JCI Standards

Module 3: Detailed Implementation of International Patient Safety Goals (IPSGs)

Module Goal: To provide participants with a thorough understanding of each International Patient Safety Goal, its rationale, specific requirements, and associated Measurable Elements (MEs) as defined in the JCI 6th Edition Standards.

Introduction to IPSGs (10 Minutes)

• Purpose & Importance:

  • Explain that IPSGs aim to promote specific, critical improvements in patient safety within healthcare organizations (Ref: p. 49).

  • Highlight that these goals address common, high-risk problem areas identified globally in healthcare (Ref: p. 49).

  • Emphasize the focus on system-wide, evidence-based, consensus solutions rather than individual blame (Ref: p. 49).

• Structure & Scoring:

  • Review the structure: Each Goal has a standard statement, an Intent (explaining rationale), and specific Measurable Elements (MEs) defining compliance requirements (Ref: p. 49).

  • Explain that IPSGs are scored like other standards ("met," "partially met," "not met") but have a separate and critical impact on the accreditation decision (Ref: p. 49). Non-compliance here can significantly jeopardize accreditation.

• Module Objective: Participants will be able to describe the requirements for each IPSG and identify key implementation strategies based on the JCI standards.

3.1 Goal 1: Identify Patients Correctly (IPSG.1) (Estimated Time: 15 Minutes)

• Goal Statement: The hospital develops and implements a process to improve accuracy of patient identifications (Ref: p. 49).

• Rationale (Intent of IPSG.1, p. 50):

  • Wrong-patient errors occur frequently across all aspects of diagnosis and treatment.

  • Patients may be unable to participate in identification (sedated, confused, comatose, sensory disabilities, newborns, name changes).

  • The core intent is twofold: 1) Reliably identify the individual as the correct recipient of care/service, and 2) Match the service/treatment to that specific individual.

• Specific Requirements (Intent & MEs, p. 50-51):

  • Use at least TWO patient identifiers. (ME 1)

    • Examples: Patient’s name, unique identification number (e.g., medical record number), date of birth, bar-coded wristband.

    • Crucially, DO NOT use: The patient’s room number or physical location as an identifier.

  • Uniform Process: The process for using the two identifiers should be consistent throughout the hospital (though the specific identifiers might differ between inpatient and outpatient settings, e.g., Name/MRN inpatient vs. Name/DOB outpatient).

  • When to Identify: Identification is required before: (ME 2)

    • Administering medications, blood, or blood products.

    • Taking blood samples or other specimens for clinical testing.

    • Providing any treatments or procedures (e.g., inserting IV, dialysis, radiation therapy).

    • Performing diagnostic procedures (e.g., cardiac cath, radiology).

  • Special Circumstances: The hospital must have a specific process for reliably identifying patients in unique situations. (ME 3)

    • Examples: Comatose or confused patients arriving without identification, newborns without finalized names.

3.2 Goal 2: Improve Effective Communication (IPSG.2, IPSG.2.1, IPSG.2.2) (Estimated Time: 25 Minutes)

• Goal Statements:

  • IPSG.2: Improve effectiveness of verbal and/or telephone communication among caregivers (Ref: p. 51).

  • IPSG.2.1: Implement a process for reporting critical results of diagnostic tests (Ref: p. 51).

  • IPSG.2.2: Implement a process for handover communication (Ref: p. 51).

• Rationale (Intent, p. 51-52):

  • Effective communication (timely, accurate, complete, unambiguous, understood) reduces errors and improves safety.

  • Verbal/telephone orders, critical test results reporting, and handovers are high-risk communication points.

  • Factors increasing risk: Accents/dialects, background noise, interruptions, unfamiliar terms, LASA drugs/numbers, illegible transcription.

• Specific Requirements (Intent & MEs, p. 51-53):

  • Verbal/Telephone Orders (IPSG.2):

    • Policy should limit use (e.g., only in urgent situations where written/electronic is not feasible).

    • Required Process:

      • Receiver writes down or enters the complete order into a computer.

      • Receiver Reads Back the complete order.

      • Giver Confirms the read-back is accurate.

      • Order is documented. (ME 1, ME 2)

    • Policy may define permissible exceptions to read-back (e.g., sterile procedures, emergencies).

• • Critical Results Reporting (IPSG.2.1):

    • Hospital must define critical values for each type of diagnostic test (lab, radiology, bedside tests, etc.). (ME 1)

    • Process must define by whom and to whom critical results are reported. (ME 2)

    • Process requires Read-Back of the reported result by the receiver, confirmed by the sender. (Ref: Intent p. 52, Implicit in ME 3 documentation req.)

    • Process defines what information is documented in the medical record upon reporting. (ME 3)

• • Handover Communication (IPSG.2.2):

    • Implement a standardized approach for handovers (shift changes, transfers between units/levels of care, discharge).

    • Standardized Critical Content: Define the minimum essential information that MUST be communicated during handovers relevant to the patient's care. (ME 1)

    • Standardized Tools/Methods: Use standardized forms, tools, checklists, or specific methods to ensure consistent and complete handovers. (ME 2) (Note: These tools are not required to be part of the permanent medical record, but documentation that the handover occurred may be required by hospital policy).

    • Improvement: Track data from adverse events related to handover communication and use it to identify and implement improvements. (ME 3)

3.3 Goal 3: Improve the Safety of High-Alert Medications (IPSG.3, IPSG.3.1) (Estimated Time: 20 Minutes)

• Goal Statements:

  • IPSG.3: Improve the safety of high-alert medications (Ref: p. 53).

  • IPSG.3.1: Manage the safe use of concentrated electrolytes (Ref: p. 53).

• Rationale (Intent, p. 53-54):

  • High-Alert Medications (HAMs) are involved in a high percentage of errors/sentinel events and carry higher risk for significant harm.

  • Examples: Investigational drugs, controlled substances, narrow therapeutic index drugs, chemotherapy, anticoagulants, psychotherapeutics, LASA meds.

  • LASA confusion is a common error source (due to naming, packaging, labeling, similar use, illegible orders).

  • Concentrated electrolytes (KCl, KPhos, NaCl >0.9%, MgSO4 ≥50%) pose extreme risk if administered incorrectly/unintentionally. Removing them from patient care units is the most effective risk reduction strategy.

• Specific Requirements (Intent & MEs, p. 53-54):

  • High-Alert Medications (IPSG.3):

    • Develop and maintain a written list of the hospital's specific HAMs, based on unique usage patterns and internal data (near misses, errors). (ME 1)

    • Develop and implement processes for managing LASA medications. (ME 2)

    • Implement processes to manage the risks associated with HAMs (consider storage, prescribing, preparation, administration, monitoring).

