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) |
is currently licensed by the Department
as a hospital or was previously licensed by the Department as a hospital and
such license expired within the previous 12 months; |
| (ii) |
is located in a rural county as defined
by O.C.G.A. § 31-6-2(32); |
| (iii) |
is located no more than 35 miles from a
licensed general hospital; |
| (iv) |
is
open 7 days a week, 24 hours a day; |
| (v) |
provides non-elective emergency treatment
and procedures for periods continuing less than 24 hours; |
| (vi) |
may provide elective, out-patient
surgical treatment and procedures for periods continuing less than 24
hours; |
| (vii) |
may provide basic
obstetrics and gynecology treatment and procedures for periods continuing less
than 24 hours; and |
| (viii) |
is
classified by the department, as provided for in this chapter, as a Rural Free
Standing Emergency Department.
Rural Free Standing Emergency Departments may provide
elective endoscopy or other elective treatment and procedures which are not
performed in an operating room environment.
|
|
| (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.
| 1. |
Services offered in
separate buildings or on separate premises, which do not by themselves meet the
definition of a hospital, including, but not limited to, satellite urgent care
centers, outpatient or mammography clinics, or hospital-owned physicians'
offices, shall be considered organized services of the hospital for the
purposes of these rules. |
| 2. |
Only
those services operated by the hospital under the permit as approved by the
Department shall be presented to the public as a service of the
hospital. |
|
| (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
Need.
| 1. |
The classification shall be one of
the following:
| (i) |
Classification as a general
hospital means a facility meets the definition of a hospital and provides
continuous care for a variety of patients who have a variety of medical
conditions. A critical access hospital shall fall under the general hospital
classification; |
| (ii) |
Classification
as a specialized hospital means a facility that meets the definition of a
hospital and provides care to a specialized or specified group of patients
and/or patients who have specified conditions. The type of specialization shall
be designated on the hospital permit; or |
| (iii) |
Classification as a Rural Free Standing
Emergency Department. |
|
| 2. |
If changes occur in the organized services offered by the hospital, including
the addition of any services requiring CON review or off-campus service
locations, the hospital's administrator or governing body shall submit to the
Department a new description of services at least thirty (30) days prior to the
change. Change in the classification of the hospital shall require application
for a new permit. |
|
| (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
closure.
| 1. |
Prior to hospital closure, the
hospital shall inform the Department of the planned storage location for
patients' medical records, medical staff information, and other critical
information after closure. The hospital shall publish in a widely circulated
newspaper(s) in the hospital's service area a notice indicating where medical
records and other critical information can be retrieved and shall notify the
Department of Transportation of the anticipated date of closure for removal of
the hospital locator signs. Following closure, the Department shall be notified
of any change in location of the patients' medical records, medical staff
information, and other critical information from the published
location. |
| 2. |
When the hospital
ceases to operate, the permit shall be returned to the Department within ten
(10) days of closure. The permit shall be considered revoked, unless placed on
inactive status as described in these rules. |
| 3. |
If the hospital is closing for a period of
less than twelve (12) months, and plans to reopen under the same ownership,
name, classification, and bed capacity, the hospital may request to have the
permit placed on temporary inactive status.
| (i) |
When placed on temporary inactive status,
the permit shall be returned to the Department within ten (10) days of closure
and the hospital shall not operate until the permit has been reactivated. The
hospital shall notify the Department of Transportation of the intended
closure. |
| (ii) |
The hospital shall
request in writing that the permit be reactivated at least thirty (30) days
prior to the desired date of reopening. Prior to reactivation of the permit,
the hospital may be subject to inspection by the Department. If the permit is
not reactivated within twelve (12) months, the permit shall be considered
revoked. |
|
|
| (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.
| (a) |
Application for
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:
| 1. |
A listing of the services
provided: |
| 2. |
Proof of hospital
ownership. In the case of corporations, partnerships, and other entities
authorized by law, the applicant shall provide a copy of its certificate of
incorporation, or other acceptable proof of its legal existence together with
the names and addresses of all persons owning five (5) percent or
more; |
| 3. |
A list of the locations of
any services offered by the hospital on separate premises; and |
| 4. |
A copy of the Certificate of Need (CON)
from the Department. |
|
| (b) |
Application Due to a Change in Name, Location, or Bed Capacity of a
Hospital. 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:
| 1. |
A listing of the service(s) to be
provided; and |
| 2. |
A copy of the
required Certificate of Need (CON) from the Department, if
applicable. |
|
| (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:
| 1. |
The hospital has failed to demonstrate
compliance with these rules and regulations; |
| 2. |
The applicant or alter ego of the
applicant has had a permit denied, revoked, or suspended within one (1) year of
the date of a new application; |
| 3. |
The applicant has transferred ownership or governing authority of a hospital
within one (1) year of the date of the new application when such transfer was
made in order to avert denial, suspension, or revocation of a permit;
or |
| 4. |
The applicant has knowingly
made any verbal or written false statement(s) of material fact in connection
with the application for the permit or on documents submitted to the Department
as part of any inspection or investigation or in the falsification or
alteration of facility records made or maintained by the hospital. |
|
| (b) |
Sanction of a Permit.
| 1. |
The Department may take an action
to sanction the hospital permit holder, subject to notice and opportunity for a
hearing, where the Department finds that the hospital has:
| (i) |
Knowingly made any verbal or written
false statement of material fact either in connection with the application for
the permit or on documents submitted to the Department as part of any
inspection or investigation or in the falsification or alteration of hospital
records made or maintained by the hospital; |
| (ii) |
Failed or refused, without legal cause,
to provide the Department with access to the premises subject to regulation or
information pertinent to the initial and continued licensing of the
hospital; |
| (iii) |
Failed to comply
with the licensing requirements of this state; or |
| (iv) |
Failed to comply with the provisions of
O.C.G.A. § 31-2-8 or Rules for General
Licensing and Enforcement Requirements, Chapter 111-8-25. |
|
| 2. |
Such sanctions may include any one or more
of the following:
| (i) |
Administration of a
public reprimand; |
| (ii) |
Suspension
of the permit; |
| (iii) |
Prohibition of
persons in management or control; |
| (iv) |
Imposition of civil penalties as
provided by law; and |
| (v) |
Revocation
of the 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.
| (a) |
Initial Inspection. There
shall be an initial inspection of a hospital prior to the opening date in order
to determine that the hospital is in substantial compliance with these rules.
Prior to this initial inspection, the hospital shall submit to the Department:
| 1. |
A copy of the certificate of
occupancy; |
| 2. |
Verification of
building safety and fire safety from local and state authorities; and |
| 3. |
Evidence of appropriate approvals by the
state architect. |
|
| (b) |
Periodic Inspections. The hospital shall be subject to periodic
inspections to determine that there is continued compliance with these rules,
as deemed necessary by the Department. |
| (c) |
Random Inspections. The
hospital may be subject to additional or more frequent inspections by the
Department where the Department receives a complaint alleging a ruleviolation
by the hospital or the Department has reason to believe that the hospital is in
violation of these rules. |
| (d) |
Plans of Correction. If violations of these licensing rules are
identified, the hospital will be given a written report of the violation that
identifies the rules violated. The hospital shall submit to the Department a
written plan of correction in response to the report of violation, which states
what the hospital will do, and when, to correct each of the violations
identified. The hospital may offer an explanation or dispute the findings or
violations in the written plan of correction, so long as an acceptable plan of
correction is submitted within ten (10) days of the hospital's receipt of the
written report of inspection. If the initial plan of correction is unacceptable
to the department, the hospital will be provided with at least one (1)
opportunity to revise the unacceptable plan of correction. The hospital shall
comply with its plan of correction. |
| (e) |
Accreditation in Place of Periodic
Inspection. The Department may accept the accreditation of a hospital by
the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO),
the American Osteopathy Association (AOA), or other approved accrediting body,
in accordance with specific standards determined by the Department to be
substantially equivalent to state standards, as representation that the
hospital is or remains in compliance with these rules.
| 1. |
Hospitals accredited by an approved
accrediting body shall present to the Department a copy of the full
certification or accreditation report each time there is an inspection by the
accreditation body and a copy of any reports related to the hospital's
accreditation status within thirty (30) days of receipt of the final report of
the inspection. |
| 2. |
Hospitals
accredited by an approved accrediting body are excused from periodic
inspections. However, these hospitals may be subjected to random inspections by
the Department for continuation of the permit when:
| (i) |
A validation study of the accreditation
process is necessary; |
| (ii) |
There
has been a complaint alleging a rule violation which the Department determines
requires investigation; |
| (iii) |
The
Department has reason to believe that there is a patient incident or situation
in the hospital that presents a possible threat to the health or safety of
patients; or |
| (iv) |
There are
additions to the services previously offered by the hospital which the
Department determines requires an on-site visit. |
|
|
|
| (2) |
Required
Reports to the Department.
| (a) |
Patient Incidents Requiring Report.
| 1. |
The hospital's duly constituted peer
review committee(s) shall report to the Department, as required below, whenever
any of the following incidents involving hospital patients occursor the
hospital has reasonable cause to believe that a reportable incident involving a
hospital patient has occurred:
| (i) |
Any
unanticipated patient death not related to the natural course of the patient's
illness or underlying condition; |
| (ii) |
Any rape which occurs in a
hospital; |
| (iii) |
Any surgery on the
wrong patient or the wrong body part of the patient; and |
| (iv) |
Effective three (3) months after the
Department provides written notification to all hospitals the hospital's duly
constituted peer review committee(s) shall also report to the Department,
whenever any of the following incidents involving hospital patients occurs or
the hospital has reasonable cause to believe that a reportable incident
involving a hospital patient has occurred:
| (I) |
Any patient injury which is unrelated to the patient's illness or underlying
condition and results in a permanent loss of limb or function; |
| (II) |
Second or third degree burns involving
twenty (20) percent or more of the body surface of an adult patientor fifteen
(15) percent or more of the body surface of a child which burns were acquired
by the patient in the hospital; |
| (III) |
Serious injury to a patient resulting
from the malfunction or intentional or accidental misuse of patient care
equipment; |
| (IV) |
Discharge of an
infant to the wrong family; |
| (V) |
Any
time an inpatient, or a patient under observation status, cannot be located,
where there are circumstances that place the health, safety, or welfare of the
patient or others at risk and the patient has been missing for more than eight
(8) hours;and |
| (VI) |
Any assault on a
patient, which results in an injury that requires treatment. |
|
|
| 2. |
The hospital's peer
review committee(s) shall make the self-report of the incident within
twenty-four (24) hours or by the next regular business day from when the
hospital has reasonable cause to believe an incident has occurred.
Theself-report shall be received by the Department in confidence and shall
include at least:
| (i) |
The name of the
hospital; |
| (ii) |
The date of the
incident and the date the hospital became aware that a reportable incident may
have occurred; |
| (iii) |
The medical
record number of any affected patient(s); |
| (iv) |
The type of reportable incident
suspected, with a brief description of the incident; and |
| (v) |
Any immediate corrective or preventative
action taken by the hospital to ensure against the replication of the incident
prior to the completion of the hospital's investigation. |
|
| 3. |
The hospital's peer review committee(s)
shall conduct an investigation of any of the incidents listed above and
complete and retain on site a written report of the results of the
investigation within forty-five (45) days of the discovery of the incident. The
complete report of the investigation shall be available to the Department for
inspection at the facility and shall contain at least:
| (i) |
An explanation of the circumstances
surrounding the incident, including the results of a root cause analysisor
other systematic analysis; |
| (ii) |
Any
findings or conclusions associated with the review; and |
| (iii) |
A summary of any actions taken to
correct identified problems associated with the incident and to prevent
recurrence of the incident and also any changes in procedures or practices
resulting from the internal evaluation using the hospital's peer review and
quality management processes. |
|
| 4. |
The Department shall hold the self-report
made through the hospital's peer review committee(s) concerning a reportable
patient incident in confidence as a peer review document or report and not
release the self-report to the public. However, where the Department determines
that a rule violation related to the reported patient incident has occurred,
the Department will initiate a separate complaint investigation of the
incident. The Department's complaint investigation and the Department's report
of any rule violation(s) arising either from the initial self-report received
from the hospital or an independent source shall be public records. |
|
| (b) |
Other Events/Incidents
Requiring Report.
