This Constitution is framed in accordance with the National Patient Safety Implementation Framework (2018-2025) issued by the Ministry of Health and Family Welfare, Government of India, the National Accreditation Board for Hospitals and Healthcare Providers (NABH) standards, the Clinical Establishments (Registration and Regulation) Act, 2010, and the World Health Organization's Global Patient Safety Action Plan 2021-2030.
Patient safety is a fundamental principle of healthcare and a critical component of quality management. The institution is committed to creating and sustaining a culture of safety where preventable harm to patients is eliminated, adverse events are reported and analyzed systematically, and continuous improvements are implemented to ensure the highest standards of safe patient care.
The Patient Safety Committee shall function as the apex body responsible for developing, implementing, monitoring, and evaluating patient safety initiatives, policies, and protocols across all clinical and support services of the institution. The Committee shall work in coordination with other institutional committees including the Infection Control Committee, Quality Assurance Committee, Medical Records Committee, and Risk Management Committee to ensure comprehensive patient safety governance.
This Constitution aims to establish clear organizational structures, roles, responsibilities, and processes for achieving the vision of "zero preventable harm" to patients receiving care at this institution.
The Committee constituted under this Constitution shall be known as the "Patient Safety Committee" (hereinafter referred to as "PSC" or "the Committee") for the purpose of promoting patient safety culture, preventing adverse events, ensuring safe clinical practices, and coordinating all patient safety activities at the institution.
For the purposes of this Constitution:
Patient Safety means the prevention of errors and adverse effects associated with healthcare that are potentially harmful to patients, and the reduction of risk of unnecessary harm to an acceptable minimum.
Adverse Event means an unintended injury or complication resulting in death, disability, prolonged hospital stay, or requiring additional medical intervention, which is caused by healthcare management rather than the patient's underlying disease process[3].
Serious Adverse Event means an adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, or requires medical or surgical intervention to prevent permanent impairment.
Sentinel Event means an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof, warranting immediate investigation and response.
Near Miss means an event or situation that could have resulted in an accident, injury, or illness but did not, either by chance or through timely intervention.
Medical Error means a failure in the treatment process that leads to, or has the potential to lead to, harm to the patient, including errors of commission (doing the wrong thing) or omission (failing to do the right thing).
Root Cause Analysis (RCA) means a systematic process for identifying the basic or contributing causal factors underlying variations in performance that lead to adverse events.
Failure Mode and Effects Analysis (FMEA) means a prospective, systematic approach to identify and prevent process and product problems before they occur.
Safety Culture means the product of individual and group values, attitudes, perceptions, competencies, and patterns of behavior that determine commitment to, and the style and proficiency of, an organization's patient safety management.
High-Alert Medication means a medication that bears a heightened risk of causing significant patient harm when used in error (e.g., insulin, anticoagulants, opioids, chemotherapy agents).
Healthcare-Associated Infection (HAI) means an infection occurring in a patient during the process of care in a hospital or healthcare facility which was not present or incubating at the time of admission.
Patient Identification means the process of correctly matching a patient to appropriately intended interventions and communicating information about the patient's identity accurately throughout the continuum of care.
Handoff Communication means the transfer of essential information and the responsibility for care of the patient from one healthcare provider to another.
Surgical Safety Checklist means the WHO Surgical Safety Checklist used to reduce surgical complications and deaths through standardized processes for sign-in, time-out, and sign-out.
Patient Safety Officer (PSO) means the designated individual responsible for coordinating and implementing patient safety activities and serving as the focal point for patient safety initiatives.
Clinical Safety Officer means a designated medical professional responsible for clinical aspects of patient safety including adverse event investigation and clinical protocol implementation.
Incident Reporting System means the mechanism for capturing, documenting, analyzing, and responding to patient safety incidents, adverse events, and near misses.
This Constitution aligns with the following frameworks and guidelines:
The NPSIF establishes six strategic objectives for patient safety in India:
Strategic Objective 1: Building institutional mechanisms for patient safety at national, state, and institutional levels
Strategic Objective 2: Creating and strengthening national adverse event reporting and learning systems
Strategic Objective 3: Building competent and committed workforce for patient safety
Strategic Objective 4: Engaging patients and families in patient safety initiatives
Strategic Objective 5: Implementing infection prevention and control programs
Strategic Objective 6: Improving safety of clinical processes and promoting rational use of medicines
The institution adopts the seven strategic objectives of the WHO Global Patient Safety Action Plan:
Zero avoidable harm in healthcare through policies and legislation
High-reliability healthcare systems and organizations
Safety of every clinical process
Patient and family engagement for safety
Health worker education, skills, and safety
Information, research, and risk management for safety
Synergy, partnerships, and solidarity for patient safety
The Committee shall implement the following WHO patient safety goals:
Goal 1: Identify patients correctly using at least two identifiers
Goal 2: Improve effective communication among caregivers
Goal 3: Improve the safety of high-alert medications
Goal 4: Ensure correct site, correct procedure, and correct patient surgery
Goal 5: Reduce the risk of healthcare-associated infections
Goal 6: Reduce the risk of patient harm from falls
5.1 The Patient Safety Committee shall consist of 12-18 members representing clinical, nursing, administrative, quality, and support services:
| S. No. | Designation and Position |
|---|---|
| 1 | Chairperson - Medical Superintendent or Dean |
