The Brazilian Society for Cardiovascular Surgery (SBCCV) and Brazilian Society for Extracorporeal Circulation (SBCEC) Standards and Guidelines for Perfusion Practice

A primary role for clinical medicine societies is to develop standards and guidelines for practice as an instrument to promote safe and effective patient care. The Brazilian Society for Cardiovascular Surgery (SBCCV) represented by its Department for Mechanical Circulatory Assistance (DECAM) and the the Brazilian Society for Extracorporeal Circulation (SBCEC) conducted a careful critical review of current clinical perfusion practices in Brazil. In addition, a literature review focused on patient safety and surgical outcomes in cardiac surgery was performed. This is the first joint initiative of these two societies (SBCCV/SBCEC) to provide a framework for safe and effective clinical perfusion practice for our cardiac surgery patients. The purpose of this pioneering work was to develop guidelines for the perfusion profession and for those involved in cardiopulmonary bypass (CPB) technology in our country. Both the SBCCV and the SBCEC recommend that institutions and clinical teams adopt the standards and guidelines outlined in this text. The standards and guidelines we recommend are based on those published by the published American Society for Extracorporeal Technology (AmSECT) with a phased adoption recommendation set as an achievable goal. Further, we recommend that cardiac surgery programs develop institution-specific protocols to support the clinical use of these guidelines.The Pioneering Era of Cardiac SurgeryOpen heart surgery has developed considerably over the past several decades including numerous pioneering efforts in Brazil regarding biomedical engineering and circulatory support [1] . Pioneer surgeons, such as John Kirklin, Francis Fontan, Euryclides Zerbini, Adib Jatene, and Denton Cooley were part of our lives and we were able to study their papers, witness their presentations and participate in professional discussions. They are passing away one after another but their work, techniques, experience and wisdom stays with us as their legacy. The impact of their methods profoundly changed the lives of our
A primary role for clinical medicine societies is to develop standards and guidelines for practice as an instrument to promote safe and effective patient care. The Brazilian Society for Cardiovascular Surgery (SBCCV) represented by its Department for Mechanical Circulatory Assistance (DECAM) and the the Brazilian Society for Extracorporeal Circulation (SBCEC) conducted a careful critical review of current clinical perfusion practices in Brazil. In addition, a literature review focused on patient safety and surgical outcomes in cardiac surgery was performed. This is the first joint initiative of these two societies (SBCCV/SBCEC) to provide a framework for safe and effective clinical perfusion practice for our cardiac surgery patients. The purpose of this pioneering work was to develop guidelines for the perfusion profession and for those involved in cardiopulmonary bypass (CPB) technology in our country. Both the SBCCV and the SBCEC recommend that institutions and clinical teams adopt the standards and guidelines outlined in this text. The standards and guidelines we recommend are based on those published by the published American Society for Extracorporeal Technology (AmSECT) with a phased adoption recommendation set as an achievable goal. Further, we recommend that cardiac surgery programs develop institution-specific protocols to support the clinical use of these guidelines.

## The pioneering era of cardiac surgery
Open heart surgery has developed considerably over the past several decades including numerous pioneering efforts in Brazil regarding biomedical engineering and circulatory support . Pioneer surgeons, such as John Kirklin, Francis Fontan, Euryclides Zerbini, Adib Jatene, and Denton Cooley were part of our lives and we were able to study their papers, witness their presentations and participate in professional discussions. They are passing away one after another but their work, techniques, experience and wisdom stays with us as their legacy. The impact of their methods profoundly changed the lives of our DOI: 10.21470/1678-9741-2018-0347 are in discussion with the Federal Councils regarding ways for this activity to be uniformly recognized by the Professions and subsequently legalized with a federal law regulating perfusion activities. Brazilian perfusionists must have the education, tools and authority to perform their job and to become active and respected members of the multidisciplinary cardiac surgery team. Several limitations currently exist which impair the advancement of perfusion practice, including educational gaps, a lack of case ownership, and a lack of tools to assess the adequacy of perfusion in real time during surgery. This is a vicious cycle which impacts outcomes and patient safety.
On a positive note, it is important to highlight the progress made by the Brazilian Society of Extracorporeal Circulation. Supported and stimulated by their society, a significant number of Brazilian perfusionists have had the opportunity to attend symposium-based perfusion related courses, exchange experiences with more advanced international programs and to discuss current techniques of extracorporeal circulation with local perfusionists and those from abroad.
In more developed countries, perfusionists have the freedom to choose perfusion products according their performance, their patient population's needs, and the information available in the literature. Each component is selected via an independent decision with the ideal components used to build the circuit. Alternatively, in Brazilian perfusion practice, it is difficult to be objective since product decisions are almost exclusively based on price and subjective preferences due to the lack of scientific publications comparing Brazilian perfusion products with those available in other markets. In our country, oxygenator manufacturers typically provide complimentary HLMs with an agreement that their oxygenator can only be guaranteed on their HLM. There is an obvious conflict of interest with such an agreement. This implied agreement has no scientific basis and, to our knowledge, is not practiced elsewhere which speaks to the need for change in Brazilian cardiac surgery. Again, our culture needs to adapt to end such practices for the benefit of our patients. This is even more of a concern when one notes that the majority of HLMs made and used in Brazil do not have servoregulating safety devices incorporated for arterial flow, cardioplegia delivery, level sensing, and bubble detectors. Servoregulation for HLM functions is not enough. Perfusionists must also be trained to operate the devices. Standards for perfusion practice, including the use of safety devices, must be established and adhered to.

