of agreement with a hospital designated under the Perinatal System. (Section 35(6) of the Act)
j) The birth center's governing body shall approve the acceptance for admission protocol and any subsequent revisions.
k) Each birth center shall establish written policies and procedures stating the medical and social risk factors that exclude women from the low-risk intrapartum group.
l) Each birth center shall establish a written risk assessment that shall be completed for each client and included in the client's clinical record. The assessment shall include a detailed medical history, a physical examination, family circumstances and other social and psychological factors.
m) Women who fail to register for acceptance with the birth center before 32 weeks gestation and who have not received prenatal care shall be excluded from admission unless a written, signed exception is made by the medical director on an individual basis. The woman 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 letter of agreement between the birth center and the hospital in the Perinatal System, pursuant to the requirement of subsection (i).
n) Criteria for antepartum acceptance and transfer to a hospital, and intrapartum and postpartum transfer to a hospital, and the certified nurse midwife-physician collaborative agreement shall be described in the birth center's established written protocols in accordance with the American Association of Birth Centers, Standards for Birth Centers. The criteria for acceptance and transfer to a hospital at any stage shall also comply with the letter of agreement between the birth center and the hospital in the Perinatal System, pursuant to the requirements of subsection (i).
o) A physician or a certified nurse midwife shall determine the general health and complete a risk assessment of the client, using the following criteria for exclusion as a birth center client. These criteria shall be applied to all clients prior to acceptance for birth center services and throughout the pregnancy for continuation of services. The medical director and Director of Nursing and Midwifery Services shall make the final determination of each client's risk.
1) Body mass index of less than 18 or greater than 40 (client will not be accepted).
2) Medical problems, including, but not limited to:
A) Heart disease, pulmonary embolus, or chronic hypertension not controlled by medication;
B) Congenital heart defects assessed as pathological by a cardiologist, placing mother and/or fetus at risk;
C) Severe renal disease;
D) Current drug or alcohol addiction;
E) Diabetes mellitus or gestational diabetes not controlled by diet;
F) Thyroid disease that is not maintained in a euthyroid state;
G) Bleeding disorder or hemolytic disease;
H) Adrenal disease;
I) Systemic collagen, connective tissue and autoimmune diseases (e.g., systemic lupus erythematosis, anti-phospholipid syndrome, progressive system sclerosis, and periarteritis nodosa);
J) Acute or chronic liver disease;
K) Neurological disorder or seizure disorder requiring use of anticonvulsant drugs;
L) Active HIV positive or confirmed active genital herpes at term;
M) Active subarachnoid hemorrhage, aneurysm;
N) Active hernia of the nucleus pulposus;
O) Active lung function disorder/COPD;
P) Active moderate to severe asthma;
Q) Tuberculosis, active; or
R) Active inflammatory bowel disease, including ulcerative colitis and Crohn's disease.
3) Previous history of obstetrical complications, including, but not limited to:
A) Previous gynecologic uterine wall surgery where uterine cavity was entered;
B) Two previous caesarean sections;
C) Previous caesarean section with documented conditions: vertical scar, placenta anterior and low lying;
D) Cervical insufficiency (and/or Shirodkar-procedure);
E) Placental abruption;
F) Postpartum hemorrhage as a result of cervical tear;
G) Postpartum hemorrhage, other causes;
H) Manual removal of a placenta.
4) Risk factors in prenatal course of current pregnancy, including, but not limited to:
A) Anemia (less than 9 gm hemoglobin concentration and not responding to therapy);
B) Complete placenta previa in third trimester;
C) Nonvertex presentation in labor;
D) Pre-eclampsia;
E) Known multiple gestation;
F) Hypertension – resting blood pressure 140/90 or an increase of 30 systolic or 15 diastolic over the client's baseline pressure;
G) Premature labor at less than 37 weeks; the client may return to the birth center if undelivered at 37 weeks;
H) Premature rupture of membrane at less than 37 weeks;
I) Prolonged rupture of membranes requiring Pitocin induction/augmentation:
J) Prolonged pregnancy (at 42 completed weeks or more);
K) Significant isoimmunization against Rh or other antigen that may affect the fetus with rising titres;
L) Pyelonephritis;
M) Toxoplasmosis;
N) Rubella;
O) Cytomegalovirus;
P) Parvovirus infection;
Q) Tuberculosis, active;
R) Syphilis;
S) Ectopic pregnancy;
T) Deep venous thrombosis;
U) Placental abruption; or
V) Dead fetus.
