Ala. Admin. Code r. 420-5-2-.02

Current through Register Vol. 42, No. 12, September 30, 2024

Section 420-5-2-.02 - Administration

(1) Governing Authority.

(a) Responsibility. The governing authority or the owner or the person or persons designated by the owner as the governing authority shall be the supreme authority of the facility, responsible for the management, control, and operation of the facility, including the appointment of a qualified medical director.

(b) Organization. The governing authority shall be formally organized in accordance with a written constitution and/or bylaws. In the event the governing authority consists of one person, this requirement must still be met. Such constitution and/or bylaws shall include:

1. Identification of the facility.

2. The purpose for which the facility is organized.

3. Length of tenure and mechanism for appointment of members of the governing body.

4. Appointment and duties of the chief executive officer.

5. Requirement that the medical staff be organized in accordance with bylaws approved by the governing authority.

6. Mechanism for appointment and reappointment at regular intervals of the medical staff members and the medical director in accordance with written bylaws.

7. Mechanism for approval of bylaws or policies governing the activities of the medical director and medical staff.

(c) Meetings. The governing authority shall meet regularly. A copy of the minutes of these meetings shall be kept as a permanent record of the facility.

(d) Notification of Chief Executive Officer. The State Board of Health shall be advised of the chief executive officer's name within 15 days of his appointment.

(2) The Chief Executive Officer.

(a) Responsibility. There shall be a competent, well trained chief executive officer who shall assume authority and responsibility for directing, coordinating, and supervising the overall activities of the facility. The chief executive officer and the medical director or other qualified employee of the facility may be one and the same person depending upon the size and degree of management and supervision required for appropriate operation of the facility.

(b) Enforcement of Medical Staff Regulations. As the authorized representative of the governing authority, the chief executive officer shall have the authority to enforce medical staff rules and regulations with regard to patient care, after consultation with appropriate members of the medical staff.

(c) Policies and Procedures. The chief executive officer shall be responsible for assuring either directly or through delegation of authority, that policies promulgated by the governing authority are carried out. Appropriate procedures to enforce these policies, assure proper patient care and safety, and meet requirements of these rules shall be developed in writing by an appropriate committee composed of professionals and shall be reviewed at least annually.

(d) Consultation. The center shall seek consultation where necessary for the improvement of efficiency of operation and the quality of patient care.

(3) Personnel.

(a) Medical Director. A qualified physician medical director shall be appointed or designated by the governing body. It shall be the responsibility of the medical director to:

1. Develop or advise appropriate personnel of the center in the development of medical procedures governing operation of the facility.

2. Either perform or assure proper performance by other physicians of medical procedures carried out in the center.

3. Periodically, at least annually, participate in a review for appropriateness of techniques and procedures relating to operations, nursing care procedures, and infection control procedures. Such review will be accomplished by the medical director, the director of nursing services and/or other personnel deemed appropriate by the medical director. Minutes of this review will be maintained and procedure manuals shall be annotated to reflect dated revisions.

(b) Director of Nursing Services. A registered professional nurse shall be responsible for proper performance of nursing services provided in the center.

(c) Qualification of Director of Nursing Services:

1. A graduate of a professional school of nursing

2. Currently licensed by the Alabama Board of Nursing

3. Have at least one year experience in surgical/recovery nursing

4. Good mental and physical health

(d) Responsibilities of Director of Nursing Services.

1. Work within the framework of policies set forth by the facility

2. Develop nursing service policies and procedures

3. Develop a job description for each category of nursing service

4. Provide a thorough orientation for new nursing personnel including written verification of their competency

5. Provide supervision of nursing service personnel

6. Provide ongoing inservice education

7. Verification of license and physical examinations to ensure that they are current.

(e) Other required Nursing Service Personnel.

1. Operating Room

(i) Personnel in the operating room must include at least one (1) registered professional nurse to serve as the circulating nurse in each operating room. Additional personnel may include another RN, LPN or surgical technician to scrub.

2. Recovery Area(s)

(i) Personnel in each recovery area must include at least one (1) registered professional nurse or licensed practical nurse and supportive personnel as needed.

(ii) At least one registered professional nurse shall be on duty at all times while the center is in operation.

(f) Non-Nursing Service Personnel. Non-nursing service personnel, i.e., aides, housekeeping, office, etc., shall be assigned in sufficient numbers and with sufficient training to meet the needs of patients.

(g) CPR Trained Personnel. A person designated to perform cardiopulmonary resuscitation and at least one other person shall remain on the premises of the facility at all times during the work day or evening from the commencement of the first surgical procedure until all patients are discharged. Individuals designated to perform cardiopulmonary resuscitation shall be properly certified and shall attend a training course in cardiopulmonary resuscitation at least annually. Each facility shall maintain adequate staffing records to demonstrate that this requirement is met.