## Why are clinical perfusion standards so important?
The Gritten Report published by the University Hospitals of Bristol National Health Service (NHS) Foundation Trust of Great Britain described the death of a five-month-old infant undergoing complex cardiac surgery and was released May 25, 2005. The Root Cause Analysis (RCA) report was led by Mark Gritten, an independent and nationally known NHS senior professional. A police investigation and coroner's inquest labeled the case 'unlawful killing' . In English law, unlawful killing means that the killing was made without lawful excuse and in violation of criminal law including murder, manslaughter, and infanticide. The finding of unlawful killing must be beyond reasonable doubt; that is, the evidence must be overwhelmingly patients with congenital heart defects, giving them the chance of enjoying a better quality of life. Now, the pioneering era of cardiac surgery has essentially ended in Brazil.
Congenital cardiac surgery is markedly changing and surgeon-centered outcomes are being replaced by teambased efforts with new paradigms requiring an adaptive work environment in institutions where cardiac surgery is performed.
As William Norwood aptly put in his paper, Our Roots, Our Future , "Institutions are not what they are by historical prerogative: the people walking the halls are responsible for maintaining the legacy and creating new vistas. " That being said, we need to continue the initial work of our pioneers and press on upgrading their achievements to ever higher standards. The era we have now entered is no longer about quantity, it is about achieving excellent whole-patient quality outcomes including optimized neurologic outcomes. We must dig deep into issues that impact the quality of outcomes, teamwork and overall transparency in our respective professions.

## Reviewing perfusion practice: time to stop living in the past
Brazil has a strong history of innovation that extends back to the earliest days of cardiac surgery when our centers pioneered advances in heart-lung machines (HLMs), cardiac valves, conduit implants, and surgical techniques. Brazil started to produce their own HLMs in 1959 and indeed used one of them to perform the first heart transplantation in South America. These innovations highlighted the teamwork primarily of surgeons and biomedical engineers. This was natural since surgeons and other physicians were the first 'perfusionists' . Additionally, perfusion products, including a series of oxygenators, were developed and manufactured domestically. While we fondly remember these great achievements, we also need to focus on the future. Unfortunately, there are still people living in the past and not adapting to evolving cardiac surgery and perfusion practices. We continue to blame our economic burden for the stagnation of our practice while paying little to no attention to the need for cultural change in the operating room.
Furthermore, clinical perfusion has not been recognized by the government as a distinctive profession until quite recently. Currently, only five professional councils recognize Perfusion as a specialty for their undergraduates: Biology, Biomedicine, Nursing, Pharmacy, and Physiotherapy. These professions do not have a standardized perfusion-specific curriculum. Consequently, perfusionist education and training is heterogenous. Furthermore, it is still the case in Brazil that perfusionists must follow the instructions of surgeons and anesthesiologists. In fact, the conduct of perfusion is only considered a medical act once the perfusion record is signed by the surgeon. This practice risks perfusionists not taking full ownership for the conduct of CPB and that raises serious safety concerns since the surgeon and anesthesiologist have much to attend to during cardiac surgery and the perfusionist is the individual who can best manage extracorporeal support with all of its nuances. These facts support the outdated paradigm whereby perfusionists are essentially asked to follow the instructions of surgeons and anesthesiologists during CPB instead of working collaboratively within a famework of well-developed perfusion practice guidelines. Currently, the SBCEC and the SBCCV Considering our context, the effort of publishing this document by the societies SBCCV and SBCEC should be considered as one of most important steps for the future of cardiopulmonary bypass practice in Brazil.
The "holy trinity" for the cardiac surgey patient-perfusionist, surgeon and anesthesist-is a critical issue for optimal outcomes in cardiac surgery. Therefore, publication in Brazil of the Standards and Guidelines for Perfusion Practice aims not only to improve CPB but also to improve overall surgical outcomes as an important quality improvment initiative.

## Perfusion and the pediatric cardiac surgery:
In the early 1950s, the pioneers of congenital cardiac surgery, among them-Bigelow, Lewis, Kirklin, Gibbon and others-realized that the time available with hypothermia and inflow occlusion would not be sufficient to safely perform lenghty intracardiac operations and that an extracorporeal support system would be needed. In 1954, Lillehei introduced the technique of controlled cross-circulation, in which a patient's parent functioned as the extracorporeal pump and oxygenator-a system that put both the parent and the child at risk. Therefore, the development of mechanical cardiopulmonary bypass circuits in the late 1950s was an important step for the progress of congenital cardiac surgery. Since then, extracorporeal perfusion circuits have come a long way to the current low prime membrane oxygenators, the use of centrifugal pumps, vacuumassisted venous drainage, electronic gas blenders, in-line oxygen analyzers and other important devices.
The array and complexity of the equipment, the perfusion techniques to manage a wide variety of patient's age and size along with the broad spectrum of surgical procedures are real challenges that require properly trained and knowledgeable perfusionists.
Because one size does not fit all, the need for a standalone Standards and Guidelines document to perform perfusion for congenital heart surgery is unquestionable and it will in many ways be unique as compared to the one used for the correction of acquired heart disease in adults.
Providing cardiopulmonary support for repair of congenital heart lesions has become a specialty standing on its own. This context should determine the strategies and processes to address these issues; the professionals, administrators, and professional societies should be engaged in planning, setting and articulating the goals of robust pediatric perfusion standards and guidelines to improve the outcomes in pediatric cardiac surgery.
The Brazilian Society for Cardiovascular Surgery (SBCCV) and the Brazilian Society for Extracorporeal Circulation (SBCEC) Standards and Guidelines for Perfusion Practice address perfusion in general. We believe that developing a specific Brazilian Pediatric Perfusion Standards and Guidelines document is essential and that it should be published in the near future to complement this document.

