Quality control and evaluation system for general thoracic surgery
Review Article

Quality control and evaluation system for general thoracic surgery

Yijiu Ren1#, Guochao Zhang2#, Xuefei Hu1, Dong Xie1, Deping Zhao1, Qi Xue2*, Chang Chen1*

1Department of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, China; 2Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Contributions: (I) Conception and design: Y Ren, C Chen; (II) Administrative support: D Zhao, C Chen; (III) Provision of study materials or patients: D Zhao, Q Xue; (IV) Collection and assembly of data: X Hu, D Xie, D Zhao; (V) Data analysis and interpretation: Y Ren, G Zhang, Q Xue; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

#These authors contributed equally to this work as co-first authors.

*These authors contributed equally to this work as co-senior authors.

Correspondence to: Chang Chen, MD, PhD, Department of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, No. 507 Zhengmin Road, Shanghai 200443, China. Email: chenthoracic@163.com; Qi Xue, MD. Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9, Dongdansantiao Street, Beijing 100021, China. Email: xueqi@cicams.ac.cn.

Abstract: This paper addresses the current absence of a robust quality control inspection and evaluation system for general thoracic surgery in China by developing a quality control scoring system. Our objective was to establish a system focusing on patient safety, operational success, and quality of care. We establish this system by reviewing existing literature and referencing the quality control standards for lung and esophageal cancer surgery in Shanghai, facilitated by a consensus of a multidisciplinary expert panel through structured workshops. Quality control of general thoracic surgery involves many aspects such as the qualifications and technical conditions of medical institutions, preoperative diagnostic assessment, surgical procedures, postoperative management, postoperative pathological diagnosis, and follow-up. The quality standards of general thoracic surgery should be evidence-based, with specific and clear criteria and requirements that comply with universally applicable principles. Refinement management is one of the core concepts of quality control in general thoracic surgery, and it should strictly follow the requirements of thoracic surgery guidelines, establish a refined management system for standard clinical pathways, clarify the quality standards of each key link in the clinical pathway, and establish a clinical quality control system combining self-assessment with supervision and inspection. The development of our quality control scoring system represents a significant advancement in the field of general thoracic surgery. This system is designed to be a robust tool for evaluating and improving surgical practices, with a focus on enhancing patient safety and outcomes. We anticipate that its implementation will standardize quality control across hospitals and lead to tangible improvements in the overall quality of thoracic surgical care in China.

Keywords: General thoracic surgery; surgery; quality control


Received: 11 June 2024; Accepted: 24 October 2024; Published online: 30 October 2024.

doi: 10.21037/ccts-24-20


Introduction

General thoracic surgery is a relatively complex type of surgery within the field of surgery, with high technical requirements, a relatively long learning curve, a high incidence of postoperative complications, and a certain surgical mortality rate. The quality of thoracic surgery is one of the important factors affecting patient outcomes (1). Establishing a quality assessment system for thoracic surgery and strengthening quality control in thoracic surgery are important measures to further improve the level of diagnosis and treatment of thoracic surgery in our country (2).

The quality of thoracic surgery includes not only the quality of surgical procedures but also many aspects such as preoperative diagnosis and assessment, determination of surgical indications, assessment of surgical risks, standardized surgical processes, control of postoperative complications, perioperative and postoperative education and nursing, as well as postoperative pathological diagnosis and follow-up. Currently, there is a lack of effective quality control inspection and evaluation systems for general thoracic surgery in China. This paper aims to explore the construction of quality control standards for thoracic surgery through literature review and in combination with the quality control standards for lung/esophageal cancer surgery in Shanghai. Relevant quality control indicators can be divided into structural indicators, process indicators, and outcome indicators, which were proposed by Donabedian in the 1970s (3). Structural indicators are planned as hardware facilities of medical facilities, process indicators are categorized as management processes of medical units, and outcome indicators are summarized as professional techniques in clinical practice. There may be differences among various thoracic surgery centers in clinical practice, and it may be difficult to unify quantification in specific indicator assessments. Therefore, we have established a scoring and quantification system using various subdivided indicators of quality control to establish a convenient and reliable quality control system, with the hope that it can be widely applied to the assessment of thoracic surgery quality.

The quality control standards established for thoracic surgery (lung cancer/esophageal cancer) are as follows: a total score of 100 points, with 10 points allocated to hardware facilities, 20 points to management level, and 70 points to professional technical level (Table 1). The quality assessment process, including the quantification of timeliness and adherence to protocols, should be conducted by a designated quality control committee within the thoracic surgery department, led by the department head or a qualified senior physician. This team will be responsible for monitoring, documenting, and analyzing the performance metrics to ensure continuous improvement in the quality of care provided.

