Arkansas Administrative Code, Division 05, Rule 007.05.20-007 - Rules for Free-Standing Birthing Centers in Arkansas | Arkansas Administrative Code

SECTION 1: PREFACE.

These rules have been prepared for the purpose of establishing criteria for minimum standards for licensure, operation and maintenance of Free-Standing Birthing Centers. By necessity they are of a regulatory nature but are considered to be practical minimum design and operational standards for their facility type. These standards are not static and are subject to periodic revisions. It is expected Free-Standing Birthing Centers will exceed these minimum requirements and will not be dependent upon future revisions as a necessary prerequisite for improved services.

SECTION 2: AUTHORITY.

These rules for Free-Standing Birthing Centers in Arkansas are duly adopted and promulgated by the Arkansas State Board of Health pursuant to the authority expressly conferred by the laws of the State of Arkansas in Ark. Code Ann. § 20-9-401 et seq.

SECTION 3: DEFINITIONS.

Free-Standing Birthing Centers - any facility which is organized to provide family-centered maternity care in which births are planned to occur in a home-like atmosphere away from the mother's usual residence following a low risk pregnancy. The facility shall not provide operative obstetrics, including use of forceps, vacuum extractions, Caesarean sections, or tubal ligations. The Free-Standing Birthing Center must be located within thirty (30) minutes of a hospital (via ambulance) which offers obstetric and nursery services and which maintains an on-call team to provide emergency C-sections and stabilization of infants.

Administrator - an individual designated to provide daily supervision and administration of the Free-Standing Birthing Center.

Certified Nurse Midwife - a trained and licensed advanced practice nurse with an arrangement with a physician in accordance with the Arkansas Nurse Practice Act, Arkansas Code Annotated 17-87-101 et seq.

Complications - any condition according to written risk criteria of the Free-Standing Birthing Center that contraindicates continued care in the Free-Standing Birthing Center.

Large Free-Standing Birthing Center - a birthing center comprised of four (4) or more birthing rooms with an exam room.

Low Risk Pregnancy - a normal uncomplicated pregnancy as determined by a generally accepted course of prenatal care and the expectation of a normal uncomplicated birth as defined by a reasonable and generally accepted criteria of maternal and fetal health.

Medical Director - a person licensed to practice medicine in the state of Arkansas.

Preterm - before the end of the thirty-seventh (37th) week of gestation.

Professional Review Committee - shall be composed of at least three (3) members. The members shall include a Physician with advanced training in Obstetrics, one (1) Certified Nurse Midwife and/or one (1) Registered Nurse (required for large Free- Standing Birthing Centers).

Qualified Physician - a person licensed to practice medicine in the State of Arkansas, who has obstetrical privileges at the licensed hospital.

Small Free-Standing Birthing Center - a birthing center comprised of three (3) or fewer birthing rooms and occupied by fewer than four (4) patients, not including newborns, at any time.

Term - at thirty-seven (37) weeks gestation, or greater.

SECTION 4: LICENSING.

A. Application for License. Application for a license or renewal of a license for a Free Standing Birthing Center shall be made to the Arkansas Department of Health on forms provided by the Division of Health Facility Services. The application shall set forth the complete name and address of the Free-Standing Birthing Center for which the license is sought and any additional information as required by the Arkansas Department of Health.

B. The Free-Standing Birthing Center shall have a written agreement with a local hospital which has twenty-four (24) hour obstetric services. The Free-Standing Birthing Center shall be within thirty (30) minutes of the hospital. If the hospital ceases to provide obstetric services, the Birthing Center shall obtain a written agreement with another hospital that provides obstetric services and is within thirty (30) minutes of the Birthing Center. If another written agreement cannot be obtained, the Birthing Center must cease providing services, notify the Division of Health Facility Services in the Arkansas Department of Health, and surrender the license to the Division. The Birthing Center may reapply for licensure once a new written agreement is obtained.

C. Fee. In accordance with Section 5 of Act 891 of 1997, each application for initial licensure of a Free-Standing Birthing Center shall be accompanied by a fee of one thousand dollars ($1000). The fee shall be payable to the Arkansas Department of Health.

D. Renewal of License. A license, unless revoked, shall be renewable annually upon payment of a fee of one thousand dollars ($1000) to the Arkansas Department of Health accompanied by an application for re-licensure. The application for annual license renewal along with the fee shall be postmarked no later than January 2 of the year for which the license is issued.

E. Issuance of License. A license shall be issued only for the premises and person or persons reflected in the application and shall be posted in a conspicuous place in the Free-Standing Birthing Center. The license shall be effective on a calendar year basis and shall expire on December 31 of each calendar year. The license shall not be transferrable and shall expire if a change of ownership occurs.

F. Change of Ownership. It shall be the responsibility of the Free-Standing Birthing Center to notify the Division of Health Facility Services in writing at least thirty (30) days prior to the effective date of a change of ownership. The following information shall be submitted for review and approval:

1. License application

2. One thousand dollars ($1000) change of ownership fee; and

3. Legal documents, ownership agreements, and other information to support re-licensure requirements.

G. Management Contract. It shall be the responsibility of the Free-Standing Birthing Center to notify the Division of Health Facility Services in writing at least thirty (30) days prior to entering into a management contract or agreement with an organization or firm. A copy of the contract or agreement shall be submitted for review to assure the arrangement does not affect the license status.

H. Closure. Once a Free-Standing Birthing Center closes, it shall no longer be considered licensed. The license issued to the Free-Standing Birthing Center shall be returned to the Division of Health Facility Services. To be eligible for re-licensure, the Free-Standing Birthing Center shall meet requirements for new construction and all the current life safety and health regulations.

I. Inspection. Any authorized representative of the Arkansas Department of Health shall have the right to enter upon or into the premises of any Free-Standing Birthing Center at any time in order to make whatever inspection it deems necessary in order to assure minimum standards and regulations are met.

SECTION 5: GOVERNING BODY.

A Free-Standing Birthing Center shall have an organized Governing Body which shall be legally responsible for maintaining patient care, establishing policies for the facility and shall be legally responsible for the conduct of the center.

A. Governing Body Bylaws. The Governing Body shall adopt written bylaws which shall be available to all members of the Governing Body. The bylaws shall ensure the following:

1. The Governing Body shall consist of three (3) or more individuals;

2. Maintenance of professional standards of practice;

3. Terms, responsibilities and methods of selecting members and officers;

4. Selection of an Administrator with responsibility for operation and maintenance of the facility;

5. Methods for establishing Governing Body committees and the duties of each committee;

6. Coordination of activities and general policies of the departments;

7. Liaison between the Governing Body and Professional Review Committee documented quarterly;

8. Quarterly Governing Body meetings with maintenance of minutes signed by an officer;

9. Provision for formal approval of the organization, bylaws, rules, regulations, and protocols of the Free-Standing Birthing Center staff and their services;

10. Method of credentialing or appointing members to the professional and other authorized staff;

11. Methods by which Quality Improvement (QI) is established;

12. Establishment of a quorum to be met in order to conduct business;

13. Annual approval of the operating budget by the Governing Body; and

14. Compliance with federal, state and local laws.

B. Governing Body Minutes. The Governing Body minutes shall include at least the following information:

1. Review, approval and revision of the Governing Body bylaws and the Professional Review Committee bylaws, rules, regulations and protocols;

2. Election of officers, as indicated in the bylaws;

3. Documentation that the liaison between the Governing Body and Professional Review Committee is maintained;

4. Appointment and reappointment of the Professional Review Committee and other credentialed staff as indicated in the bylaws;

5. Review and approval of reports received from the Professional Review Committee and Administration;

6. Review and approval of the Quality Improvement Plan of the facility, at least annually, also documentation of the quarterly Quality Improvement summaries.

C. Credential Files. An individual file shall be maintained for each physician, Certified Nurse Midwife, Advanced Practice Nurse, and other allied health practitioners practicing in the Free-Standing Birthing Center and shall include at least the following:

1. Verification of year, and school of graduation; date of licensure; postgraduate or special training and experience;

2. Specific delineation of privileges requested and granted;

3. Detailed application signed by the applicant, the chairman of the Professional Review Committee and an officer of the Governing Body;

4. Documentation of the applicant's agreement to abide by the Free-Standing Birthing Center bylaws, rules, regulations, and protocols;

5. Verification of current Arkansas license and certification as applicable;

6. Verification of each applicant's Drug Enforcement Agency (DEA) permit;

7. Verification of at least three (3) professional references;

8. Documentation of all actions taken by the Professional Review Committee and Governing Body indicating the privileges granted, approval of appointment/reappointment, and other related data; and

9. Evaluation of professional performance at the time of re-appointment.

D. Professional Review Committee Bylaws. The Professional Review Committee bylaws shall include at least the following provisions:

1. Responsible to the Governing Body for the quality of health care provided in the Free-Standing Birthing Center and for the ethical and professional practices of its members;

2. Requirements for membership;

3. Election of officers, responsibilities and terms;

4. Functions, frequency of meetings and composition (quorum) and attendance requirements;

5. Written minutes shall be maintained of all meetings and shall be signed by the chairman;

6. An appeals process if appointment/reappointment is not granted by the Governing Body;

7. Delineation of maintaining accurate and complete medical records; and

8. Approval of the bylaws and amendments by the Professional Review Committee and the Governing Body.

E. Professional Review Committee Minutes. Professional Review Committee minutes shall include at least the following:

1. Documentation of review of committee reports including quarterly Quality Improvement (QI) summaries;

2. Review, approval and revision of the Professional Review Committee bylaws, rules, regulations, and protocols;

3. Election of officers as specified by the bylaws;

4. Documentation of a practitioner designated as chairman of the committee to direct the services defined in the bylaws; and

5. Documentation of appointments, reappointments, and approval of requested privileges to the Free-Standing Birthing Center staff as specified in the bylaws, but at least every two (2) years.

F. Quality Improvement (QI) Program.

1. The Free-Standing Birthing Center shall develop, implement, and maintain a QI program. The QI plan shall be reviewed and approved annually by the Governing Body. The facility shall appoint a QI Committee with functions to include:

a. Quarterly meetings with maintenance of written minutes;

b. Collection of data on the functional activities identified as priorities in QI and benchmark against past performance and national or local standards; and

c. Development and implementation of improvement plans for identified issues, with monitoring, evaluation and documentation of effectiveness.

2. The scope of the QI Program shall include, but not be limited to, activities regarding the following:

a. Assessment of processes and outcomes. Outcome data for morbidity, mortality, maternal and infant transfers and referrals, complications, Apgar scores, patients delivering outside the center, and other performance data shall be collected and analyzed on an ongoing basis;

b. Evaluation of customer satisfaction (patients, providers, patients= families, employees);

c. Measurement of staff performance;

d. Complaint resolution;

e. Utilization data; and

f. Organizational/administrative performance.

3. Reporting. QI activities shall be reported to the Professional Review Committee and the Governing Body on a quarterly basis and shall be documented in the Governing Body meeting minutes.

4. Policies and Procedures covering all functions of the QI Program shall be maintained. All policies and procedures not contained within the QI Plan shall be maintained in a manual. The first page of the manual shall have the annual review date and signatures of the persons conducting the review.

SECTION 6: GENERAL ADMINISTRATION.