## Development of this document
The Standards and Guidelines for Perfusion Practice will serve as a useful guide for Brazilian cardiac surgical teams to develop obvious that death would result from the act when all factors are taken into account. Otherwise, a verdict of accidental death or death by misadventure would apply. The death was the result of a calcium overdose by a perfusionist that caused irreversible brain damage and subsequent death the day after surgery. The hospital put safeguards into place immediately to minimize any similar incidents happening again. Also, the National Society of Perfusionists perhaps carried some responsibility for this incident because it does not appear to have disseminated other perfusion incidents between its members.
The report concluded that this was a unique but avoidable incident that resulted in an indictment not just to the perfusionist involved in the accident, but to all perfusionists and the perfusion profession as a whole in Great Britain. Had a similar incident happened in Sao Paulo or Rio or elsewhere in Brazil, would the SBCEC or SBCCV also be held responsible?
Perfusion practice during cardiovascular surgery is recognized in the international literature as a critical component to successful patient outcomes. Therefore, as medical societies, we have the responsibility to change our culture, our commercial practices, legislation, regulations and whatever else which involves our specialty which can improve patient outcomes . The intent of our proposed standards and guidelines document is to provide a modern framework for the practice of cardiopulmonary bypass in Brazil that can maximize patient safety and outcomes.
The standards and guidelines document we developed for perfusion practice in Brazil is based on publications from AmSECT . It focuses on the role of written institutional protocols to dictate clinical practice. We worked on four main subjects:
a. empowerment of perfusion as profession with a focus on professional qualification and education standards b. standardization of perfusion practices c. mandatory safety devices d. importance of non-technical skills and patient centered team work

## Professional constraints:
Although perfusion is considered a medical act, Perfusion as a profession is still not fully regulated in Brazil. Consequently, the legal responsibility for what happens at the pump is unclear. The surgeon's knowledge of what is actually happening on the pump at all times during an operation depends upon their communications with the perfusionist. The surgeon's signature on the perfusion record is a formality which does not ensure proper care during CPB. This practice jeopardizes the development of a new generation of perfusionists who should be taking ownership for their individual perfusion cases and, of course, introducing the necessary changes to modernize existing clinical practices. The Perfusionist must be responsible for the whole procedure of extracorporeal circulation and be an active member of the cardiac surgery team, as is the case with most enters abroad.
According to the SBCEC, perfusionists are expected to have: a. Dedication to the patient b. Full integration with the team in which they work c. Professional competence d. Personal ethical and professional conduct, as well as being zealous, affable, aware and observant.
accept this document as an official position for the Standards and Guidelines for Perfusion Practice in Brazil. Both documents are included in this manuscript. The SBCCV and SBCEC endorse this comprehensive report and strongly recommend implementation.

## Minimum standards for perfusion practice in brazil:
Seven standards were identified as the minimum recomendation for perfusion practice. The SBCCV and SBCEC considers these seven standards as mandatory for all cardiac surgical centers (Appendix 1).

## Sbccv/sbcec comprehensive standards and guidelines for perfusion practice in brazil:
The Perfusion Standards listed in Appendix 2 have been modified and adapted to the Brazilian regulatoy agencies' policies and recommendations, by taking The American Society of ExtraCorporeal Technology (AmSECT) Standards and Guidelines as a model and translated to Portuguese. The final document consists of 15 areas of practice including 50 Standards and 38 Guidelines (Appendix 1) with the first standard focusing on the development of institutional protocols to support their implementation and use. Each institution must commit to working towards implementing all standards for patients undergoing cardiovascular surgery.

## Terminology
The SBCCV and SBCEC would like to point out that cardiac surgery clinicians must understand the terminology used in this report. The meanings of these words, as described in the AmSECT publications, are listed below in order to facilitate understanding and adoption of the Standards and Guidelines :
Standards: practices, technology, and/or conduct of care that institutions shall meet to fulfill the minimum requirements for cardiopulmonary bypass Guidelines: recommendation that should be considered and may assist in the development and implementation of protocols Protocols: an institution-specific written document, derived from professional standards and guidelines, which contains decision and treatment algorithms
In this document, the word shall is used to indicate a mandatory requirement In this document, the word should is used to indicate a recommendation In this document, the term surgical care team is used to indicate the components of the system: surgeon, anesthesiologist, perfusionist, nurse, and technicians

# Conclusion
The SBCCV and SBCEC both recognize the vital need for cultural and clinical changes in the application of cardiopulmonary bypass in Brazil. Cardiac surgery centers must adopt the Minimum institution-specific protocols aimed at improving the reliability, safety, and effectiveness of cardiopulmonary bypass. We are aware that the development of a Standards and Guidelines for Perfusion document alone will not change patient care or outcomes. Safe, reliable, and effective care will be best served through the implementation of institutional protocols based on these standards. SBCCV/SBCEC's Standards and Guidelines for Perfusion Practice reflect the changing landscape for perfusion leading to the safe and optimal provision of cardiopulmonary bypass for our patients as well as a working team-based environment that is supportive of these policies.
We preferred to name this document "Standards and Guidelines for Perfusion Practice" because this terminology is contemporary and coincides with the language used by other professional medical societies, including AmSECT .
The SBCCV/SBCEC Standards and Guidelines for Perfusion Practice: 2018 is primarily based on a previous document developed by AmSECT, through its Perfusion Quality Committee. Initially, AmSECT developed a draft standard for perfusion entitled the "Essentials for Perfusion Practice, Clinical Function: Conduct of Extracorporeal Circulation, " which was originally endorsed by the membership in 1993 , and then reviewed and revised on a number of occasions . In 2011, the AmSECT Board of Directors (BOD) asked the International Consortium for Evidence-Based Perfusion (ICEBP) subcommittee to review and update the "Essentials and Guidelines" document. The ICEBP conducted a careful review and critique of the document as well as its relevance and purpose, given the focus on patient safety and surgical outcomes. This initiative resulted in a revised joint document entitled, the Report from AmSECT's, International Consortium for Evidence-Based Perfusion American Society of ExtraCorporeal Technology Standards and Guidelines for Perfusion Practice: 2013 . It was developed as an outgrowth of marrying evidence-based practices from the literature with an understanding of the context in which care is currently provided. Quite notably at the same time, the Minimum Standards for Perfusion Practice in Brazil document was developed as an outgrowth of ongoing collaboration with the International Quality Improvement Collaborative for Congenital Heart Surgery (IQIC) which is managed from Boston Children's Hospital and overseen by an international steering committee. Adoption of the Minimum Standards for Perfusion Practice in Brazil document will empower perfusionists to effect change at their institution by working towards practice standards endorsed by their national organizations including minimum safety devices for all cardiopulmonary bypass cases, monitoring devices to help assess the adequacy of perfusion, and promotion of a teambased appoach for the care of cardiac surgical patients. Our vision to improve perfusion practice, and thus patient outcomes, is for the minimum standards to be adopted as soon as possible by Brazilian cardiac surgery teams with the comprehensive list of AmSECT standards phased in as soon as practial given the constraints discussed previously.
Following translation to Portuguese and critical review by colleagues, this final document was presented to the SBCCV and SBCEC for their steering commitiee aproval. A majority of the members of the steering commities of both societies voted to Standards For Perfusion Practice in Brazil as soon as possible and work towards adopting the Comprehensive Standards and Guidelines for Perfusion Practice in Brazil moving forward. Ultimately, a team-based approach utilizing nationally endorsed standards will help ensure safe and optimal cardiopulmonary bypass for all our patients and improve outcomes for the complex population we serve.

