Stratification of Facilities Based on Administered Anesthesia

Facilities are often classified on the level of the anesthetic care offered. One classification would stratify the facilities as: Class 1, Local, Regional and Topical Anesthesia; Class 2, Parenteral Sedation (not including propofol); Class 3, Parenteral Sedation Including Propofol; and Class 4, General Anesthesia. In the case of Class 3 and Class 4, an anesthesiologist or certified registered nurse anesthetist (CRNA) would be required to administer the anesthetic.

In Class 2, a qualified physician could supervise the administration of a parenteral sedation.

Operating Suite (Physical Plant)

An operating suite should include an operating room (OR), scrub area, clean area, dirty area, and a recovery room. The operating suite needs to be physically separate from the general office.

The OR should be a separate and distinct area in the suite, dedicated specifically for surgical use. All major surgery is to be performed in the OR. To maintain the sterile atmosphere, unauthorized individuals should be deterred from entering the OR. The OR should be adequately ventilated and temperature controlled for safety reasons. Hypothermia is known to increase risk of arrhythmias and infection.

The available square footage in the OR must be adequate to hold all of the personnel, equipment, sterile supplies, and medications necessary to perform the surgical procedure. It should be sufficient to accommodate emergency situations and the personnel necessary to evacuate a patient in the case of an unforeseen event. Efficiency and sterility dictate that personnel leaving the operating room to obtain supplies should be kept to a minimum, and that the storage space in the OR should allow for easy identification and inventory of the supplies.

Surfaces in the OR, such as the countertops, ceiling surface, and floors, should be smooth, easily washable, and free of particular material that might cause contamination. There must not be any tears, breaks, or cracks in these surfaces that could harbor bacteria. Any seams should be sealed with an impermeable sealant other than silicone.

The recovery-area space allocated in the suite should be sufficient to accommodate the necessary personnel, equipment, and monitoring devices necessary for a safe recovery. This area needs to be stocked with readily accessible equipment and medications for routine recoveries, as well as emergencies. Similar to the OR, the postanesthesia care unit (PACU) should be easy to clean and free from fire hazards. Space available for sterilizing instruments should be segregated into a dirty area where contaminated instruments are cleaned, and a clean area for packaging and sterilization. Separation between dirty and clean areas may be accomplished by a wall, distance, or time. The same area may be used for both purposes if, and only if, it is the documented policy of the facility to clean and disinfect the dirty utility area before assembly of packages for sterilization occurs.

Fire in an operating suite can be disastrous. Proper preparation and avoidance of problems may mitigate the devastating effects including injury and loss of life. The facility must be equipped with heat sensors and/or smoke detectors and an adequate number of appropriately placed fire extinguishers that are inspected annually. Fire-exit signs are posted and adequate emergency lighting is available. A smoke-filled room can become dark very quickly, and appropriate lighting is critical. All safety regulations of the Occupational Safety and Health Administration (OSHA) should be followed to help decrease the risk of fire. Appropriate fire precautions must be in place when using a cautery or a laser during the administration of oxygen.

Fire safety mandates that the operating suite contain sufficient number of electrical outlets that are labeled and grounded. There must be a source of emergency power, such as a generator or battery-powered inverter, with the capacity to operate anesthesia, surgical equipment, and lighting for an amount of time that is consistent with procedures performed. The generated power should be available seamlessly within 30 seconds of the power failure. Pertinent safeguards require that essential equipment should be connected to the emergency power source during surgery and recovery, thus preventing a situation whereby personnel are frantically looking for backup power outlets during an outage or, worse, in a smoke-filled room. The backup power equipment should be checked on a monthly basis and a log kept of the checks.

Equipment

Boxes 1–3 list the basic equipment that should be contained in the operating room and PACU. The equipment requirement may vary somewhat depending on the type of anesthesia administered in the facility.

The specifications, that is, the manufacturer’s recommendations for the equipment’s operation, maintenance, and cleaning, should be kept in an organized file available to all staff. Safety standards demand that only inspected equipment is permitted to be used in the suite. All equipment should be inspected at least annually by a biomedical technician. Detailed records of the equipment inspections should be kept. Some equipment, such as sterilizers, should be checked weekly with spore tests or an equivalent, and the records maintained. Automated external defibrillators and defibrillators should also be checked weekly and a performance log kept. Any repairs should be performed and documented by a biomedical technician.

Instrument Sterilization

The facility is required to have at least one autoclave that uses high-pressure steam. A gas sterilizer is an acceptable addition, and must be vented properly. High-level disinfectants, such as Cidex, may only be used for nonautoclavable equipment by which contact will be made with mucous membranes or other body surfaces that are not sterile. Protocols for proper handling and sterilization of equipment should be present in the Policy and Procedure manual (for an example of a high-level disinfection protocol, see Box 4 ). If the sterilizer produces monitoring records, they should be logged. If no monitoring record is produced, best practices may include production of a sterilizing log noting each load that is sterilized by whom, the date, the cycle that it was sterilized on, and so forth.