| 2 | Convener - Patient Safety Officer (designated senior faculty) |
| 3 | Clinical Safety Officer (Senior Clinician) |
| 4 | Chief Nursing Officer or Nursing Superintendent |
| 5 | Representative - Department of Medicine |
| 6 | Representative - Department of Surgery |
| 7 | Representative - Department of Obstetrics and Gynecology |
| 8 | Representative - Department of Pediatrics |
| 9 | Representative - Department of Anesthesiology |
| 10 | Representative - Emergency Medicine |
| 11 | Infection Control Officer or IPC Committee Representative |
| 12 | Quality Manager or Quality Assurance Representative |
| 13 | Risk Manager (if designated) |
| 14 | Pharmacist - Medication Safety Representative |
| 15 | Biomedical Engineer - Equipment Safety Representative |
| 16 | Hospital Administrator or Administrative Representative |
| 17 | Patient Representative or Patient Advocate (optional) |
| 18 | Legal Advisor or Medicolegal Consultant (optional) |
Table 1: Composition of Patient Safety Committee
Chairperson: Medical Superintendent, Dean, or senior administrative medical officer with authority to implement safety policies and allocate resources
Patient Safety Officer (PSO): Designated senior faculty member (Professor or Associate Professor) with training in patient safety, quality improvement, or healthcare management; serves full-time or with dedicated protected time
Clinical Safety Officer: Senior clinician (preferably with critical care or emergency medicine experience) responsible for clinical incident investigation
Multidisciplinary Representation: Must include representatives from major clinical departments (Medicine, Surgery, Obstetrics and Gynecology, Pediatrics, Anesthesiology, Emergency)
Nursing Leadership: Chief Nursing Officer or senior nursing superintendent mandatory as nursing staff are frontline safety implementers
Infection Control Integration: Infection Control Officer or designated IPC representative mandatory given HAI prevention is core patient safety priority
Quality and Risk Management: Quality manager and risk manager (if designated) to ensure integration of safety with institutional quality initiatives
Medication Safety: Senior pharmacist with expertise in medication safety, high-alert medications, and adverse drug reaction monitoring
Equipment Safety: Biomedical engineer responsible for medical equipment calibration, maintenance, and safety
Patient Voice: Patient representative or patient advocate (recommended) to provide patient perspective on safety concerns
Training Requirements: At least 50% of members should have completed patient safety training programs or certification courses
No Dual Roles: Members may serve on related committees (Quality, IPC, Medical Records) but must prioritize patient safety activities
The Patient Safety Committee shall be constituted for a tenure of three years
Members may be reappointed for subsequent terms based on performance and continued commitment to patient safety
Patient Safety Officer should serve full three-year term to ensure continuity and institutional knowledge
Clinical representatives may rotate annually to ensure fresh perspectives while maintaining core stability
Vacancies shall be filled within 15 days by nomination of qualified replacements
Members may resign by giving one month's written notice to the Chairperson and Management
Non-participating members (absent from three consecutive meetings without valid reason) may be replaced
The objectives and functions of the Patient Safety Committee shall include:
Develop comprehensive institutional patient safety policy aligned with national and international standards
Establish annual patient safety goals and strategic priorities for the institution
Create standard operating procedures (SOPs) for high-risk clinical processes
Develop protocols for patient identification, medication administration, surgical safety, infection control, and fall prevention
Establish policies for adverse event reporting, investigation, and corrective action
Review and update patient safety policies annually or when significant incidents occur
Align patient safety policies with NABH accreditation standards and regulatory requirements
Develop patient safety budget and resource allocation plans
Establish and maintain confidential, non-punitive incident reporting system for adverse events, near misses, and safety concerns
Develop user-friendly incident reporting forms (paper and electronic) accessible to all staff
Create reporting mechanisms through multiple channels: online forms, mobile applications, dedicated phone lines, paper forms
Ensure 24-hour availability of incident reporting system
Classify incidents by severity using standardized taxonomy (near miss, no harm event, minor harm, moderate harm, severe harm, death)
Monitor incident reporting rates across departments and shifts
Provide feedback to reporters within 48 hours acknowledging receipt of report
Maintain incident database with capability for trend analysis and pattern recognition
Ensure confidentiality of reporters and protection from punitive action (just culture approach)
Publish de-identified incident summaries and lessons learned through institutional communications
Conduct Root Cause Analysis (RCA) for all sentinel events and serious adverse events within 72 hours of occurrence
Assemble multidisciplinary RCA teams including frontline staff, subject matter experts, and patient safety personnel
Use structured RCA methodology and tools (fishbone diagrams, five whys, timeline analysis)
Identify system failures, process gaps, and human factors contributing to adverse events
Develop comprehensive corrective and preventive action plans (CAPA) with specific timelines and responsible persons
Implement immediate safety measures to prevent recurrence during investigation
Monitor effectiveness of corrective actions through follow-up assessments at 30, 60, and 90 days
Document RCA findings and action plans in standardized format
Share lessons learned from RCA with relevant departments and staff
Report sentinel events to regulatory authorities (Ministry of Health, NABH, university) as required
Maintain RCA repository for institutional learning and quality improvement
Conduct Failure Mode and Effects Analysis (FMEA) for high-risk processes before implementation
Identify high-risk clinical areas and procedures requiring proactive risk mitigation
Perform prospective safety assessments for new technologies, equipment, and clinical protocols
Conduct regular safety audits and walkarounds in clinical areas
Use healthcare failure mode and effects analysis for medication systems, laboratory processes, and procedural areas
Prioritize risks based on severity, frequency, and detectability scores
Develop and implement risk mitigation strategies for identified high-risk scenarios
Engage frontline staff in risk identification through safety rounds and suggestion systems