## Acknowlegdements
The DECAM/SBCCV and SBCEC would like to thank AmSECT for graciously allowing us to use their pioneering efforts as we work to improve perfusion practice in Brazil. Furthermore, the authors would like to thank Robert Baker, Chair of the International Consortium for Evidence Based Perfusion (ICEBP) Executive Committee for his review of this document and expert opinion as we developed this manuscript.

## Minimum standard 2:
Each perfusionist must be adequately trained through a defined education process. Staff must participate in annual continuing education activities and institutional based quality improvement programs. (See also Comprehensive Standards 2 and 13).

## Minimum standard 3:
The care team must discuss the bypass plan before incision; anticoagulation plan and target ACT values, pump flows, hematocrit management, target temperature, myocardial protection plan, blood gas management, blood pressure goals, etc. Closed-loop communication must be used during the procedure. The care team must have realtime multidisciplinary discussion regarding all concerns during bypass (i.e., blood pressure too low, poor venous drainage, falling NIRS, need for blood product transfusion, etc.). (See also Comprehensive Standards 1, 3, 5, 8 and 12).

## Minimum standard 4:
Perfusion equipment must be maintained by qualified personnel. An appropriately sized selection of equipment and standardized disposables must be used for each patient with back-up equipment available. Back-up supplies of cannulae and connectors, etc., must be located next to the primary perfusionist in the OR. The bypass circuit must be set-up on the heart-lung machine before the patient arrives in the operating room. (See also Comprehensive Standards 6 and 14).

## Minimum standard 5:
The perfusion record must include sufficient timed data to reconstruct a bypass run, include the prebypass checklist and list the products used for the case. The perfusion record must be part of part of the patient's medical record. (See also Comprehensive Standards 3,4, 5, 7, 8, 9 and 12).

## Minimum standard 6:
The follow monitoring and safety devices must be used for all patients; patient and circuit temperature probes, reservoir level sensor, bypass system and cardioplegia temperature and pressure, an arterial line filter, flow probe, one-way valve on the vent line, back-up oxygen supply, SvO2 monitoring and a hand crank. The following items should be considered for every case: NIRS monitoring and bubble detection. Servoregulation must be utilized where available. Blood gases must be verified on a defined schedule. (See also Comprehensive Standards 6, 7, 10 and 11).

## Minimum standard 7:
The perfusion team must have adequate storage space near the operating theater for back-up and emergency supplies. A comfortable chair which allows for close monitoring of the perfusion circuit should be available to the perfusoinist during bypass. (See also Comprehensive Standard 14).

## Appendix 1 padroes minimos para a pratica de perfusao no brasil
Minimum Standard 1: As praticas de perfusao devem ser orientadas por um conjunto de politicas desenvolvidas dentro da instituicao, disponiveis na forma escrita e aprovadas pelo)a) chefe da equipe cirurgica (para mais detalhes, veja Comprehensive Standard 1).

## Minimum standard 2:
Cada perfusionista deve ser treinado adequadamente em um processo de formacao definido. Toda a equipe de perfusionistas deve participar das atividades anuais de educacao continuada e dos programas de melhoria de qualidade da instituicao (para mais detalhes, veja Comprehensive Standards 2 e 13).

## Minimum standard 3:
A equipe cirurgica deve discutir o plano de perfusao antes da incisao na pele, assim como anticoagulacao e valores de TCA alvo, fluxos de perfusao, hematocrito alvo e politica transfusional, temperatura alvo, estrategia de protecao miocardica e manuseio da pressao arterial. A comunicacao em alca fechada (closed loop) deve ser usada durante todo o procedimento. A equipe deve promover uma discussao multidisciplinar em tempo real sobre todas as preocupacoes durante a circulacao extracorporea (ou seja, pressao arterial muito baixa, dificuldade com a drenagem venosa, queda dos valores da oximetria cerebral nao invasiva -near-infrared spectroscopy -NIRS, necessidade de hemoderivados, dentre outras) (para mais detalhes, veja Comprehensive Standards 1, 3, 5, 8 e 12).

## Minimum standard 4:
A manutencao do equipamento de perfusao deve ser realizada por pessoal qualificado. A escolha adequada dos equipamentos necessarios e dos descartaveis padronizados em protocolo institucional deve ser realizada para cada paciente, assim como um equipamento de reserva deve estar disponivel para a perfusao. Os suprimentos e componentes descartaveis do circuito (canulas e conectores etc.) em duplicidade devem estar localizados o mais proximo possivel do perfusionista responsavel pelo caso, preferencialmente na sala de cirurgia. O circuito de circulacao extracorporea (CEC) deve ser montado na maquina de CEC antes que o paciente chegue a sala de operacao (para mais detalhes, veja Comprehensive Standards 6 e 14).