A. Each institution shall have an Administrator responsible for the management of the institution. The responsibilities of the Administrator shall include:

1. Keeping the Governing Body fully informed of the status of the Free-Standing Birthing Center by submitting periodic written reports or by attending meetings of the Governing Body;

2. Conducting meetings at regular intervals and maintaining minutes of the meetings; and

3. Preparation of an annual operating budget to be submitted to the Governing Body for approval.

B. Policies and procedures shall be provided for the general administration of the facility and for each service. All policies and procedures shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

C. Provisions shall be made for safe storage of patient's valuables.

D. Each facility shall develop and maintain a written disaster plan which includes provisions for complete evacuation of the facility. The plan shall provide for widespread disasters, as well as for disasters occurring within the local community and birthing center. The disaster plan shall be rehearsed at least twice a year, preferably as part of a coordinated drill in which other community emergency agencies participate. One (1) drill shall simulate a disaster of internal nature and the other external. Written reports and evaluation of all drills shall be maintained.

E. There shall be a posted list of names, telephone numbers, and addresses available for emergency use. The list shall include center management personnel and staff, the local police department, the fire department, ambulance service, Red Cross, and other available emergency units. The list shall be reviewed and updated at least every six (6) months.

F. There shall be current reference material available onsite to meet the professional and technical needs of birthing center personnel including: current books, periodicals, and other pertinent materials.

G. All employees shall be required to have annual in-services on safety, fire safety, back safety, infection control, standard precautions, disaster preparedness and confidential information.

H. Procedures shall be developed for the retention and accessibility of the patients' medical records if the Free-Standing Birthing Center closes. The medical records shall be stored within the State of Arkansas for the required retention period and shall be accessible for patient use.

I. Any Free-Standing Birthing Center that closes shall meet the requirements for new construction in order to be eligible for re-licensure. Once a facility closes, it is no longer licensed. The license shall be immediately returned to Health Facility Services. To be eligible for licensure all the referenced National Fire Codes (NFPA) and health regulations shall be met.

J. The Free-Standing Birthing Center Administrator shall develop policies and procedures that, upon request of the patient, an itemized statement of all services shall be provided within thirty (30) days after discharge or thirty (30) days after request, whichever is later. The policy shall include a statement advising the patient in writing of her right to receive the itemized statement of all services.

K. A general consent for medical treatment and care shall be signed by the patient or legal guardian. Written or verbal consent shall not release the facility or its personnel from upholding the rights of its patients including but not limited to the right to privacy, dignity, security, confidentiality, and freedom from abuse or neglect.

L. The center shall have a procedure for infant identification at the time of birth which shall be sufficient to identify the infant(s) with one (1) mother. Large Free-Standing Birthing Centers shall use waterproof plastic identification bands with tag inserts written in waterproof ink. These shall be placed on the mother and infant in the birthing room at the time of delivery and shall remain in place during the entire stay.

M. A record book shall be kept up to date and shall contain the following information:

1. Mother's maiden name and father's name;

2. Baby's sex, date, time and place of birth; and

3. Physicians', Certified Nurse Midwife (CNM) and/or Registered Nurses' names.

N. There shall be written policies and procedures jointly developed by the Medical Director and the professional staff, which define the care provided at the Birthing Center.

O. There shall be written documentation of annual review of the policies and procedures, with revision as indicated.

P. Policies and procedures shall include but are not limited to:

1. Initial risk assessment;

2. Criteria for maternal transfer to an acute care facility during the antepartal, intrapartal and postpartum phases; and

3. Criteria for infant transfer to an acute care facility;

4. Admission criteria;

5. Nursing assessment;

6. Family support and participation;

7. Medication administration;

8. Care of the newborn to include administration of prophylactic medications required by the Arkansas Department of Health;

9. Emergency procedures;

10. Fetal demise;

11. Vital statistics registration;

12. Infection control; and

13. Aftercare of the mother and infant.

Q. The facility shall report to the Arkansas Department of Health, Division of Vital Statistics, a patient is transferred from the care of a lay midwife during the labor and delivery process to the hospital or other licensed healthcare facility.

SECTION 7: SERVICES.

Care in Free-Standing Birthing Centers shall be provided by a Licensed Physician and/or CNM and other qualified professionals and clinical staff with access to and availability of consulting clinical specialists. Ancillary personnel shall be available to care for the volume of patients and programs offered.

A. Services provided in Free-Standing Birthing Centers may include antepartal, intrapartal, postpartal care and the care of the newborn infant.

B. Local analgesia/anesthesia for pudendal block and episiotomy repair shall be permitted.

C. Surgical services shall be limited to those normally performed during uncomplicated childbirth, such as episiotomy and repair of lacerations.

D. The care of the newborn may include a recognized method of circumcision which limits blood loss to less than one cubic centimeter (1cc).

E. The following shall be prohibited in Free-Standing Birthing Centers:

1. Administration of general and conductive analgesia/anesthesia to include spinal and epidural analgesia/anesthesia;

2. Administration of all types conscious sedation;

3. Performance of Caesarean sections and operative obstetrics to include tubal ligations;

4. I.V. analgesia is prohibited; and

5. Stimulation or augmentation with chemical agents, e.g., oxytocics during the first and second stages of labor.

SECTION 8: PATIENT CARE SERVICES.

A. Organization.

1. The center shall be organized to ensure twenty-four (24) hour Registered Nurse coverage as needed.

2. A physician, Certified Nurse Midwife, and/or Registered Nurse, shall be available and onsite for patient care during the entire time a patient is in the center.

3. Services during labor and delivery shall be provided under protocols developed by the clinical staff and approved by the Governing Body in accordance with accepted standards of care.

4. Authority and responsibilities of all patient care staff shall be clearly defined in written policies.

5. Services shall be organized to ensure that management functions are effectively conducted. These functions shall include, but are not limited to:

a. Development and implementation of policies and procedures related to patient care;

b. Review of policies and procedures at least annually to reflect current standards of maternal and newborn care. The first page of each manual shall have the review date and approval signatures of the person(s) conducting the review;

c. Establishment of a mechanism for review and evaluation of care and services provided at the center;

d. Orientation and maintenance of qualified staff for provision of care;

e. Provisions for staff development, including at least twelve (12) in-service education programs for professional staff annually; and

f. Provisions for current nursing literature and reference materials.

6. Patients shall have access to twenty-four (24) hour telephone consultation with either a Registered Nurse or Certified Nurse Midwife or physician.

B. Qualifications.

1. The Certified Nurse Midwife shall provide documentation of current licensure, as required by the Arkansas State Board of Nursing. The documentation shall be maintained as part of the credential file for that person.

2. Licensed nursing personnel shall practice in accordance with the Nurse Practice Act of the State of Arkansas.

3. Documentation of current licensure shall be maintained for all nursing personnel who practice in the center.

4. All clinical staff of the center shall be required to provide documentation of training and continued competence in adult and Neonatal Resuscitation Program (NRP) or its equivalent.

C. Staffing.

1. A physician, Certified Nurse Midwife, or Registered Nurse with demonstrated competencies in labor and delivery shall be required to deliver one to one (1:1) care during labor, delivery and post-delivery until both mother and newborn are stable.

2. There shall be adequate numbers of professional and support staff on duty and on call to meet the patient's needs: for services routinely provided; during periods of high demand or emergency; to assure patient safety and satisfaction; and to assure that no patient in active labor is unattended.

3. During the second stage of labor, two to one (2:1) patient care is required, with one (1) of the clinical staff being a physician or Certified Nurse Midwife and the other being a Registered Nurse.

4. Clinical staff who have demonstrated ability to perform neonatal and adult resuscitation procedures shall be present during each birth.

SECTION 9: PROGRAM REQUIREMENTS.

A. The birthing center shall have written criteria for evaluation of risk status, admission, transfer, discharge, and complications requiring medical or surgical intervention. The criteria shall be developed by the clinical staff and approved by the Governing Body.

1. Criteria for admission for labor, birth, and postpartum care shall include, but is not limited to:

a. Low-risk pregnancy with the expectation of a singleton, vertex, spontaneous vaginal birth at term without complications;

b. Evidence of adequate prenatal care which begins no later than twenty-eight (28) weeks gestation and provides continuous prenatal screening; and

c. Evidence of preparation for out-of-hospital birth and early discharge.

2. Criteria shall be developed for conditions of the mother or neonate requiring transfer to an acute care facility.

3. Criteria for discharge of the mother and newborn in not more than twenty-four (24) hours from admission shall be developed and approved by the Governing Body.

B. In no event shall a patient meeting any of the following criteria be accepted as a candidate for delivery at a Free-Standing Birthing Center:

1. Females below fourteen (14) years of age;

2. Documented problems in the maternal medical history, including:

a. Heart disease;

b. Pulmonary embolus;

c. Symptomatic congenital defects;

d. Moderate to severe renal disease, including nephritis;

e. Severe mental health problems and/or current use of drugs related to its management;

f. Epilepsy or seizures after ten (10) years of age which required use of anticonvulsive medications;

g. Breech presentation;

h. Preterm labor;

i. Insulin-dependent gestational diabetes;

j. Thyroid disease which is not maintained in euthyroid state;

k. Bleeding disorder or hemolytic disease;

l. Other serious medical problems;

m. Multiple births;

n. Vaginal birth following C-section (VBAC);

o. Preeclampsia;

p. Moderate or severe asthma;

q. Severe obstructive pulmonary disease;

r. Severe systemic disease (e.g., SLE, hyperthyroidism, Marfan's syndrome);

s. Hypercoagulable state (i.e., protein S or C deficiency, AT III deficiency); or

t. History of intracranial injury.

3. Patients with the following physical findings:

a. Previous Rh sensitization;

b. Positive HIV antibody;

c. Gestation of more than twenty-eight (28) weeks with no prenatal care;

d. Hematocrit below 28%;

e. S/S (sickling) hemoglobin or abnormal protein electrophoresis;

f. Evidence of active tuberculosis; and

g. Chronic hypertension;

h. Known severe fetal abnormality;

i. Severe Polyhydramnios;

j. Severe Oligohydramnios;

k. Placenta previa.

C. Admission to the Program. Childbearing women prior to twenty-eight (28) weeks gestation seeking care in the center shall be initially screened by either the physician or Certified Nurse Midwife or Registered Nurse Practitioner, or Advanced Practice Nurse. The initial screening shall include at a minimum:

1. Complete social, family, medical, reproductive, nutritional and behavioral history;

2. Evidence of results of complete physical examination to include Papanicolaou smear and assessment for sexually transmitted diseases; and

3. Prenatal laboratory profile to include a complete blood count, blood type and Rh antibody screen if necessary, urinalysis or urine culture, tests for sexually transmitted diseases, and other tests as medically indicated.

D. Continuing prenatal care shall include a repeat evaluation of the hemoglobin or hematocrit at twenty-eight (28) to thirty-six (36) weeks gestation.

E. Free-Standing Birthing Centers shall comply with Arkansas Statutes (Act 192 of 1967 as amended by Act 481 of 1981, the same being Ark. Code Ann. 20-15-302 -304), which require newborn infants to be tested for phenylketonuria, congenital hypothyroidism and galactosemia.

F. Educational Plan for Antepartum Care.

1. There shall be a written plan which shall include but not limited to:

a. Anticipated physiologic, psychologic changes during pregnancy;

b. Fetal development;

c. Normal nutrition;

d. Warning signs of complications of pregnancy;

e. Self care to include information of the dangers of smoking, alcohol and substance abuse, the need for dental care;

f. Stages of labor;

g. Non-pharmacologic techniques to promote comfort and relaxation during labor;

h. Delivery process;

i. Immediate care of the newborn;

j. Criteria for and process of transfer to an acute care facility;

k. Normal postpartum;

l. Criteria for discharge from the center;

m. Breast-feeding;

n. Importance of immunization;

o. Child safety to include use of car seats;

p. Directions for obtaining laboratory tests for newborns required by the Arkansas Department of Health;

q. Instruction as to clothing/supplies needed at the time of discharge from the center;

r. Instruction shall be appropriate to the assessed educational level and within the cultural framework of the childbearing family; and

s. The educational plan shall include provisions for material and teaching in languages other than the dominant language where possible.