    • Ensure processes for managing HAMs and LASA meds are uniform throughout the hospital. (ME 3)

• • Concentrated Electrolytes (IPSG.3.1):

    • Implement a process that prevents inadvertent administration. (ME 1)

    • These electrolytes should NOT be present in patient care units unless clinically necessary AND identified specifically by the hospital (e.g., ICU, OR). (ME 2)

    • Where clinically necessary, they must be:

      • Clearly labeled.

      • Stored in a manner that restricts access and promotes safe use. (ME 3)

3.4 Goal 4: Ensure Safe Surgery (IPSG.4, IPSG.4.1) (Estimated Time: 25 Minutes)

• Goal Statements:

  • IPSG.4: Implement a process for preoperative verification and surgical/invasive procedure site-marking (Ref: p. 55).

  • IPSG.4.1: Implement a process for the time-out immediately prior to the start of the procedure and the sign-out after the procedure (Ref: p. 55).

• Rationale (Intent, p. 55-56):

  • Wrong-site, wrong-procedure, wrong-patient surgery/invasive procedures are significant ongoing concerns.

  • Applies to all areas where such procedures occur (OR, cath lab, interventional radiology, bedside, etc.).

  • Based on the Universal Protocol principles: Verify, Mark the Site, Time-Out. Sign-out added for post-procedure safety check.

• Specific Requirements (Intent & MEs, p. 55-57):

  • Preoperative Verification Process (IPSG.4):

    • Implement an ongoing information gathering/confirmation process (using checklist or other mechanism). (ME 1)

    • Purpose:

      • Verify correct patient, procedure, and site.

      • Ensure all relevant documents (consent, H&P), images, studies are available, correctly labeled, and displayed.

      • Verify required blood products, special medical equipment, and/or implants are available and correct.

• • Site Marking (IPSG.4):

    • Use a mark that is instantly recognizable, unambiguous, and consistent throughout the hospital (avoid "X" if possible). (ME 2)

    • Marking occurs for all cases involving laterality (left/right), multiple structures (fingers, lesions), or multiple levels (spine).

    • Marking is done by the person performing the procedure. (ME 3)

    • Involve the awake and aware patient in the marking process. (ME 3)

    • Mark must remain visible after surgical prep and draping.

• • Time-Out Process (IPSG.4.1):

    • Occurs immediately before starting the procedure. (ME 1)

    • Takes place in the location where the procedure will be done.

    • Requires active participation of the entire team (patient participation not required).

    • Team verbally agrees on: Correct patient identity, correct procedure, correct site.

    • Allows resolution of any unanswered questions/concerns.

    • Document the completion of the time-out, including date and time. (ME 1)

    • Applies uniformly to procedures outside the OR as well. (ME 3)

• • Sign-Out Process (IPSG.4.1):

    • Conducted before the patient leaves the procedure location (e.g., OR). (ME 2)

    • Verbally confirms (typically by nurse):

      • Name of procedure recorded/written.

      • Completion of instrument, sponge, needle counts (as applicable).

      • Correct labeling of any specimens (read aloud including patient name).

      • Any equipment problems to be addressed.

3.5 Goal 5: Reduce the Risk of Health Care-Associated Infections (HAIs) (IPSG.5) (Estimated Time: 10 Minutes)

• Goal Statement: Adopt and implement evidence-based hand-hygiene guidelines (Ref: p. 57).

• Rationale (Intent, p. 57):

  • HAIs are a major challenge and concern.

  • Proper hand hygiene is central to preventing transmission.

  • Guidelines are available from reputable sources (WHO, CDC, national/international bodies).

• Specific Requirements (Intent & MEs, p. 57):

  • The hospital adopts current, evidence-based hand hygiene guidelines. (ME 1)

  • The hospital implements a hand hygiene program throughout the hospital (includes education, posting guidelines). (ME 2)

  • Hand washing and hand disinfection procedures are used correctly in accordance with the guidelines. (ME 3)

  • Ensure availability of necessary supplies (soap, disinfectants, towels/drying methods) in required areas. (Ref: Intent p. 57)

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3.6 Goal 6: Reduce the Risk of Patient Harm Resulting from Falls (IPSG.6, IPSG.6.1) (Estimated Time: 15 Minutes)

• Goal Statements:

  • IPSG.6: Reduce fall risk for the inpatient population (Ref: p. 58).

  • IPSG.6.1: Reduce fall risk for the outpatient population (Ref: p. 58).

• Rationale (Intent, p. 58-59):

  • Falls cause significant patient injury in hospitals.

  • Risk factors can be patient-related (history, meds, gait, confusion), situation-related (transfers), or location-related (PT dept, narrow tables).

  • Patient risk can change, requiring reassessment (post-op, med changes).

  • The goal is to evaluate patient risk and implement measures to reduce falls and injury if falls occur. Requires a structured program.

• Specific Requirements (Intent & MEs, p. 58-59):

  • Inpatients (IPSG.6):

    • Implement a process for assessing all inpatients for fall risk using tools/methods appropriate for the patient population (e.g., pediatric tool vs. adult tool). (ME 1)

    • Implement a process for reassessment of inpatients (e.g., when condition changes, or periodically based on initial risk). (ME 2)

    • Implement measures/interventions to reduce risk for those identified as at-risk (patients, situations, locations). (ME 3)

    • Document the interventions implemented. (ME 3)

  • Outpatients (IPSG.6.1):

    • Implement a process for screening outpatients identified as potentially at risk (based on condition, diagnosis, situation, location) using appropriate tools/methods. (ME 1)

    • If screening identifies risk, implement measures/interventions to reduce fall risk. (ME 2)

    • Document the screening and interventions performed. (ME 2)

    • Implement fall reduction measures/interventions related to identified at-risk situations and locations within outpatient areas. (ME 3)

Module 3 Conclusion (5 Minutes)

• Criticality: Reiterate that IPSGs represent fundamental safety practices essential for JCI accreditation.

• Action-Oriented: Emphasize that compliance requires defined processes, staff training, consistent implementation, monitoring, and documentation.

• Link to Quality: Connect IPSG compliance back to the overall Quality Improvement and Patient Safety (QPS) program – monitoring these goals is a key part of quality assessment.

This detailed expansion of Module 3 covers the core requirements and rationale for each IPSG as presented in the JCI document. Training should incorporate practical examples relevant to the hospital's context and interactive elements to ensure understanding and application.

Module 4: Detailed Overview of JCI Patient-Centered Standards (Chapters ACC - PFE)

Module Goal: To provide participants with a comprehensive understanding of the key principles, processes, and requirements within each JCI chapter focused directly on the patient's journey and experience.

Introduction to Patient-Centered Standards (5 Minutes)

• Concept: This section forms the core of JCI's focus – ensuring care is safe, effective, timely, and respectful of patient needs, values, and preferences throughout their entire interaction with the hospital.

