FMS Chapter

FMS 1: The Organisation has a System in Place to Provide a Safe and Secure Environment 

Standard Overview:

FMS 1 is the foundational standard of the Facility Management and Safety (FMS) chapter in the NABH 6th Edition. It establishes the core principle that a hospital must have a 

systematic approach to ensure a safe and secure environment for everyone within its premises. This isn't just about reacting to incidents; it's about proactive measures, preventative strategies, and a culture of safety that permeates the entire organization.

Why is a Safe and Secure Environment Paramount in a Hospital?

• Patient Well-being: Patients are often vulnerable due to their health conditions. A safe environment minimizes the risk of hospital-acquired infections, injuries from falls, medication errors due to poor infrastructure, and other preventable harm. Security measures ensure patients feel safe and protected, fostering trust and a better healing environment.

• Staff Safety and Productivity: A safe workplace protects staff from occupational hazards (electrical, chemical, physical), violence, and security threats. This reduces staff absenteeism, improves morale, and enhances productivity, ultimately leading to better patient care.

• Visitor Safety and Comfort: Visitors are an integral part of the patient's support system. Ensuring their safety and security within the hospital premises is crucial for a positive patient experience and reflects the hospital's commitment to holistic care.

• Operational Efficiency: A well-managed and safe facility operates more efficiently. Preventative maintenance reduces equipment breakdowns, emergency preparedness minimizes disruption during crises, and security measures protect assets and operations.

• Legal and Ethical Obligations: Hospitals have a legal and ethical responsibility to provide a safe environment for all individuals within their care. Failing to do so can lead to legal liabilities, reputational damage, and most importantly, harm to individuals.

• Accreditation Requirements: NABH accreditation mandates compliance with FMS standards, including FMS 1. Demonstrating a robust system for safety and security is crucial for achieving and maintaining accreditation.

Let's delve into the Objective Elements of FMS 1:

FMS 1a: Patient-safety devices and infrastructure are installed across the organisation and inspected periodically. (CO)

(Core Objective Element - CO: This signifies a critical requirement. Non-compliance will significantly impact accreditation.)

• Intent: This objective element focuses on the physical safety measures specifically designed to protect patients. It's not enough to just have these devices; they must be installed strategically throughout the hospital and be in proper working order through regular inspections.

• Key Components - Patient Safety Devices and Infrastructure (Examples provided in slides, but let's elaborate):

  • Grab Bars:

    • Purpose: Provide support and stability to patients, particularly in bathrooms, toilets, and near beds, reducing the risk of falls, especially for elderly, mobility-impaired, or post-operative patients.

    • Installation: Must be securely fixed to walls, at appropriate heights and locations (shower areas, near toilets, beside beds). Consider different types of grab bars (straight, angled, L-shaped) based on location and need.

    • Inspection Points: Check for secure fixing (no looseness), structural integrity (no bends or breaks), cleanliness, and appropriate placement.

• • Bed Rails:

    • Purpose: Prevent patients, especially those who are confused, sedated, or at risk of falling out of bed, from accidental falls and injuries.

    • Installation: Must be compatible with the bed type, easy to operate by staff but not easily disengaged by patients (especially confused patients). Consider full and half bed rails based on patient needs and risk assessment.

    • Inspection Points: Check for proper functioning (raising and lowering mechanism), secure locking, structural integrity, cleanliness, and correct usage (raised when needed, lowered when not required).

• • Signposting:

    • Purpose: Facilitate easy navigation within the hospital for patients, families, and visitors, especially in large or complex facilities. Reduces confusion, anxiety, and delays in reaching destinations, which can be critical in emergencies.

    • Installation: Clear, visible, and strategically placed signs throughout the hospital (entrances, exits, departments, wards, restrooms, elevators, stairs). Use of universal symbols, multiple languages (bilingual if applicable), and pictorial representations.

    • Inspection Points: Check for visibility (not obstructed, well-lit), clarity (easy to read font, understandable language), accuracy (correct directions), completeness (covering all essential areas), and condition (not damaged, faded, or missing).

• • Safety Belts on Stretchers and Wheelchairs:

    • Purpose: Secure patients during transportation on stretchers and wheelchairs, preventing falls and injuries during movement within the hospital.

    • Installation/Availability: Stretchers and wheelchairs must be equipped with functional and adjustable safety belts. Ensure staff are trained on their proper use.

    • Inspection Points: Check for functionality of buckles and straps (secure locking, no damage or fraying), adjustability, cleanliness, and availability on all stretchers and wheelchairs.

• • Alarms (Visual and Auditory):

    • Purpose: Alert staff and patients to emergencies, critical situations, or patient needs. Examples include fire alarms, nurse call bells, cardiac arrest alarms, equipment malfunction alarms.

    • Installation: Strategically placed alarm systems throughout the hospital (wards, patient rooms, critical care areas, public areas). Visual alarms (flashing lights) for hearing-impaired individuals and auditory alarms (distinct sounds) for different emergencies.

    • Inspection Points: Regular testing of alarm functionality (sound and visual signals), audibility in all areas, battery backup functionality, and staff training on responding to different alarms.

• • Warning Signs (Radiation/Biohazard):

    • Purpose: Clearly identify areas with potential hazards like radiation (X-ray rooms, radiology departments) and biohazards (laboratories, waste disposal areas) to protect staff, patients, and visitors from exposure.

    • Installation: Prominent and standardized warning signs at entrances and within hazardous areas, using internationally recognized symbols and clear language.

    • Inspection Points: Check for visibility, clarity, accuracy of hazard identification, condition (not damaged or faded), and compliance with relevant regulations (e.g., for radiation safety).

• • Call Bells:

    • Purpose: Enable patients to easily summon nursing staff for assistance, comfort, or in emergencies, promoting timely response and patient satisfaction.

    • Installation: Accessible call bells within reach of patients in beds, chairs, and bathrooms. Ensure they are functional for patients with limited mobility.

    • Inspection Points: Check for functionality (ringing sound and staff station notification), accessibility for patients, cleanliness, and responsiveness of staff to call bells.

• • Fire-safety Devices:

    • Purpose: Detect, control, and suppress fires to protect lives and property in case of a fire emergency. Examples include fire extinguishers, fire sprinklers, smoke detectors, fire alarms, fire doors, emergency exit lights.

    • Installation: Strategically placed fire extinguishers, sprinklers, smoke detectors, and fire alarms throughout the hospital as per fire safety regulations and building codes. Fire doors and emergency exit lights in designated locations.

    • Inspection Points: Regular inspection and maintenance of fire extinguishers (pressure gauge, last inspection date), fire sprinklers (no obstructions, functionality), smoke detectors (testing functionality), fire alarms (testing system), fire doors (smooth operation, fire rating), and emergency exit lights (battery backup, illumination). Refer to FMS 7e for detailed maintenance plan requirements.

• Periodic Inspection:

  • Frequency: Defined by hospital policy, but should be at least quarterly or semi-annually depending on the device and risk. High-risk areas or frequently used devices may require more frequent inspections.

  • Responsibility: Designated personnel (e.g., facility management, engineering staff, safety officers) should be responsible for conducting inspections and documenting findings.

  • Documentation: Maintain records of inspections, including dates, findings, corrective actions taken, and responsible personnel. This documentation is crucial for NABH audits and demonstrating ongoing compliance.

• Note: The key takeaway for FMS 1a is proactive installation, strategic placement, and consistent verification of patient safety devices and infrastructure. It's not a one-time activity but an ongoing commitment to patient safety.

FMS 1b: The organisation has facilities for the differently-abled. (C)

(Commitment Level - C: This is a fundamental requirement for accreditation.)

• Intent: This objective element emphasizes accessibility and inclusivity within the hospital environment. It's about ensuring that individuals with disabilities can access and utilize hospital services with dignity and independence.

• Defining "Differently-abled Persons": The standard explicitly mentions three categories:

  • Physically Challenged: Individuals with mobility impairments, requiring wheelchairs, crutches, or other assistive devices. This includes those with paralysis, amputations, cerebral palsy, etc.

  • Visually Impaired: Individuals with partial or complete loss of sight. This encompasses a wide spectrum of visual limitations.

  • Mentally Impaired: Individuals with intellectual disabilities, cognitive impairments, or mental health conditions that may affect their understanding, communication, or ability to navigate the environment.

• Facilities Required (Examples, not exhaustive):

  • Wheelchair Accessible Entrances and Exits:

    • Ramps: Smooth, gradual ramps at all entrances and exits, complying with accessibility guidelines for slope, width, and handrails.

    • Automatic Doors: Consider automatic doors at main entrances and high-traffic areas for ease of access for wheelchair users and individuals with mobility limitations.

    • Wide Doorways: Doorways wide enough to accommodate wheelchairs and assistive devices (minimum width specified in accessibility standards).

• • Accessible Toilets:

    • Spacious Cubicles: Larger toilet cubicles with sufficient space for wheelchair maneuvering.

    • Grab Bars: Strategically placed grab bars near the toilet and washbasin for support and transfer.

    • Raised Toilet Seats: Consider raised toilet seats for easier transfer for some individuals.

    • Accessible Washbasins and Fixtures: Washbasins at appropriate heights, lever-operated taps, and soap dispensers within reach.

• • Accessible Parking:

    • Designated Parking Spaces: Sufficient number of designated parking spaces close to hospital entrances, marked with disability symbols and wider than regular parking spaces.

• • Accessible Elevators and Lifts:

    • Spacious Elevators: Elevators large enough to accommodate wheelchairs and attendants.

    • Braille and Auditory Signals: Elevators equipped with Braille buttons and auditory signals for floor announcements for visually impaired individuals.

    • Lowered Control Panels: Control panels at a height accessible to wheelchair users.

• • Tactile Pathways and Guidance Systems:

    • Tactile Paving: Textured paving surfaces to guide visually impaired individuals along walkways and identify hazards or changes in direction.

    • Auditory Guidance Systems: Consider audio beacons or announcements in key areas to provide directional information for visually impaired individuals.

• • Clear and Accessible Signage:

    • Large Font and Contrast: Signage with large, clear font and high contrast colors for easy readability, especially for visually impaired individuals.

    • Pictorial Symbols: Use of universal symbols alongside text for better understanding across different languages and literacy levels.

    • Tactile Signage (Braille): Consider Braille signage for key areas like restrooms, elevators, and department names.

• • Assistive Listening Devices:

    • Availability in Reception/Information Areas: For individuals with hearing impairments, consider providing assistive listening devices in reception, information desks, and waiting areas to facilitate communication.

• • Considerations for Mentally Impaired:

    • Simple and Uncluttered Environment: Minimize visual clutter and noise to create a calming and less overwhelming environment.

    • Clear and Simple Communication: Staff training on communicating effectively and patiently with individuals with cognitive impairments.

    • Safe and Supervised Waiting Areas: Designated waiting areas that are safe and allow for supervision if needed.

• Adhere to Regulatory Requirements: Hospitals must comply with national and local accessibility standards and regulations for buildings and public spaces. This includes building codes and disability rights legislation.

• Ensure Availability: It's not just about having these facilities on paper; they must be available, functional, and well-maintained for use by individuals with disabilities. Regular inspections and maintenance are necessary to ensure continued accessibility.

• Note: FMS 1b is about creating a truly inclusive hospital environment where everyone, regardless of their abilities, can access healthcare services comfortably and safely.

FMS 1c: Facility inspection rounds to ensure safety are conducted at least once a month. (CO)

(Core Objective Element - CO: Again, a critical requirement for accreditation.)

• Intent: This objective element emphasizes proactive hazard identification and risk mitigation. Regular facility inspection rounds are a crucial tool to identify potential safety and security issues before they lead to incidents or harm.

• Frequency: "At least once a month"

  • Minimum Requirement: This is the minimum frequency stipulated by NABH. Hospitals may choose to conduct inspections more frequently (e.g., weekly or bi-weekly) in high-risk areas or departments.

  • Rationale: Monthly inspections allow for regular monitoring of the facility's condition and timely identification of emerging hazards or maintenance needs. It's a balance between being thorough and being practically feasible for hospital operations.

• Potential Safety Risks - Identify using checklist:

  • Checklist Approach: Using a standardized checklist ensures comprehensiveness and consistency in inspections. The checklist should be tailored to the specific areas of the hospital and cover various aspects of safety.

  • Areas to Cover in Safety Risk Checklist (Examples):

    • Housekeeping and Cleanliness: Cleanliness of floors, walls, surfaces, restrooms; waste management; linen disposal; infection control practices.

    • Tripping Hazards: Uneven flooring, loose carpets/mats, cables/wires lying on the floor, obstacles in walkways, protruding objects.

    • Electrical Safety: Exposed wires, damaged electrical outlets, overloaded circuits, malfunctioning equipment, proper grounding.

    • Fire Safety: Obstruction of fire exits, malfunctioning fire extinguishers, blocked sprinkler heads, improperly stored flammable materials.

    • Mechanical Safety: Malfunctioning equipment, unguarded machinery, improper storage of heavy items.

    • Chemical Safety: Improper storage of chemicals, unlabeled containers, spills, ventilation in chemical storage areas.

    • Ergonomics: Poorly designed workstations, heavy lifting without proper equipment, repetitive tasks leading to strain.

    • General Maintenance: Leaking pipes, broken tiles, damaged furniture, malfunctioning lights, doors not closing properly.

    • Infection Control: Hand hygiene compliance, availability of hand sanitizers, proper segregation and disposal of biomedical waste.

• Potential Security Risk Areas and Restricted Areas - Identify and Monitor:

  • Security Risk Areas: Areas vulnerable to security breaches, theft, unauthorized access, or violence.

    • Examples: Pharmacy, cash counters, medical records room, server rooms, stores, entrances and exits, isolated areas, parking lots.

• • Restricted Areas: Areas with limited access due to safety, confidentiality, or operational reasons.

    • Examples: Operation Theaters (OTs), Intensive Care Units (ICUs), Neonatal Intensive Care Units (NICUs), labor rooms, radiology departments, laboratories, biomedical waste storage areas, equipment rooms.

• • Identification and Monitoring:

    • Physical Security Measures: Access control systems (card readers, biometric access), CCTV surveillance, security personnel deployment, secure locks and doors, perimeter security.

    • Procedural Security Measures: Visitor management protocols, staff identification badges, key control procedures, restricted access policies, security patrols.

    • Monitoring: Regularly check CCTV footage, monitor access logs, conduct security audits, and ensure security personnel are vigilant.

• Plan and Allocate Budget to Upgrade/Replace:

  • Post-Inspection Action: Inspection findings should not just be documented but acted upon.

  • Prioritization: Prioritize identified risks based on severity and potential impact.

  • Budget Allocation: Allocate budget for necessary upgrades, repairs, replacements, and safety improvements. This demonstrates a commitment to maintaining a safe environment.

  • Areas for Upgrade/Replacement (Examples):

    • Key Systems: Fire alarm system, electrical wiring, plumbing system, HVAC system, medical gas pipelines, security systems, nurse call system, elevators/lifts.

    • Buildings: Roof repairs, structural repairs, floor renovations, wall repairs, painting, weatherproofing, accessibility modifications.

    • Components: Damaged furniture, worn-out flooring, broken windows, malfunctioning equipment, outdated safety devices, inadequate lighting.

• Note: FMS 1c is about establishing a systematic process for regularly scanning the hospital environment for hazards and proactively addressing them. It's a cornerstone of preventative safety management.

FMS 1d: Inspection reports of facility rounds are documented, and corrective and preventive measures are undertaken. (C)

(Commitment Level - C: Essential for demonstrating accountability and continuous improvement.)

• Intent: This objective element emphasizes accountability, documentation, and the cycle of continuous improvement in facility safety. It's not enough to just conduct inspections; the findings must be documented, reviewed, and acted upon to prevent recurrence and improve safety proactively.

• Review: Facility inspection reports:

  • Purpose of Review: To analyze inspection findings, identify trends, assess the effectiveness of existing safety measures, and prioritize corrective and preventive actions.

  • Content of Reports: Inspection reports should be comprehensive and include:

    • Date and time of inspection.

    • Area/department inspected.

    • Name of inspector(s).

    • Checklist used (if applicable).

    • Detailed description of identified hazards or non-compliances.

    • Severity level of each hazard (e.g., low, medium, high).

    • Photographic evidence (optional but helpful).

    • Recommendations for corrective actions.

• • Review Frequency: "Once in a month": The safety committee or designated team should review inspection reports at least monthly to ensure timely action.

• Review timeframe: Once in a month. (Already covered above under "Review")

• Staff-in charge: Safety committee:

  • Safety Committee Responsibility: The hospital's safety committee (or a designated equivalent body) is typically responsible for overseeing facility safety, reviewing inspection reports, and ensuring CAPA implementation.

  • Roles of Safety Committee:

    • Setting safety goals and objectives.

    • Developing and reviewing safety policies and procedures.

    • Analyzing incident reports and inspection findings.

    • Recommending corrective and preventive actions.

    • Monitoring CAPA implementation and effectiveness.

    • Promoting safety awareness and training.

• CAPA: Take appropriate action(s).

  • Corrective Action: Actions taken to eliminate or control existing hazards or non-compliances identified during inspections. These are reactive measures to fix immediate problems.

    • Examples: Repairing a broken electrical outlet, removing a tripping hazard, cleaning up a spill, replacing a damaged fire extinguisher, fixing a leaking pipe.

• • Preventive Action: Actions taken to eliminate the root cause of hazards or non-compliances to prevent their recurrence and proactively improve safety. These are proactive measures to prevent future problems.

    • Examples: Implementing a regular cable management system to prevent cables lying on the floor, providing staff training on safe lifting techniques to prevent ergonomic injuries, revising cleaning protocols to improve infection control, conducting risk assessments before introducing new equipment or processes.

• • "Appropriate Action(s)": The actions taken must be relevant, effective, and proportionate to the identified risks. They should address the immediate hazard (corrective) and prevent similar issues from happening again (preventive).

• Document: Maintain evidence of pre and post-corrective actions taken for at least one accreditation cycle.

  • Documentation of CAPA: It's essential to document all corrective and preventive actions taken in response to inspection findings. This documentation serves as evidence of the hospital's commitment to safety and continuous improvement for NABH audits.

  • "Pre and Post-corrective Actions": Document before action (description of the problem, planned action) and after action (description of action taken, date of completion, verification of effectiveness).

  • "At least one accreditation cycle": NABH accreditation cycles are typically 3 years. Therefore, maintain CAPA records for at least 3 years to demonstrate sustained safety efforts over time.

  • Types of Documentation: CAPA logs, action taken reports, meeting minutes of safety committee discussions on CAPA, updated procedures/policies, training records related to CAPA.

• Note: FMS 1d emphasizes the closed-loop system of safety management: Inspect -> Document -> Analyze -> Act (CAPA) -> Monitor -> Repeat. This cycle ensures continuous improvement in facility safety.

FMS 1e: Before construction, renovation and expansion of existing hospital, risk assessment are carried out. (E)

(Excellence Level - E: Demonstrates a higher level of commitment and sophistication in safety management.)

• Intent: This objective element highlights the importance of proactive risk assessment before undertaking any modifications to the hospital building or infrastructure. It's about anticipating potential hazards and disruptions associated with construction, renovation, or expansion activities and implementing measures to mitigate them before they occur.

• Scope: "Before construction, renovation and expansion of existing hospital": This applies to any project that involves physical changes to the hospital building, regardless of the scale (from minor renovations to major expansions).

• Risk Assessment Focus Areas (Examples from slides, but expand):

  • Noise:

    • Risks: Construction noise can disrupt patient rest, sleep, and healing, especially in patient wards and critical care areas. It can also interfere with communication, staff concentration, and sensitive medical procedures.

    • Assessment: Estimate noise levels from construction activities, identify noise-sensitive areas in the hospital, and evaluate the potential impact on patients and staff.

    • Mitigation: Schedule noisy activities during less sensitive hours, use noise barriers or enclosures, provide ear protection to staff in noisy areas, inform patients and staff about potential noise disruptions, and monitor noise levels during construction.

• • Vibration:

    • Risks: Construction vibrations can disturb patients, interfere with sensitive medical equipment (e.g., in labs, radiology), and potentially damage building structures if heavy machinery is used.

    • Assessment: Assess the potential for vibration from construction activities (e.g., demolition, pile driving), identify vibration-sensitive areas and equipment, and evaluate the potential impact.

    • Mitigation: Use vibration-dampening techniques, schedule vibration-generating activities during less sensitive hours, monitor vibration levels, and relocate sensitive equipment if necessary.

