Eighteen Key Points of Core Medical Quality and Safety Systems

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【Bookmark!】Review of Eighteen Core Medical Quality and Safety Systems!

Recently, the National Health Commission issued the “Action Plan for Comprehensive Improvement of Medical Quality (2023-2025)”, which once again emphasizes that all medical institutions must refine, improve, and strictly implement the 18 core medical quality and safety systems. So, what are these 18 core medical quality and safety systems? It is necessary to review the key points.

I. First Diagnosis Responsibility System

A system where the first attending physician (first diagnosis physician) is responsible for the entire diagnosis and treatment management of the patient until the end of a single visit or before the patient is seen by another physician. The first diagnosis responsibility of medical institutions and departments follows the physician’s first diagnosis responsibility.

  1. Clarify the responsible party at different stages of the diagnosis and treatment process for patients.

  2. Ensure continuity of diagnosis and treatment services during the patient’s treatment process.

  3. The first diagnosis physician should properly maintain medical records to ensure traceability of medical actions.

  4. For diseases outside the scope of the medical institution’s diagnostic specialty, patients or their legal representatives should be informed and advised to seek care at the appropriate medical institution.

II. Three-Level Ward Rounds System

A system where during hospitalization, physicians of different levels conduct ward rounds to assess patients, formulate and adjust diagnosis and treatment plans, and observe treatment effects.

  1. Medical institutions implement a three-level physician ward rounds system under the leadership of the department head. The three levels may include but are not limited to chief physician or associate chief physician - attending physician - resident physician.

  2. Follow the principle that junior physicians obey senior physicians, and all physicians obey the department head.

  3. Medical institutions should clarify the decision-making and implementation authority at each physician level.

  4. The ward round cycle should be clearly defined. On workdays, ward rounds should be conducted at least twice daily; on non-workdays, at least once daily. The highest-level physician among the three levels should conduct ward rounds at least twice a week, and mid-level physicians at least three times a week. The surgeon must conduct ward rounds personally within 24 hours before and after surgery.

  5. Medical institutions should define the physician ward round code of conduct: respect patients, maintain professional appearance, protect privacy, strengthen communication, and standardize procedures.

  6. Nursing and pharmacist ward rounds may be carried out by reference to these regulations.

III. Consultation System

Consultation refers to activities where, based on diagnosis and treatment needs, medical personnel outside the department or institution assist by providing consultation opinions or diagnostic and treatment services. The system regulating consultation behavior is called the consultation system.

  1. According to the consultation scope, consultation is divided into intra-institution consultation and inter-institution consultation. Intra-institution multidisciplinary consultations should be organized by the medical management department.

  2. According to urgency, consultations are divided into emergency and routine. Intra-institution emergency consultations should arrive within 10 minutes after a consultation request, and routine consultations should be completed within 24 hours.

  3. Medical institutions should unify consultation form formats and fill-in standards, clarifying specific processes for various consultation types.

  4. In principle, consultation requesters should accompany the consultation, and consultation details should be recorded on the consultation form. The handling of consultation opinions should be documented in the medical record.

  5. For inter-institution consultations, the relevant national regulations must be strictly followed.

IV. Graded Nursing System

A system where medical and nursing staff provide graded nursing care to inpatients based on their condition and/or self-care ability.

  1. Medical institutions should formulate graded nursing systems according to national guidelines for grading [nursing management][1] and nursing service work standards.

  2. Nursing levels are generally divided into four grades: special care, level one, level two, and level three nursing.

  3. Medical and nursing staff should dynamically adjust nursing levels according to changes in patient condition and/or self-care ability.

  4. Patient nursing levels should be clearly marked.

V. Duty and Shift Handover System

A system where medical institutions and personnel ensure continuity of patient diagnosis and treatment through duty and handover mechanisms.

  1. Medical institutions should establish a hospital-wide medical duty system covering clinical, medical technology, nursing departments, and logistical departments providing treatment support, clarifying duty post responsibilities and ensuring regular operation.

  2. Hospitals implement a general hospital duty system; hospitals with conditions may set separate medical and nursing duty systems alongside the general hospital duty. Duty personnel must receive relevant training and pass assessments.

  3. Medical institutions and departments should clarify duty post responsibilities, personnel qualifications, and staffing numbers. Duty schedules should be public throughout the hospital and cover all posts and times related to patient diagnosis and treatment.

  4. On-duty medical personnel must include those licensed to practice in the institution; personnel licensed elsewhere must not be on duty alone. On-duty staff must not leave their posts without authorization and should rest at designated locations during breaks.

  5. On-duty personnel at all levels should maintain smooth communication.

  6. For patients undergoing level four surgery and critically ill patients, handover must be done bedside on the day of surgery.

  7. All diagnostic and treatment activities during duty must be promptly recorded in the medical record.

  8. Handover content should be specifically recorded in dedicated records and jointly signed by both handover and receiving personnel.

VI. Difficult Case Discussion System

A system to discuss cases with uncertain diagnoses or treatment issues promptly to clarify diagnoses or improve treatment plans.