Storage of sterile supplies should be away from potentially contaminated areas; sterile packages should be labeled to indicate date of sterilization and, if necessary, when the sterility should expire. Sterile supplies should be packaged and sealed to prevent accidental opening and, if more than 1 sterilizer is available in the facility, the package should be labeled as to which sterilizer was used, in the case of a positive spore test. Sterile and clean supplies should not be stored in the same space. Sterile packages should not be stored above a steam autoclave, to prevent contamination.

Cleaning the Facility

The entire operating suite should be cleaned and disinfected according to an established schedule created specifically to prevent cross-contamination. Blood and body-fluid spills are cleaned using an intermediate-level disinfectant (sporicidal, bactericidal, fungicidal, and virucidal). If the cleaning personnel are not part of the staff, they should sign a HIPAA (Health Insurance Portability and Accountability Act 1996) compliant confidentiality agreement in the event that any patient information is visible.

Medical wastes are stored in OSHA-acceptable containers and separated for special collection. Disposable sharps are kept in a puncture-resistant container close to the area where they are used. Finally, all garments, scrub suits, linen, blankets, and so forth do not leave the facility to be washed at home, but are cleaned by an OSHA-compliant laundry; or, if the laundry is processed on premises, a protocol geared to rid the laundry of pathogens is followed.

Medication, Intravenous Fluids, Gases

All medications present must be in date and readily identifiable. It is critical that all personnel know the location of medications, especially emergency medications. An emergency cart with a defibrillator, necessary drugs, other cardiopulmonary resuscitation equipment (such as a source of suction and intravenous setup), and the Advanced Cardiopulmonary Life Support (ACLS) algorithms resides in the suite.

All controlled substances are to be secured and locked under supervised access. A bound or secured-computer narcotic inventory and control record is required. This record must be dated and include the patient’s name or ID number, and be verified by 2 licensed members of the OR team at least weekly as well as on the day any of these agents are administered.

It is required that intravenous fluid is present in every facility, even if just local or topical anesthetics are used. If the facility presents an unusual situation in having a means to obtain and administer, there must be a protocol for the blood to be typed, cross-matched, checked, and verified. Dextran, a blood substitute, should be present in the facility, or the facility should have a means of obtaining it on a timely basis.

If potential triggering agents are present in the facility, an appropriate malignant hyperthermia emergency protocol and setup must be available. Even if succinylcholine is present and is only to be used in dire circumstances such as for bronchospasm, this setup is required. An alternative to the drug of choice (succinylcholine) is the nondepolarizing and nontriggering agent, rocuronium.

A reliable source and amount of oxygen should be present, and must include a regulator as well as the tubing and mask. Other essential equipment for a facility that would be Class 2 or greater (see later discussion) would include a laryngeal mask airway or endotracheal tube necessary to deliver the oxygen. A self-inflating Ambu bag capable of delivering positive pressure ventilation with 90% oxygen concentration, and a separate pulse oximeter for each patient, are essential.

All explosive and combustible materials are stored and handled in a safe manner according to state, local, and/or National Fire Protection Association codes. Compressed-gas cylinders should be chained to the wall or placed in an appropriate carrier.

OR Suite Staff: Medical Director, Practitioners, Personnel

A Medical Director, specifically a physician (MD or DO), is a necessity. The Medical Director must actively participate in the management of the facility. The Medical Director must be currently licensed in the state where the facility is located. The team should include a nurse and anesthesiologist or CRNA when dissociative anesthesia, intravenous sedation with propofol, or general anesthesia is performed. Determining who is appropriately credentialed and qualified to perform procedures in the facility is an arduous task, as any physician who has obtained hospital privileges can attest. The required steps are practically impossible for a smaller facility to accomplish. Each facility cannot have its own criteria for credentialing. One solution to the credentialing dilemma is to require the practitioner be credentialed by an acute care hospital for privileges consistent with privileges requested of the facility.

In addition, following the American Medical Association core principle #7, it is essential that every individual who performs procedures in the facility needs to be “…currently board certified/qualified by one of the boards recognized by the American Board of Medical specialties, American Osteopathic Association, or a board with equivalent standards approved by the state medical board.” The procedures that the practitioner performs must be “generally recognized by that certifying board as falling within the scope of training and practice of the physician providing the care.” Appropriate board certification of podiatrists or oral surgeons must also be required.

The proof of acceptable credentials is evidenced by the practitioner’s demonstration that he or she holds or has held unrestricted core privileges in his or her specialty at a licensed care hospital. The loss of hospital privileges may not be caused by a lack of clinical competence, ethical issues, and so forth; rather, the only acceptable reason for the loss of hospital privileges is economic credentialing by the care facility. If the practitioner has not maintained privileges, arrangements must be in place assuring that another practitioner of the same specialty with privileges at the local acute care hospital will assume care of the patient in the event of unforeseen hospital transfer of the patient.