p) The acceptance and admission policies of the birth center shall not discriminate against clients based on disability, race, religion, source of payment, sexual preference/orientation or any other basis recognized by applicable State and federal laws.
q) 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.
r) 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.
s) The number of women 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 265.1600 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 who has the authority and responsibility for the operation and administration of the birth center at all times. 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 medical director physician who is licensed to practice medicine in all its branches, who is 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. (Section 35(6) of the Act)
e) The governing body shall appoint a Director of Nursing and Midwifery Services.
f) 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. These shall include, but not be limited to:
1) Obstetric, pediatric, and midwifery services available on a 24-hour basis, seven days a week, which shall include obstetric and pediatric consultative services, transportation in case of emergency, admission and discharge policies and provision for referral to outside resources; and
2) Written birth center policies developed by the medical director and Director of Nursing and Midwifery Services and readily available to all staff. All staff members shall be oriented to existing policies and procedures and shall be promptly notified of changes in policies or procedures.
g) The governing body shall annually review, revise and approve client rights policies and procedures (see Section 265.1700).
Section 265.1650 Length of Stay
The maximum length of stay in a birth center shall be consistent with existing state laws (Illinois Insurance Code Section 356s) allowing a 48-hour stay or appropriate post-delivery care, if the client is discharged earlier than 48 hours. (Section 35(6) of the Act)
Section 265.1700 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) The medical director and Director of Nursing and Midwifery Services shall develop written policies and procedures to assure the individual mother the right to dignity, privacy, and safety, which shall include, but not be limited to, the requirements in subsection (d). The governing body shall review, revise, and approve the policies annually. The birth center shall follow the policies and procedures.
d) It is the right of every mother, and/or support person, to expect and receive:
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) Availability of an obstetrician, family practitioner/physician or certified nurse midwife on a 24-hour per day, 7 day per week basis from the time of admission through birth and throughout the immediate postpartum period. Additionally, a second staff person shall also be present at each birth who is licensed or certified in Illinois in a health-related field and under the supervision of the physician or certified nurse midwife 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 35(6) of the Act)
9) A copy of the birth center's rules that apply to conduct as a mother, 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 265.1750 Personnel
a) Medical Director. The services of a medical director physician, licensed to practice medicine in all its branches, who is 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 are required in birth centers. (Section 35(6) of the Act)
1) The medical director shall be appointed by and responsible to the governing body and shall have full obstetrical privileges in a licensed hospital near the birth center. The medical director may also be designated as the individual responsible for the administrative operation of the birth center. The medical director shall be responsible for:
A) 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;
B) Establishing a Written Collaborative Agreement for midwifery care management as required by Section 65-35 of the Nurse Practice Act;
C) Coordinating all professional medical consultants to the birth center (e.g., consulting obstetrical physicians, pediatricians, family physicians); and
D) Such other functions as may be deemed appropriate.
2) The medical director or a physician designee shall be available on the premises or within the proximity specified in Section 265.1250(n).
b) Administrator. The administrator 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 of the minimum qualifications and is capable of performing all of 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.
c) Director of Nursing and Midwifery Services
1) If a birth center employs certified nurse midwives, a certified nurse midwife shall be the Director of Nursing and Midwifery Services who is responsible for the development of policies and procedures for services as provided by this Part. (Section 35(6) of the Act)
2) The nursing or midwifery services shall be under the direction of a registered nurse or a certified nurse midwife who has qualifications in nursing administration and/or nursing management and who has the ability to organize, coordinate, and evaluate the service.
3) The Director of Nursing and Midwifery Services shall hold a degree in nursing and have documented experience and relevant continuing education.
4) The Director of Nursing and Midwifery Services shall be accountable to the governing body for developing and implementing policies and procedures of the birth center and for the nursing/midwifery practice.
