Safety in the Gastrointestinal Endoscopy Unit
Endoscopic Procedure Room
- Actual marking of the site is not required for endoscopic procedures because endoscopy does not involve lateral right-left distinction levels such as those found in spinal procedures or those done on multiple structures such as fingers or toes. Before starting an endoscopic procedure, the patient, staff, and performing physician should verify the correct patient and procedure to be performed.
- A reliable and adequate source for oxygen is required. Sources may include in-wall or free-standing oxygen. In some units, carbon dioxide may be used for insufflation of the GI lumen, but this is not a requirement.
- A suction source for the equipment and patient must be present either in-wall or portable. For tubing and portable suction, the manufacturer’s guidelines must be followed.
- An uninterruptible source of power, supplied either by a generator or battery source is required. The purpose of a secondary power source is to allow completion of the current procedure in the event that the primary power source malfunctions. Procedures should not be started when the only source of power is the secondary source.
- Units must practice fire safety in adherence with the NFPA 101 Life Safety Code, which also dictates the number and type of electrical outlets tied to the generator. The NFPA 101 Life Safety Code recommends that not all outlets be tied to the generator in case the generator fails to disengage once power is restored.
- The unit’s defibrillator and crash cart should be checked at the beginning of each day to ensure that all components are functional, fully stocked, and readily accessible.
- The routine monitoring of temperature and humidity within the endoscopic procedure area, although advocated by CMS to theoretically curtail growth of microorganisms and reduce fire hazard, has not been associated with safety outcomes in endoscopic units. In the absence of published guidelines on the optimal ranges for these parameters, routine monitoring of temperature and humidity is not currently warranted.
- Puncture-resistant containers for biohazardous materials and sharps should be located so that sharps are not passed over the patient.
- If special therapeutic procedures are planned, specific room features may be required, such as leaded walls when flat-table fluoroscopy is utilized.
Endoscopic Recovery Area
Storage of Supplies
2. Units should have a process for periodically verifying that supplies marked with an expiration date have not expired. Compliance with this process should be documented.
- Hand hygiene should be performed before patient contact (even if gloves are to be worn); after patient contact and before exiting the patient care area; after contact with blood, body fluids, or contaminated surfaces (even if gloves are worn); before performing invasive procedures (ie, placement or access of intravascular lines); and after glove removal.
- The use of soap and water is required when hands are visibly soiled and after caring for patients with known or suspected infectious causes of diarrhea such as C difficile. Otherwise, the use of alcohol-based hand agents is adequate.
- Staff must remove and appropriately discard used PPE before leaving the procedure room. PPE should not be reused or worn to care for more than 1 patient.
- Scrub attire may be worn from home, because endoscopic procedures are performed in a non-sterile environment.
- Individuals may elect to wear regular clothing covered by an impervious gown. There is no requirement to change clothing once the individual arrives at work.
- If clothing under the procedure room attire is contaminated with a significant amount of blood or body fluids, the items should be placed in a bag, identified as a potential biohazard, then sent for cleaning to a laundry facility capable of properly cleaning and disinfecting clothing used in healthcare settings.
Safe Medication Administration Practices
- Preparing medications for multiple patients should be done in an area away from direct patient care or procedure rooms.
- Units should appropriately label all medications, including those used for sedation, unless the medication is for immediate use (prepared and administered immediately without leaving the provider’s hand).
- Medications marked either on the container or noted in the package insert as “single patient use” should be used for a single patient only and any remaining drug should be discarded. 4. Units should use new fluid administration sets (eg, IV tubing) for each patient.
- Units should prepare and administer injections by using aseptic technique (ie, cleansing the access diaphragms of medication vials with 70% alcohol before inserting a device in the vial). Single-dose vials, ampules, bags, or bottles of IV solution should be used for a single patient only.
- Use of a single-dose vial is preferred over multipledose vials, particularly when medications will be administered to multiple patients.
- If a multiple-dose vial will be used for more than 1 patient, they should remain in a centralized medication area and should not enter the patient procedure area. These should be dated when opened and discarded according to protocols, in compliance with nationally accepted guidelines, such as those published by the Centers for Disease Control and Prevention.
- Units should not re-use a syringe to enter a medication vial or solution, even with a new needle.
- Units should not use the same syringe to administer medications to multiple patients regardless of whether the needle is changed or an intervening length of IV tubing is used.