(4) Fire Evacuation Plan.

(a) Written Evacuation Plan. A written fire control and evacuation plan shall be maintained by each facility. In addition, necessary 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 quarterly and written observations of the effectiveness of these rehearsals shall be filed and kept for at least three (3) years.

(5) 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 and 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 persons in the facility.

(b) Telephones. There shall be an adequate number of telephones to summon help in case of fire or other emergency, and these shall be located so as to be quickly accessible from all parts of the building.

(6) Records and Reports.

(a) Medical Records to be Kept. An ambulatory surgical center shall keep adequate records including admission and discharge notes, histories, physical examinations, nurses notes, social service records, operative report, anesthesia record, informed consent, follow-up care, records of tests performed, and other records as indicated. The patients' records shall be current and kept in detail consistent with good medical and professional practice based on the service provided to each patient.

(b) Authentication of Records. All records shall be written, dated and signed in an indelible manner and made a part of the patient's permanent record.

(c) Filing of Records. All patient medical records shall be filed in a manner which will facilitate easy retrieval of any individual's record. If records are filed according to a number system, alphabetical cross-indexing shall be available.

(d) Storage of Records. Storage of records shall be in such a manner as to protect them from fire and water damage.

(e) Title to Records. Records of patients are the physical property of and kept in the facility and responsibility for control of them shall rest with the chief executive officer and governing authority.

(f) 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 or other persons authorized by state or federal laws shall be permitted to review medical records as necessary for compliance.

(g) Preservation of Records. Medical records shall be preserved, either in the original or by microfilm for a period of not less than six years following the most recent discharge of the patient. In the case of a minor, records shall be kept for six years following the patient's obtaining legal age.

(h) Disposition of Records. When an ambulatory surgical 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 and/or disposal of patient medical records and x-ray files. Any ambulatory surgical center that fails to develop a plan for disposition of its records acceptable to the State Board of Health shall dispose of its records as directed by a court of appropriate jurisdiction.

(i) Vital Statistics Report. A record shall be kept of all births, deaths, and stillbirths that occur within the center. By the fifth day of each month, the chief executive officer shall make a report of such births, deaths, and stillbirths for the preceding month on such form as the State Board of Health shall provide to the county health officer, or in counties without a county health officer, to the State Registrar. This report shall be in addition to the official birth, death, and stillbirth certificates. If there are no births, deaths, or stillbirths in any month, a report stating that fact shall be made to the county health officer.

(j) Personnel Records. The facility shall maintain a personnel record of each employee. As a minimum, the record shall include:

1. Application for employment that contains information regarding education, experience, and if applicable, registration and/or licensure information of the applicant, all physical examinations and evidence of continuing or inservice education.

(k) Operating Hours. The hours and days during which the center is open to the public and the hours for any intermittent specialty service centers not daily shall be conspicuously posted for public view and information.

(l) Health Examinations. As a minimum, each employee coming in contact with patients shall have a preemployment health examination by a physician. The examination is to be repeated annually and more frequently if indicated to ascertain freedom from communicable diseases. The extent of such examinations shall be determined by the medical director and documentation made in the employee's personnel folder. The examination shall include a chest x-ray or a tuberculin test.

(m) Operative Consent. Written informed consent for the performance of any surgical procedure must be obtained from the patient in every case. Consent by parent and/or guardian must be obtained if required by law.

(7) Patient Transfer and Transport.

(a) Transfer Agreement. Facility shall have a written agreement with one or more hospitals to ensure prompt referral and back-up services for patients requiring attention for an emergency or other condition necessitating hospitalization. Policies shall be developed relating to preoperative and postoperative transportation.

(b) If a patient is unable to ride in an upright position or if such patient's condition is such that he or she needs observation or treatment by Emergency Medical Services personnel, or if the patient requires transportation on a stretcher, gurney or cot, the facility shall arrange or request transportation services only from providers who are ambulance service operators licensed by the Alabama State Board of Health. If such patient is being transported to or from a health care facility in another state, transportation services may be arranged with a transport provider licensed as an ambulance service operator in that state. For the purposes of this rule, and upright position means no more than 20 degrees from vertical.

Author: Rick Harris

Ala. Admin. Code r. 420-5-2-.02

Filed September 1, 1982. Amended: Filed February 20, 1991. Amended: Filed June 23, 2004; effective July 28, 2004.

Statutory Authority:Code of Ala. 1975, §§ 22-2-2(6), etseq.; 22-21-28, etseq.