5) The Director of Nursing and Midwifery Services shall have authority over the selection, promotion and retention of nursing/midwifery personnel based on established job descriptions.
6) A registered nurse or certified nurse midwife qualified by training shall be designated and authorized to act in the absence of the Director of Nursing and Midwifery Services on a 24-hour basis.
d) Birth Attendants and Birth Assistants
1) A birth attendant is an obstetrician, family practitioner/physician, or certified nurse midwife who attends a woman in labor from the time of admission through birth and throughout the immediate postpartum period, in accordance with Section 265.1850. (Section 35(6) of the Act)
2) A birth assistant shall be licensed or certified in Illinois in a health-related field and under the supervision of the physician or certified nurse midwife in attendance, have specialized training in labor and delivery techniques and care of newborns, and receive planned and ongoing training as needed to perform assigned duties effectively. (Section 35(6) of the Act) The birth assistant acts as the second staff person who is required by Section 35(6) of the Act to be present at each birth.
e) Professional and support staff (nurses, clerical, housekeeping, food service, maintenance, etc.) shall be on duty and on call to meet the demands for services provided to assure client safety and satisfaction.
f) At each birth there shall be two staff currently certified in:
1) Adult CPR equivalent to American Heart Associate Class C life support; and
2) Neonatal CPR equivalent to American Academy of Pediatrics/American Heart Association requirements.
g) Each birth center shall establish an employee health program that includes, at a minimum, the following:
1) An assessment of the employee's health and immunization status at the time of employment;
2) Policies regarding required immunizations;
3) Policies and procedures for the periodic health assessment of all personnel. These policies shall specify the content of the health assessment and the interval between assessments and shall comply with the Control of Tuberculosis Code;
4) All birth center employees who are exposed to blood shall have full immunization against hepatitis B or documented refusal; and
5) Annual training on infection control for birth center personnel. The training shall follow the standards set forth in the Guidelines for Infection Control in Health Care Personnel; and
6) Procedures related to 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.
h) Each birth center shall develop a system for training and continued education for all personnel according to their assigned duties and for evaluation of skills consistent with the individual's scope of practice.
i) 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.
j) A birth center shall comply with the Health Care Worker Background Check Act and the Health Care Worker Background Check Code.
k) The birth center shall check the status of all applicants with the Health Care Worker Registry prior to hiring.
Section 265.1800 Clinical Services
a) Clients shall meet all the requirements of Section 265.1550 before being admitted and receiving services at the birth center.
b) Each birth center shall assure that each woman and her 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 mother (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 shall arrange with another health care provider to make a program available to the center's clients.
1) The program shall consist of a course of instruction to expectant mothers and support persons pertaining to prenatal care and its outcome; care of the newborn; and an understanding of labor and delivery, self-care, and preparation for participation in the childbirth process.
2) The education program shall be coordinated with other health care services available in the community.
3) The birth center shall require all women 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. The location should meet the needs of the participant by encouraging and supporting attendance.
d) The birth center shall ensure that mothers have adequate prenatal care in accordance with the birth center's written policies and procedures and acceptable standards of practice. The policies shall require the following:
1) Every mother shall be involved in the development and assessment of a protocol of care.
2) Every mother shall be evaluated within four weeks after the initial request for admission for care. If the mother is at 32 weeks gestation when she makes her initial request for admission, the birth center shall evaluate the woman as soon as possible, pursuant to Section 265.1550. To establish a database of risk assessment, identify problems and needs, and develop a protocol of care, the evaluation shall include:
A) Data from history and physical examination, including documented HIV status;
B) Laboratory findings;
C) Social, nutritional and health assessments; and
D) Frequency of prenatal visits.
e) Any risk factor pertaining to labor, delivery or postpartum periods as outlined in Section 265.1550 shall be cause to discontinue care of the mother and/or newborn at the birth center.
1) If a clinical complication occurs in the course of labor or delivery or postpartum, the obstetrician, family physician or certified nurse midwife shall have the mother and newborn transferred promptly to a licensed hospital obstetrical service and shall notify the medical director.
