Subject 111-8-40 RULES AND REGULATIONS FOR HOSPITALS
These rules shall be known as the Rules and Regulations for Hospitals. The purpose of these rules is to provide for the inspection and issuance of permits for hospitals and to establish minimum requirements for facilities operating under a hospital permit.
Unless a context otherwise requires, these identified terms mean the following when used in these rules:
|(a)||Board certified means current certification of a licensed physician by a specialty board recognized by the American Board of Medical Specialties (ABMS) or American Osteopathic Association (AOA) or other nationally recognized specialty's certifying board.|
|(b)||Board eligible means a licensed physician who meets the criteria for examination for the designated specialty as published by that nationally recognized specialty's certifying board.|
|(c)||Bylaws means a set of laws or rules formally adopted internally by the facility, organization, or specified group of persons to govern internal functions or practices within that group, facility, or organization.|
|(d)||Department means the Department of Community Health of the State of Georgia.|
|(e)||Governing body means the hospital authority, board of trustees or directors, partnership, corporation, entity, person, or group of persons who maintain and control the hospital.|
|(f)||Hospital means any building, facility, or place in which are provided two (2) or more beads and other facilities and services that are used for persons received for examination, diagnosis, treatment, surgery, or maternity care for periods continuing for twenty-four (24) hours or longer and which is classified by the department as a hospital.|
|(g)||Inpatient means a person admitted to a hospital for an intended length of stay of twenty-four (24) hours or longer.|
|(h)||Rural Free Standing Emergency
Department means any hospital that downgrades its existing scope of
services to meet all of the following conditions:
|(i)||Medical record means the written or electronic collection of diagnostic and/or treatment information and data pertaining to the patient, including but not limited to identifying information and, as applicable, medical orders, assessment findings, diagnostic test results, progress notes, x-rays films, monitoring data, and details of treatment.|
|(j)||Medical staff means the body of licensed physicians, dentists, and/or podiatrists, appointed or approved by the governing body, to which the governing body has assigned responsibility and accountability for the patient care provided at the hospital.|
|(k)||Organized service(s) means any inpatient or outpatient service offered by the hospital which functions as an administrative or operational unit under the governing body of the hospital.|
|(l)||Outpatient means a person who presents to a hospital for diagnostic or treatment services and who is not admitted to the hospital as an inpatient by a member of the medical staff.|
|(m)||Patient means any person presenting at a hospital for the purpose of evaluation, diagnosis, monitoring, or treatment of a medical condition, mental condition, disease, or injury.|
|(n)||Peer review means the procedure by which professional health care providers evaluate the quality and efficiency of services ordered or performed by other professional health care providers in the hospital for the purposes of fostering safe and adequate treatment of the patients and compliance with standards set by an association of health care providers and with the laws, rules, and regulations applicable to hospitals.|
|(o)||Permit means the authorization granted by the Department to a hospital governing body to operate the hospital's authorized services.|
|(p)||Physical restraint means any manual method or physical or mechanical device used with a patient such that the patient's freedom of movement or access to his/her own body is restricted.|
|(q)||Physician means any person who is licensed to practice medicine in this state by the Georgia Composite State Board of Medical Examiners.|
|(r)||Practitioner means any individual engaged in the practice of the profession for which they are licensed, certified, or otherwise qualified or authorized to practice.|
|(s)||Professional staff means a person or persons licensed by the state of Georgia to practice a specified health profession and employed by or contracting with the hospital for the practice of that profession.|
|(t)||Rules and regulations means the set of rules formally adopted internally by a specified hospital body to provide guidance for internal functions or practices.|
|(u)||Seclusion means the confinement of a person to a room or an area where the person is prevented from leaving.|
|(v)||Surveillance means the systematic method of collecting, consolidating, and analyzing data concerning the distribution and determinants of a given disease or medical event, followed by the dissemination of that information to those who can improve the outcomes.|
|(w)||The singular indicates the plural, the plural indicates the singular, and the masculine the feminine, when consistent with the intent of these rules.|
No person, corporation, association, or other entity shall establish, operate, or maintain a hospital in Georgia without a permit or provisional permit.
|(a)|| A permit is
required for each hospital. Multi-building hospitals may request a single
permit to include all buildings provided that the hospital buildings are in
close proximity to each other, the facilities serve patients in the same
geographical area, and the facilities are operated under the same ownership,
control, and bylaws.