2. The facility shall develop instructional programs to orient family members desiring to be present at the birth.

3. There shall be written documentation in the patient record of patient/family receipt of instructions.

4. There shall be documentation of annual review and revision of the educational plan.

G. Family Participating in The Birth Process.

1. The number of individuals/family members present at the time of birth shall be determined by center policy which takes into account room size and need for infection control.

2. Individuals/family members shall abide by the center's infection control policies in regard to handwashing, apparel, etc.

3. An adult not involved in the birthing process shall be in charge of the children.

4. Children shall be screened for infectious disease by either the physician or CNM or RN prior to admission to the birthing room. Children with evidence of infectious disease will not be allowed in the birthing room.

5. Only children who have completed sibling evaluation or preparation will be allowed in the birthing room.

6. Animals, except for seeing eye dogs, shall be prohibited in the Free-Standing Birthing Center at any time.

H. Emergency Procedures. The Free-Standing Birthing Center shall have written procedures for emergency transfer of mother and/or newborn to an acute care facility.

I. Minimum Equipment for Birthing Rooms. The birthing room shall be attractively furnished and decorated; furniture, vinyl wall covering, pictures, radios, television and other amenities may be utilized so long as the potential medical needs of the mother and newborn are not compromised. The furniture shall be easily cleanable.

1. Sterile equipment shall be used for the delivery.

2. Professionals directly involved in the delivery shall wear clean attire and sterile gloves.

3. Minimum equipment for the birthing room shall include:

a. Bed with waterproof pad;

b. A heated newborn crib, bassinet or newborn examination unit;

c. Sphygmomanometer and stethoscopes - adult and newborn sizes;

d. Fetoscope;

e. Oxygen and oxygen equipment including tubing, nasal prongs, ambu bags, and masks;

f. Suction and suction equipment including DeLee traps for newborn suction;

g. Mobile or mounted spotlight or lamp;

h. Maternal and newborn airways;

i. Storage for clothing, linens and supplies;

j. Wall clock;

k. Newborn scales;

l. Tape measure;

m. Identification supplies - maternal and newborn;

n. Prophylactic medications for newborns as required by the Arkansas Department of Health;

o. Emergency call system;

p. Apgar chart;

q. Amniotic hook;

r. Bulb syringe;

s. Nitrazine paper; and

t. Emergency drugs, as identified by the facility.

SECTION 10: HEALTH INFORMATION SERVICES.

The Free-Standing Birthing Center shall maintain a system for the completion and storage of the medical record. The record shall provide a format for continuity and documentation of legible, uniform, complete and accurate maternal and infant information readily accessible and maintained in a system that ensures confidentiality.

A. General Requirements.

1. The Free-Standing Birthing Center shall adopt a record form for use that contains information required for transfer to an acute care maternal and newborn service.

2. Record reviews with criteria for identification of problems and follow-up shall be reported to the QI Committee quarterly.

3. Responsibility for the processing of records is assigned to an individual employed by the Free-Standing Birthing Center.

4. All medical records shall be retained in either the original, microfilm or other acceptable methods for ten (10) years after the last discharge.

5. Complete medical records of minors shall be retained for a period of two (2) years after the age of majority is reached.

6. The original or a copy of the original (when the original is not available) of all reports shall be filed in the medical record.

7. The record shall be permanent and shall be either typewritten or legibly written in blue or black ink.

8. All typewritten reports shall include the date of dictation and the date of transcription.

9. All dictated records shall be transcribed within forty-eight (48) hours.

10. Errors shall be corrected by drawing a single line through the incorrect data, labeling it as "Error," initialing and dating the entry.

11. Birth certificates shall be completed according to the Bureau of Vital Records, Arkansas Department of Health.

12. Policies and procedures for Health Information Services shall be developed. The manual shall have evidence of ongoing review and/or revision. The first page of the manual(s) shall have the annual review date, signature of the department supervisor and/or person(s) conducting the review.

13. Medical records shall be protected to ensure confidentiality, prevention of loss, and to ensure availability on a twenty-four (24) hour basis.

14. All medical records, whether stored within the facility or away from the facility shall be protected from destruction by fire, water, vermin, dust, etc.

15. Medical records shall be considered confidential. All medical records (including those filed outside the facility) shall be secured at all times. Records shall be available to authorized personnel from the Arkansas Department of Health.

16. Written consent of the patient or legal guardian shall be presented as authority for release of medical information. There shall be policies and procedures developed concerning all phases of release of information.

17. Original medical records shall not be removed from the facility except upon receipt of a subpoena duces tecum by a court having authority for issuing such an order.

18. Medical records shall be complete and contain all required signed documentation no later than thirty (30) days following the patient's discharge date.

19. Medical records shall be destroyed by burning or shredding. Medical records shall not be disposed of in landfills or other refuse collection sites.

20. Each entry into the medical record shall be authenticated by the individual who is the source of the information. Entries shall include observations, notes and other information included in the record.

21. Signatures shall be at least, the first initial, last name and title. Computerized signatures by code, number, initials, or the method developed by the facility are acceptable.

22. There shall be policies and procedures approved by the Arkansas Department of Health for use of computerized medical records.

B. Record Content. Each record shall include but not be limited to documentation of:

1. Demographic and patient information;

2. Orientation to program and informed consent;

3. Complete family, medical, social, reproductive, nutrition and behavioral history;

4. Initial physical examination, evaluation of risk status and laboratory test result;

5. Appropriate referral of patients who did not meet the Free-Standing Birthing Center criteria on the initial screening;

6. Documentation of each periodic examination and evaluation of risk factors;

7. Instructions, education including changes in pregnancy, self-care, nutritional counseling, preparation for labor, family preparation, explanation on examinations and laboratory tests, newborn assessment and care;

8. Monitoring of labor progress;

9. Physical assessment of newborn, e.g., Apgar score;

10. Labor and discharge summaries;

11. Home care, follow-up and referrals; and

12. Informed consent signed by the patient.

SECTION 11: PHARMACEUTICAL SERVICES.

A. Organization.

1. Free-Standing Birthing Centers shall have provisions for pharmaceutical services regarding the procurement, storage, distribution and control of all medications. The Free-Standing Birthing Center shall be in compliance with all state and federal regulations.

2. Pharmaceutical services shall be under the direction of a licensed pharmacist. A licensed pharmacist means any person licensed to practice pharmacy by the Arkansas State Board of Pharmacy who provides pharmaceutical services as defined in the Pharmacy Practice Act. The pharmacist shall make provisions that shall include but not be limited to:

a. Development and implementation of pharmacy policies and procedures;

b. Annual review and revisions of pharmacy policies and procedures, with documentation of date(s) of review;

c. Maintenance of medications in the Free-Standing Birthing Center to meet the needs of the population served;

d. Maintenance of medications in the Free-Standing Birthing Center to assure accountability; and

e. Proper storage of medications.

B. Staffing. Pharmaceutical services shall be provided by a licensed pharmacist. This service may be provided on a consulting basis. Onsite consultation by the pharmacist shall be required at least monthly, if medications other than those in the following categories are stored in the facility: emergency or eye prophylaxis drugs, oxytocics, and vitamin K. The storage of controlled substances in any manner shall require monthly onsite consultation by the pharmacist. When onsite consultation by the pharmacist is required monthly, documentation of each consult shall be recorded and maintained at the Free-Standing Birthing Center. Documentation of each consultation visit shall be recorded and maintained at the Free-Standing Birthing Center. Documentation of each visit shall include compliance with but not be limited to:

1. Proper drug storage;

2. Disposal of medications no longer needed, discontinued, or outdated;

3. Proof of receipt and administration of controlled substances and proper storage of such medications;

4. Verification that medications in stock conform to the specified quantities on posted lists;

5. Proper labeling; and

6. Maintenance of emergency carts or kits.

C. Policies and Procedures. There shall be pharmacy policies and procedures to include but not limited to:

1. Detailed job description of the licensed pharmacist;

2. Procurement of medications;

3. Distribution and storage of medications;

4. A listing of floor stock medications with minimum and maximum quantities to be maintained in the Free-Standing Birthing Center;

5. A listing of medications with exact quantities to be maintained in emergency kits;

6. Destruction of deteriorated, non-sterile, non-labeled or damaged medications by the pharmacist;

7. Listing controlled substances to be destroyed on the proper forms and either sending a copy of the form with the medications to the Arkansas Department of Health by registered mail or delivering the form and medications in person;

8. Maintenance of all drug records for a minimum of two (2) years;

9. Maintenance of medications brought to the Free-Standing Birthing Center by the patient;

10. Drug recalls;

11. Reporting of adverse drug reactions and medication errors to the attending physician and/or CNM and the Professional Review Committee;

12. Accountability of controlled substances;

13. Reporting of suspected drug loss, misuse, or diversion according to state law; and

14. Use of Automatic Medication Dispensing Devices, if applicable.

D. Drug Storage and Security. Medications maintained at the Birthing Center shall be properly stored and safeguarded to ensure:

1. Locked storage of all medications;

2. Proper lighting and ventilation as required by manufacturer;

3. Proper temperature controls with daily temperature documentation of medication refrigerators to assure storage between thirty-six and forty-six (36-46) degrees Fahrenheit or two and eight (2-8) degrees Centigrade;

4. Separate storage of biologicals and medications from food;

5. Accessibility to licensed personnel only; and

6. Proper use of any Automatic Medication Dispensing Devices.

E. Controlled Substances. The following shall be adhered to in the maintenance of controlled substances in the Free-Standing Birthing Center:

1. Controlled drugs shall be double-locked;

2. A record of the procurement and disposition of each controlled substance shall be maintained in the Free-Standing Birthing Center and readily retrievable. Each entry on the disposition record shall reflect the actual dosage administered to the patient, the patient's name, date, time, and signature of the licensed person administering the medication. The signature shall consist of a first initial, last name and title. (Licensed personnel who may legally administer controlled substances shall include only those personnel authorized by their current Practice Act and licensed by the Arkansas State Medical Board and Arkansas State Nursing Board.) Any error of entry on the disposition record shall follow a policy for correction of errors and accurate accountability. If the licensed person who procures medication from the double-locked security is not the licensed person who administers the medication, then both persons shall sign the disposition record;

3. When breakage or wastage of a controlled substance occurs, the amount given and amount wasted shall be recorded by the licensed person who wasted the medication and verified by the signature of a licensed person who witnessed the wastage. Documentation shall include how the medication was wasted. In addition to the above referenced licensed personnel, licensed pharmacists shall be allowed to witness wastage of controlled substances. When a licensed person is not available to witness wastage, the partial dose shall be sent to the Arkansas Department of Health, Division of Pharmacy Services and Drug Control for destruction;

4. There shall be an audit each shift change of all controlled substances stocked in the Free-Standing Birthing Center which shall be recorded by an oncoming nurse and witnessed by an off-going nurse. Exception: If only one (1) licensed nurse is on duty, an audit shall be conducted by that licensed nurse. When a second licensed nurse arrives, a second audit shall be conducted by both nurses on duty. If discrepancies are noted, the Director of Nursing and the Pharmacy Consultant shall be notified. As with the witnessing of wastage, licensed pharmacists shall be allowed to witness controlled substance audits; and

5. Records generated by Automatic Dispensing Devices shall comply with these requirements.

F. Medications.

1. All verbal or telephone orders for medications shall be received by a licensed nurse, Certified Nurse Midwife, or Registered Pharmacist and reduced to writing into the patient's medical record. Verbal or telephone orders shall be countersigned by the practitioner within twenty-four (24) hours. Signed facsimile orders are acceptable provided the facsimile paper is of a permanent nature.