2) Records necessary to explain the situation fully shall accompany a mother and newborn upon transfer to the hospital.
f) The maximum length of stay in a birth center shall be consistent with existing State laws allowing a 48-hour stay or appropriate post-delivery care, if the mother and infant are discharged earlier than 48 hours. (Section 35(6) of the Act) If a mother or newborn is not in satisfactory condition for discharge within 48 hours following birth, the mother or newborn shall be transferred to a hospital that has obstetrical and nursery services.
g) The written policies and procedures established by the medical director and Director of Nursing and Midwifery Services for a follow-up program of care and postpartum evaluation after discharge from the birth center shall include, but not be limited to, the following:
1) The birth center's medical director, obstetrician, family physician, or certified nurse midwife shall be accessible by telephone, 24 hours per day, to assist mothers in case of need during the postpartum period.
2) The birth center's postpartum program shall include the assessment of mother and infant, including physician examination, laboratory screening tests at appropriate times, and maternal postpartum status; and instructions in child care, including immunization, referral to sources of pediatric care, provisions for family planning services, the importance of newborn hearing screening, pursuant to Section 265.1900, and assessment of mother-child relationship, including breastfeeding.
h) No general, which includes spinal/epidural, or regional anesthesia may be administered at the birth center. (Section 35(6) of the Act) Local anesthesia for episiotomies and/or repair of lacerations may be administered in accordance with written policies and procedures established by the medical director.
i) No surgical procedures shall be performed except episiotomy, repair of episiotomy or laceration, or circumcision.
(Source: Amended at 43 Ill. Reg. 1633, effective January 18, 2019)
Section 265.1850 Labor and Birth Procedures
a) An obstetrician, family practitioner/physician or certified nurse midwife (birth attendant) shall attend each woman in labor from the time of admission through birth and throughout the immediate postpartum period. Attendance may be delegated only to another physician or certified nurse midwife. (Section 35(6) of the Act)
b) Additionally, a second staff person (birth assistant) shall also be present at each birth who is licensed or certified in Illinois in a health-related field and under the supervision of the physician or certified nurse midwife 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 35(6) of the Act)
c) The birth attendant shall be trained in the common duties associated with birth and postpartum, and use of emergency policies, procedures and equipment.
d) During the labor process, the birth attendant shall perform the following minimum duties:
1) Monitor the fetal heartbeat;
2) Monitor the mother's blood pressure, pulse and temperature;
3) Perform adult and infant cardiopulmonary resuscitation, if needed;
4) Monitor the infant's heartbeat, respiratory rate and body temperature; and
5) Assess the client's fundus and blood loss.
e) Interventions shall be limited to those required to accomplish a vaginal delivery.
Section 265.1900 Newborn Infant Care
a) Each birth center shall adopt, implement and enforce written policies and procedures for the care of the infant. The medical director and Director of Nursing and Midwifery Services shall review and revise the policies as necessary to reflect current practices. The policies shall comply with the Guidelines for Perinatal Care, published by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, and include, at a minimum:
1) Resuscitation of the newborn;
2) Within two hours after delivery, ophthalmic ointment, or drops containing tetracycline or erythromycin, instilled into the eyes of the newborn infant as a preventive against ophthalmia neonatorum in accordance with the Infant Eye Disease Act;
3) A single parenteral dose of vitamin K-1, water soluble 0.5 milligrams, given to the infant soon after birth as a prophylaxis against hemorrhagic disorder in the first days of life;
4) Documentation of a physical examination of the newborn performed before discharge;
5) Referral for any abnormalities or problems;
6) The collection of blood for newborn screening;
7) Procedures for the detection of Rh and ABO isoimmunization;
8) HIV testing pursuant to the Perinatal HIV Prevention Code; and
9) Preparation and submission of birth certificates.
b) Identification of Newborns
1) While the newborn is still in the birth room, the nurse or certified nurse midwife in the birth room shall prepare identical identification bands for both the mother and the newborn. Wrist bands alone may be used; however, it is recommended that both wrist and ankle bands be used on the newborn. The birth center shall not use footprinting and fingerprinting alone as methods of client identification. The bands shall indicate the mother's admission number, the newborn's gender, the date and time of birth, and any other information required by birth center policy. Birth room personnel shall review the bands prior to securing them on the mother and the newborn to ensure that the information on the bands is identical. The nurse or certified nurse midwife in the birth room shall securely fasten the bands on the newborn and the mother without delay as soon as he/she has verified the information on the identification bands. The birth records and identification bands shall be checked again before the newborn leaves the birth room.