## Minimum standard 5:
A ficha (registro) de perfusao deve incluir dados suficientes para reconstruir a perfusao por inteiro, incluindo um checklist pre-CEC e contendo todas as drogas e descartaveis utilizados para a conducao do caso. A ficha de perfusao deve ser parte do prontuario medico do paciente e deve ser anexada a ele. Uma copia deve ser mantida com a equipe de perfusao (para mais detalhes, veja Comprehensive Standards 3, 4, 5, 7, 8, 9 e 12).

## Minimum standard 6:
Os seguintes dispositivos de monitoracao e seguranca devem ser utilizados para todos os pacientes: sensores de temperatura no paciente, no circuito venoso e arterial e na cardioplegia; sensor de nivel de reservatorio; sensor de bolhas; sistema de pressao na linha arterial e na linha de infusao da cardioplegia; filtro de linha arterial; fluxometro na linha arterial; valvula unidirecional na linha aspiracao da aorta/ atrio esquerdo; cilindro de oxigenio de reserva; equipamento de monitoracao da SvO2; monitor de oximetria cerebral continua (NIRS); detector de bolhas e "hand cranck" para manuseio manual da bomba arterial. A servorregulacao deve ser utilizada sempre que disponivel. Os gases no sangue devem ser verificados em uma rotina predefinida em protocolo (para mais detalhes, veja Comprehensive Standards 6, 7, 10 e 11).

## Minimum standard 7:
A equipe de perfusao deve ter espaco de armazenamento adequado perto da sala de cirurgia para suprimentos de emergencia. Uma cadeira confortavel que permita um monitoramento proximo do circuito de perfusao deve estar disponivel durante a perfusao (para mais detalhes, veja Comprehensive Standard 14). 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 nontechnical staff.

## Guideline 2.3:
A standardized process to educate, train, and to evaluate annually perfusion staff should be developed and followed.

## Guideline 2.4:
It is recommended any perfusion procedure be conducted by two perfusionists, ensuring a better procedural safety. Guideline 2.5: Use of Personal Protective Equipment: The perfusionist should use Personal Protective Equipment (PPE), such as masks, goggles and procedure gloves while conducting CPB. Gloves should be changed after drawing a blood sample, blood products administrtion and manipulation (blood bag) or whenever exposed to a blood splash .

## Standard 3: perfusion record
Standard 3.1: The perfusion record (written and/or electronic) for each CPB procedure shall be included as part of the patient's permanent medical record. The perfusion record shall be maintained and stored according to institution policy for retaining patient medical records.

## Standard 3.2:
The record shall include:
- Patient information including demographics and preoperative risk factors (Appendix A) - Information sufficient to accurately describe the procedure, personnel, and equipment (Appendix B). - Patient physiological parameters documented at a frequency determined by institutional protocol (Appendix C). - Blood gas and anticoagulation monitoring results (Appendix D). - Signature of the perfusionist (and all relief perfusionists) performing the procedure.

## Guideline 3.1:
There should be perfusion (writing and/or electronic) record for each performed CPB procedure. The perfusion record must include a free text space for recording comments, including verbal orders given by the medical staff, including verbal orders given by the supervising physician.

## Guideline 3.2:
The perfusion record should include the signatures of the physician(s) providing oversight for the CPB procedure.

## Guideline 3.3:
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. - The gross/macrobubble 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. The perfusionist shall use a checklist for each CPB procedure .

## Standard 4.2:
Checklists shall be included as part of the patient's permanent medical record.

## Guideline 4.1:
The perfusionist should use checklists in a read-verify manner where critical steps that should have been performed are confirmed . 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 intraoperative period. In services where there is no availability of another professional perfusionist, a systematic routine of checking the items contained in the checklist should be adopted, in order to minimize the occurrence of adverse events.

## Guideline 4.2:
The perfusionist should use a checklist throughout the entire perioperative period (e.g., setup, prebypass, initial onset of bypass, before cessation of bypass, postbypass, and/or any return to bypass).

## Guideline 4.3:
The perfusionist should use a checklist for other ancillary perfusion services (e.g., cell salvage, intra-aortic balloon pump, extracorporeal membrane oxygenation).

## Standard 5: communication
Standard 5.1: A patient-specific management plan for the CPB procedure shall be prepared and communicated to the surgical team either during the preoperative briefing or before beginning the procedure .
Guideline 5.1: The use of cellular telephone technology in the operating room should be avoided, since it is a distracting factor and predispose the patient to the risk of contamination by potentially infectious bacteria, compromising the quality and safety of the health assistance. When their use is unavoidable, the devices must be pre-sanitized according to the institution protocol for infection control .

## Guideline 5.2:
Protocol-driven communication (e.g., closedloop) should be used to acknowledge verbal commands, verify the content, and reduce ambiguity . - The pressure monitor shall be either servoregulated 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.
- Pulmonary artery blood pressure.

## Guideline 7.4:
Continuous in-line blood gas monitoring should be used during CPB.
Guideline 7.5: Cerebral oximetry should be used during CPB.
Guideline 7.6: Arterial blood flow should be monitored continually at a point in the CPB circuit where it accurately reflects the flow delivered to the patient during CPB (e.g., distal to intracircuit shunts).

## Standard 8: anticoagulation
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 activated clotting time (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 CPB period. Director is responsible for all POCs tests performed within the institution. The clinical laboratory should provide documented standard procedures to all sites using POC devices for guidance on its pre-analytical, analytical and post-analytical phases, including: a. systematic recording and release of interim results; b. procedure for potentially critical lab test results; c. systematic review of results and release of reports by qualified professional. The clinical laboratory should keep records for the quality control program as well as the standards procedures to perform them. The clinical laboratory should promote and maintain records of its ongoing users' education process for POC equipments .
- 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 as a surrogate level detector.