2. The Free-Standing Birthing Center may procure medications for its patients through community pharmacists, or medications may be procured through the Free-Standing Birthing Center's physician or CNM's registration. Clinicians shall administer or shall order medications to be administered to patients while in the Free-Standing Birthing Center.

SECTION 12: INFECTION CONTROL FOR FREE-STANDING BIRTHING CENTERS.

A. General.

1. The facility shall develop and use a coordinated process that effectively reduces the risk of endemic and epidemic nosocomial infections in patients, health care workers and visitors.

2. The facility shall follow standard Centers for Disease Control and Prevention (CDC) precautions.

3. The Administrator shall designate a qualified individual (Registered Nurse or Laboratorian) who shall:

a. Coordinate the activities of the Infection Control Committee;

b. Direct surveillance activities;

c. Ensure policies established by the committee are carried out; and

d. Gather and report data regarding the facility's nosocomial infections.

4. There shall be policies and procedures establishing and defining the Infection Control program including:

a. Definition of nosocomial infections which conforms to the current CDC definition;

b. Measures to identify infections up to thirty (30) days postpartum, investigate and report nosocomial infections and a system of evaluating and maintaining records of infection among both patients and health care workers;

c. Methods for obtaining reports of infections in patients and health care workers in a manner and time sufficient to limit the spread of infections;

d. Measures for assessing and identifying patients and health care workers at risk for nosocomial infections and communicable diseases;

e. Measures for prevention of infections;

f. Provisions for education of patients and their families concerning infections;

g. A plan for monitoring and evaluating all aseptic and sanitation techniques employed within the facility to ensure approved infection control procedures are followed;

h. Techniques for:

1) Handwashing;

2) Scrub techniques;

3) Asepsis;

4) Sterilization;

5) Disinfection;

6) Housekeeping;

7) Linen care;

8) Liquid and solid waste disposal of both infectious and regular waste. Disposal of infectious waste shall conform to the latest edition of the Rules and Regulations Pertaining to the Management of Medical Waste from Generators and Health Care Related Facilities;

9) Disposal of placenta;

10) Sharps and needle disposal;

11) Separation of clean from dirty process; and

12) Other means of limiting the spread of contagion.

i. A requirement that disinfectants, antiseptics and germicides be used in accordance with the manufacturer's directions;

j. Employee health;

k. Visitation Rules. All children under the age of twelve (12) years shall be screened for communicable disease and shall not be admitted into the facility if they are obviously ill; and

l. Guide dogs. No animals except certified dogs for the seeing impaired will be allowed into the facility.

5. There shall be an orientation program for all new health care workers concerning the importance of infection control and each health care worker's responsibility in the facility's infection control program.

6. There shall be a plan for each employee to receive annual in-services and educational programs as indicated based on assessment of the infection control process.

7. The infection control officer shall maintain a log of infectious diseases.

8. No item shall be used past the expiration date.

9. One (1) time patient care items shall not be reused.

10. If sterilization facilities are present, the Association for the Advancement of Medical Instrumentation (AAMI) standards or the Center for Disease Control (CDC) recommended practices for sterilization in health care facilities shall be followed.

B. Infection Control Committee.

1. There shall be a Professional Review Committee appointed by the Governing Body to monitor and provide direction for the Infection Control program:

a. Administration;

b. Housekeeping;

c. Laboratory; and

d. Nursing.

2. The Governing Body shall appoint a qualified individual to serve as chairperson of the Infection Control Committee.

3. The Infection Control Committee shall meet at least every two (2) months. Minutes of the meetings shall reflect the Committee's actions in monitoring and directing the facility's Infection Control program.

4. The Committee shall fulfill the following responsibilities:

a. Assist in the development of and approval of all infection control policies and procedures within the facility;

b. Annually review and approve all infection control policies and procedures within the facility;

c. Direct all purchases of equipment and/or supplies used for disinfection, decontamination, sanitation and/or sterilization;

d. Annually review and approve all products used throughout the facility related to disinfection, decontamination, sanitation and/or sterilization and approve all interim changes;

e. At each meeting review the results of the biological spore tests on the facility's autoclaves;

f. Monitor any contractual services relative to infection control (e.g., waste management and laundry) to ensure compliance with all applicable regulations; and

g. Review any special infection control studies conducted within the facility.

C. Employee Health.

1. There shall be policies and procedures for screening health care workers for communicable diseases and monitoring health care workers exposed to patients with any communicable diseases.

2. There shall be policies regarding health care workers with infectious diseases or carrier states. The policies shall clearly state when health care workers shall not render direct patient care.

NOTE: Health care workers employed by the facility, while affected with any disease in a communicable stage or while a carrier of such diseases, or while afflicted with boils, jaundice, infected wounds, diarrhea or acute respiratory infections, shall not work in any area in any capacity in which there is a likelihood of such person contaminating food, food contact surfaces, supplies, or any surface with pathogenic organisms or transmitting disease to patients, facility personnel or other individuals within the facility.

3. There shall be a plan for ensuring that each health care worker has measures for prevention of communicable disease outbreaks, especially Mycobacterium tuberculosis (TB). All plans for the prevention of transmission of TB shall conform to the most current CDC Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health Care Facilities.

4. There shall be a plan for ensuring that all health care workers who are frequently exposed to blood and other potentially infectious body fluids are offered immunizations for Hepatitis B.

SECTION 13: NUTRITION SERVICES.

A. Free-Standing Birthing Centers shall develop policies and procedures for the provision of food and nourishments for patient consumption. Food and nourishments may be brought to the center by patients or their families, if allowed by facility policy.

B. If meals and nourishments are provided for patients by the center, the following conditions shall exist:

1. Food shall come from an approved commercial source;

2. Only prepackaged complete meals, food items (to include condiments) or snacks shall be served;

3. There shall be sufficient space provided for cold and dry storage of food items. Sufficient space shall be defined by the facility's established stock level;

4. Only disposable dishware and eating utensils shall be permitted;

5. There shall be designated space provided for the assembly and service of meals. It shall contain at least the following items:

a. Refrigerator and freezer;

b. Microwave;

c. Two (2) compartment sink with drainboard;

d. Cabinet, drawer, and counter space;

e. Can opener;

f. Small utensils;

g. Self-dispensing ice machine;

h. Trash receptacle;

i. Handwashing facilities or equivalent; and

j. Non-commercial under counter dishwasher.

6. Policies and procedures shall be established for the cleaning and maintenance of all equipment, storage and work space;

7. Temperatures for refrigeration equipment shall be maintained between thirty- six to forty (36-40) degrees Fahrenheit. A hermetically sealed indicating thermometer accurate to plus or minus three (3) degrees Fahrenheit shall be located to measure the air temperature in the warmest part of the storage unit. Temperatures shall be monitored and recorded at least three (3) times daily. Small Free-Standing Birthing Centers not providing meals or hazardous foods shall monitor and record temperatures on each day the facility is open;

8. Freezers containing foods to be stored for ten (10) days or less shall maintain zero (0) degrees Fahrenheit plus or minus ten (10) degrees Fahrenheit. Frozen foods stored for longer than ten (10) days shall be maintained at a temperature of zero (0) degrees Fahrenheit or below. A hermetically sealed indicating thermometer accurate to plus or minus three (3) degrees Fahrenheit shall be located to measure the air temperature in the warmest part of the storage unit. Temperatures shall be monitored and recorded at least three (3) times daily. Small Free- Standing Birthing Centers not providing meals or hazardous foods shall monitor and record temperatures on each day the facility is open;

9. Policies and procedures shall be established for the storage, dating and rotation of all food items. Policies must be in place to assure that food stored during periods the facility is not in operation maintains proper temperatures;

10. Employee food shall be labeled and separated from patient food in refrigerators and freezers; and

11. Signs should be visible to warn persons with pacemakers of the presence of a microwave oven, if applicable.

SECTION 14: PHYSICAL ENVIRONMENT FREE-STANDING BIRTHING CENTER.

A. Building and Grounds.

1. The building and equipment shall be maintained in a state of good repair at all times.

2. Facility premises shall be kept clean, neat and free of litter and rubbish.

3. All openings to attics and to spaces between ceilings and roof decks shall be kept closed at all times.

4. Rooms containing gas fired equipment shall not be used for storage except for noncombustible materials.

5. Corridors, attics, and passageways shall be free of storage. Exits shall not be blocked by storage of furniture or equipment at any time.

6. Emergency wireless communication shall be provided and maintained in a state of good repair.

7. Each Free-Standing Birthing Center shall develop a written preventive maintenance plan. This plan shall be available to the Department for review at any time. Such plans shall provide for maintenance as recommended by manufacturer, applicable codes, or designer.

8. All handwashing facilities shall be equipped with hands-free handles, disposable soap dispenser, paper towel dispenser and trash receptacle.

9. Vertical and horizontal transport systems shall be operated and maintained in a manner to provide for safe transport.

10. Hazardous cleaning solutions, compounds, and substances shall be labeled and kept in an enclosed storage area or approved cabinet separate from other cleaning materials.

11. Doors located on exit access corridors and those for entry to patient care areas shall be labeled as to their intended use for convenience and emergency purposes. All patient rooms shall be labeled and hazardous rooms labeled as to classification.

12. Fire safety and other safety systems shall be operated and maintained in a manner to protect patients, personnel, visitors, and property from fire and the products of combustion.

13. A supply of hot water for patient use shall be available at all times, in accordance with CDC guidelines. A month log shall be maintained as to presence/absence of hot water.

14. Heating, ventilating and air-conditioning (HVAC) systems shall be operated, and maintained in a manner to provide a comfortable and safe environment for patients, personnel, and visitors. In large Free-Standing Birthing Centers, an air filter change out log shall be maintained.

15. Plumbing systems, including equipment and systems for the supply and distribution of potable, non-potable, and/or high purity (such as deionized and sterilized) water, and equipment and systems for the complete and safe removal or dispersion of storm water and waste water, shall be operated and maintained in a manner to be adequate, safe and reliable for all required facility operations.

16. Boiler systems and hot water delivery systems shall be operated, and maintained in a manner to provide a safe supply of steam and/or hot water for all required facility operations.

17. If provided, medical gas and vacuum systems shall be operated and maintained in accordance with NFPA 99, Standard for Health Care Facilities, in a manner to provide an adequate and safe supply for all required activities.

18. Exit lights shall be illuminated at all times in accordance with NFPA 101, Life Safety Code.

19. Facilities shall have lighting levels that are conducive to efficient work, safety, and patient comfort.

20. In large Free-Standing Birthing Centers, the required emergency power generator shall be exercised weekly for thirty (30) minutes and exercised under load conditions monthly for thirty (30) minutes. An equipment log shall be maintained of all tests, malfunctions and the immediate corrective actions. Preventive maintenance work or repairs shall be noted.

21. Communication systems, including telephone, nurse call, and internal/external paging shall operate effectively and reliably at all times.

22. The electrical distribution system shall be operated and maintained in a manner to provide safe electrical power for all required activities.

B. Maintenance and Engineering.

1. The physical plant and equipment maintenance programs shall be under the direction of a person qualified by training and/or experience and licensed where required.

2. Equipment Management Program (EMP). There shall be a preventive maintenance program designed to assure the electrically powered patient care equipment used to monitor or diagnose performs properly and safely. This program shall be administered by individuals qualified through training and/or experience or by procuring a contractual maintenance agreement. The following are minimum program elements:

a. A list of electrically powered patient care equipment shall be maintained regardless of location or ownership;

b. Each device, or identical group of devices, shall have a procedure establishing minimum criteria against which performance and safety are measured. The elements of these procedures shall be based on NFPA 99, Standard for Health Care Facilities, and the manufacturer's directions;

c. Each device shall be tested at intervals of not more than six (6) months unless there is documented evidence that less frequent testing is justified;

d. Historical records documenting acceptable performance as established by the procedures shall be maintained;

e. A program to identify and repair equipment failures shall be maintained;

f. In large Free-Standing Birthing Centers, user or owner departments shall be notified of the status of their equipment when it will be out of service more than twenty-four (24) hours;

g. There shall be operator and maintenance instructions for each device on the electrically powered patient care equipment list; and

h. Individuals shall be trained to operate and maintain equipment used in the performance of their duties. This training shall be documented.