Table 1

Thoracic surgery quality control score distribution table

Evaluation projects Scores
Hardware 10
   Environment, housing setup 2
    Dedicated post-operative monitoring ward or monitoring beds 1
    Dedicated case discussion and business learning space in the department 1
   Necessary equipment, instruments 2
    Equipped with thoracoscopy, mediastinoscopy, fiberoptic bronchoscopy, ultrasonic bronchoscopy, gastroscopy, ultrasonic gastroscopy equipment and supporting instruments 1
    Specialized monitoring equipment 1
   Necessary ancillary sections 2
    Supported by endoscopy, anesthesiology, pathology, radiology and operating rooms 1
    Have the conditions to carry out intraoperative rapid pathology diagnosis; have blood transfusion guarantee and related equipment and facilities; have the ability of comprehensive rescue and management of systemic or local complications 1
   Manage maintenance 1
    Relevant instruments and equipment are available and in good condition 0.5
    Record the date of use of instruments, equipment, personnel 0.5
   Information system construction 3
    Establishment of an electronic case and medical prescription system 0.5
    Establishment of a medical imaging information system 0.5
    Establishment of a follow-up database with a dedicated person for follow-up visits 2
Management level 20
   Regulations, workflow 10
    Standardized preoperative discussion system 2
    Standardized multidisciplinary consultation system 2
    Standardized monitoring system for surgical indications (reviewed by the Director of Administration) 1
    Standardized system for discussing major complications 1
    Standardized system for discussing difficult or fatal cases 2
    Reporting of major or critical surgeries to the medical section 1
    Unscheduled reoperations and emergency surgeries, preoperative discussion or administrative director review 1
   Completeness of various operating records 2
    Preoperative discussion, surgical records, postoperative history, blood transfusion records, resuscitation records, antibiotic administration records are complete on time 1
    Difficult and critical, as well as death case discussion records are complete on time 1
   Personnel structure, qualifications, responsibilities 3
    Structure of the medical staff, with a reasonable age composition 1
    Qualification of the physician leading the group: thoracic surgeon or thoracic cardiothoracic surgeon 1
    Related ICU patient care staffing 1
   Technology access 3
    Whether to establish a surgical qualification assessment system according to surgical classification 3
   Feedback on internal control and assessment of quality of care 2
    Availability of a complete system of internal assessment and control of surgical treatments 2
Professional and technical level 70
   Single disease, clinical pathway 2
    Establishing clinical pathways for common diseases in thoracic surgery 1
    Percentage of clinical pathways accessed met 1
   Preoperative examination and clinical staging 19
    Preoperative investigations and clinical staging of lung cancer 19
      Routine preoperative tests (electrocardiogram/lung function/arterial blood gas analysis/liver and kidney function/coagulation) 3
      Bronchoscopy (peripheral ground-glass nodules ≤2 cm in diameter may be excluded) 2
      Cranial MRI or CT/abdominal B-ultrasound/chest CT enhancement/bone ECT (≤2 cm pure ground-glass nodule can be examined by chest CT only, but not by cranial MRI and bone ECT) 6
      Suspected N2 or N3 requires chest CT enhancement/E-BUS/mediastinoscopy for preoperative staging evaluation 2
      Targeted preoperative examination and management of patients with underlying medical conditions 2
    Preoperative examination and clinical staging of esophageal cancer 19
      Routine preoperative tests (electrocardiogram/lung function/arterial blood gas analysis/liver and kidney function/coagulation) 5
      Fiberoptic esophagoscopy and obtaining cytologic or histopathologic confirmation of the diagnosis 2
      Gastroscopy or barium meal of the upper gastrointestinal tract, or lower gastrointestinal imaging to assess the function of surrogate esophageal organs 2
      Enhanced CT of the chest and abdomen, color ultrasound, ultrasound of the neck to evaluate distant metastases, and cranial MRI, bone scan or PET/CT if available and necessary. 6
      Bronchoscopy is required for patients with suspected tracheal/bronchial invasion, and preoperative ultrasound endoscopy is recommended for all patients with esophageal cancer 2
      Targeted preoperative examination and management of patients with underlying medical conditions 2
   Standard treatment
    Standard treatment for lung cancer 20
      Clearance of at least 3 sets of mediastinal lymph nodes (intraoperative freezing for AIS/MIA may not be done) 6
      Intraoperative bronchial stumps are routinely sent for frozen section examination 10
      Standardized intraoperative use of antibiotics 2
      Standardized use of antibiotics in the postoperative period 2
    Standard treatment for esophageal cancer 20
      No less than 50% of patients with mid-thoracic esophageal cancer have a right-thoracic route 4
      Neoadjuvant therapy needed for locally advanced esophageal cancer 2
      The number of lymph nodes removed should not be less than 15 2
      Lymph node dissection to include and differentiate between at least the chest and abdomen 4
      Postoperative enteral nutrition should not be used in less than 30% of cases 4
      Standardized intraoperative use of antibiotics 2
      Appropriate use of antibiotics in the postoperative period 2
    Regular organization of the three basic training and assessment 1
    Quality of medical history 5
      History and course records are standardized and timely 1
      Documentation of major complication discussions is standardized and timely 1
      Well-documented consultations for major postoperative complications involving other systems 1
      ICU patient record and shift handover record norms 1
      Definitive TNM staging diagnosis 1
    Quality of lung cancer surgery and surgical safety 10
      Preoperative pathology or cytological confirmation of diagnosis of not less than 30% 2
      No more than 5% of procedures are performed by thoracotomy 2
      Palliative pneumonectomy not more than 5% of cases 2
      Thoracoscopic lobectomy rate of not less than 50% in patients with stage I lung cancer 1
      Pre- and post-operative diagnostic concordance rate of not less than 90% 1
      Blood transfusion rate of no more than 10% during hospitalization 2
    Quality of esophageal cancer surgery and surgical safety 10
      No more than 10% of procedures are performed by thoracotomy 4
      Palliative esophagectomy not more than 10% of cases 3
      Minimally invasive surgery performed in at least 30% of cases 1
      Blood transfusion rate not to exceed 40% during hospitalization 2
   Postoperative mortality and complication rates 8
    Postoperative mortality and complication rates in lung cancer 8
      Perioperative mortality rate not more than 1% 2
      Unplanned reoperation rate of no more than 1% 1
      No more than 10% major complications related to surgery 1
      Stage I healing rate of the incision should not be less than 95% 1
      Incidence of nosocomial infections not exceeding 5% 1
      Post-operative patient satisfaction rate of not less than 90% 1
      Survival rate of more than 90% at 90 days after surgery 1
    Postoperative mortality and complication rates of esophageal cancer 8
      Perioperative mortality rate not more than 1% 2
      Unscheduled reoperation rate of no more than 2% 2
      No more than 20% major complications related to surgery 2
      Stage I healing rate of incisions not less than 90% 1
      Incidence of nosocomial infections not exceeding 5% 1
    Post-operative hospitalization days for lung cancer 2
      Average hospitalization of less than 7 days after lobectomy/segmental lung resection 1
      Average hospitalization of no more than 15 days after total lung or sleeve resection 0.5
      Average post-operative hospitalization of no more than 18 d for major and special surgeries 0.5
    Post-operative hospitalization days for esophageal cancer 2
      The average hospital stay after resection of esophageal cancer should not exceed 14 days 2
   Pathology quality control 2
    Good quality control in pathology 1
    The concordance between intraoperative freezing and final paraffin pathology results should be greater than 95% 1