|(b)||A permit, either continuing or provisional, is required prior to the admission of any patients or initiation of any patient care services in the hospital. A provisional permit may be issued for a limited time to a newly established hospital to allow the hospital to demonstrate that its operational procedures equal standards specified by the rules.|
|(c)|| The permit shall designate the
classification of the hospital as determined by the Department following
evaluation of the hospital's services and in accordance with the Certificate of
|(d)||To be eligible for a permit the hospital shall be in substantial compliance with these rules and regulations and any provisions of law as applicable to the construction and operation of the hospital. In its discretion, the Department may issue a provisional permit for a limited time to a new or existing hospital to allow the hospital a reasonable length of time to come into compliance with these rules provided the Department has received an acceptable plan of correction.|
|(e)||The permit issued to the hospital shall be prominently displayed in a public area of the hospital at all times.|
|(f)||A permit is not transferable from one governing body to another nor from one hospital location to another.|
|(g)|| If the hospital
anticipates that it will close or cease to operate, the governing body shall
notify the Department at least thirty (30) days prior to the anticipated
|(h)||A new permit may be obtained by application to the Department and is required if the hospital is moved to another location, has a change in operational or trade name, has a change in ownership or classification, or has a change in the authorized bed capacity. The former permit shall be considered revoked upon the issue of a new permit and the former permit shall be returned to the Department.|
|(i)||A permit shall remain in effect unless suspended or revoked or otherwise rescinded or removed as provided in these rules.|
The following classes of hospitals are exempt from these rules:
|(1)||Federally owned and/or operated hospitals. Hospitals owned or operated by the federal government are exempt from these rules and the requirement for a Georgia hospital permit; and|
|(2)||Residential Mental Health Facilities for Children and Youth. A sub-classification of specialized hospitals which are licensed to provide twenty-four (24) hour care and have as their primary function the diagnosing and treating patients to age twenty-one (21) with psychiatric disorders are exempt from these rules in lieu of meeting the specific regulations under Chapter 111-8-68.|
An application for a permit to operate a hospital shall be submitted on forms provided by the Department. The application submitted to the Department shall be an original document. No application shall be considered by the Department unless it is complete and accompanied by all required attachments.
Initial Permit. The application for an initial permit shall be submitted
to the Department not later than thirty (30) days prior to the anticipated date
of the opening and initiation of operations by the hospital. The application
shall be signed by the hospital administrator or the executive officer of the
hospital's governing body and shall include:
|(b)||Application Due to a Change in Name, Location, or Bed Capacity of a
The application for a new permit due to a change in name, location, or authorized bed capacity of a hospital shall be submitted at least thirty (30) days prior to the proposed effective date of the change.
|(c)||Application Due to a
Change in Classification of the Hospital. The application for a new
permit due to a change in the classification for the hospital shall be
submitted at least thirty (30) days prior to the proposed effective date of the
change. The application shall be signed by the hospital administrator or the
executive officer of the governing body and shall include:
|(d)||Application Due to a Change in Ownership. The application for a new permit due to a change in ownership shall be submitted at least thirty (30) days prior to the change whenever possible. Proof of ownership documents, as required with the application for the initial permit and any other approvals required by state law, shall be submitted upon the completion of the transaction changing ownership.|
The Department may refuse to grant an initial permit, revoke a current permit, or impose other sanctions as described herein and in the rules for the "General Licensing and Enforcement Requirements," Chapter 111-8-25.
|(a)||Denial of an
Application for a Permit. The Department may refuse to grant an initial
permit or provisional permit without the requirement of holding a hearing prior
to the action. Denial of an application for a change to a permit from an
existing facility shall be subject to notice and opportunity for a hearing
following the denial. An application may be refused or denied if:
|(b)||Sanction of a Permit.
|(c)||If the sanction hearing process results in revocation of the permit, the permit shall be returned to the Department.|
|(1)||Inspections by the Department. The hospital shall be available
during all hours of operation for observation and examination by properly
identified representatives of the Department.
Reports to the Department.
There shall be full disclosure of hospital ownership to the Department at the time of the initial application and when requested. In the case of corporations and partnerships, the names of all corporate officers, partners, and all others owning five (5) percent or more of corporate stock or ownership shall be made known to the Department.
The hospital shall have an established and functioning governing body that is responsible for the conduct of the hospital as an institution and that provides for effective hospital governance, management, and budget planning.
|(a)||The governing body shall be organized under bylaws and shall be responsible for ensuring the hospital functions within the classification for which it is permitted by the Department.|
|(b)|| The governing body
shall appoint members of the medical staff within a reasonable period of time
after considering the recommendations of the medical staff, if any, and shall
ensure the following:
|(c)||If the hospital does not provide emergency services as an organized service, the governing body shall ensure that the hospital has written policies and procedures approved by the medical staff for the appraisal of emergencies, the initial treatment of emergencies, and the referral for emergency patients as appropriate.|
|(d)|| The governing body shall identify an
administrator or chief executive officer who is responsible for the overall
management of the hospital. The administrator or chief executive officer shall:
|(e)||The hospital shall advise the Department immediately and in writing of a change in the designation of the administrator or chief executive officer.|
|(f)||The governing body shall ensure that the hospital is staffed and equipped adequately to provide the services it offers to patients, whether the services are provided within the facility or under contract. All organized services providing patient care shall be under the supervision of qualified practitioners.|
|(g)||The governing body shall be responsible for compliance with all applicable laws and regulations pertaining to the hospital.|
The hospital shall develop, implement, and enforce policies and procedures to ensure that each patient is:
|(a)||Informed about the hospital's grievance process, including whom to contact to file a grievance or complaint with the hospital and that individual's telephone number, and the name, address, and telephone number of the state regulatory agency;|
|(b)||Provided an opportunity to give informed consent, or have the patient's legally authorized representative give informed consent, as required by state law, with documentation of provision of such opportunity in the patient's medical record;|
|(c)||Afforded the right to refuse medical and surgical treatment to the extent permitted by law;|
|(d)||Have advance directives honored in accordance with the law and afforded the opportunity to issue advance directives if admitted on inpatient status;|
|(e)||Provided, upon request, a written summary of hospital charge rates, per service, sufficient and timely enough to allow the patient to compare charges and make cost-effective decisions in the purchase of hospital services;|
|(f)||Provided an itemized statement of all charges for which the patient or third-party payer is being billed; and|
|(g)||Provided communication of information in a method that is effective for the recipient, whether the recipient is the patient or the patient's designated representative. If the hospital cannot provide communications in a method that is effective for the recipient, attempts to provide such shall be documented in the patient's medical record.|
Each hospital shall have an organized medical staff that operates under bylaws adopted by the medical staff and approved by the governing body. The bylaws may provide for the exercise of the medical staff's authority through committees.