| 1. |
The hospital shall
report to the Department whenever any of the following events involving
hospital operations occurs or when the hospital becomes aware it is likely to
occur, to the extent that the event is expected to cause or causes a
significant disruption of patient care:
| (i) |
A
labor strike, walk-out, or sick-out; |
| (ii) |
An external disaster or other community
emergency situation; and |
| (iii) |
Aninterruption of services vital to the continued safe operation of the
facility, such as telephone, electricity, gas, or water services. |
|
| 2. |
The hospital shall make a
report of the event within twenty-four (24) hours or by the next regular
business day from when the reportable event occurred or from when the hospital
has reasonable cause to anticipate that the event is likely to occur. The
report shall include:
| (i) |
The name of the
hospital; |
| (ii) |
The date of the
event, or the anticipated date of the event, and the anticipated duration, if
known; |
| (iii) |
The anticipated effect
on patient care services, including any need for relocation of patients;
and |
| (iv) |
Any immediate plans the
hospital had made regarding patient management during the event. |
|
| 3. |
Within forty-five (45) days
following the discovery of the event, the hospital shall complete an internal
evaluation of the hospital's response to the event where opportunities for
improvement relating to the emergency disaster preparedness plan were
identified. The hospital shall make changes in the emergency disaster
preparedness plan as appropriate. The complete report of the evaluation shall
be available to the Department for inspection at the facility. |
|
|
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:
| 1. |
That every inpatient
is under the care of a qualified member of the medical staff; |
| 2. |
That the medical staff is organized and
operates under medical staff bylaws and medical staff rules and regulations,
which shall become effective when approved by the governing body; and |
| 3. |
That the medical staff is responsible to
the governing body for the quality of all medical care provided to patients in
the hospital and for the ethical and professional practices of its members
while exercising their hospital privileges. |
|
| (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:
| 1. |
Ensure that there are effective mechanisms
in the hospital's organization to facilitate communication between the
governing body, the medical staff, the nursing staff, and other departments of
the hospital; |
| 2. |
Ensure that
patients receive the same quality of care throughout the hospital;
and |
| 3. |
Be responsible for reporting
to the appropriate licensing board any member of the medical staff whose
privileges at the hospital have been denied, restricted, or revoked, or who has
resigned from practice at the hospital, to the extent required by state
law. |
|
| (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.
| 1. |
Any physician, podiatrist, or dentist
providing patient care, whether directly or by contract with the hospital,
shall obtain clinical privileges through the hospital's medical staff
credentialing process. |
| 2. |
The
medical staff shall be responsible for the examination of credentials of any
candidate for medical staff membership and for any other individuals seeking
clinical privileges and for the recommendations to the governing body
concerning appointment of such candidates. Minimum requirements for medical
staff appointments and clinical privileges shall include:
| (i) |
Valid and current Georgia license to
practice the respective profession; |
| (ii) |
Confirmed educational qualifications for
the position of appointment; |
| (iii) |
References for practice and performance background; |
| (iv) |
Current health and mental status
sufficient to perform medical and professional duties; |
| (v) |
Current Drug Enforcement Agency
registration; if applicable; |
| (vi) |
Evidence of inquiry through relevant practitioner databases, such as databases
maintained by licensing boards and the National Practitioner Data Bank;
and |
| (vii) |
Congruity of the
qualifications and/or training requirements with the privilege
requested. |
|
| 3. |
The
medical staff shall evaluate at least biennially the credentials and
professional performance of any individual granted clinical privileges for
consideration for reappointment. |
| 4. |
The medical staff shall establish a system for the approval of temporary or
emergency staff privileges when needed. |
|
| (b) |
Medical Staff Accountability.
The medical staff shall be accountable to the governing body for the
quality of medical care provided to all patients.
| 1. |
The medical staff shall require that all
individuals granted clinical privileges comply with generally accepted
standards of practice. |
| 2. |
The
medical staff shall implement measures, including peer review, to monitor the
on-going performance of the delivery of patient care by those granted clinical
privileges, including monitoring of compliance with the medical staff bylaws,
rules and regulations, and hospital policies and procedures. |
| 3. |
The medical staff shall establish
effective systems of accountability for any hospital services ordered by
physicians and other practitioners. |
| 4. |
The medical staff shall review and, when
appropriate, recommend to the governing body denial, limitation, suspension, or
revocation of the privileges of any practitioner who does not practice in
compliance with the scope of privileges, the medical staff bylaws, rules and
regulations, generally accepted standards of practice, or hospital policies and
procedures. |
|
| (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:
| 1. |
A mechanism for participation of medical
staff in policy decisions related to patient care in all areas of the
hospital; |
| 2. |
A plan for
administrative organization of the medical staff and committees thereof, which
clearly delineates lines of authority, delegation, and responsibility for
various tasks and functions; |
| 3. |
Description of the qualifications and performance to be met by a candidate in
order for the medical staff to recommend appointment or reappointment by the
governing body; |
| 4. |
Criteria and
procedures for recommending the privileges to be granted to individual
physicians, dentists, or podiatrists; |
| 5. |
A requirement that members of the medical
staff comply with ethical and professional standards; |
| 6. |
Requirements for regular health screenings
for all active members of the medical staff that are developed in consultation
with hospital administration, occupational health, and infection control/
safety staff. The health screenings shall be sufficient to identify conditions
which may place patients or other personnel at risk for infection, injury, or
improper care. There shall be a mechanism for the reporting of the screening
results to the hospital, either through the medical staff or
otherwise; |
| 7. |
A mechanism for
ensuring physician response to inpatient emergencies twenty-four (24) hours per
day; |
| 8. |
A mechanism for physician
coverage of the emergency department and designation of who is qualified to
conduct an emergency medical screening examination where emergency services are
provided; |
| 9. |
A requirement that
referral for consultations will be provided to patients when a patient's
physical or mental condition exceeds the clinical expertise of the attending
member of the medical staff; |
| 10. |
The requirements for the patient's history and physical examination, which must
be performed either within twenty-four (24) hours after admission or within the
thirty (30) days prior to admission and updated upon admission. See Rule
for history and physical requirements when surgery is being
performed; |
| 11. |
Establishment of
procedures for the choice and control of all drugs in the hospital; |
| 12. |
The requirements for the completion of
medical records; |
| 13. |
The
requirements for verbal/telephone orders, to include which Georgia-licensed or
Georgia-certified personnel or other qualified individuals may receive
verbal/telephone orders, and the acceptable timeline for authentication of the
orders, not to exceed the timeline requirements of these rules; |
| 14. |
A mechanism for peer review of the
quality of patient care, which includes, but is not limited to, the
investigation of reportable patient incidents involving patient care as
described in Rule
;
and |
| 15. |
A procedure for review
and/or update of the bylaws and rules and regulations as necessary, but at
least once every three (3) years. |
|
| (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:
| 1. |
Criteria for when an autopsy
shall be sought and a requirement that the attending physician be notified when
an autopsy is performed; and |
| 2. |
A
requirement that every member of the medical staff provide appropriate medical
care for each of their patients until the patient is stable for discharge or
until care of the patient has been transferred to another member of the medical
staff or to another facility. |
|
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:
| 1. |
Procedures for selecting qualified
personnel; |
| 2. |
A system for
documenting the current licensure and/or certification status for those
personnel whose positions or functions require such licensure or
certification; |
| 3. |
A system for
assessing competency of all personnel providing health care services, on a time
schedule defined by hospital policy; and |
| 4. |
Policies and procedures regarding the
hospital-approved method for identification of personnel to patients, other
staff, and visitors. |
|
| (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:
| 1. |
Hospital policies and
procedures; |
| 2. |
Fire safety,
hazardous materials handling and disposal, and disaster preparedness; |
| 3. |
Policies and procedures for maintaining
patients' medical records; |
| 4. |
The
infection control program and procedures; and |
| 5. |
The updating of job-specific skills or
knowledge. |
|
| (e) |
Personnel
records shall be maintained for each employee of the hospital and shall
contain, at a minimum:
| 1. |
The employment
application or resume; |
| 2. |
Dates of
hire and position changes since hiring; |
| 3. |
The job or position description(s) for the
employee; |
| 4. |
All evaluations of
performance or competencies for the employee since the date of hire or at least
the last five (5) years; |
| 5. |
Credible evidence of current registration, licensure, or certification as
required for that position by state law; |
| 6. |
Evidence of completion of in-service
training as required by hospital policy; and |
| 7. |
Evidence of completion of any requirements
of the occupational health program at the hospital. |
|
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. |
| (b) |
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:
| 1. |
Operative procedures
and other invasive and non-invasive procedures that place patients at
risk; |
| 2. |
Nosocomial infection
rates; |
| 5. |
Patient injuries, such as,
but not limited to, those related to falls and restraint use; |
| 6. |
Errors in procedures or practices which
could compromise patient safety ("near-miss" events); |
| 7. |
Discrepancies or patterns of discrepancies
between preoperative and postoperative diagnosis, including those identified
during the pathologic review of specimens removed during surgical or invasive
procedures; |
| 8. |
Significant adverse
drug reactions (as identified by the hospital); |
| 9. |
Adverse events or patterns of adverse
events during anesthesia; |
| 10. |
Equipment malfunctions, for equipment used for patient care; and |
| 11. |
Reportable patient incidents as required
under Rule
. |
|
| (c) |
The quality management program shall
utilize a defined methodology for implementation, including at least mechanisms
and methodology for:
| 1. |
Performance
measurement including consideration of scope of services; |
| 2. |
Monitoring, evaluating, and assessing
accountability; |
| 4. |
Root cause analyses,
as appropriate, of problems identified; |
| 6. |
Identification of expected
outcomes; |
| 7. |
Reporting mechanisms;
and |
| 8. |
Authority for problem
resolution. |
|
| (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:
| 1. |
A fire safety
program including compliance with the applicable provisions of the Life
Safety Code (NFPA 101), as enforced by the state fire
marshal; |
| 2. |
An incident monitoring
system that promptly identifies, investigates, and takes effective action
regarding all incidents that involve injury to patients, employees, or visitors
or that involve significant damage to property; |
| 3. |
A program to inspect, monitor, and
maintain biomedical equipment, electrical equipment, and emergency power
generators; |
| 4. |
A program for the
monitoring and maintenance of electrical safety; |
| 5. |
Security procedures for controlling access
to sensitive areas, as defined by the hospital, for patients, employees, and
visitors; |
| 6. |
Procedures for the
safe management of medical gases; |
| 7. |
A system for patients or staff to summon
assistance, when needed, from patient rooms, bathrooms, and treatment
areas; |
| 8. |
Policies regarding
smoking which apply to employees, patients, and visitors; and |
| 9. |
Procedures for storage and disposal of
biohazardous medical waste in accordance with applicable laws. |
|
| (b) |
Cleanliness and
Sanitation. The hospital shall maintain an environment that is clean and
in good repair, through a program that establishes and maintains:
| 1. |
Standardized daily, interim, and terminal
cleaning routines for all areas; |
| 2. |
Facilities for convenient and effective hand washing throughout the
hospital; |
| 3. |
Systems for management
of linens, including collection, sorting, transport, and washing of soiled
linens, and storage and distribution of clean linens;
| (i) |
Collection and sorting procedures shall
be designed to prevent contamination of the environment and personnel.
Collection procedures shall include bagging of soiled linen at site of use.
Sorting and rinsing of soiled linens shall not take place in patient care
areas; |
| (ii) |
Clean and soiled linens
shall be transported in separate containers or carts; |
| (iii) |
The laundering process for soiled
linens shall be sufficient to remove organic soil and render the linen
incapable of causing human illness; and |
| (iv) |
Any soiled linen processing area shall
be separate from the area used for clean linen storage, from patient care
areas, and from areas where clean or sterilized supplies and equipment are
stored; |
|
| 4. |
Standards
regarding the use of hospital disinfectants; |
| 5. |
Systems for the storage and disposal of
garbage, trash, and waste in a manner that will not permit the transmission of
disease, create a nuisance, or provide a breeding place for insects or rodents;
and |
| 6. |
Procedures for the
prevention of infestation by insects, rodents, or other vermin or
vectors. |
|
| (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:
| 1. |
Local and widespread weather emergencies
or natural disasters, such as tornadoes, hurricanes, earthquakes, ice or
snowstorms, or floods; |
| 2. |
Manmade
disasters such as acts of terrorism and hazardous materials spills; |
| 3. |
Unanticipated interruption of service of
utilities, including water, gas, or electricity, either within the facility or
within a local or widespread area; |
| 4. |
Loss of heat or air
conditioning; |
| 5. |
Fire, explosion,
or other physical damage to the hospital; and |
| 6. |
Pandemics or other situations where the
community's need for services exceeds the availability of beds and services
regularly offered by the hospital. |
|
| (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:
| 1. |
The availability of
microbiology laboratory capacity to detect and investigate outbreaks; |
| 2. |
A system for obtaining appropriate
clinical specimens for culture; |
| 3. |
Access to necessary information in order to investigate infectious outbreaks;
and |
| 4. |
Administrative, physician,
and nursing support to direct hospital changes to achieve immediate control of
outbreaks and for implementation of corrective actions. |
|
| (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:
| 1. |
The approved hospital isolation system; |
| 2. |
The approved procedures for handling and
disposing of hazardous waste products; |
| 3. |
The standards for approved cleaning,
disinfection, and sterilization of all areas of the hospital; |
| 4. |
The standards for hand washing and hand
antisepsis; and |
| 5. |
A communicable
disease health-screening plan for the hospital that includes required
communicable disease activities, immunizations, exposure evaluations,
tuberculosis surveillance, and work restrictions. There shall be evidence that
the plan was developed in consultation with hospital administration, medical
staff, and safety staff. |
|
| (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:
| 2. |
A plan for on-going training on isolation
precautions, aseptic practices, and prevention of blood and body fluid
exposure; and |
| 3. |
Provision of
specially designed training programs that result from outcome and process
surveillance data. |
|
| (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:
| 1. |
Decontamination and cleaning of instruments and other items and description of
reprocessing protocols for contaminated patient equipment; |
| 2. |
Disinfecting and/or sterilizing equipment
and other items; |
| 3. |
Monitoring of
the systems used for sterilization; |
| 4. |
Procedures for ensuring the sterility of
packaged instruments and supplies; |
| 6. |
Mechanisms for protection of workers from
exposure to blood and other potentially infectious materials and environmental
hazards. |
|
| (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.
| (a) |
The medical records service shall
maintain a list of accepted abbreviations, symbols, and medical terminology to
be utilized by persons making entries into patients' medical records. |
| (b) |
The medical records service shall utilize
systems to verify the author(s) of entries in the patients' medical records.