• • Infection Control:

    • Risks: Construction activities can generate dust, debris, and airborne particles, increasing the risk of infections, especially for vulnerable patients (immunocompromised, surgical patients). Disruption of existing infection control measures (e.g., ventilation systems, water systems) can also increase infection risks.

    • Assessment: Identify potential sources of infection risk during construction (dust generation, disruption of utilities, movement of materials), assess the vulnerability of patient populations, and evaluate existing infection control protocols.

    • Mitigation: Implement strict dust control measures (e.g., barriers, negative pressure containment, HEPA filtration), maintain proper ventilation and air quality, protect water systems from contamination, ensure proper waste management, implement enhanced cleaning and disinfection protocols, monitor infection rates during construction, and train construction workers on infection control practices.

• Other Potential Risk Areas to Consider in Risk Assessment (Beyond the slides):

  • Air Quality and Ventilation: Dust, fumes, and disruption of ventilation systems.

  • Water Quality and Plumbing: Contamination of water supply, disruption of plumbing services.

  • Electrical Safety: Disruption of electrical services, temporary wiring hazards.

  • Fire Safety: Increased fire risk during construction, obstruction of fire exits, temporary fire protection measures.

  • Patient and Staff Safety during Movement: Safe routing of patients and staff around construction areas, temporary walkways, barriers, signage, and traffic control.

  • Security: Increased security risks during construction, unauthorized access to construction areas, protection of hospital assets.

  • Disruption of Services: Minimize disruption to essential hospital services (OTs, ICUs, labs, pharmacy) during construction phases.

  • Hazardous Materials: Proper handling and disposal of construction waste, including hazardous materials (e.g., asbestos, lead paint).

  • Emergency Preparedness: Update emergency plans to account for construction-related hazards and changes in building layout.

• Note: FMS 1e encourages a holistic and proactive approach to safety during hospital construction and renovation projects. By conducting thorough risk assessments beforehand, hospitals can anticipate and mitigate potential problems, ensuring patient and staff safety remains paramount throughout the project. This also contributes to minimizing disruptions and maintaining operational continuity.

In summary, FMS 1 is about establishing a comprehensive and proactive safety and security system in the hospital. It's not just about individual devices or isolated actions but a systematic approach that integrates all aspects of facility management to create a safe and secure environment for everyone within the hospital.

FMS 2: The Organisation's Environment and Facilities Operate in a Planned Manner and Promotes Environment-Friendly Measures

Standard Overview:

FMS 2 shifts the focus from basic safety and security (FMS 1) to the planned operation and environmental consciousness of the hospital's infrastructure. It emphasizes that a well-managed facility is not only safe but also operates efficiently, sustainably, and in harmony with its environment. This standard ensures that the hospital's physical environment is designed, maintained, and operated in a way that supports quality patient care and minimizes environmental impact.

Why are Planned Operation and Environment-Friendly Measures Important for Hospitals?

• Resource Optimization: Hospitals are significant consumers of resources like water, electricity, and materials. Planned operation and environment-friendly measures lead to efficient resource utilization, reducing operational costs and promoting sustainability.

• Patient Comfort and Healing Environment: Factors like appropriate space, comfortable ambient conditions (temperature, lighting, ventilation), and a visually appealing environment contribute to patient comfort and can positively influence the healing process.

• Infection Control: Proper facility design, maintenance, and environmental controls (water quality, ventilation) are crucial for infection prevention and control. Environment-friendly measures can also include using less toxic cleaning agents and promoting waste reduction, further minimizing infection risks.

• Regulatory Compliance: Hospitals are subject to various environmental regulations and building codes. FMS 2 ensures compliance with these legal requirements, avoiding penalties and demonstrating responsible operation.

• Corporate Social Responsibility: Adopting environment-friendly practices reflects a hospital's commitment to corporate social responsibility and environmental stewardship. This enhances the hospital's reputation and public image.

• Long-term Sustainability: Environment-friendly measures contribute to the long-term sustainability of the hospital by reducing resource consumption, minimizing waste, and promoting a healthier environment for the community.

• NABH Accreditation Requirements: FMS 2 is a crucial standard for NABH accreditation, demonstrating the hospital's commitment to planned operation and environmental responsibility.

Let's examine the Objective Elements of FMS 2 in detail:

FMS 2a: Facilities and space provisions are appropriate to the scope of services. (C)

(Commitment Level - C: A fundamental requirement for accreditation, highlighting the importance of adequate and suitable infrastructure.)

• Intent: This objective element underscores the principle that the hospital's physical infrastructure must be aligned with the services it offers. It's about ensuring that the hospital has adequate and appropriately designed spaces to effectively deliver its intended range of medical services. This is not just about square footage but also about the functionality and suitability of the spaces.

• Key Components:

  • Facilities and Space Provisions: This encompasses all physical spaces within the hospital, including:

    • Patient Care Areas: Wards, patient rooms (general, isolation, special care), ICUs, OTs, labor rooms, procedure rooms, emergency department, outpatient clinics, dialysis units, rehabilitation areas, etc.

    • Diagnostic and Support Services: Radiology department, laboratories, pharmacy, blood bank, CSSD, physiotherapy, dietary services, mortuary, etc.

    • Administrative and Support Areas: Administrative offices, medical records department, staff rooms, conference rooms, training areas, stores, engineering and maintenance workshops, etc.

    • Public Areas: Reception, waiting areas, lobbies, corridors, visitor restrooms, cafeteria, parking, gardens, etc.

• • Appropriate to the Scope of Services: This is the core principle. The adequacy and suitability of facilities and space provisions are judged based on:

    • Range of Services Offered: A hospital offering specialized services (e.g., cardiac surgery, neurosurgery, transplant) will require more specialized and equipped spaces compared to a general hospital.

    • Volume of Patients: High patient volume departments (e.g., emergency, outpatient clinics) will need larger and more efficiently designed spaces to handle patient flow.

    • Complexity of Procedures: Complex procedures (e.g., surgeries, interventional radiology) require specialized rooms with advanced equipment and adequate space for the medical team and equipment.

    • Patient Demographics: The needs of the patient population (e.g., pediatrics, geriatrics, bariatrics) should be considered in space design (e.g., child-friendly spaces, geriatric-friendly design).

    • Future Expansion Plans: Space planning should consider future expansion of services and patient volume to avoid space constraints in the long run.

• Considerations for "Appropriateness":

  • Adequacy of Space: Sufficient square footage for each function, considering patient beds, equipment, staff movement, and storage. Overcrowding can compromise patient safety and staff efficiency.

  • Functional Design: Layout and design of spaces should facilitate efficient workflow, minimize patient and staff movement, and promote safety. Consider adjacencies of related departments, traffic flow, and ergonomic principles.

  • Specialized Requirements: Specific areas like OTs, ICUs, laboratories, and radiology departments have unique design and infrastructure requirements (e.g., air handling, lighting, radiation shielding, infection control measures). These must be met based on the services offered.

  • Accessibility: Spaces must be designed to be accessible to all, including patients, staff, and visitors with disabilities, as per FMS 1b.

  • Ambient Conditions: Adequate ventilation, lighting (natural and artificial), temperature control, and acoustics in all areas to ensure patient comfort and a conducive working environment.

  • Storage: Sufficient and appropriately designed storage spaces for equipment, supplies, medications, medical records, and other materials to maintain organization and prevent clutter.

  • Infection Control Considerations: Design features to minimize infection risks, such as hand hygiene stations, easy-to-clean surfaces, proper ventilation, and segregation of clean and dirty areas.

• Adhere to national/international guidelines:

  • Regulatory Requirements: Hospitals must comply with national and local building codes, healthcare facility design guidelines, and space standards set by regulatory bodies.

  • Examples of Guidelines:

    • National Building Code (NBC): Provides comprehensive guidelines for building design and construction, including space standards, ventilation, fire safety, and accessibility.

    • State-Specific Healthcare Facility Design Guidelines: Many states have specific guidelines for hospital design and space requirements, often based on service types and bed capacities.

    • AERB (Atomic Energy Regulatory Board) Guidelines: Relevant for radiology departments and nuclear medicine facilities, specifying space and shielding requirements for radiation safety.

    • IPHS (Indian Public Health Standards): While primarily for public health facilities, IPHS guidelines can provide benchmarks for space and infrastructure requirements for different levels of healthcare facilities.

    • International Guidelines (e.g., from WHO, CDC, professional bodies): Can offer best practices and recommendations for specific areas like infection control, ICU design, and emergency department layout.

• Infrastructure and equipment shall be upgraded:

  • Dynamic Needs: Hospital services and technologies evolve. Infrastructure and equipment must be upgraded periodically to remain appropriate for the changing scope of services and to incorporate advancements in medical technology and facility management.

  • Planning for Upgrades: Hospitals need to have a plan for periodic assessment of infrastructure and equipment needs and budget for upgrades and replacements. This should be linked to strategic planning and service expansion plans (as mentioned in FMS 4a and 5a).

  • Examples of Upgrades: Expanding patient care areas, renovating OTs with newer technology, upgrading diagnostic equipment, improving ventilation systems, enhancing IT infrastructure, modernizing furniture and fixtures.

• Points to Remember (from Slide 13):

  • Regulatory Requirements: Emphasize compliance with all applicable regulatory requirements and guidelines.

  • Directive of government agencies like AERB guidelines: Highlight specific guidelines relevant to specialized services offered by the hospital.

• Note: FMS 2a is about strategic space planning that ensures the hospital's physical environment effectively supports its clinical services, operational efficiency, and future growth, while adhering to relevant standards and guidelines.

FMS 2b: As-built and updated drawings are maintained as per statutory requirements. (C)

(Commitment Level - C: Essential for facility management, maintenance, and emergency preparedness.)

• Intent: This objective element focuses on the importance of accurate and up-to-date documentation of the hospital's physical infrastructure in the form of "as-built" drawings. These drawings are crucial for effective facility management, maintenance, renovations, and emergency response.

• Key Components:

  • As-built Drawings: These are drawings that accurately represent the final constructed state of the building and its systems. They are created after construction or renovation is completed and reflect any changes made during the actual construction process compared to the original design drawings.

  • Updated Drawings: As the hospital undergoes renovations, expansions, or modifications, the as-built drawings must be updated to reflect these changes. This ensures that the drawings remain current and accurate over time.

  • Maintained as per statutory requirements: Many building codes and regulations mandate the maintenance of as-built drawings for buildings, especially for healthcare facilities. Compliance with these legal requirements is essential.

• Types of Drawings to be Maintained (Examples from Slide 14, but expand):

  • Site Layout:

    • Content: Shows the overall layout of the hospital campus, including building footprints, roads, parking areas, landscaping, utilities (water mains, electrical lines, gas lines), boundaries, and surrounding features.

    • Purpose: Essential for overall campus planning, wayfinding, emergency response, utility maintenance, and future expansion planning.

• • Floor Drawings:

    • Content: Detailed plan views of each floor of the building, showing room layouts, walls, doors, windows, corridors, staircases, elevators, fixtures (sinks, toilets), and room designations (department names, room numbers).

    • Purpose: Crucial for navigation within the building, space planning, furniture layout, maintenance activities, fire safety planning, and emergency evacuation planning.

• • Floor-wise Fire Evacuation Plans:

    • Content: Floor drawings specifically marked with fire exits, escape routes, fire extinguisher locations, fire alarm points, assembly areas, and other fire safety features.

    • Purpose: Essential for fire safety preparedness, staff training, and guiding evacuation during fire emergencies (FMS 7c).

• • Separate Civil, Electrical, Extra Low Voltage (ELV), Plumbing, HVAC, Piped Medical Gas Drawings and IT Network:

    • Civil Drawings: Structural details of the building (foundations, columns, beams, slabs), load-bearing walls, drainage systems, and other structural elements.

    • Electrical Drawings: Layout of electrical wiring, power distribution panels, lighting fixtures, emergency power systems, grounding systems, and electrical equipment locations.

    • Extra Low Voltage (ELV) Drawings: Layout of low voltage systems like fire alarm systems, CCTV systems, access control systems, nurse call systems, public address systems, and communication networks.

    • Plumbing Drawings: Layout of water supply pipes (potable, non-potable), drainage pipes (sewage, rainwater), fixtures (sinks, toilets, showers), water heaters, and specialized plumbing systems (e.g., for dialysis units).

    • HVAC (Heating, Ventilation, and Air Conditioning) Drawings: Layout of air ducts, air handling units, chillers, fans, filters, temperature control systems, and ventilation zones.

    • Piped Medical Gas Drawings: Layout of medical gas pipelines (oxygen, nitrous oxide, compressed air, vacuum), gas outlets, manifold rooms, alarm systems, and safety features of the medical gas system (FMS 6c).

    • IT Network Drawings: Layout of data cables, network switches, servers, communication rooms, and IT infrastructure.

    • Purpose: These detailed drawings are essential for maintenance, repairs, troubleshooting, renovations, and upgrades of each specific system. They allow maintenance staff and contractors to understand the system layout, locate components, and perform work safely and effectively.

• Designated Person:

  • Responsibility: The hospital must designate a person or department (e.g., facility manager, engineering department) who is responsible for maintaining and updating the as-built drawings.

  • Expertise: This designated person should have the necessary expertise in building plans, engineering drawings, and record-keeping to manage and update these crucial documents effectively.

• Maintain as-built and updated:

  • Regular Updates: Drawings should be updated immediately after any modifications, renovations, or additions to the building or its systems. Do not wait for long periods to update; timely updates are crucial.

  • Version Control: Implement a system for version control to track changes to the drawings and ensure that the latest version is always readily available.

  • Accessibility: Ensure that the as-built drawings are easily accessible to authorized personnel (facility management, engineering staff, safety officers, contractors, emergency responders) in both hard copy and electronic formats. Consider digital storage and retrieval systems for easier access and management.

  • Storage: Store both hard copies and electronic copies securely to protect against loss, damage, or unauthorized access.

• Note: FMS 2b emphasizes the importance of accurate and current building documentation as a fundamental tool for effective facility management, safety, and operational efficiency. It's not just about having drawings; it's about actively maintaining them as a living record of the hospital's infrastructure.

FMS 2c: There are internal and external sign postings in the organisation in a manner understood by the patient, families and community. (CO)

(Core Objective Element - CO: Crucial for patient experience, safety, and accessibility.)

• Intent: This objective element focuses on effective communication and wayfinding within and around the hospital premises through clear and understandable sign postings. Signage should be designed to cater to the diverse needs of patients, families, visitors, and the wider community, considering language, literacy levels, and visual impairments.

• Key Components:

  • Internal Sign Postings: Signage within the hospital building to guide people to different departments, services, facilities, and exits.

  • External Sign Postings: Signage outside the hospital building to direct people to the hospital campus, entrances, parking areas, specific buildings, and emergency entrances from the surrounding area.

  • In a manner understood by the patient, families and community: This is the key criterion. Signage effectiveness is judged by its ability to be easily understood by a diverse audience, including:

    • Patients: Who may be anxious, unwell, or unfamiliar with the hospital environment.

    • Families and Visitors: Who may be from different linguistic and cultural backgrounds.

    • Community: Including local residents, emergency responders, and delivery personnel.

• Considerations for "Manner Understood":

  • Language:

    • Bilingual Signage: In areas with diverse linguistic populations, signage should be bilingual, using both the local language and a widely understood language like English.

    • Pictorial Symbols: Use of universal symbols and pictograms alongside text to convey information visually, transcending language barriers and aiding those with lower literacy levels.

• • Clarity and Visibility:

    • Large Font Size: Use sufficiently large font sizes for easy readability, especially for elderly individuals and those with visual impairments.

    • High Contrast: Employ high contrast color combinations (e.g., dark text on a light background) for better visual clarity.

    • Proper Lighting: Ensure signage is well-lit, especially in dimly lit areas, corridors, and at night. Use internally illuminated signs or external lighting to enhance visibility.

    • Unobstructed Placement: Position signs in clear sight lines, avoiding obstructions from furniture, equipment, or landscaping.

• • Content and Information:

    • Clear and Concise Language: Use simple, direct language, avoiding jargon or technical terms that may not be understood by the general public.

    • Accurate Directions: Ensure directional signs provide accurate and unambiguous directions to destinations.

    • Comprehensive Coverage: Signage should cover all essential areas and services within and around the hospital, including:

      • Departments (e.g., Cardiology, Oncology, Emergency, Radiology, Pharmacy).

      • Services (e.g., Registration, Information Desk, Billing, Cafeteria, Restrooms, Waiting Areas).

      • Facilities (e.g., Elevators, Stairs, Exits, Parking, Emergency Entrance, Ambulance Bay).

      • Safety Information (e.g., Fire Exits, Emergency Assembly Points, Warning Signs for Hazards).

• • Accessibility for Visually Impaired:

    • Tactile Signage (Braille): Consider Braille signage for key areas like restrooms, elevators, and department names for visually impaired individuals.

    • Auditory Signage: In some critical areas (e.g., entrances, information desks), consider auditory announcements or guidance systems for visually impaired individuals.

• • Consistency and Standardization:

    • Uniform Design: Maintain a consistent design style for all signage throughout the hospital (font, colors, symbols) to create a cohesive and recognizable system.

    • Standard Symbols: Use internationally recognized symbols and pictograms where appropriate (e.g., restroom symbols, accessibility symbols, emergency exit symbols).

• • In consonance with statutory requirements:

    • Building Codes and Accessibility Standards: Signage must comply with relevant building codes and accessibility standards, which may specify requirements for font size, contrast, placement, and inclusion of Braille.

    • Fire Safety Regulations: Fire exit signage must meet specific regulations regarding size, illumination, and placement to ensure clear guidance during fire emergencies.

• Note (from Slide 15): "Manner implies language and/or pictorial." This highlights that effective signage is not just about text but also about using visual aids (pictorials, symbols) to enhance understanding, especially for diverse populations.

• Note: FMS 2c is about creating a user-friendly and accessible wayfinding system through well-designed and effectively implemented signage. It directly impacts patient experience, reduces anxiety and confusion, improves efficiency of movement within the hospital, and enhances safety, particularly in emergencies.

FMS 2d: Potable water and electricity are available round the clock. (CO)

(Core Objective Element - CO: Absolutely critical for basic hospital function and patient safety.)

• Intent: This objective element addresses the fundamental requirement of continuous and reliable access to essential utilities: potable water and electricity. Hospitals cannot function effectively or safely without these utilities, making their uninterrupted availability paramount.

• Key Components:

  • Potable Water: Water that is safe for drinking and human consumption, meeting established quality standards. It's essential for drinking, hand hygiene, sanitation, food preparation, medical procedures, and various hospital operations.

  • Electricity: Essential for powering medical equipment, lighting, ventilation, HVAC systems, IT infrastructure, communication systems, and all other electrical devices in the hospital.

  • Available round the clock: This signifies 24/7, 365 days a year availability. Interruptions in water or electricity supply can have severe consequences for patient care and hospital operations.

• Supply: Adequate potable water and electricity round the clock:

  • Adequate Supply: The hospital must have sufficient capacity for both water and electricity to meet its operational needs, considering peak demand periods, patient load, service volume, and future expansion plans.

  • Reliable Supply: The supply should be consistent and reliable, minimizing the risk of interruptions or fluctuations. This often involves having robust infrastructure, backup systems, and preventative maintenance programs.

  • Round the Clock Availability: Continuous supply without planned or unplanned interruptions is the goal. Hospitals must have measures in place to address any potential disruptions promptly and effectively.

• Monitor: Quality of potable water and document.

  • Water Quality Monitoring: Regular monitoring of potable water quality is crucial to ensure it remains safe for consumption and meets established standards. This involves testing for both chemical and microbiological parameters.

  • Quality Parameters: Typical water quality parameters monitored in hospitals include:

    • Microbiological: Total coliforms, fecal coliforms, E. coli, total plate count, and other relevant pathogens.

    • Bio-chemical: pH, turbidity, hardness, alkalinity, chlorides, sulfates, nitrates, fluorides, heavy metals (lead, arsenic, mercury, etc.), residual chlorine, and other chemical contaminants.

    • Endotoxin Levels (for dialysis units): Specifically for dialysis units using RO plants, endotoxin levels must be monitored stringently as per guidelines.

• • Testing Frequency (from Slide 16):

    • Bio-chemical testing: "Once in three months" - Less frequent as chemical parameters generally change slower.

    • Microbiological analysis: "Once in a month" - More frequent due to the potential for rapid microbial contamination.

    • Endotoxin levels (RO plant of dialysis unit): "Every month" - Critical for dialysis water quality and patient safety.