3. Utilities Management Program (UMP). There shall be a preventive maintenance program designed to assure that the physical plant equipment and building systems perform properly and safely. This program shall be administered by individuals qualified through training and/or experience or by procuring a contractual agreement. This program shall consist of at least the following minimum elements:

a. A list of physical plant equipment and building systems shall be maintained regardless of location or ownership;

b. Equipment and building system shall have a procedure establishing minimum criteria against which performance and safety are measured. The elements of these procedures shall be based on NFPA 99, Standard for Health Care Facilities, and the manufacturer's directions and the experience of the repair technician or operator;

c. Equipment and building system, shall be tested, serviced, or inspected at intervals of not more than twelve (12) months unless there is documented evidence that less frequent service is justified;

d. Historical records documenting acceptable performance as established by the procedures shall be maintained;

e. A program to identify and repair equipment failures shall be maintained;

f. In large Free-Standing Birthing Centers, user or owner departments shall be notified of the status of their equipment or system when it will be out of service for more than twenty-four (24) hours;

g. There shall be operator and/or maintenance instructions for each piece of equipment or building system on the list; and

h. Individuals shall be trained to operate and maintain physical plant equipment and/or building systems. This training shall be documented.

4. Life Safety Management Program. There shall be a preventive maintenance program designed to assure that all circuits of fire alarm and detection systems are tested on a quarterly basis and all components receive annual preventive maintenance. Analog detection devices that provide automatic self testing are exempt from the quarterly testing requirement. This program shall be administered by individuals qualified through training and/or experience or by procuring a contractual maintenance agreement. This program shall consist of the following minimum elements:

a. A list of all fire protection equipment or component groups shall be maintained;

b. Each piece of equipment and/or component groups, shall have a procedure establishing minimum criteria against which performance and safety are measured. The elements of these procedures shall be based on the NFPA 72, National Fire Alarm Code, the manufacturer's recommendations and the experience of the repair technician or operator;

c. Fans or dampers in air handling and smoke management systems shall be reliable and functional at all times;

d. Automatic fire extinguishing systems shall be inspected and tested annually in accordance with NFPA 13, Standard for the Installation of Sprinkler Systems, and NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations. Actual discharge of the fire extinguishing system shall not be required. Records documenting acceptable performance as established by the procedures shall be maintained;

e. A program to identify and repair equipment and/or component group failures shall be maintained;

f. Systems for transmitting fire alarms to the local fire department shall be reliable and functional at all times;

g. There shall be operator and maintenance instructions for each piece of equipment and/or component group on the list;

h. Individuals shall be trained to operate and maintain all equipment and/or component group on the list; and

i. Portable fire extinguishers shall be clearly identified. (Refer to Section 14, Safety Services.)

5. Emergency Procedures Program (EPP). There shall be written emergency procedures or a disaster management plan for utility system disruptions or failures which address the specific and concise procedures to follow in the event of a utility system malfunction or failure of the water supply, hot water system, medical gas system, sewer system, bulk waste disposal system, natural gas system, commercial power system, communication system and boiler or steam delivery system. These procedures shall contain but are not limited to the following information:

a. A method of obtaining alternative sources of essential utilities;

b. A method of shutoff and location of valves for malfunctioning systems;

c. A method of notification of facility staff in affected areas; and

d. A method of obtaining repair services.

6. There shall be sufficient supervisory and support personnel to provide maintenance services in relation to the size and complexity of the facility and the services that are provided.

7. In large Free-Standing Birthing Centers, a liaison with the QI, Infection Control and Safety Committees shall be maintained.

C. Environmental Services.

1. The environmental services shall be under the direction of a person qualified by training and/or experience and licensed where required.

2. In large Free-Standing Birthing Centers, a designee from this department shall be a member of the Infection Control Committee.

3. Dry, or untreated dusting, sweeping, or mopping, except vacuum type cleaning shall be prohibited within the facility.

D. Laundry Services.

1. Laundry may be done on- or off-site. If onsite, an area for laundry equipment with counter and storage space shelving shall be provided. Depending on size and occupancy of center, ordinary household laundry equipment may be provided. (Soiled laundry shall be held in the soiled holding area until deposited in the washer.)

2. Hot water supplied to laundry areas shall be a minimum of 110 Fahrenheit. Chlorine bleach and other laundry chemicals shall be used at effective concentrations that disinfect for the laundry size, cycle time and water temperature, as recommended by the chemical manufacturer(s).

3. Clean laundry shall be mechanically dried only.

4. Separate containers for the disposal of infectious waste and sharps shall be located in the soiled linen area.

E. Safety Services.

1. There shall be an effective program to enhance safety within the facility and grounds. In large Free-Standing Birthing Centers, the program shall be established and monitored by a Safety Committee appointed by the Administrator. Committee members shall be selected from Administration, Nursing, Maintenance, Housekeeping, the Medical Staff and others as appropriate.

2. In large Free-Standing Birthing Centers, the Safety Committee shall meet a minimum of once every three (3) months to fulfill safety objectives. Minutes of each meeting shall be recorded and kept in the facility.

3. The Administrator shall designate a specific individual to carry out policies established by the safety program.

4. The orientation program for the facility personnel shall include the importance of general safety, fire safety and the responsibility of each individual to the program.

5. The Safety Committee of large Free-Standing Birthing Centers and designated individual of small Free-Standing Birthing Centers shall have the following functions:

a. Investigation and evaluation of each accident, injury or safety hazard report;

b. Provision for safety-related information to use in orientation and education programs;

c. Monitoring the results of the safety program and analyzing the effectiveness of the program annually;

d. Conducting fire drills and disaster drills at required intervals;

e. Reporting conclusions, recommendations, and actions of Committee at least quarterly to Administration; and

f. Ensuring each department or service shall have a safety policy and procedure manual within their own area that is a part of the overall facility safety manual and establishes safety policies and procedures specific to each area.

6. Fire extinguishers shall be provided in adequate numbers, of the correct type, and shall be properly located and installed in accordance with NFPA 10, Standard for Portable Fire Extinguishers. Personnel shall be trained in the proper use of fire extinguishers and equipment. Personnel shall follow procedures in fire containment and evacuating patients in case of fire or explosion. There shall be an annual check of all fire extinguishers by qualified persons in accordance with NFPA 10, Standard for Portable Fire Extinguishers. The date the check was made and the initials of the inspector shall be recorded on the fire extinguisher or on a tag attached to the extinguisher.

7. A plan shall be available for the protection of patients, visitors, and employees for evacuation in the event of an emergency. Any fire or disaster event at the facility shall be reported immediately to the Arkansas Department of Health by telephone 661-2201 during regular working hours or to 1-800-554 -5738 or 661-2136 after normal working hours, holidays and weekends.

8. There shall be policies and procedures to address usage of tobacco. "No Smoking" signs or international symbol for no smoking shall be posted in any room or compartment where flammable liquids, combustible gases, or oxygen is used or stored, and in any other hazardous locations.

9. There shall be rules and regulations governing the routine methods of handling and storing flammable and explosive agents.

10. There shall be keys available to assure prompt access to all locked areas. All doors shall be devised so they can be opened from the inside of the locked area. Special door locking devices are acceptable in limited areas. Usage is subject to all codes and regulations.

11. All required exit doors shall remain unlocked in accordance with NFPA 101, Life Safety Code.

12. A list of Material Safety Data Sheets (MSDS) for solutions, cleaning compounds, disinfectants, vermin control chemicals, and other potentially hazardous substances used in connection with the facility shall be readily available onsite.

SECTION 15: PHYSICAL FACILITIES, FREE-STANDING BIRTHING CENTERS.

A. Definitions.

1. Accessible - having access to but which first may require the removal of a panel, door or similar covering of the item described.

2. Addition - an extension or increase in floor area, height of a building, or structure.

3. Alter or Alteration - any change(s) or modification in construction or occupancy or the installation or the assembly of any new structural components, or any change(s) to the existing structural component, in a system, building, and structure.

4. And/Or (in a choice of two (2) code provisions) - signifies that use of both provisions shall satisfy the code requirements and use of either provision is acceptable, also. The most restrictive provision shall govern. Where there is a conflict between a general requirement and a specific requirement the specific or restrictive requirement shall be applicable.

5. Architect - a duly registered architect and licensed by the State of Arkansas.

6. Corridor - a passage way into which compartments or rooms open and which is enclosed by partitions and/or walls and a ceiling, or a floor/roof deck above.

7. Dead end - a hallway, corridor or space open to a corridor so arranged that it can be entered, from an exit access corridor without passage through a door, but does not lead to an exit.

8. Engineer - a duly registered engineer and licensed by the State of Arkansas.

9. Licensing agency - Arkansas Department of Health, Division of Health Facility Services or current name.

10. Listed - equipment or materials included in a list published by a nationally recognized testing laboratory, inspection agency or other organization concerned with products evaluation that maintains periodic inspection of production of listed equipment or materials, and whose listing states either that the equipment or materials meets nationally recognized standards or has been tested and found suitable for use in a specific manner.

11. Narrative program - the narrative program describes the functional and utilizational information related to fulfillment of the Free-Standing Birthing Center's objectives. The description reflects those services necessary for complete operation of the facility. Some common elements which shall be included address policies and procedures; intent or purpose; space requirements; staff patterns, quantities, and credentials.

12. New construction - these rules establish health, safety and welfare requirements for the design of all new Free-Standing Birthing Centers and related institutions. Where new work is done within the state, all portions of the work shall comply with applicable sections of these rules.

13. Partition - an interior wall, other than folding or portable, that subdivides spaces within any story, attic or basement of a building.

14. Patient care area - any portion of a Free-Standing Birthing Center wherein patients are intended to be examined or treated.

15. Plenum - an air compartment or chamber to which one (1) or more ducts are connected and which forms part of air distribution system.

16. Readily assessable - having direct access without the need of removing any panel, door or similar covering of the item described, and without requiring the use of portable ladders, chairs, etc.

17. Renovation - construction performed within an existing facility.

18. Repair - the reconstruction or renewal of any part of an existing building for the purpose of maintenance.

19. Room - a separate, enclosed space, with doorway(s), for one (1) named function.

20. Through Penetration Protection - a system installed to resist, for a prescribed time period, the passage of flame, heat, and hot gases through openings which penetrate an entire fire resistant assembly in order to accommodate cables, cable trays, conduits, tubing, pipes, ductwork or similar terms.

21. Toilet - A room designated exclusively for a water closet, lavatory, and tub or shower.

B. General Considerations.

1. The requirements set forth herein have been established by the Department and constitute minimum requirements for new construction, new addition(s), and/or major renovations in facilities requiring licensure under these rules. These requirements are considered necessary to ensure properly planned and well constructed Free-Standing Birthing Centers which can be efficiently maintained and operated to furnish adequate services. In many instances, these minimum requirements shall need to be exceeded for the facility to function as programmed.

2. Facilities shall be accessible to the public, staff, and patients with physical disabilities. Minimum barrier free requirements shall be those set forth by the Arkansas State Building Services, Minimum Standards and Criteria -Accessibility for the Physically Disabled Standards.

3. Projects involving renovation, and additions to existing facilities shall be programmed and phased to minimize disruption of the existing functions. Access, exits and fire protection shall be maintained for the occupant's and the facility's safety.

