PRE-SEDATION EVALUATION (DRAFT)

Transcription

1 PRE-SEDATION EVALUATION (DRAFT) Physician Procedure Date/Time Practitioner Intent: ( ) Minimal/Moderate Sedation ( ) Deep Sedation H & P documented including examination specific to planned procedure Indications for stated procedure are documented Informed consent for procedure including possible sedation ( ) Confirmation that these items are competed prior to performing the procedure. Pre-Sedation Airway Assessment: History of complications with previous sedation, intubation or anesthesia, History of sleep apnea, use of CPAP and nocturnal oxygen, Pre-procedure auscultation of the heart and lungs Evaluate of facial features including obesity, beard, moustache, facial trauma or facial dysmorphisms Evaluate oral opening including 3 finger mouth opening, large incisors, large tongue, oral obstructions and visualized uvula, Evaluate neck including 3 fingers from chin to neck, 2 finger from thyroid to floor of mouth, micrognathia and retrognathia, Evaluate neck mobility including extension and neck masses. Comments This examination may not be applicable for patients <50 kg or <14 years of age ( ) I have examined this patient and determined that they are an appropriate candidate for sedation. Practitioner Signature

2 Administrative Policy and Procedure Policy Number: Subject: Sedation Page: 1 Of: 9 Effective: March 3, 1997 Revised: Approved:.DRAFT 11/19/09after meeting Deleted: Signed by Kathy Guyette, VP and Chief Nursing Officer, 3/24/2009, and original filed in Administration. Deleted: March 24, 2009 Deleted: Signed by Alan Baumgarten, Chief of Staff, 3/24/2009 PURPOSE: This policy seeks to establish minimum requirements for administering and monitoring sedation for all patients throughout Mission Hospitals. This Administrative Policy of Mission Health System, Inc. ("Mission") is applicable to Mission Hospitals, Memorial and St. Joseph campuses, the Asheville Surgery Center and other locations where services of the hospital are being provided. Site specific sedation guidelines may be more, but not less restrictive than the hospital guidelines, and must conform to requirements that patients with the same health status receive a comparable level of care throughout Mission Hospitals. These standards are intended for patients undergoing a diagnostic or therapeutic procedure. This policy is applicable to all patients undergoing procedures with the intent to receive sedation. DEFINITIONS: 1. Minimal Sedation (Anxiolysis) A drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected. 2. Moderate Sedation/Analgesia (Conscious Sedation) A drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. Deleted: Minimal Sedation ( Deleted: ) Deleted: Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.minimal Sedation 3. Deep Sedation/Analgesia A drug induced depression of consciousness during which patients cannot be easily aroused but respond purposefully after repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function

3 Policy # Sedation Page 2 of 7 is usually maintained. 4. Anesthesia Consists of general anesthesia and spinal or major regional anesthesia. It does not include local anesthesia. General anesthesia is a drug induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug induced depression of neuromuscular function. Cardiovascular function may be impaired. 5. Proceduralist The person qualified to perform the procedure. This person may be a physician, midlevel provider, or others privileged to perform an invasive procedure or may be a technologist or other personnel qualified to perform the procedure for noninvasive procedures such as chest radiographs, nuclear medicine scans, ultrasound examinations, or MRI s. 6. Sedationist The physician or advanced practitioner privileged to perform the sedation. 7. Monitor A person qualified to monitor and respond appropriately to the patient's response to medication and assist in any supportive or resuscitative measures required. The monitor will not engage in any tasks that would compromise continuous patient monitoring. SCOPE: 1. This policy applies to patients who receive drugs with the intent of sedation/analgesia for procedures. This policy does not apply to mediations given for anticonvulsant effects, minimal sedation (anxiolysis) without an intended procedure or pain control; however, should any such agents be given and followed by deeper levels of sedation (moderate sedation), appropriate monitoring/interventions in keeping with this policy should be immediately instituted. 2. This policy is not intended to address situations in which an anesthesiologist or nurse anesthetist is engaged in the administration of anesthesia/sedation. Deleted: EXCLUSIONS Formatted: No underline 3 This policy does not apply to sedation used to secure an airway, for ventilatory management, for pain control, or when sedation is used as chemical restraint in the psychiatric patient. LOCATION: Moderate Sedation may be administered in the following primary locations: Emergency Department, Intensive Care Units, Operating Rooms, Asheville Surgery Center, Radiology Department, Cardiac Cath Lab, Echo Lab, Endoscopy Department including mobile endoscopy, and Pediatrics, Pediatric Outpatient, Pediatric Adolescent Unit, Pediatric Intensive Care Unit, Neonatal Intensive Care Unit