2) 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.
3) When the newborn is taken to the mother, the nurse or other birth center staff shall examine the mother'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.
4) The umbilical cord shall be identified according to birth center policy (e.g., by the use of a different number of clamps) so that umbilical cord blood specimens are correctly labeled. 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 mother.
5) The birth center shall develop a newborn infant security system. This system shall include instructions to the mother regarding safety precautions designed to avoid abduction of her newborn infant. Electronic sensor devices may be included as well.
c) Discharge of newborn infants shall be in accordance with the birth center policies (see Section 265.1950).
d) The birth center shall communicate with the pediatric care provider and shall transfer birth and newborn records to the pediatric care provider.
e) 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.
f) Mandatory Hearing Screening
1) Each birth center shall conduct 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)
2) The facility performing the hearing screening shall report the results of the hearing screening to the Department within 7 days after screening.
A) If there is no hearing screening result or an infant does not pass the hearing screening in both ears at the same time the center shall refer the infant's parents or guardians to a health care practitioner for follow-up, and document and report the referral, including the name of the health care practitioner, to the Department in a format determined by the Department.
B) For infants born outside a birth center, the newborn's primary care provider shall refer the patient to a medical care facility for the hearing screening to be done in compliance with the Act within 30 days after birth, unless a different time period is medically indicated. (Section 5(b) of the Early Hearing Detection and Intervention Act)
(Source: Amended at 43 Ill. Reg. 1633, effective January 18, 2019)
Section 265.1950 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 mother and infant are discharged earlier than 48 hours. (Section 35(6) of the Act)
b) The birth center shall develop a discharge plan of care for all mothers and infants.
c) The discharge plan shall be based on the assessment of the mother's and infant's needs by the various disciplines responsible for their care.
d) The mother and infant shall be discharged from the birth center when both are clinically stable and have met the discharge criteria/policy established by the birth center.
e) The mother and infant shall not be discharged prior to four hours after the time of birth.
f) The birth center shall provide the mother with written discharge instructions. The discharge instructions shall include written guidelines detailing how the mother may obtain emergency assistance for herself and her infant.
g) The birth center shall develop, implement and enforce written policies to provide follow-up postnatal and postpartum care to the infant and the mother, either directly or by referral. Follow-up care may be provided in the birth center, at the mother's residence, by telephone, or by a combination of these methods.
Section 265.2000 Infection Control
a) Each birth center shall provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. 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 mother 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.
b) 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.
c) A person or persons shall be designated as infection control officer or officers to develop and implement policies governing control of infections and communicable disease. 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.
d) 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.
e) Laundry shall be processed in accordance with Section 265.2350(i).
f) The birth center shall comply with the CDC Guideline for Hand Hygiene in Health-Care Settings and the CDC Guidelines for Infection Control in Health Care Personnel.
Section 265.2050 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 under rules of the Pollution Control Board (35 Ill. Adm. Code 809).
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 265.2100 Emergency Services
a) The birth center shall have a written agreement with an emergency medical transport provider/EMS ambulance provider for emergency transportation of the mother and/or newborn infant to a 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 medical director.
Section 265.2150 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 265.2200 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 265.1550;
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, procedures and results;
8) Written progress notes, signed and dated by the person rendering the service on the day service is rendered, and incorporated into the client record on a timely basis;
9) Medication list and medication administration record, if applicable;
10) Intrapartum care;
11) Newborn assessment and care, including:
A) Apgar scores;
B) Maternal-newborn interaction;
C) Prophylactic procedures;
D) Accommodation to extra-uterine life;
E) Blood glucose when clinically indicated;
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 mother and infant;
17) Discharge plan and instructions to the client;
18) Authentication of entries by the physician or physicians, birth attendants and birth assistants who treated or cared for the client and newborn;
19) A copy of the transfer form if the client or newborn was transferred to a hospital; and
20) 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 for a period of at least 10 years, or 12 years for records involved in pending litigation. The birth center shall not destroy client records that relate to any matter that is involved in litigation if the birth center knows that the litigation has not been finally resolved.