Coordinate with biomedical engineering for equipment risk assessments
Review and update risk registers quarterly
Implement standardized patient identification protocol using minimum two identifiers (name and registration number or date of birth)
Ensure proper patient identification before all procedures, medication administration, blood transfusions, specimen collection, and diagnostic tests
Develop color-coded wristband system for allergies, fall risk, and DNR status
Implement standardized handoff communication protocols using SBAR (Situation-Background-Assessment-Recommendation) format
Establish protocols for critical test result communication and read-back verification
Develop guidelines for effective interprofessional communication during emergencies
Implement closed-loop communication for verbal orders and telephone orders
Create standardized handover checklists for shift changes, inter-department transfers, and post-operative handovers
Ensure patient identity verification during emergency situations using identification protocols
Conduct regular audits of patient identification compliance and communication effectiveness
Establish institutional formulary of high-alert medications (insulin, heparin, warfarin, potassium, opioids, chemotherapy)
Implement double-check system for high-alert medication preparation and administration
Develop look-alike-sound-alike (LASA) drug management protocols with clear labeling and storage separation
Standardize medication ordering through computerized physician order entry (CPOE) where available
Eliminate dangerous abbreviations and create approved abbreviation list
Implement standardized concentration protocols for infusions and injectable medications
Establish protocols for allergy documentation and contraindication checking
Conduct medication reconciliation at admission, transfer, and discharge
Monitor and analyze medication errors and adverse drug reactions through pharmacovigilance
Ensure secure medication storage and controlled drug monitoring
Provide regular training on safe medication practices to physicians, nurses, and pharmacists
Coordinate with pharmacy for automated dispensing systems and barcode medication administration where feasible
Implement WHO Surgical Safety Checklist mandatory for all surgical procedures
Conduct sign-in (before anesthesia induction), time-out (before skin incision), and sign-out (before patient leaves OR)
Ensure correct patient, correct site, correct procedure verification through standardized protocols
Implement surgical site marking by operating surgeon using indelible marker
Develop protocols for retained surgical items prevention (instrument count, sponge count)
Establish surgical site infection prevention bundle (antibiotic prophylaxis, skin preparation, normothermia, glycemic control)
Monitor surgical safety checklist compliance through regular audits
Implement wrong-site surgery prevention protocols including imaging review and consent verification
Develop anesthesia safety protocols for difficult airway management, malignant hyperthermia, and anaphylaxis
Ensure availability of emergency resuscitation equipment and crash carts in all procedural areas
Conduct regular surgical safety drills and simulation exercises
Track surgical complications and near misses for continuous improvement
Coordinate with Infection Control Committee to implement comprehensive infection prevention program
Ensure compliance with hand hygiene protocols and monitor hand hygiene compliance rates
Implement standard precautions and transmission-based precautions across all clinical areas
Develop protocols for healthcare-associated infection surveillance (central line-associated bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, surgical site infections)
Establish antibiotic stewardship program to promote rational use of antibiotics
Implement environmental cleaning and disinfection protocols with regular audits
Ensure proper biomedical waste segregation, handling, and disposal
Develop protocols for isolation and management of multidrug-resistant organisms
Conduct regular infection control audits and surveillance
Provide infection control training to all healthcare workers
Monitor HAI rates and implement targeted interventions for reduction
Ensure availability of personal protective equipment (PPE) and proper usage training
Implement fall risk assessment for all patients at admission and periodically during hospitalization
Use validated fall risk assessment tools (Morse Fall Scale, Hendrich II Fall Risk Model)
Identify high-risk patients with color-coded wristbands and bed/room signage
Develop fall prevention care bundles (bed rails, bed alarms, non-slip footwear, adequate lighting, toileting assistance)
Ensure call bells within patient reach and prompt response to call lights
Conduct environmental safety rounds to identify fall hazards (wet floors, poor lighting, clutter)
Provide patient and family education on fall prevention strategies
Implement post-fall protocols including immediate assessment, injury management, and fall investigation
Analyze fall incidents to identify patterns and implement preventive measures
Train staff on safe patient handling and mobility assistance
Monitor fall rates and injurious fall rates as key safety indicators
Conduct regular fall prevention audits and compliance checks
Conduct pressure ulcer risk assessment using Braden Scale at admission and daily for high-risk patients
Implement pressure ulcer prevention bundles (repositioning every 2 hours, pressure-relieving devices, skin care, nutritional support)
Ensure availability of pressure-relieving mattresses and cushions
Document skin assessments and pressure ulcer staging
Provide patient and family education on pressure ulcer prevention
Monitor hospital-acquired pressure ulcer rates
Conduct skin care audits and compliance monitoring
Coordinate with nutrition services for adequate nutritional support for at-risk patients
Implement protocols for timely reporting and follow-up of critical laboratory and radiology results
Establish critical value notification system with read-back verification
Develop policies for diagnostic error reduction including test ordering appropriateness
Ensure proper specimen labeling and patient identification during collection
Implement fail-safe mechanisms for tracking pending test results
Monitor turnaround times for critical diagnostic tests
Develop protocols for communicating unexpected findings and incidental findings to patients
Conduct diagnostic error reviews when delays or missed diagnoses occur
Coordinate with laboratory and radiology for quality assurance of diagnostic services
Ensure proper functioning and accessibility of emergency resuscitation equipment (crash carts, defibrillators, oxygen)
Conduct daily checks of crash cart contents and expiry dates