Delegation of use of computer codes, signature stamps, or other authentication
systems, to persons other than the author of the entry, is
prohibited. |
| (c) |
The hospital shall
utilize systems defined by hospital policies and procedures to ensure that
patients' medical records are kept confidential. Medical records shall be
accessible only to hospital and medical staff involved in treating the patient
and to other individuals as permitted by federal and state laws. The
Department, in exercising its licensing authority, shall have the right to
review and copy any patients' medical records. |
| (d) |
At any time during or after their course
of treatment, patients shall be provided with copies of their medical records
upon their written requests or the written requests of their authorized
representatives in accordance with state law. Copies shall be provided within a
reasonable time period not to exceed thirty (30) days after the request, unless
the patient agrees to a lengthier delivery time. Copies of records shall be
provided to patients for a reasonable fee in accordance with applicable
laws. |
| (e) |
Copies of the patient's
medical records shall be released to persons other than the patient or the
patient's legally authorized representative either at the written request of
the patient or as otherwise allowed by law. If the individual designated to
receive a copy of the record is a health care provider, the copy of the record
shall be released by the hospital in a timely manner so as not to interfere
with the continuation of the patient's treatment. |
| (f) |
Patients' medical records shall be coded
and indexed in a manner that allows for timely retrieval by diagnosis or
procedure when necessary. |
| (g) |
The
hospital shall utilize an effective process to ensure that patients' medical
records are completed within thirty (30) days after the patients are discharged
from the hospital. Records of other parts of patients' records that are not
within the control of the hospital or its medical staff shall be added to the
patients' records as soon as they become available to the hospital. |
| (h) |
The hospital shall retain all patients'
medical records at least until the fifth anniversary of the patients'
discharges. If the patient is a minor, the records must be retained for at
least five (5) years past the age of majority. Records may be preserved in the
hospital's format of choice, including but not limited to paper or electronic
format, so long as the records are readable and capable of being reproduced in
paper format upon request. |
| (i) |
Medical records shall be secured in such a manner as to provide protection from
damage or unauthorized access. |
|
| (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.
| (a) |
The date of the entry and the signature
of the person making the entry, shall accompany all entries in the patient's
medical record. Late entries shall be labeled as late entries. |
| (b) |
The hospital, through its medical staff
policies, shall appropriately limit the use of verbal/telephone orders.
Verbal/telephone orders shall be used only in situations where immediate
written or electronic communication is not feasible and the patient's condition
is determined to warrant immediate action for the benefit of the patient.
Verbal/telephone orders shall be received by an appropriately license or
otherwise qualified individual as determined by the medical staff in accordance
with state law. |
| (c) |
The individual
receiving the verbal/telephone order shall immediately enter the order into the
medical record, sign and date the order, with the time noted, and, where
applicable, enter the dose to be administered. |
| (d) |
The individual receiving the order shall
immediately repeat the order and the prescribing physician or other authorized
practitioner shall verify that the repeated order is correct. The individual
receiving the order shall document, in the patient's medical record, that the
order was "repeated and verified." |
| (e) |
The verbal/telephone order shall be
authenticated by the physician or other authorized practitioner giving the
order, or by a physician or other authorized practitioner taking responsibility
for the order, in accordance with hospital and medical staff policies.
| 1. |
Where the procedures outlined in
subparagraph (2)(d) of this rule are followed, the hospital shall require
authentication of all verbal/telephone orders no later than thirty (30) days
after the patient's discharge. |
| 2. |
As an alternative to meeting the requirements set forth in subparagraph (2)(d)
of this rule, the hospital shall require that verbal/ telephone orders be
authenticated within forty-eight (48) hours, except where the patient is
discharged within forty-eight (48) hours of the time the verbal/telephone order
was given, in which case authentication shall occur within thirty (30) days
after the patient's discharge. |
|
| (f) |
The hospital's quality improvement plan
shall include monitoring of the appropriate use of verbal/telephone orders in
accordance with these rules and hospital policy and taking appropriate
corrective action as necessary. |
|
| (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.
| (a) |
Inpatient Records. Medical
records for inpatients shall contain at least the following:
| 1. |
A unique identifying number and a patient
identification form, which includes the following when available: name,
address, date of birth, sex, and person to be notified in an
emergency; |
| 2. |
The date and time of
the patient's admission; |
| 3. |
The
admitting diagnosis and clinical symptoms; |
| 4. |
The name of the attending
physician; |
| 5. |
Any patient
allergies; |
| 6. |
Documentation
regarding advanced directives; |
| 7. |
The report from the history and physical examination; |
| 8. |
The report of the nursing assessment
performed after admission; |
| 9. |
Laboratory, radiological, electrocardiogram, and other diagnostic assessment
data or reports as indicated; |
| 10. |
Reports from any consultations; |
| 11. |
The patient's plan of care; |
| 12. |
Physician's orders or orders from another practitioner authorized by law to
give medical or treatment orders; |
| 13. |
Progress notes from staff members
involved in the patient's care, which describe the patient's response to
medications, treatment, procedures, anesthesia, and surgeries; |
| 14. |
Data, or summary data where appropriate,
from routine or special monitoring; |
| 15. |
Medication, anesthesia, surgical, and
treatment records; |
| 16. |
Documentation that the patient has been offered the opportunity to consent to
procedures for which consent is required by law; |
| 17. |
Date and time of discharge; |
| 18. |
Description of condition, final
diagnosis, and disposition on discharge or transfer; |
| 19. |
Discharge summary with a summary of the
hospitalization and results of treatment; and |
| 20. |
If applicable, the report of autopsy
results. |
|
| (b) |
Outpatient Records. Medical reports for outpatients shall contain
at least the following:
| 1. |
A unique
identifying number and a patient identification form, which includes the
following if available: name, address, date of birth, sex, and person to be
notified in an emergency; |
| 2. |
Diagnosis of the patient's condition; |
| 3. |
The name of the physician ordering
treatment or procedures; |
| 5. |
Physician's orders or
orders from another practitioner authorized by law to give medical or treatment
orders as applicable; |
| 6. |
Documentation that the patient has been offered the opportunity to consent to
procedures for which consent is required by law; |
| 7. |
Reports from any diagnostic testing;
and |
| 8. |
Sufficient information to
justify any treatment or procedure provided, report of outcomes of treatment or
procedures, and, as appropriate, progress notes and the disposition of the
patient after treatment. |
|
|
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.
| (a) |
Patient
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
needs.
| 1. |
A history and physical examination
shall be completed within the first twenty-four (24) hours after admission. A
history and physical examination completed by either the patient's physician or
the appropriate practitioner operating under the direction of the physician as
authorized by law no more than thirty (30) days prior to the admission may be
accepted but must be updated to reflect the patient's condition at the time of
admission. Where the patient is admitted solely for oromaxillofacial surgery,
such history and physical may be completed by the oromaxillofacial
surgeon. |
| 2. |
A basic nursing
assessment to include at least evaluation of physical and psychological status
sufficient to develop an initial plan of care shall be completed within the
first twelve (12) hours after admission. Within twenty-four (24) hours after
admission, a comprehensive nursing assessment will be completed to include at
least:
| (i) |
Screening and referral for further
assessment of patient needs related to social, nutritional, and functional
status; and |
| (ii) |
Screening of
educational and potential post-hospitalization needs. |
|
| 3. |
Inquiry as to the status of any advance
directives for the patient shall be made at the time of admission.
| (i) |
If a patient has an advance directive in
place that the patient wishes to invoke, but the written directive is not
available at the time of admission, there shall be a mechanism in place to
trigger a recheck by hospital personnel for the document within a reasonable
period of time. |
| (ii) |
If the patient
does not have an advance directive in place, admissions procedures shall
require that designated hospital personnel will offer information regarding
advance directives according to hospital policy and timelines. |
|
|
| (b) |
Patient's
Plan of Care.
| 1. |
On admission, the plan
of care shall be initiated by the designated hospital staff for each patient to
meet the needs identified by the initial assessments. The initial plan of care
shall be placed in the patient's record within twelve (12) hours of
admission. |
| 2. |
As the patient's
treatment progresses, the plan of care shall be updated to reflect any changes
necessary to address new or changing needs. |
|
| (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:
| 1. |
During and following an invasive
procedure; |
| 2. |
Following a change in
the patient's condition or leve l of care; |
| 3. |
During and following the administration of
blood and blood products; |
| 4. |
Following any adverse drug reaction or allergic reaction; and |
| 5. |
During and following any use of physical
restraints or seclusion. |
|
| (d) |
Other Treatment
Requirements.
| 1. |
All patients shall be
given the opportunity to participate, or have a designated representative
participate, in decisions regarding their care. |
| 2. |
Patients shall be provided treatment free
from physical restraints or involuntary seclusion, unless utilized solely for
protection during brief transport to a specified destination or authorized by a
physician's order, for a limited period of time, to protect the patient or
others from injury. Policies and procedures shall be in place to require that a
patient's physical comfort and safety needs are addressed during any period of
required physical restraint or confinement. A positioning or securing device
used to maintain the position, limit mobility, or temporarily immobilize during
medical, dental, diagnostic, or surgical procedures is not considered a
restraint. |
| 3. |
Patients shall
receive care in a manner free from all forms of abuse or neglect. |
| 4. |
Patients shall receive treatment in an
environment that respects their personal privacy, both of their physical person
and their treatment information. |
| 5. |
The hospital shall establish and enforce policies and procedures that require
that all personnel providing direct care to the patient identify themselves to
the patient by name and title or function. |
|
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.
| 1. |
The hospital policy may authorize such
vaccinations to be administered per hospital medical staff approved standing
order and protocol following an assessment for contraindications. |
| 2. |
The hospital policy must also require the
inpatient's medical record, where such vaccination is administered, to contain
an assessment for contraindications, the date of such administration and
patient response. |
|
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.
| 1. |
The chief nurse executive shall establish
and implement policies and procedures for nursing services based on generally
accepted standards of practice including the evaluation of the effectiveness of
the services in coordination with the hospital's quality management
program. |
| 2. |
The chief nurse
executive shall be responsible for ensuring that nursing personnel are oriented
to nursing policies and procedures. |
| 3. |
Nursing services shall have and follow a
written plan for organization, administrative authority, delineation of
responsibilities for patient care, and staff qualifications and competencies.
| (i) |
The nursing service plan shall include
the types and numbers of nursing personnel necessary to provide appropriate
nursing care for each patient in the hospital. |
| (ii) |
Specialty areas shall specify nursing
requirements for their areas that also define any special nursing competency
requirements, staffing patterns based on patient acuity, and the required ratio
of nurses to technical staff. |
| (iii) |
A system of patient assignment shall be defined which reflects a consideration
of patient needs and nursing staff qualifications and competencies. |
|
|
| (b) |
Delivery of
Nursing Services. Nursing services must be delivered in accordance with
patients' needs and generally accepted standards of practice.