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 265.2250 Transfer Agreement
A birth center shall be located within a ground travel time distance from the general acute care hospital with which the birth center maintains a contractual relationship, including a transfer agreement that allows for an emergency caesarian delivery to be started within 30 minutes after the decision a caesarian delivery is necessary. (Section 35(6) of the Act)
Section 265.2300 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;
c) Blood pressure equipment;
d) Thermometers;
e) Fetoscope/doptone;
f) Intravenous equipment;
g) Sterilizer;
h) Resuscitation equipment;
i) Oxygen equipment for maternal and neonate uses;
j) Instruments for delivery, episiotomy and repair; and
k) Other supplies and equipment specified by the medical director and Director of Nursing and Midwifery Services.
Section 265.2350 Environmental Management
a) The birth center shall maintain at least one birth room that provides the equipment, staff, supplies and capability for emergency procedures, pursuant to Section 265.2100, required for the physical and emotional care of a maternal client, her 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;
2) Fixed and portable work surface areas shall be maintained for use in the birth room;
3) 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;
4) 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;
5) Space shall be provided for medical record storage; and
6) 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 maternal client and her 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 facility 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) 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.
3) 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 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 265.2400 Food Services
a) Each birth center shall have the capacity to provide mothers 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 Service Sanitation 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 as ordered by the physician.
Section 265.2450 Quality Assurance and Improvement
a) 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 mother and infant.
b) 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 center;
2) Client satisfaction;
3) Review of the clinical records;
4) Incidences of morbidity and mortality of mother and infant;
5) Postpartum infections;
6) All cases transferred to a hospital for delivery, care of infant, or postpartum care of mother;
7) Incidents, problems and potential problems identified by staff of the center, including infection control;
8) Any issues of unprofessional conduct by any member of the 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;
18) Evaluation of staff on ability to manage emergency situations by unannounced periodic drills for fire, maternal/newborn emergencies, power failure, etc.
c) 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.
d) The quality improvement program for maintaining a safe environment shall include, but not be limited to:
1) Routine testing of the efficiency and effectiveness of all equipment (e.g., sphygmomanometer, doptones, 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;
3) Evaluation of maintenance policies and procedures for heat, ventilation, emergency lighting, waste disposal, water supply and laundry and kitchen equipment.
e) The quality improvement 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) Women registered for admission for care;
E) Antepartum transfers;
F) Women admitted to birth center for intrapartum care;
G) Intrapartum transfers;
H) Number of births in the birth center;
I) Percentage of breastfeeding mothers;
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) Episiotomies;
O) Fourth degree lacerations;
P) Infants with birth weight less than 2500 grams or greater than 4500 grams;
Q) Apgar scores 6 and below at five minutes;
R) Neonatal mortality; and
S) Maternal mortality.
2) Reasons for transfer:
A) Antepartum;
B) Intrapartum;
C) Postpartum; and
D) Newborn.
Section 265.2500 Reports
a) Each birth center shall submit reports pursuant to Section 35(6) of the Act and any other reports containing pertinent data required by the Department to effectively evaluate the program.
b) The birth center shall comply with the requirements of the Control of Communicable Diseases Code for reporting communicable diseases.
c) The following incidents shall be reported to the Department in writing, by mail or fax, within five calendar days after the occurrence, to the Division of Health Care Facilities and Programs, 525 West Jefferson St., Springfield, Illinois 62761, or fax 217-782-0382.
1) A death of a mother, infant, or fetus during the course of labor occurring in the birth center; and
2) A death of a mother or infant within 24 hours after discharge from the center or transfer to a 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 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 by a phone call to the Division of Health Care Facilities and Programs within 24 hours after each reportable incident or accident. If the facility is unable to contact the Division of Health Care Facilities and Programs, notification shall be made by a phone call to the Department's toll-free complaint registry number. 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 facility shall maintain a file of all written reports of reportable incidents or accidents affecting clients. A facility is not required to report an incident or accident that causes no harm to a client.