• Interconnectedness: Highlight that these chapters are not silos; they are deeply interconnected (e.g., assessment in AOP drives the plan in COP, patient rights in PFR underpin consent in ASC and education in PFE).

• Relevance: Emphasize how compliance with these standards directly impacts patient outcomes, safety, and satisfaction.

4.1 ACC: Access to Care and Continuity of Care (Estimated Time: 20 Minutes)

• Chapter Goal: To ensure patients receive the appropriate care based on their needs and the hospital's resources, and that their care is coordinated and continuous across different services, departments, and settings, including admission, transfer, and discharge.

• Key Content Areas Likely Covered:

  • Screening & Admission:

    • Processes for evaluating patients at first contact (e.g., ED, outpatient clinic, direct admission) to determine if their clinical needs match the hospital's mission, scope of services, and resource capabilities (Ref: ACC.1, p. 59).

    • Criteria and process for prioritizing patients with emergent, urgent, or immediate needs (Ref: ACC.1.1, p. 60).

    • Standardized processes for inpatient admission and outpatient registration (Ref: ACC.2, p. 61).

    • Informing patients about significant delays in diagnostic or treatment services (Ref: ACC.1.2, p. 60).

  • Patient Flow Management:

    • Processes to manage the flow of patients throughout the hospital, including admission to specialized/intensive units based on criteria (Ref: ACC.2.2.1, ACC.2.3, p. 62-63).

    • Addressing patient "boarding" in temporary locations (e.g., ED) while awaiting inpatient beds (Ref: ACC.2.2.1 Intent, p. 62).

  • Continuity of Care:

    • Designing and implementing processes to ensure care is continuous and coordinated within the hospital (among practitioners, departments, services) (Ref: ACC.3, p. 64-65).

    • Assigning responsibility for coordinating the patient's care (e.g., primary physician, case manager) (Ref: ACC.3.1, p. 65).

    • Ensuring essential patient care information is transferred with the patient when moving between units/services (Ref: ACC.3.2, p. 66).

  • Discharge, Referral, and Follow-Up:

    • Processes and criteria for planning and executing patient discharge or referral based on health status and continuing care needs (Ref: ACC.4, p. 67).

    • Planning discharge early in the care process (Ref: AOP.1.8 mentioned in ACC.4 Intent, p. 67).

    • Patient/family education related to continuing care needs (Ref: ACC.4.1, p. 68).

    • Cooperation with external providers/agencies for timely referrals (Ref: ACC.4.2, p. 68).

    • Requirements for complete discharge summaries, including content and timeliness (Ref: ACC.4.3, ACC.4.3.2, p. 69-70).

    • Providing understandable follow-up instructions (Ref: ACC.4.3.1, p. 69).

    • Managing patients leaving against medical advice (AMA) (Ref: ACC.4.5, ACC.4.5.1, p. 71-72).

  • Transfer of Patients (Internal & External):

    • Processes for safe patient transfer to other organizations based on need and receiving facility capability (Ref: ACC.5, p. 72).

    • Developing a safe transfer process including communication, responsibility during transfer, and necessary supplies/equipment (Ref: ACC.5.1, p. 73).

    • Providing a clinical summary to the receiving organization (Ref: ACC.5.2, p. 73-74).

    • Documenting the transfer process (Ref: ACC.5.3, p. 74).

  • Transportation:

    • Ensuring hospital transport services (owned or contracted) meet quality, safety, and regulatory requirements, including staff qualifications and appropriate equipment/supplies (Ref: ACC.6, p. 74-75).

4.2 PFR: Patient and Family Rights (Estimated Time: 20 Minutes)

• Chapter Goal: To identify, protect, and promote the fundamental rights of patients and their families during care, ensuring care is respectful and involves patients in decisions.

• Key Content Areas Likely Covered:

  • Supporting Rights: Hospital responsibility and leadership commitment to supporting patient/family rights (Ref: PFR.1, p. 78-79).

  • Access & Barriers: Identifying and reducing physical, language, cultural, and other barriers to accessing and receiving care (Ref: PFR.1.1, p. 79).

  • Respect & Dignity: Providing care that supports dignity, respects personal values/beliefs, and responds to spiritual/religious needs (Ref: PFR.1.2, p. 80).

  • Privacy & Confidentiality: Protecting patient privacy during care and the confidentiality of their health information (Ref: PFR.1.3, p. 80-81).

  • Protection: Protecting patients' possessions from theft/loss and protecting vulnerable patients from physical assault (Ref: PFR.1.4, PFR.1.5, p. 81-82).

  • Information & Participation: Informing patients about their care/treatment and ensuring they participate in decisions (including second opinions) (Ref: PFR.2, p. 82-83).

  • Refusal of Treatment: Informing patients/families of their right to refuse or discontinue treatment, withhold resuscitation, or forgo life-sustaining treatment, and the hospital's process for managing this (Ref: PFR.2.1, p. 83).

  • Pain & End-of-Life: Supporting the patient's right to assessment and management of pain and respectful, compassionate end-of-life care (Ref: PFR.2.2, p. 84).

  • Complaints & Conflicts: Informing patients/families about the process to voice complaints, conflicts, or differences of opinion and their right to participate in the resolution process (Ref: PFR.3, p. 84-85).

  • Understanding Rights: Informing all patients of their rights and responsibilities in an understandable manner and language (Ref: PFR.4, p. 85).

  • Consent Processes:

    • Clarity around general consent obtained at admission/registration (Ref: PFR.5, p. 85-86).

    • Detailed process for obtaining specific Informed Consent (defining the process, training staff, ensuring understandable language) (Ref: PFR.5.1, p. 86).

    • Identifying procedures requiring specific informed consent (surgery, anesthesia, sedation, blood products, high-risk treatments) (Ref: PFR.5.2, p. 87).

    • Ensuring adequate information is provided for informed consent (condition, proposed treatment, risks, benefits, alternatives, practitioners involved) (Ref: PFR.5.3, p. 87-88).

    • Process for when others (surrogates) can grant consent (Ref: PFR.5.4, p. 88).

  • Organ & Tissue Donation: Informing patients/families about choices regarding donation and hospital oversight of the procurement process (Ref: PFR.6, PFR.6.1, p. 89).

4.3 AOP: Assessment of Patients (Estimated Time: 20 Minutes)

• Chapter Goal: To ensure all patients undergo appropriate initial and ongoing assessments to identify their care needs, guide treatment planning, and evaluate response to care.

• Key Content Areas Likely Covered:

  • Defined Assessment Process: Hospital defines the scope, content, and process for patient assessment for all patients (Ref: AOP.1, p. 94).

  • Initial Assessment Content: Includes physical exam, health history, psychological, spiritual/cultural, social, and economic factors (Ref: AOP.1.1, p. 95).