| 1. |
A license registered nurse must be on duty
at all times to provide or supervise the provision of care. Critical access
hospitals are permitted some flexibility in meeting this requirement as set
forth in Rule
. |
| 2. |
Within the first twelve (12) hours after
admission, a basic nursing assessment shall be completed for each patient and a
plan of care initiated. |
| 3. |
The
patient's condition shall be monitored by nursing staff on a schedule
appropriate to the patient's needs. |
| 4. |
Nursing staff shall be responsible for
updating the patient's plan of care based on any changes in the patient's
condition. |
| 5. |
Nursing staff
administering drugs and biologicals shall act in accordance with the orders
from the medical staff responsible for the patient's care, generally accepted
standards of practice, and any federal and state laws pertaining to medication
administration. |
| 6. |
Nursing staff
shall report medication administration errors and adverse drug reactions in
accordance with established hospital policies. |
| 7. |
Blood transfusions and other blood
products shall be administered by licensed nursing staff or other qualified
practitioners as authorized by law in accordance with established hospital
policies, which shall include, at a minimum, the following:
| (i) |
Obtaining and documenting appropriate
patient consent to treatment and procedures, as required; |
| (ii) |
Responding to and reporting of
transfusion reactions; |
| (iii) |
Monitoring patients appropriately; and |
| (iv) |
Designating personnel qualified to
perform these procedures. |
|
|
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.
| (a) |
Pharmacy
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:
| 1. |
Developing, supervising, and coordinating
all activities of the pharmaceutical service to be in compliance with state
rules and regulations for hospital pharmacies including the evaluation of the
effectiveness of the services in coordination with the hospital's quality
management program; and |
| 2. |
Developing and implementing an effective system that does the following:
| (i) |
Minimizes drug errors and identifies
potential drug interactions and adverse drug reactions; |
| (ii) |
Controls the availability and storage of
drugs throughout the hospital; |
| (iii) |
Distributes and administers the drugs
in compliance with generally accepted standards of practice; |
| (iv) |
Tracks the receipt and disposition of
all scheduled drugs; |
| (v) |
Staffs
pharmaceutical services to provide sufficient qualified personnel to respond to
the pharmaceutical needs of the patient population being served, including
twenty-four (24) hours per day, seven (7) days per week emergency
coverage; |
| (vi) |
Labels and dispenses
drugs, including a requirement that only licensed pharmacists or properly
supervised licensed pharmacy interns are permitted to compound, label, and
dispense drugs or biologicals; |
| (vii) |
Manages drug recalls; |
| (viii) |
Addresses the removal of drugs when a
pharmacist is not available; |
| (ix) |
Compiles and reports data related to drug ordering; dispensing and
administration errors, and possible adverse drug reaction to the hospital's
quality management program; and |
| (x) |
Reviews all activities and functions of the hospital's pharmaceutical
services. |
|
|
| (b) |
Management of Drugs. The pharmacist shall be responsible for the
management of drugs within the hospital.
| 1. |
The hospital's pharmaceutical services shall access, compile, and make
available to medical and professional staff information relating to drug or
food interactions, drug therapy, side effects, toxicology, dosage indicators,
and routes of administration. |
| 2. |
Loss and theft of controlled substances shall be reported to the pharmacy
director, to the hospital administration, and to others as required by
applicable laws and regulations. |
| 3. |
All drugs and pharmaceuticals shall be stored in an area or on a cart which
shall be locked when unattended to prevent access by unauthorized
individuals. |
| 4. |
Outdated,
mislabeled, or otherwise unusable drugs and pharmaceuticals shall not be
available for patient use. |
| 5. |
Certain drugs and pharmaceuticals not specifically prescribed as to limitation
of time or number of doses shall be automatically discontinued after a
specified time pursuant to guidelines developed by the medical staff in
conjunction with the pharmacy director. |
| 6. |
Drug administration errors, adverse drug
reactions, and drug incompatibilities shall be immediately reported in a timely
manner to the attending physician and the pharmacist. |
| 7. |
Drugs brought into the hospital by a
patient may be administered to the patient only if the medications can be
accurately identified, properly stored and secured, and ordered by the
attending physician for the patient's hospitalization. If the drugs cannot be
administered to the patient, the drugs shall be returned to an adult member of
the patient's immediate family or returned to the patient upon discharge unless
otherwise prohibited by law. |
|
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.
| 1. |
Food Service Manager. The
hospital shall have a manager of food and dietary services who has training and
experience in management of a food service system in a health care setting and
receives on-going training. The responsibilities of the manager shall include:
| (i) |
Overall coordination and integration of
the therapeutic and administrative aspects of the service; |
| (ii) |
Development and implementation of
policies and procedures concerning the scope and conduct of dietary services,
including food preparation and delivery systems; |
| (iii) |
Orientation and training programs for
dietary service personnel and other hospital personnel involved in food
delivery on all applicable dietary services policies and procedures, including
personal hygiene, safety, infection control requirements, and proper methods of
waste disposal; |
| (iv) |
The
implementation of a system to ensure that prescribed diets are delivered to the
correct inpatients; |
| (v) |
Maintenance
of a staff of sufficient numbers of administrative and technical personnel
competent in their assigned duties to carry out the dietary service
program; |
| (vi) |
Procurement of food,
paper, chemical, and other supplies sufficient to meet the anticipated food
service needs of the hospital; and |
| (vii) |
Implementation of procedures to rotate
all food items to ensure use in a timely manner. |
|
| 2. |
Dietitian. Clinical
supervision of the hospital's dietary service shall be provided by a dietitian
on a full-time, part-time, or consultant basis, as determined by the needs of
the hospital. If supervision by the dietitian is provided by a contractual
arrangement or on a consultation basis, such services shall occur at least once
per month for not less than eight hours. The dietitian shall be responsible
for:
| (i) |
Evaluation of inpatients'
nutritional status and needs. If the admission screening identifies that an
inpatient may be nutritionally at risk, the follow-up evaluation by the
dietitian must be performed within twenty-four (24) hours of determination of
the need for evaluation of the patient; |
| (ii) |
Review and approval of all menus,
including menus for therapeutic or prescribed diets; |
| (iii) |
Participation in the development,
revision, and review of policies and procedures for dietary services; |
| (iv) |
Guidance to the manager of dietary
services and to the staff of the service on methods for maintaining
nutritionally balanced meals that meet the needs of each patient and in
maintaining sanitary dietary practices; and |
| (v) |
Appropriate documentation in the
inpatients' medical records of any evaluation of nutritional status or
needs. |
|
|
| (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. |
There
shall be a mechanism in place for the evaluation of nutritional needs for
inpatients identified during admission as needing further assessment. The
mechanism shall require that such evaluations be completed promptly, with
modifications to patients' diets, if any, recorded in the patients' medical
records within twenty-four (24) hours of notification of the need for the
evaluation. |
| 2. |
A current
therapeutic diet manual, approved by the dietitian and medical staff, shall be
readily available to all medical, nursing, and dietary service
personnel. |
| 3. |
Therapeutic diets
shall be prescribed by the member of the medical staff responsible for the care
of the inpatient. |
| 4. |
A written
order for the modified diet prescription as recorded in the inpatient's medical
record shall be readily available to dietary service personnel throughout the
duration of the order. |
| 5. |
When
clinically indicated, the dietary staff shall provide education for inpatients
regarding their diets and nutritional needs. This training shall be documented
in the inpatients' medical records. |
| 6. |
Unless medically contraindicated, at least
three (3) meals a day shall be provided for inpatients, with no more than
fifteen (15) hours elapsing between dinner and breakfast. |
| 7. |
There shall be a system for providing
means for inpatients outside the normal meal service hours, when
necessary. |
| 8. |
A system for meal
requisition shall be in place and shall require a notation regarding the
inpatients' food allergies, if any. |
| 9. |
Snacks shall be available between meals
and at night, as appropriate to each patient's needs and medical
condition. |
| 10. |
The dietary service
shall follow policies and procedures approved by the medical staff for the
management of possible food and drug interactions. |
| 11. |
Pertinent observations and information
related to special diets, the inpatients' food habits, and response to dietetic
treatment or diet modifications shall be recorded in the inpatients' medical
records. |
|
| (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 111-8-90 Rules and Regulations for
X-rays, where applicable.
| (a) |
Organization
and Staffing for Imaging Services. The hospital shall have an organizational
plan for imaging services that identifies the scope of the services provided
and the qualifications of the individuals necessary for the performance of
various aspects of imaging services and delineates the lines of authority and
accountability.
| 1. |
There shall be a qualified
director of imaging services who is a member of the medical staff and a
licensed doctor of medicine or osteopathy with knowledge and experience in
imaging services to supervise the provision of imaging services on a full-time
or part-time basis. |
| 2. |
The director
shall be responsible for all clinical aspects of the organization and delivery
of imaging services, including the evaluation of the effectiveness of the
services in coordination with the hospital's quality management
program. |
| 3. |
Basic radiological
imaging services shall be available at all times, or there shall be an on-call
procedure to provide access to qualified x-ray personnel within thirty (30)
minutes. |
| 4. |
The hospital shall have
qualified staff performing imaging services. |
|
| (b) |
Orders of Imaging Procedures. No imaging
procedures, except screening mammograms, shall be performed without an order or
referral from a licensed doctor of medicine or osteopathy, chiropractor,
dentist, podiatrist, physician assistant or nurse with advanced training where
such order is in conformity with an approved job description or nurse protocol,
and as authorized under state law for such licensed healthcare
professionals. |
| (c) |
Verbal/telephone
orders for imaging services shall be given only to health care professionals
licensed or certified by state law or authorized by medical staff rules and
regulations and other hospital policy to receive those orders, in accordance
with these rules, and shall be entered into the patient's medical record by
those licensed, certified, or authorized health care professionals. |
|
| (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.
| (a) |
Reports of all imaging interpretations and consultations shall be included in
the patient's medical record. |
| (b) |
The hospital shall have an effective procedure for notifying in a timely manner
the patient's physician and responsible nursing staff of critical
interpretations identified through imaging tests. |
| (c) |
Films, scans, and other images shall be
retained by the hospital for at least five years after the date of the
procedure unless the release of the original images is required for the care of
the patient. When original images are released, documentation of the
disposition of the original images shall be retained for the applicable
five-year period. If the patient is a minor, the records shall be retained for
at least five years past the age of majority. |
|
| (3) |
Therapeutic Radiology 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.
| (a) |
Therapeutic radiology procedures shall be
ordered by a licensed Doctor of Medicine or osteopathy and administered by
persons trained and qualified for those procedures and as required under
current state law and regulations. |
| (b) |
Reports of all imaging interpretations,
consultations, and therapies shall be included in the patient's medical
record. |
| (c) |
Radiation Safety. If
the hospital is providing diagnostic or therapeutic radiological services,
hospital policies and procedures shall be implemented to ensure that patients
and hospital staff are not exposed to unnecessary or unsafe levels of
radiation. All imaging staff and therapeutic radiology staff shall be trained
in these policies and procedures. |
| (d) |
Medical Emergencies. The hospital shall
have written protocols for managing medical emergencies in the imaging area and
therapeutic radiology area. |
| (e) |
Infectious Disease. The hospital shall have written protocols for managing
patients with infectious diseases and critical care patients in the imaging
area, or wherever imaging services are provided, and in the therapeutic
radiology area. |
|
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.
| 1. |
The hospital shall have an organizational
plan for laboratory services that identifies the scope of the services provided
and the qualifications of the individuals necessary for the performance of
various aspects of clinical laboratory services and delineates the lines of
authority and accountability. |
| 2. |
There shall be a qualified director of clinical laboratory services who is a
member of the medical staff and meets the requirements for a director set forth
in the Rules and Regulations for Clinical Laboratories, Chapter
111-8-10. |
| 3. |
The director shall be
responsible for the administration of clinical laboratory services, including
the evaluation of the effectiveness of the services in coordination with the
hospital's quality management program. |
|
| (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:
| 1. |
Designation of those tissue specimens which require examination and for
procedures for maintaining a tissue file; and |
| 2. |
Directing pathology reports to the
patient's medical record and for reporting unusual or abnormal results to the
attending physician in a timely manner. |
|
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.
| 1. |
The hospital shall have an organizational
plan for respiratory/ pulmonary services that clearly defines the necessary
staff for the services and the lines of authority and accountability. |
| 2. |
Director. There shall be a
qualified director of respiratory/pulmonary services who is a member of the
medical staff and a licensed doctor of medicine or osteopathy with knowledge,
experience, and capability to supervise the services on a full-time or
part-time basis including the evaluation of the effectiveness of the services
in coordination with the hospital's quality management program.