ICU, intensive care unit; MRI, magnetic resonance imaging; CT, computed tomography; ECT, emission computed tomography; E-BUS, endobronchial ultrasound guided tranbronchial needle aspiration; PET/CT, positron emission tomography/computed tomography; AIS, adenocarcinoma in situ; MIA, minimally invasive adenocarcinoma.


Methods

In determining the weights for each component of our scoring system, we convened a panel of experts in thoracic surgery, healthcare management, and patient advocacy. Through a series of structured workshops, the panel evaluated the relative importance of each component based on its impact on patient safety, procedural success, and overall quality of care. The final weights were agreed upon through consensus, taking into account the unique aspects of thoracic surgical procedures and the imperative for continuous quality improvement. The allocation of points to each requirement was determined through a structured consensus process involving a panel of experts in thoracic surgery, healthcare management, and patient advocacy. The panel used a modified Delphi method to assess the relative importance of each requirement based on its impact on patient outcomes and the quality of surgical care.


Hardware facilities and basic requirements of medical institutions (10 points)

Environment and housing settings (2 points)

  • Postoperative dedicated intensive care unit (ICU) or ICU beds: For conducting thoracic surgery of grade four or above, specialized ICU beds equipped with respiratory machines are required (1 point).
  • Whether there are department-specific case discussions and venues for professional learning (1 point).

Necessary equipment and instruments (2 points)

  • Equipped with thoracoscope, mediastinoscope, fiberoptic bronchoscope, ultrasound bronchoscope, gastroscopy, and ultrasound gastroscopy equipment. For conducting thoracoscopic surgery, thoracoscope and corresponding surgical instruments are required; for conducting minimally invasive esophageal cancer surgery, thoracic and abdominal endoscopes and related surgical instruments are required; for lung transplantation, heart-lung bypass machine and ECMO equipment are required (4) (1 point) (lung lobectomy thoracoscopic instrumentation configuration is shown in Table S1).
  • Professional monitoring and resuscitation equipment: High-standard anesthesia monitoring, capable of intraoperative monitoring of invasive arterial blood pressure, partial pressure of carbon dioxide, and arterial blood gas analysis; operating room and ICU equipped with bedside defibrillator (1 point).

Necessary auxiliary departments (2 points)

  • Have relevant auxiliary departments such as endoscopy, anesthesia, pathology, radiology, and operating room (1 point);
  • Have conditions for intraoperative rapid frozen section pathology diagnosis; have blood transfusion support and related equipment and facilities; have comprehensive rescue and treatment capabilities for systemic or local complications (1 point).