SUBPART B: CONSTRUCTION STANDARDS
Section 265.2550 Applicability of This Subpart
The standards in 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 250.2600(b).)
Section 265.2600 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) Each birth center shall meet the requirements of the local fire authority or the Illinois State Fire Marshal.
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 265.1100 and are effective on the dates cited in that Section.
Section 265.2650 Preparation of Drawings and Specifications − Submission Requirements
Drawings and specifications shall be executed by or be under the immediate supervision of an architect licensed in the State of Illinois. 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. 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. 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 facility and mechanical life safety systems serving the facility.
Section 265.2700 General Construction Requirements
a) Program Narrative
The program narrative shall describe the various components planned for the birth center and how they will interface with each other.
1) Size and Layout
Birth center departments' sizes and clear floor areas depend on program requirements and organization of services within the birth center. As required by community needs, combination or sharing of some functions shall be permitted, provided the layout does not compromise safety standards and medical nursing practices and receives approval from the Department.
2) Transfer and Service Agreements
Transfer and service agreements with secondary or tertiary care hospitals with full maternity services shall be in place prior to initiating the planning and construction of these facilities. These agreements shall be submitted to the Department for approval at the time of project submission.
3) Birth Center Proximity to Secondary or Tertiary Care Hospitals
A birth center shall be located within a ground travel time distance from the secondary or tertiary hospitals with which the birth center maintains a contractual relationship, including a transfer agreement that allows for an emergency caesarian delivery to be started within 30 minutes after the decision that a caesarian delivery is necessary.
b) Site
The facility shall be sited to avoid placement in a flood plain, seismic fault line, or other natural impediment to maintaining a stable operational environment.
1) Transfer Support Features
A) Part of the facility's transfer agreements with secondary and tertiary care hospitals with maternity services providers 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) Ambulance ports shall be located close to the emergency entrance and the designated client rooms holding clients requiring transfer to a secondary or tertiary care facility with maternity services.
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 accommodation for loading and off-loading clients from vehicles in an area sheltered from the weather.
Section 265.2750 Birth Unit Requirements
a) Size
A minimum of one centrally located nurse 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) Antepartum testing rooms for prospective mothers presenting with false or suspected false labor and requiring monitoring shall be provided based on the program narrative and located as close to the nurse station as possible.
A) Antepartum testing rooms shall be a single client room and shall have a minimum area of 120 square feet (11.15 square meters).
B) Each antepartum testing room shall be equipped with a hand- washing station.
2) Birth rooms. Delivery procedures in accordance with birth concepts not requiring surgical incisions may be performed in the birth rooms. The maximum number of beds per room is one, exclusive of bassinet. 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 nurse station. 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, her 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 shall be large enough and with an integral drain board and deep sink for infant bathing when not in use for hand washing.
E) Bathrooms
i) Each bathroom shall have direct access or be adjacent to a toilet room containing a toilet and lavatory.
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, during a delivery, and postpartum, and to permit the examination and treatment of the infant in the infant resuscitation area.
3) Respite Nurseries (if provided)
A respite nursery may be provided to allow for the rest of the mother when requested. The nursery shall be located 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.
c) Support Areas – General
The size and location of each support area shall depend on the numbers and types of modalities served. The following support areas shall be readily available in each birth center when required by 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 Station Requirements. Nurse stations:
i) Shall have space for counters and storage;
ii) Shall have convenient access to the hand-washing station; and
iii) May be combined with or include centers for reception and communications.
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 conveniently 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 shall 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 Machines
Each nurse station shall have equipment to provide ice for treatments and nourishment.
A) Ice-making equipment may be in the clean workroom or the nourishment room.
B) Ice intended for human consumption shall be provided in the nourishment station and shall be served from self-dispensing ice makers.
7) Clean Workroom or Clean Supply Room
Such rooms shall be separate from and have no direct connection with soiled workrooms or soiled holding rooms. If the clean workroom is used for preparing client care items, it shall contain a work counter, a hand-washing station, and storage facilities for clean and sterile supplies.