| (i) |
The director shall be responsible for all
clinical aspects of the organization and delivery of clinical respiratory care
services, including the evaluation of the effectiveness of the services in
coordination with the hospital's quality management program. |
| (ii) |
The director shall be responsible for
the development, implementation, and periodic review of policies, procedures,
and protocols for respiratory/pulmonary care, which shall reflect the scope of
services offered, including at least:
| (I) |
Routine inspection, cleaning, and maintenance procedures for respiratory
equipment, as well as protocols for their assembly and operation; |
| (II) |
Adverse reaction protocols; |
| (III) |
Safety practices and
interventions; |
| (IV) |
Staff
participation in emergency situations at the facility; |
| (V) |
Infection control procedures; |
| (VI) |
Procedures for handling, storage, and
dispensing of therapeutic gases; |
| (VII) |
Procedures for obtaining blood samples
and analysis of samples, as applicable; |
| (VIII) |
Procedures for testing of pulmonary
function, as applicable; |
| (IX) |
Procedures for therapeutic percussion and vibration and for broncho-pulmonary
drainage, as applicable; |
| (X) |
Procedures for mechanical ventilation and oxygenation support and for
administration of aerosol, humidification, and therapeutic gases, as
applicable; |
| (XI) |
Policies for
administration of medications; |
| (XII) |
A system for the reissuing and
discontinuing of respiratory therapy orders; and |
| (XIII) |
Procedures for verbal/telephone orders
taken by state-certified respiratory care professionals. |
|
|
| 3. |
There shall be a sufficient
number of qualified competent professionals and support personnel to respond to
and meet the respiratory/ pulmonary care needs of the patients. |
|
| (b) |
Delivery of
Respiratory/Pulmonary Services. Respiratory/ Pulmonary services shall be
delivered in accordance with the needs of the patients.
| 1. |
Respiratory services shall be provided
only in response to medical orders. Medical orders for services shall include
the modality to be used, the type, frequency, and duration of treatment, and
the type and dose of medications, including dilution ratios. Verbal/telephone
orders for respiratory service shall be dated, timed, and given only to
appropriately licensed or otherwise qualified individuals as determined by the
medical staff in accordance with state law and these rules and shall be entered
into the patient's medical record by those appropriately licensed or otherwise
qualified individuals. |
| 2. |
The
hospital shall provide equipment and supplies sufficient to support the scope
of the respiratory services offered. |
| 3. |
All respiratory care services provided
shall be documented in the patient's medical record, including the type of
therapy, date and time of administration, effects of therapy, and any adverse
reactions. |
| 4. |
If blood gases or
other clinical laboratory tests are performed by respiratory care staff, those
staff shall have demonstrated competency in the administration of the tests as
point-of-care technicians. |
|
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. |
| (c) |
Hospital
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.
| 1. |
Policies and procedures shall provide for
a written agreement(s) with an organ bank or storage facility with the
provisions specified in Rules for Anatomical Gifts, Chapter
, and provisions for the
training of staff authorized to request the gifts, when applicable. |
| 2. |
Where the hospital does not have the Organ
Procurement Organization handle requests for anatomical gifts, the hospital
shall designate staff authorized to make requests for anatomical gifts, and
such staff shall be appropriately trained in the following areas:
| (i) |
Psychological and emotional
considerations when dealing with bereaved families; |
| (ii) |
Social, cultural, ethical, and religious
factors affecting attitudes toward donations; |
| (iii) |
General medical concepts and issues in
organ, tissue, and eye donations; |
| (iv) |
Procedures for declaring death and
collecting and preserving organs, tissues, and/or other body parts and for how
these procedures are to be explained to decedents' families; |
| (v) |
Procedures for notifying and involving
banks or storage facilities; and |
| (vi) |
procedures for recording the outcomes of
requests. |
|
| 3. |
If the
hospital engages in harvesting tissue and/or transplanting organs and tissues
from living donors, the hospital shall develop a living donor organ/transplants
policy that addresses the issues related to such donations. |
|
| (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
. |
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.
| 1. |
There shall be a current roster of surgical privileges granted each medical
staff member available to nursing and scheduling staff in the surgical services
area(s). |
| 2. |
The hospital shall have
bylaws, rules, or policies and procedures developed by the medical staff which
require that within twenty-four (24) hours prior to surgery either a history
and physical examination or an update of a previous history and physical is
completed for every surgical patient. Where an update is used, the previous
history and physical examination must not have occurred more than thirty (30)
days prior to surgery. |
| 3. |
Roles,
responsibilities, and qualifications for any non-physician first and second
assistants participating in surgery shall be defined by the hospital medical
staff, including any limitations to their roles in patient care. |
| 4. |
Chief(s) of Surgery.
Physician member(s) of the medical staff, who have been appropriately
trained in the provision of surgical services, shall be designated by the
medical staff to direct the hospital's surgical services, and shall be
responsible for all clinical aspects of organization and delivery of the
particular surgical services including the evaluation of the effectiveness of
the services in coordination with the hospital's quality management program.
| (i) |
The chief(s) of surgery shall be
responsible for implementation of hospital policy related to medical staff
utilizing the surgical suite. |
| (ii) |
In conjunction with the hospital's medical staff, the chief(s) of surgery shall
implement procedures requiring an operative report for each surgery performed.
| (I) |
The operative report shall describe
techniques, findings, complications, tissues removed or altered, and the
general condition of the patient during and following surgery. |
| (II) |
The full operative report shall be
written or dictated immediately after surgery and signed or authenticated by
the surgeon. Where the full operative report is not available to be placed
immediately in the record, an operative/progress note by the surgeon must be
entered into the medical record immediately. |
|
|
| 5. |
Nurse Manager. A licensed
registered nurse, who has been appropriately trained in the provision of
surgical nursing services, shall manage the surgical suite(s) and shall be
responsible for:
| (i) |
Ensuring that a
sufficient number of nursing personnel are on duty in the surgical suite to
meet the needs and safety of the patients; |
| (ii) |
Ensuring that surgical technicians
perform scrub functions only under the supervision of a licensed registered
nurse who is immediately available to respond to emergencies; |
| (iii) |
Delineating the duties of scrub
personnel and circulating registered nurses in the surgical suite; |
| (iv) |
Providing for orientation and on-going
education and training of surgical personnel providing services within the
surgical suite, to include at least equipment usage and inspections, infection
control and safety in the surgical area, cardiopulmonary resuscitation, patient
rights, and informed consent; |
| (v) |
Ensuring that patients are monitored and provided with nursing care from the
time they enter the surgical suite to the time they exit the area; |
| (vi) |
Developing criteria for the use of
equipment and supplies brought into the surgical suite from other areas;
and |
| (vii) |
Ensuring that the
operating room register is current and complete. |
|
|
| (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:
| 2. |
Surgical scrub
procedures; |
| 3. |
Housekeeping
functions; |
| 4. |
Cleaning,
disinfecting, and sanitizing the area; |
| 5. |
Appropriate maintenance of the heating,
ventilation, and air conditioning systems for the surgical suite; |
| 6. |
Packaging, sterilizing, and storage of
equipment and supplies; |
| 8. |
Traffic control
patterns, including who may enter the operating room areas and under what
circumstances; and |
| 9. |
A surgical
site surveillance system appropriate to the population served. |
|
| (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
appropriate:
| 3. |
Resuscitation equipment; |
| 5. |
Aspiration/suction equipment; |
| 8. |
A end-tidal carbon dioxide
monitor. |
|
| (d) |
Post-Anesthesia Care Unit.
| 1. |
The post-anesthesia care unit shall be located in an area of the hospital in
close proximity to but physically separated from the operating room. |
| 2. |
Policies and procedures for the
post-anesthesia care unit shall include at a minimum the criteria for admission
to and discharge from the unit. |
| 3. |
If patients are not transferred to the post-anesthesia care unit following
surgery, provisions shall be made for monitoring the patient until it is
determined that the patient is stable. |
|
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
Services.
| 1. |
Anesthesia services shall
be directed by a qualified physician member of the medical staff who is
responsible for organizing the delivery of anesthesia services provided by the
hospital in accordance with generally accepted standards of practice. |
| 2. |
The anesthesia director shall be
responsible for monitoring the quality and appropriateness of anesthesia
services and for ensuring that identified problems are addressed through the
quality management program. |
| 3. |
The
anesthesia director shall be responsible for establishing an orientation and
continuing education program for anesthesia services staff that include, at a
minimum, instruction in safety precautions, emergency patient management,
equipment use and inspections, and infection control procedures in the surgical
suite. |
|
| (b) |
Anesthesia Service Delivery.
| 1. |
Anesthesia shall be administered only by qualified members of the medical staff
or qualified individuals who have been granted clinical privileges to
administer anesthesia in accordance with these rules and as permitted by state
laws and regulations. Persons qualified to administer anesthesia may include:
| (iii) |
Dentists or oral surgeons possessing an
active permit for administration of general anesthesia as issued by the State
of Georgia; |
| (iv) |
Certified
registered nurse anesthetists administering such anesthesia under the direction
and responsibility of duly licensed physicians who are members of the medical
staff; and |
| (v) |
Physician's
assistants licensed by the State of Georgia with approved job descriptions as
anesthesia assistants functioning under the direct supervision of
anesthesiologists who are members of the medical staff and as otherwise
authorized by applicable laws and regulations. |
|
| 2. |
A pre-anesthesia patient evaluation shall
be completed for each patient by a person qualified and granted privileges to
administer anesthesia within a reasonable period of time preceding the surgery.
The patient evaluation shall be updated immediately prior to induction. The
pre-anesthesia evaluation must include review of heart and lung function,
diagnostic data (laboratory, x-ray, etc., as applicable), medical and
anesthesia history, notation of anesthesia risk, any potential anesthesia
problems identified, and notation of patient's condition immediately prior to
induction. |
| 3. |
Checks of all
anesthesia equipment shall be performed and documented immediately prior to
each anesthesia administration. |
| 4. |
A person qualified and granted privileges to administer anesthesia shall be
continuously present throughout the administration of all general anesthesia or
major regional anesthesia and monitored anesthesia care. |
| 5. |
During the administration of anesthesia,
patients shall be monitored as appropriate for the nature of the anesthesia.
Such monitoring shall include as appropriate:
| (i) |
Heart and breath sounds, using a
precordial or esophageal stethoscope; |
| (iv) |
Circulatory function; |
| (v) |
The qualitative content of expired gases,
if the patient has an endotracheal tube; and |
| (vi) |
The patient's temperature. |
|
| 6. |
The intraoperative anesthesia
record shall document all pertinent actions and events that occur during the
induction, maintenance, and emergence from anesthesia. |
| 7. |
The person qualified and granted
privileges to administer anesthesia shall remain immediately available until
the patient has been determined to be stable and is ready for discharge or
transfer from the post-anesthesia care unit. |
| 8. |
A person qualified and granted privileges
to administer anesthesia shall complete the post-anesthesia evaluation for each
patient receiving anesthesia, and it shall be included in the patient's medical
record.
| (i) |
The evaluation shall note at a
minimum the presence or absence of anesthesia-related abnormalities or
complications, the patient's level of consciousness and cardiopulmonary status,
and any follow-up care needed. |
| (ii) |
For outpatients, the post-anesthesia evaluation shall be performed prior to
hospital discharge to check for anesthesia recovery in accordance with
procedures and timelines established by the hospital's medical staff. |
|
|
| (c) |
Anesthesia
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:
| 1. |
Routine maintenance and inspection of
anesthesia equipment, recorded in a service record for each machine; |
| 2. |
Emergency preparedness plans; |
| 3. |
Life safety measures, including alarm
systems for ventilators capable of detecting disconnection of any components,
monitoring for scavenger gases, and a system for internal reporting of
equipment malfunctions and unavailability; |
| 4. |
Infection control procedures sufficient to
adequately sterilize or appropriately disinfect all equipment components;
and |
| 5. |
Procedures for ensuring
patient safety. |
|
| (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:
| 1. |
Designation of the licensed personnel
authorized to administer conscious sedation and/or monitor the patient during
conscious sedation; |
| 2. |
Drugs
approved for use in administering conscious sedation; |
| 3. |
Patient monitoring requirements;
and |
| 4. |
Criteria for
discharge. |
|
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.
| 1. |
Organization. Supervision and
organization of emergency services shall be under the direction of a qualified
member of the medical staff.
| (i) |
The director
shall be responsible for the development of policies and procedures related to
emergency services and the review and update of policies as necessary. The
policies and procedures shall be approved by appropriate members of the medical
staff. |
| (ii) |
The director shall
implement systems to assess the effectiveness of the emergency service and to
address improvement issues through the hospital's quality management
program. |
| (iii) |
Staffing assignments
shall provide for sufficient nursing, medical, and technical staff to meet the
anticipated needs of emergency patient care. There shall be available to
emergency room staff procedures for accessing additional staff on an as-needed
basis to meet unanticipated needs. |
| (iv) |
Patient care responsibilities for
emergency services staff shall be specified by written policies and procedures,
which shall include training and experience requirements appropriate to the
assigned responsibilities and clearly defined lines of authority. |
|
| 2. |
Delivery of Services.