  1. Medical institutions and clinical departments should define the scope of difficult cases, including but not limited to patients: without a clear diagnosis or treatment plan; whose disease does not achieve expected effects within specified periods; with unplanned readmissions or surgeries; or who develop potentially life-threatening or severe organ damage complications.

  2. Difficult cases should be discussed by the department or medical management department. Discussions are generally chaired by the department head with all staff participating, and related department or external personnel may be invited as needed.

  3. The institution should unify difficult case discussion record formats and templates. Discussion content should be recorded in dedicated records, reviewed, and signed by the chair. Conclusions should be recorded in the medical record.

  4. At least two participants in the discussion should hold attending physician or higher professional technical titles.

VII. Emergency and Critical Patient Rescue System

A system to control the condition and save lives by rescuing emergency and critically ill patients and standardizing the rescue process.

  1. Medical institutions and clinical departments should define the scope of emergency and critically ill patients, including but not limited to patients with: critical conditions requiring immediate intervention to prevent life threat or major organ damage; unstable vital signs with deterioration tendencies, etc.

  2. Institutions should establish mechanisms to allocate and urgently dispatch rescue resources, ensuring availability of rescue equipment and drugs in each unit. Green channel mechanisms should guarantee priority treatment of emergency and critically ill patients. Institutions should assist in referrals for patients outside their treatment scope.

  3. Rescue of critical patients in clinical departments should be led by the most senior and qualified physician on site. In emergencies, medical personnel may participate or lead rescue regardless of their practice scope.

  4. Rescue records should be entered into the medical record within 6 hours after rescue, with times recorded precisely to the minute. The rescue leader must review and sign these records.

VIII. Preoperative Discussion System

A system aiming to reduce surgical risks and ensure surgical safety by requiring physicians to discuss surgical indications, methods, expected effects, risks, and contingency plans before performing surgery.

  1. Except for emergency surgeries intended for life-saving, preoperative discussions are mandatory for all inpatient surgeries, with the surgeon’s participation required.

  2. Preoperative discussions include surgical team discussions, physician group discussions, ward discussions, and full department discussions. Clinical departments must define levels of preoperative discussions they conduct and get approval from medical management. Full department discussions should be chaired by the department head or authorized deputy and may involve medical management and related departments. If surgery involves multiple disciplines or comorbidities affecting surgery, relevant departments should be invited or prior multidisciplinary consultations completed.

  3. Surgery orders and informed consent can only be issued after preoperative discussions are complete.

  4. Preoperative discussion conclusions should be recorded in the medical record.

IX. Death Case Discussion System

A system to comprehensively review the diagnosis and treatment process, summarize and accumulate experience, and continuously improve diagnostic and treatment service level by discussing causes of death, diagnoses, and treatment processes of in-hospital deaths.

  1. Death case discussions should be completed within one week of patient death. Cases involving autopsy must be re-discussed within one week after the autopsy report is issued.

  2. Discussions should be conducted department-wide, chaired by the department head, and may include medical management and related departments.

  3. Death case discussions should be recorded using unified institutional templates in dedicated records, reviewed, and signed by the chair. Results should be included in the medical record.

  4. Institutions should promptly compile and analyze all death cases and propose continuous improvement suggestions.

X. Verification System

A system that medical personnel use to verify and cross-check medical actions, instruments, facilities, medicines, etc., to prevent medical errors and ensure medical safety.

  1. The verification system should cover patient identity verification, clinical diagnosis and treatment behavior, equipment operation, and medical environment safety.

  2. Every medical action must be verified with patient identity using at least two methods. Bed numbers must never be used as identity identifiers. For unidentified patients, two staff must verify identity. When using electronic devices for identity verification, verbal confirmation is still required.

  3. Verification requirements for medical instruments, facilities, medicines, and specimens must comply with relevant national laws and standards.

XI. Surgical Safety Verification System

A system involving multiple participants verifying patient identity, surgical site, and procedures before anesthesia, before surgery, and before the patient leaves the operating room to ensure [patient safety][2].

  1. Institutions should establish surgical safety verification systems and standardized processes.

  2. Verification processes and content must comply with national regulations.

  3. Surgical safety verification checklists should be included in medical records.

XII. Surgical Grading Management System

A system to ensure patient safety by grading surgeries according to risk level, complexity, difficulty, and resource consumption.

  1. Surgeries are divided into four grades based on risk and difficulty. Specific requirements comply with national regulations.

  2. Institutions should establish surgical grading management systems and catalogs.

  3. Institutions should establish surgical grading authorization management mechanisms and maintain surgeon technical files.

  4. Institutions should regularly assess surgical physician capabilities and dynamically adjust surgical rights accordingly.

XIII. New Technology and New Project Access System

A system to ensure patient safety by managing the entire process of appraisal, review, quality control, and evaluation for medical technologies or diagnostic and treatment methods conducted for the first time in the institution.

  1. New technologies and projects to be introduced should be safe, effective, economical, appropriate, and clinically applicable.

  2. Institutions should define and regularly update the clinical application list of medical technologies and diagnostic and treatment projects.

  3. There should be established approval procedures; all new technologies and projects require approval by the institution’s relevant technical management committee and medical ethics committee before clinical application.

