5. PROCEDURES

5.1 Timing

• A. Perform the full pre-use checkout:
  • at the start of each day for each machine in service, and
  • after any machine maintenance, relocation, pipeline work, circuit replacement, vaporizer change, or suspected malfunction. (ASA)
• B. Perform an abbreviated between-case check when appropriate:
  • verify breathing circuit integrity and correct configuration,
  • verify suction function,
  • verify oxygen supply and backup cylinder readiness,
  • verify ventilator readiness and alarm functionality,
  • verify vaporizers/agent delivery readiness,
  • verify scavenging connection. (vam.anest.ufl.edu)

5.2 Full Pre-Use Checkout (Minimum Required Elements)

The checkout shall include and document, at minimum:

• A. Electrical and system self-test
  • Confirm power supply and emergency power awareness; ensure system boots normally.
  • Run workstation self-test (if available) and address any failure messages before use.
• B. Gas supply and oxygen safety
  • Confirm pipeline gas pressures are present and appropriate.
  • Confirm at least one backup oxygen cylinder is present, secured, and has adequate pressure.
  • Confirm oxygen analyzer functionality and calibration/verification per device instructions. (ASA)
• C. Flow control and vaporizers/agent delivery
  • Confirm correct vaporizer(s) present, properly seated/locked, filled appropriately, and turned off when not in use.
  • Confirm agent selection and delivery system readiness as applicable.
• D. Breathing system integrity
  • Confirm correct breathing circuit assembly and connections.
  • Perform leak test(s) appropriate to the system to confirm circuit integrity and minimize leaks. (osha.gov)
• E. Ventilator function and alarms
  • Verify ventilator mode function (manual/spontaneous/mechanical as applicable).
  • Verify airway pressure limits and disconnect/apnea alarms function.
  • Verify that alarms are audible/visible and not disabled. (ASA)
• F. Suction Confirm suction is immediately available, functional, and accessible.
• G. Scavenging Confirm scavenging system connection and functionality to reduce waste anesthetic gas exposure risk. (osha.gov)
• H. Backup equipment readiness Confirm availability of essential airway rescue equipment at the anesthetizing location and immediate access to emergency medications per departmental emergency readiness policies.

5.3 Failure Management

• A. If a safety-critical element fails, label the machine “OUT OF SERVICE,” notify biomedical engineering, and document the failure and actions taken. (ecri.org)
• B. Do not use the machine for patient care until the fault is corrected and the checkout is repeated successfully.

5. PROCEDURES

5.1 Location and Access

• A. Identify and label cart locations on the unit map; ensure 24/7 access.
• B. For NORA, either place a dedicated cart in the area or define rapid delivery time and responsible staff.

5.2 Standard Contents (Minimum Categories)

The cart shall include, at minimum:

• A. Airway assessment and cognitive aids
  • difficult airway algorithm/cognitive aid and emergency call numbers.
• B. Plan A: intubation support
  • video laryngoscope with charged battery and backup,
  • direct laryngoscope handles/blades,
  • bougies/stylets, tube exchangers,
  • ETTs of multiple sizes, syringes, tube ties.
• C. Plan B: supraglottic rescue
  • supraglottic airway devices (multiple sizes),
  • devices that facilitate intubation through supraglottic airway (if adopted locally).
• D. Plan C: facemask ventilation optimization
  • masks (multiple sizes), oral/nasal airways, two-hand mask straps (if used),
  • capnography sampling accessories as applicable.
• E. Plan D: emergency invasive airway access (eFONA)
  • cricothyrotomy kit or surgical airway kit per local standard, scalpel/bougie/tube pathway if used, and necessary consumables.
• F. Adjuncts
  • suction catheters, lubricant, Magill forceps, nebulized/topical local anesthetic supplies if awake techniques used,
  • oxygen tubing and connectors.

This approach is consistent with guideline emphasis on availability of difficult airway equipment and portable storage units. (ASA)

5.3 Daily Check (Documented)

• A. Verify presence and integrity of each item; confirm single-use items not expired and packaging intact.
• B. Verify functionality: video laryngoscope powers on and screen works; suction connectors present; eFONA kit complete.
• C. Seal the cart after check (if local practice uses tamper seals) and record checker identity/date/time.

5.4 After-Use Restocking

• A. Replace used items immediately after the case; re-seal and document return-to-service.
• B. Report missing items, failures, or repeated shortages as safety events.

5. PROCEDURES

5.1 General Rules

• A. Confirm alarm function at setup (audibility, visibility, remote display where relevant).
• B. Set default limits at the start of monitoring and confirm NIBP cycling interval is appropriate (commonly every 3–5 minutes during general anesthesia unless otherwise indicated). (ASA)
• C. If alarms are silenced for procedures requiring quiet conditions, visual monitoring must be continuous and audible alarms restored as soon as feasible.

5.2 Standard Default Alarm Limits (Adult—Starting Point)

Default limits must be adapted for pediatrics and for special populations. As a starting point, use:

• SpO₂ low: 94% (or locally approved threshold)
• HR low/high: 50 / 120 bpm
• NIBP: systolic low/high 90 / 160 mmHg (or MAP low 65)
• ETCO₂ low/high: 30 / 50 mmHg (when capnography in use)
• Ventilator pressure high: locally set per patient and mode
• Apnea/disconnect alarm: enabled whenever ventilatory support is provided

These are defaults only; patient-specific targets may be different (e.g., chronic hypercapnia, deliberate hypotension), but safety limits must remain meaningful.

5.3 Special Settings

• A. NORA limited-access environments (e.g., MRI): alarms must be visible/audible from the control area; remote displays are required where patient access is constrained. (ASA)
• B. PACU: alarm limits should be adjusted to recovery phase and oxygen plan; high-risk patients (OSA, opioid titration) require tighter vigilance.

5.4 Alarm Modification Process

• A. When modifying alarm limits for clinical reasons, confirm:
  • rationale (baseline physiology/clinical strategy),
  • alternative protective monitoring (e.g., arterial line),
  • staff awareness (PACU/handovers).
• B. Restore default limits when the indication ends.

5.5 Technical Failure

• A. If an alarm system fails, stop and correct before proceeding when feasible; if urgent continuation is required, implement equivalent alternative monitoring and escalate to biomedical engineering.

5. PROCEDURES

5.1 Storage and Access

• A. Store controlled drugs in locked cabinets/automated dispensing cabinets with restricted access.
• B. Maintain controlled access lists; remove access when staff rotate/terminate.
• C. Keys (if used) are controlled, signed in/out, and never left unsecured.

5.2 Receiving and Stocking (OR/PACU/NORA)

• A. Pharmacy supplies controlled drugs to approved locations via documented transfer with quantity and batch tracking as required.
• B. Receiving staff verify count and integrity on receipt and document acceptance.

5.3 Administration Documentation

• A. Record drug name, concentration, dose, route, time, patient identifiers, and administrator identity.
• B. Partial ampoule/syringe use must reflect exact administered dose and remaining volume for wastage.

5.4 Wastage (Witnessed Destruction)

• A. Wastage is performed immediately after administration when feasible and never saved for later use.
• B. Two authorized staff witness wastage and sign electronic/paper documentation.
• C. Wastage occurs using an approved method consistent with pharmacy/environmental safety policy.

5.5 Counts and Reconciliation

• A. Perform counts at defined intervals (e.g., each shift handover; daily; or per automated cabinet cycle count).
• B. Discrepancies trigger immediate recount and escalation.

5.6 Discrepancy Management

• A. If discrepancy persists:
  • secure the cabinet,
  • notify pharmacy supervisor and anesthesia/PACU leadership,
  • initiate investigation per hospital policy,
  • document actions and outcome,
  • report suspected diversion per policy and law.

5.7 Transport Between Areas

• A. Transport controlled drugs in locked containers with chain-of-custody documentation.
• B. Minimize carrying controlled drugs between units; use unit-based controlled supply whenever feasible.

5. PROCEDURES

5.1 High-Alert List Maintenance

• A. Maintain the hospital list using recognized references (e.g., ISMP list) and local risk review; review at least annually and after serious incidents. (ECRI and ISMP)
• B. Ensure area-specific sublists for anesthesia (e.g., vasoactive infusions, opioids, sedatives, neuromuscular blockers, concentrated electrolytes).

5.2 Storage and Segregation

• A. Separate look-alike/sound-alike medications; use tall-man lettering or pharmacy labeling where applicable.
• B. Segregate concentrated electrolytes, vasoactive agents, and neuromuscular blockers per local safety design.

5.3 Standard Concentrations and Preparation

• A. Adopt standard concentrations for common infusions (vasopressors, insulin, heparin if used, opioids).
• B. Prefer pharmacy-prepared, barcoded, ready-to-use products when available; minimize bedside compounding. (ECRI and ISMP)

5.4 Independent Double-Checks (Where Required)

• A. Define mandatory double-check scenarios (examples): initiation of vasoactive infusions, insulin infusions, PCA programming, concentrated electrolyte infusions, neuromuscular blockers in PACU/ward.
• B. Double-check must confirm: patient, drug, concentration, pump channel, dose/rate, route/line trace, and allergy constraints.

5.5 Administration and Monitoring

• A. Require continuous monitoring appropriate to drug risk (e.g., vasoactive infusions require frequent BP assessment; opioids require respiratory monitoring).
• B. Document titration targets and reassessment intervals.

5.6 Smart Pumps and Drug Libraries

• A. Use smart pump drug libraries with dose limits where available; minimize “no drug selected” programming. (ECRI and ISMP)

5. PROCEDURES

5.1 Syringe Labeling Steps

• A. Prepare one drug at a time (avoid multiple unlabeled syringes).
• B. Apply label longitudinally so graduations remain visible and name/strength are readable. (ASA)
• C. Confirm label matches vial/ampoule before drawing up and again before administration.

5.2 Infusion Bag/Syringe Pump Labeling

• A. For infusions: label container with drug name, total amount, concentration, diluent/volume, route, start time, preparer, and patient identifiers per local policy.
• B. Label the pump channel and the line near the pump and near the patient connection as appropriate.

5.3 Line Trace and Route Protection

• A. Trace the line from medication source to patient connection before initiating any infusion or bolus.
• B. Use dedicated lines for high-risk drugs when feasible (vasopressors, insulin).
• C. For neuraxial infusions, apply “EPIDURAL” labels on catheter and tubing and physically segregate from IV lines (and use safe connectors per facility design).

5.4 Exceptions

If an organizational policy allows a specific exception (e.g., immediate one-person draw-and-inject without setting down syringe), it must be explicit, limited, and not applied when multiple syringes are in use. (ECRI and ISMP)

5. PROCEDURES

5.1 Pump Selection and Setup

• A. Use syringe pumps for small-volume/high-risk infusions as per local standard.
• B. Confirm pump is on correct profile (OR/PACU/ICU) and library is current.
• C. Confirm line labeling and route trace before starting infusion.

5.2 Programming Standards

• A. Verify five rights: right patient, drug, concentration, route/line, dose/rate.
• B. Select the correct drug library entry and concentration; do not approximate with “closest option.”
• C. For high-alert infusions, require independent double-check of programming. (ECRI and ISMP)

5.3 Monitoring During Infusion

• A. Define required physiologic monitoring and reassessment intervals per drug class (vasopressors, opioids, insulin).
• B. Respond to pump alarms promptly; do not silence repeatedly without resolving cause.