When the hospital provides emergency services, the services shall comply
with the following:
| (i) |
Policies and
procedures for processing patients presenting for emergency care shall be in
writing and shall include the procedures for initial patient assessment,
prioritization for medical screening and treatment, and patient reassessment
and monitoring. |
| (ii) |
There shall be
a central log of all patients presenting for emergency care, with the
presenting complaint and the level of acuity or triage documented. Entries in
the log must be retrievable by the date and time the patient presents for
treatment; |
| (iii) |
An emergency
medical record shall be maintained for each patient which includes all
assessment and treatment information about the patient from the time of
presentation until the time of discharge or transfer; |
| (iv) |
Written protocols and standards of
practice to guide emergency interventions by non-physician staff shall be
available in the emergency services area; |
| (v) |
A licensed physician shall be available
to cover basic emergency room services either on-site or by telephone. Where
the licensed physician is providing such coverage by telephone, the physician
must be able to arrive in the emergency room within thirty (30) minutes of the
need for physician services having been determined; |
| (vi) |
The emergency services area shall have
operable equipment and sufficient and appropriate supplies and medications to
support emergency care for patients of all ages, including at least:
| (I) |
An emergency call system; |
| (III) |
Manual breathing bags and
masks; |
| (IV) |
Cardiac monitoring and
defibrillator equipment; |
| (V) |
Laryngoscopes and endotracheal tubes; |
| (VI) |
Suction equipment; and |
| (VII) |
Emergency drugs and supplies as
specified by the medical staff; |
|
| (vii) |
The hospital shall integrate functions
of the emergency services with other services of the hospital to ensure
appropriate patient care and treatment including those patients awaiting
admission or transfer to another facility, placement in a hospital bed, or
transfer to another facility; |
| (viii) |
Policies and procedures shall be
developed and implemented for the appropriate transfer of emergency patients to
other facilities or other areas of the hospital when appropriate; |
| (ix) |
The hospital shall have policies and
procedures for the management of mass casualty situations which may require the
coordination of the hospital's emergency services with other facilities, the
local Emergency Management Agency (EMA), and local ambulance service
providers; |
| (x) |
Emergency Services
Where Maternity Services Are Customarily Offered. In addition to applicable
federal laws regarding the treatment of persons requesting treatment for
emergency medical conditions that are enforced by the federal government, state
law requires any hospital which operates an emergency service to provide
appropriate and necessary emergency services to any pregnant woman who is a
resident of this state and who presents herself in active labor, to the
hospital, if those services are usually and customarily provided in that
facility. Such services shall be provided within the scope of generally
accepted practice based upon the information furnished the hospital by the
pregnant woman, including such information as the pregnant woman reveals
concerning her prenatal care, diet, allergies, previous births, general health
information, and other such information as the pregnant woman may furnish the
hospital. If, in the medical judgment of the physician responsible for the
emergency service, the hospital must transfer the patient because the hospital
is unable to provide appropriate treatment, the hospital shall provide
appropriate treatment as set forth in O.C.G.A. § 31-8-42; and |
| (xi) |
Diversion Status - Inability to Deliver
Emergency Services. The hospital shall develop and implement a diversion policy
in consultation with the medical staff which describes the process of handling
those times when the hospital must temporarily divert ambulances from
transporting patients requiring emergency services to the hospital. The policy
must include the following: when diversion is authorized to be called, who is
authorized to call and discontinue diversion, efforts the hospital will make to
minimize the usage of diversion, and how diversion will be monitored and
evaluated. In connection with going on diversion status, the hospital shall:
| (I) |
Notify the ambulance zoning system when
it is temporarily unable to deliver emergency services and is declaring itself
on diversion; |
| (II) |
Notify the
ambulance zoning system when diversion status is no longer determined to be
necessary; and |
| (III) |
Monitor and
evaluate its usage of diversion status and make changes within its control to
minimize the use of diversion status. |
|
|
|
| (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.
| (a) |
Organization of
Outpatient Services.
| 1. |
The hospital
shall develop and implement policies and procedures to ensure that outpatient
care provided meets the needs of patients in accordance with generally accepted
standards of practice. |
| 2. |
Each
outpatient service shall be staffed with sufficient qualified personnel to
promptly, safely, and effectively meet the care needs of patients. Staff
providing care to outpatients shall meet the same qualification requirements as
staff providing similar services to inpatients of the hospital. |
| 3. |
The hospital shall assign responsibility
for the periodic assessment of the quality and effectiveness of the outpatient
services provided, and this assessment shall be a part of the hospital's
quality management program. |
|
| (b) |
Outpatient Service Delivery.
| 1. |
Hospital services for outpatients shall be
provided only on the order of a licensed physician, dentist, osteopath,
physician's assistant, or advanced practice nurse as permitted by law in
accordance with the system of accountability established by the medical
staff. |
| 2. |
Outpatient services shall
be provided in a manner which ensures the privacy of each patient and the
confidentiality of the patient's disclosures. Private rooms or cubicles shall
be provided for the use of outpatients and staff for consultation purposes, as
appropriate to the needs of the service. |
| 3. |
Hospitals shall provide waiting areas for
outpatients with sufficient seating for the expected volume of
patients. |
| 4. |
Each outpatient shall
have an outpatient record, which shall be maintained and stored in a manner to
be available for subsequent outpatient or inpatient hospital visits. |
|
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
section.
| (a) |
The hospital shall establish and
utilize admission criteria for the maternal and newborn services that reflect
the level of services offered by the hospital. |
| (b) |
The hospital shall have established
mechanisms, through written agreement and other arrangement, for transfers to
or consultations with facilities providing services at the higher levels of
care for those maternal and newborn patients who require such care. The
agreements or arrangements shall ensure that there is collaboration between the
sending and receiving hospital concerning the transfer of such patients prior
to the actual need for transfer and shall include mechanisms for the
communication of information regarding the outcome of each transfer and for
periodic review of the agreements or arrangements. |
| (c) |
All hospitals offering obstetrical care
shall have facilities, staff, and equipment necessary for delivery, management,
and stabilization of expectant women who present at the hospital in active
labor and for whom delivery is imminent, regardless of the level of care
anticipated for the newborn. The hospital shall have in place a system for
communication and consultation with a board certified obstetrician or
maternal-fetal medicine specialist and a board certified neonatologist for
situations where transport of high-risk patients prior to delivery is not
feasible. |
| (d) |
The hospital shall
establish a system for receipt of prenatal records for admissions to the
maternal and newborn service other than emergency admissions to include the
results of any routine laboratory tests as required by the hospital. |
| (e) |
The hospital shall have written plans and
procedures for transfer of expectant mothers or newborns presenting at the
hospital who exceed the criteria for admission, which shall include mechanisms
for accessing transportation appropriate to the needs of the
patient(s). |
| (f) |
The hospital shall
include in the internal quality management program a systematic review of the
admissions and transfers for maternal and newborn services, with comparison to
the established admission criteria, which shall prompt corrective action when
indicated. |
| (g) |
With the exception
of hospitals permitted as specialized children's hospitals, hospitals shall
offer a level of services for maternal care comparable to the level of services
offered for neonatal care. |
|
| (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. |
| (3) |
Basic Maternal
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:
| (a) |
Organization of Basic Maternal and Newborn Services.
| 1. |
The director of obstetrical services shall
be a board eligible or board certified obstetrician, or a board eligible or
board certified family practitioner with obstetrical privileges, or shall be a
credentialed member of the medical staff with obstetrical privileges with
access to such board eligible or board certified specialists by
consultation. |
| 2. |
The director of
newborn services shall be a member of the medical staff who is a board eligible
or board certified pediatrician, or a board eligible or board certified family
practitioner, or shall be a credentialed member of the medical staff with
access to such specialists by consultation. The director of newborn services
shall be responsible for ensuring that medical care is provided for all
newborns. |
| 3. |
The perinatal nurse
manager shall be a licensed registered nurse with education and demonstrated
knowledge and experience in perinatal nursing; |
|
| (b) |
Delivery of Basic Maternal and
Newborn Services.
| 1. |
Staffing
Plan. The hospital shall follow a staffing plan that ensures the
availability of appropriate numbers of qualified staff for the perinatal
services offered, according to generally accepted standards of practice and
state licensing regulations.
| (i) |
Staffing for the Labor and Delivery Area. For the delivery of
newborns, the hospital shall provide for at least the following:
| (I) |
A birth attendant, who may be an
obstetrician, a physician with obstetrical privileges, or a certified nurse
midwife who has been granted clinical privileges in accordance with these
rules, present at the hospital or immediately available by telephone and able
to be on-site within thirty (30) minutes; |
| (II) |
A registered nurse present to assist
with each delivery; |
| (III) |
An
individual credentialed in neonatal resuscitation to be present in the delivery
room for each delivery for the purpose of receiving the newborn; |
| (IV) |
For Cesarean deliveries, an additional
physician or certified nurse midwife, a registered nurse, or a surgical
assistant or technician, able and qualified to assist with a Cesarean section,
on-site or able to arrive in sufficient time to accommodate the time limit for
emergency Cesarean section of thirty (30) minutes from the physician's decision
to operate to the initial incision; and |
| (V) |
Professional staff qualified to
administer anesthesia, on-site or able to arrive in sufficient time to
accommodate the time limit for emergency Cesarean section of thirty (30)
minutes from the physician's decision to operate to initial incision. |
|
| (ii) |
Staffing for the
Newborn Nursery. The hospital shall provide for at least:
| (I) |
A qualified registered nurse with
experience or training in the care of newborns to supervise and be responsible
for the quality of nursing care given to newborns, for nursing in-service
programs in nursery issues, for assisting the director of the newborn nursery
in carrying out his or her duties, and for the maintenance of the nursery
records; |
| (II) |
A licensed nurse on
duty in the nursery at all times in hospitals with a daily newborn nursery
census greater than ten (10) newborns; and |
| (III) |
A staff member trained in newborn
service provision present in the newborn nursery when it is occupied by any
newborn. |
|
|
| 2. |
The directors of obstetrical and newborn services shall develop and implement
written policies, procedures, and guidelines for the services that reflect
current standards of practice and address at least:
| (i) |
Admission criteria for the services based
on the level of service provided; |
| (ii) |
Guidelines and mechanisms for specialty
consultations and transfer for high-risk patients whose needs exceed the range
of services offered at the hospital; |
| (iii) |
The orientation program for maternal
and newborn services staff; |
| (iv) |
Patient care requirements for mothers and newborns, including but not limited
to nursing assessments, gestational age assessment, newborn assessments
including Apgar scoring immediately after delivery, assessment and management
of nutritional needs including feedings for the newborn whether normal or
gavage, umbilical and circumcision care, assessment of thermoregulation by the
newborn, prevention of blindness, hypoglycemia, and hemorrhagic disease for the
newborn, use of appropriate prophylaxes, patient monitoring needs, and
assessment of educational needs of the mother; |
| (v) |
Procedures for a family-centered
environment (rooming-in) as an option for each patient unless contraindicated
by the medical condition of the mother or infant or unless the hospital does
not have sufficient facilities to accommodate all such requests; |
| (vi) |
Room assignments and procedures for
traffic control and security, including such security measures as are necessary
to limit access to newborns by unauthorized persons and to prevent kidnapping
of newborns; |
| (vii) |
Guidelines for
the use of anesthetic agents for pain management and the requirements for the
qualifications and responsibilities of persons who administer the agents and
the required patient monitoring; |
| (viii) |
Guidelines for induction and
augmentation of labor and for designation of qualified personnel who must be in
attendance during these procedures; |
| (ix) |
Indicators and procedures for vaginal
birth after Cesarean section (VBAC); |
| (x) |
Indicators and procedures for operative
vaginal deliveries; |
| (xi) |
Staffing
and procedural guidelines for management of obstetrical and newborn
emergencies, including the availability of staff components to manage such
emergencies twenty-four (24) hours per day; |
| (xii) |
Guidelines for the monitoring of
newborns during the first twelve (12) hours after birth and until
discharge; |
| (xiii) |
Procedures for
infection control, including isolation procedures, visiting privileges,
individualized infant hygiene care, and specific policies regarding the
prevention and management of infectious diseases, including but not limited to
Hepatitis B, Hepatitis C, Group B Streptococcal infections, tuberculosis, human
immunodeficiency virus (HIV), and sexually transmitted diseases; |
| (xiv) |
Requirements for newborn screening
tests for metabolic disorders and hemoglobinopathies and other screenings, as
required by law. |
| (xv) |
Procedures
for continuous and unquestionable identification of newborns; |
| (xvi) |
Procedures for completing birth and
death certificates in accordance with Georgia's official vital records
registration system; and |
| (xvii) |
Guidelines for discharge of mothers and newborns, including early discharge,
and for assessment of education and other discharge needs. |
|
|
| (c) |
Physical Environment for
Maternal and Newborn Services.