  4. Potential safety hazards or technical risks must be fully evaluated before clinical application, and corresponding contingency plans formulated.

  5. Institutions should clarify personnel authorized to carry out these new technologies and projects and strengthen quality control.

  6. Institutions should establish dynamic clinical evaluation systems for these technologies and projects, tracking and assessing them throughout their application.

  7. Clinical research involving new technologies and projects must comply with national regulations.

XIV. Critical Value Reporting System

A system establishing review, reporting, and recording mechanisms for test results indicating life-threatening status to ensure patient safety.

  1. Institutions must establish specific management processes and recording standards for critical value reporting separately for inpatients and emergency/outpatients, ensuring information accuracy, timely transfer, seamless and traceable transmission stages.

  2. Institutions shall establish and regularly update critical value lists for tests potentially endangering patient life.

  3. For critical values, report-generating departments must conduct double verification and signature before release; during night or urgent situations, single-person double checks are allowed. For tests requiring immediate repetition, prompt reexamination and verification are required.

  4. When test samples or projects with critical values are sent out, the hospital should coordinate with relevant agencies on notification methods and establish traceable reporting processes to ensure timely reception by clinical departments or patients.

  5. Personnel receiving critical value information must accurately record, read back, confirm, and promptly notify relevant physicians.

  6. Institutions should uniformly develop clinical critical value information registration books and templates to ensure key elements of information reporting personnel, time, and content are traceable.

XV. Medical Record Management System

A system to accurately reflect the entire medical activity process, enable traceability of medical service actions, protect the legal rights of both doctors and patients, and ensure medical quality and safety by managing writing, quality control, preservation, and use of medical documents.

  1. Institutions should establish inpatient and outpatient medical record management and quality control systems, strictly implement national medical record writing, management, and application regulations, and set up mechanisms for inspection, evaluation, and feedback on medical record quality.

  2. Medical records must be objective, truthful, accurate, timely, complete, and standardized, with clear formats, content, and timing requirements.

  3. Institutions implementing electronic medical records must establish management systems covering creation, recording, modification, use, storage, transmission, quality control, and information security protection.

  4. Institutions should ensure the safety of medical record data; medical content recording and modification should be traceable.

  5. Encouragement exists for implementing paperless medical records.

XVI. Antimicrobial Drug Graded Management System

A system for graded management of antimicrobial drug clinical use based on safety, efficacy, bacterial resistance, price, and other factors.

  1. Antimicrobial drugs are divided into three levels: non-restricted, restricted, and special use.

  2. Institutions should strictly establish their antimicrobial drug graded management catalog and physician prescription authority accordingly, with regular adjustments.

  3. Institutions should form an expert consultation panel for special-use antimicrobial drugs and regulate their use according to rules.

  4. Institutions should establish management systems and detailed procedures for antimicrobial selection, procurement, prescription, dispensing, clinical application, and drug evaluation based on graded management principles.

XVII. Clinical Blood Use Review System

A system to audit and evaluate all procedures related to clinical blood use throughout the process, ensuring patient blood safety.

  1. Institutions must strictly implement national regulations on clinical blood use, establish blood use management committees or working groups, develop management systems for blood ordering, receipt, storage, release, inventory warnings, and clinical rational blood use, and improve application, review, monitoring, analysis, evaluation, improvement systems and procedures.

  2. Clinical blood review includes but is not limited to blood application, informed consent for transfusion, indication judgment, blood matching, blood collection and issuance, clinical transfusion, monitoring during transfusion, and post-transfusion care; all steps must be fully documented to ensure traceability and sound evaluation and application of rational blood use and adverse reaction monitoring and handling.

  3. Institutions should perfect urgent blood use management systems and processes to meet emergency treatment needs.

XVIII. Information Security Management System

A system whereby medical institutions, following relevant laws, regulations, and technical standards, ensure full-process systematic protection of patient diagnosis and treatment information collection, storage, use, transmission, processing, and release.

  1. Institutions should lawfully establish full-process patient diagnosis and treatment information management and technological protection systems, improve organizational structures, clarify management departments, and implement requirements such as information security level protection.

  2. The principal person in charge of the institution is the primary responsible person for patient diagnosis and treatment information security management.

  3. Institutions should establish risk assessment and emergency response mechanisms for information security and formulate emergency plans.

  4. Institutions should ensure patient diagnosis and treatment information is secure, authentic, continuous, complete, stable, timely, and traceable throughout the management process.

  5. Institutions must establish patient diagnosis and treatment information protection systems; usage must comply with legality, compliance, legitimacy, and necessity principles, and selling or unauthorized sharing of patient information is forbidden.

  6. Institutions should develop employee authorization management systems specifying access rights and responsibilities; institutions should support secure and convenient access, and adverse outcomes due to improper personal authorization handling are the responsibility of the authorized person.

  7. Institutions must continuously enhance patient diagnosis and treatment information security, preventing leaks, damage, or loss; carry out regular self-inspections; establish responsibility and traceability mechanisms for security incidents; and promptly take remedial actions and report to authorities in case of actual or potential information breaches, damage, or loss.

-----Source: National Health Commission