4. Codes and Standards. Nothing stated herein shall relieve the owner from compliance with building codes, ordinances, and regulations which are enforced by city, county, or other State jurisdictions. Where such codes, ordinances, and regulations are not in effect, the owner shall consult the state building codes for all components of the building type which are not specifically covered by these minimum requirements. In location where there is a history of tornadoes, floods, earthquakes or other regional disasters, planning and design shall consider the need to protect the occupants and the facility.

5. No new mechanical, electrical, plumbing, fire protection, or medical gases system shall be installed, nor any such existing system materially altered or extended, until complete plans and specifications for installation, alteration, or extensions have been submitted to the licensing agency for review and approval.

C. Plan Review. The following list illustrates the process flow which shall be used for all new construction, remodeling, and/or alterations and shall include:

1. Narrative program;

2. Site location;

3. Preliminary drawings;

4. Submission of plan review fee;

5. Final construction documents;

6. Letter of approval for construction documents;

7. Site observations during construction; and

8. Final site observation.

D. Narrative Program.

1. The facility shall supply for each project (whether new construction, addition, modernization, and renovation) a narrative program that describes the purpose of the project, the projected demand or utilization, staffing patterns, departmental relationships, space requirements, and other basic information relating to the fulfillment of the institution's objectives.

2. The facility's narrative program and/or construction documents shall be approved by all applicable Departments prior to starting construction.

E. Site Location.

1. Location.

a. The site of any Birthing Center shall be easily accessible to the community and to service vehicles such as fire protection apparatus.

b. Facilities shall be located with due regard to the accessibility by public transportation for patients, staff, and visitors, and availability of competent medical and surgical consultation.

c. The facility shall have security measures for patients, personnel, and the public consistent with the conditions and risks inherent in the location of the facility.

d. The facility shall be located to provide reliable utilities (water, natural gas, sewer and electricity). The water supply shall have the capacity to provide normal usage plus firefighting requirements. The electricity shall be of stable voltage and frequency.

e. The site shall afford good drainage and shall not be subject to flooding, located near insect breeding areas, noise, or other nuisance producing locations.

2. Roads and Parking.

a. Paved roads and walks shall be provided within the lot lines to provide access to the main entrance and service entrance, including loading and unloading areas for delivery trucks.

b. Each facility shall have parking spaces to satisfy the minimum needs of patients, employees, staff, and visitors. Space shall be provided for emergency and delivery vehicles.

3. Subsoil Investigation. Subsoil investigation shall be made to determine the subsurface soil and water conditions. The investigation shall include a sufficient number of test pits or test borings to determine, in the judgment of the architect and the structural engineer, the true subsurface conditions. Results of the investigation shall be available in the form of a soil investigation report or a foundation engineering report. The investigation shall be made in close cooperation with the architect and structural engineer and shall contain detailed recommendations for foundation design and gradings. The following is a general outline of the suggested scope of soil investigation:

a. The borings or test pits shall extend into stable soils well below the bottom of any proposed foundations. A field log of the borings shall be made and the thickness, consistency, and character of each layer recorded;

b. The amount and elevation of groundwater encountered in each pit or boring and its probable variation with the seasons and effect on the subsoil shall be determined. High or low water levels of nearby bodies of water affecting the ground level shall also be determined;

c. Laboratory tests shall be performed to determine the safe bearing value and compressibility characteristics of the various strata encountered in each pit or boring;

d. Maximum depth of frost penetration below surface of the ground shall be recorded; and

e. Tests shall be made to determine whether the soil contains alkali in sufficient quantities to affect concrete foundations.

4. Approval. The new building site shall be observed and approved by the Department before construction begins.

F. Preliminary Drawings. Schematic drawings shall be submitted to the Department for the proposed facility. Schematic drawings shall illustrate a basic understanding of the architectural, mechanical, electrical and plumbing systems. The drawings shall include schematic plans, building sections, exterior elevations (all sides), preliminary finish schedule, and general notes. Code criteria shall be submitted that is specific to the proposed facility and exhibits a knowledge of the building and fire code requirements including but not limited to construction type, fire protection ratings, means of egress and smoke compartmentalization. Drawings shall be at a scale to clearly represent the intent. A graphic and/or written scale and directional arrow shall be on each drawing.

G. Submission of Plan Review Fee. A plan review fee in the amount of one (1) percent of the total cost of construction or five hundred dollars ($500.00), whichever is less, shall be paid for the review of drawings and specifications (contract documents). The plan review fee check shall be made payable to the Division of Accounting, Arkansas Department of Health. A cost estimate shall accompany the drawings and specifications unless the maximum fee of five-hundred dollars ($500.00) is submitted. The Division of Health Facility Services (DHFS) will coordinate the review of drawings and specifications for all Arkansas Department of Health offices.

H. Final Construction Documents.

1. Requirements for drawings and specifications shall be prepared by an architect and/or engineer licensed by the State of Arkansas. The Architect and/or Engineer shall prepare and submit construction documents with the respective seals for each professional discipline. Architectural construction documents shall be prepared by an Architect and engineering (mechanical, electrical, civil and structural) construction documents shall be prepared by an (mechanical, electrical, civil and structural) Engineer.

2. Working drawings and specifications shall be prepared in a manner that clearly defines the scope of the work and is consistent with the professional standard of practice for architects and engineers. Working drawings and specifications shall be complete for contract purposes. Working drawings and specifications for each of the following disciplines of work: civil, architectural, life safety and fire protection, structural, mechanical, and electrical may include, but are not limited to, the following:

a. Civil.

1) Site survey including a legal description of the property.

2) Site plans including demolition, grading, utility and building/dimension types.

3) Sections, details, schedules, notes and legends for site plans.

b. Architectural.

1) Plans including demolition, reference, dimension, life safety, reflected ceiling, enlarged, millwork, equipment and furnishing types.

2) Sections including building, partition and detail types.

3) Elevations including interior and exterior types.

4) Details including plan and section types.

5) Schedules including drawing sheets finish, door and window types.

6) Notes including general and specific as required to clearly define the scope of work.

7) Legends including abbreviation and symbol types.

c. Life Safety and Fire Protection.

1) Limits of each smoke compartment.

2) Location of each smoke barrier wall.

3) Dimensions and gross areas of each smoke compartment.

4) Location of each fire rated wall or partition, fire separation wall and horizontal exit.

5) Location of each exit sign, fire pull station, and extinguisher cabinet and extinguisher.

6) Travel distance(s) from the most remote location(s) in the building to an exit as defined by NFPA 101 (i.e., horizontal exit, exit passageway, enclosed exit stair, exterior exit door).

d. Structural.

1) Plans including demolition, foundation, floor framing, roof framing, reference and dimension types.

2) Sections including partial building and detail types.

3) Details including plan and section types.

4) Schedules including pier, footing, beam, girder, column and reinforcing types.

5) Notes including general and specific as required to clearly define the scope of the work.

6) Legends including abbreviation and symbol types.

e. Mechanical.

1) Heating, piping, and air-conditioning systems:

a) Steam heated equipment, such as sterilizers, warmers, and steam tables;

b) Heating and steam mains and branches with pipe sizes;

c) Diagram of heating and steam risers with pipe sizes;

d) Sizes, types, and heating surfaces of boilers and oil burners, if any;

e) Pumps, tanks, boiler breeching and piping, and boiler room accessories;

f) Air-conditioning systems with required equipment, water refrigerant piping, and ductwork showing required fire smoke/dampers;

g) Exhaust, return, and supply ventilating systems with piping and required fire/smoke dampers;

h) Air quantities for all room supply, return, and exhaust ventilating duct openings;

i) A ventilation schedule specifying the following information: room number, room name, room volume (ft3), required room air changes, required outside air changes, required air movement relative to adjacent area, required air filtration (% efficiency), required room total supply air quantity (cubic feet per minute (CFM), required outside air quantity (CFM), required room exhaust air quantity (CFM), design room total supply air quantity (CFM), design room return air quantity (CFM), design outside air quantity (CFM), design room exhaust air quantity (CFM), design room air filtration (% efficiency), room design summer (F) dry bulb/wet bulb (DB/WB), room design winter ( F) DB/WB, outside air design summer ( F) DB/WB, and outside air design winter (F) DB/WB; and

j) Air filter design pressure drop both clean and dirty.

2) Plumbing, drainage, and standpipe systems:

a) Size and elevation of street sewer, house sewer, house drains, and street water main;

b) Locations and size of soil, waste, and vent stacks with connections to house drains, clean outs, fixtures and equipment;

c) Size and location of hot and cold circulating mains, branches, and risers from the service entrance and tanks;

d) Riser diagram to show all plumbing stacks with vents, water risers, and fixture connections;

e) Gas, oxygen, and special connections;

f) Standpipe and sprinkler systems; and g) Plumbing fixtures and equipment which require water and drain connections.

3) Elevators and dumbwaiters: Details and dimensions of shaft, pit and machine room, sizes of car platform and doors.

4) Kitchens, laundry, refrigeration, and laboratories detailed at a satisfactory scale (1/4 inch scale) to show the location, size, and connection of all fixed and moveable equipment.

f. Electrical.

1) All electrical wiring, outlets, smoke detectors, and equipment which require electrical connections.

2) Electrical service entrance with switches, and feeders to the public service feeders, characteristics of the light and power current and transformers and their connections, if located in the building.

3) Plan and diagram showing main switchboard power panels, light panels and equipment. Diagram of feeder and conduit sizes with a schedule of feeder breakers or switches.

4) Light outlets, receptacles, switches, power outlets, and circuits.

5) Telephone layout showing service entrance, telephone switchboard, terminal boxes, and telephone outlets.

6) Nurses' call system with outlets for beds, duty stations, door signal lights, annunciators, and wiring diagrams.

7) Staff paging and doctors in-and-out registry system with all equipment wiring, if provided.

8) Fire alarm system with stations, signal devices, control board, and wiring diagrams.

9) Emergency electrical system with outlets, transfer switch, source of supply, feeders, and circuits.

10) Medical gas alarm system.

11) All other electrically operated systems and equipment.

g. Specifications.

1) Specifications shall supplement the drawings to fully describe types, sizes, capacities, workmanship, finishes, and other characteristics of all materials and equipment and shall include the following:

a) Cover or title sheet with architect and/or engineer seal;

b) Index;

c) General conditions;

d) General requirements; and

e) Sections describing material and workmanship in detail for each class of work.

h. All construction documents and specifications shall be approved by the Department prior to the beginning of construction and a letter shall be issued from the licensing agency granting approval to commence with construction. The Department shall have a minimum of six (6) weeks to review construction documents and specifications. The Division of Health Facility Services shall coordinate the plan review with other Divisions in the Department.

I. Site Observation During Construction. The new building site shall be observed and approved by the Department before construction begins. The construction of the new building and/or addition shall be observed during the construction phases and before occupying the building and/or addition.

1. This Department is to be notified when construction begins and a construction schedule shall be submitted to determine inspection dates.

2. Representatives from the Department shall have access to the construction premises and the construction project for purposes of making whatever observations deemed necessary throughout the course of construction.

3. Periodic observations of construction shall be provided and documented by each design professional to assure construction is in compliance with the contract documents. The number and interval of periodic observations shall be approved by DHFS prior to beginning construction. Documentation of each periodic observation shall be submitted to DHFS.

4. Any deviation from the accepted construction documents shall not be permitted during construction, until the written request for change(s) in the construction is approved by this Department.