Management and maintenance (1 point)

  • Relevant instruments and equipment are available and in good condition (0.5 points);
  • Records of the use date and personnel of instruments and equipment (0.5 points).

Information system construction (3 points)

  • Establish electronic medical records and order systems (0.5 points);
  • Establish medical imaging information systems (0.5 points);
  • Establish a follow-up database, with dedicated personnel responsible for follow-up: follow-up is the only means to understand postoperative conditions of patients and evaluate long-term surgical outcomes (at least 5 years). The standards are as follows: Establish a standardized follow-up system, with designated follow-up personnel, establish a unified management database, and achieve a clinical long-term follow-up rate of over 80% (2 points).

Management level (20 points)

Rules and regulations, work processes (10 points)

  • Standardized preoperative discussion system (2 points);
  • Standardized multidisciplinary consultation system (2 points);
  • Standardized surgical indication supervision system (administrative director review, 1 point);
  • Standardized system for discussing major complications (1 point); standardized system for discussing difficult or fatal cases (2 points); reporting of major or critical surgeries to the medical affairs department (1 point); preoperative discussion or administrative director review for unplanned reoperations and emergency surgeries (1 point).

Completeness of various operation records (2 points)

Timely completion of preoperative discussions, surgical records, postoperative course records, blood transfusion records, rescue records, and antibiotic usage records (1 point); timely completion of records for discussions on difficult, critical, or fatal cases (1 point).

Personnel structure, qualifications, responsibilities (3 points)

  • Whether the structure of medical personnel and age composition is reasonable. This structure typically includes a mix of senior attending physicians, mid-career staff, and junior residents, as well as nursing staff, to ensure a balance of experience and continuity of care (1 point);
  • Whether the qualifications of attending physicians meet standards: thoracic or thoracic cardiovascular surgeons (5-7) (1 point);
    • Holding a “Physician Practicing Certificate”, with a practice scope in thoracic surgery, and being registered as an in-service physician in the institution;
    • Having more than 5 years of clinical diagnosis and treatment experience in thoracic surgery, and serving as an attending physician for more than 3 years;
    • Must understand the treatment principles and operation guidelines of various surgical procedures, and can independently perform surgeries after receiving systematic guidance and training qualifications;
    • Those who perform thoracoscopic minimally invasive surgeries must undergo thoracoscopic minimally invasive surgery qualification training.
  • Whether there are relevant ICU monitoring medical staff equipped (1 point).

Establishment of a surgical qualification assessment system

Our scoring system awards 3 points for the establishment of a surgical qualification assessment system that aligns with the surgical classification by the National Health Commission. This system is crucial for ensuring the safety and effectiveness of surgical procedures.

Surgical classification

  • First-level surgeries: basic and common procedures such as lymph node biopsies and closed thoracic drainage.
  • Second-level surgeries: intermediate surgeries including lung and pleural biopsies, excision and repair of large bullae, mediastinoscopic lymph node biopsies, and thoracic wall fenestration.
  • Third-level surgeries: major surgeries like wedge resection of the lung, lobectomy (including thoracoscopic surgery), pneumonectomy, mediastinal tumor removal, esophageal and gastric surgery, diaphragmatic resection and reconstruction, and chest wall resection and reconstruction.
  • Fourth-level surgeries: complex, emergency, and severe surgeries, including massive hemoptysis surgery, lung transplantation, tracheobronchial and vascular reconstruction/sleeve surgeries, partial left atrial resection, sternal resection and reconstruction, total pleuropneumonectomy, malignant mediastinal tumor surgery (involving major vessel replacement), superior sulcus tumor resection, and esophageal and gastric cancer surgery (secondary surgery or colon interposition) (8).

Surgical staff qualifications

  • Junior resident physicians: under the guidance of senior physicians, they gradually perform and master first-level surgeries.
  • Senior resident physicians: proficient in first-level surgeries and begin second-level surgeries under guidance.
  • Junior attending physicians: become familiar with and master second-level surgeries under guidance.
  • Senior attending physicians: master second-level surgeries and start performing third-level surgeries under guidance.
  • Junior associate chief physicians: master third-level surgeries and begin fourth-level surgeries under guidance.
  • Senior associate chief physicians: independently complete simpler fourth-level surgeries under the guidance of chief physicians.
  • Chief physicians: proficiently perform fourth-level surgeries and conduct new or major exploratory research project surgeries (new surgeries must be approved by the hospital’s ethics committee).

