(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