## Guideline 6.3:
The tubing pack should be provided by the manufacturer "pre-assembled", pre-connected and in a sterile tray separating the circuit that will be used in the surgical field of the one that will be mounted in the heartlung machine (HLM), offering more safety to the perfusion itsef and granting faster circuit assembly. Guideline 10.1: Point-of-care testing should be considered to provide accurate and timely information for blood gas analysis .

## Guideline 10.2:
Oxygen delivery and consumption calculations should be used to evaluate and optimize gas exchange :
[formula] Oxygen [/formula]

## Standard 12: blood pressure
Standard 12.1: The perfusionist, in collaboration with the physician-in-charge, shall define and communicate the intended treatment algorithm for blood pressure management before CPB, including acceptable ranges for blood pressure. Obs: in many circumstances, the physicianin-charge may direct the perfusionist to modify the intended Guideline 8.4: Additional doses of heparin during CPB should be determined by using an ACT and/or heparin/ protamine titration. Note: in patients requiring longer CPB times (>2 to 3 hours), maintenance of higher and/or patient-specific heparin concentrations during CPB may be considered to reduce hemostatic system activation, reduce consumption of platelets and coagulation proteins, and to reduce blood transfusion (Class IIb, Level of evidence B) .

## Guideline 8.5:
Heparin reversal should be confirmed by ACT and/or heparin/protamine titration.

## Standard 9: blood management
Standard 9.1: The perfusionist shall participate in efforts to minimize hemodilution and avoid unnecessary blood transfusions .

## Standard 9.2:
The perfusionist shall minimize the CPB circuit size to reduce prime volume .

## Standard 9.3:
The perfusionist shall calculate and communicate to the surgical team before initiating CPB a patient's predicted postdilutional hemoglobin or hematocrit. Guideline 9.1: Blood management efforts should include the following :
- Participate in preoperative briefings (discussions) with the surgical care team (Standard 5.1) regarding transfusion strategies and target hematocrit values. - Participation in a multidisciplinary blood management team. - Minimize hemodilution by: - Matching the size of the CPB circuit to the size of the patient; - 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; and CPB circuit blood salvage at the end of the procedure. Note: In the case of consigned equipment, the owner of the CPB machine is responsible for maintaining the perfusion set, and all liabilities and legal issues will be assigned to it. In the case of an adverse event resulting from the use of this equipment, even if the equipment is proven to be defective, even with adequate maintenance and not related to improper use by the perfusionist, the owner of the equipment and not the institution shall be held liable.
Therefore, there should be an updated document for each of the equipment used, with dates and details of preventive and corrective maintenance and that should be filed in the perfusion service/department or clinical engineering unit of the institution .

## Standard 14.3:
The organization shall have a written procedure for perfusion equipment failures .

## Standard 14.4:
Appropriate back-up perfusion supplies shall be readily available. Obs: when CPB machine is not property of the institution, the equipement's owner will be responsible for the replacement, and has legal responsibility for this action.

## Standard 15: duty hours
Standard 15.1: The perfusionist can be hired by the hospital or through a medical services company, respecting the labor laws according to the signed agreement.

## Standard 15.2:
It is briefly forbidden for the perfusionist to be engaged to perform perfusion and perform another function in the service with the same labor contract.

## Guideline 15.1
The perfusionist should receive a minimum of 8 hours of rest period for each consecutive 16-hour work period [bib_ref] Environment of Care Essentials for Health Care, Lipschultz [/bib_ref].
blood pressure management to address circumstances occurring during the CPB procedure.

## Standard 12.2:
The perfusionist shall work closely with the surgical care team to maintain blood pressure according to protocol during CPB.
Guideline 12.1: 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 13: quality assurance and improvement
Standard 13.1: The perfusionist shall actively participate in both institutional and departmental quality assurance and improvement programs.

## Guideline 13.1:
The perfusionist should collect data regarding conduction of the perfusion through a clinical registry or database.

## Guideline 13.2:
The perfusionist should use this data for quality control and improvement projects .

## Guideline13.3:
The perfusionist should evaluate the postoperative period of the patient in a standard form (Appendix E), storing data for periodic evaluation of perfusion in his service .

## Guideline 13.4:
Specific and periodic meetings should be held in his service for the review of avoidable errors occurring in his daily practice.
Guideline 13.5: Any adverse events shall be notified in writing to the responsible sector, which shall forward them to the regulatory agencies and other competent areas after their verification. The service should encourage notifications to be always carried out, establishing a direct line of communication between the team and the risk management department, guaranteeing their confidentiality . - Integrity and operation of the CEC machine and heat exchanger. - Operation of gas systems and connections to the oxygenator. - Correct identification of the patient. - Availability of blood products. - Composition of the perfusate. Guideline 3.1: Devera haver uma ficha (registro) de perfusao (escrita e/ou eletronica) para cada procedimento de CEC. A ficha de perfusao deve incluir um espaco de texto livre para registro de comentarios, incluindo ordens verbais dadas pela equipe medica pertinentes a perfusao realizada. Guideline 3.2: O registro de perfusao deve incluir as assinaturas do(s) medico(s) responsavel(is) pela supervisao da CEC.

## Guideline 3.3:
Os dados brutos (por exemplo, fluxo sanguineo, pressao e valores de temperatura) contidos em bancos de dados de perfusao eletronica devem ser armazenados por um periodo de tempo definido pela politica institucional referente a retencao de registros medicos eletronicos de pacientes.