• • Test: Collect water at the user end (tap) and perform:

    • User End (Tap) Sampling: Water samples should be collected from taps or outlets that are actually used for patient care and consumption to reflect the quality of water delivered to end-users.

    • Accredited Laboratories: Water testing should be conducted by accredited laboratories using validated methods to ensure accuracy and reliability of results.

• • Document:

    • Record Keeping: Maintain detailed records of all water quality testing, including dates of sampling, test results, laboratory reports, any deviations from standards, and corrective actions taken.

    • Trend Analysis: Regularly review water quality data to identify trends, detect any recurring issues, and proactively address potential problems.

    • Compliance Documentation: Water quality documentation serves as evidence of compliance with NABH standards and relevant water quality regulations during audits.

• In case of RO plant of the dialysis unit, collect water from inlet port of dialysis machine and test:

  • Critical Water Quality for Dialysis: Water used for dialysis must be of extremely high purity to prevent adverse patient reactions and ensure effective dialysis treatment. RO (Reverse Osmosis) plants are commonly used to purify dialysis water.

  • Inlet Port Sampling: Sampling water from the inlet port of the dialysis machine ensures that the water being used in the dialysis process is tested, not just the water leaving the RO plant. This accounts for any potential contamination in the distribution system between the RO plant and the dialysis machines.

  • Endotoxin Levels: Endotoxins are bacterial toxins that can cause severe reactions in dialysis patients. Stringent monitoring of endotoxin levels in dialysis water is essential.

  • "To ensure that the levels conform to national and/or international guidelines." - Dialysis water quality must meet stringent national and international standards (e.g., AAMI, ISO standards) for endotoxins and other contaminants.

• Note (from Slide 16): "For water quality, refer to current version of IS 10500."

  • IS 10500: Indian Standard 10500 is the standard for "Drinking Water Specification" set by the Bureau of Indian Standards (BIS). Hospitals should refer to the current version of IS 10500 for the latest water quality parameters and limits for potable water in India.

  • Compliance with IS 10500: While NABH does not mandate strict adherence to IS 10500 (unless it's a regulatory requirement), referring to it provides a benchmark for acceptable potable water quality in hospitals. Hospitals may also need to comply with local or state water quality regulations.

• Note: FMS 2d is about ensuring uninterrupted access to safe and high-quality potable water and electricity as fundamental utilities for hospital operations and patient care. It emphasizes not just supply but also continuous monitoring and documentation of water quality to maintain safety standards.

FMS 2e: Alternate sources for electricity and water are provided as a backup for any failure/shortage. (C)

(Commitment Level - C: Crucial for business continuity and patient safety during utility failures.)

• Intent: This objective element addresses the critical need for backup systems to ensure continued availability of electricity and water in case of failures or shortages in the primary supply. Hospitals cannot afford to be without these utilities, even for short durations, as it can directly impact patient safety and critical operations.

• Key Components:

  • Alternate Sources: Backup systems or resources that can provide electricity and water when the primary supply is disrupted.

  • Electricity and Water: Both utilities are essential and require alternate sources.

  • Backup for any failure/shortage: Alternate sources should be designed to kick in during any type of failure in the primary supply, whether it's a complete outage, voltage fluctuations, water supply interruptions, or reduced water pressure.

• Water - Considerations and Examples:

  • Sufficient water supply to meet organisation's requirements: The alternate water source must be capable of providing a sufficient volume of water to meet the essential needs of the hospital during a primary water supply disruption. This includes drinking water, sanitation, and critical medical uses.

  • To estimate water requirement, refer National Building Code: The National Building Code (NBC) provides guidelines for estimating water demand for various types of buildings, including hospitals, based on bed capacity, services offered, and occupancy levels. Hospitals can use these guidelines to estimate their water needs for alternate source planning.

  • Alternate sources for water. For example: Bore/open well, supply through water tanker and extra storage tanks:

    • Bore/open well: If geologically feasible, having a bore well or open well within the hospital premises can provide an independent source of groundwater. Water quality must be tested and treated if necessary before use.

    • Supply through water tanker: Arranging for water supply through water tankers from external sources is a common backup option, especially in areas with unreliable municipal water supply. Contracts with reliable tanker suppliers and designated storage areas are essential.

    • Extra storage tanks: Increasing the capacity of on-site water storage tanks (overhead tanks, underground tanks) can provide a buffer supply for a limited duration during water supply interruptions. Tank capacity should be calculated based on estimated water demand and potential outage duration.

    • Other Potential Alternate Sources: Recycled water (after appropriate treatment for non-potable uses), rainwater harvesting (if feasible and reliable).

• • Identify and mitigate risk of critical areas/services, when water is contaminated or interrupted:

    • Critical Areas/Services: Identify areas and services that are most vulnerable to water supply disruptions, such as OTs, ICUs, dialysis units, CSSD, laboratories, and patient wards.

    • Risk Mitigation: Develop specific contingency plans for these critical areas in case of water contamination or interruption. This might include:

      • Prioritizing water supply to critical areas from alternate sources.

      • Having bottled water readily available for drinking and essential medical uses in critical areas.

      • Developing protocols for temporary suspension or modification of non-essential services to conserve water.

      • Having alternative sanitation options (e.g., chemical toilets) if necessary.

• Electricity - Considerations and Examples:

  • Appropriate electric load to meet organisation's and regulatory requirements: The alternate electricity source must be capable of providing sufficient power to meet the essential electrical load of the hospital during a primary power outage. This load includes critical medical equipment, lighting, ventilation, life support systems, communication systems, and security systems. Regulatory requirements (e.g., for emergency power in hospitals) must be met.

  • Alternate sources for electricity. For example: DG sets, solar energy and UPS:

    • DG sets (Diesel Generator sets): The most common and reliable alternate power source for hospitals. DG sets should be sized to meet the essential electrical load, regularly tested and maintained, and have sufficient fuel storage for extended outages.

    • Solar energy: Solar photovoltaic (PV) systems can provide a renewable backup power source, especially during daytime outages. Battery storage can enhance their reliability for nighttime use. Solar energy can be a supplementary source or part of a hybrid system.

    • UPS (Uninterruptible Power Supply): UPS systems provide instantaneous backup power for short durations (minutes to hours) to critical equipment during brief power interruptions or switchover to DG sets. UPS systems are essential for protecting sensitive medical equipment from voltage fluctuations and power surges.

    • Other Potential Alternate Sources: Gas generators, micro-turbines, connection to a reliable secondary grid.

• • When using DG sets or UPS, consider capacity and longevity of power availability based on usage:

    • Capacity: Ensure DG sets and UPS systems are adequately sized to handle the essential electrical load. Consider future expansion needs when sizing backup systems.

    • Longevity of Power Availability:

      • DG sets: Fuel storage capacity is crucial for DG set longevity. Calculate fuel storage based on estimated outage duration and fuel consumption rate. Contracts for fuel replenishment during prolonged outages may be needed.

      • UPS: UPS battery backup time is limited. UPS systems are primarily for bridging the gap until DG sets come online or for short outages. Battery life and replacement schedules must be considered.

• • Identify and mitigate risk of critical areas/services during electrical supply failure:

    • Critical Areas/Services: Identify areas and services most vulnerable to power outages, such as OTs, ICUs, emergency department, life support systems, critical diagnostic equipment, and communication systems.

    • Risk Mitigation: Develop specific contingency plans for these areas during power failures. This might include:

      • Prioritizing power supply to critical areas from alternate sources (DG sets, UPS).

      • Having battery-operated emergency lighting and portable power sources readily available in critical areas.

      • Developing protocols for temporary suspension or modification of non-essential services to conserve power.

      • Regular drills and staff training on emergency power procedures.

• Note: FMS 2e is about building resilience into the hospital's utility infrastructure. Having reliable alternate sources for water and electricity is not just a best practice; it's a necessity for ensuring patient safety, maintaining critical services, and ensuring business continuity during unexpected utility disruptions.

FMS 2f: The organisation tests the functioning of these alternate sources at a predefined frequency. (C)

(Commitment Level - C: Essential to ensure alternate sources are functional when needed.)

• Intent: This objective element emphasizes that simply having alternate sources for electricity and water is not sufficient. To be truly effective, these backup systems must be regularly tested to ensure they are functional and will perform as intended when needed. Testing verifies their reliability and identifies any maintenance needs or malfunctions.

• Key Components:

  • Alternate Sources: Specifically refers to the alternate sources for water and electricity established as per FMS 2e (DG sets, UPS, bore wells, water tankers, etc.).

  • Functioning of these alternate sources: Testing should verify that the alternate sources can start up reliably, provide the required output (power or water flow), and operate for a reasonable duration.

  • Predefined frequency: The frequency of testing should be established based on factors like the type of alternate source, its criticality, manufacturer's recommendations, regulatory requirements, and risk assessment.

• Testing Process (General Steps):

  • Collect water from the source (for water alternate sources): If testing a bore well or water storage tank, collect water samples for quality testing before and after testing the system's operation.

  • Test its functioning: Conduct operational tests to verify the performance of the alternate source.

    • For DG sets: Start the DG set, monitor voltage, frequency, and output power, check for any malfunctions or alarms, and run it for a specified duration (e.g., 30 minutes to 1 hour) under load (simulated or actual essential load).

    • For UPS systems: Simulate a power outage to test automatic switchover to battery backup, verify battery backup time, and check for any alarms.

    • For bore wells/water tanks: Start the pump system, measure water flow rate and pressure, check for leaks or malfunctions, and run the system for a specified duration.

    • Document the test results: Record all test parameters, observations, any malfunctions or deviations from expected performance, and corrective actions taken.

• Points to Remember (from Slide 18):

  • Testing alternate source of water: Specific focus on water alternate sources.

  • "Is it used due to shortfall? Test on acceptance and at pre-defined frequency." - If the alternate water source is regularly used to supplement the primary supply due to water shortage, then testing should be done:

    • On acceptance: When the alternate source is initially installed or commissioned, perform thorough acceptance testing to verify its performance and water quality.

    • At pre-defined frequency: Establish a regular testing frequency (e.g., monthly, quarterly) to monitor its continued functionality and water quality, even when in regular use.

  • "Is it used only as an emergency measure? Test on acceptance." - If the alternate water source is intended only for emergency backup and not for routine use, then:

    • Test on acceptance: Thorough acceptance testing upon installation is crucial to ensure it will function when needed in an emergency.

    • Periodic testing (less frequent): Even if not used regularly, periodic testing (e.g., semi-annually or annually) is still recommended to verify its continued functionality and address any maintenance needs that may arise over time due to inactivity.

• Predefined Frequency:

  • Factors to consider when defining frequency:

    • Type of alternate source: DG sets may require more frequent testing than passive water storage tanks.

    • Criticality: Alternate sources for critical areas (OTs, ICUs) may require more frequent testing.

    • Manufacturer's recommendations: Follow manufacturer's guidelines for testing and maintenance.

    • Regulatory requirements: Some regulations may specify testing frequencies for emergency power systems or water backup systems in healthcare facilities.

    • Risk assessment: Assess the risk of utility outages and the potential impact on patient care to determine appropriate testing frequency.

• • Examples of frequencies:

    • DG sets: Monthly or quarterly functional testing under load, annual comprehensive maintenance and testing.

    • UPS systems: Monthly self-tests, quarterly functional tests with simulated power outage, annual battery inspection and testing.

    • Bore wells/water tanks: Annual pump system testing, water quality testing at predefined intervals (as per FMS 2d).

• Note: FMS 2f is about verifying the reliability of the hospital's backup utility systems through regular testing and documentation. This proactive approach ensures that these critical systems will function effectively when they are needed most, safeguarding patient safety and hospital operations during utility emergencies.

In summary, FMS 2 promotes a holistic approach to facility management that goes beyond basic safety to encompass planned operation and environmental responsibility. By ensuring appropriate facilities, maintaining accurate documentation, providing clear signage, and guaranteeing continuous access to essential utilities with reliable backup systems, FMS 2 contributes to a more efficient, sustainable, and patient-centric hospital environment.

FMS 3: The Organisation's Environment and Facilities Operate to Ensure the Safety of Patients, Their Families, Staff and Visitors

Standard Overview:

FMS 3 builds upon the foundational safety and security of FMS 1 and the planned operation of FMS 2. It specifically focuses on ensuring that the hospital's environment and facilities are actively managed to safeguard the well-being of all individuals within the hospital premises: patients, their families, staff, and visitors. This standard is about creating a culture of safety that is not just reactive but proactively addresses potential hazards and promotes a secure and protected environment for everyone.

Why is Ensuring Safety for Everyone Paramount in a Hospital Setting?

• Ethical Responsibility: Hospitals have a fundamental ethical obligation to protect the health and safety of all individuals who enter their premises, especially vulnerable patients seeking care.

• Legal Compliance: Hospitals are subject to various laws and regulations related to safety, security, and workplace health. FMS 3 helps ensure compliance with these legal requirements, minimizing legal liabilities and penalties.

• Reputation and Trust: A hospital with a strong safety record builds trust with patients, families, staff, and the community. A safe environment enhances the hospital's reputation and attracts patients and talented staff.

• Patient Experience and Satisfaction: Feeling safe and secure contributes significantly to a positive patient experience. When patients and families feel protected, they are more likely to be satisfied with the care provided.

• Staff Well-being and Productivity: A safe working environment protects staff from occupational hazards, violence, and security threats. This improves staff morale, reduces absenteeism, and enhances productivity, leading to better patient care.

• Operational Efficiency: Proactive safety measures prevent accidents, injuries, and security incidents, minimizing disruptions to hospital operations, reducing costs associated with incidents (e.g., compensation, investigations), and improving overall efficiency.

• NABH Accreditation Requirements: FMS 3 is a core standard for NABH accreditation, demonstrating the hospital's commitment to comprehensive safety for all stakeholders.

Let's delve into the Objective Elements of FMS 3 in detail:

FMS 3a: Operational planning identifies areas which need to have extra security and describes access to different areas in the hospital by staff, patients, and visitors. (C)*

(Commitment Level - C: The asterisk denotes that this Objective Element requires mandatory system documentation. This means a Security Manual is essential.)*

• Intent: This objective element emphasizes the importance of proactive security planning within the hospital. It's about systematically identifying areas that require enhanced security measures and establishing clear guidelines for access control for different categories of people (staff, patients, visitors) to various parts of the hospital. This planning should be documented in a Security Manual.

• Key Components:

  • Operational Planning: This refers to a documented and systematic approach to security management within the hospital. It's not ad-hoc security but a well-thought-out strategy.

  • Identifies areas which need to have extra security: Not all areas of a hospital require the same level of security. Operational planning must identify areas that are particularly vulnerable to security risks and require enhanced protection.

  • Describes access to different areas in the hospital by staff, patients, and visitors: Access control is a key aspect of security. The plan must clearly define who is authorized to access which areas and under what conditions. This needs to be differentiated for staff, patients, and visitors, as their access needs and authorizations will vary.

  • Security Manual: The operational planning and access control measures must be documented in a formal Security Manual. This manual serves as a reference document for staff, security personnel, and auditors.

• Security Manual - Key Elements:

  • People - Identify various categories of people. For example: Staff, patients and visitors:

    • Categorization of People: The security manual should clearly define different categories of people who access the hospital, recognizing their varying security needs and access privileges. Examples include:

      • Staff: Doctors, nurses, paramedics, administrative staff, support staff, security personnel, maintenance staff, contract workers, students, volunteers. Further sub-categorization within staff (e.g., by department, role) may be necessary for access control.

      • Patients: Inpatients, outpatients, day care patients, emergency patients, visitors of patients.

      • Visitors: Family members, friends, vendors, contractors, delivery personnel, pharmaceutical representatives, government officials, auditors, general public.

• • • Risk Assessment for Each Category: Consider the potential security risks associated with each category (e.g., unauthorized access to restricted areas, potential for theft or violence, vulnerability to security threats).

• • Define access to different areas as per operational security plan. For example: OT, ICU(s), NICU, labour room and ER:

    • Area Classification based on Security Risk: Categorize different areas of the hospital based on their security sensitivity and access requirements. Examples:

      • High Security/Restricted Access Areas: Operation Theaters (OTs), Intensive Care Units (ICUs), Neonatal Intensive Care Units (NICUs), labor rooms, emergency rooms (ER - certain zones), pharmacy, blood bank, medical records room, server rooms, cash counters, stores, hazardous material storage areas, research labs, VIP patient areas. Access should be strictly controlled and limited to authorized personnel only.

      • Medium Security Areas: Patient wards, diagnostic departments (radiology, laboratories), outpatient clinics, administrative areas. Access controlled but less restrictive than high-security areas.

      • Low Security/Public Access Areas: Reception, waiting areas, lobbies, corridors, cafeteria, general visitor restrooms, parking areas, gardens. Open access, but security monitoring still needed.

• • • Access Control Measures for Each Area Category: Define specific access control measures for each category of area:

      • Physical Access Control: Card readers, biometric access, keypads, security personnel at entrances, security doors, turnstiles, locks, physical barriers.

      • Procedural Access Control: Visitor registration, identification badges for staff and visitors, escort procedures, key control procedures, restricted access policies, security patrols, CCTV surveillance.

      • Access Authorization Matrix: Develop a matrix that clearly maps out which categories of people are authorized to access which areas and under what conditions (e.g., staff badges for staff areas, visitor passes for visitor areas, patient wristbands for patient areas, special access permissions for contractors).

• • Areas - Identify vulnerable areas in the hospital. For example: Dark areas and entrances to critical areas:

    • Vulnerable Area Identification: Conduct a security risk assessment to identify areas within and around the hospital that are particularly vulnerable to security threats. Examples:

      • Dark Areas: Poorly lit corridors, parking lots, isolated areas, stairwells, back entrances, storage rooms, areas with limited visibility, especially at night or during power outages. These areas can be exploited for unauthorized access, theft, or assault.

      • Entrances to Critical Areas: Uncontrolled or poorly secured entrances to high-security areas (OTs, ICUs, pharmacy, etc.).

      • Perimeter Security Weaknesses: Unsecured fences, gaps in perimeter walls, unguarded entrances to the hospital campus.

      • Cash Handling Areas: Cash counters, billing departments, finance offices, areas where cash is stored or transported.

      • Data and Server Rooms: Areas housing sensitive patient data, IT infrastructure, and critical servers.

      • Pharmacy and Stores: Areas containing valuable medications, supplies, and equipment.

      • Emergency Department: Often high-stress, crowded, and potentially volatile environment.

      • Areas with High Patient Volume: Waiting areas, outpatient clinics, reception areas, where crowd management and security monitoring are important.

• • Provide appropriate security. For example: CCTV coverage:

    • Security Measures for Vulnerable Areas: Implement enhanced security measures specifically targeted at the identified vulnerable areas. Examples:

      • Enhanced Lighting: Improve lighting in dark areas to deter crime and enhance visibility for security personnel and CCTV surveillance.

      • CCTV Coverage: Strategic placement of CCTV cameras in vulnerable areas and entrances to critical areas for surveillance and recording. Ensure adequate coverage, clear image quality, and proper recording and storage of footage.

      • Increased Security Patrols: Deploy security personnel to patrol vulnerable areas more frequently, especially during high-risk hours (night, weekends).

      • Access Control Enhancements: Strengthen access control measures at entrances to critical areas (card readers, biometric access, security guards).

      • Physical Security Upgrades: Improve perimeter security (fencing, gates, lighting), install security doors and locks, and enhance physical barriers.

      • Alarm Systems: Install intrusion detection alarms in vulnerable areas and link them to the security control room for rapid response.

      • Emergency Call Boxes/Panic Buttons: Install emergency call boxes or panic buttons in vulnerable areas for staff to quickly summon security assistance in emergencies.

• Note: FMS 3a is about moving from reactive security to proactive security planning. Having a well-documented Security Manual that addresses access control, vulnerable areas, and appropriate security measures is a fundamental step towards creating a safer hospital environment for everyone.

FMS 3b: Patient safety aspects in terms of structural safety of hospitals especially of critical areas are considered while planning, design and construction of new hospitals and re-planning, assessment and retrofitting of existing hospitals. (E)

(Excellence Level - E: Demonstrates a high level of commitment to patient safety and structural integrity, going beyond basic compliance.)

• Intent: This objective element elevates structural safety to a critical patient safety concern, especially in hospitals located in seismically active zones or regions prone to other structural hazards. It emphasizes that structural safety must be a primary consideration from the very beginning of hospital projects – from planning and design to construction and even in the re-planning and retrofitting of existing facilities.

• Key Components:

  • Patient safety aspects in terms of structural safety: Focuses on how structural design and construction directly impact patient safety. Structural failures (e.g., building collapse, damage to critical infrastructure during earthquakes or other events) can lead to mass casualties, disruption of essential services, and hinder emergency response.