  • Timeliness & Documentation: Requirements for completing and documenting initial medical and nursing assessments (e.g., within 24 hours for inpatients), with specific considerations for emergency patients (Ref: AOP.1.2, AOP.1.2.1, p. 95-96).

  • Pre-Admission/Pre-Procedure Assessments: Process for accepting assessments done outside the hospital (e.g., physician's office) and requirements for preoperative medical assessments (Ref: AOP.1.3, AOP.1.3.1, p. 96-98).

  • Screening for Specific Needs: Processes for screening nutritional status, functional needs, pain, and other special needs, with referral for further assessment when indicated (Ref: AOP.1.4, AOP.1.5, p. 98-99).

  • Special Populations: Requirements for individualized assessments for specific groups (e.g., children, elderly, terminally ill, psychiatric patients, abuse victims) (Ref: AOP.1.6, p. 99-101).

  • Dying Patients: Specific assessment and reassessment needs for dying patients and their families (Ref: AOP.1.7, p. 100-101).

  • Discharge Planning: Determining the need for discharge planning as part of the initial assessment (Ref: AOP.1.8, p. 101).

  • Reassessment: Process and intervals for reassessing patients based on condition, treatment response, and planning needs (Ref: AOP.2, p. 101-102).

  • Qualified Assessors: Ensuring assessments are conducted by qualified and competent individuals (Ref: AOP.3, p. 102).

  • Collaboration & Integration: Collaborative analysis and integration of assessment findings by the care team to prioritize needs (Ref: AOP.4, p. 103).

  • Laboratory & Radiology Services: Detailed requirements for the availability, management, safety, quality control, staffing, and result reporting for laboratory, blood bank/transfusion, and radiology/diagnostic imaging services (both internal and contracted) (Ref: AOP.5 series, AOP.6 series, p. 103-118).

4.4 COP: Care of Patients (Estimated Time: 20 Minutes)

• Chapter Goal: To ensure patient care is planned, delivered, integrated, coordinated, and appropriate based on assessment findings and patient needs.

• Key Content Areas Likely Covered:

  • Uniformity of Care: Providing consistent care quality regardless of patient's ability to pay, time of day, or location within the hospital (Ref: COP.1, p. 121).

  • Integration & Coordination: Processes to integrate and coordinate care provided by different practitioners, departments, and services (Ref: COP.2, p. 121-122).

  • Individualized Care Plan: Developing, documenting, and regularly updating an individualized care plan based on assessment, involving the patient/family (Ref: COP.2.1, p. 122-123).

  • Ordering Care: Uniform process for prescribing patient orders (medications, tests, treatments), including requirements for clarity, completeness, and authorization (Ref: COP.2.2, p. 123-124).

  • Documenting Care: Documenting procedures and treatments performed and their results/outcomes in the medical record (Ref: COP.2.3, p. 124-125).

  • High-Risk Patients & Services: Identifying and guiding care for high-risk patient populations and high-risk services using guidelines/protocols (e.g., emergency patients, life support, communicable diseases, dialysis, restraints, chemotherapy, vulnerable groups) (Ref: COP.3, p. 125-126).

  • Responding to Deterioration: Training clinical staff to recognize and respond appropriately to changes/deterioration in a patient’s condition (Ref: COP.3.1, p. 126-127).

  • Resuscitation Services: Ensuring availability of resuscitation services, equipment, medications, and trained staff throughout the hospital (Ref: COP.3.2, p. 127-128).

  • Blood & Blood Products: Guidelines and procedures for safe handling, use, and administration (Ref: COP.3.3, p. 128).

  • Food & Nutrition Therapy: Providing appropriate food choices based on nutritional status/clinical care, safe food handling/storage, providing nutrition therapy for at-risk patients (Ref: COP.4, COP.5, p. 128-129).

  • Pain Management: Supporting patients in managing pain effectively through assessment, intervention, and education (Ref: COP.6, p. 130).

  • End-of-Life Care: Providing respectful care addressing physical, psychosocial, spiritual, and cultural needs of dying patients and their families (Ref: COP.7, p. 130-131).

  • Organ/Tissue Transplant Services (If Applicable): Specific requirements for program resources, leadership, team structure, coordination, eligibility criteria, informed consent, protocols for recovery/receipt, and individualized care plans for transplant candidates/recipients and living donors (Ref: COP.8 series, COP.9 series, p. 131-139).

4.5 ASC: Anesthesia and Surgical Care (Estimated Time: 15 Minutes)

• Chapter Goal: To ensure safe and standardized provision of procedural sedation, anesthesia, and surgical care throughout the hospital.

• Key Content Areas Likely Covered:

  • Organization & Management: Availability of services, meeting professional standards/regulations, qualified leadership oversight (Ref: ASC.1, ASC.2, p. 142-143).

  • Procedural Sedation: Standardized administration/monitoring process throughout the hospital, qualified practitioners/monitors, discussing risks/benefits/alternatives (Ref: ASC.3 series, p. 144-146).

  • Anesthesia Care:

    • Preanesthesia and preinduction assessments by qualified individuals (Ref: ASC.4, p. 147).

    • Planning and documenting anesthesia care, including agent/technique used (Ref: ASC.5, p. 147-148).

    • Discussing risks, benefits, alternatives, and post-op pain control options (Ref: ASC.5.1, p. 148).

    • Physiological monitoring during anesthesia/surgery and documentation (Ref: ASC.6, p. 148).

    • Postanesthesia monitoring, documentation, and discharge criteria (Ref: ASC.6.1, p. 149).

  • Surgical Care:

    • Planning surgical care based on patient assessment (Ref: ASC.7, p. 149-150).

    • Discussing surgical risks, benefits, and alternatives (including blood use) (Ref: ASC.7.1, p. 150).

    • Documenting the surgical procedure details to facilitate continuing care (Ref: ASC.7.2, p. 150-151).

    • Planning and documenting post-surgical care (Ref: ASC.7.3, p. 151-152).

    • Special considerations for surgical procedures involving medical device implantation (selection, tracking, reporting adverse events/malfunctions, patient follow-up for recalls) (Ref: ASC.7.4, p. 152-153).

4.6 MMU: Medication Management and Use (Estimated Time: 15 Minutes)

• Chapter Goal: To ensure medications are managed and used safely and effectively throughout the entire medication process cycle.

• Key Content Areas Likely Covered:

  • Organization & Management: Organized oversight (pharmacist/qualified professional), compliance with laws/regulations, annual system review, implementation of antibiotic stewardship program (Ref: MMU.1, MMU.1.1, p. 156-158).

  • Selection & Procurement: Maintaining a medication list/formulary, process for obtaining non-formulary/unavailable medications, oversight of the list and medication use (Ref: MMU.2, MMU.2.1, p. 159-160).