## Standard 4: checklist
Standard 4.1: O perfusionista deve utilizar um checklist para cada perfusao realizada .

## Standard 4.2:
O checklist deve ser preenchido, incluido e anexado ao prontuario do paciente.

## Guideline 4.1:
O perfusionista deve fazer o checklist lendo-o em voz alta a outro perfusionista e marcando cada um dos itens apos a confirmacao de que aquela acao, definida item a item, foi realizada . O preenchimento do cheklist deve ser realizado por duas pessoas, sendo uma delas o perfusionista principal responsavel pela conducao da CEC durante o periodo intraoperatorio. Nos servicos em que nao ha a disponibilidade de outro profissional perfusionista, deve ser adotada uma rotina sistematica de verificacao dos itens contidos no checklist, com o objetivo de minimizar a ocorrencia de eventos adversos.

## Guideline 4.2:
O perfusionista deve utilizar o checklist ao longo de todo o periodo perioperatorio (p. ex., montagem da maquina de CEC, pre-CEC, fase inicial da perfusao, antes da saida da perfusao, apos a perfusao e/ou qualquer retorno a CEC).

## Guideline 4.3:
O perfusionista deve utilizar o checklist para os demais servicos auxiliares a perfusao (isto e, recuperacao sanguinea atraves de "cell salvage", balao intra-aortico, oxigenacao por membrana extracorporea -extracorporeal membrane oxygenation -ECMO, entre outros).

## Standard 5: comunicacao
Standard 5.1: Um plano de perfusao individualizado e especifico ao paciente deve ser preparado e comunicado a equipe cirurgica tanto no "briefing" quanto antes do inicio do procedimento .
Guideline 5.1: O uso de aparelhos de telefone celular em sala cirurgica deve ser evitado e em CEC deve ser proibido, visto que e um fator de distracao e predisponente para riscos ao paciente. Alem disso, a grande maioria esta contaminada por bacterias potencialmente infectantes, comprometendo a qualidade e seguranca da assistencia. Quando seu uso for Standard 2.3: O perfusionista deve assistir, participar e se envolver em cursos de educacao continuada relacionados a perfusao ao menos uma vez ao ano.

## Standard 2.4:
O pessoal de apoio deve estar disponivel no local para auxiliar o perfusionista durante os procedimentos necessarios na conducao da CEC. Guideline 2.1: Um individuo que se formar em um programa credenciado de educacao em perfusao deve preencher todos os requisitos para a certificacao da SBCEC.

## Guideline 2.2:
Um processo padronizado deve ser desenvolvido e seguido para identificar, orientar e educar a equipe de suporte de forma a garantir que todos tenham conhecimento geral das funcoes desempenhadas pelo perfusionista, fluxo cirurgico e localizacao dos itens essenciais e auxiliares necessarios durante a CEC. A equipe de apoio inclui equipes de perfusionistas, enfermagem, tecnicos e pessoal administrativo.

## Guideline 2.3:
Um programa estruturado para educar, treinar e avaliar a equipe de perfusao, ao menos anualmente, deve ser desenvolvido e seguido. Guideline 2.4: E recomendada a existencia de dois perfusionistas por procedimento, garantindo maior seguranca ao procedimento. Guideline 2.5: Utilizacao de equipamentos de protecao individual. Durante a conducao da CEC o perfusionista deve utilizar equipamentos de protecao individual (EPI), como mascaras, oculos e luvas de procedimento. As luvas devem ser trocadas apos a coleta de amostra, apos a troca de solucao (bolsa de sangue) do equipo ou sempre que estiver com respingo de sangue .

## Standard 3: ficha (registro) de perfusao
Standard 3.1: A ficha (registro) de perfusao (escrita e/ou eletronica) para cada procedimento de CEC deve ser incluida como parte do prontuario medico do paciente. O registro de perfusao deve ser mantido e armazenado de acordo com a politica da instituicao para a retencao de registros medicos (prontuario) do paciente. inevitavel, os aparelhos devem ser higienizados previamente, conforme protocolo de antissepsia da instituicao .

