In terms of sterilization, the initial decision is to determine if this is to be done in the office itself or sent to an outside vendor for processing and sterilization. If the process is to be done by an outside vendor, the surgeon and staff need to be aware of scheduling and stocking of equipment in order to ensure needed equipment such as the cystoscope or hysteroscope is clean and available. If this is done in the office, who will be completing this, and how will they be kept in compliance for maintaining the instruments? Some institutions have specific protocols that are followed in regards to sterilization (see policy for your specific institution) but stand-alone offices will need to have one.

The ultimate goal of disinfection and sterilization in office surgical practices is to reduce rates of health care-associated infections through appropriate use of both disinfection and sterilization [5]. Therefore, the type of sterilization should be addressed first. Once this has been decided, keep in mind that is important to always clean first, then disinfect or sterilize [6]. This includes removing visible tissue and fluids to allow for the removal of microorganisms and organic matter. Shortly after use, take apart the equipment for cleaning and reassemble it on the field. Sterilize all moving parts in the open position to ensure proper cleaning. If there is a question about how an instrument should be cleaned, it is suggested to first follow the manufacturer’s guidelines to avoid damaging an instrument or shortening its usefulness due to unnecessary wear and tear from improper maintenance.

All endoscopes should be disconnected and disassembled and cleaned with an enzymatic cleaner that is suitable with the cystoscope or hysteroscope (Fig. 2.2). Cleaning is needed before disinfection or sterilization. Also, single piece, reusable medical equipment such as single tooth tenaculum, Allis clamp or uterine sound should also be sterilized: each office will need to decide if it will sterilize each piece individually or as a procedure “set” and follow its own policy. Also, quality control and monitoring of sterilization equipment and of infection control is recommended and should be monitored and reviewed by the Medical Director (see below). Lastly, local and state standards and policies should be reviewed relative to the office location as well as compliance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and Occupational Safety and Health Administration (OSHA) requirements.

If sterilization will be done in the office there are several types of sterilization techniques to consider, and the choice should be determined by what is most readily available and appropriate for each office. Time, space, and cost are factors to determine when considering set-up of sterilization system. Also, the office should be certain to utilize a Food and Drug Administration (FDA)-cleared liquid chemical sterilant and high-level disinfectant that can be used to reprocess office endoscopes and other equipment [5]. Below is a brief summary of common sterilization processes as outlined by Bradley and Fluharty [6].

The next area to be addressed in regards to office set-up should be that of anesthesia and analgesia. This must be dictated by the type of procedure to be performed as well as input from the patient. The type of anesthesia used should never be altered due to limitations of equipment or personnel in the office setting. If the appropriate anesthesia needed for a specific case or a specific patient cannot be accommodated, then the case should be done in a more acute facility so it can be done safely and efficiently. With this in mind, the level of anesthesia (which includes light, moderate, or deep sedation) will dictate the equipment and the appropriate personnel needed for the case.

Once a procedure is scheduled in the office, it is necessary to first decide which level of anesthesia the office will provide, as the level of sedation needed for the procedure dictates specific protocols as listed below. The American Society of Anesthesiologists (ASA) has developed guidelines for sedation and these are discussed in more detail in Chap. 4. Level one includes the use of local anesthesia with minimal preoperative use of oral anxiolytics. Level two is moderate sedation, and level three is considered deep sedation or general anesthesia. A majority of the procedures in this text will likely need only local anesthetic with level-one sedation. On some occasions, level-two sedation may be needed. It is recommended by these authors that if sedation beyond level 2 is needed, consideration of assistance in office from an anesthesia related provider (Certified Registered Nurse Anesthetist (CRNA) or anesthiesiologist) be available during the procedure or consideration of performance of the procedure in an ambulatory surgery center (ASC) or monitored facility. The ability to rescue a patient from sedation is based on the level of anesthesia being used. Each office should develop a policy for emergency medication, resuscitation, and have the ability to rescue a patient from excessive medication. In the Report of the Presidential Task Force on Patient Safety in the Office Setting [5], it is recommended that these policies be based on ASA levels depending on the level of invasiveness.

Specifics for both local anesthetics and use of adjunct medications of analgesia or sedation are discussed more fully in Chap. 4. However, it is also advisable that gynecologic surgeons planning to perform in-office procedures review the document, “Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists” [8].

In-office anesthesia and analgesia requires assessment of in-office medication use and safety. All medications necessary to complete a specific procedure need to be present and immediately available in the procedure room for use during an in-office surgery; this includes mediations that may be necessary to reverse or “rescue” any potential complications or oversedation. When a procedure will include a controlled medication, this must be stored, registered, and removed from a secure location. All medication use needs to be recorded and monitored with a medication log including the use of local anesthetics as well as controlled substances such as anxiolytics and medications used for pain relief. Medications need to be periodically checked for expiration dates to allow replacement as needed. It is frustrating to schedule an in-office surgery only to find that an important medication needed has passed its expiration date. The person(s) responsible for the medications needs to be present in the room during the procedure. Who this person is depends on the level of anesthesia that is being used. The responsible party ranges from nurse, CRNA, or anesthesiologist. The surgeon assumes responsibility for the first two. Once the procedure is complete, patient monitoring postoperatively will need to be correlated to the level of sedation achieved during the surgery. Many states are now requiring specific accreditation dependent upon if moderate sedation or deeper anesthesia is to be administered in office [9] and most states have regulations set forth by state pharmacy boards for specifics regarding use and distribution of in-office medication. Each physician is advised to avail him or herself of state and local guidelines regarding purchase, use, and storage of medications in the office setting.

Medication safety has been clearly recognized as a source of patient harm in the office setting [10]. One first step to overcome this potential problem is a clear process to assess patients’ medications and allergies before beginning the procedure. While the advent of the computerized medical record has seemingly streamlined this process, a member of the office team should document medications and allergies prior to the start of the procedure as well as inform the surgeon and members of the team at the beginning of the procedure, such as during a procedural “time out”. Use of standardized doses and schedules for each procedure are recommended. However, during or after the procedure and during urgent situations in the office, increased stress or the use of “verbal orders” may increase the possibility of error in prescribing and administering or monitoring medications [11].

Joint Commission has published Ambulatory Care National Safety Goals (NPSG) with specifics to medication safety in the ambulatory setting. In regards to medication safety, NPSG.03.04.01 Improve the safety of giving medications states,” Label all medications, medication containers, and other solutions on and off the sterile field in perioperative and other procedural settings. Note that medication containers include syringes, medicine cups, and basins” [12]. This means that any medication, whether given orally, intravenously (IV), or intramuscularly (IM) to the patient before the procedure, used in a syringe during a procedure (such as with local anesthesia) or if given in oral, IV or IM in recovery after the procedure should have labels that include the following: