Pediatric and Congenital Perfusion Practice

Standard 1.1: As a mechanism for applying each standard to clinical practice, an institution or service provider shall develop and implement an operating procedure (protocol) for each of the standards.
Standard 1.2: The protocol shall be:

• Approved by the Chairman of Cardiac Surgery, or his/her designee, Director of Perfusion or equivalent, and other relevant clinical governance committees if available.
• Reviewed and revised annually or more frequently when deemed necessary.

Guideline 1.1: Deviation from protocol may be at the discretion of the Surgical Care Team and should be documented in the perfusion record.

Standard 2.1: A Perfusionist, who is Board Certified by the American Board of Cardiovascular Perfusion or who demonstrates equivalent qualifications and competency, shall conduct cardiopulmonary bypass (CPB).
Standard 2.2: Perfusionist competency shall be assessed annually to evaluate compliance with departmental protocols. Standard 2:3: The Perfusionist shall attend, participate, and engage in perfusion-related continuing education courses on an annual basis.
Standard 2.4: Support staff shall be available on site to assist the primary Perfusionist during CPB procedures
Standard 2.5: A process to educate, train, and annually evaluate perfusion staff shall be developed and followed.
Guideline 2.1: An individual graduating from an accredited perfusion education program should complete all requirements for American Board of Cardiovascular Perfusion certification within 3 years of graduation.
Guideline 2.2: A standardized process should be developed and followed to identify, orient and educate support staff to ensure they have general knowledge of the duties performed by the Perfusionist, flow of the operation and location of primary and ancillary items required during CPB. Support staff may include a Perfusionist, nursing, technical, or non- technical staff.
Guideline 2.3: American Board of Cardiovascular Perfusion continuing education units (CEUs) should be obtained from pediatric content whenever possible.

Standard 3.1: A patient-specific management plan for the cardiopulmonary bypass (CPB) procedure shall be prepared and communicated to the surgical team either during the pre- operative briefing or prior to beginning the procedure.
Standard 3.2: The primary Perfusionist shall use a set handoff protocol e.g. SBAR when transitioning the management of the case to a second Perfusionist.
Guideline 3.1: The use of cellular telephone technology in the operating room should be guided by the principles of ST-59 Statement on use of cell phones in the operating room, written by the American College of Surgeons.
Guideline 3.2: Protocol driven communication (e.g. closed-loop), should be utilized to acknowledge verbal commands, verify the content, and reduce ambiguity.
Guideline 3.3: The primary Perfusionist should participate in the post-procedure debrief with the surgical team.

Standard 4:1: The perfusion record (written and/or electronic) for each cardiopulmonary bypass (CPB) procedure shall be included as part of the patient’s permanent medical record. The perfusion records shall be maintained and stored according to institution policy for retaining patient medical records.
Standard 4.2: The record shall include:

• Patient information including demographics and pre-operative risk factors.
• Information sufficient to accurately describe the procedure, personnel, and equipment.
• Patient physiological parameters documented at a frequency determined by institutional protocol.
• Blood gas and anticoagulation monitoring results.
• Signature of the Perfusionist (and all relief Perfusionists) performing the procedure.

Guideline 4.1: The perfusion record should include open text (factual) commentary including supervising physician verbal orders pertinent to the CPB procedure.
Guideline 4.2: The perfusion record should include the signatures of the physician(s) providing oversight for the CPB procedure.
Guideline 4.3: Raw data (e.g. blood flow, pressure and temperature values) contained in electronic perfusion databases should be stored for a time period in accordance with your institution’s policy for retaining electronic patient medical records.

Standard 5.1: The Perfusionist shall use a checklist for each cardiopulmonary bypass (CPB) procedure.
Standard 5.2: Checklists shall be included as part of the patient's permanent medical record.
Guideline 5.1: The Perfusionist should use checklists in a read-verify manner where critical steps that should have been performed are confirmed.10 Completion of the checklist should be performed by two people, one person being the primary Perfusionist responsible for operation of the heart lung machine during the intra-operative period.
Guideline 5.2: The Perfusionist should utilize a checklist throughout the entire peri-operative period (e.g. set-up, pre-bypass, initial onset of bypass, prior to cessation of bypass, post bypass, and/or any return to bypass).
Guideline 5.3: The Perfusionist should utilize a checklist for other ancillary perfusion services (e.g. cell salvage, intra-aortic balloon pump, extracorporeal membrane oxygenation).

Standard 6.1: Pressure monitoring of the arterial line, cardioplegia delivery systems and venous reservoir (when augmented venous drainage is utilized), shall be employed during cardiopulmonary bypass (CPB) procedures.

• The pressure monitor shall be either servo regulated to control the arterial/cardioplegia pump or to allow interruption to the arterial/cardioplegia flow.
• The pressure monitor shall include an audible and visual alarm.

Standard 6.2: A bubble detector shall be employed during CPB procedures

• The gross/macro bubble detector shall be used to control the arterial pump or to allow interruption of the arterial blood flow.
• The detector system shall include an audible and visual alarm, and be positioned according to manufacturer instructions for use to enable timely identification and action.

Standard 6.3: A level sensor shall be employed during CPB procedures utilizing a (hard- shell) reservoir.

• The level sensor shall be either servo regulated to control the arterial pump or to allow interruption of the arterial blood flow.
• The level sensor shall include an audible and visual alarm, and be positioned according to manufacturer’s instructions to allow an appropriate reaction time and a safe operational volume.

Standard 6.4: Temperature monitoring of the arterial outflow from the oxygenator shall be employed during CPB procedures.

• The temperature sensor shall include an audible and visual alarm to prevent high arterial outlet temperatures.

Standard 6.5: An arterial-line filter shall be employed during CPB procedures.
Standard 6.6: A one-way valve in the vent line shall be employed during CPB procedures.
Standard 6.7: A method for retrograde flow avoidance when using a centrifugal pump shall be employed during CPB procedures.

• Examples of retrograde avoidance systems may include the following:
  • One way flow valves
  • Hard stop detent controls to prevent accidental reduction in pump speed
  • Electronically activated arterial line clamps
  • Low speed visual and audible alarm.

Standard 6.8: An anesthetic gas scavenge line shall be employed whenever inhalation agents are introduced into the circuit during CPB procedures.
tandard 6.9: Hand cranks shall be readily available during CPB procedures.
Standard 6.10: A back-up gas supply shall be available during CPB procedures.
Standard 6.11: A back-up battery supply for the CPB machine shall be available during CPB procedures.
Guideline 6.1: A ventilating gas oxygen analyzer should be employed during CPB procedures.
Guideline 6.2: A level sensor should be employed during CPB procedures utilizing a soft shell reservoir.

• The level sensor should be either servo regulated to control the arterial pump or to allow interruption of the arterial blood flow.
• The level sensor should include an audible and visual alarm, and be positioned according to manufacturer’s instructions to allow an appropriate reaction time and a safe operational volume.
• The use of an air bubble detector distal to the outlet can be used utilized as a surrogate level detector.

Guideline 6.3: The gross/macro bubble detector should be used to control the cardioplegia pump to allow interruption of the cardioplegia and/or modified ultrafiltration (MUF) blood flow.

Standard 7.1: Patient arterial blood pressure shall be monitored continually during cardiopulmonary bypass (CPB).
Standard 7.2: Arterial line pressure shall be monitored continually during CPB.
Standard 7.3: Arterial blood flow shall be monitored continually during CPB.
Standard 7.4: Cardioplegia dose, delivery method, line pressure (antegrade), coronary sinus pressure (retrograde) and ischemic intervals shall be monitored continually during CPB.
Standard 7.5: Patient and device temperatures shall be monitored continually during CPB.

• Patient (e.g. nasopharyngeal, rectal, bladder, esophageal)
• Heart lung machine (arterial, venous and cardioplegia)
• Heater cooler (H20 temperature)

Standard 7.6: Blood gas analysis shall be monitored continually or at regular intervals during CPB.
Standard 7.7: Continuous blood gas monitoring shall be used during CPB.
Standard 7.8 Hematocrit (or hemoglobin) shall be monitored continually during CPB.
Standard 7.9: Oxygen fraction and gas flow rates shall be monitored continually during CPB.
Standard 7.10: The percentage of venous line occlusion of the venous occluder shall be monitored continually during CPB.
Standard 7.11: Venous oxygen saturation shall be monitored continually during CPB.
Standard 7.12: Cerebral oximetry shall be monitored during CPB.
Standard 7.13: Arterial blood flow shall be monitored continually at a point in the CPB circuit where it accurately reflects the flow delivered to the patient during CPB (eg distal to intra- circuit shunts).
Guideline 7.1: Carbon dioxide removal should be monitored continually during CPB.
Guideline 7.2: Arterial oxygen saturation should be monitored continually during CPB.
Guideline 7.3: The following patient pressures should be monitored during CPB

• Central venous pressure

Guideline 7.4: Somatic oximetry should be monitored continually during CPB.

Standard 8.1: The Perfusionist, in collaboration with the physician-in-charge, shall define the intended treatment algorithm for anticoagulation management (heparin) and an alternative algorithm for when heparin is not suitable, including acceptable ranges for ACT.
Standard 8.2: The Perfusionist shall work closely with the surgical care team to monitor and treat the patient’s anticoagulation status before, during, and after the cardiopulmonary bypass (CPB) period.
Guideline 8.1: The surgical care team should determine the target activated clotting time by considering relevant factors; including variability in the measurement of activated clotting time (ACT) attributed to the device’s performance characteristics.
Guideline 8.2: Patient-specific initial heparin dose should be determined by one of the following methods:

• Weight
• Dose Response Curve (automated or manual)
• Blood Volume
• Body Surface Area

Guideline 8.3: Anticoagulation monitoring should include the testing of ACT. Additional monitoring tests may include:

• Heparin level measurement (e.g. heparin/protamine titration or unfractionated heparin level)
• Partial Thromboplastin Time
• Thromboelastograph
• Thrombin Time
• Anti Xa

Guideline 8.4: A process should exist for identifying and managing heparin resistance.
Guideline 8.5: Additional doses of heparin during CPB should be determined by using an ACT and/or Heparin/Protamine titration.
Guideline 8.6: Heparin reversal should be confirmed by ACT and/or heparin/protamine titration.

Standard 9.1: Gas exchange shall be maintained during cardiopulmonary bypass (CPB) according to protocol, accounting for:

• The individual patient characteristics/risk profile
• Oxygenator type, design and instructions for use.
• Blood flow, temperature, metabolic demand, and cerebral oximetry.

Standard 9.2: Devices used to measure gas exchange shall be calibrated according to the manufacturer’s instructions for use.
Standard 9.3: Blood gas analysis shall be performed and recorded according to protocol.
Standard 9.4: The use of supplemental CO2 and a microregulator shall be available to optimize blood gas management.
Guideline 9.1: Point-of-Care testing should be considered to provide accurate and timely information for blood gas analysis.
Guideline 9.2: Oxygen delivery and consumption calculations should be utilized to evaluate and optimize gas exchange.

• Oxygen Delivery: DO₂ = 10 x CI x CaO₂
• Oxygen Consumption: VO₂ = 10 x CI x (CaO₂ – CvO₂)

Where:
CaO₂ (arterial oxygen content) = (Hb x 1.36 x SaO₂) + (0.0031 x PaO₂), and CvO₂ (mixed venous oxygen content) = (Hb x 1.36 x SvO₂) + (0.0031 x PvO₂)

Standard 10.1: Target blood flow rates shall be determined prior to cardiopulmonary bypass (CPB) according to protocol.
Standard 10.2: Blood flow rates shall be calculated utilizing one of the following methods:

• L/min/m²
• L/kg/min

Standard 10.3: The Perfusionist shall work closely with the surgical care team to maintain targeted blood flow rate during CPB.
Standard 10.4: Aortic root vent flow shall be monitored and CPB flow shall be adjusted to accommodate for shunting so that total blood flow to the patient is not compromised.
Guideline 10.1: Variance from intended and targeted blood flow should be communicated to the physician-in-charge.
Guideline 10.2: Appropriate blood flow rate should be determined by evaluation of:

• Acid base balance
• Base Excess
• Anesthetic level
• Arterial blood pressure
• Cerebral oximetry
• Lactate burden
• Oxygen delivery and consumption (refer to guideline 10.2 for formula)
  • Venous pO₂
  • Arterial pO₂
  • Hemoglobin concentration
  • Arterial oxygen saturation
• Systemic vascular resistance (SVR)
• Temperature Venous oxygen saturation

Standard 11.1: The Perfusionist, in collaboration with the physician-in-charge, shall define and communicate the intended treatment algorithm for blood pressure management prior to cardiopulmonary bypass (CPB), including acceptable ranges for blood pressure based on age or weight.
Standard 11.2: The Perfusionist shall work closely with the surgical care team to maintain blood pressure according to protocol during CPB.
Guideline 11.1: Variance from intended and targeted blood pressure should be documented and communicated to the physician-in-charge to allow for changes in the blood pressure management plan.

Standard 12.1: The Perfusionist shall select circuit components taking into consideration prime volume, surface area, safety, and the expected metabolic requirements of the patient.
Standard 12.2: Both the number and size of shunts within the circuit shall be minimized to prevent steal from arterial blood flow.
Guideline 12.1: The Perfusionist should consider assisted venous return taking into consideration any patient specific contraindications.

Standard 13.1: The Perfusionist shall consider the impact the prime has on the smaller circulating blood volume of the pediatric patient and its effect on:  electrolyte levels  colloid osmotic pressure  coagulation
Standard 13.2: When priming with exogenous blood, a circuit prime gas and electrolyte levels shall be obtained prior to initiation of bypass and adjustments made to correct any physiologic abnormalities.
Guideline 13.1: When priming with exogenous blood, the use of prebypass ultrafiltration (preBUF) or washed red blood cells should be used during priming procedure.
Guideline 13.2: The perfusionist should consider matching prime composition to the individual patient values.

Standard 14.1: Cardiotomy suction shall be discontinued at the onset of protamine administration to avoid clotting within the CPB circuit.

Standard 15.1: The Perfusionist shall participate in efforts to minimize hemodilution and avoid unnecessary blood transfusions.
Standard 15.2: The Perfusionist shall minimize the cardiopulmonary bypass (CPB) circuit size to reduce prime volume. See Standard 12. Circuitry
Standard 15.3: The Perfusionist shall calculate and communicate to the surgical team prior to initiating CPB, a patient’s predicted post-dilutional hemoglobin or hematocrit.
Standard 15.4: Minimum acceptable hematocrit during and prior to termination of cardiopulmonary bypass (CPB) shall be maintained according to institutional protocol.
Guideline 15.1: Blood management efforts should include the following:

• Participation in a multidisciplinary blood management team.
• Minimize hemodilution by:
  • Matching the size of the CPB circuit to the size of the patient. See Standard 12: Circuitry.
  • Autologous priming of CPB circuit, including retrograde arterial and venous antegrade priming
• Biocompatible coating on the surface of all CPB components
• Perioperative blood cell recovery and reinfusion after being appropriately processed.
• CPB circuit blood salvage at the end of the procedure
• Preoperative whole blood removal: Acute Normovolemic Hemodilution (ANH)

Guideline 15.2: Point-of-Care hemostasis monitoring should be utilized to minimize blood loss. Monitoring may include:

• International normalized ratio
• Partial thromboplastin time
• Thrombin time
• Thromboelastography/Thromboelastometry
• Platelet count
• Platelet function analysis

Guideline 15.3: The surgical team should consider the age of transfused blood.
Guideline 15.4: Efforts should be made to reduce the total number of donor exposures and utilize components from the same donor whenever possible.

Standard 16.1: Fluid balance shall be monitored continually and documented during cardiopulmonary bypass (CPB).
Guideline 16.1: The use of modified ultrafiltration (MUF) should be utilized (unless contraindicated) to optimize hemodynamics and hematocrit.
Guideline 16.2: The use of dilutional or zero balance ultrafiltration (ZBUF) should be considered during CPB.

Standard 17.1: Procedures identified preoperatively to be at elevated risk of requiring conversion to cardiopulmonary bypass (CPB) shall have a protocol for transition to CPB.
Standard 17.2: One Perfusionist shall be assigned for each such procedure.
Standard 17.3: A heart-lung machine consisting of a sterile extracorporeal set-up and ancillary equipment shall be readily available for the procedure.
Guideline 17.1: The level of readiness for utilizing CPB during a surgical procedure should be determined through consultation with the surgical team.
Guideline 17.2: A heart-lung machine consisting of a sterile extracorporeal set-up and ancillary equipment should be readily available for emergency procedures or as part of disaster planning protocols.

Standard 18.1: At minimum, the “n+1” staffing model shall be utilized at all times, where “n” equals the number of operating/procedure rooms in use at any given time at a single site.
Guideline 18.1: An on-call Perfusionist should be present and clinically ready for unscheduled and emergency procedures within 60 minutes of being called.

Standard 19.1: In order for the Perfusionist to ensure proper provision of care, he/she shall receive an adequate rest period between scheduled work hours.
Guideline 19.1: The Perfusionist should receive a minimum of 8 hours of rest period for every 16-hour consecutive work period.

Standard 20.1: The Perfusionist shall actively participate in both institutional and departmental quality assurance and improvement programs.
Guideline 20.1: The Perfusionist should collect data concerning the conduct of perfusion via a clinical registry or database.
Guideline 20.2: The Perfusionist should use such data for quality assurance, and improvement projects.

Standard 21.1: The Perfusionist shall assure that properly maintained and functioning equipment is used in the conduct of cardiopulmonary bypass (CPB), including (but not limited to):

• Heart lung machine
  • Pumps
  • Timers
  • Pressure monitors
  • Temperature monitors
  • Low Level alarm
  • Air bubble detector(s)
  • Blood flow sensors
• Heater/Cooler
• Anesthetic vaporizer
• Oxygen Blender/Flow Meter
• Oxygen analyzer
• Ancillary Equipment
  • IABP
  • VAD device
  • Cell salvage device

Standard 21.2: Preventive maintenance on perfusion equipment shall be performed by appropriately trained and qualified manufacturer technicians, representatives or Bio-Medical technicians. Regularly scheduled maintenance shall be documented by the perfusion department and/or Bio-Medical engineering staff. The interval of such maintenance shall be consistent with manufacturer recommendations, applicable external accrediting agency guidelines and institutional requirement.
Standard 21.3: The organization shall follow a protocol for perfusion equipment failures
Standard 21.4: Appropriate backup perfusion supplies shall be readily available.
Standard 21.5: The organization shall follow a protocol for acknowledging and addressing perfusion equipment notices (e.g., recalls, warnings, and advisories).