| 1. |
Obstetrical and newborn service areas shall be located, arranged, and utilized
so as to provide for every reasonable protection from infection and from
cross-infection. The physical arrangements shall separate the obstetric
patients from other patients with the exception of non-infectious gynecological
patients. |
| 2. |
Rooms used for
patients in labor shall be located with convenient access to the delivery
room(s). If labor rooms also serve as birthing rooms, the rooms shall be
equipped to handle obstetric and neonatal emergencies. |
| 3. |
Delivery suites shall be used for no
purpose other than for the care of obstetrical patients. Each room shall have
the necessary equipment and facilities for infection control and for the
management of obstetric and neonatal emergencies. Delivery suites shall be
designed to include an anesthesia supply and equipment storage room and a
communication system to ensure that emergency backup personnel can be summoned
when needed. |
| 4. |
A newborn
stabilization area shall be located within each delivery room or birthing room
and shall be equipped with oxygen and suction outlets. |
| 5. |
The newborn nursery shall have an air
temperature maintained at 75-80 degrees Fahrenheit, with a relative humidity of
thirty percent to sixty percent (30% - 60%). |
| 6. |
Air from other areas of the hospital shall
not be recirculated into the newborn nursery. Ventilation of the nursery
suite(s) shall provide the equivalent admixture of a minimum of six (6) total
air changes per hour. |
| 7. |
Life-sustaining nursery equipment and lighting for the nursery areas shall be
connected to outlets with an automatic transfer capability to emergency
power. |
| 8. |
Each labor room, delivery
room, birthing room, and nursery station shall be equipped with sufficient
power outlets to handle the equipment required for the provision of patient
care without the use of extension cords,"cheater" plugs, or multiple outlet
adapters, which are prohibited. |
|
| (d) |
Clinical Laboratory, X-Ray, and
Ultrasound Services. Diagnostic support services such as laboratory,
x-ray, and ultrasound, shall be available on an on-call basis, with the
capability to perform studies as needed for maternal and newborn care;
and |
| (e) |
Records Requirements.
| 1. |
The medical record for each
maternity patient shall be maintained in accordance with Section
of these rules, with
the following additions:
| (i) |
The medical
record for each maternity patient shall contain a copy of the patient's
prenatal records, submitted at or before the time of admission; |
| (ii) |
The admission data shall include the
date and time of notification of the birth attendant, the condition on
admission of the mother and fetus, labor and membrane status, presence of
bleeding, if any, fetal activity level, and time and content of the most recent
meal ingested; and |
| (iii) |
Labor and
postpartum care notes shall be included. |
|
| 2. |
The medical record for each newborn shall
be cross-referenced with the mother's medical record and shall contain the
following additional record information:
| (i) |
Physical assessment of the newborn, including Apgar scores, presence or absence
of three cord vessels, and vital signs; |
| (ii) |
Accommodation to extra uterine life
including the ability to feed and description of maternal-newborn
interaction; |
| (iii) |
Treatments and
care provided to the newborn to include the specimens collected, newborn
screening tests performed, and appropriate prophylaxes; |
| (iv) |
The infant's footprint and mother's
fingerprint, or comparable positive newborn identification information;
and |
| (v) |
Report of the physical
examination of the newborn prior to discharge, performed by an appropriately
credentialed physician, physician's assistant, nurse practitioner, or nurse
midwife. |
|
| 3. |
The hospital
shall maintain a register of births, in which is recorded the name of each
patient admitted for delivery, the date of admission, date and time of birth,
type of delivery, names of physicians or other birth attendants, assisting
staff and anesthetists, the sex, weight, and gestational age of the infant, the
location of the delivery, and the fetal outcome of the delivery. |
| 4. |
The hospital shall maintain annual
statistics regarding the number of births and number of infant deaths. Death
statistics for infants shall include birth weights, gestational ages, race,
sex, age at death, and cause of death. |
|
|
| (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:
| (a) |
Organization of Intermediate Maternal and Newborn Services.
| 1. |
The director of obstetric services shall
be a member of the medical staff who is a board eligible or board certified
obstetrician or board eligible or board certified maternal-fetal medicine
specialist; provided, however, within five (5) years from the effective date of
these rules, the director of obstetric services shall be a board certified
obstetrician or board certified maternal-fetal medicine specialist. |
| 2. |
The director of newborn services shall be
a member of the medical staff who is board eligible or board certified
pediatrician or board eligible or board certified neonatologist; provided,
however, within five (5) years from the effective date of these rules, the
director of newborn services shall be a board certified pediatrician or board
certified neonatologist. |
| 3. |
A board
eligible or board certified neonatologist shall be available to participate in
care for the neonates. |
| 4. |
The
perinatal nurse manager shall be a licensed registered nurse with the training
and demonstrated knowledge and experience in care of high-risk maternal care
and moderately ill newborns. |
| 5. |
When a neonate is on mechanical ventilation or when a high risk maternity
patient is being managed, a respiratory therapist, certified lab
technician/blood gas technician, and an x-ray technologist shall be on-site and
available to the maternal and newborn services area on a twenty-four (24) hour
basis. |
| 6. |
If the facility offers
care for newborns requiring parenteral support, a licensed dietitian and a
licensed pharmacist with parenteral experience shall be on staff. |
|
| (b) |
Delivery of Intermediate
Maternal and Newborn Services. Service delivery shall meet the
requirements of the basic maternal and newborn services, with the following
additions or exceptions:
| 1. |
The hospital
shall provide care for expectant mothers and newborns requiring the basic level
of maternal and newborn services, as well as for those requiring an
intermediate level of care; |
| 2. |
Portable x-ray and ultrasound equipment and services shall be available on a
twenty-four (24) hour basis; |
| 3. |
The
intermediate level nursery shall provide care to neonates expected to require
no more than short-term mechanical ventilation or parenteral support. Such
support, if needed for more than forty-eight (48) hours, shall be authorized
daily by the consulting neonatologist, or the neonate shall be transferred to a
facility with a higher (intensive) level of care; and |
| 4. |
Written policies, procedures, protocols,
and guidelines shall reflect the pre-defined level of care provided. Criteria
for admission to and discharge from the intermediate level nursery shall be
defined in the written policies and procedures. |
|
| (c) |
Physical Environment for
Intermediate Maternal and Newborn Services. The physical environment
shall meet the requirements of the basic maternal and newborn services, with
the following additional requirements:
| 1. |
There shall be provided in the intermediate level nursery sufficient space
between each patient station to allow for easy access for staff and visitors on
three (3) sides of the patient bed and to allow for easy access with portable
diagnostic and support equipment as may be required; |
| 2. |
Each patient station in the intermediate
level nursery shall have at least two (2) oxygen outlets, two (2) compressed
air outlets, and two (2) suction outlets; |
| 3. |
There shall be adequate lighting provided
for patient care while avoiding extra illumination of adjacent neonates;
and |
| 4. |
The patient bed areas shall
be designed to minimize the impact of noise on the infants. |
|
|
| (5) |
Intensive
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
exceptions:
| (a) |
The director of intensive
obstetric services shall be a member of the medical staff who is a board
certified obstetrician or board certified maternal-fetal medicine
specialist; |
| (b) |
The director of
intensive newborn services shall be a member of the medical staff who is a
board certified pediatrician or board certified neonatologist; |
| (c) |
The hospital shall have on call, on a
twenty-four (24) hour basis, a board certified obstetrician or maternal-fetal
medicine specialist to provide on-site supervision and management of maternal
patients; |
| (d) |
The hospital shall
have available for consultation a maternal-fetal medicine specialist; |
| (e) |
The hospital shall have on call, on a
twenty-four (24) hour basis, a board certified neonatologist to provide on-site
supervision and management of neonates; |
| (f) |
The hospital shall provide pediatric
subspecialties on staff or have a mechanism to provide consultation and care
for pediatric subspecialties in a timely manner; |
| (g) |
The nursery manager of the intensive care
nursery shall have demonstrated knowledge, training, and experience in neonatal
intensive care nursing and shall have a dedicated assignment to the intensive
care nursery; |
| (h) |
The hospital
shall have on staff pharmacology personnel competent in perinatal pharmacology.
Total parenteral nutrition shall be available; and |
| (i) |
The hospital shall have on staff a
licensed physical therapist or occupational therapist and a licensed dietitian
with training and experience in neonatal care. |
|
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:
| 1. |
Chronological age,
weight, and length or height; |
| 2. |
For infants and young children, a measurement of head circumference; |
| 4. |
A statement as to the developmental age
and growth of the child as related to established norms; and |
| 5. |
Family relationships, including expected
family involvement during treatment. |
|
| (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. |
| (2) |
Organization and
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.
| (a) |
Medical
Director. The medical director for dialysis services shall be a
physician member of the medical staff qualified to provide oversight to the
specialized care required for dialysis patients and the medical director shall
have at least one-year's experience in care for patients with end stage renal
disease. |
| (b) |
Nursing
Services. A registered nurse with demonstrated clinical competencies in
providing dialysis services for patients shall be available during all dialysis
treatments. Nursing staff and dialysis care technicians providing dialysis
services shall have evidence of education, training, and demonstrated
competencies in the provision of appropriate dialysis services and emergency
care of patients receiving dialysis. |
| (c) |
Policies and Procedures for
Dialysis Services. Where the hospital provides dialysis services
directly to its patients, the hospital shall develop and implement policies and
procedures that address the special needs of dialysis patients and shall
include at least the following:
| 1. |
Maintenance of dialysis equipment; |
| 2. |
Water treatment system safety; |
| 4. |
Reuse of dialyzers and dialysis supplies,
if applicable, and |
| 5. |
Care of
dialysis patients experiencing common complications of dialysis
treatments. |
|
| (d) |
Contracted Services. Where the hospital provides dialysis services
through a contract arrangement, the hospital must contract with a
Georgia-licensed End Stage Renal Disease Facility. The contract must outline
what specific services shall be provided and include who will be responsible
for the maintenance of the dialysis equipment, the water treatment safety
system, infection control, reuse of dialyzers and supplies, if applicable, the
clinical qualification of staff to be provided, and the clinical supervision
that will be provided to dialysis patients during the administration of
dialysis treatments. |
|
| (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.
| (a) |
Director of Psychiatric and Substance Abuse Services. The director
of psychiatric and substance abuse services shall be a licensed physician
member of the medical staff appropriately trained and qualified to supervise
the provision of these services.
| 1. |
If the
hospital offers substance abuse services only, the director shall be a licensed
physician member of the medical staff certified or eligible for certification
in addiction medicine by the American Society of Addiction Medicine or the
American Osteopathic Academy of Addiction Medicine or a licensed physician
member of the medical staff appropriately trained and qualified to supervise
the service. If the director of the substance abuse services meets this
certification requirement but is not board certified in psychiatry, the
hospital must have a board eligible or board certified psychiatrist on staff to
be utilized for psychiatric consultation as needed. |
| 2. |
The director of the psychiatric and/or
substance abuse services shall be responsible for all clinical aspects of the
organization and delivery of services and for the evaluation of the
effectiveness of the services in coordination with the hospital's quality
management program. |
|
| (b) |
Staffing for Psychiatric and Substance Abuse Services. The
hospital shall provide sufficient clinical and support staff to assess and
address the needs of psychiatric and substance abuse patients and to ensure the
maintenance of a safe therapeutic environment for patients and staff.
| 1. |
Nursing Manager/Director. The
nursing care for the psychiatric and/or substance abuse services shall be
supervised by a licensed registered nurse with at least three (3) years of
clinical psychiatric and/or substance abuse experience. Authorization from the
Georgia Board of Nursing to practice as a Clinical Nurse Specialist,
Psychiatric/Mental Health may substitute for two (2) years of the required
clinical experience. |
| 2. |
Counseling Services. Counseling services for the psychiatric and
substance abuse services shall be supervised by a master's level clinician
licensed in social work, marriage and family therapy, professional counseling,
or a clinical nurse specialist, psychiatric mental health. |
| 3. |
Clinical Psychologist. A
licensed clinical psychologist shall be available to provide testing and
treatment consultation for patients as needed. |
| 4. |
Child Psychiatrist. If
psychiatric services are provided for children, a board eligible or board
certified child psychiatrist shall be on staff. |
| 5. |
Special Staffing Requirements for
Inpatient Psychiatric or Substance Abuse Services. Hospitals providing
inpatient psychiatric and/or substance abuse care shall provide:
| (i) |
A physician, with training and
qualifications appropriate to the services offered, present in the hospital or
available on call on a twenty-four (24) hour basis; |
| (ii) |
At least one registered nurse on duty at
all times; and |
| (iii) |
Rehabilitative
and therapeutic activity staff, trained and qualified to meet the needs of the
patients as specified in the patients' individualized service plans. |
|
|
| (c) |
Policies and
Procedures for Psychiatric and Substance Abuse Services. In addition to
hospital policies and procedures otherwise required by these rules, the
hospital providing psychiatric and/or substance abuse services shall develop
and implement policies and procedures that address the special needs of the
population served, to include at least:
| 1. |
Admission and discharge criteria and procedures, which comply with Georgia laws
concerning involuntary admissions or treatment; |
| 2. |
Safety and security precautions for the
prevention of suicide, assault, and patient injury; |
| 3. |
The handling of medical emergencies,
including but not limited to suicide attempts, cardiac arrest, aspiration, or
seizures; |
| 4. |
Special procedures,
such as electro convulsive therapy (ECT) and medical detoxification, as
applicable; and |
| 5. |
Procedures for
the use of seclusion and restraint in accordance with O.C.G.A. Chapters 3 and 7
of Title 37 and these rules. |
|
|
| (3) |
Patient's Rights in Psychiatric and
Substance Abuse Services.