Implement code blue (cardiac arrest), code red (fire), code yellow (missing patient), code orange (hazardous material) protocols
Conduct regular mock drills for emergency codes
Ensure rapid response team availability for deteriorating patients
Develop protocols for managing obstetric emergencies, pediatric emergencies, and trauma
Monitor response times for emergency codes
Provide regular training on Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS)
Ensure availability of emergency medications and equipment in all critical areas
Implement stringent patient identification and blood product verification protocols
Ensure ABO compatibility checking and crossmatching before transfusion
Monitor patients during transfusion for adverse reactions
Develop protocols for managing transfusion reactions
Maintain cold chain for blood product storage
Coordinate with blood bank for quality assurance of blood products
Monitor transfusion-related incidents and near misses
Provide training on safe transfusion practices to nursing and medical staff
Coordinate with biomedical engineering department for preventive maintenance schedules
Ensure calibration and safety checks of all medical equipment
Develop protocols for reporting equipment malfunctions
Investigate equipment-related incidents and coordinate with manufacturers
Ensure proper user training before operating complex medical equipment
Monitor medical device adverse events and report to national materiovigilance program
Maintain equipment maintenance logs and safety records
Ensure availability of backup equipment for critical life-support systems
Develop patient education materials on patient safety including medication safety, fall prevention, hand hygiene, infection prevention
Encourage patients and families to participate in safety initiatives (speak up campaigns, hand hygiene reminders)
Implement patient safety orientation at admission
Provide clear communication about treatment plans, medications, and discharge instructions
Encourage patients to ask questions and clarify doubts
Implement patient complaint and grievance redressal mechanisms with timely resolution
Include patient representatives in patient safety committee meetings and initiatives
Conduct patient satisfaction surveys with focus on safety experiences
Implement open disclosure policy for adverse events with compassionate communication to patients and families
Provide counseling and support services to patients affected by adverse events
Conduct patient safety culture surveys annually to assess institutional safety climate
Promote just culture principles balancing accountability with non-punitive reporting
Provide mandatory patient safety orientation for all new employees within first week
Conduct annual patient safety training refresher programs for all staff
Organize specialized training programs on high-risk topics (medication safety, surgical safety, infection control, fall prevention)
Implement simulation-based training for emergency management and crisis situations
Conduct Team STEPPS or similar team training programs for effective interprofessional collaboration
Recognize and reward staff for reporting safety concerns and contributing to safety improvements
Develop patient safety champions in each department to promote safety initiatives
Conduct regular safety huddles and briefings at departmental and institutional levels
Share patient safety alerts, bulletins, and newsletters highlighting lessons learned and best practices
Integrate patient safety competencies into staff performance evaluations
Define and monitor institutional patient safety indicators including:
Adverse event reporting rate per 1000 patient days
Medication error rate per 1000 medication doses
Healthcare-associated infection rates (CLABSI, CAUTI, VAP, SSI)
Fall rate and injurious fall rate per 1000 patient days
Hospital-acquired pressure ulcer rate
Surgical safety checklist compliance rate
Hand hygiene compliance rate
Patient identification compliance rate
Mortality rate and unexpected death rate
Readmission rate within 30 days
Transfusion reaction rate
Equipment malfunction incident rate
Establish benchmarks and targets for each safety indicator
Monitor indicators monthly and trend over time
Compare performance against national benchmarks where available
Implement control charts and statistical process control for indicator monitoring
Present indicator performance to hospital management and governing body quarterly
Publish safety indicators on institutional website for transparency
Use indicator data to prioritize safety improvement initiatives
Ensure compliance with National Patient Safety Implementation Framework requirements
Prepare for and maintain NABH accreditation with focus on patient safety standards
Comply with Clinical Establishments Act and state regulations on patient safety
Report serious adverse events to regulatory authorities as mandated
Maintain documentation required for regulatory inspections and accreditation surveys
Implement recommendations from external audits and regulatory inspections
Coordinate with legal and risk management for medico legal aspects of patient safety
Encourage patient safety research projects by faculty and postgraduate students
Participate in national and international patient safety research networks
Implement evidence-based patient safety interventions
Conduct quality improvement projects using PDSA (Plan-Do-Study-Act) cycles
Publish patient safety research and improvement initiatives in peer-reviewed journals
Present patient safety work at conferences and academic forums
Innovate technology solutions for patient safety (mobile apps, electronic reporting systems)
Collaborate with other institutions for multi-center patient safety studies
Provide executive leadership and strategic direction for institutional patient safety initiatives
Preside over Patient Safety Committee meetings and ensure productive discussions
Approve patient safety policies, protocols, and action plans
Allocate resources (human, financial, infrastructure) for patient safety programs
Champion patient safety culture across the institution
Ensure accountability for patient safety at all levels of organization
Represent institution in patient safety forums and regulatory interactions
Review serious adverse events and approve corrective action plans
Monitor institutional patient safety indicators and performance
Communicate patient safety priorities to hospital management and governing body
Ensure integration of patient safety with quality improvement and accreditation activities
Sign patient safety reports and regulatory submissions
Serve as primary coordinator and focal point for all patient safety activities
Develop and implement institutional patient safety strategic plan
Manage incident reporting system and ensure timely response to all reports
Coordinate adverse event investigations and root cause analyses
Maintain patient safety database including incidents, RCAs, action plans, and indicators