5.4 Drug Library Governance

• A. Establish a multidisciplinary governance group (pharmacy, anesthesia, nursing, biomed, IT). (ashp.org)
• B. Build libraries using standard concentrations and safe limits; test changes before deployment. (ECRI and ISMP)
• C. Review override patterns and “no drug selected” events as quality signals and correct system gaps. (ISMP Canada)

5.5 Maintenance and Safety

• A. Pumps undergo scheduled preventive maintenance and electrical safety checks.
• B. Battery readiness required for transport and NORA environments.

5. PROCEDURES

5.1 Recognition

Suspect oxygen pipeline failure when any of the following occur:

• pipeline pressure alarms,
• abrupt fall in pipeline pressure gauges,
• oxygen analyzer indicates falling inspired oxygen not explained by settings,
• multiple rooms report simultaneous oxygen supply issues. (england.nhs.uk)

5.2 Immediate Clinical Response (Patient First)

• A. Announce “OXYGEN SUPPLY FAILURE” and call for help.
• B. Ensure ventilation and oxygenation:
  • Switch anesthesia machine oxygen source to cylinder and open cylinder fully; confirm pressure.
  • Confirm oxygen delivery using oxygen analyzer and pulse oximetry; increase vigilance.
  • If needed, use self-inflating bag with oxygen from cylinder source. (associationofanaesthetists-publications.onlinelibrary.wiley.com)
• C. Reduce oxygen consumption where safe:
  • stop nonessential pipeline oxygen devices,
  • prioritize critical patients and areas,
  • postpone elective cases if supply instability persists.

5.3 Area and Hospital Escalation

• A. Notify: anesthesia leadership, OR control desk, facilities/medical gas plant team, hospital command center as per emergency plan. (england.nhs.uk)
• B. Confirm which zones are affected (single room vs multiple).
• C. Implement institutional oxygen conservation plan if widespread.

5.4 Intraoperative Management During Failure

• A. If a case is ongoing: continue anesthesia safely using cylinder supply and clinically appropriate techniques; evaluate whether to proceed, expedite, or pause based on stability and cylinder capacity.
• B. Ensure a second full cylinder is immediately available for prolonged cases.

5.5 Transport Considerations

• A. For transfers during oxygen system instability, transport with adequate cylinder capacity, monitoring, and airway rescue readiness. (associationofanaesthetists-publications.onlinelibrary.wiley.com)

5.6 Recovery and Return to Normal Operations

• A. Do not resume elective activity until facilities confirm stable pipeline supply and alarms clear; repeat equipment checks after restoration.
• B. Document incident, actions, and lessons learned.

5. PROCEDURES

5.1 Immediate Patient Safety Actions

• A. Stop or correct medication delivery as clinically appropriate.
• B. Stabilize the patient; provide antidotes/reversal agents if indicated.
• C. Inform responsible clinician and team; document clinical facts in the medical record.

5.2 Reporting

• A. Submit an incident report including: drug(s) involved, concentration, route, time, contributing factors (look-alike, labeling, pump programming), and patient outcome. (منظمة الصحة العالمية)
• B. Near-misses must be reported; they are high-value learning signals.

5.3 Investigation and Analysis

• A. Classify severity (no harm, mild, moderate, severe, death) and type (wrong drug, wrong dose, omission, timing, labeling, pump programming).
• B. For serious events: perform structured analysis (RCA) and identify contributing system factors (workflow, human factors, packaging, storage, staffing). (منظمة الصحة العالمية)

5.4 Feedback and Learning

• A. Share de-identified learning with staff promptly.
• B. Implement risk controls, for example:
  • standard concentrations and smart pump library updates, (ECRI and ISMP)
  • syringe/line labeling reinforcement, (ASA)
  • controlled drug process strengthening,
  • high-alert medication segregation and double-check design. (ECRI and ISMP)

5.5 Monitoring Effectiveness

• A. Track recurrent event types and high-risk drugs; monitor compliance with corrective actions.
• B. Use additional detection sources beyond voluntary reports (e.g., chart review, smart pump override reports) as recommended in perioperative medication safety guidance. (ECRI and ISMP)