  • Storage: Proper and safe storage conditions (stability, security, controlled substances), managing special handling meds (e.g., nutritional products, radioactive), uniform storage/monitoring of emergency meds, medication recall system (Ref: MMU.3 series, p. 160-162).

  • Ordering & Transcribing: Policies guiding safe prescribing/ordering/transcribing, defining elements of a complete order, identifying authorized prescribers, managing illegible/unclear orders, documenting orders in medical record (Ref: MMU.4 series, p. 162-164).

  • Preparing & Dispensing: Preparing/dispensing in safe/clean environment, following laws/standards, appropriateness review of orders prior to dispensing, system for safe dispensing (right dose/patient/time), labeling meds not immediately administered (Ref: MMU.5 series, p. 165-167).

  • Administration: Identifying authorized administrators, verification process (correct med/dose/route based on order, correct patient), managing patient self-administration or meds brought from home, managing samples (Ref: MMU.6 series, p. 168-169).

  • Monitoring: Monitoring medication effects (therapeutic and adverse), process for documenting/reporting adverse drug events, medication errors, and near misses (Ref: MMU.7, MMU.7.1, p. 169-170).

4.7 PFE: Patient and Family Education (Estimated Time: 10 Minutes)

• Chapter Goal: To ensure patients and families receive education and training necessary to participate in care decisions and support continuity of care.

• Key Content Areas Likely Covered:

  • Supporting Participation: Providing education to support patient/family involvement in care decisions and processes (Ref: PFE.1, p. 174).

  • Assessing Needs: Assessing and recording patient/family educational needs (Ref: PFE.2, p. 174).

  • Assessing Learning Ability: Assessing patient/family ability and willingness to learn (literacy, language, barriers, motivation, cognitive/physical limitations) (Ref: PFE.2.1, p. 175).

  • Effective Methods: Using educational methods that account for values/preferences and allow sufficient interaction for learning (Ref: PFE.3, p. 175).

  • Collaboration: Health care practitioners collaborate to provide coordinated education (Ref: PFE.4, p. 176).

Module 4 Conclusion (5 Minutes)

• Recap: Briefly reiterate the seven patient-centered chapters and their core focus.

• Integration: Re-emphasize the strong links between these chapters (e.g., how assessment informs care planning, rights underpin consent, education supports participation and continuity).

• Foundation: Stress that these standards lay the groundwork for safe, high-quality, patient-focused care as envisioned by JCI.

This detailed expansion provides a robust overview of the likely content within Module 4, drawing inferences from chapter titles and foundational principles described elsewhere in the provided document excerpts. Remember to tailor the actual training delivery based on the specific audience's roles and needs.

Module 5: Detailed Overview of JCI Healthcare Organization Management Standards (Chapters QPS - MOI)

Module Goal: To equip participants with a comprehensive understanding of the essential organizational systems, structures, and processes required by JCI to support safe, high-quality patient care and effective hospital operations.

Introduction to Organization Management Standards (5 Minutes)

• Shift in Focus: While Module 4 focused directly on the patient experience, this module examines the critical organizational infrastructure – the management systems, leadership responsibilities, resource management, and staff support systems – necessary to make high-quality patient care possible and sustainable.

• Foundation for Care: Emphasize that robust management systems are not separate from patient care; they are the foundation upon which safe and effective clinical practice is built. Deficiencies in these areas often lead to patient safety risks.

• Interconnectedness: Highlight the links between these management chapters (e.g., FMS identifies risks managed through QPS, SQE ensures competent staff for all areas, MOI supports data needs for QPS and GLD).

5.1 QPS: Quality Improvement and Patient Safety (Estimated Time: 20 Minutes)

• Chapter Goal: To establish a comprehensive, data-driven framework for continuously monitoring, evaluating, and improving the quality and safety of care and organizational processes.

• Key Content Areas Likely Covered:

  • Leadership & Program Structure:

    • Requirement for qualified individual(s) to lead and manage the quality/safety program (Ref: QPS.1, p. 181).

    • Governing body approval and leadership support/resource allocation (Ref: GLD.1.2, GLD.4, p. 213, 216).

    • Integrating quality/safety efforts across all departments and services (Ref: QPS.2, p. 182).

  • Measure Selection & Data Collection:

    • Leadership role in setting hospital-wide measurement priorities (Ref: GLD.5, p. 218).

    • Process for selecting relevant measures (clinical and managerial), potentially using JCI Library of Measures or other evidence-based sources (Ref: QPS.2, APR.7, p. 182, 36).

    • Coordination of data collection across the hospital (Ref: QPS.2, p. 182).

    • Using scientific and other information to support program activities (Ref: QPS.3, p. 182).

  • Data Analysis & Validation:

    • Systematic aggregation and analysis of data to support care, management, and improvement (Ref: QPS.4, QPS.4.1, p. 183-184).

    • Participation in external databases for benchmarking/comparison (Ref: QPS.4, p. 183).

    • Analyzing data for undesirable trends and variations (Ref: QPS.8, p. 187).

    • Analysis of improvement impact on cost and efficiency (Ref: QPS.5, p. 185).

    • Internal process for validating data accuracy and reliability (Ref: QPS.6, p. 185-186).

  • Managing High-Risk Events:

    • Defined process for identifying, reporting, analyzing (Root Cause Analysis - RCA), and managing Sentinel Events (Ref: QPS.7, p. 186-187).

    • Defined process for identifying, reporting, and analyzing Near Misses (Ref: QPS.9, p. 188).

  • Improvement & Sustainability:

    • Using data analysis to drive improvements (Ref: QPS.8, p. 187).

    • Planning, testing, implementing, and sustaining quality and safety improvements (Ref: QPS.10, p. 188).

  • Risk Management: Ongoing, proactive program to identify and reduce risks to patients and staff (e.g., using FMEA, HVA) (Ref: QPS.11, p. 189).

5.2 PCI: Prevention and Control of Infections (Estimated Time: 20 Minutes)

• Chapter Goal: To identify and reduce the risks of acquiring and transmitting infections among patients, staff, visitors, and the broader community through a coordinated, evidence-based program.

• Key Content Areas Likely Covered:

  • Program Leadership & Structure:

    • Oversight by one or more qualified individuals (education, training, experience) (Ref: PCI.1, p. 193).

    • Designated coordination mechanism involving physicians, nurses, and others (Ref: PCI.2, p. 193-194).

    • Ensuring the program covers all areas and staff within the hospital (Ref: PCI.2, p. 193-194).

  • Resources & Knowledge Base:

    • Program based on current science, guidelines, laws, and sanitation standards (Ref: PCI.3, p. 194-195).

    • Leadership provides adequate resources (staffing, supplies, technology) (Ref: PCI.4, p. 195).

  • Program Goals & Risk Reduction Strategies:

    • Comprehensive program design identifying and reducing infection risks associated with procedures and processes (Ref: PCI.5, p. 195-196).