Prepare agenda for Patient Safety Committee meetings in consultation with Chairperson
Conduct regular safety rounds and walkarounds in clinical areas
Develop patient safety training programs and educational materials
Liaise with regulatory authorities on patient safety reporting and compliance
Monitor implementation of corrective actions from adverse event investigations
Compile patient safety indicators and prepare monthly and quarterly reports
Coordinate with quality manager, infection control officer, and risk manager
Represent institution at state and national patient safety forums
Maintain patient safety resource library and best practice repository
Communicate patient safety alerts and advisories to relevant departments
Prepare annual patient safety report for management and regulatory bodies
Facilitate patient safety culture surveys and analyze results
Manage patient safety budget and resource allocation
Lead clinical aspects of adverse event investigation with medical expertise
Conduct immediate clinical assessment of patients affected by adverse events
Provide clinical guidance on corrective actions and safety interventions
Review clinical protocols and identify opportunities for safety improvement
Conduct peer review of clinical incidents involving diagnostic or treatment errors
Mentor clinical staff on patient safety principles and practices
Participate in root cause analysis teams for serious clinical incidents
Liaise with clinical departments for implementing safety protocols
Review and approve clinical patient safety protocols and guidelines
Conduct clinical safety audits and assessments
Provide clinical input for FMEA and proactive risk assessments
Lead nursing staff engagement in patient safety initiatives
Ensure nursing compliance with patient safety protocols (patient identification, medication administration, fall prevention, pressure ulcer prevention)
Investigate nursing-related adverse events and implement corrective actions
Conduct nursing safety audits and competency assessments
Develop and update nursing policies and procedures for patient safety
Coordinate nursing education on patient safety topics
Monitor nursing-sensitive safety indicators (falls, pressure ulcers, medication errors)
Promote patient safety culture among nursing staff
Ensure adequate nursing staffing levels for safe patient care
Participate in root cause analysis for nursing-related incidents
Implement nursing safety innovations and best practices
Represent departmental perspective on patient safety issues
Implement patient safety protocols within their respective departments
Report department-specific adverse events and safety concerns to committee
Participate in adverse event investigations involving their departments
Ensure department staff compliance with institutional patient safety policies
Conduct department-level safety audits and quality improvement initiatives
Promote patient safety culture within department through regular communication
Identify department-specific risks and propose mitigation strategies
Participate in development of specialty-specific safety protocols
Serve as patient safety champions within their departments
Coordinate infection prevention and control activities with patient safety initiatives
Monitor healthcare-associated infection rates and investigate outbreaks
Ensure compliance with hand hygiene and infection control protocols
Conduct infection control audits and environmental surveillance
Provide input on infectious disease-related patient safety concerns
Develop and update infection control policies
Train staff on infection prevention measures
Report HAI data to patient safety committee and regulatory authorities
Integrate patient safety with institutional quality improvement programs
Ensure patient safety standards compliance for NABH accreditation
Conduct quality audits with focus on patient safety processes
Analyze patient safety data for quality improvement opportunities
Implement quality improvement methodologies (PDSA, Six Sigma, Lean) for safety initiatives
Coordinate preparation for regulatory and accreditation surveys
Monitor patient safety performance indicators and quality metrics
Facilitate quality improvement teams for safety projects
Lead medication safety initiatives across the institution
Monitor medication errors and adverse drug reactions
Implement high-alert medication safety protocols
Conduct medication use evaluations and safety audits
Develop and maintain formulary with focus on safety
Provide education on safe medication practices to healthcare providers
Coordinate pharmacovigilance activities and reporting
Manage look-alike-sound-alike drug protocols
Participate in medication error investigations
Ensure proper medication storage and labeling
Implement medication reconciliation processes
Ensure safety and proper functioning of all medical equipment
Implement preventive maintenance schedules and conduct safety inspections
Investigate equipment-related incidents and coordinate repairs
Provide equipment safety training to clinical staff
Monitor medical device adverse events and report to materiovigilance program
Ensure equipment calibration and performance verification
Coordinate with manufacturers for equipment recalls and safety alerts
Maintain equipment safety records and maintenance logs
Assess safety of new equipment before clinical use
Ensure availability of backup equipment for critical systems
Identify and assess institutional risks related to patient safety
Develop risk mitigation strategies and monitor implementation
Coordinate insurance claims related to adverse events
Maintain risk register and incident database
Conduct proactive risk assessments (FMEA) for high-risk processes
Liaise with legal advisors on medicolegal aspects of patient safety
Analyze trends in adverse events for risk management purposes
Coordinate disclosure of adverse events to patients and families
Provide patient and family perspective on safety concerns
Represent patient interests in patient safety policy development
Participate in patient safety committee meetings and discussions
Provide feedback on patient education materials and communication
Advocate for transparency and open communication about safety
Assist in developing patient engagement strategies for safety
Review patient complaints related to safety issues
Promote patient participation in safety initiatives
The Patient Safety Committee shall meet at least once per month (minimum 12 meetings per year)
Emergency meetings may be convened within 24-48 hours for sentinel events or urgent safety concerns
Notice of meeting with agenda circulated at least 5 days in advance
Quorum: Minimum seven members including Chairperson or Patient Safety Officer, Clinical Safety Officer, Chief Nursing Officer, and at least one clinical department representative