  • Especially of critical areas: Prioritizes structural safety in critical areas of the hospital, where structural failure would have the most severe consequences for patient care and safety. Examples:

    • Operation Theaters (OTs): Structural integrity is crucial for maintaining sterile environments and ensuring continued operation during and after structural events.

    • Intensive Care Units (ICUs): Structural failure in ICUs would directly endanger critically ill patients relying on life support systems.

    • Emergency Department (ER): ER needs to remain structurally sound and operational to receive and treat casualties during emergencies.

    • Radiology and Diagnostic Departments: Structural integrity is needed to protect sensitive and expensive diagnostic equipment and ensure continued diagnostic services.

    • Pharmacy and Blood Bank: Structural safety is vital to safeguard essential medications and blood supplies.

    • Utility Rooms and Essential Infrastructure: Structural integrity of rooms housing generators, water tanks, medical gas systems, and other essential infrastructure is critical for maintaining hospital functionality.

• • Considered while planning, design and construction of new hospitals and re-planning, assessment and retrofitting of existing hospitals: This applies to all phases of hospital projects:

    • Planning Phase: Site selection, preliminary structural design concepts, risk assessments for structural hazards.

    • Design Phase: Detailed structural design, incorporating relevant building codes, seismic codes, and safety standards.

    • Construction Phase: Adherence to design specifications, quality control during construction, structural integrity testing and certification.

    • Re-planning and Assessment of Existing Hospitals: Regular structural assessments of existing buildings, especially older ones or those in high-risk areas.

    • Retrofitting of Existing Hospitals: Strengthening or upgrading the structural elements of existing hospitals to improve their resistance to structural hazards (e.g., seismic retrofitting).

• Follow latest version of Indian Seismic Code IS: 1893 (Part 1).

  • Indian Seismic Code IS: 1893 (Part 1): This is the primary Indian standard for earthquake-resistant design of structures. Part 1 specifically deals with general provisions and buildings.

  • Latest Version: Hospitals must ensure they are using the latest version of IS 1893 (Part 1) as seismic codes are periodically updated based on new research and learnings from past earthquakes. Compliance with the current code is crucial for ensuring adequate seismic resistance.

  • Seismic Design Principles: IS 1893 (Part 1) outlines principles and methodologies for designing buildings to withstand earthquake forces, including:

    • Seismic zoning and hazard assessment.

    • Design spectrum for different soil types and seismic zones.

    • Structural systems and materials suitable for earthquake resistance.

    • Analysis and design procedures for seismic loads.

    • Detailing requirements for earthquake-resistant construction.

• Make provisions for structural and non-structural elements.

  • Structural Elements: Load-bearing components of the building that provide structural support and stability, such as:

    • Foundations, columns, beams, slabs, shear walls, bracing systems.

    • These elements must be designed and constructed to withstand earthquake forces and other structural loads as per IS 1893 and other relevant codes.

• • Non-structural Elements: Components of the building that are not part of the primary structural system but can still pose safety hazards during earthquakes or structural events if not properly designed and secured. Examples:

    • Architectural Elements: Cladding, facades, partitions, ceilings, parapets, chimneys, signage.

    • Mechanical, Electrical, and Plumbing (MEP) Systems: HVAC equipment, piping, ductwork, electrical panels, lighting fixtures, sprinklers, medical gas systems, elevators, escalators.

    • Medical Equipment and Furniture: Heavy medical equipment (MRI, CT scanners), large furniture, storage racks.

    • Importance of Non-structural Safety: Damage to non-structural elements can cause injuries, block escape routes, disrupt essential services, and hinder post-earthquake recovery.

    • Non-structural Mitigation Measures:

      • Anchoring and Bracing: Secure non-structural elements to the building structure using appropriate anchors, braces, and restraints to prevent overturning, sliding, or falling during earthquakes.

      • Flexible Connections: Use flexible connections for MEP systems to accommodate building movement without causing damage or ruptures.

      • Seismic Restraints for Equipment: Install seismic restraints for heavy medical equipment and furniture to prevent them from toppling or shifting during earthquakes.

      • Proper Design and Detailing: Design non-structural elements to be inherently more resilient to seismic forces (e.g., lightweight materials, flexible cladding systems).

• Points to Remember (from Slide 21) - Reference documents:

  • National Disaster Management guidelines: NDMA guidelines provide a broader framework for disaster preparedness and mitigation in India, including specific guidance on earthquake risk reduction in healthcare facilities.

  • Hospital safety 2016: Likely refers to a specific publication or guideline document on hospital safety, potentially related to disaster preparedness or structural safety. (Need to verify specific document for training context).

  • WHO guide on hospital safety index: guide for evaluators 2nd edn, 2015: The WHO Hospital Safety Index is a tool for assessing and improving the safety and disaster resilience of hospitals. The guide provides a framework for evaluating various aspects of hospital safety, including structural safety, non-structural safety, and emergency preparedness.

• Note: FMS 3b represents a shift towards resilient hospital design and construction. By proactively addressing structural and non-structural safety from the planning stage, hospitals can significantly enhance their ability to withstand structural hazards, protect patients and staff, and maintain essential services during and after such events. This is particularly critical for hospitals in earthquake-prone regions but is a best practice for all hospitals to ensure long-term safety and operational continuity.

FMS 3c: The organisation conducts electrical safety audits for the facility. (C)

(Commitment Level - C: A fundamental safety practice to prevent electrical hazards and fires.)

• Intent: This objective element emphasizes the importance of regular and systematic electrical safety audits to identify and mitigate electrical hazards within the hospital facility. Electrical hazards are a significant cause of fires and injuries in healthcare settings, and proactive audits are essential for prevention.

• Key Components:

  • Electrical safety audits: Systematic inspections and assessments of the hospital's electrical systems and installations to identify potential safety hazards, non-compliances, and areas for improvement.

  • For the facility: Audits should cover all areas of the hospital, including patient care areas, administrative areas, utility rooms, and external electrical installations.

  • Conducts: Implies that the hospital must actively perform electrical safety audits, not just have a policy but implement it in practice.

  • Frequency: While the standard doesn't specify frequency directly, the "When should the audit be done?" section on Slide 22 indicates "At least once a year."

• What is the intent of electrical safety audits? (from Slide 22):

  • To minimise electrical risks to persons and property: The primary goal is to reduce the risk of electrical shocks, electrocution, electrical burns, and other electrical injuries to patients, staff, and visitors. It also aims to protect hospital property from electrical fires and equipment damage.

  • To prevent fire due to short-circuiting: Short circuits are a common cause of electrical fires. Audits help identify potential short circuit hazards (damaged wiring, overloaded circuits, faulty equipment) and ensure preventive measures are in place.

• When should the audit be done? (from Slide 22):

  • At least once a year: This is the minimum recommended frequency for comprehensive electrical safety audits. High-risk areas or areas with older electrical infrastructure may require more frequent audits.

  • Part of electric system maintenance plan: Electrical safety audits should be integrated into the hospital's overall electrical system maintenance plan (FMS 4c). This ensures that audits are a routine and planned activity, not just an afterthought.

• What should the audit incorporate? (from Slide 22):

  • Statutory requirements (such as National electrical code 2023), wherever applicable: Electrical safety audits must be conducted in accordance with all applicable national and local electrical safety regulations, codes, and standards.

    • National Electrical Code (NEC): In India, the relevant code is the National Electrical Code (NEC). Hospitals should refer to the latest version of NEC (e.g., NEC 2023 if current) for electrical safety standards and requirements.

    • Other Regulations: Local electrical safety regulations, fire safety codes, and workplace safety regulations may also be applicable.

    • Compliance Check: The audit should specifically check for compliance with relevant statutory requirements.

• What to Audit - Key Areas to Cover in Electrical Safety Audit:

  • Electrical Wiring and Cabling:

    • Condition of wiring (insulation damage, aging, fraying).

    • Proper wiring methods and materials used.

    • Adequate wire sizing for load.

    • Secure and properly terminated connections.

    • Absence of exposed wires or loose connections.

    • Compliance with wiring codes (e.g., conduit usage, cable management).

• • Electrical Panels and Distribution Boards:

    • Proper labeling and identification of circuits.

    • Circuit breakers and fuses of appropriate ratings.

    • Functionality of circuit breakers and fuses.

    • Condition of panel boards (corrosion, overheating).

    • Adequate grounding and bonding.

    • Accessibility and clearance around panels.

• • Electrical Outlets and Receptacles:

    • Proper type and rating of outlets.

    • Functionality of outlets (grounding, voltage).

    • Absence of damaged or loose outlets.

    • Use of appropriate covers and faceplates.

    • Avoidance of overloaded outlets and extension cords.

• • Lighting Fixtures and Systems:

    • Proper type and wattage of lighting fixtures.

    • Functionality of lighting fixtures and emergency lights.

    • Secure mounting and wiring of fixtures.

    • Adequate lighting levels in all areas.

    • Use of energy-efficient lighting.

• • Electrical Equipment:

    • Regular inspection and maintenance of electrical equipment (medical equipment, kitchen equipment, laundry equipment, etc.).

    • Equipment grounding and bonding.

    • Functionality of equipment safety features (ground fault circuit interrupters - GFCIs, safety interlocks).

    • Proper use of equipment and staff training.

• • Emergency Power Systems:

    • Functionality of emergency generators (DG sets) and UPS systems (as per FMS 2e and 2f).

    • Testing and maintenance records for emergency power systems.

    • Adequacy of emergency power coverage for critical areas.

• • Grounding and Bonding Systems:

    • Verification of proper grounding and bonding of electrical systems and equipment to minimize electrical shock hazards and prevent build-up of static electricity.

    • Continuity testing of grounding systems.

• • Lightning Protection Systems:

    • If applicable, inspection of lightning protection systems (lightning rods, grounding conductors) to ensure they are in good condition and functional.

• • Hazardous Area Classification:

    • In areas with flammable materials or medical gases, verification of appropriate electrical equipment and wiring for hazardous area classifications to prevent explosions or fires.

• Point to Remember (from Slide 22): To prevent fire incidents - Thermal imaging equipment can be used to detect loose connection in the system.

  • Thermal Imaging: Thermal imaging cameras can be a valuable tool during electrical safety audits. They can detect "hot spots" in electrical panels, wiring, and connections that may indicate loose connections, overloaded circuits, or overheating components, which are potential fire hazards.

  • Proactive Detection: Thermal imaging allows for early detection of electrical problems before they lead to failures or fires, enabling proactive maintenance and corrective actions.

• Note (from Slide 22): The audit can be incorporated into the electric system maintenance plan. This reinforces the idea of integrating electrical safety audits as a routine part of the hospital's maintenance program for electrical systems (FMS 4c).

• Note: FMS 3c is about proactive prevention of electrical hazards through regular and comprehensive electrical safety audits. It's not just about compliance but about creating a safer environment for everyone by identifying and mitigating electrical risks before they cause harm or damage.

FMS 3d: There is a procedure which addresses the identification and disposal of material(s) not in use in the organisation. * (C)

(Commitment Level - C: Asterisk indicates mandatory documentation. A written procedure for disposal of unused materials is required.)*

• Intent: This objective element focuses on effective management of materials that are no longer needed or usable within the hospital. Accumulation of unused materials can create clutter, safety hazards, infection risks, and inefficient space utilization. A documented procedure for identification and disposal ensures a systematic and safe approach.

• Key Components:

  1. Procedure which addresses the identification and disposal of material(s) not in use: The hospital must have a written procedure that outlines the steps for identifying materials that are no longer needed and the process for their proper disposal.

  2. Material(s) not in use: This broadly refers to any items that are obsolete, damaged, non-functional, surplus, or otherwise no longer required for hospital operations.

• Examples of not in use material (from Slide 23):

  1. Non-functioning items: Broken equipment, damaged furniture, malfunctioning devices, expired consumables, outdated technology, irreparable items.

  2. Excess unwanted material: Surplus inventory, overstocked supplies, items no longer needed due to changes in service or technology, promotional materials that are no longer relevant.

  3. General waste: Non-biomedical waste generated in offices, administrative areas, and non-clinical areas (paper waste, packaging materials, general trash).

  4. Scrap material: Metal scrap, waste from maintenance activities, discarded building materials, broken parts.

• Procedure for Identification and Disposal - Key Steps:

  1. Identification of Material Not in Use:

     • Regular Inventory Checks: Conduct periodic inventory checks in different departments and storage areas to identify items that are obsolete, damaged, surplus, or no longer needed.

     • User Department Reporting: Establish a system for staff to report items that are no longer functional or required in their departments.

     • Maintenance and Repair Records: Maintenance and repair records can help identify equipment that is beyond economical repair and needs to be condemned.

     • Obsolescence Tracking: Track the lifespan and obsolescence of equipment and supplies, especially technology-based items and consumables with expiry dates.

• 2. Segregation and Collection:

     • Segregate by Type: Segregate identified materials based on their type (e.g., non-functional equipment, excess supplies, general waste, scrap metal) and potential hazards (if any).

     • Designated Collection Areas: Establish designated collection areas for different types of unused materials, ensuring they are stored safely and do not create clutter or hazards.

• 3. Condemnation (for Equipment and Assets):

     • Evaluation for Condemnation: For equipment, furniture, and other assets, evaluate their condition, repair costs, and remaining lifespan to determine if they should be condemned (deemed unusable and to be disposed of).

     • Condemnation Authorization: Establish a process for authorizing condemnation, typically involving department heads, asset management, or a designated committee.

     • Documentation of Condemnation: Document the condemnation process, including reasons for condemnation, authorization details, and asset identification.

• 4. Disposal Methods:

     • Dispose - General Waste: General waste can be disposed of through regular waste management channels (municipal waste collection, recycling if applicable).

     • Dispose - Scrap Material (Recycling): Scrap metal and recyclable materials should be sent for recycling through authorized recyclers.

     • Dispose - Non-functional Equipment (E-waste): Electronic waste (e-waste) should be disposed of responsibly through authorized e-waste recyclers or collection programs, complying with e-waste regulations.

     • Dispose - Hazardous Materials: If any of the "not in use" materials are hazardous (e.g., expired chemicals, batteries, e-waste containing hazardous components), they must be disposed of as hazardous waste, following specific hazardous waste management procedures (FMS 3e and relevant regulations).

     • Donation or Sale (if applicable): In some cases, functional but surplus equipment or furniture may be considered for donation to charitable organizations or sale, if legally and ethically permissible and following hospital policies.

• 5. Documentation and Record Keeping:

     • Maintain Records of Disposal: Document all disposal activities, including dates, types of materials disposed of, disposal methods used, quantities, and any relevant disposal certificates or records (e.g., from recyclers, waste disposal agencies).

     • Tracking and Auditing: Establish a system for tracking disposal activities and periodically auditing the procedure to ensure effectiveness and compliance.

• Note: FMS 3d is about promoting organization, safety, and efficiency by systematically managing and disposing of materials that are no longer needed. A well-defined procedure prevents clutter, reduces hazards, ensures responsible waste management, and optimizes hospital space.

FMS 3e: Hazardous materials are identified and used safely within the organisation. (CO)*

(Core Objective Element - CO: Asterisk indicates mandatory documentation. Hazardous materials identification, safe use, and management procedures are critical and require documentation.)*

• Intent: This objective element addresses the critical aspect of hazardous materials management in hospitals. Hospitals use a wide range of hazardous materials, and their improper handling, storage, and disposal can pose significant risks to patients, staff, visitors, and the environment. FMS 3e emphasizes the need to identify, safely use, and manage these materials through documented procedures.

• Key Components:

  1. Hazardous materials are identified: The first step is to systematically identify all hazardous materials used in the hospital. This requires a comprehensive inventory and classification process.

  2. And used safely within the organisation: Once identified, hazardous materials must be handled, stored, transported, and used in a manner that minimizes risks and protects personnel and the environment. This requires documented procedures, training, and appropriate safety measures.

• Examples of hazardous materials (from Slide 24):

  1. Chemicals: Disinfectants, sterilants, cleaning agents, laboratory reagents, pharmaceuticals, chemotherapy drugs, anesthetic gases, solvents, paints, adhesives, and various other chemicals used in different hospital departments.

  2. Biological materials (blood, body fluids & micro cultures): Infectious waste, sharps, cultures, specimens, contaminated materials from patient care, laboratory waste, and other biological materials that can transmit diseases.

  3. Mercury: Mercury-containing devices (thermometers, sphygmomanometers), dental amalgam waste, fluorescent lamps, and other mercury-containing items.

  4. Nuclear isotopes: Radioactive materials used in nuclear medicine, radiology, and research, including radiopharmaceuticals, sealed sources, and radioactive waste.

  5. Medical gases: Oxygen, nitrous oxide, anesthetic gases, compressed air, vacuum, and other medical gases, which can be flammable, explosive, or pose asphyxiation hazards if not handled properly (addressed in detail in FMS 6).

  6. LPG gas: Liquefied Petroleum Gas used for cooking, heating, or in laboratories, which is flammable and explosive.

  7. Steam: High-pressure steam used for sterilization and other purposes, posing burn hazards.

  8. ETO (Ethylene Oxide): A highly toxic and carcinogenic gas used for sterilization of heat-sensitive medical equipment.

• Procedure for Hazardous Materials Management - Key Steps:

  1. Identify and document: Hazardous material:

     • Hazardous Material Inventory: Create a comprehensive inventory of all hazardous materials used in the hospital. This should include:

       • Name of the material (both common and chemical name).

       • Manufacturer and supplier.

       • Quantity stored and used.

       • Location of storage and use.

       • Hazard classification (flammable, toxic, corrosive, radioactive, biohazard, etc.).

• 1. • Material Safety Data Sheets (MSDS): Obtain and maintain MSDS for each hazardous material from the manufacturer or supplier. MSDS provides detailed information about the hazards, safe handling procedures, first aid measures, spill response, storage requirements, and disposal methods for each material.

     • Hazardous Material Labeling: Properly label all containers of hazardous materials with clear and conspicuous labels indicating the material name, hazard symbols, and precautionary information.

     • Designated Hazardous Material Officer/Team: Assign responsibility for hazardous material management to a designated officer or team (e.g., safety officer, infection control team, biomedical engineering).

• 2. Develop procedures for hazardous waste management: Based on material safety data sheets (MSDS) and compile applicable statutory requirements:

     • Hazardous Waste Management Plan: Develop a comprehensive hazardous waste management plan that outlines procedures for:

       • Segregation: Segregating hazardous waste from general waste at the point of generation.

       • Collection: Safe collection and transportation of hazardous waste within the hospital.

       • Storage: Designated and secure storage areas for different types of hazardous waste, complying with storage requirements (ventilation, temperature, segregation, spill containment).

       • Treatment (if applicable): On-site treatment of certain hazardous waste types (e.g., autoclave for infectious waste, chemical neutralization).

       • Disposal: Proper disposal of hazardous waste through authorized hazardous waste treatment, storage, and disposal facilities (TSDFs) or waste management agencies, complying with all applicable regulations.

• 2. • MSDS as Source of Information: Use MSDS information to guide the development of safe handling, storage, and disposal procedures for each hazardous material.

     • Statutory Requirements: Compile and incorporate all applicable national, state, and local regulations related to hazardous waste management, biomedical waste management, chemical safety, radiation safety, and other relevant laws.

• 3. Follow documented procedure: For sorting, storage, handling, transportation and disposal of hazardous material:

     • Implementation of Procedures: Ensure that all staff who handle hazardous materials are trained on and strictly adhere to the documented hazardous material management procedures.

     • Training and Awareness: Provide regular training to all relevant staff on:

       • Identification of hazardous materials and their associated risks.

       • Safe handling procedures for each type of hazardous material.

       • Proper use of personal protective equipment (PPE).

       • Spill response procedures (FMS 3f).

       • Hazardous waste segregation, collection, and storage procedures.

       • Emergency procedures and contact information.

• 3. • Enforcement and Monitoring: Monitor compliance with hazardous material procedures through regular inspections, audits, and observation of work practices. Implement corrective actions for any deviations or non-compliances.

• Note: FMS 3e is about creating a robust system for managing hazardous materials from "cradle to grave" - from identification and safe use to proper disposal. This system is essential for protecting the health and safety of everyone in the hospital and minimizing environmental impact, and it absolutely requires documented procedures and ongoing staff training and vigilance.

FMS 3f: The plan for managing spills of hazardous materials is implemented. * (C)

(Commitment Level - C: Asterisk indicates mandatory documentation. A documented spill management plan for hazardous materials is required and must be implemented.)*

• Intent: This objective element focuses on emergency preparedness for accidental spills of hazardous materials. Spills can occur during handling, storage, transportation, or use of hazardous materials. A well-defined and implemented spill management plan is crucial for containing spills, minimizing exposure, and safely cleaning up and decontaminating the affected area.

• Key Components:

  • Plan for managing spills of hazardous materials: The hospital must have a written spill management plan that outlines the steps to be taken in case of a spill. This plan should be specific to the types of hazardous materials used in the hospital and the potential spill scenarios.

  • Is implemented: It's not enough to just have a plan on paper; the plan must be actively implemented through staff training, provision of spill response equipment, and regular drills to ensure preparedness.

• Managing spills - Key Elements of a Spill Management Plan (from Slide 25):

  • Develop a plan based on MSDS:

    • MSDS as Primary Source: The spill management plan should be developed based on the specific hazards and spill response information provided in the MSDS for each hazardous material used in the hospital. MSDS will outline recommended spill containment, cleanup, and first aid measures for each substance.

    • Material-Specific Procedures: Tailor spill response procedures to the specific properties and hazards of different hazardous materials (e.g., procedures for chemical spills will differ from those for biohazard spills or radioactive spills).

• • Summarise key elements (Easy to understand and translated into local language):

    • Simplified and Clear Procedures: The spill management plan should be summarized into clear, concise, and easy-to-understand steps that staff can quickly follow in an emergency. Avoid overly technical jargon.

    • Local Language Translation: Translate the summarized spill response procedures into the local language(s) spoken by hospital staff to ensure clear communication and comprehension, especially in multilingual settings.

    • Visual Aids: Use visual aids like flowcharts, diagrams, and posters to illustrate spill response steps and make them readily accessible and memorable for staff.

• Organisation - Implementation of the Spill Management Plan (from Slide 25):

  • Ensure availability of spill management plan in areas where hazardous materials are stored:

    • Plan Accessibility: Make the spill management plan readily available in all areas where hazardous materials are stored, handled, or used. This can include posting copies of the summarized procedures, keeping hard copies of the full plan readily accessible, and making it available electronically on shared drives or hospital intranet.

    • Strategic Placement: Place copies of the summarized plan and spill response contact information in prominent locations, such as chemical storage rooms, laboratories, pharmacy, cleaning supply areas, and emergency response stations.

• • Train staff in handling hazardous materials:

    • Spill Response Training: Provide comprehensive training to all staff who may be involved in responding to hazardous material spills. This training should cover:

      • Types of hazardous materials used in the hospital and their potential spill hazards.

      • Location and content of the spill management plan.

      • Steps to take upon discovering a spill (alerting, evacuation, securing the area).

      • Proper use of PPE for spill response.

      • Spill containment and cleanup procedures for different types of spills.

      • Use of HAZMAT kit(s) and spill response equipment.

      • Decontamination procedures.

      • Reporting and documentation requirements after a spill.

• • • Regular Drills and Exercises: Conduct periodic spill response drills and exercises to test the effectiveness of the plan, assess staff preparedness, and identify areas for improvement.

• • Provide HAZMAT kit(s) to staff who handle spills:

    • HAZMAT Kit Contents: Provide readily accessible HAZMAT (Hazardous Materials) spill kits in areas where spills are likely to occur. HAZMAT kits should be appropriate for the types of hazardous materials used in the area and should contain:

      • Personal Protective Equipment (PPE): Gloves (chemical-resistant, appropriate for biohazards if needed), respirators (if required for specific materials), eye protection (goggles, face shields), protective clothing (aprons, coveralls).

      • Containment Materials: Absorbent materials (pads, granules, booms) to contain and absorb liquid spills.

      • Neutralizing Agents: Neutralizing agents (if applicable and safe to use for specific chemicals).

      • Cleanup Tools: Brooms, scoops, dustpans, disposal bags, containers for contaminated materials.

      • Warning Signs and Barrier Tape: To cordon off the spill area and warn others.

      • Spill Response Guide: A quick reference guide summarizing spill response steps and contact information.

    • 
      

    • Kit Accessibility and Maintenance: Ensure HAZMAT kits are easily accessible, clearly marked, and regularly inspected and replenished to ensure all items are present and in good condition. Staff should be trained on the location and contents of HAZMAT kits.

• Note: FMS 3f is about being prepared for the unplanned event of a hazardous material spill. Having a well-developed, documented, and implemented spill management plan, along with trained staff and readily available HAZMAT kits, is crucial for minimizing the impact of spills, protecting personnel, and ensuring a safe and effective response.

In summary, FMS 3 is a comprehensive standard that focuses on ensuring the safety of everyone in the hospital by addressing a wide range of potential hazards – from security threats and structural vulnerabilities to electrical risks and hazardous material management. It emphasizes proactive planning, documented procedures, regular audits, staff training, and continuous improvement to create a truly safe and secure healthcare environment.

FMS 4: The Organisation has a Programme for the Facility, Engineering Support Services and Utility System

Standard Overview:

FMS 4 transitions from general safety and environmental considerations to the core operational aspects of a hospital's infrastructure. It mandates that the hospital must have a structured and comprehensive programme for managing its facility, engineering support services, and utility systems. This isn't just about reactive maintenance; it's about proactive planning, preventative measures, and a systematic approach to ensure that all essential infrastructure elements are reliably available, properly maintained, and effectively support patient care and hospital operations.

Why is a Programme for Facility, Engineering, and Utility Systems Essential for Hospitals?

• Reliability and Continuity of Services: Hospitals are heavily reliant on their infrastructure. A robust programme ensures the reliable and continuous operation of essential utilities (electricity, water, medical gases, HVAC), engineering systems (lifts, fire safety), and facility components (buildings, furniture), preventing disruptions to patient care and critical services.

• Patient Safety: Malfunctioning equipment, utility failures, or poorly maintained facilities can directly compromise patient safety. A well-managed programme minimizes risks associated with equipment breakdowns, environmental hazards, and infrastructure failures.

• Equipment Longevity and Cost-Effectiveness: Preventative maintenance and planned management extend the lifespan of equipment and facilities, reducing premature replacements and minimizing long-term operational costs. Reactive maintenance is often more expensive and disruptive than planned preventative measures.

• Regulatory Compliance: Hospitals are subject to various regulations related to building safety, equipment maintenance, utility standards, and environmental compliance. FMS 4 helps ensure adherence to these regulatory requirements.

• Operational Efficiency: A well-maintained and managed facility operates more efficiently. Reduced downtime of equipment, optimized utility consumption, and a functional environment contribute to smoother workflows and improved staff productivity.

• Infection Control: Proper maintenance of HVAC systems, water systems, and general facility cleanliness is crucial for infection prevention and control. A robust programme supports infection control efforts by maintaining a hygienic and safe environment.

• NABH Accreditation Requirements: FMS 4 is a critical standard for NABH accreditation, demonstrating the hospital's commitment to systematic management of its essential infrastructure.

Let's examine the Objective Elements of FMS 4 in detail:

FMS 4a: The organisation plans for utility and engineering equipment in accordance with its services and strategic plan. (C)

(Commitment Level - C: Emphasizes proactive planning and alignment with hospital strategy.)

• Intent: This objective element underscores the importance of strategic planning for utility and engineering equipment. Equipment procurement, upgrades, and maintenance should not be ad-hoc but rather be driven by the hospital's service offerings and long-term strategic goals. This ensures that infrastructure investments are aligned with the hospital's overall direction and future needs.

• Key Components:

  • The organisation plans for utility and engineering equipment: Planning should be a formal and documented process, not just informal decision-making. This implies having a defined process for equipment planning, budgeting, procurement, and lifecycle management.

  • Utility and engineering equipment: This encompasses a broad range of equipment essential for hospital operation:

    • Utility Equipment: DG sets (generators), UPS systems, water pumps, water treatment plants (RO, STP), water storage tanks, medical gas plants and pipelines, compressed air systems, vacuum systems, boilers, chillers, air compressors, fuel tanks, etc.

    • Engineering Support Services Equipment: Lifts/elevators, escalators, fire fighting systems (fire alarms, sprinklers, extinguishers), HVAC systems (air handling units, chillers, ductwork), plumbing systems, electrical distribution systems, building management systems (BMS), etc.

• • In accordance with its services and strategic plan: Equipment planning must be directly linked to:

    • Hospital Services: The range of medical services offered by the hospital (e.g., cardiology, oncology, surgery, critical care) dictates the types and quantities of utility and engineering equipment needed. Expansion or changes in services will necessitate adjustments in equipment planning.

    • Strategic Plan: The hospital's long-term strategic plan (e.g., growth plans, expansion of bed capacity, introduction of new specialties, technological upgrades) should guide equipment planning. Equipment investments should support the hospital's strategic direction and future aspirations.

• Consider future requirements while planning. For example: DG sets and Chiller plants:

  • Future-Proofing: Equipment planning should not just address current needs but also anticipate future requirements. Hospitals are dynamic environments, and demands on infrastructure can change rapidly.

  • Examples - DG sets and Chiller plants:

    • DG sets: When planning for DG sets, consider future expansion of bed capacity, addition of energy-intensive equipment (e.g., MRI, CT scanners), and potential increase in power demand. Choose DG sets with sufficient capacity and scalability for future growth.

    • Chiller plants: Plan chiller plant capacity based on current and projected cooling load, considering hospital expansion, climate change impacts, and potential increase in HVAC demand. Select chillers with energy-efficient technologies for long-term cost savings and environmental sustainability.

• • Other Equipment Examples for Future Planning: Water treatment capacity, medical gas plant capacity, elevator/lift capacity, HVAC system capacity, electrical distribution capacity.

• Implement plans fully:

  • Execution of Plans: Equipment planning is not just about creating documents; it's about implementing the plans effectively. This involves:

    • Budget Allocation: Allocating sufficient budget for equipment procurement, installation, commissioning, and ongoing maintenance as per the plan.

    • Procurement Process: Establishing a transparent and efficient procurement process for equipment, ensuring quality, value for money, and timely delivery.

    • Installation and Commissioning: Proper installation and commissioning of equipment by qualified personnel, following manufacturer guidelines and relevant standards.

    • Resource Allocation: Assigning necessary resources (personnel, time, materials) for plan implementation.

• Review plans on periodic basis:

  • Dynamic Nature of Needs: Hospital needs, technology, and regulations change over time. Equipment plans should not be static but rather be reviewed and updated periodically to remain relevant and effective.

  • Periodic Review Frequency: Establish a regular review cycle for equipment plans (e.g., annually, bi-annually).

  • Review Aspects: Periodic review should include:

    • Assessment of current equipment adequacy: Are current equipment capacities still sufficient for current service volumes and patient load?

    • Evaluation of equipment performance and condition: Are equipment performing as expected? Are there any recurring maintenance issues or signs of aging?

    • Review of strategic plan updates: Have there been any changes in the hospital's strategic plan that necessitate adjustments to equipment plans?

    • Technology updates and advancements: Are there newer, more efficient, or more effective equipment technologies available that should be considered for upgrades or replacements?

    • Regulatory changes: Have there been any changes in regulations or standards that impact equipment requirements or maintenance practices?

• Select, rent, update or upgrade equipment by a collaborative process.

  • Collaborative Decision-Making: Equipment selection, procurement, rental, upgrades, and updates should not be solely decided by one department (e.g., engineering) but rather be a collaborative process involving relevant stakeholders.

  • Stakeholders in Collaborative Process (from Note on Slide 27):

    • End-users: Departments and staff who will directly use the equipment (e.g., medical departments, nursing staff, technicians). Their input on functional requirements, usability, and performance is crucial.

    • Management: Hospital administration and senior management to ensure alignment with strategic goals, budget constraints, and overall hospital priorities.

    • Finance Department: To manage budget allocation, procurement costs, and financial aspects of equipment investments.

    • Engineering Department: To provide technical expertise on equipment specifications, installation requirements, maintenance needs, and infrastructure compatibility.

• • Benefits of Collaborative Process:

    • Better equipment selection: Ensures equipment chosen is best suited to the hospital's needs and user requirements.

    • Improved buy-in from stakeholders: Increases ownership and support for equipment decisions across departments.

    • Optimized resource allocation: Ensures equipment investments are financially sound and strategically aligned.

    • Reduced errors and rework: Collaborative input minimizes the risk of selecting inappropriate equipment or overlooking important considerations.

• Note (from Slide 27): Collaborative process implies that end-user, management, finance and engineering departments are involved in equipment selection process. This clarifies the intended scope of the collaborative approach.

• Note: FMS 4a is about strategic and collaborative infrastructure planning. By linking equipment decisions to hospital services, strategic goals, and involving relevant stakeholders, hospitals can ensure that their utility and engineering infrastructure is robust, future-proof, and effectively supports their mission of providing quality patient care.

FMS 4b: Equipment is inventoried, and proper logs are maintained as required. (C)

(Commitment Level - C: Fundamental for asset management, maintenance, and accountability.)

• Intent: This objective element emphasizes basic asset management principles for all utility and engineering equipment. Having a comprehensive inventory and maintaining proper logs is essential for tracking equipment, managing maintenance, ensuring accountability, and facilitating efficient operations.

• Key Components:

  • Equipment is inventoried: All utility and engineering equipment must be systematically inventoried and recorded in a register or database. This inventory serves as a central record of all assets.

  • Proper logs are maintained: For each piece of equipment, proper logs must be maintained to record essential information, maintenance activities, performance history, and other relevant details. These logs are crucial for equipment lifecycle management.

  • As required: The extent of inventory information and the types of logs maintained should be "as required" - meaning they should be sufficient to effectively manage and maintain the equipment, meet regulatory requirements, and support hospital operations. The "Points to Remember" on Slide 28 provide guidance on what to document.

• Equipment Inventory - Information to Include:

  • Unique Identification: Assign a unique identifier (equipment ID, asset tag number) to each piece of equipment for easy tracking and referencing.

  • Equipment Name/Description: Clear and concise description of the equipment (e.g., "Diesel Generator Set - Main," "OT Chiller Unit #1," "Elevator #2").

  • Manufacturer and Model: Manufacturer's name and equipment model number for identification and sourcing spare parts.

  • Serial Number: Equipment serial number (if applicable) for unique identification and warranty tracking.

  • Location: Current location of the equipment within the hospital (e.g., "Generator Room," "OT #3," "Ward 2B").

  • Date of Purchase/Installation: Date of acquisition or installation for depreciation tracking, warranty information, and lifecycle management.

  • Supplier/Vendor: Name and contact information of the equipment supplier or vendor.

  • Warranty Information: Warranty period, terms, and contact information for warranty claims.

  • Commissioning Date: Date when the equipment was commissioned and put into service.

  • Initial Condition Assessment: Record of the equipment's condition at the time of inventory (e.g., "New," "Used," "Good Condition," "Requires Minor Repairs").

  • Responsibility (Department/Person): Department or individual responsible for the equipment's operation and maintenance.

• Proper Logs to be Maintained - Types of Logs and Information:

  • Maintenance Logs: Detailed records of all maintenance activities performed on the equipment, including:

    • Date and time of maintenance.

    • Type of maintenance (preventive, breakdown, corrective).

    • Description of work performed.

    • Parts replaced (with part numbers).

    • Readings taken (pressure, temperature, voltage, etc.) before and after maintenance.

    • Name of personnel performing maintenance.

    • Next scheduled maintenance date.

• • Operational Logs: Records of equipment operation, performance, and usage, including:

    • Operating hours, run time.

    • Performance parameters (output, efficiency, etc.).

    • Any operational issues or abnormalities.

    • Energy consumption (if relevant).

    • Usage data (e.g., elevator usage count).

• • Inspection Logs: Records of periodic inspections conducted on the equipment, including:

    • Date of inspection.

    • Inspection checklist used.

    • Findings of inspection (condition assessment, identified issues).

    • Corrective actions recommended and taken.

    • Name of inspector.

    • Next scheduled inspection date.

• • Calibration Logs (for calibrated equipment): Records of calibration activities, including:

    • Date of calibration.

    • Calibration standard used.

    • Calibration results (before and after calibration).

    • Calibration certificate (if applicable).

    • Due date for next calibration.

• • Breakdown/Failure Logs: Records of equipment breakdowns, failures, and downtime, including:

    • Date and time of breakdown.

    • Description of failure.

    • Root cause analysis (if conducted).

    • Corrective actions taken to repair the equipment.

    • Downtime duration.

    • Impact on operations (if any).

• • Repair Logs: Detailed records of equipment repairs, including:

    • Date and time of repair.

    • Description of repair work performed.

    • Parts replaced (with part numbers).

    • Cost of repair.

    • Name of personnel performing repair.

    • Verification of repair effectiveness.

• • Training Logs: Records of staff training on equipment operation and maintenance, including:

    • Name of staff trained.

    • Date of training.

    • Training topic/module.

    • Trainer's name.

    • Training effectiveness assessment (if conducted).

• Points to Remember (from Slide 28) - Document the following:

  • Relevant quality conformance certificates/marks: Document and file quality certificates (e.g., ISO certifications, CE marks) and conformance marks obtained for the equipment, demonstrating compliance with quality standards and regulations.

  • Manufacturer factory test certificate: Obtain and retain the manufacturer's factory test certificate, which verifies that the equipment has passed factory testing and meets specified performance standards before shipment.

  • Installation report: Document the equipment installation process, including:

    • Date of installation.

    • Installer details (company/personnel).

    • Installation checklist or procedure followed.

    • Pre-commissioning tests performed.

    • Commissioning report verifying proper installation and functionality.

• Note: FMS 4b is about establishing a solid foundation for equipment management through accurate inventory and comprehensive log keeping. This basic level of asset management is crucial for effective maintenance planning, performance monitoring, regulatory compliance, and informed decision-making regarding equipment lifecycle and replacements.

FMS 4c: The documented operational and maintenance (preventive and breakdown) plan is implemented. (CO)*

(Core Objective Element - CO: Asterisk indicates mandatory documentation. A documented operational and maintenance plan is a critical requirement.)*

• Intent: This objective element emphasizes the importance of a documented and implemented operational and maintenance plan for all utility and engineering equipment and facility components. This plan should encompass both preventive maintenance (to proactively prevent failures) and breakdown maintenance (to address failures when they occur). It's about shifting from reactive maintenance to a proactive, planned approach.

• Key Components:

  • Documented operational and maintenance (preventive and breakdown) plan: The hospital must have a written plan that clearly outlines procedures for:

    • Operational aspects: Standard operating procedures (SOPs) for routine equipment operation, start-up, shutdown, and normal usage.

    • Preventive maintenance (PM): Scheduled maintenance tasks performed at regular intervals to prevent equipment failures, extend equipment lifespan, and maintain performance.

    • Breakdown maintenance (BM) / Corrective maintenance (CM): Procedures for responding to equipment breakdowns, failures, and malfunctions, including troubleshooting, repair, and restoration of equipment functionality.

• • Is implemented: The documented plan must be actively implemented in practice. This means:

    • Maintenance schedules are followed.

    • Preventive maintenance tasks are performed as planned.

    • Breakdown maintenance is responded to promptly and effectively.

    • Maintenance activities are documented in logs (as per FMS 4b).

    • Resources (personnel, budget, spare parts) are allocated for plan implementation.

• Scope of the Plan - Coverage (from Slides 29-32): The operational and maintenance plan should cover a wide range of areas:

  • Utility equipment: DG sets, UPS systems, water pumps, water treatment plants, medical gas plants, compressed air systems, vacuum systems, boilers, chillers, etc.

  • Engineering equipment: Lifts/elevators, escalators, fire fighting systems, HVAC systems, plumbing systems, electrical distribution systems, BMS, etc.

  • Electrical systems: Electrical wiring, panels, outlets, lighting systems, grounding systems, emergency power systems, etc.

  • Water management: Water storage tanks, water distribution systems, water treatment units, STP, plumbing fixtures, etc.

  • HVAC: Chiller units, AHUs, FCUs, ductwork, air filters, ventilation systems, temperature control systems, etc.

  • Facility and furniture: Building civil work (walls, floors, roof), fixed furniture (nurse stations, counters, shoe racks), loose furniture (chairs, trolleys, emergency carts), doors, windows, fixtures, etc.

• Content of the Operational and Maintenance Plan - Key Elements for Each Area (Examples based on Slides 30-32):

  • Equipment maintenance plan (Utility and engineering equipment - Slide 30):

    • Consider manufacturer's recommendations: Refer to manufacturer's manuals and guidelines for recommended maintenance schedules, procedures, and spare parts for each piece of equipment.