|(a)||Organization of the Medical Staff. The medical staff shall be
organized and may operate through defined committees as appropriate.
|(b)||Medical Staff Accountability.
The medical staff shall be accountable to the governing body for the
quality of medical care provided to all patients.
|(c)||Medical Staff Bylaws and Rules and Regulations. The medical staff
of the hospital shall adopt and enforce bylaws and rules and regulations which
provide for the self-governance of medical staff activities and accountability
to the governing body for the quality of care provided to all patients. The
bylaws and rules and regulations shall become effective when approved by the
governing body and shall include at a minimum:
|(d)||Other Medical Staff
Policies. If not addressed through the medical staff bylaws or rules and
regulations, the medical staff shall develop and implement policies to address,
at a minimum:
The hospital shall select and organize sufficient qualified and competent personnel to meet patients' needs and in a manner appropriate to the scope and complexity of the services offered.
|(a)|| The hospital shall establish and
implement human resources policies and procedures to include at least:
|(b)||Written Job Descriptions. The hospital shall have a written description of responsibilities and job duties, with qualification requirements, for each position or job title at the hospital.|
|(c)||Health Screenings. The hospital shall have in place a mechanism and requirement for initial, regular, and targeted health screenings of personnel who are employed or under contract with the hospital or providing patient care services within the hospital setting. The screening shall be sufficient in scope to identify conditions that may place patients or other personnel at risk for infection, injury, or improper care. The health-screening program shall be developed in consultation with hospital administration, medical staff, occupational health, and infection control/safety staff.|
|(d)||Personnel Training Programs. The hospital shall have and implement
a planned program of training for personnel to include at least:
records shall be maintained for each employee of the hospital and shall
contain, at a minimum:
The governing body shall establish and approve a plan for a hospital-wide quality management program, which includes the use of peer review committees. The purpose of the quality management program is to measure, evaluate, and improve the provision of patient care.
|(a)||The scope and organization of the quality management program shall be defined and shall include all patient services and clinical support services, contracted services, and patient care services provided by the medical staff.|
The hospital's quality management program shall be designed to systematically
collect and assess performance data, prioritize data, and take appropriate
action on important processes or outcomes related to patient care, including
but not limited to:
|(c)|| The quality management program shall
utilize a defined methodology for implementation, including at least mechanisms
and methodology for:
|(d)||Results or findings from quality management activities shall be disseminated to the governing body, the medical staff, and any services impacted by the results.|
|(e)||The hospital shall take and document action to address opportunities for improvement identified through the quality management program.|
|(f)||There shall be an on-going evaluation of the quality management program to determine its effectiveness, which shall be presented at least annually for review and appropriate action to the medical staff and governing body.|
The hospital shall be equipped and maintained to provide a clean and safe environment for patients, employees, and visitors.
|(a)||Safety. The hospital shall
develop and implement an effective hospital-wide safety program that includes
the following components:
Sanitation. The hospital shall maintain an environment that is clean and
in good repair, through a program that establishes and maintains:
|(c)||Light, Temperature, and Ventilation. The hospital shall provide adequate lighting, ventilation, and control of temperature and air humidity for optimal patient care and safety of the hospital's patients and staff and shall monitor and maintain such systems to function at least minimally to the design standards current at the time of approved facility construction or renovation.|
|(d)||Space. The hospital shall provide sufficient space and equipment for the scope and complexity of services offered.|
The hospital shall prepare for potential emergency situations that may affect patient care by the development of an effective disaster preparedness plan that identifies emergency situations and outlines an appropriate course of action. The plan must be reviewed and revised annually, as appropriate, including any related written agreements.