    • Risk-based approach to focus prevention efforts (using surveillance data) (Ref: PCI.6, p. 196).

    • Tracking infection risks, rates, and trends (surveillance) (Ref: PCI.6.1, p. 196-197).

  • Specific Risk Areas:

    • Medical Equipment/Devices/Supplies: Proper cleaning, disinfection, sterilization, storage; managing expired supplies; process for safe reuse of single-use devices (if applicable) (Ref: PCI.7, PCI.7.1, p. 197-199).

    • Infectious Waste: Proper disposal of infectious waste and body fluids (Ref: PCI.7.2, p. 199-200).

    • Sharps Safety: Safe handling and disposal of sharps and needles (Ref: PCI.7.3, p. 200).

    • Food Services: Reducing infection risks associated with food operations (storage, preparation) (Ref: PCI.7.4, p. 201).

    • Construction Risks: Reducing infection risk during demolition, construction, renovation (using risk assessment) (Ref: PCI.7.5, p. 201).

  • Transmission Prevention:

    • Use of barrier precautions and isolation procedures (including managing airborne infections and influxes, use of negative pressure rooms) (Ref: PCI.8, PCI.8.1, PCI.8.2 p. 202-203).

    • Availability and correct use of Personal Protective Equipment (PPE), soap, disinfectants (Ref: PCI.9, p. 204).

  • Integration & Education:

    • Integrating infection control data/activities with the overall quality/safety program (Ref: PCI.10, p. 204-205).

    • Providing ongoing education on infection control practices to staff, physicians, patients, families (Ref: PCI.11, p. 205).

5.3 GLD: Governance, Leadership, and Direction (Estimated Time: 25 Minutes)

• Chapter Goal: To define the structure, roles, responsibilities, and accountabilities of the hospital's governance, executive leadership, and department/service leaders to ensure effective management and direction aligned with the mission.

• Key Content Areas Likely Covered:

  • Governance (Level I):

    • Defined structure and authority (bylaws, policies) (Ref: GLD.1, p. 211).

    • Operational responsibilities and accountabilities documented (approving mission, plans, policies, budget, CEO appointment/evaluation, education/research oversight) (Ref: GLD.1.1, p. 212).

    • Approval and oversight of the quality and patient safety program (receiving/acting on reports) (Ref: GLD.1.2, p. 213).

  • Chief Executive(s) (Level II):

    • Responsibility for hospital operations and compliance with laws/regulations (Ref: GLD.2, p. 213).

  • Hospital Leadership (Level III):

    • Collective identification and responsibility for defining mission and creating programs/policies (Ref: GLD.3, p. 214).

    • Planning clinical services based on patient needs (Ref: GLD.3.1, p. 215).

    • Ensuring effective communication throughout the hospital (Ref: GLD.3.2, p. 215-216).

    • Ensuring uniform programs for staff recruitment, retention, development, education (Ref: GLD.3.3, p. 216).

    • Planning, developing, implementing the quality/safety program and communicating results (Ref: GLD.4, GLD.4.1, p. 216-218).

    • Prioritizing hospital-wide improvement activities and assessing their impact (Ref: GLD.5, p. 218-219).

    • Accountability for clinical and nonclinical contracts (review, selection, monitoring, quality integration, credentialing for contracted practitioners) (Ref: GLD.6 series, p. 219-220).

    • Making resource decisions (human, technical) considering quality/safety implications; supply chain safety management (Ref: GLD.7, GLD.7.1, p. 221-222).

  • Department/Service Leaders (Level IV):

    • Structure for clinical staff organization and accountability (Ref: GLD.8, p. 223).

    • Qualified individuals direct each department/service (Ref: GLD.9, p. 224).

    • Defining, integrating, and coordinating services provided by the department (Ref: GLD.10, p. 225).

    • Departmental participation in quality/safety improvement; using data for staff performance evaluation; selecting/implementing clinical practice guidelines (Ref: GLD.11 series, p. 225-228).

  • Organizational & Clinical Ethics: Establishing a framework for ethical management (business and clinical), promoting an ethical culture, protecting patient rights, managing conflicts of interest (Ref: GLD.12 series, p. 228-230).

  • Culture of Safety: Creating, supporting, monitoring, and improving a hospital-wide culture of safety (Ref: GLD.13, GLD.13.1, p. 230-231).

  • Health Professional Education & Research (Where Applicable): Oversight and guidance for non-AMC hospital education programs; guidance and oversight for human subjects research (Ref: GLD.14 - GLD.19, p. 231-235).

5.4 FMS: Facility Management and Safety (Estimated Time: 20 Minutes)

• Chapter Goal: To ensure the physical environment is safe, functional, and supportive of patient care through effective management of buildings, grounds, equipment, and utilities.

• Key Content Areas Likely Covered:

  • Leadership & Planning:

    • Compliance with relevant laws, regulations, codes (building, fire safety), and inspection requirements (Ref: FMS.1, p. 239).

    • Developing written programs to manage risks (safety/security, hazmat, emergencies, fire, med equipment, utilities) (Ref: FMS.2, p. 240).

    • Oversight by qualified individual(s) (Ref: FMS.3, p. 241).

  • Safety & Security:

    • Program for a safe physical facility (inspections, risk reduction) (Ref: FMS.4, p. 242).

    • Program for a secure environment (monitoring, access control, protecting vulnerable individuals) (Ref: FMS.4.1, p. 242).

    • Planning/budgeting for upgrades/replacement based on inspections/regulations (Ref: FMS.4.2, p. 242).

    • Pre-construction risk assessment (PCRA) process for demolition, construction, renovation (Ref: FMS.4.2.1, p. 243).

  • Hazardous Materials & Waste: Program for inventory, safe handling, storage, use, labeling, spill response, and proper disposal (Ref: FMS.5, FMS.5.1, p. 244-246).

  • Emergency Management/Disaster Preparedness: Developing, maintaining, and testing an emergency management program (identifying risks, hospital role, communication, resource/clinical management, staff roles) (Ref: FMS.6, p. 246-247).

  • Fire Safety: Program for prevention, early detection, suppression, abatement, safe exit; testing systems/devices; managing smoking restrictions (Ref: FMS.7 series, p. 247-249).

  • Medical Equipment: Program for inventory, inspection, testing, preventive maintenance, documentation; managing hazard notices/recalls (Ref: FMS.8, FMS.8.1, p. 249-250).

  • Utility Systems: Program for effective/efficient operation; inventory, inspection, testing, maintenance, improvement; ensuring availability/reliability of essential utilities (potable water, electricity) including backup sources and testing; monitoring water quality (Ref: FMS.9 series, p. 250-253).

  • Program Monitoring & Education: Collecting/analyzing data from all FMS programs to support planning/improvement; educating/training/testing staff on their roles in FMS programs (Ref: FMS.10, FMS.11 series, p. 254-255).