    • Consider risk level: Prioritize maintenance based on the criticality and risk level of the equipment. Equipment that is critical for patient safety or essential services (e.g., DG sets, medical gas systems) should have more frequent and rigorous maintenance.

    • Consider past maintenance history: Analyze past maintenance logs and breakdown history to identify recurring issues, predict potential failures, and adjust maintenance schedules accordingly. Equipment with a history of frequent breakdowns may require more intensive preventive maintenance or replacement consideration.

• • Electrical maintenance plans (Electrical systems - Slide 30):

    • Should incorporate statutory requirements (where applicable): Ensure the electrical maintenance plan incorporates all applicable statutory requirements and electrical safety codes (e.g., NEC, local electrical regulations) regarding inspection, testing, and maintenance of electrical systems.

    • Should include transformers, LT and/or HT panel maintenance and lifts: Specifically include maintenance procedures for critical electrical components like transformers, low tension (LT) and high tension (HT) panels, and lifts/elevators, as these are essential for hospital operations and safety.

  • 
    

  • Water maintenance plans (Water management - Slide 31):

    • Should include regular cleaning of water storage tanks, water treatment, RO unit and STP: Include procedures for regular cleaning and disinfection of water storage tanks, maintenance of water treatment plants (chlorination, filtration), RO units (for dialysis water), and sewage treatment plants (STP) to ensure water quality and prevent contamination and waterborne diseases.

• • HVAC maintenance plans (HVAC - Slide 31):

    • Should include chiller unit, AHU, FCU and various air-conditioners: Include maintenance procedures for all components of the HVAC system, such as chiller units, air handling units (AHUs), fan coil units (FCUs), ductwork cleaning, and individual air conditioners.

    • Should adhere to manufacturer's recommendations and good infection control practice requirement (such as timely cleaning and/or replacement of filters): Follow manufacturer guidelines for HVAC equipment maintenance and incorporate infection control best practices, particularly regarding timely cleaning and replacement of air filters in HVAC systems to maintain air quality and minimize airborne infections.

• • Facility and furniture maintenance plans (Facility and furniture - Slide 32):

    • Civil work as wall, floor and roof: Include procedures for regular inspection and maintenance of civil structures like walls, floors, and roofs to identify and address structural issues, leaks, cracks, and damage.

    • Fixed furniture like nurse stations, shoe racks: Include maintenance procedures for fixed furniture (nurse stations, counters, built-in shelves) to ensure structural integrity, functionality, and cleanliness.

    • Loose furniture like emergency cart, chairs, trolleys: Include maintenance procedures for loose furniture (chairs, tables, trolleys, emergency carts) to ensure functionality, safety, and cleanliness.

    • Should adhere to manufacturers' recommendations and good infection control practice requirement (such as regular inspections, timely repair of civil structure, servicing of furniture): Follow manufacturer guidelines for furniture maintenance and incorporate infection control best practices, such as regular inspections, timely repair of civil structures to prevent water damage and mold growth, and regular servicing and cleaning of furniture to maintain hygiene and prevent wear and tear.

• Point to Remember (from Slide 29):

  • Operator: Trained to handle equipment: Ensure that staff who operate utility and engineering equipment are properly trained on their operation, safety procedures, and basic troubleshooting. Training records should be maintained (FMS 4e).

  • Operational plan: Assist operator in operating equipment daily: Provide readily accessible operational manuals, checklists, or SOPs to guide operators in the daily operation of equipment, ensuring consistent and safe practices.

  • Organisation: Use original equipment manual or develop operational plan for the concerned equipment: The hospital should use manufacturer-provided equipment manuals as the basis for developing operational and maintenance plans or create its own detailed operational plans if manufacturer manuals are insufficient or not available.

• Note (from Slide 32): The organisation should ensure availability of planned preventive maintenance tracker for utility equipment, facility items and furniture.

  • Preventive Maintenance Tracker: Use a system (manual or computerized) to track planned preventive maintenance schedules, completed tasks, upcoming maintenance, and overdue maintenance. This tracker helps ensure that PM activities are performed on time and are not missed.

  • Benefits of PM Tracker: Improved maintenance scheduling, reduced risk of missed maintenance, better equipment uptime, proactive identification of maintenance needs, and enhanced accountability.

• Note: FMS 4c is about moving from reactive to proactive maintenance and establishing a robust system for managing the operational and maintenance aspects of the hospital's infrastructure. A well-documented and implemented plan is essential for ensuring equipment reliability, minimizing downtime, extending equipment lifespan, reducing maintenance costs, and ultimately contributing to patient safety and operational efficiency.

FMS 4d: Utility equipment, are periodically inspected and calibrated (wherever applicable) for their proper functioning. (C)

(Commitment Level - C: Emphasizes regular verification of equipment performance and accuracy.)

• Intent: This objective element highlights the importance of regular inspection and calibration of utility equipment, particularly those that are critical for hospital operations or patient safety. Inspection verifies the physical condition and functionality, while calibration ensures the accuracy of measurement and control equipment.

• Key Components:

  • Utility equipment: Refers to the same range of utility equipment as in FMS 4a and 4c (DG sets, UPS, water pumps, medical gas plants, etc.).

  • Are periodically inspected: Regular physical inspections of equipment to assess their condition, identify potential problems, and ensure they are functioning correctly.

  • And calibrated (wherever applicable): Calibration is the process of verifying and adjusting the accuracy of measuring instruments and control devices. It is particularly important for equipment that measures critical parameters (pressure, temperature, flow, etc.) that impact patient safety or operational efficiency.

  • For their proper functioning: The overall goal of inspection and calibration is to ensure that utility equipment is functioning properly and reliably, meeting its intended performance specifications and safety requirements.

• Utility equipment - Examples (from Slide 33):

  • Pressure gauges of steam steriliser: Pressure gauges on steam sterilizers are critical for ensuring proper sterilization temperatures and pressures are achieved. They must be periodically calibrated to ensure accurate readings and effective sterilization.

  • Temperature gauges for medication refrigerators: Temperature gauges in medication refrigerators are crucial for maintaining the required temperature range for temperature-sensitive medications and vaccines. They must be calibrated to ensure accurate temperature readings and prevent medication spoilage or loss of efficacy.

  • Other Examples of Utility Equipment Requiring Inspection and Calibration:

    • Pressure gauges on medical gas pipelines and pressure regulators.

    • Temperature sensors in HVAC systems and temperature-controlled environments (laboratories, pharmacies).

    • Flow meters in water treatment plants and medical gas systems.

    • Electrical meters and voltage testers.

    • Scales used for medication compounding or dietary services.

• Inspect periodically:

  • Inspection Frequency: Define a periodic inspection schedule for each type of utility equipment based on manufacturer recommendations, criticality, usage frequency, and risk assessment. Inspection frequencies can range from daily checks to monthly, quarterly, semi-annual, or annual inspections.

  • Inspection Checklist: Use standardized inspection checklists to ensure comprehensive and consistent inspections. Checklists should cover:

    • Visual inspection for damage, leaks, corrosion, wear and tear.

    • Functional checks of equipment operation, alarms, and safety features.

    • Verification of readings and parameters (pressure, temperature, flow, voltage, etc.).

    • Lubrication, cleaning, and tightening of connections (as applicable).

    • Verification of calibration status and due dates.

• • Documentation of Inspection: Record all inspections in logs, documenting date, inspector name, inspection findings, any issues identified, and corrective actions taken.

• Calibrate (wherever applicable) in-house or outsource:

  • Calibration Requirement: Identify equipment that requires calibration based on manufacturer recommendations, regulatory requirements, and the criticality of the measurement or control function.

  • Calibration Frequency: Establish calibration frequencies based on equipment type, manufacturer guidelines, regulatory requirements, and accuracy requirements.

  • Calibration Methods:

    • In-house calibration: If the hospital has the necessary calibration standards, equipment, and trained personnel, calibration can be performed in-house.

    • Outsource calibration: For specialized equipment or when in-house calibration is not feasible, outsource calibration to accredited calibration laboratories or certified service providers.

• • Calibration Traceability: Ensure that calibration is traceable to national or international measurement standards. This means using calibrated reference standards and documenting the traceability chain.

  • Calibration Certificates: Obtain calibration certificates from external calibration providers or generate calibration certificates for in-house calibrations. Calibration certificates should include:

    • Equipment identification.

    • Calibration date.

    • Calibration standard used.

    • Calibration results (before and after adjustment).

    • Calibration uncertainty.

    • Due date for next calibration.

    • Name of calibrating personnel/laboratory.

• • Documentation of Calibration: Maintain calibration logs, calibration certificates, and records of calibration activities.

• Note (from Slide 33): The organisation should maintain traceability to national/international/manufacturers' guidelines/standards.

  • Traceability: Emphasizes the importance of traceability in both inspection and calibration activities.

    • Traceability to Guidelines: Inspection and calibration procedures should be based on manufacturer guidelines, relevant national or international standards (e.g., ISO standards, IEC standards), and industry best practices.

    • Traceability to Standards (Calibration): Calibration should be performed using reference standards that are traceable to national or international measurement standards (e.g., NIST in the US, NPL in India). This ensures the accuracy and reliability of calibration results.

• Note: FMS 4d is about ensuring the accuracy and reliability of utility equipment performance through regular inspection and calibration. This is not just about routine maintenance but about verifying that equipment is functioning within acceptable limits and providing accurate measurements and controls, which is crucial for patient safety, operational efficiency, and regulatory compliance.

FMS 4e: Competent personnel operate, inspect, test and maintain equipment and utility systems. (C)

(Commitment Level - C: Highlights the importance of qualified staff for infrastructure management.)

• Intent: This objective element underscores the critical role of competent personnel in ensuring the safe and effective operation, inspection, testing, and maintenance of all utility and engineering equipment and systems. Infrastructure management is not just about equipment and procedures; it's fundamentally about having qualified and trained staff to perform these tasks.

• Key Components:

  • Competent personnel: Staff who possess the necessary qualifications, knowledge, skills, experience, and training to perform their assigned tasks effectively and safely. Competence is not just about formal qualifications but also about practical skills and ongoing training.

  • Operate, inspect, test and maintain equipment and utility systems: Competent personnel are required for all aspects of equipment lifecycle management:

    • Operation: Routine operation of equipment, start-up, shutdown, and normal usage.

    • Inspection: Periodic inspections to assess equipment condition and identify issues.

    • Testing: Functional testing, performance testing, safety testing, and calibration testing.

    • Maintenance: Preventive maintenance, corrective maintenance, repairs, and overhauls.

• • Equipment and utility systems: Covers the same broad range of infrastructure systems as in previous FMS 4 objective elements.

• Personnel in-charge - Should have appropriate competency (Qualification, experience and training). (from Slide 34):

  • Appropriate Competency: Personnel assigned to operate, inspect, test, and maintain equipment must possess the required competency, which is a combination of:

    • Qualification: Formal educational qualifications, certifications, licenses, or degrees relevant to their assigned tasks (e.g., electrical engineers, mechanical engineers, biomedical engineers, HVAC technicians, plumbers, certified technicians).

    • Experience: Practical experience in operating, inspecting, testing, and maintaining similar types of equipment and systems in a hospital or similar setting.

    • Training: Specific training on the equipment they are responsible for, including:

      • Equipment-specific operation manuals and procedures.

      • Safety procedures and precautions for working with the equipment.

      • Maintenance procedures (preventive and corrective).

      • Troubleshooting techniques.

      • Emergency procedures.

      • Relevant regulations and standards.

• • • Competency Assessment: Hospitals should have a system for assessing and verifying the competency of personnel assigned to infrastructure management tasks. This may involve:

      • Review of qualifications and experience.

      • Practical skills assessments and demonstrations.

      • Written or oral examinations.

      • Performance evaluations and feedback.

• Organisation - Responsibilities to Ensure Competency (from Slide 34):

  • Ensure availability of sufficient personnel. For example: Supervisors, tradesmen, personnel trained in fire safety and electrical safety:

    • Adequate Staffing Levels: Maintain sufficient numbers of qualified personnel to effectively manage the hospital's infrastructure. Staffing levels should be based on the size and complexity of the facility, the amount of equipment, maintenance workload, and operational demands.

    • Categories of Personnel: Ensure availability of different categories of personnel with specialized skills:

      • Supervisors/Engineers: To oversee maintenance activities, plan maintenance schedules, manage teams, and provide technical guidance.

      • Tradesmen/Technicians: Skilled tradesmen (electricians, plumbers, HVAC technicians, mechanics, etc.) to perform hands-on maintenance, repairs, and installations.

      • Specialized Personnel: Personnel with specialized training in areas like fire safety, electrical safety, medical gas systems, water treatment, biomedical equipment, etc.

• • Ensure availability of necessary infrastructure, tools and PPE. For example: Ladder, voltmeter, spanner, safety boots and gloves:

    • Infrastructure Support: Provide adequate infrastructure to support maintenance activities, such as:

      • Maintenance workshops and storage areas.

      • Testing and calibration equipment.

      • Spare parts inventory and management system.

      • Access to equipment manuals and technical documentation.

• • • Tools and Equipment: Provide all necessary tools, equipment, and instruments for maintenance tasks, including:

      • Hand tools (spanners, screwdrivers, wrenches, pliers, etc.).

      • Power tools (drills, saws, grinders, etc.).

      • Testing instruments (voltmeters, multimeters, pressure gauges, thermometers, etc.).

      • Specialized tools for specific equipment maintenance.

• • • Personal Protective Equipment (PPE): Provide appropriate PPE to maintenance personnel to ensure their safety while performing their duties, including:

      • Safety helmets, safety glasses, face shields.

      • Safety boots, safety gloves (electrical resistant, chemical resistant, etc.).

      • Hearing protection, respirators (if required for specific tasks).

      • High-visibility vests.

• • Provide necessary inventories. For example: Bulbs, taps and paints:

    • Spare Parts and Consumables Inventory: Maintain an adequate inventory of essential spare parts, consumables, and materials to facilitate timely repairs and preventive maintenance. Examples:

      • Spare bulbs, lamps, lighting fixtures.

      • Spare taps, valves, plumbing fittings.

      • Paints, coatings, lubricants, filters, belts, seals, etc.

      • Commonly replaced components for critical equipment.

• • • Inventory Management System: Implement an inventory management system to track stock levels, reorder points, and ensure timely replenishment of spare parts and consumables.

• Note: FMS 4e is about investing in human capital for infrastructure management. Having competent and well-supported personnel is as important as having well-maintained equipment. Qualified staff are essential for ensuring safe, reliable, and efficient operation of the hospital's infrastructure, directly impacting patient safety and overall hospital performance.

FMS 4f: Maintenance staff is contactable round the clock for emergency repairs. (C)

(Commitment Level - C: Ensures timely response to emergencies and minimizes downtime.)

• Intent: This objective element emphasizes the need for 24/7 availability of maintenance staff to respond to emergency repairs and equipment breakdowns at any time, day or night. Hospitals operate continuously, and infrastructure emergencies can occur at any hour. Prompt response is crucial to minimize downtime and prevent disruptions to patient care.

• Key Components:

  • Maintenance staff is contactable round the clock: This means having a system in place to ensure that maintenance personnel can be reached and mobilized at any time of day or night, 24 hours a day, 7 days a week, 365 days a year.

  • For emergency repairs: The 24/7 contactability is specifically for emergency repairs - urgent situations that require immediate attention to prevent patient safety risks, service disruptions, or equipment damage. This is not necessarily for routine maintenance requests that can be scheduled during regular working hours.

• System for 24/7 Contactability and Response - Options:

  • On-call Roster: Maintain an on-call roster for different trades (electrical, plumbing, HVAC, biomedical, etc.) that rotates among maintenance staff. On-call staff are responsible for being available to respond to emergency calls outside of regular working hours.

  • Dedicated Shift Staff: Have a dedicated team of maintenance staff working in shifts, including night shifts and weekends, to provide 24/7 coverage. This may be more suitable for larger hospitals with a higher volume of emergency maintenance needs.

  • Outsourced Emergency Maintenance Contracts: Establish contracts with external maintenance service providers who can provide 24/7 emergency response for specific equipment or systems (e.g., elevator maintenance, DG set maintenance).

  • Combination of Approaches: A hybrid approach combining on-call roster for in-house staff and outsourced contracts for specialized equipment may be optimal for some hospitals.

• Is the staff on duty not able to perform emergency repair? (from Slide 35):

  • Escalation Protocol: Establish a clear escalation protocol for situations where the staff initially contacted (e.g., on-duty shift staff) are not able to handle the emergency repair, either due to complexity, skill limitations, or workload.

  • Ensure availability of more qualified/experience staff to perform the task. (from Slide 35): The escalation protocol should ensure that:

    • More qualified staff can be contacted: The on-call roster should include senior technicians, supervisors, or engineers who have higher levels of expertise and can handle more complex emergency repairs.

    • Experienced staff can be mobilized: Even if not on the immediate on-call roster, experienced maintenance staff who are familiar with the hospital's infrastructure and equipment should be readily contactable and able to be mobilized if needed for critical emergencies.

    • Timely Escalation: The escalation process should be efficient and timely to avoid delays in response to emergencies.

• Points to Remember (from Slide 35) - Maintenance escalation matrix:

  • Maintenance escalation matrix: Develop a written maintenance escalation matrix that clearly defines:

    • Contact points for different types of emergencies: Specific contact numbers for electrical emergencies, plumbing emergencies, HVAC emergencies, elevator emergencies, etc.

    • Levels of escalation: Initial contact (e.g., on-duty staff), first level escalation (on-call supervisor), second level escalation (engineering manager), etc.

    • Contact information for each escalation level: Phone numbers, pager numbers, email addresses, etc.

    • Response time expectations for each escalation level.

• • "It should be available at the nursing station and other departments." The maintenance escalation matrix should be readily accessible and visible at nursing stations, key departments (e.g., emergency, ICU, OT), security control rooms, and other relevant locations so that staff can quickly access contact information in emergencies.

  • Maintenance staff - "It should be available 24/7." Reiterates the core requirement of 24/7 availability of maintenance staff for emergency repairs.

• Note: FMS 4f is about ensuring rapid response to infrastructure emergencies. Having a 24/7 contactable maintenance team and a clear escalation protocol is crucial for minimizing downtime, mitigating patient safety risks, and ensuring the continuous operation of essential hospital services, even in the face of unexpected equipment failures or utility disruptions.

FMS 4g: Downtime for critical equipment breakdowns is monitored from reporting to inspection and implementation of corrective actions. (A)

(Achievement Level - A: Demonstrates a higher level of performance in equipment management.)

• Intent: This objective element focuses on performance monitoring and improvement in equipment maintenance. It emphasizes the need to track and analyze downtime for critical equipment breakdowns, from the initial report to the final implementation of corrective actions. Monitoring downtime helps identify areas for improvement in maintenance practices, equipment reliability, and response times.

• Key Components:

  • Downtime for critical equipment breakdowns: Focuses specifically on downtime associated with critical equipment. Downtime is the period when equipment is out of service due to failure or breakdown.

  • Critical equipment: Equipment that is essential for patient care, life support, critical diagnostics, or essential hospital operations. Breakdown of critical equipment can have significant negative consequences.

  • Is monitored from reporting to inspection and implementation of corrective actions: Downtime monitoring should encompass the entire lifecycle of a breakdown event:

    • Reporting: Time when the breakdown is reported by users or staff.

    • Inspection: Time taken for maintenance personnel to inspect the equipment and diagnose the problem.

    • Implementation of corrective actions: Time taken to repair the equipment, procure spare parts, perform necessary maintenance, and restore equipment functionality.

• • Monitored: Downtime must be actively tracked, recorded, and analyzed to identify trends, areas for improvement, and measure performance.

• Define critical engineering and utility equipment. At a minimum, it should include: DG set, Lifts, UPS, Fire related equip, RO water plant-dialysis, Water pumps. (from Slide 36):

  • Definition of Critical Equipment: The hospital must define its own list of critical equipment that requires downtime monitoring. This list should be based on a risk assessment and should include equipment whose failure would have a significant impact on patient care or hospital operations.

  • Minimum List Examples (Slide 36): The slide provides a minimum list of examples, which hospitals should consider including in their critical equipment list:

    • DG set (Diesel Generator Set): Emergency power supply.

    • Lifts (Elevators): Patient and staff transport, especially in multi-story buildings.

    • UPS (Uninterruptible Power Supply): Backup power for critical equipment during power interruptions.

    • Fire related equipment: Fire alarms, sprinklers, fire extinguishers, essential for fire safety.

    • RO water plant-dialysis: Essential for dialysis water purification and patient care in dialysis units.