|(a)|| The disaster preparedness plan shall
include at a minimum plans for the following emergency situations:
|(b)||There shall be plans to ensure sufficient staffing and supplies to maintain safe patient care during the emergency situation.|
|(c)||There shall be plans for the emergency transport or relocation of all or a portion of the hospital patients, should it be necessary, in vehicles appropriate to the patient's condition(s) when possible, including written agreements with any facilities which have agreed to receive the hospital's patients in these situations.|
|(d)||The hospital shall document participation of all areas of the hospital in quarterly fire drills.|
|(e)||In addition to fire drills, the hospital shall have its staff rehearse portions of the disaster preparedness plan, with a minimum of two (2) rehearsals each calendar year either in response to an emergency or through planned drills, with coordination of the drills with the local Emergency Management Agency (EMA) whenever possible.|
|(f)||The plan shall include the notification to the Department of the emergency situation as required by these rules.|
|(g)||The hospital shall provide a copy of the internal disaster preparedness plan to the local Emergency Management Agency (EMA) and shall include the local EMA in development of the hospital's plan for the management of external disasters.|
|(h)||The hospital's disaster preparedness plan shall be made available to the Department for inspection upon request.|
|(i)||The Department may suspend any requirements of these rules and the enforcement of any rules where the Governor of the State of Georgia has declared a public health emergency.|
The hospital shall have an effective infection control system to reduce the risks of nosocomial infections in patients, health care workers, volunteers, and visitors.
|(a)||The hospital shall designate qualified infection control staff to coordinate the infection control program.|
|(b)||The administrative and medical staff of the hospital, as well as staff from appropriate organized services, shall participate in the infection control program.|
|(c)||The infection control program shall function from a well-designed surveillance plan that is based on accepted epidemiological principles, is tailored to meet the needs of the hospital, and includes both outcome and process surveillance methodologies.|
|(d)||The surveillance plan shall require collection of sufficient baseline data on the incidence of nosocomial infections in order that outbreaks can be identified.|
|(e)|| The infection control methodologies for
effective investigation and control of outbreaks, once identified, shall
include at least:
|(f)|| The program shall specify policies and
procedures for infection control that apply to all areas of the hospital, and
these shall include at least the following:
|(g)|| The infection control program shall have
an organized and effective on-going education plan for hospital health care
workers and volunteers that includes at least:
|(h)||The hospital shall designate which departments are responsible for the reporting of communicable diseases as required by law.|
|(i)||The infection control program shall be evaluated at least annually to determine the effectiveness of the program at lowering the risks and improving the trends of nosocomial infections in patients, health care workers, and volunteers. Changes in the infection control program shall reflect consideration of the results of the evaluations.|
Each hospital shall designate a sterile processing service area designated for the decontamination, cleaning, sterilizing of reusable equipment, instruments, and supplies.
|(a)|| With the collaboration of the infection
control program, the staff providing sterile processing services shall develop
and implement standardized policies and procedures that conform to generally
accepted standards of practice for:
|(b)||The sterile processing service shall be staffed by qualified personnel.|
|(1)||Management of Patients' Medical
Records. The hospital shall have an efficient and organized medical
records service that establishes the policies and procedures for the
maintenance of the medical records for all patients and that is
administratively responsible for the management of those records.
|(2)||Entries in the Medical
Record. All entries in the patient's medical records shall be accurate
and legible and shall contain sufficient information to support the diagnosis
and to describe the treatment provided and the patient's progress and response
to medications and treatments. Inpatient records shall also contain sufficient
information to justify admission and continued hospitalization.
|(3)||Minimum Requirements for Patients'
Medical Records. Upon completion, medical records for inpatients and
outpatients shall contain, at minimum, the documents as specified below.
Records for patients at the hospital for other specialized services, such as
emergency services or surgical services, shall contain such additional
documentation as required for those services.
All patient care services provided by the hospital shall be under the direction of a member of the medical staff or a licensed physician, dentist, osteopath, or podiatrist who has been granted hospital privileges.
Assessment/Screening on Admission. The hospital shall provide each
inpatient with an appropriate assessment of the patient's condition and needs
at the time of admission. Such assessments shall be provided by personnel
authorized by hospital policy or the medical staff bylaws and/or rules and
regulations and shall be designed to trigger referral for further assessment
Plan of Care.
|(c)||Reassessments of the Patient's
Condition. Reassessment of the patient's condition shall be performed
periodically at appropriate intervals and defined in hospital policy. In
addition, reassessments shall occur at least as follows:
The hospital shall utilize an effective and on-going discharge planning process that identifies post-hospital needs of inpatients and arranges for appropriate resource referral and follow-up care.
|(a)||On admission, the nursing assessment shall identify patients who are likely to suffer adverse consequences upon discharge in the absence of adequate discharge planning.|
|(b)||For those patients identified as needing a discharge plan, designated qualified staff shall complete an evaluation of post-hospital needs and shall develop a plan for meeting those needs. The discharge plan shall be revised as needed with changes in the patient's condition.|
|(c)||The hospital shall provide education to patients, and their family members or interested persons as necessary or as requested by the patient, to prepare them for the patient's post-hospital care.|
|(d)||The hospital shall arrange for the initial implementation of any discharge plan, including, as applicable, any transfer or referral of the patient to appropriate facilities, agencies, or outpatient services for follow-up or ancillary care. The hospital shall be responsible for the transfer of any necessary medical information to other facilities for the purpose of post-hospital care.|
|(e)||The hospital shall regularly reassess the discharge planning process to ensure that it is responsive to patients' discharge needs.|
|(f)|| The hospital shall adopt and enforce a
policy requiring annually during influenza season (inclusive of at least
October 1st through March 1st) and prior to discharge, any inpatient 65 years
of age or older shall be offered vaccinations for the influenza virus and
pneumococcal disease unless contraindicated and contingent on availability.