J. Final Site Observation.

1. Upon completion of construction and prior to the approval by the Department to occupy and use the facility, the owner shall be furnished a minimum of one (1) complete set of reproducible drawings and specifications, and one (1) complete legible set of as built drawings and specifications showing all construction, fixed equipment, and mechanical and electrical systems as installed and built. The Department shall also be provided one (1) complete set of as built drawings and specifications. In addition, the owner shall be furnished a complete set of installation, operation, and maintenance manuals and parts lists for the installed equipment at the time as built prints are provided.

2. No facility shall occupy any new structure or major addition or renovation space until the appropriate approval has been received from the local building and fire authorities and licensing agency.

K. List of Referenced Publications. Codes and standards which have been referenced in whole or in part in the various sections of this document are listed below. The most current codes and standards adopted at the time of this publication are used. Later issues will normally be acceptable where requirements for function and safety are not reduced; however, editions of different dates may have portions renumbered or retitled. Care shall be taken to ensure that appropriate sections are used. Names and addresses of originators are also included for information.

1. American National Standards Institute (ANSI) Standard A17.1, "American National Standard Safety Code for Elevators, Dumbwaiters, Escalators and Moving Stairs."

2. American Society of Civil Engineers, (ASCE), "Minimum Design Loads for Buildings and Other Structures."

3. American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE), "Handbook of Fundamentals" and "Handbook of Applications."

4. American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE), Standard 52, "Method of Testing Air Cleaning Devices Used in General Ventilation for Removing Particulate Matter."

5. Arkansas State Building Services, Minimum Standards and Criteria -Accessibility for the Physically Disabled Standards.

6. Arkansas Fire Prevention Code, Volume I - Fire Prevention (Standard Fire Prevention Code with Arkansas Amendments) and Volume II - Building Construction (Standard Building Code with Arkansas Amendments).

7. Arkansas State Mechanical Code, Arkansas Department of Health.

8. Arkansas State Plumbing Code, Arkansas Department of Health.

9. DOP Penetration Test Method, MIL STD No. 282, "Filter Units, Protective Clothing, Gas Mask Components and Related Products: Performance Test Methods."

10. Illuminating Engineering Society of North America, IESNA Publication CP29, "Lighting for Health Care Facilities."

11. Laws, Rules, and Regulations Governing Boiler Inspection, Arkansas Department of Labor.

12. National Council on Radiation Protection (NCRP), Report No. 33, "Medical X-ray and Gamma Ray Protection for Energies Up to 10 MeV Equipment Design and Use, 1986."

13. National Council on Radiation Protection (NCRP), Report No. 49, "Medical X-ray and Gamma Ray Protection for Energies up to 10 MeV Structural Shielding Design and Evaluation, 1976."

14. National Council on Radiation Protection (NCRP), Radiation Protection Design Guidelines for 0.1pi29100, MeV Particle Accelerator Facilities.

15. National Fire Codes - 1998.

16. Rules Pertaining to the Management of Regulated Waste from Health Care Related Facilities, Arkansas Department of Health.

17. Rules Pertaining to Swimming Pools and Other Related Facilities - Arkansas Department of Health.

L. Availability of Codes and Standards. The codes and standards referenced in various Sections throughout this document can be ordered, if they are Government publications, from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402. Copies of non-government publications can be obtained at the addresses listed below.

1. Air Conditioning and Refrigeration Institute, 1501 Wilson Boulevard, Arlington, VA 22209.

2. American National Standards Institute, 1430 Broadway, New York, NY 10018.

3. American Society of Civil Engineers, 345 East 47th Street, New York, NY 10017.

4. American Society for Testing and Materials, 1916 Race Street, Philadelphia, PA 19103.

5. American Society of Heating, Refrigerating, and Air Conditioning, 1741 Tullie Circle, NE, Atlanta GA 30329.

6. Arkansas State Building Services, 1515 West 7th Street, Suite 700, Little Rock, AR 72201.

7. Arkansas Department of Labor, 10421 West Markham, Little Rock, AR 72205.

8. Illuminating Engineering Society of North America (IESNA), 120 Wall Street, 17th Floor, New York, NY 10005.

9. National Council on Radiation Protection and Measurement, 7910 Woodmont Avenue, Suite 1016, Bethesda, MD 20814.

10. National Fire Protection Association, 1 Batterymarch Park, Post Office Box 9101, Quincy, MA 02269-9101.

11. National Technical Information System (NTIS), 5285 Port Royal Road, Springfield, VA 22161.

12. Defense Printing Service, 700 Robbins Avenue, Building 4D, Philadelphia, PA 19111 (for DOP Penetration Test Method).

13. Southern Building Code Congress International, Inc., 900 Montclair Road, Birmingham, AL 35213.

14. Underwriters' Laboratories, Inc. 333 Princeton Road, Northbrook, IL 60062.

SECTION 16: CLINICAL FACILITIES, FREE-STANDING BIRTHING CENTERS.

The extent (number and types) of the administrative, clinical and diagnostic facilities to be provided shall be determined by the services contemplated and the estimated patient load as described in the approved narrative program. The planning of Free-Standing Birthing Center shall provide for the privacy and dignity of the patient during interview, examination, and treatment.

A. General. Each element provided in the Free-Standing Birthing Center shall meet the requirements outlined herein as a minimum, with the understanding that the elements shall be expanded where needed.

B. Birthing Room(s). Birthing rooms shall be adjacent to a toilet room and shall have storage space sufficient to accommodate the belongings of occupants, bedding, equipment, and supplies. In addition, the following shall be provided:

1. Birthing rooms shall be adequate in size to accommodate one (1) patient, her family, and attending staff. Each birthing room shall have a minimum floor area of one hundred sixty (160) square feet, excluding vestibule toilets;

2. An area for equipment and supplies for routine and remedial newborn care, separate from the equipment supplies for maternal care, shall be provided in each birthing room in built-in cabinets, closets, or furniture;

3. Medications, syringes, specimen containers, and instrument packs shall be contained in storage areas not accessible to children; and

4. The plan for the birthing room shall be such that it will permit the need for emergency transfer by stretcher unimpeded.

C. Nurses' Station(s). Facilities for charting, clinical records, work counter, communication system, space for supplies and convenient access to handwashing facilities shall be provided.

D. Medication Distribution. This may be a medication preparation room or unit, a self-contained medication dispensing unit, or another approved system. A medication dispensing unit may be located at the nursing station, in the clean workroom, or in an alcove or other space under direct control of the nursing or pharmacy staff.

E. Clean Workroom or Clean Holding Room. The clean workroom shall contain a work counter and handwashing and storage facilities. A clean holding room shall be part of a system for storage and distribution of clean supply materials and shall be similar to clean workroom except that the work counter and handwashing facilities may be omitted.

F. Soiled Workroom or Soiled Holding Room. The soiled workroom shall contain a clinical sink or equivalent flushing rim fixture, sink equipped for handwashing, work counter, waste receptacle. A soiled holding room shall be part of a system for collection and disposal of soiled materials and shall be similar to the soiled workroom except that the clinical sink and the work counter may be omitted.

G. If a stretcher is provided, stretcher storage space shall be out of the direct line of traffic.

SECTION 17: PHYSICAL FACILITIES, DETAILS AND FINISHES.

A. Details.

1. Small Free-Standing Birthing Centers shall meet minimum construction requirements as described by NFPA 101, Life Safety Code, Chapter 26 with the exceptions noted herein.

2. Renovation in small Free-Standing Birthing Centers shall meet minimum construction requirements as described by NFPA 101, Life Safety Code, Chapter 27 with the exceptions noted herein.

3. Large Free-Standing Birthing Centers shall meet minimum construction requirements as described by NFPA 101, Life Safety Code, Chapter 12, Section 6 with the exceptions noted herein.

4. Renovation in large Free-Standing Birthing Centers shall meet minimum construction requirements as described by NFPA 101, Life Safety Code, Chapter 13, Section 6 with the exceptions noted herein.

5. Renovations, including new additions, shall not diminish the level of safety that existed prior to the start of the work; however, safety in excess of that required for new facilities is not required.

6. In large Free-Standing Birthing Centers, the minimum corridor width shall be six (6) feet. Work corridors less than six (6) feet long may be four (4) feet wide. In small Free-Standing Birthing Centers, the minimum corridor width shall be forty-four (44) inches.

7. Items such as drinking fountains, fold-down writing surfaces, telephone booths, vending machines, etc., shall not restrict corridor traffic or reduce the corridor width below the required minimum.

8. The minimum door width for patient use shall be two (2) feet ten (10) inches. If the facility services patients transported in beds, the minimum door width shall be three (3) feet eight (8) inches.

9. Rooms containing bathtubs, sitz baths, showers, and water closets, subject to occupancy by patients, shall be equipped with doors and hardware which shall permit access from the outside in any emergency. When such rooms have only one (1) opening or are small, the doors shall be capable of opening outwards or be otherwise designed to be opened without need to push against a patient who may have collapsed within the room.

10. Doors, sidelights, borrowed lights, and windows located within eighteen (18) inches of the floor shall be glazed with safety glass, wire glass, or plastic glazing material that shall resist breaking and shall not create dangerous cutting edges when broken. Safety glass or plastic glazing materials shall be used for shower doors and bath enclosures.

11. Thresholds and expansion joint covers shall be flush with the floor surface to facilitate use of wheelchairs and carts.

12. Location and arrangement of handwashing facilities shall permit proper use and operation.

13. Lavatories and handwashing facilities shall be securely anchored to withstand an applied downward vertical load of not less than two hundred fifty (250) pounds on the front of the fixture.

14. Ceiling heights shall be as follows:

a. Boiler rooms shall have ceiling clearances not less than two (2) feet six (6) inches above the main boiler heater and connecting piping;

b. Rooms containing ceiling-mounted equipment or ceiling-mounted surgical light fixtures shall have height required to accommodate the equipment or fixtures, with a minimum height of nine (9) feet in new construction; and

c. All other rooms shall not have less than seven (7) feet eight (8) inches. Suspended tracks, rails, and pipes located in the path of normal traffic shall be not less than seven (7) feet above the floor and clearances in other areas may be six (6) feet eight (8) inches above the floor.

15. Rooms containing heat-producing equipment (such as boiler or heater rooms and laundries) shall be insulated and ventilated to prevent any adjacent partition surface from exceeding a temperature of ten degrees (10) Fahrenheit above ambient room temperature.

16. Approved fire extinguishers shall be provided in locations throughout the building in accordance with NFPA Standard No. 10. Extinguishers located in exit corridors shall be recessed.

17. Rooms for patient medical records and archived patient medical records that remain on site shall be kept in a one (1) hour fire rated enclosure and protected by a smoke detection system. Circulating records at nurse's station or in active working areas are excluded from this requirement. Offsite buildings or freestanding buildings used for storage of archived patient medical records shall be built of noncombustible materials and provide security and smoke detection systems. Both onsite and offsite records shall be arranged in an accessible manner and stored at least six (6) inches above the floor and protected against undue destruction from dust, vermin, water, etc.

18. Fluorescent light fixtures shall be provided with protective covers if used in food preparation and serving areas and patient care and treatment spaces.

19. No operable fireplace shall be permitted in the facility. Inoperable fireplace(s) shall be sealed at the upper and lower portions of the flue.

B. Finishes.

1. Cubicle curtains and draperies shall be noncombustible or flame retardant and shall pass both the large and small scale tests of NFPA Standard 701.

2. Interior wall, ceiling and floor finish classifications shall be in accordance with NFPA 101, 26-3.3.

3. Floor materials shall be easily cleanable and appropriately wear resistant. Floors in areas used for food preparation or food assembly shall be water resistant and grease-proof. Joints in tile and similar material in such areas shall be resistant to food acids. In all areas frequently subject to wet cleaning methods, floor-materials shall not be physically affected by germicidal and cleaning solutions. Floors that are subject to traffic while wet (such as shower and bath areas) shall have a non-slip surface.