Responsibilities and protocols

  • The attending physician, upon signature approval, may perform first-level and second-level thoracic surgeries. They are fully responsible for medical quality, with the group’s attending physician taking ultimate responsibility.
  • If an attending physician at the associate chief level performs surgeries exceeding 4 hours in duration or with intraoperative blood loss exceeding 2,000 mL, they must seek guidance from the department’s appointed chief physician.
  • If an attending physician at the chief level performs surgeries exceeding 6 hours in duration or with intraoperative blood loss exceeding 4,000 mL, they must report to the department head and inform the medical affairs department.
  • In cases of changes in surgical plans during surgery, such as exploratory thoracotomy or expanding the resection range, assistance from a senior director physician within the department is required.

Internal control and evaluation feedback of medical quality

Hospitals and surgical departments are mandated to implement a robust internal evaluation system that includes critical indicators for each surgical team to ensure surgical quality (2 points). These indicators are as follows:

  • Number of surgeries performed: this reflects the volume of surgical cases handled by a team, which is often linked to better patient outcomes (9).
  • Number of surgeries at different levels: this stratifies surgeries into first-level (basic surgeries like lymph node biopsies), second-level (intermediate surgeries like lung biopsies), third-level (major surgeries like lobectomies), and fourth-level (complex surgeries like lung transplantations), aligning with the surgical classification by the National Health Commission.
  • Rate of unplanned reoperations: unplanned reoperations within 90 days post-surgery are considered a measure of surgical quality and patient safety (10).
  • Perioperative mortality rate: the rate of deaths occurring within 30 days of surgery or before discharge is a key indicator, with efforts to reduce perioperative mortality a continuous goal (11).
  • 7-day readmission rate: a 7-day readmission rate is an early indicator of postoperative care quality. It is chosen for its immediacy in reflecting complications post-discharge.
  • Rate of major complications: tracking major complications within 30 days of surgery provides insight into the effectiveness of the surgical procedure and postoperative care.
  • Proportion of patients receiving transfusions exceeding 800 mL: this indicator is associated with surgical complexity and patient outcomes.
  • Average length of hospital stay: this includes the total time from admission to discharge, with efforts to reduce lengths of stay where appropriate without compromising care.

Professional technical level (70 points)

To ensure surgical efficacy and safety, it is crucial to adhere to surgical indications, select appropriate surgical approaches, strictly adhere to aseptic and tumor-free principles, emphasize meticulous anatomical dissection to minimize accidental injuries and intraoperative bleeding, and strive to minimize surgical trauma while ensuring thoroughness. Simultaneously, perioperative management should be strengthened, with a focus on preventing and managing postoperative complications to comprehensively improve surgical treatment quality.

Establishment of disease-specific clinical pathways (2 points)

  • Establish clinical pathways for common diseases in thoracic surgery (12,13) (1 point);
  • Achieve the standard proportion of patients entering clinical pathways (1 point).

Preoperative examination and clinical staging

Preoperative examination and clinical staging of lung cancer (14,15) (15 points)

  • Routine preoperative examinations [electrocardiogram (ECG)/pulmonary function/arterial blood gas analysis/liver and kidney function/coagulation] (3 points);
  • Bronchoscopy (not required for peripheral ground-glass nodules with a diameter ≤2 cm) (2 points);
  • Head magnetic resonance imaging (MRI) or computed tomography (CT)/abdominal ultrasound/chest CT with contrast enhancement/bone emission computed tomography (ECT) examination (only chest CT is needed for pure ground-glass nodules ≤2 cm, head MRI and bone ECT examination are optional) (16) (6 points);
  • Suspected N2 or N3 staging requires chest CT with contrast enhancement/endobronchial ultrasound guided tranbronchial needle aspiration (E-BUS)/mediastinoscopy for preoperative staging assessment. Patients with suspected multi-station and multi-group N2-positive lymph nodes are not recommended for direct surgery, and may choose neoadjuvant treatment before reassessment (2 points);
  • Patients with underlying medical conditions should undergo targeted examinations and management preoperatively. Patients with other major organ dysfunction should undergo relevant specialist consultation (2 points).

Preoperative examination and clinical staging of esophageal cancer (19 points)

  • Routine preoperative examinations (ECG/pulmonary function/arterial blood gas analysis/liver and kidney function/coagulation) (5 points);
  • Esophagoscopy with histopathological confirmation (2 points);
  • Gastric endoscopy or upper gastrointestinal barium meal, or lower gastrointestinal contrast radiography to evaluate the function of adjacent organs (2 points);
  • Chest and abdominal enhanced CT, color ultrasound, neck ultrasound to evaluate distant metastasis, with optional head MRI, bone scan, or PET/CT examination if available and necessary (6 points);
  • Bronchoscopy is required for suspected trachea/bronchus involvement (2 points), and all patients with esophageal cancer are recommended to undergo preoperative endoscopic ultrasound examination;
  • Patients with underlying medical conditions should undergo targeted examinations and management preoperatively. Patients with other major organ dysfunction should undergo relevant specialist consultation (2 points).

