Current through Register Vol. 42, No. 11, August 30, 2024
(1)
Governing
Authority.
(a) Responsibility. The
governing authority is the person or persons responsible for the management,
control, and operation of the facility, including the appointment of persons to
fill the minimum staffing requirements. The governing authority shall ensure
that the facility is organized, equipped, staffed and administered in a manner
to provide adequate care for each patient admitted.
(b) Notification of Clinic Administrator. The
State Board of Health shall be advised of the clinic administrator's name
within fifteen days of appointment.
(2)
Policies and Procedures.
Policies and procedures for operation of the facility shall be formulated and
reviewed annually by the governing authority. They shall include at least the
following:
(a) Purpose of the facility, to
include scope and quality of services;
(b) Method to ensure compliance with all
relevant federal, state, and local laws that govern operations of the
facility;
(c) Inservice training
requirements;
(d) The person to
whom responsibility for operation and maintenance of the facility is assigned
and methods established by the licensee for holding such individual
accountable;
(e) Provision for
annual review and evaluation of the facility's policies, procedures, management
and operation;
(f) Provision for a
facility-wide quality improvement program.
(g) Patient rights and grievance
procedures;
(h) Functional safety
and maintenance policies and procedures;
(i) Incident reporting;
(j) Informed Consent;
(k) Patient Care Policies and
Procedures.
(l) Handling of
confidential records.
(3) There shall be a facility-wide quality
improvement program to evaluate patient care and facility services. The program
shall be ongoing, have statistical summaries and a written plan of
implementation.
(4)
Clinic
Schedule. A schedule listing the days during which the clinic will
perform procedures shall be furnished to the Alabama Department of Public
Health, Division of Health Care Facilities. Any changes to the schedule or
cancellation of procedure days shall be reported to the Division prior to the
schedule change taking effect.
(5)
Personnel.
(a) Each abortion
clinic shall utilize personnel to provide services who have appropriate
training and qualifications for the services that they provide.
(b) Personnel Files. There shall be a
personnel file for each employee which shall include:
1. Job Description. A written job description
that describes the duties and responsibilities, position title, authority, and
qualifications for each employee.
2. Application. The licensee shall obtain
written applications for employment from all employees. The licensee shall
obtain and verify information on the application as to education, training,
experience, and appropriate licensure, if applicable.
3. Orientation. There shall be a written
orientation program to familiarize each new staff member with the facility and
its policies and procedures, to include at a minimum, fire and disaster safety,
medical emergencies, infection control, and patient confidentiality. There
shall be documentation of completion of this orientation maintained in the
personnel file.
(c)
Medical Director. Each abortion facility shall have a medical director who
shall be responsible for supervising all clinical functions and ensuring that
the facility meets the requirements of these rules and all professional
standards of care. The medical director has ultimate responsibility for the
development and implementation of all protocols and policies used by the
facility. The medical director shall be board eligible or board certified in
obstetrics and gynecology and shall have had at least 12 months experience in
treatment of gynecological problems in a surgical environment. The medical
director shall ensure that all clinical staff, including both facility and
outside covering physicians associated with the facility, are competent as
required by these rules and professional standards of care.
(d) Physician Qualifications.
1. Only a physician may perform an abortion.
Only a physician may give, sell, dispense, administer, or otherwise prescribe
an abortion-inducing drug. All physicians performing abortions at the facility
shall be qualified through training and experience in performing abortions and
recognizing and managing complications.
2. Before a physician performs any procedure
at the facility, the Medical Director shall credential each physician on the
basis of his or her qualifications, and a file shall be kept at the facility
detailing the qualifications and experience of each physician. This file must,
at a minimum, include:
(i) proof of licensure
in Alabama and all other states in which the physician is or has ever been
licensed,
(ii) a record of any
adverse actions ever taken against the physician's license in Alabama or any
other state,
(iii) a current
resume,
(iv) a record of staff
privileges at any accredited hospital in the United States,
(v) a report from the National Practitioner
Databank and
(vi) proof of the
nature of the physician's training and experience.
This file shall be kept current. The medical director shall
review the physician's qualifications at the time the physician is hired and at
least yearly thereafter. This review shall include direct observation of the
physician's clinical skills, and the results of this review shall be placed in
the physician's file.
3. For the purposes of this section,
acceptable proof of training and experience for a physician performing a
procedure at the facility shall consist of at least one of the following:
(i) Certification from an accredited
residency or fellowship program in the United States that the physician has
been trained to perform abortions and manage and recognize
complications;
(ii) Certification
from an accredited hospital in the United States that the physician's staff
privileges include performing abortions;
(iii) Verification from a properly trained
disinterested physician that the disinterested physician has had direct
observation of the physician's clinical skill in performing both medical and
surgical abortions at a range of gestational ages and finds them to be
satisfactory and within the standard of care. For the purposes of this
paragraph, a properly trained physician shall meet the requirements of either
(i), (ii), or (iii).