The hospital shall have an organized nursing service that provides twenty-four (24) hour nursing care to meet the needs of patients. Critical access hospitals are exempted from providing on-site twenty-four (24) hour nursing care when there are no hospitalized patients.
|(a)||Organization of Nursing Services.
The hospital's nursing services shall be directed by a licensed
registered nurse who shall be responsible for implementing a system for
supervision and evaluation of nursing clinical activities.
Nursing Services. Nursing services must be delivered in accordance with
patients' needs and generally accepted standards of practice.
The hospital shall provide or have access to effective pharmaceutical services to meet the needs of its patients in accordance with generally accepted standards of practice and applicable laws and regulations.
Director. All pharmaceutical services in the hospital shall be under the
direction of a pharmacist licensed in Georgia. The responsibilities of the
director of pharmaceutical services shall include:
|(b)||Management of Drugs. The pharmacist shall be responsible for the
management of drugs within the hospital.
The hospital shall have an organized food and dietary service that is directed and staffed by an adequate number of qualified personnel to meet the nutritional needs of hospital patients. All hospital food service areas and operations shall comply with current federal and state laws and rules concerning food service.
|(a)||Organization of Food and Dietary Services.
|(b)||Physical Environment Requirements for Food Service Areas. The hospital shall provide adequate space, equipment, and supplies for efficient, safe, and sanitary receiving, storage, refrigeration, preparation, and service of food. The physical environments for food service activities must meet the requirements of state regulations for food service.|
|(c)||Delivery of Dietary Services.
Dietary services shall be delivered in accordance with the nutritional
needs of the hospital's patients.
|(1)||Imaging Services. The
hospital shall maintain or arrange for effective imaging services to meet the
needs of patients. The radiological imaging services shall be provided by the
hospital in accordance with the rules under Chapter 290-5-22 Rules and
Regulations for X-rays, where applicable.
|(2)||Reports of Imaging
Interpretations. Interpretation of imaging test results or procedures
shall be made only by those medical staff designated as qualified to interpret
those tests or procedures. Interpretations must be signed and dated by the
medical staff providing the interpretation.
Services. Radiation oncology services, if provided, must be directed by
a physician with training and experience in therapeutic radiology. The service
must have a medical oncologist and hematologist available for consultation.
The hospital shall maintain or arrange for clinical laboratory services to meet the needs of hospital patients.
|(a)||Organization and Staffing for
Clinical Laboratory Services. The administration, performance, and
operation of all laboratories used by the hospital, as well as any laboratory
functions performed by the hospital, shall conform to the Rules and Regulations
for Licensure of Clinical Laboratories, Chapter 111-8-10.
|(b)||The hospital shall have emergency laboratory services available at all times.|
|(c)||The hospital shall provide for medical staff a written description of all laboratory services available.|
|(d)||Reports of laboratory procedures and results shall be included in the patient's medical record.|
|(e)||The hospital shall have an effective procedure for notifying in a timely manner the patient's physician and responsible nursing staff of critical values from laboratory tests.|
|(f)||The hospital shall require that the laboratory report any epidemiologically significant pathogens to the hospital's infection control program.|
|(g)||Tissue Pathology. Hospitals which provide surgery services shall
have or arrange for tissue pathology services through a licensed or certified
clinical laboratory which has a system for:
The hospital shall provide or arrange for effective services to meet the respiratory/ pulmonary needs of patients and shall define in writing the scope and complexity of the respiratory/pulmonary services offered by the facility.
|(a)||Organization and Staffing of Respiratory/Pulmonary Services.
Respiratory/Pulmonary Services. Respiratory/ Pulmonary services shall be
delivered in accordance with the needs of the patients.