Decisions taken by consensus; if voting required, simple majority prevails (Chairperson has casting vote in case of tie)
Members with conflicts of interest must declare and recuse themselves from discussions
Minutes recorded documenting attendance, incidents reviewed, investigations conducted, corrective actions approved, and follow-up plans
Minutes approved in subsequent meeting and signed by Chairperson
Confidentiality maintained regarding patient identities and individual staff members involved in incidents
Action items tracked with responsible persons and deadlines
Standing agenda items:
Review of adverse events and near misses since last meeting
Updates on ongoing investigations and RCAs
Status of corrective action implementation
Patient safety indicator performance review
Safety audit findings and recommendations
New safety initiatives and policy updates
Training program updates
Regulatory compliance issues
Any other safety matters
All of the following must be reported through the incident reporting system:
Sentinel Events: Patient death or serious harm from healthcare (wrong-site surgery, patient suicide, medication error resulting in death, retained surgical instrument)
Adverse Events: Unintended harm to patient requiring additional intervention (hospital-acquired infection, medication error with harm, fall with injury, pressure ulcer development, blood transfusion reaction)
Near Misses: Events that could have caused harm but did not, either by chance or intervention (incorrect medication prepared but caught before administration, blood product intended for wrong patient but identified before transfusion)
Unsafe Conditions: Situations with potential to cause harm (malfunctioning equipment, inadequate staffing, missing emergency supplies, environmental hazards)
Medication Errors: Any preventable event related to medication use (wrong drug, wrong dose, wrong route, wrong patient, wrong time, omission)
Equipment Failures: Medical device malfunction or failure affecting patient care
Healthcare-Associated Infections: New infections acquired during hospitalization
Patient Falls: All falls regardless of injury
Security Incidents: Patient elopement, infant abduction, violence against staff or patients
Laboratory and Diagnostic Errors: Specimen mislabeling, critical result delays, incorrect reports
Incidents shall be classified using the following severity scale:
| Level | Classification | Description |
|---|---|---|
| 0 | Near Miss | No harm; error caught before reaching patient |
| 1 | No Harm Event | Error reached patient but no harm occurred |
| 2 | Minor Harm | Temporary harm requiring minor intervention |
| 3 | Moderate Harm | Temporary harm requiring additional treatment |
| 4 | Severe Harm | Permanent harm or major intervention required |
| 5 | Death | Patient death resulted from incident |
Table 3: Incident Severity Classification Scale
Sentinel Events (Level 5): Immediate verbal notification to Patient Safety Officer, Clinical Safety Officer, and Chairperson; written report within 2 hours
Serious Adverse Events (Level 4): Verbal notification within 2 hours; written report within 24 hours
Moderate Harm Events (Level 3): Written report within 24 hours
Minor Harm Events (Level 2): Written report within 48 hours
No Harm Events and Near Misses (Level 0-1): Written report within 72 hours
All staff encouraged to report near misses and unsafe conditions promptly regardless of timeline
Initial Response (within 2 hours for serious events):
Immediate assessment of patient condition and provision of necessary care
Implementation of interim safety measures to prevent recurrence
Preservation of evidence (equipment, medications, documentation)
Notification of patient safety team and relevant stakeholders
Preliminary Assessment (within 24 hours):
Patient Safety Officer reviews incident report and classifies severity
Determines level of investigation required (Level 5 = comprehensive RCA; Level 3-4 = focused RCA; Level 0-2 = departmental review)
Assembles investigation team for serious events
Root Cause Analysis (within 45 days for sentinel events; within 30 days for serious adverse events):
Multidisciplinary RCA team conducts comprehensive investigation
Review of medical records, policies, procedures, and physical environment
Interviews with involved staff (non-punitive, focus on systems)
Timeline reconstruction of events leading to incident
Identification of root causes and contributing factors using structured tools
Causal factor classification: communication failures, training gaps, equipment issues, policy violations, system design flaws, human factors
Development of comprehensive corrective and preventive action plan (CAPA)
Documentation of RCA findings in standardized format
Corrective Action Implementation:
Action plans approved by Patient Safety Committee
Assignment of responsible persons and deadlines for each action
Immediate actions implemented within 7 days
Intermediate actions completed within 30 days
Long-term actions initiated within 60 days
Communication of actions to relevant departments and staff
Effectiveness Monitoring:
Follow-up assessment at 30, 60, and 90 days post-implementation
Verification of action completion and effectiveness
Monitoring of relevant safety indicators for improvement
Re-assessment if actions prove ineffective
Communication and Learning:
De-identified case summaries and lessons learned shared through safety bulletins
Staff education sessions on findings and preventive measures
Updates to policies and protocols based on learnings
Contribution to institutional knowledge base
Open and honest communication with patients and families following adverse events
Disclosure conducted by senior clinician or Patient Safety Officer within 24 hours
Expression of empathy and apology (without admission of liability) as appropriate
Explanation of what happened, contributing factors, and actions taken
Information about ongoing investigation and future preventive measures
Availability of counseling and support services
Regular updates to patient and family during investigation
Documentation of disclosure conversation in medical record
Legal consultation as appropriate while prioritizing transparency
New Employee Patient Safety Orientation: 4-hour program within first week covering:
Introduction to patient safety principles and just culture
Incident reporting system and expectations
Key safety protocols (patient identification, medication safety, infection control)
Emergency codes and response procedures
Hand hygiene and standard precautions
Annual Patient Safety Refresher: 2-hour annual mandatory training for all staff
Specialty-Specific Safety Training: Role-based training for:
Physicians: Diagnostic safety, medication prescribing, surgical safety
Nurses: Medication administration, fall prevention, patient identification
Pharmacists: Medication safety, high-alert drugs, error prevention