5.5 SQE: Staff Qualifications and Education (Estimated Time: 25 Minutes)

• Chapter Goal: To ensure the hospital has a sufficient number of qualified, competent staff to meet patient needs, and that staff competence is maintained and developed through orientation, training, and education.

• Key Content Areas Likely Covered:

  • Planning & Recruitment:

    • Leaders define education/skill/knowledge requirements for all staff (Ref: SQE.1, p. 259).

    • Responsibilities defined in current job descriptions (Ref: SQE.1.1, p. 259).

    • Processes for recruiting, evaluating, appointing staff (Ref: SQE.2, p. 260).

    • Staffing strategy identifying number/types/qualifications needed, reviewed and updated (Ref: SQE.6, SQE.6.1, p. 263).

  • Competence & Evaluation:

    • Process to ensure clinical staff competence matches patient needs (initial and ongoing evaluation) (Ref: SQE.3, p. 261).

    • Process to ensure nonclinical staff competence matches hospital needs (initial and ongoing evaluation) (Ref: SQE.4, p. 262).

  • Personnel Information: Documented personnel information maintained for each staff member (qualifications, health info, orientation/education records, performance reviews), kept confidential and standardized (Ref: SQE.5, p. 262).

  • Orientation, Training & Education:

    • Orientation for all staff (hospital, department/unit, job specifics) (Ref: SQE.7, p. 264).

    • Ongoing in-service/other education provided based on needs assessment, resources provided (Ref: SQE.8, p. 264-265).

    • Training/competence in resuscitation techniques (Ref: SQE.8.1, p. 265).

  • Staff Health & Safety: Program addressing physical/mental health, safe work conditions, occupational exposures, immunizations/vaccinations, safe patient handling, managing workplace violence, second victim support, work-related injury management (Ref: SQE.8.2, SQE.8.2.1, p. 265-267).

  • Medical Staff Specifics:

    • Uniform process for gathering/verifying credentials (primary source verification) (Ref: SQE.9, SQE.9.1, p. 267-271).

    • Uniform, transparent appointment process (Ref: SQE.9.2, p. 267-271).

    • Standardized, objective process for assigning clinical privileges (Ref: SQE.10, p. 271-272).

    • Ongoing standardized process for monitoring/evaluating medical staff performance (behavior, professional growth, clinical results) (Ref: SQE.11, p. 273-276).

    • Process for reappointment and renewal/modification of privileges (at least every 3 years) (Ref: SQE.12, p. 277-278).

  • Nursing Staff Specifics: Uniform process for credentials; assigning responsibilities based on credentials; participation in quality improvement (Ref: SQE.13, SQE.14, SQE.14.1, p. 278-279).

  • Other Health Care Practitioners: Uniform process for credentials; assigning responsibilities based on credentials; participation in quality improvement (Ref: SQE.15, SQE.16, SQE.16.1, p. 280-281).

5.6 MOI: Management of Information (Estimated Time: 15 Minutes)

• Chapter Goal: To ensure information is managed effectively and securely to support patient care, decision-making, and organizational performance.

• Key Content Areas Likely Covered:

  • Planning & Design: Planning information management processes to meet internal/external needs (Ref: MOI.1, p. 286).

  • Privacy, Confidentiality, Security: Maintaining information privacy/confidentiality/security, including data integrity; defining access levels (Ref: MOI.2, p. 287).

  • Record Retention: Determining and managing retention times for records/data/information, ensuring secure destruction (Ref: MOI.3, p. 288).

  • Standardization: Use of standardized diagnosis/procedure codes; standardized use of approved symbols/abbreviations (including do-not-use list) (Ref: MOI.4, p. 288-289).

  • Meeting User Needs: Providing data/information timely and in a useful format (Ref: MOI.5, p. 289).

  • Protection: Protecting records/information from loss, destruction, tampering, unauthorized access/use (Ref: MOI.6, p. 290).

  • Staff Education: Educating staff on information use and management principles (Ref: MOI.7, p. 290-291).

  • Document Management: Consistent management of written documents (policies, procedures, programs) - review/approval, currency, changes, identity, retention (Ref: MOI.8, MOI.8.1, p. 291-292).

  • Medical Record Management:

    • Initiating and maintaining a standardized medical record for every patient (content, format, entry location) (Ref: MOI.9, p. 292).

    • Ensuring sufficient information to identify patient, support diagnosis, justify treatment, document course/results (Ref: MOI.9.1, p. 292-293).

    • Specific content requirements for emergency records (Ref: MOI.10, p. 293).

    • Identifying authorized individuals for record entries; identifying author/time for each entry; managing corrections/overwrites (Ref: MOI.11, MOI.11.1, p. 294).

    • Process for managing copy-and-paste function in electronic records (Ref: MOI.11.1.1, p. 294-295).

    • Regular assessment of medical record content and completeness (Ref: MOI.12, p. 295-296).

  • 
    

  • Health Information Technology (HIT): Assessing/testing HIT systems before implementation; evaluating usability/effectiveness/safety post-implementation; program for managing planned/unplanned data system downtime (Ref: MOI.13, MOI.14, p. 296-298).

Module 5 Conclusion (5 Minutes)

• Recap: Briefly review the six organizational management chapters (QPS, PCI, GLD, FMS, SQE, MOI) and their primary focus.

• Synergy: Reinforce how strong performance in these areas creates the necessary environment and provides the essential resources and competent staff required to deliver the patient-centered care outlined in Module 4.

• Continuous Cycle: Emphasize that management standards are not static; they require ongoing monitoring, evaluation, and improvement, feeding back into the quality cycle (QPS).

This detailed module expansion covers the critical management functions essential for a well-run, safe, and quality-focused hospital according to the likely scope of the JCI standards listed.

Module 6: Detailed Overview of JCI Academic Medical Center (AMC) Hospital Standards (Chapters MPE & HRP)

Module Goal: To provide participants from designated AMC Hospitals with a specific understanding of the JCI standards governing medical education and human subjects research, emphasizing integration with hospital operations, quality, and patient safety.

Introduction to AMC Standards (10 Minutes)

• Defining the AMC Hospital (JCI Context): Review the specific JCI definition and the mandatory eligibility criteria an organization must meet to be surveyed under these standards (Ref: p. 8, p. 13):

  • Organizational/administrative integration with a medical school.

  • Being the principal site for educating both medical students (undergraduates) AND postgraduate medical trainees (residents/interns) from that school.

  • Actively conducting medical research involving human subjects with formal oversight (IRB/Ethics Committee).

• Purpose & Rationale: Explain why JCI has these specific standards:

  • Recognizing the unique resources and responsibilities AMCs represent (Ref: p. 8).

  • Ensuring education and research activities are deliberately integrated into the hospital's quality and patient safety framework, not existing in silos (Ref: p. 8).