4 Policy # Sedation Page 3 of 7 and Trauma Care Unit. Secondary locations may be used when the personnel and equipment needed to perform moderate sedation (as outlined in this policy) are present. Deep Sedation may be administered in adult and pediatric Intensive Care Units, Neonatal Intensive Care Unit, Pediatric Outpatient, Trauma Care Unit, Cardiac Cath Lab, Radiology, and in the Emergency Department. PRIVILEGING AND SKILL COMPETENCY: Practitioners responsible for the administration of moderate and deep sedation will be privileged through the Medical Staff Credentials Committee. This committee, in consultation with Anesthesiology Clinical Services, establishes the credentialing process and criteria. The RN monitoring the patient during procedures requiring moderate sedation will have BLS certification and will demonstrate satisfactory completion of the sedation learning module. The RN monitoring the patient during procedures requiring deep sedation will have ACLS certification and will demonstrate satisfactory completion of the sedation learning module. The person monitoring the pediatric patients during procedures requiring moderate or deep sedation will be a Pediatric Advanced Life Support (PALS) and/or Emergency Nurse Pediatric Course (ENPC) certified RN and will demonstrate successful completion of the pediatric sedation learning module. PATIENT SELECTION: 1. The need for any short term, therapeutic, diagnostic, or surgical procedure and subsequent use of sedation will remain under the individual practitioner's practice direction. 2. There must be a documented pre-sedation evaluation of the patient prior to any short term therapeutic, diagnostic, or surgical procedure requiring sedation. A. Pre-Sedation Evaluation to include: 1. A medical history and physical examination that should include an examination specific to procedure being performed 2. Indications for the stated procedure, 3. Confirmation of informed consent including possible sedation, 4. A Pre-Sedation Airway assessment documenting, a. History of complications with previous sedation, intubation or anesthesia, b. History of sleep apnea, use of CPAP and nocturnal oxygen, c. Pre-procedure auscultation of heart and lungs, d. Facial features that could indicate difficulty with oxygen mask including obesity, beard, moustache, facial trauma, and facial dysmophisms, e. Oral opening including three finger mouth opening, large incisors, large tongue, oral obstructions and visualized uvula, f. Neck size and shape including 3 fingers from chin to neck, 2 fingers from Deleted: procedure Deleted: moderate or deep Deleted: A Formatted: Indent: Left: 54 pt Deleted: must be performed and documented in the medical record prior to procedure or sedation. Minimal content required includes: Deleted: E Deleted: Deleted:. Formatted: Indent: Left: 36 pt, First line: 18 pt Deleted: /symptoms Deleted: Formatted: Numbered + Level: 1 + Numbering Style: a, b, c, + Start at: 1 + Alignment: Left + Aligned at: 72 pt + Tab after: 90 pt + Indent at: 90 pt

