Ala. Admin. Code r. 540-X-10-.11 - Reporting Requirement

(1) Reporting to the Alabama Board of Medical Examiners is required within three (3) business days of the occurrence and will include all surgical related deaths and all events related to a procedure(s) that resulted in an emergency transfer of the surgical patient to the hospital, anesthetic or surgical events requiring CPR, unscheduled hospitalization related to the surgery, and surgical site deep wound infection.
(2) Office Administration. The following summarizes some of the important written documents and polices and procedures that office-based practices are encouraged to develop and implement. The policies and procedures should undergo periodic review and updating. Office-based surgery practices are encouraged to utilize on-site patient safety surveys that are performed by professional trade associations, nationally recognized accrediting agencies and/or other organizations experienced in providing emerging risk-reduction strategies associated with office-based surgery.
(a) Policies and Procedures. Written policies and procedures can assist office-based practices in providing safe and quality surgical care, assure consistent personnel performance, and promote an awareness and understanding of the inherent rights of patients. The following are important aspects of an office-based practice that should benefit from simple policy and procedure statements.
1. Emergency Care and Transfer Plan: A plan shall be developed for the provision of emergency medical care as well as the safe and timely transfer of patients to a nearby hospital should hospitalization be necessary.
(i) Age appropriate emergency supplies, equipment and medication should be provided in accordance with the scope of surgical and anesthesia services provided at the practitioner's office.
(ii) In an office where anesthesia services are provided to infants and children, the required emergency equipment should be appropriately sized for a pediatric population, and personnel should be appropriately trained to handle pediatric emergencies (currently trained in APLS or PALS).
(iii) At least one physician currently trained in ACLS must be immediately and physically available until the last patient is past the first stage of recovery. A practitioner who is qualified in resuscitation techniques and emergency care should be present and available until all patients having more than local anesthesia or minor conductive block anesthesia have been discharged from the office (Advanced adult or pediatric life support certified).
(iv) In the event of untoward anesthetic, medical or surgical emergencies, personnel should be familiar with the procedures and plan to be followed, and able to take the necessary actions. All office personnel should be familiar with a documented plan for the timely and safe transfer of patients to a nearby hospital. This plan should include arrangements for emergency medical services, if necessary, or when appropriate escort of the patient to the hospital by an appropriate practitioner. If advanced cardiac life support is instituted, the plan should include immediate contact with emergency medical services.
2. Medical Record Maintenance and Security: The practice should have a procedure for initiating and maintaining a health record for every patient evaluated or treated. The record should include a procedure code or suitable narrative description of the procedure and should have sufficient information to identify the patient, support the diagnosis, justify the treatment and document the outcome and required follow-up care. For procedures requiring patient consent, there should be a documented informed written consent. If analgesia/sedation, minor or major conduction blockade or general anesthesia are provided, the record should include documentation of the type of anesthesia used, drugs (type, time and dose) and fluids administered, the record of monitoring of vital signs, level of consciousness during the procedure, patient weight, estimated blood loss, duration of the procedure, and any complications related to the procedure or anesthesia. Procedures should also be established to assure patient confidentiality and security of all patient data and information.
3. Infection Control Policy: The practice should comply with state and federal regulations regarding infection control. For all surgical procedures, the level of sterilization should meet current OSHA requirements. There should be a procedure and schedule for cleaning, disinfecting and sterilizing equipment and patient care items. Personnel should be trained in infection control practices, implementation of universal precautions, and disposal of hazardous waste products. Protective clothing and equipment should be readily available12.
4. Federal and State Laws and Regulations: Federal and state laws and regulations that affect the practice should be identified and procedures developed to comply with those requirements. The following are some of the key requirements upon which office-based practices should focus:
(i) Non-Discrimination (see Civil Rights statutes and the Americans with Disabilities Act).
(ii) Personal Safety (see Occupational Safety and Health Administration information)
(iii) Controlled Substance Safeguards.
(iv) Laboratory Operations and Performance (CLIA).
(v) Personnel Licensure Scope of Practice and Limitations


Ala. Admin. Code r. 540-X-10-.11
New Rule: Filed October 17, 2003; effective November 21, 2003.
Rule 540-X-10-.10 was renumbered .11 as per certification filed September 22, 2011; effective October 27, 2011.

Authors: Alabama Board of Medical Examiners ad hoc Committee: Arthur F. Toole, III, M.D.; Jorge A. Alsip, M.D.; James G. Chambers, III, M.D.; Craig H. Christopher, M.D.; Alcus Ray Hudson, M.D.; Pamela D. Varner, M.D.; James E. West, M.D.; and Task Force Sub-Committee: Jeff Plagenhoef, M.D.; Eric Crum, M.D.; Dan J. Coyle, Jr., M.D.; Gary Monheit, M.D.; Robert Hurlbutt, IV, M.D.; C. Paul Perry, M.D.; W. Guinn Paulk, M.D.; Mark McIlwain, D.M.D., M.D.; Jerald Clanton, D.M.D., M.D.; Patrick J. Budny, M.D.; James W. Northington, M.D.; David Franco, M.D.; Thomas E. Moody, M.D.

Statutory Authority: Code of Ala. 1975, ยง 34-24-53.

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