Standard treatment

Standard treatment for lung cancer (20 points)

  • Clearance of at least 3 or more mediastinal lymph node stations [intraoperative frozen section for adenocarcinoma in situ (AIS)/minimally invasive adenocarcinoma (MIA) may be omitted] (17) (6 points);
  • Intraoperative routine frozen section examination of the bronchial stump (18) (10 points);
  • Standard use of antibiotics intraoperatively (2 points);
  • Appropriate use of antibiotics postoperatively (2 points). Points are awarded for the judicious use of postoperative antibiotics, in line with the enhanced recovery after surgery (ERAS) guidelines that recommend against the continuation of antibiotics beyond 24 hours post-surgery unless there’s a specific indication (19).

Standardization and homogenization scheme of minimally invasive precision technology for pulmonary lobectomy based on domestic innovative medical equipment is shown in Appendix 1.

Standard treatment for esophageal cancer (20 points)

  • For middle thoracic esophageal cancer, the proportion of right thoracic access should not be less than 50% (4 points);
  • Locally advanced esophageal cancer requires neoadjuvant therapy (2 points);
  • The number of lymph nodes cleared should not be less than 15 (20); National Comprehensive Cancer Network (NCCN) guidelines recommend clearing at least 15 lymph nodes for patients who have not received neoadjuvant therapy (2 points);
  • The scope of lymph node clearance should include the chest and abdomen, with differentiation (4 points);
  • Postoperative enteral nutrition use should not be less than 30% (4 points);
  • Standard use of antibiotics intraoperatively (2 points);
  • Standard use of antibiotics postoperatively (2 points).

Regular organization of basic training and assessment (1 point)

A training needs assessment is built as a systematic process of identifying the knowledge, skills, and competencies required by organization (1 point).

Quality of medical history (5 points)

  • Standard and timely medical history and course records (1 point);
  • Standard and timely records of major complications discussions (1 point);
  • Comprehensive consultation records for major postoperative complications involving other systems (1 point);
  • Standard ICU course records and handover records (1 point);
  • Clear TNM staging diagnosis (1 point).

Surgical quality and safety

Quality and safety of lung cancer surgery (21) (10 points)

  • Preoperative pathological or cytological diagnosis rate not less than 30% (2 points);
  • Proportion of exploratory thoracotomies not exceeding 5% (2 points);
  • Proportion of palliative lung resections not exceeding 5% (2 points);
  • For stage I lung cancer patients, proportion of thoracoscopic lung resections not less than 50% (21,22) (1 point);
  • Preoperative and postoperative diagnostic consistency rate not less than 90% (1 point);
  • Transfusion rate during hospitalization not exceeding 10% (2 points).

Quality and safety of esophageal cancer surgery (10 points)

  • Proportion of exploratory thoracotomies not exceeding 5% (4 points);
  • Proportion of palliative esophageal resections not exceeding 10% (3 points);
  • Proportion of minimally invasive surgeries for esophageal cancer not less than 30% (1 point);
  • Transfusion rate during hospitalization not exceeding 40% (2 points).

Postoperative mortality and complication rates

Postoperative mortality and complication rates for lung cancer (8 points)

  • Perioperative mortality rate not exceeding 1% (1 point);
  • Unplanned reoperation rate not exceeding 1% (1 point);
  • Rate of major surgery-related complications not exceeding 10% (2 points);
  • Incisional grade I healing rate not less than 95% (1 point);
  • Rate of nosocomial infections not exceeding 5% (1 point).
  • Post-operative patient satisfaction rate of not less than 90% (1 point).
  • Survival rate of more than 90% at 90 days after surgery (1 point).

Postoperative mortality and complication rates for esophageal cancer (8 points)

  • Perioperative mortality rate not exceeding 1% (2 points);
  • Unplanned reoperation rate not exceeding 2% (2 points);
  • Rate of major surgery-related complications not exceeding 20% (2 points); these complications are categorized and defined as follows:
    • Cardiovascular complications: including but not limited to arrhythmias, myocardial infarction, and heart failure.
    • Pulmonary complications: such as pneumonia, respiratory failure, and prolonged ventilator dependence.
    • Infectious complications: encompassing surgical site infections, urinary tract infections, and sepsis.
    • Thromboembolic complications: including deep vein thrombosis (DVT) and pulmonary embolism (PE).
    • Neurological complications: such as stroke and peripheral neuropathy.
    • Wound-related complications: involving dehiscence, infection, and poor wound healing.
    • Hematological complications: such as excessive bleeding requiring transfusion, coagulopathy, and thrombocytopenia.
    • Renal complications: including acute kidney injury and the need for renal replacement therapy.
    • Readmission or reoperation: due to any of the above complications or other surgery-related issues.
  • Incisional grade I healing rate not less than 90% (1 point);
  • Rate of nosocomial infections not exceeding 5% (1 point).
  • Post-operative patient satisfaction rate of not less than 90% (1 point).
  • Survival rate of more than 90% at 90 days after surgery (1 point).