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 (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 shall be provided at the ratio of one housekeeping closet per 10 birth rooms. The room shall:
A) Contain a service sink or floor receptor;
B) Have space for storage of supplies, housekeeping equipment, and housekeeping carts; and
C) Be well ventilated and have negative air pressure relationship to adjacent areas.
e) Support Areas for Staff
1) Staff Toilet Rooms
Toilet rooms for staff and visitors shall be conveniently located in the birth unit. Client toilet rooms cannot satisfy this requirement.
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 shall be located in the general public access areas, but shall be capable of providing access to the client areas.
B) The room shall 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)
A) This room is to be used for meetings, conferences, and Lamaze training classes.
B) The room shall be equipped with storage closets for chairs, tables, mats, exercise equipment and supplies as required by the program narrative.
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
Sufficient space shall be included in all mechanical and electrical equipment rooms for proper maintenance of equipment. Provisions shall also be made for 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 shall be located so that equipment may be moved directly to the exterior without interference with other work.
j) Administrative and Public Areas
An entrance at grade level, sheltered from inclement weather, and accessible to handicapped persons (in accordance with the Illinois Accessibility Code) shall be provided.
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 265.2800 Plumbing
All plumbing systems shall be designed and installed in accordance with the Illinois Plumbing Code.
Section 265.2850 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) Insofar as practical, the birth center shall include provisions for recovery of waste cooling and heating energy (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 shall 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.). These units 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 Table 2.1-3 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 Table 2.1-2 and the applicable notes of the AIA Guidelines. The ventilation rates shown in Table 2.1-2 do not preclude the use of higher, more appropriate rates.
B) Air Change Rates. Air supply and exhaust in rooms for which no minimum total air change rate is noted may vary down to zero in response to room load. For rooms listed in Table 2.1-2 of the AIA Guidelines, where VAV systems are used, minimum total air change shall be within limits noted.
C) Temperature and Humidity. Space temperature and relative humidity shall be as indicated in Table 2.1-2 of the AIA Guidelines.
D) 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.
E) Mechanical Ventilation. Although natural ventilation for nonsensitive 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 kept by and at the birth center at all times.
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) Birth room ventilation systems shall operate at all times, except during maintenance and conditions requiring shutdown by the building's fire alarm system.
B) During unoccupied hours, birth room air change rates may be reduced, provided that the positive room pressure is maintained as required in Table 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 Table 2.1-2 of the AIA Guidelines.
c) Thermal Insulation and Acoustical Provisions. See Section 1.6-2.2.1 of the AIA Guidelines.
d) HVAC Air Distribution
1) Return Air Systems. For client care areas, return air shall 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
A) Fresh Air Intakes
i) 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.)
ii) 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).
iii) 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.
B) Relief Air. Relief air is exempt from the 25-foot (7.62-meter) separation requirement. Relief air is defined as air that otherwise could be returned (recirculated) to an air handling unit from the occupied space, but is being discharged to the outdoors to maintain building pressure, such as during outside air economizer operation.
C) Gravity Exhaust. Where conditions permit, gravity exhaust shall be permitted for nonclient areas such as boiler rooms, central storage, etc.
D) Construction Requirements. The bottoms of air distribution devices (supply/return/exhaust) shall be at least 3 inches (7.62 centimeters) above the floor.
e) 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 in Table 2.1-3 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.
f) Steam and Hot Water Systems. See Section 1.6-2.2.3 of the AIA Guidelines.
Section 265.2900 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 located 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 located 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 located 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) Receptacles in Client Care Areas
A) Birth Rooms. Each birth room shall have duplex-grounded receptacles.
i) 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.
ii) Receptacles may be omitted from exterior walls where construction or room configuration makes installation impractical.
B) Birth rooms shall have receptacles as required (Section 2.1-10.3.7.2(1) of the AIA Guidelines).
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
Section 265.2950 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 265.3000 Security Systems
Birth centers shall be designed for active and passive security systems that shall be placed carefully and shall not interfere with the life and safety features necessary to operate and maintain a healthy and functional environment.