4.
An outside covering physician shall have staff privileges at a hospital within
the same standard metropolitan statistical area that permit him or her to
perform dilation and curettage, laparotomy procedures, hysterectomy, and any
other procedures reasonably necessary to treat abortion-related
complications.
(e)
Required Professional Nursing Personnel. Nursing care shall be under the
supervision of a registered professional nurse currently licensed in Alabama.
At least one registered professional nurse shall be on duty to provide or
supervise all nursing care of patients in preparation, during the termination
procedure, the recovery period, and initial discharge by the attending
physician. Other nursing service personnel shall remain on duty as required to
meet the needs of each patient.
(f)
Non-Nursing Service Personnel. Non-nursing service personnel; i.e., counselors,
housekeeping workers, office workers, etc., shall be assigned in sufficient
numbers and shall have sufficient training to meet the needs of all
patients.
(g) Cardio-Pulmonary
Resuscitation. A person designated to perform cardio-pulmonary resuscitation
and at least one other person shall remain on the facility premises from the
moment the first patient is sedated until all patients have left the facility
premises. Individuals designated to perform cardio-pulmonary resuscitation
shall be properly certified and attend a training class in cardio-pulmonary
resuscitation at least annually. Each facility shall maintain adequate staffing
records to demonstrate that this requirement is met.
(h) Employees who develop signs or symptoms
of infectious skin lesions or diseases that would be capable of transmission to
patients through normal staff to patient contact shall not be permitted to have
patient contact until free from such signs and symptoms.
(6)
Fire Evacuation Plan.
(a) Written Evacuation Plan. A written fire
control and evacuation plan shall be maintained by each facility. In addition,
instructions and fire evacuation routes shall be posted in conspicuous places
in the facility and shall be kept current.
(b) Fire Drills. Fire drills shall be
conducted at least semi-annually for the staff and written observations of the
effectiveness of these rehearsals shall be filed and kept at least three
years.
(7)
Communication Facilities.
(a)
Call System. Arrangements shall be provided within the facility to summon
additional personnel or help when or if needed in the event of emergency
conditions. Requirements will depend on the size of physical configuration of
the facility. In general, if all personnel (or occupants) are within hearing
distance of any area of the facility, this would be deemed sufficient.
Otherwise, there shall be a call system to all portions of the building
normally occupied by personnel of the facility.
(b) Telephones. There shall be two or more
telephones to summon help in case of fire or other emergency, and these shall
be located so as to be accessible from all parts of the building.
(8)
Records and
Reports.
(a) Medical Records to be
Kept. An abortion facility shall keep adequate records, including procedure
schedules, histories, results of examinations, nurses' notes, records of tests
performed, copy of report of abortion made to the Center for Health Statistics,
and all forms required by law.
(b)
Authentication of Records. All records shall be legibly written, dated, and
signed in an indelible manner with the identity of the writer
indicated.
(c) Filing of Records.
All patient medical records shall be filed in a manner which will facilitate
easy retrieval of any individual's record.
(d) Storage of Records. Records shall be
stored in filing cabinets.
(e)
Title to Records. Records of patients are the physical property of the licensee
and responsibility for control and maintenance shall rest with the governing
authority. Information in the patient's record shall be disclosed to the
patient or her designee upon written request within a reasonable amount of
time. This may be conditioned upon the payment of a reasonable copying
charge.
(f) Disposition of Records.
When an abortion or reproductive health center ceases to operate either
voluntarily or by revocation of its license, the governing body (licensee) at
or prior to such action shall develop a proposed plan for the disposition of
its medical records. Such plan shall be submitted to the State Board of Health
and shall contain provisions for the proper storage, safeguarding and
confidentiality, transfer or disposal of medical records. Any abortion or
reproductive health center that fails to develop a plan of disposition of its
records acceptable to the State Board of Health shall dispose of its records as
directed by a court of appropriate jurisdiction.
(g) Records shall be Confidential. Records
and information regarding patients shall be confidential. Access to these
records shall be determined by the governing authority of the facility.
Inspectors for licensure shall be permitted to review medical records to
determine compliance with these Rules.
(h) Preservation of Records. Medical records
shall be preserved either in the original or by microfilm for a period of not
less than four years.
(9)
Patient Referral.
(a) Referral. Licensee shall maintain a
24-hour answering service. Patients shall receive a return call within a
reasonable time.
Authors: Rick Harris, W. T. Geary, Jr., M.D.,
Brian Hale
Statutory Authority:
Code of Ala.
1975, §§
22-21-20, et
seq.