Postoperative hospital stay

Postoperative hospital stay for lung cancer (2 points)

  • Average length of hospital stay after lung lobe/segment resection not exceeding 7 days (1 point);
  • Average length of hospital stay after total lung or sleeve resection not exceeding 15 days (0.5 points);
  • Average length of hospital stay after major or special surgery not exceeding 18 days (23) (0.5 points).

Postoperative hospital stay for esophageal cancer (2 points)

Average length of hospital stay after esophageal cancer resection should not exceed 14 days.

Pathology quality control (2 points)

  • Pathology quality should include: intraoperative frozen sections should indicate the malignancy of the lesion. For lung adenocarcinoma, subtypes should be distinguished, including AIS, MIA, and invasive adenocarcinoma. Gross examination of specimens should include tumor location, size, gross type, visible depth of infiltration, distance between upper and lower margins and tumor edge. Pathological diagnosis results should include tumor histological subtype, degree of differentiation, depth of invasion, whether the margins are involved by cancer, vascular and neural invasion, as well as the number of detected lymph nodes and metastatic lymph nodes [lung adenocarcinoma diagnosis should include subtypes, and if it is invasive adenocarcinoma, it should include the classification and proportion of various subtypes, and whether there are accompanying risk factors such as spread through air spaces (STAS)] (1 point).
  • The consistency rate between intraoperative frozen sections and final paraffin pathology results should be higher than 95%. Tumor gene testing or immunological markers testing can help guide targeted therapy or immunotherapy, and units with conditions should perform such testing (1 point).

Other management requirements

  • Conduct specialized clinical techniques in thoracic surgery: thoracoscopic lung surgery, thoracoscopic esophageal surgery, mediastinoscopy, endobronchial ultrasound (EBUS) surgery, and tracheoscopy/esophagoscopy interventions.
  • Establish a registration system for surgical instruments and consumables to ensure traceability of their sources. Retain part of the barcode or other qualified certification documents of surgical instruments and consumables in the patient’s hospitalization medical records.
  • Prohibit the unauthorized reuse of disposable surgical instruments and consumables.

Implementing quality control in thoracic surgery: a streamlined approach

To effectively implement and enforce a quality control system for general thoracic surgery across various institutions, the following streamlined steps can be taken:

  • Establish a regulatory body: create a centralized authority to ensure accurate documentation and compliance with quality standards.
  • Training and accreditation: provide mandatory training for healthcare professionals and implement periodic accreditation to maintain quality standards.
  • Data collection and updating: rely on electronic medical records for ongoing data collection and system updates, with regular evaluations by the regulatory body.
  • Regular audits: perform routine internal and external audits to assess quality compliance, with external audits ensuring transparency.
  • Feedback and improvement: offer feedback to institutions based on audit results to guide corrective actions and promote continuous improvement.
  • Incentivize compliance: recognize institutions that meet or exceed quality standards with certifications and research opportunities to encourage adherence.

Comparison of thoracic surgery quality control at home and abroad

Thoracic surgery often faces challenges such as complex surgeries, significant trauma, difficulty in accurate preoperative assessment, and relatively high complication rates. Abroad, organizations such as the European Society of Thoracic Surgeons (ESTS) and the American Association for Thoracic Surgery (AATS) rely on the establishment of large-scale databases, including the ESTS database and the American National Cancer Database (24,25) (NCDB), to carry out quality control for various centers. The ESTS has established a lung cancer surgery assessment system to evaluate the quality control level of thoracic surgery in its member hospitals, issuing accreditation to hospitals that meet the qualifications for thoracic surgery. They invite hospitals providing data for the ESTS database to participate in the evaluation. Data provided by participating centers within 2 years from preoperative, intraoperative, and postoperative perspectives are selected to calculate the Composite Performance Score (CPS) of the surveyed center. For units that meet the requirements of CPS, ESTS will commission an external supervisory company and a designated thoracic surgeon to visit the applying center and evaluate various aspects such as the qualifications of the center’s doctors, the setup of diagnostic support departments, operating room facilities, ICUs, emergency units, patient care upon discharge, and surgical volume. A report will be issued based on the evaluation. The ESTS Database Committee will review the report and, upon approval of the applying unit, announce the list of qualified units on the ESTS annual meeting, official website, and annual report. Qualified units may participate in or apply for high-quality research projects based on the ESTS database. Units that pass the review process will need to undergo reevaluation every 36 months (26,27).

Similarly, the American Association for Thoracic Surgery has established the General Thoracic Surgery Database (STS GTSD, Society of Thoracic Surgeons General Thoracic Surgery Database) for general thoracic surgery. This database collects data voluntarily provided by 274 institutions across all 44 states in the United States. A total of 20,657 cases of the most representative lung lobectomy surgeries in thoracic surgery were selected as the evaluation standard. The comprehensive performance scores for participating institutions are calculated based on the lung cancer resection risk model published by the American Joint Committee on Cancer (AJCC). STS calculates the 95% confidence interval of the score results and categorizes participating institutions into three levels: below expected, as expected, and above expected. The esophageal cancer resection surgeries of participating institutions are also graded using the same method. STS is also committed to incorporating this rating system into the National Quality Forum (NQF) and expanding the number of participating units to establish a unified quality control system nationwide in the United States (28).