- Units should dispose of used syringes and needles at the point of use in a sharps container that is closable, puncture-resistant, and leak-proof.
- Units should develop a clearly defined policy for the management of sharps and sharps-related injuries, including the reporting of blood and body fluid exposures. This should be in compliance with federal, state, and local guidelines.
- Units should maintain a log of sedation medications wasted between patients that can be used to reconcile used and wasted vials at the end of the day.
- If tubes of lubricant are used for more than one examination, the unit should observe appropriate infection control habits and discard any tube that has potentially been contaminated.
- Although the multiple-society guideline recommends using sterile water in the irrigation bottle, it is acceptable to use tap water because this has been shown to be safe. The rates of bacterial cultures are no different with the use of tap water versus sterile water, and neither has been associated with clinical infections.
- Units should follow federal and state requirements for the protection of healthcare personnel from exposure to blood-borne pathogens.
Safe Handling of Potentially Contaminated Equipment or Surfaces
2. Follow the manufacturer’s directions for surface disinfection of patient care items.
- B Appropriate contact time of disinfectant to achieve germicidal kill should be followed.
- Alcohol should not be used to clean environmental surfaces.
- The unit should have a terminal cleansing plan that includes methods and chemical agents for cleansing and disinfecting the procedural space at the end of the day.
- Agents for terminal cleansing should have efficacy in spore removal, which may differ from requirements for agents used in sterile operating rooms.
- Before the first case of the day, staff should verify that all procedural and recovery areas have been properly cleansed.
- A training and competency assessment program should be in place for staff members who are involved in terminal cleansing to ensure proper and safe handling and use of the chemicals.
- Staffing models in the preprocedure area should support activities required to prepare patients for endoscopy.
- The ratio of RNs to patients in preprocedure care is variable depending on the complexity of the patient mix.
Intraprocedure Staffing Based on Level of Sedation
- No sedationdOne assistant (RN, LPN, or UAP) other than the physician performing the procedure should be present to assist with the technical aspects of the procedure.
- Moderate sedation (also known as conscious sedation)d Sedation should be directed by a physician who is credentialed and privileged to do so. Moderate sedation can be administered by an RN. During the period in which the patient is sedated, the RN must monitor the patient for vital sign changes, hypoxemia, and comfort. The RN may assist with minor, interruptible tasks. In the event that more intense technical assistance is required, a second assistant (RN, LPN, or UAP) should be available to join the care team for the technical aspects of the procedure.
- Deep sedationd — Most institutions require that deep sedation be administered by an anesthesia professional such as an anesthesiologist, certified registered nurse anesthetist (CRNA), or anesthesiologist assistant who is credentialed and privileged to do so. In this situation, the anesthesia provider should be responsible for administering sedation and monitoring the patient. A second staff person (RN, LPN, or UAP) is required to assist with technical aspects of the procedure.
- An RN is required to monitor patients who have received sedation until the patient is stabilized and to assess for adverse events related to the endoscopic procedure.
- Once the patient is stable, postprocedure activities such as providing food or drinks and assistance in changing clothes can be performed by an RN, LPN, or UAP.
- The ratio of RNs to patients in the postprocedure setting is variable depending on the complexity of the patient mix.
- Sedation — Sedation should be administered by an RN under the supervision of the endoscopist who is credentialed and privileged to do so or by anesthesia personnel (physician or CRNA) who are credentialed and privileged to do so. These individuals should be specifically trained in endoscopic sedation, including the modes of action and adverse events of the sedative agents being used. This training should be documented. The staff administering sedation must have the knowledge and skills to recognize when the sedation level becomes deeper than planned and to manage and support patients’ cardiopulmonary responses to sedation accordingly. On verification of the RN’s training, the unit should document the privileging of the RN to provide moderate sedation under the direct supervision of a physician. LPNs and UAPs are not qualified to administer sedation.
- Technical assistance — Technical assistance can be provided by a variety of staff members, including UAPs, LPNs, RNs, and GI technicians. Training in the use of endoscopic equipment, accessories, and ancillary equipment should be documented and include an objective assessment of initial competence and annual competency testing thereafter to ensure and document that skills are maintained.
- A written policy on staff training along with the type and frequency of core competency assessment should be documented.
- Basic and advanced cardiac life support — All staff with clinical responsibilities must have basic life support certification. At least one individual with advanced cardiac life support certification must be present in the unit when patients are present.