## Guideline 5.2:
A comunicacao padronizada por meio de protocolos especificos (p. ex., closed loop communication) deve ser utilizada para o reconhecimento dos comandos verbais, verificacao de conteudo e reducao de ambiguidade .
Guideline 5.3: O perfusionista principal devera participar do "debrief" pos-operatorio com toda a equipe cirurgica. O laboratorio clinico deve disponibilizar, nos locais de realizacao de TLR, procedimentos documentados com orientacoes sobre suas fases pre-analitica, analitica e posanalitica, incluindo: a. Sistematica de registro e liberacao de resultados provisorios. b. Procedimento para resultados potencialmente criticos. c. Sistematica de revisao de resultados e liberacao de laudos por profissional habilitado. O laboratorio clinico deve manter registros dos controles da qualidade, bem como procedimentos para sua realizacao.O laboratorio clinico deve promover e manter registros de seu processo de educacao permanente para os usuarios dos equipamentos de TLR . Guideline 8.4: As doses adicionais de heparina durante a CEC devem ser determinadas usando a titulacao pelo TCA e/ ou heparina/protamina. Nota: em pacientes que requerem tempos de CEC mais longos (> 2 a 3 horas), pode-se considerer a manutencao de concentracoes de heparina mais altas e/ou especificas para o paciente durante a CEC, para reduzir a ativacao do sistema de coagulacao e o consumo de plaquetas e proteinas de coagulacao, assim como evitar ou reduzir a transfusao de hemoderivados (Classe IIb, Nivel de evidencia B) . Guideline 10.1: Exames realizados com dispositivos "pointof-care" devem ser considerados para propiciar informacoes precisas e instantaneas para analise de gases no sangue . Guideline 10.2: O calculo da oferta e consumo de oxigenio deve ser utilizado para avaliar e otimizar a troca gasosa : Oferta de oxigenio: DO 2 = 10 x IC x CaO 2 Consumo de oxigenio: VO 2 = 10 x IC x (CaO 2 -CvO 2 ) Em que: CaO 2 (conteudo de oxigenio arterial) = (Hb x 1,36 x SaO 2 ) + (0,0031 x PaO 2 ) e CvO 2 (conteudo de oxigenio venoso misto) = (Hb x 1,36 x SvO 2 ) + (0,0031 x PvO 2 ) HB = hemoglobina IC = indice cardiaco PaO 2 = pressao parcial de oxigenio no sangue arterial PvO 2 = pressao parcial de oxigenio no sangue venoso SaO 2 = saturacao arterial de oxigenio SvO 2 = saturacao venosa de oxigenio Standard 11: Fluxo de perfusao Standard 11.1: O fluxo de perfusao alvo deve ser determinado antes de iniciar a CEC de acordo com o protocolo institucional. Obs.: superficie corporea x indice cardiaco = fluxo sanguineo calculado, no qual a superficie corporea em metros quadrados e igual a raiz quadrada da altura vezes o peso dividido por 3.600 (altura  peso/3.600), utilizando altura em centimetros (cm) e peso em kilogramas (kg). . Standard 9.2: O perfusionista deve minimizar o tamanho do circuito de CEC no intuito de reduzir o volume do prime . Standard 9.3: O perfusionista deve calcular e comunicar a equipe cirurgica o hematocrito/hemoglobina pos-dilucional previsto para o paciente antes de iniciar a CEC. Guideline 9.1: As definicoes dos protocolos de transfusao de hemoderivados (patient blood management -PBM) devem incluir :
- Participacao do perfusionista nas discussoes (briefings) pre-operatorias com toda a equipe cirurgica (Standard 5.1) em relacao as estrategias de transfusao e valores "alvos" de hematocrito. - Participacao do perfusionista no grupo multidisciplinar de PBM.
Minimizar a hemodiliucao por meio de:
- Selecao do tamanho do circuito de CEC compativel com o tamanho do paciente. - Preenchimento do circuito com sangue autologo, incluindo enchimento retrogrado do circuito com sangue (retrograde autologous priming -RAP). - Utilizacao de tubos com revestimento biocompativel/ bioativos em todos os componentes de CEC. - Recuperacao perioperatoria de celulas sanguineas (cell savage) e reinfusao apos processamento adequado. - Recuperacao do sangue do circuito de CEC ao final do procedimento ("blood cell savage" do "prime" do circuito). Obs.: em equipamentos consignados, o proprietario da maquina de CEC e responsavel pela manutencao no equipamento de perfusao, e todas as responsabilidades e questoes legais serao imputadas a ele. Em caso de evento adverso decorrente do uso deste equipamento, quando comprovada falha, mesmo com provas de manutencao adequada e nao relacionada ao uso indevido por parte do perfusionista, o dono do equipamento, e nao a instituicao, devera ser responsabilizado.
Portanto, deve existir um documento atualizado para cada um dos equipamentos utilizados, com as datas e os detalhes de manutencao preventiva e corretivas e que deve ser arquivado na unidade de perfusao ou de engenharia clinica da instituicao .

## Standard 14.3:
A instituicao deve ter o procedimento padrao por escrito documentando as falhas potenciais e ocorridas no equipamento de perfusao, bem como as condutas a serem adotadas ou correcoes implementadas .

## Standard 14.4:
Os suprimentos necessarios de perfusao de "backup" devem estar prontamente disponiveis.
Obs.: quando a maquina de CEC nao e propriedade da instituicao (em caso de equipamento consignado), o proprietario do equipamento sera responsavel pela substituicao e tera responsabilidade legal em caso de evento adverso decorrente do uso deste equipamento, quando comprovada falha nao relacionada ao uso indevido por parte do perfusionista. .
Guideline13.3: O perfusionista deve avaliar em ficha padrao (Appendix E) o pos-operatorio do paciente, armazendo dados para avaliacoes periodicas da perfusao no servico .

## Guideline 13.4:
Reunioes especificas e periodicas devem ser realizadas para a revisao de erros evitaveis que ocorram no servico.
Guideline 13.5: Todo e qualquer evento adverso deve ser notificado por escrito ao setor responsavel, o qual dara encaminhamento as agencias regulatorias e demais orgaos competentes apos apuracao. O servico deve incentivar a realizacao constante das notificacoes, estabelecendo uma linha de comunicacao direta entre a equipe e a gerencia de risco, garantindo seu sigilo . [bib_ref] Environment of Care Essentials for Health Care, Lipschultz [/bib_ref].
[fig] Standard 6. 3: A level sensor shall be used during CPB procedures using 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 the 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 used 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 used during CPB procedures.Standard 6.6:A one-way valve in the vent line shall be used during CPB procedures.Standard 6.7:A method for retrograde flow avoid-ance when using a centrifugal pump shall be used during CPB procedures. At least one method to prevent retrograde flow shall be used for systems using centrifugal pumps for systemic circulation. 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; or  A low-speed visual and audible alarm. [/fig]
[fig] Standard 6. 8: An anesthetic gas scavenge line shall be used whenever inhalation agents are introduced into the circuit during CPB procedures. [/fig]
[fig] Standard 6. 9: Hand cranks shall be readily available during CPB procedures. [/fig]
[fig] Standard 6: 10: A back-up gas supply shall be available during CPB procedures. [/fig]
[fig] Guideline 5. 3: The primary perfusionist should participate in the postprocedure debrief with the surgical team. [/fig]
[fig] . 1: Pressure monitoring of the arterial line, cardioplegia delivery systems, and venous reservoir (when vacuum assisted venous drainage is used) shall be used during CPB procedures. [/fig]
[fig] Guideline 7. 3: As seguintes pressoes do paciente devem ser monitoradas durante a CEC:  Pressao venosa central (PVC); e/ou  Pressao da arteria pulmonar. Guideline 7.4: Os gases sanguineos devem ser continuamente monitorados (in-line) durante a CEC. [/fig]