Ala. Admin. Code r. 420-5-1-.02

Current through Register Vol. 42, No. 6, March 29, 2024

Section 420-5-1-.02 - Administration

(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.

Ala. Admin. Code r. 420-5-1-.02

Filed September 1, 1982. Amended: Filed August 16, 1990. Repealed and Replaced: Filed April 17, 2003; effective May 22, 2003. Amended: Filed February 21, 2007; effective March 28, 2007. Amended: Filed May 16, 2007; effective June 20, 2007. Amended: Filed November 15, 2013; effective December 20, 2013.

Authors: Rick Harris, W. T. Geary, Jr., M.D., Brian Hale

Statutory Authority:Code of Ala. 1975, §§ 22-21-20, et seq.