4. Floors and wall bases in birthing rooms shall be coved with the floor, tightly sealed within the wall, and constructed without voids.

5. Wall finishes shall be washable and, in the vicinity of plumbing fixtures, shall be smooth and water resistant.

6. Floors and walls penetrated by pipes, ducts, and conduits shall be tightly sealed to minimize entry of rodents and insects.

7. Ceilings in birthing rooms and soiled/clean utility rooms shall be washable, waterproof, lay-in vinyl coated gypsum board, gypsum board, plaster or equivalent.

8. Ceilings shall have access panels a minimum of two (2) feet by two (2) feet provided where mechanical or electrical maintenance or repair to the facilities above the ceiling shall include, but not be limited to, cut-off valves, air filters, clean out plugs, etc.

SECTION 18: PHYSICAL FACILITIES, MECHANICAL REQUIREMENTS.

A. General.

1. Prior to completion and acceptance of the facility, all mechanical systems shall be tested, balanced, and operated to demonstrate to the owner or his representative that the installation and performance of these systems conform to the requirements of the plans and specifications. The test and balance report shall be based on ASHRAE Systems Guide Standards, and a copy of the final report shall be on file at the facility.

2. Upon completion of the contract, the owner shall be furnished with a complete set of manufacturers' operating, maintenance instructions, and parts list with numbers and description of each piece of equipment. He shall also be provided with instructions in the operational use of systems and equipment as required.

B. Thermal and Acoustical Insulation.

1. Insulation shall be provided for the following within the building:

a. Boilers, smoke breeching, and stacks;

b. Steam supply and condensate return piping;

c. Hot water piping above 110 F and all hot water heaters, generators, and convertors;

d. Chilled water, refrigerant, and other process piping and equipment operating with fluid temperature below ambient dew point;

e. Water supply and drain piping on which condensation may occur;

f. Air ducts and casing with outside surface temperature below ambient dew point; and

g. Other piping, ducts, and equipment as necessary to maintain the efficiency of the system.

2. Insulation on cold surfaces shall include an exterior vapor barrier.

3. Insulation, including finishes on the exterior surfaces of ducts, pipes, and equipment, shall have a flame spread rating of twenty-five (25) or less and a smoke developed rating of fifty (50) or less as determined by an independent testing laboratory in accordance with NFPA 255. The smoke development rating for pipe insulation shall not exceed one hundred fifty (150).

4. Interior duct lining is a potential health hazard and shall not be permitted.

C. Steam and Hot Water Systems and Pressure Vessels.

1. All pressure vessels shall have the ASME seal and shall meet the requirements of the Arkansas Boiler Inspector, Arkansas Department of Labor.

2. Boilers shall have the capacity, based upon the net ratings published by the Hydronics Institute or another acceptable national standard, to supply the normal requirements of all systems and equipment.

3. Supply and return mains and risers of cooling, heating, and process steam systems shall be valved to isolate the various sections of each system. Each piece of equipment shall be valved at the supply and return ends.

D. Air Conditioning, Heating and Ventilating Systems.

1. For laundries a maximum average design temperature of 83-85 F at summer design conditions shall be assumed, with higher temperatures permitted adjacent to heat producing equipment such as ironers. For all other occupied areas a design temperature of 72 F for cooling and heating design conditions shall be assumed.

2. All air-supply and air-exhaust systems shall be mechanically operated.

3. Outdoor intakes shall be located as far as practical but not less than twenty-five (25) feet in large Free-Standing Birthing Centers and ten (10) feet in all other Free-Standing Birthing Centers from exhaust outlets of ventilating systems, combustion equipment stacks, medical/surgical vacuum systems, plumbing vents stacks, or areas which may collect vehicular exhaust and other noxious fumes. The bottom of outdoor air intakes serving central systems shall be located as high as practical but not less than six (6) feet above the ground level, or if installed above the roof, three (3) feet above the roof level. Exhaust outlets from areas that may be contaminated shall be above roof level and arranged to minimize recirculation of exhaust air into the building.

4. It shall be prohibited to use exit access corridors, separated from building use areas by fire-rated partitions and providing access to exit, for return or exhaust from adjoining air-conditioned spaces through louvers or other devices mounted in corridor doors, partitions, or ceilings.

5. The space above ceilings shall not be used as plenum space to supply to, return air from, or to exhaust air from any patient care area in large Free- Standing Birthing Centers.

6. In large Free-Standing Birthing Centers, all central air conditioning systems shall be equipped with two (2) filters. Filter bed number one (1) shall be located upstream of the air conditioning equipment and have an efficiency of no less than thirty (30) percent. Filter bed number two (2) shall be located downstream of any fan or blowers and have an efficiency of no less than ninety (90) percent. Filtration efficiency ratings shall be based on dust spot efficiency per ASHRAE 52-76.

7. Non-central air handling systems, i.e., individual room units that are used for heating and cooling purposes (fan-coil units, heat pump units, etc.), shall be equipped with permanent (cleanable) or replaceable filters. The filters shall have a minimum efficiency of 68 percent weight arrestance. These units may be used as recirculating units only. All outdoor air requirements shall be met by a separate central air handling system with the proper filtration.

8. Direct gas-fired space heating equipment (i.e. products of combustion are not separated from the air stream) shall not be used in patient care areas.

9. Duct humidifiers, when located upstream of final filters, shall be located a minimum of fifteen (15) feet upstream of final filters or shall be fitted with water removal devices which do not allow any water droplets to reach the filter. Humidifiers shall be connected to air flow proving switches that prevent humidification unless the required volume of air flow is present or high limit humidistats are provided. All duct takeoffs shall be sufficiently downstream of the humidifier to ensure complete moisture dissemination. Humidifiers that utilize direct contact of water with the air stream shall not be used.

10. Air handling duct systems shall meet the requirements of NFPA 90A and those contained herein. When approved for use, flexible duct lengths shall be limited to a maximum of fourteen (14) feet.

11. Penetrations in barriers that have been designed to provide radiation shielding shall not compromise the effectiveness of the shielding.

12. Fire, smoke dampers, and smoke detectors shall be constructed, located, and installed in accordance with the requirements of NFPA 101.

13. Boiler rooms shall be provided with sufficient outdoor air to maintain maximum combustion rates of equipment and to limit temperatures in working stations to 10 F above design temperature.

SECTION 19: PHYSICAL FACILITIES, PLUMBING AND OTHER PIPING SYSTEMS.

All plumbing systems shall be designed and installed in accordance with the requirements of the latest edition of the Arkansas State Plumbing Code. Only metal piping or piping material of a type approved by the Arkansas Department of Health for corrosive wastes, etc., shall be permitted.

A. Plumbing Fixtures.

1. The material used for plumbing fixtures shall be nonabsorbent acid-resistant material.

2. All fixtures used by the staff and all lavatories used by patients and food handlers shall be trimmed with valves which can be operated without the use of hands.

3. Clinical sinks shall have an integral trap in which the upper portion of the water trap provides a visible seal.

B. Water Supply Systems.

1. Systems shall be designed to supply water at sufficient pressure to operate all fixtures and equipment during maximum demand periods.

2. Each water service main, branch main, riser, and branch to a group of fixtures shall be valved. Stop valves shall be provided at each fixture. Appropriate panels for access shall be provided at all valves where required.

3. Backflow preventers (vacuum breakers) shall be installed on hose bibs, laboratory sinks, janitors' sinks, and on all other fixtures to which hoses or tubing can be attached.

4. Water distribution systems shall be arranged to provide hot water at each hot water outlet at all times. Hot water at shower, bathing, and handwashing facilities shall not exceed 110 degrees F.

5. The hot water heating equipment and storage tank(s) shall be fabricated of corrosion-resistant metal or lined with noncorrosive material.

C. Drainage Systems.

1. Drain lines from sinks in which acid wastes may be poured shall be fabricated from an acid-resistant material.

2. Building sewers shall discharge into a community sewage system. Where such a system is not available, a facility providing sewage treatment shall conform to applicable local and state regulations.

D. All piping, except control line tubing, shall be identified as to content. All valves shall be tagged, and a valve schedule shall be maintained at the facility for permanent record.

E. Gas and Vacuum Systems.

1. Gas and vacuum systems if installed shall be in accordance with NFPA 99, Chapter 4. In large Free-Standing Birthing Centers, a piped medical gas system shall be required and shall be installed in accordance with NFPA 99, Chapter 4.

SECTION 20: PHYSICAL FACILITIES, ELECTRICAL REQUIREMENTS.

All material and equipment, including conductors, controls, and signaling devices shall be installed to provide a complete electrical system with the necessary characteristics and capacity to supply the electrical facilities shown in the specifications or indicated on the plans. Compliance shall be in accordance with applicable Sections of NFPA 70 and NFPA 99. All materials shall be listed as complying with available standards of Underwriters' Laboratories, Inc., or other similarly established standards.

A. Performance Tests. All electrical installations, including alarm, nurses call and communication systems shall be tested to demonstrate that equipment is installed and operates as planned and specified. A written record of performance tests on special electrical systems and equipment shall be supplied to the owner.

B. Lighting. All spaces occupied by people, machinery, and equipment within buildings, approaches to buildings, and parking lots shall have lighting. Lighting levels shall be in accordance with IES Lighting Handbook (1987, Volume II, Applications) and Lighting for Health Care Facilities (1985).

C. Equipment Installation in Special Areas. Ground fault circuit interrupters shall comply with NFPA 70. When ground fault circuit interrupters (GFCI) are used in critical areas, provisions shall be made to insure that other essential equipment is not affected by activation of one (1) interrupter.

D. Nurses' Call System. In large Free-Standing Birthing Centers, a nurses emergency call system shall be provided for patients' use at each patient's toilet, bath, sitz bath, and shower room. This system shall be accessible to a collapsed patient lying on the floor. Inclusion of a pull cord shall satisfy this standard. The emergency call signal (i.e., visible and audible) shall be distinguishable from the normal nurse call signal, and the call light shall be cancelable only at the station of origin. The signal shall activate an enumerator panel at the nurse station, a visible signal in the corridor at the patient's door, and at other areas defined by the functional program. Provisions for emergency call shall also be needed in outpatient and treatment areas where patients may be subject to incapacitation.

E. Fire Alarm System. A protected premises fire alarm system as defined in Chapter 3 of NFPA 72, National Fire Alarm Code shall be required. In large Free-Standing Birthing Centers, fire alarm systems shall conform to NFPA 101, Life Safety Code, 12-6.3.4.

F. Emergency Electrical Service. Emergency egress lighting (battery back-up) and delivery rooms lighting (battery back-up) shall be provided. In large Free- Standing Birthing Centers, emergency lighting and power shall be provided in accordance with NFPA 99, NFPA 101, and NFPA 110 with eight (8) hours of onsite fuel.

SECTION 21: SEVERABILITY.

If any provision of these Rules, or the application thereof to any person or circumstances is held invalid, such provisions or applications of these Rules that can give effect without the invalid provisions or applications will be enforced, and to this end the provisions hereto are declared to be severable.

CERTIFICATION

This will certify that the foregoing revisions to the Rules for Freestanding Birthing Centers in Arkansas were adopted by the State Board of Health of Arkansas at a regular session of said Board held in Little Rock, Arkansas, on the P' day of August, 2019.

Arkansas Administrative CodeAgency 007 - ARKANSAS DEPARTMENT OF HEALTHDivision 05 - Health Facility ServicesRule 007.05.20-007 - Rules for Free-Standing Birthing Centers in Arkansas

Arkansas Administrative Code
Agency 007 - ARKANSAS DEPARTMENT OF HEALTH
Division 05 - Health Facility Services
Rule 007.05.20-007 - Rules for Free-Standing Birthing Centers in Arkansas