The hospital shall participate, as appropriate, in the procurement of anatomical gifts.
|(a)||Receipt of Donations. The hospital shall receive donations of organs or tissues for the purposes of medical and dental education, research, advancement of medical or dental science, therapy, or transplantation only in accordance with the provisions of the "Georgia Anatomical Gift Act," O.C.G.A. Section 44-5-140, and the applicable rules of Chapter 111-8-5.|
|(b)||Voluntary Expression of Intent to Donate. The hospital shall establish and implement policies and procedures for documenting requests by patients regarding their intentions for disposition of their bodies or organs and for seeing that these expressed intentions are honored upon death when possible.|
Requests for Anatomical Gifts. The hospital shall establish and
implement policies and procedures for requesting anatomical gifts on or before
the occurrence of death in the absence of a patient's expressed intentions.
|(d)||Physicians Participating in the Removing or Transplanting of Organs or Tissues. Where the medical staff participates in organ recovery, the hospital shall designate which medical staff members may not participate in the procedures for removing and transplanting of organs and body parts in accordance with the Rules for Anatomical Gifts, Chapter 111-8-5-.08.|
If the hospital provides surgical services, the services shall be provided in a manner which protects the health and safety of the patients and follows current accepted standards of medical and surgical practice. Personnel, equipment, policies and procedures, and the number of operating rooms shall be appropriate for the scope of services offered.
|(a)||Organization of Surgical Services.
The hospital shall have an organizational plan which defines lines of
authority, responsibility, and accountability within all operating room areas
where surgical procedures are performed.
|(b)||Infection Control in the
Surgical Suite. The hospital shall develop and implement infection
control procedures specific to the surgical services areas, which include at
least requirements for:
|(c)||Minimum Equipment for
the Surgical Suite. The following emergency equipment shall be available
and functional for the operating room(s) and for the post-anesthesia area, as
|(d)||Post-Anesthesia Care Unit.
Any hospital offering surgical or obstetrical services shall have an organized anesthesia service which shall be responsible for all anesthesia delivered at the hospital. The anesthesia services will be provided in a manner which protects the health and safety of patients in accordance with generally accepted standards of practice.
|(a)||Organization of Anesthesia
|(b)||Anesthesia Service Delivery.
Safety Precautions. Safety precautions related to the administration of
anesthesia shall be clearly identified in written policies and procedures which
are enforced and shall include at a minimum:
|(d)||Conscious sedation. The hospital shall develop and implement, with
the assistance of the anesthesia services director, policies and procedures for
the administration of conscious sedation, which shall be applicable
hospital-wide. These policies and procedures shall be approved by appropriate
members of the medical staff and shall include at least the following:
If the hospital provides nuclear medicine services, those services shall be organized and effective. The nuclear medicine services shall be provided in a manner consistent with applicable state laws and regulations and generally accepted standards of practice.
|(a)||Radioactive materials used in the provision of nuclear medicine services shall be prepared by personnel authorized as defined by state law to prepare radiopharmaceuticals and shall be labeled, used, transported, stored, and disposed of in a manner consistent with the "Georgia Radiation Control Act," O.C.G.A. Chapter 31-13 et seq., and applicable rules.|
|(b)||If a clinical laboratory is utilized in the provision of nuclear medicine services, the laboratory shall be licensed to perform these services as required by the Rules and Regulations for Clinical Laboratories, Chapter 111-8-10.|
|(c)||Nuclear medicine services shall be directed by a doctor of medicine or osteopathy who is a member of the medical staff qualified to perform and supervise those services. The director shall be responsible for the administration of nuclear medical services, including the evaluation of the effectiveness of the services in coordination with the hospital's quality management program.|
|(d)||Nuclear medicine procedures shall be administered and/or supervised by licensed doctors of medicine or osteopathy as authorized by state law.|
The hospital shall provide, within its capabilities, services to persons in need of emergency care.
|(a)||Full-time Emergency Services.
If the hospital offers emergency care as an organized service and/or
holds itself out to the public as offering emergency services, the service
shall be included in the scope of services submitted with the application for
the hospital permit and shall be offered twenty-four (24) hours per day.
|(b)||Hospitals Without Organized Emergency Services. Hospitals not providing an organized emergency service shall have current policies and procedures and sufficient qualified staff to provide for the appraisal and initial treatment of any patients or persons presenting with an emergency medical or psychiatric condition, within the capabilities of the hospital, and for referral of the patient for further treatment when appropriate.|
Outpatient services offered by the hospital, including but not limited to ambulatory care services and off-campus clinics, shall be integrated with other hospital services and systems and shall be provided in accordance with applicable rules in this Chapter for the specific service.
|(b)||Outpatient Service Delivery.
The hospital shall define the scope of rehabilitation services provided to patients. The hospital may offer limited or comprehensive rehabilitation services including such services as physical therapy, occupational therapy, audiology, speech-language pathology, or other services.