Laboratory staff: Specimen handling, critical value reporting
Support staff: Environmental safety, infection control
High-Risk Procedure Training: Simulation-based training for emergency procedures, code management, difficult airway, obstetric emergencies
TeamSTEPPS or Similar Team Training: Interprofessional teamwork and communication training conducted annually
Root Cause Analysis Training: For patient safety committee members and department heads
Patient Safety Leadership Training: For senior administrators and department heads
Monthly patient safety grand rounds presenting case studies and lessons learned
Quarterly patient safety newsletters highlighting recent incidents, corrective actions, and best practices
Safety huddles and briefings at department level (daily or weekly)
Morbidity and mortality conferences with focus on systems analysis
Access to online patient safety courses and certification programs
Participation in national patient safety webinars and conferences
Patient safety journal clubs reviewing recent literature
Poster presentations and publications on patient safety initiatives
Training attendance records maintained by HR and Patient Safety Office
Competency assessments for high-risk procedures
Annual patient safety knowledge tests for clinical staff
Training certificates issued for completed programs
Training compliance tracked and reported to management
Non-compliant staff identified and targeted for additional training
Training effectiveness evaluated through post-training assessments and safety indicator improvements
The institution shall monitor the following patient safety indicators monthly:
| Indicator | Target Benchmark |
|---|---|
| Incident reporting rate per 1000 patient days | > 20 reports |
| Medication error rate per 1000 doses | < 1 error |
| Central line-associated bloodstream infection (CLABSI) rate | < 1 per 1000 line days |
| Catheter-associated urinary tract infection (CAUTI) rate | < 2 per 1000 catheter days |
| Ventilator-associated pneumonia (VAP) rate | < 2 per 1000 ventilator days |
| Surgical site infection (SSI) rate | < 3% of procedures |
| Hand hygiene compliance rate | > 90% |
| Patient fall rate per 1000 patient days | < 3 falls |
| Injurious fall rate per 1000 patient days | < 1 fall with injury |
| Hospital-acquired pressure ulcer rate (Stage II+) | < 2% of admissions |
| Surgical safety checklist compliance rate | 100% |
| Patient identification compliance (2 identifiers) | > 95% |
| Mortality rate (overall) | Monitor trend |
| Unexpected death rate requiring review | All investigated |
| 30-day readmission rate | < 10% |
| Blood transfusion reaction rate | < 1% of transfusions |
| Wrong-site surgery incidents | Zero |
| Retained surgical items | Zero |
| Equipment malfunction incidents | Monitor trend |
| Patient complaint rate regarding safety | Monitor trend |
Table 4: Patient Safety Indicators and Target Benchmarks
Indicators shall be:
Calculated monthly and trended over time using run charts and control charts
Compared against internal historical data and external benchmarks (NABH, national data)
Presented to Patient Safety Committee monthly
Reported to hospital management and governing body quarterly
Analyzed for special cause variation requiring investigation
Used to prioritize safety improvement initiatives
Publicly displayed (de-identified) on hospital dashboards and website
The Patient Safety Committee shall prepare a comprehensive annual report by April 30 each year containing:
Executive summary of patient safety activities and achievements
Committee composition, meeting frequency, and attendance
Total number of incidents reported by severity level and category
Incident reporting rate trend over past 3 years
Summary of serious adverse events and sentinel events with de-identified case descriptions
Root cause analyses conducted with major findings and corrective actions
Patient safety indicators performance with year-over-year comparison
Status of corrective action implementation from previous year
Safety culture survey results and trends
Training programs conducted with number of participants
New patient safety policies and protocols implemented
Safety audits conducted with compliance rates
Infrastructure and technology improvements for safety
Patient and family engagement activities
Regulatory inspections, accreditation surveys, and findings
Research and publications on patient safety
Challenges encountered and mitigation strategies
Budget utilization for patient safety activities
Action plan and priorities for upcoming year
Appendices: Patient safety policy documents, incident reporting forms, RCA templates
Annual report submitted to:
Management and Governing Body of the institution
Ministry of Health and Family Welfare (as required)
State Health Department
National Medical Commission (as part of institutional compliance)
NABH during accreditation cycle
University/Affiliating body
Posted on institutional website for public transparency
The Patient Safety Committee shall coordinate closely with:
Infection Control Committee: Joint initiatives on HAI prevention, hand hygiene, antibiotic stewardship; sharing of infection surveillance data
Quality Assurance Committee: Integration of safety with quality improvement; alignment on accreditation standards and audits
Medical Records Committee: Ensuring accurate documentation; access to medical records for incident investigation
Pharmacy and Therapeutics Committee: Medication safety initiatives; formulary decisions with safety implications; adverse drug reaction monitoring
Biomedical Engineering Committee: Equipment safety and maintenance; investigation of equipment-related incidents
Disaster Management Committee: Emergency preparedness; coordination during disasters and mass casualty events
Institutional Ethics Committee: Ethical aspects of adverse event disclosure; protection of research participants
Risk Management Committee: Proactive risk assessment; liability management; insurance claims related to adverse events
Medical Education Unit: Integration of patient safety in curriculum; faculty development on safety topics
Nursing Services Committee: Implementation of nursing safety protocols; nursing competency and training
Blood Transfusion Committee: Transfusion safety protocols; investigation of transfusion reactions
Anti-Ragging Committee and Internal Complaints Committee: Creating safe environment for students and staff
Hospital Management Committee: Resource allocation; policy approvals; strategic planning for safety
The institution shall provide:
Dedicated Patient Safety Office with secure storage for confidential incident reports
Meeting room for committee meetings and RCA sessions
Computer systems with incident reporting software and database
Display boards in clinical areas for safety awareness posters and indicators
Safety equipment: bed alarms, fall mats, pressure-relieving devices, non-slip footwear