- Units should comply with applicable federal and state laws regarding licensure and/or certification of all staff involved in the administration and monitoring of sedation and document training and competencies.
- Established discharge criteria should be attained before discharge from the endoscopy unit. Patients who received IV sedation during their endoscopic procedure should be discharged in the presence of a responsible individual. A written policy on discharge requirements should be documented.
- An agreement should exist between the unit and a hospital facility for the transfer of patients who require escalation of care. A written transfer agreement should be documented.
- A focused history and physical examination, including the patient’s current medications and ASA classification, should be completed before the start of the procedure.
- All sedation-related equipment, before initial use and then at intervals dictated by the manufacturer’s guidelines, should be examined and verified to be in proper working order by a qualified biotechnician.
- Oxygen, suction for the mouth, and electronic equipment that can monitor and display pulse, blood pressure, oxygen saturation, and continuous electrocardiographic rhythm assessment should be available in the procedure room. A written policy for equipment checks and maintenance should be in place. A log to monitor compliance should be maintained.
2. Units should have procedures in place to rescue patients who are sedated deeper than intended.
3. When the target level is moderate sedation (also known as conscious sedation):
- The individual assigned responsibility for patient monitoring may perform brief, interruptible tasks.
- Minimal monitoring requirements include electronic assessment of blood pressure, respiratory rate, heart rate, and pulse oximetry combined with visual monitoring of the patient’s level of consciousness and discomfort.
- Currently, there are inadequate data to support the routine or required use of capnography during endoscopic procedures in adults when moderate sedation is the target.
- The individual responsible for patient monitoring must be dedicated solely to that task and may not perform any other function during the procedure.
- The use of capnography in EUS, ERCP, and colonoscopy to assess the adequacy of ventilation may reduce the incidence of hypoxemia and apnea, but its impact on the frequency of other sedationrelated adverse events such as bradycardia and hypotension is unknown. As such, capnography may be considered for the performance of endoscopy under deep sedation. However, there is no safety data to date to support the universal use of capnography in such cases.
- Documentation of the clinical assessments and monitoring data during sedation and recovery is required.
- Written policies detailing the methods of drug storage, monitoring of drug inventory and expiration dates, and documentation of compliance with these policies are required.
- There should be an individual qualified by training and licensure (such as a physician or pharmacist) who is directly responsible for overseeing medication usage in the unit.
- Medications should be securely stored under environmental conditions consistent with the manufacturer’s instructions on the label. The use of single-dose vials for all sedative and analgesic medications is strongly recommended.
- Controlled substances should be stored in a doublelocked cabinet, and a daily medication log compliant with state and federal regulations should be maintained. Disposal of unused narcotics and other controlled drugs should be witnessed by 2 individuals and documented.
- Medications should be given only under the order of the supervising physician or anesthesia professionals when applicable.
- Reversal agents for opioids and benzodiazepines should be readily available.
- A written policy should be in place for the identification, documentation, and review of adverse drug reactions.
- Appropriate pharmaceutical agents, oxygen, oral suction, laryngoscope, Ambu bag, and defibrillator should be readily available in the unit.
- Units should train and periodically provide in-service education for staff in the use of equipment for emergency management. Training and assessment of competency should be documented.
Safety in the Gastrointestinal Endoscopy Unit
January 30, 2014
External Publication Status
Country of Publication
Present recommendations for endoscopy units in implementing and prioritizing safety efforts and to provide an endoscopy-specific guideline by which to evaluate endoscopy units.
Female, Male, Adolescent, Adult, Child, Infant, Older adult
Health Care Settings
Ambulatory, Emergency care, Hospital, Operating and recovery room, Outpatient
Nurse anesthetist, medical assistant, nurse, nurse practitioner, physician, physician assistant
Counseling, Prevention, Management
D011315 - Preventive Medicine, D020776 - Endoscopes, Gastrointestinal
preventive care, endoscopy unit, gastrointestinal endoscopy
Calderwood, A. H., Chapman, F. J., Cohen, J., Cohen, L. B., Collins, J., Day, L. W., & Early, D. S. (2014). Guidelines for safety in the gastrointestinal endoscopy unit. Gastrointestinal Endoscopy, 79(3), 363–372. doi:10.1016/j.gie.2013.12.015