Continued maintenance of privileges requires that each physician, podiatrist, or oral and maxillofacial surgeon submits to the facility a copy of his or her current appropriate state license. Any actions affecting the practitioner, Medical Director, or any other member of the team must be reported to the governing body within a reasonable specified time period.

The personnel who work in the OR suite must meet acceptable standards as defined by their professional governing bodies, where applicable. Every employee should have a file that contains documentation (as outlined in Box 5 ). Be aware that according to OSHA regulations, these files should be kept for 30 years. There should be a written manual containing job descriptions, confidentiality policies, vacation policies, payment procedures, and so forth. Every employee should become familiar with the policies contained in this manual.

There is a regularly employed and licensed registered nurse, physician (other than the operating surgeon), or physician’s assistant designated as the person responsible for patient care in all areas of the suite. All operating suite personnel are under the immediate supervision of this individual.

The OR personnel must be knowledgable in treating cardiopulmonary and anaphylactic emergencies. The OR personnel are familiar with operation and location of equipment, medication, and procedures used in the treatment of such emergencies. At least one member of the OR team, preferably the surgeon or the anesthesia provider, must hold current ACLS certification. Everyone else should possess at least a current Basic Cardiopulmonary Life Support certification (see Box 4 ).

The safety of all OR suite personnel is essential. There is a written policy for personal protective equipment for specific tasks in the facility such as instrument cleaning, disposal of biological waste, and surgery. Badge testing is required if a gas sterilizer, x-ray equipment, or high-level disinfectant is used in the facility. A Facility Safety Manual should provide employees with information about hazardous chemicals used and methods to minimize exposure to them. Material safety data sheets on all potentially hazardous substances found in the facility should be located in this manual.

Anesthesia: Anesthesiologist/CRNA

In facilities where dissociative anesthesia with propofol, spinal or epidural blocks, or general anesthesia is administered, an anesthesiologist or CRNA must provide the anesthetic care. These individuals must be qualified for such patient care, their credentials verified, and the documentation kept on file. These persons must be responsible for the monitoring of all life-support systems and ensure that all anesthesia equipment is in proper working order.

If responsible for supervising anesthesia or providing anesthesia, the qualified physician or CRNA must be present in the operating suite throughout the anesthetic. If sedation is being supervised by the operating surgeon, he or she must have knowledge of anesthetics and resuscitative techniques. Podiatrists and oral surgeons must use an anesthesiologist or a supervising physician to administer anesthesia other than local.

A physician is responsible for determining the medical status of the patient, and must examine the patient immediately before surgery. The anesthesia care provider must verify that an anesthesia care plan has been developed and documented. The patient must be informed of such a plan and receive preoperative instruction by the anesthesia provider supervising the anesthetic.

During the procedure, besides administering medication the individual responsible for the anesthetic care should monitor and record the patient’s vital signs on a frequent basis. Appropriate fluids should be administered, oxygenation maintained, and temperature monitored, especially if clinically significant changes in body temperature are expected. Forced air warmers, blanket warmers, or other devices should be used to maintain patient temperature. Sequential compression devices should be used for cases other than local anesthesia and of longer duration.

Anesthesia personnel should be familiar with the facility’s emergency protocol for cardiopulmonary emergencies and other internal and external disasters. These individuals should be trained and knowledgable about the facility’s protocols for safe and timely transfer of a patient to an alternative care facility when extended or emergency services are required.

Protocols, Policies, and Procedures

Documentation: Medical Records

Medical records are to be kept in the facility. The record should include an intake sheet completed by the patient providing most of his or her medical history and demographics. A history and physical examination commensurate with the procedure to be performed, a preoperative anesthesia evaluation with an anesthesia care plan, and informed consent should be contained in the chart. All laboratory results must be present and reviewed. The review should be initialed and dated by the surgeon at the time of evaluation. All other reports, such as pathology reports and medical clearance reports, must be reviewed and initialed. A written operative report, anesthesia record, and recovery record should be present. Best practice would also include an OR record. Finally, postoperative notes should be present.

Quality Assessment and Quality Improvement

The facility has a written quality improvement program in place, which should include surveys of projects that monitor and evaluate patient care, evaluate methods to improve patient care, identify and correct deficiencies within the facility, and alert the Medical Director to identify and resolve problems. To monitor performance, a review of a set number of random cases and any operative sequelae occurring within 30 days of the surgery should be performed on a regular basis. Peer review must be conducted by a recognized peer-review organization or a physician, podiatrist, or oral and maxillofacial surgeon other than the operating surgeon.

Each Unanticipated Operative Sequelae chart review must include the following information, in addition to the operation performed: identification of the problem, immediate treatment or disposition of the case, outcome, reason for problem, and assessment of efficacy of treatment.