  • Addressing the inherent risks and complexities associated with training and research in a patient care environment.

• Module Structure: Overview of the two chapters covered: MPE and HRP.

6.1 MPE: Medical Professional Education (Estimated Time: 30 Minutes)

• Focus: Ensuring medical education is conducted safely, effectively, and consistently within the hospital environment, aligned with both academic and hospital goals.

• Key Content Areas (Based on MPE.1 - MPE.7, p. 303-308):

  • MPE.1 (Governance & Leadership Oversight):

    • Requirement for formal approval and ongoing monitoring of the hospital's participation in medical education by the governing entity and hospital leadership.

    • Ensuring the education mission aligns with the overall hospital mission, strategic plans, and resources.

    • Process for obtaining, reviewing, and accepting the educational parameters from the sponsoring academic program(s).

    • Establishing and reviewing metrics to evaluate the scope, activities, goal achievement, compliance, and patient/staff satisfaction related to education programs.

  • MPE.2 (Resources & Environment):

    • Assessing and ensuring adequacy of clinical staff (number, expertise) to support and advance education goals.

    • Ensuring sufficient patient population (volume, case mix) for clinical learning.

    • Providing adequate facilities (classrooms, study/rest areas, libraries/online resources) and technology to support effective learning and evidence-based practice.

  • MPE.3 (Clinical Teaching Staff):

    • Clear identification of all clinical staff involved in teaching and supervision.

    • Defining each teaching staff member's role, responsibilities, and relationship to the academic institution (including academic titles, if any).

    • Maintaining a complete and current list of teaching staff and their titles/roles.

    • Process for monitoring academic appointments/requirements.

  • MPE.4 (Supervision):

    • Defining and providing the required frequency and intensity of supervision for each type and level of student/trainee (based on competence, not just title/year).

    • Ensuring students/trainees understand who provides supervision and how it will occur and be documented.

    • Uniform process for documenting required supervision consistently across programs/departments.

    • Establishing uniform expectations for all staff who provide supervision.

    • Monitoring compliance with supervision documentation requirements.

  • MPE.5 (Program Coordination & Management):

    • Defined operational mechanism and management structure for medical education within the hospital.

    • Maintaining a complete, current list of all medical students and trainees.

    • Documenting key information for each student/trainee (enrollment status, academic classification, licensure/certification, achievements, competencies, accommodation needs, factors influencing supervision level).

  • MPE.6 (Policy Compliance & Safety Integration):

    • Ensuring students and trainees comply with all relevant hospital policies and procedures.

    • Providing orientation to hospital-wide programs (quality, patient safety, IPSGs, infection control, medication safety, etc.).

    • Integrating students/trainees into quality and safety monitoring programs.

    • Supervisors consider compliance with safety programs during trainee evaluations.

  • MPE.7 (Trainees Working Outside Program Scope):

    • Process for evaluating and granting permission (through credentialing, privileging, job specification) when trainees provide services outside the defined parameters of their academic program (e.g., moonlighting).

    • Ensuring such work is evaluated according to relevant hospital SQE standards.

6.2 HRP: Human Subjects Research Programs (Estimated Time: 30 Minutes)

• Focus: Ensuring all research involving human subjects conducted within the hospital is ethically sound, protects participants, complies with regulations, and is integrated with hospital operations.

• Key Content Areas (Based on HRP.1 - HRP.7.1, p. 309-316):

  • HRP.1 & HRP.1.1 (Leadership Accountability & Resources):

    • Hospital leadership's ultimate accountability for protecting human research subjects, irrespective of sponsor.

    • Establishing mechanisms for compliance with all relevant regulatory (e.g., ICH/WHO GCP) and professional requirements.

    • Promoting a culture of ethical research conduct.

    • Providing adequate resources (staff, budget, indemnity insurance for adverse events).

    • Identifying the official(s) responsible for research policy development and compliance oversight.

  • HRP.2 (Scope of Research):

    • Leadership defines the scope (types, locations) of human subjects research permitted within the hospital.

    • Identifying required facilities and resources to support the defined scope.

    • Defining qualifications for staff permitted to participate as investigators/team members.

    • Defining circumstances under which hospital staff may participate as research subjects.

  • HRP.3 & HRP.3.1 (Sponsor Requirements & CROs):

    • Establishing requirements for research sponsors to ensure ethical conduct (quality/safety monitoring, ethical methods, qualified teams, data integrity/protection, unbiased reporting, appropriate incentives).

    • Process for managing research where duties are contracted out to a Contract Research Organization (CRO), including clear delineation of accountabilities and monitoring responsibilities.

  • HRP.4 (Research Review Process):

    • Creating or contracting for an independent review process (IRB/Ethics Committee) for initial and ongoing review of all non-exempt human subjects research.

    • Supporting the structure and operational requirements of the review function.

    • Ensuring compliance with applicable laws/regulations regarding review.

    • Specifying requirements for external review bodies (if used).

    • Process for identifying research exempt from review and documenting review activities.

    • Annual leadership review of the review processes.

  • HRP.5 (Conflict of Interest):

    • Process for identifying and managing potential financial and non-financial conflicts of interest related to research for individuals, committees, and the institution.

    • Providing ongoing education and monitoring related to conflicts of interest.

  • HRP.6 (Integration with Quality & Safety):

    • Integrating research activities into hospital-wide quality and safety processes (e.g., reporting research-related sentinel/adverse events, near misses).

    • Inclusion of research-related activities in relevant hospital programs (hazmat, medical equipment, medication management).

    • Incorporating staff participation in research into ongoing professional practice evaluation.

  • HRP.7 & HRP.7.1 (Informed Consent for Research):

    • Establishing and implementing a robust informed consent process specific to research participation.

    • Providing potential participants with comprehensive information (research explanation, duration, procedures, risks, benefits, alternatives, confidentiality, voluntariness, right to withdraw, compensation/treatment for injury, contact information).

    • Establishing safeguards to protect vulnerable populations from coercion or undue influence (including hospital staff).

    • Process for documenting consent and re-consenting if protocols change significantly.

    • Informing patients/families how to access relevant clinical research opportunities.

Module 6 Conclusion (5 Minutes)

• Integration is Key: Reiterate the central theme – the necessity for AMCs to seamlessly integrate their education and research functions into the hospital's core operational, quality, and patient safety structures.

• Shared Responsibility: Emphasize that protecting patients and ensuring quality applies equally in teaching and research contexts as it does in routine clinical care.

• Value Proposition: Briefly touch on how well-managed education and research programs contribute to the hospital's mission, reputation, and advancement of healthcare.

This detailed expansion for Module 6 provides a framework for training professionals in Academic Medical Centers on the specific JCI requirements related to their unique educational and research roles, linking these back to broader hospital operations and patient safety principles.