|(a)||Organization of Limited Rehabilitation Services. Where a hospital chooses to offer limited rehabilitation services, which are typically single or stand-alone therapy discipline(s), the rehabilitation service(s) shall be coordinated by an appropriately qualified individual assigned responsibility for the clinical aspects of organization and delivery of the rehabilitation service(s) provided by the hospital. The coordinator shall be responsible for monitoring the quality and appropriateness of rehabilitation services and for ensuring that identified problems are addressed through the quality management program.|
|(b)||Organization of Comprehensive Rehabilitation Services. Where a hospital chooses to offer a comprehensive rehabilitation service program which provides integrated and coordinated multidisciplinary therapy services as an organized inpatient service, the director must be a qualified member of the medical staff with appropriate training and experience.|
|(c)||Professional and paraprofessional staff providing patient care shall meet licensing or registration requirements consistent with state law.|
|(d)||Rehabilitation services shall be provided in accordance with orders from the licensed practitioner responsible for the patient's care. Orders for services shall be entered in the patient's medical record with the date of the order and shall be signed by the person giving the order. If rehabilitation services are provided by the hospital on an outpatient basis, the hospital shall specify how orders from outside sources will be managed.|
|(e)||Following assessment, treatment services shall be provided according to a written treatment plan, which specifies the goals of treatment and the frequency and expected duration of services.|
|(f)||There shall be a functional system for recording in the patient's medical record the patient's response to treatment and for communicating information regarding the patient's response or progress to the ordering licensed practitioner.|
|(1)|| No later than 90 days after the effective
date of these rules, if the hospital offers an organized service for the
provision of care for expectant mothers and newborns, it shall clearly define
the level of services provided according to the levels described in these rules
(basic, intermediate, or intensive) and comply with the rules set forth in this
|(2)||The hospital shall have sufficient staff, space, facilities, equipment, and supplies to support the range of maternal and infant services offered, according to generally accepted standards of practice.|
and Newborn Services. All hospitals offering maternal and newborn
services shall offer at least a basic level of those services. The basic level
of maternal and newborn services shall provide comprehensive care for women
with low-risk pregnancies, anticipated uncomplicated deliveries, and apparently
normal developing fetuses with estimated gestation of thirty-six (36) weeks or
greater and for newborns with anticipated birth weights of 2500 grams or
greater. The maternal and newborn services of these hospitals shall meet the
following minimum requirements:
|(4)||Intermediate Maternal and Newborn
Services. The hospital offering intermediate maternal and newborn
services shall offer comprehensive care for women with the potential or
likelihood for only certain pre-defined high-risk complications and with
anticipated delivery of a newborn at greater than thirty-two (32) weeks'
gestation and birth weight greater than 1500 grams who are anticipated to have
only such medical conditions which can be expected to resolve rapidly. The
maternal and newborn service shall meet all of the requirements for provision
of the basic services as described above in these rules, with the following
additions or exceptions:
Maternal and Newborn Services. The hospital offering an intensive level
of maternal and newborn services shall provide services for normal and
high-risk maternal, fetal, and newborn conditions. The hospital providing the
intensive level of services shall meet all requirements for basic and
intermediate maternal and newborn services, with the following additions and/or
Any hospital providing care to infants and children shall have facilities, equipment, and policies and procedures specific to the provision of services for pediatric patients.
|(a)||Hospital policies shall define the ages of patients considered to be appropriate for pediatric services and the scope of services to be provided to them.|
|(b)||Staff providing services to pediatric patients shall have experience and training in serving the pediatric population and shall have documented in-service training at least annually on age-specific care issues for the pediatric population served by the hospital.|
|(c)|| Protocols for screening and assessment of
pediatric patients shall be approved by the medical staff and shall be
individualized for the age and presenting signs and symptoms of the patient. In
addition to the screening and assessment information required for all patients,
the general screening and assessment protocol for pediatric patients shall
include at a minimum:
|(d)||The hospital shall establish and implement policies and procedures to prohibit access to pediatric patients by unauthorized persons and to prevent kidnapping or elopement of pediatric patients.|
|(e)||The hospital shall provide space and equipment to allow for visitation of family members in the patient rooms and to allow for overnight stay of a parent or guardian where the parent or guardian's presence does not interfere with the course of treatment. The pediatric patient's medical record shall clearly indicate persons who are not permitted to visit the pediatric patient.|
|(f)||Medical supplies and equipment including emergency equipment appropriate to the size and age of the pediatric patient shall be available in all areas of the hospital providing services to pediatric patients.|
|(g)||The phone number for the Poison Control Center shall be available in a conspicuous place in the pediatric service area(s).|
|(h)||Where pediatrics is provided as an organized service, there must be a qualified physician member of the medical staff with experience or training in pediatrics assigned responsibility for directing the clinical aspects of organization and delivery of all pediatric services provided by the hospital. The pediatric medical director shall be responsible for monitoring the quality and appropriateness of pediatric services in coordination with the hospital's quality management program and for ensuring that identified opportunities for improvement are addressed.|
|(i)||Hospitals providing services to pediatric patients as an organized service shall have space, facilities, and appropriately sized equipment for providing those services apart from adult patient rooms and newborn units and shall provide for regular and routine cleaning of play equipment in the pediatric area according to protocols established for that purpose by the hospital's infection control program.|
|(1)||If the hospital provides acute inpatient dialysis services or outpatient services either directly or through contract arrangements, the scope and organization of those services shall be defined.|
Administration of Renal Dialysis Services. The hospital shall have an
organizational plan for dialysis services which clearly defines lines of
authority, responsibility, and accountability and which includes provision for
adequate staffing to provide dialysis care according to generally accepted
standards of practice.