Domestically, efforts in this area started later, and there has yet to be standardized administrative and professional academic management by national bodies and industry associations. It’s challenging to directly apply the experiences and achievements from abroad. There are relatively few reports on quality control in thoracic surgery. Chengdu City has established a Thoracic Surgery Medical Quality Control Center, which conducts quality assessments of public tertiary hospitals and above within the city. They have established a collaborative network at the central, regional, and local levels. Data related to quality control are collected, a “Quality Control Manual” has been compiled, and disease-specific clinical pathways have been established. They have also introduced big data management to guide the quality control work of member hospitals. The Shanghai Thoracic Surgery Association has also made exploratory efforts in this regard. Leveraging the Shanghai Clinical Quality Control Center for Thoracic Surgery and combining it with the clinical work experience of Shanghai Pulmonary Hospital, they have discussed and formulated the Shanghai Municipal Standards for the Diagnosis and Treatment Quality Control of Lung/Esophageal Cancer Surgery. This standardization covers detailed content on quality control, including hardware facilities, management levels, and professional technical standards, providing a basis for standard quality control of thoracic surgery in Shanghai. Supporting research and innovation is a critical strategy for enhancing the safety and efficacy of thoracic surgery, as exemplified by the ESTS and the AATS. Through publications like the Journal of Thoracic and Cardiovascular Surgery (JTCVS), AATS disseminates original research on techniques and developments in thoracic procedures. China can enhance its global impact by publishing its research findings and encouraging knowledge sharing.

While our quality control system has been tailored for lung and esophageal cancer surgeries, it is designed with the flexibility to be adapted to other thoracic procedures. For instance, the system can incorporate procedure-specific metrics such as those for emergency surgeries, aortic surgeries, and minimally invasive techniques. The key is to maintain a core set of quality indicators while adding procedure-specific metrics that reflect the unique aspects of each thoracic procedure.


Current situation and prospects

Establishing and ensuring quality control in thoracic surgery is a systematic endeavor. It requires a comprehensive evaluation and analysis of data to form complete preoperative, intraoperative, and postoperative assessments. Standardized plans and implementations must be put in place, with quality control standards dynamically adjusted based on medical practice. A clinical quality control system that integrates self-assessment with supervisory checks must be established. Furthermore, a system for accountability for mortality events and perioperative complications needs to be developed. A three-tier quality control system at the national, provincial, and hospital levels, along with a two-way communication and cooperation mechanism, should be established. Expert committees and professional quality control teams must be assembled. These teams should conduct regular inspections and assessments of thoracic surgery quality, provide recommendations, and require corrective actions for identified issues. To accommodate the rapid technological advancements in thoracic surgery, our quality control system is designed with future-proofing in mind. We will implement regular review cycles to evaluate the system’s alignment with new surgical techniques and technologies. Additionally, we will establish protocols for incorporating emerging technologies that demonstrate improved patient outcomes. Our quality indicators will be adaptive, reflecting the integration of new techniques, and we will actively engage stakeholders to inform updates. Data-driven decisions will guide our updates, and we will maintain alignment with regulatory standards. In the future, there should be a focus on strengthening standardized specialty training in thoracic surgery. Gradual establishment of a thoracic surgery admission system and implementation of standardized clinical pathways are crucial. Clear quality standards for each key step in clinical pathways must be defined to effectively enhance the overall level of thoracic surgery diagnosis and treatment in China.


Conclusions

The development of our quality control scoring system represents a significant advancement in the field of general thoracic surgery. This system is designed to be a robust tool for evaluating and improving surgical practices, with a focus on enhancing patient safety and outcomes. We anticipate that its implementation will standardize quality control across hospitals and lead to tangible improvements in the overall quality of thoracic surgical care in China.


Acknowledgments

Funding: This study was funded by the National Key Research and Development Program of China (No. 2022YFC2407404).


Footnote

Peer Review File: Available at https://ccts.amegroups.com/article/view/10.21037/ccts-24-20/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available https://ccts.amegroups.com/article/view/10.21037/ccts-24-20/coif). C.C. serves as an unpaid Associate Editor-in-Chief of Current Challenges in Thoracic Surgery from October 2023 to September 2025. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.


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doi: 10.21037/ccts-24-20
Cite this article as: Ren Y, Zhang G, Hu X, Xie D, Zhao D, Xue Q, Chen C. Quality control and evaluation system for general thoracic surgery. Curr Chall Thorac Surg 2024;6:24.

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