    • Water pumps: Essential for water supply to various parts of the hospital.

• • Hospital-Specific Critical Equipment: Hospitals should expand this list to include other equipment critical to their specific services and operations, such as:

    • Medical gas plants (oxygen, nitrous oxide, etc.).

    • HVAC systems (especially in OTs, ICUs, laboratories).

    • Sterilization equipment (autoclaves, ETO sterilizers).

    • Critical medical equipment (ventilators, patient monitors, infusion pumps, dialysis machines, etc.).

    • Communication systems, IT infrastructure, security systems.

• Maintain complaint attendance register (physical/electronic). Indicate date and time of: Receipt of complaint, Allotment of job, Completion of job. (from Slide 36):

  • Complaint Attendance Register: Establish a system (physical register or electronic system) to log all equipment breakdown complaints or maintenance requests.

  • Key Data Points to Record in Register:

    • Date and Time of Receipt of Complaint: Record the exact date and time when the equipment breakdown is reported. This marks the start of downtime.

    • Date and Time of Allotment of Job: Record the date and time when the maintenance job is assigned to maintenance personnel for inspection and repair.

    • Date and Time of Completion of Job: Record the date and time when the repair is completed, and the equipment is restored to functional status. This marks the end of downtime.

    • Other Relevant Information: Equipment ID, location, department reporting the breakdown, description of the problem, name of maintenance personnel assigned, root cause analysis (if conducted), corrective actions taken, spare parts used.

• Points to Remember (from Slide 36):

  • User department: Ratify completion of job: After repair is completed, the user department (department that reported the breakdown) should ratify or confirm that the equipment is functioning correctly and the job is completed to their satisfaction. This ensures user verification and closure of the maintenance request.

  • Start of downtime: Time when complaint was lodged: Downtime starts from the moment the complaint is reported.

  • End of downtime: Time when completion of job was ratified: Downtime ends when the user department confirms job completion and equipment functionality. The downtime duration is the time elapsed between these two points.

• Downtime Analysis and Reporting:

  • Downtime Calculation: Calculate downtime duration for each breakdown event (End time - Start time).

  • Downtime Metrics: Track and analyze downtime metrics for critical equipment over time, such as:

    • Mean Time To Repair (MTTR): Average time taken to repair a breakdown (total downtime / number of breakdowns). Lower MTTR is better.

    • Mean Time Between Failures (MTBF): Average time between equipment failures (total uptime / number of breakdowns). Higher MTBF is better.

    • Total Downtime per Period (e.g., per month, per quarter): Total accumulated downtime for all critical equipment during a specific period.

    • Frequency of Breakdowns: Number of breakdowns for each equipment type or category.

• • Trend Analysis: Analyze downtime data to identify trends, recurring equipment failures, and areas where maintenance performance can be improved.

  • Reporting to Management: Regularly report downtime metrics and analysis findings to hospital management, engineering department, and safety committee to inform maintenance planning, equipment replacement decisions, and quality improvement initiatives.

• Note: FMS 4g is about data-driven maintenance management. By systematically monitoring downtime, analyzing trends, and using data to inform maintenance strategies, hospitals can improve equipment reliability, reduce downtime, enhance operational efficiency, and ultimately improve patient care and safety.

FMS 4h: Written guidance supports equipment replacement, identification of unwanted material and disposal. * (C)

(Commitment Level - C: Asterisk indicates mandatory documentation. Written guidance for equipment replacement and disposal is required.)*

• Intent: This objective element focuses on planned and systematic equipment lifecycle management, specifically addressing equipment replacement, identification of unwanted material, and proper disposal. It emphasizes that equipment lifecycle decisions should be guided by written procedures and strategic considerations, not just ad-hoc decisions.

• Key Components:

  • Written guidance supports equipment replacement: The hospital must have documented guidelines or procedures for making decisions about equipment replacement. Replacement should be a planned activity, not just reactive to breakdowns.

  • Identification of unwanted material and disposal: This also links back to FMS 3d and emphasizes that procedures for identifying and disposing of unwanted materials should be part of the overall equipment lifecycle management and facility management programme.

  • Guidance supports: The written guidance should provide a framework and criteria to support decision-making, not necessarily rigid rules, allowing for flexibility based on specific circumstances.

• Replace/dispose (condemn): Based on strategic plans, upgrade/update path and equipment log. (from Slide 37):

  • Criteria for Equipment Replacement/Disposal - Guiding Factors: Decisions to replace or dispose of equipment should be based on a combination of factors outlined in the written guidance:

    • Strategic Plans: Alignment with the hospital's strategic plan and service expansion plans. If equipment is no longer aligned with the hospital's strategic direction or if newer technology offers significant advantages, replacement may be considered.

    • Upgrade/update path: Availability of equipment upgrades or updates that can extend the equipment's lifespan, improve performance, or enhance functionality. If upgrades are not feasible or cost-effective, replacement may be a better option.

    • Equipment Log (maintenance history, performance data, downtime): Review equipment logs (as per FMS 4b and 4g) to assess equipment condition, maintenance history, breakdown frequency, downtime, repair costs, and performance trends. Equipment with frequent breakdowns, high repair costs, declining performance, or exceeding its useful lifespan should be considered for replacement.

    • Other Factors:

      • Age of equipment and expected lifespan: Equipment approaching or exceeding its expected lifespan may be prone to failures and higher maintenance costs.

      • Availability of spare parts and maintenance support: If spare parts are becoming difficult to obtain or maintenance support is diminishing, replacement may be necessary to ensure continued equipment functionality.

      • Safety and regulatory compliance: If equipment no longer meets current safety standards or regulatory requirements, replacement is mandatory.

      • Technological obsolescence: If equipment is technologically obsolete and newer technology offers significant clinical or operational advantages, replacement may be considered for improved patient care or efficiency.

      • Life cycle cost analysis: Compare the cost of continued maintenance and repair versus the cost of replacement, considering long-term operational expenses, energy efficiency, and potential benefits of newer equipment.

• Written Guidance Content - Key Elements:

  • Procedure for Equipment Replacement Decisions: Outline the process for initiating equipment replacement requests, evaluation criteria, approval process, and documentation requirements.

  • Criteria for Equipment Condemnation: Clearly define criteria for condemning equipment as unusable, based on factors like age, condition, repair costs, obsolescence, and safety concerns.

  • Disposal Procedures: Outline procedures for proper and responsible disposal of condemned equipment, considering environmental regulations, data security (for equipment containing patient data), and potential for recycling or reuse (where applicable and ethical). Link to FMS 3d procedures for disposal of unwanted materials.

  • Budgeting and Financial Approval: Address budgeting for equipment replacement, financial approval processes, and considerations for capital expenditure planning.

  • Roles and Responsibilities: Clearly define roles and responsibilities for equipment replacement decisions (e.g., department heads, engineering department, procurement department, finance department, equipment committee).

• Maintain: Records of condemnation and disposal of equipment and waste. (from Slide 37):

  • Documentation of Condemnation and Disposal: Maintain records of all equipment condemnation and disposal activities, including:

    • Equipment identification and description.

    • Date of condemnation.

    • Reason for condemnation.

    • Authorization for condemnation.

    • Disposal method used (e.g., recycling, donation, disposal as waste).

    • Date of disposal.

    • Disposal records or certificates (if applicable).

• Note (from Slide 37): The organisation should dispose unusable utility & engineering equipment and waste material in a systematic manner. Reinforces the need for a planned and systematic approach to equipment disposal, not just haphazardly discarding old equipment.

• Note: FMS 4h is about strategic equipment lifecycle management. By having written guidance for equipment replacement and disposal, hospitals can make informed decisions, optimize equipment investments, ensure responsible disposal of obsolete equipment, and maintain a modern and efficient infrastructure that supports quality patient care for the long term.

In summary, FMS 4 is a comprehensive standard that establishes the framework for a robust and systematic programme for managing the hospital's facility, engineering support services, and utility systems. By focusing on planning, inventory, maintenance, competency, emergency response, performance monitoring, and lifecycle management, FMS 4 ensures that the hospital's infrastructure is reliable, efficient, safe, and effectively supports its mission of providing quality healthcare services.

FMS 5: The Organisation has a Programme for Medical Equipment Management 

Standard Overview:

FMS 5 marks a shift in focus from general facility and utility management to the specialized domain of Medical Equipment Management. This standard recognizes that medical equipment is at the heart of healthcare delivery, directly impacting diagnosis, treatment, monitoring, and patient safety. FMS 5 mandates that hospitals must have a comprehensive and well-structured programme for managing their medical equipment throughout its lifecycle – from planning and procurement to operation, maintenance, calibration, and eventual disposal. This programme ensures that medical equipment is safe, effective, reliable, and readily available when needed for patient care.

Why is a Programme for Medical Equipment Management Crucial in Hospitals?

• Patient Safety: Medical equipment malfunctions, inaccuracies, or improper use can directly harm patients. A robust management programme minimizes risks associated with equipment failures, ensures equipment is safe for patient use, and promotes error-free operation.

• Clinical Effectiveness and Quality of Care: Accurate and functional medical equipment is essential for effective diagnosis, treatment, and monitoring. Proper management ensures equipment performs optimally, contributing to accurate diagnoses, effective therapies, and improved patient outcomes.

• Regulatory Compliance and Accreditation: Hospitals are subject to stringent regulations related to medical device safety and quality. NABH accreditation mandates compliance with FMS 5, demonstrating adherence to best practices in medical equipment management.

• Equipment Longevity and Cost Optimization: Preventive maintenance, regular calibration, and planned replacement extend the lifespan of medical equipment, maximizing their return on investment and optimizing equipment-related costs. Reactive maintenance and premature replacements are significantly more expensive in the long run.

• Operational Efficiency: A well-managed medical equipment programme reduces equipment downtime, ensures equipment availability when needed, and minimizes disruptions to clinical workflows, enhancing overall operational efficiency.

• Technological Advancement and Innovation: A systematic programme facilitates the adoption of new medical technologies, upgrades, and replacements in a planned and strategic manner, keeping the hospital at the forefront of medical advancements and improving service delivery.

• Accountability and Traceability: A structured programme with inventory, logs, and documentation ensures accountability for medical equipment, facilitates traceability of maintenance and calibration history, and supports informed decision-making regarding equipment lifecycle management.

Let's delve into the Objective Elements of FMS 5 in detail:

FMS 5a: The organisation plans for medical equipment in accordance with its services and strategic plan. (C)

(Commitment Level - C: Emphasizes strategic and service-aligned equipment planning.)

• Intent: This objective element emphasizes that medical equipment planning must be strategic and directly aligned with the hospital's service offerings and overall strategic direction. Equipment procurement, upgrades, and replacements should not be isolated decisions but rather be part of a broader strategic framework that supports the hospital's clinical goals and service delivery model.

• Key Components:

  • The organisation plans for medical equipment: Planning should be a formal and documented process, indicating a systematic approach to medical equipment management. This involves defined processes for needs assessment, budgeting, procurement, and lifecycle planning.

  • In accordance with its services and strategic plan: Medical equipment planning must be directly driven by:

    • Hospital Services: The specific medical services offered by the hospital (e.g., cardiology, oncology, orthopedics, critical care, surgery) directly determine the types and quantities of medical equipment required. Expansion or changes in service offerings will necessitate adjustments in equipment planning.

    • Strategic Plan: The hospital's long-term strategic plan (e.g., expansion of specialties, increasing bed capacity, developing centers of excellence, adopting advanced technologies, improving patient experience) should guide medical equipment investments. Equipment procurement and upgrades should be strategically aligned to support the hospital's overall vision and goals.

• Consider future requirements while planning.

  • Anticipating Future Needs: Medical equipment planning must look beyond immediate needs and anticipate future requirements based on:

    • Projected Patient Volume: Estimate future patient volume for different services and plan equipment capacity accordingly.

    • Service Expansion Plans: If the hospital plans to expand existing services or introduce new specialties, equipment planning must factor in the equipment needs for these expansions.

    • Technological Advancements: Anticipate future technological advancements in medical equipment and plan for upgrades or replacements to adopt newer technologies and enhance clinical capabilities.

    • Obsolescence and Replacement Cycles: Plan for the eventual obsolescence and replacement of existing equipment based on their expected lifespans and technological advancements.

• Ensure it is appropriate to scope of services.

  • Scope of Services Alignment: Equipment procurement must be directly relevant and appropriate to the scope of services offered by each department and the hospital as a whole. Avoid procuring equipment that is not needed or underutilized for the services provided.

  • Matching Equipment to Service Needs: Carefully assess the specific equipment needs for each department and service line, considering:

    • Types of procedures and treatments performed.

    • Patient demographics and case mix.

    • Volume of procedures and patient throughput.

    • Specialized equipment needs for specific services (e.g., cardiac catheterization lab equipment for cardiology, linear accelerator for radiation oncology).

• Define differential financial clearance based on the policy. For example: Departmental head can decide on purchase of BP apparatus.

  • Financial Clearance Policy: Establish a clear policy and process for financial clearance and approval of medical equipment purchases. This policy should define different levels of financial authority and approval based on equipment cost, criticality, and budget implications.

  • Differential Approval Levels: Implement a system of differential financial clearance, where lower-value, routine equipment purchases can be approved at departmental levels (e.g., departmental heads), while higher-value, more critical equipment purchases require higher levels of approval (e.g., hospital administration, equipment committee, finance committee).

  • Example - BP Apparatus: For routine, lower-cost items like blood pressure (BP) apparatus, the departmental head (e.g., head of nursing, OPD in-charge) may be authorized to make purchase decisions within a defined budget, streamlining the procurement process for everyday equipment. This reduces bureaucracy and allows for faster acquisition of essential items.

• Select, rent, update or upgrade equipment by a collaborative process.

  • Collaborative Decision-Making: Decisions regarding medical equipment selection, procurement, rental, upgrades, and updates should be made through a collaborative process involving relevant stakeholders.

  • Stakeholders in Collaborative Process (Point to Remember on Slide 39):

    • End-users: Clinicians (doctors, nurses, technicians) who will directly use the equipment. Their clinical expertise, understanding of patient needs, and operational requirements are crucial for informed equipment selection.

    • Management: Hospital administration and senior management to ensure alignment with strategic goals, budget constraints, and overall hospital priorities.

    • Finance: Finance department to manage budget allocation, procurement costs, and financial aspects of equipment investments.

    • Engineering & Biomedical: Biomedical engineering department to provide technical expertise on equipment specifications, compatibility, maintenance requirements, and lifecycle costs. Engineering department may be involved for facility infrastructure compatibility (electrical, space, etc.).

• • Benefits of Collaborative Process:

    • Clinically Relevant Equipment Selection: Ensures equipment chosen meets the specific clinical needs of patients and practitioners.

    • Improved User Satisfaction: Involving end-users in the selection process increases their ownership and satisfaction with the equipment.

    • Optimized Resource Allocation: Ensures equipment investments are financially sound and strategically aligned with hospital priorities.

    • Reduced Errors and Incompatibility Issues: Collaborative input minimizes the risk of selecting inappropriate equipment or overlooking important technical or operational considerations.

• Point to Remember (from Slide 39) - Refer IPHS guideline for minimum medical equipment.

  • IPHS Guidelines: IPHS (Indian Public Health Standards) guidelines, while primarily for public health facilities, provide benchmarks and recommendations for minimum equipment requirements at different levels of healthcare facilities. Hospitals can refer to IPHS guidelines as a starting point or reference for determining the minimum medical equipment needed for various services and departments.

  • Benchmarking and Guidance: IPHS guidelines can help hospitals assess their equipment adequacy, identify potential gaps in equipment inventory, and provide a basis for planning minimum equipment requirements. However, hospitals should also consider their specific service mix, patient load, and strategic goals when determining their equipment needs, going beyond just the minimum IPHS recommendations if necessary.

• Note: FMS 5a is about strategic medical equipment planning that is driven by clinical needs, service offerings, and the hospital's overall strategic vision. A well-planned approach ensures that equipment investments are effective, sustainable, and contribute to improved patient care and hospital performance.

FMS 5b: Medical equipment is inventoried and proper logs are maintained as required. (C)

(Commitment Level - C: Fundamental for medical equipment asset management and accountability.)

• Intent: This objective element emphasizes the basic principles of asset management specifically for medical equipment. Having a comprehensive inventory and maintaining proper logs is crucial for tracking medical devices, managing maintenance, ensuring accountability, and facilitating regulatory compliance.

• Key Components:

  • Medical equipment is inventoried: All medical equipment, including medical devices, must be systematically inventoried and recorded in a dedicated medical equipment inventory system (register, database, or CMMS - Computerized Maintenance Management System). This inventory serves as a central record of all medical equipment assets.

  • Proper logs are maintained: For each piece of medical equipment, proper logs must be maintained to record essential information, maintenance activities, calibration records, performance history, and other relevant details specific to medical devices. These logs are crucial for equipment lifecycle management, regulatory compliance, and patient safety.

  • As required: The extent of inventory information and the types of logs maintained should be "as required" - meaning they should be sufficient to effectively manage and maintain medical equipment, meet regulatory requirements for medical devices, and support hospital operations and patient safety. The "Document" section on Slide 40 and subsequent objective elements provide guidance on what to document.

• Classify (from Slide 40): Medical equipment and medical devices based on risk defined by medical devices regulations.

  • Risk-Based Classification: Medical equipment and medical devices should be classified based on their risk level, as defined by medical device regulations (e.g., CDSCO - Central Drugs Standard Control Organization in India, FDA in the US, EU MDR in Europe).

  • Risk Classes: Medical device regulations typically classify devices into different risk classes (e.g., Class A, B, C, D or Class I, IIa, IIb, III) based on the potential risk to patients and users associated with their use. Higher risk classes (e.g., Class D or Class III) are subject to more stringent regulatory controls and require more rigorous management.

  • Classification Criteria: Risk classification is usually based on factors like:

    • Intended use of the device.

    • Potential for harm if the device malfunctions or is used incorrectly.

    • Duration of contact with the patient.

    • Invasiveness of the device.

    • Whether the device supports or sustains life.

• • Importance of Classification: Risk classification informs the level of management and control required for each device. Higher-risk devices will require more stringent maintenance, calibration, and monitoring procedures. Inventory systems should include risk classification information for each device.

• Provide (from Slide 40): Unique identifier for all equipment (including equipment on rental basis and used for demonstration purpose).

  • Unique Identifier: Assign a unique identifier (equipment ID, asset tag number, barcode, QR code) to each piece of medical equipment, including:

    • Owned Equipment: Equipment purchased and owned by the hospital.

    • Rental Equipment: Equipment rented or leased from external vendors (important to track rented equipment as well).

    • Demonstration/Loaner Equipment: Equipment provided by vendors for demonstration or evaluation purposes (also needs to be tracked and managed while in the hospital).

• • Purpose of Unique Identifier: Unique identifiers are essential for:

    • Accurate Inventory Tracking: Distinguishing between individual pieces of equipment of the same type.

    • Maintenance and Calibration Records: Linking maintenance and calibration logs to specific equipment instances.

    • Location Tracking: Knowing the current location of each piece of equipment within the hospital.

    • Accountability: Assigning responsibility for specific equipment to departments or individuals.

    • Asset Management: Tracking equipment lifecycle, depreciation, and replacement planning.

    • Theft Prevention: Deterring theft and facilitating equipment recovery if lost or stolen.

• Document (from Slide 40): Quality conformance certificates/marks, manufacturer factory test certificate.

  • Documentation to Maintain for Each Medical Equipment Item:

    • Quality Conformance Certificates/Marks: Obtain and retain quality certificates (e.g., ISO 13485 certification for medical devices, CE marks for devices marketed in the European Union, BIS certification in India) and conformance marks that demonstrate the equipment meets applicable quality and safety standards. These certificates provide assurance of equipment quality and regulatory compliance.

    • Manufacturer Factory Test Certificate: Obtain and retain the manufacturer's factory test certificate, which verifies that the equipment has passed factory testing and meets specified performance standards before shipment. This certificate provides evidence of equipment quality and functionality at the time of manufacture.

• Other Essential Information to Include in Medical Equipment Inventory (Beyond Slide 40 - expanding on "as required"):

  • Equipment Name/Description: Precise and descriptive name of the equipment (e.g., "Patient Monitor - Multiparameter," "Infusion Pump - Volumetric").

  • Manufacturer and Model: Manufacturer's name and equipment model number for identification, spare parts sourcing, and technical documentation.

  • Serial Number: Equipment serial number for unique identification and warranty tracking.

  • Location: Current location of the equipment within the hospital (department, room number).