|(3)||Appropriate Treatment. The hospital shall provide dialysis services in accordance with accepted standards of care for the persons requiring dialysis services.|
|(4)||Quality Improvement. The hospital shall ensure that problems identified during the on-going monitoring of the dialysis services are addressed in the hospital quality improvement program. Contracted services must participate in the hospital quality improvement program.|
|(5)||Outpatient Chronic Dialysis Services. A hospital choosing to provide outpatient dialysis services directly as an integral part of the hospital to persons with end stage renal disease on a regularly recurring basis must meet the rules set forth in the Rules and Regulations for End Stage Renal Disease Facilities, Chapter 111-8-22, which are herein incorporated by reference, except for .03, .04, and .19.|
|(1)||If the hospital provides psychiatric and/or substance abuse treatment services as an organized service, the scope of those services, including whether the services are provided for inpatients, outpatients, or both, shall be defined in the hospital's application for permit and meet the requirements set forth in this section and generally accepted standards of care.|
|(2)||Organization and Administration of Psychiatric and Substance Abuse
Services. The hospital shall have a plan for the service which clearly
defines lines of authority, responsibility, and accountability and which
includes provision for adequate staffing to provide patient care according to
generally accepted standards of practice.
|(3)||Patient's Rights in Psychiatric and
Substance Abuse Services.
Patient Assessment and Treatment.
|(5)||Physical Space and Design Requirements for Inpatient Psychiatric and
Substance Abuse Services.
Hospitals providing inpatient psychiatric and substance abuse services shall have:
Critical access hospitals (CAHs) shall be required to comply with the entirety of this chapter, as applicable to the scope of services offered, with the following exceptions and/or additions:
|(a)||Prior to application for a hospital permit, the hospital shall be approved for critical access hospital status by the Georgia Department of Community Health.|
|(b)|| The CAH shall be a member of a rural
health network having at least one (1) additional hospital that furnishes acute
care hospital services, which will serve as an affiliate hospital for the CAH.
The CAH shall have current written agreement(s) with affiliate hospital(s)
which include provisions for:
CAH's organization, scope, and availability of patient care services shall be
defined and approved by the governing body, medical staff, and affiliate
hospital. The CAH shall have:
Rural Free Standing Emergency Departments shall be required to comply with the entirety of this chapter, as applicable to the scope of services offered by the Rural Free Standing Emergency Department, with the following exceptions and/or additions:
|(a)||The Rural Free Standing Emergency Department shall make all reasonable efforts to secure written agreement(s) with hospital(s) within 35 miles which include provisions for patient referral and transfer between the facilities, with the use of emergency and non-emergency transportation.|
|(b)||The Rural Free Standing Emergency Department's organization, scope, and availability of patient care services shall be defined and approved by the governing body.|
|(c)||The Rural Free Standing Emergency Department shall have operational policies developed with participation from one (1) or more licensed physicians. The operational policies must describe the patient care services the Rural Free Standing Emergency Department will provide directly and those that will be provided through contract or other arrangement.|
|(d)||A Rural Freestanding Emergency Department that is not otherwise subject to the federal Emergency Medical Treatment & Labor Act, 42 U.S.C. 1395 dd shall provide to each patient, without regard to the individual's ability to pay, an appropriate medical screening examination to determine whether an emergency medical condition exists, and if so, shall provide stabilizing treatment within its capability. If the Rural Freestanding Emergency Department is unable to stabilize the patient within its capability, or if the patient requests, it shall implement a transfer of the patient to another facility that has the capability of stabilizing the patient.|
|(1)||General. The hospital shall
be designed and constructed in accordance with the needs of the patients being
|(2)||Special Requirements for Mobile, Transportable, and Relocatable Units.
If the hospital utilizes, by ownership or contract, mobile, relocatable,
or transportable units for the provision of hospital services, the units shall
meet the following requirements:
|(3)||Emergency Lighting and Power. The hospital shall have access to
emergency lighting and electrical power meeting the following requirements:
A hospital may request a waiver or variance of a specific rule by application on forms provided by the Department. A waiver or variance may be granted in accordance with the following considerations:
|(a)|| The Department may grant or deny the
request for waiver or variance at its discretion. If the waiver or variance is
granted, the Department may establish conditions which must be met by the
hospital in order to operate under the waiver or variance. Waivers or variances
may be granted with consideration of the following:
|(b)||Waivers and variances granted by the Department shall be for a time certain, as determined by the Department; and|
|(c)||Waivers and variances granted to a facility shall be recorded and shall be available to interested parties upon request.|
A hospital that fails to comply with these rules and regulations shall be subject to sanctions and/or permit revocation as provided by law. The enforcement and administration of these rules and regulations shall be as prescribed in the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25, pursuant to O.C.G.A. § 31-2-8.
In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof. The remaining rules or portions of rules shall remain in full force and effect, as if such rule or portions thereof so determined, declared or adjudged invalid or unconstitutional were not originally a part of these rules.