Emergency equipment: crash carts, defibrillators, oxygen, suction
Adequate lighting, handrails, non-slip flooring in patient areas
Secure medication storage areas
Electronic incident reporting system Patient safety database for tracking incidents, RCAs, and corrective actions
Data analytics tools for trending and pattern recognition
Electronic medical records system (if available) with clinical decision support
Computerized physician order entry (CPOE) for medication ordering (if feasible)
Barcode medication administration system (if feasible)
Communication systems: staff pagers, overhead paging, emergency call system
Access to patient safety literature databases and online resources
Annual budget for Patient Safety Office operations
Funding for patient safety training programs and workshops
Budget for safety equipment and supplies
Support for attending patient safety conferences
Allocation for patient safety research and quality improvement projects
Budget for patient safety campaigns and awareness materials
Funding for external consultants or auditors as needed
Dedicated administrative staff for Patient Safety Office
Data entry and database management support
Clerical support for meeting coordination and documentation
IT support for incident reporting system and database
Access to legal counsel for medicolegal issues
Communication support for safety alerts and bulletins
Patient Safety Champion Awards:
Best Reporter Award for staff reporting most safety concerns
Patient Safety Innovation Award for implementing new safety solutions
Department Safety Excellence Award for best departmental safety performance
Nursing Safety Excellence Award
Patient Safety Leadership Award
Recognition Programs:
Certificates of appreciation for safety contributions
Feature stories in institutional newsletter
Public recognition at hospital events and meetings
Letters of commendation for personnel files
Performance Integration:
Patient safety competencies included in staff performance evaluations
Safety incident reporting rates considered in departmental performance reviews
Patient safety achievements considered for promotions
Continuous Learning Opportunities:
Sponsorship for patient safety certification courses
Support for presenting at patient safety conferences
Opportunities to lead safety improvement projects
Patient Safety Committee constitution and composition displayed on institutional website
Patient safety policy and incident reporting procedures available on intranet and at nursing stations
Patient safety indicators displayed on dashboards in clinical areas and administrative offices
Patient safety information included in patient admission packets and waiting areas
Hand hygiene reminders, fall prevention posters, and infection control signage prominently displayed
Emergency code cards and protocols posted at nursing stations
WHO surgical safety checklist displayed in operating rooms
Patient rights and responsibilities including safety participation posted in patient areas
Patient safety hotline number and incident reporting mechanisms publicized
Regular patient safety bulletins and newsletters circulated to staff
Annual patient safety report published on website
Patient safety achievements highlighted in media and public relations activities
This Constitution may be amended from time to time in accordance with:
Changes in National Patient Safety Implementation Framework or regulatory guidelines
Updates in WHO patient safety standards and best practices
NABH accreditation standard revisions
Institutional needs based on safety performance and incident trends
Feedback from staff, patients, and external auditors
Advancements in patient safety science and technology
Amendments require approval from Patient Safety Committee, Hospital Management, and Governing Body, with notification to regulatory authorities.
This Constitution shall come into effect from the date of approval by the Management of Netaji Subhas Medical College and Hospital.
Adopted by:
FOR AND ON BEHALF OF THE INSTITUTION:
Dr. __________________ [Name & Signature] Principal/Director Netaji Subhas Medical College & Hospital Date: _______________ Seal:
Prof. _________________ [Name & Signature] Chairperson, Governing Body Date: _______________
APPROVED AND NOTIFIED BY:
Sitwanto Devi Mahila Kalyan Sansthan
Secretary: _________________ [Name & Signature] Date: _______________
CONFIDENTIAL PATIENT SAFETY INCIDENT REPORT
Report Number: ________________ Date and Time of Report: ________________
SECTION 1: REPORTER INFORMATION
Name of Reporter: ________________ Department: ________________ Contact: ________________
(Reporter identity kept confidential)
SECTION 2: INCIDENT INFORMATION
Date and Time of Incident: ________________ Location: ________________
Patient Initials (not full name): _________ MRN: _________ Age: _____ Gender: _____
Type of Incident (check all that apply): ? Medication Error ? Patient Fall ? Healthcare-Associated Infection ? Surgical/Procedural Complication ? Diagnostic Error or Delay ? Equipment Malfunction ? Transfusion Reaction ? Patient Identification Error ? Communication Failure ? Near Miss ? Other: ________________
Severity Level: ? Near Miss (Level 0) ? No Harm (Level 1) ? Minor Harm (Level 2) ? Moderate Harm (Level 3) ? Severe Harm (Level 4) ? Death (Level 5)
SECTION 3: INCIDENT DESCRIPTION
What happened? (Describe the incident in detail):
____________________________________________________________________________________
What were the contributing factors?
____________________________________________________________________________________
What immediate actions were taken?
____________________________________________________________________________________
SECTION 4: RECOMMENDATIONS
What can be done to prevent this from happening again?
____________________________________________________________________________________
Reporter Signature: ______________________ Date: ________________
FOR PATIENT SAFETY OFFICE USE ONLY
Received by: ________________ Date: ___________ Acknowledgment sent: __________
Investigation required: ? Yes ? No Assigned to: ________________ Expected completion: __________
ROOT CAUSE ANALYSIS REPORT
Incident ID: ________________ Date of Incident: ________________
RCA Team Members: ______________________________________________________
Incident Summary: (Brief description of what happened)
Timeline of Events: (Chronological sequence)
Causal Factors Identified:
_________________________________________
_________________________________________
_________________________________________
Root Causes: (Underlying system factors)
Corrective and Preventive Actions (CAPA):
| Action | Responsible Person | Timeline | Status |
|---|---|---|---|
Follow-up Assessment Dates: 30 days _______, 60 days _______, 90 days _______
RCA Completed by: ________________ Date: __________
Approved by PSC: ________________ Date: __________