5 Policy # Sedation Page 4 of 7 thyroid to floor of mouth, micrognathia and retrognathia, g. Neck mobility including ability to extend and neck masses. B. There is to be a reevaluation immediately prior to administration of intravenous medications to determine that the patient is at this time an appropriate candidate for sedation. 3. Practitioners are encouraged to consult with a member of the Anesthesiology Clinical Service when there is a question regarding the appropriate delivery of sedation. INFORMED CONSENT: Informed consent for any short term therapeutic, diagnostic or surgical procedure in which moderate or deep sedation is to be employed will be signed, dated, and timed and will include the risks/benefits/alternatives of sedation as appropriate. The informed consent should read "(Procedure) with sedation". MANAGEMENT: Minimal/Moderate Sedation 1. The minimum number of personnel for employing moderate sedation shall be two. The Proceduralist is the person qualified to perform the procedure. The Sedationist is the physician or advanced practitioner privileged to perform moderate sedation. The Sedationist selects and orders the medications to produce sedation. If the Proceduralist is also the Sedationist, then a monitor is needed. If the Sedationist is not the Proceduralist, then a monitor is not necessary. The monitor is the person qualified to monitor and respond appropriately to the patient s response to medication and assist in any supportive or resuscitative measures required. The monitor will not engage in any tasks that would compromise continuous patient monitoring. The Sedationist and the monitor will be available to the patient from the time of administration of sedation until recovery or until the care of the patient is transferred to personnel performing recovery care. 2. The following minimum equipment must be present and ready for use in the room where moderate sedation is being administered. A. Oxygen. B. Suction. C. Emergency airway equipment. D. Cardiac monitor if indicated by practitioner. E. Noninvasive blood pressure monitor or manual blood pressure cuff applied. F. Pulse oximeter applied with audible variable pitch pulse tone and low threshold alarm. G. Code cart with defibrillator must be located in close proximity to the procedure/sedation area. H. Reversal agents. Deleted:. Auscultation of heart and lungs. Deleted: Airway assessment Previous anesthesia/sedation history. Formatted: Indent: Left: 0 pt Deleted: Components of airway assessment include relevant history and a physical exam, including habitus and features of the head and neck, mouth, and jaw. Factors which may be associated with difficulty in airway management include: <#>History of difficult intubation, sleep apnea, or advanced rheumatoid arthritis. <#>Obesity or dysmorphic facial features. <#>Short neck, limited neck extension, or neck masses. <#>Small oral opening or nonvisible uvula. <#>Micrognathia or retrognathia Deleted: diagnostic, Deleted: Minimal Sedation (Anxiolyxis). <#>The practitioner selects and orders the medication. The use of intravenous Versed is considered at least minimal sedation. <#>Obtain vital signs to include blood pressure, pulse, respirations, and oxygen saturation prior to the administration of medication for minimal sedation. A RN monitor will continuously monitor oxygen saturation and document vital signs and the patient's response to medication. Documentation will occur every fifteen (15) minutes during the procedure, at the end of the procedure, and one hour following procedure or until the patient meets discharge criteria.

6 Policy # Sedation Page 5 of 7 3. All patients receiving IV moderate sedation must have a patent IV with continuous administration of IV fluids per practitioner order. Patent saline or heparin locks (INTs) are acceptable for patients with contraindications to IV fluids. IV fluid for resuscitation should be readily available. The need for IV access in patients receiving sedation by any other route of administration shall be determined by the practitioner. 4. The patient's NPO status will be assessed. The recommended guidelines for nonurgent/non emergent procedures is the patient be NPO for a minimum of two (2) hours for clear liquids, six (6) hours for light meal (nonfat, nonmeat, example: toast), and eight (8) hours for other solid food. Infants may have breast milk up to four (4) hours or infant formula up to six (6) hours prior to procedure. Deep Sedation. 1. The minimum number of personnel for employing deep sedation shall be two. The Proceduralist is the person qualified to perform the procedure. The Sedationist is the physician privileged to perform deep sedation. The Sedationist selects and orders the medications required for deep sedation. If the Proceduralist is also the Sedationist, then a monitor must be present. If the Sedationist is not the Proceduralist, then no monitor is required. The monitor is the person competent to monitor and respond appropriately to the patient s response to medication and assist in any supportive or resuscitative measures required. The monitor will not engage in any tasks that would compromise continuous patient monitoring. The Sedationist and the monitor will be available to the patient from the time of administration of sedation until recovery or until the care of the patient is transferred to personnel performing recovery care. When Propofol is being administered for deep sedation, the minimum number of personnel shall be three. If the Sedationist is not the Proceduralist, then one additional monitor is required. The monitor is the person competent to monitor and respond appropriately to the patient s response to medication and assist in any supportive or resuscitative measures required. The monitor will not engage in any tasks that would compromise continuous patient monitoring. If the Sedationist is also the Proceduralist, then two additional persons are required. One monitor is the person competent to monitor and respond appropriately to the patient s response to medication and assist in any supportive or resuscitative measures required. The monitor will not engage in any tasks that would compromise continuous patient monitoring. A second monitor capable of assistance in maintaining a patent airway and supporting respirations in case ventilatory function is impaired. The second monitor may be another physician or may be a respiratory therapist. 2. The following minimum equipment must be available for use where deep sedation is being administered. A. Oxygen.