  • Date of Purchase/Installation: Date of acquisition or installation for depreciation, warranty tracking, and lifecycle management.

  • Supplier/Vendor: Name and contact information of the equipment supplier or vendor.

  • Warranty Information: Warranty period, terms, and contact details for warranty claims.

  • Commissioning Date: Date when the equipment was commissioned and put into clinical use.

  • Risk Classification (as per medical device regulations).

  • Preventive Maintenance Schedule: Defined schedule for preventive maintenance tasks.

  • Calibration Schedule: Defined schedule for calibration (if applicable).

  • Responsible Department/User: Department or individual primarily responsible for the equipment's use and upkeep.

• Note: FMS 5b is about establishing a comprehensive and well-organized medical equipment inventory system as a foundational element of medical equipment management. This inventory, along with associated documentation and logs, provides the essential data for effective maintenance planning, performance monitoring, regulatory compliance, and informed decision-making regarding equipment lifecycle and replacements.

FMS 5c: The documented operational and maintenance (preventive and breakdown) plan for medical equipment is implemented. (CO)*

(Core Objective Element - CO: Asterisk indicates mandatory documentation. A documented operational and maintenance plan for medical equipment is a critical requirement.)*

• Intent: This objective element emphasizes the importance of a documented and implemented operational and maintenance plan specifically for medical equipment. This plan should encompass both operational procedures (for safe and effective equipment use) and maintenance procedures (preventive and breakdown) to ensure equipment reliability, longevity, and patient safety. It's about proactively managing medical equipment rather than just reacting to failures.

• Key Components:

  • Documented operational and maintenance (preventive and breakdown) plan for medical equipment: The hospital must have a written plan dedicated to medical equipment that outlines procedures for:

    • Equipment Operation: Standard operating procedures (SOPs) for safe and effective use of each type of medical equipment, including pre-use checks, operating instructions, safety precautions, and user responsibilities.

    • Preventive Maintenance (PM): Scheduled maintenance tasks performed at regular intervals to prevent equipment failures, extend equipment lifespan, maintain performance accuracy, and ensure safety.

    • Breakdown Maintenance (BM) / Corrective Maintenance (CM): Procedures for responding to medical equipment breakdowns, malfunctions, or failures, including troubleshooting, repair, and restoration of equipment functionality.

• • Is implemented: The documented plan must be actively implemented in practice. This means:

    • Operational procedures are followed by equipment users.

    • Preventive maintenance schedules are adhered to.

    • Breakdown maintenance is responded to promptly and effectively.

    • Maintenance activities are documented in logs (as per FMS 5b).

    • Resources (personnel, budget, spare parts) are allocated for plan implementation.

• Content of the Operational and Maintenance Plan - Key Elements (from Slide 41):

  • Equipment operation:

    • Operator: Is trained to handle equipment: Ensure that all personnel who operate medical equipment (clinicians, nurses, technicians, etc.) are properly trained on the specific equipment they are authorized to use. Training should cover:

      • Equipment operation procedures (start-up, operation, shutdown).

      • Safety features and precautions.

      • Troubleshooting basic issues.

      • User responsibilities and reporting procedures.

      • Relevant SOPs and equipment manuals.

• • • Organisation: Use original equipment manual/develop a plan for the concerned equipment: The hospital should utilize the original equipment manufacturer's (OEM) manuals as the primary source of information for developing operational procedures and maintenance schedules. If OEM manuals are insufficient or not available, the hospital should develop its own detailed operational and maintenance plans based on best practices and expert input.

• • Operational plan:

    • Should assist operator in operating equipment daily: Provide readily accessible operational plans or SOPs to assist operators in the daily use of medical equipment. These plans should be user-friendly, concise, and readily available at the point of use.

    • Should include evaluation of safe usage of equipment (validation with respect to instruction manual), user training of equipment, operational check and verification of set parameter: Operational plans should encompass elements that ensure safe and effective equipment usage:

      • Evaluation of safe usage (validation with respect to instruction manual): Operational procedures should be validated against the manufacturer's instruction manual to ensure safe and correct usage practices.

      • User training of equipment: As mentioned above, training is a critical component of safe operation. Operational plans should reinforce the need for proper user training and competency assessment.

      • Operational check: Daily or pre-use checks should be included in operational plans to verify equipment functionality and safety before each use (e.g., visual inspection, self-tests, basic functional checks).

      • Verification of set parameter: Operational plans should include steps to verify that equipment parameters (e.g., settings, dosages, modes) are correctly set before each use, based on patient needs and clinical protocols.

• • Maintenance plan:

    • Should include periodic checks, execution of timely preventive maintenance and response to breakdown (even at night and weekends): The maintenance plan should be comprehensive and address:

      • Periodic checks: Regular inspections, functional checks, and performance tests performed at scheduled intervals (e.g., daily, weekly, monthly) to proactively identify potential issues and ensure equipment is in good working order.

      • Execution of timely preventive maintenance: Preventive maintenance tasks (cleaning, lubrication, parts replacement, adjustments, etc.) must be executed on time according to the defined schedule to prevent equipment failures and extend lifespan.

      • Response to breakdown (even at night and weekends): The maintenance plan must include procedures for responding to equipment breakdowns and malfunctions promptly, even outside of regular working hours (nights, weekends, holidays), as medical equipment emergencies can occur at any time. This links back to FMS 4f regarding 24/7 maintenance staff availability.

• Note (from Slide 41): There should be a planned preventive maintenance tracker. Similar to FMS 4c, a preventive maintenance tracker is essential for medical equipment as well.

  • Preventive Maintenance Tracker (for Medical Equipment): Use a system (CMMS, spreadsheets, databases) to track planned preventive maintenance schedules for medical equipment, completed PM tasks, upcoming PM, and overdue PM. This ensures PM is performed as scheduled and not missed.

  • Benefits of PM Tracker (Medical Equipment): Improved equipment reliability, reduced downtime, extended equipment lifespan, enhanced patient safety, proactive identification of maintenance needs, and better compliance with regulatory requirements.

• Note: FMS 5c is about establishing a proactive and systematic approach to medical equipment operation and maintenance. A well-documented and implemented plan, encompassing operational procedures, preventive maintenance, and breakdown response, is crucial for ensuring medical equipment safety, reliability, effectiveness, and longevity, ultimately contributing to improved patient care and safety within the hospital.

FMS 5d: Medical equipment is periodically inspected and calibrated for their proper functioning. (C)

(Commitment Level - C: Emphasizes regular verification of medical equipment performance and accuracy, especially for measurement devices.)

• Intent: This objective element emphasizes the critical need for periodic inspection and calibration of medical equipment, especially those used for measurement and monitoring patient vital signs or delivering therapies. Inspection verifies physical condition and functionality, while calibration ensures the accuracy and reliability of measurements, which is paramount for accurate diagnosis, treatment, and patient safety.

• Key Components:

  • Medical equipment: Refers to all medical equipment, but this objective element is particularly focused on equipment used for measurement and monitoring.

  • Is periodically inspected: Regular physical inspections of medical equipment to assess their condition, identify potential problems, and ensure they are functioning correctly and safely.

  • And calibrated (wherever applicable): Calibration is the process of verifying and adjusting the accuracy of measuring instruments. It's essential for medical equipment that provides quantitative measurements (e.g., vital signs monitors, infusion pumps, ventilators, lab equipment) to ensure readings are accurate and reliable. Calibration is "wherever applicable" because not all medical equipment requires calibration (e.g., simple examination lights).

  • For their proper functioning: The overall goal of inspection and calibration is to ensure that medical equipment is functioning properly and accurately, meeting its intended performance specifications and safety requirements, and providing reliable data for clinical decision-making.

• Medical equipment (Used for measurement) - Examples (from Slide 42):

  • Medical equipment (Used for measurement): The slide title explicitly clarifies the focus on measurement equipment.

  • Pressure gauges of steam steriliser: (Already mentioned in FMS 4d, but also relevant for medical sterilization processes).

  • Temperature gauges for medication refrigerators: (Also mentioned in FMS 4d, but equally crucial for medication safety).

  • Other Examples of Medical Equipment Requiring Inspection and Calibration:

    • Patient monitors (ECG, SpO2, NIBP, respiration monitors).

    • Infusion pumps (syringe pumps, volumetric pumps).

    • Ventilators.

    • Defibrillators and pacemakers.

    • Electrosurgical units (ESUs).

    • Audiometers and spirometers.

    • Laboratory equipment (analyzers, centrifuges, microscopes).

    • Weighing scales (patient scales, infant scales).

    • Thermometers and sphygmomanometers (if electronic or requiring calibration).

    • Medical imaging equipment (X-ray, CT, MRI scanners - although calibration for these is highly specialized and often vendor-managed).

• Inspect periodically (Weekly/monthly/annually). (from Slide 42):

  • Inspection Frequency: Define inspection frequencies for different types of medical equipment based on:

    • Manufacturer recommendations.

    • Equipment criticality and risk level.

    • Frequency of use.

    • Regulatory requirements.

    • Hospital policy.

    • Examples of Inspection Frequencies (from Slide 42): "Weekly/monthly/annually" - indicating a range of frequencies depending on the equipment. Daily or pre-use checks may also be necessary for certain equipment.

• • Inspection Checklist: Develop standardized inspection checklists for each type of medical equipment, covering:

    • Visual inspection for damage, wear and tear, leaks, loose connections, frayed cables, etc.

    • Functional checks of equipment operation, controls, displays, alarms, and safety features.

    • Verification of readings and parameters (if applicable, though calibration is the primary method for accuracy verification).

    • Cleaning and disinfection (as appropriate).

    • Verification of calibration status and due dates.

• • Documentation of Inspection: Record all inspections in equipment logs, documenting date, inspector name, inspection findings, any issues identified, and corrective actions taken.

• Calibrate (wherever applicable) inhouse or outsource. (from Slide 42):

  • Calibration Requirement: Determine which medical equipment requires calibration based on manufacturer specifications, regulatory requirements, risk assessment, and clinical needs for accurate measurements.

  • Calibration Frequency: Establish calibration frequencies for each calibrated medical device, typically based on manufacturer recommendations and regulatory guidelines. Calibration intervals can range from monthly to annually, or even less frequent for some equipment.

  • Calibration Methods:

    • In-house calibration: If the hospital has a well-equipped biomedical engineering department with trained personnel, calibration can be performed in-house for certain types of equipment.

    • Outsource calibration: For specialized or high-precision equipment, or when in-house calibration is not feasible, outsource calibration to accredited calibration laboratories or certified service providers. Outsourcing is common for complex equipment like ventilators, defibrillators, and certain lab analyzers.

• • Calibration Traceability: Ensure calibration is traceable to national or international measurement standards (e.g., NIST, NPL).

  • Calibration Certificates: Obtain calibration certificates from external providers or generate certificates for in-house calibrations, documenting: equipment ID, calibration date, standard used, results, uncertainty, next calibration date, and calibrating personnel/lab.

• Commission for use (only after calibration and conformance testing). (from Slide 42):

  • Pre-use Commissioning: Before putting new or repaired/maintained medical equipment back into clinical use, it must undergo a proper commissioning process.

  • Commissioning Steps:

    • Calibration (if applicable): Ensure equipment requiring calibration is calibrated before commissioning.

    • Conformance Testing: Conduct conformance testing to verify that the equipment is functioning as per manufacturer specifications, meets safety standards, and performs accurately. This may include functional tests, performance tests, and safety tests.

    • Documentation of Commissioning: Document the commissioning process and results, including calibration certificates, conformance test reports, and a sign-off confirming the equipment is ready for clinical use.

    • "Only after calibration and conformance testing": This emphasizes that equipment should not be put into clinical use until commissioning, including calibration and conformance testing, is successfully completed.

• Maintain traceability to national/ international/ manufacturers' guidelines /standards. (from Slide 42):

  • Traceability (Medical Equipment): Similar to FMS 4d, traceability is crucial for medical equipment inspection and calibration.

    • Traceability to Guidelines/Standards: Inspection and calibration procedures should be based on manufacturer guidelines, relevant medical device standards (e.g., IEC 60601 series for medical electrical equipment, ISO 13485 for medical device quality management), and national/international standards for metrology and calibration.

    • Traceability to Measurement Standards (Calibration): Calibration standards and reference instruments used should be traceable to national or international measurement standards to ensure the accuracy and reliability of calibration results.

• Points to Remember (from Slide 42) - Medical equipment should be re-calibrated after repair/ breakdown.

  • Re-calibration after Repair/Breakdown: Whenever medical equipment that requires calibration undergoes repair or breakdown maintenance that could potentially affect its measurement accuracy, it must be re-calibrated before being returned to clinical use. Repair or component replacement can alter calibration settings, so re-calibration is essential to verify and restore accuracy.

• Note: FMS 5d is about ensuring the accuracy and reliability of medical equipment measurements through regular inspection and calibration. This is not just a technical requirement; it's a fundamental aspect of patient safety, as accurate medical measurements are the foundation for proper diagnosis, treatment planning, and monitoring of patient conditions. Rigorous inspection, calibration, commissioning, and traceability are all essential components of this objective element.

FMS 5e: Qualified and trained personnel operate and maintain medical equipment. (C)

(Commitment Level - C: Highlights the importance of competent staff for medical equipment management, both for operation and maintenance.)

• Intent: This objective element reinforces the critical role of qualified and trained personnel in both the operation and maintenance of medical equipment. Medical equipment is complex and often carries significant patient safety risks if used or maintained improperly. Competent staff are essential for safe and effective equipment management.

• Key Components:

  • Qualified and trained personnel: Staff who possess the necessary qualifications, knowledge, skills, experience, and training to safely and effectively operate and maintain medical equipment. Competence for medical equipment management requires both clinical/operational skills and technical/maintenance skills, depending on the role.

  • Operate and maintain medical equipment: This objective element addresses both:

    • Operation: Safe and effective clinical use of medical equipment by clinicians, nurses, technicians, and other authorized personnel.

    • Maintenance: Preventive maintenance, corrective maintenance, calibration, repairs, and technical upkeep of medical equipment by biomedical engineers, technicians, and maintenance staff.

• Safe and effective use - Provide training to operator. For example: Nurse should be trained to use blood gas analyser and ECG. (from Slide 43):

  • Safe and Effective Use: Ensuring medical equipment is used safely and effectively for its intended clinical purpose. This requires proper training and competency of equipment operators.

  • Provide training to operator: Hospitals must provide adequate and documented training to all personnel who are authorized to operate medical equipment. Training should be:

    • Equipment-specific: Tailored to the specific types of medical equipment the operator will be using.

    • Comprehensive: Covering all aspects of safe and effective operation, including:

      • Equipment operation procedures (start-up, operation, shutdown).

      • Safety features and precautions.

      • Clinical applications and indications for use.

      • Interpretation of equipment outputs and readings (if applicable).

      • Basic troubleshooting and problem identification.

      • User responsibilities and reporting procedures.

      • Relevant SOPs and equipment manuals.

• • • Competency-based: Training should include competency assessments (practical demonstrations, written tests) to verify that operators have acquired the necessary skills and knowledge.

    • Documented: Maintain records of all training provided to operators, including dates, content, trainers, and competency assessments.

• • Example: Nurse should be trained to use blood gas analyser and ECG:

    • Blood Gas Analyser: Nurses using blood gas analyzers in critical care settings must be thoroughly trained on:

      • Proper sample collection and handling techniques.

      • Equipment operation, calibration, and quality control procedures.

      • Interpretation of blood gas results and their clinical significance.

      • Troubleshooting common issues and alarms.

• • • ECG (Electrocardiograph): Nurses performing ECGs must be trained on:

      • Proper patient preparation and electrode placement.

      • Equipment operation and settings.

      • Recording ECG tracings and ensuring quality.

      • Basic interpretation of ECG rhythms and identification of abnormalities.

      • Safety precautions during ECG recording.

• Maintenance - Is done by a biomedical engineer/technologist/ Instrumentation engineer/technologist with relevant training and experience. (from Slide 43):

  • Maintenance by Qualified Personnel: Maintenance, calibration, repair, and technical upkeep of medical equipment must be performed by qualified and trained personnel, typically biomedical engineers, biomedical equipment technicians (BMETs), or instrumentation engineers/technologists.

  • Competency for Maintenance Personnel: Maintenance personnel should possess:

    • Relevant Qualifications: Formal education in biomedical engineering, electronics engineering, instrumentation engineering, or related technical fields. Certifications (e.g., CBET - Certified Biomedical Equipment Technician) are also valuable.

    • Training on Medical Equipment Maintenance: Specific training on the maintenance, calibration, troubleshooting, and repair of different types of medical equipment. This may include OEM training, specialized technical courses, and continuing education.

    • Experience in Medical Equipment Maintenance: Practical experience in maintaining medical equipment in a hospital or healthcare setting. Experience builds skills and familiarity with common equipment issues and maintenance procedures.

    • Knowledge of Standards and Regulations: Familiarity with relevant medical device standards (IEC 60601, ISO 13485), safety regulations, and hospital policies related to medical equipment maintenance.

• • Role of Biomedical Engineers/Technologists/Instrumentation Engineers/Technologists: These professionals are specifically trained to:

    • Perform preventive maintenance and corrective maintenance on medical equipment.

    • Calibrate medical devices to ensure measurement accuracy.

    • Troubleshoot and repair malfunctioning equipment.

    • Manage medical equipment inventory and maintenance records.

    • Ensure equipment safety and regulatory compliance.

    • Provide technical support and training to clinical staff on equipment use.

• Note: FMS 5e is about investing in human capital for medical equipment management. Having qualified and well-trained personnel for both equipment operation and maintenance is paramount for ensuring patient safety, maximizing equipment effectiveness, and maintaining a high standard of healthcare service. It's a critical investment in the hospital's infrastructure and clinical capabilities.

FMS 5f: Written guidance supports medical equipment replacement and disposal. * (C)

(Commitment Level - C: Asterisk indicates mandatory documentation. Written guidance for medical equipment replacement and disposal is required.)*

• Intent: This objective element is very similar to FMS 4h but specifically focuses on medical equipment lifecycle management, emphasizing planned and systematic replacement and disposal of medical devices. It requires documented guidance to ensure that these decisions are strategic, justified, and aligned with the hospital's needs and resources.

• Key Components:

  • Written guidance supports medical equipment replacement: The hospital must have documented guidelines or procedures for making decisions about medical equipment replacement. Replacement should be a strategic and planned process, not just reactive to equipment failures.

  • And disposal: Written guidance should also cover the proper and responsible disposal of medical equipment that is no longer usable or has reached the end of its lifecycle.

  • Guidance supports: The written guidance provides a framework and criteria to support decision-making, allowing for flexibility based on specific equipment and hospital circumstances.

• Replace/dispose (condemn): Based on strategic plans, upgrade/update path and equipment log. (from Slide 44):

  • Criteria for Medical Equipment Replacement/Disposal - Guiding Factors: Decisions to replace or dispose of medical equipment should be guided by a combination of factors, as outlined in the written guidance:

    • Strategic plans: Alignment with the hospital's strategic plan, service expansion plans, and adoption of new technologies. If existing equipment no longer supports strategic goals or if newer technology offers significant clinical advantages, replacement should be considered.

    • Upgrade/update path: Assess the availability and feasibility of equipment upgrades or software updates that can extend equipment lifespan, improve performance, or enhance functionality. If upgrades are not viable or cost-effective, replacement is a better option.

    • Equipment log (maintenance history, performance data, downtime): Review equipment logs (as per FMS 5b and 5h) to evaluate equipment condition, maintenance history, breakdown frequency, downtime, repair costs, and performance trends. Medical equipment with frequent breakdowns, high repair costs, declining performance, or exceeding its useful lifespan should be prime candidates for replacement.

    • Other Factors specific to Medical Equipment:

      • Clinical effectiveness and safety: If equipment is no longer clinically effective, poses safety risks, or is outdated compared to current medical standards, replacement is essential.

      • Technological obsolescence: Medical technology advances rapidly. Equipment that is technologically obsolete and limits the hospital's ability to provide state-of-the-art care should be considered for replacement.

      • Regulatory compliance: If equipment no longer meets current medical device regulations or safety standards, replacement is mandatory.

      • Patient safety concerns: Equipment with recurring safety issues or potential for patient harm should be prioritized for replacement.

      • Availability of spare parts and maintenance support: If spare parts are becoming difficult to obtain or vendor support is diminishing, replacement may be necessary.

      • Life cycle cost analysis: Compare the cost of continued maintenance and repair versus the cost of replacement, considering long-term operational expenses, clinical benefits, and potential risks of using outdated equipment.