| (a) |
In
addition to the rights afforded all patients at the hospital, the hospital
shall ensure that patients served by the psychiatric and substance abuse
services shall have the right to:
| 1. |
Receive
treatment in the hospital using the least restrictive methods possible;
and |
| 2. |
Participate to the extent
possible in the development, implementation, and review of their individualized
service plan. |
|
| (b) |
Any
permissible restriction of patient rights by the hospital program shall be
imposed only in order to protect the health and safety of the patient or others
and shall be temporary. The nature, extent, and reason for the restriction
shall be entered into the patient's medical record as a written order by a
physician or licensed psychologist and reviewed for necessity as required by
state law. |
|
| (4) |
Patient Assessment and Treatment.
| (a) |
In addition to other assessment and treatment procedures otherwise required by
these rules, psychiatric and substance abuse service programs at the hospital
shall provide:
| 1. |
For inpatients:
| (i) |
With the admission assessments performed
within twenty-four (24) hours of admission, a psychiatric or substance abuse
evaluation as indicated by the reason for admission; and |
| (ii) |
An individualized service plan,
initiated within the first twelve (12) hours after admission and updated as
needs are identified through assessments; |
|
| 2. |
For outpatients:
| (i) |
Within seven (7) days following the
initiation of outpatient services, a complete assessment of patient needs,
including an evaluation sufficient to identify significant medical conditions
which may impact the course of treatment; and |
| (ii) |
Within ten (10) days following
initiation of outpatient services, an individualized service plan developed and
implemented to address needs identified; |
|
| 3. |
Each patient's individualized service plan
shall be developed from the patient's needs as identified through
psychological, medical, and social assessment and shall be an organized
statement of the proposed treatment process which serves to guide the providers
and patient through the duration of the service provision. The service plan
shall reflect the following:
| (i) |
The patient's
participation, to the extent possible, in the development of the individualized
service plan; |
| (ii) |
Measurable goals
and/or objectives to be met toward the established discharge criteria;
and |
| (iii) |
Regular review of the
patient's progress toward goals and/or objectives in the individualized service
plan, with modifications to the plan made in response to progress or lack of
progress as reflected in progress notes recorded at each visit which document
the patient's status and response to treatment; |
|
| 4. |
At the time of development of the
patient's treatment plan and with the participation of the patient, a discharge
plan shall be developed for each inpatient or an aftercare plan for each
outpatient. The discharge/aftercare plan shall be re-evaluated periodically
during treatment to identify any need for revision; and |
| 5. |
All medications administered or prescribed
for psychiatric or substance abuse patients shall be solely for the purpose of
providing effective treatment or habilitation as described in the
individualized service plan and/or for protecting the safety of the patient or
others and shall not be used for punishment or for the convenience of
staff. |
|
| (b) |
If the
hospital is not able to meet the patient needs as identified, including any
acute medical or surgical needs, the hospital shall assist the patient in
locating and accessing services to meet those needs, which may include transfer
to another facility. |
|
| (5) |
Physical Space and Design Requirements for Inpatient Psychiatric and
Substance Abuse Services. Hospitals providing inpatient psychiatric and substance abuse
services shall have:
| (a) |
At least one
seclusion area must be available to be used for the involuntary confinement of
patients when necessary. The seclusion area shall be large enough to provide
access to the patient from all sides of the bed or mattress and to accommodate
emergency life-sustaining equipment, have a door that opens outward, and have
provision for direct patient observations at all times by staff; |
| (b) |
A design conforming to the suicide
prevention recommendations from the Guidelines for Design and
Construction of Hospital and Healthcare Facilities, produced by the
American Institute of Architects' Academy of Architecture for Health with the
assistance of the U.S. Department of Health and Human Services, which is hereby
adopted by reference; |
| (c) |
A day
room that allows for social interaction, dining, and group therapy
activities; |
| (d) |
Space for storage
of patient's personal belongings and for securing valuables; |
| (e) |
A system for summoning help from within
the immediate service area or other areas of the hospital in the event of an
emergency. |
|
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:
| 1. |
Patient
referral and transfer between the facilities, with the use of emergency and
non-emergency transportation; |
| 2. |
Credentialing of medical and professional staff; and |
| 3. |
Participation in quality management
activities. |
|
| (c) |
The
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:
| 1. |
Operational
policies for the CAH shall be developed with participation from one (1) or more
licensed physicians, one (1) or more healthcare practitioners if on the staff
of the critical access hospital, and at least one (1) member of the affiliated
hospital's staff who is not on the staff of the CAH; |
| 2. |
Operational policies for the CAH which
describe the patient care services the CAH will provide directly and those that
will be provided through contract or other arrangement; |
| 3. |
No more than twenty-five (25) inpatient
beds or as currently defined in federal regulations. Of these beds, at least
two (2), but no more than fifteen (15), shall be used for acute inpatients. If
the CAH has approved swing bed services, a maximum of twenty-three (23) beds
may be utilized for swing bed patients; |
| 4. |
An average length of stay for patients of
no more than ninety-six (96) hours or as currently defined in federal
regulations; |
| 5. |
A mechanism in
place to ensure that emergency care is available twenty-four (24) hours per
day. The CAH shall not be required to remain open twenty-four (24) hours per
day when it does not have inpatients.
| (i) |
The
CAH shall, in accordance with the local emergency response systems, establish
procedures under which a physician is immediately available by telephone or
radio contact, on a 24-hour per day basis, to receive emergency calls, provide
information or treatment of emergency patients, and refer patients to the CAH
or other appropriate location for treatment. |
| (ii) |
A physician or limited health care
practitioner with training in emergency care shall be on-call and immediately
available by telephone or radio contact and available to be on-site at the CAH
within thirty (30) minutes. |
| (iii) |
The CAH shall have equipment, supplies, and medications available for treating
emergencies, as are required of other organized hospital emergency
services. |
| (iv) |
Staff assigned to
provide emergency patient care shall have training in handling medical and
non-medical emergencies; and |
|
| 6. |
A registered nurse or licensed practical
nurse shall be on duty whenever the critical access hospital has one (1) or
more inpatients. |
|
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
served.
| (a) |
The design and construction
specifications for the hospital shall conform to those nationally accepted
standards for hospital design and construction as set forth in the
Guidelines for Design and Construction of Hospital and Healthcare
Facilities, published by the American Institute of Architects' Press,
which has been accepted for use by the Department and which are current, as
determined by the Department to be applicable, at either:
| 1. |
The time of construction of the hospital
when the initial permit was obtained; or |
| 2. |
The time of request for approval for
renovation(s) or addition(s) to areas of the hospital which impact patient
care. |
|
| (b) |
Compliance
with standards acceptable to the Department shall be determined by a state
architect designated by the Department to review hospital design and
construction specifications.
| 1. |
All parts of
the facility shall be subject to the architect's review, including new and
existing buildings, additions, alterations, or renovations to existing
structures, any mobile, transportable, or relocatable units, and any off-site
structures intended to house hospital services or functions. |
| 2. |
The hospital shall notify the Department
prior to initiating new construction, modifications, or additions and shall
submit plans for such new construction for review and approval by the state
architect designated by the Department. |
|
| (c) |
The hospital shall have evidence of a
satisfactory inspection of all buildings and structures, including any mobile
units, by the local representative of the state fire marshal, the local fire
and building authorities (where required by local ordinance), and the state
architect. |
| (d) |
Designated space for
the laundry, power plant, mechanical equipment, ambulance entrance, autopsy or
morgue, loading dock, incinerator, garbage can cleaning, and storage areas for
garbage and trash shall be constructed or arranged to avoid unreasonable noise,
steam, odors, hazards to patients, and unsightliness relative to patient
bedrooms, dining rooms, and lounge areas. |
| (e) |
Electrical, mechanical, and plumbing work
and equipment shall be designed and installed in accordance with local and
state ordinances. |
|
| (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:
| (a) |
If the
unit is used to provide routine ancillary services for hospital inpatients or
to provide services for the hospital emergency room, there shall be a covered
or enclosed walkway from the hospital to the unit to ensure patient safety from
the outside elements; |
| (b) |
The unit
shall be located so as to prevent diesel or exhaust fumes from the tractor or
unit generator from entering the fresh air intake of either the unit or the
facility; |
| (c) |
The unit shall have
means of preventing unit movement, either by blocking the wheels or use of pad
anchors; |
| (d) |
The hospital shall
provide waiting areas for the unit and, in close proximity to the unit, patient
and staff toilet facilities for use by the staff providing services from the
unit and for use by the patients accessing the services in the unit; |
| (e) |
Each unit shall be accessible to
wheelchair and stretcher bound patients; |
| (f) |
The hospital shall provide access to hand
washing facilities for staff in the unit, as appropriate to the services
provided in the unit and sufficient to allow compliance with the hospital's
infection control program; |
| (g) |
The
hospital shall have a plan for the handling of emergencies that may occur in
the unit. The unit shall be connected to the hospital communication system for
access to emergency response services; |
| (h) |
Waste lines to the unit shall be designed
and constructed to discharge into an approved sewage system. The hospital shall
ensure that back-flow prevention is installed at the point of water connection
on the unit; |
| (i) |
If stairs are used
to access the unit, they shall have stable handrails; and |
| (j) |
The hospital shall ensure that approaches
to the unit have adequate lighting for safe negotiation at all hours of
operation. |
|
| (3) |
Emergency Lighting and Power. The hospital shall have access to
emergency lighting and electrical power meeting the following requirements:
| (a) |
Functioning automatic emergency lighting
equipment in all corridors in nursing units and in each operating room,
delivery room, emergency room, exit, elevator, and stairway; and |
| (b) |
A functioning emergency electrical
system. The emergency electrical system shall be so controlled that after
interruption of the normal electric power supply, the generator is brought to
full voltage and frequency and connected within ten (10) seconds through one or
more primary automatic transfer switches to all emergency lighting; all alarms;
blood banks; nurses' call; equipment necessary for maintaining telephone
service; pump for central suction system; and receptacles in operating rooms
and delivery rooms, patient corridors, patient rooms, recovery rooms, intensive
care nursing areas, and nurseries. All other lighting and equipment required to
be connected to the emergency system shall either be connected through the
above-described primary automatic transfer switching or shall be subsequently
connected through other automatic or manual transfer switching. Receptacles
connected to the emergency system shall be distinctively marked for
identification. Storage-battery-powered lights, provided to augment the
emergency lighting during the interim of transfer switching immediately
following an interruption of the normal service supply, shall not be used as a
substitute for the requirement of a generator. Where fuel is normally stored on
the site, the storage capacity shall be sufficient for twenty-four (24) hour
operation. Where fuel is normally piped underground to the site from a utility
distribution system, storage facilities on the site will not be
required. |
|
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:
| 1. |
Variance. A variance may be
granted by the Department upon a showing by the applicant that the particular
rule or regulation that is the subject of the variance request should not be
applied as written because strict application would cause undue hardship. The
applicant must also show that adequate standards exist for affording protection
for the health, safety, and care of patients, and these existing standards
would be met in lieu of the exact requirements of the rule or
regulation. |
| 2. |
Waiver.
The Department may dispense altogether with the enforcement of a rule
or regulation by granting a waiver upon a showing by the applicant that the
purpose of the rule or regulation is met through equivalent standards affording
equivalent protection for the health, safety, and care of the
patients. |
| 3. |
Experimental
Waiver or Variance. The Department may grant a waiver or variance to allow
experimentation and demonstration of new and innovative approaches to delivery
of services upon a showing by the applicant that the intended protections
afforded by the rule or regulation in question are met and the innovative
approach has the potential to improve service delivery;
|
|
| (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.