7 Policy # Sedation Page 6 of 7 B. Suction. C. Emergency airway equipment. D. Cardiac monitor applied. E. Noninvasive blood pressure monitor or manual blood pressure cuff applied. F. Pulse oximeter applied with audible variable pitch pulse tone and low threshold alarm. G. Code cart with defibrillator must be located in close proximity to the procedure/sedation area. H. Reversal agents. 3. All patients receiving IV deep sedation must have a patent IV with continuous administration of IV fluids per practitioner order. Patent saline or heparin locks (INTs) are acceptable for patients with contraindications to IV fluids. IV fluid for resuscitation should be readily available. The need for IV access in patients receiving sedation by any other route of administration shall be determined by the practitioner. 4. The patient's NPO status will be assessed. The recommended guidelines for nonurgent/non emergent procedures is the patient be NPO for a minimum of two (2) hours for clear liquids, six (6) hours for light meal (nonfat, nonmeat, example: toast), and eight (8) hours for other solid food. Infants may have breast milk up to four (4) hours or infant formula up to six (6) hours prior to procedure. PROCEDURE MANAGEMENT: 1. A standardized sedation flow sheet will be completed by the monitor for all patients receiving moderate or deep sedation. 2. Documentation on the sedation flow sheet must include: A. Verification that informed consent is signed. B. Weight. C. NPO status. D. Prior adverse drug reactions including allergies. E. Premedication. F. Beginning and end time of procedure. G. Baseline blood pressure, pulse, respiratory rate, oxygen saturation on room air (unless the patient is receiving oxygen preprocedure), level of consciousness. H. Name, dose, route, and time of all drugs given. I. Patient response to all medications given. J. Oxygen delivery. K. Type and amount of IV fluids (if administered). L. Any adverse drug reactions or significant responses; management and outcome of these events. 3. Minimum monitoring will include: blood pressure, pulse, respiratory rate, oxygen saturation, level of consciousness (cardiac monitoring required for deep sedation). Minimum monitoring must be documented on the flow sheet at least every ten minutes during the procedure for the adult patient; document on the flow sheet at least every five minutes during the procedure for the pediatric patient. When frequent monitoring of blood pressure and pulse interrupt the procedure, those measures will be waived intraprocedure.

8 Policy # Sedation Page 7 of 7 POST PROCEDURE MANAGEMENT FOR MODERATE OR DEEP SEDATION: 1. Patients who receive sedation will be monitored post procedure. They will be considered recovered when monitoring shows a return to safe physiological and psychological levels. An equivalent to the Aldrete Scoring System will be used. Deleted: This flow sheet will be deleted Lou 2. Any person receiving a reversal agent must be observed for one hour after the last dose of reversal agent. 3. Inpatient monitoring and documentation: A. Blood pressure, pulse, respirations, oxygen saturation, and level of consciousness at least every fifteen minutes. B. Observation of any post procedure complications, management of those events, and patient response. C. Name, dose, time, route and response of any medications given in the post procedure period. D. Discharge summary and verbal report to nurse caring for patient on patient care unit. Include pre-procedure vital signs and level of consciousness, any problems encountered during or post procedure, total medications given, IV fluid total, and status of IV. 4. Outpatient monitoring and documentation: A. Blood pressure, pulse, respiration, oxygen saturation, and level of consciousness at least every fifteen minutes. B. Observation of any post procedure complications, management of those events and patient response. C. Name, dose, time, route and response of any medications given in the post procedure period. D. Verbal and written discharge instructions to patient and responsible adult accompanying patient and driving them home to include restrictions following sedation. PERFORMANCE IMPROVEMENT: The Chairperson or designee of the Anesthesiology Clinical Service is responsible to oversee the monitoring and evaluation of sedation use. The following data is gathered for review following the administration of sedation: > Unplanned intubation > Unplanned admission or transfer to higher level of care > Administration of reversal agent > Drop in oxygen saturation to less than 92% not responsive rapidly to oxygen therapy > Nausea and vomiting > Unable to complete procedure > Achieved sedation level deeper than intent > Failure to comply with documentation requirements CMS: WHAT CONSTITUTES... [1]

9 Page 7: [1] Deleted 11/18/ :30:00 PM This flow sheet will be deleted Lou

10 CMS: WHAT CONSTITUTES SURGERY? For the purposes of determining compliance with the hospital surgical services Conditions of Participation (CoP), CMS relies, with minor modification, upon the definition of surgery developed by the American College of Surgeons. Accordingly, the following definition is used to determine whether or not a procedure constitutes surgery and is subject to this CoP: Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery also is the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles. The tissue can be cut, burned, vaporized, frozen, sutured, probed, or manipulated by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic, or chemical means. Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system also is considered to be surgery (this does not include the administration by nursing personnel of some injections, subcutaneous, intramuscular, and intravenous, when ordered by a physician). All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical procedure are not eliminated by using a light knife or laser in place of a metal knife, or scalpel. This definition does not include such things as x-ray examinations, MRI s, nuclear medicine examinations, ultrasounds used for examination only, placement of noncentral intravenous catheters, and other such activities.